Cosmetic Product Safety Report Explanation (CPSR)
Cosmetic Product Safety Report (CPSR) is also commonly referred to as ‘Safety Assessment‘. The Cosmetic Product Safety Report (CPSR) is a vital document, and failure to include it in the Product Information File (PIF) or prepare it correctly can lead to significant penalties, product withdrawal, and RAPEX notification. Non-compliance can result in thorough inspections of all products, emphasizing the importance of adhering to relevant regulations.
PART A
Annex I of REGULATION (EC) No 1223/2009 provides detailed information that the Safety Assessor should collect and analyze to identify and quantify potential hazards of a cosmetic product on human health.
- Composition of the cosmetic product
- Characteristics and stability of the cosmetic product
- Microbiological quality of the cosmetic product
- Presence of impurities/traces and packaging info
- Intended use of the product.
- Exposure to cosmetic product and substances
- Toxicology of cosmetic product substances
- Adverse effects from using the cosmetic product
- Relevant information about the cosmetic product
These elements are essential for the Safety Assessor to assess the safety and compliance of the cosmetic product.
PART B
PART B of the CPSR covers the safety assessment of the cosmetic product, which comprises:
- Conclusion statement on product safety under Article 3 of REGULATION (EC) No 1223/2009.
- Label warnings & instructions: statement on following Article 19(1)(d) by labeling any warnings & instructions of use.
- Reasoning: Explanation of scientific reasoning for assessment conclusion, considering safety margins, interactions of substances, stability impacts, and toxicological profiles, with a particular focus on cosmetic products for children under three and those for external intimate hygiene. Justification for consideration or non-consideration of toxicological profiles should also be included.
- Approval of Part B by the Qualified Assessor.
These elements are critical for evaluating cosmetic product safety and compliance with regulations. The Safety Assessor must explain their scientific reasoning and provide evidence to support the assessment conclusion, while also demonstrating their competence through credentials and approval of Part B.