Key takeaways
The CPSR combines safety information in Part A with a qualified assessor's conclusions and reasoning in Part B.
Submit the actual formula with supplier evidence, relevant test reports, packaging details and intended use.
Any omission of required safety data needs a scientific justification, not an assumption that the product is low risk.
Keep the report current when new safety information or relevant product changes arise.
A Cosmetic Product Safety Report (CPSR) is the documented safety assessment of a cosmetic product, based on its composition, packaging and conditions of use. For an EU launch, the Responsible Person must ensure that the assessment is completed and the report prepared before placing the product on the market. The CPSR belongs in the Product Information File (PIF); it is not the whole PIF or a regulator’s product approval. EU Cosmetics Regulation Articles 10 and 11 establish these duties.1
Give the assessor records that describe the product you intend to sell. An ingredient list and supplier brochures alone do not provide enough information.
Establish the assessment scope before commissioning tests
Confirm the markets, product type, intended users, application area, frequency of use and final packaging before agreeing the assessment brief. These details affect the exposure assessment and the evidence needed. A rinse-off body product and a leave-on lip product cannot be assessed on the same use assumptions. Annex I expressly includes application site, amount, duration, frequency and foreseeable exposure routes.1
This guide uses the EU CPSR framework. Great Britain has its own version of the Cosmetics Regulation, also requiring a safety assessment and CPSR. Northern Ireland follows the EU framework. OPSS explains the GB and Northern Ireland requirements separately.23
For EU Part B, the assessor must hold 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)). Ask for evidence of the assessor’s qualifications and, where needed, equivalence. Acceptance for GB alone does not establish eligibility for an EU assessment.14
Use your cosmetic formulation brief as the starting point, then replace development intentions with the agreed commercial specification. Tell the assessor early if the product is intended for children under three or exclusively for external intimate hygiene: Annex I requires a specific assessment for these uses.1
What belongs in Part A?
Part A contains the safety information used in the assessment. Part B records the qualified assessor’s conclusion, necessary warnings, scientific reasoning and credentials, with the date and signature. The Responsible Person must ensure the work is completed; commissioning an assessor does not transfer that responsibility.1
Use this checklist to collect the evidence; it does not replace Annex I’s ten headings. The Commission’s CPSR guidelines explain how the underlying data should be assembled and justified.4
| Evidence area | Prepare for the assessor | Check before sending |
|---|---|---|
| Formula and identity | Quantitative formula, ingredient identities and functions; composition of supplied mixtures | Formula version matches the product being assessed |
| Raw materials | Specifications, relevant toxicological information, purity and impurity data; fragrance identity and regulated-substance information | Documents cover the actual supplier grades |
| Physical properties and stability | Finished-product specification, methods, stability results and durability rationale | Tested formula and packaging are identified |
| Microbiological quality | Relevant raw-material and finished-product specifications, test results and preservation evidence | Any proposed test omission has a scientific rationale |
| Packaging | Materials in contact with the formula, supplier information and relevant compatibility evidence | Bottle, closure, liner and dispensing parts are covered where relevant |
| Use and exposure | Application site, user population, amount and frequency, rinse-off or leave-on use, instructions | Claims and artwork do not describe a different use |
| Safety history and other evidence | Available undesirable-effect data, relevant studies and a clear statement of what is not yet known | New-product status is not presented as a history of safe use |
Supply the formula behind the ingredient list
Give the assessor the quantitative composition, not just the INCI label. The Commission’s guidance calls for raw-material weight percentages and identification and quantification of substances within supplied mixtures, including indirectly added preservatives. It discourages unexplained concentration ranges; where ranges are unavoidable, the highest concentration is used for the toxicological assessment.4
Ask suppliers for the composition and safety information needed to evaluate their materials in your finished product. A trade name may cover a blend of an active, carrier and preservative. A sales sheet may describe only the active. Resolve any gaps between those documents before submission. Arrange confidential disclosure where necessary so the assessor does not have to infer the blend’s composition.
For fragrances, supply the name, code and supplier, together with regulated-substance information and other evidence relevant to the safety assessment. The Commission also describes a route for confidential fragrance safety information; confidentiality does not remove the need for adequate evidence.4
Keep the supplier records in a raw-material documentation pack that the assessor can search. A separate register of missing documents, with a supplier contact and expected delivery date, helps the brand team chase gaps.
Connect testing to the finished formula and pack
Send full reports with sample identification, methods, conditions and results, rather than an email saying a test passed. The assessor needs to establish whether the evidence applies to the commercial product.
For stability, the Commission’s guidance calls for evidence that the tested composition corresponds to the marketed product, together with the methods and results supporting minimum durability and, where applicable, period after opening. It also addresses interactions between packaging and formulation.4 Your stability and packaging compatibility plan should therefore identify the exact pack under review.
Preservation challenge testing and microbiological quality testing answer different questions. The Commission’s guidance allows scientifically justified differences in the evidence required for different product categories. Describing a product as natural, waterless or protected by its dispenser is not, by itself, a justification for omitting data. Where required data are considered unnecessary, the absence must be justified in Part A and validated in the assessor’s Part B reasoning.4
Agree the testing rationale with the assessor before commissioning work. The challenge testing and microbial limits guide explains why one result does not substitute for the other.
Resolve inconsistencies before the final assessment
Hypothetical example: A brand submits a facial lotion tested in an airless pump, then chooses a wide-mouth jar for launch. The formula spreadsheet still identifies the pump, and the proposed instructions now suggest application to the face and neck twice daily.
Send the revised packaging and use information to the assessor, who can determine whether the existing evidence remains adequate and what further work is needed. Changing to a jar does not automatically require a particular test, but the assessor needs to check whether the existing report covers the new pack. Packaging, exposure and microbiological quality all form part of the safety evaluation.14
List the current formula, pack, artwork and supporting reports by version in a submission index. Ask the assessor to return a written gap list identifying the missing evidence, who must supply it and whether it blocks completion. These are workflow recommendations, not additional statutory document titles.
Check the signed report and keep it current
Check that the report covers the final commercial formula, packaging and use, and that Part B contains the assessor’s reasoning, credentials and required warnings or instructions. Annex I specifies these elements; a short certificate without them is not a substitute.1
Do not treat a positive safety conclusion as proof of every marketing claim. Evidence for claimed effects is a separate PIF consideration under Article 11. The PIF preparation guide explains the wider file.
Article 10 requires the CPSR to remain up to date as relevant information emerges. The Commission’s guidance identifies review triggers including new scientific evidence, formulation or raw-material specification changes, changed use conditions and undesirable-effect trends.14 Put a named contact in charge of sending those changes to the assessor. Keep the signed report linked to the product version it assesses; changes may need further review.
Regulatory sources checked on 25 October 2026. This guide supports dossier preparation; the qualified assessor must determine the evidence and conclusions for the individual product.
