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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 1852/2001note, 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) 2017/2470note 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 Councilnote, 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 Councilnote, 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 hesperidinnote, the HPLC-UV analysis, the NMR analyses for the determination of the identity of glucosyl hesperidinnote, the detailed description of the production processnote, the stability reportsnote, the chromosome aberration test in cultured mammalian cells treated with glucosyl hesperidinnote, the micronucleus test of glucosyl hesperidin in mice and cultured mammalian cellnote, the bacterial reverse mutation test of glucosyl hesperidinnote, the Salmonella typhimurium and Escherichia coli reverse mutation assaynote, the composition of glucosyl hesperidin as tested in the 4-week oral toxicity study and the 90-day oral toxicity studynote, the 4-week oral toxicity studynote, the 90-day oral toxicity study in rats including the results of clinical biochemistrynote, and the teratogenicity study of glucosyl hesperidin in ratsnote.
(5)On 23 September 2021, the Commission, requested the European Food Safety Authority (‘the Authority’) 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 foodnote 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,
HAS ADOPTED THIS REGULATION:
Article 1#
1.Glucosyl hesperidin is authorised to be placed on the market within the Union.Glucosyl hesperidin shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2.The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2#
Only the company Nagase Viita Co., Ltd.note is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 20 February 2025, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Nagase Viita Co., Ltd.
Article 3#
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Nagase Viita Co., Ltd.
Article 4#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(1)in Table 1 (Authorised novel foods), the following entry is inserted:Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsData protection‘Glucosyl hesperidinSpecified food categoryMaximum levels
1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Glucosyl hesperidin’.
2.The labelling of food supplements containing the novel food shall bear a statement that the novel food should not be consumed by infants and young children/children under 10 years of age (*)
(*)depending on the age groups the food supplement is intended for.Authorised on 20 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Nagase Viita Co., Ltd, Nihon-Seimei Okayama Bldg., II Shinkan, 1-1-3 Shimoishii, Kita-ku, Okayama, 700-0907, Japan.During the period of data protection, the novel food glucosyl hesperidin is authorised for placing on the market within the Union only by Nagase Viita Co., Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Nagase Viita Co., Ltd.’Soft drinks marketed in relation to physical exercise525 mg/LEnergy drinks525 mg/LFood supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children115 mg/day for children between 3 to 10 years of age200 mg/day for general population older than 10 years of age
(2)in Table 2 (Specifications), the following entry is inserted:Authorised novel food | SpecificationGlucosyl hesperidin | Description/Definition:The novel food is a pale yellow to yellow-brown powder consisting of monoglucosyl hesperidin and produced enzymatically from hesperidin, which is isolated from the peels, juice, or seeds of citrus fruits, and dextrin.Following the inactivation of the enzymes used in the process, the solution undergoes a multistep purification process that includes filtration, chromatographic separation, intermediate concentration and decolourisation. The purified solution is then concentrated by evaporation, micro-filtrated and spray-dried.Characteristics/composition:Chemical (IUPAC) name: (2S)-7 -[(O-6-Deoxy-α-l-mannopyranosyl-(1→6)-O-[α-d-glucopyranosyl-(1→4)]-β-d-glucopyranosyl)oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-oneSynonym: 4G-α-d-glucopyranosyl-hesperidinCAS No: 161713–86- 6Chemical formula: C34H44O20Monoglucosyl hesperidin (MGH) (dry basis) 75,0-85,0 %Hesperidin (dry basis):10-20 %Loss on drying ≤ 6 %Residue on ignition ≤ 2 %Heavy metalsLead ≤ 0,1 mg/kgArsenic ≤ 0,1 mg/kgMicrobiological criteriaTotal aerobic microbial count: ≤ 100 CFU/gTotal coliforms: Not detected in 10 gSalmonella spp. Not detected in 25 gYeast and moulds: ≤ 100 CFU/gCFU: colony forming units.
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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