Dansk standard DS/EN ISO 18416 1. udgave 2009-07-07 Kosmetik Mikrobiologi Påvisning af Candida albicans Cosmetics Microbiology Detection of Candida albicans
DS/EN ISO 18416 København DS projekt: M235504 ICS: 07.100.99; 71.100.70 Første del af denne publikations betegnelse er: DS/EN ISO, hvilket betyder, at det er en international standard, der har status både som europæisk og dansk standard. Denne publikations overensstemmelse er: IDT med: ISO 18416:2007. IDT med: EN ISO 18416:2009. DS-publikationen er på engelsk. DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard DS-information publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en teknisk rapport, eller europæisk præstandard DS-håndbog samling af standarder, eventuelt suppleret med informativt materiale DS-hæfte publikation med informativt materiale Til disse publikationstyper kan endvidere udgives tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis fuldtekstpublikation (publikationen er trykt i sin helhed) godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) elektronisk (publikationen leveres på et elektronisk medie) DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD IDT: Når publikationen er identisk med en given publikation. EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men præsentationen er ændret. NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en given standard, men udarbejdet på baggrund af denne. MOD: Når publikationen er modificeret i forhold til en given publikation.
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 18416 June 2009 ICS 07.100.99; 71.100.70 English Version Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007) Cosmétiques - Microbiologie - Détection de Candida albicans (ISO 18416:2007) This European Standard was approved by CEN on 23 May 2009. Kosmetik - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2007) 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 references concerning such national standards may be obtained on application to the CEN 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 member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18416:2009: E
EN ISO 18416:2009 (E) Contents Page Foreword...3 2
EN ISO 18416:2009 (E) Foreword The text of ISO 18416:2007 has been prepared by Technical Committee ISO/TC 217 Cosmetics of the International Organization for Standardization (ISO) and has been taken over as EN ISO 18416:2009 by Technical Committee CEN/SS H99 Products for household and leisure use - Undetermined the secretariat of which is held by CMC. 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 December 2009, and conflicting national standards shall be withdrawn at the latest by December 2009. 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. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18416:2007 has been approved by CEN as a EN ISO 18416:2009 without any modification. 3
INTERNATIONAL STANDARD ISO 18416 First edition 2007-07-15 Cosmetics Microbiology Detection of Candida albicans Cosmétiques Microbiologie Détection de Candida albicans Reference number ISO 18416:2007(E) ISO 2007
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ISO 18416:2007(E) Contents Page Foreword... iv Introduction... v 1 Scope... 1 2 Normative references... 1 3 Terms and definitions... 1 4 Principle... 2 5 Diluents and culture media... 2 5.1 General... 2 5.2 Diluent for the yeast suspension (tryptone sodium chloride solution)... 3 5.3 Culture media... 3 6 Apparatus and glassware... 5 7 Strains of microorganisms... 5 8 Handling of cosmetic products and laboratory samples... 6 9 Procedure... 6 9.1 General recommendation... 6 9.2 Preparation of the initial suspension in the enrichment broth... 6 9.3 Incubation of the inoculated enrichment broth... 7 9.4 Detection and identification of Candida albicans... 7 10 Expression of the results (detection of Candida albicans)... 8 11 Neutralization of the antimicrobial properties of the product... 8 11.1 General... 8 11.2 Preparation of inoculum... 8 11.3 Validation of the detection method... 9 12 Test report... 9 Annex A (informative) Other media... 11 Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids... 15 Bibliography... 16 ISO 2007 All rights reserved iii
ISO 18416:2007(E) Foreword ISO (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 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) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 identifying any or all such patent rights. ISO 18416 was prepared by Technical Committee ISO/TC 217, Cosmetics. iv ISO 2007 All rights reserved
ISO 18416:2007(E) Introduction Microbiological examinations of cosmetic products are carried out according to an appropriate microbiological risk analysis in order to ensure their quality and safety for consumers. Microbiological risk analysis depends on several parameters such as: potential alteration of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of user (adults, children, including under 3 years). For cosmetics and other topical products, the detection of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans may be relevant because they can cause skin or eye infections. The detection of other kinds of microorganism might be of interest since those microorganisms (including indicators of faecal contamination, e.g. Escherichia coli) suggest hygienic failure during the manufacturing process. ISO 2007 All rights reserved v
INTERNATIONAL STANDARD ISO 18416:2007(E) Cosmetics Microbiology Detection of Candida albicans 1 Scope This International Standard gives general guidelines for the detection and identification of the specified microorganism Candida albicans in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations. In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis so as to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, those with extreme ph values, etc. The method described in this International Standard is based on the detection of Candida albicans in a nonselective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required. NOTE For the detection of Candida albicans, subcultures can be performed on non-selective culture media followed by suitable identification steps (e.g. using identification kits). Because of the large variety of cosmetic products within this field of application, this method might not be suited in every detail to some products (e.g. certain water-immiscible products). Other International Standards (e.g. ISO 18415) might be appropriate. Other methods (e.g. automated) can be substituted for the test presented here provided that their equivalence has been demonstrated or the method has been otherwise validated. 2 Normative references 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 21148:2005, Cosmetics Microbiology General instructions for microbiological examination EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 product portion of an identified cosmetic product received in the laboratory for testing 3.2 sample portion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspension ISO 2007 All rights reserved 1