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Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (Text with EEA relevance)

Type Regulation
Publication 2023-07-28
Last updated 2026-08-13
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 96
Reform history JSON API
1.

Where, having carried out an evaluation under Article 79(1), a Member State finds that although a battery is in compliance with Articles 6 to 10 and Articles 12, 13 and 14, it presents a risk to the human health or safety of persons, to the protection of property or to the environment (‘compliant battery which presents a risk’), it shall without delay require the relevant economic operator to take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature of the risk, to ensure that the compliant battery which presents a risk, when made available on the market, no longer presents that risk, to withdraw that battery from the market or to recall it.

2.

The economic operator shall ensure that corrective action is taken in respect of all the compliant batteries which present a risk that the economic operator has made available on the market throughout the Union.

3.

The Member State shall immediately inform the Commission and the other Member States where the situation referred to in paragraph 1 occurs. That information shall include all available details, in particular the data necessary for the identification of compliant batteries which present a risk, the origin and the supply chain of such batteries, the nature of the risk involved and the nature and duration of the national measures taken.

4.

The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, proposing appropriate measures. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 90(3).

5.

On duly justified imperative grounds of urgency relating to the protection of human health and the safety of persons, and to the protection of property or the environment, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 90(4).

6.

The Commission shall address the implementing act referred to in paragraphs 4 and 5 to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 82

Joint activities

Market surveillance authorities may carry out joint activities with organisations representing economic operators or end-users. Such joint activities may include the setting up by Member States or market surveillance authorities of battery competence centres, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the requirements laid down in this Regulation, in accordance with Article 9 of Regulation (EU) 2019/1020.

Article 83

Formal non-compliance
1.

Without prejudice to Article 79, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

  • (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 20 of this Regulation;
  • (b) the CE marking has not been affixed;
  • (c) the identification number of the notified body, where required under Annex VIII, has been affixed in violation of Article 20 or has not been affixed;
  • (d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;
  • (e) the technical documentation referred to in Annex VIII is either not available, or not complete;
  • (f) the information referred to in Article 38(7) or Article 41(3) is absent, false or incomplete;
  • (g) any other administrative requirement provided for in Article 38 or 41 has not been met;
2.

Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the battery being made available on the market or ensure that it is withdrawn from the market or recalled.

Article 84

Non-compliance with due diligence obligations
1.

Where a Member State finds that an economic operator does not fulfil its due diligence obligations laid down in Articles 48, 49 and 50, it shall require the relevant economic operator to put an end to the non-compliance concerned.

2.

Where the non-compliance referred to in paragraph 1 persists and where there is no other effective means available to put an end to the non-compliance, the Member State concerned shall take all appropriate measures to restrict or prohibit the batteries made available on the market by the economic operator referred to in paragraph 1 from being made available on the market and, if the non-compliance is serious, ensure that they are withdrawn from the market or recalled.

CHAPTER XI Green public procurement and procedure for amending restrictions on substances

Article 85

Green public procurement
1.

Contracting authorities, as defined in Article 2(1), point (1), of Directive 2014/24/EU or Article 3(1) of Directive 2014/25/EU, or contracting entities, as defined in Article 4(1) of Directive 2014/25/EU shall, when procuring batteries or products containing batteries in situations covered by those Directives, take account of the environmental impacts of those batteries over their life cycle with a view to ensuring that such impacts are kept to a minimum.

2.

From 12 months after the date of entry into force of the first delegated act referred to in paragraph 3 of this Article, establishing award criteria for procurement procedures, the obligation laid down in paragraph 1 of this Article shall be fulfilled through the application of those award criteria. Any procurement procedure carried out by contracting authorities or contracting entities for the purchase of batteries, or products containing batteries, that fall within the scope of Articles 7 to 10 shall make reference in its technical specifications and award criteria to that first delegated act to ensure that those batteries, or products containing batteries, are procured with significantly lower environmental impacts over their life cycle.

3.

The Commission shall, 12 months after the adoption of the latest of the delegated acts referred to in Article 7(2), fourth subparagraph, point (a), Article 8(1), Article 9(2) and Article 10(5), adopt delegated acts in accordance with Article 89 supplementing this Regulation by establishing award criteria for procurement procedures for batteries, or products containing batteries, based on the sustainability requirements laid down in Articles 7 to 10.

Article 86

Restriction procedure for substances
1.

If the Commission considers that the use of a substance in the manufacture of batteries, or the presence of a substance in the batteries when they are placed on the market, or during their subsequent life cycle stages, including during repurposing or treatment of waste batteries, poses a risk to human health or the environment that is not adequately controlled and needs to be addressed on a Union-wide basis, it shall request the Agency to prepare a restriction dossier which conforms to the requirements of Annex XV to Regulation (EC) No 1907/2006. The restriction dossier shall include a socioeconomic assessment, including an analysis of alternatives.

2.

Within 12 months of the receipt of the request from the Commission referred to in paragraph 1 of this Article and if the restriction dossier prepared by the Agency pursuant to that paragraph demonstrates that action is necessary on a Union-wide basis, in addition to any measures already in place, the Agency shall suggest restrictions in order to initiate the process described in paragraphs 4 to 9 of this Article and Articles 87 and 88.

3.

If a Member State considers that the use of a substance in the manufacture of batteries, or the presence of a substance in the batteries when they are placed on the market, or during their subsequent life cycle stages, including during repurposing or treatment of waste batteries, poses a risk to human health or the environment that is not adequately controlled and needs to be addressed on a Union-wide basis, it shall notify the Agency that it proposes to prepare a restriction dossier. The Member State shall prepare a restriction dossier. The restriction dossier shall include a socioeconomic assessment, including an analysis of alternatives.

