EU Cosmetic Safety Assessment

Key requirement for the EU cosmetic safety assessment

A key requirement under the EU Cosmetic Regulation is to have a cosmetic safety assessment performed, which results in the Cosmetic Product Safety Report (CPSR). The CPSR is the cosmetic product “passport” to the EU market. The safety assessment of a cosmetic product considers all relevant product information, compiled together into the Product Information File (PIF), as well as the EU Cosmetic Regulation, and regulatory and toxicology data.

Input for the EU cosmetic safety assessment

To perform the cosmetic product safety assessment and to create the Cosmetic Product Safety Report (CPSR) the following product information is required:

• The exact composition of each individual ingredient in the formulation.
• The exact composition of the product formulation.
• The finished product’s Certificate of Analysis (CoA).
• The stability test report to substantiate the product shelf life.
• The results of the Preservation Efficacy Test (PET)/Challenge Test to substantiate the Period After Opening (PAO).
• Packaging material compliance that ensures the suitability of use for the cosmetic product.
• Additional information may be needed depending on the ingredients and quantities used, the claims that are made, etc.

How are cosmetic safety assessments performed?

To make a cosmetic safety assessment the following has to be substantiated:

• Regulatory compliance with the Annexes II-VI of the EU Cosmetic Regulation.
• The safety of the product and its ingredients based on toxicology data and the exposure to the product (exposure scenario).
• Stability of the product throughout the shelf-life, before and after opening the product.
• Compatibility of the product packaging that is in direct contact with the cosmetic formulation.
• Compatibility of the product packaging that is in direct contact with the cosmetic formulation.

Key parts of the Cosmetic Product Safety Report (CPSR) are the compliance with the Annexes II-VI of the EU Cosmetics Regulation, and the toxicological safety of the product and all of its ingredients. For the official legislative text related to the set-up of the Cosmetic Product Safety Report (CPSR) you can visit the European Commission website.

How to Do It Yourself with DIY Compliance Manager?

At DIY we have restructured and interpreted all regulatory data. And we have included this data in the DIY regulatory database to make it possible for you to run an instant Regulatory Compliance Report of your cosmetic product formulation.

To assess the regulatory compliance (and the safety of your cosmetic product (future feature)), all you need to do is:

1. Enter your cosmetic formulation.
2. See the regulatory compliance (and safety)status.
3. Download your report for full details.

For a full CPSR (future feature) including regulatory compliance and toxicological safety, you will be asked to enter additional data relating to shelf-life, Period After Opening (PAO), packaging, etc.