SIST EN ISO 21150:2009
(Main)Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
This International Standard gives general guidelines for the detection and identification of the specified microorganism Escherichia coli 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 products to which this International Standard is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc. This International Standard specifies a method that is based on the detection of Escherichia coli in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate depending on the level of detection required.
Kosmetik - Mikrobiologie - Nachweis von Escherichia coli (ISO 21150:2006)
Diese Internationale Norm gibt allgemeine Anleitungen für den Nachweis und die Identifizierung des vorgege-benen Mikroorganismus Escherichia coli in kosmetischen Mitteln. Die in dieser Internationalen Norm vorgege¬benen Mikroorganismen können in Übereinstimmung mit nationalen Praktiken oder Regelungen von Land zu Land unterschiedlich sein.
Um die Qualität des Produkts und die Sicherheit für Verbraucher sicherzustellen, ist es ratsam, eine geeignete mikrobiologische Risikoanalyse zur Bestimmung der Arten von kosmetischen Mitteln durchzuführen, für die diese Internationale Norm gültig ist. Produkte, die ein geringes mikrobiologisches Risiko darstellen, umfassen Produkte mit geringer Wasseraktivität, alkoholisch wässrige Produkte, Produkte mit extremen pH Werten usw.
In dieser Internationalen Norm wird ein Verfahren festgelegt, das auf dem Nachweis von Escherichia coli in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon) basiert, gefolgt von einer Isolation auf einem selektiven Agarmedium. In Abhängigkeit von der erforderlichen Nachweisgrenze können andere Verfahren angemessen sein.
ANMERKUNG Für den Nachweis von Escherichia coli kann eine Subkultivierung auf nicht selektiven Nährmedien erfolgen, gefolgt von geeigneten Schritten zur Identifizierung (z. B. unter Anwendung von Identifizierungskits).
Wegen der großen Vielfalt an kosmetischen Mitteln innerhalb dieses Anwendungsbereichs ist dieses Verfahren möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte). Andere Internationale Normen können zutreffen. Ersatzweise können für die hier aufgeführten Untersuchungen andere Verfahren (z. B. automatisierte) zur Anwendung kommen, vorausgesetzt, dass deren Gleichwertigkeit nach¬gewiesen oder das Verfahren anderweitig validiert wurde.
Cosmétiques - Microbiologie - Détection d'Escherichia coli (ISO 21150:2006)
L'ISO 21150:2006 donne des lignes directrices générales pour la détection et l'identification du micro-organisme spécifié Escherichia coli dans les produits cosmétiques. Les micro-organismes considérés comme spécifiés dans l'ISO 21150:2006 peuvent différer d'un pays à un autre, suivant les pratiques ou réglementations nationales.
L'ISO 21150:2006 spécifie une méthode basée sur la détection d'Escherichia coli dans un milieu liquide non sélectif (milieu liquide d'enrichissement), suivie de l'isolement du micro-organisme sur un milieu gélosé sélectif. D'autres méthodes peuvent être appropriées en fonction du niveau de détection requis.
En raison de la grande variété de produits cosmétiques entrant dans ce domaine d'application, la présente méthode peut ne pas être, en tout point, adaptée à certains produits (par exemple à certains produits non miscibles dans l'eau). D'autres Normes internationales (par exemple l'ISO 18415) peuvent être plus adaptées.
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli (ISO 21150:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21150:2009
01-oktober-2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli
(ISO 21150:2006)
Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
Kosmetik - Mikrobiologie - Nachweis von Escherichia coli (ISO 21150:2006)
Cosmétiques - Microbiologie - Détection d'Escherichia coli (ISO 21150:2006)
Ta slovenski standard je istoveten z: EN ISO 21150:2009
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 21150:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 21150:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 21150:2009
EUROPEAN STANDARD
EN ISO 21150
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Detection of Escherichia coli (ISO
21150:2006)
Cosmétiques - Microbiologie - Détection d'Escherichia coli Kosmetik - Mikrobiologie - Nachweis von Escherichia coli
(ISO 21150:2006) (ISO 21150:2006)
This European Standard was approved by CEN on 30 May 2009.
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 Ref. No. EN ISO 21150:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 21150:2009
EN ISO 21150:2009 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 21150:2009
EN ISO 21150:2009 (E)
Foreword
The text of ISO 21150:2006 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 21150:2009.
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 21150:2006 has been approved by CEN as a EN ISO 21150:2009 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 21150:2009
---------------------- Page: 6 ----------------------
SIST EN ISO 21150:2009
INTERNATIONAL ISO
STANDARD 21150
First edition
2006-04-15
Cosmetics — Microbiology — Detection
of Escherichia coli
Cosmétiques — Microbiologie — Détection d'Escherichia coli
Reference number
ISO 21150:2006(E)
©
ISO 2006
---------------------- Page: 7 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(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 bacterial suspension (tryptone sodium chloride solution). 3
5.3 Culture media . 3
6 Apparatus and glassware. 6
7 Strains of microorganisms . 6
8 Handling of cosmetic products and laboratory samples . 6
9 Procedure. 6
9.1 General recommendations. 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 Escherichia coli. 7
10 Expression of the results (detection of Escherichia coli) . 8
11 Neutralization of the antimicrobial properties of the product. 8
11.1 General. 8
11.2 Preparation of inoculum. 9
11.3 Validation of the detection method. 9
12 Test report. 10
Annex A (informative) Other enrichment broths. 11
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 14
Bibliography . 15
© ISO 2006 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(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 21150 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(E)
Introduction
Microbiological examinations of cosmetic products are to be 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, etc.);
⎯ type of users (adults, children under 3 years, etc.).
