Glucosyl hesperidin authorised as a novel food: monoglucosyl hesperidin 75.0–85.0 % and hesperidin 10–20 % on a dry basis, up to 525 mg/L in sports and energy drinks; EFSA — batches tested by HPLC-UV and HPLC-RI in ISO/IEC 17025 accredited laboratories, identity confirmed by NMR
Commission Implementing Regulation (EU) 2025/167, published on 31 January 2025, adds to the Union list of novel foods glucosyl hesperidin (Nagase Viita Co., Ltd., Japan; exclusivity until 20 February 2030) — produced enzymatically from hesperidin from citrus peel, juice or seeds and dextrin. Authorised uses are non-alcoholic drinks marketed in relation to physical exercise, energy drinks and food supplements (excluding infants and young children). In its opinion of 25 June 2024 EFSA found it safe with a margin of exposure of about 200 to a NOAEL of about 1000 mg/kg bw per day. A corrigendum of 5 May 2025 added the end date of data protection.
- Specification (annex): light yellow to yellowish-brown powder; CAS No 161713-86-6, C₃₄H₄₄O₂₀, synonym 4G-α-D-glucopyranosyl hesperidin. Monoglucosyl hesperidin (MGH) 75.0–85.0 % and hesperidin 10–20 % on a dry basis, loss on drying ≤ 6 %, residue on ignition ≤ 2 %, lead and arsenic ≤ 0.1 mg/kg; aerobic microorganisms ≤ 100 CFU/g, total coliforms not detected in 10 g, Salmonella not detected in 25 g, yeasts and moulds ≤ 100 CFU/g. Process: two enzymatic reactions, enzyme inactivation, filtration, chromatographic separation, decolourisation, microfiltration and spray drying.
- Methods (EFSA): ten batches; MGH 75.9–77.8 % (HPLC-UV for batches 1–5, HPLC-RI for 6–10, in-house methods), hesperidin 14.3–15.0 %, diglucosyl hesperidin 0.23–0.31 %, monoglucosyl narirutin 2.40–2.88 % (HPLC-RI); the structures of α-MGH and hesperidin including the configuration of the anomeric carbons were confirmed by NMR. The laboratories are accredited to ISO/IEC 17025:2017. Free oligosaccharides from dextrin (β- and γ-cyclodextrin) about 0.8 %; water solubility > 197 g/100 g at 25 °C against about 2 mg/100 g for hesperidin.
- Toxicology (EFSA): no genotoxicity concerns; in the 90-day rat study the NOAEL was about 1000 mg/kg bw per day, with a factor of 200 the intake providing a sufficient margin is 5 mg/kg bw per day. Human studies with up to 3 g/day for 12 weeks showed no clinically relevant changes. MGH is hydrolysed to hesperidin in the jejunum and further to rutinose and hesperetin in the colon; mainly conjugates such as hesperetin glucuronide reach the blood.
- Maximum levels (annex): 525 mg/L in non-alcoholic drinks marketed in relation to physical exercise and in energy drinks; in food supplements 115 mg/day for children aged 3–10 years and 200 mg/day above 10 years. The supplement label must state that it should not be consumed by infants and young children or children under 10 years (depending on the target group). In 2024 the applicant replaced the original uses (hot drinks, soft drinks, confectionery) with isotonic drinks and withdrew supplements for young children.