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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Product Safety Under the Cosmetics Directive
In the Cosmetics Directive under Article 7a, the following information must be included on the product label for the competent authority to inspect and review. This has become known as the Product Information
Package or the dossier. Under the new Regulation No. 1223/2009, this information has been retained as preamble item 7, albeit with several changes.

Qualitative and quantitative compositions: The qualitative information includes the INCI names of the ingredients and the quantitative description is the exact amount of each present. In fragrance compositions, the name, code and identity of the supplier should be provided.

Microbiological details: The physical, chemical and microbiological specifications of the raw materials used must be provided, in addition to the microbiological specifications of finished product and the microbiological control criteria for the product.

Method of manufacture: The method of manufacture provided must comply with good manufacturing practices (GMPs) and those responsible for manufacturing must have the required education or experience to meet this requirement.

Safety assessment: The human health safety assessment of the finished product must be provided. This should take into consideration the general toxicological profile of the ingredients, their chemical structure and levels of exposure. The assessment should pay special attention to the specific exposure characteristics of the anatomical sites to which the product will be applied, or to the population for which the product is intended. Among other things, a specific assessment should be carried out for cosmetic products intended for use on children under the age of three, and for cosmetic products intended for use in external intimate hygiene.