kSIST ISO/FDIS 29621:2010

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products

The objective of ISO 29621:2010 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.

Cosmétiques - Microbiologie - Lignes directrices pour l'évaluation du risque et l'identification de produits à faible risque microbiologique

L'ISO 29621:2010 a pour objectif d'aider les fabricants de cosm�tiques et les instances r�glementaires � d�terminer, en fonction d'une �appr�ciation du risque�, les produits finis qui pr�sentent un faible risque de contamination microbienne au cours de la fabrication et/ou de l'utilisation, et, par cons�quent, ne n�cessitent pas la mise en œuvre des Normes internationales de microbiologie relatives aux cosm�tiques.

Kozmetika - Mikrobiologija - Smernice za oceno tveganja in prepoznavanja izdelkov, ki ne predstavljajo večjega mikrobiološkega tveganja

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Jul-2009
• ICS: 07.100.40 - Cosmetics microbiology
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 03-Mar-2011
• Due Date: 08-Mar-2011
• Completion Date: 03-Mar-2011
• Ref Project: ISO 29621:2010 - Cosmetics -- Microbiology -- Guidelines for the risk assessment and identification of microbiologically low-risk products

RELATIONS

• Revised: SIST EN ISO 29621:2011 - Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)
• Effective Date: 01-Apr-2011

Standards Content (sample)

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
---------------------- Page: 1 ----------------------
ISO 29621:2010(E)
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ii © ISO 2010 – All rights reserved
---------------------- Page: 2 ----------------------
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

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.
© ISO 2010 – All rights reserved v
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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]
© ISO 2010 – All rights reserved 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

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

defined as the ratio of the water vapour pressure of the product to that of pure water at the same temperature:

p n
a==
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;
n is the number of moles of solute;
n is the number of moles of water.

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

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 ),

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

but will not grow. Lowered a causes an increase in the lag phase of growth, decrease in growth and

decrease in total cell count. At very low values of a , it can be assumed that the lag phase becomes infinite,

i.e. no growth. In low a environments, cells shall use energy to accumulate compatible solutes to maintain

internal pressure. The growth of most bacteria is confined to an a above 0,90. Yeast and mould can grow at

a much lower a with a limiting value above 0,60. See reference [1].

Listed below are examples of the minimum water activity levels required for growth of selected

microorganisms.
Table 1 — Approximate minimum water activity, a ,
required for growth of selected microorganisms
(see reference [2])
Microorganism a
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

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
---------------------- Page: 1 ----------------------
ISO 29621:2010(F)
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ii © ISO 2010 – Tous droits réservés
---------------------- Page: 2 ----------------------
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

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]
© ISO 2010 – Tous droits réservés 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

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

à celle de l'eau pure à la même température:
p n
p nn+
01 2
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ISO 29621:2010(F)
p est la tension de vapeur d'eau de la solution;
p est la tension de vapeur de l'eau pure;
n est le nombre de moles du soluté; et
n est le nombre de moles d'eau.

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

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

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

aucune croissance. Dans des milieux présentant une faible a , il faut que les cellules utilisent de l'énergie

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

[1]

des valeurs de a beaucoup plus faibles avec une valeur limite au-dessus de 0,60 .

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

[2]
d'une sélection de micro-organismes
Activité de l'eau
Micro-organisme
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.
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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

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

WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.

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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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 2006 – All rights reserved
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oSIST ISO/DIS 29621:2009
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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. 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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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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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

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

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)].
Where,
p is the vapor pressure of the solution,
po is the vapor pressure of pure water,
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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

to grow and produce metabolites in various conditions and a . The influence of reduced a on micro

w w

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

but will not grow. Lowered a causes an increased in the lag phase of growth, decrease in growth and

decrease in total cell count. At very low a it can be assumed that the lag phase becomes infinite i.e. no

growth. In low a environments, cells must use energy to accumulate compatible solutes to maintain internal

pressure. The growth of most bacteria is confined to a above 0.90. Yeast and mold can grow at a much lower

a with a limiting value above 0.60.

Listed below are examples of the minimum water activity levels required for growth of selected

microorganisms.

Approximate Minimum Water Activity (a ) required for Growth of Selected Microorganisms

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

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

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

of some microorganisms. Hair Curl relaxers, due to their extreme pH (around 12), prevent the growth of

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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be created which will not support microbial growth. These concepts may be visualized as “

...