1、BSI Standards PublicationBS EN ISO 11930:2012Cosmetics Microbiology Evaluation of the antimicrobialprotection of a cosmeticproduct (ISO 11930:2012)Incorporating corrigendum February 2014BS EN ISO 11930:2012National forewordThis British Standard is the UK implementation of EN ISO 11930:2012. It is id
2、entical to ISO 11930:2012, incorporating corrigendum May 2013.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include
3、all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 84258 0ICS 07.100.99; 71.100.70Compliance with a British Standard cannot confer immunity fromlegal obligations.
4、This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2012.Amendments/corrigenda issued since publicationDate Text affected28 February 2014 Implementation of ISO corrigendum May 2013, endorsed by CEN correction notice 17 July 2013: Table B.1
5、 amended.BRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11930 April 2012 ICS 07.100.99; 71.100.70 English Version Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012, Corrected version 2013-05-01) Cosmtiques - Microbio
6、logie - valuation de la protection antimicrobienne dun produit cosmtique (ISO 11930:2012, Version corrig 2013-05-01) Kosmetische Mittel - Mikrobiologie - Bewertung des antimikrobiellen Schutzes eines kosmetischen Produktes (ISO 11930:2012, korrigierte Fassung 2013-05-01) This European Standard was a
7、pproved by CEN on 31 March 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nation
8、al standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own languag
9、e and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, H
10、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Manag
11、ement Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11930:2012: E3 Foreword This document (EN ISO 11930:2012, Corrected version 2013-05-01) has been prepared by Technical Committ
12、ee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2012,
13、and conflicting national standards shall be withdrawn at the latest by October 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. A
14、ccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
15、 Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11930:2012, Corrected version 2013-05-01 has been approved by CEN as a EN ISO 11930:2012 wit
16、hout any modification. BS EN ISO 11930:2012 EN ISO 11930:2012 (E)iiiContents Foreword iii Introduction . v 1 Scope 1 1.1 Preservation efficacy test . 1 1.2 Procedure for evaluating the antimicrobial protection of the cosmetic product . 1 2 Normative references 2 3 Terms and definitions . 2 4 Princip
17、le . 3 5 Preservation efficacy test . 3 5.1 General . 3 5.2 Materials, apparatus, reagents and culture media . 3 5.2.1 Materials - Apparatus 3 5.2.2 Diluents, neutralisers and culture media 4 5.3 Microbial strains 6 5.4 Preparation and enumeration of inocula 7 5.4.1 General . 7 5.4.2 Preparation of
18、bacterial and Candida albicans suspensions . 7 5.4.3 Preparation of Aspergillus brasiliensis (previously A. niger) spores suspension 8 5.5 Demonstration of the neutraliser efficacy 9 5.5.1 Principle . 9 5.5.2 Procedure . 9 5.5.3 Calculations . 9 5.5.4 Interpretation of results and conclusion on neut
19、raliser efficacy . 10 5.6 Determination of the preservation efficacy of the formulation 10 5.6.1 Procedure . 10 5.6.2 Counting of colonies . 11 5.6.3 Calculations . 12 5.7 Interpretation of test results and conclusions . 13 5.7.1 General case (the efficacy of neutraliser is demonstrated for all stra
20、ins) 13 5.7.2 Case of formulations for which the efficacy of neutraliser is not demonstrated for some strains . 13 5.8 Test report 14 6 Overall evaluation of the antimicrobial protection of the cosmetic product 15 6.1 General . 15 6.2 Case 1 The Preservation Efficacy test has been performed on the f
21、ormulation . 15 6.3 Case 2 - The Preservation Efficacy test has not been performed on the formulation . 15 Annex A (normative) Decision diagram . 17 Annex B (normative) Evaluation criteria for the Preservation Efficacy Test (5.7) 18 Annex C (informative) Examples of neutralisers for the antimicrobia
22、l activity of preservatives and washing liquids 19 Annex D (informative) Packaging Characteristics 20 Bibliography 21 BS EN ISO 11930:2012 ISO 11930:2012 (E) ISO 2013 All rights reservediv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standar
23、ds bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organi
24、zations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in
25、 the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 %
26、of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11930 was prepared by Technical Committee ISO/TC 217, Cosmet
