CLP:
ECHA’s RAC Classifies Talc as Presumed Carcinogen
RAC’s Classification Decision: The European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) has concluded that talc should be classified as a category 1B carcinogen under the CLP Regulation, surpassing the proposed category 2 classification by the Netherlands. This classification implies that talc could be added to the list of substances of very high concern (SVHC), which would affect its use under EU regulations, including the general ban in cosmetic products for categories 1A, 1B, and 2.
Evidence and Justification: For the first time, RAC utilized a provision in CLP Annex I allowing classification based on limited evidence from human and animal studies. The committee cited findings of limited evidence of lung carcinogenicity in rats following inhalation and limited human evidence of ovarian cancer following perineal exposure. Additionally, RAC recommended a specific target organ toxicity, repeat exposure (STOT RE) classification for the lungs.
Industry Response and Concerns: The European association of talc producers (Eurotalc) disagrees with the RAC’s conclusion, arguing that available evidence does not meet carcinogenicity criteria. They are preparing to challenge the classification before the European Commission’s final decision. The industry has highlighted that classification applies to all exposure routes unless evidence conclusively shows certain routes do not present the same hazard, a condition unmet for talc.
Parallels and Differences with Titanium Dioxide Case: Some industry groups drew comparisons to titanium dioxide, which was classified as a category 2 carcinogen in 2020 but later overturned in court in 2022 due to RAC’s failure to consider all relevant factors, such as lung overload. However, RAC chair Roberto Scazzola emphasized that talc’s case differs, with lung tumours being only part of the supporting evidence.
Alignment with IARC Findings: The decision is in line with the International Agency for Research on Cancer (IARC), which classified talc as probably carcinogenic based on limited evidence of human ovarian cancer and sufficient evidence in animals.
Exclusion of Asbestos-Containing Talc: The classification proposal only pertains to talc that does not contain asbestos or asbestiform fibres, ensuring clarity in its regulatory implications.
PCN:
Harmonised Format for Poison Centre Notifications Mandatory by 2025
Transition Period Ending: As of 1 January 2025, all poison centre notifications for hazardous mixtures in the EU must be submitted in a harmonised format as specified by Annex VIII of the CLP Regulation. This marks the end of the transition period, during which companies were allowed to follow non-harmonised national requirements for notifications.
Requirements for Continued Market Access: To continue placing hazardous mixtures on the market after this deadline, companies must:
- Submit notifications in the harmonised format outlined in Annex VIII.
- Include the unique formula identifier (UFI) on product labels.
Preparation and Submission: ECHA advises companies to use the ECHA Submission portal for preparing and submitting notifications in the required format. This ensures compliance with the updated regulatory requirements.
Support Available: For assistance, companies can refer to the support page on the poison centre website or contact their national helpdesk or the ECHA Helpdesk for guidance on the new submission process and compliance measures.
These steps are essential for companies to adhere to EU regulations and maintain market access for their hazardous mixtures post-2024.
Cosmetics:
Hazardous Chemicals Found in Cosmetic Products: ECHA Pilot Enforcement Results
Inspection Findings: A recent pilot enforcement project by ECHA’s Enforcement Forum revealed that 6% of nearly 4,500 inspected cosmetic products in 13 EEA countries contained hazardous substances banned under POPs and REACH regulations. The inspection focused on identifying perfluorooctanoic acid (PFOA), long-chain perfluorocarboxylic acids (PFCAs), and cyclic siloxanes D4 and D5.
Banned Substances Identified: Authorities discovered 285 products containing banned hazardous chemicals, including:
- Perfluorononyl dimethicone
- Perfluorooctylethyl triethoxysilane
- Perfluorononylethyl carboxydecyl PEG-10 dimethicone
- Cyclopentasiloxane (D5), cyclomethicone (D4, D5, and D6 blend), and cyclotetrasiloxane (D4)
These substances are restricted due to their classification as persistent organic pollutants (POPs) or (very) persistent, (very) bioaccumulative, and toxic (PBT/vPvB), posing risks to human health and the environment.
Key Product Findings:
- Perfluorononyl dimethicone was mostly found in eyeliners and lipliners.
- D4 and D5 were identified in hair conditioners and hair masks.
These chemicals break down slowly in the environment, accumulate in humans and wildlife, and have been linked to reproductive toxicity and suspected carcinogenic effects.
Enforcement Actions: National authorities have acted to remove non-compliant products from the market, primarily starting with written advice to suppliers. Investigations are still ongoing for approximately half of the cases at the time of the report.
