Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

This document gives general instructions for carrying out microbiological examinations of cosmetic
products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis
(e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these
instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible
products).

Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen Untersuchung (ISO 21148:2017)

Dieses Dokument gibt allgemeine Anleitungen für die Durchführung von mikrobiologischen Unter-suchungen kosmetischer Mittel, damit deren Qualität und Sicherheit in Übereinstimmung mit einer entsprechenden Risikoanalyse (z. B. geringe Wasseraktivität, hydroalkoholischer Anteil, extreme pH Werte) sichergestellt ist.
Wegen der großen Vielfalt an kosmetischen Mitteln und potentiellen Anwendungsmöglichkeiten innerhalb dieses Anwendungsbereichs sind diese Anleitungen möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte).

Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques (ISO 21148:2017)

ISO 21148:2017 donne des règles générales pour la réalisation d'examens microbiologiques sur des produits cosmétiques afin de garantir leur qualité et leur innocuité, conformément à une analyse de risque appropriée (par exemple faible activité de l'eau, produit hydro-alcoolique, valeurs de pH extrêmes).
En raison de la grande variété de produits entrant dans le champ d'application de la présente norme et de leurs usages potentiels, ces règles peuvent ne pas être adaptées en tout point à certains produits (par exemple produits non miscibles à l'eau).

Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO 21148:2017)

V tem dokumentu so podana splošna navodila za izvajanje mikrobioloških pregledov kozmetičnih izdelkov, da se zagotovi njihova kakovost in varnost v skladu z ustrezno analizo tveganja (npr. izdelkov z nizko aktivnostjo vode ali s skrajnimi vrednostmi pH, hidro-alkoholnih izdelkov).
Zaradi velike raznolikosti izdelkov in možnosti njihove uporabe na tem področju uporabe ta navodila morda niso v celoti primerna za nekatere izdelke (npr. tiste, ki se ne mešajo z vodo).

General Information

Status
Published
Public Enquiry End Date
07-Mar-2016
Publication Date
08-Oct-2017
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Sep-2017
Due Date
11-Nov-2017
Completion Date
09-Oct-2017

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SLOVENSKI STANDARD
SIST EN ISO 21148:2017
01-november-2017
1DGRPHãþD
SIST EN ISO 21148:2009
Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO
21148:2017)

Cosmetics - Microbiology - General instructions for microbiological examination (ISO

21148:2017)

Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen

Untersuchung (ISO 21148:2017)

Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques

(ISO 21148:2017)
Ta slovenski standard je istoveten z: EN ISO 21148:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
SIST EN ISO 21148:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21148:2017
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SIST EN ISO 21148:2017
EN ISO 21148
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 07.100.99; 71.100.70 Supersedes EN ISO 21148:2009
English Version
Cosmetics - Microbiology - General instructions for
microbiological examination (ISO 21148:2017)

Cosmétiques - Microbiologie - Instructions générales Kosmetische Mittel - Mikrobiologie - Allgemeine

pour les examens microbiologiques (ISO 21148:2017) Anleitungen zur mikrobiologischen Untersuchung (ISO

21148:2017)
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 21148:2017 E

worldwide for CEN national Members.
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SIST EN ISO 21148:2017
EN ISO 21148:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 21148:2017
EN ISO 21148:2017 (E)
European foreword

This document (EN ISO 21148:2017) 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 December 2017, and conflicting national standards

shall be withdrawn at the latest by December 2017.

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 21148:2009.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 21148:2017 has been approved by CEN as EN ISO 21148:2017 without any modification.

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SIST EN ISO 21148:2017
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SIST EN ISO 21148:2017
INTERNATIONAL ISO
STANDARD 21148
Second edition
2017-06
Cosmetics — Microbiology — General
instructions for microbiological
examination
Cosmétiques — Microbiologie — Instructions générales pour les
examens microbiologiques
Reference number
ISO 21148:2017(E)
ISO 2017
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SIST EN ISO 21148:2017
ISO 21148:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 21148:2017
ISO 21148:2017(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Premises ........................................................................................................................................................................................................................ 1

4.1 Test areas ..................................................................................................................................................................................................... 1

4.2 Additional areas ..................................................................................................................................................................................... 2

4.3 Location of the premises ................................................................................................................................................................ 2

4.4 Equipping the premises .................................................................................................................................................................. 2

4.5 Maintenance .............................................................................................................................................................................................. 3

5 Equipment ................................................................................................................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Microbiological cabinets ................................................................................................................................................................. 3

5.3 Balances ........................................................................................................................................................................................................ 3

