Regulatory Update on ISO Targets 1,4-Dioxane in Cosmetics

What the Draft Standard Covers

ISO/AWI 24913 specifies the use of automatic headspace gas chromatography mass spectrometry (HS-GC-MS) to detect and measure 1,4-dioxane in a wide range of cosmetic products, including hair and body wash, face cream, shampoo, toothpaste, liquid soap, solid soap, and lotion. 

Since 1,4-dioxane is classified as a potential human carcinogen by the U.S. Environmental Protection Agency (EPA), the development of this standard directly addresses health risks and consumer safety concerns. The draft outlines comprehensive methods, including definitions of terms, calculation of quantification limits, and validation protocols to ensure accurate and reliable results. 

Why It Matters 

The proposed standard introduces stricter quality control requirements and may lead to increased compliance costs for manufacturers. By defining clear testing procedures, it helps companies meet international safety standards, strengthens regulatory alignment, and reassures consumers about product safety. 

Who Should Pay Attention 

This update is highly relevant for regulatory affairs teams, QA specialists, cosmetic manufacturers, laboratory analysts, and compliance managers. Organizations in these areas should begin assessing their current testing capabilities and aligning them with the new ISO framework. 

Next Steps

Businesses should review their testing protocols for 1,4-dioxane, evaluate whether they need new equipment or lab partnerships, and closely monitor further announcements from ISO/TC 217. Preparing early will minimize disruption when the standard advances to later stages of implementation. 

To support teams in managing regulatory change, RegASK provides solutions that streamline global regulatory monitoring and adaptation. 

RegASK is an AI-driven solution for Regulatory Intelligence and Workflow Orchestration helping life sciences and consumer packaged goods companies stay ahead of changing global regulations and guidelines with predictive insights. It combines smart documentation, automated workflows, and integrated experts to enable faster adaptation, which ultimately reduces operational risk. Learn more or book a demo now. 

FAQs

Annex 22 is new guidance issued by PIC/S that sets regulatory expectations for the use of AI and ML in GMP-regulated pharmaceutical manufacturing.

The standard applies to products such as hair and body wash, face cream, shampoo, toothpaste, liquid soap, solid soap, and lotion. 

1,4-dioxane can appear as a contaminant during cosmetic manufacturing and is classified as a potential human carcinogen by the U.S. Environmental Protection Agency. 

RegASK enables compliance teams to track evolving standards like ISO/AWI 24913, streamline testing protocol updates, and reduce the operational risks of non-compliance through AI-driven intelligence and workflow automation.