Cosmetic Product Safety Report (CPSR)
Safety assessment of cosmetic products by a qualified safety assessor, as required by Article 10 and Annex I of Regulation (EC) 1223/2009.
Get a quoteWhat it is
The Cosmetic Product Safety Report (CPSR) is the safety assessment that every cosmetic product needs before it is placed on the EU market. Part A sets out the safety information: composition, physical and chemical characteristics and stability, microbiological quality, impurities and packaging material, normal and reasonably foreseeable use, exposure, the toxicological profile of the substances and undesirable effects. Part B is the safety assessment itself: the conclusion, label warnings and instructions of use, the reasoning, and the assessor's credentials and approval. The CPSR is part of the Product Information File (PIF).
What we do
- Review of the formula (INCI names and percentages) against the annexes of Regulation (EC) 1223/2009
- Collection of the raw-material data the safety assessor needs
- CPSR Part A (safety information) and Part B (safety assessment), signed by a qualified safety assessor
- Warnings and conditions of use to put on the label
- Ready to use in the Product Information File (PIF) and the CPNP notification
Who needs it
Every cosmetic product placed on the EU market needs a CPSR drawn up according to Annex I before it is sold, and the assessor must hold a qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10). Brands from outside the EU often have test reports or a formula but no CPSR in the EU format, or a CPSR that no longer matches the current formula or label.
What you provide
- Full quantitative formula (INCI names and percentages)
- Raw-material specifications and safety data sheets (SDS)
- Stability and compatibility data, and preservative efficacy (challenge) test where applicable
- Microbiological test results
- Label artwork and intended use (who uses it, where on the body, how often)
Common problems we help with
- CPSR missing or not in the Annex I format
- Formula changed after the CPSR was signed
- Missing raw-material data delays the assessment
- Claims or warnings on the label do not match the CPSR
How it works
- Send the formula, label and available test data
- We check completeness and list any missing data
- Assessment by the safety assessor; questions go through us
- You receive the signed CPSR (Parts A and B) and the label warnings
- If you also appoint us as Responsible Person, we use it directly for the PIF and the CPNP notification
Related services
Related articles
Ask about this service
Request a quote for this service
or email contact@ibertrust.info. We reply by email with a written proposal.
Ready to sell in the EU with confidence?
Tell us your products, markets and sales channels. We reply with a tailored proposal.
Get a quotecontact@ibertrust.info
IberTrust Global