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According to the Regulation (EC) No 1223/2009, any cosmetic product being placed in the European market is required to be safe for use. To comply with the regulation, a cosmetic safety assessor assigned for the product is required to submit a Cosmetic Product Safety Report (CPSR), which demonstrates the safety of the product. It is the most important element of the Product Information File (PIF) associated with the cosmetic product. The CPSR is a comprehensive report including multiple modules and is stored in various databases. It should contain, as a minimum, all the information defined in Annex I of the regulation. The information provided in the CPSR should be easily retrievable, directly available and easily understood. It should be authored in a very transparent manner and should reflect the information asked for, in Annex I. In case, if some information cannot be directly included in the document, its reference document can be linked to the CPSR.

As per Annex I, the CPSR must contain two parts:

  • Part A – Cosmetic product safety information
  • Part B – Cosmetic product safety assessment

Part A – Cosmetic product safety information

Part A contains all the necessary data regarding the safety assessment of the cosmetic product. This module consists of ten sections. If all the required data is available, the CPSR can be concluded, else, necessary tests must be conducted, further.

  1. Composition of the cosmetic product: qualitative and quantitative
  2. Stability of the cosmetic product and its characteristics; both chemical and physical
  3. Microbiological specifications of the cosmetic product
  4. Information about the packaging material, such as impurities, traces of prohibited ingredients etc.
  5. Foreseeable use of the product
  6. Exposure to the cosmetic product and its secondary exposure routes
  7. Exposure to the substances
  8. Toxicological effects of the ingredients  
  9. Undesirable effects and serious undesirable effects
  10. Data related to the cosmetic product

Part B – Cosmetic product safety assessment

Part B consists of notes from the Cosmetic Safety Assessor on the safety of the product and has 4 sections.

  1. Conclusion of the safety assessment
  2. Instructions and warnings regarding the usage and labeling of the product
  3. Reasoning
  4. Assessor’s credentials and approval of part B

The CPSR is necessary for ensuring the safety and efficacy of a cosmetic product for placing it in the European market. Therefore, authoring and compiling it is a crucial task for EU market entrants. Are you the one? Then we may request you to Consult a pool of qualified and proven safety assessors. Reach out sales@freyrsolution.com.