(A complex combination of hydrocarbons obtained from the fractionation stabilisation of thermal cracked hydrocarbons from a petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane and propane.)

(A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.)

2.  Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances, suppliers shall ensure before the placing on the market that the packaging of aerosol dispensers referred to above is marked visibly, legibly and indelibly with:

(Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatised compounds and mineral substances.)

Where a chemical safety report is required and where a waste stage analysis has been performed, the information on the waste management measures shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.

[A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40 °C (104 °F).]

5.2.4. An estimation of the exposure levels shall be performed for all human populations (workers, consumers and humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the substance is known or reasonably foreseeable. Each relevant route of human exposure (inhalation, oral, dermal and combined through all relevant routes and sources of exposure) shall be addressed. Such estimations shall take account of spatial and temporal variations in the exposure pattern. In particular, the exposure estimation shall take account of:

(A complex combination of hydrocarbons produced by distillation of products from the cracking of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C4, predominantly of propane and propylene, and boiling in the range of approximately - 51 °C to - 1 °C.)

an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;

[A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 190 °C (– 4 °F to 374 °F).]

( 7 )  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.

the final budget of the Agency pursuant to Article 96 before the beginning of the financial year, adjusting it, where necessary, according to the Community contribution and any other revenue of the Agency;

►M70   9.4.  Long-term toxicity testing shall be proposed by the registrant or may be required by the Agency if the results of the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects of the substance or of transformation and degradation products on terrestrial organisms. The choice of the appropriate test(s) shall be made on the basis of the outcome of the chemical safety assessment. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.  ◄

Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distillation residue, vacuum distillation lights; Base oil — unspecified

Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:

2.1. The objective of the hazard assessment for physicochemical properties shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008.

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected).

For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).

Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of thermal cracked hydrocarbons from a petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2,2 10-6 m2.s-1 at 40 °C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200 °C to 300 °C.)

7.14bis.  The study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.

[A complex combination of hydrocarbons obtained from distillation of products from a catalytic reforming process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 35 °C to 120 °C (95 °F to 248 °F). It contains a relatively large proportion of branched chain hydrocarbons with the aromatic components removed.]

— the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made, or

If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly.

(A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94 °C to 99 °C.)

[The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.]

1.3.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrants shall indicate and justify the action or decision he has taken as a result.

7.  Member States may allow wood treated with other types of CCA solutions that was in use in the Community before 30 September 2007:

If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B, or T properties in accordance with Section 3.1 of this Annex. If the result from the screening tests or other information indicate that the substance may have PBT or vPvB properties, the registrant shall generate relevant additional information as set out in Section 3.2 of this Annex. In case the generation of relevant additional information would require information listed in Annexes IX or X, the registrant shall submit a testing proposal. Where the process and use conditions of the substance meet the conditions as specified in Section 3.2(b) or (c) of Annex XI the additional information may be omitted, and subsequently the substance is considered as if it is a PBT or vPvB in the registration dossier. No additional information needs to be generated for the assessment of PBT/vPvB properties if there is no indication of P or B properties following the result from the screening test or other information.

( 43 ) The IMO has developed various legal instruments related to dangerous and polluting goods differentiating between how the goods are carried (packaged and bulk) and by type of cargo (solid, liquid and liquefied gases). Rules on the carriage of dangerous cargoes and the ships that carry these cargoes are found in the International Convention for the Safety of Life at Sea (SOLAS, 1974), as amended, and the International Convention on Maritime Pollution (MARPOL 73/78), as amended. These conventions are supplemented by the following codes: IMDG, IMSBC, IBC and IGC.

[A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 to C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 150 °C to 220 °C (302 °F to 428 °F).]

— the substance is known to cause germ cell mutagenicity, meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B, and appropriate risk management measures are implemented,

(A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150 to 300 °C or a semi-solid or solid with a melting point up to 70 °C. It is composed primarily of naphthalene and alkyl naphthalenes.)

(A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately - 12 °C to 5 °C.)

[A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60 °C to 80 °C (140 °F to 176 °F).]

For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provided that the downstream user makes his request at least 12 months before the deadline in question.

(A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately - 20 °C to 190 °C.)

(A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 60 °C to 200 °C.)

— the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or

the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or

(A complex combination of hydrocarbons obtained by the treatment of a residual oil with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400 °C.)

Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:

Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OL L 60, 2.3.2013, p. 1).

(A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydro-carbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 90 °C to 160 °C.)

[A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80 °C to 218 °C (176 °F to 424 °F).]

(A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400 °C.)

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address all nanoforms that are covered by the registration.

In all cases, the information provided shall be adequate for the purpose of classification, labelling and/or risk assessment, and adequate and reliable documentation shall be provided, including:

2.  Shall not be manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0,3 % after 9 May 2020 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

[A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C (275 °F to 410 °F).]

(A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C.)

►M70   9.1.  Long-term toxicity testing other than the tests referred to in points 9.1.5 and 9.1.6 shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects of the substance on aquatic organisms. The choice of the test(s) shall be made on the basis of the results of the chemical safety assessment.  ◄

5.  Paragraph 1(b) shall not apply to disposable textiles. ‘Disposable textiles’ means textiles that are designed to be used only once or for a limited time and are not intended for subsequent use for the same or a similar purpose.

(The distillation fraction boiling in the range of approximately 181 to 186 °C from the crude bases obtained from the neutralised, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.)

( 6 )  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

The product identifier shall be provided in accordance with Article 18(2) of Regulation (EC) No 1272/2008 in the case of a substance and in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008 in the case of a mixture, and as provided on the label in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

(A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallisation of anthracene oil from bituminous high temperature tar and boiling in the range of 330 to 350 °C. It contains chiefly anthracene, carbazole and phenanthrene.)

As regards pure gas, the C i (coefficient of oxygen equivalency) as per ISO 10156 ‘Gases and gas mixtures – Determination of fire potential and oxidizing ability for the selection of cylinder valve outlets’, or as per an equivalent method, may be provided;

In the case of a mixture, where information does not apply to the mixture as a whole, the entries shall clearly indicate to which substance in the mixture the data apply.

The provisions of Title IV shall not apply to the following ►M3  mixtures ◄ in the finished state, intended for the final user:

In addition to the indication of the SADT as specified in point (j) of subsection 9.1, the following information may be provided:

On the basis of these reviews, the Commission may, if appropriate, present legislative proposals to extend this obligation.

The Executive Director or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Committees and working groups convened by the Agency or its committees as observers. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of the Committee members, or the Management Board.

If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration.

8.  Mixtures that do not contain the statement ‘Mixture for use in tattoos or permanent make-up’ shall not be used for tattooing purposes.

(A complex combination of hydrocarbons produced by the distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists predominantly of propylene with some ethane and propane.)

(A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35 °C to 230 °C.)

— any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings,

manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;

(A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.)

(A complex combination produced from the first tower used in the distillation of crude oil. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations.

identified use: means a use of a substance on its own or in a ►M3  mixture ◄ , or a use of a ►M3  mixture ◄ , that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user;

An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.

(g)  safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC) No 1272/2008.

(A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed. It consists of hydrocarbons having carbon numbers in the range of C1 through C5 and hydrogen.)

— adequate data from the corresponding in vivo study, (namely in vivo chromosomal aberration (or micronucleus) study regarding point 8.4.2 or in vivo mammalian gene mutation study regarding point 8.4.3), are available,

2.  Neoprene-based contact adhesives containing cyclohexane and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010.

(The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220 to 230 °C. It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.)

the use(s) of that substance on its own or in a ►M3  mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or

— Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (*5), and

supplier of a substance or a ►M3  mixture ◄ : means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a ►M3  mixture ◄ , or a ►M3  mixture ◄ ;

(A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2 10-6 m2.s-1 at 100 °C.)

[The residue from the fractional distillation of wash oil boiling in the approximate range of 270 °C to 330 °C (518 °F to 626 °F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.]

in an individual concentration of ≥ 0,1  % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in ►M3  mixtures ◄ and/or the incorporation of the substance in articles, where this is relevant;

2.3. The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 9.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

[A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85 °C to 195 °C (185 °F to 383 °F).]

If the mixture does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008, this shall be clearly stated.

1.  Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

In addition to the properties mentioned in subsection 9.1, other physical and chemical parameters shall be indicated, such as the properties listed in subsections 9.2.1 and 9.2.2, if their indication is relevant for the safe use of the substance or mixture.

3.0.4. The hazard assessment shall comprise the following three steps, which shall be clearly identified as such in the Chemical Safety Report:

It shall forward annually any information relevant to the outcome of the evaluation procedures in accordance with Article 96(6).

( 3 )  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

[The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.]

(A complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.)

The labelling of articles containing asbestos shall be in the official language or languages of the Member State(s) where the article is placed on the market.

(A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

Duty to communicate information down the supply chain for substances on their own or in ►M3  mixtures ◄ for which a safety data sheet is not required

[A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6.]

[A complex combination of hydrocarbons obtained by the treatment and distillation of debenzenized light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 95 °C to 200 °C (203 °F to 392 °F).]

For nanoforms, whether of inorganic or organic substances, for which the partition coefficient n-octanol/water is not applicable the study of dispersion stability shall be considered instead.

Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum; Petroleum gas

In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of one tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency:

(A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230 °C to 400 °C.)

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of between 13-15 10-6 m2.s-1 at 40 °C.)

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:

the wearing of suitable protective equipment (including personal protective equipment referred to under section 8 of the safety data sheet) to prevent any contamination of skin, eyes and personal clothing;

— a substance is known to have an adverse effect on sexual function or fertility, meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment,

[The oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.]

[A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200 °C to 325 °C (392 °F to 617 °F).]

— for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude self-heating of the substance up to 400 °C.

(A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.)

(A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9,5 10-6 m2.s-1 at 40 °C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240 °C to 400 °C.)

In cases where one safety data sheet is used to cover variants of a liquid mixture or liquefied gas mixture, a range for the vapour pressure shall be indicated.

a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI ( 62 ).

The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in ►M3  mixtures ◄ or in articles, with a view to coordinating Member States in these activities.

This subsection lists properties, safety characteristics and test results, which may be useful to include in the safety data sheet when a substance or mixture is classified in the respective physical hazard class. Data deemed relevant with regard to a specific physical hazard but not resulting in classification (e.g. negative test results close to the criterion), may also be appropriate to indicate.

(A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiling range of 225 to 255 °C. Composed primarily of substituted dinuclear aromatic hydrocarbons.)

0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall be explained and justified in the chemical safety report.

The Executive Director shall be appointed on the grounds of merit and documented administrative and management skills, as well as his relevant experience in the fields of chemical safety or regulation. The Management Board shall take its decision by a two-thirds majority of all members with a right to vote.

For each substance, the information given in this section shall be sufficient to enable each substance to be identified and the different nanoforms to be characterised. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.

the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5;

A Member State whose rapporteur has not forwarded by 1 June 2008 the risk evaluation and, where appropriate, the strategy for limiting the risks, in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall:

The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

The safety data sheet shall indicate whether the absolute density (units e.g. g/cm3 or kg/m3 ) and/or the relative density (dimensionless) is being reported.

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 220 to 450 °C. This stream is likely to contain organic sulfur compounds.)

2.  Shall not be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 February 2022, unless:

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000  mg/kg body weight).

— appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liable to result in adverse effects after prolonged exposure.

It shall be indicated whether the substance or mixture is environmentally hazardous according to the criteria of the UN Model Regulations (as reflected in ADR, RID and ADN), and whether it is a marine pollutant according to the IMDG Code and the Emergency Response Procedures for Ships Carrying Dangerous Goods. If the substance or mixture is authorised or intended for carriage by inland waterways in tank-vessels, it shall be indicated whether the substance or mixture is environmentally hazardous in tank-vessels only according to ADN.

(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)

new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;

(A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

2.  Shall not be placed on the market in road vehicles after 6 August 2027 if, under the test conditions specified in Appendix 14, the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m3.

[A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35 °C to 210 °C (95 °F to 410 °F).]

a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

(The volatile organic liquid condensed from the gas evolved in the low temperature (less than 700 °C) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.)

The report referred to in Article 117(1) shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken pursuant to Articles 125 and 126 during the previous reporting period. The common issues to be covered in the reports shall be agreed by the Forum. The Commission shall make these reports available to the Agency and the Forum.

(A complex combination obtained from recycled hydrotreated blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons produced by distillation of crude oil. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately - 20 °C to 180 °C.)

For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:

►M70   8.4.1.  The in vitro gene mutation study in bacteria does not need to be conducted for nanoforms where it is not appropriate. In such case, an in vitro study referred to in Annex VIII, point 8.4.3, shall be provided.  ◄

— based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient), or

3.1. The following particulars shall appear on clearly legible and indelible labelling on the packaging of packaged articles containing asbestos:

(A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31 °C to 40 °C.)

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

The provision of services for which there are several potential providers may require a call for an expression of interest:

When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, the assessment shall cover the hazard, PBT and vPvB assessment of nanoforms(s) as used.

(e)  in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009 (*22), the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;

(A complex combination of hydrocarbons obtained by the distillation of crude petroleum. It consists predominantly of aliphatic, aromatic and cycloaliphatic hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400 °C.)

The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year and the multiannual work programme to the Member States, the European Parliament, the Council and the Commission, and shall have them published.

(**)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

( 66 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

The following total percentage (by mass) of flammable components may be provided, unless the aerosol is classified as Aerosol category 1 because it contains more than 1 % (by mass) flammable components or has a heat of combustion of at least 20 kJ/g and is not submitted to the flammability classification procedures (see the Note in Paragraph 2.3.2.2 of Annex I to Regulation (EC) No 1272/2008);

[A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10 and boiling in the range of approximately 80 °C to 180 °C (175 °F to 356 °F).]

(A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35 °C to 210 °C.)

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 20 °C to 100 °C.)

(The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350 to 400 °C. Consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.)

draw attention to operations and conditions which create new risks by altering the properties of the substance or mixture, and to appropriate countermeasures; and

REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  of 16 December 2008

1.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint. 2.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide to prevent the fouling by micro-organisms, plants or animals of: (a)  all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes; (b)  cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c)  any totally or partly submerged appliance or equipment. 3.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters. ►M6   4.  Tri-substituted organostannic compounds: (a)  Tri-substituted organostannic compounds such as tributyltin (TBT) compounds and triphenyltin (TPT) compounds shall not be used after 1 July 2010 in articles where the concentration in the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin. (b)  Articles not complying with point (a) shall not be placed on the market after 1 July 2010, except for articles that were already in use in the Community before that date. 5.  Dibutyltin (DBT) compounds: (a)  Dibutyltin (DBT) compounds shall not be used after 1 January 2012 in mixtures and articles for supply to the general public where the concentration in the mixture or the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin. (b)  Articles and mixtures not complying with point (a) shall not be placed on the market after 1 January 2012, except for articles that were already in use in the Community before that date. (c)  By way of derogation, points (a) and (b) shall not apply until 1 January 2015 to the following articles and mixtures for supply to the general public: — one-component and two-component room temperature vulcanisation sealants (RTV-1 and RTV-2 sealants) and adhesives, — paints and coatings containing DBT compounds as catalysts when applied on articles, — soft polyvinyl chloride (PVC) profiles whether by themselves or coextruded with hard PVC, — fabrics coated with PVC containing DBT compounds as stabilisers when intended for outdoor applications, — outdoor rainwater pipes, gutters and fittings, as well as covering material for roofing and façades, (d)  By way of derogation, points (a) and (b) shall not apply to materials and articles regulated under Regulation (EC) No 1935/2004. 6.  Dioctyltin (DOT) compound: (a)  Dioctyltin (DOT) compounds shall not be used after 1 January 2012 in the following articles for supply to, or use by, the general public, where the concentration in the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin: — textile articles intended to come into contact with the skin, — gloves, — footwear or part of footwear intended to come into contact with the skin, — wall and floor coverings, — childcare articles, — female hygiene products, — nappies, — two-component room temperature vulcanisation moulding kits (RTV-2 moulding kits). (b)  Articles not complying with point (a) shall not be placed on the market after 1 January 2012, except for articles that were already in use in the Community before that date.  ◄

[A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20 °C to 190 °C (– 4 °F to 374 °F).]

(A complex combination of hydrocarbons obtained by the stabilisation of light straight-run naphtha. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

2.  Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

( 4 )  OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

where information on interactions between substances in a mixture is not available, assumptions shall not be made and instead the health effects of each substance shall be listed separately.

0.6.1. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps 1 to 4 in accordance with the respective sections of this Annex:

Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulphuriser overhead fractionation; Refinery gas

(The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40 to 180 °C. Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.)

Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12 fraction; Low boiling point naphtha — unspecified

8.7.2.  Pre-natal developmental toxicity study (OECD TG 414) on one species; the preferred species is the rat or the rabbit. The route of administration shall be oral if the substance is a solid or liquid, and inhalation if the substance is a gas; deviations may be made if scientifically justified, for example through evidence of equivalent or higher systemic exposure via another relevant route of human exposure or route-specific toxicity.

3.  Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material in the article.

The data included in this subsection shall apply to the substance or mixture as placed on the market. In the case of a mixture, the data should describe the toxicological properties of the mixture as a whole, except if Article 6(3) of Regulation (EC) No 1272/2008 applies. If available, the relevant toxicological properties of the hazardous substances in a mixture shall also be provided, such as the LD50, acute toxicity estimates or LC50.

(A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3.

(A complex combination of hydrocarbons produced by distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers in the range of C1 through C6, predominantly C1 through C4.)

Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows:

The pH of the substance or mixture as supplied, or where the product is a solid, the pH of an aqueous liquid or solution at a given concentration, shall be indicated.

(A complex combination of hydrocarbons produced by the distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists predominantly of propylene with some ethane and propane.)

This section of the safety data sheet shall provide information to enable evaluation of the environmental impact of the substance or mixture where it is released to the environment. Subsections 12.1 to 12.7 of the safety data sheet shall provide a short summary of the data including, where available, relevant test data and clearly indicating species, media, units, test duration and test conditions. This information may assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measures and transport. If it is stated that a particular property does not apply (because the available data shows that the substance or mixture does not meet the criteria for classification) or if information on a particular property is not available, the reasons shall be indicated. Additionally, if a substance or mixture is not classified for other reasons (for example, due to the technical impossibility of obtaining the data or to inconclusive data) this should be clearly stated on the safety data sheet.

3.  Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that neoprene-based contact adhesives containing cyclohexane in concentrations equal to or greater than 0,1 % by weight that are placed on the market for supply to the general public after 27 December 2010 are visibly, legibly and indelibly marked as follows:

1.  Shall not be placed on the market after 27 December 2010, as a constituent of mixtures in concentrations equal to or greater than 0,1 % by weight of MDI for supply to the general public, unless suppliers shall ensure before the placing on the market that the packaging:

(A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370 °C to 550 °C.)

0.4. Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or ‘category’ of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or ‘category’ of substances. The manufacturer or importer shall provide a justification for this. Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and risk management measures.

(A complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with natural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.)

[A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66 °C to 121 °C (151 °F to 250 °F).]

The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance.

(An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.)

1.3.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Where applicable, Specific Concentration limits resulting from the application of Article 10 of Regulation (EC) No 1272/2008 and Articles 4 to 7 of Directive 1999/45/EC shall be presented and, if they are not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.

Shall not be placed on the market in thermal paper in a concentration equal to or greater than 0,02 % by weight after 2 January 2020.

(A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200 to 230 °C. It contains chiefly phenols and pyridine bases.)

— if the substance is a solid which possesses explosive or pyrophoric properties. These properties should always be considered before considering flammability, or

In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification.

Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, may be considered as a group, or category, of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.

the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;

This section of the safety data sheet shall describe the requirements for fighting a fire caused by the substance or mixture, or arising in its vicinity.

4.1.1. First aid instructions shall be provided by relevant routes of exposure. Subdivisions shall be used to indicate the procedure for each route, such as inhalation, skin, eye and ingestion.

— effects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study.

[The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200 °C to 230 °C (392 °F to 446 °F). Composed primarily of m- and p-ethylphenol as well as cresols and xylenols.]

The Management Board shall adopt rules of procedure for voting, including the conditions for a member to vote on behalf of another member. The Management Board shall act by a two-thirds majority of all members with the right to vote.

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C5.)

(A complex combination of hydrocarbons obtained as first runnings from the depentaniser column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6, predominantly pentanes and pentenes, and boiling in the range of approximately 25 °C to 40 °C.)

substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.

If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result, unless testing is not required in accordance with Annexes VII to X or the other rules in this Annex.

1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance and the following groups of effects:

Where a test method offers flexibility in the study design, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physicochemical properties or biological effects of the test substance, justification shall be provided.

0.8. The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios may describe the appropriate risk management measures for several individual processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further mention of Exposure Scenario in this Annex and Annex II includes Exposure Categories if they are developed.

[A complex combination of hydrocarbons resulting from treatment of full-range straight-run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 220 °C (– 4 °F to 429 °F).]

In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality.

( 11 )  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

[A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200 °C to 250 °C (392 °F to 482 °F).]

a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction received by the Agency and opined upon, the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; complaints received and the action taken; an overview of the activities of the Forum;

For nanoforms without high dissolution rate in biological media, the study shall include toxicokinetic investigations on, among others, the recovery period and, where relevant, lung clearance. Toxicokinetic investigations do not need to be performed if equivalent toxicokinetic information on the nanoform is already available.

[A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60 °C to 70 °C (140 °F to 158 °F).]

— for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit, or

(A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 to 200 °C.)

(A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;

(b)  Wood treated with CCA solution in accordance with point (a) may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:

(A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

[A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.]

( 41 ) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

(A complex combination of hydrocarbons that is used as the feed into the Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

(A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10, and boiling in the range of approximately 80 °C to 180 °C.)

examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question.

(A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60 °C to 70 °C.)

Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atmospheric distillation residue, distillation lights; Base oil — unspecified

(A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.)

(A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150 to 400 °C.)

Where a mixture has a unique formula identifier (UFI) in accordance with section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 and that UFI is indicated in the safety data sheet, then the UFI shall be provided in this subsection.

[A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 220 °C (90 °F to 430 °F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.]

8.6.1.  Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

(A complex combination of hydrocarbons obtained from stabilisation of catalytic reformed naphtha. It consists of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

1 000 mg/kg (individually or in combination with other phthalates in this entry or in other entries of Annex XVII that are classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B

— there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or

(c)  motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles;

— no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).

[The distillate from high temperature coal tar having an approximate distillation range of 130 °C to 250 °C (266 °F to 410 °F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.]

(A complex combination of hydrocarbons obtained from the distillation of the butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

(A complex combination of hydrocarbons obtained by recycling the gases of the benzene unit. It consists primarily of hydrogen with various small amounts of carbon monoxide and hydrocarbons having carbon numbers in the range of C1 through C6.)

(The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.)

4. Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when:

substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;

Information from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:

a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances;

(A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C4 through C10, and boiling in the range of approximately –20 °C to 180 °C.)

(A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C.)

9.1.5.  Long-term toxicity testing on invertebrates (preferred species Daphnia), (unless already provided as part of Annex VII requirements)

Where a test method offers flexibility in the study design, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physicochemical properties or biological effects of the test substance, justification shall be provided.

Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)

8.8.1.  Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information.

Benzidine based azo dyes; 4,4'-diarylazobiphenyl dyes, with the exception of those specified elsewhere in ►M5  Annex VI to Regulation (EC) No 1272/2008 ◄

(The aqueous extract produced by an acidic wash of alkali-washed naphthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.)

(A complex combination of hydrocarbon produced by the distillation of products from a hydrocracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4. It may also contain small amounts of hydrogen and hydrogen sulfide.)

(The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.)

(A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of from approximately 205 °C to 400 °C.)

Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 3 ), Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control ( 4 ); Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( 5 ) and Directive 2004/37/EC;

( 64 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

0.2.5. The date of compilation of the safety data sheet shall be given on the first page. When a safety data sheet has been revised and the new, revised version is provided to recipients, the changes shall be brought to the attention of the recipients in Section 16 of the safety data sheet, unless the changes have been indicated elsewhere. For the revised safety data sheets, the date of compilation, identified as ‘Revision: (date)’, shall appear on the first page, as well as one or more indications of which version is replaced, such as version number, revision number, or supersedes date.

(Fraction of the distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 to 180 °C. Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.)

[A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 °C to 340 °C (320 °F to 644 °F).]

5.1.2. Where a manufacturer, importer or downstream user applies for an application for an authorisation for a specific use, exposure scenarios need only be developed for that use and the subsequent life-cycle steps.

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulphide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.)

[The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.]

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.

(A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.)

The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Regulation (EC, Euratom) No 2343/2002 unless specifically necessary for the Agency's operation and with the Commission's prior consent.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report.

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).

(A complex combination obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulphide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

3.2.2. For a mixture not meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, substances present in an individual concentration equal to or greater than the following concentrations shall be indicated, together with their concentration or concentration range:

(The complex combination of dry gases from a gas concentration unit. It consists of hydrogen, hydrogen sulphide and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

(a)  motor fuels which are covered by Directive 98/70/EC; (b)  substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation; ►M33   (c)  natural gas placed on the market for use by consumers, provided that the concentration of benzene remains below 0,1 % volume/volume.  ◄

(The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydro-carbons, phenolic compounds, nitrogen bases and thiophene.)

5.2.3. A characterisation of possible degradation, transformation, or reaction processes, and an estimation of environmental distribution and fate shall be performed.

(A complex combination of liquid hydrocarbons obtained by recrystallisation of dewaxed hydrocracked solvent-refined petroleum distillates.)

(A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40 °C to 80 °C.)

— packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption,

►M70  An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be proposed by the registrant or may be required by the Agency in case of particular concerns on (developmental) neurotoxicity or (developmental) immunotoxicity justified by any of the following: ◄

(The distillate from a mixture of coal and tar and aromatic petroleum streams having an approximate distillation range of 220 to 450 °C. Composed primarily of three- to four-membered condensed ring aromatic hydrocarbons.)

[A complex combination of hydrocarbons produced by the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C15 and boiling in the range of approximately 43 °C to 250 °C (110 °F-500 °F).]

(A complex combination obtained by the liquid-vapour separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

6.3.3. Any other information shall be provided relating to spills and releases, including advice on inappropriate containment or clean-up techniques, such as by indications like ‘never use …’.

( 18 ) Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).

On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet if he is required to prepare one, as appropriate.

8.4.  Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.

This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.

(A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

If the substance is not registered, but the safety data sheet covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics shall be indicated.

For gases, vapours, mist or dust, the type of protective equipment to be used shall be specified based on the hazard and potential for exposure, including air-purifying respirators, specifying the proper purifying element (cartridge or canister), the adequate particulate filters and the adequate masks, or self-contained breathing apparatus.

Where there is a substantial amount of test data on the substance or mixture, it may be necessary to summarise results of the critical studies used, for example, by route of exposure.

In cases where one safety data sheet is used to cover variants of a mixture which may have different colours, the term ‘various’ can be used to describe the colour.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C50 and boiling in the range of approximately 230 to 600 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(The oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.)

(A complex combination of olefinic and paraffinic hydrocarbons having carbon numbers in the range of C3 through C5 which are used as alkylation feed. Ambient temperatures normally exceed the critical temperature of these combinations.)

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or

Information shall be provided on whether the substance meets the criteria for persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with Annex XIII, whether the substance was included in the list established in accordance with Article 59(1) for having endocrine disrupting properties, and whether the substance is a substance identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 ( 35 ) or Commission Regulation (EU) 2018/605 ( 36 ). For a mixture, information shall be provided for each such substance that is present in the mixture at a concentration equal to or greater than 0,1 % by weight.

8. Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to ►M3  Regulation (EC) No 1272/2008 ◄ or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

— for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19,

— the substance is incapable of reacting exothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms).

substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

0.2. The chemical safety assessment shall be prepared by one or more competent person(s) who have appropriate experience and received appropriate training, including refresher training.

( 42 ) Compliance with the IMDG Code is mandatory for the carriage of packaged dangerous goods by sea as provided for in Chapter VII/Reg. 3 of SOLAS and MARPOL Annex III Prevention of Pollution by Harmful Substances Carried by Sea in Packaged Form.

(The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80 °C. Composed primarily of polyalkyphenols, resin gums, and inorganic salts.)

(The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.)

(A complex combination produced from the first tower used in the distillation of crude oil. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

This section of the safety data sheet shall provide information for proper waste management of the substance or mixture and/or its container to assist in the determination of safe and environmentally preferred waste management options, consistent with the requirements of Directive 2008/98/EC of the European Parliament and of the Council ( 40 ) by the Member State in which the safety data sheet is being supplied. Information relevant for the safety of persons conducting waste management activities shall complement the information given in section 8.

(A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 190 °C. This stream is likely to contain 10 % vol. or more benzene.)

[A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.]

the duration of the test shall be sufficiently long to allow the determination of the steady state concentration and shall not exceed 28 days;

(A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

if labelling takes the form of direct printing on the articles, a single colour contrasting with the background colour is sufficient.

