Key takeaway
What This Development Means
The European Chemicals Agency's Committee for Risk Assessment (RAC) has adopted 13 new opinions on the harmonised classification and labelling of various hazardous substances during its September 2024 meeting. Key substances affected include talc, eugenol, and tebuconazole, which are widely used in industries ranging from cosmetics to agriculture. The updated classifications focus on the substances' potential health risks, including carcinogenicity, reproductive toxicity, and environmental harm. These changes will impact regulatory compliance for industries that utilize these chemicals, prompting a shift toward enhanced safety measures.
Why did RAC classify talc (EC 238-877-9, CAS 14807-96-6) as Carcinogen 1B?
RAC classified talc as Carcinogen 1B (H350) due to evidence from both animal and human studies suggesting that exposure to talc may cause cancer. Animal studies showed lung tumors in female rats exposed via inhalation, and human studies linked genital/perineal use of talc with ovarian tumors in women. While RAC considered whether the classification should apply to specific exposure routes, there wasn't enough data to exclude any routes, including oral exposure. Therefore, under the CLP Regulation, the classification applies to all routes of exposure, as the hazard could not be conclusively limited to one type.
What industries are most affected by RAC’s new classifications?
Industries like cosmetics, pharmaceuticals, agriculture, and manufacturing will be most affected by RAC’s new classifications. Substances such as talc, eugenol, borate minerals, and tebuconazole are widely used in these sectors, and the updated labelling and safety requirements will require companies to reassess their product formulations and safety measures.
In its September 2024 meeting, the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) adopted 13 new opinions on the harmonised classification and labelling (CLH) of various hazardous substances. The substances, identified by their EC and CAS numbers, span multiple industries and pose potential risks to human health and the environment.
RAC Opinions
Talc (EC 238-877-9, CAS 14807-96-6)
Used in pharmaceuticals, cosmetics, and as a food additive, talc now faces stricter regulation. The RAC upgraded its classification to Carcinogen 1B (H350), marking it as a substance that may cause cancer if inhaled. This change impacts manufacturers relying on talc in products such as baby powder and industrial fillers.
Eugenol (EC 202-589-1, CAS 97-53-0)
Eugenol, found in personal care products and fragrances, was classified as Acute Toxicity 4 (H302), Eye Irritation 2 (H319), and Aquatic Chronic 2 (H411), identifying risks from ingestion, eye irritation, and long-term aquatic harm. RAC declined the dossier submitter's proposal for skin irritation classification.
3,5-Dimethylpyrazole (EC 200-657-5, CAS 67-51-6)
Used in polymer and coating production, 3,5-dimethylpyrazole was classified as Acute Toxicity 4 (H302) for its harmful effects if swallowed. It also received a Reproductive Toxicity 1B (H360FD) classification due to its potential to harm fertility and the unborn child, along with concerns over liver and blood damage under STOT RE 2 (H373).
Borate Minerals Group: Ulexite, Colemanite, Tincalconite
Ulexite (EC 296-662-5, CAS 1319-33-1)Colemanite (EC 296-640-5, CAS 1318-33-8)Tincalconite (CAS 12045-88-4)
These borate minerals, essential in ceramics and glaze production, are now classified as Reproductive Toxicity 1B (H360FD), indicating risks to fertility and fetal development. This impacts industries that utilize borates in products such as ceramic glazes.
Ethylenebis[nitrilo-Bis(methylene)]tetrakisphosphonic Acid (EC 215-851-5, CAS 1429-50-1)
Along with its salts (EC 287-370-9, CAS 85480-89-3; EC 251-910-1, CAS 234274-30-1), this substance is commonly used in cleaning products and water softeners. It has been classified as Carcinogen 1B (H350), with a general concentration limit (GCL) of 0.1%. This regulation will affect a wide range of water treatment products.
2-Pyrrolidone (EC 210-483-1, CAS 616-45-5)
Widely used in the pharmaceutical and polymer industries, 2-pyrrolidone was classified as Reproductive Toxicity 1B (H360D), posing risks to the unborn child. RAC supported the classification with a specific concentration limit (SCL) of 3%, which will impact manufacturers using it as a solvent or intermediate.
Thermally Treated Garlic Juice (No EC/CAS Listed)
Used as a biocide and plant protection product, thermally treated garlic juice has been classified under Skin Sensitization 1B (H317) due to its potential to cause allergic skin reactions. This classification targets industries using this substance in biocidal products.
Rape Oil (EC 232-299-0, CAS 8002-13-9)
Rape oil, a plant protection product, was initially proposed for chronic aquatic toxicity. However, RAC decided against this classification and settled on Aquatic Chronic 4 (H413), marking long-term risks to aquatic ecosystems.
Tebuconazole (ISO) (EC 403-640-2, CAS 107534-96-3)
A fungicide commonly used in agriculture, tebuconazole was classified as Reproductive Toxicity 1B (H360FD), and further warnings were issued for liver damage from prolonged exposure. Its environmental risk classifications include Aquatic Chronic 1 (H410), making it highly toxic to aquatic life.
The RAC’s adoption of these 13 opinions will have far-reaching consequences for industries using these substances, driving companies to review their use and comply with the latest regulatory changes. These updates reflect an ongoing effort to improve public health and environmental safety across the EU.
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