Genetically modified soybean MON 94637: what importers and manufacturers must do in 2026

Key data

Importers and manufacturers of food and feed operating with soybean as raw material have a new variety authorized in the European market. The Implementing Decision (EU) 2026/1185, published on 4 June 2026, opens the door to the marketing of products derived from genetically modified soybean MON 94637, developed by Bayer, for both human and animal consumption.

The authorization is supported by the favorable opinion issued by the EFSA in October 2025, which concluded that this variety is as safe as its conventional equivalent for human health, animal health and the environment. The regulation is based on Regulation (EC) No 1829/2003 on genetically modified food and feed.

What does this regulation establish?

Decision 2026/1185 authorizes three categories of products derived from MON 94637 soybean:

• Food containing or composed of MON 94637 soybean
• Food ingredients produced from this variety
• Feed containing, composed of or produced from MON 94637 soybean

The regulation also establishes the following specific conditions and restrictions:

The exclusion of cultivation is a key element: the authorization covers only import, processing and marketing of derived products, not agricultural production on European soil. Any batch of MON 94637 soybean entering the EU must be accompanied by labeling that explicitly indicates this restriction.

Economic and operational impact

The authorization generates both opportunities and operational obligations for companies in the sector:

• Supply opportunity: Companies that were already importing MON 94637 soybean from third countries (mainly South and North America) can now operate with greater legal certainty, without the risk of batches being rejected at the border due to lack of EU authorization.
• Labeling obligation: Food and ingredient manufacturers must review and update their labels to comply with the requirement to indicate the absence of cultivation purpose. This involves costs for packaging review and technical documentation.
• Update of internal records: Operators must verify that MON 94637 soybean is correctly listed in the Community Register of genetically modified food and feed before marketing derived products.
• Traceability and documentation: Regulation (EC) No 1829/2003 requires complete traceability of GMOs in the food chain. Companies must ensure that their suppliers can prove the origin and variety of soybean used.
• Monitoring reports: Although the obligation to submit annual environmental monitoring reports falls on the authorization holder (Bayer), operators in the chain may be required to provide data on use and distribution.

Who does it affect?

• Soybean importers bringing batches of MON 94637 from third countries (Argentina, Brazil, USA, etc.)
• Food manufacturers using soybean or derivatives (oil, flour, soy protein) as an ingredient
• Feed manufacturers for animals incorporating genetically modified soybean in their formulations
• Logistics and customs operators managing the clearance of MON 94637 soybean batches at EU ports and borders
• Distributors and wholesalers of agricultural raw materials marketing this variety
• Quality and labeling departments of food companies that must update technical sheets and packaging

Practical example

A Spanish compound feed manufacturer for livestock regularly imports soybean from Argentina. Among the batches received are shipments containing MON 94637 soybean. Before Decision 2026/1185, these batches could generate regulatory uncertainty or be held in customs due to lack of express authorization in the EU.

From 4 June 2026, the company can:

1. Import and use MON 94637 soybean in its feed formulations with full legal coverage.
2. Market the resulting feed in any EU Member State, provided that the labeling indicates that the product is not intended for cultivation.
3. Verify that the MON 94637 variety is listed in the Community Register of genetically modified food and feed before first marketing.

If the company omits the labeling requirement or markets the product before verifying the registration, it incurs non-compliance with Regulation (EC) No 1829/2003, with the sanctioning consequences that each Member State has provided for in its national transposition legislation.

What should companies do now?

1. Verify if you use MON 94637 soybean: Contact suppliers and request documentation identifying the genetic variety of soybean batches received or planned.
2. Check registration: Confirm that MON 94637 soybean is listed in the Community Register of genetically modified food and feed before marketing derived products.
3. Review and update labeling: Ensure that all products containing or produced from MON 94637 soybean include the statement that they are not intended for cultivation, as required by Decision 2026/1185.
4. Update traceability documentation: Review internal traceability systems so that the MON 94637 variety is identified throughout the supply chain, as required by Regulation (EC) No 1829/2003.
5. Inform the legal and quality department: Communicate the new authorization to teams responsible for regulatory compliance, labeling and procurement so they update procedures and supplier contracts.
6. Do not initiate cultivation in the EU: Remember that the authorization expressly excludes cultivation in European territory. Any agricultural use of this variety in the EU would be illegal.

Official source

Consult complete 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_202601185