Article 6

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.

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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.