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Regulation (EU) 2025/2509 CHAPTER VIII — MARKET SURVEILLANCE

Article 45–Article 48 · 4 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Procedure for dealing with toys presenting a risk at national level

Article 45

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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 persons, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. The relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose. 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. The market surveillance authorities shall inform the relevant notified body accordingly. 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. 3.   The economic operator shall ensure that appropriate corrective action is taken in respect of all the toys concerned that the economic operator has made available on the market throughout the Union. 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. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 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: (a) failure of the toy to meet the essential safety requirements; (b) shortcomings in the harmonised standards referred to in Article 15; or (c) shortcomings in the common specifications referred to in Article 16. 6.   Market surveillance authorities of Member States other than the Member State initiating the procedure set out in 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. 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. 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. 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.

Union safeguard procedure

Article 46

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1.   Where, on completion of the procedure set out in Article 45(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 law, 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. 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. 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. 2.   If the national measure is considered to be justified, all Member States shall take the measures necessary to ensure that the non-compliant toy is withdrawn from their market or recalled, and shall inform the Commission accordingly. If the national measure is considered to be unjustified, the Member State concerned shall withdraw it. 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 15 of this Regulation or the common specifications referred to in Article 16 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.

Formal non-compliance

Article 47

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1.   Without prejudice to Article 45, 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: (a) the CE marking has been affixed in violation of Article 17 or 18; (b) the CE marking has not been affixed; (c) the digital product passport has not been drawn up in accordance with Article 19; (d) the data carrier through which the digital product passport is accessible has not been affixed in accordance with Article 19(7); (e) the technical documentation referred to in Article 27 is either not available or not complete. 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.

Commission action concerning toys that present a risk

Article 48

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1.   Where the Commission becomes aware of a toy or a specific category of toys made available on the market which presents a risk to the health and safety of persons but is nonetheless in compliance with the particular safety requirements, or which presents such a risk and is raising doubts about compliance with the particular safety requirements, it is empowered to adopt implementing acts setting out measures to ensure that the toy or category of toys, when made available on the market, no longer presents that risk, to withdraw it from the market or to recall it where all of the following conditions are met: (a) it emerges from prior consultations with the market surveillance authorities that the approach to dealing with the risk differs from one market surveillance authority to another; and (b) the risk cannot, due to its nature, be dealt with in accordance with other procedures laid down by this Regulation. 2.   The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 53(3). On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission is empowered to adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 53(4).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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