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to the website of DGK and IKW for safety assessors.


The principle of safety assessment of cosmetic products was anchored in the European Cosmetics legislation for the first time through Directive 93/35/EEC (6th Amendment to the EC Cosmetics Directive 76/768/EEC). Manufacturers and distributors of cosmetic products were required to subject every product prior to its placing on the market to a comprehensive assessment of its safety for human health. In the meantime – after the entry into force of the EC Cosmetics Regulation [Regulation (EC) No 1223/2009] in January 2010 – the requirements concerning the safety assessment have been specified in more detail and concretised (in Annex I of the Regulation).

For this task a safety assessor has to be appointed who is personally responsible for the safety of a cosmetic product. This means that the product must meet all requirements of the EC Cosmetics Regulation in terms of its effects on human health in the event of normal or reasonably foreseeable use of a cosmetic product. When preparing a safety assessment, the expert must first of all review all existing basic requirements of cosmetic legislation (substance regulations, labelling provisions etc). The more extensive assessment must be in conformity with Article 10 and Annex I of the EC Cosmetics Regulation. In this connection the toxicological profiles of all ingredients and the exposure conditions to be expected must be taken into due account.

For the elaboration of the safety assessment the legislator has specified a certain group of persons. Article 10 of the EC Cosmetics Regulation stipulates in Section 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 recognised as equivalent by a member state.“

However, such a course alone is as a rule not sufficient. In view of a competent assessment of the safety of cosmetic products, interdisciplinary knowledge is necessary, in particular in the fields of chemistry, toxicology, dermatology and (cosmetics) law, so that the corresponding person must engage in continuing education in these specific areas on a regular basis, in order to be permanently informed about the current state of science and technology.