En 7 August 2025, el International Organization for Standardization (ISO) announced the registration of a new project, ISO/AWI 24913, developed by ISO Technical Committee 217 (ISO/TC 217). This draft international standard establishes a unified method for detecting and quantifying 1,4-dioxane in cosmetic products using advanced gas chromatography mass spectrometry (HS-GC-MS).
The project is currently in stage 20.00, marking it as a newly registered work item in the development phase. The standard will provide detailed procedures and validation methods to ensure compliance with international safety specifications.
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 Agencia de Protección Ambiental de los Estados Unidos (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.
Por qué es importante
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.
¿Quién debería prestar atención?
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.
Próximos pasos
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.
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Preguntas frecuentes
What is ISO/AWI 24913?
El Anexo 22 es una nueva guía emitida por PIC/S que establece expectativas regulatorias para el uso de IA y ML en la fabricación farmacéutica regulada por GMP.
Which cosmetic products are affected by the draft standard?
The standard applies to products such as hair and body wash, face cream, shampoo, toothpaste, liquid soap, solid soap, and lotion.
Why is 1,4-dioxane a regulatory concern?
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.
¿Cómo puedo? RegASK help organizations adapt to this update?
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.
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