EN ISO 11930:2012
(Main)Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012, Corrected version 2013-05-01)
Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012, Corrected version 2013-05-01)
ISO 11930:2012 comprises a preservation efficacy test and a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk.
ISO 11930:2012 provides a procedure for interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both.
Kosmetische Mittel - Mikrobiologie - Bewertung des antimikrobiellen Schutzes eines kosmetischen Produktes (ISO 11930:2012, korrigierte Fassung 2013-05-01)
1.1 Allgemeines
Diese Norm umfasst:
die Prüfung der Wirksamkeit der Konservierung;
das Verfahren für die Bewertung des allgemeinen antimikrobiellen Schutzes eines kosmetischen Produktes, das aufgrund einer Risikobewertung nach ISO 29621 nicht als risikoarm gilt.
Diese Internationale Norm liefert ein Verfahren zur Interpretation der Daten, die durch die Prüfung der Wirksamkeit der Konservierung oder der mikrobiologischen Risikobewertung, oder beidem, ermittelt wurden.
1.2 Prüfung der Wirksamkeit der Konservierung
Diese Prüfung ist ein Referenzverfahren, das zur Beurteilung der Konservierung von kosmetischen Rezepturen angewendet werden kann. Es gilt für kosmetische Produkte auf dem Markt.
Diese Prüfung ist für die kosmetischen Produkte nicht erforderlich, bei denen das mikrobiologische Risiko als niedrig bestimmt wurde (siehe Anhang A und ISO 29621).
Diese Prüfung ist vor allem für wasserlösliche oder wassermischbare kosmetische Mittel bestimmt, und kann eine Anpassung erfordern, z. B. bei Prüfprodukten, in denen sich Wasser in der internen Phase befindet. Die in dieser Norm beschriebene Prüfung beinhaltet bei jedem Prüfmikroorganismus das Inkontaktbringen der Rezeptur mit einem kalibrierten Inoculum, und die Messung der Veränderungen in der Mikroorganismenzahl bei festgelegten Zeitintervallen für eine festgelegte Zeitdauer und bei einer festgelegten Temperatur.
ANMERKUNG Diese Prüfung kann als Leitfaden für die Entwicklung einer hausinternen Methode für den Entwicklungsprozess eines kosmetischen Mittels angewendet werden. In diesem Fall kann die Prüfung modifiziert oder erweitert werden, oder beides, z. B. zur Berücksichtigung von vorherigen Daten und verschiedenen Variablen (mikrobielle Stämme, Medien, Einwirkungszeit der Bebrütungsbedingungen usw.). Die Übereinstimmungskriterien können den spezifischen Zielvorgaben angepasst werden. In der Entwicklungsphase von kosmetischen Produkten können gegebenenfalls andere Verfahren zur Bestimmung der Wirksamkeit der Konservierungsrezepturen angewendet werden.
1.3 Verfahren für die Bewertung des antimikrobiellen Schutzes eines kosmetischen Produktes
Dieses Verfahren basiert auf der sorgfältigen Berücksichtigung folgender Punkte:
- Ergebnisse der Prüfung der Wirksamkeit der Konservierung. Nicht alle kosmetischen Produkte werden eine Prüfung der Wirksamkeit der Konservierung erfordern (siehe Anhang A und ISO 29621).
- Rezeptureigenschaften und Daten, die sich aus der mikrobiologischen Risikobewertung (siehe ISO 29621) ergeben. Die Analyse der mikrobiologischen Risikobewertung erfolgt auf der Grundlage einer allgemeinen Herangehensweise. Die Analyse fasst Variablen zusammen, z. B. die Eigenschaften und die Zusammensetzung der Rezeptur, deren Herstellungsbedingungen, die Eigenschaften der Verpackung, in der die Rezeptur auf den Markt gebracht wird, Empfehlungen für die Anwendung des kosmetischen Produktes, und falls von Bedeutung, den Anwendungsbereich und die Verbraucher¬zielgruppe (siehe Anhang D).
Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit cosmétique (ISO 11930:2012, Version corrigé 2013-05-01)
L'ISO 11930:2012 comprend un essai d'efficacité de la protection antimicrobienne et une procédure permettant d'évaluer la protection antimicrobienne globale d'un produit cosmétique qui n'est pas identifié comme étant à faible risque microbiologique.
L'ISO 11930:2012 fournit une procédure pour l'interprétation des données résultant de l'essai d'efficacité de la protection antimicrobienne ou de l'évaluation du risque microbiologique, ou des deux.
