What is the difference between Safety Testing and Safety Assessment?

The Cosmetics Regulation (EC) 1223/2009 lists the requirements for the safety of a cosmetic product and includes a clear obligation for manufacturers to compile the Product Information File (PIF) prior to placing a cosmetic product on the European market.

The Cosmetic Product Safety Report (CPSR), identified in Annex I of the EC 1223/2009, is one of the essential elements when building the PIF of a cosmetic product. The CPSR always includes two parts:

–          Part A: Safety Information

–          Part B: Safety Assessment

The Safety Information (Part A) includes but is not limited to:

·         The quantitative and qualitative composition of the cosmetic product;

·         The physical-chemical characteristics, microbiological specifications and stability of the cosmetic product (safety tests);

·         The physical-chemical characteristics, microbiological and toxicological specifications of the raw materials;

·         The impurities, traces and information about the packaging material;

·         Normal and reasonably foreseeable use of the cosmetic product;

·         Exposure to the cosmetic product and substances;

·         Undesirable effects and serious undesirable effects

The documents forming part of the Safety Information are generally obtained from the suppliers of the raw materials and the producers of the finished product.

The Safety Assessment (Part B) includes but is not limited to:

·         Conclusion on the safety of the cosmetic product;

·         Statement on the need to label any particular warnings and instructions of use;

·         Explanation of the scientific reasoning leading to the assessment conclusion, based on the possible interactions of the substances contained in the cosmetic product and also on the Safety Information documentation;

·         Justification of the consideration and non-consideration of the raw materials’ toxicological profiles;

·         Consideration of the impact of the stability on the safety of the cosmetic product;

As you can see, the Safety Assessment is based on, among others, the safety testing that is part of all the safety information provided in Part A of the CPSR. The Safety Assessment thus provides a conclusion on how safe the cosmetic product is to use.

Would you like to know which safety tests may be needed for your cosmetic products? Talk to our team of European regulatory and compliance experts, or to get a quote on any of our services, by contacting Obelis today!

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José Amsing

Senior Consultant


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