,"On December 12, 2025, the European Commission published Delegated Regulation (EU) 2025/2017 in the Official Journal of the European Union, introducing an important update to the compositional rules for infant formula and follow-on formula manufactured from protein hydrolysates. The amendment will apply from January 1, 2026.
The regulation adds a new category, “Protein-related requirements – Group E,” to the existing framework governing protein sources used in infant and follow-on formula. This new group specifically covers formulas produced using cow’s milk whey protein hydrolysate with a minimum of 80% protein concentrate.
Under Group E, the regulation clearly defines:
1.Processing requirements for the authorized whey protein hydrolysate
2.Amino acid composition criteria to ensure nutritional adequacy
3.A permitted protein content range of 0.48–0.67 g per 100 kJ, aligned with infant nutritional needs
The update is based on a positive safety and suitability assessment by the European Food Safety Authority (EFSA). By formally authorizing this additional protein source, the amendment expands the range of compliant protein hydrolysates that may be used in infant and follow-on formula.
Overall, the new rules are expected to increase formulation flexibility for manufacturers, support innovation in infant nutrition, and facilitate market access within the EU, while maintaining a high level of consumer safety and regulatory oversight."
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