Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, van Loveren Henk, Gerazova-Efremova Katerina, Roldán-Torres Ruth, Knutsen Helle Katrine
EFSA J. 2022 Jun 10;20(6):e07326. doi: 10.2903/j.efsa.2022.7326. eCollection 2022 Jun.
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 D mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from mushroom that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D (ergosterol) to vitamin D (ergocalciferol). The NF contains levels of vitamin D in the form of vitamin D in the range of 125-375 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 1.125 or 2.25 µg vitamin D per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements, for infants from 7 to 11 months at a maximum of 10 µg vitamin D/day and of 15 µg vitamin D/day for individuals aged 1 year or older, as well as in foods for special medical purposes (FSMPs) and total and meal diet replacement for weight control. For the adult population, the maximum intended use level in FSMPs is 15 µg vitamin D/day and 5 µg vitamin D/meal in total and meal diet replacement for weight control. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel notes uncertainty regarding the calculated combined exposures to vitamin D for the general population, given the fact that the range of foods fortified with vitamin D has increased over the years, as well as the marketing of high-dose vitamin D supplements.
应欧盟委员会的要求，欧洲食品安全局（EFSA）营养、新型食品及食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2015/2283，就维生素D蘑菇粉作为新型食品（NF）发表意见。该新型食品由经过紫外线（UV）照射的蘑菇制成，以促使维生素原D（麦角固醇）转化为维生素D（麦角钙化醇）。该新型食品中维生素D的含量为125 - 375微克/克。所提供的关于该新型食品生产工艺、成分和规格的信息不存在安全问题。申请人打算将该新型食品作为一种成分添加到各种食品和饮料中，添加量为每100克或100毫升食用食品中含有1.125或2.25微克维生素D。申请人还打算将该新型食品添加到食品补充剂中，7至11个月大的婴儿每天最多添加10微克维生素D，1岁及以上个体每天最多添加15微克维生素D，以及添加到特殊医学用途食品（FSMPs）和用于体重控制的全餐及代餐食品中。对于成年人，在特殊医学用途食品中的最大预期使用量为每天15微克维生素D，在用于体重控制的全餐及代餐食品中每餐最多添加5微克维生素D。专家小组得出结论，在拟议的使用条件下，该新型食品是安全的。鉴于多年来强化维生素D的食品种类有所增加以及高剂量维生素D补充剂的销售情况，专家小组指出，对于普通人群维生素D的计算综合摄入量存在不确定性。
