(fra kommisjonsforordningen)

(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 has established a Union list of novel foods. 

(3) On 14 February 2018, Imperial College Hammersmith Campus (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place inulin-propionate ester on the Union market as a novel food. The applicant requested for the novel food to be used in cereal bars and fruit smoothies intended for the general population. 

(4) On 14 February 2018, the applicant also made a request to the Commission for the protection of the following proprietary data: batch-to-batch analyses, including quantification of inulin and propionate and in-house analytical methods, and a human trial study. 

(5) On 16 July 2018, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to provide a scientific opinion on inulin-propionate ester as a novel food. 

(6) On 25 June 2025, the Authority adopted its scientific opinion on the ‘Safety of inulinpropionate ester as a novel food pursuant to Regulation (EU) 2015/2283’ in accordance with Article 11 of Regulation (EU) 2015/2283. 

(7) In its scientific opinion, the Authority concluded that that the novel food, inulinpropionate ester, is safe under the proposed conditions of use. 

(8) The scientific opinion of the Authority covers the compositional data of the novel food, including chemical and microbiological parameters. However, in the Authority’s opinion, these parameters are not reflected in the specifications of the novel food. To ensure the safety of the novel food, it is necessary that the specifications of the novel food include relevant chemical and microbiological parameters. 

(9) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data concerning batch-to-batch analyses, including quantification of inulin and propionate and in-house analytical methods, without which it could not have assessed the novel food and reached its conclusion. 

(10) 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. 

(11) 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. 

(12) 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, batch-to-batch analyses, including quantification of inulin and propionate and in-house analytical methods, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place inulin-propionate ester on the market within the Union during a period of five years from the entry into force of this Regulation. 

(13) 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. 

(14) It is appropriate that the inclusion of inulin-propionate ester as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. 

(15) Inulin-propionate ester 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. 

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