Changes between two versions
What changed between the adopted text of 13 Mar 2024 and the adopted text of 25 Nov 2025
These two texts have too little in common to compare paragraph by paragraph: they are different documents rather than versions of one (for example one group’s motion and the joint text that was adopted).
+13 added · −888 removed · 5 changed paragraphs, packaging included.
Part 8 of 16: Paragraphs 421–480
Removed: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 30.
Removed:Article 27 Information obligation of notifying authorities
Removed: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.
Removed:The Commission shall make that information publicly available.
Removed:Article 28 Requirements relating to notified bodies
Removed:1. For the purposes of notification under 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.
Removed:2. Conformity assessment bodies shall be established under the national law of a Member State and shall have legal personality.
Removed:3. A conformity assessment body shall be a third-party body independent of the organisation or the toy it assesses.
Removed: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 a third-party body for the purposes of the first subparagraph.
Removed: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.
Removed: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.
Removed: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.
Removed: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.
Removed: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.
Removed:At all times and for each conformity assessment procedure and each kind or category of toy in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the following:
Removed:(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
Removed:(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures;
Removed:(c) appropriate policies and procedures that distinguish between tasks it carries out as a notified body and other activities;
Removed:(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.
Removed:A conformity assessment body shall have the meansresources necessary to efficiently 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. [Am. 162]
Removed:7. The personnel responsible for carrying out the conformity assessment activities (the ‘assessment personnel’) shall have the following:
Removed:(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
Removed:(b) satisfactoryin-depth knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; [Am. 163]
Removed:(c) appropriatein-depth knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation; [Am. 164]
Removed:(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
Removed:8. The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured.
Removed: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.
Removed: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.
Removed:10. The personnel of a conformity assessment body shall observerespect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Intellectual property rights and trade secrets, in accordance with Directive (EU) 2016/943, shall be protected. [Am. 165]
Removed: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 under Article 40, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Removed:Article 29 Presumption of conformity of notified bodies
Removed: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 28 insofar as the applicable harmonised standards cover those requirements.
Removed:Article 30 Subsidiaries of and subcontracting by notified bodies
Removed:1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 28, and shall inform the notifying authority accordingly.
Removed:2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.
Removed:3. Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or subsidiaries in all their elements.
Removed:4. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
Removed: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 under Annex IV.
Removed:Article 31 Application for notification
Removed:1. A conformity assessment body shall submit an application for notification under this Regulation to the notifying authority of the Member State in which it is established.
Removed:2. The application referred to in paragraph 1 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 28.
Removed:Article 32 Notification procedure
Removed:1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 28.
Removed: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.
Removed: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.
Removed: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.
Removed:Only such a body shall be considered a notified body for the purposes of this Regulation.
Removed:5. The notifying authority shall inform the Commission and the other Member States of any subsequent relevant changes to the notification.
Removed:Article 33 Identification numbers and lists of notified bodies
Removed:1. The Commission shall assign an identification number to each notified body.
Removed:It shall assign a single identification number even where the same body is notified under several Union acts.
Removed:2. The Commission shall make publicly available a list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.
Removed:The Commission shall ensure that the list is kept up to date.
Removed:Article 34 Changes to notifications
Removed:1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 28, 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.
Removed: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.
Removed:Article 35 Challenge to the competence of notified bodies
Removed: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.
Removed: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.
Removed:3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.