经过评估,专家小组得出结论,在建议的使用条件下L-5-甲基四氢叶酸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 mo
nosodium salt of l-5-methyltetrahydrofolic acid (5-MTHF) as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of folate from this source in the co
ntext of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006. The NF is produced by chemical synthesis and co
nsists of at least 95% (w/w) of 5-MTHF and 4%C5% (w/w) of sodium. It is proposed to be used as a partial or complete substitute to folic acid and other sources of added folate in a number of food categories. The production process, composition, specifications and stability of the NF do not raise safety concerns. When used as an ingredient in different food matrices, proper processing/storage co
nditions need to be co
nsidered to preserve the stability of the NF. Regarding bioavailability, the Panel co
nsiders that the NF readily dissociates into Na and l-methylfolate ions, which subsequently are absorbed and enter the circulation. Thus, the bioavailability of 5-MTHF from the NF is comparable to that of other currently authorised salts of 5-MTHF. The Panel co
nsiders that the co
nsumption of the NF is not nutritio
nally disadvantageous as long as the combined intake of the NF and the other supplemental forms of folate under their authorised co
nditions of use is below the ULs established for the different age groups of the general population. The Panel co
ncludes that the NF is safe under the proposed co
nditions of use. The Panel also co
ncludes that the NF is a source from which folate is bioavailable.
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