| Résumé : |
Cosmetic products made available on the market must not present a health risk to the user. To ensure adequate product safety, attention must be paid to relevant safety considerations as already during development, as well as in manufacturing and release decisions. EU legislators set specific legal requirements for these processes, the most important of which is Regulation (EC) 1223/2009. This contains the requirement for the safety assessment by which the aforementioned requirements are checked.
The safety assessment also includes aspects of microbiological product safety. Even though the requirements for microbiological quality are presented somewhat generally (Annex I, Part A, 3 of the regulation), further relevant details to ensure the fulfilment and maintenance of these requirements can be derived from other basic requirements of the regulation (e.g. Art. 5, 8, 10, 11 and requirements for the safety report [Annex I, Parts A and B]) and the quality agreement that is now standard practice. Also of importance for the microbiological requirements are the SCCS Notes of Guidance (SCCS, 2012), which provide technical details on limit values, challenge tests and aspects of good manufacturing practice (GMP) that are relevant for microbiology.
A prerequisite for the safety assessment is the detection, estimation and evaluation of risks, in the first instance from microbial product contamination, and subsequently from any resulting damage. The risk estimation and evaluation must therefore first address a presumptive contamination and prospective countermeasures. In addition, a risk assessment is particularly necessary if, despite countermeasures in development and production, microbial contamination of the product is detected. Depending upon the risk assessment of possible damage, follow-up actions in the form of corrections and corrective actions have to be taken. This latter case is handled in Part II. |
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Microbiological safety assessment of cosmetic products in practice in SOFW JOURNAL, Vol. 142, N° 1 (01/2016)
