European Regulations

EU bans terbutryn, BIT and TMAD in biocides: what manufacturers must do by 2026

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Equipo Editorial CambiosLegales
03 Jul 2026 7 min 2 views

Key data

RegulationCommission Implementing Decision (EU) 2026/1420 of 30 June 2026
Publication3 July 2026
Entry into force30 June 2026
Affected partiesManufacturers, importers and distributors of biocidal products containing terbutryn, BIT or TMAD
CategoryEuropean Regulation
Legal basisRegulation (EU) No 528/2012 of the European Parliament and of the Council
Types of affected productsType 9 (preservatives for fibres, leather, rubber and polymerised materials) and Type 12 (preservatives for food or feed)
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Manufacturers and importers of industrial biocides face a direct ban: the European Commission has denied approval of three active substances for specific uses through the Implementing Decision (EU) 2026/1420, published on 3 July 2026 and effective from 30 June 2026. The consequence is immediate: no biocidal product containing these substances can continue to be marketed or used in the EU for the affected product types.

What does this regulation establish?

Implementing Decision 2026/1420 denies approval as existing active substances of three compounds for use in biocides, under the framework of Regulation (EU) No 528/2012. The following table summarises the three substances, their technical designation and the affected product type:

Active substanceTechnical designationProduct type (PT) affectedDenied use
TerbutrynTerbutrynPT 9Preservatives for fibres, leather, rubber and polymerised materials
BIT1,2-benzisothiazol-3(2H)-onePT 9Preservatives for fibres, leather, rubber and polymerised materials
TMADTetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazol-2,5(1H,3H)-dionePT 12Preservatives for food or feed

Non-approval means that these substances do not meet the safety or efficacy requirements set out in Regulation (EU) 528/2012 for the indicated uses. As a direct consequence, biocidal products formulated with them lose their legal basis to circulate in the European market for those product types.

The specific deadlines for market withdrawal will follow the transitional provisions of Regulation (EU) 528/2012. The regulation does not establish a single immediate withdrawal date, but refers to those transitional mechanisms, which may vary depending on the authorisation status of each product in each Member State.

Economic and operational impact

The impact is significant for industrial sectors that use biocides in material preservation and microbiological control processes. The most direct operational and economic consequences are:

  • Withdrawal of current formulations: products containing terbutryn, BIT or TMAD for PT 9 and PT 12 uses must be withdrawn from the market. This involves costs for stock management, returns and destruction or reclassification of inventory.
  • Mandatory reformulation: companies wishing to maintain their product lines will need to identify alternative active substances approved under Regulation 528/2012 and reformulate their biocides, with associated R&D, validation and registration costs.
  • New authorisations: if compliant alternatives are available, it will be necessary to initiate a new authorisation process with the European Chemicals Agency (ECHA), which involves time and resources.
  • Risk of supply interruption: industrial customers using these biocides in their processes (tanneries, rubber manufacturers, food industry) will need validated alternatives to avoid interrupting their production.

Who does it affect?

  • Manufacturers of biocidal products that have formulations containing terbutryn, BIT or TMAD in their portfolio for preservation of fibres, leather, rubber, polymerised materials or preservatives for food and feed.
  • Importers of biocides from third countries containing these active substances for product types 9 or 12.
  • Distributors and wholesalers with stock of affected biocidal products that must manage withdrawal from their warehouses and sales channels.
  • End-user industries that apply these biocides in their processes: leather and skin sector, rubber and plastics manufacturers, textile industry, food sector and animal feed manufacturers.
  • Compliance managers and R&D departments of chemical companies that must manage the transition to alternative substances.

Practical example

A Spanish manufacturer of preservatives for leather and leather goods uses BIT (1,2-benzisothiazol-3(2H)-one) as the active substance in its product type 9 biocide. Following the publication of Decision 2026/1420, that product can no longer be marketed or applied in the EU for that use.

The manufacturer must act on several fronts simultaneously: first, review available stock and determine what volume is covered by the transitional provisions of Regulation 528/2012; second, identify whether there is any alternative active substance approved for PT 9 that can replace BIT in its formulation; and third, if the alternative exists, initiate the authorisation process for the new product with ECHA before the transitional period expires. If no viable alternative is found, it will have to discontinue that product line.

The same scenario applies to a supplier of preservatives for animal feed using TMAD (PT 12): its product loses its legal basis and must be reformulated or withdrawn from the market following the transitional deadlines.

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What should companies do now?

  1. Audit your product catalogue: identify all biocides marketed or used that contain terbutryn, BIT or TMAD in product types 9 and 12. Include both own products and raw materials purchased from third parties.
  2. Review stock and contracts: calculate the volume of affected inventory and analyse current supply contracts to anticipate claims or renegotiations with customers and suppliers.
  3. Consult transitional provisions: verify with your legal or regulatory team the exact withdrawal deadlines that apply according to the authorisation status of each product in each Member State, in accordance with Regulation (EU) 528/2012.
  4. Identify alternative approved active substances: consult the ECHA register of approved active substances for product types 9 and 12, and assess the technical and economic feasibility of substitution.
  5. Initiate reformulation and new authorisation process: if a compliant alternative exists, start as soon as possible the development, validation and authorisation request process for the new biocidal product with ECHA or the competent national authority.
  6. Communicate with customers and supply chain: proactively inform industrial customers using these biocides in their processes so they can plan the transition without interruptions to their production.

Frequently asked questions

What substances does Decision 2026/1420 exactly ban and for what uses?

The Decision denies approval of three active substances: terbutryn and BIT (1,2-benzisothiazol-3(2H)-one) for biocides of product type 9 (preservatives for fibres, leather, rubber and polymerised materials), and TMAD (tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazol-2,5(1H,3H)-dione) for biocides of product type 12 (preservatives for food or feed). The ban applies exclusively to these product types; other uses of these substances in different product types are not affected by this decision.

When must I withdraw biocidal products with these substances from the market?

Implementing Decision 2026/1420 entered into force on 30 June 2026. The exact deadlines for market withdrawal are governed by the transitional provisions of Regulation (EU) No 528/2012, which may vary depending on the authorisation status of each product in each Member State. It is essential to review the specific regulatory situation of each product with your legal or regulatory team to determine the applicable deadline.

Can I continue selling existing stock of products with BIT or terbutryn?

It depends on the transitional deadlines established by Regulation (EU) 528/2012 for each product and Member State. Non-approval prevents marketing and use for product types 9 and 12, but transitional provisions may allow a limited period to exhaust or withdraw already manufactured stock. It is necessary to verify the specific situation of each current national authorisation.

What should I do if I want to replace these substances with alternatives?

You must identify alternative active substances approved for product types 9 or 12 in the ECHA register, reformulate the biocidal product and request a new authorisation in accordance with Regulation (EU) 528/2012. Decision 2026/1420 expressly states that manufacturers may request new authorisations if they have compliant alternatives.

Which industrial sectors are most affected by this ban?

The sectors with the greatest impact are those using biocides of types 9 and 12 in their processes: leather and leather goods industry, rubber and plastics manufacturers, textile sector (fibre preservatives), and food industry and animal feed manufacturers (PT 12 with TMAD). Manufacturers and importers of the biocidal products themselves containing these substances are also affected.

Official source

Consult full regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601420



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