EU Regulation 2026/743: Infant Formula Compliance | Freyr

The EU Just Updated Its Infant Formula Rules — Here's What Regulation (EU) 2026/743 Changes

Infant nutrition regulation in the European Union just took a notable step forward. Commission Delegated Regulation (EU) 2026/743 amends the existing framework under Delegated Regulation (EU) 2016/127, adding a new set of protein-related compositional rules — referred to as "Group F" — for a specific protein hydrolysate used in infant and follow-on formula.

For formula manufacturers, exporters, and regulatory teams working in or with the EU market, this update is worth understanding in detail.

What Is Regulation (EU) 2026/743?

Adopted on March 30, 2026, this delegated regulation modifies the protein requirements that apply to infant and follow-on formula made from protein hydrolysates. It was published in the Official Journal of the European Union on June 9, 2026, and becomes applicable across all EU Member States 20 days after that publication date.

The amendment is grounded in updated scientific assessments from the European Food Safety Authority (EFSA) regarding the safety and nutritional suitability of protein hydrolysates in infant formula.

Why This Update Matters

Infant formula sits among the most heavily regulated food categories anywhere in the world, and for good reason — Regulation (EU) 2016/127 was designed to guarantee that formula meets the nutritional needs of infants during a critical developmental window.

As protein-processing science and manufacturing techniques evolve, the EU periodically revisits these standards. Regulation 2026/743 is meant to:

• Strengthen nutritional quality and safety

• Create room for manufacturer innovation

• Keep the rules aligned with the latest EFSA scientific opinions

• Permit the marketing of formula made from the newly, positively assessed protein hydrolysate

What Actually Changed

A Wider List of Approved Protein Hydrolysates

Previously, only a small number of hydrolyzed protein formulations had cleared EU evaluation and approval. This amendment opens the door to additional hydrolysates, provided they satisfy the updated criteria — expanding what manufacturers can legally bring to market.

A New Classification: Group F

The regulation establishes "Group F" as a distinct category of protein requirements, built specifically to accommodate hydrolysate formulations that differ compositionally from earlier approved versions but have nonetheless been judged safe and nutritionally adequate.

In practice, Group F:

• Gives manufacturers more flexibility in how they compose formula

• Makes room for new, scientifically validated product development

• Supports formulations that don't fit neatly into prior categories

The Approved Protein Source

Group F is built around a hydrolysate derived from a specific combination:

• Whey protein concentrate from cow's milk

• Skimmed cow's milk protein concentrate

• A whey-to-casein ratio of 60:40

• Manufacturing and hydrolysis conditions specified in Annexes I and II of the amended Regulation (EU) 2016/127

This whey-casein ratio is notable because it mirrors the protein profile of human milk more closely, which may translate into better digestibility and nutrient absorption for infants.

A Defined Protein Content Range

Formula built on Group F hydrolysates must fall within a specific protein content window — roughly 0.55 to 0.67 g per 100 kJ, expressed as a defined g-per-100-kcal range in the regulation itself. The goal is straightforward: enough protein to support healthy growth, without tipping into levels that could pose risks to infants.

A Minimum L-Carnitine Requirement

The regulation also sets a minimum L-carnitine level of 1.2 mg per 100 kcal for formula containing Group F hydrolysates. L-carnitine supports:

• Fat metabolism

• Energy production

• Overall infant growth and development

The Science Behind the Change

EFSA evaluations underpin virtually every regulatory shift in this space. Before any new hydrolysate is approved, it typically goes through:

• Clinical evaluation in the relevant infant population

• Detailed assessment of amino acid composition

• A broader safety and nutritional adequacy review

This particular amendment traces back to an EFSA scientific opinion issued January 29, 2025, which found the Group F protein hydrolysate to be a nutritionally safe and appropriate protein source for infant and follow-on formula, so long as it's used within the compositional requirements set out in Regulation (EU) 2016/127.

What This Means for Manufacturers

Compliance and reformulation. Companies working with affected hydrolysates will need to revisit existing formulations, update product composition and labeling, and confirm alignment with the new protein and nutrient thresholds. Non-compliance carries real consequences — including potential market withdrawal within the EU.

New room for innovation. At the same time, Group F opens up genuine opportunities: next-generation hydrolyzed formulas, products engineered for improved digestibility, and more differentiation across the EU market.

Trade implications. Exporters selling into the EU need to ensure their products meet the updated standards and that documentation reflects the new regulatory requirements. Because so much global infant formula trade flows through EU compliance, this change is likely to ripple outward to manufacturers well beyond Europe's borders.

What It Means for Parents and Caregivers

For the people actually feeding their babies with these products, the practical upside is:

• Tighter safety controls

• Potential for improved, more digestible formulas

• Greater transparency around what's in the formula they're buying

The Bottom Line

Regulation (EU) 2026/743 is an incremental but meaningful update to the EU's infant formula framework. By widening the list of approved protein hydrolysates and introducing the Group F category, the EU is trying to balance two goals at once: keeping the door open for scientific innovation while holding the line on safety and quality.

For manufacturers, that means new compliance work paired with new market opportunities — and for regulatory teams navigating the transition, working with experienced partners can make the difference between a smooth rollout and a scramble against the applicability deadline.