DANSK DSF/PREN ISO 11930 REV PDF

This International Standard comprises: – a preservation efficacy test; – a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk, based on a risk assessment described in ISO 29621. This International Standard provides a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both. 1.2 Preservation efficacy test This test is a reference method that is to be used to evaluate the preservation of a cosmetic formulation. It applies to cosmetic products in the market place. This test is not required for those cosmetic products for which the microbiological risk has been determined to be low (see Annex A and ISO 29621). This test is primarily designed for water-soluble or water-miscible cosmetic products and can require adaptation, for example to test products in which water is the internal phase. The test described in this International Standard involves, for each test micro-organism, placing the formulation in contact with a calibrated inoculum, and then measuring the changes in the micro-organism count at set time intervals for a set period and at a set temperature. NOTE – This test can be used as a guideline to develop an in-house method during the development cycle of cosmetic products. In this case, the test can be modified or extended, or both, for example to make allowance for prior data and different variables (microbial strains, media, incubation conditions exposure time, etc.). Compliance criteria can be adapted to specific objectives. During the development stage of cosmetic products, other methods, where relevant, can be used to determine the preservation efficacy of formulations. 1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product This procedure is based on careful consideration of the following points. – Results of the preservation efficacy test. Not all cosmetic products will require a preservation efficacy test (see Annex A and ISO 29621). – Formulation characteristics and data provided by the microbiological risk assessment (see ISO 29621). The analysis of the microbiological risk assessment is based on an overall approach. In particular, it integrates variables such as characteristics and composition of the formulation, its production conditions, the characteristics of the packaging in which the formulation will be delivered to the market place, recommendations for use of the cosmetic product and, when relevant, the area of application and the targeted user population (see Annex D).