5.4 Homogenizer ............................................................................................................................................................................................ 4

5.5 pH–meter ..................................................................................................................................................................................................... 4

5.6 Autoclave ...................................................................................................................................................................................................... 4

5.7 Incubator ...................................................................................................................................................................................................... 4

5.8 Water baths ................................................................................................................................................................................................ 4

5.9 Refrigerator or cold-storage room ......................................................................................................................................... 4

5.10 Freezer ........................................................................................................................................................................................................... 4

5.11 Sterilizing oven ....................................................................................................................................................................................... 5

5.12 Colony-counting device ................................................................................................................................................................... 5

5.13 Other equipment ................................................................................................................................................................................... 5

6 Strains of microorganisms ......................................................................................................................................................................... 5

7 Personnel ..................................................................................................................................................................................................................... 6

7.1 Competence ............................................................................................................................................................................................... 6

7.2 Hygiene .......................................................................................................................................................................................................... 6

8 Preparation of the apparatus and glassware .......................................................................................................................... 6

8.1 Preparation ................................................................................................................................................................................................ 6

8.2 Sterilization ................................................................................................................................................................................................ 6

8.2.1 Sterilization by dry heat ............................................................................................................................................ 6

8.2.2 Sterilization by moist heat ....................................................................................................................................... 7

8.3 Disposable apparatus ........................................................................................................................................................................ 7

8.4 Management of clean apparatus and glassware ........................................................................................................ 7

8.5 Management of sterile apparatus and glassware ...................................................................................................... 7

8.6 Treatment of contaminated material ................................................................................................................................... 7

8.7 Washing ......................................................................................................................................................................................................... 7

9 Preparation and sterilization of culture media and reagents ............................................................................... 8

9.1 General ........................................................................................................................................................................................................... 8

9.2 Water ............................................................................................................................................................................................................... 8

9.3 Preparation of culture media ...................................................................................................................................................... 8

9.3.1 General...................................................................................................................................................................................... 8

9.3.2 Rehydration .......................................................................................................................................................................... 8

9.3.3 Measurement of pH ....................................................................................................................................................... 8

9.3.4 Dispensing ............................................................................................................................................................................. 8

9.4 Sterilization ................................................................................................................................................................................................ 9

9.4.1 General...................................................................................................................................................................................... 9

9.4.2 Sterilization by moist heat ....................................................................................................................................... 9

9.4.3 Sterilization by filtration ........................................................................................................................................... 9

© ISO 2017 – All rights reserved iii
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SIST EN ISO 21148:2017
ISO 21148:2017(E)

9.5 Storage ........................................................................................................................................................................................................... 9

9.5.1 General...................................................................................................................................................................................... 9

9.5.2 Laboratory-prepared culture media and reagents ............................................................................. 9

9.5.3 Ready-to-use culture media and reagents ..............................................................................................10

9.6 Melting of agar culture media .................................................................................................................................................10

9.7 Preparation of Petri dishes ........................................................................................................................................................10

10 Laboratory samples ........................................................................................................................................................................................10

10.1 General ........................................................................................................................................................................................................10

10.2 Sampling the cosmetic product .............................................................................................................................................10

10.3 Transport ..................................................................................................................................................................................................10

10.4 Receipt and storage ..........................................................................................................................................................................11

10.5 Handling products and samples............................................................................................................................................11

10.6 Conservation and destruction of products ..................................................................................................................11

11 Operating practices ........................................................................................................................................................................................11

11.1 Hygienic precautions during the testing ........................................................................................................................11

11.2 Preparation of the initial suspension and of sample dilutions ...................................................................12

11.2.1 General...................................................................................................................................................................................12

11.2.2 Water-miscible product ..........................................................................................................................................12

11.2.3 Water-immiscible products .................................................................................................................................13

11.3 Counting methods .............................................................................................................................................................................13

11.4 Detection methods ............................................................................................................................................................................13

12 Expression of results .....................................................................................................................................................................................13

13 Neutralization of the antimicrobial properties of the product .........................................................................13

Annex A (informative) Basic identification techniques .................................................................................................................14

Annex B (informative) Basic techniques for counting and plating ....................................................................................19

Annex C (informative) Preparation and calibration of inoculums .....................................................................................20

Bibliography .............................................................................................................................................................................................................................21

iv © ISO 2017 – All rights reserved
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SIST EN ISO 21148:2017
ISO 21148:2017(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/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.

