Regulatory Update
Recently, the European Commission submitted a draft Implementing Decision to the World Trade Organization (WTO), proposing the non-approval of Terbutryn, 1,2-Benzisothiazol-3(2H)-one (BIT), and TMAD as existing active substances for use in specific biocidal product types.
During the review process of these substances for specific product types (PT), the original participants failed to support them in a timely manner or withdrew their support. Additionally, the European Chemicals Agency (ECHA) did not receive any valid notifications to take over the role of participant within the prescribed deadline. Consequently, these active substance/product-type combinations will not be approved.
Detailed List of Non-Approved Substance/Product-Type Combinations
The European Commission has drafted a decision to designate the following three active substance/product-type combinations as non-approved:
Terbutryn
CAS No.: 886-50-0
Product-type 9 (Fibre, leather, rubber and polymerised materials preservatives)
1,2-Benzisothiazol-3(2H)-one (BIT)
CAS No.: 2634-33-5
Product-type 9 (Fibre, leather, rubber and polymerised materials preservatives)
TMAD (Chemical name: Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione)
CAS No.: 5395-50-6
Product-type 12 (Slimicides)
Market Impact and Compliance Challenges for "Treated Articles"
Once this decision is formally adopted and enters into force, the aforementioned active substances shall not be used in the specified biocidal product types on the EU market. Furthermore, although “non-approval” primarily targets the biocidal products themselves, upstream and downstream enterprises in the supply chain must re-evaluate compliance after the regulation takes effect. This is particularly important for products entering the EU as “Treated Articles,” which must ensure that the biocidal active substances used are legal in the EU.
Industry Action Plan
In response to this EU regulatory development, it is recommended that relevant enterprises take the following measures:
Self-check product formulations: Immediately verify biocidal products or related treated articles for export to the EU to confirm whether they contain Terbutryn (PT 9), BIT (PT 9), or TMAD (PT 12).
Initiate substitution assessment: If your products involve the aforementioned restricted uses, immediately begin screening for alternative active substances and conduct formulation stability and efficacy verification to ensure the switch is completed before the regulation enters into force.
Monitor the comment deadline: The draft is currently in the WTO notification and comment period, with a deadline of May 1, 2026. If enterprises have substantive comments, they may submit feedback through relevant channels.
For more information or assistance, please feel free to contact us at customer@reach24h.com.
