DIN EN ISO 11930-2013 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930 2012 Corrected version 2013-05-01) German version EN IS.pdf

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1、October 2013 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 07.100.99; 71.100.70!%)V/“2065112www.din.deDDIN EN ISO 11930Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic product(ISO 11930:2012, Corrected version 2013-05-01);English version EN ISO 11930:2012,English translation of DIN EN ISO 11930:2013-10Kosmetische Mittel Mikr

3、obiologie Bewertung des antimikrobiellen Schutzes eines kosmetischen Produktes(ISO 11930:2012, korrigierte Fassung 2013-05-01);Englische Fassung EN ISO 11930:2012,Englische bersetzung von DIN EN ISO 11930:2013-10Cosmtiques Microbiologie Evaluation de la protection antimicrobienne dun produit cosmtiq

4、ue (ISO 11930:2012,Version corrig 2013-05-01);Version anglaise EN ISO 11930:2012,Traduction anglaise de DIN EN ISO 11930:2013-10SupersedesDIN EN ISO 11930:2012-07www.beuth.deDocument comprises 30 pagesIn case of doubt, the German-language original shall be considered authoritative.09.13 DIN EN ISO 1

5、1930:2013-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11930:2012) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The responsible German body involve

6、d in its preparation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-07-01 AA Kosmetische Mittel. The DIN Standards corresponding to the International Standards referred to in this document are as fo

7、llows: ISO 16212 DIN EN ISO 16212 ISO 18415 DIN EN ISO 18415 ISO 21148 DIN EN ISO 21148 ISO 21149 DIN EN ISO 21149 ISO 22716 DIN EN ISO 22716 ISO 29621 DIN EN ISO 29621 Amendments Compared with DIN EN ISO 11930:2012-07, the following correction has been made: a) in Table B.1, line “Criteria A”, last

8、 column (T28), the words “and NI” have been added. Previous editions DIN EN ISO 11930: 2012-07 DIN EN ISO 11930:2013-10 3 National Annex NA (informative) Bibliography DIN EN ISO 16212, Cosmetics Microbiology Enumeration of yeast and mould DIN EN ISO 18415, Cosmetics Microbiology Detection of specifi

9、ed and non-specified microorganisms DIN EN ISO 21148, Cosmetics Microbiology General instructions for microbiological examination DIN EN ISO 21149, Cosmetics Microbiology Enumeration and detection of aerobic mesophilic bacteria DIN EN ISO 22716, Cosmetics Good Manufacturing Practices (GMP) Guideline

10、s on Good Manufacturing Practices DIN EN ISO 29621, Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products DIN EN ISO 23908:2013-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11930 April 201

11、2 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 - Microbiologie - valuation de la protection antimicrobienne dun produit cosmtique (ISO 11930:2012, Version

12、 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 approved by CEN on 31 March 2012. CEN members are bound to comply with the CEN/CENELEC Internal Re

13、gulations 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 national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN me

14、mber. 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 language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

15、 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

16、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form a

17、nd by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11930:2012: EContents Foreword . 3 Introduction . 4 1 Scope 5 1.1 Preservation efficacy test . 5 1.2 Procedure for evaluating the antimicrobial protection of the cosmetic product . 5 2 Normative references 6 3 Terms and def

18、initions . 6 4 Principle . 7 5 Preservation efficacy test . 7 5.1 General . 7 5.2 Materials, apparatus, reagents and culture media . 7 5.2.1 Materials - Apparatus 7 5.2.2 Diluents, neutralisers and culture media 8 5.3 Microbial strains 10 5.4 Preparation and enumeration of inocula 11 5.4.1 General .

19、 11 5.4.2 Preparation of bacterial and Candida albicans suspensions . 11 5.4.3 Preparation of Aspergillus brasiliensis (previously A. niger) spores suspension 12 5.5 Demonstration of the neutraliser efficacy 13 5.5.1 Principle . 13 5.5.2 Procedure . 13 5.5.3 Calculations . 13 5.5.4 Interpretation of

20、 results and conclusion on neutraliser efficacy . 14 5.6 Determination of the preservation efficacy of the formulation 14 5.6.1 Procedure . 14 5.6.2 Counting of colonies . 15 5.6.3 Calculations . 16 5.7 Interpretation of test results and conclusions . 17 5.7.1 General case (the efficacy of neutralis

21、er is demonstrated for all strains) 17 5.7.2 Case of formulations for which the efficacy of neutraliser is not demonstrated for some strains . 17 5.8 Test report 18 6 Overall evaluation of the antimicrobial protection of the cosmetic product 19 6.1 General . 19 6.2 Case 1 The Preservation Efficacy t

22、est has been performed on the formulation . 19 6.3 Case 2 - The Preservation Efficacy test has not been performed on the formulation . 19 Annex A (normative) Decision diagram . 21 Annex B (normative) Evaluation criteria for the Preservation Efficacy Test (5.7) 22 Annex C (informative) Examples of ne

23、utralisers for the antimicrobial activity of preservatives and washing liquids 23 Annex D (informative) Packaging Characteristics 24 Bibliography 25 2ISO 11930:2012(E) DIN EN ISO 11930:2013-10Foreword This document (EN ISO 11930:2012, Corrected version 2013-05-01) has been prepared by Technical Comm

24、ittee 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 201

25、2, 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

26、. According 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, Irela

27、nd, 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

28、without any modification. 3ISO 11930:2012(E) DIN EN ISO 11930:2013-10Introduction This International Standard is to be used 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; in

29、herent characteristics of the formulation; package design; manufacturing process. This International Standard defines a series 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 wi

30、th evaluation criteria is also described in this International Standard. The data generated by the risk assessment (see ISO 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. 4ISO 11930:2012(E) DIN E

31、N ISO 11930:2013-101 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 ISO 29621. This International St

32、andard 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 appl

33、ies 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 adap

34、tation, 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 i

35、ntervals 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 varia

36、bles (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 f

37、or 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 charact

38、eristics 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 ch

39、aracteristics 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). 5ISO 11930:2012(E) DIN EN ISO 11930:2013-102 Normative references

40、 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 Microbiology Enumeration of

41、 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 bacteria ISO 22716, Cosm

42、etics 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 and definitions give

43、n 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 container for shipmen

44、t 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 process and protective

45、 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 by interested parti

46、es 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 6ISO 11930:2012(E) DIN EN ISO 11930:2013-103.7 consumer end user of a cosmetic product 4 Principle The eval

47、uation 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 preservation efficacy test is described in 5.1. b) The c

48、haracteristics 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 procedure for the interpretation of data gene

49、rated 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 value is calculated