Commission Implementing Regulation (EU) 2025/167 of 30 January 2025 authorising the placing on the market of glucosyl hesperidin as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2025/167
• Articles: 5

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.  ( 18 ) 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.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Glucosyl hesperidin

Specified food category

Maximum 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 exercise

525 mg/L

Energy drinks

525 mg/L

Food supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children

115 mg/day for children between 3 to 10 years of age

200 mg/day for general population older than 10 years of age

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised novel food

Specification

‘ Glucosyl 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-one

Synonym: 4G-α-d-glucopyranosyl-hesperidin

CAS No: 161713–86- 6

Chemical formula: C 34 H 44 O 20

Monoglucosyl hesperidin (MGH) (dry basis) 75,0-85,0 %

Hesperidin (dry basis):10-20 %

Loss on drying ≤ 6 %

Residue on ignition ≤ 2 %

Heavy metals

Lead ≤ 0,1 mg/kg

Arsenic ≤ 0,1 mg/kg

Microbiological criteria

Total aerobic microbial count: ≤ 100 CFU/g

Total coliforms: Not detected in 10 g

Salmonella spp. Not detected in 25 g

Yeast and moulds: ≤ 100 CFU/g

CFU: colony forming units.’