Undesirable effects and cosmetovigilance after product launch
How to receive, assess, document and report undesirable and serious undesirable effects associated with cosmetic products in the EU.
Read the guide →Service area 02 · specialist support
Cosmetic product safety assessment and CPSR
The CPSR is the foundation of documented cosmetic product safety. The assessment must connect reliable data on ingredients, exposure, use, target population, microbiological quality and packaging.
Scope of support
What we can deliver for your project
Preparation and review of the CPSR, toxicological assessment of ingredients, exposure, margin of safety and finished product safety.
- 11Preparation of CPSR Part A and Part B
- 12Toxicological assessment of ingredients
- 13Calculation of systemic exposure and margin of safety
- 14Assessment of local effects, irritation and sensitisation
- 15Assessment of impurities, traces and packaging materials
- 16Assessment of products for children or sensitive groups
- 17Safety assessment of fragrance compositions and essential oils
- 18Review of stability, compatibility and microbiological quality
- 19Update of an existing CPSR following formula or regulatory changes
- 20Independent expert review of a CPSR prepared by another assessor
Project outcomes
From a question to an actionable regulatory solution
The exact scope is confirmed after reviewing the product, target markets and available documentation.
01
CPSR Part A and Part B
02
Documented toxicological approach
03
Review of input data quality
04
Recommendations for missing evidence and testing
Frequently asked questions
Before the project starts
Is the CPSR the same as the PIF?+
No. The CPSR is the mandatory safety component of the broader Product Information File.
Can an existing CPSR be updated?+
Yes. A review is needed after relevant changes to the formula, use, packaging, ingredient data or legislation.
Do you assess products intended for children?+
Yes, where suitable data are available and the specific conditions of use and exposure are clearly defined.
New fragrance allergen labelling requirements: 2026 and 2028 deadlines
What Regulation (EU) 2023/1545 changes for fragrance allergen labelling, which thresholds apply and how to prepare formulas and labels for 2026 and 2028.
Read the guide →Reformulating a cosmetic product after regulatory change
How to plan reformulation after an ingredient restriction and align testing, CPSR, PIF, labelling, CPNP and packaging stocks.
Read the guide →Next step
Do you have a product or portfolio for the EU market?
Send us the essential product details, target markets and available documentation. We will respond by email.