Commission Implementing Regulation (EU) 2026/1378

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)The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Jatropha curcas L. (edible variety) kernels as an authorised novel food.

(4)Commission Implementing Regulation (EU) 2022/965^note authorised the placing on the market of Jatropha curcas L. (edible variety) kernels as a novel food, including data protection and market exclusivity granted to the company JatroSolutions GmbH, subsequently acquired by the company Chuta Nut GmbH in October 2022.

(5)On 9 May 2023, the company Chuta Nut GmbH (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to change the conditions of use and the specifications of the novel food Jatropha curcas L. (edible variety) kernels. The applicant requested to include two additional forms of the novel food, namely kernels in the form of flour and kernels in the form of paste, both consisting of 100 % ground kernels. The applicant also requested an increase of the maximum use levels of the novel food in the previously authorised food categories from 5 g/100 g to 30 g/100 g. Additionally, the applicant requested a change of the specifications concerning an increase of the fat content range in the final novel food from 54 %-61 % to 54 %-64 %.

(6)On 9 May 2023, the applicant also made a request to the Commission for the protection of the following proprietary data: production process^note, compositional data^note, nutritional information^note and toxicological information^note.

(7)On 19 January 2024, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on the change of the conditions of use and the specifications of the novel food Jatropha curcas L. (edible variety) kernels.

(8)On 29 September 2025, the Authority adopted its scientific opinion on the ‘Safety of changes in the conditions of use and the specifications of edible Jatropha curcas L. (Chuta) as a novel food pursuant to Regulation (EU) 2015/2283’^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)In its scientific opinion, the Authority concluded that the novel food, Jatropha curcas L. (edible variety) kernels, flour and paste, is safe under the new proposed conditions of use and the specifications.

(10)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data on the production process, compositional data, nutritional information and toxicological information without which it could not have assessed the novel food and reached its conclusion.

(11)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.

(12)The applicant declared that they held proprietary and exclusive rights of reference to the relevant studies, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(13)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 the production process, compositional data, nutritional information and toxicological information, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place Jatropha curcas L. (edible variety) kernels under the extended conditions of use on the market within the Union during a period of five years from the entry into force of this Regulation.

(14)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.

(15)The previously authorised food category ‘kernels as such, candied or sugar preserved and as processed nuts’ should be revised in order to ensure clarity as regards the foods covered by that category. It is therefore appropriate to define that food category as ‘kernels as such, or processed whole kernels to be consumed as snack (e.g. roasted, candied, salted or similar), including mixes with other nuts, seeds, and/or dried fruits’.

(16)The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

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

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