Bixlozone approved in the EU: what manufacturers and farmers need to do

Key data

Manufacturers and distributors of plant protection products in the EU face a new regulatory landscape from 31 March 2026: bixlozone has been approved as an active substance through Commission Implementing Regulation (EU) 2026/747, published on 1 April 2026. This does not mean immediate market access, but rather the start of a national authorisation process that each Member State must complete before products containing this substance can be placed on the market and used.

The approval falls within the framework of Regulation (EC) No 1107/2009, which governs the placing of plant protection products on the market throughout the European Union. Bixlozone is now incorporated into the annex of approved active substances of Commission Implementing Regulation (EU) No 540/2011, which is amended by this new regulation.

What does this regulation establish?

Regulation (EU) 2026/747 establishes the following key elements:

• Formal approval of bixlozone as an active substance in accordance with Regulation (EC) No 1107/2009.
• Authorisation for Member States to approve plant protection products containing bixlozone, subject to specific conditions of use.
• Amendment of Commission Implementing Regulation (EU) No 540/2011 to include bixlozone in the annex of approved active substances.
• Obligation for manufacturers and distributors to adapt their product authorisation applications to the new requirements established.
• The approval is subject to a defined period of validity and to conditions of continuous risk assessment.

The following table summarises the regulatory changes introduced by this regulation:

Economic and operational impact

The approval of bixlozone has direct consequences for the operations of the various actors in the plant protection product value chain:

• Manufacturers: They must initiate or adapt the dossiers for product authorisation applications before the competent national authorities. This involves administrative, technical and assessment costs that will vary depending on the Member State.
• Agricultural distributors: They cannot place products containing bixlozone on the market until a valid national authorisation exists in the country where they operate. Catalogue and stock planning must take this timeframe into account.
• Farmers: The European approval opens up an opportunity to access new plant protection tools, but effective access depends on the speed with which each Member State processes national authorisations.
• Continuous risk assessment: The approval has a defined period of validity. Manufacturers and distributors must monitor potential reviews or renewals to avoid disruptions to commercialisation.

Who is affected?

• Plant protection product manufacturers wishing to include bixlozone in their formulations and place them on the market in the EU.
• Agricultural distributors operating in one or more Member States and managing plant protection product catalogues.
• Farmers and agricultural holdings seeking to expand their range of authorised plant protection treatments.
• Agricultural technical advisors and regulatory compliance consultants advising sector companies on product authorisations.
• Regulatory and legal affairs departments of agrochemical companies with a presence in the EU.

Practical example

A plant protection product manufacturer based in Spain wishing to launch a new herbicide with bixlozone as the active substance cannot do so immediately, even though the European approval has been in force since 31 March 2026.

The process to be followed is as follows:

1. Verify that the formulation meets the specific conditions of use established in Regulation (EU) 2026/747.
2. Adapt the product authorisation application dossier to the new requirements arising from the inclusion of bixlozone in the annex of Regulation (EU) No 540/2011.
3. Submit the national authorisation application to the competent Spanish authority (the Ministry of Agriculture, Fisheries and Food).
4. Await the resolution of the national authorisation before commencing the commercialisation and distribution of the product.

Only once that national authorisation has been obtained will Spanish farmers be able to purchase and apply the product. A distributor that incorporates this product into its catalogue before a valid national authorisation exists would be in breach of the plant protection product marketing regulations.

What should companies do now?

1. Manufacturers: Review Regulation (EU) 2026/747 and the specific conditions of use approved for bixlozone, and assess whether current or pipeline products need to adapt their authorisation dossier.
2. Distributors: Do not add to the catalogue or place on the market any products containing bixlozone until confirming that a valid national authorisation exists in each Member State where they operate.
3. Regulatory departments: Update monitoring of Commission Implementing Regulation (EU) No 540/2011 in its amended version, and incorporate bixlozone into approved active substance management systems.
4. All actors: Monitor the period of validity of the approval and the conditions of continuous risk assessment to anticipate potential reviews or renewals that may affect commercialisation.
5. Technical advisors: Inform farmer clients that access to products containing bixlozone is not immediate and depends on the processing of national authorisations in each country.

Official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, please consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R0747