EU Cosmetic Regulation 1223/2009, GMP and the SCCS state that all products without a low risk formulation must have results available for each batch of product released onto the market. Furthermore products are separated into two categories; products aimed at children under the age of 3 and/or mucous membranes and other products. SCCS states that microbial content limits per batch are based on Cosmetics – Microbiology – Microbial Limits EN ISO 17516:2014 and these can be found in table 1.
Microbial Limits stage 1
Aerobic Mesophilic Bacteria (AMB) & Yeast and Mould (Y+M) Total Viable Count (TVC)
MSL tests cosmetic products according to their internal technical methods TM 5.4.1 & TM 5.4.2. These are based on: TM 5.4.1 - Cosmetics – Microbiology - Enumeration and detection of aerobic mesophilic bacteria BS EN ISO 21149:2009 and TM 5.4.2 - Cosmetics – Microbiology - Enumeration of Yeast and Moulds ISO 16212:2011.
Stage one allows brands and manufacturers to quantify any bacterial contaminations they may have however the test has a detectability limit of 10cfu/g. This stage provides information on the severity of contamination.
Microbial Limits stage 2
MSL’s microbial limits stage 2 (specifics) is based on ISO 17516:2014. This stage allows brands and manufacturers to confirm if there is <1 organism per gram of product or whether growth contains any of the specified organisms.
Where required MSL can perform a microbial limits test to USP 62 standards. This is an alternative to ISO 17516:2014 where additional organisms are tested for such as C. difficile & Salmonella. This is sometimes requested by customers, particularly those sold in the USA and powders.