SIST EN ISO 11930:2019
(Main)Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2019)
Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2019)
This document specifies a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both, when evaluating the overall antimicrobial protection of a cosmetic product.
It comprises:
— a preservation efficacy test;
— a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not considered low risk, based on a risk assessment described in ISO 29621.
The preservation efficacy test is a reference method to evaluate the preservation of a cosmetic formulation. It is applicable to cosmetic products in the marketplace.
This test does not apply to those cosmetic products for which the microbiological risk has been determined to be low according to Annex A and ISO 29621.
This test is primarily designed for water-soluble or water-miscible cosmetic products and can be used with modification to test products in which water is the internal (discontinuous) phase.
NOTE This test can be used as a guideline to establish a development 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.
Kosmetische Mittel - Mikrobiologie - Bewertung des antimikrobiellen Schutzes eines kosmetischen Produktes (ISO 11930:2019)
Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit cosmétique (ISO 11930:2019)
Le présent document spécifie un mode opératoire pour l'interprétation des données résultant de l'essai d'efficacité de la protection antimicrobienne et/ou de l'appréciation du risque microbiologique lors de l'évaluation globale de la protection antimicrobienne d'un produit cosmétique.
Il comprend:
— un essai d'efficacité de la protection antimicrobienne; et
— un mode opératoire permettant d'évaluer la protection antimicrobienne globale d'un produit cosmétique qui n'est pas identifié comme étant à faible risque microbiologique d'après l'appréciation du risque décrite dans l'ISO 29621.
L'essai d'efficacité de la protection antimicrobienne est une méthode de référence pour évaluer la protection antimicrobienne d'une formulation cosmétique. Il s'applique aux produits cosmétiques disponibles sur le marché.
Cet essai n'est pas applicable aux produits cosmétiques pour lesquels il a été démontré que le risque microbiologique est faible, conformément à l'Annexe A et à l'ISO 29621.
Cet essai est principalement conçu pour les produits cosmétiques solubles dans l'eau ou miscibles à l'eau, et peut être utilisé avec modification pour soumettre à essai des produits dont la phase interne (discontinue) est aqueuse.
NOTE Cet essai peut servir de ligne directrice pour établir une méthode de développement au cours du cycle de développement d'un produit cosmétique. Dans ce cas, l'essai peut être modifié et/ou élargi, par exemple pour prendre en compte des données antérieures et différents paramètres (souches microbiennes, milieux, conditions et durée d'incubation, etc.). Les critères de conformité peuvent être adaptés à des objectifs spécifiques. Au cours de la phase de développement des produits cosmétiques, d'autres méthodes peuvent être utilisées, le cas échéant, pour déterminer l'efficacité de la protection antimicrobienne des formulations.
Kozmetika - Mikrobiologija - Vrednotenje protimikrobne zaščite kozmetičnih izdelkov (ISO 11930:2019)
Ta dokument določa postopek za interpretacijo podatkov, pridobljenih s preskusom ohranjanja učinkovitosti ali z oceno mikrobiološkega tveganja ali obojega pri vrednotenju skupne protimikrobne zaščite kozmetičnih izdelkov.
Vključuje:
– preskus ohranjanja učinkovitosti;
– postopek za ocenjevanje celotne protimikrobne zaščite kozmetičnih izdelkov, ki na podlagi ocene tveganja, navedene v standardu ISO 29621, ne veljajo za izdelke z nizkim tveganjem.
Preskus ohranjanja učinkovitosti je referenčna metoda za vrednotenje ohranjanja kozmetične formulacije. Uporablja se za kozmetične izdelke na trgu.
Ta preskus se ne uporablja za tiste kozmetične izdelke, za katere je bilo ugotovljeno, da je njihovo mikrobiološko tveganje nizko v skladu z dodatkom A in standardom ISO 29621.
