Recently, the European Union published multiple draft Implementing Decisions and Regulations on biocidal active substances through the World Trade Organization (WTO). In accordance with the EU Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012), the European Commission plans to approve the application for the renewal of approval of hydrochloric acid for specific product-types, while formally drafting the non-approval of two active substances, medetomidine and DMDMH, based on health and environmental risks. The relevant drafts are expected to be formally adopted in September 2026.
According to the notifications and draft texts published by the EU, this regulatory update primarily involves the following three active substances:
Key Highlights
1. Renewal of Approval for Hydrochloric Acid
The EU plans to renew the approval of hydrochloric acid for use in product-type 2 (private area and public health area disinfectants and other biocidal products). Its minimum degree of purity requirement is 99.9%, and the new expiry date of approval will be extended to 30 September 2041. The draft emphasizes that during the product assessment phase for product authorisation, particular attention must be paid to the exposure risks of non-professional users.
2. Non-renewal of Medetomidine
This substance was originally used in product-type 21 (antifouling products). The ECHA evaluation concluded that medetomidine has endocrine-disrupting properties that may cause adverse effects in humans and non-target organisms, and it is very persistent (vP) and toxic (T). Since safer alternatives such as DCOIT and copper thiocyanate already exist on the market, the EU has decided not to renew its approval. Treated articles treated with or incorporating this substance are only allowed to be placed on the market for a period of 180 days after the entry into force of the Decision.
3. Non-approval of DMDMH
The application for the approval of 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH) for product-type 6 (in-can preservatives) and product-type 13 (metalworking-fluid preservatives) has been formally rejected. The main reasons are that the participant withdrew its support, and failed to provide sufficient efficacy data as well as ecotoxicological safety data covering the specification and relevant impurities of the substance.
REACH24H Reminder
The WTO consultation period for these three drafts will end between late August and early September 2026, with formal adoption planned for September 2026. The decisions will enter into force on the twentieth day following their publication in the Official Journal of the European Union. Industry enterprises should closely monitor the publication date of the final decisions and proactively carry out compliance planning and supply chain adjustments to avoid the risk of compulsory market removal after the transition period.
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