kSIST ISO/FDIS 29621:2010

INTERNATIONAL ISO
STANDARD 29621
First edition
2010-06-01
Corrected version
2011-06-15

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

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ISO 29621:2010(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland

ii © ISO 2010 – All rights reserved

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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 2010 – All rights reserved iii

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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.
This corrected version of ISO 29621:2010 incorporates the following corrections:
⎯ in the last sentence of the first paragraph and the first sentence of the third paragraph of 3.2.3, the word
intercellular has been replaced by intracellular;
⎯ the first and second sentences of the fifth paragraph of 3.2.3 have been corrected so that the pH values
are the same as in Table 2;
⎯ in the third paragraph of 3.2.4, > has been replaced by ≥.
iv © ISO 2010 – All rights reserved

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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.
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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 regulatory bodies define
those finished products that, based on a risk assessment, present a low risk of microbial contamination during
production and/or use, and therefore, do not require the application of microbiological International Standards
for cosmetics.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
risk
effect of uncertainty on objectives
[ISO Guide 73:2009, definition 1.1]
NOTE Microbiological risk is associated with the ability of a product to:
⎯ support the growth of microorganisms and the probability that those microorganisms can cause harm to the user;
⎯ support the presence of specified microorganisms as identified in cosmetic microbiological International Standards,
e.g. ISO 18415, ISO 18416, ISO 22717, ISO 22718 and ISO 21150.
2.2
risk assessment
overall process of risk identification, risk analysis (2.3) and risk evaluation (2.4)
[ISO Guide 73:2009, definition 3.4.1]
2.3
risk analysis
process to comprehend the nature of risk (2.1) and to determine the level of risk
[ISO Guide 73:2009, definition 3.6.1]
2.4
risk evaluation
process of comparing the results of risk analysis (2.3) with risk criteria (2.5) to determine whether the
risk (2.1) and/or its magnitude is acceptable or tolerable
[ISO Guide 73:2009, definition 3.7.1]
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ISO 29621:2010(E)
2.5
risk criteria
terms of reference against which the significance of a risk (2.1) is evaluated
[ISO Guide 73:2009, definition 3.3.1.3]
2.6
microbiologically low-risk products
products whose environment denies microorganisms the physical and chemical requirements for growth
and/or survival
NOTE 1 This category of low-risk products applies to microbiological contamination which may occur during
manufacturing and/or use by the consumer.
NOTE 2 A product whose packaging prevents the ingress of microorganisms is considered a microbiological low-risk
product during its use.
NOTE 3 The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would not constitute
a low-risk product.
3 Risk assessment factors
3.1 General
A number of product characteristics needs to be evaluated when performing a microbial risk assessment, to
determine if that product should be subject to the published microbiological International Standards for
cosmetics or other relevant methods. These characteristics include the composition of the product, the
production conditions, packaging and a combination of these factors.
3.2 Composition of the product
3.2.1 General characteristics
Products with certain physico-chemical characteristics do not allow the proliferation of microorganisms of
concern to cosmetic products. Any number of physico-chemical factors or combinations thereof in a product
can create a hostile environment that will not support microbial growth and/or survival. Combinations of sub-
lethal factors will increase the hostility of the environment and increase the lag phase. If the environment is
hostile enough, the lag phase will be extended to infinity and therefore cause cell death. Combinations of
lethal factors will cause rapid cell death. The following factors should be considered in determining whether
cosmetic products present a hostile environment.
3.2.2 Water activity, a , of formulation
w
Water is one of the most important factors controlling the rate of growth of an organism. It is not the total
moisture content that determines the potential for growth but the available water in the formulation. The
metabolism and reproduction of microorganisms demand the presence of water in an available form. The
most useful measurement of water availability in a product formulation is water activity, a . Water activity is
w
defined as the ratio of the water vapour pressure of the product to that of pure water at the same temperature:
p n
2
a==
w
p nn+
()
01 2
2 © ISO 2010 – All rights reserved

