News
05.07.2013 -
Cosmetics - Preservation Efficacy Testing according to DIN EN ISO 11930:2012
The standard DIN EN ISO 11930:2012 (Cosmetic products – Microbiology – Evaluation of the antimicrobial protection of a cosmetic product) will be of great importance in the future within the context of product development and safety assessment. The standard provides specific guidelines for the implementation and evaluation of preservative challenge tests.
Both the new EU Cosmetics Regulation (EC) No 1223/2009 on safety assessment and the guidelines of the Scientific Committee on Consumer Safety (SCCS, 2010) of the EU Commission require challenge tests for cosmetics. However, no further specifications are made regarding the implementation and evaluation of challenge tests.
So far, in Germany, the cosmetics industry most frequently refers to the guidelines of the European Pharmacopoeia for the implementation and evaluation of preservative challenge tests.
In the future, the new recommendations of DIN EN ISO 11930:2012 regarding challenge tests will take precedence, as Article 12 of the EU Cosmetics Regulation requires the use of "relevant harmonized standards."
The main contents of DIN EN ISO 11930:2012 are:
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Investigation methods for conducting a preservative challenge test
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Evaluation criteria for preservative challenge tests
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Procedures for assessing the antimicrobial protection of a cosmetic product
The BAV newsletter "Special Newsletter Cosmetics Part 3 in 2013" deals with the main contents of DIN EN ISO 29621:2011 (Cosmetic products – Microbiology – Guidelines for risk assessment and identification of microbiologically low-risk products) as well as DIN EN ISO 11930:2012 (Cosmetic products – Microbiology – Evaluation of the antimicrobial protection of a cosmetic product).