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EU Biocide Ban: Terbutryn, BIT, TMAD Non-Approval Impacts Trade

by  BlidFive

Country: European Union
Notification Date: 2026-03-02

Overview

The European Union has issued a draft Commission Implementing Decision proposing the non-approval of three active substances: terbutryn, 1,2-Benzisothiazol-3(2H)-one (BIT), and tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD). This decision impacts their use in specific biocidal product-types under Regulation (EU) No 528/2012. The proposed non-approval stems from a lack of participant support or timely notification to the European Chemicals Agency (ECHA) during the review program.

Key Details
  • Country: European Union
  • Document Symbol: G/TBT/N/EU/1193
  • Notification Date: 2026-03-02
  • Comment Deadline: Not specified
  • Effective Date: Decision enters into force 20 days after publication; treated articles prohibition applies 180 days after the decision.
Summary of Changes

This draft decision proposes the non-approval of terbutryn for biocidal product-type 9, BIT for product-type 9, and TMAD for product-type 12. Product-type 9 covers preservatives for fibre, leather, rubber, and polymerised materials, while product-type 12 pertains to slimicides. The rationale is that participants in the review programme for existing active substances withdrew their support, or no new participant submitted a notification to ECHA within the set timeframe. Consequently, these substances will not be approved for use in biocidal products within the EU.

A significant implication is that articles treated with or incorporating these active substances cannot be placed on the Union market 180 days after the final decision comes into force. This extends the regulatory scope beyond the biocidal products themselves to a wide range of consumer and industrial goods.

Impact Assessment
  • Which products or sectors are affected: Manufacturers and distributors of biocidal products falling under product-types 9 and 12 that currently use terbutryn, BIT, or TMAD will be directly impacted. Additionally, any sector producing or importing treated articles (e.g., textiles, leather goods, plastics, paints, coolants) incorporating these substances will be affected.
  • Potential impact on international trade: Exporters of biocidal products and treated articles to the EU market that rely on these substances will face market access restrictions. They will need to reformulate products or find alternative suppliers to comply with EU regulations.
  • Compliance requirements for exporters: Businesses must ensure their biocidal products and treated articles destined for the EU do not contain these non-approved active substances after the respective deadlines. This requires a thorough review of their supply chain and product formulations.
  • Market access implications: Companies that fail to comply risk their products being denied entry or removed from the EU market, leading to potential financial losses and operational disruptions.
What Businesses Should Do
  • Recommended actions for affected companies: Companies should immediately review their product portfolios and supply chains to identify any reliance on terbutryn, BIT, or TMAD. Begin exploring and validating alternative approved active substances or treatment methods.
  • Compliance timeline: The decision itself will be effective 20 days after its publication in the Official Journal. The prohibition on treated articles applies 180 days following the effective date of the decision. Businesses must prepare to meet these deadlines.
  • Resources or contacts for more information: Consult Regulation (EU) No 528/2012, the European Chemicals Agency (ECHA) website for biocides, and relevant national competent authorities. Stay updated on the final publication of this implementing decision.
Conclusion

This draft EU decision signifies a critical regulatory shift for the biocidal products industry and related sectors. The non-approval of terbutryn, BIT, and TMAD underscores the EU's commitment to stringent chemical safety standards. Proactive monitoring and timely adaptation of product formulations are essential for businesses to maintain compliance, ensure uninterrupted market access, and avoid trade disruptions within the European Union.

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Official Notification: https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/GTBTNEU1193.docx
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