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ISO 29621:2010(E)
where
p is the vapour pressure of the solution;
p is the vapour pressure of pure water;
0
n is the number of moles of solute;
1
n is the number of moles of water.
2
When a solution becomes more concentrated, vapour pressure decreases, and the water activity falls from a
maximum of 1,00 (a for pure water). These conditions have been categorized with respect to their capacity to
w
grow and produce metabolites in various conditions and values of a . The influence of reduced a on
w w
microorganisms is well documented. As the amount of free water in a formulation is reduced (decrease in a ),
w
the microorganism is faced with the challenge of maintaining a state of turgor within the cell. Loss of turgor will
result in slower growth and eventually death of the cell. Many organisms survive under conditions of low a
w
but will not grow. Lowered a causes an increase in the lag phase of growth, decrease in growth and
w
decrease in total cell count. At very low values of a , it can be assumed that the lag phase becomes infinite,
w
i.e. no growth. In low a environments, cells shall use energy to accumulate compatible solutes to maintain
w
internal pressure. The growth of most bacteria is confined to an a above 0,90. Yeast and mould can grow at
w
a much lower a with a limiting value above 0,60. See reference [1].
w
Listed below are examples of the minimum water activity levels required for growth of selected
microorganisms.
Table 1 — Approximate minimum water activity, a ,
w
required for growth of selected microorganisms
(see reference [2])
Microorganism a
w
Most bacteria 0,90
Pseudomonas species 0,96
Enterobacteriacae
0,93
Staphylococcus aureus 0,86
Most spoilage yeast 0,70
Most spoilage mould 0,60
The above water activity values should be considered as reference points, since microbial growth may occur
at lower values depending on differences in temperature, pH or nutrient content of the product formulation.
Even though water activity values are important in assisting in the risk analysis for microbial contamination,
water activity should not be used as the sole indicator in determining whether product testing is necessary for
a particular product formulation. Other factors such as manufacturing and filling temperatures should be taken
into consideration to determine if a product requires further microbiological testing.
3.2.3 pH of formulation
The use of acidic pH is a common practice in the food industry for protection against bacteria and these same
principles apply to cosmetics. The combination of acidic pH and a has been thoroughly studied (see
w
reference [3]). In many instances, the level of inhibition on microbial activity depends on the specific acid
being used. Acidic conditions around pH 5 favour mould and yeast proliferation but will not support bacterial
growth. As the pH falls below pH 3,0, the conditions for growth of yeast become hostile (see reference [4]);
this is because intracellular pH has to be maintained within relatively narrow limits.
© ISO 2010 – All rights reserved 3

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ISO 29621:2010(E)
Alkaline pH may also create a hostile environment and may in some products be used as part of their
preservative system. Liquid soaps wi
...

NORME ISO
INTERNATIONALE 29621
Première édition
2010-06-01
Version corrigée
2011-06-15


Cosmétiques — Microbiologie — Lignes
directrices pour l'appréciation du risque
et l'identification de produits à faible
risque microbiologique
Cosmetics — Microbiology — Guidelines for the risk assessment and
identification of microbiologically low-risk products



Numéro de référence
ISO 29621:2010(F)
©
ISO 2010

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ISO 29621:2010(F)
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DOCUMENT PROTÉGÉ PAR COPYRIGHT


©  ISO 2010
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous
quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit
de l'ISO à l'adresse ci-après ou du comité membre de l'ISO dans le pays du demandeur.
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Publié en Suisse

ii © ISO 2010 – Tous droits réservés

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ISO 29621:2010(F)
Sommaire Page
Avant-propos .iv
Introduction.v
1 Domaine d'application .1
2 Termes et définitions .1
3 Facteurs d'appréciation du risque.2
3.1 Généralités.2
3.2 Composition du produit.2
3.2.1 Caractéristiques générales.2
3.2.2 Activité de l'eau, a , de la formulation.2
w
3.2.3 pH de la formulation.4
3.2.4 Teneur en alcool .4
3.2.5 Matières premières pouvant créer un milieu hostile .5
3.3 Conditions de fabrication .5
3.4 Emballage.6
3.5 Facteurs combinés.6
4 Produits identifiés comme étant à faible risque .6
Bibliographie.7

© ISO 2010 – Tous droits réservés iii

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ISO 29621:2010(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 29621 a été élaborée par le comité technique ISO/TC 217, Cosmétiques.
La présente version corrigée de l'ISO 29621:2010 inclut plusieurs corrections terminologiques tout au long du
document.
iv © ISO 2010 – Tous droits réservés

