What changed between the adopted text of 13 Mar 2024 and the adopted text of 25 Nov 2025

Removed: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.

Removed:Article 36 Operational obligations of notified bodies

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

Removed: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.

Removed: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.

Removed: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.

Removed: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.

Removed: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.

Removed: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.

Removed:Article 37 Appeals against decisions of notified bodies

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

Removed:Article 38 Information obligation of notified bodies

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

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

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

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

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

Removed: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.

Removed: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.

Removed:Article 39 Exchange of experience

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

Removed:Article 40 Coordination of notified bodies

Removed: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.

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

Removed:CHAPTER VII MARKET SURVEILLANCE

Removed: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]

Removed: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]

Removed: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.

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

Removed: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.

Removed:3. The economic operator shall ensure that appropriate corrective action is taken in respect of all the concerned toys that the economic operator has made available on the market throughout the Union.

Removed:4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take appropriate provisional measures to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it.

Removed:The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

Removed:5. The information referred to in paragraph 4, second subparagraph, shall include all available details, in particular the data necessary for the identification of the non-compliant toy including the unique product identifier, the origin of that toy, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:

Removed:(a) failure of the toy to meet the essential safety requirements;

Removed:(b) shortcomings in the harmonised standards referred to in Article 13;

Removed:(c) shortcomings in the common specifications referred to in Article 14.

Removed:6. Market surveillance authorities of Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned, and, in the event of disagreement with the notified national measure, of their objections.

Removed:7. Where, within 3 months of receipt of the information referred to in paragraph 4, second subparagraph, no objection has been raised by either a market surveillance authority of a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified.

Removed:8. Market surveillance authorities of other Member States shall ensure that appropriate restrictive measures, such as withdrawal of the toy from their market, are taken without delay in respect of the toy concerned, and shall inform the Commission and the other Member States of those measures.

Removed:9. The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020 and strictly enforce Article 19 of that Regulation given the vulnerability of children to defective, unsafe or counterfeit products. [Am. 168]

Removed:Article 42 Union safeguard procedure

Removed:1. Where, on completion of the procedure set out in Article 41(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasons to believe that a national measure could be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.

Removed:On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.

Removed:The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.

Removed:2. If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant toy is withdrawn or recalled from their market, and shall inform the Commission accordingly.

Removed:If the national measure is considered unjustified, the Member State concerned shall withdraw it.

Removed:3. Where the national measure is considered to be justified and the non-compliance of the toy is attributed to shortcomings in the harmonised standards referred to in Article 13 of this Regulation or the common specifications referred to in Article 14 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 or amend the common specifications as appropriate.

Removed:Article 43 Formal non-compliance

Removed:1. Without prejudice to Article 41, where a market surveillance authority makes one of the following findings with regard to a toy, it shall require the relevant economic operator to put an end to the non-compliance concerned:

Removed:(a) the CE marking has been affixed in violation of Article 15 or 16;

Removed:(b) the CE marking has not been affixed;

Removed:(c) the digital product passport has not been drawn up in accordance with Article 17; [Am. 169]

Removed:(d) the data carrier through which the digital product passport is accessible has not been affixed in accordance with Article 17(5); [Am. 170]

Removed:(e) the technical documentation referred to in Article 23 is either not available or not complete.

Removed:2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take appropriate measures to restrict or prohibit the making available on the market of the toy, or ensure that the toy is recalled or withdrawn from the market.

Removed:Article 44 National measures concerning toys which are compliant with the particular safety requirements but which present a risk

Removed:1. Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operator to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.

Removed:2. The economic operator shall ensure that corrective action is taken in respect of all the toys concerned that the economic operator has made available on the market throughout the Union.

Removed:3. The market surveillance authority of the Member State shall immediately inform the Commission and the other Member States of its findings and any subsequent actions taken by the economic operator. That information shall include all available details, in particular the data necessary for the identification of the toy concerned including the unique product identifier, the origin and the supply chain of the toy, the nature of the risk involved and the nature and duration of the national measures taken.