The Scientific Committee on Consumer Safety (SCCS) of the European Commission recommends the following limits for the microbiological quality of cosmetic products: The SCCS's notes of guidance for the testing of cosmetic substances and their safety evaluation, 9. Revision SCCS/1564/15 (see page 84). These limits are also demanded by ÖNORM EN ISO 17516: 2015 01 01 Cosmetic Products – Microbiology – Microbiological limits (ISO 17516:2014).
Quantitative Specification
Category 1: products for babies and infants or for use in the area of the eyes and on mucous membranes – total number of germs live for aerobic mesophilic microorganisms: not more than 10² colony forming units per gram or milliliter (CFU/g or ml).
Category 2: other products - total number of germs live for aerobic mesophilic microorganisms: not more than 10³ CFU/g or ml.
Qualitative Specification
The health safety of cosmetic products may encounter a number of pathogenic agents. The indicator pathogens described in the following serves as an orientation for assessments. If there are enough grounds for suspicion, tests for other pathogens should be carried out, as required.
The following specific microorganisms must not be found: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans.
Preservation
The Cosmetics Regulation (EC) 1223/2009 provides that the Safety Report Part A (according to Annex I, Item 3) also uses results from preservation contamination tests for the assessment of microbiological quality.
Guidelines
The Industrieverband für Körperpflege- und Waschmittel e. V. (IKW; industrial association for body hygiene and detergents) has published a very detailed guideline for microbiological quality management (MQM) of cosmetic products (IKW 1998).
AGES - Austrian Agency for Health and Food Safety
