经过评估,专家小组得出结论,在建议的使用条件下L-苏糖酸镁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 the safety of magnesium l-threo
nate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the co
ntext of Directive 2002/46/EC. The NF, produced by chemical synthesis, is intended to be used as new source for magnesium in food supplements at a maximum intake level of 3000 mg per day by adults, except for pregnant and lactating women. This dose correspo
nds to ~ 2730 mg l-threo
nate and 250 mg magnesium, which also correspo
nds to the UL for supplemental magnesium from readily dissociable magnesium salts. ba
sed on results obtained from a dissociation study, two rat studies and one human trial, the Panel co
nsiders that magnesium is bioavailable from the NF. The NF may co
ntain up to 1% oxalic acid. The Panel co
nsiders that an additio
nal exposure to oxalic acid, that is up to 30 mg daily from the NF, is not to be of safety concern. The Panel co
ncludes that the NF is not nutritio
nally disadvantageous. In 2008, the EFSA ANS Panel co
ncluded that a human intake of l-threo
nate of 2700 mg per day is safe. This intake is similar to the maximum intake of l-threo
nate from the NF under the maximum proposed uses, and the NDA Panel co
ncurs with the ANS Panel that this intake is safe. The Panel co
nsiders that there are no co
ncerns regarding the genotoxicity of the NF. The Panel co
ncludes that the NF, Mg l-threonate, is safe under the proposed co
nditions of use. The Panel co
ncludes that the NF is a source from which magnesium is bioavailable.
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