In the highly regulated European Union (EU) cosmetics market, safety is non-negotiable. Before a product, whether it’s a simple lip balm or a complex anti-aging serum, can be legally placed on the market, it must have its safety scientifically verified. This mandatory verification comes in the form of the Cosmetic Product Safety Report (CPSR).
The CPSR is the cornerstone of the Product Information File (PIF) and acts as the product’s safety passport, demonstrating compliance with the strict requirements of EU Regulation (EC) No 1223/2009.
The Role of the CPSR in Safety Substantiation
The core function of the CPSR is safety substantiation. It provides definitive scientific evidence that the cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions. This exhaustive report must be prepared and signed by a qualified safety assessor—a professional with relevant expertise in toxicology, medicine, or pharmacy.
The CPSR is systematically divided into two critical parts, each serving a unique, interconnected function.
Part A: Cosmetic Product Safety Information (The Data)
Part A is the foundation of the report—the comprehensive data gathering section. It is the responsibility of the brand or the Responsible Person (RP) to collect all this technical information, which then enables the assessor to perform the evaluation in Part B.
This section provides the scientific fingerprint of the product, including:
- Quantitative and Qualitative Composition: The exact, full formula of the product, detailing every ingredient and its precise concentration.
- Physical/Chemical Characteristics and Stability: Proof that the product is physically sound, stable throughout its stated shelf life, and chemically compatible with its packaging (based on stability and compatibility testing).
- Microbiological Quality: Evidence, usually from a Preservation Efficacy Test (Challenge Test), that the product is free from harmful microbial contamination and that its preservative system is effective.
- Impurities, Traces, and Packaging Material: Information regarding any unavoidable trace substances and confirmation that the packaging material (plastic, glass, etc.) will not leach contaminants into the product.
- Toxicological Profile of Substances & Exposure Assessment: Detailed safety data (toxicological profiles) for all raw materials, combined with an assessment of how the consumer will realistically use the product (frequency, application site, etc.).
Part B: Cosmetic Product Safety Assessment (The Conclusion)
Part B is where the qualified safety assessor takes all the raw data from Part A and applies expert judgment to determine the final risk level. This is the official cosmetic safety assessment.
This final, signed section contains the following critical elements:
- Assessment Conclusion: The definitive statement confirming whether the product is considered safe for the proposed use. The assessor validates that the exposure levels of all ingredients fall within acceptable safety margins (Margin of Safety – MoS).
- Labelled Warnings and Instructions for Use: Specification of any necessary warnings (e.g., “Do not use on damaged skin”) or specific instructions that must appear on the product labeling.
- Reasoning: The detailed scientific justification for the conclusions drawn, linking the toxicological data in Part A to the final safety determination.
- Assessor’s Credentials: The formal documentation proving the safety assessor holds the required qualifications to legally sign the report.
In short, Part A provides the “what” and “why” (the data and risk factors), while Part B provides the final “yes/no” (the conclusion and legal acceptance). Together, the CPSR is the non-negotiable compliance step that ensures consumer safety and unlocks access to the competitive European market.
