Notification
Article 21
Member States shall notify the Commission and the other Member States of the conformity assessment bodies authorised to carry out conformity assessment tasks in accordance with this Regulation.
Regulation (EU) 2023/1542 CHAPTER V — Notification of conformity assessment bodies
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Notifying authorities
Article 22
1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 27. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body as defined in Regulation (EC) No 765/2008 and in accordance with the provisions of that Regulation. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity, that body shall be a legal entity, comply mutatis mutandis with the requirements laid down in Article 23 and have arrangements to cover liabilities arising from its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Requirements relating to notifying authorities
Article 23
1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated in such a way that the objectivity and impartiality of its activities are safeguarded. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the conformity assessment bodies applying for notification in accordance with Article 28. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform and shall not provide consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. However, it shall exchange information on notified bodies with the Commission as well as with notifying authorities of other Member States and other relevant national authorities. 6. A notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks.
Information obligation on notifying authorities
Article 24
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Requirements relating to notified bodies
Article 25
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. 2. A conformity assessment body shall be established under the national law of a Member State and shall have legal personality. 3. A conformity assessment body shall be a third-party body independent from business and as regards the batteries it assesses, in particular from battery manufacturers, the battery manufacturers’ trade partners, shareholding investors on the battery manufacturers’ plants and from other notified bodies and the notified bodies’ business associations, parent companies or subsidiaries. 4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the batteries which they assess, nor the representative of any of those parties. That prohibition shall not preclude the use of assessed batteries that are necessary for the operations of the conformity assessment body or the use of such batteries for personal purposes. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, importation, distribution, installation, use or maintenance of those batteries, or represent the parties engaged in those activities. They shall not engage in any activity that could conflict with their independence of judgement or their integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. A conformity assessment body shall ensure that the activities of its parent or sister companies, subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities. 5. A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. 6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it in Annex VIII, periodical audits in accordance with Article 48(2) and third-party verification in accordance with Article 51 in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times, and for each conformity assessment procedure set out in Annex VIII, for periodical audits in accordance with Article 48(2) and third-party verification in accordance with Article 51, and for each category of batteries in relation to which it has been notified, a conformity assessment body shall have at its disposal: (a) the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) the necessary descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of those procedures and their ability to be reproduced; (c) appropriate policies and procedures to distinguish between activities that it carries out as a notified body and other tasks; (d) the necessary procedures for the performance of conformity assessment tasks which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the battery technology in question and the mass or serial nature of the production process. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks related to its conformity assessment activities in an appropriate manner and shall have access to all necessary information, testing equipment or facilities. This shall include establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of personnel to specific tasks, and conformity assessment decisions, without delegating them to a subcontractor or a subsidiary. 7. The personnel responsible for carrying out conformity assessment tasks shall have the following: (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the requirements and obligations laid down in Articles 6 to 10 and Articles 12, 13 and 14 and in Articles 48 to 52, of the applicable harmonised standards referred to in Article 15 and common specifications referred to in Article 16 and of the relevant provisions of Union harmonisation legislation and of national law; (d) the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out. 8. The impartiality of a conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessments tasks shall not depend on the number of conformity assessments carried out or on the results of those assessments. 9. A conformity assessment body shall take out liability insurance unless liability is assumed by the state in accordance with national law in the notifying Member State, or the Member State itself is directly responsible for the conformity assessment. 10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment tasks in accordance with Annex VIII, periodical audits in accordance with Article 48(2), or third-party verification in accordance with Article 51, except in relation to the notifying authority and national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected. 11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment tasks is informed of, the relevant standardisation activities and the activities of the sectoral coordination group of notified bodies established pursuant to Article 37 and shall apply as general guidance the administrative decisions and documents produced by that group.
Presumption of conformity of notified bodies
Article 26
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards, or parts thereof, for which references have been published in the Official Journal of the European Union , it shall be presumed to comply with the requirements laid down in Article 25 in so far as the applicable harmonised standards cover those requirements.
Subsidiaries of and subcontracting by notified bodies
Article 27
1. Where a notified body subcontracts specific tasks related to conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 25 and shall inform the notifying authority accordingly. 2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established. 3. A notified body may subcontract activities or have activities carried out by a subsidiary only with the agreement of the client. 4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and concerning the work carried out by them under Article 48(2) and Article 51 and under Annex VIII.
