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Regulation (EU) 2024/1781 CHAPTER XII — SAFEGUARD PROCEDURES

Article 69–Article 71 · 3 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 products presenting a risk at national level

Article 69

1.   Where the market surveillance authorities have sufficient reason to believe that a product covered by a delegated act adopted pursuant to Article 4 presents a risk, they shall carry out an evaluation covering all requirements relevant to the risk and laid down in this Regulation or in that delegated act. Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in this Regulation or in the applicable delegated act adopted pursuant to Article 4, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the non-compliance to an end. That corrective action may include, inter alia, the actions listed in Article 16(3) of Regulation (EU) 2019/1020. 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 corrective action which they have required the economic operator to take. 3.   The relevant economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union. 4.   Where the relevant economic operator does not take corrective action within the period referred to in paragraph 1, second subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the making available of the product concerned on their national market, to withdraw it from that market or to recall it. They shall inform the Commission and the other Member States, without delay, of those measures. 5.   The information to be provided to the Commission and the other Member States in accordance with paragraph 4 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the non-compliance involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. The market surveillance authorities shall also indicate whether the non-compliance is due to either: (a) the failure of the product to meet requirements set out in the relevant delegated act adopted pursuant to Article 4 of this Regulation; or (b) shortcomings in the harmonised standards or common specifications referred to in Articles 41 and 42 of this Regulation conferring a presumption of conformity. 6.   Member States other than the Member State initiating the procedure 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 product concerned, and, in the event of disagreement with the notified national measure, of their objections. 7.   Where, within three months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. That provisional measure may specify a period other than three months in order to take account of the specificities of the products or requirements concerned. 8.   Member States shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.

Union safeguard procedure

Article 70

1.   Where, on completion of the procedure set out in Article 69(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to 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 decide by means of an implementing act whether the national measure is justified or not. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 73(3). The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2.   If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. 3.   Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in Article 41 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. 4.   Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the common specifications referred to in Article 42, the Commission shall, without delay, adopt implementing acts amending or repealing the common specifications concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 73(3).

Formal non-compliance

Article 71

1.   Where a Member State makes one of the following findings, it shall require the relevant economic operator to bring the non-compliance concerned to an end: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 46 of this Regulation; (b) the CE marking has not been affixed; (c) the identification number of the notified body has been affixed in violation of Article 46 or has not been affixed where required; (d) the EU declaration of conformity has not been drawn up; (e) the EU declaration of conformity has not been drawn up correctly; (f) the technical documentation is not available, not complete or contains errors; (g) the information referred to in Article 27(6) or Article 29(3) is absent, false or incomplete; (h) any other administrative requirement provided for in Article 27 or Article 29 or in the applicable delegated act adopted pursuant to Article 4 is not fulfilled. 2.   Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.

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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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