Cosmetic Safety Assessment

The Cosmetic Product Safety Report (CPSR) is a mandatory document that demonstrates the safety of a cosmetic product before it is placed on the market. Preparing a CPSR requires specialized expertise in cosmetic legislation, toxicology, and product safety assessment.

A Cosmetic Safety Assessment evaluates the product’s toxicological profile, chemical composition, exposure levels, and overall safety for human use based on the finished formulation and intended conditions of use.

The Cosmetic Safety Assessor responsible for preparing the CPSR must possess the qualifications required by the applicable cosmetic legislation, including an appropriate university degree in fields such as pharmacy, biology, chemistry, biochemistry, bioengineering, toxicology, microbiology, dermatology, or medicine, together with the necessary professional experience and training.

Manufacturers placing cosmetic products on the market are required to maintain a Product Information File (PIF) and appoint a Responsible Technical Person to ensure compliance with cosmetic legislation, Good Manufacturing Practices (GMP), and other applicable regulatory requirements.

For cosmetic products intended for the European Union market, the CPSR must be prepared through an EU-based Responsible Person (RP). Bilim Laboratory cooperates with international regulatory partners to support cosmetic products intended for export to the European market.

Documents Required for a Cosmetic Safety Assessment (CPSR)

• Manufacturer and distributor information (company name and contact details)
• GMP Compliance Certificate
• Product formulation (including INCI names and CAS numbers of all ingredients)
• Safety Data Sheets (SDS/MSDS) for all raw materials
• Allergen information for raw materials (particularly fragrances), including IFRA documentation where applicable
• Certificates of Analysis (CoA) and specifications for raw materials (chemical, physical, and microbiological)
• Toxicological profiles of formulation ingredients
• Information on impurities, residues, and packaging materials
• Finished product specification (chemical, physical, and microbiological)
• Finished product Safety Data Sheet (SDS/MSDS)
• Preservative Efficacy Test (Challenge Test) Report
• Stability Test Report
• Reports supporting product claims (where applicable)
• Packaging material information
• Product labels
• Documentation supporting marketing claims
• Dermatological Test Report (when dermatological claims are made)

For more information or to request a quotation for Cosmetic Product Safety Assessment (CPSR) preparation and the required laboratory testing services, please contact Bilim Laboratory.