Full formula
Every ingredient with its exact percentage and INCI name, including the composition of fragrance and raw-material blends.
Your EU Responsible Person for cosmetics under Regulation (EC) No 1223/2009
Every cosmetic product placed on the EU market needs a safety assessment before it is sold (Article 10 of Regulation (EC) No 1223/2009). The result is the Cosmetic Product Safety Report - the core document of the Product Information File.
The CPSR is a written report, structured as set out in Annex I of the Regulation, that documents why a specific cosmetic product is safe for human health under normal and reasonably foreseeable conditions of use. It is product-specific: each formulation needs its own assessment, although closely related variants (for example shades of the same foundation) can often be covered in one report when the assessor justifies it. The Commission published guidelines on Annex I in Implementing Decision 2013/674/EU.
Part B is the assessor's conclusion: whether the product is safe, which warnings and instructions of use must appear on the label, the scientific reasoning behind the conclusion, and the assessor's credentials and signature.
The safety assessment must be carried out by a person holding a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State (Article 10(2)). The Regulation does not require the assessor to be based in the EU, but the report has to meet the EU framework - a safety file prepared for another market is rarely usable as-is.
Every ingredient with its exact percentage and INCI name, including the composition of fragrance and raw-material blends.
Specifications, safety data sheets and certificates of analysis from your suppliers, including impurity data.
Stability and compatibility with packaging, and a preservative efficacy (challenge) test for water-containing products.
Intended use, target users and the label text, so warnings can be checked against Annexes III to VI.
The number of ingredients and how well-documented they are, whether the product is used on children, around the eyes or on damaged skin, whether it contains nanomaterials or substances with specific Annex III limits, and whether stability and challenge tests already exist. Missing supplier documentation is the most common cause of delay. We review CPSR status as part of our Responsible Person compliance review.
Yes. Article 10 requires a safety assessment for every cosmetic product before it is placed on the EU market, and the resulting CPSR is part of the Product Information File.
Usually not as-is. The CPSR must follow Annex I of Regulation (EC) No 1223/2009 and check the formula against the EU annexes, so an existing file is typically used as input for a new EU report.
Yes. The CPSR is an EU-wide document. Together with a single CPNP notification, it covers the product in every Member State where it is sold.
The Responsible Person keeps it in the Product Information File and makes it available to market surveillance authorities on request.
The file the CPSR belongs to, and what else must be in it.
The warnings from Part B end up on your label.
Notification comes after the safety assessment, not before.
Note: This guide provides general information about Regulation (EC) No 1223/2009, not legal advice. Specific obligations depend on your product and supply chain. Last reviewed 30 September 2026.
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