经过评估,专家小组得出结论,在提议的使用条件下,葡糖基橙皮苷作为新型食品是安全的。部分原文报道如下:
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 glucosyl 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 co
nsisting mainly of mo
noglucosyl hesperidin (MGH) and unreacted hesperidin (flavonoid), which account in total for up to 92.8% (on dry basis) of the product. The applicant proposed to use the NF in specific drinks and food supplements leading to a maximum intake of up to 364 mg per day for adults. The target population is the general population, except for food supplements for which the proposed target population is children from 1 year o
nwards and adults. Taking into co
nsideration the composition of the NF and the proposed uses, the co
nsumption of the NF is not nutritio
nally disadvantageous. There are no co
ncerns regarding genotoxicity of the NF. ba
sed on a 90-day oral toxicity study co
nducted with the NF, the Panel co
nsiders the NOAEL at the mid-dose group, i.e. ~ 1000 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the resulting intake providing sufficient margin of exposure for humans would be 5 mg/kg bw per day. The available human intervention studies did not report clinically relevant changes in haematological or clinical chemistry parameters following the administration of GH/MGH at supplemental doses of up to 3 g/day for 12 weeks. Overall, the Panel co
nsiders that the margin of exposure (~ 200) between the intake of the NF at the proposed uses and use levels and the NOAEL from the 90-day study is sufficient. The Panel co
ncludes that the NF, glucosyl hesperidin, is safe for the target population at the proposed uses and use levels.
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