EN ISO 29621:2017
(Main)Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)
ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2017)
Dieses Dokument gibt Kosmetikherstellern und Aufsichtsbehörden, ausgehend von einer Risikobewertung, Hilfestellung bei der Festlegung derjenigen Fertigprodukte, die während der Herstellung und/oder der vorgesehenen Anwendung ein niedriges Risiko für eine mikrobielle Verunreinigung darstellen und demzufolge die Anwendung Internationaler Normen zur Mikrobiologie von kosmetischen Mitteln nicht erfordern.
Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et l'identification de produits à faible risque microbiologique (ISO 29621:2017)
ISO 29621:2017 donne des lignes directrices aux fabricants de cosmétiques et aux instances réglementaires afin de les aider 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 prévue, et, par conséquent, ne nécessitent pas la mise en ?uvre des Normes internationales de microbiologie relatives aux cosmétiques.
Kozmetika - Mikrobiologija - Smernice za oceno tveganja in prepoznavanja izdelkov, ki ne predstavljajo večjega mikrobiološkega tveganja (ISO 29621:2017)
Ta dokument podaja smernice za proizvajalce kozmetičnih izdelkov in regulativne organe za pomoč pri opredelitvi končnih izdelkov, ki na podlagi ocene tveganja predstavljajo nizko tveganje za mikrobiološko onesnaženje med proizvodnjo in/ali predvideno uporabo in zato ne zahtevajo uporabe mikrobioloških mednarodnih standardov za kozmetične izdelke.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 29621:2017
01-november-2017
1DGRPHãþD
SIST EN ISO 29621:2011
.R]PHWLND0LNURELRORJLMD6PHUQLFH]DRFHQRWYHJDQMDLQSUHSR]QDYDQMD
L]GHONRYNLQHSUHGVWDYOMDMRYHþMHJDPLNURELRORãNHJDWYHJDQMD ,62
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of
microbiologically low-risk products (ISO 29621:2017)Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation
von mikrobiologisch risikoarmen Produkten (ISO 29621:2017)Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et
l'identification de produits à faible risque microbiologique (ISO 29621:2017)Ta slovenski standard je istoveten z: EN ISO 29621:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
SIST EN ISO 29621:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 29621:2017
EN ISO 29621
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 29621:2011
English Version
Cosmetics - Microbiology - Guidelines for the risk
assessment and identification of microbiologically low-risk
products (ISO 29621:2017)
Cosmétiques - Microbiologie - Lignes directrices pour Kosmetische Mittel - Mikrobiologie - Leitlinien für die
l'appréciation du risque et l'identification de produits à Risikobewertung und Identifikation von
faible risque microbiologique (ISO 29621:2017) mikrobiologisch risikoarmen Produkten (ISO
29621:2017)This European Standard was approved by CEN on 25 February 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29621:2017 E
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SIST EN ISO 29621:2017
EN ISO 29621:2017 (E)
Contents Page
European foreword ....................................................................................................................................................... 3
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EN ISO 29621:2017 (E)
European foreword
This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC 217
"Cosmetics" in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of
which is held by AFNOR.This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2017, and conflicting national standards
shall be withdrawn at the latest by September 2017.Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.This document supersedes EN ISO 29621:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.Endorsement notice
The text of ISO 29621:2017 has been approved by CEN as EN ISO 29621:2017 without any modification.
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SIST EN ISO 29621:2017
INTERNATIONAL ISO
STANDARD 29621
Second edition
2017-03
Cosmetics — Microbiology —
Guidelines for the risk assessment
and identification of microbiologically
low-risk products
Cosmétiques — Microbiologie — Lignes directrices pour
l’appréciation du risque et l’identification de produits à faible risque
microbiologique
Reference number
ISO 29621:2017(E)
ISO 2017
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Risk assessment factors ................................................................................................................................................................................ 2
4.1 General ........................................................................................................................................................................................................... 2
4.2 Composition of the product ......................................................................................................................................................... 2
4.2.1 General characteristics ............................................................................................................................................... 2
4.2.2 Water activity, a , of formulation ...................................................................................................................... 2
4.2.3 pH of formulation ............................................................................................................................................................ 4
4.2.4 Raw materials that can create a hostile environment ..................................................................... 4
4.3 Production conditions ...................................................................................................................................................................... 6
4.4 Packaging ..................................................................................................................................................................................................... 6
4.5 Combined factors .................................................................................................................................................................................. 6
5 Identified low-risk products .................................................................................................................................................................... 7
Bibliography ................................................................................................................................................................................................................................ 8
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ISO 29621:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the voluntary nature of ISO standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.This document was prepared by ISO/TC 217, Cosmetics.