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ISO 29621:2010(F)
Introduction
Chaque fabricant de cosmétiques a une double responsabilité concernant la qualité microbiologique de ses
produits. La première est de s'assurer que le produit, tel qu'il est acheté, est exempt des teneurs en micro-
organismes et des types de micro-organismes qui pourraient nuire à la qualité du produit lui-même ainsi qu'à
la santé des consommateurs. La seconde est de s'assurer que les micro-organismes introduits lors de
l'utilisation normale du produit n'altéreront ni la qualité ni la sécurité du produit.
La première étape consisterait à réaliser une appréciation du risque microbiologique du produit afin de
déterminer si les Normes internationales de microbiologie relatives aux cosmétiques sont applicables.
L'appréciation du risque microbiologique est fondée sur un certain nombre de facteurs généralement admis
comme étant importants lors de l'évaluation des effets indésirables sur la qualité du produit et la santé des
consommateurs. L'appréciation sert de guide pour déterminer s'il convient de réaliser des essais pour garantir
la qualité du produit et, si oui, le niveau d'essai nécessaire. La conduite d'une appréciation du risque
microbiologique implique un jugement professionnel et/ou une analyse microbiologique, si nécessaire, afin de
déterminer le niveau de risque.
La nature et la fréquence des essais varient en fonction du produit. Il convient d'évaluer l'importance des
micro-organismes présents dans des produits cosmétiques non stériles en fonction de l'utilisation du produit,
de la nature du produit, et de la possibilité d'atteinte à la santé de l'utilisateur.
Le degré de risque dépend de l'aptitude du produit à permettre la croissance de micro-organismes et de la
probabilité que ceux-ci puissent nuire à la santé de l'utilisateur. Beaucoup de produits cosmétiques
fournissent des conditions optimales pour la croissance microbienne, dont l'eau, les substances nutritives, le
pH et d'autres facteurs de croissance. En outre les conditions de température et d'humidité relative dans
lesquelles un grand nombre de produits cosmétiques sont fabriqués, conservés et utilisés par les
consommateurs favorisent la croissance de mésophiles qui pourraient nuire à la santé des utilisateurs ou
altérer le produit. Pour ces types de produits, la qualité des produits finis est maîtrisée par la mise en œuvre
des bonnes pratiques de fabrication (BPF) des cosmétiques (voir l'ISO 22716) au cours du processus de
fabrication, en utilisant des conservateurs et en effectuant des essais de contrôle selon des méthodes
appropriées.
Pour certains produits cosmétiques la probabilité d'une contamination microbiologique est extrêmement faible
(voire inexistante) en raison des caractéristiques des produits qui créent un milieu hostile pour la survie et/ou
la croissance des micro-organismes. Ces caractéristiques sont exposées en détail dans la présente Norme
internationale. Si le danger (effets indésirables sur la qualité d'un produit et sur la santé des consommateurs)
peut rester identique pour ces produits, la probabilité d'une occurrence est extrêmement faible. Ces produits,
identifiés comme «hostiles» et fabriqués conformément aux BPF, présentent un risque global très faible pour
l'utilisateur.
Par conséquent, les produits qui satisfont aux caractéristiques énoncées dans la présente Norme
internationale ne nécessitent pas d'essais microbiologiques de routine.
L'objectif de ces lignes directrices est d'aider les fabricants de cosmétiques et les instances réglementaires à
déterminer quand, en fonction d'une «appréciation du risque», la mise en œuvre systématique des Normes
internationales de microbiologie relatives aux cosmétiques et d'autres méthodes pertinentes n'est pas
nécessaire.
© ISO 2010 – Tous droits réservés v

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NORME INTERNATIONALE ISO 29621:2010(F)

