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) 1: (Scientific Opinion)

Research output: Contribution to journal › Journal article › Commissioned

Standard

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) 1 : (Scientific Opinion). / Turck, Dominique; Bresson, Jean Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; McArdle, Harry J.; Naska, Androniki; Neuhäuser-Berthold, Monika; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Loveren, Henk Van; Vinceti, Marco; Willatts, Peter; Fewtrell, Mary; Przyrembel, Hildegard; Titz, Ariane; Martínez, Silvia Valtueña; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).

In: E F S A Journal, Vol. 19, No. 3, 6556, 2021.

Research output: Contribution to journal › Journal article › Commissioned

Harvard

Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser-Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Sjödin, A, Stern, M, Tomé, D, Loveren, HV, Vinceti, M, Willatts, P, Fewtrell, M, Przyrembel, H, Titz, A, Martínez, SV & EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 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) 1: (Scientific Opinion)', E F S A Journal, vol. 19, no. 3, 6556. https://doi.org/10.2903/j.efsa.2021.6556

APA

Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch-Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Neuhäuser-Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Sjödin, A., Stern, M., Tomé, D., Loveren, H. V., Vinceti, M., ... EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (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) 1: (Scientific Opinion). E F S A Journal, 19(3), [6556]. https://doi.org/10.2903/j.efsa.2021.6556

Vancouver

Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M 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) 1: (Scientific Opinion). E F S A Journal. 2021;19(3). 6556. https://doi.org/10.2903/j.efsa.2021.6556

Author

Turck, Dominique ; Bresson, Jean Louis ; Burlingame, Barbara ; Dean, Tara ; Fairweather-Tait, Susan ; Heinonen, Marina ; Hirsch-Ernst, Karen Ildico ; Mangelsdorf, Inge ; McArdle, Harry J. ; Naska, Androniki ; Neuhäuser-Berthold, Monika ; Nowicka, Grażyna ; Pentieva, Kristina ; Sanz, Yolanda ; Sjödin, Anders ; Stern, Martin ; Tomé, Daniel ; Loveren, Henk Van ; Vinceti, Marco ; Willatts, Peter ; Fewtrell, Mary ; Przyrembel, Hildegard ; Titz, Ariane ; Martínez, Silvia Valtueña ; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). / 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) 1 : (Scientific Opinion). In: E F S A Journal. 2021 ; Vol. 19, No. 3.

Bibtex

@article{052f2ab7f1764703826052be2a742395,
title = "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) 1: (Scientific Opinion)",
abstract = "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 specific dossiers, and in the light of applicable Union guidelines 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.",
keywords = "Follow-on-formula, Food allergy, Guidance, Infant formula, Milk proteins, Protein hydrolysates",
author = "Dominique Turck and Bresson, {Jean Louis} and Barbara Burlingame and Tara Dean and Susan Fairweather-Tait and Marina Heinonen and Hirsch-Ernst, {Karen Ildico} and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Monika Neuh{\"a}user-Berthold and Gra{\.z}yna Nowicka and Kristina Pentieva and Yolanda Sanz and Anders Sj{\"o}din and Martin Stern and Daniel Tom{\'e} and Loveren, {Henk Van} and Marco Vinceti and Peter Willatts and Mary Fewtrell and Hildegard Przyrembel and Ariane Titz and Mart{\'i}nez, {Silvia Valtue{\~n}a} and {EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)}",
note = "CURIS 2021 NEXS 144",
year = "2021",
doi = "10.2903/j.efsa.2021.6556",
language = "English",
volume = "19",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
number = "3",

}

RIS

TY - JOUR

T1 - 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) 1

T2 - (Scientific Opinion)

AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser-Berthold, Monika

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Loveren, Henk Van

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Fewtrell, Mary

AU - Przyrembel, Hildegard

AU - Titz, Ariane

AU - Martínez, Silvia Valtueña

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

N1 - CURIS 2021 NEXS 144

PY - 2021

Y1 - 2021

N2 - 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 specific dossiers, and in the light of applicable Union guidelines 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.

AB - 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 specific dossiers, and in the light of applicable Union guidelines 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.

KW - Follow-on-formula

KW - Food allergy

KW - Guidance

KW - Infant formula

KW - Milk proteins

KW - Protein hydrolysates

UR - http://www.scopus.com/inward/record.url?scp=85103593329&partnerID=8YFLogxK

U2 - 10.2903/j.efsa.2021.6556

DO - 10.2903/j.efsa.2021.6556

M3 - Journal article

C2 - 33791040

AN - SCOPUS:85103593329

VL - 19

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 3

M1 - 6556

ER -

ID: 260239302