CHAPTER IIISAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
Article 10Safety assessment
1
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.
The responsible person shall ensure that:
a
the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
b
an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;
c
the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
F1...
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 F2the Secretary of State.
3
Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product F3must comply with the Good Laboratory Practice Regulations 1999, or with F4... international standards recognised as being equivalent by the F5Secretary of State.