ISO 21149-2017 PDF

Full title and description

ISO 21149:2017 — Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria. An International Standard that specifies laboratory procedures (plate counts, membrane filtration and enrichment) and associated sample handling, diluents and media for enumerating or demonstrating the absence of aerobic mesophilic bacteria in cosmetic products.

Abstract

ISO 21149:2017 provides general, standardized methods for the enumeration and detection of aerobic mesophilic bacteria in a wide range of cosmetic products. Methods covered include plate-count techniques and membrane filtration for colony enumeration, and enrichment procedures to detect absence/presence. The standard describes required diluents, neutralizers, culture media and sample preparation notes; it permits validated alternative methods where equivalence is demonstrated. Amendment 1 (2022) updates media compositions and preparation details.

General information

• Status: Published (International Standard; confirmed in ISO review cycle)
• Publication date: June 2017 (ISO 21149:2017); Amendment 1 published 2022 (ISO 21149:2017/Amd 1:2022, issued Aug–Sep 2022 by ISO/CEN adoption)
• Publisher: International Organization for Standardization (ISO) — Technical Committee ISO/TC 217 (Cosmetics)
• ICS / categories: 07.100.40 (Cosmetics microbiology); related classifications reported: 07.100.99, 71.100.70
• Edition / version: Edition 2 (2017); amended by Amendment 1 (2022)
• Number of pages: 24 (ISO published edition)

Scope

The standard applies to the microbiological examination of cosmetic products for aerobic mesophilic bacteria. It gives procedures for counting viable aerobic mesophilic bacteria (plate count and membrane filtration) and for demonstrating the absence of such bacteria by enrichment. The document is intended for a wide range of cosmetic matrices but notes that some product types (for example certain water-immiscible products) may require adapted or alternative procedures; users are advised to perform a microbiological risk assessment to determine applicability.

Key topics and requirements

• Principles and selection of methods: plate-count (pour-plate, spread-plate), membrane filtration and enrichment-based detection.
• Sample handling and preparation: instructions for water-miscible and water-immiscible products, homogenization and choice of diluents.
• Diluents and neutralizers: formulation and use of neutralizing diluents to counteract preservatives or antimicrobial ingredients in cosmetics.
• Culture media and incubation: specifications for culture media and aerobic incubation conditions required for enumeration; Amendment 1 (2022) updates compositions (e.g., Eugon/modifications) and preparation steps for enrichment media and agar.
• Counting and interpretation: procedures for colony counting, calculation of results, and criteria for reporting presence/absence after enrichment.
• Identification and follow-up: guidance that isolates obtained can be identified using appropriate identification methods (referenced standards in the bibliography).
• Method equivalence and alternatives: allowance for validated automated or alternative methods where equivalence or suitability has been demonstrated.
• Quality and risk considerations: recommendation to perform microbiological risk analysis (see ISO 29621) to determine the need and applicability of tests for specific product types.

Typical use and users

Routine and investigative microbiological testing in cosmetic industry quality control and R&D; contract and independent microbiology laboratories that test cosmetic products; regulatory and conformity assessment bodies; manufacturers implementing product release, stability and shelf-life testing; consultants developing test plans and microbiological specifications.

Related standards

ISO 21149 is part of the cosmetics microbiology suite (ISO/TC 217). Key related documents include ISO 29621 (guidelines for identifying low‑microbiological‑risk products), ISO 21148 (general instructions for microbiological examination), ISO 21150 (detection of Escherichia coli), ISO 22717 (detection of Pseudomonas aeruginosa), ISO 22716 (cosmetics — Good Manufacturing Practices), ISO 18415/18416 (detection of specified/non‑specified microorganisms and Candida albicans) and other ISO microbiology methods and regional/adopted versions (EN ISO 21149 and national adoptions). Users should consult the bibliography of ISO 21149 for the full set of referenced standards.

Keywords

cosmetics, microbiology, aerobic mesophilic bacteria, enumeration, plate count, membrane filtration, enrichment, diluents, neutralizers, culture media, ISO 21149, amendment 2022, QC, laboratory method

FAQ

Q: What is this standard?

A: ISO 21149:2017 is an ISO International Standard that specifies laboratory methods for enumerating and detecting aerobic mesophilic bacteria in cosmetic products (plate counts, membrane filtration and enrichment procedures).

Q: What does it cover?

A: It covers the principles and step-by-step procedures for sample preparation, choice and preparation of diluents/neutralizers, culture media specifications, incubation and colony counting, and enrichment methods to demonstrate absence of bacteria. Amendment 1 (2022) provides updates to media compositions and preparation details.

Q: Who typically uses it?

A: Cosmetic manufacturers, contract testing laboratories, regulatory bodies and quality/control personnel use the standard for routine testing, product release, stability studies and investigation of microbial contamination.

Q: Is it current or superseded?

A: The current edition is ISO 21149:2017 (Edition 2), published June 2017. It was amended by ISO 21149:2017/Amd 1:2022 (amendment published in 2022). ISO records indicate the 2017 edition with the 2022 amendment is the active/confirmed version following ISO review.

Q: Is it part of a series?

A: Yes. ISO 21149 is part of the ISO/TC 217 cosmetics microbiology family of standards that together address detection and enumeration of specified and non‑specified microorganisms, sampling, risk assessment and good manufacturing practice (examples include ISO 21148, ISO 21150, ISO 22717, ISO 29621 and others).

Q: What are the key keywords?

A: Cosmetics, microbiology, aerobic mesophilic bacteria, enumeration, plate count, membrane filtration, enrichment, neutralizers, culture media, ISO 21149.