Cosmétiques — Microbiologie — Lignes directrices pour
l'appréciation du risque et l'identification de produits à faible
risque microbiologique
1 Domaine d'application
La présente Norme internationale a pour objectif d'aider les fabricants de cosmétiques et les instances
réglementaires à déterminer, en fonction d'une «appréciation du risque», les produits finis qui présentent un
faible risque de contamination microbienne au cours de la fabrication et/ou de l'utilisation, et, par conséquent,
ne nécessitent pas la mise en œuvre des Normes internationales de microbiologie relatives aux cosmétiques.
2 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s'appliquent.
2.1
risque
effet de l'incertitude sur l'atteinte des objectifs
[ISO Guide 73:2009, définition 1.1]
NOTE Le risque microbiologique est associé à l'aptitude du produit à:
⎯ permettre la croissance de micro-organismes et la probabilité que ceux-ci puissent nuire à la santé de l'utilisateur;
⎯ permettre la présence de micro-organismes spécifiés identifiés dans les Normes internationales de microbiologie
relatives aux cosmétiques, par exemple l'ISO 18415, l'ISO 18416, l'ISO 22717, l'ISO 22718 et l'ISO 21150.
2.2
appréciation du risque
ensemble du processus d'identification des risques, d'analyse du risque (2.3) et d'évaluation du risque
(2.4)
[ISO Guide 73:2009, définition 3.4.1]
2.3
analyse du risque
processus mis en œuvre pour comprendre la nature d'un risque (2.1) et pour déterminer le niveau de risque
[ISO Guide 73:2009, définition 3.6.1]
2.4
évaluation du risque
processus de comparaison des résultats de l'analyse du risque (2.3) avec les critères de risque (2.5) afin
de déterminer si le risque (2.1) et/ou son importance sont acceptables ou tolérables
[ISO Guide 73:2009, définition 3.7.1]
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ISO 29621:2010(F)
2.5
critères de risque
termes de référence vis-à-vis desquels l'importance d'un risque (2.1) est évaluée
[ISO Guide 73:2009, définition 3.3.1.3]
2.6
produits à faible risque microbiologique
produits dont l'environnement ne satisfait pas les besoins physiques et chimiques des micro-organismes pour
leur croissance et/ou survie
NOTE 1 Cette catégorie de produits à faible risque prend en considération la contamination microbienne pouvant se
produire au cours de la fabrication et/ou de l'utilisation du produit par le consommateur.
NOTE 2 Un produit dont l'emballage empêche l'entrée des micro-organismes est considéré comme étant un produit à
faible risque microbiologique pendant son utilisation.
NOTE 3 L'introduction de conservateurs ou d'autres composés antimicrobiens dans une formulation ne suffit pas pour
obtenir un produit à faible risque.
3 Facteurs d'appréciation du risque
3.1 Généralités
Un certain nombre de caractéristiques du produit nécessitent d'être évaluées lorsqu'on procède à une
appréciation du risque microbiologique pour déterminer si le produit en question relève des Normes
internationales de microbiologie publiées relatives aux cosmétiques ou d'autres méthodes pertinentes. Ces
caractéristiques incluent la composition du produit, les conditions de fabrication, l'emballage et une
combinaison de ces facteurs.
3.2 Composition du produit
3.2.1 Caractéristiques générales
Les produits qui présentent certaines caractéristiques physicochimiques ne permettent pas la prolifération de
micro-organismes préoccupants dans les produits cosmétiques. Différents facteurs physicochimiques ou
combinaisons de ces derniers peuvent créer dans un produit un milieu hostile, défavorable à la croissance
et/ou survie microbienne. Les combinaisons de facteurs sublétaux augmenteront l'hostilité du milieu et
prolongeront la phase de latence. Si le milieu est suffisamment hostile, la phase de latence sera prolongée
jusqu'à l'infini et provoquera ainsi la mort de la cellule. Les combinaisons de facteurs létaux provoqueront la
mort rapide des cellules. Il convient de prendre en considération les facteurs suivants lorsqu'on détermine si
les produits cosmétiques présentent un milieu hostile.
3.2.2 Activité de l'eau, a , de la formulation
w
L'eau constitue l'un des facteurs les plus importants dans la vitesse de croissance d'un organisme. Ce n'est
pas la teneur totale en eau qui détermine les possibilités de croissance mais la quantité d'eau disponible dans
la formulation. Le métabolisme et la reproduction des micro-organismes exigent la présence d'eau sous une
forme disponible. La mesure la plus utile de la disponibilité en eau dans une formulation de produit est
l'activité de l'eau, a . L'activité de l'eau est définie comme le rapport de la tension de vapeur d'eau du produit
w
à celle de l'eau pure à la même température:
p n
2
a
==
w
p nn+
()
01 2
2 © ISO 2010 – Tous droits réservés

