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
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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SIST EN ISO 11930:2019
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SIST EN ISO 11930:2019
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
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 11930:2019
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 2019 – All rights reserved iii
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SIST EN ISO 11930:2019
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, 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 of 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 www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
This second edition cancels and replaces the first edition (ISO 11930:2012), which has been technically
revised. The main changes compared to the previous edition are as follows.
— Two types of diluents, composition 1 and composition 2 can be used as the diluents for bacteria and
Candida albicans on the revised version (5.2.3).
— 5.6.2 Paragraph 2 has been changed to “When counts of surviving microorganisms obtained in
5.6.1.4 c) are less than 30 for bacteria and C. albicans or less than 15 for A. brasiliensis at the dilution
where neutralization has been checked, record the number of colonies on Petri dishes and express
results by multiplying by the dilution factor. If no colonies are observed at the dilution where
neutralization has been checked, note the result as <1 and multiply by the dilution factor.”
iv © ISO 2019 – All rights reserved
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
Introduction
This document is designed 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 document 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 document.
The test described in this document involves, for each test microorganism, placing the formulation in
contact with a calibrated inoculum, and then measuring the changes in the microorganism count at set
time intervals for a set period and at a set temperature.
The data generated by the risk assessment (see ISO 29621) or by the preservation efficacy test, or both,
are used to establish the level of antimicrobial protection required to minimize user risk.
© ISO 2019 – All rights reserved v
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SIST EN ISO 11930:2019
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SIST EN ISO 11930:2019
INTERNATIONAL STANDARD ISO 11930:2019(E)
Cosmetics — Microbiology — Evaluation of the
antimicrobial protection of a cosmetic product
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
ISO 21148:2017, Cosmetics — Microbiology — General instructions for microbiological examination
ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of
microbiologically low-risk products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 21148 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
— IEC Electropedia: available at https: //www .electropedia .org/
3.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
3.2
cosmetic product
cosmetic formulation (3.1) that has undergone all stages of production, including packaging in its final
container
3.3
antimicrobial protection of a cosmetic product
ability of a cosmetic product (3.2) to overcome microbial contamination that might present a potential
risk to the user or to the aesthetic and functional integrity of the product, during intended use
Note 1 to entry: The overall antimicrobial protection includes preservation of the formulation, the specific
manufacturing process and protective packaging.
3.4
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation (3.1)
EXAMPLE Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water-
activity values.
3.5
reference method
method applied by interested parties to assess a product on the market and in case of dispute
3.6
development method
in-house method
method used during the development stage of a product before the product is put on the market
3.7
consumer
end user of a cosmetic product (3.2)
4 Principle
The evaluation of the antimicrobial protection of a cosmetic product combines the following elements
(see Annex A).
a) The characteristics of its formulation (see ISO 29621) or the results of the preservation efficacy
test (if performed), or both.
The preservation efficacy test is described in Clause 5.
b) The characteristics of the cosmetic product in conjunction with the production conditions
(see ISO 22716 and ISO 29621), the packaging materials and, if justified, recommendations for use
of the product (see ISO 29621) and, when relevant, the area of application and the targeted user
population (see Annex D).
This document describes a procedure for the interpretation of data generated by the preservation
efficacy test (if appropriate) and by the microbiological risk assessment.
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
5 Preservation efficacy test
5.1 General
The evaluation of the preservation of a cosmetic formulation is based on inoculation of the formulation
with calibrated inocula (prepared from relevant strains of microorganisms). The number of surviving
microorganisms is measured at defined intervals during a period of 28 days. For each time and
each strain, the log reduction value is calculated and compared to the minimum values required for
evaluation criteria A or B (see Annex B).
When used as a reference method, procedures shall be strictly followed in order to avoid variability
in results. To determine the preservation efficacy of a formulation during product development, other
suitable development methods may be used.
