SIST EN ISO 11930:2019

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

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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.


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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
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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.”
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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.
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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
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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.
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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
...