This second edition cancels and replaces the first edition (ISO 29621:2010), which has been technically
revised.iv © ISO 2017 – All rights reserved
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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 International Standards apply.Microbiological risk assessment is based on a number of factors generally accepted as important in
evaluating the adverse effects on product quality and consumer health. It is intended as a guide in
determining what level of testing, if any, is necessary to assure the quality of the product. Conducting
a microbiological risk assessment involves professional judgment and/or a microbiological analysis, if
necessary, to determine the level of risk.The nature and frequency of testing vary according to the product. The significance of microorganisms
in non-sterile cosmetic products is to be evaluated in terms of the use of the product, the nature of the
product and the potential harm to the user.The degree of risk depends on the ability of a product to support the growth of microorganisms and
on the probability that those microorganisms can cause harm to the user. Many cosmetic products
provide optimum conditions for microbial growth, including water, nutrients, pH and other growth
factors. In addition, the ambient temperatures and relative humidity at which many cosmetic products
are manufactured, stored and used by consumers, will promote growth of mesophiles that could cause
harm to users or cause degradation of the product. For these types of products, the quality of the
finished goods is controlled by applying cosmetic good manufacturing practices (GMPs) (see ISO 22716)
during the manufacturing process, using preservatives and conducting control tests using appropriate
methods.The likelihood of microbiological contamination for some cosmetic products is extremely low (or
non-existent) due to product characteristics that create a hostile environment for survival/growth of
microorganisms. These characteristics are elaborated in this document. While the hazard (adverse
effects on product quality and consumer health) may remain the same for these products, the likelihood
of an occurrence is extremely low. These products identified as “hostile” and produced in compliance
with GMPs pose a very low overall risk to the user.Therefore, products that comply with the characteristics outlined in this document do not require
microbiological testing.This document gives guidance to cosmetic manufacturers and regulatory bodies to determine when,
based on a “risk assessment,” the application of the microbiological International Standards for
cosmetics and other relevant methods is not necessary.© ISO 2017 – All rights reserved v
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SIST EN ISO 29621:2017
INTERNATIONAL STANDARD ISO 29621:2017(E)
Cosmetics — Microbiology — Guidelines for the risk
assessment and identification of microbiologically low-risk
products
1 Scope
This document gives guidance to cosmetic manufacturers and regulatory bodies to help define those
finished products that, based on a risk assessment, present a low risk of microbial contamination
during production and/or intended use, and therefore, do not require the application of microbiological
International Standards for cosmetics.2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
risk
effect of uncertainty on objectives
Note 1 to entry: 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.[SOURCE: ISO Guide 73:2009, 1.1, modified]
3.2
risk assessment
overall process of risk identification, risk analysis (3.3) and risk evaluation (3.4)
[SOURCE: ISO Guide 73:2009, 3.4.1]3.3
risk analysis
process to comprehend the nature of risk (3.1) and to determine the level of risk
[SOURCE: ISO Guide 73:2009, 3.6.1]© ISO 2017 – All rights reserved 1
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3.4
risk evaluation
process of comparing the results of risk analysis (3.3) with risk criteria (3.5) to determine whether the
risk (3.1) and/or its magnitude is acceptable or tolerable[SOURCE: ISO Guide 73:2009, 3.7.1]
3.5
risk criteria
term of reference against which the significance of a risk (3.1) is evaluated
[SOURCE: ISO Guide 73:2009, 3.3.1.3, modified]
3.6
microbiologically low-risk product
product whose environment denies microorganisms the physical and chemical requirements for
growth and/or survivalNote 1 to entry: This category of low-risk products applies to microbiological contamination which may occur
during manufacturing and/or intended use by the consumer.Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a
microbiological low-risk product during its use.Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would
not necessarily constitute a low-risk product.4 Risk assessment factors
4.1 General
A number of product characteristics needs to be evaluated when performing a microbial risk assessment
to determine if that product should be subjected 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.
4.2 Composition of the product4.2.1 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.
4.2.2 Water activity, a , of formulationWater 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 require the presence of water in an
available form. The most useful measurement of water availability in a product formulation is water
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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 [see Formula (1)]:a == (1)
nn+
0 ()
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 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
w wlag 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. Some yeast and mould can grow at a much lower a with a limiting value
w wabove 0, 60 (see References [1] and [2]).