1.  Cement and cement-containing mixtures shall not be placed on the market, or used, if they contain, when hydrated, more than 2 mg/kg (0,0002 %) soluble chromium VI of the total dry weight of the cement. 2.  If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of cement or cement-containing mixtures is visibly, legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below the limit indicated in paragraph 1. 3.  By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing mixtures are handled solely by machines and in which there is no possibility of contact with the skin. ►M21   4.  The standard adopted by the European Committee for Standardization (CEN) for testing the water-soluble chromium (VI) content of cement and cement-containing mixtures shall be used as the test method for demonstrating conformity with paragraph 1.  ◄ ►M25   5.  Leather articles coming into contact with the skin shall not be placed on the market where they contain chromium VI in concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of the total dry weight of the leather. 6.  Articles containing leather parts coming into contact with the skin shall not be placed on the market where any of those leather parts contains chromium VI in concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of the total dry weight of that leather part. 7.  Paragraphs 5 and 6 shall not apply to the placing on the market of second-hand articles which were in end-use in the Union before 1 May 2015.  ◄

[Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100 °C to 200 °C (212 °F to 392 °F).]

Information on any consultation of stakeholders and how their views have been taken into account shall be included in the dossier.

(Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240 to 260 °C. Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.)

by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X;

[The product obtained by treatment of coal tar oil alkaline extract with CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and other organic and inorganic impurities.]

( 10 )  OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/253/EC (OJ L 91, 29.3.2006, p. 48).

Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:

6.5. For those human effects and those environmental spheres for which it was not possible to determine a DNEL or a PNEC, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario shall be carried out.

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205 °C to 400 °C.)

(A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205 °C to 400 °C.)

Member States may exclude from the provision of the first subparagraph articles intended to be placed on the market in their territory. The labelling of these articles must however bear the wording ‘contains asbestos’;

(i)  the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;

7.  The supplier referred to in point (b) of paragraph 2 shall ensure that the recipient is provided with training material and courses pursuant to paragraphs 4 and 5 in the official language(s) of the Member State(s) where the substance(s) or mixture(s) are supplied. The training shall take into consideration the specificity of the products supplied, including composition, packaging, and design.

[The distillation fraction boiling in the range of approximately 181 °C to 186 °C (356 °F to 367 °F) from the crude bases obtained from the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.]

2.  Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73 °C to 85 °C.)

However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant for authorisation, or, in the case of a proposed restriction, the interested party. The information provided can address the socio-economic impacts at any level.

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).

the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;

[4-[4,4′-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no. 202-027-5)

As regards pure flammable gas, the following information may be provided in addition to data on the explosion limits referred to in point (g) of subsection 9.1:

(A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(A complex combination of hydrocarbons from the distillation of saturated and unsaturated aliphatic hydrocarbons usually ranging in the carbon numbers C3 through C6. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C6, predominantly piperylenes.)

[A complex combination of hydrocarbons obtained as first runnings from the depentanizer column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6, predominantly pentanes and pentenes, and boiling in the range of approximately 25 °C to 40 °C (77 °F to 104 °F).]

If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient.

Without prejudice to Community provisions on safety and hygiene at work, the label affixed to the article which may, in the context of its use, be processed or finished, shall be accompanied by any safety instructions which may be appropriate for the article concerned, and in particular by the following:

(A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 288 °C to 371 °C.)

[A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.]

(A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed and recycled to conserve hydrogen. It consists primarily of hydrogen. It may also contain various small amounts of carbon monoxide, carbon dioxide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

1. Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight.

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic fractionation process. It contains predominantly ethane, ethylene, propane, and propylene.)

(The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.)

(The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700 °C) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.)

8.1.4. Where a chemical safety report is required or where a DNEL as referred to in Section 1.4 of Annex I or a PNEC as referred to in Section 3.3 of Annex I is available, the relevant DNELs and PNECs for the substance shall be given for the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.

5.  Without prejudice to other Community provisions concerning the classification, labelling and packaging of substances and mixtures, by 6 December 2011 paint strippers containing dichloromethane in a concentration equal to or greater than 0,1 % by weight shall be visibly, legibly and indelibly marked as follows:

Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by a supplier who is a distributor or a downstream user provided that:

(A complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C2 through C8.)

exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and

4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol (with ≥ 0,1 % of Michler’s ketone (EC No 202-027-5) or Michler’s base (EC No 202-959-2))

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

Where a chemical safety report is required, the results of the PBT and vPvB assessment as set out in the chemical safety report shall be given.

Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.

(A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

►M70   8.4.  The studies referred to in points 8.4.2 and 8.4.3 do not need to be conducted in any of the following cases: — adequate data from the corresponding in vivo study, (namely in vivo chromosomal aberration (or micronucleus) study regarding point 8.4.2 or in vivo mammalian gene mutation study regarding point 8.4.3), are available, — the substance is known to cause germ cell mutagenicity, meeting the criteria for classification as germ cell mutagen category 1A or 1B, and appropriate risk management measures are implemented, — the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented. — In case of a positive result in any of the in vitro genotoxicity studies referred to in Annex VII or this Annex, which gives rise to concern, the registrant shall propose, or the Agency may require, an appropriate in vivo study referred to in Annex IX, point 8.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate. — In case an in vitro mutagenicity study referred to in points 8.4.2 or 8.4.3 is not applicable for the substance, the registrant shall provide a justification and shall propose or the Agency may require an appropriate in vivo study referred to in Annex IX, point 8.4.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate.  ◄

(A complex combination of hydrocarbons obtained by dewaxing heavy paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of equal to or greater than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.)

The murine local lymph node assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test shall be provided.

0.3.2. All pages of a safety data sheet, including any annexes, shall be numbered and shall bear either an indication of the length of the safety data sheet (such as ‘page 1 of 3’) or an indication whether there is a page following (such as ‘Continued on next page’ or ‘End of safety data sheet’).

— there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches.

(Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300 °C. Composed primarily of aromatic compounds.)

a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;

the formaldehyde concentration in the air of the test chamber shall be measured at least twice per day throughout the test with a time interval between two consecutive samplings of 3 hours at a minimum; the measurement shall be repeated until sufficient data are available to determine the steady state concentration;

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;

(A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.)

(e)  pipes for non-drinking water if the recovered PVC is used in the middle layer of a multilayer pipe and is entirely covered with a layer of newly produced PVC in compliance with paragraph 1 above.

substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;

►M3   3.  Liquid substances or mixtures ►M3  — ◄ fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a)  hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b)  hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c)  hazard class 4.1; (d)  hazard class 5.1.  ◄

If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.

If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical method shall be performed.

4.  Section 2.3 of Safety Data Sheets shall contain the following information: ‘mixtures of (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and/or any of its mono-, di- or tri-O-(alkyl) derivatives in a concentration equal to or greater than 2 ppb and organic solvents in spray products, are for professional users only and marked “Fatal if inhaled”’.

providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in ►M3  mixtures ◄ or in articles;

The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of international organisations with interests in the field of chemicals regulation to participate as observers in the work of the Agency.

Directives 93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008.

the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

2.  Articles shall not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations greater than 0,1 % by weight.

(The complex combination of hydrocarbons from the distillation of products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.)

(A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 196 °C.)

(A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19 10-6 m2.s-1 at 40 °C.)

1 000 mg/kg (individually or in combination with other phthalates in this entry or in other entries of Annex XVII that are classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B

6.2. The risk characterisation shall consider the human populations (exposed as workers, consumers or indirectly via the environment and if relevant a combination thereof) and the environmental spheres for which exposure to the substance is known or reasonably foreseeable, under the assumption that the risk management measures described in the exposure scenarios in the Section 5 have been implemented. In addition, the overall environmental risk caused by the substance shall be reviewed by integrating the results for the overall releases, emissions and losses from all sources to all environmental compartments.

Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.

the likelihood that workers or the general public or the environment are exposed to the substance under normal or reasonably foreseeable conditions of use is negligible; and

[A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33 °C to 184 °C (91 °F to 363 °F).]

( 20 )  OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).

1.  Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020.

scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;

Shall not be placed on the market after 27 June 2010, for supply to the general public, as a constituent of paints, paint strippers, cleaning agents, self-shining emulsions or floor sealants in concentrations equal to or greater than 0,1 % by weight.

(A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.)

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint. ►M21   However, Member States may, in accordance with the provisions of International Labour Organization (ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors, as well as the placing on the market for such use. Where a Member State makes use of this derogation, it shall inform the Commission thereof.  ◄

The Commission shall prepare a list of the Member States which have made use of the derogation in this paragraph and make it publicly available over the Internet.

[A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148,8 °C to 204,4 °C. (300 °F to 400 °F).]

in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 6 ) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 7 );

0.2.3. The information in the safety data sheet shall be written in a clear and concise manner. The safety data sheet shall be prepared by a competent person who shall take into account the specific needs and knowledge of the user audience, as far as they are known. Suppliers of substances and mixtures shall ensure that such competent persons have received appropriate training, including refresher training.

30.  Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 5 or Appendix 6, respectively. ◄

If no human information is available, this part shall contain the statement: ‘No human information is available’. However, if human information is available, it shall be presented, if possible in the form of a table.

4.  Compliance with the emission limit specified in the first subparagraph of paragraph 1 shall be demonstrated in accordance with Technical Specification CEN/TS 16516, adapted as follows:

[The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]

(A complex combination of hydrocarbons obtained from the distillation of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C16 and boiling in the range of approximately 200 °C to 300 °C.)

8.4.5.  An appropriate in vivo mammalian germ cell genotoxicity study, if there is a positive result in an available in vivo mammalian somatic cell genotoxicity study, which gives rise to concern. The in vivo mammalian germ cell genotoxicity study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.

this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within seven days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within seven days upon request and at the same time inform the enforcement authority thereof.

— Long-term toxicity testing on invertebrates (preferred species Daphnia), (Annex IX, point 9.1.5) shall be proposed by the registrant or may be required by the Agency when it is unlikely that short-term toxicity testing can provide a true measure of the intrinsic aquatic toxicity of the substance, for instance:

(The complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils approximately below 288 °C.)

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol.

(b)  textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing;

In addition to the specific rules set out in column 2 of Annexes VII to X, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. Under dossier evaluation the Agency may assess these adaptations to the standard testing regime.

require the registrant to submit further information directly related to the risk identified. This request shall be accompanied by a written justification;

The specific concentration limit, the M-factor and the acute toxicity estimate for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or determined in accordance with Annex I to that Regulation shall be indicated, if available.

For nanoforms, use of any physicochemical property (e.g. octanol-water partition coefficient) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.

[A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31 °C to 40 °C (88 °F to 104 °F).]

(A complex combination of gases obtained from flash of the effluents after the hydrogenation reaction. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

8.4.6.  A second in vivo mammalian somatic cell genotoxicity study, if there is a positive result in any of the in vitro genotoxicity studies referred to in Annex VII or Annex VIII, which gives rise to both chromosomal aberration concern and gene mutation concern. The second study shall address chromosomal aberration or gene mutation, as appropriate, which has not been addressed by the first in vivo mammalian somatic cell genotoxicity study.

►M62   (a)  4 July 2019 (*1); (b)  by way of derogation from point (a), 22 June 2022 for uses as follows: — for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council (*4), in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), — in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.  ◄

[A complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 195 °C (73 °F to 383 °F).]

if an M-factor has been provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;

phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007;

If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

This point also applies to substances and mixtures referred to in Note 2 of section 2.1.3 of Annex I of Regulation (EC) No 1272/2008, and to other substances and mixtures which show a positive effect if heated under confinement.

(The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70 to 120 °C.)

►M70  For nanoforms without high dissolution rate in biological media a toxicokinetics study shall be proposed by the registrant or may be required by the Agency in case such an assessment cannot be performed on the basis of relevant available information, including from the study conducted in accordance with 8.6.1 ◄

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed).

phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and

[A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.]

8.6.4.  Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:

(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)

[The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.]

3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical safety report shall contain the sentence: ‘This information is not available’. The justification, including reference to any literature research carried out, shall be included in the technical dossier. For any environmental sphere for which information is available, but the manufacturer or importer believes that it is not necessary to conduct the hazard assessment, the manufacturer or importer shall present a justification, with reference to pertinent information, under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under heading 12.

The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a mixture or in an article.

(A complex combination of hydrocarbons obtained from the hydrodesulphurisation of naphtha. It consists of hydrogen, methane, ethane, and propane.)

(A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65 °C to 70 °C.)

(A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 to 340 °C.)

liaising with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organisations, as necessary;

[The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38 °C (100 °F).]

3.  Azodyes, which are contained in Appendix 9, ‘List of azodyes’ shall not be placed on the market, or used, as substances, or in mixtures in concentrations greater than 0,1 % by weight, where the substance or the mixture is intended for colouring textile and leather articles.

[A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C (275 °F to 410 °F).]

[A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20 °C to 135 °C (58 °F to 275 °F).]

(A complex combination of hydrocarbons obtained by recycling the gases of the benzene unit. It consists primarily of hydrogen with various small amounts of carbon monoxide and hydrocarbons having carbon numbers in the range of C1 through C6.)

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII and VIII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.

For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free;

(A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha followed by fractionation of the total effluent. It consists of hydrogen, methane, ethane and propane.)

[A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C (149 °F to 446 °F).]

[A complex combination of hydrocarbons obtained from catalytic isomerization of straight chain paraffinic C4 through C6 hydrocarbons. It consists predominantly of saturated hydrocarbons such as isobutane, isopentane, 2,2-dimethylbutane, 2-methylpentane, and 3-methylpentane.]

(A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30 °C to 250 °C.)

1.  Shall not be manufactured, placed on the market or used as substances or in mixtures after 10 October 2017 if the concentration of mercury in the mixtures is equal to or greater than 0,01 % by weight.

(A complex combination of hydrocarbons obtained by removing straight chain paraffin hydrocarbons as a solid by treatment with an agent such as urea. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps:

— indications of an effect for which the available evidence is inadequate for toxicological evaluation and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or

The above approach shall also apply if there is a gap of available information for one or more nanoforms of the substance included in the jointly submitted registration dossier.

(The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300 to 470 °C. The product may also contain heteroatoms.)

[A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]

[A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 220 °C (194 °F to 428 °F).]

0.6.3. Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:

a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes. For this purpose and without prejudice to column 2 of Sections 8.6 and 8.7 of Annexes IX and X, a DNEL derived from a 28-day repeated dose toxicity study shall not be considered appropriate to omit a 90-day repeated dose toxicity study, and a DNEL derived from a screening test for reproductive/developmental toxicity shall not be considered appropriate to omit a prenatal developmental toxicity study or an extended one-generation reproductive toxicity study.

12.  For the purposes of this entry, C9-C14 PFCA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to C9-C14 PFCAs.

study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;

[A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 °C to 255 °C (455 °F to 491 °F).]

(The extract oil boiling in the range of approximately 220 to 265 °C from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.)

this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and

[The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.]

For nanoforms, in addition the testing of dissolution rate in water as well as in relevant biological and environmental media shall be considered.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

— specific mechanisms/modes of action of the substance with an association to (developmental) neurotoxicity and/or (developmental) immunotoxicity (e.g. cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects), or

(The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200 to 230 °C. Composed primarily of m- and p-ethylphenol as well as cresols and xylenols.)

— the substance is known to be a germ cell mutagen, meeting the criteria for classification in the hazard class germ cell mutagenicity (category 1A or 1B) and appropriate risk management measures are implemented, or

for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:

This information shall be consistent with that in the Safety Data Sheet where such a Safety Data Sheet is required according to Article 31.

— the substance is known to cause germ cell mutagenicity, meeting the criteria for classification as germ cell mutagen category 1A or 1B, and appropriate risk management measures are implemented,

Disodium {5-[(4′-((2,6-hydroxy-3-((2-hydroxy-5-sulphophenyl)azo)phenyl)azo) (1,1′-biphenyl)-4-yl)azo]salicylato(4-)} cuprate(2-); CI Direct Brown 95

8.1.5. Where a control banding approach is used to decide on risk management measures in relation to specific uses, sufficient detail shall be given to enable effective management of the risk. The context and limitations of the specific control banding recommendation shall be made clear.

8.7.2.  Pre-natal developmental toxicity study (OECD TG 414) in a second species, the preferred species is the rat or the rabbit, whichever was not used in the first study under Annex IX. The route of administration shall be oral if the substance is a solid or liquid, and inhalation if the substance is a gas; deviations may be made if scientifically justified, for example through evidence of equivalent or higher systemic exposure via another relevant route of human exposure or route-specific toxicity.

— failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or

(A complex combination of hydrocarbons obtained by treating the extract, obtained from a solvent extraction process, with hydrogen in the presence of a catalyst under conditions primarily to remove sulphur compounds. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 % wt or more of four- to six-membered condensed ring aromatic hydrocarbons.)

[A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.]

(A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of straight run distillates and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

The proper shipping name as provided in column 2, ‘Name and description’, of Table A of Chapter 3.2 Dangerous Goods List of the UN Model Regulations, in ADR, in RID and in Tables A and C of Chapter 3.2 of ADN, supplemented, when applicable, with the technical name in brackets as required, shall be provided, unless it was used as the product identifier in subsection 1.1. If the UN number and the proper shipping name remain unchanged in different transport modes, it is not necessary to repeat this information. As regards maritime transport, in addition to the UN proper shipping name, the technical name for goods to be transported covered by the IMDG Code shall be indicated, where appropriate.

(A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.)

Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recommendations by supplier). This need not be an exhaustive list.

agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.

(A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists of hydrocarbon having carbon numbers predominantly in the range of C1 through C4.)

the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;

(A complex combination of hydrocarbons obtained from lignite carbonisation tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.)

that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

[A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200 °C to 230 °C (392 °F to 446 °F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.]

1.  Shall not be used as substances or in mixtures, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.

4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report. The assessment shall address all nanoforms that are covered by the registration:

[The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]

Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated, such as:

1.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for the treatment of wood. Furthermore, wood so treated shall not be placed on the market.

Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions.

(A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C15 through C50.)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)Text with EEA relevance

(f)  the loading rate, expressed in thickness and density, shall be recorded during the sampling of the cellulose insulation mixtures or articles to be tested.

site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.

where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or

(A complex combination of hydrocarbons obtained from stabilisation of catalytic reformed naphtha. It consists of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

[The volatile organic liquid condensed from the gas evolved in the low-temperature (less than 700 °C (1 292 °F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.]

If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him.

1.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use to prevent the fouling by micro-organisms, plants or animals of:

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof;

— there are factors indicating that short-term aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes,

[A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20 °C to 120 °C (– 4 °F to 248 °F).]

[A complex combination of hydrocarbons from the base-freed fraction from the distillation of coal tar, boiling in the range of approximately 250 °C to 280 °C (482 °F to 536 °F). It consists predominantly of biphenyl and isomeric diphenylnaphthalenes.]

o-Dianisidine based azo dyes; 4,4'-diarylazo-3,3'-dimethoxybiphenyl dyes with the exception of those mentioned elsewhere in ►M5  Annex VI to Regulation (EC) No 1272/2008 ◄

[The extract oil boiling in the range of approximately 220 °C to 265 °C (428 °F to 509 °F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.]

( 12 )  OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;

2.  Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

(A complex combination of hydrocarbons obtained from fractionation stabilisation of catalytic reformed naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.)

— indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, and in particular for nanoforms indirect genotoxicity), or

►M70   9.2.  Further information on degradation shall be generated or further degradation testing as described in Annex IX shall be proposed if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the degradation of the substance. That could for example be the case if additional information on degradation as set out in Annex XIII, point 3.2.1, is required to assess PBT or vPvB properties of the substance in accordance with subsection 2.1 of that Annex. For nanoforms that are not soluble, nor have high dissolution rate, such test(s) shall consider morphological transformation (e.g. irreversible changes in particle size, shape and surface properties, loss of coating), chemical transformation (e.g. oxidation, reduction) and other abiotic degradation (e.g. photolysis). The choice of the appropriate test(s) shall be made on the basis of the results of the chemical safety assessment. In case the generation of additional information requires further testing in accordance with Annex IX, the registrant shall propose or the Agency may require such testing.  ◄

For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information:

Where a substance has previously been registered less than 12 years earlier as referred to in Article 26(3), the potential registrant:

(A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160 to 190 °C.)

The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 10(1) of Regulation (EEC) No 793/93 and shall carry out the tasks of Article 46(3) and Article 48 of this Regulation.

Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.

The substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard phrases: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard phrase: H340), toxic for reproduction in Category 1A, 1B and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard phrase: H372 or H373), according to Regulation EC No 1272/2008;

[The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.]

Other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700 °C) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.)

— Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers (*4),

(RS)-2,6-dinitro-4-octylphenyl crotonates and (RS)-2,4-dinitro-6-octylphenyl crotonates in which ‘octyl’ is a reaction mass of 1-methylheptyl, 1-ethylhexyl and 1-propylpentyl groups

In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.

[The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.]

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;

(A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204 °C.)

Families of substances or mixtures or specific substances, such as water, air, acids, bases, oxidising agents, with which the substance or mixture could react to produce a hazardous situation (like an explosion, a release of toxic or flammable materials, or a liberation of excessive heat), shall be listed and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given.

Advice shall be provided related to suitable fabric for personal protective clothing (such as ‘appropriate: butylene’; ‘not appropriate: PVC’).

(The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700 °C) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.)

Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is visibly, legibly and indelibly marked as follows:

(A complex combination obtained by the fractionation of products from the fluidised catalytic cracker and gas oil desulphuriser. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

[A complex combination of hydrocarbons obtained by the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having a carbon number predominantly in the range of C4 through C6 and boiling in the range of approximately 0 °C to 80 °C (32 °F to 176 °F).]

[The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]

[A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130 °C to 200 °C (266 °F to 392 °F).]

(A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the catalytic hydrotreatment of a solvent deasphalted short residue having a viscosity of 8 10-6 m2.s-1 at approximately 100 °C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C40 and boiling in the range of approximately 300 °C to 500 °C.)

(i)  ‘professional’ means any natural or legal person, including workers and self-employed workers undertaking paint stripping in the course of their professional activity outside an industrial installation;

The UN number or the ID number (i.e. the four-figure identification number of the substance, mixture or article preceded by the letters ‘UN’ or ‘ID’) from the UN Model Regulations, IMDG, ADR, RID, ADN or ICAO TI shall be provided.

[The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oil boiling substantially below 145 °C (293 °F). Composed primarily of C7 and C8 aliphatic and aromatic hydrocarbons.]

The following information held by the Agency on substances whether on their own, in ►M3  mixtures ◄ or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):

If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.

4.  Without prejudice to other Community legislation on workers protection, paint strippers containing dichloromethane in concentrations equal to or greater than 0,1 % by weight may be used in industrial installations only if the following minimum conditions are met:

(A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C3 through C5.)

[A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C (95 °F to 374 °F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.]

6. Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption.

[The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C5-7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having carbon number predominantly of C5. This stream may contain benzene.]

(A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

2.3.5. All necessary qualitative analytical data specific for the identification of the substance, such as ultra-violet, infra-red, nuclear magnetic resonance, mass spectrum or diffraction data

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00

Information shall be provided on hazards that may arise from the substance or mixture, like hazardous combustion products that form when the substance or mixture burns, such as ‘may produce toxic fumes of carbon monoxide if burning’ or ‘produces oxides of sulphur and nitrogen on combustion’.

Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them.

For some substances or mixtures, it may be important to emphasise that special means to provide specific and immediate treatment shall be available at the workplace.

10.1.2. If data for mixtures are not available, data on substances in the mixture shall be provided. In determining incompatibility, the substances, containers and contaminants that the substance or mixture might be exposed to during transportation, storage and use shall be considered.

68.  Linear and branched perfluorocarboxylic acids of the formula CnF2n +1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C9-C14 PFCAs),

(A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.)

(The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.)

downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a ►M3  mixture ◄ , in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

(A complex combination of hydrocarbons obtained by distillation of heat-soaked steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.)

(A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

a list of relevant hazard statements and/or precautionary statements. Write out the full text of any statements, which are not written out in full under sections 2 to 15;

The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

(A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130 °C to 205 °C.)

Shall not be placed on the market, or used, as a substance, or in mixtures in a concentration equal to, or greater than 0,1 % by weight.

(A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.)

(A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25 and produces a finished oil with a viscosity in the order of 32 10-6 m2.s-1 to 37 10-6 m2.s-1 at 100 °C.)

the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008;

6.  The training shall comply with the provisions set by the Member State in which the industrial or professional user(s) operate. Member States may implement or continue to apply their own national requirements for the use of the substance(s) or mixture(s), as long as the minimum requirements set out in paragraphs 4 and 5 are met.

( 46 ) IBC Code means the International Code for the Construction and Equipment of Ships carrying dangerous Chemicals in Bulk, as amended.

(A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205 °C to 400 °C.)

References to emergency information services shall be provided. If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving information relating to health referred to in Article 45 of Regulation (EC) No 1272/2008), its telephone number shall be given and can suffice. If availability of such services is limited for any reasons, such as hours of operation, or if there are limits on specific types of information provided, this shall be clearly stated.

8.6.3.  A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:

The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet supplied to him in accordance with Section 5 of Annex I.

(a)  awareness, evaluation and management of risks to health, including information on existing substitutes or processes, which under their conditions of use are less hazardous to the health and safety of workers;

new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;

(A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200 °C.)

notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC;

Distillates (petroleum), steam-cracked, C8-12 fraction, polymd., distillation lights; low boiling point naphtha — unspecified

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

8.4.3.  In vitro gene mutation study in mammalian cells, if a negative result in Annex VII, Section 8.4.1. and Annex VIII, Section 8.4.2.

The Agency shall prepare guidance for the preparation of SEAs. SEAs, or contributions to them, shall be submitted in the format specified by the Agency in accordance with Article 111.

(A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

Distillates (petroleum), hydrotreated heavy naphtha, deisohexaniser overheads; Low boiling point hydrogen treated naphtha

( 38 ) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).

(a)  articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin;

(A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C25 through C39 and produces a finished oil with a viscosity of approximately 44 10-6 m2.s-1 at 50 °C.)

except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances.

Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account.

(A complex combination of hydrocarbons obtained from fractionation of distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabiliser tail gas. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C5, predominantly methane and ethane.)

A substance that fulfils the persistence and bioacumulation criteria of Sections 1.2.1 and 1.2.2 shall be considered to be a vPvB substance.

transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

The name corresponds to the International Chemical Identification used for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007;

— mixtures and articles containing recovered PVC if their concentration of cadmium (expressed as Cd metal) does not exceed 0,1 % by weight of the plastic material in the following rigid PVC applications:

For nanoforms the potential confounding effect of dispersion in octanol and water shall be assessed when conducting the study.

There may also be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3), leading to a reasoned justification that they provide the information that would enable a conclusion on the information requirement.

— electrical contacts in any sector of use, where that is necessary to ensure the reliability required of the apparatus on which they are installed.

►M70   9.2.2.1.  The study does not need to be conducted in any of the following cases: — the substance is readily biodegradable, — the substance is highly insoluble in water, — based on the structure, the substance does not have chemical groups that can hydrolyse. For nanoforms, the study may not be waived on the basis of high insolubility in water alone.  ◄

[A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160 °C to 190 °C (320 °F to 374 °F).]

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons from the fractionation stabilisation products from polymerisation of naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.)

Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States.

(A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerised hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120 to 215 °C.)

The supplier of the safety data sheet, whether it is the manufacturer, importer, only representative, downstream user or distributor, shall be identified. The full address and telephone number of the supplier shall be given as well as an email address for a competent person responsible for the safety data sheet.

[A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120 °C to 130 °C (248 °F to 266 °F).]

(A complex combination of hydrocarbons from the distillation of saturated and unsaturated hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly butane and isobutane. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C4, predominantly isobutane.)

(A complex combination of hydrocarbons produced by distillation of products from a catalytic fractionation process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.)

Information in this section of the safety data sheet shall relate to the protection of human health, safety and the environment. It shall assist the employer in devising suitable working procedures and organisational measures according to Article 5 of Directive 98/24/EC and Article 5 of Directive 2004/37/EC.

(The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxid. Composed primarily of the alkali salts of various phenolic compounds.)

2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one

1.  Shall not be placed on the market after 3 February 2021 in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, in concentrations equal to or greater than 0,01 % by weight of that textile article or of each part of the textile article.

Where a chemical safety report is required, the information in this subsection of the safety data sheet shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.

A substance that fulfils the persistence, bioaccumulation and toxicity criteria of Sections 1.1.1, 1.1.2 and 1.1.3 shall be considered to be a PBT substance.

[A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65 °C to 70 °C (149 °F to 158 °F).]

(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazin-2,4-diyl)bis[(amino-1-methylethyl)-ammonium] formate

— a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), or

(A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30 °C to 260 °C.)

3.  For the purpose of this entry ‘industrial and professional user(s)’ means any worker or self-employed worker handling diisocyanates on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) or supervising these tasks.

(A complex combination stripped from the liquid product of the heavy distillate hydrotreater desulphurisation process. It consists of hydrogen, hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(c)  ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.

submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted under Article 16 of that Directive.

Where a test method offers flexibility in the study design, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physicochemical properties or biological effects of the test substance, justification shall be provided.

In all cases, adequate justification and documentation shall be provided. The justification shall be based on a thorough and rigorous exposure assessment in accordance with section 5 of Annex I and shall meet any one of the following criteria:

Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure of the environment to the substance shall be given for the exposure scenarios set out in the annex to the safety data sheet.

1.  Shall not be used, as substance or as mixtures in aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes such as the following:

However, the first paragraph shall not apply to this substance (DBB) or mixtures containing it if these are intended solely for conversion into articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %.

