Change of GMO Authorization Holders in the EU: What Companies Must Do in 2026

Key data

If your company imports, distributes, or processes products that contain, are composed of, or have been produced from genetically modified organisms, this regulation directly affects you. The Implementing Decision (EU) 2026/1819, published on 29 July 2026, modifies previous acts authorizing the marketing of GMOs regarding who is listed as the holder of those authorizations and who acts as the legal representative in the European Union.

The usual reason for this type of change is mergers, acquisitions, or corporate restructuring among companies in the sector. When a company changes hands or is reorganized, regulatory authorizations must be updated to reflect the new legal reality. Failing to do so is equivalent to operating with outdated documentation, which can result in regulatory violations.

What does this regulation establish?

Decision 2026/1819 modifies certain previous authorization acts relating to products that:

• Contain genetically modified organisms (GMOs)
• Are composed of GMOs
• Have been produced from GMOs

The specific change it introduces affects two elements of those authorizations:

• The authorization holder: the legal entity that holds the right to market the product in the EU.
• The representative in the Union: the person or entity designated to act on behalf of the holder before European authorities when the holder is not established in the EU.

The regulation does not introduce new restrictions on the products themselves nor does it modify the technical conditions of existing authorizations. The scope is strictly administrative and legal: updating who is listed as legally responsible for those authorizations.

This type of implementing decision is common under the Regulation (EC) No 1829/2003 on genetically modified food and feed, which requires that any change in the identity of an authorization holder be formally approved by the European Commission.

Economic and operational impact

The direct impact of this regulation is not a new fee or fixed regulatory cost: it is the cost of documentary adaptation and the risk of non-compliance if no action is taken.

The actual cost will depend on the volume of affected products, the number of references with labeling that must be updated, and the complexity of each company's legal structure. For operators with few references, it may be a minor procedure. For distributors with extensive catalogs of GMO products, the update may require systematic review.

Who does it affect?

• GMO authorization holders whose data has changed due to merger, acquisition, or corporate restructuring
• Legal representatives in the EU of companies not established in Europe that market authorized GMO products
• Importers of products that contain, are composed of, or have been produced from GMOs authorized in the EU
• Distributors that market these products in the European market and must verify that their documentation reflects the current holder
• Processing companies that use authorized GMO raw materials and need to prove the authorization chain
• Legal and compliance advisors who manage authorizations for their clients in the agri-food sector

Practical example

Imagine a Spanish company that imports genetically modified soy from a US supplier. That supplier was acquired by another business group during 2025. The authorization for marketing in the EU continued to be listed under the original company's name.

With Decision 2026/1819, the European Commission formalizes the change of holder in that authorization, now reflecting the name of the new business group. The Spanish importing company must now:

• Verify that the traceability documents it receives from the supplier already mention the new holder
• Update any reference to the authorization holder in its own labeling if this information appears on it
• Ensure that its customs representative and legal advisor are aware of the change to avoid problems in future customs clearances

Failing to act is equivalent to maintaining outdated documentation, which can generate problems during inspections or customs clearance of future imports.

What should companies do now?

1. Identify if your company operates with authorized GMO products in the EU: review your catalog of raw materials, finished products, and ingredients to detect if any are subject to a GMO marketing authorization.
2. Verify if the holder of your authorizations has changed: consult Decision 2026/1819 to check if any of the authorizations affecting you are listed among those modified.
3. Update internal legal documentation: contracts with suppliers, traceability records, and any document mentioning the authorization holder must reflect the new name.
4. Review product labeling: if your product labeling includes references to the GMO authorization holder, plan the update of labels to avoid non-conformities.
5. Notify competent authorities if applicable: depending on your role in the supply chain, it may be necessary to communicate the change to the competent national authority on GMO matters.
6. Alert your legal or compliance advisor: this type of administrative change usually has implications for distribution contracts, licenses, and representation agreements that must be reviewed.

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_202601819