Cosmetic Product Safety Report – CPSR

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The Cosmetic Product Safety Report (CPSR) is a mandatory document required under the EU Cosmetic Regulation (EC) No 1223/2009, specifically Article 10 and Annex I. It ensures that every cosmetic product placed on the European market is safe for human health when used under normal or reasonably foreseeable conditions.

The CPSR is divided into two main parts as outlined in Annex I of the Regulation:

Part A – Cosmetic Product Safety Information

Part A contains all the scientific and technical data necessary to evaluate the safety of the cosmetic product. This includes:

• Product identification and category

• Quantitative and qualitative composition (INCI list and ingredient concentrations)

• Physical/chemical characteristics and stability of the product

• Microbiological quality

• Impurities, traces, and packaging material information

• Normal and reasonably foreseeable use

• Exposure assessment for each ingredient and product type

• Toxicological profile of each substance used

• Undesirable effects and serious undesirable effects (UE/SUE) data

• Other relevant information from human studies or literature sources

Part B – Cosmetic Product Safety Assessment

Part B is prepared and signed by a qualified Safety Assessor, a professional with a background in toxicology, pharmacy, or a related scientific field.
It contains:

• An expert evaluation of the information provided in Part A

• A conclusion on product safety under the intended conditions of use

• Labeling considerations and specific warnings if applicable

• Reasoning supporting the safety conclusion

• Assessor’s credentials and signature

The CPSR serves as a cornerstone of cosmetic product compliance within the EU. It must be included in the Product Information File (PIF) and made available to competent authorities upon request.

At Lexora Consultancy, our qualified safety assessors prepare fully compliant CPSRs according to the latest EU guidelines, ensuring that your cosmetic products meet all safety and regulatory requirements before being placed on the European market.