Notification
Article 28
Open ↗Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks in accordance with this Regulation.
Source
Regulation (EU) 2025/2509 CHAPTER VII — 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 29
Open ↗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 for the purposes of this Regulation, and for the monitoring of notified bodies, including compliance with Article 34. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 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 and shall comply mutatis mutandis with the requirements laid down in Article 30. In addition, that body shall have arrangements to cover liabilities arising out of 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 30
Open ↗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 so as to safeguard the objectivity and impartiality of their activities. 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. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall it offer or provide consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains in accordance with Union and national law. 6. A notifying authority shall have a sufficient number of competent personnel and adequate resources at its disposal for the proper performance of its tasks. 7. A notifying authority shall monitor the nature and amount of tasks performed by subsidiaries of or subcontractors to notified bodies in accordance with Article 34.
Information obligation of notifying authorities
Article 31
Open ↗Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Requirements relating to notified bodies
Article 32
Open ↗1. For the purposes of notification pursuant to this Regulation, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. It shall be accredited in accordance with Regulation (EC) No 765/2008. 2. Conformity assessment bodies 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 of the organisation or the toy it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be a third-party body for the purposes of the first subparagraph. 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, installer, purchaser, owner, user or maintainer of the toys which they assess, nor the authorised representative of any of those parties. This shall not preclude use of the assessed toys that is necessary for the operations of the conformity assessment body or the use of those toys 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, installation, use or maintenance of those toys, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 5. Conformity assessment bodies and their 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 the conformity assessment tasks assigned to it by Annex IV and 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 and each kind or category of toys in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the necessary: (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures; (c) policies and procedures that distinguish between tasks it carries out as a notified body and other activities; and (d) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process. A conformity assessment body shall have the resources necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. 7. The personnel responsible for carrying out the conformity assessment activities (the ‘assessment personnel’) 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) in-depth knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) in-depth knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 15 and the common specifications referred to in Article 16; and (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. 8. The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. 9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment. 10. The personnel of a conformity assessment body shall observe professional secrecy in accordance with applicable Union and national law with regard to all information obtained in carrying out their tasks pursuant to Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected. 11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established pursuant to Article 44, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Presumption of conformity of notified bodies
Article 33
Open ↗Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union , it shall be presumed to comply with the requirements set out in Article 32 insofar as the applicable harmonised standards cover those requirements.
Subsidiaries of and subcontracting by notified bodies
Article 34
Open ↗1. Where a notified body subcontracts specific tasks connected with a conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 32, and shall inform the notifying authority accordingly. 2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever they are established. 3. Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or subsidiaries in all their elements. 4. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 5. Notified bodies 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 the work carried out by them pursuant to Annex IV.
Application for notification
Article 35
Open ↗1. A conformity assessment body shall submit an application for notification in accordance with this Regulation to the notifying authority of the Member State in which it is established. 2. The application referred to in paragraph 1 of this Article shall be accompanied by a description of the conformity assessment activities and the toys for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 32.
Notification procedure
Article 36
Open ↗1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 32. 2. Notifying authorities shall notify conformity assessment bodies to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. 3. The notification shall include full details of the conformity assessment activities and the relevant accreditation certificate. The notification shall also include information on any tasks to be performed by subsidiaries and subcontractors. 4. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two months of a notification. Only such a body shall be considered to be a notified body for the purposes of this Regulation. 5. The notifying authority shall inform the Commission and the other Member States of any subsequent relevant changes to the notification.
Identification numbers and lists of notified bodies
Article 37
Open ↗1. The Commission shall assign an identification number to each notified body. It shall assign a single identification number even where the same body is notified pursuant to several Union acts. 2. The Commission shall make publicly available a list of bodies notified pursuant to this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Changes to notifications
Article 38
Open ↗1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 32, 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, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available to the responsible notifying authorities and market surveillance authorities, at their request.
Challenge to the competence of notified bodies
Article 39
Open ↗1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention 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 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 the requirements for notification, it shall, by means of an implementing act, request the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary.
Operational obligations of notified bodies
Article 40
Open ↗1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedure provided for in Annex IV. 2. Notified bodies shall carry out the conformity assessment activities set out in this Regulation in a proportionate manner, avoiding unnecessary burdens for economic operators. They shall perform their activities in accordance with this Regulation taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process. When performing their activities, the notified bodies shall respect the degree of rigour and the level of protection required for the compliance of the toy with this Regulation. 3. Where a notified body finds that the toy does not meet the essential safety requirements, the requirements in corresponding harmonised standards, where such standards are applied, or the requirements in corresponding common specifications referred to in Article 16, where such specifications are applied, it shall require that manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate as referred to in Part II, point 6, of Annex IV. 4. Where, in the course of the monitoring of conformity following the issue of an EU-type examination certificate, a notified body finds that a toy no longer complies, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EU-type examination certificate if necessary. 5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EU-type examination certificates, as appropriate. 6. Where a notified body is informed by a market surveillance authority that a toy for which the notified body has issued an EU-type examination certificate does not comply with the essential safety requirements, it shall withdraw the EU-type examination certificate in respect of that toy.
Appeals against decisions of notified bodies
Article 41
Open ↗A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Information obligation of notified bodies
Article 42
Open ↗1. Notified bodies shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate; (b) any circumstances affecting the scope of and conditions for their notification; (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (d) on request, conformity assessment activities performed within the scope of their notification, and any other activity performed, including cross-border activities and subcontracting. 2. Notified bodies shall provide the other bodies notified pursuant to this Regulation which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results. 3. Notified bodies shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation that relates to any EU-type examination certificate which they have issued or withdrawn, or that relates to any refusal to issue such a certificate, including test reports and the technical documentation referred to in Article 27.
Exchange of experience
Article 43
Open ↗The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.
Coordination of notified bodies
Article 44
Open ↗The Commission shall ensure that appropriate coordination and cooperation between bodies notified pursuant to this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies. Notified bodies shall participate in the work of that group or groups, directly or by means of designated representatives.
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