Turck Dominique, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen-Ildico, Kearney John, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Engel Karl-Heinz, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Pöting Annette, Poulsen Morten, Sanz Yolanda, Schlatter Josef Rudolf, van Loveren Henk, Amundsen Mathias, Knutsen Helle Katrine
EFSA J. 2019 Apr 9;17(4):e05659. doi: 10.2903/j.efsa.2019.5659. eCollection 2019 Apr.
In 2018, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that whey basic protein isolate obtained by ion exchange chromatography from skimmed cow's milk is safe for human consumption under the proposed conditions of use as infant and follow on formula, meal replacement beverages, foods for special medical purposes and food supplements. Following a request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant seeks to extend the conditions of use to infant (powder 30 mg/100 g and reconstituted 3.9 mg/100 mL) and follow on formulae (powdered 30 mg/100 g and reconstituted 4.2 mg/100 mL) as foods for special medical purposes as well as in food supplements for infants (25 mg/day). The Panel considers that the proposed extended uses would not increase the potential intake of the NF compared to that assessed in its 2018 opinion. The Panel concludes that whey basic protein isolate is safe at the extended uses and use levels.
2018年，欧洲食品安全局（EFSA）营养、新型食品及食品过敏原专家委员会（NDA）得出结论，在作为婴儿配方奶粉、后续配方奶粉、代餐饮料、特殊医学用途食品和食品补充剂的拟用条件下，通过离子交换色谱法从脱脂牛奶中获得的乳清碱性蛋白分离物供人类食用是安全的。应欧盟委员会要求，EFSA NDA专家委员会被要求根据欧盟法规（EU）2015/2283，就乳清碱性蛋白分离物作为新型食品（NF）在特殊医学用途食品和婴儿食品补充剂中的扩展用途发表科学意见。申请人寻求将使用条件扩展至婴儿（粉状30毫克/100克，复原后3.9毫克/100毫升）和后续配方奶粉（粉状30毫克/100克，复原后4.2毫克/100毫升）作为特殊医学用途食品，以及婴儿食品补充剂（25毫克/天）。专家委员会认为，与2018年意见中评估的相比，拟议的扩展用途不会增加新型食品的潜在摄入量。专家委员会得出结论，在扩展用途和使用水平下，乳清碱性蛋白分离物是安全的。
