Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic Microbiology (ISO/TR 19838:2016)

ISO/TR 19838:2016 gives general guidelines to explain the use of ISO cosmetic microbiological standards depending on the objective (in-market control, product development, etc.) and the product to be tested.
ISO/TR 19838:2016 can be used to fulfil the requirements of the ISO standard on microbiological limits (ISO 17516).

Microbiologie - Cosmétique - Lignes directrices pour l'application des Normes ISO à la microbiologie cosmétique (ISO/TR 19838:2016)

ISO/TR 19838:2016 fournit des lignes directrices générales pour expliquer l'utilisation des normes ISO relatives à la microbiologie cosmétique en fonction de l'objectif visé (contrôle sur le marché, développement de produit, etc.) et du produit à soumettre à essai.
ISO/TR 19838:2016 peut être utilisé pour satisfaire aux exigences de la norme ISO sur les limites microbiologiques (ISO 17516).

Kozmetika - Mikrobiologija - Smernice za uporabo standardov ISO o mikrobiologiji v kozmetiki (ISO/TR 19838:2016)

To tehnično poročilo podaja splošne smernice, ki razlagajo uporabo standardov ISO o mikrobiologiji v kozmetiki glede na cilj (nadzor trga, razvoj izdelkov itd.) in preskusni izdelek.
To tehnično poročilo je mogoče uporabljati za izpolnjevanje zahtev standarda ISO o mikrobioloških mejnih vrednostih (ISO 17516).

General Information

Status
Published
Publication Date
24-May-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
25-May-2016
Completion Date
25-May-2016

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SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 19838:2016
01-november-2016
Kozmetika - Mikrobiologija - Smernice za uporabo standardov ISO o mikrobiologiji
v kozmetiki (ISO/TR 19838:2016)
Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic
Microbiology (ISO/TR 19838:2016)
Microbiologie - Cosmétique - Lignes directrices pour l'application des Normes ISO à la
microbiologie cosmétique (ISO/TR 19838:2016)
Ta slovenski standard je istoveten z: CEN ISO/TR 19838:2016
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST-TP CEN ISO/TR 19838:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TP CEN ISO/TR 19838:2016

---------------------- Page: 2 ----------------------

SIST-TP CEN ISO/TR 19838:2016


CEN ISO/TR 19838
TECHNICAL REPORT

RAPPORT TECHNIQUE

May 2016
TECHNISCHER BERICHT
ICS 07.100.99; 71.100.70
English Version

Microbiology - Cosmetics - Guidelines for the application of
ISO standards on Cosmetic Microbiology (ISO/TR
19838:2016)
Microbiologie - Cosmétique - Lignes directrices pour
l'application des Normes ISO à la microbiologie
cosmétique (ISO/TR 19838:2016)


This Technical Report was approved by CEN on 18 April 2016. It has been drawn up by the Technical Committee CEN/TC 392.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 19838:2016 E
worldwide for CEN national Members.

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SIST-TP CEN ISO/TR 19838:2016
CEN ISO/TR 19838:2016 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST-TP CEN ISO/TR 19838:2016
CEN ISO/TR 19838:2016 (E)
European foreword
This document (CEN ISO/TS 19838:2016) 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of ISO/TR 19838:2016 has been approved by CEN as CEN ISO/TR 19838:2016 without any
modification.
3

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SIST-TP CEN ISO/TR 19838:2016

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SIST-TP CEN ISO/TR 19838:2016
TECHNICAL ISO/TR
REPORT 19838
First edition
2016-05-15
Microbiology — Cosmetics —
Guidelines for the application of ISO
standards on Cosmetic Microbiology
Microbiologie — Cosmétique — Lignes directrices pour l’application
des normes ISO relatives à la microbiologie cosmétique
Reference number
ISO/TR 19838:2016(E)
©
ISO 2016