Application for notification
Article 28
1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment module or modules set out in Annex VIII or the procedures set out in Article 48(2) and Article 51, and of the batteries for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where applicable, issued by a national accreditation body attesting that the conformity assessment body meets the requirements laid down in Article 25. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2 of this Article, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 25, including appropriate documentation demonstrating that the conformity assessment body is independent within the meaning of Article 25(3).
Notification procedure
Article 29
1. A notifying authority shall only notify conformity assessment bodies which meet the requirements laid down in Article 25. 2. The notifying authority shall send a notification to the Commission and the notifying authorities of the other Member States of each conformity assessment body referred to in paragraph 1 using the electronic notification tool developed and managed by the Commission. 3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules or the procedures set out in Article 48(2) and Article 51, the categories of batteries concerned and the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate as referred to in Article 28(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to meet the requirements laid down in Article 25. 5. The conformity assessment body concerned shall perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the notification, where it includes an accreditation certificate referred to in Article 28(2), or within two months of the notification, where it includes documentary evidence referred to in paragraph 4 of this Article. Only such a conformity assessment body shall be considered to be a notified body for the purposes of this Regulation. 6. The notifying authority shall inform the Commission and the other Member States of any subsequent changes to the notification referred to in paragraph 2.
Identification numbers and lists of notified bodies
Article 30
1. The Commission shall assign an identification number to each notified body. It shall assign a single number even where the body is notified under several Union acts. 2. The Commission shall make publicly available and keep updated a list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified.
Changes to notifications
Article 31
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 25 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification pursuant to paragraph 1, or where a notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Challenge to the competence of notified bodies
Article 32
1. The Commission shall investigate all cases where it has a doubt, or a doubt is brought to its attention, in particular by economic operators and other relevant stakeholders, regarding the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requiring the notifying Member State to take the necessary corrective action, including withdrawal of the notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 74(2).
Operational obligations of notified bodies
Article 33
1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedures set out in Article 48(2), Article 51 or Annex VIII, as determined by the scope of the notification made in accordance with Article 29. 2. A notified body shall carry out conformity assessments in a proportionate manner, avoiding the creation of an unnecessary burden for economic operators, and taking due account of the size of an undertaking, the sector in which the undertaking operates, the structure of the undertaking, the degree of complexity of the battery to be assessed and the mass or serial nature of the production process. The notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the battery and of economic operators with this Regulation. 3. Where a notified body finds that the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13, 14, 49 and 50, in corresponding harmonised standards referred to in Article 15, common specifications referred to in Article 16 or other technical specifications have not been met, it shall require the manufacturer or other relevant economic operator to take appropriate corrective action in anticipation of a second and final conformity assessment, unless the deficiencies cannot be remedied. Where the deficiencies cannot be remedied, the notified body shall not issue the certificate of conformity or approval decision. 4. Where, in the course of the monitoring of conformity following the issue of an approval decision, a notified body finds that there is no longer compliance, it shall require the manufacturer or the economic operator referred to in Article 48(1) as applicable, to take appropriate corrective action and shall suspend or withdraw the approval decision, if necessary. 5. Where corrective action as referred to in paragraph 4 is not taken or does not have the required effect, the notified body shall restrict, suspend or withdraw the approval decision, as appropriate.
Appeal against decisions of notified bodies
Article 34
Member States shall ensure that an appeal procedure against the decisions of notified bodies is available.
Information obligation on notified bodies
Article 35
1. A notified body shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision; (b) any circumstances affecting the scope of, or the conditions for, its notification; (c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities; (d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting. 2. A notified body shall provide other notified bodies carrying out similar conformity assessment activities covering the same categories of batteries with relevant information on issues relating to: (a) negative and, on request, positive conformity assessments; and (b) any restriction, suspension or withdrawal of an approval decision.
Exchange of experience and good practice
Article 36
The Commission shall provide for the organisation of exchange of experience and good practice between the Member States’ authorities responsible for notification policy.
Coordination of notified bodies
Article 37
The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral coordination group of notified bodies. Notified bodies shall participate in the work of the sectoral coordination group, directly or by means of designated representatives.
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