PDF(Pubmed)
Abstract：
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 vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from Agaricus bisporus mushroom powder that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains concentrations of vitamin D in the form of vitamin D2 in the range of 245-460 μg/g. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF as an ingredient in a variety of foods and beverages in amounts that result in either 1.2 or 2.4 μg vitamin D2 per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements at a maximum of 15 μg vitamin D2/day for individuals above 1 year of age, as well as in foods for special medical purposes (FSMPs). The estimates for combined intake of vitamin D from the NF, the background diet and fortified foods, were below the ULs for vitamin D as established previously by the NDA Panel for children, adolescents and adults, i.e. 50 and 100 μg/day. The estimated combined vitamin D intake in infants (6-12 months) is also below the UL for vitamin D of 35 μg/day. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous for the proposed target population. The Panel concludes that the NF is safe under the proposed conditions of use.
摘要：
根据欧盟委员会的要求，EFSA营养小组，根据法规（EU）2015/2283，要求新型食品和食品过敏原（NDA）对维生素D2蘑菇粉作为新型食品（NF）发表意见。NF由双孢蘑菇粉产生,所述双孢蘑菇粉已经暴露于紫外线(UV)照射以诱导维生素原D2(麦角钙化醇)向维生素D2(麦角钙化醇)的转化。NF包含浓度为245-460μg/g的维生素D2形式的维生素D。提供的关于生产过程的信息，NF的成分和规格不会引起安全问题。本申请人打算将NF作为一种成分添加到各种食品和饮料中,其量使得每100g或100mL所消耗的食品中产生1.2或2.4μg维生素D2。申请人还打算在食品补充剂中添加NF，对于1岁以上的个体，最高为15μg维生素D2/天，以及用于特殊医疗目的的食品（FSMPs）。对来自NF的维生素D的综合摄入量的估计，背景饮食和强化食品，低于NDA儿童小组先前确定的维生素D的ULs，青少年和成人，即50和100μg/天。婴儿（6-12个月）估计的维生素D综合摄入量也低于35μg/天的维生素D的UL。小组认为，考虑到NF的组成和拟议的使用条件，NF的消耗对于建议的目标人群在营养上不是不利的。小组的结论是，在拟议的使用条件下，NF是安全的。
