CEN ISO/TR 19838:2016

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO/TR 19838:2016(E)
© 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
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ii © ISO 2016 – All rights reserved

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/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

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.
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 me
...