European Union has adopted Commission Delegated Regulation (EU) 2026/743, amending Delegated Regulation (EU) 2016/127 to introduce a new category of protein hydrolysates for use in infant formula and follow-on formula. The Regulation was published in the Official Journal of the European Union and will become applicable 20 days after publication across all EU Member States. The amendment adds a new protein hydrolysate category, designated as Protein-related Requirements Group F, to the compositional requirements set out in Annexes I, II and III of Regulation (EU) 2016/127. Manufacturers may now use this authorized protein hydrolysate in infant and follow-on formula, provided specified compositional and processing criteria are met.
1.Added a new authorized protein hydrolysate category (Group F) for use in infant formula and follow-on formula.
2.Expanded the list of permitted protein hydrolysates under Regulation (EU) 2016/127.
3.Authorized use of skimmed cow's milk and whey protein concentrate mixtures with a 60:40 whey-to-casein ratio as the protein source.
4.Established a protein content range of 2.3–2.8 g/100 kcal for formulas manufactured using Group F hydrolysates.
5.Introduced specific hydrolysis and heat-treatment processing requirements for the new protein source.
6.Required hydrolysis using a metalloprotease under defined pH and temperature conditions.
7.Set a minimum L-carnitine level of 1.2 mg/100 kcal for infant formula containing Group F protein hydrolysates.
8.Updated Annex III to include amino acid requirements applicable to Group F formulas.
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