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UK HSE Publishes Non-Approval Decisions for Multiple Biocidal Active Substances

Recently, the UK Health and Safety Executive (HSE) published a decision in accordance with Article 89(5) of the Great Britain Biocidal Products Regulation (GB BPR), formally announcing the non-approval of a series of active substance and Product Type (PT) combinations. This decision covers multiple biocidal/insecticidal substances widely used in the market, and will enter into force on April 1, 2026.


I. Background


According to the GB BPR and the relevant review regulation (Assimilated Regulation (EU) No 1062/2014), existing biocidal active substances must complete a review within a specified period to continue being legally used on the UK market. The Brexit transition period ended on December 31, 2020. For active substances originally included in the EU review program, supporting companies were required to resubmit applications to the UK HSE within the stipulated timeframe.

The non-approval decision stems primarily from the following scenarios:

1. Failure to resubmit applications: Some original applicants failed to resubmit data dossiers to HSE within the deadline;

2. Voluntary withdrawal of support: Some companies explicitly informed HSE that they would no longer support the relevant substances;

3. No uptake: HSE subsequently issued an Open Invitation, but received no valid notifications, or received expressions of interest but complete dossiers were not submitted before the deadline.

In the above circumstances, the relevant active substances are deemed "unsupported" in the GB review program, and HSE has made non-approval decisions in accordance with the law.


II. Main Content: Substances Involved and Key Milestones


According to the official announcement, the following active substance/product type combinations will be removed from the approval list (see official annex for details):

1. List of Major Substances Involved

· Bromine-based disinfectants (PT2, PT11, PT12): Including various precursor combinations generating active bromine from the reaction of sodium bromide with calcium hypochlorite, chlorine, or sodium hypochlorite;

· Pyrethroids (PT18, PT19): Chrysanthemum cinerariaefolium, extract, commonly found in insecticides and repellents/attractants;

· Other substances: Monolinuron (PT2), 2,2-Dibromo-3-nitrilopropionamide (DBNPA, PT2), Silver nitrate (PT1), Peanut butter (PT19, as an attractant), etc.

2. Key Compliance Timelines

To minimize market impact, the regulation establishes a clear transition period for relevant products:

· Non-approval date: April 1, 2026

· Cut-off date for placing Treated Articles on the market: September 28, 2026

o Note: After this date, articles treated with the aforementioned active substances (e.g., antimicrobial-treated textiles, materials, etc.) may no longer be placed on the GB market.

· Making available on the market end date for biocidal products: April 1, 2027

· Use end date for products: October 1, 2027


III. Impact Analysis


This regulatory adjustment will have a direct impact on enterprises exporting disinfectant/pesticidal products to the UK (Great Britain) or producing/selling them locally:

1. Disinfectants and Preservatives Sector: PT2, PT11, and PT12 products using active bromine generation systems are heavily affected. Addressing industry concerns, HSE assessments suggest there are sufficient alternative active substances currently on the market, so the overall impact is expected to be manageable.

2. Insecticides Sector: Chrysanthemum cinerariaefolium, extract (PT18 insecticides, PT19 repellents/attractants) is a widely used active substance of natural origin in organic farming and household hygiene. Although support notifications were received, complete dossiers were not submitted within the deadline, resulting in inclusion in the non-approval scope. Relevant enterprises need to pay special attention.

3. Supply Chain Adjustment Pressure: Enterprises using ingredients like DBNPA and silver nitrate should immediately assess the compliance status of their products in the UK market and complete inventory clearance or formulation adjustments within the transition period.


IV. Compliance Suggestions


In response to these changes, it is recommended that relevant enterprises take the following measures:

1. Comprehensive Product Formulation Review: Audit all products placed or intended for the GB market to confirm if they involve the non-approved active substance/product type combinations.

2. Develop Inventory Clearance Plans: Strictly adhere to the April 1, 2027 (sales deadline) and October 1, 2027 (use deadline) timelines to avoid compliance risks and inventory losses.

3. Focus on "Treated Articles": If your downstream products (e.g., antimicrobial-treated textiles, furniture, etc.) use the aforementioned substances, ensure you stop placing such articles on the GB market before September 28, 2026. This deadline is earlier than the phase-out period for the biocidal products themselves.

4. Seek Alternatives: Given the widespread application of bromine-based and pyrethroid substances, R&D departments are advised to quickly identify alternative active substances already on the GB BPR approved list and initiate registration or authorization applications for new products.


Conclusion


The UK HSE Decision No. 2026-001 further reflects the trend of the UK continuing to refine and tighten its biocidal regulatory system post-Brexit. As the key date of April 1, 2026, approaches, the time window available for enterprises to respond to relevant regulatory adjustments has tightened significantly. Enterprises are advised to monitor regulatory dynamics early and deploy compliance strategies in advance to reduce compliance risks and ensure supply chain stability and business continuity.

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