EN ISO 21150:2015

Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)

ISO 21150:2015 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 (see ISO 29621) risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
The method described in this International Standard 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 (ISO 18415) 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 shown to be suitable.

Kosmetische Mittel - Mikrobiologie - Nachweis von Escherichia coli (ISO 21150:2015)

Diese Internationale Norm gibt allgemeine Anleitungen für den Nachweis und die Identifizierung des festgelegten Mikroorganismus Escherichia coli in kosmetischen Mitteln. Die in dieser Internationalen Norm festgelegten 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 anwendbar ist. Produkte, die ein geringes mikrobiologisches Risiko (siehe ISO 29621) darstellen, umfassen jene mit geringer Wasseraktivität, alkoholisch wässrige Produkte, Produkte mit extremen pH Werten usw.
Das in dieser Internationalen Norm beschriebene Verfahren basiert auf dem Nachweis von Escherichia coli in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon), 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 (ISO 18415) können geeignet sein. Ersatzweise können für die hier aufgeführten Untersuchungen andere Verfahren (z. B. automatisierte) zur Anwendung kommen, voraus¬gesetzt, dass deren Gleichwertigkeit nach¬gewiesen oder sich das Verfahren anderweitig als geeignet erwiesen hat.

Cosmétiques - Microbiologie - Détection d'Escherichia coli (ISO 21150:2015)

ISO 21150:2015 donne des lignes directrices générales pour la détection et l'identification du microorganisme spécifié Escherichia coli dans les produits cosmétiques. Les microorganismes considérés comme spécifiés dans la présente Norme internationale peuvent différer d'un pays à l'autre suivant les pratiques ou les réglementations nationales.
Pour garantir la qualité du produit et la sécurité des consommateurs, il est conseillé d'effectuer une analyse appropriée du risque microbiologique afin de déterminer les types de produits cosmétiques qui relèvent de la présente Norme internationale. Les produits considérés comme présentant un faible risque microbiologique (voir ISO 29621) comprennent ceux ayant une faible activité de l'eau, les produits hydroalcooliques, ceux ayant des valeurs de pH extrêmes, etc.
La méthode décrite dans la présente Norme internationale est basée sur la détection d'Escherichia coli dans un milieu liquide non sélectif (bouillon d'enrichissement), suivie d'un isolement sur un milieu gélosé sélectif. D'autres méthodes peuvent être appropriées en fonction du niveau de détection exigé.
NOTE          Pour la détection d'Escherichia coli, il est possible de réaliser des subcultures sur des milieux de culture non sélectifs, puis de procéder aux étapes appropriées d'identification (par exemple en utilisant des kits d'identification).
En raison de la grande variété de produits cosmétiques relevant de ce domaine d'application, il se peut que cette méthode ne soit pas adaptée en tous points à certains produits (par exemple aux produits non miscibles à l'eau). D'autres Normes internationales (ISO 18415) peuvent être appropriées. Il est possible de remplacer l'essai présenté ici par d'autres méthodes (par exemple des méthodes automatisées) sous réserve que leur équivalence ait été démontrée ou que la méthode ait été par ailleurs indiquée comme adéquate.

Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli (ISO 21150:2015)

Ta mednarodni standard podaja splošne smernice za ugotavljanje prisotnosti in prepoznavanje
mikroorganizma Escherichia coli v kozmetičnih izdelkih. Mikroorganizmi, ki so upoštevani, kot so določeni v tem mednarodnem standardu, se lahko v različnih državah zaradi državnih praks ali predpisov razlikujejo. Za namen zagotovitve kakovosti in varnosti izdelkov za stranke je priporočljivo izvesti ustrezno mikrobiološko analizo tveganja, s katero se določijo vrste kozmetičnih izdelkov,
za katere se uporablja ta mednarodni standard. Izdelki, za katere se meni, da predstavljajo nizko mikrobiološko (glejte ISO 29621) tveganje, vključujejo tiste z nizko aktivnostjo vode, hidro-alkoholne izdelke, skrajne vrednosti pH itd. Metoda, opisana v tem mednarodnem standardu, temelji na ugotavljanju prisotnosti Escherichia coli v neselektivnem tekočem gojišču (obogatitven bujon), ki mu sledi izolacija na selektivnem agarskem gojišču. Ustrezne so lahko tudi druge metode, odvisno od zahtevane ravni ugotavljanja prisotnosti. OPOMBA: Za namen ugotavljanja prisotnosti mikroorganizma Escherichia coli je mogoče precepljene kulture vzgojiti v neselektivnem gojišču kultur, čemur sledijo ustrezni koraki prepoznavanja (npr. uporaba kompletov za prepoznavanje).
Zaradi velike raznolikosti kozmetičnih izdelkov na tem področju uporabe ta metoda morda ni primerna za nekatere izdelke (npr. tiste, ki se ne mešajo z vodo). Uporabljajo se lahko drugi mednarodni standardi (ISO 18415). Druge metode (npr. avtomatske) je mogoče zamenjati za tukaj predstavljene preskuse, če je bila dokazana njihova enakovrednost ali je bila metoda drugače dokazana za primerno.

