EN ISO 16212:2017
(Main)Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
ISO 16212:2017 gives general guidelines for enumeration of yeast and mould present in cosmetics by counting the colonies on selective agar medium after aerobic incubation.
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 products to which ISO 16212:2017 is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity or extreme pH values, hydro-alcoholic products, etc.
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 methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
Yeast enumerated can be identified using suitable identification tests, for example, tests described in the standards listed in the Bibliography. Mould enumerated can be identified by other appropriate methods, if necessary.
Kosmetische Mittel - Mikrobiologie - Zählung von Hefen und Schimmelpilzen (ISO 16212:2017)
Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures (ISO 16212:2017)
L'ISO 16212:2017 donne des lignes directrices générales pour le dénombrement des levures et des moisissures présentes dans les cosmétiques par dénombrement des colonies en milieu gélosé sélectif après une incubation aérobie.
Pour garantir la qualité du produit et la sécurité des consommateurs, il est conseillé d'effectuer une analyse de risque microbiologique appropriée, afin de déterminer les types de produits cosmétiques qui relèvent de l'ISO 16212:2017. Les produits considérés comme présentant un faible risque microbiologique (voir l'ISO 29621) comprennent ceux ayant une faible activité de l'eau ou des valeurs de pH extrêmes, les produits hydro-alcooliques, etc.
En raison de la grande variété de produits cosmétiques entrant dans ce domaine d'application, la présente méthode pourrait ne pas être applicable en tout point à certains produits (par exemple à certains produits non miscibles à l'eau). 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.
Les levures dénombrées peuvent être identifiées à l'aide d'essais d'identification appropriés, par exemple ceux décrits dans les normes indiquées dans la Bibliographie. Les moisissures dénombrées peuvent être identifiées en utilisant d'autres méthodes appropriées, si nécessaire.
Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni (ISO 16212:2017)
V tem dokumentu so podane splošne smernice za ugotavljanje števila kvasovk in plesni v kozmetičnih izdelkih s štetjem kolonij na selektivnem agarskem gojišču po aerobni inkubaciji.
Za zagotovitev 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 dokument. Izdelki, ki po ocenah predstavljajo nizko mikrobiološko tveganje (glej ISO 29621), vključujejo izdelke z nizko aktivnostjo vode ali s skrajnimi vrednostmi pH, hidro-alkoholne izdelke itd.
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). Druge metode (npr. avtomatizirane) lahko nadomestijo v tem dokumentu opisani preskusi, če je bila dokazana njihova enakovrednost ali je bila metoda kako drugače opredeljena kot primerna.
Naštete kvasovke je mogoče identificirati z ustreznimi identifikacijskimi preskusi, na primer s preskusi, opisanimi v standardih, navedenih v bibliografiji. Naštete plesni je mogoče identificirati z drugimi ustreznimi metodami, če je to potrebno.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 16212:2011
Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni (ISO
16212:2017)
Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
Kosmetische Mittel - Mikrobiologie - Zählung von Hefen und Schimmelpilzen (ISO
16212:2017)
Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures (ISO
16212:2017)
Ta slovenski standard je istoveten z: EN ISO 16212:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16212
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 16212:2011
English Version
Cosmetics - Microbiology - Enumeration of yeast and
mould (ISO 16212:2017)
Cosmétiques - Microbiologie - Dénombrement des Kosmetische Mittel - Mikrobiologie - Zählung von
levures et des moisissures (ISO 16212:2017) Hefen und Schimmelpilzen (ISO 16212:2017)
This European Standard was approved by CEN on 26 April 2017.
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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16212:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 16212:2017) 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 January 2018 and conflicting national standards shall
be withdrawn at the latest by January 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 16212:2011.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16212:2017 has been approved by CEN as EN ISO 16212:2017 without any modification.
INTERNATIONAL ISO
STANDARD 16212
Second edition
2017-06
Cosmetics — Microbiology —
Enumeration of yeast and mould
Cosmétiques — Microbiologie — Dénombrement des levures et des
moisissures
Reference number
ISO 16212:2017(E)
©
ISO 2017
ISO 16212:2017(E)
© ISO 2017, Published in Switzerland
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ISO 16212:2017(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 2
4.1 General . 2
4.2 Plate count . 2
4.3 Membrane filtration . 2
5 Diluents, neutralizers and culture media . 3
5.1 General . 3
5.2 Neutralizing diluents and diluents . 3
5.3 Diluent for yeast suspension (tryptone sodium chloride solution) . 4
5.4 Culture media . 4
6 Apparatus and glassware . 5
7 Strain 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 . 6
9.2.1 General. 6
9.2.2 Water-miscible products. 6
9.2.3 Water-immiscible products . 6
9.3 Counting methods . 6
9.3.1 Dilutions for counting methods . 6
9.3.2 Plate-count methods . 7
10 Counting of colonies (plate counts and membrane filtration methods) .7
11 Expression of results . 8
11.1 Method of calculation for plate count . 8
11.2 Interpretation . 9
12 Neutralization of the antifungicidal properties of the product .10
12.1 General .10
12.2 Preparation of inoculum .11
12.3 Suitability of counting methods .11
12.3.1 Principle .11
12.3.2 Suitability test of the pour-plate method .11
12.3.3 Suitability of the surface spread method .11
12.3.4 Suitability of the membrane filtration method .11
13 Test report .12
Annex A (informative) Other neutralizing diluents .13
Annex B (informative) Other diluents .15
Annex C (informative) Other culture media .16
Annex D (informative) Neutralizers of antifungicidal activity of preservatives and
rinsing liquids .18
Bibliography .19
ISO 16212:2017(E)
Foreword
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