(A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C.)

As regards a gas mixture, the words ‘oxidising gas Category 1 (tested as per ISO 10156 (or as per an equivalent method))’ may be indicated as regards tested mixtures, or the calculated oxidising power as per ISO 10156 or as per an equivalent method;

These rules shall in particular lay down the procedures for appointing and replacing the Chairman, replacing members and the procedures for delegating certain tasks to working groups.

Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals ( 31 ) or under Article 181a(3) of the Treaty, provided that both the following conditions are met:

the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and

(The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.)

(A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidise mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.)

(A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a middle distillate with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 290 °C to 350 °C. It produces a finished oil having a viscosity of 2 10-6 m2.s-1 at 100 °C.)

By 1 June 2010, the Commission shall, if necessary, prepare a draft amendment to Annex XVII in accordance with either of the following:

When the substance or mixture is classified as flammable liquid, data on the boiling point and flash point do not need to be provided under this point as that data are to be indicated in accordance with the subsection 9.1. Information on sustained combustibility may be provided.

Articles 11 and 19 provide for the possibility for the lead registrant to submit parts of the registration information on behalf of other member registrants.

Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d).

Conditions such as temperature, pressure, light, shock, static discharge, vibrations or other physical stresses that might result in a hazardous situation shall be listed (‘conditions to avoid’) and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given. As regards desensitised explosives, information on measures to be taken in order to avoid the unintentional removal of the desensitising agent shall be provided, and conditions to avoid shall be listed if the substance or mixture is not sufficiently desensitised.

The Index number is the identification code given to the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Substances are listed in the Appendix according to this index number.

(A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately - 40 °C to 80 °C.)

[A complex combination of hydrocarbons from distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 220 °C (148 °F to 428 °F).]

1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (EC No 201-559-5)

(A complex combination produced by the fractionation of the overhead product of the fluidised catalytic cracking process. It consists of hydrogen, hydrogen sulphide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

[The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.]

0.3.1. A safety data sheet is not a fixed length document. The length of the safety data sheet shall be commensurate with the hazard of the substance or mixture and the information available.

Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 1: Determination of certain aromatic amines derived from azo colorants

►M70   9.5.1.  Long-term toxicity testing shall be proposed by the registrant or may be required by the Agency if the results of the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects of the substance or of relevant transformation and degradation products on sediment organisms. The choice of the appropriate test(s) shall be made on the basis of the results of the chemical safety assessment.  ◄

Where additional safety information is provided on the packaging, this shall not weaken or contradict the particulars given in accordance with points (a) and (b).

(b)  measures to minimise evaporation from strip tanks comprising: lids for covering strip tanks except during loading and unloading; suitable loading and unloading arrangements for strip tanks; and wash tanks with water or brine to remove excess solvent after unloading;

From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.

The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 23 ), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 24 ) or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 25 ).

Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom. fraction; Low boiling point cat-reformed naphtha

1.  Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005 %) of the weight of the toy or part of toy.

— the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited human exposure.

0.1.2. The information on substances provided in the safety data sheet shall be consistent with the information in the registration and in the chemical safety report, where required. Where a chemical safety report has been completed, the relevant exposure scenario(s) shall be placed in an annex to the safety data sheet.

A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:

(A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30, and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

[A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93 °C to 180 °C (200 °F to 356 °F).]

Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following:

(A complex combination of hydrocarbons obtained from the hydrodesulphurisation of naphtha. It consists of hydrogen, methane, ethane, and propane.)

The physical state (gas, liquid or solid) shall generally be indicated at standard conditions of temperature and pressure.

Shall not be placed on the market to the general public after 9 May 2019 in windscreen washing or defrosting fluids, in a concentration equal to or greater than 0,6 % by weight.

(A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.)

(A complex combination of hydrocarbons obtained from refractionation of products from a catalytic cracking process. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

This section of the safety data sheet shall contain other information that is not included in sections 1 to 15, including information on the revision of the safety data sheet such as:

— the substance is of low toxicological activity (a comprehensive and informative dataset showing no toxicity in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.

Other studies on developmental neurotoxicity and/or developmental immunotoxicity instead of cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) of the Extended One-Generation Reproductive Toxicity Study may be proposed by the registrant in order to clarify the concern on developmental toxicity.

It may not always be possible to obtain information on the hazards of a substance or mixture. In cases where data on the specific substance or mixture are not available, data on similar substances or mixtures, if appropriate, may be used, provided the relevant similar substance or mixture is identified. Where specific data are not used, or where data are not available, this shall be clearly stated.

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic reformed naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

Criteria for substances and, when applicable, for nanoforms thereof, registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):

(A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 130 °C to 220 °C.)

The EC number, i.e. Einecs, Elincs or NLP, is the official number of the substance within the European Union. The Einecs number can be obtained from the European Inventory of Existing Commercial Chemical Substance (Einecs). The Elincs number can be obtained from the European List of Notified Substances. The NLP number can be obtained from the list of ‘No-longer-polymers’. These lists are published by the Office for Official Publications of the European Communities.

whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

(A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40 to 180 °C. Composed primarily of a complex mixture of hydrocarbons.)

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.

(The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90 to 160 °C. It consists predominantly of benzene, toluene and xylenes.)

(A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20 °C to 100 °C.)

(Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction process and boiling in the range of approximately 30 to 300 °C. Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.)

(b)  ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

1.  Shall not be placed on the market for supply to the general public after 2 January 2021 individually or in any combination, in a concentration equal to or greater than 2 ppb by weight of the mixtures containing organic solvents, in spray products.

(A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.)

3.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included.

(The complex combination obtained from the depentaniser stabilisation of hydrotreated kerosine. It consists primarily of hydrogen, methane, ethane, and propane with various small amounts of nitrogen, hydrogen sulphide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C4 through C5.)

by 1 June 2016 for all registrations received by 1 June 2013 containing proposals for testing in order to fulfil the information requirements in Annex IX only;

results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

►M70   8.7.3.  Extended One-Generation Reproductive Toxicity Study (OECD TG 443), basic test design (cohorts 1A and 1B without extension to include an F2 generation), one species, unless already provided as part of Annex IX requirements. The route of administration shall be oral if the substance is a solid or liquid, and inhalation if the substance is a gas; deviations may be made if scientifically justified, for example through evidence of equivalent or higher systemic exposure via another relevant route of human exposure or route-specific toxicity.  ◄

2.  Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 12 December 2023 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.

(A complex combination of hydrocarbons produced by distillation of products from a catalytic fractionation process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.)

results of screening tests referred to in section 2.11.4.2 of Annex I to Regulation (EC) No 1272/2008, if relevant and available;

When selecting dossiers for compliance checking, the Agency shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria: ◄

In those cases where the downstream user considers that information, in addition to that provided by the supplier, is necessary for producing his Chemical Safety Report, the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting for results of further testing, he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that he has put in place. The above record taking shall address all nanoforms that are covered by his own uses or his identified uses down the supply chain. Such information shall be relevant to the nanoforms.

The Forum shall aim to have a broad range of relevant expertise among its members. To this end the Forum may co-opt a maximum of five additional members chosen on the basis of their specific competence. These members shall be appointed for a term of three years, which shall be renewable. Members of the Management Board may not be members of the Forum.

(A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85 to 195 °C.)

The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.

0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate heading of the chemical safety report and a reference shall be made to the justification in the technical dossier. The fact that no information is required shall also be stated in the safety data sheet.

(b)  the employer or self-employed ensures that industrial or professional user(s) have successfully completed training on the safe use of diisocyanates prior to the use of the substance(s) or mixture(s).

SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 13 );

If the safety data sheet pertains to one or more nanoforms, or substances that include nanoforms, this shall be indicated by using the word ‘nanoform’.

Some properties are substance specific, i.e. bioaccumulation, persistence and degradability, and that information shall be given, where available and appropriate, for each relevant substance in the mixture (i.e. those which are required to be listed in section 3 of the safety data sheet and are hazardous to the environment or PBT/vPvB – substances). Information shall also be provided for hazardous transformation products arising from the degradation of substances and mixtures.

if the clothing, related accessory, textile other than clothing or footwear is for use by consumers and the substance is present in a concentration, measured in homogeneous material, equal to or greater than that specified for that substance in Appendix 12.

(A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane, and boiling in the range of approximately - 11,7  °C to 27,8  °C.)

A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:

Shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 0,1 % by weight for the following purposes:

Subject to Articles 6, 7, 21 and 23, substances on their own, in ►M3  mixtures ◄ or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.

This subsection of the safety data sheet shall indicate whether the supplier has carried out a chemical safety assessment for the substance or the mixture.

0.2.1. The safety data sheet shall enable users to take the necessary measures relating to protection of human health and safety at the workplace, and protection of the environment. The writer of the safety data sheet shall take into account that a safety data sheet must inform its audience of the hazards of a substance or a mixture and provide information on the safe storage, handling and disposal of the substance or the mixture.

placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

8.7.2.  An additional pre-natal developmental toxicity study in a second species, that is the other preferred species to the one used in the first study, shall be proposed by the registrant or may be required by the Agency if there is a concern for developmental toxicity based on the outcome of the first study and all other relevant data. That could be the case for example if the study on the first species shows developmental toxicity not meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B; May damage the unborn child (H360D). Deviations from the default route of administration and deviations in the choice of species shall be scientifically justified.

6.   INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFATCURER OR IMPORTER

8.2.2.1. The information on use of personal protective equipment shall be consistent with good occupational hygiene practices and in conjunction with other control measures, including engineering controls, ventilation and isolation. Where appropriate, section 5 shall be referred to for specific fire/chemical personal protective equipment advice.

(A complex combination of hydrocarbons produced by distillation of products from the cracking of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C4, predominantly of propane and propylene, and boiling in the range of approximately - 51 °C to - 1 °C.)

(A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.)

any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction or the amendment of restrictions under Directive 76/769/EEC.

(A complex combination of hydrocarbons obtained by the treatment of Foot's oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.)

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene-polypropylene pyrolysis-derived; Pyrolysis products

— the substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than -200, or

Where experimental data are not available, the supplier shall consider whether reliable and relevant information obtained from models can be provided.

the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet;

distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a ►M3  mixture ◄ , for third parties;

(The complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.)

Information on any other adverse effects on the environment shall be included where available, such as environmental fate (exposure), photochemical ozone creation potential, ozone depletion potential or global warming potential.

E-glass microfibers of representative composition; [Calcium-aluminium-silicate fibres with random orientation with the following representative composition (% given by weight): SiO2 50,0-56,0 %, Al2O3 13,0-16,0 %, B2O3 5,8-10,0 %, Na2O < 0,6 %, K2O < 0,4 %, CaO 15,0-24,0 %, MgO < 5,5 %, Fe2O3 < 0,5 %, F2 < 1,0 %. Process: typically produced by flame attenuation and rotary process. (Additional individual elements may be present at low levels; the process list does not preclude innovation).]

1.1.1.   Data on physical-chemical properties from experiments not carried out according to the test methods referred to in Article 13(3)

[A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200 °C to 230 °C (392 °F to 446 °F). It contains chiefly phenols and pyridine bases.]

(A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C32 and produces a finished oil with a viscosity in the order 17 10-6 m2.s-1 to 23 10-6 m2.s-1 at 40 °C.)

Indications shall be given whether any extinguishing media are inappropriate for a particular situation involving the substance or mixture (e.g. avoid high pressure media which could cause the formation of a potentially explosible dust-air mixture).

Information on adverse effects on the environment caused by endocrine disrupting properties shall be provided where available, for the substances identified as having endocrine disrupting properties in subsection 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for the environment.

As regards waxes and pastes, the softening point/range may be indicated instead of the melting point and freezing point.

For the purposes of point (a) Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of.

(A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallisation of anthrancene oil from bituminous coal high temperature tar and boiling in the approximate range of 350 to 360 °C. It contains chiefly anthracene, carbazole and phenanthrene.)

as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ( 9 ) and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council ( 10 );

Whenever possible, substances are designated by their IUPAC names. Substances listed in Einecvs (European Inventory of Existing Commercial Chemical Substances), Elincs (European List of Notified Substances) or the list of ‘No-longer-polymers’ are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

safety instructions which must be selected in accordance with the particulars in this Annex, inasmuch as they are relevant for the particular article.

Where a test method offers flexibility in the study design, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physicochemical properties or biological effects of the test substance, justification shall be provided.

(A tar obtained from low temperature carbonisation and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.)

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A or 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented.

(A complex combination of hydrocarbons produced by the distillation of products from the catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C5 and boiling in the range of approximately - 48 °C to 32 °C.)

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

[A complex combination of hydrocarbons produced by distillation of crude oil. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately – 20 °C to 180 °C (– 4 °F to 356 °F).]

— fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for training;

In addition to the oral route (8.5.1.) or to the inhalation route (8.5.2) for nanoforms, for substances other than gases, the information mentioned under 8.5.1. to 8.5.3. shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided.

In all cases, adequate and reliable documentation of the applied method shall be provided. Such documentation shall include:

(A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extended from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils; upgraded shale oils and liquid coal fuels are not included in this definition.)

(A complex combination produced by low-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.)

(A complex combination of hydrocarbons obtained by catalytic dehydrosulphurisation of thermal-cracked light vacuum petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C20 and boiling in the range of approximately 270 °C to 370 °C.)

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.

(A complex combination of hydrocarbons obtained during the sorption of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80 °C to 135 °C.)

(a)  articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are produced;

For substances subject to registration, brief summaries of the information derived from the application of Annexes VII to XI shall be given, including, where appropriate, a reference to the test methods used. For substances subject to registration, the information shall also include the result of the comparison of the available data with the criteria given in Regulation (EC) No 1272/2008 for CMR, categories 1A and 1B, following point 1.3.1 of Annex I to this Regulation.

3.  By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 9 May 2024 in relation to placing on the market for use, or use, as a solvent or reactant in the process of coating wires.

— spraying in open air, with limited or only natural ventilation (includes large industry working halls) and spraying with high energy (e.g. foams, elastomers);

— the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

[A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.]

(A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 220 °C.)

use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels ( 22 );

Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight for any use except:

A mixture of: N-[3-hydroxy-2-(2-methylacryloylamino-methoxy)propoxymethyl]-2-methylacrylamide; N-[2,3-Bis-(2-methylacryloylamino-methoxy)propoxymethyl]-2-methylacrylamide; methacrylamide; 2-methyl-N-(2-methyl-acryloylaminomethoxymethyl)-acrylamide; N-2,3-dihydroxypropoxymethyl)-2-methylacrylamide

(A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;

When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:

(The reaction product obtained by neutralising coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.)

(c)  in articles referred to in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0,5 μg/cm2/week for a period of at least two years of normal use of the article.

Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:

(A complex combination produced by low-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.)

3. Substances which result from a chemical reaction occurring upon end use of other substances, ►M3  mixtures ◄ or articles and which are not themselves manufactured, imported or placed on the market.

(Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240 to 400 °C. Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.)

The classification of the substance or the mixture which results from the application of the classification criteria in Regulation (EC) No 1272/2008 shall be given. Where the supplier has notified information regarding the substance to the classification and labelling inventory in accordance with Article 40 of Regulation (EC) No 1272/2008, or has provided that information as part of a registration pursuant to this Regulation, the classification given in the safety data sheet shall be the same as the classification provided in that notification or registration.

[A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330 °C to 350 °C (626 °F to 662 °F). It contains chiefly anthracene, carbazole and phenanthrene.]

The information required in this subsection shall be provided, unless an exposure scenario containing that information is attached to the safety data sheet.

Only applies to self-reactive substances and mixtures, organic peroxides, and other substances and mixtures that may decompose.

(A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816 °C of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.)

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C13 and boiling in the range of approximately 65 °C to 230 °C.)

Information shall be provided on other hazards which do not result in classification but which may contribute to the overall hazards of the substance or mixture, such as formation of air contaminants during hardening or processing, dustiness, explosive properties which do not fulfil the classification criteria of part 2 Section 2.1 of Annex I to Regulation (EC) No 1272/2008, dust explosion hazards, cross-sensitisation, suffocation, freezing, high potency for odour or taste, or environmental effects like hazards to soil-dwelling organisms, or photochemical ozone creation potential. The statement ‘May form explosible dust-air mixture if dispersed’ is appropriate in the case of a dust explosion hazard.

[Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 °C to 300 °C (356 °F to 572 °F). Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.]

(A complex combination of gases obtained from the reformer and from the purges from the hydrogenation reactor. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities.

0.6.4. A summary of all the relevant information used in addressing the points above shall be presented under the relevant heading of the Chemical Safety Report (Section 7).

Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;

Additional safety and environmental information is required to address the needs of seafarers and other transport workers in the bulk transport of dangerous goods in sea-going or inland navigation bulk carriers or tank-vessels subject to International Maritime Organisation (IMO) or national regulations. Subsection 14.7 recommends the inclusion of basic classification information when such cargoes are transported in bulk according to the relevant IMO instruments. In addition, ships carrying oil or oil fuel, as defined in Annex I of MARPOL ( 33 ), in bulk or bunkering oil fuel are required, before loading, to be provided with a ‘material safety data sheet’ in accordance with the IMO’s Maritime Safety Committee (MSC) resolution ‘Recommendations for Material Safety Data Sheets (MSDS) for MARPOL Annex I Oil Cargo and Oil Fuel’ (MSC.286(86)). Therefore, in order to have one harmonised safety data sheet for maritime and non-maritime use, the additional provisions of Resolution MSC.286(86) may be included in the safety data sheets, where appropriate, for marine transport of MARPOL Annex I cargoes and marine fuel oils.

(A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

[A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200 °C to 250 °C (392 °F to 482 °F).]

3.  A professional benefiting from the derogation referred to in paragraph 2 shall operate only in Member States which have made use of that derogation. The training referred to in paragraph 2 shall cover as a minimum:

5.  By way of derogation to paragraph 2, the use of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be allowed until 4 July 2025 for:

— In case an in vitro mutagenicity study referred to in points 8.4.2 or 8.4.3 is not applicable for the substance, the registrant shall provide a justification and shall propose or the Agency may require an appropriate in vivo study referred to in Annex IX, point 8.4.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate.

The proposal shall include the identity of the substance and the restriction(s) proposed for the manufacture, placing on the market or use(s) and a summary of the justification.

[A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0 °C to 230 °C (25 °F to 446 °F).]

specify waste treatment containers and methods including the appropriate methods of waste treatment of both the substance or mixture and any contaminated packaging (for example, incineration, recycling, landfilling);

[A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.]

This section of the safety data sheet shall describe the other regulatory information on the substance or mixture that is not already provided in the safety data sheet (such as whether the substance or mixture is subject to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer ( 54 ), Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC ( 55 ) or Regulation (EC) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of dangerous chemicals ( 56 )).

3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the (1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12. ►M51  The assessment shall address all nanoforms that are covered by the registration. ◄

2.4. Characterisation of nanoforms of a substance: For each of the characterisation parameters, the information provided may be applicable to either an individual nanoform or a set of similar nanoforms provided that the boundaries of the set are clearly specified.

Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

►M37   1.  The manufacture, placing on the market and use of these fibres and of articles and mixtures containing these fibres added intentionally is prohibited. However, if the use of diaphragms containing chrysotile for electrolysis installations in use on 13 July 2016 had been exempted by a Member State in accordance with the version of this paragraph in force until that date, the first subparagraph shall not apply until 1 July 2025 to the use in those installations of such diaphragms or of chrysotile used exclusively in the maintenance of such diaphragms, provided that such use is carried out in compliance with the conditions of a permit set in accordance with Directive 2010/75/EU of the European Parliament and of the Council (*17). Any downstream user benefiting from such an exemption shall send, by 31 January of each calendar year to the Member State in which the relevant electrolysis installation is located, a report indicating the amount of chrysotile used in diaphragms pursuant to the exemption. The Member State shall transmit a copy to the European Commission. Where, in order to protect the health and safety of workers, a Member State requires monitoring of chrysotile in air by downstream users, the results shall be included in that report.  ◄ 2.  The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, restrict, prohibit or make subject to specific conditions, the use of such articles before they are disposed of or reach the end of their service life. Member States may allow placing on the market of articles in their entirety containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health. Member States shall communicate these national measures to the Commission by 1 June 2011. The Commission shall make this information publicly available. 3.  Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, the placing on the market and use of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if suppliers ensure before the placing on the market that articles bear a label in accordance with Appendix 7 to this Annex.

( 25 )  OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.

the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;

[A complex combination of hydrocarbons from the distillation of hydrocarbons usually ranging in carbon numbers from C3 through C5, predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C5, predominantly 2-methyl-2-butene.]

The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.

(A complex combination of hydrocarbon produced by the distillation of products from a hydrocracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4. It may also contain small amounts of hydrogen and hydrogen sulfide.)

Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C.)

[A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94 °C to 99 °C (201 °F to 210 °F).]

full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed;

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)Text with EEA relevance

[The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.]

facilitate, for the purposes of registration, the exchange of the information specified in Article 10(a) (vi) and (vii) between potential registrants, thereby avoiding the duplication of studies; and

substances on their own or in ►M3  mixtures ◄ , registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:

This section of the safety data sheet shall prescribe how the substance or mixture shall be identified and how the identified relevant uses, the name of the supplier of the substance or mixture and the contact detail information of the supplier of the substance or mixture, including an emergency contact, shall be provided in the safety data sheet.

8.1.2. Information on currently recommended monitoring procedures shall be provided at least for the most relevant substances.

2.  By way of derogation from paragraph 1, Member States may allow on their territories and for certain activities the use, by specifically trained professionals, of paint strippers containing dichloromethane and may allow the placing on the market of such paint strippers for supply to those professionals.

[A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135 °C to 210 °C (275 °F to 410 °F). May also include unsaturated hydrocarbons such as indene and coumarone.]

Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight where the substance or mixture is used in adhesives or spray paints intended for supply to the general public.

(A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists predominantly of butane, isobutane and butadiene.)

(A complex combination separated by distillation of a gas stream containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers in the range of C1 through C6 or obtained by cracking ethane and propane. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C2, hydrogen, nitrogen, and carbon monoxide.)

a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;

a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of straight-run naphtha, distillation tail gas and catalytic reformed naphtha stabiliser tail gas. It consists of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly butane and isobutane.)

[A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140 °C to 210 °C (284 °F to 410 °F).]

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

(A complex combination of hydrocarbons obtained by the fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

providing advice and assistance to manufacturers and importers registering a substance in accordance with Article 12(1);

►M21   56.  Methylenediphenyl diisocyanate (MDI) CAS No 26447-40-5 EC No 247-714-0 including the following specific isomers: (a)  4,4’-Methylenediphenyl diisocyanate: CAS No 101-68-8 EC No 202-966-0; (b)  2,4’-Methylenediphenyl diisocyanate: CAS No 5873-54-1 EC No 227-534-9; (c)  2,2’-Methylenediphenyl diisocyanate: CAS No 2536-05-2 EC No 219-799-4  ◄

The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture in the Community and all identified uses.

the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and;

(A complex combination of hydrocarbons produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C. It contains a relatively large proportion of unsaturated hydrocarbons.)

(b)  Wood treated in industrial installations or by professionals according to subparagraph (a) which is placed on the market for the first time or retreated in situ may be used for professional and industrial use only, for example on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (for example stakes for tree support) and in harbours and waterways.

(A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.)

[The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5 °C (41 °F).]

Shall not be placed on the market, or used, as substance or in mixtures, where the substance or mixture is intended for the manufacturing or processing of non-ferrous metals.

Where relevant, this section shall provide information on the transport classification for each of the following international agreements which are transposing the UN Model Regulations for specific transport modes: the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) and the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN), all three of which have been implemented by Directive 2008/68/EC of the European Parliament and of the Council ( 41 ), as well as the International Maritime Dangerous Goods (IMDG) Code ( 42 ) for the transport of packaged goods and the relevant IMO codes for the transport of bulk cargo by sea ( 43 ) and the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI) ( 44 ).

If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.

(This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol and o-, m- and p-cresol and boiling in the range of 140 to 215 °C.)

8.4.7.  A second in vivo mammalian germ cell genotoxicity study, if there is a positive result in in vivo mammalian somatic cell genotoxicity studies, which gives rise to both chromosomal aberration concern and gene mutation concern. The second study shall address the chromosomal aberration or gene mutation, as appropriate, which has not been addressed by the first in vivo mammalian germ cell genotoxicity study.

3.  By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol dispensers referred to Article 8 (1a) of Council Directive 75/324/EEC (*2).

(A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately - 20 °C to 120 °C.)

[The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80 °C (176 °F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.]

(A complex combination of hydrocarbons obtained by fractionation of miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4, predominantly propane.)

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

— ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,

making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1);

(The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.)

(A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C3 through C5.)

1 000 mg/kg (individually or in combination with other phthalates in this entry or in other entries of Annex XVII that are classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B

Where different forms of a substance are covered by one safety data sheet, relevant information shall be included, clearly indicating which information is related to which form. Alternatively, a separate safety data sheet may be prepared per form or group of forms.

3.1. Overall manufacture, quantities used for production of an article that is subject to registration, and/or imports in tonnes per registrant per year in:

►M70  An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be proposed by the registrant or may be required by the Agency in case of particular concerns on (developmental) neurotoxicity or (developmental) immunotoxicity justified by any of the following: ◄

the generic concentration limits given in parts 3 to 5 of Annex I to Regulation (EC) No 1272/2008, taking into account the concentrations specified in the notes to certain tables in part 3 in relation to the obligation to make available a safety data sheet for the mixture upon request, and for aspiration hazard (Section 3.10 of Annex I to Regulation (EC) No 1272/2008) ≥ 1 %;

(A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:

(The complex combination obtained from the depentaniser stabilisation of hydrotreated kerosine. It consists primarily of hydrogen, methane, ethane, and propane with various small amounts of nitrogen, hydrogen sulphide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C4 through C5.)

Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use, and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.

2.3. Composition of each substance. Where a registration covers one or more nanoforms, these nanoforms shall be characterised pursuant to section 2.4 of this Annex.

[The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.]

(A complex combination obtained from the hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.

(A complex combination of hydrocarbons obtained from fractionation stabilisation of light straight-run naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

( 36 ) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

(A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately - 51 °C to - 34 °C.)

Where a chemical safety report is required, the information in this section of the safety data sheet shall be consistent with the information given for the identified uses in the chemical safety report and the exposure scenarios showing control of risk from the chemical safety report set out in the annex to the safety data sheet.

(A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidised catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

[A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately – 164 °C to – 0,5 °C (– 263 °F to 31 °F).]

2.  Furthermore, the textile and leather articles referred to in paragraph 1 shall not be placed on the market unless they conform to the requirements set out in that paragraph.

1.  Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI ( 64 ).

[The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27 °C to 210 °C (80 °F to 410 °F).]

(a)  effective ventilation in all processing areas, in particular for the wet processing and the drying of stripped articles: local exhaust ventilation at strip tanks supplemented by forced ventilation in those areas, so as to minimise exposure and to ensure compliance, where technically feasible, with relevant occupational exposure limits;

allow safe handling of the substance or mixture, such as containment and measures to prevent fire as well as aerosol and dust generation;

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400 °C.)

(A complex combination of hydrocarbons obtained by subjecting naphtha from a catalytic cracking process to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons boiling in a range of approximately 35 °C to 210 °C.)

The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management Board.

[The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70 °C to 120 °C (158 °F to 248 °F).]

[A complex combination of hydrocarbons obtained by distillation of the polymerized C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.]

The definitions of the terms gas, liquid and solid, as provided in Section 1.0 of Annex I to Regulation (EC) No 1272/2008, shall apply.

the preparation of the statement of revenue and expenditure and the implementation of the budget of the Agency pursuant to Articles 96 and 97;

the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 11 );

(A complex combination obtained by the liquid-vapour separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

1.  Shall not be placed on the market for the first time after 27 June 2010 as a substance, or in mixtures that contain more than 28 % by weight of nitrogen in relation to ammonium nitrate, for use as a solid fertiliser, straight or compound, unless the fertiliser complies with the technical provisions for ammonium nitrate fertilisers of high nitrogen content set out in Annex III to Regulation (EC) No 2003/2003 of the European Parliament and of the Council (*10). ►M54   ◄

(A complex combination of hydrocarbons obtained by the crystallisation of tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.)

Polycyclic-aromatic Hydrocarbons (PAH), classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen or germ cell mutagen category 1A, 1B or 2

(A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390 °C.)

(A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9, and boiling in the range of approximately 110 °C to 165 °C.)

one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;

►M70   9.3.  Further information on bioaccumulation shall be generated if additional information on bioaccumulation as set out in Annex XIII, point 3.2.2, is required to assess PBT or vPvB properties of the substance in accordance with subsection 2.1 of that Annex. In case the generation of additional information requires further testing in accordance with Annex IX or Annex X, the registrant shall propose or the Agency may require such testing.  ◄

(A complex combination of hydrocarbons produced from distillation of the gas and gasoline fractions from the catalytic cracking process. It contains predominantly ethane and ethylene.)

(A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanising. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.)

(A complex combination of hydrocarbons produced by distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers in the range of C1 through C6, predominantly C1 through C4.)

(The complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.)

When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis.

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

In cases where variations in density are possible, e.g. due to batch manufacture, or where one safety data sheet is used to cover several variants of a substance or mixture, a range may be indicated.

