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if the application is in relation to points (a) and (b) of point 1 of Annex I, a target which is a 25 % reduction on the average specific emissions of CO2 in 2007 or, where a single application is made in respect of a number of connected undertakings, a 25 % reduction on the average of those undertakings’ average specific emissions of CO2 in 2007.’;

(8) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23).

Greenhouse gas emissions related to energy supply and vehicle manufacturing and disposal are significant components of the current overall road transport carbon footprint and are likely to significantly increase in importance in the future. Policy action should therefore be taken to guide manufacturers towards optimal solutions taking account of, in particular, greenhouse gas emissions associated with the generation of energy supplied to vehicles such as electricity and alternative fuels, and to ensure that those upstream emissions do not erode the benefits related to the improved operational energy use of vehicles aimed for under Regulation (EC) No 443/2009.

In recognition of the disproportionate impact on the smallest manufacturers resulting from compliance with specific emissions targets defined on the basis of the utility of the vehicle, the high administrative burden of the derogation procedure, and the marginal resulting benefit in terms of CO2 emissions reduction from the vehicles sold by those manufacturers, manufacturers responsible for fewer than 1 000 new passenger cars registered in the Union annually should be excluded from the scope of the specific emissions target and the excess emissions premium. In order to ensure from the earliest point legal certainty for those manufacturers, it is essential that this derogation apply from 1 January 2012.

(4) Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1).

It is appropriate to clarify that, for the purpose of verifying compliance with the target of 95 g CO2/km, CO2 emissions should continue to be measured in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council (4) and its implementing measures and innovative technologies.

3. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

‘3. A supplier or a manufacturer who applies for a measure to be approved as an innovative technology or innovative technology package shall submit a report, including a verification report undertaken by an independent and certified body, to the Commission. In the event of a possible interaction of the measure with another innovative technology or innovative technology package already approved, the report shall mention that interaction and the verification report shall evaluate to what extent that interaction modifies the reduction achieved by each measure.’;

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Pursuant to Article 13(5) of Regulation (EC) No 443/2009 of the European Parliament and of the Council (3) the Commission is to review the modalities of achieving the 95 g CO2/km target by 2020 in a cost-effective manner, including the formulae set out in Annex I to that Regulation and the derogations provided for in Article 11 thereof. It is appropriate that this Regulation be as neutral as possible from the point of view of competition, socially equitable and sustainable.

The total contribution of those technologies to reducing the specific emissions target of a manufacturer may be up to 7 g CO2/km.’;

(*1) Decision No 280/2004/EC of the European Parliament and of the Council of 11 February 2004 concerning a mechanism for monitoring Community greenhouse gas emissions and for implementing the Kyoto Protocol (OJ L 49, 19.2.2004, p. 1)."

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

To enable the automotive industry to engage in long-term investment and innovation, it is desirable to provide indications as to how Regulation (EC) No 443/2009 should be amended for the period beyond 2020. Those indications should be based on an assessment of the necessary rate of reduction in line with the Union’s long-term climate goals and the implications for the development of cost effective CO2-reducing technology for cars. The Commission should, by 2015, review such aspects and submit a report to the European Parliament and to the Council on its findings. That report should include, where appropriate, proposals for amending Regulation (EC) No 443/2009 with a view to establishing CO2 emission targets for new passenger cars beyond 2020, including the possible setting of a realistic and achievable target for 2025, based on a comprehensive impact assessment that will consider the continued competitiveness of the car industry and its dependent industries, while maintaining a clear emissions-reduction trajectory comparable to that achieved in the period up to 2020. When developing such proposals, the Commission should ensure they are as neutral as possible from the point of view of competition and are socially equitable and sustainable.

(7) Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union’s integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1).

Regulation (EU) No 333/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EC) No 443/2009 to define the modalities for reaching the 2020 target to reduce CO 2 emissions from new passenger cars

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The Commission shall be empowered to adopt delegated acts in accordance with Article 14a in order to amend the data requirements and data parameters set out in Annex II.’;

The procedure for granting derogations to niche manufacturers should continue beyond 2020. However, in order to ensure that the reduction effort required by niche manufacturers is consistent with that of large volume manufacturers, a target 45 % lower than the average specific emissions of niche manufacturers in 2007 should therefore apply from 2020.

if the application is in relation to point (c) of point 1 of Annex I, a target which is a 45 % reduction on the average specific emissions of CO2 in 2007 or, where a single application is made in respect of a number of connected undertakings, a 45 % reduction on the average of those undertakings’ average specific emissions of CO2 in 2007.’;

Since the objective of this Regulation, namely to define the modalities for reaching the 2020 target to reduce CO2 emissions from new passenger cars, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

5. A delegated act adopted pursuant to the second subparagraph of Article 8(9), Article 11(8), the third subparagraph of Article 13(2) and the second subparagraph of Article 13(7) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

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In its impact assessment, the Commission assessed the availability of footprint data and the use of footprint as the utility parameter in the formulae set out in Annex I to Regulation (EC) No 443/2009. On the basis of that assessment, the Commission has concluded that the utility parameter used in the formula for 2020 should be mass. Nevertheless, the lower cost and merits of a change to footprint as the utility parameter should be considered in the future review.

