EN ISO 18415:2011

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2007)

ISO 18415:2007 gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.
Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans.
The method described in ISO 18415:2007 is based on the detection of microbial growth in a non-selective liquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation of microorganisms on non-selective agar media. Other methods can be appropriate depending on the level of detection required.
In ISO 18415:2007 specific indications are given for identification of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under the conditions described in this International Standard, may be identified by using suitable tests according to a general scheme.

Kosmetik - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO 18415:2007)

Diese Internationale Norm gibt allgemeine Anleitungen sowohl für den Nachweis und die Identifizierung von spezifizierten Mikroorganismen in kosmetischen Mitteln als auch für den Nachweis und die Identifizierung von anderen Arten nichtspezifizierter aerober mesophiler Mikroorganismen in kosmetischen Mitteln.
Die in dieser Internationalen Norm als spezifiziert angesehenen Mikroorganismen können in Übereinstimmung mit nationalen Praktiken oder Regelungen von Land zu Land unterschiedlich sein. Die meisten der als spezifiziert angesehenen Mikroorganismen schließen die folgenden Arten ein: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus und Candida albicans.
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, auf die diese Internationale Norm anwendbar ist. Produkte, die ein geringes mikrobiologisches Risiko darstellen, umfassen Produkte mit geringer Wasseraktivität, alkoholisch-wässrige Produkte, Produkte mit extremen pH Werten usw.
Das in dieser Internationalen Norm beschriebene Verfahren basiert auf dem Nachweis von mikrobiellem Wachstum in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon), geeignet für den Nachweis einer mikrobiellen Kontamination, gefolgt von einer Isolierung der Mikroorganismen auf einem nicht selektiven Agarmedium. In Abhängigkeit von der erforderlichen Nachweisgrenze können andere Verfahren geeignet sein.
In der vorliegenden Internationalen Norm sind spezielle Hinweise zur Identifizierung von Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus und Candida albicans angeführt. Andere Mikro-organismen, die unter den in dieser Internationalen Norm beschriebenen Bedingungen wachsen, können unter Anwendung geeigneter Untersuchungen nach einem allgemeinen Schema identifiziert werden (siehe Anhang A). Weitere Normen (z. B. ISO 18416, ISO 21150, ISO 22717, ISO 22718) können angebracht sein.
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). Ersatzweise können für die hier aufgeführten Untersuchungen andere Verfahren (z. B. automatisierte) zur Anwendung kommen, vorausgesetzt, dass deren Gleichwertigkeit nachgewiesen oder das Verfahren anderweitig validiert wurde.

Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés (ISO 18415:2007)

L'ISO 18415:2007 donne des lignes directrices générales pour la détection et l'identification de microorganismes spécifiés dans les produits cosmétiques, et aussi pour la détection et l'identification d'autres sortes de microorganismes mésophiles aérobies non spécifiés, 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 réglementations nationales. La plupart des microorganismes considérés comme spécifiés comprennent une ou plusieurs espèces, parmi les suivantes: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus et Candida albicans.
La méthode décrite dans l'ISO 18415:2007 est fondée sur la détection d'une croissance microbienne dans un milieu liquide non sélectif (milieu liquide d'enrichissement) qui permet de détecter une contamination microbienne, suivie d'un isolement des microorganismes sur un milieu gélosé non sélectif. D'autres méthodes peuvent être appropriées, en fonction du niveau de détection requis.
Dans l'ISO 18415:2007, des indications spécifiques sont données pour l'identification de Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus et Candida albicans. D'autres microorganismes qui se développent dans les conditions décrites dans la présente Norme internationale, peuvent être identifiés en mettant en oeuvre des essais appropriés conformes à un schéma général.

Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti specifičnih in nespecifičnih mikroorganizmov (ISO 18415:2007)

Ta mednarodni standard podaja splošne smernice za ugotavljanje prisotnosti in identifikacijo specifičnih mikroorganizmov v kozmetičnih izdelkih ter za ugotavljanje prisotnosti in identifikacijo drugih vrst mezofilnih nespecifičnih mikroorganizmov v kozmetičnih izdelkih. Mikroorganizmi, ki v tem mednarodnem standardu veljajo za specifične, se lahko razlikujejo od države do države v skladu z nacionalnimi praksami ali predpisi. Večina od mikroorganizmov, ki veljajo za specifične, vključujejo eno ali več naslednjih vrst: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus in Candida albicans. Za zagotavljanje kakovosti izdelka in varnosti za potrošnike je priporočljivo opraviti ustrezno analizo mikrobiološkega tveganja, da se določijo vrste kozmetičnih izdelkov, za katere velja ta mednarodni standard. Izdelki, pri katerih je nizko mikrobiološko tveganje, so izdelki z nizko aktivnostjo vode, hidroalkoholni izdelki, izdelki z ekstremnimi vrednostmi pH itd. Metoda, opisana v tem mednarodnem standardu, temelji na ugotavljanju prisotnosti mikrobne rasti v neselektivnem tekočem gojišču (obogatitveno gojišče), primernem za ugotavljanje mikrobne kontaminacije, temu pa sledi izolacija mikroorganizmov na neselektivnem agarskem gojišču. Lahko so primerne tudi druge metode, odvisno od zahtevane ravni detekcije. V tem mednarodnem standardu so posebej navedena navodila za identifikacijo vrst Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus in Candida albicans. Drugi mikroorganizmi, ki rastejo v pogojih, opisanih v tem mednarodnem standardu, se lahko identificirajo z uporabo ustreznih preskusov v skladu s splošno shemo (glej dodatek A). Ustrezajo lahko drugi standardi (npr. ISO 18416, ISO 21150, ISO 22717, ISO 22718). Zaradi velike raznolikosti kozmetičnih izdelkov v tem okviru uporabe ta metoda za nekatere izdelke morda ni primerna v vsaki podrobnosti (npr. za nekatere izdelke, ki se ne mešajo z vodo). Preskus, ki je tu predstavljen, lahko nadomestijo druge metode (npr. avtomatske), če je bila dokazana njihova enakovrednost ali da je bila metoda kako drugače validirana.

