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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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Preamble item 19 states: It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.
Additional preamble items related to safety include:
(36) Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.
(37) In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.
(41) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small- and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products, could be facilitated by Commission guidelines.
(50) In the safety assessment of a cosmetic product, it should be possible to take into account the results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.
(51) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular, Directive 2005/29/EC of the European Parliament and of the Council of 11 May, 2005, concerning unfair business-to-consumer commercial practices in the internal market (1) OJ L 149, 11.6.2005, p. 22. (1) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.
In addition to these preamble items, Articles 3, 8, 10 and 11 and Annex 1 address product safety. For the reader’s information, 36 other Articles do not deal with safety and these will be discussed in future columns. The following information on Articles 3, 8, 10 and 11 appears as it is written in the regulation.
Article 3: Safety
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account of the following: (a) presentation including conformity with Directive 87/357/EEC (products appearing to be other than they are, or endanger the health or safety of consumers); (b) labeling; (c) instructions for use and disposal; (d) any other indication or information provided by the responsible person defined in Article 4. Article 8: GMP 1. The manufacture of cosmetic products shall comply with GMPs with a view to ensuring the objectives of Article 1. 2. Compliance with GMPs shall be presumed where the manufacture is in accordance with the relevant harmonized standards, the references of which have been published in the Official Journal of the European Union.
Article 10: Safety Assessment
1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. The responsible person shall ensure that:
(a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; (
c) the cosmetic product safety report is kept up-to-date in view of additional relevant information generated subsequent to placing the product on the market.
The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC. The European Commission, in close cooperation with all stake- holders, shall adopt appropriate guidelines to enable undertakings, in particular small- and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).