On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for cosmetic product safety reports. The Implementing Decision will enter into force in mid-December 2013.
Under the Cosmetics Regulation, cosmetic products placed on the EU market must be safe for human health when used under normal and reasonably foreseeable conditions of use, taking into account, among other things, the product’s presentation and labelling. A legal or natural person designated within the EU as the “responsible person” must ensure that each cosmetic product placed on the EU market has a cosmetic product safety report drawn up in accordance with the requirements of Annex I of the Cosmetics Regulation. This safety report forms part of the product’s information file, which the responsible person must keep for a period of 10 years following the placing on the market of the last batch of product.
The Commission’s guidelines supplement the minimum requirements for cosmetic product safety reports described in Part A and Part B of Annex I of the Cosmetics Regulation. They follow the format of Annex I and set out additional information on each heading of each part of the Annex. Part A of the Annex relates to the cosmetic product safety information, i.e., the data necessary for the safety assessment of the product, while Part B relates to the safety assessment itself and the reasons for drawing conclusions as to the product’s safety.
The guidelines are not intended to replace the knowledge and expertise of the qualified safety assessor, defined in Article 10(2) of the Cosmetics Regulation, who should remain the only professional allowed to carry out the cosmetic product safety assessment described in Part B of Annex I. However, they provide clarity on the requirements of the cosmetic product safety report, which will assist manufacturers and importers of cosmetic products intended for the EU market, and their designated responsible persons, comply with their regulatory obligations under EU law.