Prior to the test, neutralizer efficacy shall be established (see 5.5), and the microbiological quality of
the product shall be determined (in accordance with ISO 21149 and ISO 16212, or with ISO 18415)
to ensure that any microorganisms present in the test sample do not interfere with recovery of test
organisms.
5.2 Materials, apparatus, reagents and culture media
5.2.1 General
When water is used in diluents, neutralizers or culture media preparation, use distilled water or
purified water as specified in ISO 21148:2017, 8.2.
5.2.2 Materials
In addition to the microbiology laboratory equipment described in ISO 21148, the following materials
should be used
5.2.2.1 Glass beads, 3 mm to 4 mm in diameter.
5.2.2.2 Sintered glass filter, of porosity 2 (40 µm to 100 µm).
5.2.2.3 Sterile glass containers with closures, of suitable volumes.
5.2.2.4 Centrifuge, capable of a centrifugal force of 2 000g.
5.2.3 Diluents
5.2.3.1 General
Unless otherwise specified, all reagents shall be equilibrated at ambient temperature before use. When
available, ready-to-use reagents and media may be used.
5.2.3.2 Diluents for bacteria and Candida albicans
5.2.3.2.1 Composition 1
Sodium chloride 8,5 g
Water 1 000 ml
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
5.2.3.2.2 Preparation
Dissolve sodium chloride in the water by mixing. Dispense into suitable containers. Sterilize in the
autoclave at 121 °C for 15 min.
5.2.3.2.3 Composition 2
Tryptone pancreatic digest of casein 1,0 g
Sodium chloride 8,5 g
Water 1 000 ml
5.2.3.2.4 Preparation
Dissolve the components in the water by mixing while heating. Dispense into suitable containers.
Sterilize in the autoclave at 121 °C for 15 min. After sterilization, the pH shall be equivalent to 7,0 ± 0,2,
when measured at room temperature.
5.2.3.3 Diluent for preparation of Aspergillus brasiliensis: polysorbate solution
Prepare a solution of polysorbate 80 (0,5 g/l). Dissolve by mixing while heating until complete
dissolution is achieved. Dispense the solution into suitable containers. Sterilize in the autoclave at
121 °C for 15 min.
5.2.4 Neutralizer
5.2.4.1 General
The suitability and effectiveness of the neutralizing agent with respect to the test strains used and to
the tested formulation shall be demonstrated as specified in 5.5.
The neutralizer described in 5.2.4.2 is frequently used. Examples of other suitable neutralizers are
given in Annex C (see Table C.1).
5.2.4.2 Eugon LT 100 liquid broth
5.2.4.2.1 General
This medium contains ingredients that neutralize inhibitory substances present in the sample (lecithin
1)
®
and polysorbate 80) and dispersing agent octoxynol 9 (Triton X100 ). It may be prepared as described
in 5.2.4.2.2, or from dehydrated culture medium, according to the manufacturer’s instructions. A ready-
to-use medium may also be used.
5.2.4.2.2 Composition
Pancreatic digest of casein 15 g
Papaic digest of soybean meal 5 g
Sodium chloride 4 g
L-cystine 0,7 g
1) Triton X100® is an example of a suitable product available commercially. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product.
4 © ISO 2019 – All rights reserved
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
Sodium sulphite 0,2 g
Glucose 5,5 g
Egg lecithin 1 g
Polysorbate 80 5 g
Octoxynol 9 1 g
Water 1 000 ml
5.2.4.2.3 Preparation
Dissolve successively into boiling water polysorbate 80, octoxynol 9 and egg lecithin until they are
completely dissolved. Dissolve the other components by mixing while heating. Dispense the medium
into suitable containers. Sterilize in the autoclave at 121 °C for 15 min. Mix well after sterilization while
the liquid is still hot to redissolve settled substances. After sterilization, the pH shall be equivalent to
7,0 ± 0,2 when measured at room temperature.