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ISO 29621:2010(F)
où
p est la tension de vapeur d'eau de la solution;
p est la tension de vapeur de l'eau pure;
0
n est le nombre de moles du soluté; et
1
n est le nombre de moles d'eau.
2
Lorsqu'une solution devient plus concentrée, la tension de vapeur diminue et l'activité de l'eau baisse à partir
du maximum de 1,00 (valeur de a pour de l'eau pure). Ces conditions ont été classées par catégories à
w
l'égard de leur aptitude à la croissance et à la production de métabolites dans diverses conditions et pour
diverses valeurs de a . L'influence d'une a réduite sur les micro-organismes est bien documentée. Au fur et
w w
à mesure que la quantité d'eau libre présente dans la formulation diminue (baisse de a ), le micro-organisme
w
doit s'efforcer de maintenir un état de turgescence à l'intérieur de la cellule. La perte de turgescence
entrainera à une croissance plus lente et finalement à la mort de la cellule. Beaucoup de micro-organismes
survivent dans des conditions de faible a mais ne croîtront pas. Une a réduite induit un allongement de la
w w
phase de latence, une diminution de la croissance et une réduction du nombre total de cellules. À de très
faibles activités de l'eau a , il peut être supposé que la phase de latence devienne infinie, ce qui correspond à
w
aucune croissance. Dans des milieux présentant une faible a , il faut que les cellules utilisent de l'énergie

w
pour accumuler les solutés compatibles au maintien de la pression interne. La croissance de la majorité des
bactéries nécessite des valeurs de a supérieures à 0,90. Les levures et les moisissures peuvent croître à
w
[1]
des valeurs de a beaucoup plus faibles avec une valeur limite au-dessus de 0,60 .
w
Une liste d'exemples des niveaux minimaux de l'activité de l'eau requis pour la croissance de micro-
organismes sélectionnés est donnée dans le Tableau 1.
Tableau 1 — Valeurs minimales approximatives d'activité de l'eau, a , requises pour la croissance
w
[2]
d'une sélection de micro-organismes
Activité de l'eau
Micro-organisme
a
w
La majorité des bactéries 0,90
Pseudomonas species 0,96
Entérobactéries (Enterobacteriaceae) 0,93
Staphylococcus aureus 0,86
La plupart des levures d'altération 0,70
La plupart des moisissures d'altération 0,60
Il convient de considérer les valeurs de l'activité de l'eau indiquées ci-dessus comme des points de repère,
étant donné que la croissance microbienne peut se produire à des valeurs inférieures en fonction des
variations de température, de pH et de teneur en substances nutritives de la formulation du produit. Même si
les valeurs de l'activité de l'eau sont importantes pour aider à réaliser l'analyse du risque de contamination
microbienne, il est recommandé de ne pas utiliser l'activité de l'eau comme seul indicateur pour déterminer si
des essais sont nécessaires pour une formulation de produit particulière. Pour déterminer si un produit
nécessite des essais microbiologiques complémentaires, il convient de prendre en compte d'autres facteurs
tels que les températures de fabrication et de remplissage.
© ISO 2010 – Tous droits réservés 3

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ISO 29621:2010(F)
3.2.3 pH de la formulation
L'utilisation d'un pH acide est de pratique courante dans l'industrie alimentaire pour offrir une protection contre
les bactéries et ces mêmes principes s'appliquent aux cosmétiques. La combinaison d'un pH acide et de
[3]
l'activité de l'eau, a , a fait l'objet d'études approfondies . Dans beaucoup de cas, le niveau d'inhibition de
w
l'activité microbienne est spécifique de l'acide utilisé. Des conditions acides aux alentours d'un pH 5 favorisent
la prolifération de levures et de moisissures mais ne permettront pas la croissance bactérienne. Au fur et à
mesure que le pH tombe en dessous d'un pH 3,0, les conditions deviennent hostiles à la croissance de
[4]
levures . Cela
...

