EN ISO 22717:2015

• Abstract:

  ISO 22717:2015 gives general guidelines for the detection and identification of the specified microorganism Pseudomonas aeruginosa in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations.; In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological (see ISO 29621) risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.; The method described in this International Standard is based on the detection of Pseudomonas aeruginosa in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection required.; NOTE For the detection of Pseudomonas aeruginosa, subcultures can be performed on non-selective culture media followed by suitable identification steps (e.g. using identification kits).; Because of the large variety of cosmetic products within this field of application, this method may not be appropriate in every detail for some products (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.

• Status: Published
• Publication Date: 15-Dec-2015
• Withdrawal Date: 29-Jun-2016
• ICS: 07.100.40 - Cosmetics microbiology
• ICS: 07.100.99 - Other standards related to microbiology
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392 - Cosmetics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Dec-2015
• Completion Date: 16-Dec-2015
• Mandate: M/426 - Standardisation mandate assigned to CEN concerning the microbiological analysis of cosmetic products
• Ref Project: SIST EN ISO 22717:2016 - Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2015)

• Replaces: EN ISO 22717:2009 - Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2006)
• Effective Date: 23-Dec-2015
• Refers: ISO 21148:2005 - Cosmetics — Microbiology — General instructions for microbiological examination
• Effective Date: 25-Aug-2026
• Refers: EN 12353:2021 - Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
• Effective Date: 28-Jan-2026
• Refers: EN ISO 15792-1:2008/A1:2011 - Welding consumables - Test methods - Part 1: Test methods for all-weld metal test specimens in steel, nickel and nickel alloys (ISO 15792-1:2000/Amd 1:2011)
• Effective Date: 28-Jan-2026
• Referred By: EN 71-20:2025 - Safety of toys - Part 20: Microbiological safety of toys containing accessible aqueous media
• Effective Date: 28-Jan-2026
• Consolidated By: ISO 22717:2015 - Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa
• Effective Date: 12-Feb-2026
• Amended By: EN ISO 22717:2015/A1:2022 - Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa - Amendment 1 (ISO 22717:2015/Amd 1:2022)
• Effective Date: 22-Sep-2021

Overview

EN ISO 22717:2015 - Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa provides standardized guidelines for detecting and identifying Pseudomonas aeruginosa in cosmetic products. The method centers on enrichment in a non-selective liquid medium (enrichment broth) followed by isolation on a selective agar medium. The standard emphasizes performing a microbiological risk analysis to determine which product types require testing and notes that methods may need adaptation for certain product matrices.

Key topics and requirements

• Scope and risk approach: Advises a product-specific microbiological risk analysis; identifies low-risk categories (e.g., low water activity, hydro‑alcoholic formulations, extreme pH).
• Testing principle: Enrichment in non-selective broth → isolation on selective agar → identification (including subculture on non-selective media and use of identification kits).
• Sample handling & preparation: Procedures for water‑miscible, water‑immiscible and filterable products; neutralization of preservatives when necessary.
• Media and reagents: Specifications for diluents, enrichment broths and selective agar; annexes provide alternative enrichment broths and neutralizers.
• Suitability and validation: Requirement to demonstrate method suitability for specific products (neutralizer efficacy, recovery, detection limits).
• Flexibility for alternative methods: Allows substitution with other validated or equivalent methods (including automated systems) provided equivalence is demonstrated.
• Reporting: Clear guidance on expressing detection results and documenting test reports.

Practical applications and users

Who uses EN ISO 22717:2015:

• Cosmetic manufacturers - to support product release testing and in-house quality control.
• Contract microbiology laboratories - for reliable, standardized assays accepted by clients and regulators.
• Regulatory bodies and auditors - as a reference for compliance assessment and investigation of contamination events.
• R&D and formulation scientists - to evaluate preservative strategies and product robustness against contamination.