This second edition cancels and replaces the first edition (ISO 21148:2005), of which it constitutes a

minor revision.
It also incorporates the Technical Corrigendum ISO 21148:2005/Cor 1:2006.
The following changes have been made:

a) in the Introduction, “validated” was changed to “demonstrated to be suitable”;

b) in Clause 6, “validation of the methodology” was changed to “verification of the methods’

suitability”;
c) in 8.2.1, “validated” was changed to “demonstrated to be suitable”;
d) in Clause 13, “validated” was changed to “demonstrated”;
e) in A.5, “validated” was changed to “demonstrated to be suitable”;
f) in B.3, editorial changes were applied.
© ISO 2017 – All rights reserved v
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SIST EN ISO 21148:2017
ISO 21148:2017(E)
Introduction

The purpose of this document is to help ensure that the general techniques used for conducting cosmetic

microbiological examinations are the same in other laboratories that adopt these standards, to help

achieve homogeneous results in different laboratories and to contribute towards the protection of the

health of the laboratory personnel by preventing risk of infection.

When conducting microbiological examinations for cosmetic products, it is especially important that:

— only those microorganisms which are present in the samples be isolated or enumerated;

— the microorganisms do not contaminate the environment.

In order to achieve this, it is necessary to pay attention to personal hygiene and to use working

techniques which ensure, as far as possible, exclusion of extraneous contamination.

Since, in this document, it is possible to give only a few examples of the precautions to be taken during

microbiological examinations, a thorough knowledge of the microbiological techniques and of the

microorganisms involved is essential. It is important that the analyses be conducted as accurately as

possible, including calculation of the number of microorganisms.

A large number of manipulations can, for example, unintentionally lead to cross-contamination and the

analyst should always verify the accuracy of the results given by his/her technique. It is necessary to

take special precautions, not only for reasons of hygiene, but also to ensure good reproducibility of

the results. It is not possible to specify all the precautions to be taken in all circumstances, but this

document at least provides the main measures to be taken when preparing, sterilizing and storing the

media and the equipment.

The given recommendations will allow enumeration and detection of mesophilic microorganisms which

may grow under aerobic conditions.

The recommendations are applicable to the determination of the absence of, or limited occurrence of

specified microorganisms that are of interest for cosmetic products.

The test methods are described in the individual standards. Alternative microbiological procedures

can be used provided that their equivalence has been demonstrated or the method has been otherwise

demonstrated to be suitable. The choice of a specific method, or combination of methods mentioned in

these International Standards will depend on the purpose for performing the test and it is for the user

to decide which approach is best for his/her application.
vi © ISO 2017 – All rights reserved
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SIST EN ISO 21148:2017
INTERNATIONAL STANDARD ISO 21148:2017(E)
Cosmetics — Microbiology — General instructions for
microbiological examination
1 Scope

This document gives general instructions for carrying out microbiological examinations of cosmetic

products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis

(e.g. low water activity, hydro-alcoholic, extreme pH values).

Because of the large variety of products and potential uses within this field of application, these

instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible

products).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
product
portion of an identified cosmetic product received in the laboratory for testing
3.2
sample

portion of the product (3.1) (at least 1 g or 1 ml) that is used in the test to prepare the initial

suspension (3.3)
3.3
initial suspension

suspension (or solution) of the sample (3.2) in a defined volume of an appropriate enrichment broth

3.4
sample dilution
dilution of the initial suspension (3.3)
4 Premises
4.1 Test areas

The areas required for the specific operation of a microbiology laboratory are as follows:

— receipt, storage, preparation and processing of the samples;
— preparation and sterilization of culture media, apparatus and glassware;
© ISO 2017 – All rights reserved 1
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SIST EN ISO 21148:2017
ISO 21148:2017(E)

— performance of analyses: weighing, dilutions, inoculations, subculturing, incubation, maintenance

of the strain, etc.;

— decontamination and cleaning of apparatus, glassware and processing of the analysis waste.

4.2 Additional areas
The areas included in this category are, for example:
— entrances, corridors, stairways, lifts;
— administrative areas (e.g. secretarial, offices, documentation rooms, etc.);
— cloakrooms and toilets;
— archive rooms;
— stores.
4.3 Location of the premises

The environment within which the microbiological analyses are carried out shall not affect the

reliability of the analyses.

Care shall be taken to locate the premises so as to avoid risk of cross-contamination.

Care shall be taken to ensure protection against extreme conditions such as excess temperature, dust,

humidity, steam, noise, vibration, exposure to direct sunlight, etc.

The surface area shall be sufficiently large to keep the work areas clean and orderly.

During the course of the tests, care shall be taken to limit access to the test areas to only those persons

required to conduct the tests.
Separate rooms and/or separate areas and/or specific enclosur
...

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