Microbiological Requirements

Changed on: 10.02.2017

Microbiological Requirements

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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).


Ö-/ISO Standards for Microbiology and Cosmetics

The following ÖNORMENs (Austrian standards) are available at www.austrian-standards.at:

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO/DIS 29621:2016)
ÖNORM EN ISO 29621: 2016 05 01

Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014)
ÖNORM EN ISO 17516: 2015 01 01

Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005)
ÖNORM EN ISO 21148: 2009 10 01

Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006)
ÖNORM EN ISO 21149: 2009 10 01

Cosmetics - Microbiology - Detection of Staphylococcus aureus (ISO 22718:2015)
ÖNORM EN ISO 22718: 2016 04 01

Cosmetics – Microbiology – Detection of Pseudomonas aeruginosa (ISO/FDIS 22717:2015)
ÖNORM EN ISO 22717: 2015 08 01

Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015)
ÖNORM EN ISO 18416: 2016 04 01

Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)
ÖNORM EN ISO 21150: 2016 04 01

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2007, corrected version 2007-12)
ÖNORM EN ISO 18415: 2011 07 15

Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2008)
ÖNORM EN ISO 16212: 2011 07 15

Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012, Corrected version 2013-05-01)
ÖNORM EN ISO 11930: 2014 03 01

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