EN ISO TR 19838-2016 en Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic Microbiology.pdf

1、Microbiology Cosmetics Guidelines for the application of ISO standards on CosmeticMicrobiologyPD CEN ISO/TR 19838:2016BSI Standards PublicationNational forewordThis Published Document is the UK implementation of CEN ISO/TR19838:2016.The UK participation in its preparation was entrusted to TechnicalC

2、ommittee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 201

3、6.Published by BSI Standards Limited 2016ISBN 978 0 580 87556 4ICS 07.100.99; 71.100.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 30 June 2016. Amendments/c

4、orrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TR 19838:2016g3g3g3g23g8g6g11g17g12g6g4g15g3g21g8g19g18g21g23g3g21g4g19g19g18g21g23g3g23g8g6g11g17g12g20g24g8g3g23g8g6g11g17g12g22g6g11g8g21g3g5g8g21g12g6g11g23g3CEN ISO/TR 19838 g3 g3g3 g16g131g155g3g884g882g883g888g3g

5、12g6g22g3g882g889g484g883g882g882g484g891g891g482g3g889g883g484g883g882g882g484g889g882g3g8g144g137g142g139g149g138g3g25g135g148g149g139g145g144g3g3g16g139g133g148g145g132g139g145g142g145g137g155g3g486g3g6g145g149g143g135g150g139g133g149g3g486g3g10g151g139g134g135g142g139g144g135g149g3g136g145g148g3

6、g150g138g135g3g131g146g146g142g139g133g131g150g139g145g144g3g145g136g3g12g22g18g3g149g150g131g144g134g131g148g134g149g3g145g144g3g6g145g149g143g135g150g139g133g3g16g139g133g148g145g132g139g145g142g145g137g155g3g523g12g22g18g512g23g21g3g883g891g890g885g890g483g884g882g883g888g524g3g16g139g133g148g145

7、g132g139g145g142g145g137g139g135g3g486g3g6g145g149g143g177g150g139g147g151g135g3g486g3g15g139g137g144g135g149g3g134g139g148g135g133g150g148g139g133g135g149g3g146g145g151g148g3g142g821g131g146g146g142g139g133g131g150g139g145g144g3g134g135g149g3g17g145g148g143g135g149g3g12g22g18g3g157g3g142g131g3g143g

8、139g133g148g145g132g139g145g142g145g137g139g135g3g133g145g149g143g177g150g139g147g151g135g3g523g12g22g18g512g23g21g3g883g891g890g885g890g483g884g882g883g888g524g3g3g3g3g3g23g138g139g149g3g23g135g133g138g144g139g133g131g142g3g21g135g146g145g148g150g3g153g131g149g3g131g146g146g148g145g152g135g134g3g13

9、2g155g3g6g8g17g3g145g144g3g883g890g3g4g146g148g139g142g3g884g882g883g888g484g3g12g150g3g138g131g149g3g132g135g135g144g3g134g148g131g153g144g3g151g146g3g132g155g3g150g138g135g3g23g135g133g138g144g139g133g131g142g3g6g145g143g143g139g150g150g135g135g3g6g8g17g512g23g6g3g885g891g884g484g3g3g6g8g17g3g143g

10、135g143g132g135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g132g145g134g139g135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g481g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g

11、146g148g151g149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g149g150g145g144g139g131g481g3g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g142g131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g14

12、4g139g131g481g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g144g137g131g148g155g481g3g12g133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g155g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g

13、15g151g154g135g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g481g3g17g145g148g153g131g155g481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145g143g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g1

14、35g144g139g131g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g134g481g3g23g151g148g141g135g155g3g131g144g134g3g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3g3g3g3g8g24g21g18g19g8g4g17g3g6g18g16g16g12g23g23g8g8g3g9g18g21g3g22g23g4g17g7

15、g4g21g7g12g29g4g23g12g18g17g3g6g18g16g12g23g50g3g8g24g21g18g19g50g8g17g3g7g8g3g17g18g21g16g4g15g12g22g4g23g12g18g17g3g8g24g21g18g19g34g12g22g6g11g8g22g3g14g18g16g12g23g8g8g3g9g111g21g3g17g18g21g16g24g17g10g3g3g3g3CEN-CENELECg3Management Centre: Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g88

16、8g3g6g8g17g3 g4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144g3g139g144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155g3g143g135g131g144g149g3g148g135g149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g

17、6g8g17g3g144g131g150g139g145g144g131g142g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g6g8g17g3g12g22g18g512g23g21g3g883g891g890g885g890g483g884g882g883g888g3g8PD CEN ISO/TR 19838:2016CEN ISO/TR 19838:2016 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TR 19838:2016CEN ISO/T

18、R 19838:2016 (E) 3 European foreword This document (CEN ISO/TS 19838:2016) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. Attention is drawn to the possibility that some of th

19、e 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. Endorsement notice The text of ISO/TR 19838:2016 has been approved by CEN as CEN ISO/TR 19838:2016 without any modification. PD CEN ISO/TR

20、19838:2016ISO/TR 19838:2016(E)Foreword ivIntroduction v1 Scope . 1g884g3 g23g135g148g143g149g3g131g144g134g3g134g135g976g139g144g139g150g139g145g144g149 . 13 Microbial content . 23.1 General requirements . 2g885g484g884g3 g8g144g151g143g135g148g131g150g139g145g144g3g145g136g3g143g135g149g145g146g138

21、g139g142g139g133g3g143g139g133g148g145g145g148g137g131g144g139g149g143g149g3g523g132g131g133g150g135g148g139g131g481g3g155g135g131g149g150g149g3g131g144g134g3g143g145g151g142g134g149g524 . 3g885g484g885g3 g7g135g150g135g133g150g139g145g144g3g145g136g3g149g146g135g133g139g976g139g135g134g3g143g139g13

22、3g148g145g145g148g137g131g144g139g149g143g149 . 3g885g484g886g3 g7g135g150g135g133g150g139g145g144g3g145g136g3g149g146g135g133g139g976g139g135g134g3g131g144g134g3g144g145g144g486g149g146g135g133g139g976g139g135g134g3g143g139g133g148g145g145g148g137g131g144g139g149g143g149 . 44 Antimicrobial preserva

23、tion. 54.1 General requirements . 54.2 Evaluation of the preservation of a cosmetic formulation 54.3 Evaluation of the preservation of a cosmetic product 65 Examples of microbial content results 65.1 General . 6g887g484g884g3 g8g155g135g3g143g131g141g135g486g151g146g3g148g135g143g145g152g135g148 . 6

24、5.3 Mascara 65.4 Face cream 75.5 Shampoo . 8g888g3 g8g154g131g143g146g142g135g149g3g145g136g3g139g144g150g135g148g146g148g135g150g131g150g139g145g144g3g145g136g3g146g148g135g149g135g148g152g131g150g139g145g144g3g135g136g976g139g133g131g133g155g3g150g135g149g150g3g148g135g149g151g142g150g149.8Annex A

25、 (informative) Relationship between the ISO cosmetic microbiology standards .11Annex B (informative) Relationship between the ISO standards dealing with the microbial content of cosmetics 12Annex C (informative) Evaluation of the microbial content of a cosmetic product 13Annex D (informative) Interp

26、retation of test results .14Bibliography .15 ISO 2016 All rights reserved iiiContents PagePD CEN ISO/TR 19838:2016ISO/TR 19838:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards g132g145g134g139g135g149g3g523g12g22g18g3g143g135g143

27、g132g135g148g3g132g145g134g139g135g149g524g484g3g23g138g135g3g153g145g148g141g3g145g136g3g146g148g135g146g131g148g139g144g137g3g12g144g150g135g148g144g131g150g139g145g144g131g142g3g22g150g131g144g134g131g148g134g149g3g139g149g3g144g145g148g143g131g142g142g155g3g133g131g148g148g139g135g134g3g145g151g

28、150g3g150g138g148g145g151g137g138g3 g12g22g18g3 g150g135g133g138g144g139g133g131g142g3 g133g145g143g143g139g150g150g135g135g149g484g3 g8g131g133g138g3 g143g135g143g132g135g148g3 g132g145g134g155g3 g139g144g150g135g148g135g149g150g135g134g3 g139g144g3 g131g3 g149g151g132g140g135g133g150g3 g136g145g14