5.2.5 Culture media
5.2.5.1 General
Culture media may be prepared as in 5.2.5.2, 5.2.5.3 and 5.2.5.4, or from dehydrated culture media
according to the manufacturer’s instructions. Ready-to-use media may be used when their composition
and/or growth yields are comparable to those of the formulae given in 5.2.5.2.1, 5.2.5.3.1 and 5.2.5.4.1.
5.2.5.2 Culture medium for bacteria: tryptic soy agar (TSA) or soybean casein digest agar
medium
5.2.5.2.1 Composition
Pancreatic digest of casein 15,0 g
Papaic digest of soybean meal 5,0 g
Sodium chloride 5,0 g
Agar 15,0 g
Water 1 000 ml
5.2.5.2.2 Preparation
Dissolve the components or the dehydrated complete medium in the water by mixing while heating.
Dispense the medium into suitable containers. Sterilize in the autoclave at 121 °C for 15 min. Mix well
after sterilization while the liquid is still hot to redissolve settled substances. After sterilization and
cooling down, the pH shall be equivalent to 7,3 ± 0,2 when measured at room temperature.
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SIST EN ISO 11930:2019
ISO 11930:2019(E)
5.2.5.3 Culture medium for C. albicans: Sabouraud dextrose agar medium (SDA)
5.2.5.3.1 Composition
Dextrose 40,0 g
Peptic digest of animal tissue 5,0 g
Pancreatic digest of casein 5,0 g
Agar 15,0 g
Water 1 000 ml
5.2.5.3.2 Preparation
Dissolve the components or the dehydrated complete medium in the water by mixing while heating.
Dispense the medium into suitable containers. Sterilize in an autoclave at 121 °C for 15 min. After
steri
...
SLOVENSKI STANDARD
oSIST prEN ISO 11930:2018
01-april-2018
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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.
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oSIST prEN ISO 11930:2018
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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 Demonstration of the neutraliser 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 neutraliser 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 . 12
5.7 Interpretation of test results and conclusions . 13
5.7.1 General case (the efficacy of neutraliser is demonstrated for all strains) . 13
5.7.2 Case of formulations for which the efficacy of neutraliser is not demonstrated for some
strains . 13
5.8 Test report . 14
6 Overall evaluation of the antimicrobial protection of the cosmetic product . 15
6.1 General . 15
6.2 Case 1 – The Preservation Efficacy test has been performed on the formulation . 15
6.3 Case 2 - The Preservation Efficacy test has not been performed on the formulation . 15
Annex A (normative) Decision diagram . 17
COPYRIGHT PROTECTED DOCUMENT
Annex B (normative) Evaluation criteria for the Preservation Efficacy Test (5.7) . 18
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may Annex C (informative) Examples of neutralisers for the antimicrobial activity of preservatives and
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
w ashing liquids . 19
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
Annex D (informative) Packaging Characteristics . 20
below or ISO’s member body in the country of the requester.
ISO copyright office
Bibliography . 21
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
© ISO 2012 – All rights reserved iii
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(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 media . 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 Demonstration of the neutraliser 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 neutraliser 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 . 12
5.7 Interpretation of test results and conclusions . 13
5.7.1 General case (the efficacy of neutraliser is demonstrated for all strains) . 13
5.7.2 Case of formulations for which the efficacy of neutraliser is not demonstrated for some
strains . 13
5.8 Test report . 14
6 Overall evaluation of the antimicrobial protection of the cosmetic product . 15
6.1 General . 15
6.2 Case 1 – The Preservation Efficacy test has been performed on the formulation . 15
6.3 Case 2 - The Preservation Efficacy test has not been performed on the formulation . 15
Annex A (normative) Decision diagram . 17
Annex B (normative) Evaluation criteria for the Preservation Efficacy Test (5.7) . 18
Annex C (informative) Examples of neutralisers for the antimicrobial activity of preservatives and
washing liquids . 19
Annex D (informative) Packaging Characteristics . 20
Bibliography . 21
© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(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.
