EU Cosmetic Safety Assessment
All cosmetic products sold in the EU must be assessed for their safety and compliance with the legislation by a qualified safety assessor with appropriate qualifications in line with the legal requirements of the EU Cosmetics Regulation 1223/2009. Safety Assessment Experts looks after your compliance and regulatory needs making it a stress free experience for you. Based on the specifications and tests of the cosmetic product we perform a thorough cosmetic product safety assessment to ensure your product is safe and legal for sale, and thereby complete your product’s cosmetic product safety report (CPSR).
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EU Cosmetic Safety Assessment
One of the legal requirements before placing a cosmetic product on the EU market is to have a safety assessment of the product. This means that there should be an evaluation by a qualified professional to guarantee the safety of the cosmetic product and its ingredients. As stated in Article 10.1 of Cosmetic Regulation (EC) No. 1223/2009, 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.
But how is the assessment of the safety of cosmetic products done? The safety assessment is made based on the cosmetic product safety information in Part A of the Cosmetic Product Safety Report (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 a final formulation. He/she uses an appropriate weight-of-evidence approach for reviewing data from all existing sources and takes particular consideration to the toxicological profile of the substances contained in the product.
The safety assessor makes a conclusion on the safety of the cosmetic product 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. He/she also states whether there is a need to label any particular warnings and instructions of use in accordance with Article 19.1(d). For cosmetic products intended for use 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 which is compiled in the product’s Product Information File (PIF). Upon placing the product on the market, the safety assessment shall be kept up to date in view of additional relevant information generated.
What do our customers say
Thank you for the fabulous and super fast work. Tanja is great and easy to work with! It was the fastest SA I had ever done, but formally it’s exactly the same as those done by other companies with less competitive prices.
I ordered a safety assessment for my shampoo at CE.way. I was very satisfied with their responsiveness. I gathered the documentation and they helped me gather all of the missing tests necessary for the safety assessment. The safety assessment itself was done very fast.