(*2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;"

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(3) Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community’s integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1).

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‘3. The Commission shall determine the means for collecting excess emissions premiums under paragraph 1 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).’;

The lack of alternative fuel infrastructure and of common technical specifications for the vehicle-infrastructure interface could be an obstacle to the market uptake of ultra-low emission vehicles. Ensuring the building-up of such infrastructure in the Union could facilitate the work of market forces and contribute to economic growth in Europe.

‘The Commission shall adopt, by means of implementing acts, detailed provisions for a procedure to approve the innovative technologies or innovative technology packages referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2) of this Regulation.’;

Under Regulation (EC) No 443/2009, the Commission is required to carry out an impact assessment in order to review the test procedures with a view to reflecting adequately the real CO2 emissions behaviour of cars. There is a need to amend the currently used ‘New European Driving Cycle’ (NEDC), to ensure its representativeness regarding real driving conditions and to avoid the underestimation of real CO2 emissions and fuel consumption. A new, more realistic and reliable test procedure should be agreed as soon as feasible. Work in this direction is proceeding through the development of a Worldwide harmonized Light vehicles Test Procedure (WLTP) in the framework of the United Nations Economic Commission for Europe but has not yet been completed. In order to ensure that specific CO2 emissions quoted for new passenger cars are brought more closely into line with the emissions actually generated during normal conditions of use, the WLTP should be applied at the earliest opportunity. In view of that context, Annex I to Regulation (EC) No 443/2009 establishes emission limits for 2020 as measured in accordance with Regulation (EC) No 715/2007 and Annex XII to Commission Regulation (EC) No 692/2008 (5). When the test procedures are amended, the limits set in Annex I to Regulation (EC) No 443/2009 should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles. Accordingly, the Commission should carry out a robust correlation study between the NEDC and the new WLTP test cycles to ensure its representativeness regarding real driving conditions.

(5) Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 199, 28.7.2008, p. 1).

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

In calculating the average specific emissions of CO2, each new passenger car with specific emissions of CO2 of less than 50 g CO2/km shall be counted as:

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‘1. Upon application by a supplier or a manufacturer, CO2 savings achieved through the use of innovative technologies or a combination of innovative technologies (“innovative technology packages”) shall be considered.

High fossil fuel prices have a negative impact on economic recovery and on energy security and affordability in the Union. Increasing, therefore, the efficiency and sustainability of new passenger cars and light commercial vehicles, thus reducing the dependency on oil, is a priority.

(2) Position of the European Parliament of 25 February 2014 (not yet published in the Official Journal) and decision of the Council of 10 March 2014.

‘5. By 31 December 2015, the Commission shall review the specific emissions targets and the modalities set out herein, as well as the other aspects of this Regulation, including whether a utility parameter is still needed and whether mass or footprint is the more sustainable utility parameter, in order to establish the CO2 emissions targets for new passenger cars for the period beyond 2020. In that regard, the assessment of the necessary rate of reduction shall be in line with the Union’s long-term climate goals and the implications for the development of cost effective CO2-reducing technology for cars. The Commission shall submit a report to the European Parliament and to the Council with the result of that review. That report shall include any appropriate proposals for amending this Regulation, including the possible setting of a realistic and achievable target, based on a comprehensive impact assessment that will consider the continued competitiveness of the car industry and its dependent industries. When developing such proposals, the Commission shall ensure they are as neutral as possible from the point of view of competition and are socially equitable and sustainable.’;

OJ L 103, 5.4.2014, p. 15–21 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In order to ensure uniform conditions for the implementation of Regulation (EC) No 443/2009, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (9).

With a view to ensuring that real world emissions are adequately reflected, and measured CO2 values are strictly comparable, the Commission should ensure that those elements in the testing procedure that have a significant influence on measured CO2 emissions are strictly defined in order to prevent the utilisation of test cycle flexibilities by manufacturers. The deviations between type-approval CO2 emission values and emissions derived from vehicles offered for sale should be addressed, including by considering an in-service conformity test procedure that should ensure independent testing of a representative sample of vehicles for sale, as well as ways of addressing cases of demonstrated substantial divergence between survey and initial type-approval CO2 emissions.

amending Regulation (EC) No 443/2009 to define the modalities for reaching the 2020 target to reduce CO2 emissions from new passenger cars

for the year in which it is registered in the period from 2020 to 2022, subject to a cap of 7,5 g CO2/km over that period for each manufacturer.’;

3. The delegation of power referred to in the second subparagraph of Article 8(9), Article 11(8), the third subparagraph of Article 13(2) and the second subparagraph of Article 13(7) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

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The Commission shall be empowered to adopt delegated acts in accordance with Article 14a in order to adapt the formulae set out in Annex I, using the methodology adopted pursuant to the first subparagraph, while ensuring that reduction requirements of comparable stringency for manufacturers and vehicles of different utility are required under the old and new test procedures.’;

The further development of the worldwide market for advanced technologies aimed at improving the efficiency of passenger cars is in line with the Commission’s Communication of 21 January 2011 entitled: ‘A resource-efficient Europe — Flagship initiative under the Europe 2020 strategy’, which supports the shift to a resource-efficient, low-carbon economy for achieving sustainable growth.