0.1.1. This Annex sets out the requirements that the supplier shall fulfil for the compilation of a safety data sheet that is provided for a substance or a mixture in accordance with Article 31.

11. The following substances unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC and provided that they do not contain constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC or concentration limits set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the lifecycle of the substance and those data have been ascertained to be adequate and reliable:

Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or ►M3  mixtures ◄ that they use or may be exposed to in the course of their work.

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or

Other physical and chemical parameters shall be indicated if their indication is relevant for the safe use of the substance or mixture.

The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.

The absolute density and/or the relative density based on water at 4 °C as reference (also referred to as the specific gravity) shall be indicated.

(A complex combination of olefinic and paraffinic hydrocarbons having carbon numbers in the range of C3 through C5 which are used as alkylation feed. Ambient temperatures normally exceed the critical temperature of these combinations.)

(c)  The prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31 (a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use.

[A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C4 through C10, and boiling in the range of approximately – 20 °C to 180 °C (– 4 °F to 356 °F).]

(The oil obtained from condensation of the vapours from the heat treatment of pitch. Composed primarily of two-to four-ring aromatic compounds boiling in the range of 200 to greater than 400 °C.)

(A complex combination of hydrocarbons obtained by treating thermal cracked distillates with hydrogen in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(The complex combination of hydrocarbons from the distillation of products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.)

(A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent extracts; Low boiling point modified naphtha

(A complex combination of hydrocarbons obtained from the redistillation of the effluents from the treatment of paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C27 and boiling in the range of approximately 330 °C to 340 °C.)

►M70   9.2.  Further degradation testing shall be proposed by the registrant or may be required by the Agency, if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the degradation of the substance and its transformation and degradation products. The choice of the appropriate test(s) and test media shall be made on the basis of the results of the chemical safety assessment.  ◄

Mobility in soil is the potential of the substance or the components of a mixture, if released to the environment, to move under natural forces to the groundwater or to a distance from the site of release. The potential for mobility in soil shall be given where available. Information on mobility in soil can be determined from relevant mobility data such as adsorption studies or leaching studies, known or predicted distribution to environmental compartments, or surface tension. For example, soil adsorption coefficient (Koc) values can be predicted from Kow. Leaching and mobility can be predicted from models.

(b)  the supplier ensures that the recipient of the substance(s) or mixture(s) is provided with information on the requirements referred to in point (b) of paragraph 1 and the following statement is placed on the packaging, in a manner that is visibly distinct from the rest of the label information: ‘As from 24 August 2023 adequate training is required before industrial or professional use’.

The self-accelerating decomposition temperature (SADT) and the volume to which it applies, or the decomposition onset temperature shall be indicated.

(A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.)

(The oil remaining after the removal, by a crystallisation process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.)

(The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225 to 320 °C. Composed primarily of polyalkylphenols.)

0.1.3. The safety data sheet shall mention in each relevant section whether and which different nanoforms it covers and link the relevant safety information to each of those nanoforms. As provided for in Annex VI, the term ‘nanoform’ in this Annex refers to a nanoform or a set of similar nanoforms.

Refractory Ceramic Fibres, Special Purpose Fibres, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008; [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18 % by weight]

(g)  in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column;

(A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.)

(A complex combination of hydrocarbons produced by distilling cracked steam cracked distillate and/or its fractionation products. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 to low molecular weight polymers.)

Evidence shall be provided that implemented risk management measures (including those identified in registrations under Articles 10 to 14) are not sufficient.

Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) (with ≥ 0,1 % w/w 4-heptylphenol, branched and linear)

substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;

Distillates (petroleum), alkene-alkyene manuf. pyrolysis oil, mixed with high-temperature coal tar, indene fraction; Redistillates

[A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 °C to 255 °C (437 °F to 491 °F).]

The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline.

(A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a solvent deasphalted short residue with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C30 and boiling in the range of approximately 300 °C to 400 °C. It produces a finished oil having a viscosity of 4 10-6 m2.s-1 at approximately 100 °C.)

any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

(A complex combination obtained from various processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety report. Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified.

[A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 70 °C to 100 °C (158 °F to 212 °F).]

(a)  the substance has uses leading to significant exposure of consumers or professionals, taking into account, inter alia, consumer exposure from articles, and

A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate;

(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)

Other studies on developmental neurotoxicity and/or developmental immunotoxicity instead of cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) of the Extended One-Generation Reproductive Toxicity Study may be proposed by the registrant in order to clarify the concern on developmental toxicity.

(A complex combination produced by the high-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.)

[A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130 °C to 205 °C (266 °F to 401 °F).]

(A complex combination of hydrocarbons obtained by treating a petroleum fraction, derived from a pyrolysis process, with hydrogen in the presence of a catalyst. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C.)

(The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.)

(A complex combination of hydrocarbons obtained by distillation of hydrodesulphurised and dearomatised light petroleum fractions. It consists predominantly of C7 paraffins and cycloparaffins boiling in a range of approximately 90 °C to 100 °C.)

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person:

(iv)  fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to the following conditions:

(A complex combination of hydrocarbons obtained from the fractionation of products from catalytic cracking, catalytic reforming and hydrodesulphurising processes treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity (category 1A or 1B or 2) and carcinogenicity (category 1A or 1B), and appropriate risk management measures are implemented, or

(A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35 °C to 230 °C.)

(A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65 °C to 230 °C.)

(i)  textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety;

For metals and sparingly soluble metal compounds, information on transformation/dissolution in aqueous media shall be provided.

( 30 )  OJ 17, 6.10.1958, p. 385/58. Regulation as last amended by Council Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

(A complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.

( 23 )  OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003.

(f)  articles that are biocidal products within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council (*23);

a Secretariat, which shall work under the leadership of the Executive Director and provide technical, scientific and administrative support for the Committees and the Forum and ensure appropriate coordination between them. It shall also undertake the work required of the Agency under the procedures for pre-registration, registration and evaluation as well as preparation of guidance, database maintenance and information provision;

(e)  the statement "Contains nickel. Can cause allergic reactions." if the mixture contains nickel below the concentration limit specified in Appendix 13;

[Pyridine bases boiling in the range of approximately 125 °C to 160 °C (257 °F to 320 °F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.]

(A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic reformed naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

8.4.4.  An appropriate in vivo mammalian somatic cell genotoxicity study, if there is a positive result in any of the in vitro genotoxicity studies referred to in Annex VII or Annex VIII, which gives rise to concern. The in vivo mammalian somatic cell genotoxicity study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.

(A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33 °C to 60 °C.)

Employers and self-employed workers shall preferably replace dichloromethane with a chemical agent or process which, under its conditions of use, presents no risk, or a lower risk, to the health and safety of workers.

This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in section 3 of the safety data sheet.

(A complex combination produced by scrubbing the overhead gas from the fluidised catalytic cracker. It consists of hydrogen, nitrogen, methane, ethane and propane.)

a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests.

any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;

Each Member State shall nominate a member to the Management Board. The members thus nominated shall be appointed by the Council.

prepare a documentation of how it considers that any other risks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation.

(A complex combination of hydrocarbons obtained from the fractionation stabilisation products from isomerised naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

[A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomerized. It consists predominantly of hexane isomers boiling in the range of approximately 60 °C to 66 °C (140 °F to 151 °F).]

The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.

8.6.2.  Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in ►M3  mixtures ◄ or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

As regards a flammable gas mixture, the following information may be provided in addition to data on the explosion limits referred to in point (g) of subsection 9.1:

Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences.

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150 °C to 345 °C.)

(A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C.)

►M62   (a)  4 January 2021 (*2); (b)  by way of derogation from point (a), 22 December 2023 for uses as follows: — for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, — in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.  ◄

making arrangements, upon request from the Management Board, for the execution of any further function(s) (within the remit of Article 77) allotted to the Agency by delegation from the Commission;

in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food ( 14 );

Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:

(3)  the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.

2.5. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified.

[The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90 °C to 160 °C (194 °F to 320 °F). It consists predominantly of benzene, toluene and xylenes.]

( 52 ) Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (OJ L 208, 5.8.2002, p. 10).

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C14 through C42 and boiling in the range of approximately 250 to 545 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150 °C to 345 °C.)

(A complex combination of hydrocarbons obtained by the fractionation of the full-range straight-run naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

(A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.)

In the case of a substance of unknown or variable composition, complex reaction products or biological materials (UVCB):

(b)  Perboric acid (H3BO2(O2)), monosodium salt trihydrate; perboric acid, sodium salt, tetrahydrate; perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate

[A complex combination of hydrocarbons separated from the gases from vapour recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 196 °C(– 4 °F to 384 °F).]

Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by the supplier of the mixture provided that:

a Forum for Exchange of Information on Enforcement (hereinafter referred to as the Forum) which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation;

(d)  in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than:

[The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340 °C to 400 °C (644 °F to 752 °F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.]

The chemical identity of any impurity, stabilising additive, or individual constituent other than the main constituent, which is itself classified and which contributes to the classification of the substance shall be provided as follows:

(A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C10 through C22 and boiling in the range of approximately 160 °C to 370 °C.)

(i)  articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004;

(A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350 to 600 °C. This stream is likely to contain 5 wt % more of four- to six-membered condensed ring aromatic hydrocarbons.)

(The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.)

(A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.

(A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated aliphatic hydrocarbons.)

(A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.)

Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘the lead registrant’).

By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. ►M3  However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014. ◄ When carrying out the review the Commission shall take into account all relevant factors, including:

(A complex combination of hydrocarbons obtained by the fractionation of the full-range straight-run naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

(The distillate from lignite tar boiling in the range of approximately 80 to 250 °C. Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.)

The choice of the study will depend on the remaining information gaps and the results of the chemical safety assessment.

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370 °C to 550 °C.)

(A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100 to 220 °C according to DIN 52025.)

phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.

Distillates (petroleum), light distillate hydrotreating process, low-boiling; Low boiling point hydrogen treated naphtha

(f)  in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight:

[Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240 °C to 260 °C (464 °F to 500 °F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.]

(A complex combination produced by desulphurisation of gas oils with diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen and aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.)

medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and ►M3  mixtures ◄ which ensure the same level of information provision and protection as Directive 1999/45/EC;

— systems with special treatment where the process water is pre-treated to remove the organic fraction completely prior to biological waste water treatment (degreasing of sheepskin);

►M70   9.4.  These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified. The choice of the appropriate test(s) shall be made on the basis of the results of the chemical safety assessment. In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall propose or the Agency may require long-term toxicity testing as referred to in Annex X instead of short-term toxicity testing.  ◄

On the basis of the examination under paragraph 1, the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 50 and 51:

2.  Paragraph 1 shall not apply to the placing on the market of second-hand textile articles or of new textile articles produced, without the use of NPE, exclusively from recycled textiles.

Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5). ◄

provided that the concentration of an individual substance is equal to or greater than 0,1 %, substances that meet any of the following criteria:

If the classification, including the hazard statements, is not written out in full, reference shall be made to section 16 where the full text of each classification, including each hazard statement, shall be given.

Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner.

(The distillate from high temperature coal tar having an approximate distillation range of 130 to 250 °C. Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.)

(A complex combination of hydrocarbons obtained by dewaxing light paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane, and boiling in the range of approximately - 11,7  °C to 27,8  °C.)

(A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

►M70   9.2.  Further degradation testing shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the degradation of the substance and its transformation or degradation products. The choice of the appropriate test(s) and test media shall be made on the basis of the results of the chemical safety assessment.  ◄

The Agency shall, until 31 December 2027, also select a percentage no lower than 20 % of the total received by the Agency for registrations in tonnage bands of less than 100 tonnes per year.

1.  Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

with dispersive or diffuse use(s) particularly where such substances are used in consumer mixtures or incorporated into consumer articles; and

[A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80 °C to 135 °C (176 °F to 275 °F).]

Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending; Low boiling point thermally cracked naphtha

(A complex combination of hydrocarbons obtained from refractionation of products from a catalytic cracking process. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

Before using a mixture for tattooing purposes, the person using the mixture shall provide the person undergoing the procedure with the information marked on the package or included in the instructions for use pursuant to this paragraph.

Reported properties shall be clearly identified and reported in the appropriate measurement units. The method of determination shall be provided, including measurement and reference conditions, if relevant for the interpretation of the numerical value. Unless specified otherwise, standard conditions of temperature and pressure are 20 °C and 101,3 kPa, respectively.

an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;

(A complex combination obtained from the reformers. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

1.  Shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 August 2023, unless:

1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1.

(A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately - 217 °C to - 12 °C.)

A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C1 through C6, predominantly C1 through C5.)

a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or

In case the melting point is above the measuring range of the method, it shall be indicated up to which temperature no melting point was observed.

Structural similarity for UVCB substances shall be established on the basis of similarities in the structures of the constituents, together with the concentration of these constituents and variability in the concentration of these constituents. If it can be demonstrated that the identification of all individual constituents is not technically possible or impractical, the structural similarity may be demonstrated by other means, to enable a quantitative and qualitative comparison of the actual composition between substances.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored exposure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI ( 60 ).

►M70   8.4.  In case of a positive result in the in vitro gene mutation study in bacteria referred to in point 8.4.1 of this Annex, which gives rise to concern, the registrant shall perform an in vitro study referred to in Annex VIII, point 8.4.2. Based on the positive result of any of those in vitro genotoxicity studies, the registrant shall propose, or the Agency may require, an appropriate in vivo study referred to in Annex IX, point 8.4.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate. The in vitro gene mutation study in bacteria does not need to be conducted if this test is not applicable for the substance. In this case, the registrant shall provide a justification and perform an in vitro study referred to in Annex VIII, point 8.4.3. In case of a positive result in that study the registrant shall perform an in vitro cytogenicity study referred to in Annex VIII, point 8.4.2. Based on the positive result in any of those in vitro genotoxicity studies, or in case one of the Annex VIII in vitro tests is not applicable for the substance, the registrant shall propose, or the Agency may require, an appropriate in vivo study referred to in Annex IX, point 8.4.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate. The in vitro gene mutation study in bacteria referred to in point 8.4.1 and follow-up testing do not need to be conducted in any of the following cases: — the substance is known to cause germ cell mutagenicity, meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B, and appropriate risk management measures are implemented, — the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented.  ◄

per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;

performing the tasks allotted to it under Title II; including facilitating the efficient registration of imported substances, in a way consistent with the Community's international trading obligations towards third countries;

(A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulphur to hydrogen sulphide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil having a viscosity of greater than 10-5 m2.s-1 at 40 °C.)

The assessment shall address all nanoforms that are covered by the registration. Justifications and conclusions drawn from the assessment shall be relevant to the nanoforms, from their receipt by the downstream user, for his own uses and for his identified uses further down the supply chain.

[A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110 °C to 165 °C (230 °F to 329 °F).]

— In case of a positive result in any of the in vitro genotoxicity studies referred to in Annex VII or this Annex, which gives rise to concern, the registrant shall propose, or the Agency may require, an appropriate in vivo study referred to in Annex IX, point 8.4. The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate.

(A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.)

if it is compatible with the duties of the Agency, in particular the need to provide a high level of protection of human health and the environment.

(A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.)

if a M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;

The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration.

2.    Measurement of formaldehyde concentration in the interior of vehicles referred to in paragraph 2, first subparagraph, of entry 77

a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.

0.6.2. In the cases referred to in point 0.6.3 the chemical safety assessment shall also include the following steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected), or

2.4. For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the substance to cause the effect resulting from the manufacture and identified uses.

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic polymerised naphtha. It consists of aliphatic hydrocarbons having carbon numbers in the range of C2 through C6, predominantly C2 through C4.)

10.  This restriction shall apply without prejudice to other Union legislation on the protection of safety and health of workers at the workplace.

for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008 or for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media.

(The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27 °C to 210 °C.)

For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.

(A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.)

(A complex combination of hydrocarbons obtained by fractionation of hydrodesulphurised thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 195 °C.)

(A complex combination of hydrocarbons produced by distillation of products from combined gas streams in a gas concentration reabsorber. It consists predominantly of hydrogen, carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide and hydrocarbons having carbon numbers in the range of C1 through C3.)

A comparison of the available information with the criteria in Annex XIII for PBT according to Article 57(d), and vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), according to the relevant parts of Sections 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in Part B of the Chemical Safety Report in Annex I.

As regards mixtures the auto-ignition temperature for the mixture shall be indicated, if available. If the value for the mixture is not available, the auto-ignition temperature(s) of the ingredients with the lowest auto-ignition temperature(s) shall be indicated.

[The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190 °C to 270 °C (374 °F to 518 °F). Composed primarily of substituted dinuclear aromatics.]

[A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C (194 °F to 446 °F).]

[The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130 °C to 210 °C (266 °F to 410 °F). Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.];

For a given health effect, if a mixture has not been tested for its health effects as a whole, relevant information on relevant substances listed under section 3 shall be provided.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

(A complex combination obtained from the reformers. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons obtained by the treatment and distillation of light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 35 °C to 80 °C.)

Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulphuriser overhead fractionation; Refinery gas

— in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.

The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of third countries to participate in the work of the Agency.

competent authority: means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

the substance is handled according to the conditions set out in Article 18(4)(a) to (f) during all manufacturing and production stages including the waste management of the substance during these stages.

(A complex combination of hydrocarbons by fractionation from hydrodesulphurised coker distillate stocks. It consists of hydrocarbons having carbon numbers predominantly in the range of C12 through C21 and boiling in the range of approximately 200 °C to 360 °C.)

Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:

Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justification.

(A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed and recycled to conserve hydrogen. It consists primarily of hydrogen. It may also contain various small amounts of carbon monoxide, carbon dioxide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

— existing information on the substance itself derived from relevant available in vivo or non-animal approaches (e.g. abnormalities of the CNS, evidence of adverse effects on the nervous or immune system in studies on adult animals or animals exposed prenatally), or

robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

11.1.11.2. It is necessary to consider whether the concentration of each substance is sufficient to contribute to the overall health effects of the mixture. The information on toxic effects shall be presented for each substance, except for the following cases:

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C30 and boiling in the range of approximately 205 °C to 450 °C. It contains a relatively large proportion of tricyclic aromatic hydrocarbons.)

The type of eye/face protection equipment required shall be specified based on the hazard of the substance or mixture and potential for contact, such as safety glasses, safety goggles, face-shield.

The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance.

(A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 190 °C.)

2.  For the purpose of this entry, ‘spray products’ means aerosol dispensers, pump sprays, trigger sprays, marketed for proofing or impregnation spray applications.

exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;

The measures necessary to put the provisions of this Regulation efficiently into effect shall be adopted in accordance with the procedure referred to in Article 133(3).

(A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50 °C to 200 °C. The proportion of benzene hydrocarbons may vary up to 30 % wt and the stream may also contain small amounts of sulphur and oxygenated compounds.)

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 190 °C.)

1.  Shall not be placed on the market: (a)  in fever thermometers; (b)  in other measuring devices intended for sale to the general public (such as manometers, barometers, sphygmomanometers, thermometers other than fever thermometers). 2.  The restriction in paragraph 1 shall not apply to measuring devices that were in use in the Community before 3 April 2009. However Member States may restrict or prohibit the placing on the market of such measuring devices. 3.  The restriction in paragraph 1(b) shall not apply to: (a)  measuring devices more than 50 years old on 3 October 2007; (b)  barometers (except barometers within point (a)) until 3 October 2009. ►M19   ◄ ►M19   5.  The following mercury-containing measuring devices intended for industrial and professional uses shall not be placed on the market after 10 April 2014: (a)  barometers; (b)  hygrometers; (c)  manometers; (d)  sphygmomanometers; (e)  strain gauges to be used with plethysmographs; (f)  tensiometers; (g)  thermometers and other non-electrical thermometric applications. The restriction shall also apply to measuring devices under points (a) to (g) which are placed on the market empty if intended to be filled with mercury. 6.  The restriction in paragraph 5 shall not apply to: (a)  sphygmomanometers to be used: (i)  in epidemiological studies which are ongoing on 10 October 2012; (ii)  as reference standards in clinical validation studies of mercury-free sphygmomanometers; (b)  thermometers exclusively intended to perform tests according to standards that require the use of mercury thermometers until 10 October 2017; (c)  mercury triple point cells which are used for the calibration of platinum resistance thermometers. 7.  The following mercury-using measuring devices intended for professional and industrial uses shall not be placed on the market after 10 April 2014: (a)  mercury pycnometers; (b)  mercury metering devices for determination of the softening point. 8.  The restrictions in paragraphs 5 and 7 shall not apply to: (a)  measuring devices more than 50 years old on 3 October 2007; (b)  measuring devices which are to be displayed in public exhibitions for cultural and historical purposes.  ◄

[A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately – 10 °C to 230 °C (14 °F to 446 °F).]

Any supplier of a substance on its own or in a ►M3  mixture ◄ who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:

(A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C.)

The properties listed in subsections 9.1 and 9.2 may be presented in a form of a list. Within the subsections, the order of listing the properties may be different if deemed appropriate.

(A complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to the Safety Data Sheet.

3.2.4. For the substances indicated in subsection 3.2 the name and, if available, the registration number, as assigned under Article 20(3) of this Regulation, shall be given.

In addition, if the supplier is not located in the Member State where the substance or mixture is placed on the market and he has nominated a responsible person for that Member State, a full address and telephone number for that responsible person shall be given.

— possible developmental or reproductive toxicity of the substance predicted from information on structurally related substances, (Q)SAR estimates or in vitro methods.

(A complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane and propane.)

establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list established in accordance with Regulation (EC) No 1272/2008. ◄ It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. The Agency shall make other information in the databases available on request in accordance with Article 118;

The type of gloves to be worn when handling the substance or mixture shall be clearly specified based on the hazard of the substance or mixture and potential for contact and with regard to the amount and duration of dermal exposure, including:

the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or

2.3.7. Description of the analytical methods or the appropriate bibliographical references that are necessary for the identification of the substance (including the identification and quantification of its constituents and, where appropriate, its impurities and additives). The description shall consist of the experimental protocols followed and the relevant interpretation of the results reported under points 2.3.1 to 2.3.6. This information shall be sufficient to allow the methods to be reproduced.

(A complex combination of hydrocarbons produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately - 70 °C to 0 °C.)

Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance including on all nanoforms of the substance that are covered by the registration, regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.

The safety data sheet shall include the following 16 headings in accordance with Article 31(6) and in addition the subheadings also listed except section 3, where only subsection 3.1 or subsection 3.2 needs to be included as appropriate:

9.  Paragraph 2(c) shall apply from 31 December 2030 to semiconductors used in spare or replacement parts for finished electronic equipment placed on the market before 31 December 2023.

(Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400 to 470 °C. Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.)

(A complex combination of hydrocarbons obtained by treating light catalytic cracked distillates with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150 °C to 400 °C. It contains a relatively large proportion of bicyclic aromatic hydrocarbons.)

(A complex combination of hydrocarbons obtained as the solvent soluble fraction from C3-C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400 °C.)

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C5.)

if an article has asbestos-based components, it is sufficient for these components only to bear the label. The labelling may be dispensed with if smallness of size or unsuitability of packaging make it impossible for a label to be affixed to the component.

Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 December 2010 to the following substances:

(A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallisation of anthracene oil from bituminous light temperature tar and boiling in the range of approximately 290 to 340 °C. It contains chiefly trinuclear aromatics and their dihydro derivatives.)

[A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73 °C to 85 °C (163 °F to 185 °F).]

( *3 ) ISO 12219-10: Interior air of road vehicles – Part 10: Whole vehicle test chamber – Specification and methods for the determination of volatile organic compounds in cabin interiors – Trucks and buses.

For substances subject to registration, the product identifier shall be consistent with that provided in the registration and the registration number assigned under Article 20(3) of this Regulation shall also be indicated. Additional identifiers may be provided even if they have not been used in the registration.

(A complex combination of hydrocarbons obtained from catalytic isomerisation of straight chain paraffinic C4 through C6 hydrocarbons. It consists predominantly of saturated hydrocarbons such as isobutane, isopentane, 2,2-dimethylbutane, 2-methylpentane, and 3-methylpentane.)

(A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100 to 220 °C according to DIN 52025.)

(A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of two-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260 to 290 °C.)

6.4. For any exposure scenario, the risk to humans and the environment can be considered to be adequately controlled, throughout the lifecycle of the substance that results from manufacture or identified uses, if:

(A complex combination of hydrocarbons obtained by the extraction of hydrogen from a gas stream which consists primarily of hydrogen with small amounts of nitrogen, carbon monoxide, methane, ethane, and ethylene. It contains predominantly hydrocarbons such as methane, ethane, and ethylene with small amounts of hydrogen, nitrogen and carbon monoxide.)

[A complex combination of hydrocarbons obtained by the treatment and distillation of light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 35 °C to 80 °C (95 °F to 176 °F).]

at the Executive Director's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries;

For all nanoforms covered by the registration certain specific information items shall be provided. Nanoforms shall be characterised as provided for in this Annex. The registrant shall justify why the information provided in the joint registration, covering the information requirements for the registered substances with nanoforms, is adequate for assessing the nanoforms. Information relevant to cover information requirements for such a substance can also be submitted separately by individual registrants, where justified in accordance with Article 11(3).

You’ve now found the staple t-shirt of your wardrobe. It’s made of a thicker, heavier cotton, but it’s still soft and comfy. Able to fit any lifestyle, whether on the flight line or not!

3.0.1. The objective of the environmental hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008 and to identify the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is known as the Predicted No-Effect Concentration (PNEC).

(A complex combination of hydrocarbons obtained by the stabilisation of light straight-run naphtha. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

1.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included. For instance, for acute effects it is usually not possible to establish the quantitative dose (concentration)-response (effect) relationship on the basis of the results of a test conducted in accordance with test methods laid down in a Commission Regulation as specified in Article 13(3). In such cases it suffices to determine whether and to which degree the substance has an inherent capacity to cause the effect.

(A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127 °C to 188 °C.)

If nanoforms covered by a registration are grouped or placed in a ‘category’ with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner.

( 27 )  OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for bioaccumulation or unlikely direct and indirect exposure of the aquatic compartment.

where the substance is not incorporated in an article the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4)(a) to (f) apply;

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

2.  For the purposes of this entry use of a mixture ‘for tattooing purposes’ means injection or introduction of the mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the aim of making a mark or design on his or her body.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required.

(9)  co-formulants in pesticides and biocides. However national authorisations for pesticides or biocidal products containing nonylphenol ethoxylates as co-formulant, granted before 17 July 2003, shall not be affected by this restriction until their date of expiry.

9.  This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or generate a vapour pressure of more than 300 kPa at temperature of 50 °C, with the exception of formaldehyde (CAS No 50-00-0, EC No 200-001-8).

The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as the Member State Committee) and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45.

(A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately - 40 °C to 80 °C.)

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

(A complex combination of hydrocarbons obtained by distillation of a blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide, and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

5.  If Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended after 4 January 2021 to classify or re-classify a substance such that the substance then becomes caught by point (a), (b), (c) or (d) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the date of application of that new or revised classification is after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect on the date of application of that new or revised classification.

(A complex combination obtained by absorbing hydrogen from a hydrogen rich stream. It consists of hydrogen, carbon monoxide, nitrogen, and methane with small amounts of C2 hydrocarbons.)

The chemical identity of the main constituent of the substance shall be provided by providing at least the product identifier or one of the other means of identification given in subsection 1.1.

(substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof)

Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:

9. The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f):

The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.

(A complex combination of hydrocarbons obtained from the fractionation stabilisation products from isomerised naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

(A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230 to 255 °C. Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.)

Where an only representative has been appointed, details of the non-Union manufacturer or formulator may also be provided.

or, if the abovementioned is not reasonably practicable as in the case of, for example, smallness of size of the article, the unsuitable nature of the article's properties or certain technical difficulties by means of a hand-out with labelling in accordance with 3.1.

polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

(The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155 to 180 °C. Composed primarily of indene, indan and trimethylbenzenes.)

(A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 343 °C to 399 °C.)

(The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190 to 270 °C. Composed primarily of substituted dinuclear aromatics.)

the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.

(b)  the number of cases of reported and recognised occupational asthma and occupational respiratory and dermal diseases in relation to diisocyanates;

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.

Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the duty of professional secrecy.

Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).

0.11. When assessing the risk of the use of one or more substances incorporated into a special ►M3  mixture ◄ (for instance alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account.

(A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380 °C.)

The competent authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.

(A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydro-carbons having carbon numbers predominantly in the range of C2 through C5.)

3.2.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.

[The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.]

(A complex combination of hydrocarbons obtained by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121 to 510 °C.)

A substance is defined in accordance with Article 3(1) and identified in accordance with section 2 in this Annex. A substance is always manufactured or imported in at least one form. A substance can also occur in more than one form.

The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.

(A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 220 °C.)

[The liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30 °C to 300 °C (86 °F to 572 °F). Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.]

if the product identifier is not available, one of the other names (usual name, trade name, abbreviation) or identification numbers.

(A complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint. ►M21   However, Member States may, in accordance with the provisions of International Labour Organization (ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors, as well as the placing on the market for such use. Where a Member State makes use of this derogation, it shall inform the Commission thereof.  ◄

[A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65 °C to 230 °C (148 °F to 446 °F).]

Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.

(A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 35 °C to 125 °C, benzene and toluene.)

