News
Dec 25, 2025 - Cosmetics
Safety reports for cosmetic products - microbiological requirements
According to the Regulation (EC) No 1223/2009, a safety report must be prepared for each cosmetic end product. Annex I, Part A, Point 3 of the mentioned regulation specifies the following requirements for microbiological quality:
“The microbiological specifications of the substances or mixtures and the cosmetic product. Special attention is needed for cosmetic products applied near the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on the elderly, and on individuals with compromised immune response.
Results of a preservation challenge test.”
It should be noted that proof of the microbiological quality of the end product as well as data on the microbiological quality of the raw materials used must be provided. ISO 17516 generally forms the basis for the assessment of microbiological quality (including for the raw materials used).
Furthermore, a result of a preservation challenge test (PCT) must be available. There are no methodological requirements, but ISO 11930 has established itself as the state of the art. Tests according to other standards such as Ph.Eur. or USP are also acceptable.
If the end product or a raw material is a microbiologically low-risk product (the criteria are defined in ISO 29621), testing may be waived in individual cases. This must be logically argued and documented accordingly.
We comprehensively support you with all tests required for the safety report and also advise you on classification as microbiologically low-risk.
Source: