1、BSI Standards PublicationBS EN ISO 17516:2014Cosmetics Microbiology Microbiological limitsBS EN ISO 17516:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17516:2014.The UK participation in its preparation was entrusted to TechnicalCommittee CW/217, Cosme
2、tics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI Sta
3、ndardsLimited 2014ISBN 978 0 580 78701 0ICS 07.100.99; 71.100.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publication
4、Date Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17516 October 2014 ICS 07.100.99; 71.100.99 English Version Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014) Cosmtiques - Microbiologie - Limites microbiologiques (ISO 17516:2014) Kosmetische Mittel - Mikrob
5、iologie - Mikrobiologische Grenzwerte (ISO 17516:2014) This European Standard was approved by CEN on 9 August 2014. 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
6、 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 member. This European Standard exists in three official versions (English, French, German). A version in any other languag
7、e 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,
8、Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR
9、STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17516:2014 EBS EN ISO 17516:201
10、4EN ISO 17516:2014 (E) 3 Foreword This document (EN ISO 17516:2014) 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. This European Standard shall be given the status of a nation
11、al standard, either by publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rig
12、hts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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,
13、Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Un
14、ited Kingdom. Endorsement notice The text of ISO 17516:2014 has been approved by CEN as EN ISO 17516:2014 without any modification. BS EN ISO 17516:2014ISO 17516:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Principle 14 Microbiological limits for cosmetics 2An
15、nex A (normative) Flowchart for interpretation of test results 3Bibliography 4 ISO 2014 All rights reserved iiiBS EN ISO 17516:2014ISO 17516:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of
16、 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 organizations, governmental and non-governmental
17、, 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.The procedures used to develop this document and those intended for its further maintenance are described in the ISO
18、/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that
19、 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent dec
20、larations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about
21、ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Cosmetics.iv ISO 2014 All rights reservedBS EN ISO 17516:2014ISO 17516:2014(E)IntroductionEvery cosmeti
22、c manufacturer has a responsibility relative to the microbiological safety and quality of its products to ensure that they have been produced under hygienic conditions. Cosmetic products are not expected to be sterile. However they shall not contain excessive amounts of microorganisms nor specified
23、microorganisms that have the potential to affect the product quality or consumer safety. Moreover, some cosmetic products which are considered to have low microbiological risk (see ISO 29621) may not need to be subjected to routine microbiological testing and manufacturers can decide not to test if
24、they can ensure products meet this standard.The manufacturer should follow the Good Manufacturing Practices described in ISO 22716 and take the necessary precautions to limit the introduction of microorganisms from raw materials, processing and packaging. When necessary, microbiological testing may
25、be performed using ISO 21148, ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717, and ISO 22718.The objective of this International Standard is to develop acceptable quantitative and qualitative limits for cosmetic finished products. ISO 2014 All rights reserved vBS EN ISO 17516:2014BS
26、 EN ISO 17516:2014Cosmetics Microbiology Microbiological limits1 ScopeThis International Standard is applicable for all cosmetics and assists interested parties in the assessment of the microbiological quality of the products. Microbiological testing does not need to be performed on those products c
27、onsidered to be microbiologically low risk (see ISO 29621).2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1productportion of an identified cosmetic product received in the laboratory for testing2.2aerobic mesophilic microorganismsmesophilic bact
28、eria, yeast and mould growing aerobically under the conditions specified in ISO 21149 and ISO 162122.3specified microorganismaerobic mesophilic bacteria or yeast that is undesirable in a cosmetic product because it can cause skin or eye infection or is an indication of hygienic failureSOURCE: ISO 18
