SIST-TP CEN ISO/TR 19838:2016

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

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).

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
• Public Enquiry End Date: 16-Mar-2016
• Publication Date: 16-Oct-2016
• ICS: 07.100.40 - Cosmetics microbiology
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Sep-2016
• Due Date: 13-Nov-2016
• Completion Date: 17-Oct-2016
• Ref Project: CEN ISO/TR 19838:2016 - Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic Microbiology (ISO/TR 19838:2016)

Standards Content (Sample)

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.

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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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CEN ISO/TR 19838:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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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.
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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
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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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved
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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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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.
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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.
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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.
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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.

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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
...