If the restriction dossier demonstrates that action on a Union-wide basis is necessary, in addition to any measures already in place, the Member State shall submit it to the Agency in the format set out in Annex XV to Regulation (EC) No 1907/2006, in order to initiate the process described in paragraphs 4 to 9 of this Article, and Articles 87 and 88.

4.

For the purposes of the restriction dossier and the restriction process, the Agency or Member States shall take into account any dossier, chemical safety report or risk assessment submitted to the Agency or a Member State under the Regulation (EC) No 1907/2006. The Agency or Member States shall also take into account any available information and refer to any relevant risk assessment submitted for the purposes of other Union law covering the life cycle of the substance used in the battery, including the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall provide information to the Agency or Member State concerned on request.

5.

Access to information held by the Agency in performing the tasks defined in Article 6 of this Regulation and in this Article shall be subject to Article 118 of Regulation (EC) No 1907/2006.

6.

The Agency shall maintain a list of substances for which a restriction dossier under this Article is planned by or in progress in either the Agency or a Member State.

7.

The Committee for Risk Assessment, set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, and the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1)(d) of that Regulation, shall check whether the restriction dossier submitted conforms to the requirements of Annex XV to that Regulation. Within 30 days of receipt of the dossier, 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 respective Committee, otherwise the procedure under this Article shall be terminated.

8.

The Agency shall publish without delay the intention of the Commission or a Member State to initiate the restriction process for a substance, under this Article, and shall inform stakeholders concerned.

9.

The Agency shall make publicly available on its website the restriction dossier, including the restrictions suggested pursuant to paragraphs 2 and 3 without delay, clearly indicating its date of publication. The Agency shall invite all stakeholders concerned to submit individually or jointly, within four months of the date of publication:

  • (a) comments on the restriction dossier and the suggested restrictions;
  • (b) a socioeconomic analysis of the suggested restrictions, including an analysis of alternatives, or information which can contribute to such an analysis, examining the advantages and drawbacks of the suggested restrictions. Such analysis shall conform to the requirements of Annex XVI to Regulation (EC) No 1907/2006.
10.

The delegated acts referred to in Article 6(2) shall be adopted within nine months following the receipt of the opinion of the Committee for Socioeconomic Analysis of the Agency referred to in Article 87(2). If the Committee for Socioeconomic Analysis does not adopt an opinion by the deadline set in Article 87(2) or (5), as applicable, the Commission shall take into account the socioeconomic impact of the restriction, including the availability of alternatives for the substance and shall adopt a delegated act by the deadline set in Article 87(2).

11.

Where the draft amendment to Annex I diverges from the original proposal of the restriction dossier, prepared pursuant to the procedure laid down in this Article and Articles 87 and 88, or if it does not take the opinions from the Agency into account, the Commission shall attach a detailed explanation of the reasons for the differences.

Article 87

Opinion of the Agency’s Committees
1.

Within 12 months of the date of publication referred to in Article 86(9), the Committee for Risk Assessment shall adopt an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health or the environment, based on its consideration of the relevant parts of the restriction dossier. This opinion shall take account of the restriction dossier prepared by the Agency at the request of the Commission or by the Member State, and the views of interested parties referred to in Article 86(9), point (a).

2.

Within 15 months of the date of publication referred to in Article 86(9), the Committee for Socioeconomic Analysis shall adopt an opinion on the suggested restrictions, based on its consideration of the relevant parts of the restriction dossier and the socioeconomic impact. Prior to that, it shall prepare a draft opinion on the suggested restrictions and on the related socioeconomic impact, taking account of the analyses or information according to Article 86(9), point (b), if there are any.

3.

The Agency shall publish the draft opinion of the Committee for Socioeconomic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from the publication of that draft opinion.

4.

The Committee for Socioeconomic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set in paragraph 3 of this Article. That opinion shall take account of the comments of interested parties submitted under Article 86(9), point (b), and paragraph 3 of this Article.

5.

Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions suggested in the restriction dossier, the Agency shall postpone the deadline for the opinion of the Committee for Socioeconomic Analysis by a maximum of 90 days.

6.

Where the Committees for Risk Assessment and Socioeconomic Analysis provide an opinion pursuant to paragraphs 1 and 2 of this Article, they shall make use of rapporteurs under Article 87 of Regulation (EC) No 1907/2006 and in line with the conditions provided therein.

Article 88

Submission of an opinion to the Commission
1.

The Agency shall submit to the Commission without delay the opinions of the Committees for Risk Assessment and Socioeconomic Analysis on restrictions suggested pursuant to Article 86. Where the opinions of the Committees for Risk Assessment and Socioeconomic Analysis diverge significantly from the suggested restrictions, the Agency shall submit an explanatory note to the Commission providing a detailed explanation of the reasons for such differences. If one or both of the Committees do not adopt an opinion by the deadline set in Article 87(1) and (2), respectively, the Agency shall inform the Commission accordingly, stating the reasons.

2.

The Agency shall publish the opinions of the two Committees on its website without delay.

3.

The Agency shall provide the Commission or a Member State on request with all documents and evidence submitted to or considered by it.

CHAPTER XII Delegated powers and committee procedure

Article 89

Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.

The power to adopt delegated acts referred to in Article 6(2), Article 7(1), (2) and (3), Article 8(1) and (5), Article 9(2), Article 10(5) and (6), Article 11(4), Article 12(3), Article 13(8), Article 14(4), Article 48(8), Article 53(3), Article 59(7), Article 60(8), Article 70(4), Article 71(4), (5) and (6), Article 72(4), Article 77(2) and (3), and Article 85(3) shall be conferred on the Commission for a period of five years from 17 August 2023. The Commission shall draw up a report in respect of the delegation of power no 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 no later than three months before the end of each period.

3.

