EN ISO 29621:2011

SLOVENSKI STANDARD
01-april-2011
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Cosmetics - Microbiology - Guidelines for the risk assessment and identification of
microbiologically low-risk products (ISO 29621:2010)
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Bewertung und Identifikation von
mikrobiologisch risikoarmen Produkten (ISO 29621:2010)
Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et
l'identification de produits à faible risque microbiologique (ISO 29621:2010)
Ta slovenski standard je istoveten z: EN ISO 29621:2011
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.

EUROPEAN STANDARD
EN ISO 29621
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2011
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Guidelines for the risk assessment
and identification of microbiologically low-risk products (ISO
29621:2010)
Cosmétiques - Microbiologie - Lignes directrices pour Kosmetische Mittel - Mikrobiologie - Leitlinien für die
l'appréciation du risque et l'identification de produits à faible Risikobewertung und Identifikation von mikrobiologisch
risque microbiologique (ISO 29621:2010) risikoarmen Produkten (ISO 29621:2010)
This European Standard was approved by CEN on 22 December 2010.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29621:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 29621:2010 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 29621:2011 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by NEN.
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 July 2011, and conflicting national standards shall be withdrawn at the
latest by July 2011.
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.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 29621:2010 has been approved by CEN as a EN ISO 29621:2011 without any modification.

INTERNATIONAL ISO
STANDARD 29621
First edition
2010-06-01
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 29621:2010(E)
©
ISO 2010
ISO 29621:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 29621:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Terms and definitions .1
3 Risk assessment factors.2
3.1 General.2
3.2 Composition of the product .2
3.2.1 General characteristics.2
3.2.2 Water activity, a , of formulation .2
w
3.2.3 pH of formulation.3
3.2.4 Alcohol content .4
3.2.5 Raw materials that can create a hostile environment .4
3.3 Production conditions .5
3.4 Packaging.5
3.5 Combined factors .5
4 Identified low-risk products.6
Bibliography.7

ISO 29621:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 29621 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2010 – All rights reserved

ISO 29621:2010(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 should 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 product, 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 International Standard. 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. Those 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 International Standard do not require
routine microbiological testing.
The objective of these guidelines is to help cosmetic manufacturers and regulatory bodies to determine when,
based on a “risk assessment,” the routine application of the microbiological International Standards for
cosmetics and other relevant methods is not necessary.
INTERNATIONAL STANDARD ISO 29621:2010(E)

Cosmetics — Microbiology — Guidelines for the risk
assessment and identification of microbiologically low-risk
products
1 Scope
The objective of this International Standard is to help cosmetic manufacturers and regulato
...