EU Infant Formula Regulation 2026: New Group F Protein Hydrolysate Requirements Under Regulation (EU) 2026/743

What the New EU Requirements Mean for Infant Formula Manufacturers, Exporters and Regulatory Teams

The European Union has introduced new compositional requirements for infant and follow-on formula containing a specific protein hydrolysate through Commission Delegated Regulation (EU) 2026/743.

The amendment modifies Delegated Regulation (EU) 2016/127, which establishes specific compositional and information requirements for infant formula and follow-on formula.

The update introduces a new Group F category of protein requirements for a specific protein hydrolysate that has been scientifically evaluated for use in infants and follow-on formula.

For infant formula manufacturers, food companies, ingredient suppliers, exporters and regulatory professionals, the amendment creates a need to review formulation, protein composition, nutrient levels, technical documentation and EU market compliance.

The change also demonstrates how evolving EFSA scientific assessments can translate into specific amendments to EU food-composition legislation.

What Is Commission Delegated Regulation (EU) 2026/743?

Commission Delegated Regulation (EU) 2026/743 amends Regulation (EU) 2016/127 concerning the compositional requirements applicable to infants and follow-on formula manufactured from protein hydrolysates.

The amendment introduces specific compositional requirements for a protein hydrolysate assessed as suitable for infants and follow-on formula.

The regulation was adopted on 30 March 2026 and published in the Official Journal of the European Union on 9 June 2026.

It reflects the EU's continuing approach of updating infant nutrition requirements in response to scientific evidence concerning the safety, nutritional adequacy and suitability of specific protein sources and hydrolysates.

For manufacturers, the practical implication is that formulas using the newly covered hydrolysate must be evaluated against the amended compositional conditions before being placed on the EU market.

Why Does the 2026 Update Matter?

Infant and follow-on formula are subject to detailed EU compositional requirements because they are intended for a particularly sensitive population.

Regulation (EU) 2016/127 sets requirements in areas including:

• Protein sources
• Protein content
• Amino acids
• Vitamins and minerals
• Other nutrients
• Ingredients and substances
• Labelling and information
• Specific compositional conditions

The 2026 amendment demonstrates that these requirements can evolve when new scientific evidence supports the use of additional protein sources or manufacturing approaches.

The update aims to provide a regulatory pathway for a specific hydrolyzed protein while maintaining defined nutritional and compositional controls.

Key Changes Introduced by Regulation (EU) 2026/743

Introduction of the New Group F Category

One of the most important aspects of the amendment is the introduction of Group F.

The new category provides compositional requirements for the specific protein hydrolysate covered by the amendment.

This is significant because protein hydrolysates can differ considerably according to:

• Protein source
• Degree of hydrolysis
• Hydrolysis process
• Amino acid profile
• Peptide distribution
• Whey-to-casein composition
• Manufacturing conditions

Therefore, authorization of one hydrolysate does not automatically mean that all hydrolyzed protein systems can be treated identically.

Manufacturers must establish that their ingredients and finished formulas correspond to the regulatory specifications applicable to the relevant group.

Approved Protein Source: Whey–Casein Combination

The Group F requirements apply to a protein hydrolysate manufactured from specified milk-derived protein sources.

The composition includes:

• Whey protein concentrates derived from cow's milk
• Skimmed cow's milk protein concentrate
• A 60:40 whey protein-to-casein ratio
• Defined manufacturing and hydrolysis conditions

The precise identity and manufacturing characteristics of the hydrolysate therefore become important elements of regulatory assessment.

Manufacturers should verify that their supplier documentation demonstrates consistency between the commercial ingredient, manufacturing process and regulatory specification.

Protein Content Requirements

The amended framework establishes a specific protein-content range for infants and follow-on formulas using the relevant hydrolysate.

The specified requirement is approximately:

2.8–3.0 g protein per 100 kcal

with the corresponding energy-based expression specified in the regulation.

