European Commission amends protein requirements for hydrolysed infant and follow-on formula
Formula manufacturers using the new hydrolysate must meet EU Group F composition and processing rules to market it
Change
Commission Delegated Regulation (EU) 2026/743 of 30 March 2026 amends Delegated Regulation (EU) 2016/127 to add Protein-related requirements group F for infant and follow-on formula manufactured from protein hydrolysates; published in the Official Journal on 9 June 2026 and entering into force 20 days after publication.
Why it matters
The amendment creates a binding compositional and processing boundary for formulas using the specified hydrolysate: Group F formulas must meet precise source-mix ratios (whey:casein 60:40), pH and temperature hydrolysis ranges, enzyme inactivation and heat-treatment durations, contain at least 0.55 g/100 kJ (2.3 g/100 kcal) protein, and comply with the Annex III amino-acid pattern and L-carnitine minimum. The change follows an EFSA safety and suitability opinion of 29 January 2025 on the specific hydrolysate. Products manufactured from this hydrolysate that do not meet the Group F requirements cannot be lawfully placed on the EU market after the regulation enters into force.
Implications
- — Infant and follow-on formula manufacturers may place products manufactured from the specified hydrolysate on the EU market only if the formula conforms to Group F compositional and processing requirements, including a minimum protein content of 0.55 g/100 kJ and the Annex III amino-acid pattern; non-compliant products cannot be marketed after entry into force.
- — Product development and quality-control teams at formula manufacturers may manufacture Group F formulas only when manufacturing records demonstrate the prescribed processing parameters (whey:casein 60:40 source mix, hydrolysis pH 6.9–7.6, temperature 50–55.5 °C, and the required enzyme inactivation/heat-treatment steps); absence of documented conformity prevents market placement.
- — EU Member State competent authorities for food and infant-formula enforcement must apply the amended Annexes I–III and refuse market placement or take enforcement action against infant and follow-on formula that do not meet the Group F requirements from the regulation's effective date.
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