经过评估,专家小组得出结论,骨化二醇一水合物作为新型食品对大于11岁的儿童和成人(包括孕妇和哺乳期妇女)最?0微克/天是安全的,3-10岁的儿童最?微克/是安全的。部分原文报道如下:
EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on Safety of calcidiol mo
nohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283, including its bioavailability as a me
tabolite of vitamin D3 when added for nutritio
nal purposes to food supplements. On 5 July 2023, EFSA adopted the Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a co
nversion factor for calcidiol monohydrate. This opinion co
ncerns an updat
ed exposure assessment for vitamin D and proposes a co
nversion factor for calcidiol mo
nohydrate into vitamin D3 of 2.5 for labelling purposes. In addition, in reference to the EFSA opinion on the safety of calcidiol monohydrate, the Commission had received a letter from the pharmaceutical company EirGen Pharma Ltd requesting a revision of this opinion ba
sed on new data co
ncerning calcidiol. ba
sed on the information and data co
nsidered in this scientific technical report, EFSA co
ncludes that the novel food calcidiol mo
nohydrate proposed for use in food supplements is a bioavailable source of the biologically active me
tabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D, that a co
nversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed co
nditions of use and use levels, and that it is safe under the proposed co
nditions of use and use levels, i.e. up to 10 g/day for children 11 years old and adults, including pregnant and lactating women, and up to 5 g/day for children 3C10 years of age.
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