附属書VIII 適合性評価手続

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 referred to in point 1 or to verify the conformity 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 and class referred to in Article 7, 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.

2.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.

3.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure that the manufactured battery is in conformity with the applicable requirements referred to in point 1.

4.Verification

1.A notified body chosen by the manufacturer shall carry out appropriate examinations, calculations, measurements and tests, as set out in the relevant harmonised standards referred to in Article 15, common specifications referred to in Article 16, or both, or equivalent tests, to check the conformity of the battery with the applicable requirements referred to in point 1, or have them carried out. In the absence of such a harmonised standard or common specification, the notified body concerned shall decide on the appropriate examinations, calculations, measurements and tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations, calculations, measurements and tests carried out and shall affix its identification number to the approved battery, or have it affixed under its responsibility.

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

5.CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each 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.

The manufacturer shall draw up an EU declaration of conformity in accordance with Article 18 for each battery and keep it at the disposal of the national authorities for 10 years after the battery has been placed on the market. The EU declaration of conformity shall identify the battery 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.

6.Manufacturer’s authorised representative

The manufacturer’s obligations set out in points 2.2, 4.2 and 5 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.