(A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C. It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 % vol. or more benzene.)

(A complex combination of hydrocarbons from the distillation of saturated and unsaturated hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly butane and isobutane. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C4, predominantly isobutane.)

Briefly summarised information shall be provided on the most important symptoms and effects, both acute and delayed, from exposure.

In some cases, there are classification requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance and the group entry will be annotated with the phrase ‘except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008’.

For dossiers for the purposes of identifying substances referred to in Article 57(d) and Article 57(e), relevant information from the registration dossiers and other available information as described in Section 3 shall be considered.

(A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.)

— effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or

(The distillate from coal tar having an approximate distillation range of 100 to 450 °C. Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.)

3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphere ( 32 ).

(The distillation residue remaining after the distillation of the neutralised, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.)

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented.

The information required by this Annex shall be included in the safety data sheet, where applicable and available, in the relevant subsections set out in Part B. The safety data sheet shall not contain blank subsections.

[A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816 °C (1 500 °F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.]

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C.)

(A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.)

The inclusion of additional relevant and available information in the relevant subsections may be necessary in some cases in view of the wide range of properties of substances and mixtures.

The sub-chronic toxicity study (90 days) (Annex IX, point 8.6.2) shall be proposed by the registrant, or may be required by the Agency if:

(The distillation from alkali-washed naphthalene oil having an approximate distillation range of 180 to 220 °C. Composed primarily of naphthalene, alkylbenzenes, indene and indan.)

3.  By way of derogation to paragraph 2, the concentration limit shall be 10 ppm for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, where they are present in a substance to be used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met for the manufacturing of fluorochemicals with a perfluoro carbon chain length equal to or shorter than 6 atoms. The Commission shall review this limit no later than 25 August 2023.

(A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulphuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.)

When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, an appropriate metric for the assessment and presentation of the results in steps 1- 6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation is preferable, ensuring availability of mass metric information.

[A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately – 49 °C to 68 °C (– 57 °F to 155 °F).]

use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

Potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate;

3.3. Articles containing asbestos and which are packaged only in loose plastic wrapping or the like shall be regarded as packaged articles and shall be labelled in accordance with 3.2. If articles are separated from such packages and placed on the market unpackaged, each of the smallest units supplied shall be accompanied by labelling particulars in accordance with 3.1.

(A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390 °C to 550 °C.)

[A complex combination of hydrocarbons obtained as the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C8 and boiling in the range of approximately 100 °C to 200 °C (212 °F to 392 °F).]

[A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 125 °C (94 °F to 257 °F), benzene and toluene.]

the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods.

(A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.)

Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g).

This section of the safety data sheet shall recommend the appropriate response to spills, leaks, or releases, to prevent or minimise the adverse effects on persons, property and the environment. It shall distinguish between responses to large and small spills, in cases where the spill volume has a significant impact on the hazard. If the procedures for containment and recovery indicate that different practices are required, these shall be indicated in the safety data sheet.

(A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C.)

(h)  in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that substance in that Appendix.

( 35 ) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

1.  Shall not be placed on the market, or used, in cellulose insulation mixtures or cellulose insulation articles after 14 July 2018 unless the emission of ammonia from those mixtures or articles results in a concentration of less than 3 ppm by volume (2,12 mg/m3) under the test conditions specified in paragraph 4.

1.1.4. Where an only representative has been appointed in accordance with Article 8(1), the following information regarding the natural or legal person established outside the Union who appointed the only representative: name, address, telephone number, email address, contact person, location of the production site(s) or formulation site(s), as appropriate, company website, as appropriate and national company identification number(s), as appropriate.

(A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulphide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

Properties, safety characteristics and test results listed below may be useful to indicate as regards a substance or a mixture:

recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;

as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.)

submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and relevant stakeholder organisations.

Each safety data sheet shall include the properties mentioned below. If it is stated that a particular property does not apply or if information on a particular property is not available, this shall be clearly indicated, giving the reasons where possible.

For the identification of PBT and vPvB substances in the registration dossier, the registrant shall consider the information as described in Annex I and in Section 3 of this Annex.

(A complex combination of hydrocarbons obtained by solvent dearomatisation of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370 °C to 450 °C.)

The information required by the employer to fulfil his commitments under Union environmental protection legislation shall be specified.

If points (a), (b) or (c) apply, the manufacturer or importer shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment, or the nature of the disagreement, as the case may be.

(The distillation fraction boiling in the range of approximately 180 to 200 °C from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.)

The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or ►M3  mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.

(The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70 to 120 °C.)

[A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately – 20 °C to 190 °C (– 4 °F to 374 °F).]

1.1.3. All non-human information used to assess a particular effect on humans and to establish the dose (concentration) – response (effect) relationship, shall be briefly presented, if possible in the form of a table or tables, distinguishing between in vitro, in vivo and other information. The relevant test results (e.g. ATE, LD50, NO(A)EL or LO(A)EL) and test conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

(c)  measures for the safe handling of dichloromethane in strip tanks comprising: pumps and pipework for transferring paint stripper to and from strip tanks; and suitable arrangements for safe cleaning of tanks and removal of sludge;

If available and appropriate, further information may be indicated, such as whether the effect of ignition is other than a normal combustion (e.g. an explosion) and the ignitability under non-standard conditions.

The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.

(A complex combination of hydrocarbons obtained from lignite carbonisation tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.)

Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.

in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2  % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C.)

3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there is more than one study addressing the same effect, then the study or studies giving rise to the highest concern shall be used to draw a conclusion and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study being used but also for all studies reaching a higher concern than the study being used. For substances where all available studies indicate no hazards an overall assessment of the validity of all studies should be performed.

(The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70 to 210 °C.)

(A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.)

Any relevant Union provisions relating to waste or, in their absence, any relevant national or regional provisions in force shall be referred to.

Detergents as defined by Regulation (EC) No 648/2004 of the European Parliament and of the Council (1). The derogation shall apply until 1 June 2013.

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

( 39 )  Note: The term ‘explosion limit’ is synonymous to ‘flammability limit’, used outside the Union.

appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and

For registrants, the information on the supplier of the safety data sheet and, if provided, on the supplier of the substance or mixture, shall be consistent with the information on the identity of the manufacturer, importer or only representative provided in the registration.

[A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30 °C to 205 °C (86 °F to 401 °F).]

When using a range of percentages, if the effects of the mixture as a whole are not available, the health and environmental hazards shall describe the effects of the highest concentration of each ingredient.

(A complex combination of hydrocarbons obtained as residue from the distillation of steam-cracked heat-soaked naphtha and boiling in the range of approximately 150 °C to 350 °C.)

In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.

Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg.; Low boiling point thermally cracked naphtha

effectiveness: the restriction must be targeted to the effects or exposures that cause the risks identified, capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to the risk;

if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0,5 μg/cm2/week.

5.2.1. The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant heading of the Chemical Safety Report and where required and in accordance with Article 31, summarised in an annex to the safety data sheet. The exposure estimation entails three elements: (1) emission estimation; (2) assessment of chemical fate and pathways; and (3) estimation of exposure levels.

(A complex combination stripped from the liquid product of the unifiner desulphurisation process. It consists of hydrogen sulphide, methane, ethane, and propane.)

8.4.7.  The study does not need to be conducted if there is clear evidence that neither the substance nor its metabolites reach the germ cells.

The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database.

9.1.6.  Fish short-term toxicity tests on embryo and sac-fry stages (OECD TG 212) that were initiated before 14 April 2022 shall be considered appropriate to address this standard information requirement provided that the substance is not highly lipophilic (log Kow > 4) or there is no indication of endocrine disrupting properties or any other specific mode of action.

In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted.

The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors, and shall have it published.

— a pre-natal developmental toxicity study (OECD TG 414) referred to in Annex IX, point 8.7.2 or an Extended One-Generation Reproductive Toxicity Study (OECD TG 443) referred to in Annex IX, point 8.7.3 is available or proposed by the registrant; or a Two-Generation Reproductive Toxicity Study (OECD TG 416) is available,

(Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 to 300 °C. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.)

a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

[A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C (194 °F to 446 °F).]

(A complex combination obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulphide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons produced by treating a dewaxed light paraffinic distillate with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.)

Any data generated as from 1 June 2008 shall not be considered as existing data and shall not be subject to the general rules for adaptation laid down in this point (1.1).

(A complex combination obtained by the fractionation of products from the fluidised catalytic cracker and gas oil desulphuriser. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.

Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant).

the downstream user is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment.

When nanoforms are covered by the registration, the above approach shall address the nanoforms separately. For grouping different nanoforms of the same substance, the molecular structural similarities alone may not serve as a justification.

(A complex combination of hydrocarbons obtained from a treating process to remove acidic materials. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of aliphatic hydrocarbons.)

A mixture of: disodium (6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-);

(A complex combination of hydrocarbons obtained by the fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(Pyridine bases boiling in the range of approximately 125 to 160 °C obtained by distillation of neutralised acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.)

Two-generation reproductive toxicity studies (B.35, OECD TG 416) that were initiated before 13 March 2015 shall be considered appropriate to address this standard information requirement.

(A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.)

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 % wt or more four- to six-membered ring aromatic hydrocarbons.)

(The feed gas to the amine system for removal of hydrogen sulphide. It consists primarily of hydrogen. Carbon monoxide, carbon dioxide, hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 may also be present.)

The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:

Trisodium-[4'-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4''-(6-benzoylamino-3-sulfonato-2-naphthylazo)biphenyl-1,3',3'',1'''-tetraolato-O, O', O'', O''']copper(II)

(A complex combination stripped from the liquid product of the heavy distillate hydrotreater desulphurisation process. It consists of hydrogen, hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

8.2.  An in vivo study for serious eye damage/eye irritation shall be conducted only if the in vitro study/studies) under point 8.2.1 of Annex VII is/are not applicable, or the results of this/these study/studies) are not adequate for classification and risk assessment.

[A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.]

Chromium (VI) compounds, with the exception of barium chromate and of compounds specified elsewhere in ►M5  Annex VI to Regulation (EC) No 1272/2008 ◄

1.1.2.   Data on human health and environmental properties from experiments not carried out according to GLP or the test methods referred to in Article 13(3)

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

[A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 190 °C (– 4 °F to 374 °F). It contains a relatively large proportion of unsaturated hydrocarbons.]

2.  Articles which are the subject of paragraph 1 shall not be placed on the market unless they conform to the requirements set out in that paragraph.

this supplier provides the full registration number to the Member State authority responsible for enforcement (the enforcement authority) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof.

If nanoforms are covered by the registration, physicochemical characteristics, in particular particle size, shape and other morphological parameters, surface functionalisation and surface area, as well as molecular structure shall be taken into consideration when determining if one of the conditions above are met.

(The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150 °C from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.)

Where appropriate, information shall be provided on clinical testing and medical monitoring for delayed effects, specific details on antidotes (where they are known) and contraindications.

Distillates (petroleum), naphtha steam cracking-derived, solvent-refined light hydrotreated; Low boiling point modified naphtha

[Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 °C to 300 °C (86 °F to 572 °F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.]

Where technically and scientifically justified, the methodologies set out in Annex XI.1.5 shall be used within a registration dossier when two or more forms of a substance are ‘grouped’ for the purposes of one, more or possibly all the information requirements.

— the substance is known to be a germ cell mutagen, meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B and appropriate risk management measures are implemented,

Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the test methods referred to in Article 13(3), more specifically on the technical limitations of a specific method, shall always be respected.

(A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C20 and boiling in the range of approximately 205 °C to 345 °C.)

In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:

The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available.

The ancillary requirements in paragraphs 7 and 8 of column 2 of this entry apply to all mixtures for use for tattooing purposes, whether or not they contain a substance falling within points (a) to (d) of this column of this entry.

(A complex combination of hydrocarbons obtained from hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons obtained from sulphur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65 10-6 m2.s-1 at 50 °C.)

8.1.1. Where available, the following national limit values, including the legal basis of each of them, which are currently applicable in the Member State in which the safety data sheet is being provided shall be listed for the substance or for each of the substances in the mixture. When listing occupational exposure limit values, the chemical identity as specified in section 3 shall be used.

(Off gases produced by the benzene unit. It consists primarily of hydrogen. Carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6, including benzene, may also be present.)

9.1.  Long-term aquatic toxicity testing referred to in Annex IX, subsection 9.1, in addition to short-term toxicity testing shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects on aquatic organisms, for example when further information is needed for the refinement of the PNEC or if additional toxicity information as set out in Annex XIII, point 3.2.3, would be necessary to assess PBT or vPvB properties of the substance.

(A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulphurised and dearomatised. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120 °C to 130 °C.)

[A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45 °C to 185 °C (113 °F to 365 °F).]

Tail gas (petroleum), hydrodesulphurised distillate and hydrodesulphurised naphtha fractionator, acid-free; Petroleum gas

(A complex combination of hydrocarbons separated from the gases from vapour recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 196 °C.)

(A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100 to 220 °C according to DIN 52025.)

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C1 through C6, predominantly C1 through C5.)

(A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 with which natural gas may also be mixed.)

(A complex combination of hydrocarbons obtained by the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6 and boiling in the range of approximately 0 °C to 80 °C.)

Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.

This section of the safety data sheet is meant for use primarily by medical professionals, occupational health and safety professionals and toxicologists. A concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects shall be provided, including where appropriate information on toxicokinetics, metabolism and distribution. The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.

(A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35 °C to 160 °C.)

(A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydro-carbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 220 °C.)

request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.

in the case of mixtures, an indication of which of the methods of evaluating information referred to in Article 9 of Regulation (EC) No 1272/2008 was used for the purpose of classification;

8.7.3.   ►M70  An Extended One-Generation Reproductive Toxicity Study with the extension of cohort 1B to include the F2 generation shall be proposed by the registrant or may be required by the Agency if: ◄

— Long-term toxicity testing on fish referred to in Annex IX, point 9.1.6, shall be proposed by the registrant or may be required by the Agency when it is unlikely that short-term toxicity testing can provide a true measure of the intrinsic aquatic toxicity of the substance, for instance:

More specific information on the flammability may be indicated based on the respective hazard classification. The information provided in subsection 9.2.1 shall not be provided in this point.

(A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated, microcrystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C20.)

trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate

Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:

(A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidise mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.)

(A complex combination of hydrocarbons obtained by the extraction of hydrogen from a gas stream which consists primarily of hydrogen with small amounts of nitrogen, carbon monoxide, methane, ethane, and ethylene. It contains predominantly hydrocarbons such as methane, ethane, and ethylene with small amounts of hydrogen, nitrogen and carbon monoxide.)

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons obtained from fractionation stabilisation of catalytic reformed naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

►M3   40.  Substances classified as flammable gases category 1 or 2, flammable liquids categories 1, 2 or 3, flammable solids category 1 or 2, substances and mixtures which, in contact with water, emit flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 or pyrophoric solids category 1, regardless of whether they appear in Part 3 of Annex VI ►M21  to Regulation (EC) No 1272/2008 ◄ or not.  ◄

1.  Shall not be placed on the market for the first time after 27 June 2010, for supply to the general public, as a constituent of neoprene-based contact adhesives in concentrations equal to or greater than 0,1 % by weight in package sizes greater than 350 g.

— the substance is known to be a germ cell mutagen, meeting the criteria for classification in the hazard class germ cell mutagenicity (category 1A or 1B) and appropriate risk management measures are implemented, or

[A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.]

(A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.)

The supplier of a substance or a ►M3  mixture ◄ shall provide the recipient of the substance or ►M3  mixture ◄ with a safety data sheet compiled in accordance with Annex II:

(b)  in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;

in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;

(A complex combination of hydrocarbons obtained from the distillation of products from the catalytic cracking of gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

[A complex combination of hydrocarbons obtained from a catalytic cracked gas stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.]

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C2 through C4, predominantly C3.)

(A complex combination of hydrocarbons obtained by hydrodesulphurisation of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304 to 548 °C. Likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(A complex combination of hydrocarbons produced by the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C15 and boiling in the range of approximately 43 °C to 250 °C.)

(A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.)

( *1 ) EN 16516: Construction products – Assessment of release of dangerous substances – Determination of emissions into indoor air.

Information shall be provided for each hazard class or differentiation. If it is stated that the substance or mixture is not classified for a particular hazard class or differentiation, the safety data sheet shall clearly state whether this is due to lack of data, technical impossibility to obtain the data, inconclusive data or data which are conclusive although insufficient for classification; in the latter case the safety data sheet shall specify ‘based on available data, the classification criteria are not met’.

if it is unlikely that these effects will occur at the concentrations present, such as when a mild irritant is diluted to below a certain concentration in a non-irritant solution;

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(d).

[A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35 °C to 200 °C (95 °F to 428 °F).]

(A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 70 °C to 100 °C.)

The Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance.

2.   Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59

[The distillate from coke oven light oil having an approximate distillation range below 100 °C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic polymerised naphtha. It consists of aliphatic hydrocarbons having carbon numbers in the range of C2 through C6, predominantly C2 through C4.)

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity (category 1A or 1B or 2) and carcinogenicity (category 1A or 1B), and appropriate risk management measures are implemented, or

2.  By way of derogation, paragraph 1 shall not apply to placing on the market of cellulose insulation mixtures intended to be used solely for the production of cellulose insulation articles, or to the use of those mixtures in the production of cellulose insulation articles.

(A complex combination of hydrocarbons obtained by refining crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 23 10-6 m2.s-1 at 40 °C.)

(A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 through C4.)

(A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.)

(A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately - 164 °C to - 42 °C.)

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

(A complex combination obtained by separation of the liquid phase from the effluent from the hydrogenation reaction. It consists predominantly of hydrogen, hydrogen sulphide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

These properties shall be indicated at standard pressure. A boiling point at lower pressure might however be indicated, in case the boiling point is very high or in case decomposition occurs before boiling at standard pressure.

8.2.2.2. Taking into account Regulation (EU) 2016/425 of the European Parliament and of the Council ( 38 ) and referring to the appropriate CEN standards, detailed specifications shall be given on which equipment will provide adequate and suitable protection, including:

(The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816 °C of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C9 and boiling at approximately 204 °C.)

(A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 16 10-6 m2.s-1 at 40 °C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C29 and boiling in the range of approximately 250 °C to 425 °C.)

(A complex combination of hydrocarbons obtained from the distillation of the reaction products of propane with propylene. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons that is used as the feed into the Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

[A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 °C to 200 °C (167 °F to 392 °F).]

(a)  medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b)  cosmetic products as defined by Directive 76/768/EEC; (c)  the following fuels and oil products: — motor fuels which are covered by Directive 98/70/EC, — mineral oil products intended for use as fuel in mobile or fixed combustion plants, — fuels sold in closed systems (e.g. liquid gas bottles); ►M3   (d)  artists’ paints covered by Regulation (EC) No 1272/2008;  ◄ ►M14   (e)  the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date;  ◄ ►M61   (f)  devices covered by Regulation (EU) 2017/745.  ◄

[This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m- and p-cresol and boiling in the range of 140 °C to 215 °C (284 °F to 419 °F).]

2.  Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures containing them in concentrations equal to or greater than 0,1 % by weight is visibly, legibly and indelibly marked as follows:

The Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following information is available in the Agency database:

[A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35 °C to 230 °C (95 °F to 446 °F).]

— Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (*6).

(A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

6.  If Annex II or Annex IV to Regulation (EC) No 1223/2009 is amended after 4 January 2021 to list or change the listing of a substance such that the substance then becomes caught by point (e), (f) or (g) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect from the date falling 18 months after entry into force of the act by which that amendment was made.

(The feed gas to the amine system for removal of hydrogen sulphide. It consists primarily of hydrogen. Carbon monoxide, carbon dioxide, hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 may also be present.)

[The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.]

If data from a test method using the reference conditions specified above are not available or suitable for the measurement of the formaldehyde released from a specific article, data obtained from a test method using non-reference conditions may be used, where there is a scientifically valid correlation between the results of the test method used and the reference conditions.

(A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C.)

(The complex combination of dry gases from a gas concentration unit. It consists of hydrogen, hydrogen sulphide and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;

The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:

adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);

— a substance is known to cause developmental toxicity, meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment.

[A complex combination of hydrocarbons obtained by crystallization of naphthalene oil.Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.]

( 40 ) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

(A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80 to 160 °C.)

[A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C (95 °F to 374 °F).]

[A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C (149 °F to 446 °F).]

(A colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 149 °C to 205 °C.)

[A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 190 °C (– 4 °F to 374 °F).]

5.  Wood treated with arsenic compounds that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4 may remain in place and continue to be used until it reaches the end of its service life.

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented.

(Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 to 280 °C. Composed primarily of hydrogenated two-ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.)

(A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

[A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C (266 °F to 410 °F).]

a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII;

The Agency shall keep an up-to-date list of experts. The list shall include the experts referred to in the first subparagraph and other experts identified directly by the Secretariat.

(The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.)

(A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

The formaldehyde released from articles referred to in paragraph 1, first subparagraph of entry 77 shall be measured in the air of a test chamber under the following cumulative reference conditions:

[A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33 °C to 60 °C (91 °F to 140 °F).]

[technical product – reaction mass of 4-methyl-m-phenylene diamine (EC No 202-453-1) and 2-methyl-m-phenylene diamine (EC No 212-513-9)]

5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of the process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The first assessment will be based on the required minimum and all available hazard information and on the exposure estimation that corresponds to the initial assumptions about the operating conditions and risk management measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that risks to human health and the environment are not adequately controlled, then it is necessary to carry out an iterative process with amendment of one or a number of factors in hazard or exposure assessment with the aim to demonstrate adequate control. The refinement of hazard assessment may require generation of additional hazard information. The refinement of exposure assessment may involve appropriate alteration of the operational conditions or risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario, resulting from the final iteration (a final exposure scenario), shall be included in the chemical safety report and attached to the safety data sheet in accordance with Article 31.

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:

(A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulphide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

— there are factors indicating that short-term aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes,

(d)  articles exclusively for industrial or professional use unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use;

Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:

— the substance is a gas. In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.

(A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C20 through C50.)

[A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35 °C to 160 °C (95 °F to 320 °F).]

a safety data sheet is not required to be communicated with the substance or ►M3  mixture ◄ in accordance with Article 31;

there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

1.  Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles which can be placed in the mouth by children. 2.  Such toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market. ►M30   ◄ 4.  For the purpose of this entry ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.

the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or

[The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70 °C to 120 °C (158 °F to 248 °F).]

[A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C (266 °F to 410 °F).]

2.  For the purposes of this entry, ‘wash-off cosmetic products’ means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application.

where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).

use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;

(d)  personal protective equipment that complies with Directive 89/686/EEC comprising: suitable protective gloves, safety goggles and protective clothing; and appropriate respiratory protective equipment where compliance with relevant occupational exposure limits cannot be otherwise achieved;

one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;

The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a ►M3  mixture ◄ or in an article or a group of substances.

(A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately - 51 °C to - 34 °C.)

(A complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.)

For nanoforms without high dissolution rate in biological media, the study shall include toxicokinetic investigations on, among others, the recovery period and, where relevant, lung clearance. Toxicokinetic investigations do not need to be performed if equivalent toxicokinetic information on the nanoform is already available.

To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in ►M3  mixtures ◄ or in articles which is not of a confidential nature.

the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;

(A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

(A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370 °C to 450 °C.)

Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).

the substance is present in a ►M3  mixture ◄ in a concentration lower than any of the concentrations set out in Article 14(2);

the uncertainty arising, among other factors, from the variability in the experimental information and from intra- and inter-species variation;

(A complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

10.1.1. The reactivity hazards of the substance or mixture shall be described. Specific test data shall be provided for the substance or mixture as a whole, where available. However, the information may also be based on general data for the class or family of substance or mixture if such data adequately represent the anticipated hazard of the substance or mixture.

Note that as there is no test method to determine the oxidising properties of gaseous mixtures, the evaluation of these properties must be realised by an estimation method based on the comparison of the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air.

(c)  in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;

This section of the safety data sheet shall describe the initial care in such a way that an untrained responder can understand and provide it without the use of sophisticated equipment and without the availability of a wide selection of medications. If medical attention is required, the instructions shall state this, including its urgency.

medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;

keeping a Manual of Decisions and Opinions based on conclusions from the Member State Committee regarding interpretation and implementation of this Regulation;

2.3.6. All necessary quantitative analytical data specific for the identification of the substance, such as chromatographic, titrimetric, elemental analysis or diffraction data

Safety data sheets shall also be required for the special cases listed in paragraph 1.3 of Annex I to Regulation (EC) No 1272/2008 for which there are labelling derogations.

( 17 ) Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC and revising the list of Member States designated as rapporteurs for those substances (OJ L 98, 7.4.2001, p. 6).

[The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220 °C to 230 °C (428 °F to 446 °F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.]

As regards nanoforms of a substance for which the n-octanol/water partition coefficient does not apply, the dispersion stability in different media shall be indicated.

where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

( 21 )  OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a weight-of-evidence approach.

subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;

the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or

( 37 ) Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).

There is sufficient weight of evidence when information from several independent sources together enable, through a reasoned justification, a conclusion on the information requirement, while the information from each single source alone is insufficient to fulfil the information requirement. The justification must have regard to the information that would otherwise be obtained from the study that shall normally be performed for this information requirement.

the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.

This section of the safety data sheet shall provide advice on safe handling practices. It shall emphasise precautions that are appropriate to the identified uses referred to under subsection 1.2 and to the unique properties of the substance or mixture.

(A complex combination of hydrocarbons from the distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 49 °C to 63 °C.)

substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;

2.  Articles or any parts thereof containing one or more of these substances shall not be placed on the market after 10 October 2017 if the concentration of mercury in the articles or any part thereof is equal to or greater than 0,01 % by weight.

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, ►M3  mixture ◄ or article.

[A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20 °C to 130 °C (68 °F to 266 °F).]

[A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30 °C to 250 °C (86 °F to 482 °F).]

(A complex combination of hydrocarbons obtained from stripping stabilisation of catalytic hydrodesulphurised vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(a)  road vehicles exclusively for industrial or professional use unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use;

List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2.1

[A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.]

(A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.)

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1 000 tonnes or more in accordance with Article 12(1)(e). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen, methane, and ethane with various small amounts of hydrogen sulphide and aliphatic hydrocarbons having carbon numbers predominantly in the range C3 through C5.)

At least a brief description of the identified uses (for example, floor cleaning, or industrial use in polymer production, or professional use in cleaning agents) relevant for the recipient(s) of the substance or mixture shall be indicated.

it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;

1.  Shall not be placed on the market in articles, after 6 August 2026, if, under the test conditions specified in Appendix 14, the concentration of formaldehyde released from those articles exceeds:

(A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400 °C.)

8.5.2.  Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

(A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135 to 210 °C. May also include unsaturated hydrocarbons such as indene and coumarone.)

substances presenting a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, if those substances are present in concentrations equal to or greater than the lowest of any of the following:

(The anthracene-rich solid obtained by the crystallisation and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.)

The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1).

(A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

( 19 ) Commission Decision 2003/565/EC of 25 July 2003 extending the time period provided for in Article 8(2) of Council Directive 91/414/EEC (OJ L 192, 31.7.2003, p. 40).

(A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230 °C to 350 °C. It produces a finished oil having a viscosity of 2 10-6 m2.s-1 at 100 °C.)

For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, the Commission, on behalf of the Agency, and using the budget provided for the latter, may:

For substances indicated in this subsection by means of an alternative chemical name in accordance with Article 24 of Regulation (EC) No 1272/2008, the registration number, EC number and other precise chemical identifiers are not necessary.

0.2.4. The language used in the safety data sheet shall be simple, clear and precise, avoiding jargon, acronyms and abbreviations. Statements such as ‘may be dangerous’, ‘no health effects’, ‘safe under most conditions of use’ or ‘harmless’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not be used.

3.1.3. All information used to assess the effects on a specific environmental sphere shall be briefly presented, if possible in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

(A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.

(A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately –10 °C to 130 °C.)

(A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of straight run distillates and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained from fractionation of hydrodesulphurised naphtha and distillate hydrocarbon streams and treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

The Management Board shall appoint the Executive Director pursuant to Article 84 and an accounting officer in accordance with Article 43 of Regulation (EC, Euratom) No 2343/2002.

( 24 )  OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.

(A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325 to 365 °C. It contains predominantly anthracene and phenanthrene and their alkyl derivatives.)

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

If the substance is classified as germ cell mutagen category 1A or 1B, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required.

( 48 ) IGC Code means the International Code for the Construction and Equipment of Ships Carrying Liquefied Gases in Bulk, including applicable amendments in accordance with which the vessel has been certified.

— in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.

(A complex combination of hydrocarbons obtained by distillation from the product of naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 230 °C.)

(A complex combination of hydrocarbons obtained by distillation of the polymerised C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.)

Shall not be placed on the market or used, as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight, where the substance or the mixture is placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas.

(A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230 °C to 400 °C.)

8.9.1.  A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:

As regards mixtures, if it is technically not possible to determine their boiling point or range, this shall be indicated; in that case, the boiling point of the lowest boiling ingredient shall also be indicated.

that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

(A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.)

— indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, and in particular for nanoforms indirect genotoxicity), or

If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.

The applicable label elements in accordance with Article 25(1) to (6) and Article 32(6) of Regulation (EC) No 1272/2008 shall be provided.

