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BS EN ISO 11930:2019

BS EN ISO 11930:2019

$142.49

Cosmetics. Microbiology. Evaluation of the antimicrobial protection of a cosmetic product

Published By Publication Date Number of Pages
BSI 2019 32
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This document specifies a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both, when evaluating the overall antimicrobial protection of a cosmetic product.

It comprises:

  • a preservation efficacy test;

  • a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not considered low risk, based on a risk assessment described in ISO 29621.

The preservation efficacy test is a reference method to evaluate the preservation of a cosmetic formulation. It is applicable to cosmetic products in the marketplace.

This test does not apply to those cosmetic products for which the microbiological risk has been determined to be low according to Annex A and ISO 29621.

This test is primarily designed for water-soluble or water-miscible cosmetic products and can be used with modification to test products in which water is the internal (discontinuous) phase.

NOTE This test can be used as a guideline to establish a development 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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Principle
11 5 Preservation efficacy test
5.1 General
5.2 Materials, apparatus, reagents and culture media
5.2.1 General
5.2.2 Materials
5.2.3 Diluents
12 5.2.4 Neutralizer
13 5.2.5 Culture media
14 5.3 Microbial strains
15 5.4 Preparation and enumeration of inocula
5.4.1 General
5.4.2 Preparation of bacterial and Candida albicans suspensions
16 5.4.3 Preparation of Aspergillus brasiliensis spore suspension
17 5.5 Demonstration of the neutralizer efficacy
5.5.1 Principle
5.5.2 Procedure
5.5.3 Calculations
18 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
19 5.6.2 Counting of colonies
5.6.3 Calculations
20 5.7 Interpretation of test results and conclusions
5.7.1 Criteria
21 5.7.2 General case (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
22 6 Overall evaluation of the antimicrobial protection of the cosmetic product
6.1 General
6.2 Case 1 — Preservation efficacy test has been performed on the formulation
23 6.3 Case 2 — Preservation efficacy test has not been performed on the formulation
24 Annex A (normative) Decision diagram
25 Annex B (normative) Evaluation criteria for the preservation efficacy test
26 Annex C (informative) Examples of neutralizers for the antimicrobial activity of preservatives and washing liquids
28 Annex D (informative) Packaging characteristics
29 Bibliography

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BS EN ISO 11930:2019
$142.49