SIST EN ISO 29621:2011
(Main)Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)
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.
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Bewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2010)
Die Zielstellung dieser Internationalen Norm besteht darin, ausgehend von einer Risikobewertung Kosmetik-herstellern und Aufsichtsbehörden bei der Festlegung derjenigen Fertigprodukte zu helfen, die während der Herstellung und/oder Anwendung ein niedriges Risiko für eine mikrobielle Verunreinigung darstellen und dem-zufolge 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 29621:2010)
L'ISO 29621:2010 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.
Kozmetika - Mikrobiologija - Smernice za oceno tveganja in prepoznavanja izdelkov, ki ne predstavljajo večjega mikrobiološkega tveganja (ISO 29621:2010)
Cilj tega mednarodnega standarda je pomagati kozmetičnim proizvajalcem in regulativnim organom opredeliti tiste končne izdelke, ki glede na oceno tveganja pomenijo nizko tveganje mikrobiološke kontaminacije med proizvodnjo in/ali uporabo in zato ne zahtevajo uporabe mikrobioloških mednarodnih standardov za kozmetiko.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 29621:2011
01-april-2011
.R]PHWLND0LNURELRORJLMD6PHUQLFH]DRFHQRWYHJDQMDLQSUHSR]QDYDQMD
L]GHONRYNLQHSUHGVWDYOMDMRYHþMHJDPLNURELRORãNHJDWYHJDQMD ,62
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of
microbiologically low-risk products (ISO 29621:2010)
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Bewertung und Identifikation von
mikrobiologisch risikoarmen Produkten (ISO 29621:2010)
Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et
l'identification de produits à faible risque microbiologique (ISO 29621:2010)
Ta slovenski standard je istoveten z: EN ISO 29621:2011
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 29621:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 29621:2011
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SIST EN ISO 29621:2011
EUROPEAN STANDARD
EN ISO 29621
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2011
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Guidelines for the risk assessment
and identification of microbiologically low-risk products (ISO
29621:2010)
Cosmétiques - Microbiologie - Lignes directrices pour Kosmetische Mittel - Mikrobiologie - Leitlinien für die
l'appréciation du risque et l'identification de produits à faible Risikobewertung und Identifikation von mikrobiologisch
risque microbiologique (ISO 29621:2010) risikoarmen Produkten (ISO 29621:2010)
This European Standard was approved by CEN on 22 December 2010.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29621:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 29621:2011
EN ISO 29621:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 29621:2011
EN ISO 29621:2011 (E)
Foreword
The text of ISO 29621:2010 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 29621:2011 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by July 2011, and conflicting national standards shall be withdrawn at the
latest by July 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 29621:2010 has been approved by CEN as a EN ISO 29621:2011 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 29621:2011
---------------------- Page: 6 ----------------------
SIST EN ISO 29621:2011
INTERNATIONAL ISO
STANDARD 29621
First edition
2010-06-01
Cosmetics — Microbiology — Guidelines
for the risk assessment and identification
of microbiologically low-risk products
Cosmétiques — Microbiologie — Lignes directrices pour l'appréciation
du risque et l'identification de produits à faible risque microbiologique
Reference number
ISO 29621:2010(E)
©
ISO 2010
---------------------- Page: 7 ----------------------
SIST EN ISO 29621:2011
ISO 29621:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 29621:2011
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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SIST EN ISO 29621:2011
ISO 29621:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 29621 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 29621:2011
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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SIST EN ISO 29621:2011
---------------------- Page: 12 ----------------------
SIST EN ISO 29621:2011
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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SIST EN ISO 29621:2011
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
---------------------- Page: 14 ----------------------
SIST EN ISO 29621:2011
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
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QDYDQMDKosmetische Mittel - Mikrobiologie - Leitlinien für die Bewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2010)Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et l'identification de produits à faible risque microbiologique (ISO 29621:2010)Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)71.100.70SULSRPRþNLCosmetics. Toiletries07.100.99Drugi standardi v zvezi z mikrobiologijoOther standards related to microbiologyICS:Ta slovenski standard je istoveten z:FprEN ISO 29621kSIST FprEN ISO 29621:2010en,fr,de01-oktober-2010kSIST FprEN ISO 29621:2010SLOVENSKI
STANDARDkSIST ISO/FDIS 29621:20101DGRPHãþD
kSIST FprEN ISO 29621:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 29621
August 2010 ICS 07.100.99; 71.100.70 English Version
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)
Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et l'identification de produits à faible risque microbiologique (ISO 29621:2010)
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Bewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2010) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 392.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 29621:2010: EkSIST FprEN ISO 29621:2010
FprEN ISO 29621:2010 (E) 2 Contents Page Foreword .3 kSIST FprEN ISO 29621:2010
FprEN ISO 29621:2010 (E) 3 Foreword The text of ISO 29621:2010 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 29621:2010 by Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by NEN. This document is currently submitted to the Unique Acceptance Procedure. Endorsement notice The text of ISO 29621:2010 has been approved by CEN as a FprEN ISO 29621:2010 without any modification.
kSIST FprEN ISO 29621:2010
kSIST FprEN ISO 29621:2010
Reference numberISO 29621:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO29621First edition2010-06-01Cosmetics — 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
kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
©
ISO 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2010 – All rights reserved
kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) © ISO 2010 – All rights reserved iii 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, aw, 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
kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) iv © ISO 2010 – All rights reserved 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. kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) © ISO 2010 – All rights reserved v 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. kSIST FprEN ISO 29621:2010
kSIST FprEN ISO 29621:2010
INTERNATIONAL STANDARD ISO 29621:2010(E) © ISO 2010 – All rights reserved 1 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] kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) 2 © ISO 2010 – All rights reserved 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, aw, 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, aw. Water activity is defined as the ratio of the water vapour pressure of the product to that of pure water at the same temperature: ()2w012npapnn==+ kSIST FprEN ISO 29621:2010
ISO 29621:2010(E) © ISO 2010 – All rights reserved 3 where p is the vapour pressure of the solution; p0 is the vapour pressure of pure water; n1 is the number of moles of solute; n2 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 (aw for pure water). These conditions have been categorized with respect to their capacity to grow and produce metabolites in various conditions and values of aw. The influence of reduced aw on microorganisms 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 aw but will not grow. Lowered aw causes an increase in the lag phase of growth, decrease in growth and decrease in total cell count. At very low values of aw, it can be assumed that the lag phase becomes infinite, i.e. no growth. In low aw environments, cells shall use energy to accumulate compatible solutes to maintain internal pressure. The growth of most bacteria is confined to an aw above 0,90. Yeast and mould can grow at a much lower aw 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 microo
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