Recently, the European Commission and the European Chemicals Agency (ECHA) have published a series of regulatory updates regarding the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012). The core changes involve key active substances including cypermethrin, DBNPA, specific formaldehyde releasers, and ethanol. These updates will directly impact the compliance status of relevant biocidal products in the EU market.
Latest Compliance Developments and Impact Analysis
Cypermethrin — Pending Withdrawal of Approval
According to the latest TBT notification published by the World Trade Organization (WTO) and a draft Commission decision, cypermethrin no longer meets the approval conditions under Article 4(1) of the BPR following the applicant’s voluntary withdrawal of their renewal application in May 2025. Consequently, the EU proposes to repeal Implementing Decision (EU) 2025/362, which had previously extended its approval in product-type 8 (PT8, wood preservatives) to November 30, 2027. Once this repeal enters into force, PT8 products containing cypermethrin will lose their legal status in the EU and face immediate market withdrawal. This will severely impact wood preservative manufacturers and related supply chains. It is strongly recommended that relevant enterprises immediately halt the development of new PT8 products containing this substance, conduct a thorough inventory of existing stock, and swiftly identify approved alternative substances to ensure business continuity.
DBNPA — Formal Approval Granted
On March 31, 2026, the European Commission formally approved 2,2-dibromo-2-cyanoacetamide (DBNPA, CAS No.: 10222-01-2) as an active substance for use in product-type 11 (PT11, preservatives for liquid-cooling and processing systems). This approval provides clear regulatory certainty for suppliers of industrial water treatment and cooling system preservatives, stabilizing market expectations. Manufacturers of PT11 products containing DBNPA are advised to promptly begin compiling their dossiers and preparing for the biocidal product authorisation process in accordance with BPR requirements to ensure compliant market access.
Specific Formaldehyde Releasers — Non-approval Decision
The European Commission has officially decided not to approve “formaldehyde released from the reaction product of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1)” as an active substance for product-type 6 (PT6, in-can preservatives). As PT6 products primarily involve the preservation of coatings, detergents, and similar products during storage, this specific ingredient will be prohibited for use in preservative formulations across the EU. This places manufacturers under significant pressure to either remove products from the market or urgently reformulate them. Affected companies must immediately initiate the reformulation process, substituting this ingredient with approved preservatives from the BPR Union list to ensure a smooth and compliant transition.
Ethanol — Positive BPC Opinion Published
Recently, ECHA’s Biocidal Products Committee (BPC) published a positive review opinion supporting ethanol as an active substance for PT1 (human hygiene), PT2 (surface disinfection), and PT4 (food and feed area). As the most widely used disinfectant ingredient, this positive opinion marks a critical milestone toward its final approval, sending a highly favorable signal to the vast hand and surface disinfectant market. Disinfectant manufacturers should closely monitor the upcoming publication of the formal approval decision. In the meantime, companies should proactively plan for data collection, testing, and budget allocation for the subsequent product authorisation phase to ensure swift compliance once the regulation enters into force.
Summary and Outlook
Overall, the EU is accelerating its final regulatory decisions on biocidal active substances. As these regulatory deadlines approach, the transition period left for enterprises is extremely limited. Industry practitioners and compliance managers are advised to closely track the final publication milestones of the aforementioned regulations, comprehensively audit their product portfolios, and formulate substance substitution plans and product authorisation strategies as early as possible to minimize regulatory risks.
To help enterprises navigate complex EU biocidal regulatory requirements, REACH24H delivers one-stop compliance services covering the Biocidal Products Regulation (BPR) for active substances. We support clients in equivalence evaluation, technical documentation preparation, and secure compliant market access across the European Union.
Should you have any inquiries or require professional regulatory support, please contact our team at customer@reach24h.com.
