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. 2021 Mar 26;19(3):e06556. doi: 10.2903/j.efsa.2021.6556

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

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2,✉, Dominique Turck, Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser‐Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Anders Sjödin, Martin Stern, Daniel Tomé, Henk Van Loveren, Marco Vinceti, Peter Willatts, Mary Fewtrell, Hildegard Przyrembel, Ariane Titz, Silvia Valtueña Martínez
PMCID: PMC7996106  PMID: 33791040

Abstract

Endorsement date 21 January 2021
Implementation date 27 March 2021
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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.

Keywords: protein hydrolysates, infant formula, follow‐on‐formula, guidance, food allergy, milk proteins

Suggested citation: EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , Turck D, Bresson J‐L, 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, Van Loveren H, Vinceti M, Willatts P, Fewtrell M, Przyrembel H, Titz A, Valtueña Martínez S, 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). EFSA Journal 2021;19(3):6556, 26 pp. doi: 10.2903/j.efsa.2021.6556

Requestor: European Commission

Question number: EFSA‐Q‐2020‐00592

Panel members in 2017: Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, AndronikiNaska, Monika Neuhäuser‐Berthold, GrażynaNowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Henk Van Loveren, Marco Vinceti and Peter Willatts.

Acknowledgements: Efsa wishes to thank the Panel on Nutrition, Novel Foods and Food Allergens (NDA) that endorsed this output in 2021: Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, AndronikiNaska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. EFSA staff members: Sara De Berardis, Daniela Maurici, Ariane Titz and Silvia Valtueña Martínez for the support provided to this scientific output.

1

The guidance was adopted on 5 April 2017 by the former Panel on Dietetic products, Nutrition and Allergies. The revision only aims to inform food business operators of the new provisions set out in the General Food Law (Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain), and to guide to EFSA's practical arrangements implementing these new requirements. For this purpose, the revision concerns only the administrative part. The scientific content remains unchanged. The present guidance (revision 1) was endorsed on 21 January 2021 by the Panel on Nutrition, Novel Foods and Food Allergens (NDA): Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, AndronikiNaska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti.

This Guidance is applicable for applications submitted as of 27 March 2021

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