A high level of protection of health and the environment underpins the EU legal framework on genetically modified food and feed, by requiring a prior authorisation based on a comprehensive risk assessment performed by the European Food Safety Authority (EFSA).

The risk assessment for soy leghemoglobin referred to by the Honourable Members was performed by two scientific Panels[1]^,[2], following established methodologies and relevant risk assessment guidance.

The data submitted concerned the actual strain used for producing this soy leghemoglobin ( MXY0541) and both EFSA Panels[3]^,[4] concluded favourably on the safety of the soy leghemoglobin produced from this strain.

Regulation (EC) No 1829/2003[5] provides for the protection of confidential information while ensuring that the key elements of the Genetically Modified Organisms (GMO) Panel opinion are disclosed to the public in accordance with its Article 30 and the relevant provisions of Regulation (EC) No 178/2002[6].

In compliance with Article 6(7) of Regulation (EC) No 1829/2003, EFSA did not disclose certain parts of the opinion in the published version.

The Commission is in the process of adopting a decision on the request for confidential treatment of certain information in the dossier, made by the applicant, which EFSA took into account when redacting parts of the Panel opinion.

Should the Commission decide not to grant confidentiality requested by the applicant for certain elements, the Commission will ask EFSA to adapt the published opinion accordingly and will reopen the public consultation based on the updated version.

The Commission is currently considering EFSA’s opinion in view of preparing a draft decision concerning this application in accordance with the procedure of Article 7 of Regulation (EC) No 1829/2003.

Last updated: 19 June 2025