This corrected version of ISO 11930:2012 incorporates the following correction:
— in Table B.1, in the Criteria A row, final column (T28), the words "and NI" have been added.
The following have been deleted in clause 5.2.2.2.1 Composition:
Pancreatic digest casein 1,0 g
The components, while heating and after sterilization, the pH shall be equivalent to 7,0 0,2 when measured at
room temperature.
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(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.
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oSIST prEN ISO 11930:2018
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oSIST prEN ISO 11930:2018
INTERNATIONAL STANDARD ISO/DIS 11930:2018(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 characteristics and data provided by the microbiological risk assessment (see ISO 29621).
The analysis of the microbiological risk assessment is based on an overall approach. In particular, it
integrates variables such as characteristics and composition of the formulation, its production conditions,
the characteristics of the packaging in which the formulation will be delivered to the market place,
recommendations for use of the cosmetic product and, when relevant, the area of application and the
targeted user population (see Annex D).
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(E)
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
ISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 22716, Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing
Practices
ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of
microbiologically low-risk products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 21148 and the following apply.
3.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
3.2
cosmetic product
finished cosmetic product that has undergone all stages of production, including packaging in its final
container for shipment
3.3
antimicrobial protection of a cosmetic product
ability of a cosmetic product to overcome microbial contamination that might present a potential risk to the
user
NOTE The overall antimicrobial protection includes preservation of the formulation, the specific manufacturing
process and protective packaging.
3.4
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation
EXAMPLES Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water-activity values.
3.5
reference method
method applied by interested parties to assess a product on the market and in case of dispute
3.6
development method
in-house method
method used during the development stage of a product before the product is put on the market
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(E)
3.7
consumer
end user of a cosmetic product
4 Principle
The evaluation of the antimicrobial protection of a cosmetic product combines the following elements (see
Annex A).
a) The characteristics of its formulation (see ISO 29621) or the results of the preservation efficacy test (if
performed), or both.
The preservation efficacy test is described in 5.1.
b) The characteristics of the cosmetic product in conjunction with the production conditions (see ISO 22716
and ISO 29621), the packaging materials and, if justified, recommendations for use of the product (see
ISO 29621).
This International Standard describes a procedure for the interpretation of data generated by the preservation
efficacy test (if appropriate) and by the microbiological risk assessment.
5 Preservation efficacy test
5.1 General
The evaluation of the preservation of a cosmetic formulation is based on inoculation of the formulation with
calibrated inocula (prepared from relevant strains of micro-organisms). The number of surviving
micro-organisms is measured at defined intervals during a period of 28 days. For each time and each strain,
the log reduction value is calculated and compared to the minimum values required for evaluation criteria A or
B (see Annex B).
When used as a reference method, procedures shall be strictly followed in order to avoid variability in results.
To determine the preservation efficacy of a formulation during product development, other suitable
development methods may be used (see 1.2).
Prior to the test, the microbiological quality of the product shall be determined in accordance with ISO 21149
and ISO 16212, or with ISO 18415.
NOTE The micro-organisms present in the test sample should not interfere with the recovery of the test organisms.
In the test, the neutralization of the possible antimicrobial activity of the tested sample shall be checked and
demonstrated (see 5.5).
5.2 Materials, apparatus, reagents and culture media
General specifications and instructions are given in ISO 21148. When water is used in a formula, use distilled
water or purified water as specified in ISO 21148:2005, 8.2.
5.2.1 Materials
Use usual microbiology laboratory equipment (see ISO 21148) and:
5.2.1.1 Glass beads, 3 mm to 4 mm in diameter.
5.2.1.2 Sintered glass filter, of porosity 2 (40 µm to 100 µm).
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(E)
5.2.1.3 Roux flasks.
5.2.1.4 Sterile glass containers with closures, of suitable volumes.
5.2.1.5 Centrifuge, capable of a centrifugal force of 2 000 g.
5.2.2 Diluents, neutralizers and culture media
5.2.2.1 General
Unless otherwise specified, all reagents shall be equilibrated at ambient temperature before use. When
available, ready-to-use reagents and media may be used.
