经过评估,专家小组得出结论,枳椇果、梗热水提取物作为新型食品的安全性尚未确定。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 the safety of Hovenia dulcis fruit extract as a novel food (NF) for its use in food supplements. The NF co
ncerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but co
ntains co
ntradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (a
bout 90%), a
bout 2% proteins, 5% moisture, less than 1% fat and a
bout 2% ash. In addition, the NF co
ntains small amounts of flavo
noids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant seco
ndary me
tabolites. Given these limitations, the Panel co
nsiders that the data provided by the applicant do not demo
nstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chro
nic disease, such as liver malfunction. Limited information was provided on a history of co
nsumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel co
ncludes that the safety of the NF has not been established.
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