29、8g3 g153g138g139g133g138g3 g131g3 g150g135g133g138g144g139g133g131g142g3committee has been established has the right to be represented on that committee. International g145g148g137g131g144g139g156g131g150g139g145g144g149g481g3 g137g145g152g135g148g144g143g135g144g150g131g142g3 g131g144g134g3 g144g14

30、5g144g486g137g145g152g135g148g144g143g135g144g150g131g142g481g3 g139g144g3 g142g139g131g139g149g145g144g3 g153g139g150g138g3 g12g22g18g481g3 g131g142g149g145g3 g150g131g141g135g3 g146g131g148g150g3 g139g144g3 g150g138g135g3 g153g145g148g141g484g3g12g22g18g3g133g145g142g142g131g132g145g148g131g150g13

31、5g149g3g133g142g145g149g135g142g155g3g153g139g150g138g3g150g138g135g3g12g144g150g135g148g144g131g150g139g145g144g131g142g3g8g142g135g133g150g148g145g150g135g133g138g144g139g133g131g142g3g6g145g143g143g139g149g149g139g145g144g3g523g12g8g6g524g3g145g144g3g131g142g142g3g143g131g150g150g135g148g149g3g14

32、5g136g3electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the g134g139g136g136g135g148g135g144g150g3g150g155g146g135g149

33、g3g145g136g3g12g22g18g3g134g145g133g151g143g135g144g150g149g3g149g138g145g151g142g134g3g132g135g3g144g145g150g135g134g484g3g23g138g139g149g3g134g145g133g151g143g135g144g150g3g153g131g149g3g134g148g131g136g150g135g134g3g139g144g3g131g133g133g145g148g134g131g144g133g135g3g153g139g150g138g3g150g138g135

34、g3editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).g4g150g150g135g144g150g139g145g144g3g139g149g3g134g148g131g153g144g3g150g145g3g150g138g135g3g146g145g149g149g139g132g139g142g139g150g155g3g150g138g131g150g3g149g145g143g135g3g145g136g3g150g138g135g3g135g142g135g143g135g

35、144g150g149g3g145g136g3g150g138g139g149g3g134g145g133g151g143g135g144g150g3g143g131g155g3g132g135g3g150g138g135g3g149g151g132g140g135g133g150g3g145g136g3g146g131g150g135g144g150g3g148g139g137g138g150g149g484g3g12g22g18g3g149g138g131g142g142g3g144g145g150g3g132g135g3g138g135g142g134g3g148g135g149g146

36、g145g144g149g139g132g142g135g3g136g145g148g3g139g134g135g144g150g139g136g155g139g144g137g3g131g144g155g3g145g148g3g131g142g142g3g149g151g133g138g3g146g131g150g135g144g150g3g148g139g137g138g150g149g484g3g7g135g150g131g139g142g149g3g145g136g3g131g144g155g3g146g131g150g135g144g150g3g148g139g137g138g150

37、g149g3g139g134g135g144g150g139g976g139g135g134g3g134g151g148g139g144g137g3g150g138g135g3g134g135g152g135g142g145g146g143g135g144g150g3g145g136g3g150g138g135g3g134g145g133g151g143g135g144g150g3g153g139g142g142g3g132g135g3g139g144g3g150g138g135g3g12g144g150g148g145g134g151g133g150g139g145g144g3g131g14

38、4g134g512g145g148g3on the ISO list of patent declarations received (see www.iso.org/patents).g4g144g155g3g150g148g131g134g135g3g144g131g143g135g3g151g149g135g134g3g139g144g3g150g138g139g149g3g134g145g133g151g143g135g144g150g3g139g149g3g139g144g136g145g148g143g131g150g139g145g144g3g137g139g152g135g14

39、4g3g136g145g148g3g150g138g135g3g133g145g144g152g135g144g139g135g144g133g135g3g145g136g3g151g149g135g148g149g3g131g144g134g3g134g145g135g149g3g144g145g150g3constitute an endorsement.g9g145g148g3 g131g144g3 g135g154g146g142g131g144g131g150g139g145g144g3 g145g144g3 g150g138g135g3 g143g135g131g144g139g1

