EU’s RAC Strengthens Talc Regulation with Stricter Carcinogen Classification

On 26 September 2024, the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) concluded that talc should be classified as a Category 1B carcinogen and STOT RE1 under the Classification, Labelling and Packaging (CLP) Regulation. Although a lower classification (Category 2 carcinogen) was proposed by the proposal submitter the Netherlands, RAC opted for the more stringent Category 1B, indicating greater concern about talc’s potential to cause cancer.

Implications of the New Classification

The Category 1B classification means that talc (Mg₃H₂(SiO₃)₄; CAS No 14807-96-6) is suspected of causing cancer in humans, which may lead to its designation as a substance of very high concern (SVHC). This new classification could have a significant impact on industries that rely on talc, particularly in cosmetics, pharmaceuticals and other consumer products.

Evidence Behind the Decision

RAC's decision was based on limited human and animal evidence, a first for the committee, which usually bases its conclusions on sufficient evidence from animal studies. Talc has been linked to lung tumours in female rats following inhalation and ovarian tumours in humans following perineal exposure. The Committee also agreed on a classification for specific target organ toxicity (STOT RE) related to repeated lung exposure.

Industry Reaction and Regulatory Implications

The European talc industry, represented by Eurotalc, strongly opposes this classification, claiming that the evidence does not meet the criteria for carcinogenicity. Nevertheless, tighter regulatory controls on talc-containing products are expected as the new classification addresses all routes of exposure due to insufficient data to exclude other routes, such as oral ingestion.

 Future Regulatory Outlook

RAC’s decision is expected to influence regulatory frameworks across Europe and beyond. As authorities continue to assess the safety of talc, manufacturers will need to prepare for tighter regulations and increased scrutiny of products containing talc.

Other Classification and Labelling Decisions from the RAC Meeting

In addition to the classification of talc, RAC adopted opinions on harmonised classification and labelling (CLH) for twelve other substances including:

• Eugenol (CAS 97-53-0): Widely used in perfumes, cosmetics, and cleaning products. Classified as Acute Toxicity 4, Eye Irritation 2 and Aquatic Chronic 2, but no classification for skin irritation.

• 3,5-Dimethylpyrazole (CAS 67-51-6): Used in the manufacture of polymers and coatings. RAC supported the classifications Acute Toxicity 4 and Reproductive Toxicity 1B proposed by Belgium.

• Borate Minerals Group: RAC supported a Reproductive Toxicity 1B classification potential risks to fertility.

The full list of opinions is available here. These decisions reflect the ongoing work of RAC to ensure the safety of chemicals in the EU. The full opinions will be published on the ECHA website shortly.

Opinions on Chromium Compounds

RAC also adopted opinions on chromium compounds, which are commonly used in metal plating, pigments and corrosion protection. These included opinions on the use of chromium trioxide and other compounds of hexavalent chromium (Cr(VI)), which are known carcinogens. The full list of adopted opinions can be found here.