---------------------- Page: 7 ----------------------

SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 8 ----------------------

SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Microbial content . 2
3.1 General requirements . 2
3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds) . 3
3.3 Detection of specified microorganisms . 3
3.4 Detection of specified and non-specified microorganisms . 4
4 Antimicrobial preservation. 5
4.1 General requirements . 5
4.2 Evaluation of the preservation of a cosmetic formulation . 5
4.3 Evaluation of the preservation of a cosmetic product . 6
5 Examples of microbial content results . 6
5.1 General . 6
5.2 Eye make-up remover . 6
5.3 Mascara. 6
5.4 Face cream . 7
5.5 Shampoo . 8
6 Examples of interpretation of preservation efficacy test results. 8
Annex A (informative) Relationship between the ISO cosmetic microbiology standards .11
Annex B (informative) Relationship between the ISO standards dealing with the microbial
content of cosmetics .12
Annex C (informative) Evaluation of the microbial content of a cosmetic product .13
Annex D (informative) Interpretation of test results .14
Bibliography .15
© ISO 2016 – All rights reserved iii

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SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 217, Cosmetics.
iv © ISO 2016 – All rights reserved

---------------------- Page: 10 ----------------------

SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(E)

Introduction
Every cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its
products.
— The first is to ensure that the product, as purchased, is free from the numbers and types of
microorganisms that could affect product quality and consumer health. This is generally ensured
by applying cosmetic good manufacturing practice (GMP) (see ISO 22716) during the manufacturing
and packaging operations and, if necessary, by using microbial content tests on finished products.
— The second is to ensure that microorganisms introduced during normal product use will not
adversely affect the quality or safety of the product. This is generally ensured by conducting
preservation efficacy tests (or challenge tests) during the development stage of the new product.
In order to ensure product quality and safety for consumers, it is advisable that an appropriate
microbiological risk analysis be performed to determine the types of cosmetic products to which this
Technical Report would be applicable.
— Products considered to present a low microbiological risk are described in ISO 29621. These
products identified as “hostile” and produced in compliance with GMP pose a very low overall risk
to the user. Therefore, products that comply with the characteristics outlined in ISO 29621 do not
require microbiological testing including both challenge test and end product testing.
— For those products which are not considered “hostile”, the microbiological quality has to be
assessed by conducting tests with appropriate methods. ISO TC 217 provides a comprehensive set
of standards to assess the antimicrobial preservation of cosmetic products and the microbiological
quality of finished products (methods and limits). Manufacturers can decide not to test if they can
demonstrate that their products comply with those requirements specified in ISO 17516 and/or
ISO 11930.
© ISO 2016 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST-TP CEN ISO/TR 19838:2016

---------------------- Page: 12 ----------------------

SIST-TP CEN ISO/TR 19838:2016
TECHNICAL REPORT ISO/TR 19838:2016(E)
Microbiology — Cosmetics — Guidelines for the
application of ISO standards on Cosmetic Microbiology
1 Scope
This Technical Report gives general guidelines to explain the use of ISO cosmetic microbiological
standards depending on the objective (in-market control, product development, etc.) and the product
to be tested.
This Technical Report can be used to fulfil the requirements of the ISO standard on microbiological
limits (ISO 17516).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
2.2
cosmetic product
finished cosmetic product that has undergone all stages of production, including packaging in its final
container for shipment
2.3
sample
one or more representative elements selected from a set to obtain information about that set
2.4.1
microbial content
estimated number of viable aerobic mesophilic microorganisms (bacteria, yeasts and
moulds) within a cosmetic
2.4.2
microbial content
detectable specified or non-specified microorganisms within a cosmetic sample
2.5
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation
EXAMPLE Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water activity
values, etc.
2.6
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 1 to entry: The overall antimicrobial protection includes preservation of the formulation, the specific
manufacturing process and protective packaging.
© ISO 2016 – All rights reserved 1

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SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(E)

