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Chapter XIV · Final provisions › 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.

Done at Strasbourg, 12 July 2023.

For the European Parliament

The President

R. METSOLA

For the Council

The President

P. NAVARRO RÍOS

(1)   OJ C 220, 9.6.2021, p. 128.

(2)  Position of the European Parliament of 14 June 2023 (not yet published in the Official Journal) and decision of the Council of 28 June 2023.

(3)  Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1).

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

(5)  Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).

(6)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

(7)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(8)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(9)  Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34).

(10)  Commission Regulation (EU) No 617/2013 of 26 June 2013 implementing Directive 2009/125/EC of the European Parliament and of the Council with regard to ecodesign requirements for computers and computer servers (OJ L 175, 27.6.2013, p. 13).

(11)  Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10).

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

(13)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

(14)  Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).

(15)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

(16)  Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).

(17)  Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

(18)  Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (OJ L 158, 14.6.2019, p. 125).

(19)  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(20)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(21)  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(22)  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

(23)  Regulation (EU) 2017/821 of the European Parliament and of the Council of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas (OJ L 130, 19.5.2017, p. 1).

(24)   OJ L 282, 19.10.2016, p. 4.

(25)  Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

(26)  Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38).

(27)  Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).

(28)  Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).

(29)  Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1).

(30)  Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1).

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

(32)  Commission Regulation (EU) No 493/2012 of 11 June 2012 laying down, pursuant to Directive 2006/66/EC of the European Parliament and of the Council, detailed rules regarding the calculation of recycling efficiencies of the recycling processes of waste batteries and accumulators (OJ L 151, 12.6.2012, p. 9).

(33)  Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC (OJ L 342, 22.12.2009, p. 1).

(34)  Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (OJ L 190, 12.7.2006, p. 1).

(35)  Commission Regulation (EC) No 1418/2007 of 29 November 2007 concerning the export for recovery of certain waste listed in Annex III or IIIA to Regulation (EC) No 1013/2006 of the European Parliament and of the Council to certain countries to which the OECD Decision on the control of transboundary movements of wastes does not apply (OJ L 316, 4.12.2007, p. 6).

(36)  Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3.).

(37)  Commission Implementing Regulation (EU) 2022/1267 of 20 July 2022 specifying the procedures for the designation of Union testing facilities for the purposes of market surveillance and verification of product compliance in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council (OJ L 192, 21.7.2022, p. 21).

(38)  Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

(39)  Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).

(40)   OJ L 123, 12.5.2016, p. 1.

(41)  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).

(42)  Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18).

(43)  Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).

(44)  Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38).

(45)  Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ L 158, 14.6.2019, p. 54).

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

ANNEX I

RESTRICTION ON SUBSTANCES

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 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

Portable batteries, whether or not 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.

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 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.

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) (1) 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.

(1)  IEC mentions charge and capacity. Both represent the same physical quantity (charge); the only difference is that charge is expressed in C = A*s whereas capacity is expressed in A*h. In practice, capacity is used in most cases.

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

Parameters related to electrochemical performance and durability

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);

2.

the battery category and information identifying the battery in accordance with Article 38(6);

3.

the place of manufacture (geographical location of a battery manufacturing plant);

4.

the date of manufacture (month and year);

5.

the weight;

6.

the capacity;

7.

the chemistry;

8.

the hazardous substances present in the battery, other than mercury, cadmium or lead;

9.

usable extinguishing agent;

10.

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

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;

2.

where possible, the remaining power capability;

3.

where possible, the remaining round trip efficiency;

4.

the evolution of self-discharging rates;

5.

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;

2.

the energy throughput;

3.

the capacity throughput;

4.

the tracking of harmful events, such as the number of deep discharge events, time spent in extreme temperatures, time spent charging in extreme temperatures;

5.

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.

2.

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.

3.

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.

4.

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.

2.

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.

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