Resources/CPSR & PIF
CPSR & PIF: the EU's cosmetic safety documentation
Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings. See Regulation (EC) No 1223/2009 for current text.
The Cosmetic Product Safety Report (CPSR) and Product Information File (PIF) are often mentioned together because they are: the CPSR is one of the five required components inside the PIF. Neither is submitted to a regulator up front — both must simply exist and be kept available before the product goes on the EU market.
What is a CPSR? (Article 10 / Annex I)
Before placing a cosmetic product on the market, the responsible person must ensure it has undergone a safety assessment and that a CPSR exists, structured exactly as Annex I of the Regulation:
- Part A — safety information: quantitative and qualitative formulation, physical/chemical characteristics and stability, microbiological quality, impurities and packaging material, normal and reasonably foreseeable use, exposure to the product and to individual substances, toxicological profile of each substance, undesirable effects, and other relevant product information.
- Part B — safety assessment: the assessor's conclusion, labelled warnings and instructions for use, reasoning behind the conclusion, and the assessor's credentials/signature.
Under Article 10(2), Part B can only be signed by a qualified safety assessor — someone holding a diploma or other formal qualification from a university course of theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, or a course recognized as equivalent by a Member State. An unsigned CPSR, or one signed by someone without that qualification, doesn't satisfy Article 10.
What is a PIF, and what does it require? (Article 11)
The PIF wraps the CPSR with four other required parts:
- A description of the cosmetic product
- The Cosmetic Product Safety Report (above)
- A description of the manufacturing method and a statement of GMP compliance
- Proof of the effect claimed, where the nature of the claim justifies it
- Data on any animal testing carried out by the manufacturer, agents, or suppliers
Under Article 11(2), the responsible person must keep the PIF readily accessible (electronic or other format) at the address on the product label. Under Article 11(3), its contents must be in a language the competent authority can readily understand. Both obligations run for 10 years after the last batch of the product was placed on the market. There's no submission step — the obligation is availability on request, not filing.
A CPSR is only as good as the ingredient data behind it — confirm every substance's regulatory status before your safety assessor signs off. Run a free INCI compliance scan, or sign in to check a full formulation across EU and export markets at once.
Related: CPNP notification guide, Cosmetic GMP (ISO 22716), EU CosIng and INCI basics.