Background and Project Aim: ECHA oversees REACH and POPs regulations applicable to cosmetic products. This project, conducted from November 2023 to April 2024, aimed to reinforce harmonized enforcement of these regulations by focusing on PFOA, PFCAs, and D4/D5 in cosmetics.
Consumer Awareness: Consumers should be vigilant as these banned substances were found across different product types and price ranges. The ingredient list remains a simple tool for consumers to check product compliance.
This effort aligns with ECHA’s mission to ensure safer products and adherence to EU chemical safety regulations.
REACH:
ECHA Endorses Non-Vertebrate HYBIT Test for Bioaccumulation Studies
Approval for Shrimp-Based Test: The European Chemicals Agency’s (ECHA) Member State Committee (MSC) has unanimously approved the use of the Hyalella azteca bioconcentration test (HYBIT), a non-vertebrate method involving freshwater shrimp, as an alternative to the standard bioaccumulation test on fish. This decision supports the reduction of vertebrate use in testing under REACH regulations.
Background on HYBIT: The HYBIT test can involve up to 1,500 freshwater shrimp exposed to a test chemical for up to two weeks. This method is outlined in the OECD Test Guideline (TG) 321, which was published in June and included in ECHA’s 2023 guidance for evaluating persistent, bioaccumulative, and toxic (PBT) and very persistent, very bioaccumulative (vPvB) substances.
Application and Conditions: ECHA’s secretariat confirmed that the HYBIT test meets REACH standard information requirements for bioaccumulation where aqueous exposure is feasible. However, if aqueous exposure is not feasible, ECHA will continue to require the use of OECD TG 305 with dietary exposure methods. Notably, during discussions, an observer noted that HYBIT has not yet been validated for inorganic substances.
Future Implications: The MSC has agreed that this new policy will be used in upcoming dossier evaluations, marking a significant step toward more sustainable and ethical testing practices in chemical safety assessments.
Biocides:
EU Approves Prallethrin and Silver Zinc Zeolite for Biocidal Use
New Biocide Approvals: The European Commission has approved the use of prallethrin and silver zinc zeolite under the Biocidal Products Regulation (BPR). These approvals are set to become effective on 1 March 2026 and will remain valid until 29 February 2036.
Details of Prallethrin Approval:
- Prallethrin, widely used in household insecticides targeting mosquitoes, has been approved for product-type 18.
- It qualifies as a very persistent and toxic substance, categorizing it as a candidate for substitution. This classification mandates a comparative assessment before products containing prallethrin can be authorized for the EU market to ensure potential risks are adequately evaluated.
Details of Silver Zinc Zeolite Approval:
- Approved for use in various biocidal product types:
– Disinfectants and algaecides not intended for direct application on humans or animals (product-type 2).
– Film preservatives (product-type 7).
– Preservatives for fibre, leather, rubber, and polymerised materials (product-type 9).
- Products containing silver zinc zeolite will be subject to conditions, including restrictions ensuring that textiles incorporating this substance are not intended for direct skin contact.
Regulatory Backing and Implementation: These approvals were supported by ECHA’s Biocidal Products Committee (BPC) during its March meeting. The formal implementing regulations reflect the Commission’s commitment to managing the safe use of biocidal substances in the EU market while protecting public and environmental health.
Pyrethroid Biocides to Require Cat Risk Warning Labels
New Labeling Requirement: The EU competent authorities (CAs) for biocides have decided that from 2025, all biocidal products containing pyrethroids must carry a label warning of the potential risks these substances pose to cats. This requirement applies to wood preservatives (product-type 8), insecticides (product-type 18), and repellents and attractants (product-type 19), regardless of the concentration of pyrethroids they contain.
Reason for the Measure: Cats have a slower metabolism for processing pyrethroids, leading to accumulation in the liver that can result in severe health issues or even death. This increased sensitivity makes it crucial for product labels to include a warning to ensure cat owners are aware of the potential dangers.
Current Status and Next Steps:
- The specific wording of the warning has not yet been finalized but is expected to mention the risk of severe adverse reactions in cats.
- The labeling requirement will be part of the authorizations granted or renewed for biocidal products starting 1 January 2025. However, it will not automatically apply to authorizations granted via mutual recognition in sequence or simplified notification, unless included in the original authorization by the evaluating competent authority.
Further Investigations: While some EU member states permit flea and tick treatments for cats containing pyrethroids, the European Commission, ECHA, and the European Medicines Agency plan to continue exploring ways to mitigate the risks associated with these products.
