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
Documents
- EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (Sjodin)_EFSA Journal_2021_Vol 19(3)_6556
Final published version, 716 KB, PDF document
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.
Original language | English |
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Article number | 6556 |
Journal | E F S A Journal |
Volume | 19 |
Issue number | 3 |
Number of pages | 26 |
ISSN | 1831-4732 |
DOIs | |
Publication status | Published - 2021 |
- Follow-on-formula, Food allergy, Guidance, Infant formula, Milk proteins, Protein hydrolysates
Research areas
ID: 260239302