prEN ISO 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
• Publication Date: 07-Feb-2028
• ICS: 07.100.40 - Cosmetics microbiology
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 2 - Microbiological methods
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 16-Jul-2026
• Completion Date: 16-Jul-2026
• Ref Project: oSIST prEN ISO 17516:2026 - Cosmetics - Microbiology - Microbiological limits (ISO/FDIS 17516:2026)

• Consolidated By: ISO/FDIS 17516 - Cosmetics — Microbiology — Microbiological limits
• Effective Date: 12-Feb-2026
• Revises: EN ISO 17516:2014 - Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014)
• Effective Date: 17-Dec-2025

Overview

prEN ISO 17516:2026 (ISO/FDIS 17516:2026), Cosmetics - Microbiology - Microbiological Limits defines internationally recognized microbiological criteria for evaluating the quality and safety of cosmetic products. Developed by CEN and ISO Technical Committee 217, this standard ensures that finished cosmetic products comply with microbiological limits to safeguard consumer health and product integrity. It applies to all cosmetics except those demonstrated to pose a low microbiological risk, providing a framework for manufacturers and regulatory authorities.

Key Topics

• Microbiological Limits in Cosmetics: Specifies acceptable quantitative and qualitative levels of microorganisms in finished cosmetic products. These limits include maximum counts for aerobic mesophilic microorganisms, as well as the mandatory absence of certain pathogenic species.

• Categories of Microorganisms:

  • Aerobic mesophilic bacteria, yeasts, and moulds
  • Specified microorganisms, such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans

• Product Groupings: Special criteria apply to cosmetics for children under three, eye area use, and mucous membrane applications.

• Risk Assessment: Allows for exemption from routine microbiological testing for low-risk products when justified by a documented risk assessment according to ISO 29621.

• Good Manufacturing Practices: Recommends adherence to ISO 22716 to minimize contamination during production and packaging.

Applications

• Industry Compliance: Cosmetic manufacturers use prEN ISO 17516 to verify that their products meet global microbiological safety requirements before market release, reducing the risk of product recalls and regulatory issues.

• Quality Control: Laboratory professionals utilize the standard to design and implement effective microbiological testing procedures, ensuring batches are within specified limits for pathogens and spoilage organisms.

• Regulatory Reference: Regulatory authorities may cite ISO 17516 or incorporate its requirements into national legislations, establishing a clear benchmark for cosmetic safety.

• Product Development: R&D and formulation scientists refer to prEN ISO 17516 during ingredient sourcing and product design to select preservatives and packaging formats that maintain microbiological quality over shelf-life.

• Consumer Protection: By following this standard, manufacturers contribute to high levels of hygiene and safety in beauty and personal care products, minimizing the risk of infections or adverse reactions linked to microbial contamination.

Related Standards

For a comprehensive approach to cosmetic microbiology and product safety, prEN ISO 17516 references and aligns with several other key standards:

• ISO 29621: Guidelines for microbiological risk assessment and identification of low-risk cosmetic products
• ISO 22716: Good Manufacturing Practices (GMP) for the cosmetics industry
• ISO 21148: General instructions for microbiological examination of cosmetics
• ISO 21149 / ISO 16212: Enumeration and detection of bacteria, yeast, and mould
• ISO 18415 / ISO 21150 / ISO 22717 / ISO 22718 / ISO 18416: Detection methods for specified pathogens
• ISO 11930: Evaluation of antimicrobial protection of a cosmetic product
• International Pharmacopoeias (USP, EP): Microbial enumeration and quality test methods

By integrating prEN ISO 17516 into their operational protocols, stakeholders in the cosmetics supply chain enhance product safety, fulfill regulatory expectations, and demonstrate a commitment to best practices in cosmetics microbiology.

Keywords: cosmetic microbiological limits, microbiological safety, cosmetic product testing, ISO 17516, cosmetics standard, CEN, product safety, quality control, GMP, pathogen testing in cosmetics.

SLOVENSKI STANDARD
01-september-2026
Kozmetika - Mikrobiologija - Mikrobiološke mejne vrednosti (ISO/FDIS 17516:2026)
Cosmetics - Microbiology - Microbiological limits (ISO/FDIS 17516:2026)
Kosmetische Mittel - Mikrobiologie - Mikrobiologische Grenzwerte (ISO/FDIS
17516:2026)
Cosmétiques - Microbiologie - Limites microbiologiques (ISO/FDIS 17516:2026)
Ta slovenski standard je istoveten z: prEN ISO 17516
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
International
Standard
ISO/FDIS 17516
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
ISO/FDIS 17516:2026(en) © ISO 2026

FINAL DRAFT
ISO/FDIS 17516:2026(en)
International
Standard
ISO/FDIS 17516
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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 17516:2026(en) © ISO 2026

ii
ISO/FDIS 17516:2026(en)
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
ISO/FDIS 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/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
ISO/FDIS 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
[1]
cosmetic products which ar
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