(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 26 March 2021, the company Nagase Viita Co., 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 glucosyl hesperidin on the Union market as a novel food. The applicant requested glucosyl hesperidin to be used in several hot beverages, non-alcoholic beverages and confectionery for the general population, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council , excluding infants. Subsequently, on 14 May 2024, the applicant modified the proposed used of glucosyl hesperidin in the application (several hot beverages, non-alcoholic beverages and confectionery) and replace them by functional drinks but at the same levels. As this category can be interpreted by consumers as a nutrition claim according to the provisions of Regulation (EC) 1925/2006 of the European Parliament and of the Council , and in order to ensure clarity, it is appropriate that the designation of ‘functional drink’ is replaced by ‘soft drinks marketed in relation to physical exercise’ and ‘energy drinks’. On 26 September 2024, the applicant withdrew the request for use in food supplements for young children from the application. 
(4)    On 26 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data, namely, the certificates of analysis for raw materials and for glucosyl hesperidin , the HPLC-UV analysis, the NMR analyses for the determination of the identity of glucosyl hesperidin , the detailed description of the production process , the stability reports , the chromosome aberration test in cultured mammalian cells treated with glucosyl hesperidin , the micronucleus test of glucosyl hesperidin in mice and cultured mammalian cell , the bacterial reverse mutation test of glucosyl hesperidin , the Salmonella typhimurium and Escherichia coli reverse mutation assay , the composition of glucosyl hesperidin as tested in the 4-week oral toxicity study and the 90-day oral toxicity study , the 4-week oral toxicity study , the 90-day oral toxicity study in rats including the results of clinical biochemistry , and the teratogenicity study of glucosyl hesperidin in rats .
(5)    On 23 September 2021, the Commission, requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of glucosyl hesperidin as a novel food.
(6)    On 25 June 2024, the Authority adopted its scientific opinion on the Safety of glucosyl hesperidin as a Novel food  in accordance with Article 11 of Regulation (EU) 2015/2283.
(7)    In its scientific opinion, the Authority concluded that glucosyl hesperidin is safe under the proposed conditions of use for the proposed target population. Therefore, that scientific opinion gives sufficient grounds to establish that glucosyl hesperidin, when used in soft drinks marketed in relation to physical exercise, energy drinks, and in food supplements as defined in Directive 2002/46/EC but excluding infants, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283. (8)    In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the certificates of analysis for raw materials and for glucosyl hesperidin, the HPLC-UV analysis, the NMR analyses for the determination of the identity of glucosyl hesperidin, the detailed description of the production process, the stability reports, the chromosome aberration test in cultured mammalian cells treated with glucosyl hesperidin, the micronucleus test of glucosyl hesperidin in mice and cultured mammalian cell, the composition of glucosyl hesperidin as tested in the 4-week oral toxicity study and the 90-day oral toxicity study, the 4-week oral toxicity study, the 90-day oral toxicity study in rats including the results of clinical biochemistry, and the teratogenicity study of glucosyl hesperidin in rats without which it could not have assessed the novel food and reached its conclusion.
(9)    The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data at the time they submitted the application. 
(10)    The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific studies and data, namely, the certificates of analysis for raw materials and for glucosyl hesperidin, the HPLC-UV analysis, the NMR analyses for the determination of the identity of glucosyl hesperidin, the detailed description of the production process, the stability reports, the chromosome aberration test in cultured mammalian cells treated with glucosyl hesperidin, the micronucleus test of glucosyl hesperidin in mice and cultured mammalian cell, the composition of glucosyl hesperidin as tested in the 4-week oral toxicity study and the 90-day oral toxicity study, the 4-week oral toxicity study, the 90-day oral toxicity study in rats including the results of clinical biochemistry, and the teratogenicity study of glucosyl hesperidin in rats should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place glucosyl hesperidin on the market within the Union during a period of five years from the entry into force of this Regulation.
(11)    However, restricting the authorisation of glucosyl hesperidin and the reference to the scientific studies and data contained in the applicant’s file for the sole use by them 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.
(12)    It is appropriate that the inclusion of glucosyl hesperidin 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.
(13)    Glucosyl hesperidin 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. 
(14)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,