27、ics. This corrected version of ISO 11930:2012 incorporates the following correction: in Table B.1, in the Criteria A row, final column (T28), the words “and NI“ have been added. BS EN ISO 11930:2012 ISO 11930:2012 (E) ISO 2013 All rights reservedvIntroduction This International Standard is to be use
28、d in the overall evaluation of the antimicrobial protection of a cosmetic product. The antimicrobial protection of a product can come from many sources: chemical preservation; inherent characteristics of the formulation; package design; manufacturing process. This International Standard defines a se
29、ries of steps to be taken when assessing the overall antimicrobial protection of a cosmetic product. A reference method for a preservation efficacy test (challenge test) along with evaluation criteria is also described in this International Standard. The data generated by the risk assessment (see IS
30、O 29621) or by the preservation efficacy test, or both, are to be used to establish the level of antimicrobial protection required to minimize user risk. BS EN ISO 11930:2012 ISO 11930:2012 (E) ISO 2013 All rights reservedINTERNATIONAL STANDARD ISO 11930:2012(E)1Cosmetics Microbiology Evaluation of
31、the antimicrobial protection of a cosmetic product 1 Scope 1.1 General 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
32、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
33、 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 cosmet
34、ic 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 mi
35、cro-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 fo
36、r 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
37、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
38、 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, i
39、ts 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). ISO 2013 All rights reserved2 2 N
40、ormative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 16212, Cosmetics Microbio
41、logy Enumeration of yeast and mould ISO 18415, Cosmetics Microbiology Detection of specified and non-specified microorganisms ISO 21148, Cosmetics Microbiology General instructions for microbiological examination ISO 21149, Cosmetics Microbiology Enumeration and detection of aerobic mesophilic bacte
42、ria ISO 22716, Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufacturing Practices ISO 29621, Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products 3 Terms and definitions For the purposes of this document, the terms a
43、nd definitions given in ISO 21148 and the following apply. 3.1 cosmetic formulation preparation of raw materials with a qualitatively and quantitatively defined composition 3.2 cosmetic product finished cosmetic product that has undergone all stages of production, including packaging in its final co
44、ntainer for shipment 3.3 antimicrobial protection of a cosmetic product ability of a cosmetic product to overcome microbial contamination that might present a potential risk to the user NOTE The overall antimicrobial protection includes preservation of the formulation, the specific manufacturing pro
45、cess and protective packaging. 3.4 preservation of a cosmetic formulation set of means used to avoid microbial proliferation in a cosmetic formulation EXAMPLES Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water-activity values. 3.5 reference method method applied
46、by interested parties to assess a product on the market and in case of dispute 3.6 development method in-house method method used during the development stage of a product before the product is put on the market BS EN ISO 11930:2012 ISO 11930:2012 (E) ISO 2013 All rights reserved33.7 consumer end us
47、er of a cosmetic product 4 Principle The evaluation of the antimicrobial protection of a cosmetic product combines the following elements (see Annex A). a) The characteristics of its formulation (see ISO 29621) or the results of the preservation efficacy test (if performed), or both. The preservatio
48、n efficacy test is described in 5.1. b) The characteristics of the cosmetic product in conjunction with the production conditions (see ISO 22716 and ISO 29621), the packaging materials and, if justified, recommendations for use of the product (see ISO 29621). This International Standard describes a
49、procedure for the interpretation of data generated by the preservation efficacy test (if appropriate) and by the microbiological risk assessment. 5 Preservation efficacy test 5.1 General The evaluation of the preservation of a cosmetic formulation is based on inoculation of the formulation with calibrated inocula (prepared from relevant strains of micro-organisms). The number of surviving micro-organisms is measured at defined intervals during a period of 28 days. For each time and each strain, the log reduction
