Talc should be classified as a Category 1B carcinogen (“presumed to be carcinogenic to humans”) under the EU Classification, Labelling, and Packaging (CLP) Regulation, according to a final opinion released by the European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) on July 9, 2025. Furthermore, talc is suggested to be categorized as a chemical that mostly affects the lungs and is a Specific Target Organ Toxicity – Repeated Exposure (STOT RE) Category 1.

I. Background

The naturally occurring mineral talc (chemical formula: Mg₃H₂(SiO₃)₄) finds extensive use in industrial, food, medicinal, and cosmetic applications. For decades, there have been ongoing debates about its possible carcinogenicity. Baby powders containing talc have previously been the subject of safety warnings or court decisions from nations like the US, Canada, and South Korea. Inconsistent categorization now occurs in the EU, with some businesses labeling talc as carcinogenic while others do not consider it dangerous.

II. Key Conclusions

1. Carcinogenicity

• Animal research: Female rats with lung adenomas and adenocarcinomas were found in a 1993 National Toxicology Program (NTP) long-term inhalation study.

• Human epidemiology: Despite confounding variables (such as recall bias and past asbestos exposure), more than 30 case-control studies and three meta-analyses consistently show a 20–30% higher risk of ovarian cancer linked to perineal use of talc-based products.

• Mechanical support: Talc promotes oxidative stress and chronic inflammation, which are linked to carcinogenic pathways.

2. Specific Target Organ Toxicity Repeated Exposure (STOT RE)

• Human data: Pneumoconiosis, decreased lung function, and pulmonary fibrosis have all been related to miners’ and mill workers’ prolonged inhalation of talc.

• Research on animals: Long-term inhalation caused pulmonary fibrosis, granulomatous inflammation, and reduced lung function in rats.

III. Next Steps

Carc. 1B (H350) + STOT RE 1 (H372, inhalation, lungs) is the unified categorization that the RAC determined was necessary despite methodological constraints due to strong evidence from animal carcinogenicity studies, adequate human data on ovarian cancer risk, and unambiguous pulmonary toxicity data. A final decision is anticipated by early 2026 after the opinion has been sent to the European Commission and EU Member States for assessment. All talc-containing goods sold in the EU will have to alter their labels within 18 months if the rule is approved.

Stay ahead in sustainability compliance with Global PCCS —where expert insights meet the latest regulations. Unlock a future where compliance fuels sustainability, helping your business thrive in a greener, well-regulated world. For more information, contact us at info@globalpccs.com