Europe: Update of Delegated Regulation (EU) 2016/127 for infant and follow-on formula manufactured from protein hydrolysates

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The Commission delegated Regulation (EU) 2016/127 established new requirements for infant formula and follow‐on formula manufactured from protein hydrolysates. These requirements may be amended in order to allow the placing on the market of formulae manufactured from protein hydrolysates with a composition different from the one already positively assessed (and authorized in Regulation (EU) 2016/127), following a case‐by‐case evaluation of their safety and suitability by EFSA.

EFSA issued a scientific opinion on 28 November 2020 on the nutritional safety and suitability of the specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by Danone Trading ELN B.V. The Authority concluded that the protein hydrolysate in question is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 0,55 g/100 kJ (2,3 g/100 kcal) protein and complies with the other compositional criteria set out in Delegated Regulation (EU) 2016/127.

Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates has been published on 1 April 2022 in order to allow the placing on the market of infant and follow-on formula manufactured from the protein hydrolysate in question. Therefore, the requirements for protein hydrolysates set out in Regulation (EU) 2016/127 have been updated and adapted to include also the requirements concerning this protein hydrolysate.

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