--- title: "EU CPSR preparation" description: "Prepare an EU Cosmetic Product Safety Report." image: "https://cosmetic-labs.com/wp-content/uploads/eu-cpsr-format-service-1200x1200-1.webp" --- # EU CPSR preparation > Prepare an EU Cosmetic Product Safety Report. Source: https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/eu-cpsr-format Created: 2025-05-28T00:13:28+00:00 Modified: 2026-10-25T11:29:27+00:00 Author: Emilie SCHOL EU CPSR preparation | Cosmetic Labs ## What is EU CPSR preparation? The two-part safety report, one component of the wider PIF. The EU CPSR is a market-specific safety-report deliverable. Toxicological assessment can contribute to it but is not an interchangeable service. ### Why do you need this service? CPSR preparation assembles product safety information and a qualified assessor’s reasoned conclusion for the EU PIF. It is a safety assessment process, not formatting for product approval or a guaranteed launch timetable. ## Be the first company on this service page No published company profiles are linked to EU CPSR preparation or its more specific services yet. Explore the service categories or add an explicitly supported capability to your company profile. [List your company](https://cosmetic-labs.com/account/companies/new) Definition ## EU Cosmetic Product Safety Report preparation The CPSR is the safety report required under Regulation (EC) No 1223/2009 and forms part of the Product Information File. Preparation brings together product information and a qualified safety assessor’s reasoned assessment. It is not a routine application for approval or a substitute for the Responsible Person’s other obligations. ### Part A: cosmetic product safety information Qualitative and quantitative composition and ingredient identities - Physical and chemical characteristics and stability information - Microbiological quality and relevant preservative-efficacy evidence - Impurities, traces and information about packaging material - Normal and reasonably foreseeable use and exposure - Toxicological profiles and available undesirable-effect information The assessor identifies what evidence is needed for the actual product. Challenge tests, tolerance studies or other new testing should not be assumed mandatory in every case without a reasoned assessment. ### Part B: safety assessment The qualified assessor records the safety conclusion, required warnings and instructions, reasoning and assessor credentials. Missing or unsuitable evidence must be addressed before a supported conclusion can be reached. ### Maintain the report The CPSR must be kept up to date as relevant information changes. Formula, supplier, packaging, exposure or emerging safety information may require reassessment even if the ingredient list looks unchanged. Completion time depends on the available data and any additional work needed, not a fixed report-writing period. Applications ## Prepare a new product assessment Part A gathers composition, stability, microbiological quality, packaging-related information, exposure and toxicological evidence. The assessor identifies gaps for the actual product rather than assuming the same new tests are required for every formula. Part B records the safety conclusion, reasoning, required warnings or instructions and assessor credentials. The Responsible Person retains other compliance obligations. A complete-looking dossier cannot substitute for missing evidence or an unsupported conclusion. ### Reassess relevant changes Formula, supplier, packaging, intended-use or emerging safety information may require an update. Changes can matter even when the ingredient list appears unchanged. Keep the report current as relevant information changes, with the review needs and completion period agreed for the actual amendment. ExplorationLearn more about Market Compliance DossiersFind market-specific cosmetic dossier services, including US documentation, EU CPSR preparation, China NMPA filing support and safety dossier assembly. Explore another Market Compliance Dossiers page on cosmetic-labs.com. #### [Safety Dossier](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/safety-dossier) Assemble a scoped cosmetic safety dossier from toxicological assessment, ingredient review and supporting evidence for the intended market requirements. [Check this service](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/safety-dossier) #### [US Cosmetic Compliance Documentation](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/fda-documentation) Prepare a scoped US cosmetic compliance file with safety evidence, label review and registration or listing support where those duties apply. [Check this service](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/fda-documentation) #### [China NMPA Filing & Registration Support](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/china-nmpa) Prepare China cosmetic filing or registration records for the specific product and route, with safety, ingredient and labelling requirements reviewed. [Check this service](https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/china-nmpa) Continue with [Google](https://cosmetic-labs.com/?lean_auth=start&provider=google&redirect_to=https://cosmetic-labs.com/&error_return=https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/eu-cpsr-format) [LinkedIn](https://cosmetic-labs.com/?lean_auth=start&provider=linkedin&redirect_to=https://cosmetic-labs.com/&error_return=https://cosmetic-labs.com/services/market-access/regulatory-compliance/market-compliance-dossiers/eu-cpsr-format) What does “Verified” mean? Verified means the claimant’s company affiliation was checked. Something not right?Let us know if any information on this page is incorrect or if you have concerns about who manages it. [Report an issue](https://cosmetic-labs.com/platform/contact) © 2026 Cosmetic Labs. 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