ISO/FDIS 17516

• Abstract:

  ISO 17516:2014 is applicable for all cosmetics and assists interested parties in the assessment of the microbiological quality of the products. Microbiological testing does not need to be performed on those products considered to be microbiologically low risk.

• Status: Not Published
• ICS: 07.100.40 - Cosmetics microbiology
• Technical Committee: ISO/TC 217 - Cosmetics
• Drafting Committee: ISO/TC 217/WG 1 - Microbiological standards and limits
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 14-Jul-2026
• Completion Date: 14-Jul-2026

• Consolidates: prEN ISO 17516 - Cosmetics - Microbiology - Microbiological limits (ISO/DIS 17516:2026)
• Effective Date: 12-Feb-2026
• Consolidates: ISO 21219-21:2025 - Intelligent transport systems — Traffic and travel information (TTI) via transport protocol experts group, generation 2 (TPEG2) — Part 21: Geographic location referencing (TPEG-GLR)
• Effective Date: 27-Dec-2025
• Revises: ISO 17516:2014 - Cosmetics — Microbiology — Microbiological limits
• Effective Date: 13-Dec-2025

Overview

ISO/FDIS 17516: Cosmetics - Microbiology - Microbiological Limits sets internationally recognized microbiological quality criteria for finished cosmetic products. Developed by ISO Technical Committee 217, this standard provides quantitative and qualitative microbial limits, supporting the overall microbiological safety of cosmetic products. It is applicable to all cosmetics, except those identified as microbiologically low-risk, as outlined in ISO 29621.

Meeting microbiological quality standards is crucial for consumer safety and maintaining product integrity. Compliance with ISO/FDIS 17516 helps manufacturers, brand owners, and regulatory bodies assess, control, and ensure that cosmetic products are safe under normal or reasonably foreseeable use.

Key Topics

• Microbial Limits for Cosmetics:
  Specifies acceptable microbial counts and absence requirements for certain indicator organisms in cosmetic products.

• Specified vs. Non-Specified Microorganisms:
  Defines critical organisms, such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans, which must not be present in finished products.

• Product Categorization:
  Differentiates products specifically intended for infants, children under three, eye area, or mucous membranes, which are subject to stricter microbiological limits compared to other cosmetics.

• Interpretation of Results:
  Provides criteria and a flowchart (Annex A) for interpreting microbiological test results, considering inherent variability in testing methods.

• Exemptions for Low-Risk Products:
  Recognizes that some cosmetics, when assessed as low risk per ISO 29621, do not require routine microbiological testing.

Applications

Implementing ISO/FDIS 17516 brings clear practical benefits to the cosmetics industry:

• Product Development and Safety Assurance:
  Enables manufacturers to design and validate products that meet defined microbiological limits, thereby supporting safe use by consumers.

• Quality Control:
  Provides a benchmark for routine batch testing, environmental monitoring, and root cause analysis in case of contamination or product recalls.

• Regulatory Compliance:
  Helps brands and manufacturers demonstrate alignment with international and national regulations, assisting with market access and product registration.

• Risk Management:
  Allows manufacturers to perform a risk assessment on product formulations and production processes, determining when routine microbiological testing is necessary or can be omitted for low-risk products.

• Consumer Confidence:
  Reinforces trust among consumers and retailers by showing commitment to highest standards of safety and hygiene in cosmetic products.

Related Standards

ISO/FDIS 17516 references and aligns with several key standards in cosmetic microbiology and quality management, including:

• ISO 29621: Guidelines for risk assessment and identification of microbiologically low-risk cosmetic products.
• ISO 22716: Guidelines for Good Manufacturing Practices (GMP) in cosmetics.
• ISO 21148, ISO 21149, ISO 16212: General instructions, enumeration and detection methods for various microorganisms in cosmetics.
• ISO 18415, ISO 18416, ISO 21150, ISO 22717, ISO 22718: Detection of specific pathogens linked to cosmetic contamination.
• ISO 11930: Evaluation of antimicrobial protection of a cosmetic product.
• Pharmacopoeial Methods: US Pharmacopoeia <61> and European Pharmacopoeia 2.6.12 for microbial testing of non-sterile products.

Summary

ISO/FDIS 17516 serves as an essential standard for the cosmetic industry to set, test, and maintain microbiological quality and safety. Adherence ensures manufacturers deliver safe cosmetics to consumers, facilitates international trade, and upholds regulatory requirements across diverse markets. For robust product safety and brand assurance, ISO/FDIS 17516 should be part of any comprehensive cosmetics quality management system.

