SIST EN ISO 18416:2016

Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015)

ISO 18416:2015 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 to determine the types of cosmetic product 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 Candida albicans in a non-selective 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 may not be appropriate in every detail for some products (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.

Kosmetische Mittel - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2015)

Diese Internationale Norm gibt allgemeine Anleitungen für den Nachweis und die Identifizierung des festgelegten Mikroorganismus Candida albicans 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 Candida albicans in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon), gefolgt von einer Isolation auf einem selek¬tiven Agarmedium. In Abhängigkeit von der erforderlichen Nachweisgrenze können andere Verfahren an¬gemessen sein.
ANMERKUNG   Für den Nachweis von Candida albicans 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, vorausgesetzt, dass deren Gleichwertigkeit nach¬gewiesen oder sich das Verfahren anderweitig als geeignet erwiesen hat.

Cosmétiques - Microbiologie - Détection de Candida albicans (ISO 18416:2015)

ISO 18416:2015 donne des lignes directrices générales pour la détection et l'identification du microorganisme spécifié Candida albicans 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 préférable d'effectuer une analyse appropriée du risque microbiologique pour 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 repose d'abord sur la détection de Candida albicans 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 de Candida albicans, 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 appropriée 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 les essais présentés 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 kvasovke Candida albicans (ISO 18416:2015)

Ta mednarodni standard podaja splošne smernice za ugotavljanje prisotnosti in prepoznavanje mikroorganizma Candida albicans 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 velja ta mednarodni standard. Izdelki, za katere se meni, da predstavljajo nizko mikrobiološko tveganje (glej ISO 29621), vključujejo tiste z nizko aktivnostjo vode, hidro-alkoholne izdelke, skrajne vrednosti pH itd. Metoda, opisana v tem mednarodnem standardu, temelji na ugotavljanju prisotnosti Candida albicans 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 Candida albicans 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
• Public Enquiry End Date: 29-Sep-2015
• Publication Date: 01-Feb-2016
• ICS: 07.100.40 - Cosmetics microbiology
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Jan-2016
• Due Date: 14-Mar-2016
• Completion Date: 02-Feb-2016
• Mandate: M/426 - Standardisation mandate assigned to CEN concerning the microbiological analysis of cosmetic products
• Ref Project: EN ISO 18416:2015 - Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015, Corrected version 2016-12-15)

Relations

• Replaces: SIST EN ISO 18416:2009 - Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)
• Effective Date: 01-Mar-2016
• Amended By: SIST EN ISO 18416:2016/A1:2023 - Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1 (ISO 18416:2015/Amd 1:2022)
• Effective Date: 01-Apr-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 18416:2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti kvasovke Candida albicans
(ISO 18416:2015)
Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015)
Kosmetische Mittel - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2015)
Cosmétiques - Microbiologie - Détection de Candida albicans (ISO 18416:2015)
Ta slovenski standard je istoveten z: EN ISO 18416:2015
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18416
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 07.100.99; 71.100.70 Supersedes EN ISO 18416:2009
English Version
Cosmetics - Microbiology - Detection of Candida albicans
(ISO 18416:2015)
Cosmétiques - Microbiologie - Détection de Candida Kosmetische Mittel - Mikrobiologie - Nachweis von
albicans (ISO 18416:2015) Candida albicans (ISO 18416:2015)
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 18416:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18416:2015) 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 juin 2016, and conflicting national standards shall be
withdrawn at the latest by juin 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 18416:2009.
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 18416:2015 has been approved by CEN as EN ISO 18416:2015 without any modification.
INTERNATIONAL ISO
STANDARD 18416
Second edition
2015-12-01
Cosmetics — Microbiology —
Detection of Candida albicans
Cosmétiques — Microbiologie — Détection de Candida albicans
Reference number
ISO 18416:2015(E)
©
ISO 2015
ISO 18416:2015(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
the requester.
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ii © ISO 2015 – All rights reserved

ISO 18416:2015(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 yeast 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 suitability test (see Clause 11) . 3
5.3.3 Enrichment broth . 4
5.3.4 Selective agar medium for isolation of Candida albicans . 4
5.3.5 Corn meal agar with 1 % polysorbate 80 . 5
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
9.2.1 General. 6
9.2.2 Water-miscible products. 6
9.2.3 Water-immiscible products . 6
9.2.4 Filterable products . 6
9.3 Incubation of the inoculated enrichment broth . 7
9.4 Detection and identification of Candida albicans . 7
9.4.1 Isolation . 7
9.4.2 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 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 media .10
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and
rinsing liquids .14
Bibliography .15
ISO 18416:2015(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
described in the ISO
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