Safety of glucosyl hesperidin as a Novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on gluco-syl hesperidin (GH) as a novel food (NF) pursuant to Regulation (EU) 2015/2283.The NF, which is produced from hesperidin and dextrin by enzymatic reactions,is a powder consisting mainly of monoglucosyl hesperidin (MGH) and unreactedhesperidin (flavonoid), which account in total for up to 92.8% (on dry basis) of theproduct. The applicant proposed to use the NF in specific drinks and food supple-ments leading to a maximum intake of up to 364 mg per day for adults. The targetpopulation is the general population, except for food supplements for which theproposed target population is children from 1 year onwards and adults. Taking intoconsideration the composition of the NF and the proposed uses, the consumptionof the NF is not nutritionally disadvantageous. There are no concerns regardinggenotoxicity of the NF. Based on a 90-day oral toxicity study conducted with theNF, the Panel considers the NOAEL at the mid-dose group, i.e. ~ 1000 mg/kg bodyweight (bw) per day. By applying an uncertainty factor of 200, the resulting intakeproviding sufficient margin of exposure for humans would be 5 mg/kg bw per day.The available human intervention studies did not report clinically relevant changesin haematological or clinical chemistry parameters following the administration ofGH/MGH at supplemental doses of up to 3 g/day for 12 weeks. Overall, the Panelconsiders that the margin of exposure (~ 200) between the intake of the NF at theproposed uses and use levels and the NOAEL from the 90-day study is sufficient.The Panel concludes that the NF, glucosyl hesperidin, is safe for the target popula-tion at the proposed uses and use levels