5.2.2.2 Diluent
5.2.2.2.1 Composition
Sodium chloride 8,5 g
Water 1 000 ml
5.2.2.2.2 Preparation
Dissolve Sodium chloride in the water by mixing. Dispense into suitable containers. Sterilize in the autoclave
at 121 °C for 15 min.
5.2.2.2.3 Polysorbate solution (for preparation of A. brasiliensis spore suspension)
Prepare a solution of polysorbate 80 (0,5 g/l). Dissolve by mixing while heating until complete dissolution is
achieved. Dispense the solution into suitable containers. Sterilize in the autoclave at 121 °C for 15 min.
5.2.2.3 Neutralizer
5.2.2.3.1 General
The suitability and effectiveness of the neutralizing agent with respect to the test strains used and to the
tested formulation shall be demonstrated as specified in 5.5.
The neutralizer described in 5.2.2.3.2 is frequently used. Examples of other suitable neutralizers are given in
Annex C.
5.2.2.3.2 Eugon LT 100 liquid broth
5.2.2.3.2.1 General
This medium contains ingredients which neutralize inhibitory substances present in the sample (lecithin and
® 1
polysorbate 80) and dispersing agent octoxynol 9 (Triton X100 ). It may be prepared as described in
5.2.2.3.2.2, or from dehydrated culture medium, according to the manufacturer's instructions. A ready-to-use
medium may also be used.
5.2.2.3.2.2 Composition
15 g
Pancreatic digest of casein
1
Triton X100® is an example of a suitable product available commercially. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of this product.
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oSIST prEN ISO 11930:2018
ISO/DIS 11930:2018(E)
5 g
Papaic digest of soybean meal
4 g
Sodium chloride
0,7 g
L-cystine
0,2 g
Sodium sulphite
5,5 g
Glucose
1 g
Egg lecithin
5 g
Polysorbate 80
1 g
Octoxynol 9
1 000 ml
Water
5.2.2.3.2.3 Preparation
Dissolve successively into boiling water polysorbate 80, octoxynol 9 and egg lecithin until they are completely
dissolved. Dissolve the other components by mixing while heating. Dispense the medium into suitable
containers. Sterilize in the autoclave at 121 °C for 15 min. Mix well after sterilization while the liquid is still hot
to redissolve settled substances. After sterilization, the pH shall be equivalent to 7,0 ± 0,2 when measured at
room temperature.
5.2.2.4 Culture media
5.2.2.4.1 General
Culture media may be prepared as in 5.2.2.4.2, or from dehydrated culture media according to the
manufacturer's instructions. Ready-to-use media may be used when their composition and/or growth yields
are comparable to those of the formulae given in 5.2.2.4.2.1.
5.2.2.4.2 Culture medium for bacteria: tryptic soy agar (TSA) or soybean casein digest agar medium
5.2.2.4.2.1 Composition
Pancreatic digest of casein 15,0 g
Papaic digest of soybean meal 5,0 g
Sodium chloride 5,0 g
Agar 15,0 g
Water 1 000 ml
5.2.2.4.2.2 Preparation
Dissolve the components or the dehydrated complete medium in the water by mixing while heating. Dispense
the medium into suitable containers. Sterilize in the autoclave at 121 °C for 15 min. Mix well after sterilization
while the liquid is still hot to redissolve settled substances. After sterilization and cooling down, the pH shall be
equivalent to 7,3 ± 0,2 when measured at room temperature.
5.2.2.4.3 Culture medium for C. albicans: Sabouraud dextrose agar medium (SDA)
5.2.2.4.3.1 Composition
© ISO 2018 – All rights reserved 5
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