Microbiological safety of cosmetic products and potential risks for consumers

Abstract

The European regulatory framework in the field of cosmetic products requires of manufacturers to provide an assessment of microbial limits tests and results of preservation challenge test, as well as microbiological stability data which should be documented in the cosmetic product safety report. During the development of a cosmetic product, it is necessary to consider the risk of microbiological contamination in the selection of starting cosmetic ingredients and packaging, manufacturing process, alongside with conditions of storage and use. The deviation of the microbiological quality of the cosmetic product from the manufacturer's specification presents a risk for consumers, especially if it is used around the eyes, on mucous membranes in general, on damaged skin or it is intented for use in specific groups of consumers (children under the age of 3, elderly people and immunocompromised persons).

Važeći evropski regulatorni okvir u oblasti kozmetičkih proizvoda zahteva od proizvođača da obezbede procenu mikrobiološkog kvaliteta (engl. microbial limits test) i ispitivanje efikasnosti konzervansa (test izazivanja/izazova, engl. challenge test), kao i da se podaci o mikrobiološkoj stabilnosti dokumentuju u izveštaju o bezbednosti. Tokom razvoja kozmetičkog proizvoda neophodno je razmotriti rizik od mikrobiološke kontaminacije pri izboru polaznih sirovina i pakovanja, proizvodnog postupka, kao i uslova čuvanja i upotrebe. Odstupanje mikobiološkog kvaliteta kozmetičkog proizvoda od proizvođačke specifikacije predstavlja rizik po potrošače, a naročito ukoliko se primenjuju u predelu oka, na sluzokožama ili su namenjeni specifičnim grupama potrošača (deca mlađa od 3 godine, starije i imunokompromitovane osobe).