COMMISSION IMPLEMENTING DECISION
of 25 November 2013
on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
(Text with EEA relevance)
(2013/674/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular the third subparagraph of Article 10(1) thereof,
Whereas:
(1)
It is essential that cosmetic products made available on the Union market be safe for human health when used under normal and reasonably foreseeable conditions of use. To that end, Regulation (EC) No 1223/2009 requires that, in order to establish that a cosmetic product is safe under those conditions, cosmetic products undergo a safety assessment.
(2)
The operator designated as the responsible person in accordance with Regulation (EC) No 1223/2009 is to ensure that, for each cosmetic product which is to be placed on the Union market, a cosmetic product safety report is drawn up on the basis of the relevant information and in accordance with the requirements laid down in Annex I to Regulation (EC) No 1223/2009.
(3)
In order to facilitate the understanding of the requirements of Annex I to Regulation (EC) No 1223/2009 by all undertakings, and especially small and medium-size enterprises, the Regulation requires that the Commission adopts appropriate guidelines.
(4)
This Decision sets out appropriate guidelines on Annex I to Regulation (EC) No 1223/2009. They were developed with the contribution of the relevant stakeholders, including representatives of small and medium-sized enterprises.
(5)
The guidelines should assist responsible persons in complying with their regulatory obligations. However, they are not meant to replace the knowledge and expertise of the qualified safety assessor, as required by Article 10(2) of Regulation (EC) No 1223/2009, who should remain the only professional allowed to carry out the cosmetic product safety assessment as described in Part B of Annex I.
(6)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DECISION:
Article 1
The guidelines to enable undertakings to comply with the requirements laid down in Annex I to Regulation (EC) No 1223/2009 on cosmetic products are set out in the Annex to this Decision.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 25 November 2013.