Chapter VI — Union market surveillance and Union safeguard procedures

Article 43 — Procedure at national level for dealing with products within the scope of this Regulation presenting a risk¶

1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product within the scope of this Regulation presents a risk to the health or safety of persons, and, where appropriate, domestic animals or property, and, where applicable, to the environment, they shall carry out an evaluation in relation to the product concerned covering all relevant 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 the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product within the scope of this Regulation does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action, as provided for in Article 16(3) of Regulation (EU) 2019/1020, to bring the non-compliance to an end or to eliminate hazards or, if that is not possible, minimise the risk specified by the market surveillance authorities within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph.

   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 economic operator to take.

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of the products within the scope of this Regulation concerned that the economic operator has made available on the market, throughout the Union.

4. Where the relevant economic operator does not take the corrective action referred to in paragraph 1, second subparagraph, within the specified period or where the non-compliance, referred to in paragraph 1, second subparagraph, or the risk referred to in paragraph 1, first subparagraph, persists, the market surveillance authorities shall ensure that the product concerned is withdrawn or recalled, or that making it available on the market is prohibited or restricted. In such cases, the market surveillance authorities shall ensure that the public, the Commission and the other Member States are informed accordingly, without delay.

5. The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product within the scope of this Regulation, the origin of that product, the nature of the non-compliance alleged 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) the failure of the product to meet the requirements relating to the essential health and safety requirements set out in Annex III;

   (b) shortcomings in the harmonised standards referred to in Article 20(1);

   (c) shortcomings in the common specifications referred to in Article 20(6).

6. 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 product within the scope of this Regulation concerned, and, in the event of disagreement with the adopted 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 to be justified.

8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product, are taken in respect of the product within the scope of this Regulation concerned without delay.

Article 44 — Union safeguard procedure¶

1. Where, on completion of the procedure set out in Article 43(4), (6) and (7) objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legal acts, 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 in the form of a decision 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 to the relevant economic operator or operators.

2. If the national measure is considered to be justified, all Member States shall ensure that appropriate restrictive measures, such as withdrawal, are taken in respect of the non-compliant product within the scope of this Regulation, and shall inform the Commission accordingly.

   If the national measure is considered to be unjustified, the Member State concerned shall withdraw that measure.

3. Where the national measure is considered to be justified and the non-compliance of the product within the scope of this Regulation is attributed to shortcomings in the harmonised standards referred to in Article 43(5), point (b), of this Regulation or common specifications referred to in Article 43(5), point (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 or in Article 20(8) of this Regulation respectively.

Article 45 — Compliant products within the scope of this Regulation which present a risk¶

1. Where, having carried out an evaluation under Article 43(1), a Member State finds that although a product within the scope of this Regulation is in compliance with the essential health and safety requirements set out in Annex III, it presents a risk to the health and safety of persons and, where appropriate, domestic animals or to property, and, where applicable, to the environment, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw that product or to recall it within a reasonable period, commensurate with the nature of the risk.

2. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products within the scope of this Regulation concerned that the economic operator has made available on the market, throughout the Union.

3. The Member State shall immediately inform the Commission and the other Member States about the product which presents a risk, as referred to in paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of that product, the nature of the risk involved and the nature and duration of the national measures taken.

4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken.

   On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not and, where necessary, order appropriate measures.

   That implementing act shall be adopted in accordance with the examination procedure referred to in Article 48(3).

   On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 48(4).

5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.

Article 46 — Formal non-compliance¶

1. Without prejudice to Article 43, where a Member State makes one of the following findings with regard to machinery or a related product, 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 30 of Regulation (EC) No 765/2008 or of Article 24 of this Regulation;

   (b) the CE marking has not been affixed;

   (c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 24(3) or has not been affixed;

   (d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

   (e) the technical documentation is either not available or not complete;

   (f) the information referred to in Article 10(6) or Article 13(3) is absent, false or incomplete;

   (g) any other administrative requirement provided for in Article 10 or Article 13 is not fulfilled.

2. Without prejudice to Article 43, where a Member State makes one of the following findings with regard to partly completed machinery, it shall require the relevant economic operator to put an end to the non-compliance concerned:

   (a) the EU declaration of incorporation has not been drawn up or has not been drawn up correctly;

   (b) the technical documentation is either not available or not complete;

   (c) the information referred to in Article 11(5) or Article 14(3) is absent, false or incomplete;

   (d) any other administrative requirement provided for in Article 11 or Article 14 is not fulfilled.

3. Where the non-compliance referred to in paragraphs 1 and 2 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product within the scope of this Regulation concerned being made available on the market or ensure that it is recalled or withdrawn from the market.