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Scientific 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

Turck, D; Bresson, J-L; Burlingame, B; Dean, T; Fairweather-Tait, S; Heinonen, M; Hirsch-Ernst, KI; ... Martinez, SV; + view all (2017) Scientific 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. EFSA Journal , 15 (5) , Article e04779. 10.2903/j.efsa.2017.4779. Green open access

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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.

Type: Article
Title: Scientific 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
Open access status: An open access version is available from UCL Discovery
DOI: 10.2903/j.efsa.2017.4779
Publisher version: https://doi.org/10.2903/j.efsa.2017.4779
Language: English
Additional information: This is an open access article under the terms of the Creative Commons Attribution‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. http://creativecommons.org/licenses/by-nd/4.0/
Keywords: protein hydrolysates, infant formula, follow-on-formula, application, guidance, food allergy, milk proteins
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Population, Policy and Practice Dept
URI: https://discovery.ucl.ac.uk/id/eprint/10088308
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