Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Société des Produits Nestlé S.A. in reducing the risk of developing atopic dermatitis.
Résumé
The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing aspecific protein hydrolysate derived from whey protein isolate and concentrate and manufactured bySoci et e des Produits Nestl e S.A., in reducing the risk of developing atopic dermatitis in infants with afamily history of allergy. This was following the submission of a dossier by Soci et e des Produits Nestl eS.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysatefrom which the infant formula is produced is included in Annex I and II of Commission delegatedRegulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow-onformulae. This opinion does not cover the assessment of the nutritional safety and suitability of theinfant 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 isnot sufficiently characterised with respect to the molecular weight distribution of peptides. From thehuman intervention studies submitted, no conclusions could be drawn on the efficacy of the infantformula 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 underevaluation and the reduction in the risk of developing atopic dermatitis in infants with a family historyof allergy
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EFSA Journal - 2021 - - Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey.pdf (1.69 Mo)
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