The delegation of power referred to in Article 6(2), Article 7(1), (2) and (3), Article 8(1) and(5), Article 9(2), Article 10(5) and (6), Article 11(4), Article 12(3), Article 13(8), Article 14(4), Article 48(8), Article 53(3), Article 59(7), Article 60(8), Article 70(4), Article 71(4), (5) and (6), Article 72(4), Article 77(2) and (3), and Article 85(3) 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.

4.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.

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

6.

A delegated act adopted pursuant to Article 6(2), Article 7(1), (2) and (3), Article 8(1) and (5), Article 9(2), Article 10(5) and(6), Article 11(4), Article 12(3), Article 13(8), Article 14(4), Article 48(8), Article 53(3), Article 59(7), Article 60(8), Article 70(4), Article 71(4), (5) and (6), Article 72(4), Article 77(2) and (3), or 85(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three 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.

Article 90

Committee procedure
1.

The Commission shall be assisted by the committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

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

4.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

CHAPTER XIII Amendments

Article 91

Amendments to Regulation (EU) 2019/1020

Regulation (EU) 2019/1020 is amended as follows:

  • (1) in Article 4(5), the text ‘(EU) 2016/42535 and (EU) 2016/42636’ is replaced by the following: ‘(EU) 2016/425 ([^E0007]), (EU) 2016/426 ([^E0008]) and (EU) 2023/1542 ([^E0009])
  • (2) in Annex I, point 21 of the list of Union harmonisation legislation is replaced by the following:
  • ‘21. Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1) ;’.

Article 92

Amendment to Directive 2008/98/EC

In Article 8a(7) of Directive 2008/98/EC, the following subparagraph is added:

‘ For batteries, as defined in Article 3(1), point (1), of Regulation (EU) 2023/1542 of the European Parliament and of the Council ([^E0010]), Member States shall take measures to ensure that extended producer responsibility schemes that have been established before 4 July 2018, comply with this Article by 18 August 2025.

CHAPTER XIV Final provisions

Article 93

Penalties

By 18 August 2025 Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Article 94

Review
1.

By 30 June 2031, the Commission shall review and draw up a report on the application of this Regulation and its impact on the environment, human health and the functioning of the internal market and submit it to the European Parliament and to the Council.

2.

Taking account of technical progress and practical experience gained in Member States, the Commission shall, in its report, include an evaluation on the following aspects of this Regulation:

  • (a) the list of common formats falling under the definition of portable batteries of general use;
  • (b) the sustainability and safety requirements laid down in Chapter II, including the possible need to introduce an export ban on batteries which are non-compliant with the restrictions set out in Annex I;
  • (c) the labelling and information requirements laid down in Chapter III;
  • (d) the battery due diligence requirements laid down in Articles 48 to 53;
  • (e) the measures regarding management of waste batteries laid down in Chapter VIII, including the possibility of introducing two sub-categories of portable batteries namely rechargeable and non-rechargeable portable batteries, with separate collection targets, and of introducing a separate collection target for portable batteries of general use;
  • (f) the measures regarding the battery passport set out in Chapter IX;
  • (g) infringements and the effectiveness, proportionality and dissuasiveness of penalties as set out in Article 93;
  • (h) analysis of the impact of this Regulation on the competitiveness of, and on the investments in, the batteries sector, and of the administrative burden resulting from this Regulation.

Where appropriate, the report referred to in paragraph 1 shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.

3.

Taking into account the revision of Regulation (EC) No 1907/2006, the Commission shall in its report include a specific evaluation of the need for a legislative proposal to amend Articles 6, 86, 87 and 88 of this Regulation.

4.

The Commission shall assess whether any amendment to Chapter VII is necessary in the light of the adoption, if any, of Union legislative acts laying down rules on sustainable corporate governance and due diligence, including obligations for companies regarding human rights adverse impacts and environmental adverse impacts in relation to their own operations, the operations of their subsidiaries and branches, and their value chain operations.

The Commission shall publish a report containing the results of such assessment by 12 months after the date of entry into force of any of the legislative acts referred to in the first subparagraph, or by 30 June 2031, whichever is the earliest. Where appropriate, the Commission shall accompany its report with a legislative proposal amending Chapter VII.

5.

By 30 June 2031, the Commission shall submit a report to the European Parliament and the Council assessing the feasibility and the technical consequences of extending the scope of the definition of ‘LMT battery’ in Article 3, point (11), in particular by including batteries powering non-wheeled vehicles. The report shall be accompanied, where appropriate, by a legislative proposal.

6.

By 1 January 2025, the Commission shall assess how best to introduce harmonised standards for a common charger for, respectively, rechargeable batteries designed for light means of transport, as well as for rechargeable batteries incorporated into specific categories of electrical and electronic equipment covered by Directive 2012/19/EU. Charging devices for categories and classes of radio equipment under Article 3(4) of Directive 2014/53/EU shall be excluded from the scope of that assessment.

Article 95

Repeal and transitional rules

Directive 2006/66/EC is repealed with effect from 18 August 2025.

However, the following provisions shall continue to apply as set out below:

  • (a) Article 11 until 18 February 2027;
  • (b) Article 12(4) and (5) until 31 December 2025, except as regards the provision concerning transmission of data to the Commission which shall continue to apply until 30 June 2027;
  • (c) Article 21(2) until 18 August 2026.

References to the repealed Directive shall be construed as references to this Regulation.

Article 96

Entry into force and application
1.

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

2.

It shall apply from 18 February 2024, save as set out in the second subparagraph and in other provisions of this Regulation.

