President European Commission

 

Dear President,

I have received a complaint against the European Commission.

The complaint concerns the Commission’s authorisation of fermented rapeseed cake as a novel food (Implementing Regulation 2025/682 of 8 April 2025). The novel food product was authorised based on an earlier EFSA risk assessment that concerned partially defatted rapeseed powder.

The complainant considers that the Commission has failed to provide adequate reasoning and lacked transparency regarding the scientific basis underlying the authorisation. The complainant would like the Commission to provide an explanation of the scientific criteria, internal assessment, and reasoning used to conclude that the fermentation and specification changes in question did not alter the safety profile of the product. He would also like the Commission to indicate whether any internal comparative notes or analysis exist and make them accessible where possible.

The European Ombudsman is not a scientific body. However, as a body tasked with promoting good administration in the activities of EU institutions, the Ombudsman can examine whether the Commission has put in place procedures to ensure that it complies with applicable obligations, as well as whether it has addressed the complainant’s procedural and substantive concerns in a comprehensive and reasonable manner. 

I have therefore decided to open an inquiry into this complaint, in part to obtain a written reply from the Commission on the concerns raised by the complainant, notably on those concerns that the Commission has not yet (fully) addressed in its correspondence with the complainant. I would appreciate if the Commission could address, in its reply, the specific concerns raised in the complaint.

I also seek to obtain more general information about the Commission’s administrative practice when applying Regulation (EU) 2015/2283 (the Novel Food Regulation). Therefore, I would be grateful if the Commission could explain its practice and, in particular, reply to the questions that are enclosed.

Please note that I am likely to send your reply and related enclosures to the complainant for comments^[1]. I may also decide to publish your reply.

I would be grateful to receive the Commission's reply by 31 March 2026. If, during this inquiry, the Commission becomes involved in court proceedings concerning the same subject matter as this complaint, I would ask you to let us know.

The Inquiries Officer responsible is Mr Koen Roovers.

Yours sincerely,

Teresa Anjinho
European Ombudsman

Strasbourg, 27/01/2026

 

Annex: Questions addressed to the Commission in case 3566/2025/KR

Questions concerning the specific case:

1. On which basis did the Commission consider that the previous EFSA risk assessment covered the modifications sought by the applicant prior to the adoption of the Implementing Regulation 2025/682 of 8 April 2025 concerning the authorisation of fermented rapeseed cake as a novel food? Does the Commission have any documentation that includes its internal assessment in this regard? If so, the Commission is invited to share this documentation with the Ombudsman’s Office.
2. How did the Commission comply with its obligation to make public a summary of the application, including the scientific evidence demonstrating that the novel food does not pose a safety risk to human health, in accordance with Article 10(1) and (2)e of Regulation 2015/2283?
3. How did the Commission deal with the concerns raised by the complainant as regards the completeness of the public health risk information that it made public in this case?

General questions:

1. How does the Commission decide whether to request an opinion from EFSA on an application for authorising the placing on the market within the Union of a novel food and updating the Union list, in accordance with Article 10(3) of Regulation 2015/2283? Does the Commission have internal documents which guide or inform this decision, reflecting, in particular, how the Commission decides if an update is liable to have an effect on human health? If so, the Commission is invited to share these documents with the Ombudsman’s Office.
2. Is there a specific procedure that the Commission follows when receiving information that may call into question the scientific basis underlying the authorisation of a novel food product? If so, the Commission is invited to share any relevant documents with the Ombudsman’s Office.

 

[1] If you wish to submit documents or information that you consider to be confidential, and which should not be disclosed to the complainant, please mark them ‘Confidential’. Encrypted emails can be sent to our dedicated mailbox. Information and documents of this kind will be deleted from the European Ombudsman’s files shortly after the inquiry has ended.