ISO 29621:2017

Overview

ISO 29621:2017 - Cosmetics - Microbiology: Guidelines for the risk assessment and identification of microbiologically low-risk products provides guidance to cosmetic manufacturers and regulatory bodies on when finished cosmetic products can be considered microbiologically low-risk. The standard explains how to perform a microbiological risk assessment to determine whether full microbiological testing (and application of other cosmetic microbiology International Standards) is necessary. Its focus is on product characteristics, production and packaging factors that create a hostile environment for microbial survival and growth.

Key Topics

• Scope and definitions - clear definition of “microbiologically low-risk product” and the purpose of risk assessment.
• Risk assessment factors - evaluation framework based on:
  • Composition of the product (physico‑chemical characteristics that inhibit growth)
  • Water activity (aw) - available water controls microbial growth; reference points noted (e.g., aw < 0.7 commonly prevents growth; aw > 0.8 can permit proliferation)
  • pH of formulation - acidic or alkaline extremes can be hostile (examples: pH ~5 favors yeasts/moulds, pH