The following provisions shall apply as follows:

  • (a) Article 11 shall apply from 18 February 2027;
  • (b) Article 17 and Chapter VI shall apply from 18 August 2024, except for Article 17(2) which shall apply from 12 months after the date of the first publication of the list referred to in Article 30(2);
  • (c) Chapter VIII shall apply from 18 August 2025.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Column 1 Designation of the substance or group of substances Column 2 Conditions of restriction
1. Mercury CAS No 7439-97-6 EC No 231-106-7 and its compounds Batteries, whether or not present in and incorporated into appliances, light means of transport or other vehicles, shall not contain more than 0,0005  % of mercury (expressed as mercury metal) by weight.
2. Cadmium CAS No 7440-43-9 EC No 231-152-8 and its compounds 1. Portable batteries, whether or not present in and incorporated into appliances, light means of transport or other vehicles, shall not contain more than 0,002  % of cadmium (expressed as cadmium metal) by weight. 2. Electric vehicle and SLI batteries, incorporated in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858 shall not contain more than 0,01  % of cadmium (expressed as cadmium metal) by weight in homogeneous material. 3. Point 2 shall not apply to electric vehicle batteries used as spare parts for electric vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858 placed on the market before 31 December 2008.
3. Lead CAS No 7439-92-1 EC No 231-100-4 and its compounds 1. From 18 August 2024, portable batteries, whether or not present in and incorporated into appliances, shall not contain more than 0,01  % of lead (expressed as lead metal) by weight. 2. The restriction set out in point 1 shall not apply to portable zinc-air button cells until 18 August 2028. 3. Portable batteries incorporated in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858, shall not contain more than 0,1  % of lead (expressed as lead metal) by weight in homogeneous material. 4. Point 3 shall not apply to Portable Batteries incorporated in, or used as spare parts for, vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858, type approved before 1 January 2024. 5. Electric vehicle batteries incorporated in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858, shall not contain more than 0,1  % of lead (expressed as lead metal) by weight in homogeneous material.
6. Point 5 shall not apply to: (a) electric vehicle batteries used in high voltage systems [^E0012] incorporated in, or used as spare part for, in vehicles of the categories M1 and N1, as defined in Regulation (EU) 2018/858 and type approved before 1 January 2019; (b) electric vehicle batteries not covered by point (a) of this point incorporated in or used as spare part for vehicles, including special purpose vehicles, of the categories M1 and N1, as defined in Regulation (EU) 2018/858, and type approved before 1 January 2024. 7. SLI batteries incorporated in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858, shall not contain more than 0,1  % of lead (expressed as lead metal) by weight in homogeneous material.
8. Point 7 shall not apply to: (a) SLI batteries used in 12 V applications for vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858 [^E0013]; (b) SLI batteries used in 24 V applications in special purpose vehicles of the categories M1 and N1 as defined in Regulation (EU) 2018/858 [^E0014]; (c) SLI batteries used in other applications than those covered by points (a) and (b) of this point in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858 that are type approved before 1 January 2024.
4. Hexavalent chromium CAS No 18540-29-9EC No 606-053-1 and its compounds Batteries incorporated in vehicles, including special purpose vehicles, of the categories M1 and N1 as defined in Regulation (EU) 2018/858, shall not contain more than 0,1  % of hexavalent chromium, expressed as hexavalent chromium metal, by weight in homogeneous material.

Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357, ELI: http://data.europa.eu/eli/dir/2014/35/oj).

Systems that have a voltage of > 75 V DC as provided for in Article 1 of Directive 2014/35/EU of the European Parliament and of the Council [^E0011].

This exemption shall be reviewed in 2030.

This exemption shall be reviewed in 2030.

ANNEX II

CARBON FOOTPRINT

1. Scope

This Annex provides essential elements on how to calculate the carbon footprint.

The methodology for calculation and verification of the carbon footprint to be provided for by means of the delegated act adopted pursuant to Article 7 shall build on the essential elements included in this Annex, be in compliance with the latest version of the Commission Product Environmental Footprint (PEF) method and relevant Product Environmental Footprint Category Rules (PEFCRs) and reflect the international agreements and technical/scientific progress in the area of life cycle assessment.

The calculation of the life cycle carbon footprint shall be based on the bill of materials, the energy and the auxiliary materials used in a specific manufacturing plant to produce a specific battery model. In particular, the electronic components, for example battery management units and safety units, and the cathode materials shall be accurately identified, as they can become the main contributor for the battery carbon footprint.

2. Definitions

For the purposes of this Annex, the following definitions apply:

  • (a) ‘activity data’ means the information associated with processes while modelling Life Cycle Inventories (LCI), whereby the aggregated LCI results of the process chains that represent the activities of a process are each multiplied by the corresponding activity data and then combined to derive the carbon footprint associated with that process;
  • (b) ‘bill of materials’ means a list of the raw materials, sub-assemblies, intermediate assemblies, sub-components and parts, and the quantities of each, needed to manufacture the battery;
  • (c) ‘company-specific data’ means data that are directly measured or collected from one or multiple facilities (site-specific data) that are representative of the activities of the company, such data are also known as ‘primary data’;
  • (d) ‘functional unit’ means the qualitative and quantitative aspects of the functions, services, or both, provided by the battery;
  • (e) ‘life cycle’ means the consecutive and interlinked stages of a product system, from raw material acquisition or generation from natural resources to final disposal (ISO 14040:2006 or an equivalent standard);
  • (f) ‘life cycle inventory (LCI)’ means the combined set of exchanges of elementary, waste and product flows in an LCI dataset;
  • (g) ‘life cycle inventory (LCI) dataset’ means a document or file with life cycle information on a specified product or other reference, such as the site or process, covering descriptive metadata and quantitative life cycle inventory, which could include a unit process dataset, partially aggregated or an aggregated dataset;
  • (h) ‘reference flow’ means the measure of the outputs from processes in a given product system required to fulfil the function expressed by the functional unit (based on ISO 14040:2006 or an equivalent standard);
  • (i) ‘secondary data’ means data that are not directly collected or measured from a specific process within the supply-chain of the company or estimated by that company, but that are sourced from a third party LCI database or other sources; such data include industry average data, for example from published production data, government statistics, and industry associations, as well as literature studies, engineering studies and patents, and can also be based on financial data, and contain proxy data and other generic data; and also include primary data that go through a horizontal aggregation step;
  • (j) ‘system boundary’ means the aspects included or excluded from the life cycle stages.

