EU CPSR preparation
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.
Who provides EU CPSR preparation services?
Companies linked to EU CPSR preparation or a more specific service
Certified Cosmetics
Certified Cosmetics provides cosmetic safety assessments, product files, notifications, label reviews and laboratory-testing coordination from Almere.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.
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.
Find 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.