Practical benefits:

• Helps ensure consumer safety by detecting a clinically relevant opportunistic pathogen.
• Provides a reproducible framework to compare results across labs and jurisdictions.
• Supports preservation effectiveness testing by integrating neutralizer and suitability procedures.

Related standards

• ISO 29621 - Guidance on microbiological risk assessment for cosmetics
• ISO 18415 - Microbiology of cosmetics: specific methods for certain product types
• ISO 21148 - General instructions for microbiological examination of cosmetics
• EN 12353 - Preservation of test organisms (relevant to culture maintenance)

Keywords: EN ISO 22717:2015, Pseudomonas aeruginosa detection, cosmetics microbiology, enrichment broth, selective agar, microbiological risk analysis, neutralization, suitability test, cosmetic quality control.

SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 22717:2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Pseudomonas
aeruginosa (ISO 22717:2015)
Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2015)
Kosmetische Mittel - Mikrobiologie - Nachweis von Pseudomonas aeruginosa (ISO
22717:2015)
Cosmétiques - Microbiologie - Détection de Pseudomonas aeruginosa (ISO 22717:2015)
Ta slovenski standard je istoveten z: EN ISO 22717:2015
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22717
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 07.100.99; 71.100.70 Supersedes EN ISO 22717:2009
English Version
Cosmetics - Microbiology - Detection of Pseudomonas
aeruginosa (ISO 22717:2015)
Cosmétiques - Microbiologie - Détection de Kosmetische Mittel - Mikrobiologie - Nachweis von
Pseudomonas aeruginosa (ISO 22717:2015) Pseudomonas aeruginosa (ISO 22717:2015)
This European Standard was approved by CEN on 26 September 2015.

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, 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22717:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 22717:2015) 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
This document supersedes EN ISO 22717:2009.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22717:2015 has been approved by CEN as EN ISO 22717:2015 without any modification.

INTERNATIONAL ISO
STANDARD 22717
Second edition
2015-11-15
Cosmetics — Microbiology —
Detection of Pseudomonas aeruginosa
Cosmétiques — Microbiologie — Détection de Pseudomonas
aeruginosa
Reference number
ISO 22717:2015(E)
©
ISO 2015
ISO 22717:2015(E)
© ISO 2015, 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
the requester.
ISO copyright office
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Tel. [phone]
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ii © ISO 2015 – All rights reserved

ISO 22717:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Diluents and culture media . 2
5.1 General . 2
5.2 Diluent for the bacterial suspension (tryptone sodium chloride solution) . 3
5.2.1 General. 3
5.2.2 Composition . 3
5.2.3 Preparation . 3
5.3 Culture media . 3
5.3.1 General. 3
5.3.2 Agar medium for the suitability test (see Clause 11) [soybean–casein
digest agar medium (SCDA) or tryptic soy agar (TSA)] . 3
5.3.3 Enrichment broth . 4
5.3.4 Selective agar medium for isolation of Pseudomonas aeruginosa . 5
5.3.5 Selective agar medium for confirmation of Pseudomonas aeruginosa . 5
6 Apparatus and glassware . 6
7 Strains of microorganisms . 6
8 Handling of cosmetic products and laboratory samples . 6
9 Procedure. 6
9.1 General recommendation . 6
9.2 Preparation of the initial suspension in the enrichment broth . 6
9.2.1 General. 6
9.2.2 Water-miscible products. 7
9.2.3 Water-immiscible products . 7
9.2.4 Filterable products . 7
9.3 Incubation of the inoculated enrichment broth . 7
9.4 Detection and Identification of Pseudomonas aeruginosa . 7
9.4.1 Isolation . 7
9.4.2 Identification of Pseudomonas aeruginosa . 7
10 Expression of results (detection of Pseudomonas aeruginosa) . 8
11 Neutralization of the antimicrobial properties of the product . 8
11.1 General . 8
11.2 Preparation of the inoculum . 8
11.3 Suitability of the detection method . 8
11.3.1 Procedure . 8
11.3.2 Interpretation of suitability test results . 9
12 Test report . 9
Annex A (informative) Other enrichment broths .10
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and
rinsing liquids .12
Bibliography .13
ISO 22717:2015(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 217, Cosmetics.
This second edition cancels and replaces the first edition (ISO 22717:2006), of which it constitutes a
minor revision.
iv © ISO 2015 – All rights reserved

