Castenmiller Jacqueline, Hirsch-Ernst Karen-Ildico, Kearney John, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Turck Dominique, Vinceti Marco, Marchelli Rosangela, van Loveren Henk, Dumas Céline, Titz Ariane, de Henauw Stefaan
EFSA J. 2021 Jun 16;19(6):e06603. doi: 10.2903/j.efsa.2021.6603. eCollection 2021 Jun.
The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing a specific protein hydrolysate derived from whey protein isolate and concentrate and manufactured by Société des Produits Nestlé S.A., in reducing the risk of developing atopic dermatitis in infants with a family history of allergy. This was following the submission of a dossier by Société des Produits Nestlé S.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysate from which the infant formula is produced is included in Annex I and II of Commission delegated Regulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow-on formulae. This opinion does not cover the assessment of the nutritional safety and suitability of the infant formula or the safety of the food enzymes used in the manufacture of the protein hydrolysate. The Panel considers that, in relation to the effect that is claimed, the infant formula under evaluation is not sufficiently characterised with respect to the molecular weight distribution of peptides. From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy.
欧盟委员会要求欧洲食品安全局评估一款婴儿配方奶粉的功效，该配方奶粉含有一种从乳清蛋白分离物和浓缩物中提取的特定蛋白水解物，由雀巢产品有限公司生产，用于降低有过敏家族史的婴儿患特应性皮炎的风险。这是在雀巢产品有限公司根据欧盟法规（EU）2016/127向欧盟委员会提交一份档案之后。生产该婴儿配方奶粉所用的蛋白水解物作为适合用于生产婴儿配方奶粉和后续配方奶粉的蛋白质来源，已列入欧盟委员会授权法规（EU）2016/127的附件一和附件二中。本意见不涉及对该婴儿配方奶粉的营养安全性和适用性或生产蛋白水解物所用食品酶的安全性的评估。专家小组认为，就所声称的效果而言，所评估的婴儿配方奶粉在肽的分子量分布方面没有得到充分表征。从提交的人体干预研究中，无法得出该婴儿配方奶粉在降低患特应性皮炎风险方面的功效结论。专家小组得出结论，在所评估的婴儿配方奶粉的消费与有过敏家族史的婴儿患特应性皮炎风险降低之间，尚未确立因果关系。