Additionally, the harmonised rules for the calculation of the carbon footprint of batteries shall include any further definition necessary for their interpretation.

3. Functional unit and reference flow

The functional unit is defined as one kWh (kilowatt-hour) of the total energy provided by the battery system over the battery’s service life, measured in kWh. The total energy is obtained from the number of cycles multiplied by the amount of delivered energy over each cycle.

The reference flow is the weight of battery needed to fulfil a specific function and shall be measured in kg of battery per kWh of the total energy delivered by the battery over its service life. All quantitative input and output data collected by the manufacturer to quantify the carbon footprint shall be calculated in relation to the reference flow.

By way of exception to the first paragraph, for back-up batteries that have as their primary function to ensure continuity of a power source, the functional unit is defined as the ability to provide one kWmin (kilowatt-minute) of backup power capability at any moment over the lifetime of the battery. Accordingly, the reference flow for back-up batteries is the weight of battery needed to fulfil the defined function and shall be measured in kg of battery per kWmin of backup power capability divided by the service life of the battery in years. All quantitative input and output data collected by manufacturers of back-up batteries to quantify the carbon footprint shall be calculated in relation to that reference flow.

In exceptional cases, such as for batteries for hybrid non -plug-in vehicles, the methodology may define a different functional unit.

4. System boundary

The following life cycle stages and the processes involved therein shall be included in the system boundary:

Life cycle stage Processes involved
Raw material acquisition and pre-processing Includes mining and other relevant sourcing, pre-processing and transport of active materials, up to the manufacturing of battery cells and battery components (active materials, separator, electrolyte, casings, active and passive battery components), and electric or electronic components.
Main product production Assembly of battery cells and assembly of batteries with the battery cells and the electric or electronic components
Distribution Transport to the point of sale
End of life and recycling Collection, dismantling and recycling

The following processes involved in the life cycle stages shall be excluded from the system boundary:

  • — manufacturing of equipment for the assembly and recycling of batteries, as carbon footprint impacts have been calculated as negligible in the PEFCRs for high specific energy rechargeable batteries for mobile applications;
  • — the battery assembly process using the original equipment manufacturer (OEM) system components; this process corresponds for the most part to mechanical assembly and it is included inside the OEM equipment or vehicle assembly line; the consumption of energy and material for this specific process is negligible when compared to the manufacturing process of OEM components.

The use phase shall be excluded from the life cycle carbon footprint calculations, as it is not under the direct influence of manufacturers except where it is demonstrated that choices made by battery manufacturers at the design stage can make a non-negligible contribution to that impact.

5. Use of company-specific and secondary datasets

Due to the high number of battery components and the complexity of manufacturing processes, the economic operator shall limit, where justified, the use of company specific data to process and component analysis of the battery-specific parts.

In particular, all activity data related to the battery’s anode, cathode, electrolyte, separator and cell-casing shall refer to a specific battery model produced in a specific production plant. Accordingly, no default activity data shall be used. The battery-specific activity data shall be used in combination with the relevant PEF-compliant secondary datasets.

As the carbon footprint declaration is specific to a battery model produced in a defined production site, sampling of data collected from different plants producing the same battery model shall not be allowed.

Where there is a change in the bill of materials or energy mix used to produce a battery model, the carbon footprint for that battery model shall be recalculated.

The harmonised rules to be provided for via a delegated act as referred to in Article 7(1) shall include detailed modelling of the following life cycle stages:

  • — raw material acquisition and pre-processing,
  • — production,
  • — distribution,
  • — own electricity production,
  • — end of life.

6. Carbon footprint impact assessment

The carbon footprint of the battery shall be calculated using the ‘climate change’ life cycle impact assessment method recommended in the 2019 Joint Research Centre report entitled ‘Suggestions for updating the Product Environmental Footprint (PEF) method’.

The results shall be provided as characterised results without normalisation and weighting. The list of characterization factors to be used is available at the European Platform on Life Cycle Assessment (LCA).

7. Offsets

Offsets are calculated relative to a baseline that represents a hypothetical scenario for what emissions would have been in the absence of the mitigation project that generates the offsets.

Offsets shall not be included in the carbon footprint declaration, but may be reported separately as additional environmental information and used for communication purposes.

8. Carbon footprint performance classes

Depending on the distribution of the values in the carbon footprint declarations of batteries placed on the market, a meaningful number of classes of performance shall be identified, with category A being the best class with the lowest carbon footprint life cycle impact, to enable market differentiation of the battery categories referred to in Article 7(1).

The setting of the threshold for each class of performance, as well as the width of that class, shall be based on the distribution of performances of the battery categories referred to in Article 7(1) placed on the market in the previous three years, the expected technological improvements, and other technical factors.

9. Maximum carbon thresholds

Based on the information collected through the carbon footprint declarations and the relative distribution of the carbon footprint performance classes of battery models placed on the market, and taking into account the scientific and technical progress in the field, the Commission shall set maximum life cycle carbon footprint thresholds for the battery categories referred to in Article 7(1), after having carried out a dedicated impact assessment to determine the values for the thresholds.

In setting maximum life cycle carbon footprint thresholds referred to in the first subparagraph, the Commission shall take into account the relative distribution of the carbon footprint values for batteries on the market, the extent of progress in reducing the carbon footprint of batteries placed on the market and the actual and potential contribution of those life cycle carbon footprint thresholds to the Union’s objectives on sustainable mobility and climate neutrality by 2050.