Kozmetika - Mikrobiologija - Vrednotenje protimikrobne zaščite kozmetičnih izdelkov (ISO 11930:2012)
Ta mednarodni standard vključuje naslednje: – preizkus ohranjanja učinkovitosti; – postopek za ocenjevanje celotne antimikrobske zaščite kozmetičnega izdelka, ki ne velja za izdelek z nizkim tveganjem, na podlagi ocene tveganja, navedene v standardu ISO 29621. Ta mednarodni standard zagotavlja postopek za interpretacijo podatkov, pridobljenih s preizkusom ohranjanja učinkovitosti ali z oceno mikrobiološkega tveganja ali obojega.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2012
.R]PHWLND0LNURELRORJLMD9UHGQRWHQMHSURWLPLNUREQH]DãþLWHNR]PHWLþQLK
L]GHONRY ,62
Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic
product (ISO 11930:2012)
Kosmetische Mittel - Mikrobiologie - Bewertung des mikrobiellen Schutzes eines
kosmetischen Produktes (ISO 11930:2012)
Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit
cosmétique (ISO 11930:2012)
Ta slovenski standard je istoveten z: EN ISO 11930:2012
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11930
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Evaluation of the antimicrobial
protection of a cosmetic product (ISO 11930:2012)
Cosmétiques - Microbiologie - Évaluation de la protection Kosmetische Mittel - Mikrobiologie - Bewertung des
antimicrobienne d'un produit cosmétique (ISO 11930:2012) mikrobiellen Schutzes eines kosmetischen Produktes (ISO
11930:2012)
This European Standard was approved by CEN on 31 March 2012.
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, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11930:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11930:2012) 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 October 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
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, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11930:2012 has been approved by CEN as a EN ISO 11930:2012 without any modification.
INTERNATIONAL ISO
STANDARD 11930
First edition
2012-04-01
Cosmetics — Microbiology — Evaluation
of the antimicrobial protection of a
cosmetic product
Cosmétiques — Microbiologie — Évaluation de la protection
antimicrobienne d’un produit cosmétique
Reference number
ISO 11930:2012(E)
©
ISO 2012
ISO 11930:2012(E)
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 copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11930:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
1.1 General . 1
1.2 Preservation efficacy test . 1
1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Principle . 2
5 Preservation efficacy test . 3
5.1 General . 3
5.2 Materials, apparatus, reagents and culture media . 3
5.3 Microbial strains . 6
5.4 Preparation and enumeration of inocula . 7
5.5 Demonstration of the neutralizer efficacy . 8
5.6 Determination of the preservation efficacy of the formulation .10
5.7 Interpretation of test results and conclusions .12
5.8 Test report .13
6 Overall evaluation of the antimicrobial protection of the cosmetic product .14
6.1 General .14
6.2 Case 1 — The preservation efficacy test has been performed on the formulation .14
6.3 Case 2 — The preservation efficacy test has not been performed on the formulation .14
Annex A (normative) Decision diagram .16
Annex B (normative) Evaluation criteria for the preservation efficacy test (see 5.7) .17
Annex C (informative) Examples of neutralizers for the antimicrobial activity of preservatives and
washing liquids .18
Annex D (informative) Packaging characteristics.19
Bibliography .20
ISO 11930:2012(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 11930 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2012 – All rights reserved
ISO 11930:2012(E)
Introduction
This International Standard is to be used in the overall evaluation of the antimicrobial protection of a
cosmetic product.
The antimicrobial protection of a product can come from many sources:
— chemical preservation;
— inherent characteristics of the formulation;
— package design;
— manufacturing process.
This International Standard defines a series of steps to be taken when assessing the overall antimicrobial
protection of a cosmetic product. A reference method for a preservation efficacy test (challenge test) along with
evaluation criteria is also described in this International Standard.
The data generated by the risk assessment (see ISO 29621) or by the preservation efficacy test, or both, are
to be used to establish the level of antimicrobial protection required to minimize user risk.
INTERNATIONAL STANDARD ISO 11930:2012(E)
Cosmetics — Microbiology — Evaluation of the antimicrobial
protection of a cosmetic product
1 Scope
1.1 General
This International Standard comprises:
— a preservation efficacy test;
— a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered
low risk, based on a risk assessment described in ISO 29621.
This International Standard provides a procedure for the interpretation of data generated by the preservation
efficacy test or by the microbiological risk assessment, or both.
1.2 Preservation efficacy test
This test is a reference method that is to be used to evaluate the preservation of a cosmetic formulation. It
applies to cosmetic products in the market place.
This test is not required for those cosmetic products for which the microbiological risk has been determined to
be low (see Annex A and ISO 29621).
This test is primarily designed for water-soluble or water-miscible cosmetic products and can require adaptation,
for example to test products in which water is the internal phase. The test described in this International Standard
involves, for each test micro-organism, placing the formulation in contact with a calibrated inoculum, and then
measuring the changes in the micro-organism count at set time intervals for a set period and at a set temperature.
NOTE This test can be used as a guideline to develop an in-house method during the development cycle of cosmetic
products. In this case, the test can be modified or extended, or both, for example to make allowance for prior data
and different variables (microbial strains, media, incubation conditions exposure time, etc.). Compliance criteria can be
adapted to specific objectives. During the development stage of cosmetic products, other methods, where relevant, can
be used to determine the preservation efficacy of formulations.
1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product
This procedure is based on careful consideration of the following points.
— Results of the preservation efficacy test. Not all cosmetic products will require a preservation efficacy test
(see Annex A and ISO 29621).
— Formulation ch
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