2.7
microbiologically low-risk products
products whose environment denies microorganisms the physical and chemical requirements for
growth and/or survival (hostile products)
Note 1 to entry: This category of low-risk products applies to microbiological contamination which may occur
during manufacturing and/or use by the consumer.
Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a
microbiological low-risk product during its use.
Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would
not necessarily constitute a low-risk product.
2.8
microbiological Risk Assessment (low risk products)
evaluation of product characteristics to determine if that product may be subject to microbial
contamination
Note 1 to entry: These characteristics include the composition of the product, the production conditions,
packaging and a combination of these factors (see ISO 29621).
3 Microbial content
3.1 General requirements
There are eight International Standards dealing with the microbial content of cosmetic samples (see
Annex A).
— ISO 16212
— ISO 17516
— ISO 18415
— ISO 18416
— ISO 21149
— ISO 21150
— ISO 22717
— ISO 22718
Additionally, ISO 21148 gives general instructions for carrying out microbiological examinations of
cosmetic products.
Because of the large variety of cosmetic products within this field of application, the methods described
in these International Standards may not be appropriate for some products in every detail (e.g. certain
water immiscible products).
Other methods (e.g. automated) may be substituted for the tests presented here provided that their
equivalence has been demonstrated or the method has been otherwise verified.
The possible inhibition of microbial growth by the sample should be neutralized to allow the detection
of viable microorganisms. In all cases and whatever the methodology, the neutralization of the
antimicrobial properties of the product should be checked and demonstrated.
The study of the neutralization of the antimicrobial activity should be performed when the tests have to
be carried out on new products and whenever there is a change in the experimental conditions of the test.
2 © ISO 2016 – All rights reserved

---------------------- Page: 14 ----------------------

SIST-TP CEN ISO/TR 19838:2016
ISO/TR 19838:2016(E)

The given International Standards will allow the following:
— the enumeration and detection of mesophilic microorganisms which may grow under aerobic
conditions;
— the determination of the absence of specified microorganisms that are of interest for cosmetic
products;
and, therefore, to estimate if the product under test complies with the requirements of the International
Standard on microbiological limits (ISO 17516).
The test methods are described in the individual standards. The choice of a specific method, or
combination of methods, will depend on the purpose for performing the test. It is up to the user to
decide which approach is best for each application.
Depending on the expected level of contamination of the sample to be tested, two different approaches
can be used (see Annex A).
— Quantitative tests (enumeration) are to be used when there is no information on the microbiological
quality of the sample or if it is expected to be contaminated.
— Qualitative tests (detection) can be used if the sample is presumably free from microbial
contamination (e.g. based on product history) and can be very useful from an economical and
production time standpoint.
In the event where microorganisms are detected, the presence of specified microorganisms should be
checked according to 3.3 or 3.4.
3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds)
For bacteria, the enumeration method described in ISO 21149 involves enumeration of colonies on a
non-selective agar medium. Enumeration of colonies can be performed by a plate count method or a
filtration method using a specified culture medium incubated under defined conditions.
The results are expressed as follows:
“[number of] aerobic mesophilic bacteria per gram or per millilitre of product, expressed as cfu/g
or cfu/ml”.
For yeasts and moulds, the method described in ISO 16212 involves enumeration of colonies by a plate
count method or a filtration method using a specified culture medium with antibiotic incubated under
defined conditions.
An alternative condition using the culture medium without antibiotic is proposed in ISO 16212.
The results are expressed as follows:
“[number of] yeast and mould per
...

SLOVENSKI STANDARD
kSIST-TP FprCEN ISO/TR 19838:2016
01-marec-2016
Kozmetika - Mikrobiologija - Smernice za uporabo standardov ISO o mikrobiologiji
v kozmetiki (ISO/DTR 19838:2015)
Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic
Microbiology (ISO/DTR 19838:2015)
Microbiologie - Cosmétique - Lignes directrices pour l'application des Normes ISO à la
microbiologie cosmétique (ISO/DTR 19838:2015)
Ta slovenski standard je istoveten z: FprCEN ISO/TR 19838
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
kSIST-TP FprCEN ISO/TR 19838:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016

---------------------- Page: 2 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
TECHNICAL ISO/TR
REPORT 19838
First edition
Microbiology — Cosmetics —
Guidelines for the application of ISO
standards on Cosmetic Microbiology
Microbiologie — Cosmétique — Lignes directrices pour l’application
des Normes ISO à la microbiologie cosmétique
PROOF/ÉPREUVE
Reference number
ISO/TR 19838:2015(E)
©
ISO 2015