ANNEX III

ELECTROCHEMICAL PERFORMANCE AND DURABILITY PARAMETERS FOR PORTABLE BATTERIES OF GENERAL USE

Part A

Parameters for non-rechargeable batteries

  • 1.Minimum average duration: minimum average time reached by a sample of batteries on discharge when used under specific conditions, such as temperature and relative humidity.
  • 2.Delayed discharge performance: the relative decrease of the minimum average duration, with the initially measured minimum average duration as the reference point, after a defined period and under specific conditions, such as temperature and relative humidity.
  • 3.Resistance to leakage: resistance to unplanned escape of electrolyte, gas or other material.

Part B

Parameters for rechargeable batteries

  • 1.Rated capacity: the capacity value of a battery, under specific conditions, such as temperature and relative humidity, and declared by the manufacturer.
  • 2.Charge (capacity) ([^E0015]) retention: the capacity that a battery can deliver after storage, under specific conditions, such as temperature and relative humidity, for a specific time, without a subsequent recharge and expressed as a percentage of the rated capacity.
  • 3.Charge (capacity) recovery: the capacity that a battery can deliver with a subsequent recharge after storage, under specific conditions, such as temperature and relative humidity, for a specific time and expressed as percentage of the rated capacity.
  • 4.Endurance in cycles the number of charge and discharge cycles a battery can perform under specific conditions, such as temperature and relative humidity, before the capacity drops below a specified fraction of the rated capacity.
  • 5.Resistance to leakage: resistance to unplanned escape of electrolyte, gas or other material.

ANNEX IV

ELECTROCHEMICAL PERFORMANCE AND DURABILITY REQUIREMENTS FOR LMT BATTERIES, INDUSTRIAL BATTERIES WITH A CAPACITY GREATER THAN 2 KWH AND ELECTRIC VEHICLE BATTERIES

For the purposes of this Annex the following definitions apply:

  • (1) ‘Rated capacity’ means the total number of ampere-hours (Ah) that can be withdrawn from a fully charged battery under reference conditions.
  • (2) ‘Capacity fade’ means the decrease over time and upon usage in the amount of charge that a battery can deliver at the rated voltage, with respect to the original rated capacity.
  • (3) ‘Power’ means the amount of energy that a battery is capable of providing over a given period under reference conditions.
  • (4) ‘Power fade’ means the decrease over time and upon usage in the amount of power that a battery can deliver at the rated voltage.
  • (5) ‘Internal resistance’ means the opposition to the flow of current within a cell or a battery under reference conditions, that is, the sum of electronic resistance and ionic resistance to the contribution to total effective resistance including inductive/capacitive properties.
  • (6) ‘Energy round trip efficiency’ means the ratio of the net energy delivered by a battery during a discharge test to the total energy required to restore the initial state of charge by a standard charge.

Part A

  • 1.Rated capacity (in Ah) and capacity fade (in %).
  • 2.Power (in W) and power fade (in %).
  • 3.Internal resistance (in Ω) and internal resistance increase (in %).
  • 4.Where applicable, energy round trip efficiency and its fade (in %).
  • 5.The expected life-time of the battery under the reference conditions for which it has been designed, in terms of cycles, except for non-cycle applications, and calendar years.

Part B

Elements to explain the measurements for parameters listed in Part A

  • 1.Applied discharge rate and charge rate.
  • 2.Ratio between nominal battery power (W) and battery energy (Wh).
  • 3.Depth of discharge in the cycle-life test.
  • 4.Power capability at 80 % and 20 % state of charge.
  • 5.Any calculations performed with the measured parameters, if applicable.

ANNEX V

SAFETY PARAMETERS

1. Thermal shock and cycling

This test shall be designed to evaluate changes in the integrity of the battery arising from expansion and contraction of cell components upon exposure to extreme and sudden changes in temperature, and potential consequences of such changes. During a thermal shock, the battery shall be exposed to two temperature limits and held at each temperature limit for a specified period.

2. External short circuit protection

This test shall evaluate the safety performance of a battery when applying an external short circuit. The test can evaluate the activation of the overcurrent protection device or the ability of cells to withstand the current without reaching a hazardous situation (e.g. thermal runaway, explosion, fire). The main risk factors are heat generation at cell level and electrical arcing, which can damage circuitry or lead to reduced isolation resistance.

3. Overcharge protection

This test shall evaluate the safety performance of a battery in overcharge situations. The main safety risks during overcharge are the decomposition of the electrolyte, cathode and anode breakdown, exothermic decomposition of the solid electrolyte interphase (SEI) layer, separator degradation, and lithium plating, which can lead to self-heating of the battery and thermal runaway. The factors affecting the outcome of the test shall, as a minimum, include, the charging rate and the finally reached state of charge. The protection can be ensured either by voltage control (interruption after reaching the limit charging voltage) or current control (interruption after exceeding maximum charging current).

4. Over-discharge protection

This test shall evaluate the safety performance of a battery in over-discharge situations. Safety risks during over-discharge include polarity reversal leading to oxidation of the anode current collector (Copper) and to plating on the cathode side. Even minor over-discharge can cause dendrite formation and ultimately short-circuiting.

5. Over-temperature protection

This test shall evaluate the effect of temperature control failure or failure of other features for protection against internal overheating during operation.

6. Thermal propagation protection

This test shall evaluate the safety performance of a battery in thermal propagation situations. A thermal runaway in one cell can cause a cascading reaction throughout the entire battery which can be composed of numerous cells. It can lead to severe consequences including a significant gas release. The test shall take into account the tests that are under development for transport applications by ISO and the UN Global Technical Regulation.

7. Mechanical damage by external forces

These tests shall simulate one or more situations in which a battery is accidentally exposed to mechanical stresses and remains operational for the purpose for which it was designed. The criteria to simulate these situations should reflect real life uses.

