Genetically modified corn resistant to insects and herbicides receives a favorable EFSA assessment ahead of possible authorization in the EU
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The European Food Safety Authority has published a favorable scientific assessment of genetically modified maize Bt11 × MIR162 × MON 89034 × NK603 and its subcombinations, intended for food and feed. The variety combines four genetic modifications associated with resistance to certain insects and tolerance to herbicides. The European Commission has opened a public consultation until 15 November 2026, and the EFSA opinion does not yet constitute a marketing authorization.
A genetically modified maize for resistance to certain insects and tolerance to herbicides has received a favorable scientific assessment from the European Food Safety Authority (EFSA), ahead of possible authorization for use in food and feed on the European market. The opinion, published on 15 October 2026, concerns the variety Bt11 × MIR162 × MON 89034 × NK603 and its subcombinations. EFSA experts concluded that the assessed maize is as safe as the conventional and non-genetically modified varieties used for comparison, within the limits of the assessment conducted. The European Commission has opened a public consultation on the opinion, and comments may be submitted until 15 November.
In brief
1. EFSA favorably assessed maize combining four genetic modifications for protection against certain pests and tolerance to herbicides.
2. The application concerns use in food and feed, including import and processing. It does not include cultivation of the maize in the EU.
3. The assessment concerns both the combination of the four modifications and the subcombinations covered by the application.
4. Citizens, organizations, and other interested participants may submit comments to the European Commission until 15 November 2026.
5. The scientific opinion does not automatically authorize marketing. Any approval requires a separate decision, in accordance with the European procedure.
The assessment concerns application GMFF-2025-33624, submitted by Syngenta Crop Protection AG under Regulation (EC) No 1829/2003 on genetically modified food and feed. The product was obtained through the conventional crossing of four previously genetically modified maize lines: Bt11, MIR162, MON 89034, and NK603. The result combines the characteristics introduced into the parental lines, without this combination itself constituting a new genetic modification technique.
The four modifications pursue two main categories of agricultural characteristics. Some enable the plant to produce proteins that act against certain harmful insects, particularly those from the order Lepidoptera, which includes various species of moths and butterflies. Others confer tolerance to herbicides containing glufosinate-ammonium or glyphosate. The presence of these characteristics in a single plant may be relevant to agricultural systems in which such products are used, but the opinion on food and feed safety does not constitute approval of herbicide use or a general assessment of the agricultural practices associated with them.
An important part of the examination concerns the effects of combining the genetic modifications. The fact that each parental line has previously been assessed does not eliminate the obligation to analyze the product resulting from the cross. Experts must examine whether the association of characteristics may produce interactions relevant to safety, including through the effects of newly expressed proteins or any changes in the plant's composition. EFSA has previously assessed the four individual events and several of their subcombinations, without identifying safety concerns that would alter its previous conclusions.
The assessment of maize with multiple genetic events involves the molecular characterization of the product and its comparison with conventional plants. Within EFSA procedures, information on the genetic modifications, agronomic characteristics, composition, potential toxicity, allergenicity, and nutritional value is examined. The analysis is limited to the characteristics and uses covered by the application. The safety conclusion relates to the assessed variety, the respective subcombinations, and the available scientific data, without constituting a general approval of all genetically modified organisms.
In the case of Bt11 × MIR162 × MON 89034 × NK603, the EFSA assessment indicates no additional safety concerns for human or animal health or for the environment compared with the comparator varieties, within the scope of use analyzed. This finding is the scientific stage of the European procedure and provides the Commission with the information necessary to examine the application. However, the food safety authority does not decide alone whether the product will be authorized on the European market.
The scope of the application is essential to understanding its consequences. The request covers placing on the market products that contain, consist of, or are produced from the genetically modified maize, for food and feed use, as well as import and processing under the relevant legal conditions. It does not request authorization for cultivation in the European Union. Therefore, any favorable decision would not grant farmers the right to cultivate this maize combination in the Member States on the basis of that authorization.
The distinction between import, processing, and cultivation has implications for environmental risk assessment. The import of grains intended for industrial or feed use may involve the possibility of the accidental release of viable seeds, but it does not entail the intentional and extensive introduction of the crop into fields. The assessment must take into account the scope of the requested authorization and the relevant exposure scenarios, which differ from those associated with authorization for commercial cultivation.
The European Commission opened a public consultation on the EFSA opinion on 15 October. According to the official page for consultations on genetically modified organisms, the deadline for submitting comments is 15 November 2026. The procedure allows citizens, organizations, authorities, and other interested participants to submit comments on the risk assessment. Scientific comments are forwarded to EFSA, which examines whether they affect the conclusions of the opinion.
The consultation does not constitute a referendum on authorization, and submitting comments does not automatically result in a change to EFSA's conclusion. Its role is to allow relevant information and observations to be examined before the risk management stage. Any objections must be assessed against the data and criteria applicable to the procedure, including when they concern aspects that were not sufficiently clarified in the initial documentation.
After the scientific stage and the public consultation, the European Commission may prepare a draft decision on authorization under Regulation (EC) No 1829/2003. The procedure involves the participation of representatives of the Member States within the competent committee. Depending on the voting outcome and the applicable procedural stages, the file may follow the path laid down by European comitology rules. An authorization is granted through a separate act of the Commission, not through publication of the EFSA opinion.
If the product is authorized, its marketing will have to comply with the conditions set out in that decision and with European rules on the traceability and labeling of genetically modified organisms. The regulations establish obligations for operators in the food and feed chain, so that information about products containing or obtained from genetically modified organisms is transmitted and presented in accordance with the applicable requirements. The exact conditions of any potential authorization for this maize combination cannot be considered established before the corresponding act is adopted.
For the agricultural sector and the feed industry, the file is relevant because maize and derived products are raw materials used in numerous production chains. The possibility of importing a genetically modified combination may influence operators' commercial options, depending on price, availability, and demand. However, the published opinion does not demonstrate that new quantities have already entered the European market or that farmers' supply conditions have changed.
Consequently, the EFSA assessment constitutes a necessary stage for possible authorization, without having the legal effect of a marketing decision. The next verifiable deadline is 15 November 2026, when the public consultation ends. After examining the comments, the Commission and the Member States may continue the authorization procedure, within which it will be determined whether the product may be placed on the European market and under what conditions.
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