Commission Implementing Regulation (EU) 2025/2242

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001^note, and in particular Article 12(1) thereof,Whereas:

(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470^note has established a Union list of novel foods.

(3)On 30 April 2024, the company Lycored Ltd (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place yellow tomato extract on the Union market as a novel food. The applicant requested for the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council^note for adult population.

(4)On 30 April 2024, the applicant also made a request to the Commission for the protection of the following proprietary data: Reverse Mutation Assay Ames Test^note and Micronucleus Test in Human Lymphocytes in vitro^note.

(5)On 13 August 2024, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on yellow tomato extract as a novel food.

(6)On 24 March 2025, the Authority adopted its scientific opinion on the ‘Safety of yellow tomato extract as a novel food pursuant to Regulation (EU) 2015/2283’^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)In its scientific opinion, the Authority concluded that yellow tomato extract is safe under the proposed conditions of use.

(8)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data: Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, without which it could not have assessed the novel food and reached its conclusion.

(9)The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283.

(10)The applicant declared that they held proprietary and exclusive rights of reference to Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11)The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place yellow tomato extract on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13)It is appropriate that the inclusion of yellow tomato extract a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In line with the conditions of use of food supplements containing yellow tomato extract as proposed by the applicant, it is necessary to inform the consumers in that regard by appropriate labelling about the uses of food supplements containing yellow tomato extract.

(14)Yellow tomato extract should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION: