(1) Commission Delegated Regulation (EU) 2016/127 (2) lays down, amongst others, specific compositional requirements for infant formula and follow-on formula manufactured from protein hydrolysates. It provides that infant and follow-on formula manufactured from protein hydrolysates are to comply with the requirements for protein content, protein source, protein processing as well as with the requirements for indispensable and conditionally indispensable amino acids and L-carnitine as set out in point 2.3 of Annex I and point 2.3 of Annex II to that Regulation.

(5)Taking into account the conclusions of the Authority’s opinion of 2020, it is appropriate 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 should be updated and adapted to include also the requirements concerning this protein hydrolysate.

Article 1

Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.