29、415:2007, definition 3.6 modified terminology has changed.2.3.1Escherichia coligram-negative rod, motile, smooth coloniesSOURCE: ISO 21150:2006, definition 3.62.3.2Pseudomonas aeruginosagram-negative rod, motile; smooth colonies pigmented brown or greenishSOURCE: ISO 22717:2006, definition 3.62.3.3S
30、taphylococcus aureusgram-positive cocci, mainly joined in grape-like clusters, smooth colonies generally pigmented in yellowSOURCE: ISO 22718:2006, definition 3.62.3.4Candida albicansyeast that forms white to beige, creamy and convex colonies on the surface of a selective mediumSOURCE: ISO 18416:200
31、7, definition 3.63 PrincipleCosmetics, the raw materials of which they are composed and the conditions under which they are manufactured are not required to be sterile. However the microorganisms present in a product should not INTERNATIONAL STANDARD ISO 17516:2014(E) ISO 2014 All rights reserved 1B
32、S EN ISO 17516:2014ISO 17516:2014(E)have an adverse effect on consumer safety or product quality during intended or foreseeable use. Therefore, quantitative and/or qualitative microbiological limits are established for finished cosmetic products.Less than or equal to 1 103CFU per gram or ml of produ
33、ct is considered as an acceptable number for topical applications. However, it is considered that particular attention should be paid to cosmetics specifically intended for use in the eye area, for children under three years of age and on mucous membranes where less than or equal to 1 102CFU per gra
34、m or ml of product is considered acceptable. In addition, interpretation of out of limit results shall consider the inherent variability of the plate count method (see Table 1).Additionally it is expected that product shall be free from E. coli, S. aureus, P. aeruginosa and C. albicans in 1 g or 1 m
35、l of product.This International Standard sets microbiological limits for cosmetics. When necessary, International standard test methods (see Annex A) should be used to assess compliance.4 Microbiological limits for cosmeticsTo ensure the quality of the product and consumer safety it is crucial that
36、the number of non-specified microorganisms recovered from the product remains stable or declines over the product life. The presence of non-specified microorganisms shall not be considered as objectionable, provided that they do not have the ability to grow in the product. This can be based on a ris
37、k assessment that includes preservation efficacy studies (e.g. ISO 11930) or by the demonstration that the product cannot support microbial growth (ISO 29621).Based on these considerations the following microbiological limits mentioned in Table 1 shall apply.Table 1 Microbiological limits for cosmet
38、icsTypes of microorganismsProducts specifically intended for children under three years of age, the eye area or the mucous membranesOther productsTotal Aerobic Mesophilic Microor-ganisms (Bacteria plus yeast and mould) 1 102CFU per g or mla 1 103CFU per g or mlbEscherichia coli Absence in 1 g or 1 m
39、l Absence in 1 g or 1 mlPseudomonas aeruginosa Absence in 1 g or 1 ml Absence in 1 g or 1 mlStaphyloccocus aureus Absence in 1 g or 1 ml Absence in 1 g or 1 mlCandida albicans Absence in 1 g or 1 ml Absence in 1 g or 1 mlDue to inherent variability of the plate count method, according to USP Chapter
40、 61 or EP Chapter 2.6.12, Interpretation of results, results considered out of limit ifa 200 CFU/g or ml,b 2 000 CFU/g or ml.NOTE When colonies of bacteria are detected on Sabouraud Dextrose agar, Sabouraud Dextrose agar containing antibiotics may be used.2 ISO 2014 All rights reservedBS EN ISO 1751
41、6:2014ISO 17516:2014(E)Annex A (normative) Flowchart for interpretation of test resultsDetection ofmicroorganisms?Productspecig976ically intended for Children under 3 years of age, the eye area or mucous membranes?Microbial examination of nonsterile products: microbial enumeration tests Microbial ex
42、amination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use24 Andean Community: “Resolution 1418 Adiciones a la resolucion 797 Lmites de conteni-do microbiologico de productos cosmeticos”: Gaceta oficial del acuerdo de Cartagena Ao XXVI
43、II Numro 1953 13 June 201125 Mercosul/GM/RES. N 51/98- parmetros de controle microbiologico para produtos de hygiene pessoal, cosmeticos e perfumes4 ISO 2014 All rights reservedBS EN ISO 17516:2014ISO 17516:2014(E)26 MCCA (Guatemala, El Salvador, Nicaragua, Honduras et Costa Rica): Reglamento tcnico
44、 Centroamericano RTCA 71.03.45:07 Productos cosmeticos. Verificacion de la calidad27 Microbiology Guidelines CTFA 2007 ISO 2014 All rights reserved 5This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standa
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