Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

CHAPTER VIII NON-COMPLIANCE, SAFEGUARD CLAUSE

Article 25 Non-compliance by the responsible person

1. Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:

(a) the good manufacturing practice referred to in Article 8;

(b) the safety assessment referred to in Article 10;

(c) the requirements for the product information file referred to in Article 11;

(d) the provisions on sampling and analysis referred to in Article 12;

(e) the notification requirements referred to in Articles 13 and 16;

(f) the restrictions for substances referred to in Articles 14, 15 and 17;

(g) the animal testing requirements referred to in Article 18;

(h) the labelling requirements referred to in Article 19(1), (2), (5) and (6);

(i) the requirements related to product claims set out in Article 20;

(j) the access to information for the public referred to in Article 21;

(k) the communication of serious undesirable effects referred to in Article 23;

(l) the information requirements on substances referred to in Article 24.

2. Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.

3. The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.

4. In the case of serious risks to human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State in which the cosmetic product is made available on the market, it shall inform the Commission and the competent authorities of the other Member States of the measures which it has required the responsible person to take.

5. The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:

(a) where an immediate action is necessary in the event of serious risk to human health; or

(b) where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.

In the event of serious risks to human health, that competent authority shall inform the Commission and the competent authorities of the other Member States, without delay, of the measures taken.

6. In the absence of a serious risk to human health, in the event that the responsible person does not take all appropriate measures, the competent authority shall without delay inform the competent authority of the Member State in which the responsible person is established of the measures taken.

7. For the purposes of paragraphs 4 and 5 of this Article, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety(1) shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products(2) shall also apply.

Article 26 Non-compliance by distributors

Competent authorities shall require distributors to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within a given reasonable time limit, commensurate with the nature of the risk, where there is non-compliance with obligations laid down in Article 6.

Article 27 Safeguard clause

1. In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.

2. The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States the measures taken and any supporting data.

For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

3. The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.

4. Where the provisional measures are justified, Article 31(1) shall apply.

5. Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.

Article 28 Good administrative practices

1. Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based. It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.

2. Except in the case where immediate action is necessary for reasons of serious risk to human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.

3. Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with regard to the distributor for any decisions taken pursuant to Articles 26 and 27.

(1)

OJ L 11, 15.1.2002, p. 4.

(2)

OJ L 218, 13.8.2008, p. 30.