SLOVENSKI STANDARD
oSIST ISO/DIS 29621:2009
01-junij-2009
.R]PHWLND0LNURELRORJLMD6PHUQLFH]DRFHQRWYHJDQMDLQSUHSR]QDYDQMD
L]GHONRYNLQHSUHGVWDYOMDMRYHþMHJDPLNURELRORãNHJDWYHJDQMD
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of
microbiologically low-risk products
Cosmétiques - Microbiologie - Lignes directrices pour l'évaluation du risque et
l'identification de produits à faible risque microbiologique
Ta slovenski standard je istoveten z: ISO/DIS 29621
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST ISO/DIS 29621:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST ISO/DIS 29621:2009

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oSIST ISO/DIS 29621:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 29621
ISO/TC 217 Secretariat: ISIRI
Voting begins on: Voting terminates on:
2008-09-22 2009-02-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Cosmetics — Microbiology — Guidelines for the risk
assessment and identification of microbiologically low-risk
products
Cosmétiques — Microbiologie — Lignes directrices pour l'évaluation du risque et l'identification de produits à
faible risque microbiologique
ICS 07.100.99; 71.100.70

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
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RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2008

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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
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©
ii ISO 2008 – All rights reserved

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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
Contents Page
1 Scope.1
2 Terms and definitions .1
3 Risk Assessment Factors.2
4 Identified Low Risk Products .6
5 Annex A.7
6 Bibliography.10
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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
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.

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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
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 ISO 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 and the significance of micro-organisms 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 products, the quality of the finished goods are controlled by applying
cosmetic GMPs (see ISO 22716) during the manufacturing process, use of 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.
Those products identified as “hostile” and produced in compliance with GMPs pose a very low overall risk to
the user.
Therefore, products which comply with the characteristics outlined in this document do not require routine
microbiological testing.
The objective of this guideline is to help cosmetic manufacturers and regulatory bodies to determine when,
based on a “risk assessment,” the routine application of the ISO Microbiological Standards and other
relevant methods are not necessary.

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oSIST ISO/DIS 29621:2009

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oSIST ISO/DIS 29621:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 29621

Cosmetics — Microbiology — Guidelines for the risk
assessment and identification of microbiologically low-risk
products
1  Scope
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate
microbiological risk assessment so as to determine the types of cosmetic products to which the
microbiology standards apply. The objective of this guideline is to define those finished products which
present a low risk of microbial contamination during production and/or use, and therefore, do not require
the application of the ISO microbiological cosmetic standards.
2 Terms and Definitions
For the purposes of this International Standard, the following terms and definitions apply.
2.1
risk
Combination of the probability of an event and it’s consequence (ISO Guideline 73 2002)
2.1.1 Microbiological risk is associated with the ability of a product to:
• Support the growth of micro organisms and the probability that those micro organisms can cause
harm to the user.
• Support the presence of specified micro organisms as identified in ISO Cosmetic Microbiological
Standards - 18415, 18416, 22717, 22718, 21150.
2.2
risk assessment
Overall process of risk analysis and risk evaluation (ISO Guide73 2002)
2.3
risk analysis
Systematic use of information to identify sources and to estimate the risk (ISO Guide73 2002)
2.4
risk evaluation
Process of comparing the estimated risk against given risk criteria to determine the significance of the risk.

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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
2.5
risk criteria
Terms of reference by which the significance of risk is assessed. (ISO Guide73 2002)
2.6
low microbiological risk products
Products whose environment denies microorganisms the physical and chemical requirements for growth
and /or survival. This category of low risk products applies to microbiological contamination which may
occur during manufacturing and/or use by the consumer.
2.6.1 A product whose composition denies microorganisms the physical and chemical requirements
for growth and /or survival is considered microbiological low-risk products for both production and use.
2.6.2 A product whose packaging prevents the ingress of microorganisms is considered a
microbiological low - risk product during its use.

3  Risk Assessment Factors
3.1 General
A number of product characteristics need to be evaluated when performing a microbial risk assessment to
determine if that product should be subject to the published ISO microbiological quality standards or other
relevant methods. These characteristics include the composition of the product, the production conditions and
the packaging.

