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PIF: who may be safety assessor?

©CosmeticOBS-L'Observatoire des Cosmétiques

Annex 1 to Cosmetics Regulation requires that the safety assessor shall prove his qualification. The requirements are described in Article 10, Paragraph 2.

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Under Article 10 of the Regulation, “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.”

A qualified person with a diploma in a “similar discipline” could be, for example, a veterinarian, a biochemist or a chemist with appropriate background and experience. Further guidance on this is expected from the European Commission.
It is most obviously in a company’s interest that the safety assessment should be sound and supportable. It is recommended that substantial experience (in addition to formal qualifications) may be appropriate for this function to be adequately fulfilled. Training programs on risk assessment exist at European as well as at Member States’ national level, some of them particularly focusing on cosmetic products.

The safety assessor may be a company employee or a consultant. He need not necessarily be based within the EU.

Cosmetics Europe - FEBEA

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