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 Mittels (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

Status
Published
Publication Date
12-Feb-2019
Withdrawal Date
30-Aug-2019
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
13-Feb-2019
Completion Date
13-Feb-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11930:2019
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
SIST EN ISO 11930:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11930:2019

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SIST EN ISO 11930:2019


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.

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SIST EN ISO 11930:2019
EN ISO 11930:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11930:2019
EN ISO 11930:2019 (E)
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.


3

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...

SLOVENSKI STANDARD
oSIST prEN ISO 11930:2018
01-april-2018
.R]PHWLND0LNURELRORJLMD9UHGQRWHQMHSURWLPLNUREQH]DãþLWHNR]PHWLþQLK
L]GHONRY ,62',6
Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic
product (ISO/DIS 11930:2018)
Kosmetische Mittel - Mikrobiologie - Bewertung des antimikrobiellen Schutzes eines
kosmetischen Produktes (ISO/DIS 11930:2018)
Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit
cosmétique (ISO/DIS 11930:2018)
Ta slovenski standard je istoveten z: prEN ISO 11930 rev
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN ISO 11930:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 11930:2018

---------------------- Page: 2 ----------------------
oSIST prEN ISO 11930:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11930
ISO/TC 217 Secretariat: ISIRI
Voting begins on: Voting terminates on:
2018-02-19 2018-05-14
Cosmetics — Microbiology — Evaluation of the
antimicrobial protection of a cosmetic product
Cosmétiques — Microbiologie — Évaluation de la protection antimicrobienne d'un produit cosmétique
ICS: 07.100.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11930:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018

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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(E) ISO 11930:2012(E)

Contents
Foreword . iii
Introduction . v
1 Scope . 1
1.1 Preservation efficacy test . 1
1.2 Procedure for evaluating the antimicrobial protection of the cosmetic product . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Principle . 3
5 Preservation efficacy test . 3
5.1 General . 3
5.2 Materials, apparatus, reagents and culture medi a . 3
5.2.1 Materials - Apparatus . 3
5.2.2 Diluents, neutralisers and culture media . 4
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 (previously A. niger) spores suspension . 8
5.5 Demon
...

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