Regularising cosmetics

Regulatory Affairs professionals mainly supervise the authorisation procedures for the marketing of chemical companies’ products.

Safety assessment

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. (Art. 10.1 Reg (CE) n. 1223/2009).

The Safety assessment is a complex process. It provides experienced knowledge of products’ composition, chemical and physical properties of its ingredients, the production processes, the final function and the method of the product application. The standard for this evaluation, based on scientific method and top technique, are very high in order to guarantee customers protection. The evaluator is a key figure of this process for its experience that is necessary for the compilation of the security evaluation.

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. (Art. 10.2 Reg (CE) n. 1223/2009).

The Responsible Person must choose a suitable Safety Assessor with qualification and strong and specific experience in the cosmetology field. The safety assessor is compelled to sign the safety report and to attach evidence of its qualification to the P.I.F.

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