1、BS EN ISO 29621:2017Cosmetics Microbiology Guidelines for the riskassessment and identificationof microbiologically low-riskproducts (ISO 29621:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 29621:2017 BRITISH STANDARDNational forewordThis British Sta
2、ndard is the UK implementation of EN ISO 29621:2017. It supersedes BS EN ISO 29621:2011 which iswithdrawn. 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.
3、This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 93291 5 ICS 07.100.40 Compliance with a British Standard cannot con
4、fer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 29621 March 2
5、017 ICS 07.100.40 Supersedes EN ISO 29621:2011English Version Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017) Cosmtiques - Microbiologie - Lignes directrices pour lapprciation du risque et lidentification de pro
6、duits faible risque microbiologique (ISO 29621:2017) Kosmetische Mittel - Mikrobiologie - Leitlinien fr die Risikobewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2017) This European Standard was approved by CEN on 25 February 2017. CEN members are bound to comply wi
7、th 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 national standards may be obtained on application to the CEN-CENELEC Mana
8、gement 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 language and notified to the CEN-CENELEC Management Centre has the same st
9、atus 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal
10、ta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
11、 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 29621:2017 EBS EN ISO 29621:2017EN ISO 29621:2017 (E) 3 European foreword This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ i
12、n 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 September 2017, and conflicting national
13、standards shall be withdrawn at the latest by September 2017. 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. This document supersedes
14、 EN ISO 29621:2011. 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, Former Yugoslav Republic of Ma
15、cedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 29621:2017 has been appr
16、oved by CEN as EN ISO 29621:2017 without any modification. BS EN ISO 29621:2017ISO 29621:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Risk assessment factors 24.1 General . 24.2 Composition of the product . 24.2.1 General characteristics . 24.2.2 Wa
17、ter activity, aw, of formulation 24.2.3 pH of formulation 44.2.4 Raw materials that can create a hostile environment . 44.3 Production conditions 64.4 Packaging . 64.5 Combined factors 65 Identified low-risk products 7Bibliography 8 ISO 2017 All rights reserved iiiContents PageBS EN ISO 29621:2017IS
18、O 29621:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards 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
19、 for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC)
20、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/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be note
21、d. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).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 identifyin
22、g 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 declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenienc
23、e of users and does not constitute an endorsement.For an explanation on the voluntary nature of ISO standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Techn
24、ical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 29621:2010), which has been technically revised.iv ISO 2017 All rights reservedBS EN ISO 29621:20
25、17ISO 29621:2017(E)IntroductionEvery cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its products. The first is to ensure that the product, as purchased, is free from the numbers and types of microorganisms that could affect product quality and consumer hea
26、lth. The second is to ensure that microorganisms introduced during normal product use will not adversely affect the quality or safety of the product.The first step would be to perform a microbiological risk assessment of the product to determine if the cosmetic microbiological International Standard
27、s apply.Microbiological risk assessment is based on a number of factors generally accepted as important in evaluating the adverse effects on product quality and consumer health. It is intended as a guide in determining what level of testing, if any, is necessary to assure the quality of the product.
28、 Conducting a microbiological risk assessment involves professional judgment and/or a microbiological analysis, if necessary, to determine the level of risk.The nature and frequency of testing vary according to the product. The significance of microorganisms in non-sterile cosmetic products is to be
29、 evaluated in terms of the use of the product, the nature of the product and the potential harm to the user.The degree of risk depends on the ability of a product to support the growth of microorganisms and on the probability that those microorganisms can cause harm to the user. Many cosmetic produc
30、ts provide optimum conditions for microbial growth, including water, nutrients, pH and other growth factors. In addition, the ambient temperatures and relative humidity at which many cosmetic products are manufactured, stored and used by consumers, will promote growth of mesophiles that could cause
31、harm to users or cause degradation of the product. For these types of products, the quality of the finished goods is controlled by applying cosmetic good manufacturing practices (GMPs) (see ISO 22716) during the manufacturing process, using preservatives and conducting control tests using appropriat
32、e methods.The likelihood of microbiological contamination for some cosmetic products is extremely low (or non-existent) due to product characteristics that create a hostile environment for survival/growth of microorganisms. These characteristics are elaborated in this document. While the hazard (adv
33、erse effects on product quality and consumer health) may remain the same for these products, the likelihood of an occurrence is extremely low. These products identified as “hostile” and produced in compliance with GMPs pose a very low overall risk to the user.Therefore, products that comply with the
34、 characteristics outlined in this document do not require microbiological testing.This document gives guidance to cosmetic manufacturers and regulatory bodies to determine when, based on a “risk assessment,” the application of the microbiological International Standards for cosmetics and other relev
35、ant methods is not necessary. ISO 2017 All rights reserved vBS EN ISO 29621:2017BS EN ISO 29621:2017Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products1 ScopeThis document gives guidance to cosmetic manufacturers and regulatory bodies t
36、o help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.2 Normative referencesThere are no norma
37、tive references in this document.3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/
38、ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1riskeffect of uncertainty on objectivesNote 1 to entry: Microbiological risk is associated with the ability of a product to support the growth of microorganisms and the probability that those microorganisms can cause harm to
39、the user; support the presence of specified microorganisms as identified in cosmetic microbiological International Standards, e.g. ISO 18415, ISO 18416, ISO 22717, ISO 22718 and ISO 21150.SOURCE: ISO Guide 73:2009, 1.1, modified3.2risk assessmentoverall process of risk identification, risk analysis
40、(3.3) and risk evaluation (3.4)SOURCE: ISO Guide 73:2009, 3.4.13.3risk analysisprocess to comprehend the nature of risk (3.1) and to determine the level of riskSOURCE: ISO Guide 73:2009, 3.6.1INTERNATIONAL STANDARD ISO 29621:2017(E) ISO 2017 All rights reserved 1BS EN ISO 29621:2017ISO 29621:2017(E)
41、3.4risk evaluationprocess of comparing the results of risk analysis (3.3) with risk criteria (3.5) to determine whether the risk (3.1) and/or its magnitude is acceptable or tolerableSOURCE: ISO Guide 73:2009, 3.7.13.5risk criteriaterm of reference against which the significance of a risk (3.1) is ev
42、aluatedSOURCE: ISO Guide 73:2009, 3.3.1.3, modified3.6microbiologically low-risk productproduct whose environment denies microorganisms the physical and chemical requirements for growth and/or survivalNote 1 to entry: This category of low-risk products applies to microbiological contamination which
43、may occur during manufacturing and/or intended use by the consumer.Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a microbiological low-risk product during its use.Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a f
44、ormulation by itself would not necessarily constitute a low-risk product.4 Risk assessment factors4.1 GeneralA number of product characteristics needs to be evaluated when performing a microbial risk assessment to determine if that product should be subjected to the published microbiological Interna
45、tional Standards for cosmetics or other relevant methods. These characteristics include the composition of the product, the production conditions, packaging and a combination of these factors.4.2 Composition of the product4.2.1 General characteristicsProducts with certain physico-chemical characteri
46、stics do not allow the proliferation of microorganisms of concern to cosmetic products. Any number of physico-chemical factors or combinations thereof in a product can create a hostile environment that will not support microbial growth and/or survival. Combinations of sub-lethal factors will increas
47、e the hostility of the environment and increase the lag phase. If the environment is hostile enough, the lag phase will be extended to infinity and therefore cause cell death. Combinations of lethal factors will cause rapid cell death. The following factors should be considered in determining whethe
48、r cosmetic products present a hostile environment.4.2.2 Water activity, aw, of formulationWater is one of the most important factors controlling the rate of growth of an organism. It is not the total moisture content that determines the potential for growth but the available water in the formulation
49、. The metabolism and reproduction of microorganisms require the presence of water in an available form. The most useful measurement of water availability in a product formulation is water 2 ISO 2017 All rights reservedBS EN ISO 29621:2017ISO 29621:2017(E)activity, aw. Water activity is defined as the ratio of the water vapour pressure of the product to that of pure water at the same temperature see Formula (1):appnnnw=+()0212(1)wherep is the vapour pressure of the solution;p0is the vapour pressure of pure water;n1is the number of
