Open AccessScientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates
Author(s) -
Turck Dominique,
Bresson JeanLouis,
Burlingame Barbara,
Dean Tara,
FairweatherTait Susan,
Hein Marina,
HirschErnst Karen Ildico,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
NeuhäuserBerthold 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
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4779
Subject(s) - authorization , european commission , infant formula , presentation (obstetrics) , medicine , legislation , environmental health , computer science , business , european union , political science , pediatrics , computer security , law , surgery , economic policy
Abstract Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation. 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.