D4, D5, and D6 Siloxane Restriction, EPA Stops Accepting Studies from Lab, and More
Headlines at a Glance
The Headlines in Focus
EU Tightens Regulations on Siloxanes
From 6 June 2026, the EU will enforce stricter regulations on D4, D5, and D6 siloxanes, banning their use in concentrations ≥0.1% by weight. These chemicals, found in many consumer products, are being restricted due to their environmental impact. Previous regulations targeted wash-off cosmetics, but the new rules extend to other consumer and professional products, aiming to reduce environmental contamination. Deferrals are granted for specific industries, with full compliance for non-wash-off cosmetics by 2027 and medical devices by 2031. The regulation will be effective 20 days after its official publication.
EPA Halts Data from Non-compliant Lab
The U.S. EPA has stopped accepting studies from Palamur Biosciences Lab in Telangana, India, due to data falsification concerns. An inspection by the Indian NGCMA confirmed that data from 58 studies were falsified. Consequently, the EPA advises pesticide registrants not to use data from Palamur. Only one pending registration action relies on Palamur data, and the affected registrant has been notified to replace these studies. The EPA continues to enforce GLP standards to ensure the integrity of pesticide registration data, safeguarding public health and the environment.
EPA Takes Action on Chemical Safety in AZ, CA, and NV
The EPA has announced enforcement actions against eight facilities in Arizona, California, and Nevada for deficiencies in chemical safety plans. The Clean Air Act requires facilities handling hazardous substances to implement risk management plans, detailing accident prevention and emergency response.
Key Case in California: K2 Pure Solutions Nocal in Pittsburg faced significant issues including incomplete documentation and inadequate emergency procedures. The EPA's settlement includes an $85,189 penalty and mandates safety improvements. K2 will also provide $363,031 in emergency response resources to Contra Costa Health Services.
Penalties for Late Risk Management Plans:
These actions underscore the EPA's dedication to enforcing chemical safety laws, protecting communities, and supporting emergency responders.
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EU Rejects BOMBEX? PEBBYS? CS Over Health Concerns
The European Commission has rejected the authorisation of BOMBEX? PEBBYS? CS, a biocidal product for treating wasps’ and hornets’ nests, due to health and environmental concerns. France and Germany raised objections about toxic substances, including isocyanates and PBT/vPvB chemicals, found during manufacturing.
Key Issues:
Findings: The European Chemicals Agency (ECHA) confirmed the presence of genotoxic carcinogens in the product. The applicant failed to provide adequate methods for detecting these substances, leading to the Commission's decision.
Outcome: The product does not meet EU safety conditions and cannot be authorised. The decision underscores the importance of stringent safety data to protect health and the environment.
Biofa GmbH vs. ECHA: Appeal Decision on Data Sharing
The ECHA Board of Appeal has ruled on the case between Biofa GmbH (Germany) and Armosa Tech SA (Belgium) concerning data and cost-sharing for the biocidal substance silicon dioxide/kieselguhr. The dispute began when Armosa Tech sought to join the Article 95 list of authorized suppliers, leading to prolonged, unsuccessful negotiations with Biofa.
Key Points:
Claims by Biofa:
Board of Appeal Findings:
Decision: The appeal was dismissed, upholding ECHA’s decision to allow Armosa Tech to refer to Biofa’s data with cost-sharing. The appeal fee was not refunded.
This decision highlights the importance of clear agreements and good faith negotiations in data-sharing under the Biocidal Products Regulation, setting a precedent for future industry disputes.