(A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallisation process. It is composed primarily of naphthalene and alkyl naphthalenes.)

This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in section 3 of the safety data sheet.

[A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C13 and boiling in the range of approximately 65 °C to 230 °C (149 °F to 446 °F).]

[A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha followed by the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulphide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.)

— fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for testing unless all releases are contained;

Member States making use of this derogation shall define appropriate provisions for the protection of the health and safety of those professionals using paint strippers containing dichloromethane and shall inform the Commission thereof.

The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them.

the steady state concentration of formaldehyde measured in the test chamber shall be used to verify the compliance with the limit value of formaldehyde released from articles referred to in paragraph 1, first subparagraph, of entry 77.

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen and methane with various small amounts of carbon monoxide, carbon dioxide, nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C5.)

it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before the entry into force of this Regulation and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive;

1.  Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

(A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

(A complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

[A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10 °C to 35 °C (14 °F to 95 °F).]

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(A complex combination of hydrocarbons obtained from the distillation of the butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

(A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.)

A supplier of a cellulose insulation mixture containing inorganic ammonium salts shall inform the recipient or consumer of the maximum permissible loading rate of the cellulose insulation mixture, expressed in thickness and density.

The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following:

(The liquid product of condensation of vapours emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30 to 300 °C. Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.)

The identification shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant transformation and/or degradation products.

Further testing for nanoforms covered by the registration shall be considered by the registrant or may be required by the Agency in accordance with Article 41, if there is an indication that specific additional particle properties significantly influence the hazard of or the exposure to those nanoforms.

— the available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3.

More than one dataset may be required for one or more information requirements whenever there are significant differences in the properties relevant for the hazard, exposure and risk assessment and management of nanoforms. The information shall be reported in such a manner that it is clear which information in the joint submission pertains to which nanoform of the substance.

(A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately - 164 °C to - 42 °C.)

[The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.]

(A complex residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic fractionation process. It contains predominantly ethane, ethylene, propane, and propylene.)

[The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.]

(A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of not less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

[A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20 °C to 190 °C (– 4 °F to 374 °F). This stream is likely to contain 10 vol. % or more benzene.]

(a)  a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation, signed on December 7, 1944 , in Chicago;

Carbadox (INN); methyl 3-(quinoxalin-2-ylmethylene)carbazate 1,4-dioxide; 2-(methoxycarbonylhydrazonomethyl) quinoxaline 1,4-dioxide

(A complex combination of hydrocarbons from the distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C15 through C39 and boiling in the range of approximately 260 °C to 600 °C.)

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C.)

1.  Shall not be placed on the market for the first time after 27 June 2010, for supply to the general public, as a constituent of spray paints or spray cleaners in aerosol dispensers in concentrations equal to or greater than 3 % by weight.

Any actor in the supply chain of a substance or a ►M3  mixture ◄ shall communicate the following information to the next actor or distributor up the supply chain:

[The aqueous extract produced by an acidic wash of alkali-washed naphthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.]

(a)  in the case of plant and machinery already in service on 18 June 1994, until such plant and machinery is disposed of;

Bioaccumulative potential is the potential of the substance or certain substances in a mixture to accumulate in biota and, eventually, to pass through the food chain. Test results relevant to assess the bioaccumulative potential shall be given. This shall include reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), or other relevant parameters related to bioaccumulation, if available.

the sensitivity of the human (sub-)population to which the quantitative and/or qualitative information on exposure applies.

The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.

(A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

Tail gas (petroleum), hydrodesulphurised distillate and hydrodesulphurised naphtha fractionator, acid-free; Petroleum gas

the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000 .

For mixtures, a value for the mixture shall be indicated, if available. Otherwise, the flash point(s) of the substance(s) with the lowest flash point(s) shall be indicated.

(A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;

at the Commission's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries;

[A complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C2 through C8.]

Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain.

2.  Spray paints and spray cleaners in aerosol dispensers containing DEGBE and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010.

the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

— the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent. In such cases, an indication of whether the solution density is higher or lower than the solvent density is sufficient, or

(A complex residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic reformed naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).

(A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.)

1.  Shall not be placed on the market as a substance on its own or in mixtures in a concentration equal to or greater than 0,3 % after 9 May 2020 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 14,4 mg/m3 for exposure by inhalation and 4,8 mg/kg/day for dermal exposure.

[A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C (194 °F to 446 °F).]

(A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulphide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

[A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately – 10 °C to 130 °C (14 °F to 266 °F).]

(A complex combination of hydrocarbons provided by thermal cracking and absorber operations and by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately minus 164 °C to minus 0,5  °C.)

(A complex combination of hydrocarbons obtained by the treatment and distillation of debenzenised light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 95 °C to 200 °C.)

(A complex combination of hydrocarbons obtained from the distillation of the reaction products of propane with propylene. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

4.  The training referred to in point (b) of paragraph 1 shall include the instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace without prejudice to any national occupational exposure limit value or other appropriate risk management measures at national level. Such training shall be conducted by an expert on occupational safety and health with competence acquired by relevant vocational training. That training shall cover as a minimum:

(A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately - 12 °C to 5 °C.)

— from 1 January 2023, uses of fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall only be allowed to sites where all releases can be contained;

The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.

[A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50 °C to 200 °C (122 °F to 392 °F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts of sulfur and oxygenated compounds.]

Potential adverse health effects and symptoms associated with exposure to the substance or mixture and its ingredients or known by-products shall be described. Available information shall be provided on the symptoms related to the physical, chemical, and toxicological characteristics of the substance or mixture following exposure. The first symptoms at low exposures through to the consequences of severe exposure shall be described, such as ‘headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death’.

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(A complex combination of hydrocarbons obtained by crystallisation of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.)

(A complex combination produced by the fractionation of the overhead product of the fluidised catalytic cracking process. It consists of hydrogen, hydrogen sulphide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons produced by distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

(A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately - 164 °C to - 0,5  °C.)

(A complex combination obtained from recycled reactor gases. It consists primarily of hydrogen with various small amounts of carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.)

for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.

The most important adverse physical, human health and environmental effects shall be listed in accordance with sections 9 to 12 of the safety data sheet, in such a way as to allow non-experts to identify the hazards of the substance or mixture.

(a)  The substances and mixtures may be used for wood treatment in industrial installations or by professionals covered by Community legislation on the protection of workers for in situ retreatment only if they contain:

(A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha followed by fractionation of the total effluent. It consists of hydrogen, methane, ethane and propane.)

(A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C24 through C50 and produces a finished oil with a viscosity in the order of 16 10-6 m2.s-1 to 75 10-6 m2.s-1 at 40 °C.)

It shall be indicated whether the substance or mixture is ignitable, i.e. capable of catching fire or being set on fire, even if not classified for flammability.

If it is necessary to protect a part of the body other than the hands, the type and quality of protection equipment required shall be specified, such as gauntlets, boots, bodysuit based on the hazards associated with the substance or mixture and the potential for contact.

Where the supplier has waived a test under Section 3 of Annex XI, he shall indicate the specific conditions of use relied on to justify the waiving.

[The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.]

8.4.5.  The study does not need to be conducted if there is clear evidence that neither the substance nor its metabolites reach the germ cells.

[A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3 °C to 194 °C (37 °F to 382 °F).]

— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or

[A complex combination of hydrocarbons from the distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately – 49 °C to 63 °C (– 57 °F to 145 °F).]

Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.

• 100% ring-spun cotton • 4.5 oz/y² (153 g/m²) • Pre-shrunk • Shoulder-to-shoulder taping • Quarter-turned to avoid crease down the center

This section of the safety data sheet shall describe the applicable occupational exposure limits and necessary risk management measures.

(A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.)

(A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.)

intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

— for solids which either melt above 300 °C or decompose before boiling. In such cases the boiling point under reduced pressure may be estimated or measured, or

the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

[A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.]

( 65 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

►M64   8.2.1.  If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/studies for this endpoint shall be performed by the registrant or may be required by the Agency.  ◄

(A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of not less than 19 10-6 m2.s-1 at 40 °C.)

(c)  Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that all treated wood placed on the market is individually labelled ‘For professional and industrial installation and use only, contains arsenic’. In addition, all wood placed on the market in packs shall also bear a label stating ‘Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking’.

[A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150 °C to 300 °C (302 °F to 572 °F) or a semi-solid or solid with a melting point up to 70 °C (158 °F). It is composed primarily of naphthalene and alkyl naphthalenes.]

(A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C21 through C33 and boiling in the range of approximately 350 °C to 480 °C.)

(A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomerised. It consists predominantly of hexane isomers boiling in the range of approximately 60 °C to 66 °C.)

— there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or

(A complex combination separated as a gas from hydrocarbon gases by chilling. It consists primarily of hydrogen with various small amounts of carbon monoxide, nitrogen, methane, and C2 hydrocarbons.)

[A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.]

( 32 ) In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing different trophic levels.

(A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

[A complex combination of hydrocarbons obtained by treating a petroleum fraction, derived from a pyrolysis process, with hydrogen in the presence of a catalyst. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C (95 °F to 374 °F).]

6.1. The risk characterisation shall be carried out for each exposure scenario and shall be presented under the relevant heading of the Chemical Safety Report.

5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

(A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66 °C to 121 °C.)

if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;

[A complex combination of hydrocarbons obtained by subjecting naphtha from a catalytic cracking process to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons boiling in a range of approximately 35 °C to 210 °C (95 °F to 410 °F).]

Information shall be provided on any special precautions, which a user should or must take or be aware of in connection with transport or conveyance either within or outside his premises, for all relevant modes of transport.

The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the potential for bioaccumulation of the substance is solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9).

[A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290 °C to 340 °C (554 °F to 644 °F). It contains chiefly trinuclear aromatics and their dihydro derivatives.]

substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;

(The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340 to 400 °C. It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.)

0.11.bis  When nanoforms are covered by the chemical safety assessment, an appropriate metric for the assessment and presentation of the results in steps 1-6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation, including mass metric information, is preferable. When possible, a method for reciprocal conversion shall be indicated.

(A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C.)

(A complex combination produced by scrubbing the overhead gas from the fluidised catalytic cracker. It consists of hydrogen, nitrogen, methane, ethane and propane.)

Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:

(The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70to 180 °C. Composed primarily of a complex mixture of hydrocarbons.)

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150 °C to 400 °C. It contains a relatively large proportion of bicyclic aromatic hydrocarbons.)

The description of appropriate exposure control measures shall relate to the identified use(s) of the substance or mixture as referred to in subsection 1.2. This information shall be sufficient to enable the employer to carry out an assessment of risk to the safety and health of workers arising from the presence of the substance or mixture in accordance with Articles 4 to 6 of Directive 98/24/EC and Articles 3 to 5 of Directive 2004/37/EC, where appropriate.

(A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C21 through C29 and produces a finished oil with a viscosity of approximately 13 10-6 m2.s-1 at 50 °C.)

[The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.]

This section of the safety data sheet shall describe the empirical data relating to the substance or mixture, if relevant. Article 8(2) of Regulation (EC) No 1272/2008 shall apply.

a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under ►M3  Title V of Regulation (EC) No 1272/2008 ◄ and any other questions that arise from the operation of this Regulation relating to risks to human health or the environment;

The specific conditions of use must be communicated through the supply chain in accordance with Article 31 or 32, as the case may be.

information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories;

As regards liquefied gas cargoes in bulk, the product name and the ship type required according to the IGC Code or its earlier versions, namely EGC Code or GC Code shall be provided.

A single safety data sheet may be provided to cover more than one substance or mixture where the information in that safety data sheet fulfils the requirements of this Annex for each of those substances or mixtures.

(A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanising. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.)

(A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.

— serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or

(A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

As regards solid bulk cargoes, the bulk cargo shipping name shall be provided. It shall be indicated whether or not the cargo is considered harmful to the marine environment (HME) according to Annex V of MARPOL, whether it is a material hazardous only in bulk (MHB) ( 53 ) according to the IMSBC Code, and as which cargo group it should be considered according to the IMSBC.

1 000 mg/kg (individually or in combination with other phthalates in this entry or in other entries of Annex XVII that are classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B

(A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreated light distillate from steam-cracked naphtha.)

(A complex combination of hydrocarbons obtained from fractionation stabilisation of light straight-run naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

3.4. Form (substance, ►M3  mixture ◄ or article) and/or physical state under which the substance is made available to downstream users. Concentration or concentration range of the substance in ►M3  mixtures ◄ made available to downstream users and quantities of the substance in articles made available to downstream users.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use:

[A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230 °C to 255 °C (446 °F to 491 °F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.]

11.1.11.1. The substances in a mixture may interact with each other in the body, resulting in different rates of absorption, metabolism and excretion. As a result, the toxic actions may be altered and the overall toxicity of the mixture may be different from that of the substances in it. This shall be taken into account when providing toxicological information in this subsection of the safety data sheet.

When nanoforms are covered by the registration, a characterisation of the dissolution rate, the particle aggregation, the agglomeration and of the particle surface chemistry changes shall be included.

(A complex combination of gases obtained from flash of the effluents after the hydrogenation reaction. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140 to 170 °C according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.)

(A complex combination stripped from the liquid product of the unifiner desulphurisation process. It consists of hydrogen sulphide, methane, ethane, and propane.)

( 34 ) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen, methane, and ethane with various small amounts of hydrogen sulphide and aliphatic hydrocarbons having carbon numbers predominantly in the range C3 through C5.)

[A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120 °C to 215 °C (248 °F to 419 °F).]

Where a chemical safety report is required, the information in this section of the safety data sheet shall be consistent with the information given for the identified uses in the chemical safety report and the exposure scenarios showing control of risk from the chemical safety report set out in the annex to the safety data sheet.

A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:

statement on whether spontaneous ignition occurs when poured or within five minutes thereafter, as regards solids in powder form,

(A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 to 255 °C.)

substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

(A complex combination produced by desulphurisation of gas oils with diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen and aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.)

Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined in the exposure scenarios for the identified uses are communicated down the supply chain.

—  This product should not be used under conditions of poor ventilation unless a protective mask with an appropriate gas filter (i.e. type A1 according to standard EN 14387) is used.’

A downstream user of a cellulose insulation mixture containing inorganic ammonium salts shall ensure that the maximum permissible loading rate communicated by the supplier is not exceeded.

6.3.2. Appropriate advice shall be provided on how to clean-up a spill. Appropriate clean-up procedures may include any of the following:

(A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.)

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented,

Disodium 4-amino 3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphtalene-2,7-disulphonate; C.I. Direct Black 38

( 50 ) GC Code means the Code for the Construction and Equipment of Ships Carrying Liquefied Gases in Bulk (Gas Carrier Code), as amended.

If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly.

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

0.3. The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The assessment shall address all nanoforms that are covered by the registration. The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.

The transport hazard class (and subsidiary risks) assigned to the substances or mixtures on the basis of the predominant hazard that they present according to the UN Model Regulations shall be provided. As regards inland transport, the transport hazard class (and subsidiary risks) assigned to the substances or mixtures on the basis of the predominant hazard that they present according to ADR, RID and ADN shall be provided.

article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

Thus the information to be considered includes information related to the hazards of the substance, the exposure arising from the manufacture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account.

3.  In the case of a Member State that, on 14 July 2016, has national provisional measures in place that have been authorised by the Commission pursuant to Article 129(2)(a), the provisions of paragraphs 1 and 2 shall apply from that date.

(c)  articles in constructions, that are exclusively used outside the building shell and vapour barrier and that do not emit formaldehyde into indoor air;

This section of the safety data sheet shall describe the stability of the substance or mixture and the possibility of hazardous reactions occurring under certain conditions of use and also if released into the environment, including, where appropriate, a reference to the test methods used. If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be given.

[A complex combination of hydrocarbons obtained by distillation of hydrodesulfurized and dearomatized light petroleum fractions. It consists predominantly of C7 paraffins and cycloparaffins boiling in a range of approximately 90 °C to 100 °C (194 °F to 212 °F).]

[Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 °C to 280 °C (356 °F to 536 °F). Composed primarily of hydrogenated two- ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.]

(a)  Sodium perborate; perboric acid, sodium salt; perboric acid, sodium salt, monohydrate; sodium peroxometaborate; perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate

If the effects of the mixture as a whole are available, the classification determined from this information shall be included under section 2.

( 8 )  OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C.)

[A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.]

[A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]

0.7. The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s) implemented for the manufacturer's production, the manufacturer or importer's own use, and those recommended by the manufacturer or importer to be implemented for the identified use(s).

1.  Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

(A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha followed by the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.)

(A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150 °C to 290 °C.)

A number of group entries are included in Part 3 of Annex VI to Regulation (EC) No 1272/2008. In these cases, the classification requirements will apply to all substances covered by the description.

in the case of a revised safety data sheet, a clear indication of where changes have been made to the previous version of the safety data sheet, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes, if appropriate. A supplier of a substance or mixture shall be able to provide an explanation of the changes upon request;

(A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270 to 600 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole.

Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulphurised; Distillate aromatic extract (treated)

this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.

( 5 )  OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

As regards nanoforms, the dissolution rate in water or in other relevant biological or environmental media shall be indicated in addition to the water solubility.

(A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.; Low boiling point cat-cracked naphtha

This subsection only applies when cargoes are intended to be carried in bulk according to IMO instruments: Chapter VI or Chapter VII of SOLAS ( 45 ), Annex II or Annex V of MARPOL, the IBC Code ( 46 ), the IMSBC Code ( 47 ), and the IGC Code ( 48 ) or its earlier versions, namely EGC Code ( 49 ) or GC Code ( 50 ).

(A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulphuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.)

As regards liquid mixtures or liquefied gas mixtures, a range for the vapour pressure or at least the vapour pressure of the most volatile ingredient(s), where the vapour pressure of the mixture is predominantly determined by that or those ingredient(s), shall be indicated.

3.2. In the case of a manufacturer or producer of articles: brief description of the technological process used in manufacture or production of articles.

(A complex combination of hydrocarbons provided by thermal cracking and absorber operations and by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately - 164 °C to - 0,5  °C.)

(A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerised C5 olefins and boiling in the range of approximately 33 °C to 184 °C.)

(A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130 °C to 200 °C.)

[A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350 °C to 360 °C (662 °F to 680 °F). It contains chiefly anthracene, carbazole and phenanthrene.]

(A complex combination of hydrocarbons obtained by fractionation of miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4, predominantly propane.)

(a)  in any post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 μg/cm2/week (migration limit);

If relevant, it shall be stated if the substance or mixture may react or polymerise, releasing excess pressure or heat, or creating other hazardous conditions. The conditions under which the hazardous reactions may occur shall be described.

The study shall be performed on one species. The need to perform a study at this tonnage level or the next on a second strain or a second species may be considered and a decision should be based on the outcome of the first test and all other relevant available data.

2.  Shall not be placed on the market in toys or childcare articles, individually or in any combination of the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.

Information on adverse health effects caused by endocrine disrupting properties shall be provided, where available, for the substances identified as having endocrine disrupting properties in Subsection 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for human health.

[A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36,1 °C to 193,3 °C (97 °F to 380 °F).]

A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than:

7.8.  The study does not need to be conducted if the substance is inorganic. If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.

(A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists of hydrocarbon having carbon numbers predominantly in the range of C1 through C4.)

— a conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat. 1A), and

(The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefactionator bottoms or washed carbolic oil boiling substantially below 145 °C. Composed primarily of C7 and C8 aliphatic and aromatic hydrocarbons.)

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic reformed naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered.

10.  This entry does not apply to the placing on the market of a mixture for use for tattooing purposes, or to the use of a mixture for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, within the meaning of Regulation (EU) 2017/745, or when used exclusively as a medical device or an accessory to a medical device, within the same meaning. Where the placing on the market or use may not be exclusively as a medical device or an accessory to a medical device, the requirements of Regulation (EU) 2017/745 and of this Regulation shall apply cumulatively.

2.3.3. Typical concentration and concentration range (in percentage) of constituents, groups of constituents that cannot be identified individually and impurities as specified in point 2.3.2

(A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40 °C.)

Information shall be provided on likely routes of exposure and the effects of the substance or mixture via each possible route of exposure, that is, through ingestion (swallowing), inhalation or skin/eye exposure. If health effects are not known, this shall be stated.

substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

(a)  the substance has uses leading to significant exposure of consumers or professionals, taking into account, inter alia, consumer exposure from articles, and

(A complex combination separated as a gas from hydrocarbon gases by chilling. It consists primarily of hydrogen with various small amounts of carbon monoxide, nitrogen, methane, and C2 hydrocarbons.)

A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under the relevant heading(s).

(A complex combination obtained from recycled reactor gases. It consists primarily of hydrogen with various small amounts of carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.)

— exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

(A complex combination of hydrocarbons obtained from distillation of products from a catalytic reforming process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 35 °C to 120 °C. It contains a relatively large proportion of branched chain hydrocarbons with the aromatic components removed.)

1.1.4. If one study is available then a robust study summary should be prepared for that study. If there are several studies addressing the same effect, then, having taken into account possible variables (e.g. conduct, adequacy, relevance of test species, quality of results, etc.), normally the study or studies giving rise to the highest concern shall be used to establish the DNELs and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study being used but also for all studies demonstrating a higher concern than the study being used. It is important irrespective of whether hazards have been identified or not that the validity of the study be considered.

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50, and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

If the substance or mixture covered by this safety data sheet is the subject of specific provisions in relation to the protection of human health or the environment at Union level (such as authorisations given under Title VII or restrictions under Title VIII) these provisions shall be mentioned. Where an authorisation granted under Title VII imposes conditions or monitoring arrangements to a downstream user of the substance or mixture, they shall be provided.

0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour and tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet.

It shall be indicated if the substance or mixture is stable or unstable under normal ambient and anticipated storage and handling conditions of temperature and pressure. Any stabilisers which are, or may need to be, used to maintain the chemical stability of the substance or mixture shall be described. The safety significance of any change in the physical appearance of the substance or mixture shall be indicated. As regards desensitised explosives, information on the shelf life and instructions on how to verify desensitisation shall be provided, and it shall be indicated that removal of the desensitising agent will turn the product into an explosive.

any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.

Flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione

without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

5.2.2. The emission estimation shall consider the emissions during all relevant parts of the life-cycle of the substance resulting from the manufacture and each of the identified uses. The life-cycle stages resulting from the manufacture of the substance cover, where relevant, the waste stage. The life-cycle stages resulting from identified uses cover, where relevant, the service-life of articles and the waste stage. The emission estimation shall be performed under the assumption that the risk management measures and operational conditions described in the exposure scenario have been implemented. ►M51  When nanoforms are covered by the registration, the emission estimation for these shall, where relevant, take account of situations when the conditions outlined in Annex XI section 3.2 point (c) are fulfilled. ◄

(A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101 to 555 °C.)

1.0.1. The objectives of the human health hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008; and to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL).

(A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydro-carbons having carbon numbers predominantly in the range of C2 through C5.)

in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

— articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,

(A complex combination of hydrocarbons obtained by the crystallisation of tar oil. It consists of aromatic and polycyclic hydrocarbons primarily fluorene and some acenaphthene.)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(A complex combination of hydrocarbons obtained from the fractionation of products from catalytic cracking, catalytic reforming and hydrodesulphurising processes treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

To enable proper control measures to be taken, all relevant information on the substance or mixture shall be provided. The information in this section shall be consistent with the information provided in the registration or in the chemical safety report, where required, and with the classification of the substance or mixture.

2.4.3. Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number

Where necessary because of the size of the package, the information listed in the first subparagraph, except for point (a), shall be included instead in the instructions for use.

(A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180 °C.)

(A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.)

In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification will be applied.

The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:

1.  Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

— da reliable sub-chronic (90 days) or chronic toxicity study is available or proposed by the registrant, provided that an appropriate species, dosage, solvent and route of administration are used, or

(A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140 °C to 210 °C.)

8.1.1.2. the national occupational exposure limit values that correspond to Union limit values in accordance with Directive 2004/37/EC, including any notations as referred to in Article 2(3) of Decision 2014/113/EU;

(A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.)

(The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148 °C.)

[The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.]

(A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20 °C to 200 °C.)

(A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60 to 80 °C.)

(A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulphide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190 °C to 330 °C.)

a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(An aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.)

(A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.)

Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.

(A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.)

— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;

Where experimental data are not available, the supplier shall consider whether reliable and relevant information obtained from models can be provided.

Where a substance has been registered as an isolated intermediate (on-site or transported), the supplier shall indicate that this safety data sheet is consistent with the specific conditions relied on to justify the registration in accordance with Article 17 or 18.

(A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately - 88 °C to 99 °C.)

(A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

1.  From 1 January 2010, extender oils shall not be placed on the market, or used for the production of tyres or parts of tyres if they contain: — more than 1 mg/kg (0,0001 % by weight) BaP, or, — more than 10 mg/kg (0,001 % by weight) of the sum of all listed PAHs. The standard EN 16143:2013 (Petroleum products — Determination of content of Benzo(a)pyrene (BaP) and selected polycyclic aromatic hydrocarbons (PAH) in extender oils — Procedure using double LC cleaning and GC/MS analysis) shall be used as the test method for demonstrating conformity with the limits referred to in the first subparagraph. Until 23 September 2016, the limits referred to in the first subparagraph may be regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by weight as measured by the Institute of Petroleum standard IP 346:1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limits of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is measured by the manufacturer or importer every six months or after each major operational change, whichever is earlier. 2.  Furthermore, tyres and treads for retreading manufactured after 1 January 2010 shall not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1. These limits shall be regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds). 3.  By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1. 4.  For the purpose of this entry ‘tyres’ shall mean tyres for vehicles covered by: — Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers (*4), — Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (*5), and — Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (*6). ►M24   5.  Articles shall not be placed on the market for supply to the general public, if any of their rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use, contain more than 1 mg/kg (0,0001 % by weight of this component) of any of the listed PAHs. Such articles include amongst others: — sport equipment such as bicycles, golf clubs, racquets — household utensils, trolleys, walking frames — tools for domestic use — clothing, footwear, gloves and sportswear — watch-straps, wrist-bands, masks, head-bands 6.  Toys, including activity toys, and childcare articles, shall not be placed on the market, if any of their rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use, contain more than 0,5 mg/kg (0,00005 % by weight of this component) of any of the listed PAHs. 7.  By way of derogation from paragraphs 5 and 6, these paragraphs shall not apply to articles placed on the market for the first time before 27 December 2015. 8.  By 27 December 2017, the Commission shall review the limit values in paragraphs 5 and 6 in the light of new scientific information, including migration of PAHs from the articles referred to therein, and information on alternative raw materials and, if appropriate, modify these paragraphs accordingly.  ◄ ►M65   9.  Granules or mulches shall not be placed on the market for use as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications if they contain more than 20 mg/kg (0,002 % by weight) of the sum of all listed PAHs. 10.  Granules or mulches shall not be used as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications if they contain more than 20 mg/kg (0,002 % by weight) of the sum of all listed PAHs. 11.  Granules or mulches placed on the market for use as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications shall be marked with a unique identification number of the batch. 12.  Paragraphs 9 to 11 shall apply from 10 August 2022. 13.  Granules or mulches that are in use in the Union on 9 August 2022 as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications may remain in place and continue to be used there for the same purpose. 14.  For the purposes of paragraphs 9 to 13: (a)  ‘granules’ are mixtures that appear as solid particles in the size range from 1 to 4 mm, which are made from rubber or other vulcanised or polymeric material of recycled or virgin origin, or obtained from a natural source; (b)  ‘mulches’ are mixtures that appear as flake-shaped solid particles in the size range from 4 to 130 mm length and 10 to 15 mm width, which are made from rubber or other vulcanised or polymeric material of recycled or virgin origin, or obtained from a natural source; (c)  ‘infill material in synthetic turf pitches’ consists of granules used in synthetic turf pitches to improve the sport technical performance characteristics of the turf system; (d)  ‘use in loose form on playgrounds or in sport applications’ is any use of granules or mulches in loose form on playgrounds or for sport purposes other than as infill material in synthetic turf pitches.  ◄

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 190 °C.)

When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.

Other relevant information on adverse health effects shall be included even when not required by the classification criteria.

1-[4-[4-[[(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone

— In case of serious concerns about potential adverse effects on sexual function, fertility or development, the registrant shall propose, or the Agency may require either an Extended One-Generation Reproductive Toxicity Study (OECD TG 443), referred to in Annex IX, point 8.7.3, or a pre-natal developmental toxicity study (OECD TG 414), referred to in Annex IX, point 8.7.2, instead of the screening study (OECD TG 421 or 422) to address those concerns. Those serious concerns include among others:

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30, and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).

exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;

10.   ►C9  Until 25 August 2024, the concentration limit referred to in paragraph 2 shall be 2 000 ppb for the sum of C9-C14 PFCAs in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups. From 26 August 2024, the concentration limit shall be 100 ppb for the sum of C9-C14 PFCAs in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups. ◄ All emissions of C9-C14 PFCAs during the manufacture and use of fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups shall be avoided and, if not possible, reduced as far as technically and practically possible. This derogation shall not apply to articles referred to in paragraph 2(c). The Commission shall review this derogation no later than 25 August 2024.

