Scientific and technical guidance for the ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
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Titre :
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)
Auteur(s) :
Turck, Turck [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bresson, Jean-Louis [Auteur]
Burlingame, Barbara [Auteur]
Dean, Tara [Auteur]
Fairweather-Tait, Susan [Auteur]
Heinonen, Marina [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Neuhauser-Berthold, Monika [Auteur]
Nowicka, Grazyna [Auteur]
Pentieva, Kristina [Auteur]
Sanz, Yolanda [Auteur]
Sjodin, Anders [Auteur]
Stern, Martin [Auteur]
Tome, Daniel [Auteur]
van Loveren, Henk [Auteur]
Vinceti, Marco [Auteur]
Willatts, Peter [Auteur]
Fewtrell, Mary [Auteur]
Przyrembel, Hildegard [Auteur]
Titz, Ariane [Auteur]
Martinez, Silvia Valtuena [Auteur]

Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bresson, Jean-Louis [Auteur]
Burlingame, Barbara [Auteur]
Dean, Tara [Auteur]
Fairweather-Tait, Susan [Auteur]
Heinonen, Marina [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Neuhauser-Berthold, Monika [Auteur]
Nowicka, Grazyna [Auteur]
Pentieva, Kristina [Auteur]
Sanz, Yolanda [Auteur]
Sjodin, Anders [Auteur]
Stern, Martin [Auteur]
Tome, Daniel [Auteur]
van Loveren, Henk [Auteur]
Vinceti, Marco [Auteur]
Willatts, Peter [Auteur]
Fewtrell, Mary [Auteur]
Przyrembel, Hildegard [Auteur]
Titz, Ariane [Auteur]
Martinez, Silvia Valtuena [Auteur]
Titre de la revue :
EFSA Journal
Nom court de la revue :
EFSA J
Numéro :
19
Date de publication :
2021-03
ISSN :
1831-4732
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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 ...
Lire la suite >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.Lire moins >
Lire la suite >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.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
CHU Lille
Inserm
Université de Lille
Inserm
Université de Lille
Date de dépôt :
2021-07-06T12:44:31Z
2024-01-09T08:56:56Z
2024-01-09T08:56:56Z
Fichiers
- EFSA Journal - 2021 - - Scientific and technical guidance for the preparation and presentation of a dossier for evaluation.pdf
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