8. Internal short circuit

This test shall evaluate the safety performance of a battery in internal short-circuit situations. The occurrence of internal short circuits, one of the main concerns for battery manufacturers, potentially leads to venting, thermal runaway, and sparking which can ignite the electrolyte vapours escaping from the cell. The generation of such internal short circuits can be triggered by manufacturing imperfections, the presence of impurities in the cells or dendritic growth of lithium, and is the cause of most in-field safety incidents. Multiple internal short circuit scenarios are possible (e.g. electrical contact of cathode/anode, aluminium current collector/copper current collector, aluminium current collector/anode) each with a different contact resistance.

9. Thermal abuse

During this test, the battery shall be exposed to elevated temperatures (in IEC 62619 the temperature is 85 °C) which can trigger exothermal decomposition reactions and lead to a thermal runaway in the cell.

10. Fire test

The risk of explosion shall be assessed by exposing the battery to fire.

11. Emission of gases

Batteries can contain significant amounts of potentially hazardous materials, for example highly flammable electrolytes, corrosive and toxic components. If exposed to certain conditions, the integrity of the battery could be compromised, resulting in the release of hazardous gases. Therefore, it is important to identify emissions of gases from substances released from the battery during tests: the risk of toxic gases emitted from non-aqueous electrolytes shall be properly taken into account for all safety parameters listed in points 1 to 10.

ANNEX VI

LABELLING, MARKING AND INFORMATION REQUIREMENTS

Part A: General information on batteries

Information on the label of a battery shall comprise the following information regarding the battery:

    1. information identifying the manufacturer in accordance with Article 38(7);
    1. the battery category and information identifying the battery in accordance with Article 38(6);
    1. the place of manufacture (geographical location of a battery manufacturing plant);
    1. the date of manufacture (month and year);
    1. the weight;
    1. the capacity;
    1. the chemistry;
    1. the hazardous substances present in the battery, other than mercury, cadmium or lead;
    1. usable extinguishing agent;
    1. critical raw materials present in the battery in a concentration of more than 0,1 % weight by weight.

Part B: Symbol for separate collection of batteries

Image omitted; see official source

Part C: QR code

The QR code shall be in high contrast to the background colour and of a size that is easily readable by a commonly available QR reader, such as those integrated in hand-held communication devices.

ANNEX VII

PARAMETERS FOR DETERMINING THE STATE OF HEALTH AND EXPECTED LIFETIME OF BATTERIES

Part A

Parameters for determining the state of health of electric vehicle batteries, stationary battery energy storage systems and LMT batteries:

For electric vehicle batteries:

state of certified energy (SOCE).

For stationary battery energy storage systems and LMT batteries:

    1. the remaining capacity;
    1. where possible, the remaining power capability;
    1. where possible, the remaining round trip efficiency;
    1. the evolution of self-discharging rates;
    1. where possible, the ohmic resistance.

Part B

Parameters for determining the expected lifetime of stationary battery energy storage systems and LMT batteries:

    1. the date of manufacture of the battery and, where appropriate, the date of putting into service;
    1. the energy throughput;
    1. the capacity throughput;
    1. the tracking of harmful events, such as the number of deep discharge events, time spent in extreme temperatures, time spent charging in extreme temperatures;
    1. the number of full equivalent charge-discharge cycles.

ANNEX VIII

CONFORMITY ASSESSMENT PROCEDURES

Part A

MODULE A – INTERNAL PRODUCTION CONTROL
1. Description of the module

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4, and ensures and declares on its sole responsibility that the batteries concerned meet the requirements laid down in Articles 6, 9, 10, 12, 13 and 14 that apply to them.

2. Technical documentation

The manufacturer shall draw up the technical documentation. The documentation shall make it possible to assess the battery’s conformity with the relevant requirements referred to in point 1 and shall include an adequate analysis and assessment of the risks.

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the battery. The technical documentation shall, where applicable, contain at least the following elements:

  • (a) a general description of the battery and its intended use;
  • (b) the conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;
  • (c) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (b) and the operation of the battery;
  • (d) a specimen of the label required in accordance with Article 13;
  • (e) a list of the harmonised standards referred to in Article 15, applied in full or in part, including an indication of which parts have been applied, a list of the common specifications referred to in Article 16, applied in full or in part, including an indication of which parts have been applied, and a list of other relevant technical specifications used for measurement or calculation purposes;
  • (f) where the harmonised standards and the common specifications referred to in point (e) have not been applied or are not available, a description of the solutions adopted to meet the applicable requirements laid down in Articles 6, 9, 10, 12, 13 and 14 or to verify the compliance of batteries with those requirements;
  • (g) the results of design calculations made and the examinations carried out, and the technical or documentary evidence used; and
  • (h) the test reports.
3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure the batteries comply with the technical documentation referred to in point 2 and with the applicable requirements referred to in point 1.

4. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking to each individual battery that meets the applicable requirements referred to in point 1, or, where that is not possible or not warranted due to the nature of the battery, to the packaging and the documents accompanying the battery.

The manufacturer shall draw up an EU declaration of conformity for each battery model in accordance with Article 18 and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the last battery belonging to the respective battery model has been placed on the market. The EU declaration of conformity shall identify the battery model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the national authorities upon request.

5. Manufacturer’s authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by the manufacturer’s authorised representative, on its behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.

Part B

MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. Description of the module

Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 4 and 7, and ensures and declares on its sole responsibility, without prejudice to the obligations of other economic operators in accordance with this Regulation, that the batteries concerned meet the applicable requirements laid down in Articles 7 and 8, or, at the choice of the manufacturer, all applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14.

2. Technical documentation

The manufacturer shall draw up the technical documentation. The technical documentation shall make it possible to assess the battery’s conformity with the relevant requirements referred to in point 1, and shall include an adequate analysis and assessment of the risks.

