Explanatory note to the scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates (with a view to amend Regulation (EU) 2016/127)

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Published on: Thu, 27 Aug 2020

The European Food Safety Authority (EFSA) identified the need to provide further clarification on the scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates, specifically about (1) the scope of the nutritional safety and suitability assessment, (2) the control formulae that are used in studies to demonstrate the nutritional safety and suitability of a protein hydrolysate, (3) information to be provided in relation to the enzyme(s) that is/are used in the production of the protein hydrolysates, (4) information needed and to be provided for the characterisation of a formula manufactured from protein hydrolysates, (5) clarifications on data requirements in relation to the characterisation of the protein hydrolysate/of the formula for which the application is made.

This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4779/full

Explanatory note to the scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates (with a view to amend Regulation (EU) 2016/127)