Prior to placing a cosmetic product on the market, a cosmetic Product Safety Report (PSR) must be written to demonstrate its safety of use. The PSR is the most important section of the Cosmetic Product Information File, and consists of two parts:

• Part A – Cosmetic product safety information

This part comprises all data based on which the product safety assessment can be carried out, including: product formulation, intended use and exposure, (toxicological and purity) profile of each product ingredient and dermatological (patch) test results.

• Part B – Cosmetic product safety assessment

The cosmetic product safety assessment (PSA) must be carried out by an expert in pharmacy, toxicology, medicine or a similar discipline. PSA is not a standardized procedure, but involves the evaluation of a product on a case-by-case basis, taking into account both hazard and exposure. Using a weight-of-evidence approach, science-based conclusions are drawn based on the body of information collected in Part A.

Need help?

The Chemical Compliance Coach can support you in collecting all required data and –where necessary – prepare and monitor preservation and microbial challenge tests, shelf life and stability tests (real time and/or accelerated) and toxicological product safety (i.e. irritation and sensitisation) tests. We further have the toxicological expertise to perform safety assessments for your cosmetic products, and offer PIF-maintenance services to ensure your documentation is always up-to-date.