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The European Union has taken a significant step forward in infant nutrition regulation with the adoption of Commission Delegated Regulation (EU) 2026/743. This latest amendment updates the existing Delegated Regulation (EU) 2016/127, introducing a new set of protein-related compositional requirements (Group F) for a specific protein hydrolysate used in infant and follow-on formula.
This development is expected to impact formula manufacturers, exporters, and regulatory professionals across the EU and beyond.
What Is Regulation (EU) 2026/743?
Commission Delegated Regulation (EU) 2026/743, adopted on March 30, 2026, modifies previous EU rules governing protein requirements in infant and follow-on formula made from protein hydrolysates.
The regulation was officially published in the Official Journal of the European Union on June 9, 2026, and will become applicable 20 days after publication across all EU Member States.
This amendment reflects updated scientific assessments, particularly from the European Food Safety Authority (EFSA), on the safety and suitability of protein hydrolysates in infant nutrition.
Why Does This Update Matter?
Infant formula is one of the most tightly regulated food categories in the world. Under Regulation (EU) 2016/127, strict compositional requirements ensure that infant formula meets the nutritional needs of babies during the early months of life.
With evolving scientific evidence and innovation in protein processing, the EU continues to update these standards. Regulation 2026/743 aims to:
- Improve nutritional quality and safety
- Expand innovation opportunities for manufacturers
- Align regulations with new EFSA scientific opinions
- Enable the marketing of infant and follow-on formula manufactured from the specific protein hydrolysate positively assessed by EFSA.
Key Changes Introduced
Expansion of Authorized Protein Hydrolysates
One of the most important updates is the expansion of the list of permitted protein hydrolysates under Regulation (EU) 2016/127.
Until now, only a limited number of hydrolyzed protein formulations have been positively evaluated and approved. The new amendment allows additional hydrolysates to enter the EU market, provided they meet updated criteria.
Introduction of a New Category: Group F
The regulation introduces a new category of protein requirements known as “Group F.”
This category is designed to accommodate new hydrolysate formulations that differ from previously approved compositions but have been deemed safe and nutritionally suitable.
Key highlights of Group F include:
- Enables greater flexibility in formula composition
- Helps manufacturers develop innovative infant nutrition products
- Supports scientifically validated new formulations
Approved Protein Sources: Whey–Casein Blend
Group F applies to a protein hydrolysate manufactured from:
- Whey protein concentrate derived from cow's milk and skimmed cow's milk protein concentrate
- A protein source with a whey protein-to-casein ratio of 60:40
- Specific manufacturing and hydrolysis conditions defined in Annexes I and II of Regulation (EU) 2016/127, as amended
This composition aligns closely with human milk protein characteristics, which may support better digestibility and nutrient absorption.
Defined Protein Content Range
The regulation introduces a precise protein content requirement for formulas using Group F hydrolysates:
- 3–2.8 g per 100 kcal
(equivalent to approximately 0.55–0.67 g per 100 kJ)
This ensures that formulas deliver adequate protein levels while avoiding excessive intake, which can be harmful to infants.
Minimum L-Carnitine Requirement
To support infant metabolism and energy production, the regulation sets a minimum level of 1.2 mg/100 kcal L-carnitine in infant formula containing Group F protein hydrolysates.
L-carnitine plays an essential role in:
- Fat metabolism
- Energy production
- Infant growth and development
Scientific Basis Behind the Amendment
The EU’s regulatory approach is heavily based on EFSA scientific evaluations. Each new hydrolysate must undergo:
- Clinical evaluation in target populations
- Assessment of amino acid composition
- Safety and nutritional adequacy analysis
The amendment follows EFSA's scientific opinion of 29 January 2025, which concluded that the specific protein hydrolysate covered by Group F is a nutritionally safe and suitable protein source for infant and follow-on formula when used in compliance with the compositional requirements set out in Regulation (EU) 2016/127.
Impact on Infant Formula Manufacturers
Compliance and Reformulation
Manufacturers must:
- Review existing formulations
- Update product composition and labeling
- Ensure compliance with new protein and nutrient thresholds
Failure to comply could lead to market withdrawal within the EU.
Innovation Opportunities
The introduction of Group F opens the door to:
- Development of next-generation hydrolyzed formulas
- Improved digestibility-focused products
- Greater product differentiation in the EU market
International Trade Implications
Exporters to the EU must also ensure that:
- Their products align with updated standards
- Documentation reflects new regulatory requirements
This regulation may have global ripple effects, especially in countries exporting infant formula to Europe.
What Does This Mean for Consumers?
For parents and caregivers, this regulation enhances:
- Safety assurance through stricter controls
- Product innovation with potentially improved formulas
- Transparency in formula composition
Ultimately, the changes aim to ensure that infants receive safe, nutritionally optimized products during critical stages of development.
Conclusion
The adoption of Commission Delegated Regulation (EU) 2026/743 represents an important advancement in the evolving regulatory framework for infant formula within the European Union. By expanding the list of authorized protein hydrolysates and introducing the new Group F category, the EU continues to promote scientific innovation while maintaining stringent safety and quality standards.
For manufacturers, this brings both new compliance requirements and market opportunities, while ensuring consumers continue to benefit from safe, high-quality infant nutrition products across Europe. Partnering with Freyr Solutionsand consulting experienced regulatory experts can help manufacturers and brand owners streamline compliance processes, reduce regulatory complexity, and accelerate market readiness.