General Information

• Status: Withdrawn
• Publication Date: 07-Jun-2011
• Withdrawal Date: 20-Jun-2017
• ICS: 07.100.01 - Microbiology in general
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 21-Jun-2017
• Ref Project: SIST EN ISO 18415:2011 - Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2007)

Relations

• Replaced By: EN ISO 18415:2017 - Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)
• Effective Date: 28-Jun-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
.R]PHWLND0LNURELRORJLMD8JRWDYOMDQMHSULVRWQRVWLVSHFLILþQLKLQQHVSHFLILþQLK
PLNURRUJDQL]PRY,62
Cosmetics - Microbiology - Detection of specified and non-specified microorganisms
(ISO 18415:2007)
Kosmetik - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten
Mikroorganismen (ISO 18415:2007)
Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés
(ISO 18415:2007)
Ta slovenski standard je istoveten z: EN ISO 18415:2011
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 18415
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Detection of specified and non-
specified microorganisms (ISO 18415:2007)
Cosmétiques - Microbiologie - Détection des micro- Kosmetik - Mikrobiologie - Nachweis von spezifizierten und
organismes spécifiés et non spécifiés (ISO 18415:2007) nichtspezifizierten Mikroorganismen (ISO 18415:2007)
This European Standard was approved by CEN on 12 May 2011.

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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18415:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 18415:2007 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 18415:2011 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by NEN.
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 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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, Croatia, 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 18415:2007 has been approved by CEN as a EN ISO 18415:2011 without any modification.

INTERNATIONAL ISO
STANDARD 18415
First edition
2007-09-01
Corrected version
2007-12-01
Cosmetics — Microbiology — Detection
of specified and non-specified
microorganisms
Cosmétiques — Microbiologie — Détection des micro-organismes
spécifiés et non spécifiés
Reference number
ISO 18415:2007(E)
©
ISO 2007
ISO 18415:2007(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 2007
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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved

ISO 18415:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Principle. 3
5 Diluents and culture media. 3
5.1 General. 3
5.2 Diluent for the microbial suspension (tryptone sodium chloride solution) . 3
5.3 Culture media . 4
6 Apparatus and glassware . 5
7 Strains of microorganism . 5
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 initial suspension . 7
9.4 Isolation of specified and non-specified microorganisms. 7
9.5 Procedure for identification of the specified microorganism: Pseudomonas aeruginosa. 7
9.6 Procedure for identification of the specified microorganism: Escherichia coli . 8
9.7 Procedure for identification of the specified microorganism: Staphylococus aureus . 8
9.8 Procedure for the identification of the specified microorganism: Candida albicans. 9
9.9 Procedure for the identification of non-specified microorganisms . 9
10 Expression of the results. 10
10.1 Detection of specified microorganisms .10
10.2 Detection of non-specified microorganisms . 10
10.3 Absence of microorganisms . 10
11 Neutralization of the antimicrobial properties of the product. 10
11.1 General. 10
11.2 Preparation of inoculum . 10
11.3 Validation of detection method by enrichment . 11
12 Test report . 12
Annex A (informative) General scheme for identification of microorganisms . 13
Annex B (informative) Other Media . 14
Annex C (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 17
Bibliography . 18

ISO 18415:2007(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 18415 was prepared by Technical Committee ISO/TC 217, Cosmetics.
This corrected version of ISO 18415:2007 contains the following corrections:
⎯ p. 2, 3.6.1: modification of definition;
⎯ p. 3, 3.8: correction of term's number;
⎯ p.8, 9.7.1: correction of text in the second paragraph.
iv © ISO 2007 – All rights reserved

ISO 18415:2007(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 skin pathogens such as Staphylococcus aureus,
Pseudomonas aeruginosa and Candida albicans may be relevant because they can cause skin or eye
infection. 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 18415:2007(E)

Cosmetics — Microbiology — Detection of specified and non-
specified microorganisms
1 Scope
This International Standard gives general guidelines for the
...