The Regulation requires every product placed on the EU Market to have a detailed safety assessment, known as a Cosmetic Product Safety Report (CPSR). This CPSR is the key to ensuring a product is safe when used in the expected way by a consumer and is the most important document held in the Product Information File.
The CSPR must be completed by a suitably qualified toxicologist with a qualification which is recognised by the member states. At MSL we have an in-house Safety Assessor who, alongside his PhD in Chemistry, has years of experience in the assessment of Cosmetic Products and has assessed thousands of products.
The Cosmetic Product Safety Report consists of two parts:
• Part A – Cosmetic Product Safety Information
• Part B – Cosmetic Product Safety Assessment
Part A holds the product information and test data. This includes the quantitative and qualitative formulation, physical/chemical characteristics and stability, microbial quality, impurities, traces in the product and information on the packaging material, normal and foreseeable use, exposure to the product, exposure to the ingredients, toxicological profile of the ingredients and undesirable effects of the product.
Part B is the safety assessor’s expert opinion as to why the product is safe to be placed on the market.
In order to complete the CPSR a large amount of documentation is required about the cosmetic product:
• Method of Manufacture
• GMP Certification
• Qualitative and Quantitative Formulation
• Raw Material Safety Data Sheets
• Details of any Serious or Undesirable effects
• IFRA Certificate and Allergen Declarations for artificial fragrances
• Stability Test Data
• Challenge Test Data (if applicable)
• Microbial Limits Test Data (if applicable)
• SPF Test Data (if applicable)
It may be difficult to collect this data, especially if you are a brand who does not manufacture the product. We are experienced in the gathering of this documentation, and we can utilise our many contacts within the cosmetics industry to do so. Please contact us if you need any more information on Cosmetic Product Safety Reports.