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Safety assessment of cosmetic products
Prior to introduction on the market, the responsible person ensures, in order to demonstrate that the product is safe for human health when used under normal or reasonably foreseeable conditions of use, that safety is evaluated on the basis of the relevant information and that a Product Information File (PIF) is established, according to Annex I of the regulation (EC) n°1223/2009.
Part B of the PIF is the cosmetic product safety assessment. This part of the PIF contains the assessment conclusion, labelled warnings and instructions of use, as well as explanation of the scientific reasoning leading to the assessment conclusion.
The responsible person ensures :
- that 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.
- that an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources
- that 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.
The cosmetic product safety assessment 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.
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