Division 4.4 Assessor’s credentials and approval of Part B

The safety assessor is to be a professional with the necessary knowledge and expertise to draw up an accurate safety assessment, as indicated by the qualification requirements in Article 10(2) of Regulation (EC) No 1223/2009. That section of the cosmetic product safety report aims at ensuring that this requirement is met and that the necessary evidence is provided.

That section of the safety report is required to list the name and address of the safety assessor and to be dated and signed.

The result of the safety assessment is to be signed stating the date of preparation or be issued based on an electronic release establishing a clear relationship between the assessor, the formulation and the date of assessment. The electronic version should be protected from abuse by unauthorised persons.

In accordance with Article 10(2) of Regulation (EC) No 1223/2009, the safety assessor is required to be ‘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’.

A person who has obtained qualifications in a third country may act as a safety assessor if they have completed ‘a course recognised as equivalent [to a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline] by a Member State’.

Proof is to be provided of the safety assessor’s qualification (i.e. copy of the diploma and, where needed, proof of equivalence) laid down in Article 10 of Regulation (EC) No 1223/2009.