(A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a ►M3  mixture ◄ , shall include the authorisation number on the label before they place the substance or a ►M3  mixture ◄ containing the substance on the market for an authorised use without prejudice to ►M3  Directive 67/548/EEC and Regulation (EC) No 1272/2008 ◄ ►M3   and Directive 1999/45/EC ◄ . This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9).

where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20 °C to 135 °C.)

Advice shall be provided on any environmental precautions to be taken related to accidental spills and release of the substance or mixture, such as keeping away from drains, surface and ground water.

1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 11.

(A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

(A complex combination obtained by absorbing hydrogen from a hydrogen rich stream. It consists of hydrogen, carbon monoxide, nitrogen, and methane with small amounts of C2 hydrocarbons.)

[A complex combination of hydrocarbons obtained by distillation of heat-soaked steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.]

substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;

— the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or

[The residue from the distillation of alkali-washed naphthalene oil having an approximate distillation range of 220 °C to 300 °C (428 °F to 572 °F). Composed primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.]

Octanol-water partitioning coefficient experimentally determined in accordance with Section 7.8 of Annex VII or estimated by (Q)SAR models in accordance with Section 1.3 of Annex XI;

(A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.)

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 220 °C. It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 % vol. or more benzene.)

supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;

(A complex combination of hydrocarbons obtained from fractionation of distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabiliser tail gas. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C5, predominantly methane and ethane.)

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230 °C to 400 °C.)

(A complex combination of hydrocarbons obtained by treating cracked distillates with hydrogen in the presence of a catalyst. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, ►M3  MIXTURES ◄ AND ARTICLES

(The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.)

[A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 60 °C to 200 °C (140 °F to 392 °F).]

(A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3 °C to 194 °C.)

[The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816 °C (1 500 °F) of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C9 and boiling at approximately 204 °C (400 °F).]

3.1.4. All information used to assess the environmental fate of the substance shall be briefly presented, if possible in the form of a table or tables. The relevant test results and test conditions and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

(A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.)

(A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50 to 140 °C. Composed primarily of a complex mixture of aromatic compounds.)

[The distillate from lignite tar boiling in the range of approximately 80 °C to 250 °C (176 °F to 482 °F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.]

(A complex combination of hydrocarbons produced by the distillation of products from the catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C5 and boiling in the range of approximately - 48 °C to 32 °C.)

(A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

(A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.)

Flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin

►M64   8.7.  The studies do not need to be conducted if: — the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity (category 1A or 1B or 2) and carcinogenicity (category 1A or 1B), and appropriate risk management measures are implemented, or — the substance is known to be a germ cell mutagen, meeting the criteria for classification in the hazard class germ cell mutagenicity (category 1A or 1B) and appropriate risk management measures are implemented, or — the substance is of low toxicological activity (a comprehensive and informative dataset showing no toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. If a substance is known to have an adverse effect on sexual function and fertility, meeting the criteria for classification in the hazard class reproductive toxicity (category 1A or 1B: May damage fertility (H360F)), and the available data are adequate to support a robust risk assessment, then no further testing for sexual function and fertility shall be necessary. If a substance is known to cause developmental toxicity, meeting the criteria for classification in the hazard class reproductive toxicity (category 1A or 1B: May damage the unborn child (H360D)), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity shall be necessary.  ◄

0.2.2. The information provided by safety data sheets shall also meet the requirements set out in Directive 98/24/EC. In particular, the safety data sheet shall enable employers to determine whether any hazardous chemical agents are present in the workplace and to assess any risk to the health and safety of workers arising from their use.

— reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation

8.  The employer or self-employed shall document the successful completion of the training referred to in paragraphs 4 and 5. The training shall be renewed at least every five years.

(A complex combination of hydrocarbons produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately - 70 °C to 0 °C.)

[A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35 °C to 230 °C (95 °F to 446 °F).]

High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by heating in the presence of water

0,1 % of a substance classified as skin sensitiser category 1 or 1B, respiratory sensitiser category 1 or 1B, or carcinogenic category 2;

(A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280 °C to 400 °C.)

►M56  1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

(A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C.)

(A complex combination of hydrocarbons obtained by treating cracked distillates with hydrogen in the presence of a catalyst. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).

8.7.1.  Screening for reproductive/developmental toxicity (OECD TG 421 or TG 422); the preferred species is the rat. The route of administration shall be oral if the substance is a solid or liquid, and inhalation if the substance is a gas; deviations may be made if scientifically justified, for example through evidence of equivalent or higher systemic exposure via another relevant route of human exposure or route-specific toxicity.

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C20 and boiling in the range of approximately 205 °C to 345 °C.)

Testing in accordance with Section 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Testing in accordance with Section 8.6.1 of Annex VIII may be omitted only for registrants producing less than 100 tonnes per year per manufacturer or importer, based on the exposure scenario(s) developed in the Chemical Safety Report.

[The distillation residue remaining after the distillation of the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.]

7.  Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after 4 January 2022, the mixture is marked with the following information:

(A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

In addition, for each entry, the reasons why no classification is given for a hazard class or differentiation of a hazard class should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification),

—  Persons suffering from asthma, eczema or skin problems should avoid contact, including dermal contact, with this product.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205 °C to 400 °C.)

(*)  Regulation (EU) 2016/425 of the European Parliament and of the Council of of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).

A substance fulfils the ‘very bioaccumulative’ criterion (vB) when the bioconcentration factor in aquatic species is higher than 5 000 .

(The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130 to 210 °C. Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.)

( 31 )  OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 777/2006 (OJ L 136, 24.5.2006, p. 9).

The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:

— a reliable chronic toxicity study is available or proposed by the registrant, provided that an appropriate species and route of administration are used, or;

(A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150 to 210 °C.)

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI ( 66 ).

If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.

When generating an exposure scenario it will be necessary to make initial assumptions about the operating conditions and risk managements measures. If the initial assumptions lead to a risk characterisation indicating inadequate protection of human health and the environment, then it shall be necessary to carry out an iterative process with amendment of one or a number of factors until adequate control can be demonstrated. This may require the generation of additional hazard or exposure information or appropriate alteration of the process, operating conditions or risk management measures. Therefore, iterations may be made between on the one hand developing and revising an (initial) exposure scenario, which includes developing and implementing risk management measures, and on the other hand generating further information to produce the definitive exposure scenario. The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard assessment and/or exposure assessment.

8.4.4.  The in vivo mammalian somatic cell genotoxicity study does not need to be conducted if there are adequate results available from an appropriate in vivo mammalian somatic cell genotoxicity study.

(A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulphuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.)

8.1.3. If air contaminants are formed when using the substance or mixture as intended, applicable occupational exposure limit values and/or biological limit values for these shall also be listed.

(The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.)

(A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 19 10-6 m2.s-1 at 40 °C.)

[The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148 °C (298 °F).]

(A complex combination of hydrocarbons obtained from the distillation of polymerised steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.)

(a)  clothing, related accessories or footwear, or parts of clothing, related accessories or footwear, made exclusively of natural leather, fur or hide;

3.  Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that paints other than spray paints containing DEGBE in concentrations equal to or greater than 3 % by weight of that are placed on the market for supply to the general public are visibly, legibly and indelibly marked by 27 December 2010 as follows:

When, in accordance with Article 11(1), the lead registrant submits information referred to in Article 10, point (a)(iv), (vi), (vii) and (ix), the lead registrant shall describe the composition(s), nanoform or set of similar nanoforms to which this information relates in accordance with points 2.3.1 to 2.3.4 and subsection 2.4 of this Annex. Each member registrant relying on information submitted by the lead registrant shall indicate which information thus submitted pertains to which composition, nanoform or set of similar nanoforms of the substance that the registrant identifies in accordance with Article 10, point (a)(ii), and Article 11(1).

[A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20 °C to 200 °C (68 °F to 392 °F).]

(A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.)

(A complex combination of hydrocarbons from the distillation of hydrocarbons usually ranging in carbon numbers from C3 through C5, predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C5, predominantly 2-methyl-2-butene.)

[A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160 °C to 180 °C (320 °F to 356 °F).]

In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or ►M3  mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.

(A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information, because risk management measures and operational conditions which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely.

If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report.

[A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]

Two-generation reproductive toxicity studies (B.35, OECD TG 416) that were initiated before 13 March 2015 shall be considered appropriate to address this standard information requirement.

— adverse effects related to sexual function, fertility or development based on available information, not meeting the criteria for classification as reproductive toxicity category 1A or 1B,

(A complex combination of hydrocarbons produced by a naphtha unifiner desulphurisation process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

(A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C.)

(A complex combination of hydrocarbons obtained as the extract from solvent extraction of intermediate paraffinic top solvent distillate that is treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C36.)

the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposures are always well below the derived DNEL or PNEC;

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

8.1.  An in vivo study for skin corrosion/irritation shall be conducted only if the in vitro study/studies under points 8.1.1 and/or 8.1.2 of Annex VII is(are) not applicable, or the results of this/these study/studies is/are not adequate for classification and risk assessment.

(A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.)

(A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

(A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

(A complex combination of hydrocarbons obtained by treating intermediate catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C30 and boiling in the range of approximately 205 to 450 °C. It contains a relatively large proportion of tricyclic aromatic hydrocarbons.)

without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or ►M3  mixture ◄ , including information about its precise use as an intermediate;

►M64   8.7.  The studies do not need to be conducted if: — the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity (category 1A or 1B or 2) and carcinogenicity (category 1A or 1B), and appropriate risk management measures are implemented, or — the substance is known to be a germ cell mutagen, meeting the criteria for classification in the hazard class germ cell mutagenicity (category 1A or 1B) and appropriate risk management measures are implemented, or — the substance is of low toxicological activity (a comprehensive and informative dataset showing no toxicity in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. If a substance is known to have an adverse effect on sexual function and fertility, meeting the criteria for classification in the hazard class reproductive toxicity (category 1A or 1B: May damage fertility (H360F)), and the available data are adequate to support a robust risk assessment, then no further testing for sexual function and fertility shall be necessary. If a substance is known to cause developmental toxicity, meeting the criteria for classification in the hazard class reproductive toxicity (category 1A or 1B: May damage the unborn child (H360D)), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity shall be necessary.  ◄

— carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation

2.2.1. Molecular formula and structural formula (including SMILES notation and other representation if available) and description of crystal structure(s)

8.7.3.  An Extended One-Generation Reproductive Toxicity Study with the extension of cohort 1B to include the F2 generation shall be proposed by the registrant or may be required by the Agency if:

For substances and mixtures designed for specific end use(s), recommendations shall relate to the identified use(s) referred to in subsection 1.2 and be detailed and operational. If an exposure scenario is attached, reference to it may be made or the information as required in subsections 7.1 and 7.2 shall be provided. If an actor in the supply chain has carried out a chemical safety assessment for the mixture, it is sufficient that the safety data sheet and the exposure scenarios are consistent with the chemical safety report for the mixture, rather than with the chemical safety reports for each substance in the mixture. If industry or sector specific guidance is available, detailed reference to it (including source and issuing date) may be made.

as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

8.1.1.1. the national occupational exposure limit values that correspond to Union occupational exposure limit values in accordance with Directive 98/24/EC, including any notations as referred to in Article 2(3) of Commission Decision 2014/113/EU ( 37 );

(A complex combination of hydrocarbons produced from distillation of the gas and gasoline fractions from the catalytic cracking process. It contains predominantly ethane and ethylene.)

(f)  the statement "Contains chromium (VI). Can cause allergic reactions." if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13;

— the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.

[A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately – 20 °C to 100 °C (– 4 °F to 212 °F).]

the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;

The packing group number from the UN Model Regulations shall be provided, if applicable, as required by the UN Model Regulations, ADR, RID and ADN. The packing group number is assigned to certain substances in accordance with their degree of hazard.

2.4.2. Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm

(A complex combination obtained by separation of the liquid phase from the effluent from the hydrogenation reaction. It consists predominantly of hydrogen, hydrogen sulphide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

( 16 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

(A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19 10-6 m2.s-1 at 40 °C.)

3.  The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2.

if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;

based on the physicochemical properties, the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or

(A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120 °C to 210 °C and C9 and higher aromatic hydrocarbons.)

Shall not be placed on the market or used as a substance or constituent of mixtures in a concentration, equal to or greater than 0,1 % by weight for grouting applications after 5 November 2012.

(f)  materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011 (*21);

[A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]

(A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed. It consists of hydrocarbons having carbon numbers in the range of C1 through C5 and hydrogen.)

Those provisions shall include a requirement that a professional shall hold a certificate that is accepted by the Member State in which that professional operates, or provide other documentary evidence to that effect, or be otherwise approved by that Member State, so as to demonstrate proper training and competence to safely use paint strippers containing dichloromethane.

(A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

(The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.)

(A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 through C4.)

The registrant shall identify what information is required for the registration. First, the relevant Annex or Annexes to be followed shall be identified, according to tonnage. These Annexes set out the standard information requirements, but shall be considered in conjunction with Annex XI, which allows variation from the standard approach, where it can be justified. In particular, information on exposure, use and risk management measures shall be considered at this stage in order to determine the information needs for the substance.

[A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30 °C to 260 °C (86 °F to 500 °F).]

(A complex combination obtained from various processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35 °C to 200 °C.)

The product identifier, the concentration or concentration ranges and the classifications shall be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of mixtures may choose to list in addition all substances in the mixture, including substances not meeting the criteria for classification. This information shall enable the recipient to identify readily the hazards of the substances in the mixture. The hazards of the mixture itself shall be given in section 2.

substances, on their own, in a ►M3  mixture ◄ or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

(A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19 10-6 m2.s-1 at 40 °C.)

Where reliable and relevant experimental data are available, that data shall be provided and take precedence over information obtained from models.

(A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45 °C to 185 °C.)

[A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons]

If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified.

Based on the classification, at least the following elements appearing on the label in accordance with Regulation (EC) No 1272/2008 shall be provided: hazard pictogram(s), signal word(s), hazard statement(s) and precautionary statement(s). A graphical reproduction of the full hazard pictogram in black and white or a graphical reproduction of the symbol only may be substituted for the colour pictogram provided in Regulation (EC) No 1272/2008.

(Refined, partly refined, or unrefined petroleum products by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100 °C to 200 °C.)

[A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately – 20 °C to 220 °C (– 4 °F to 428 °F).]

( 22 )  OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC) No 1882/2003.

The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either:

The objective of the exposure assessment shall be to make a quantitative and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The assessment shall address all nanoforms that are covered by the registration. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:

(A complex combination of hydrocarbons obtained from hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(A complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

[A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 130 °C to 220 °C (266 °F to 428 °F).]

(A complex combination of hydrocarbons produced by distillation of products from combined gas streams in a gas concentration reabsorber. It consists predominantly of hydrogen, carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide and hydrocarbons having carbon numbers in the range of C1 through C3.)

(A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.)

The labelling of any article intended for domestic use which is not covered by Section 5 and which is likely, during use, to release asbestos fibres shall, if necessary, contain the following safety instruction: ‘replace when worn’.

— the substance is known to be a genotoxic carcinogen, meeting the criteria for classification both in the hazard class germ cell mutagenicity category 1A, 1B or 2 and in the hazard class carcinogenicity category 1A or 1B, and appropriate risk management measures are implemented.

[A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240 °C to 280 °C (464 °F to 536 °F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.]

Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk. The competent authority shall update this information as appropriate.

the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals;

— existing information on effects caused by substances structurally analogous to the substance being studied, suggesting such effects or mechanisms/modes of action.

4.1 The hazard classification of the substance(s), resulting from the application of Title I and II of Regulation (EC) No 1272/2008 for all hazard classes and categories in that Regulation,

(The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380 to 410 °C. Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds.)

The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.

(A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80 °C to 218 °C.)

Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within six months of the date of publication:

[The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700 °C (1 292 °F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.]

If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated.

(A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

Advice shall be provided on any protective actions to be taken during firefighting, such as ‘keep containers cool with water spray’, and on special protective equipment for firefighters, such as boots, overalls, gloves, eye and face protection and breathing apparatus.

( 15 ) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1). Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).

except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 190 °C to 340 °C. This steam is likely to contain organic sulphur compounds.)

A mixture of: 4-[[bis-(4-fluorophenyl)-methylsilyl]methyl]-4H-1,2,4-triazole; 1-[[bis-(4-fluorophenyl)methyl-silyl]methyl]-1H-1,2,4-triazole

1.  Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in Appendix 8, in detectable concentrations, i.e. above 30 mg/kg (0,003 % by weight) in the articles or in the dyed parts thereof, according to the testing methods listed in Appendix 10, shall not be used, in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity, such as:

(c)  the list of ingredients in accordance with the nomenclature established in the glossary of common ingredient names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name, the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients at the time of formulation. ‘Ingredient’ means any substance added during the process of formulation and present in the mixture for use for tattooing purposes. Impurities shall not be regarded as ingredients. If the name of a substance, used as ingredient within the meaning of this entry, is already required to be stated on the label in accordance with Regulation (EC) No 1272/2008, that ingredient does not need to be marked in accordance with this Regulation;

4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.

If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted.

Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene

Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extraction, C3-5 and C3-5 unsaturated, butadiene-free; Petroleum gas

The uses which the supplier advises against and the reasons why shall, where applicable, be stated. This need not be an exhaustive list.

(b)  is marked visibly, legibly and indelibly as follows, and without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures:

in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition ( 12 ).

— a reliable short-term toxicity study (28 days) is available showing severe toxicity effects meeting the criteria for classifying the substance as STOT RE (category 1 or 2), for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, or

substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;

In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).

3.2.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.

[A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C (194 °F to 446 °F).]

The information in points 2.4.2 – 2.4.5 shall be clearly assigned to the different nanoforms or sets of similar nanoforms identified in point 2.4.1

if the information is duplicated, it shall be listed only once for the mixture overall, such as when two substances both cause vomiting and diarrhoea;

(A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30 °C to 170 °C.)

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 12(1)(c). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex VII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.

the name of the substance as specified in Section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes;

6.3.1. Appropriate advice shall be provided on how to contain a spill. Appropriate containment techniques may include any of the following:

Information shall be provided on whether delayed or immediate effects can be expected after short- or long-term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, information on the experimental data shall be summarised, with details on either animal data and the species clearly identified or the in vitro tests and the cell types clearly identified. It shall be indicated whether toxicological data is based on human or animal data or on in vitro tests.

In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:

[A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150 °C to 210 °C (302 °F to 410 °F).]

(A complex combination of hydrocarbons obtained by treating thermal cracked distillates with hydrogen in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

— failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or

As regards liquid bulk cargoes, the product name shall be provided (if different from that given in subsection 1.1) as required by the shipment document and in accordance with the name used in the lists of product names given in chapters 17 or 18 of the IBC Code or the latest edition of the IMO’s Maritime Environment Protection Committee (MEPC).2/Circular ( 51 ). Ship type required and pollution category shall be indicated, as well as the IMO hazard class, in accordance with Annex I (3) B (a) of Directive 2002/59/EC of the European Parliament and of the Council ( 52 ).

(A complex combination of hydrocarbons obtained from fractionation of hydrodesulphurised naphtha and distillate hydrocarbon streams and treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

— existing information on the substance itself derived from relevant available in vivo or non-animal approaches (e.g. abnormalities of the CNS, evidence of adverse effects on the nervous or immune system in studies on adult animals or animals exposed prenatally), or

Deviations from the default route of administration and deviations in the choice of species shall be scientifically justified.

(A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0 °C to 230 °C.)

unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

— the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 °C, or

1 000 mg/kg (individually or in combination with other phthalates in this entry or in other entries of Annex XVII that are classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B

If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II.

[A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20 °C to 100 °C (68 °F to 212 °F).]

his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in Section 1 of Annex VI;

(A complex combination of hydrocarbons obtained by the subjection of a petroleum fraction to several of the following steps: filtration, centrifugation, atmospheric distillation, vacuum distillation, acidification, neutralisation and clay treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C20.)

[The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155 °C to 180 °C (311 °F to 356 °F). Composed primarily of indene, indan and trimethylbenzenes.]

9.3.4.  Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(e).

As regards mixtures, it shall be indicated if the mixture is fully or only partially soluble in or miscible with water or other solvent.

(A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately - 10 °C to 230 °C.)

(The distillate from coke oven light oil having an approximate distillation range below 100 °C. Composed primarily of C4 to C6 aliphatic hydrocarbons.)

1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

— the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

the loading factor, expressed as the ratio of the total surface area of the test piece to the volume of the test chamber, shall be (1 ± 0,02) m2/m3. This loading factor corresponds to the testing of wood-based panels; for other material or products, if such a loading factor is clearly not realistic under foreseeable conditions of use, loading factors in accordance with Section 4.2.2 of EN 16516 ( *1 ) may be used;

[A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.]

(A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.)

ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with;

(A complex combination of hydrocarbons obtained from a catalytic cracked gas stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.)

In addition, information on exposure, use and risk management measures in accordance with article 10 and this Annex should be collected. Considering all this information together, the registrant will be able to determine the need to generate further information.

Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State whose competent authority has requested further information in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC.

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00

( 26 )  OJ L 158, 30.4.2004, p. 7, corrected in OJ L 229, 29.6.2004, p. 5. Regulation as amended by Council Regulation (EC) No 1195/2006 (OJ L 217, 8.8.2006, p. 1).

Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.

(A complex combination of organic compounds obtained as a filtrate from the crystallisation of the naphthalene fraction from coal tar and boiling in the range of approximately 200 to 230 °C. Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.)

[A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiling range of 225 °C to 255 °C (437 °F to 491 °F). Composed primarily of substituted dinuclear aromatic hydrocarbons.]

These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions. The Chairman of each Committee shall be an employee of the Agency.

2.  Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters, irrespective of their use.

— the substance is of low toxicological activity (a comprehensive and informative dataset showing no toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.

Results obtained from suitable in vitro methods may indicate the presence of a certain dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well developed according to internationally agreed test development criteria (e.g. the European Centre for the Validation of Alternative Methods (ECVAM)) criteria for the entry of a test into the prevalidation process). Depending on the potential risk, immediate confirmation requiring testing beyond the information foreseen in Annexes VII or VIII or proposed confirmation requiring testing beyond the information foreseen in Annexes IX or X for the respective tonnage level may be necessary.

( 61 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The CAS number, if available, and the IUPAC name, if available, may also be given.

[The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.]

Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4). It shall specify for each substance:

4.  Paragraph 1 shall not apply to clothing, related accessories, textiles other than clothing, or footwear within the scope of Regulation (EU) 2016/425 of the European Parliament and of the Council (*) or Regulation (EU) 2017/745 of the European Parliament and of the Council (**).

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 190 °C. It contains a relatively large proportion of unsaturated hydrocarbons.)

[A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreated light distillate from steam-cracked naphtha.]

[An acid sludge by-product of the sulfuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.]

[The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150 °C (302 °F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.]

(The liquid product from various refinery streams, usually residues. The composition is complex and varies with the source of the crude oil.)

(A complex combination produced by the high-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.)

1.  Shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight. 2.  For the purposes of paragraph 1: (i)  ‘jewellery articles’ shall include jewellery and imitation jewellery articles and hair accessories, including: (a)  bracelets, necklaces and rings; (b)  piercing jewellery; (c)  wrist watches and wrist-wear; (d)  brooches and cufflinks; (ii)  ‘any individual part’ shall include the materials from which the jewellery is made, as well as the individual components of the jewellery articles. 3.  Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making. 4.  By way of derogation, paragraph 1 shall not apply to: (a)  crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC (*14); (b)  internal components of watch timepieces inaccessible to consumers; (c)  non-synthetic or reconstructed precious and semiprecious stones (CN code 7103 , as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures containing these substances; (d)  enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C. 5.  By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the first time before 9 October 2013 and jewellery articles produced before 10 December 1961. ►M31   6.  By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly.  ◄ ►M31   7.  Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article. For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size. 8.  By way of derogation, paragraph 7 shall not apply to: (a)  jewellery articles covered by paragraph 1; (b)  crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC; (c)  non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances; (d)  enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C; (e)  keys and locks, including padlocks; (f)  musical instruments; (g)  articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight; (h)  the tips of writing instruments; (i)  religious articles; (j)  portable zinc-carbon batteries and button cell batteries; (k)  articles within the scope of: (i)  Directive 94/62/EC; (ii)  Regulation (EC) No 1935/2004; (iii)  Directive 2009/48/EC of the European Parliament and of the Council (*15); (iv)  Directive 2011/65/EU of the European Parliament and of the Council (*16) 9.  By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly. 10.  By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016.  ◄ ►M63   11.  Doing either of the following acts after 15 February 2023 in or within 100 metres of wetlands is prohibited: (a)  discharging gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b)  carrying any such gunshot where this occurs while out wetland shooting or as part of going wetland shooting. For the purposes of the first subparagraph: (a)  ‘within 100 metres of wetlands’ means within 100 metres outward from any outer boundary point of a wetland; (b)  ‘wetland shooting’ means shooting in or within 100 metres of wetlands; (c)  if a person is found carrying gunshot in or within 100 metres of wetlands while out shooting or as part of going shooting, the shooting concerned shall be presumed to be wetland shooting unless that person can demonstrate that it was some other type of shooting. The restriction laid down in the first subparagraph shall not apply in a Member State if that Member State notifies the Commission in accordance with paragraph 12 that it intends to make use of the option granted by that paragraph. 12.  If at least 20 % in total of the territory, excluding the territorial waters, of a Member State are wetlands, that Member State may, in place of the restriction laid down in the first subparagraph of paragraph 11, prohibit the following acts throughout the whole of its territory from 15 February 2024: (a)  the placing on the market of gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b)  the discharging of any such gunshot; (c)  carrying any such gunshot while out shooting or as part of going shooting. Any Member State intending to make use of the option granted by the first subparagraph shall notify the Commission of this intention by 15 August 2021. The Member State shall communicate the text of the national measures adopted by it to the Commission without delay and in any event by 15 August 2023. The Commission shall make publicly available without delay any such notices of intention and texts of national measures received by it. 13.  For the purposes of paragraphs 11 and 12: (a)  ‘wetlands’ means areas of marsh, fen, peatland or water, whether natural or artificial, permanent or temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water the depth of which at low tide does not exceed 6 metres; (b)  ‘gunshot’ means pellets used or intended for use in a single charge or cartridge in a shotgun; (c)  ‘shotgun’ means a smooth-bore gun, excluding airguns; (d)  ‘shooting’ means any shooting with a shotgun; (e)  ‘carrying’ means any carrying on the person or carrying or transporting by any other means; (f)  in determining whether a person found with gunshot is carrying gunshot ‘as part of going shooting’: (i)  regard shall be had to all the circumstances of the case; (ii)  the person found with the gunshot need not necessarily be the same person as the person shooting. 14.  Member States may maintain national provisions for protection of the environment or human health in force on 15 February 2021 and restricting lead in gunshot more severely than provided for in paragraph 11. The Member State shall communicate the text of those national provisions to the Commission without delay. The Commission shall make publicly available without delay any such texts of national provisions received by it.  ◄ ►M72   15.  Shall not be placed on the market or used in articles produced from polymers or copolymers of vinyl chloride (‘PVC’), if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material. 16.  Paragraph 15 shall apply with effect from 29 November 2024. 17.  By way of derogation, paragraph 15 shall not apply to PVC articles containing recovered flexible PVC until 28 May 2025. 18.  By way of derogation, paragraph 15 shall not apply to the following PVC articles containing recovered rigid PVC until 28 May 2033, if the concentration of lead is lower than 1,5 % by weight of the recovered rigid PVC: (a)  profiles and sheets for exterior applications in buildings and civil engineering works, excluding decks and terraces; (b)  profiles and sheets for decks and terraces, provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0,1 % by weight; (c)  profiles and sheets for use in concealed spaces or voids in buildings and civil engineering works (where they are inaccessible during normal use, excluding maintenance, for example, cable ducts); (d)  profiles and sheets for interior building applications, provided that the entire surface of the profile or sheet facing the occupied areas of a building after installation is produced using PVC or other material for which the concentration of lead is lower than 0,1 % by weight; (e)  multi-layer pipes (excluding pipes for drinking water), provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0,1 % by weight; (f)  fittings, excluding fittings for pipes for drinking water. From 28 May 2026, rigid PVC recovered from the categories of articles referred to in points (a) to (d) shall only be used for the production of new articles of any of those categories. Suppliers of PVC articles containing recovered rigid PVC with a concentration of lead equal to or greater than 0,1 % by weight of the PVC material shall ensure, before placing those articles on the market, that they are visibly, legibly and indelibly marked with the statement: ‘Contains ≥ 0,1 % lead’. Where the marking cannot be provided on the article due to the nature of the article, it shall be on the packaging of the article. Suppliers of PVC articles containing recovered rigid PVC shall submit to national enforcement authorities upon request documentary evidence to substantiate the claims on the recovered origin of the PVC in those articles. Certificates issued by schemes to provide proof of traceability and recycled content, such as those developed according to EN 15343:2007 or equivalent recognised standards, may be used to substantiate such claims for PVC articles produced in the Union. Claims made on the recovered origin of the PVC in imported articles shall be accompanied by a certificate that provides equivalent proof of traceability and recycled content, issued by an independent third party. By 28 May 2028, the Commission shall review this paragraph in light of new scientific information and, if appropriate, modify it accordingly. 19.  By way of derogation, paragraph 15 shall not apply to: (a)  PVC-silica separators in lead acid batteries, until 28 May 2033; (b)  articles covered by paragraph 1, in accordance with paragraphs 2 to 5, and by paragraph 7 in accordance with paragraphs 8 and 10; (c)  articles within the scope of: (i)  Regulation (EC) No 1935/2004; (ii)  Directive 2011/65/EU; (iii)  Directive 94/62/EC; (iv)  Directive 2009/48/EC. 20.  By way of derogation, paragraph 15 shall not apply to PVC articles placed on the market until 28 November 2024.  ◄

(A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C35 and produces a finished oil with a viscosity in the order of 37 10-6 m2.s-1 to 44 10-6 m2.s-1 at 40 °C.)

