Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates (revision 1) - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2021

Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates (revision 1)

Jean-Louis Bresson
  • Fonction : Auteur
Barbara Burlingame
  • Fonction : Auteur
Tara Dean
  • Fonction : Auteur
Susan Fairweather-Tait
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Karen Ildico Hirsch-Ernst
  • Fonction : Auteur
Inge Mangelsdorf
  • Fonction : Auteur
Harry J. Mcardle
  • Fonction : Auteur
Androniki Naska
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Grazyna Nowicka
  • Fonction : Auteur
Kristina Pentieva
  • Fonction : Auteur
Yolanda Sanz
  • Fonction : Auteur
Anders Sjodin
  • Fonction : Auteur
Martin Stern
  • Fonction : Auteur
Daniel Tome
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur
Marco Vinceti
  • Fonction : Auteur
Peter Willatts
  • Fonction : Auteur
Mary Fewtrell
  • Fonction : Auteur
Hildegard Przyrembel
  • Fonction : Auteur
Ariane Titz
  • Fonction : Auteur
Silvia Valtuena Martinez
  • Fonction : Auteur

Résumé

Following a request from the European Commission, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an 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 nutritional 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 specificdossiers, and in the light of applicable Unionguidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre-submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.
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hal-04381482 , version 1 (09-01-2024)

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Turck Turck, Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, et al.. Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates (revision 1). EFSA Journal, 2021, EFSA Journal, 19, ⟨10.2903/j.efsa.2021.6556⟩. ⟨hal-04381482⟩

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