---------------------- Page: 3 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(E)

ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the International Organization for Standardization (ISO), and pro-
cessed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final draft was
established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two-month approval vote in ISO and formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 4 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Microbial content . 2
3.1 General requirements . 2
3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds) . 3
3.3 Detection of specified microorganisms . 3
3.4 Detection of specified and non-specified microorganisms . 4
4 Antimicrobial preservation. 5
4.1 General requirements . 5
4.2 Evaluation of the preservation of a cosmetic formulation . 5
4.3 Evaluation of the preservation of a cosmetic product . 6
5 Examples of microbial content results . 6
5.1 General . 6
5.2 Eye make-up remover . 6
5.3 Mascara. 6
5.4 Face cream . 7
5.5 Shampoo . 8
6 Examples of interpretation of preservation efficacy test results. 8
Annex A (informative) Relationship between the ISO cosmetic microbiology standards .11
Annex B (informative) Relationship between the ISO standards dealing with the microbial
content of cosmetics .12
Annex C (informative) Evaluation of the microbial content of a cosmetic product .13
Annex D (informative) Interpretation of test results .14
Bibliography .15
© ISO 2015 – All rights reserved PROOF/ÉPREUVE iii

---------------------- Page: 5 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 217, Cosmetics.
iv PROOF/ÉPREUVE © ISO 2015 – All rights reserved

---------------------- Page: 6 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(E)

Introduction
Every cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its
products.
— The first is to ensure that the product, as purchased, is free from the numbers and types of
microorganisms that could affect product quality and consumer health. This is generally ensured
by applying cosmetic good manufacturing practice (GMP) (see ISO 22716) during the manufacturing
and packaging operations and, if necessary, by using microbial content tests on finished products.
— The second is to ensure that microorganisms introduced during normal product use will not
adversely affect the quality or safety of the product. This is generally ensured by conducting
preservation efficacy tests (or challenge tests) during the development stage of the new product.
In order to ensure product quality and safety for consumers, it is advisable that an appropriate
microbiological risk analysis be performed to determine the types of cosmetic products to which this
Technical Report would be applicable.
— Products considered to present a low microbiological risk are described in ISO 29621. These products
identified as “hostile” and produced in compliance with GMP pose a very low overall risk to the user.
Therefore, products that comply with the characteristics outlined in this Technical Report do not
require microbiological testing including both challenge test and end product testing.
— For those products which are not considered “hostile”, the microbiological quality has to be assessed
by conducting tests with appropriate methods. ISO TC 217 provides a comprehensive set of standards
to assess the antimicrobial preservation of cosmetic products and the microbiological quality of
finished products (methods and limits). Manufacturers can decide not to test if they can demonstrate
that their products comply with those requirements specified in ISO 17516 and/or ISO 11930.
© ISO 2015 – All rights reserved PROOF/ÉPREUVE v

---------------------- Page: 7 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016

---------------------- Page: 8 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
TECHNICAL REPORT ISO/TR 19838:2015(E)
Microbiology — Cosmetics — Guidelines for the
application of ISO standards on Cosmetic Microbiology
1 Scope
This Technical Report gives general guidelines to explain the use of ISO cosmetic microbiological
standards depending on the objective (in-market control, product development, etc.) and the product
to be tested.
This Technical Report can be used to fulfil the requirements of the ISO standard on microbiological
limits (ISO 17516).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
2.2
cosmetic product
finished cosmetic product that has undergone all stages of production, including packaging in its final
container for shipment
2.3
sample
one or more representative elements selected from a set to obtain information about that set
2.4.1
microbial content
estimated number of viable aerobic mesophilic microorganisms (bacteria, yeasts and
moulds) within a cosmetic
2.4.2
microbial content
detectable specified or non-specified microorganisms within a cosmetic sample
2.5
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation
EXAMPLE Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water
activity values, etc.
2.6
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 1 to entry: The overall antimicrobial protection includes preservation of the formulation, the specific
manufacturing process and protective packaging.
© ISO 2015 – All rights reserved PROOF/ÉPREUVE 1

