The Cosmetic Product Safety Report (CPSR) is the cornerstone of the Product Information File (PIF), which is created by examining in detail all available data to ensure a comprehensive safety assessment, taking into account how the product will be used and the levels of exposure to its ingredients. A cosmetic product sold in the EU must be safe for human health when used as intended. To ensure safety, the responsible person (the manufacturer or marketer) must adhere to the following requirements outlined in Article 3 of Regulation (EC) No. 1223/2009:
Presentation: The product must meet the requirements of relevant EU directives.
Labelling: All product labels must be clear and informative.
Instructions: Proper instructions for use and disposal must be provided.
Information: Any additional information given by the responsible person must be considered.
As detailed in Article 10 of Regulation (EC) No. 1223/2009, the responsible person must ensure that an qualified safety assessor carries out a safety assessment based on relevant information and creates a Cosmetic Product Safety Report (CPSR).
The CPSR consists of two parts taken from the Cosmetics Regulation 1223/2009;
Part A – Cosmetic Product Safety Information
Part B – Cosmetic Product Safety Assessment
The quantitative and qualitative composition of the cosmetic product
Physical/chemical characteristics and stability of the cosmetic product
Microbiological quality
Impurities, traces, information about the packaging material
Normal and reasonably foreseeable use
Exposure to the cosmetic product
Exposure to the substances
Toxicological profile of the substances
Undesirable effects and serious undesirable effects
Information on the cosmetic product
Assessment conclusions
Labelled warnings and instructions for use
Reasoning for the conclusions drawn
Assessors credentials and approval of Part B
Given the complexity of cosmetic regulations, it’s advisable to work with qualified safety assessors who understand the nuances of different product categories. If you need assistance with CPSR preparation tailored to your specific products, feel free to check out our Cosmetic Safety Assessment services.