FINAL DRAFT
International
Standard
ISO/TC 217
Cosmetics — Microbiology —
Secretariat: INSO
Microbiological limits
Voting begins on:
Cosmétiques — Microbiologie — Limites microbiologiques 2026-07-14
Voting terminates on:
2026-10-06
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 217
Cosmetics — Microbiology —
Secretariat: INSO
Microbiological limits
Voting begins on:
Cosmétiques — Microbiologie — Limites microbiologiques
Voting terminates on:
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Microbiological limits for cosmetics . 2
Annex A (normative) Flowchart for interpretation of test results . 4
Bibliography . 5

iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of 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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
This second edition cancels and replaces the first edition (ISO 17516:2014), of which it constitutes a minor
revision.
The changes are as follows:
— Clause 2 has been added and subsequent clauses have been renumbered;
— the bibliography has been updated.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
Every cosmetic manufacturer has a responsibility relative to the microbiological safety and quality of its
products to ensure that they have been produced under hygienic conditions. Cosmetic products are not
expected to be sterile. However, they shall not contain excessive amounts of microorganisms nor specified
microorganisms that have the potential to affect the product quality or consumer safety. Moreover, some
[1]
cosmetic products which are considered to have low microbiological risk (see ISO 29621 ) may not need to
be subjected to routine microbiological testing, and manufacturers can decide not to test if they can ensure
products meet this standard.
[2]
The manufacturer should follow the Good Manufacturing Practices described in ISO 22716 and take the
necessary precautions to limit the introduction of microorganisms from raw materials, process
...

Style Definition: List Continue 1: Indent: Left: 0 cm,
ISO/DISFDIS 17516
Hanging: 0.63 cm, Bulleted + Level: 1 + Aligned at: 0
cm + Indent at: 0.63 cm
ISO/TC 217
Secretariat: INSO
Date: 2026-06-1530
Cosmetics — Microbiology — Microbiological limits
Cosmétiques — Microbiologie — Limites microbiologiques
Formatted: French (France)
DISFDIS stage
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ISO/DISFDIS 17516:2026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (France)
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 17516:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Principle. iii
Microbiological limits for cosmetics. iii
(normative) Flowchart for interpretation of test results . iii
Bibliography . iii
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Microbiological limits for cosmetics . 2
Annex A (normative) Flowchart for interpretation of test results . 4
Bibliography . 7

iii
ISO/DISFDIS 17516:2026(en)
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/directiveswww.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. 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.
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 onof the voluntary nature of 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: Foreword -
Supplementary informationwww.iso.org/iso/foreword.html.
The committee responsible for thisThis document iswas prepared by Technical Committee ISO/TC 217,
Cosmetics.
This second edition cancels and replaces the first edition (ISO 17516:2014), of which it constitutes a minor
revision.
The changes are as follows:
— Clause 2 has been added and subsequent clauses have been renumbered;
— the bibliography has been updated.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DISFDIS 17516:2026(en)
Introduction
Every cosmetic manufacturer has a responsibility relative to the microbiological safety and quality of its
products to ensure that they have been produced under hygienic conditions. Cosmetic products are not
expected to be sterile. However, they shall not contain excessive amounts of microorganisms nor specified
microorganisms that have the potential to affect the product quality or consumer safety. Moreover, some
cosmetic products which are considered to have low microbiological risk (see ISO 29621ISO 29621) may not
need to be subjected to routine microbiological testing, and manufacturers can decide not to test if they can
ensure products meet this standard.
The manufacturer should follow the Good Manufacturing Practices described in ISO 22716ISO 22716 and take
the necessary precautions to limit the introduction of microorganisms from raw materials, processing and
packagi
...

PROJET FINAL
Norme
internationale
ISO/TC 217
Cosmétiques — Microbiologie —
Secrétariat: INSO
Limites microbiologiques
Début de vote:
Cosmetics — Microbiology — Microbiological limits 2026-07-14
Vote clos le:
2026-10-06
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
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INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
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NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 217
Cosmétiques — Microbiologie —
Secrétariat: INSO
Limites microbiologiques
Début de vote:
Cosmetics — Microbiology — Microbiological limits
2026-07-14
Vote clos le:
2026-10-06
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Principe. 2
5 Limites microbiologiques relatives aux produits cosmétiques . 2
Annexe A (normative) Logigramme pour l'interprétation des résultats d'essai . 4
Bibliographie . 5

iii
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 (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir https://www.iso.org/directives).
L'ISO attire l'attention sur le fait que la mise en application du présent document peut entraîner l'utilisation
d'un ou de plusieurs brevets. L'ISO ne prend pas position quant à la preuve, à la validité et à l'applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l'ISO n’avait pas
reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d'avertir les responsables de la mise en application du présent document que des informations
plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à l'adresse
www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou partie de
tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l'intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 217, Cosmétiques.
Cette seconde édition annule et remplace la première édition (ISO 17516:2014), dont elle constitue une
révision mineure.
Les modifications sont les suivantes:
— l'Article 2 a été ajouté et les articles suivants ont été renumérotés;
— la Bibliographie a été mise à jour.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l'adresse www.iso.org/members.html.

iv
Introduction
Chaque fabricant de produits cosmétiques est responsable de la sécurité microbiologique et de la qualité
de ses produits et doit s’assurer qu’ils ont été produits dans des conditions hygiéniques. Les produits
cosmétiques ne sont pas censés être stériles. Toutefois, ils ne doivent pas contenir de quantités excessives
de micro-organismes ni de micro-organismes spécifiés susceptibles d’affecter la qualité du produit ou
la sécurité du consommateur. De plus, il peut ne pas être nécessaire de soumettre certains produits
[1]
cosmétiques considérés comme présentant un faible risque microbiologique (voir l’ISO 29621 ) à des essais
microbiologiques de routine et les fabricants peuvent choisir de ne pas les soumettre à essai s’ils peuvent
assurer que leurs produits satisfont aux caractéristiques énoncées dans la présente norme
...