‘8. The Commission shall be empowered to adopt delegated acts in accordance with Article 14a laying down rules to supplement paragraphs 1 to 7 of this Article, as regards the interpretation of the eligibility criteria for derogations, the content of the applications, and the content and assessment of programmes for the reduction of specific emissions of CO2.’;

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‘9. The Commission shall adopt detailed rules on the procedures for monitoring and reporting of data under this Article and on the application of Annex II by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).

In recognition of the high research and development and unit production costs of early generations of ultra-low emission vehicles, it is appropriate to accelerate and facilitate, on an interim basis and to a limited extent, the process of their introduction into the Union market at their initial stages of commercialisation. Actors at different levels should give appropriate attention to identifying and disseminating best practices for stimulating demand for ultra-low emission vehicles.

Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results.

The wording of Article 3(2) of Regulation (EC) No 443/2009 should be adjusted to ensure that the concept of connected undertakings is in line with Council Regulation (EC) No 139/2004 (6) as well as with Article 3(2) of Regulation (EU) No 510/2011 of the European Parliament and of the Council (7).

1. The Commission shall be assisted by the Climate Change Committee established by Article 9 of Decision No 280/2004/EC of the European Parliament and of the Council (*1). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (*2).

The procedure for granting a derogation to small-volume manufacturers should be simplified to allow for more flexibility in terms of when an application for a derogation is to be submitted by such manufacturers and when the Commission is to grant such a derogation.

‘From 2020 onwards, this Regulation sets a target of 95 g CO2/km for the average emissions of the new car fleet as measured in accordance with Regulation (EC) No 715/2007 and Annex XII to Regulation (EC) No 692/2008 and its implementing measures and innovative technologies.’;

The power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in order to amend Annex II to Regulation (EC) No 443/2009 as regards data requirements and data parameters; supplement the rules on the interpretation of the eligibility criteria for derogations from the specific emissions targets, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2; adjust the figure of M0, referred to in Annex I to Regulation (EC) No 443/2009, to the average mass of new passenger cars in the previous three calendar years; and adapt the formulae in Annex I to Regulation (EC) No 443/2009. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

‘4. With effect from 1 January 2012, Article 4, Article 8(4)(b) and (c), Article 9 and Article 10(1)(a) and (c) shall not apply to a manufacturer which, together with all of its connected undertakings, is responsible for fewer than 1 000 new passenger cars registered in the Union in the previous calendar year.’;

2. The power to adapt delegated acts referred to in the second subparagraph of Article 8(9), Article 11(8), the third subparagraph of Article 13(2) and the second subparagraph of Article 13(7) shall be conferred on the Commission for a period of five years from 8 April 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Regulation (EC) No 443/2009 confers powers on the Commission to implement some of its provisions in accordance with the procedures laid down in Council Decision 1999/468/EC (8). As a consequence of the entry into force of the Treaty of Lisbon, those powers need to be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU).

This is a field action notification by the manufacturer, Fresenius USA Inc. for Blood Pump Rotor Spare Parts that are compatible with 2008 series hemodialysis machine. The Blood Pump Rotor turns to move the blood along the blood pump segment of the machine. An increased number of complaints were reported to the manufacturer on the Blood Pump Rotor (p/n - f40015481 rev a, implemented in May 2020) after a period of use by clinics noting loose/dislodged guide sheaves. After thorough review of the complaints and root cause investigation, the manufacturer updated the Blood Pump Rotor design to p/n - f40015481 rev c to address customer complaints for bent guide pins due to improper unloading of blood lines. The rev a part was installed as a component of the arterial blood pump on the 2008 series hemodialysis machines during the period May 2020 till Apr 2024. The blood pump rotor is also sold as a spare part for the 2008 series blood pump module. Since, rev c design is now complete, and the part is now available, Fresenius USA has initiated a field action notification to conduct medical device correction if necessary.

(6) Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation) (OJ L 24, 29.1.2004, p. 1).

(9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

It is appropriate to retain the approach of setting the target based on a linear relationship between the utility of the car and its target CO2 emissions as expressed by the formulae set out in Annex I to Regulation (EC) No 443/2009, since this allows the diversity of the passenger car market and the ability of manufacturers to address different consumer needs to be maintained, thus avoiding any unjustified distortion of competition.

‘7. The Commission shall, by means of implementing acts, determine the correlation parameters necessary in order to reflect any change in the regulatory test procedure for the measurement of specific CO2 emissions referred to in Regulation (EC) No 715/2007 and Regulation (EC) No 692/2008. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2) of this Regulation.

‘For the purposes of determining each manufacturer’s average specific emissions of CO2, the following percentages of each manufacturer’s new passenger cars registered in the relevant year shall be taken into account: