DIN EN ISO 29621-2017 Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621 2017) German version EN ISO.pdf

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1、July 2017 English price group 12No 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).ICS 07.100.40!%h1“2691494www.din.deDIN

2、EN ISO 29621Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically lowrisk products (ISO 29621:2017);English version EN ISO 29621:2017,English translation of DIN EN ISO 29621:2017-07Kosmetische Mittel Mikrobiologie Leitlinien fr die Risikobewertung und Iden

3、tifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2017);Englische Fassung EN ISO 29621:2017,Englische bersetzung von DIN EN ISO 29621:2017-07Cosmtiques Microbiologie Lignes directrices pour lapprciation du risque et lidentification de produits faible risque microbiologique (ISO 29621:2

4、017);Version anglaise EN ISO 29621:2017,Traduction anglaise de DIN EN ISO 29621:2017-07SupersedesDIN EN ISO 29621:201104www.beuth.deDocument comprises 20 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.07.17 DIN EN ISO 29621:20

5、17-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” (Secretariat: ISIRI, Iran) in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The responsible

6、 German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-07-01 AA “Cosmetics”. The DIN Standards corresponding to the International Standards referred to in this d

7、ocument are as follows: ISO 11930 DIN EN ISO 11930 ISO 16212 DIN EN ISO 16212 ISO 18415 DIN EN ISO 18415 ISO 18416 DIN EN ISO 18416 ISO 21150 DIN EN ISO 21150 ISO 22716 DIN EN ISO 22716 ISO 22717 DIN EN ISO 22717 ISO 22718 DIN EN ISO 22718 Amendments This standard differs from DIN EN ISO 29621:2011-

8、04 as follows: a) in Table 1, the list of selected microorganisms has been extended; b) Clause 4 has been extended by 4.2.4.2 “Ammonia and monoethanolamine” and 4.2.4.3 “Polar organic solvents (e.g. ethyl acetate and butyl acetate)”; c) in Table 2, examples of low-risk products have been included; d

9、) the Bibliography has been updated; e) the standard has been editorially revised. Previous editions DIN EN ISO 29621: 2011-04 DIN EN ISO 29621:2017-07 3 National Annex NA (informative) Bibliography DIN EN ISO 11930, Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic pro

10、duct DIN EN ISO 16212, Cosmetics Microbiology Enumeration of yeast and mould DIN EN ISO 18415, Cosmetics Microbiology Detection of specified and non-specified microorganisms DIN EN ISO 18416, Cosmetics Microbiology Detection of Candida albicans DIN EN ISO 21150, Cosmetics Microbiology Detection of E

11、scherichia coli DIN EN ISO 22716, Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufacturing Practices DIN EN ISO 22717, Cosmetics Microbiology Detection of Pseudomonas aeruginosa DIN EN ISO 22718, Cosmetics Microbiology Detection of Staphylococcus aureus DIN EN ISO 29621:2017-07

12、4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 29621 March 2017 ICS 07.100.40 Supersedes EN ISO 29621:2011 English Version Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)

13、 Cosmtiques Microbiologie Lignes directrices pour lapprciation du risque et lidentification de produits faible risque microbiologique (ISO 29621:2017) Kosmetische Mittel Mikrobiologie Leitlinien fr die Risikobewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2017) This

14、 European Standard was approved by CEN on 25 February 2017. 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 refere

15、nces 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 language made by translation under the responsibility of a CEN

16、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, Estonia, Finland, Former Yugoslav Republic of Macedonia,

17、 France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION E

18、UROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 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 E EN ISO 29621:2017 (E) 2 Contents Page European foreword . 3 Forewo

19、rd 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Risk assessment factors 7 4.1 General 7 4.2 Composition of the product . 7 4.2.1 General characteristics . 7 4.2.2 Water activity, aw, of formulation . 7 4.2.3 pH of formulation 9 4.2.4 Raw materials that can create

20、 a hostile environment . 9 4.3 Production conditions 11 4.4 Packaging 11 4.5 Combined factors . 11 5 Identified low-risk products 12 Bibliography . 13 DIN EN ISO 29621:2017-07 EN ISO 29621:2017 (E) 3 European foreword This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC

21、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 September 2017, and conf

22、licting national 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 do

23、cument supersedes 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 Yugosl

24、av Republic of Macedonia, 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 29621:2

25、017 has been approved by CEN as EN ISO 29621:2017 without any modification. DIN EN ISO 29621:2017-07 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

26、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, in liaison with ISO, also take part in the wo

27、rk. 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/IEC Directives, Part 1. In particular the diff

28、erent 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 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document

29、 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 declarations received (see www .iso .org/

30、 patents).Any 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 voluntary nature of ISO standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as informat

31、ion about ISOs adherence to the World Trade Organization (WTO) principles in the Technical 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)

32、, which has been technically revised.EN ISO 29621:2017 (E) 4 DIN EN ISO 29621:2017-07 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 o

33、f microorganisms that could affect product quality and consumer health. 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

34、to determine if the cosmetic microbiological International Standards 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

35、testing, if any, is necessary to assure the quality of the product. 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 signi

36、ficance of microorganisms in non-sterile cosmetic products is to be 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 th

37、ose microorganisms can cause harm to the user. Many cosmetic products 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 use

38、d by consumers, will promote growth of mesophiles that could cause 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

39、, using preservatives and conducting control tests using appropriate 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 cha

40、racteristics are elaborated in this document. While the hazard (adverse 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 lo

41、w overall risk to the user.Therefore, products that comply with the 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 mi

42、crobiological International Standards for cosmetics and other relevant methods is not necessary.EN ISO 29621:2017 (E) 5 DIN EN ISO 29621:2017-07 1 ScopeThis document gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment

43、, 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 normative references in this document.3 Terms and definitionsFor the purpos

44、es 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/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ o

45、bp3.1riskeffect 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 the user; support the presence of specified microorganisms as identifi

46、ed 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 (3.3) and risk evaluation (3.4)SOURCE: ISO Guide 73:2009, 3.4.13.3risk

47、 analysisprocess to comprehend the nature of risk (3.1) and to determine the level of riskSOURCE: ISO Guide 73:2009, 3.6.1EN ISO 29621:2017 (E) 6 DIN EN ISO 29621:2017-07 3.4risk evaluationprocess of comparing the results of risk analysis (3.3) with risk criteria (3.5) to determine whether the risk

48、(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 evaluatedSOURCE: ISO Guide 73:2009, 3.3.1.3, modified3.6microbiologically low-risk productproduct whose environment denies microorg

49、anisms the physical and chemical requirements for growth and/or survivalNote 1 to entry: This category of low-risk products applies to microbiological contamination which 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