[A complex combination of hydrocarbons obtained by distillation from the product of a naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 230 °C (86 °F to 446 °F).]

1.0.5. For any effect for which no relevant information is available, the relevant section shall contain the sentence: ‘This information is not available’. The justification, including reference to any literature search carried out, shall be included in the technical dossier.

The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.

any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of this Regulation but for which a decision under Directive 76/769/EEC has not yet been taken;

(A complex residuum from the distillation of catalytic reformer fractionator residue. It boils above approximately 399 °C.)

Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in Article 69(6)(a).

2.4.4. Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate

Where a substance being registered is manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 separately.

the carriage of dangerous substances and dangerous substances in dangerous ►M3  mixtures ◄ by rail, road, inland waterway, sea or air.

(A complex combination of hydrocarbons resulting from treatment of full-range straight-run, naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 220 °C.)

— for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is:

( 60 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

The full test does not need to be conducted for solids if the preliminary test clearly indicates that the test substance has oxidising properties.

[A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 90 °C to 160 °C (194 °F to 320 °F).]

(A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately - 217 °C to - 12 °C.)

Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum; Petroleum gas

[The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700 °C (1 292 °F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.]

[A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120 °C to 210 °C (248 °F to 380 °F) and C9 and higher aromatic hydrocarbons.]

[A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127 °C to 188 °C (262 °F to 370 °F).]

providing technical and scientific guidance on the operation of this Regulation for Member State competent authorities and providing support to the helpdesks established by Member States under Title XIII;

The Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 64.

This section of the safety data sheet shall provide basic classification information for the transport/shipment of substances or mixtures mentioned in section 1 by road, rail, sea, inland waterways or air. Where such information is not available or relevant this shall be stated.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g.

(A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30 °C to 205 °C.)

►M70   9.1.1.  The study does not need to be conducted in any of the following cases: — there are factors indicating that short-term aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, — a long-term aquatic toxicity study on invertebrates is available. — For nanoforms, the study may not be waived on the basis of high insolubility in water alone. — The registrant may propose long-term toxicity testing instead of short-term toxicity testing. — Long-term toxicity testing on invertebrates (preferred species Daphnia), (Annex IX, point 9.1.5) shall be proposed by the registrant or may be required by the Agency when it is unlikely that short-term toxicity testing can provide a true measure of the intrinsic aquatic toxicity of the substance, for instance: — if the substance is poorly water soluble (solubility below 1 mg/L), or — for nanoforms with low dissolution rate in the relevant test media.  ◄

(A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists predominantly of butane, isobutane and butadiene.)

(a)  Relating to the substances and mixtures for the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C and if they are authorised in accordance with Article 5(1) of Directive 98/8/EC. Wood so treated shall not be placed on the market before fixation of the preservative is completed.

o-Tolidine based dyes; 4,4'-diarylazo-3,3'-dimethylbiphenyl dyes, with the exception of those mentioned elsewhere in ►M5  Annex VI to Regulation (EC) No 1272/2008 ◄

The registrant shall then compare the information needs for the substance with the information already available and the extent to which currently available information can be applied to all nanoforms covered by the registration and identify where there are gaps.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

29.  Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4, respectively.

( *2 ) ISO 12219-1: Interior air of road vehicles – Part 1: Whole vehicle test chamber – Specification and method for the determination of volatile organic compounds in cabin interiors.

In vivo skin sensitisation studies that were carried out or initiated before 10 May 2017, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.

the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.

This section of the safety data sheet shall describe the chemical identity of the ingredient(s) of the substance or mixture, including impurities and stabilising additives as set out below. Appropriate and available safety information on surface chemistry shall be indicated.

Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration;

1.  Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 12 December 2023 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 6 mg/m3 for exposure by inhalation and 1,1 mg/kg/day for dermal exposure.

where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.

This Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with an application for authorisation, as specified in Article 62(5)(a), or in connection with a proposed restriction, as specified in Article 69(6)(b).

Where the classification criteria for a particular hazard class are not met, information supporting this conclusion shall be provided.

In addition to the indication of the SADT as specified in point (j) of subsection 9.1, the following information may be provided:

The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using Part B, Sections 9 and 10, of the format set out in Section 7 of Annex I and the other sections of this format, if appropriate.

As regards flammable liquids, at least the lower explosion limit shall be indicated. If the flash point is approximately – 25 °C or higher, it may not be possible to determine the upper explosion limit at standard temperature; in that case, it is recommended to indicate the upper explosion limit at a higher temperature. If the flash point is higher than 20 °C, it may not be possible to determine the lower or the upper explosion limit at standard temperature; in that case, it is recommended to indicate both the lower and the upper explosion limits at a higher temperature.

It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.

[A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately – 88 °C to 99 °C (– 127 °F to 210 °F).]

(A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 with which natural gas may also be mixed.)

[A complex combination of hydrocarbons produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65 °C to 230 °C (148 °F to 446 °F). It contains a relatively large proportion of unsaturated hydrocarbons.]

►M70   9.1.2.  The study does not need to be conducted if there are factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. For nanoforms, the study may not be waived on the basis of high insolubility in water alone.  ◄

Consolidated text: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)Text with EEA relevance

that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;

8.1.1.4. the national biological limit values that correspond to Union biological limit values in accordance with Directive 98/24/EC, including any notations as referred to in Article 2(3) of Decision 2014/113/EU;

alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses.

(A complex combination of hydrocarbons obtained from stripping stabilisation of catalytic hydrodesulphurised vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.

3.  By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 12 December 2024 in relation to placing on the market for use, or use, as a solvent in direct or transfer polyurethane coating processes of textiles and paper material or the production of polyurethane membranes, and from 12 December 2025 in relation to placing on the market for use, or use, as a solvent in the dry and wet spinning processes of synthetic fibres.

( 63 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.

1.    Measurement of formaldehyde released to indoor air from articles referred to in paragraph 1, first subparagraph, of entry 77

analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.

[Fraction of the distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.]

[A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30 °C to 170 °C (86 °F to 338 °F).]

If the boiling point is above the measuring range of the method, the temperature up to which no boiling point was observed shall be indicated.

(A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20 °C to 130 °C.)

( 53 ) Materials hazardous only in bulk (MHB) means materials which may possess chemical hazards when carried in bulk other than materials classified as dangerous goods in the IMDG Code.

( 59 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30, and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s).

[The distillation fraction boiling in the range of approximately 180 °C to 200 °C (356 °F to 392 °F) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.]

In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation.

If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b):

For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation.

any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

The information shall be written in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

3.6. Information on waste quantities and composition of waste resulting from manufacture of the substance, the use in articles and identified uses

(A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.)

(The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.)

— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000  mg/kg body weight).

Where a substance being registered is manufactured or imported in one or several nanoforms, the information on manufacture and use under 3.1-3.7 shall include separate information on the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4.

a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI.

11.  The concentration limit referred to in paragraph 2 shall be 1 000 ppb for the sum of C9-C14 PFCAs, where these are present in PTFE micro powders produced by ionising irradiation or by thermal degradation, as well as in mixtures and articles for industrial and professional uses containing PTFE micro powders. All emissions of C9-C14 PFCAs during the manufacture and use of PTFE micro powders shall be avoided and, if not possible, reduced as far as technically and practically possible. The Commission shall review this derogation no later than 25 August 2024.

— low-density polyethylene (LDPE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10]

The following information on substances whether on their own, in ►M3  mixtures ◄ or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:

(A complex combination of hydrocarbons from the distillation of saturated and unsaturated aliphatic hydrocarbons usually ranging in the carbon numbers C3 through C6. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C6, predominantly piperylenes.)

— in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.

(A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C35 and boiling in the range of approximately 260 to 500 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

If there is sufficient weight of evidence, the information requirement is fulfilled. Consequently, further testing on vertebrate animals shall be omitted and further testing not involving vertebrate animals may be omitted.

— for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council (*4), in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19),

[A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 196 °C (73 °F to 385 °F).]

[A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5]

(A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.)

0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms. The requirements speof the following hazard classes or categories setcific to nanoforms of a substance in this Annex apply to all nanoforms covered by the registration and without prejudice to requirements applicable to other forms of that substance. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration.

(A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 49 °C to 68 °C.)

(A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.)

[The distillate from alkali-washed naphthalene oil having an approximate distillation range of 180 °C to 220 °C (356 °F to 428 °F). Composed primarily of naphthalene, alkylbenzenes, indene and indan.]

— the substance is known to cause germ cell mutagenicity, meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B, and appropriate risk management measures are implemented,

(A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160 °C to 180 °C.)

In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately.

3.  If a substance not listed in Appendix 13 falls within more than one of points (a) to (g) of paragraph 1, the strictest concentration limit laid down in the points in question shall apply to that substance. If a substance listed in Appendix 13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down in point (h) of paragraph 1 shall apply to that substance.

(A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen and methane with various small amounts of carbon monoxide, carbon dioxide, nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C5.)

the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;

(A complex combination separated by distillation of a gas stream containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers in the range of C1 through C6 or obtained by cracking ethane and propane. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C2, hydrogen, nitrogen, and carbon monoxide.)

(A complex combination of hydrocarbons produced by a naphtha unifiner desulphurisation process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallisation (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.)

Known and reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating shall be listed. Hazardous combustion products shall be included in section 5 of the safety data sheet.

the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the adsorptive properties of the substance are solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9).

The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f).

(A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

►M49  28.  Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively.

if the article contains crocidolite, the words ‘contains asbestos’ used in the standard wording shall be replaced by ‘contains crocidolite/blue asbestos’.

(A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36,1  °C to 193,3  °C.)

( 9 )  OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003.

as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption ( 8 );

[The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.]

— the substance is known to cause germ cell mutagenicity, meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B, and appropriate risk management measures are implemented,

The Management Board may appoint additional members and their alternates, on recommendation by the Executive Director, following the same procedure, if this is necessary to ensure that the appeals can be processed at a satisfactory rate.

(c)  substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex

Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha C5 fraction; Low boiling point naphtha — unspecified

The Agency or Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency or Member State under this Regulation. The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request.

A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins

any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.

The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the adsorptive properties of the substance are solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9).

1.4.1. Based on the outcomes of steps 1 and 2, (a) DNEL(s) shall be established for the substance, reflecting the likely route(s), duration and frequency of exposure. ►M10  For some hazard classes, especially germ cell mutagenicity and carcinogenicity, the available information may not enable a toxicological threshold, and therefore a DNEL, to be established. ◄ If justified by the exposure scenario(s), a single DNEL may be sufficient. However, taking into account the available information and the exposure scenario(s) in Section 9 of the Chemical Safety Report it may be necessary to identify different DNELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women) and for different routes of exposure. A full justification shall be given specifying, inter alia, the choice of the information used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance for which the DNEL is valid. If more than one route of exposure is likely to occur, then a DNEL shall be established for each route of exposure and for the exposure from all routes combined. When establishing the DNEL, the following factors shall, inter alia, be taken into account:

Information shall be provided regarding relevant Union safety, health and environmental provisions (for example, Seveso category/named substances in Annex I to Council Directive 96/82/EC ( 57 )) or regarding the national regulatory status of the substance or mixture (including the substances in the mixture), including advice on action that should be taken by the recipient as a result of these provisions. Where relevant the national laws of the relevant Member States which implement these provisions and any other national measures that may be relevant shall be mentioned.

The advice provided shall be consistent with the physical and chemical properties described in section 9 of the safety data sheet. If relevant, advice shall be provided on specific storage requirements including:

(A complex combination obtained from recycled hydrotreated blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles;

explosion limits, if tested, or an indication of whether the classification and category assignment is based on calculation;

When specifying protective equipment to be worn for materials that represent a thermal hazard, special consideration shall be given to the construction of the personal protective equipment.

recipient of a substance or a ►M3  mixture ◄ : means a downstream user or a distributor being supplied with a substance or a ►M3  mixture ◄ ;

the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as the sunset date) which should take into account, where appropriate, the production cycle specified for that use;

(A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities, present. It consists of hydro-carbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93 °C to 180 °C.)

— there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches.

(The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.)

►M70   8.7.3.  Extended One-Generation Reproductive Toxicity Study (OECD TG 443), basic test design (cohorts 1A and 1B without extension to include an F2 generation), one species, if the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, or OECD TG 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. The route of administration shall be oral if the substance is a solid or liquid, and inhalation if the substance is a gas; deviations may be made if scientifically justified, for example through evidence of equivalent or higher systemic exposure via another relevant route of human exposure or route-specific toxicity.  ◄

(The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80 to 180 °C. Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)

radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ( 1 );

(A complex combination of gases obtained from the reformer and from the purges from the hydrogenation reactor. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

(A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.)

(A complex combination of hydrocarbons obtained from the distillation of products from the catalytic cracking of gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40 °C to 80 °C.)

Degradability is the potential for the substance or the appropriate substances in a mixture to degrade in the environment, either through biodegradation or other processes, such as oxidation or hydrolysis. Persistence is the lack of demonstration of degradation in the situations defined in Sections 1.1.1 and 1.2.1 of Annex XIII. Test results relevant to assess persistence and degradability shall be given where available. If degradation half-lives are quoted it must be indicated whether these half-lives refer to mineralisation or to primary degradation. The potential of the substance or certain substances in a mixture to degrade in sewage treatment plants shall also be mentioned.

The following information shall be considered for screening for P, vP, B, vB and T properties in the cases referred to in the second paragraph of Section 2.1 and may be considered for screening for P, vP, B, vB and T properties in the context of Section 2.2.

5.2.5. Where adequately measured representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Appropriate models can be used for the estimation of exposure levels. Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties can also be considered.

( 62 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

(A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately - 10 °C to 35 °C.)

package (type, size, net mass of substance or mixture), based on which the ‘division’ within the explosive class was assigned, or based on which the substance or mixture was exempted from classification as explosive.

This Annex lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), and very persistent and very bioaccumulative substances (vPvB substances) as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance.

a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);

— other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or

When, in accordance with Article 11(3), a registrant submits information referred to in Article 10, point (a)(iv), (vi), (vii) or (ix), separately, this registrant shall describe the composition(s), nanoform or set of similar nanoforms of the substance to which this information relates in accordance with points 2.3.1 to 2.3.4 and subsection 2.4 of this Annex.

3.  Without prejudice to the implementation of other Union provisions concerning the classification, packaging and labelling of substances and mixtures, the packaging of spray products containing (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and/or TDFAs combined with organic solvents as referred to in paragraph 1 and placed on the market for professional use shall be marked clearly and indelibly: ‘for professional users only’ and ‘Fatal if inhaled’ with the pictogram GHS06.

(A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.)

Where the use of an alternative chemical name is permitted in accordance with Article 24 of Regulation (EC) No 1272/2008, that name can be used.

(A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 to 255 °C.)

substances, on their own, in ►M3  mixtures ◄ or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:

6.  Wood treated with CCA type C that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4:

(A complex combination of hydrocarbons obtained from the fractionation stabilisation of straight-run naphtha, distillation tail gas and catalytic reformed naphtha stabiliser tail gas. It consists of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly butane and isobutane.)

(A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C2 through C4, predominantly C3.)

Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene

where the substance is incorporated in an article in which it is permanently embedded in a matrix or otherwise rigorously contained by technical means, it is demonstrated and documented that all of the following conditions are fulfilled:

(A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 to C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 150 °C to 220 °C.)

(A complex combination of hydrocarbons obtained as the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C8 and boiling in the range of approximately 100 °C to 200 °C.)

2.4.6. Description of the analytical methods or the appropriate bibliographical references for the information elements in this subsection (2.4). The description shall consist of the experimental protocols followed and the relevant interpretation of the results reported under points 2.4.2 to 2.4.5. This information shall be sufficient to allow the methods to be reproduced.

(A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.)

(A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150 °C to 345 °C.)

(A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

(A complex combination of hydrocarbons produced by treating dewaxed heavy paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.)

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

The particle size (median equivalent diameter, method of calculation of the diameter (number-, surface- or volume-based) and the range in which this median value varies), shall be indicated. Other properties may also be indicated, such as size distribution (e.g. as a range), shape and aspect ratio, aggregation and agglomeration state, specific surface area and dustiness. If the substance is in nanoform or if the mixture supplied contains a nanoform, those characteristics shall be indicated in this subsection, or referred to if already specified elsewhere in the safety data sheet.

(The extract produced by the acid extraction of bases from crude coal tar aromatic oils, neutralisation, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.)

If results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted.

As regards mixtures, if it is technically not possible to determine the melting point/freezing point, this shall be indicated.

the name(s) of substance(s) as specified in Section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 and 1.5 of Annex XI.

the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;

A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.

This information shall be given where available and appropriate, for each individual substance in the mixture, which is required to be listed in section 3 of the safety data sheet.

For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be included.

(A complex combination of hydrocarbons from the fractionation stabilisation products from polymerisation of naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.)

Information on toxicity using data from tests performed on aquatic and/or terrestrial organisms shall be provided when available. This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on soil micro- and macroorganisms and other environmentally relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or mixture has inhibitory effects on the activity of microorganisms, the possible impact on sewage treatment plants shall be mentioned.

(Residue from the distillation of crude phenanthrene boiling in the approximate range of 340 to 420 °C. It consists predominantly of phenanthrene, anthracene and carbazole.)

(A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C15 through C36 and boiling in the range of approximately 260 to 480 °C. This stream is likely to contain 5 wt % or more or four- to six-membered condensed ring aromatic hydrocarbons.)

This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work and the European Agency for Health and Safety at Work.

not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;

This section of the safety data sheet shall describe the hazards of the substance or mixture and the appropriate warning information associated with those hazards.

where the substance or mixture is intended for supply to the general public and/or is intended for diffusive applications such as in surface cleaning and cleaning of fabrics.

(A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30, and produces a finished oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few normal paraffins.)

Hydrocarbon oils, arom., mixed with polyethylene and polypropylene, pyrolysed, light oil fraction; Heat treatment products

(A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.)

(a)  in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;

[A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204 °C (400 °F).]

(A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C35 and boiling in the range of approximately 250 to 545 °C.)

[The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225 °C to 320 °C (437 °F to 608 °F). Composed primarily of polyalkylphenols.]

[A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.]

(A complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250 °C to 400 °C.)

— the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or

(A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160 to 400 °C. This stream is likely to contain 5 wt % or more of four- or six-membered condensed ring aromatic hydrocarbons.)

6.  Paragraphs 1 and 2 shall apply without prejudice to the application of any stricter restrictions set out in this Annex or in other applicable Union legislation.

3.2.1. For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances (see also Table 1.1) shall be indicated, together with their concentration or concentration range in the mixture:

The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (Einecs), at 400-010-9 (Elincs) and at 500-001-0 (NLP). This number is indicated in the column entitled ‘EC No’.

(Off gases produced by the benzene unit. It consists primarily of hydrogen. Carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6, including benzene, may also be present.)

preparing draft opinions of the Management Board concerning the proposed rules of procedure of the Committees and of the Forum;

4.2 The resulting hazard label for the substance(s), resulting from the application of Title III of Regulation (EC) No 1272/2008,

(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'-dipyridinium dichloride dihydrochloride

1.  Shall not be used in: — ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, — tricks and jokes, — games for one or more participants, or any article intended to be used as such, even with ornamental aspects, 2.  Articles not complying with paragraph 1 shall not be placed on the market. ►M61   3.  Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they: — can be used as fuel in decorative oil lamps for supply to the general public, and — present an aspiration hazard and are labelled with H304.  ◄ 4.  Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN). ►M61   5.  Without prejudice to the implementation of other Union provisions relating to the classification, labelling and packaging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met: (a)  lamp oils, labelled with H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: ‘Keep lamps filled with this liquid out of the reach of children’; and, by 1 December 2010, ‘Just a sip of lamp oil – or even sucking the wick of lamps – may lead to life-threatening lung damage’; (b)  grill lighter fluids, labelled with H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: ‘Just a sip of grill lighter fluid may lead to life threatening lung damage’; (c)  lamps oils and grill lighters, labelled with H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010.  ◄ ►M61   ◄ ►M61   ◄

Before being appointed, the candidate selected by the Management Board shall be invited as soon as possible to make a statement before the European Parliament and to answer questions from Members of Parliament.

(A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidised catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.)

If no decomposition was observed, it shall be indicated up to which temperature no decomposition was observed, e.g. ‘no decomposition observed up to x °C’.

1.  Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question is or are present in the following circumstances:

For road vehicles, including trucks and buses, the formaldehyde concentration shall be measured in ambient mode in accordance with the conditions specified in ISO 12219-1 ( *2 ) or ISO 12219-10 ( *3 ), and the concentration measured shall be used to verify the compliance with the limit value referred to in paragraph 2, first subparagraph, of entry 77.

[The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70 °C to 210 °C (158 °F to 410 °F).]

►M57  To check compliance of registration dossiers with this Regulation, the Agency shall select, until 31 December 2023, a percentage of those dossiers no lower than 20 % of the total received by the Agency for registrations in tonnage bands of 100 tonnes or more per year.

(The residue from the distillation of alkali-washed naphthalene oil having an approximate distillation range of 220 to 300 °C. Composed primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.)

— specific mechanisms/modes of action of the substance with an association to (developmental) neurotoxicity and/or (developmental) immunotoxicity (e.g. cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects), or

Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

(A complex combination of hydrocarbons produced by distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.)

(A complex combination of hydrocarbons obtained by treatment of heavy catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C35 and boiling in the range of approximately 260 to 500 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)

3.  For the purposes of paragraphs 1 and 2, ‘textile article’ means any unfinished, semi-finished or finished product which is composed of at least 80 % textile fibres by weight, or any other product that contains a part which is composed of at least 80 % textile fibres by weight, including products such as clothing, accessories, interior textiles, fibres, yarn, fabrics and knitted panels.

(A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 °C to 230 °C.)

For the purpose of this entry, the codes and chapters indicated in square brackets are the codes and chapters of the tariff and statistical nomenclature of Common Customs Tariff as established by Council Regulation (EEC) No 2658/87 (*1). ►M13   1.  Shall not be used in mixtures and articles produced from the following synthetic organic polymers (hereafter referred to as plastic material): — polymers or copolymers of vinyl chloride (PVC) [3904 10] [3904 21] — polyurethane (PUR) [3909 50] — low-density polyethylene (LDPE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10] — cellulose acetate (CA) [3912 11] — cellulose acetate butyrate (CAB) [3912 11] — epoxy resins [3907 30] — melamine-formaldehyde (MF) resins [3909 20] — urea-formaldehyde (UF) resins [3909 10] — unsaturated polyesters (UP) [3907 91] — polyethylene terephthalate (PET) [3907 60] — polybutylene terephthalate (PBT) — transparent/general-purpose polystyrene [3903 11] — acrylonitrile methylmethacrylate (AMMA) — cross-linked polyethylene (VPE) — high-impact polystyrene — polypropylene (PP) [3902 10] Mixtures and articles produced from plastic material as listed above shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight of the plastic material. By way of derogation, the second subparagraph shall not apply to articles placed on the market before 10 December 2011. The first and second subparagraphs apply without prejudice to Council Directive 94/62/EC (*13) and acts adopted on its basis. By 19 November 2012, in accordance with Article 69, the Commission shall ask the European Chemicals Agency to prepare a dossier conforming to the requirements of Annex XV in order to assess whether the use of cadmium and its compounds in plastic material, other than that listed in subparagraph 1, should be restricted. ►M35   2.  Shall not be used or placed on the market in paints with codes [3208 ] [3209 ] in a concentration (expressed as Cd metal) equal to or greater than 0,01 % by weight. For paints with codes [3208 ] [3209 ] with a zinc content exceeding 10 % by weight of the paint, the concentration of cadmium (expressed as Cd metal) shall not be equal to or greater than 0,1 % by weight. Painted articles shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,1 % by weight of the paint on the painted article.  ◄ 3.  By way of derogation, paragraphs 1 and 2 shall not apply to articles coloured with mixtures containing cadmium for safety reasons. 4.  By way of derogation, paragraph 1, second subparagraph shall not apply to: — mixtures produced from PVC waste, hereinafter referred to as ‘recovered PVC’, — mixtures and articles containing recovered PVC if their concentration of cadmium (expressed as Cd metal) does not exceed 0,1 % by weight of the plastic material in the following rigid PVC applications:— (a)  profiles and rigid sheets for building applications; (b)  doors, windows, shutters, walls, blinds, fences, and roof gutters; (c)  decks and terraces; (d)  cable ducts; (e)  pipes for non-drinking water if the recovered PVC is used in the middle layer of a multilayer pipe and is entirely covered with a layer of newly produced PVC in compliance with paragraph 1 above. Suppliers shall ensure, before the placing on the market of mixtures and articles containing recovered PVC for the first time, that these are visibly, legibly and indelibly marked as follows: ‘Contains recovered PVC’ or with the following pictogram: In accordance with Article 69 of this Regulation, the derogation granted in paragraph 4 will be reviewed, in particular with a view to reducing the limit value for cadmium and to reassess the derogation for the applications listed in points (a) to (e), by 31 December 2017.  ◄ 5.  For the purpose of this entry, ‘cadmium plating’ means any deposit or coating of metallic cadmium on a metallic surface. Shall not be used for cadmium plating metallic articles or components of the articles used in the following sectors/applications: (a)  equipment and machinery for: — food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11] — agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436] — cooling and freezing [8418] — printing and book-binding [8440] [8442] [8443] (b)  equipment and machinery for the production of: — household goods [7321] [8421 12] [8450] [8509] [8516] — furniture [8465] [8466] [9401] [9402] [9403] [9404] — sanitary ware [7324] — central heating and air conditioning plant [7322] [8403] [8404] [8415] In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above is prohibited. 6.  The provisions referred to in paragraph 5 shall also be applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below: (a)  equipment and machinery for the production of: — paper and board [8419 32] [8439] [8441] textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452] (b)  equipment and machinery for the production of: — industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431] — road and agricultural vehicles [chapter 87] — rolling stock [chapter 86] — vessels [chapter 89] 7.  However, the restrictions in paragraphs 5 and 6 shall not apply to: — articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels, — electrical contacts in any sector of use, where that is necessary to ensure the reliability required of the apparatus on which they are installed. ►M13   8.  Shall not be used in brazing fillers in concentration equal to or greater than 0,01 % by weight. Brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. For the purpose of this paragraph brazing shall mean a joining technique using alloys and undertaken at temperatures above 450 °C. 9.  By way of derogation, paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications and to brazing fillers used for safety reasons. 10.  Shall not be used or placed on the market if the concentration is equal to or greater than 0,01 % by weight of the metal in: (i)  metal beads and other metal components for jewellery making; (ii)  metal parts of jewellery and imitation jewellery articles and hair accessories, including: — bracelets, necklaces and rings, — piercing jewellery, — wrist-watches and wrist-wear, — brooches and cufflinks. ►C5   11.  By way of derogation, paragraph 10 shall not apply to articles placed on the market before 10 December 2011 and jewellery more than 50 years old on 10 December 2011.  ◄  ◄

Where a substance being registered is also manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 where relevant.

non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

2.  By way of derogation, in relation to the placing on the market of formaldehyde [CAS No 50-00-0] in jackets, coats or upholstery, the relevant concentration for the purposes of paragraph 1 shall be 300 mg/kg during the period between 1 November 2020 and 1 November 2023. The concentration specified in Appendix 12 shall apply thereafter.

(A complex combination of hydrocarbons obtained by distillation of a blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide, and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

(Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 to 180 °C. Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.)

(A complex combination obtained from the hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.)

(b)  aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;

the use(s) of that substance on its own or in a ►M3  mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or

substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;

(A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200 °C to 350 °C.)

at the Executive Director's request, drawing up an opinion on any other aspects concerning the safety of substances on their own, in ►M3  mixtures ◄ or in articles.

— fire-fighting foam stockpiles that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be managed in accordance with Article 5 of Regulation (EU) 2019/1021.

(An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150 °C to 360 °C.)

4.  The aerosol dispensers referred to in paragraphs 1 and 2 shall not be placed on the market unless they conform to the requirements indicated.

— existing information on effects caused by substances structurally analogous to the substance being studied, suggesting such effects or mechanisms/modes of action.

(A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147 °C to 300 °C and produces a finished oil having a viscosity of 18 10-6 m2.s-1 at 50 °C.)

(a)  any established training requirements and other risk management measures related to the industrial and professional uses of diisocyanates foreseen in national law;

(A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20 °C to 190 °C.)

[The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.]

(A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.)

9.6.1.  Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.

uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.

(The product obtained by treatment of coal tar oil alkaline extract with CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and other organic and inorganic impurities.)

(A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350 to 600 °C. This stream is likely to contain 5 wt % or more of four- to six-membered condensed ring aromatic hydrocarbons.)