Ta preskus je primarno zasnovan za kozmetične izdelke, ki so topni v vodi ali se mešajo z vodo, in jih je z modifikacijo mogoče uporabiti za preskušanje proizvodov, v katerih je voda notranja (prekinjena) faza.
OPOMBA: Ta preskus je mogoče uporabiti kot smernico za vzpostavitev razvojne metode med razvojnim ciklom kozmetičnih izdelkov. V tem primeru je mogoče preskus spremeniti ali razširiti ali oboje, na primer, da se upoštevajo predhodni podatki in različne spremenljivke (mikrobni sevi, mediji, čas izpostavljenosti v pogojih inkubacije itd.).
Merila skladnosti je mogoče prilagoditi posebnim ciljem. V fazi razvoja kozmetičnih izdelkov je mogoče za določitev učinkovitosti ohranjanja formulacij uporabiti druge metode, kjer je to ustrezno.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST EN ISO 11930:2012
Kozmetika - Mikrobiologija - Vrednotenje protimikrobne zaščite kozmetičnih
izdelkov (ISO 11930:2019)
Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic
product (ISO 11930:2019)
Kosmetische Mittel - Mikrobiologie - Bewertung des antimikrobiellen Schutzes eines
kosmetischen Produktes (ISO 11930:2019)
Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit
cosmétique (ISO 11930:2019)
Ta slovenski standard je istoveten z: EN ISO 11930:2019
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11930
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2019
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 11930:2012
English Version
Cosmetics - Microbiology - Evaluation of the antimicrobial
protection of a cosmetic product (ISO 11930:2019)
Cosmétiques - Microbiologie - Évaluation de la Kosmetische Mittel - Mikrobiologie - Bewertung des
protection antimicrobienne d'un produit cosmétique antimikrobiellen Schutzes eines kosmetischen
(ISO 11930:2019) Produktes (ISO 11930:2019)
This European Standard was approved by CEN on 27 December 2018.
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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11930:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11930:2019) 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 August 2019, and conflicting national standards shall
be withdrawn at the latest by August 2019.
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 11930:2012.
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 11930:2019 has been approved by CEN as EN ISO 11930:2019 without any modification.
INTERNATIONAL ISO
STANDARD 11930
Second edition
2019-01
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 11930:2019(E)
©
ISO 2019
ISO 11930:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 11930:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Preservation efficacy test . 3
5.1 General . 3
5.2 Materials, apparatus, reagents and culture media . 3
5.2.1 General. 3
5.2.2 Materials . 3
5.2.3 Diluents . 3
5.2.4 Neutralizer . 4
5.2.5 Culture media . 5
5.3 Microbial strains . 6
5.4 Preparation and enumeration of inocula . 7
5.4.1 General. 7
5.4.2 Preparation of bacterial and Candida albicans suspensions . 7
5.4.3 Preparation of Aspergillus brasiliensis spore suspension . 8
5.5 Demonstration of the neutralizer efficacy . 9
5.5.1 Principle . 9
5.5.2 Procedure . 9
5.5.3 Calculations . 9
5.5.4 Interpretation of results and conclusion on neutralizer efficacy.10
5.6 Determination of the preservation efficacy of the formulation .10
5.6.1 Procedure .10
5.6.2 Counting of colonies.11
5.6.3 Calculations .11
5.7 Interpretation of test results and conclusions .12
5.7.1 Criteria .12
5.7.2 General case (efficacy of the neutralizer is demonstrated for all strains) .13
5.7.3 Case of formulations for which the efficacy of the neutralizer is not
demonstrated for some strains .13
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 — Preservation efficacy test has been performed on the formulation.14
6.3 Case 2 — Preservation efficacy test has not been performed on the formulation .15
Annex A (normative) Decision diagram .16
Annex B (normative) Evaluation criteria for the preservation efficacy test .17
Annex C (informative) Examples of neutralizers for the antimicrobial activity of
preservatives and washing liquids .18
Annex D (informative) Packaging characteristics .20
Bibliography .21
ISO 11930:2019(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,
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.