What is a CPSR, and who signs the Cosmetic Product Safety Report?

## What Is a CPSR, and Who Signs the Cosmetic Product Safety Report? The **Cosmetic Product Safety Report (CPSR)** is a formal safety assessment output required before placing cosmetic products on the EU market. Understanding who creates it, who signs it, and its relationship to the Responsible Person is essential. ### What Is a CPSR? According to Article 10 of Regulation (EC) No 1223/2009, the CPSR is the formal safety assessment report that must be completed before a cosmetic product can be placed on the market^{<a href="#cite-7">[1]</a>}. It's a comprehensive document that demonstrates the product is safe for human health under normal or reasonably foreseeable conditions of use. ### What Must Be in the CPSR? The CPSR must include two parts^{<a href="#cite-7">[1]</a>}: #### Part A: Product Safety Information - Product description and composition - Physical and chemical characteristics - Microbiological quality - Impurities, traces, and information about packaging - Normal and reasonably foreseeable use - Exposure to the cosmetic product - Exposure to substances - Toxicological profile of substances - Undesirable effects and serious undesirable effects - Information on the cosmetic product #### Part B: Cosmetic Product Safety Assessment - Assessment conclusion - Warnings and instructions for use - Reasoning - Assessor's credentials and approval - Part B must be signed by a qualified safety assessor ### Who Creates the CPSR? The CPSR is typically created by: - **Qualified Safety Assessor** - A person with appropriate qualifications (pharmacy, toxicology, medicine, chemistry, or similar) who conducts the safety assessment - **RP Coordinates** - The Responsible Person ensures the CPSR is created and maintained, but typically doesn't create it themselves - **Manufacturer Provides Data** - The manufacturer provides product information, formulations, and testing data needed for the assessment ### Who Signs the CPSR? **Part B of the CPSR must be signed by a qualified safety assessor**^{<a href="#cite-7">[1]</a>}. The assessor must have: - Appropriate qualifications (pharmacy, toxicology, medicine, chemistry, or similar) - Sufficient experience in cosmetic product safety assessment - Ability to make independent safety judgments **The RP does NOT typically sign the CPSR** - The RP ensures the CPSR exists and is complete, but the safety assessor signs it. ### CPSR Creation Checklist Before market placement, ensure: - [ ] Qualified safety assessor is engaged - [ ] All product information is provided to assessor - [ ] Safety assessment is conducted - [ ] Part A (Product Safety Information) is complete - [ ] Part B (Safety Assessment) is complete and signed by qualified assessor - [ ] CPSR is included in the Product Information File (PIF) - [ ] RP has verified CPSR is complete ### Relationship Between CPSR and RP The RP's role regarding CPSR: - ✅ **RP must ensure** the product undergoes a safety assessment^{<a href="#cite-7">[2]</a>} - ✅ **RP must ensure** the CPSR is created and kept up to date - ✅ **RP maintains** the CPSR as part of the PIF - ✅ **RP coordinates** the safety assessment process (typically) - ❌ **RP does NOT** typically conduct the safety assessment - ❌ **RP does NOT** sign the CPSR (safety assessor does) ### Practical Workflow **Typical CPSR Process:** 1. Manufacturer provides product information to RP 2. RP coordinates with qualified safety assessor 3. Safety assessor conducts assessment and creates CPSR 4. Safety assessor signs Part B of CPSR 5. RP verifies CPSR is complete 6. RP includes CPSR in PIF 7. Product can be placed on market ### When Must CPSR Be Updated? The CPSR must be kept up to date when: - Product formulation changes - New safety information becomes available - Undesirable effects are reported - Product use conditions change - New scientific data emerges ### Common CPSR Mistakes to Avoid - ❌ No CPSR before market placement - ❌ CPSR not signed by qualified assessor - ❌ Incomplete CPSR (missing Part A or Part B) - ❌ Outdated CPSR (not updated when products change) - ❌ RP trying to sign CPSR themselves (without qualifications) - ❌ Missing CPSR in PIF ### CPSR Readiness Checklist Before placing products on the market: - [ ] Qualified safety assessor is identified - [ ] Safety assessment is conducted - [ ] CPSR Part A is complete - [ ] CPSR Part B is complete and signed by qualified assessor - [ ] CPSR is included in PIF - [ ] RP has verified CPSR completeness - [ ] Process for CPSR updates is established ### Next Steps 1. Understand CPSR requirements for your products 2. Identify qualified safety assessor 3. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers that can coordinate CPSR creation --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: <a id="cite-7"></a>[1] [Regulation (EC) No 1223/2009 - Article 10](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223) <a id="cite-7"></a>[2] [Regulation (EC) No 1223/2009 - Article 11](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)