ISO 17516-2014 PDF

Full title and description

ISO 17516:2014 — Cosmetics — Microbiology — Microbiological limits. An International Standard that specifies microbiological limits and criteria to assist in the assessment of the microbiological quality of finished cosmetic products.

Abstract

ISO 17516:2014 provides quantitative and qualitative microbiological limits for finished cosmetics. It identifies objectionable microorganisms and sets acceptable total viable count limits for different product categories, and specifies absence/acceptance criteria for specified pathogenic or quality‑affecting organisms. The standard is intended to help manufacturers and testing laboratories assess product microbiological quality and to support risk‑based decisions about when microbiological testing is required.

General information

• Status: Published (confirmed in 2020); under revision / replacement by ISO/DIS 17516 (draft in development).
• Publication date: October 2014 (Edition 1).
• Publisher: International Organization for Standardization (ISO), Technical Committee ISO/TC 217.
• ICS / categories: 07.100.40 (Cosmetics microbiology).
• Edition / version: Edition 1 (2014) — current edition until formally replaced.
• Number of pages: 5 (ISO published English edition: 5 pages).

Scope

Applies to finished cosmetic products and provides microbiological limits to be used when assessing product quality and safety. The standard: defines objectionable microorganisms for cosmetics; gives numerical limits for total viable counts according to product categories (e.g., more stringent limits for products used on young children or on mucous membranes/eye area); and specifies absence/acceptance criteria for specified organisms in defined test sample sizes. It is not a method standard (testing methods are given in related ISO methods) and notes that microbiological testing is not required for products assessed as microbiologically low risk.

Key topics and requirements

• Sets maximum acceptable total viable counts for finished cosmetics (typical limits cited in practice: ≤1 × 10² CFU/g or mL for products intended for infants, for use around the eyes, or on mucous membranes; ≤1 × 10³ CFU/g or mL for most other products).
• Requires absence (not detectable in the stated test portion) of specified objectionable microorganisms in defined sample sizes — commonly listed organisms include Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans (and other specified Enterobacteriaceae where applicable).
• Defines the notion of an "objectionable microorganism" as organisms that may cause infection or indicate hygienic failure and gives guidance for identifying such organisms.
• Emphasizes manufacturer responsibility for microbiological safety and for applying a risk‑based approach to testing and limits (including consideration of product use, formulation, preservation, packaging and manufacturing hygiene).
• Refers users to complementary ISO method standards for enumeration and detection (e.g., standards for aerobic mesophilic counts, yeast and mould enumeration, and detection methods for specific pathogens).

Typical use and users

Used by cosmetic manufacturers, quality control and microbiology laboratories, regulatory affairs professionals and conformity assessment bodies. It supports product release testing, supplier and raw material assessment, investigation of product complaints, and development of internal microbiological specifications and quality systems.

Related standards

Part of the ISO/TC 217 family of cosmetics‑microbiology standards. Commonly referenced related standards include ISO 21149 (enumeration and detection of aerobic mesophilic bacteria), ISO 16212 (enumeration of yeast and mould), ISO 18416 (detection of Candida albicans), ISO 22717 (detection of Pseudomonas aeruginosa), ISO 22718 (detection of Staphylococcus aureus), ISO 21150 (detection of Escherichia coli) and ISO 29621 (guidelines for risk assessment and identification of microbiologically low‑risk products).

Keywords

cosmetics; microbiology; microbiological limits; total viable count; objectionable microorganisms; Pseudomonas aeruginosa; Staphylococcus aureus; Candida albicans; Escherichia coli; ISO/TC 217; product safety; risk assessment.

FAQ

Q: What is this standard?

A: ISO 17516:2014 is an international standard that specifies microbiological limits and acceptance/absence criteria for finished cosmetic products to help assess microbiological quality and safety.

Q: What does it cover?

A: It covers quantitative limits for total viable counts for different product categories and qualitative criteria for the absence of specified objectionable organisms in defined test samples; it also defines what constitutes an objectionable microorganism and promotes a risk‑based approach to microbiological testing.

Q: Who typically uses it?

A: Cosmetic manufacturers, QC and microbiology laboratories, regulatory and compliance teams, and auditors use it to set product specifications, run release testing, investigate microbiological issues, and demonstrate conformity with good manufacturing practice.

Q: Is it current or superseded?

A: The standard was published in October 2014 (Edition 1) and was confirmed in 2020. ISO has been developing a revised edition (ISO/DIS 17516) to replace the 2014 edition; until the revision is published the 2014 edition remains the current published standard.

Q: Is it part of a series?

A: Yes. ISO 17516 sits within the suite of ISO/TC 217 cosmetics microbiology standards and is intended to be used together with related method and guidance standards (for enumeration, detection of specific organisms and risk assessment) in the cosmetics microbiology series.

Q: What are the key keywords?

A: Cosmetics, microbiology, microbiological limits, total viable count, objectionable microorganisms, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, ISO/TC 217.