For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus,
Pseudomonas aeruginosa and Candida albicans may be relevant. The detection of other kinds of
microorganisms might be of interest since these microorganisms (including indicators of faecal contamination,
e.g. Escherichia coli) suggest hygienic failure during manufacturing process.
© ISO 2006 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 21150:2009
---------------------- Page: 12 ----------------------
SIST EN ISO 21150:2009
INTERNATIONAL STANDARD ISO 21150:2006(E)
Cosmetics — Microbiology — Detection of Escherichia coli
1 Scope
This International Standard gives general guidelines for the detection and identification of the specified
microorganism Escherichia coli 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 products to which this International
Standard is applicable. Products considered to present a low microbiological risk include those with low water
activity, hydro-alcoholic products, extreme pH values, etc.
This International Standard specifies a method that is based on the detection of Escherichia coli in a
non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other
methods may be appropriate depending on the level of detection required.
NOTE For the detection of Escherichia coli, 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 to some products in every detail (e.g. certain water-immiscible products). Other International Standards
may 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.
1)
ISO 21148:— , Cosmetics — Microbiology — General instructions for microbiological examination
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) which is used in the test to prepare the initial suspension
1)
To be published.
© ISO 2006 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(E)
3.3
initial suspension
suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth
3.4
sample dilution
dilution of the initial suspension
3.5
specified microorganism
aerobic mesophilic bacteria or yeast which is undesirable in a cosmetic product because it can cause skin or
eye infection, or it can be recognized as an indicator of hygienic failure in the manufacturing process
3.6
Escherichia coli
Gram-negative rod, motile, smooth colonies
NOTE 1 The main characteristics for identification are catalase positive, oxidase negative, fermentation of lactose,
production of indole, growth on selective medium containing bile salts with characteristic colonies.
NOTE 2 Escherichia coli can be isolated from the moist environmental sources (air, water, soil) and is a faecal
contamination indicator.
3.7
enrichment broth
non-selective liquid medium containing suitable neutralizers and/or dispersing agents and validated for the
product under test
4 Principle
The first step of the procedure is to perform an enrichment by using a non-selective broth medium to increase
the number of microorganisms without the risk of inhibition by the selective ingredients that are present in
selective/differential growth media.
The second step (isolation) of the test is performed on a selective medium followed by identification tests.
The possible inhibition of microbial growth by the sample shall be neutralized to allow the detection of viable
[5]
microorganisms . In all cases and whatever the methodology, the neutralization of the antimicrobial
[6] [7] [8]
properties of the product shall be checked and validated .
5 Diluents and culture media
5.1 General
Use the general instructions given in ISO 21148. When water is mentioned in this document, use distilled
water or purified water as specified in ISO 21148.
The enrichment broth is used to disperse the sample and to increase the initial microbial population. It may
contain neutralizers if the specimen to be tested has antimicrobial properties. The efficacy of the neutralization
shall be demonstrated (see Clause 11). Information relative to suitable neutralizers is given in Annex B.
The following enrichment broth is suitable for checking the presence of Escherichia coli according to this
International Standard provided that it is validated according to Clause 11.
Other diluents and culture media may be used if they have been demonstrated to be suitable for use.
2 © ISO 2006 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(E)
5.2 Diluent for the bacterial suspension (tryptone sodium chloride solution)
The diluent is used for the preparation of bacterial suspension used for the validation procedure (see
Clause 11).
5.2.1 Composition
Tryptone, pancreatic digest of casein 1,0 g
Sodium chloride 8,5 g
Water 1 000 ml
5.2.2 Preparation
Dissolve the components in water by mixing while heating. Dispense into suitable containers. Sterilize in the
autoclave at 121 °C for 15 min.
After sterilization and cooling down, the pH shall be equivalent to 7,0 ± 0,2 when measured at room
temperature.
5.3 Culture media
5.3.1 General
Culture media may be prepared using the descriptions provided below or from dehydrated culture media,
according to the instructions from the manufacturer. The instructions provided by the supplier of the media
should be followed.
NOTE Ready-to-use media may be used when their composition and/or growth yields are comparable to those of the
formulas given herein.
5.3.2 Agar medium for validation [soybean-casein digest agar medium (SCDA) or tryptic soy agar
(TSA)]
5.3.2.1 Composition
Pancreatic digest of casein 15,0 g
Papaic digest of soybean meal 5,0 g
Sodium chloride 5,0 g
Agar 15,0 g
Water 1 000 ml
5.3.2.2 Preparation
Dissolve the components or the dehydrated complete medium in the water by mixing while heating. Dispense
the medium into suitable containers. Sterilize in the autoclave at 121 °C for 15 min.
After sterilization and cooling down, the pH shall be equivalent to 7,3 ± 0,2 when measured at room
temperature.
© ISO 2006 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 21150:2009
ISO 21150:2006(E)
5.3.3 Enrichment broth
5.3.3.1 Eugon LT 100 broth
5.3.3.1.1 General
This medium contains ingredients
⎯ which neutralize inhibitory substances present in the sample: lecithin and polysorbate 80,
⎯ dispersing agent: octoxynol 9.
5.3.3.1.2 Composition
Pancreatic digest of casein 15,0 g
Papaic digest of soybean meal 5,0 g
L-cystine 0,7 g
Sodium chloride 4,0 g
Sodium sulfite 0,2 g
Glucose 5,5 g
Egg lecithin 1,0 g
Polysorbate 80 5,0 g
Octoxynol 9 1,0 g
Water 1 000 ml
5.3.3.1.3 Preparation
Dissolve the components, polysorbate 80, octoxynol 9 and egg lecithin, successively into boiling water until
their complete dissolution. Dissolve the other components by mixing while
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.