Bohn Torsten, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen-Ildico, Katrine Knutsen Helle, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Bresson Jean-Louis, Castle Laurence, Fewtrell Mary, Przyrembel Hildegard, Dumas Céline, Titz Ariane, Turck Dominique
EFSA J. 2022 Mar 9;20(3):e07141. doi: 10.2903/j.efsa.2022.7141. eCollection 2022 Mar.
The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in infant and follow-on formula by HIPP-Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in infant and/or follow-on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow's milk protein with the same protein content. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. However, given that it is consumed with complementary foods and the protein source is considered nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 1.9 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.
欧盟委员会要求欧洲食品安全局就一种特定的蛋白质水解物的营养安全性和适用性发表意见。该蛋白质水解物源自浓缩乳清蛋白，由HIPP-Werk Georg Hipp OHG用于婴儿配方奶粉和后续配方奶粉。提交给欧盟委员会的档案旨在请求修订（欧盟）2016/127号法规中关于可用于婴儿配方奶粉和/或后续配方奶粉的蛋白质来源的规定。本意见不涵盖对用于生产蛋白质水解物的食品酶的安全性评估。所评估的蛋白质水解物在水解蛋白质的比例方面有充分的特征描述。在提供的相关干预研究中，用蛋白质含量为1.9克/100千卡的蛋白质水解物制成的婴儿配方奶粉，作为婴儿唯一的营养来源食用3个月，其生长情况与用相同蛋白质含量的完整牛乳蛋白制成的配方奶粉相当。没有提供关于这种蛋白质来源在后续配方奶粉中的营养安全性和适用性的实验数据。然而，鉴于它与辅食一起食用，并且该蛋白质来源在作为婴儿唯一营养来源的婴儿配方奶粉中被认为营养安全且适宜，专家小组认为该蛋白质水解物也是用于后续配方奶粉的营养安全且适宜的蛋白质来源。专家小组得出结论，所评估的蛋白质水解物是用于婴儿配方奶粉和后续配方奶粉的营养安全且适宜的蛋白质来源，只要使用该水解物的配方奶粉含有至少1.9克/100千卡的蛋白质，并且符合欧盟委员会授权法规（EU）2016/127的成分标准及其附件IIIA中的氨基酸模式。
