What changed between the plenary report and the adopted text

Added:Article 29 Presumption of conformity of notified bodies

Added: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.

Added:Article 30 Subsidiaries of and subcontracting by notified bodies

Added: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.

Added:2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.

Added:3. Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or subsidiaries in all their elements.

Added:4. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

Added: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.

Added:Article 31 Application for notification

Added: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.

Added: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.

Added:Article 32 Notification procedure

Added:1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 28.

Added: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.

Added: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.

Added: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.

Added:Only such a body shall be considered a notified body for the purposes of this Regulation.

Added:5. The notifying authority shall inform the Commission and the other Member States of any subsequent relevant changes to the notification.

Added:Article 33 Identification numbers and lists of notified bodies

Added:1. The Commission shall assign an identification number to each notified body.

Added:It shall assign a single identification number even where the same body is notified under several Union acts.

Added: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.

Added:The Commission shall ensure that the list is kept up to date.

Added:Article 34 Changes to notifications

Added: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.

Added: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.

Added:Article 35 Challenge to the competence of notified bodies

Added: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.

Added: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.

Added:3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

Added: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.

Added:Article 36 Operational obligations of notified bodies

Added:1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedure provided for in Annex IV.

Added: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 under 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.

Added: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.

Added: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 14, 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.

Added:4. Where, in the course of the monitoring of conformity following the issue of a EU-type examination certificate, a notified body finds that a toy is no longer in compliance, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EU-type examination certificate if necessary.

Added: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.

Added:6. Where a notified body is informed by a market surveillance authority that a toy for which the notified body has issued a EU-type examination certificate is not in conformity with the essential safety requirements, it shall withdraw the EU-type examination certificate in respect of that toy.

Added:Article 37 Appeals against decisions of notified bodies

Added:A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.

Added:Article 38 Information obligation of notified bodies

Added:1. Notified bodies shall inform the notifying authority of the following:

Added:(a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate;

Added:(b) any circumstances affecting the scope of and conditions for their notification;

Added:(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

Added:(d) on request, conformity assessment activities performed within the scope of their notification, and any other activity performed, including cross-border activities and subcontracting.

Added:2. Notified bodies shall provide the other bodies notified under 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.

Added: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 23.

Added:Article 39 Exchange of experience

Added:The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

Added:Article 40 Coordination of notified bodies

Added:The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies.

Added:Notified bodies shall participate in the work of that group or groups, directly or by means of designated representatives.

Added:CHAPTER VII MARKET SURVEILLANCE

Added:Article 41 Procedure for dealing with toys presenting a risk at National levelmeasures concerning toys which are not compliant with the particular safety requirements [Am. 166]

Added:1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of personschildren, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. They shall immediately inform the relevant economic operator, in accordance with Article 4(1) and (2) of Regulation (EU) 2019/1020, of the procedure they have initiated and of the possible risk they have identified in the toy, and give the economic operator the opportunity to react. The relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose. [Am. 167]

Added:Where, in the course of that evaluation, a market surveillance authority finds that a toy does not comply with the requirements laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate corrective action in accordance with Article 16(3) of Regulation (EU) 2019/1020 within a reasonable period of time prescribed by the market surveillance authority and taking into account the nature of the risk.

Added:The market surveillance authorities shall inform the relevant notified body accordingly.

Added:2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the relevant economic operator to take.