ISO 16212-2017 PDF

Full title and description

ISO 16212:2017 — Cosmetics — Microbiology — Enumeration of yeast and mould. This International Standard gives general guidelines for enumerating yeasts and moulds present in finished cosmetic products by counting colonies on a selective agar medium after aerobic incubation, and provides guidance on applicability, sample preparation and interpretation of results for quality and safety control of cosmetic products.

Abstract

ISO 16212:2017 specifies a culture‑based colony counting method for the enumeration of yeast and moulds in cosmetics. The method covers selection of appropriate selective media, incubation conditions, sample preparation (including neutralization where required), colony counting and reporting. It notes that a microbiological risk assessment should be used to determine applicability (products considered low risk are excluded) and that alternative or automated methods may be used if equivalence is demonstrated.

General information

• Status: Published (International Standard; edition reviewed/confirmed).
• Publication date: June 2017 (Edition 2, published June 2017).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 217 (Cosmetics).
• ICS / categories: 07.100.40 (Cosmetics — Microbiology).
• Edition / version: Edition 2 (2017); includes Amendment 1 published in 2022 (ISO 16212:2017/Amd 1:2022).
• Number of pages: ISO lists 19 pages for the ISO PDF (national/adopted versions may show different page counts—e.g., some national adoptions/EN versions record higher page counts when including national forewords or amendments).

Scope

This standard gives general guidelines for enumeration of yeasts and moulds present in cosmetic products by colony counting on selective agar following aerobic incubation. It is intended for use as a laboratory method for routine quality control and stability testing where enumeration of fungal contaminants is required; it also describes limitations and notes product types that may be considered low microbiological risk (and therefore outside the routine application) and products for which the method may need adaptation.

Key topics and requirements

• Principle of enumeration by plating on selective agar and aerobic incubation conditions.
• Sample preparation, dilution and neutralization techniques appropriate for cosmetics matrices.
• Selection and use of suitable selective media for yeasts and moulds.
• Colony counting procedures, calculation of results (CFU per g or mL), and reporting conventions.
• Recognition of method limitations, applicability notes for water‑immiscible products and guidance to use alternative/automated methods when equivalence is shown.
• Recommendation to perform microbiological risk assessment (see ISO 29621) to determine applicability.
• Identification guidance for isolates where identification of yeast or moulds is required (reference to other identification standards/methods).

Typical use and users

Primary users are cosmetic manufacturers (quality control and R&D), contract testing laboratories, regulatory testing bodies and laboratories maintaining product safety/quality systems. The method is used for routine batch release testing, stability/benchmark testing, investigation of suspected contamination events, and method validation/comparison when introducing alternate enumeration technologies.

Related standards

ISO 16212 is part of the cosmetics‑microbiology family of standards developed by ISO/TC 217. Closely related standards include ISO 29621 (guidelines for microbiologically low‑risk products), ISO 21149 (enumeration and detection of aerobic mesophilic bacteria), ISO 11930 (evaluation of antimicrobial protection/preservation efficacy), ISO 22717 (detection of Pseudomonas aeruginosa) and ISO 22718 (detection of Staphylococcus aureus). These documents are commonly referenced together for a comprehensive microbiological testing program for cosmetics.

Keywords

cosmetics, microbiology, yeast, mould, enumeration, colony counting, selective agar, aerobic incubation, ISO/TC 217, microbiological risk assessment.

FAQ

Q: What is this standard?

A: ISO 16212:2017 is an International Standard that specifies a laboratory method for enumeration of yeasts and moulds in cosmetic products by colony counting on selective agar after aerobic incubation.

Q: What does it cover?

A: It covers sample preparation, choice of selective media, incubation conditions, counting and calculation of colony forming units (CFU), reporting of results, and notes on applicability and limitations for various cosmetic product types.

Q: Who typically uses it?

A: Cosmetic manufacturers, QC/R&D laboratories, contract testing labs and regulatory or compliance testing organizations use this standard as part of routine microbiological quality control and product safety testing.

Q: Is it current or superseded?

A: ISO 16212:2017 (Edition 2) is the current edition; it was reviewed/confirmed and has an Amendment 1 published in 2022. The 2008 edition was withdrawn and superseded by the 2017 edition.

Q: Is it part of a series?

A: Yes — it is part of the ISO cosmetics‑microbiology suite of standards maintained by ISO/TC 217 and is intended to be used alongside related methods such as ISO 29621, ISO 21149, ISO 11930 and organism‑specific detection standards (ISO 22717, ISO 22718, etc.).

Q: What are the key keywords?

A: Key keywords are cosmetics, yeast, mould, enumeration, colony counting, selective agar, microbiological testing, CFU, ISO/TC 217.