General Information

• Status: Published
• Publication Date: 15-Dec-2015
• Withdrawal Date: 29-Jun-2016
• ICS: 07.100.40 - Cosmetics microbiology
• ICS: 07.100.99 - Other standards related to microbiology
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392 - Cosmetics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Dec-2015
• Completion Date: 16-Dec-2015
• Mandate: M/426 - Standardisation mandate assigned to CEN concerning the microbiological analysis of cosmetic products
• Ref Project: SIST EN ISO 21150:2016 - Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)

Relations

• Replaces: EN ISO 21150:2009 - Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006)
• Effective Date: 28-Jan-2015
• Amended By: EN ISO 21150:2015/A1:2022 - Cosmetics - Microbiology - Detection of Escherichia coli - Amendment 1 (ISO 21150:2015/Amd 1:2022)
• Effective Date: 22-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 21150:2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli
(ISO 21150:2015)
Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)
Kosmetische Mittel - Mikrobiologie - Nachweis von Escherichia coli (ISO 21150:2015)
Cosmétiques - Microbiologie - Détection d'Escherichia coli (ISO 21150:2015)
Ta slovenski standard je istoveten z: EN ISO 21150:2015
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21150
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 07.100.99; 71.100.70 Supersedes EN ISO 21150:2009
English Version
Cosmetics - Microbiology - Detection of Escherichia coli
(ISO 21150:2015)
Cosmétiques - Microbiologie - Détection d'Escherichia Kosmetische Mittel - Mikrobiologie - Nachweis von
coli (ISO 21150:2015) Escherichia coli (ISO 21150:2015)
This European Standard was approved by CEN on 26 September 2015.

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-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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21150:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21150:2015) has been prepared by Technical Committee ISO/TC 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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 EN ISO 21150:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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 Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21150:2015 has been approved by CEN as EN ISO 21150:2015 without any modification.
INTERNATIONAL ISO
STANDARD 21150
Second edition
2015-12-01
Cosmetics — Microbiology —
Detection of Escherichia coli
Cosmétiques — Microbiologie — Détection d’Escherichia coli
Reference number
ISO 21150:2015(E)
©
ISO 2015
ISO 21150:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved

ISO 21150:2015(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
5.2.1 General. 3
5.2.2 Composition . 3
5.2.3 Preparation . 3
5.3 Culture media . 3
5.3.1 General. 3
5.3.2 Agar medium for the suitability test (see Clause 11) [soybean-casein
digest agar medium (SCDA) or tryptic soy agar (TSA)] . 3
5.3.3 Enrichment broth . 4
5.3.4 Selective agar medium for isolation of Escherichia coli . 4
5.3.5 Selective agar medium for confirmation of Escherichia coli . 5
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 recommendation . 6
9.2 Preparation of the initial suspension in the enrichment broth . 6
9.2.1 General. 6
9.2.2 Water-miscible products. 7
9.2.3 Water-immiscible products . 7
9.2.4 Filterable products . 7
9.3 Incubation of the inoculated enrichment broth . 7
9.4 Detection and identification of Escherichia coli . 7
9.4.1 Isolation . 7
9.4.2 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 . 8
11.3 Suitability of the detection method . 8
11.3.1 Procedure . 8
11.3.2 Interpretation of suitability test results . 9
12 Test report . 9
Annex A (informative) Other enrichment broths .10
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and
rinsing liquids .13
Bibliography .14
ISO 21150:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
...