ISO 22717:2015(E)
Introduction
Microbiological examinations of cosmetic products are carried out according to an appropriate
microbiological risk analysis in order to ensure their quality and safety for consumers.
Microbiological risk analysis depends on several parameters such as the following:
— potential alteration of cosmetic products;
— pathogenicity of microorganisms;
— site of application of the cosmetic product (hair, skin, eyes, mucous membranes);
— type of users (adults, children under 3 years).
For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus
aureus, Pseudomonas aeruginosa and Candida albicans may be relevant because they can cause skin
or eye infections. The detection of other kinds of microorganism might be of interest since these
microorganisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic
failure during the manufacturing process.
INTERNATIONAL STANDARD ISO 22717:2015(E)
Cosmetics — Microbiology — Detection of Pseudomonas
aeruginosa
1 Scope
This International Standard gives general guidelines for the detection and identification of the
specified microorganism Pseudomonas aeruginosa in cosmetic products. Microorganisms considered
as specified in this International Standard might differ from country to country according to national
practices or regulations.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate
microbiological risk analysis to determine the types of cosmetic product to which this International
Standard is applicable. Products considered to present a low microbiological (see ISO 29621) risk
include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
The method described in this International Standard is based on the detection of Pseudomonas
aeruginosa in a non-selective liquid medium (enrichment broth), followed by isolation on a selective
agar medium. Other methods may be appropriate, depending on the level of detection required.
NOTE For the detection of Pseudomonas aeruginosa, subcultures can be performed on non-selective culture
media followed by suitable identification steps (e.g. using identification kits).
Because of the large variety of cosmetic products within this field of application, this method may
not be appropriate in every detail for some products (e.g. certain water immiscible products). Other
International Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) may be
substituted for the tests presented here provided that their equivalence has been demonstrated or the
method has been otherwise shown to be suitable.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 21148:2005, Cosmetics — Microbiology — General instructions for microbiological examination
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal
(including bacteriophages) activity
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
product
portion of an identified cosmetic product received in the laboratory for testing
3.2
sample
portion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspension
ISO 22717:2015(E)
3.3
initial suspension
suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth
3.4
sample dilution
dilution of the initial suspension
3.5
specified microorganism
aerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and is recognized as a
skin pathogen species that may be harmful for human health or as an indication of hygienic failure in
the manufacturing process
3.6
Pseudomonas aeruginosa
gram-negative rod, motile; smooth colonies pigmented brown or greenish
Note 1 to entry: The main characteristics for identification are: growth on selective cetrimide agar medium,
oxidase positive, production of diffusible fluorescent pigments and production of a soluble phenazine pigment
(pyocyanin) in suitable media.
Note 2 to entry: Pseudomonas aeruginosa may be isolated from a wide variety of environmental sources,
especially in water and has a very high potential to spoil many different substrates. It may produce infections of
human skin or eye area. It is undesirable in cosmetic products for its potential pathogenicity and its capacity to
affect the physico-chemical properties of the cosmetic formula.
3.7
enrichment broth
non-selective liquid medium containing suitable neutralizers and/or dispersing agents and
demonstrated to be suitable for the product under test
4 Principle
The first step of the procedure is to perform an enrichment by using a non-selective broth medium to
increase the number of microorganisms without the risk of inhibition by the selective ingredients that
are present in selective/differential growth media.
The second step of the test (isolation) is performed on a selective medium followed by identification tests.
The possible inhibition of microbial growth by the sample sha
...