40、44g137g3 g145g136g3 g12g22g18g3 g149g146g135g133g139g976g139g133g3 g150g135g148g143g149g3 g131g144g134g3 g135g154g146g148g135g149g149g139g145g144g149g3 g148g135g142g131g150g135g134g3 g150g145g3 g133g145g144g136g145g148g143g139g150g155g3assessment, as well as information about ISOs adherence to the W

41、TO principles in the Technical Barriers to Trade (TBT) see the following URL: g9g145g148g135g153g145g148g134g3g486g3g22g151g146g146g142g135g143g135g144g150g131g148g155g3g139g144g136g145g148g143g131g150g139g145g144The committee responsible for this document is ISO/TC 217, Cosmetics.iv ISO 2016 All ri

42、ghts reservedPD CEN ISO/TR 19838:2016ISO/TR 19838:2016(E)Introductiong8g152g135g148g155g3 g133g145g149g143g135g150g139g133g3 g143g131g144g151g136g131g133g150g151g148g135g148g3 g138g131g149g3 g131g3 g134g151g131g142g3 g148g135g149g146g145g144g149g139g132g139g142g139g150g155g3 g148g135g142g131g150g139

43、g152g135g3 g150g145g3 g150g138g135g3 g143g139g133g148g145g132g139g145g142g145g137g139g133g131g142g3 g147g151g131g142g139g150g155g3 g145g136g3 g139g150g149g3products.g516g3 g23g138g135g3 g976g139g148g149g150g3 g139g149g3 g150g145g3 g135g144g149g151g148g135g3 g150g138g131g150g3 g150g138g135g3 g146g148

44、g145g134g151g133g150g481g3 g131g149g3 g146g151g148g133g138g131g149g135g134g481g3 g139g149g3 g136g148g135g135g3 g136g148g145g143g3 g150g138g135g3 g144g151g143g132g135g148g149g3 g131g144g134g3 g150g155g146g135g149g3 g145g136g3g143g139g133g148g145g145g148g137g131g144g139g149g143g149g3g150g138g131g150g3

45、g133g145g151g142g134g3g131g136g136g135g133g150g3g146g148g145g134g151g133g150g3g147g151g131g142g139g150g155g3g131g144g134g3g133g145g144g149g151g143g135g148g3g138g135g131g142g150g138g484g3g23g138g139g149g3g139g149g3g137g135g144g135g148g131g142g142g155g3g135g144g149g151g148g135g134g3g132g155g3g131g146g

46、146g142g155g139g144g137g3g133g145g149g143g135g150g139g133g3g137g145g145g134g3g143g131g144g151g136g131g133g150g151g148g139g144g137g3g146g148g131g133g150g139g133g135g3g523g10g16g19g524g3g523g149g135g135g3g12g22g18g3g884g884g889g883g888g524g3g134g151g148g139g144g137g3g150g138g135g3g143g131g144g151g136g

47、131g133g150g151g148g139g144g137g3g131g144g134g3g146g131g133g141g131g137g139g144g137g3g145g146g135g148g131g150g139g145g144g149g3g131g144g134g481g3g139g136g3g144g135g133g135g149g149g131g148g155g481g3g132g155g3g151g149g139g144g137g3microbial content testsg3g145g144g3g976g139g144g139g149g138g135g134g3g1

48、46g148g145g134g151g133g150g149g484 The second is to ensure that microorganisms introduced during normal product use will not g131g134g152g135g148g149g135g142g155g3 g131g136g136g135g133g150g3 g150g138g135g3 g147g151g131g142g139g150g155g3 g145g148g3 g149g131g136g135g150g155g3 g145g136g3 g150g138g135g3

49、 g146g148g145g134g151g133g150g484g3 g23g138g139g149g3 g139g149g3 g137g135g144g135g148g131g142g142g155g3 g135g144g149g151g148g135g134g3 g132g155g3 g133g145g144g134g151g133g150g139g144g137g3g146g148g135g149g135g148g152g131g150g139g145g144g3g135g136g976g139g133g131g133g155g3g150g135g149g150g149 (or challenge tests) during the development stage of the new product.g12g144g3 g145g148g134g135g148g3 g150g145g3 g135g144g149g151g148g135g3 g146g148g145g134g151g133g150g3 g147g151g131g142g139g150g155g3 g131g144g134g3 g149g131g136g135g150g155g3 g136g145g148g3 g133g145g144g149g151g14