---------------------- Page: 9 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(E)

2.7
microbiologically low-risk products
products whose environment denies microorganisms the physical and chemical requirements for
growth and/or survival (hostile products)
Note 1 to entry: This category of low-risk products applies to microbiological contamination which may occur
during manufacturing and/or use by the consumer.
Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a
microbiological low-risk product during its use.
Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would
not necessarily constitute a low-risk product.
2.8
microbiological Risk Assessment (low risk products)
evaluation of product characteristics to determine if that product may be subject to microbial
contamination
Note 1 to entry: These characteristics include the composition of the product, the production conditions,
packaging and a combination of these factors (see ISO 29621).
3 Microbial content
3.1 General requirements
There are eight International Standards dealing with the microbial content of cosmetic samples
(see Annex A).
— ISO 16212
— ISO 17516
— ISO 18415
— ISO 18416
— ISO 21149
— ISO 21150
— ISO 22717
— ISO 22718
Additionally, ISO 21148 gives general instructions for carrying out microbiological examinations of
cosmetic products.
Because of the large variety of cosmetic products within this field of application, the methods described
in these International Standards may not be appropriate for some products in every detail (e.g. certain
water immiscible products).
Other methods (e.g. automated) may be substituted for the tests presented here provided that their
equivalence has been demonstrated or the method has been otherwise verified.
The possible inhibition of microbial growth by the sample should be neutralized to allow the detection
of viable microorganisms. In all cases and whatever the methodology, the neutralization of the
antimicrobial properties of the product should be checked and demonstrated.
The study of the neutralization of the antimicrobial activity should be performed when the tests have to
be carried out on new products and whenever there is a change in the experimental conditions of the test.
2 PROOF/ÉPREUVE © ISO 2015 – All rights reserved

---------------------- Page: 10 ----------------------
kSIST-TP FprCEN ISO/TR 19838:2016
ISO/TR 19838:2015(E)

The given International Standards will allow the following:
— the enumeration and detection of mesophilic microorganisms which may grow under aerobic
conditions;
— the determination of the absence of specified microorganisms that are of interest for cosmetic
products;
and, therefore, to estimate if the product under test complies with the requirements of the International
Standard on microbiological limits (ISO 17516).
The test methods are described in the individual standards. The choice of a specific method, or
combination of methods, will depend on the purpose for performing the test. It is up to the user to
decide which approach is best for each application.
Depending on the expected level of contamination of the sample to be tested, two different approaches
can be used (see Annex A).
— Quantitative tests (enumeration) are to be used when there is no information on the microbiological
quality of the sample or if it is expected to be contaminated.
— Qualitative tests (detection) can be used if the sample is presumably free from microbial
contamination (e.g. based on product history) and can be very useful from an economical and
production time standpoint.
In the event where microorganisms are detected, the presence of specified microorganisms should be
checked according to 3.3 or 3.4.
3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds)
For bacteria, the enumeration method described in ISO 21149 involves enumeration of colonies on a
non-selective agar medium. Enumeration of colonies can be performed by a plate count method or a
filtration method using a specified culture medium incubated under defined conditions.
The results are expressed as follows:
“[number] of aerobic mesophilic bacteria per gram or per milliliter of product, expressed as
cfu/g or cfu/ml”.
For yeasts and moulds, the method described in ISO 16212 involves enumeration of colonies by a plate
count method or a filtration method using a specified culture medium with antibiotic incubated under
defined conditions.
An alternative condition using the culture medium without antibiotic is proposed in ISO 16212.
The results are expressed as follows:
“[number] of yeast and mould per gram or per milliliter of product expressed, as cfu/g or cfu/ml”.
3.3 Detection of specified microorganisms
The detection of skin pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa and Candida
albicans may be relevant. The detection of other kinds of microorganisms might be of interest since
these microorganisms (including indicators of fecal contamination e.g. Escherichia coli) suggest hygienic
failure during the manufacturing process.
The methods are described in ISO 18416 (C. albicans), ISO 21150 (E. coli) ISO 22717 (P. aeruginosa), and
ISO 22718
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