EU Regulation No. 1223/2009 Part 1: Product Safety

By: David Steinberg, Steinberg & Associates

Posted: July 30, 2010, from the August 2010 issue of Cosmetics & Toiletries.

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2. The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.

3. Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June, 1988, for the purpose of assessing the safety of a cosmetic product shall comply with community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognized as being equivalent by the Commission or the ECHA.

Article 11: Product Information File
1. When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

2. The product information file shall contain the following information and data, which shall be updated as necessary:
(a) a description of the cosmetic product, which enables the product information file to be clearly attributed to the cosmetic product;
(b) the cosmetic product safety report referred to in Article 10(1);
(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.