3.2 Composition of the product
Products with certain physico-chemical characteristics do not allow the proliferation of microorganisms of
concern to cosmetic products. Any number of physiochemical factors or combinations thereof in a product can
create a hostile environment that will not support microbial growth and / or survival. Combinations of sub-lethal
factors will increase the hostility of the environment and increase the lag phase. If the environment is hostile
enough, the lag phase will be extended to infinity and therefore cause cell death. Combinations of lethal
factors will cause rapid cell death. The following factors  should be considered in determining whether
cosmetic products present a hostile environment.
3.2.1 Water activity (a ) of formulation
w
Water is one of the most important factors controlling the rate of growth of an organism. It is not the total
moisture content that determines the potential for growth but the available water in the formulation. The
metabolism and reproduction of microorganisms demands the presence of water in an available form. The
most useful measurement of water availability in a product formulation is water activity (a ). Water activity is
w
defined as the ratio of the water vapor pressure of the product to that of pure water at the same temperature:
 a = p/po = [n2/(n1 + n2)].
w
Where,
p is the vapor pressure of the solution,
po is the vapor pressure of pure water,
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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
n1 is the number of moles of solute, and
n2 is the number of moles of water.
When a solution becomes more concentrated, vapor pressure decreases, and the water activity falls from a
maximum of 1.00 (a ) for pure water. These conditions have been categorized with respect to their capacity
w
to grow and produce metabolites in various conditions and a . The influence of reduced a on micro
w w
2
organisms is well documented. . As the amount of free water in a formulation is reduced (decrease in aw) the
microorganism is faced with the challenge of maintaining a state of turgor within the cell. Loss of turgor will
result in slower growth and eventually death of the cell. Many organisms survive under conditions of low a
w
but will not grow. Lowered a causes an increased in the lag phase of growth, decrease in growth and
w
decrease in total cell count. At very low a it can be assumed that the lag phase becomes infinite i.e. no
w
growth. In low a environments, cells must use energy to accumulate compatible solutes to maintain internal
w
pressure. The growth of most bacteria is confined to a above 0.90. Yeast and mold can grow at a much lower
w
i
a with a limiting value above 0.60.
w
Listed below are examples of the minimum water activity levels required for growth of selected
microorganisms.
ii
Approximate Minimum Water Activity (a ) required for Growth of Selected Microorganisms
w
 Most bacteria     0.90
 Pseudomonas species  0.96
Enterobacteriaceae        0.93
Staphylococcus aureus 0.86
Most spoilage yeast  0.70
Most spoilage mold  0.60
The above water activity values should be considered as reference points since microbial growth may
occur at lower values depending on differences in temperature, pH or nutrient content of the product
formulation. Even though water activity values are important in assisting in the risk analysis for microbial
contamination, water activity should not be used as the sole indicator in determining whether product
testing is necessary for a particular product formulation. Other factors such as manufacturing and filling
temperatures should be taken into consideration to determine if a product requires further microbiological
testing.
3.2.2 pH of Formulation
The use of acid pH is a common practice in the food industry for protection against bacteria and, these
iii
same principals apply to cosmetics. The combination of acidic pH and a has been thoroughly studied. In
w
many instances the level of inhibition on microbial activity depends on the specific acid being used. Acidic
conditions around pH 5 favor mold and yeast proliferation but will not support bacterial growth. As the pH
iv
falls below pH 3.5, the conditions for growth of yeast become hostile. This is because intercellular pH
must be maintained within relatively narrow limits.
Alkaline pH may also create a hostile environment and in some products used as part of their preservative
system. Liquid soaps with alkaline pH (pH 9.0 – 10.0) present an environment unfavorable for the growth
v
of some microorganisms. Hair Curl relaxers, due to their extreme pH (around 12), prevent the growth of
vi
virtually all microorganisms that would be likely to contaminate cosmetic products.
The reason for this is that the extreme pH, either acid or alkaline, makes it necessary for microorganisms
to expend energy on maintenance of intercellular pH rather than growth. When pH is used in combination
with chelating agents, glycols, anti-oxidants, water activity, and high surfactant levels, an environment can
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oSIST ISO/DIS 29621:2009
ISO/DIS 29621
be created which will not support microbial growth. These concepts may be visualized as “
...