EU opens separate maize authorisation and renewal consultations

The European Commission has announced separate consultations on European Food Safety Authority (EFSA) opinions covering two genetically modified maize combinations for food and feed. The 15 October 2026 notice concerns a new application for Bt11 × MIR162 × MON 89034 × NK603; the 16 October notice concerns renewal of an existing authorisation for Bt11 × MIR162 × MIR604 × GA21. These are different event combinations and legal procedures. Neither consultation grants a marketing authorisation or approves cultivation.

The first dossier is GMFF-2025-33624 and covers the four-event stack Bt11 × MIR162 × MON 89034 × NK603 together with specified subcombinations. The Commission’s consultation register identifies an EFSA opinion dated 15 October and a deadline of 15 November 2026 for public comments. The scope concerns food and feed uses, including import and processing under any eventual authorisation. It is not an application for commercial cultivation in the European Union.

The second dossier, GMFF-2025-35594, concerns renewal of authorisation for Bt11 × MIR162 × MIR604 × GA21 and its specified subcombinations. The Commission’s 16 October notice permits comments for one month but does not specify the first dossier’s 15 November deadline for this second case. It concerns an existing authorisation under renewal review, not a first application for the combination. The consultation neither renews that authorisation itself nor permits cultivation.

Each stack combines genetically modified events by conventional crossing. Bt11 and MIR162 feature in both dossiers, but the other components differ: the new application includes MON 89034 and NK603, whereas the renewal concerns MIR604 and GA21. Depending on the event, traits relate to insect resistance or herbicide tolerance. A risk assessment for one complete combination cannot simply be copied to another because the set of expressed proteins and possible interactions differ.

EFSA evaluates the molecular characteristics of the events and assesses whether their combination changes the evidence relevant to food, feed or environmental safety within the intended scope. Comparative analysis may include composition, agronomic characteristics and newly expressed proteins. Publication of a scientific opinion is followed by risk management under EU law; the consultation stage seeks comments that could affect how that evidence is considered. No outcome is asserted here for either full scientific opinion beyond its publication.

Maize is processed into starch, sweeteners, oils and other fractions, while feed manufacturers use maize as an ingredient in compound formulations. These industrial uses depend on knowing the exact regulatory status of the imported raw material. An authorisation determines the permitted legal pathway for the material within its stated scope, but does not itself set the purchasing specification for a particular factory. A processor still needs to establish the identity and regulatory status of the lots it buys, together with any applicable contractual segregation or labelling requirements.

In complex commodity chains, genetic event identification is more precise than a general declaration that material is genetically modified. Event-specific analytical methods can be used to detect and quantify relevant genetic sequences in suitable samples. The European Union Reference Laboratory has published validated real-time PCR methods and a verification report associated with the Bt11 × MIR162 × MON 89034 × NK603 stack. Method validation supports official control and traceability; it is not a decision to authorise marketing or cultivation.

A consignment may contain grain from a crop with all four events or a specified combination of fewer events, making the authorisation scope important to record keeping. A regulatory decision must identify precisely which combinations are covered. Operators cannot assume that approval of a named four-event maize automatically applies to every possible combination with unrelated events. The terms of the eventual authorisation, if issued, determine the scope.

Regulation (EC) No 1829/2003 separates EFSA’s scientific evaluation from the Commission and Member States’ authorisation procedure. The Commission provides an opportunity for comments on EFSA opinions, and scientific submissions are sent to EFSA to determine whether they affect its conclusions. A public consultation cannot itself widen the scope of an existing authorisation, grant new import permissions or allow cultivation. Those outcomes require the relevant legal decisions.

Traceability and labelling rules provide another layer of control once material is legally placed on the market. Regulation (EC) No 1830/2003 establishes relevant requirements for communicating information about genetically modified organisms and products produced from them through supply chains. The exact obligations depend on product status and applicable rules, including relevant thresholds and exemptions. Consultation notices do not waive those duties or permit operators to treat an unapproved event as authorised.

The new application, GMFF-2025-33624, has an EFSA opinion dated 15 October and an explicit 15 November consultation deadline. The separate renewal, GMFF-2025-35594, was announced for comment on 16 October with a one-month window, without that same stated deadline. Ingredient suppliers and processors must distinguish the two event combinations and await the relevant regulatory decisions before changing assumptions about permitted uses.