ISO 11930:2012
Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
ISO 11930:2012 comprises a preservation efficacy test and a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk.
ISO 11930:2012 provides a procedure for interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both.
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1 Scope
1.1 General
1.2 Preservation efficacy test
1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product
2 Normative references
3 Terms and definitions
4 Principle
5 Preservation efficacy test
5.1 General
5.2 Materials, apparatus, reagents and culture media
5.2.1 Materials
5.2.2 Diluents, neutralizers and culture media
5.3 Microbial strains
5.4 Preparation and enumeration of inocula
5.4.1 General
5.4.2 Preparation of bacterial and Candida albicans suspensions
5.4.3 Preparation of A. brasiliensis (previously A. niger) spore suspension
5.5 Demonstration of the neutralizer efficacy
5.5.1 Principle
5.5.2 Procedure
5.5.3 Calculations
5.5.4 Interpretation of results and conclusion on neutralizer efficacy
5.6 Determination of the preservation efficacy of the formulation
5.6.1 Procedure
5.6.1.1 Unpacking and aliquoting of test product
5.6.1.2 Inoculation of test microorganisms
5.6.1.3 Incubation of the inoculated formulation
5.6.1.4 Sampling and enumeration
5.6.2 Counting of colonies
5.6.3 Calculations
5.6.3.1 General
5.6.3.2 Determination of the initial numbers of microorganisms, N and N0
5.6.3.3 Enumeration of the microorganisms at each sampling time, Nx
5.6.3.4 Reduction in microbial counts
5.7 Interpretation of test results and conclusions
5.7.1 Criteria
5.7.2 General case (the efficacy of the neutralizer is demonstrated for all strains)
5.7.3 Case of formulations for which the efficacy of the neutralizer is not demonstrated for some strains
5.8 Test report
6 Overall evaluation of the antimicrobial protection of the cosmetic product
6.1 General
6.2 Case 1 — The preservation efficacy test has been performed on the formulation
6.3 Case 2 — The preservation efficacy test has not been performed on the formulation
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1 Scope
1.1 General
1.2 Preservation efficacy test
1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product
2 Normative references
3 Terms and definitions
4 Principle
5 Preservation efficacy test
5.1 General
5.2 Materials, apparatus, reagents and culture media
5.2.1 Materials
5.2.2 Diluents, neutralizers and culture media
5.3 Microbial strains
5.4 Preparation and enumeration of inocula
5.4.1 General
5.4.2 Preparation of bacterial and Candida albicans suspensions
5.4.3 Preparation of A. brasiliensis (previously A. niger) spore suspension
5.5 Demonstration of the neutralizer efficacy
5.5.1 Principle
5.5.2 Procedure
5.5.3 Calculations
5.5.4 Interpretation of results and conclusion on neutralizer efficacy
5.6 Determination of the preservation efficacy of the formulation
5.6.1 Procedure
5.6.1.1 Unpacking and aliquoting of test product
5.6.1.2 Inoculation of test microorganisms
5.6.1.3 Incubation of the inoculated formulation
5.6.1.4 Sampling and enumeration
5.6.2 Counting of colonies
5.6.3 Calculations
5.6.3.1 General
5.6.3.2 Determination of the initial numbers of microorganisms, N and N0
5.6.3.3 Enumeration of the microorganisms at each sampling time, Nx
5.6.3.4 Reduction in microbial counts
5.7 Interpretation of test results and conclusions
5.7.1 Criteria
5.7.2 General case (the efficacy of the neutralizer is demonstrated for all strains)
5.7.3 Case of formulations for which the efficacy of the neutralizer is not demonstrated for some strains
5.8 Test report
6 Overall evaluation of the antimicrobial protection of the cosmetic product
6.1 General
6.2 Case 1 — The preservation efficacy test has been performed on the formulation
6.3 Case 2 — The preservation efficacy test has not been performed on the formulation