EN ISO 29621:2017

SLOVENSKI STANDARD
01-november-2017
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SIST EN ISO 29621:2011
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Cosmetics - Microbiology - Guidelines for the risk assessment and identification of
microbiologically low-risk products (ISO 29621:2017)
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation
von mikrobiologisch risikoarmen Produkten (ISO 29621:2017)
Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et
l'identification de produits à faible risque microbiologique (ISO 29621:2017)
Ta slovenski standard je istoveten z: EN ISO 29621:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 29621
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 29621:2011
English Version
Cosmetics - Microbiology - Guidelines for the risk
assessment and identification of microbiologically low-risk
products (ISO 29621:2017)
Cosmétiques - Microbiologie - Lignes directrices pour Kosmetische Mittel - Mikrobiologie - Leitlinien für die
l'appréciation du risque et l'identification de produits à Risikobewertung und Identifikation von
faible risque microbiologique (ISO 29621:2017) mikrobiologisch risikoarmen Produkten (ISO
29621:2017)
This European Standard was approved by CEN on 25 February 2017.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29621:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 29621:2017) 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 September 2017, and conflicting national standards
shall be withdrawn at the latest by September 2017.
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.
This document supersedes EN ISO 29621:2011.
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 29621:2017 has been approved by CEN as EN ISO 29621:2017 without any modification.

INTERNATIONAL ISO
STANDARD 29621
Second edition
2017-03
Cosmetics — Microbiology —
Guidelines for the risk assessment
and identification of microbiologically
low-risk products
Cosmétiques — Microbiologie — Lignes directrices pour
l’appréciation du risque et l’identification de produits à faible risque
microbiologique
Reference number
ISO 29621:2017(E)
©
ISO 2017
ISO 29621:2017(E)
© ISO 2017, 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 2017 – All rights reserved

ISO 29621:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Risk assessment factors . 2
4.1 General . 2
4.2 Composition of the product . 2
4.2.1 General characteristics . 2
4.2.2 Water activity, a , of formulation . 2
w
4.2.3 pH of formulation . 4
4.2.4 Raw materials that can create a hostile environment . 4
4.3 Production conditions . 6
4.4 Packaging . 6
4.5 Combined factors . 6
5 Identified low-risk products . 7
Bibliography . 8
ISO 29621:2017(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 voluntary nature of ISO 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 the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by ISO/TC 217, Cosmetics.
This second edition cancels and replaces the first edition (ISO 29621:2010), which has been technically
revised.
iv © ISO 2017 – All rights reserved

ISO 29621:2017(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. The second is to ensure that
microorganisms introduced during normal product use will not adversely affect the quality or safety of
the product.
The first step would be to perform a microbiological risk assessment of the product to determine if the
cosmetic microbiological International Standards apply.
Microbiological risk assessment is based on a number of factors generally accepted as important in
evaluating the adverse effects on product quality and consumer health. It is intended as a guide in
determining what level of testing, if any, is necessary to assure the quality of the product. Conducting
a microbiological risk assessment involves professional judgment and/or a microbiological analysis, if
necessary, to determine the level of risk.
The nature and frequency of testing vary according to the product. The significance of microorganisms
in non-sterile cosmetic products is to be evaluated in terms of the use of the product, the nature of the
product and the potential harm to the user.
The degree of risk depends on the ability of a product to support the growth of microorganisms and
on the probability that those microorganisms can cause harm to the user. Many cosmetic products
provide optimum conditions for microbial growth, including water, nutrients, pH and other growth
factors. In addition, the ambient temperatures and relative humidity at which many cosmetic products
are manufactured, stored and used by consumers, will promote growth of mesophiles that could cause
harm to users or cause degradation of the product. For these types of products, the quality of the
finished goods is controlled by applying cosmetic good manufacturing practices (GMPs) (see ISO 22716)
during the manufacturing process, using preservatives and conducting control tests using appropriate
methods.
The likelihood of microbiological contamination for some cosmetic products is extremely low (or
non-existent) due to product characteristics that create a hostile environment for survival/growth of
microorganisms. These characteristics are elaborated in this document. While the hazard (adverse
effects on product quality and consumer health) may remain the same for these products, the likelihood
of an occurrence is extremely low. These products identified as “hostile” and produced in compliance
with GMPs pose a very low overall risk to the user.
Therefore, products that comply with the characteristics outlined in this document do not
...