One of the legal requirements before placing a cosmetic product on the EU market is to ensure that the product has undergone a safety assessment (part B of the CPSR).
CPSR （ Cosmetic Product Safety Report ）is comprised of two parts
Part A: Cosmetic Product Safety Information
Part B: Cosmetic Product Safety Assessment
This means that the product should be evaluated by a qualified professional in order to guarantee the safety of the cosmetic product and its ingredients and their compliance with the regulation. According to the regulation, the safety assessor should possess 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 an EU Member State.
The safety assessment is based on the cosmetic product safety information gathered in Part A of the CPSR. The safety assessor takes into account the product’s quantitative and qualitative composition, physical and chemical characteristics, stability, microbiological quality, packaging material, normal and reasonably foreseeable use, data on undesirable effects and the anticipated systemic exposure to individual ingredients in the final formulation. An appropriate weight-of-evidence approach for reviewing data from all existing sources is used while taking particular consideration of the toxicological profile of the substances contained in the product.
The safety assessor makes a conclusion on the safety of the cosmetic product and its compliance with the regulation and provides an explanation of the scientific reasoning leading to the assessment conclusion)・ Where relevant, margins of safety, possible interactions of the substances contained and the impacts of the stability on the product’s safety shall be assessed and discussed. The assessor also states whether there is a need to put any particular warnings and instructions of use on the label. For cosmetic products intended to be used on children under the age of three (3) and for cosmetic products intended exclusively for use in external intimate hygiene, a specific assessment inter alia shall be accomplished・
The duly signed safety assessment and the proof of credentials of the safety assessor are then included in Part B of the CPSR. Upon placing the product on the market, the safety assessment shall be kept up to date in view of additional relevant information generated.
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