Turck Dominique, Bresson Jean-Louis, Burlingame Barbara, Dean Tara, Fairweather-Tait Susan, Heinonen Marina, Hirsch-Ernst Karen Ildico, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Neuhäuser-Berthold Monika, Nowicka Grażyna, Pentieva Kristina, Sanz Yolanda, Sjödin Anders, Stern Martin, Tomé Daniel, Van Loveren Henk, Vinceti Marco, Willatts Peter, Fewtrell Mary, Przyrembel Hildegard, Titz Ariane, Valtueña Martínez Silvia
EFSA J. 2017 May 11;15(5):e04781. doi: 10.2903/j.efsa.2017.4781. eCollection 2017 May.
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety and suitability for use by infants of follow-on formulae (FOF) based on cow's milk intact protein with a protein content of at least 1.6 g/100 kcal (rounded value) that meet otherwise the requirements of relevant EU legislation. If the formula under evaluation is considered to be safe and suitable for use by infants, the NDA Panel is also asked to advise on whether FOF based on goat's milk intact protein, soy protein isolates or protein hydrolysates are also safe and suitable for infants under the same conditions. The Panel concludes that the use of FOF with a protein content of at least 1.6 g/100 kcal from either intact cow's milk protein or intact goat's milk protein otherwise complying with the requirements of relevant EU legislation is safe and suitable for healthy infants living in Europe with an intake of complementary foods of a sufficient quality. This conclusion does not apply to infant formula (IF). The Panel also concludes that the safety and suitability of FOF with a protein content of at least 1.6 g/100 kcal manufactured from either protein hydrolysates or soy protein isolates cannot be established with the available data. The same conclusion applies to IF. The NDA Panel endorsed a draft of this scientific opinion on 14 December 2016 for public consultation. The draft document has been revised and updated according to the comments received, where appropriate.
应欧盟委员会的要求，欧洲食品安全局（EFSA）的营养产品、营养与过敏专家组（NDA）被要求就基于牛奶完整蛋白质且蛋白质含量至少为1.6克/100千卡（四舍五入值）的较大婴儿配方奶粉（FOF）对婴儿的安全性和适用性发表科学意见，前提是该产品符合欧盟相关法规的其他要求。如果所评估的配方奶粉被认为对婴儿安全且适用，NDA专家组还被要求就基于羊奶完整蛋白质、大豆分离蛋白或蛋白质水解物的FOF在相同条件下对婴儿是否也安全且适用提供建议。专家组得出结论，对于生活在欧洲且摄入了足够优质辅食的健康婴儿，使用蛋白质含量至少为1.6克/100千卡、来自完整牛奶蛋白或完整羊奶蛋白且符合欧盟相关法规要求的FOF是安全且适用的。这一结论不适用于婴儿配方奶粉（IF）。专家组还得出结论，根据现有数据无法确定由蛋白质水解物或大豆分离蛋白制成的蛋白质含量至少为1.6克/100千卡的FOF的安全性和适用性。同样的结论也适用于IF。NDA专家组于2016年12月14日批准了这份科学意见草案以供公众咨询。该文件草案已根据收到的意见进行了适当修订和更新。
