CHAPTER 2

Where a competent authority submits a product or type of product to an evaluation to determine whether or not to adopt a decision as referred to in Article 2(1), it may request from the economic operator identified in accordance with Article 8, with due regard to the principle of proportionality, any of the following in particular: relevant information concerning the characteristics of the product or type of product in question; relevant and readily available information on the lawful marketing of the product in another Member State. Member States shall not refuse certificates or test reports issued by a conformity-assessment body accredited for the appropriate field of conformity-assessment activity in accordance with Regulation (EC) No 765/2008 on grounds related to the competence of that body. Where a competent authority intends to adopt a decision as referred to in Article 2(1), it shall send the economic operator identified in accordance with Article 8 written notice of that intention, specifying the technical rule on which the decision is to be based and setting out technical or scientific evidence to the effect that: the intended decision is justified on one of the grounds of public interest set out in Article 30 of the Treaty or by reference to other overriding reasons of public interest; and the intended decision is appropriate for the purpose of achieving the objective pursued and does not go beyond what is necessary in order to attain that objective. Any intended decision shall be based on the characteristics of the product or type of product in question. The economic operator concerned shall, following receipt of such notice, be allowed at least 20 working days in which to submit comments. The notice shall specify the time limit within which comments may be submitted. Any decision as referred to in Article 2(1) shall be taken and notified to the economic operator concerned and to the Commission within a period of 20 working days from the expiry of the time limit for the receipt of comments from the economic operator referred to in paragraph 1 of this Article. It shall take due account of those comments and shall state the grounds on which it is based, including the reasons for rejecting the arguments, if any, put forward by the operator, and the technical or scientific evidence as referred to in paragraph 1 of this Article. Where duly justified by the complexity of the issue, the competent authority may, once only, extend the period specified in the first subparagraph by a maximum of 20 working days. That extension shall be duly reasoned and shall be notified to the economic operator before the expiry of the initial period. Any decision as referred to in Article 2(1) shall also specify the remedies available under the law in force in the Member State concerned and the time limits applying to such remedies. Such a decision may be challenged before national courts or tribunals or other instances of appeal. Where, after giving written notice in accordance with paragraph 1, the competent authority decides not to adopt a decision as referred to in Article 2(1), it shall immediately inform the economic operator concerned accordingly. When the competent authority fails to notify the economic operator of a decision as referred to in Article 2(1) within the period specified in paragraph 2 of this Article, the product shall be deemed to be lawfully marketed in that Member State insofar as the application of its technical rule as referred to in paragraph 1 of this Article is concerned. The competent authority shall not temporarily suspend the marketing of the product or type of product in question, during the procedure laid down in this Chapter, except where either: under normal or reasonably foreseeable conditions of use, the product or type of product in question poses a serious risk to the safety and health of the users; or the marketing of the product or type of product in question is generally prohibited in a Member State on grounds of public morality or public security. The competent authority shall immediately notify the economic operator identified in accordance with Article 8 and the Commission of any suspension as referred to in paragraph 1 of this Article. In the cases referred to in paragraph 1(a) of this Article, that notification shall be accompanied by a technical or scientific justification. Any suspension of the marketing of a product pursuant to this Article may be challenged before national courts or tribunals or other instances of appeal. References to the economic operators in Articles 4, 6 and 7 shall be considered references: to the manufacturer of the product, if established in the Community, or the person who has placed the product on the market or requests to the competent authority that the product be placed on the market; where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in point (a), to the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, to the importer of the product; where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a) and (b), to any professional in the supply chain whose activity may affect any property of the product regulated by the technical rule which is being applied to it; where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a), (b) and (c), to any professional in the supply chain whose activity does not affect any property of the product regulated by the technical rule which is being applied to it.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.