EN ISO 21150:2009
(Main)Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
ISO 21150:2006 gives general guidelines for the detection and identification of the specified microorganism Escherichia coli in cosmetic products. Microorganisms considered as specified in ISO 21150:2006 might differ from country to country according to national practices or regulations.
ISO 21150:2006 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.
Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water-immiscible products). Other International Standards may be more appropriate.
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, voraus¬gesetzt, 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
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
ISO 21150:2006(E)
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ii © ISO 2006 – All rights reserved
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 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
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.
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 2
...
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