Listed in Table 1 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
microorganismsWater activity Water activity
Bacteria Molds and yeast
(a ) (a )
w w
Pseudomonas aeruginosa 0,97 Rhizopus nigricans 0,93
Bacillus cereus 0,95 Mucor plumbeus 0,92
Clostridium botulinum, Rhodotorula mucilaginosa
0,95 0,92
Type A
Escherichia coli 0,95 Saccharomyces cerevisiae 0,90
Clostridium perfringens 0,95 Paecilomyces variotii 0,84
Lactobacillus viridescens 0,95 Penicillium chrysogenum 0,83
Salmonella spp. 0,95 Aspergillus fumigatus 0,82
Enterobacter aerogenes 0,94 Penicillium glabrum 0,81
Bacillus subtilis 0,90 Aspergillus flavus 0,78
Micrococcus lysodeikticus 0,93 Aspergillus brasiliensis 0,77
Staphylococcus aureus Zygosaccharomyces rouxii
0,86 0,62
(see Reference [2]) (osmophilic yeast)
Halobacterium halobium Xeromyces bisporus
0,75 0,61
(halophilic bacterium) (xerophilic fungi)
The water activity values in Table 1 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
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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. USP indicates
that pharmaceutical products with water activities below 0,75 prevent microbial growth. Generally,
anhydrous product formulations will have low water activity levels (e.g. <0,7) (see References [3],
[4] and [5]). A water activity level greater than 0,8 is required for microorganisms to proliferate in
a product formulation (see References [6] and [7]). Because the possibility of microbial proliferation
is non-existent in product formulations that have a water activity level lower than 0,7, there is no
need to conduct preservative challenge testing in these types of product formulations. In the absence
of chemical preservatives, a low water activity level alone is more than sufficient to keep a product
adequately preserved (see Reference [8]). Similar values may apply to cosmetics. Other factors, such as
manufacturing and filling temperatures, should be taken into consideration to determine if a product
requires further microbiological testing.4.2.3 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 [9]). 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 [10]); this is because intracellular pH has to be maintained within relatively
narrow limits.Alkaline pH may also create a hostile environment and may in some products be used as part of
their preservative system. Liquid soaps with alkaline pH (pH 9,0 to pH 10,0) present an environment
unfavourable for the growth of some microorganisms (see Reference [11]). 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 (see Reference [12]).The reason for this is that the extreme pH, either acidic or alkaline, makes it necessary for
microorganisms to expend energy on maintenance of intracellular pH rather than growth. When pH
is used in combination with chelating agents, glycols, antioxidants, water activity and high surfactant
levels, an environment can be created which will not support microbial growth.These concepts may be visualized as “hurdles” that microorganisms shall overcome in order to grow
(see Reference [13]).In certain product types, where extreme pH levels are reported, those considered pH ≤3,0 and pH ≥10,0
do not require microbiological testing, including both challenge-test and end product testing. At all
other pH values (>3,0 but <10,0), a combination of pH and other physico-chemical factors needs to be
evaluated to determine potential risk. Data to support the conclusion that the microbiological risk is
low may need to be generated, either through experimental design or review of product history.
4.2.4 Raw materials that can create a hostile environment4.2.4.1 Alcohol
Microbial growth is prevented in aqueous systems containing >20 % by volume mass of absolute ethyl
alcohol. However, lower alcohol levels (5 % to 10 %) may have additive or synergistic activity when
combined with other physico-chemical factors (see Reference [14]).Ethanol, n-propanol and iso-propanol are the most frequently used aliphatic alcohols in cosmetic
preparations (see Reference [15]). Their antimicrobial efficacy increases with molecular weight and
chain length. The concentration in which they are present in a product determines whether they will
kill or merely inhibit microorganisms. Data in the literature indicate that the microbiostatic effect
of alcohol is quite high in the range of 10 % to 20 %, and will allow for a reduction in preservation.
Depending on the pH of the substrate, 15 % to 18 % ethyl alcohol has generally been considered
acceptable for preservation (see Reference [16]).4 © ISO 2017 – All rights reserved
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Products containing alcohol levels ≥20 % by volume mass do not require microbiological testing
(challenge-test and end product testing). At levels below 20 %, other physico-chemical factors need to
be evaluated to determine potential risk. Data to support the conclusion that the microbiological risk is
low may need to be generated, either through experimental design or review of product history.
4.2.4.2 Ammonia and monoethanolamineAmmonia and monoethanolamine, two alkaline agents, are commonly used in hair dyes where they
serve three important purposes: i) swell the hair fibre to allow dye precursors to better penetrate, ii)
generate the active peroxide species necessary for melanin bleaching and dye formation, iii) participate
[12]to the bleaching of melanin. They are also used in waving lotions, which involve the reduction of
the structural disulphide bonds of the hair. They facilitate the penetration of waving lotion, which is
usually alkaline and is applied to the hair once it is set in rollers. Besides these primary functions, as
alkalizers, ammonia and monoethanolamine are expected to create a hostile environment for microbial
growth in the products in which they are used (see References [17] and [18]).Products containing ammonia level ≥0,5 % and/or monoethanolamine level ≥1 % deny microorganisms
the physical and chemical requirements for growth and/or survival, and can therefore be considered as
microbiologically low-risk (see Reference [15]).4.2.4.3 Polar organic solvents (e.g. ethyl acetate and butyl acetate)
Butyl acetate and ethyl acetate are organic solvents commonly used in nail polishes. These are basically
made from nitrocellulose dissolved in solvents. Solvents are liquids used to mix the other ingredients
(film formers, resins, plasticizers, pigments, etc.) in a nail polish to yield a uniformly spread product.
Besides this primary function, these organic solvents, when used at concentration >10 %, create a
hostile environment for microbial growth in the formulae in which they are used (see Table 2).
Mixtures of these solvents, which are characteristic of nail varnish compositions, have a high
microbiocidal activity on the tested strains within a short time (see Reference [19]).
Solvent-based nail polishes can therefore be considered low microbiological risk and do not require
microbiological testing (challenge-test and end product testing).4.2.4.4 Other raw materials that can create a hostile environment
The use of certain raw m
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