Cosmetic Product Safety Report (CPSR)
Every cosmetic sold in the EU needs a safety report signed by a qualified safety assessor. Care Europe coordinates yours, from France, alongside your Product Information File.
A CPSR (Cosmetic Product Safety Report) is the safety assessment that Article 10 of Regulation (EC) No 1223/2009 requires before any cosmetic product is placed on the EU market. It has two parts: Part A, the safety information about the product, and Part B, the safety assessment signed by a qualified safety assessor. It forms part of the Product Information File. Care Europe coordinates your CPSR with a qualified assessor.
If you plan to sell a cosmetic product in the EU, the Responsible Person must be able to show a cosmetic product safety report for it. The report is not a formality: it is the document an EU authority asks for first, and it has to be signed by a person who holds the qualification Article 10(2) sets out. We collect the formula, specification and stability information the assessor needs, coordinate the assessment, and make sure the finished report sits correctly in your Product Information File.
What a CPSR contains
The report follows Annex I of Regulation (EC) No 1223/2009. Part A, the cosmetic product safety information, covers the composition of the product, its physical and chemical characteristics and stability, microbiological quality, impurities and packaging, normal and reasonably foreseeable use, exposure, the toxicological profile of each substance and known undesirable effects. Part B, the cosmetic product safety assessment, sets out the assessor’s conclusion, any warnings or instructions of use that must appear on the label, the reasoning behind the assessment, and the assessor’s credentials and signature.
Who can sign a CPSR
Article 10(2) requires the safety assessment to be carried out by a person who holds a diploma or other evidence of formal qualifications in pharmacy, toxicology, medicine or a similar discipline. A formulation consultant drafting the document is not the same as a qualified assessor signing it. We coordinate the work with a qualified safety assessor so the report you hold can be defended if an authority asks for the assessor’s credentials.
How the CPSR fits in your file
The CPSR is one part of the Product Information File that the Responsible Person keeps at the address on the label for ten years after the last batch is placed on the market. It has to be updated when the formula, the supplier of an ingredient or the intended use changes. If Care Europe is also your EU Responsible Person, the report, the file and the CPNP notification are prepared together, so they describe the same product.
How we work
We start with your formula, ingredient specifications, stability and microbiological data, and packaging details, and tell you what is missing before the assessor starts. We then coordinate the assessment, review the warnings and label statements it produces, and file the signed report in your Product Information File. Tell us on the first call which markets you plan to sell in, so the EU and UK files are prepared together.
Inbegrepen diensten en methoden
- ✓Formula and ingredient specification review
- ✓Physical, chemical and stability data check
- ✓Microbiological quality data
- ✓Packaging and impurity information
- ✓Exposure assessment inputs
- ✓Toxicological profile of each substance
- ✓Qualified safety assessor coordination
- ✓Warnings and label statement review
- ✓Product Information File placement
- ✓Updates when the formula or supplier changes
Regelgevende normen en naleving
- Regulation (EC) No 1223/2009
- Article 10 & Annex I
- Article 11 (Product Information File)
- SCCS Notes of Guidance
- ISO 22716 (GMP)
Sectoren die we bedienen
- US & Canadian cosmetic brands
- Skincare & haircare brands
- Amazon EU & e-commerce sellers
- Private label brands
- Indie beauty brands
- Contract manufacturers
Consultatie aanvragen
Vertel ons over uw product en regelgevende uitdaging. We reageren binnen 24 uur met een eerlijke beoordeling en een duidelijke volgende stap.
Gratis beoordeling →Veelgestelde vragen
What is a CPSR?
A CPSR is a Cosmetic Product Safety Report, the safety assessment required by Article 10 of Regulation (EC) No 1223/2009 for every cosmetic product placed on the EU market. Part A gathers the safety information and Part B is the assessor’s signed conclusion.
Is a CPSR required to sell cosmetics in the EU?
Yes. The safety assessment must be completed before the product is placed on the EU market and kept in the Product Information File. The Responsible Person answers to authorities for it.
Who is allowed to sign a CPSR?
A safety assessor who holds a diploma or other formal qualification in pharmacy, toxicology, medicine or a similar discipline, as set out in Article 10(2). The assessor’s credentials are part of the report.
What is the difference between the CPSR and the Product Information File?
The Product Information File is the full technical dossier for a product. The CPSR is one component of it, alongside the product description, method of manufacture, proof of effect and other documents.
Do I need a new CPSR when I change a formula?
Usually yes. A change to the formula, an ingredient supplier or the intended use can change the safety assessment, so the report is reviewed and updated to match.
Do US cosmetic brands need a CPSR?
Not for the US market, where the rules differ, but any product you sell in the EU needs one. A brand outside the EU also needs an EU Responsible Person to hold the file.
Waarom merken Care Europe kiezen voor cosmetic product safety report (cpsr)
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