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the battery. The technical documentation shall, where applicable, contain at least the following elements:

  • (a) a general description of the battery and its intended use;
  • (b) the conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;
  • (c) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (b) and the operation of the battery;
  • (d) a specimen of the label required in accordance with Article 13;
  • (e) a list of the harmonised standards referred to in Article 15, the common specifications referred to in Article 16, or of both, applied, and, in the event of partly applied harmonised standards, common specifications, or both, an indication of which parts have been applied;
  • (f) a list of other relevant technical specifications used for measurement or calculation purposes and descriptions of the solutions adopted to meet the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14 or to verify the compliance of batteries with those requirements, where harmonised standards, common specifications, or both, have not been applied or are not available;
  • (g) the results of design calculations made and the examinations carried out, and the technical or documentary evidence used;
  • (h) a study supporting the carbon footprint values referred to in Article 7(1) and the carbon footprint class referred to in Article 7(2), containing the calculations made in accordance with the methodology set out in the delegated act adopted pursuant to Article 7(1), fourth subparagraph, point (a), and the evidence and information determining the input data for those calculations;
  • (i) a study supporting the recycled content share referred to in Article 8, containing the calculations made in accordance with the methodology set out in the delegated act adopted pursuant to Article 8(1), second subparagraph, and the evidence and information determining the input data for those calculations; and
  • (j) the test reports.
3. Availability of technical documentation

The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the battery has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the batteries concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

5. Quality system
  • 1.The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the batteries concerned.
  • The application shall include:
  • (a) the name and address of the manufacturer and, if the application is lodged by the manufacturer’s authorised representative, its name and address as well;
  • (b) a written declaration that the same application has not been lodged with any other notified body;
  • (c) all relevant information for the battery category envisaged;
  • (d) the documentation concerning the quality system referred to in point 5.2;
  • (e) the technical documentation referred to in point 2.
  • 2.The quality system shall ensure that the batteries comply with the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14.
  • All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall make it possible to have a consistent interpretation of the quality programmes, plans, manuals and records.
  • The quality system documentation shall, in particular, contain an adequate description of:
  • (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
  • (b) the procedures for documenting and monitoring the parameters and data necessary for calculating and updating the recycled content share referred to in Article 8 and, where applicable, the carbon footprint values and class referred to in Article 7;
  • (c) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
  • (d) the examinations, calculations, measurements and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
  • (e) the quality records, such as inspection reports and calculation, measurement and test data, calibration data, qualification reports on the personnel concerned;
  • (f) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
  • 3.The notified body shall assess the quality system to determine whether it meets the requirements referred to in point 5.2.
  • It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
  • In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14.
  • The audit shall include an assessment visit to the manufacturer’s premises.
  • The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14 and to carry out the necessary examinations, calculations, measurements and tests with a view to ensuring that the battery complies with those requirements. The auditing team shall check the reliability of data used for the calculation of the recycled content share referred to in Article 8 and, where applicable, the carbon footprint values and class referred to in Article 7 as well as the proper implementation of the relevant calculation methodology.
  • After having assessed the quality system, the notified body shall notify its decision to the manufacturer. The notification shall contain the conclusions of the audit and the reasons for that decision.
  • 4.The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.
  • 5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
  • The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to meet the requirements referred to in point 5.2 or whether reassessment is necessary.
  • The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
  • 6.Surveillance under the responsibility of the notified body
    1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising from the approved quality system.
    1. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
  • (a) the quality system documentation referred to in point 5.2;
  • (b) the technical documentation referred to in point 2;
  • (c) the quality records, such as inspection reports and calculation, measurement and test data, calibration data and qualification reports on the personnel concerned.
    1. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and shall provide the manufacturer with an audit report. During such audits, the notified body shall check at least the reliability of data used for the calculation of the recycled content share referred to in Article 8 and, where applicable, the carbon footprint values and class referred to in Article 7, as well as the proper implementation of the relevant calculation methodology.
    1. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out examinations, calculations, measurements and tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
  • 7.CE marking and EU declaration of conformity
    1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual battery that meets the applicable requirements referred to in point 1, or, where that is not possible or is not warranted due to the nature of the battery, to the packaging and the documents accompanying the battery.
    1. The manufacturer shall draw up an EU declaration of conformity for each battery model in accordance with Article 18 and keep it at the disposal of the national authorities for 10 years after the last battery belonging to the respective battery model has been placed on the market. The EU declaration of conformity shall identify the battery model for which it has been drawn up.
  • A copy of the EU declaration of conformity shall be made available to the national authorities upon request.
  • 8.Availability of quality system documentation
  • The manufacturer shall, for a period of 10 years after the battery has been placed on the market, keep at the disposal of the national authorities:
  • (a) the quality system documentation referred to in point 5.2;
  • (b) the change referred to in point 5.5, as approved;
  • (c) the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.
  • 9.Information obligations of the notified body
  • Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
  • Each notified body shall inform the other notified bodies of quality system approvals which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of quality system approvals which it has issued.
  • 10.Manufacturer’s authorised representative
  • The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.

Part C

MODULE G – CONFORMITY BASED ON UNIT VERIFICATION
1. Description of the module

Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 5, and ensures and declares on its sole responsibility, without prejudice to the obligations of other economic operators in accordance with this Regulation, that the battery concerned, which has been subject to the provisions of point 4, is in conformity with the applicable requirements laid down in Articles 7 and 8, or, at the choice of the manufacturer, all applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14.

2. Technical documentation
  • 1.The manufacturer shall draw up the technical documentation and make it available to the notified body referred to in point 4. The technical documentation shall make it possible to assess the battery’s conformity with the relevant requirements referred to in point 1 and shall include an adequate analysis and assessment of the risks.

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