For manufacturers, this means that formulation teams should verify the protein contribution of the hydrolysate alongside the overall finished-product composition.

The assessment should consider:

• Total protein concentration
• Protein source
• Amino acid profile
• Energy contribution
• Other protein-containing ingredients
• Finished-product specifications
• Analytical verification

A formulation that uses the appropriate hydrolysate but does not meet the applicable finished-product compositional requirements may still require reformulation or regulatory review.

Minimum L-Carnitine Requirement

Another important compositional requirement concerns L-carnitine.

For infant formula containing the Group F protein hydrolysate, the amendment establishes a minimum L-carnitine level of:

1.2 mg per 100 kcal

L-carnitine has an important role in fatty-acid metabolism and energy utilization.

Manufacturers should therefore verify L-carnitine content during formulation review and ensure that the final product complies with the applicable compositional requirements.

This should also be reflected consistently across:

• Formula specifications
• Ingredient calculations
• Laboratory results
• Technical documentation
• Regulatory submissions
• Product information and labelling

Scientific Basis of the Amendment

The EU approach to infant formula composition is closely connected with scientific evaluation.

The amendment follows an EFSA scientific assessment dated 29 January 2025 concerning the specific protein hydrolysate covered by the new requirements.

The scientific evaluation considered factors relevant to the suitability of the protein hydrolysate for infants and follow-on formula, including its:

• Nutritional suitability
• Amino acid composition
• Safety
• Protein characteristics
• Use in the target population

The regulatory amendment translates the scientific assessment into defined compositional conditions that manufacturers must follow.

This illustrates an important principle for the infant nutrition sector:

Scientific assessment and regulatory authorization must be considered together when developing new formula ingredients.

What Does This Mean for Infant Formula Manufacturers?

1. Formulation Review

Manufacturers using the relevant protein hydrolysate should review existing formulations against the new Group F requirements.

The review should cover:

• Protein source
• Protein concentration
• Whey-to-casein ratio
• Hydrolysis process
• L-carnitine
• Overall nutrient composition

2. Supplier Qualification

Ingredient suppliers should provide appropriate technical documentation demonstrating that the hydrolysate meets the applicable specifications.

Companies should evaluate:

• Ingredient identity
• Manufacturing process
• Composition
• Specifications
• Certificate of analysis
• Batch consistency
• Regulatory documentation

3. Technical Documentation

Regulatory teams should ensure that the technical file supporting the product reflects the current formulation and regulatory requirements.

Any discrepancy between supplier information, formulation records and finished-product documentation should be investigated.

Labelling and Regulatory Compliance

Changes to formulation can trigger a review of product information and labelling.

Manufacturers should assess whether the regulatory update effects:

• Ingredient declarations
• Nutritional information
• Product descriptions
• Mandatory statements
• Preparation instructions
• Technical specifications
• Supporting documentation

The labelling assessment should be performed together with the formulation and regulatory review rather than as a separate exercise.

International Trade Implications

The impact of the amendment extends beyond companies manufacturing within the EU.

Exporters supplying infant and follow-on formula to EU markets should verify that their products meet the amended EU requirements.

This is particularly relevant for:

• Infant formula manufacturers outside the EU
• Global nutrition companies
• Contract manufacturers
• Ingredient suppliers
• Private-label formula companies
• Importers and distributors

Companies exporting products to Europe should ensure that formulation specifications, supplier documentation and regulatory dossiers remain aligned with the EU requirements applicable.

2026 EU Infant Formula Compliance Checklist

Frequently Asked Questions

1. What does Regulation (EU) 2026/743 change?

It amends Regulation (EU) 2016/127 by introducing specific compositional requirements for a protein hydrolysate covered under the new Group F category.

2. What is Group F?

Group F is a new category of protein requirements introduced for the specific hydrolysate covered by the amendment.

3. What protein source is covered?

The relevant hydrolysate is manufactured from specified cow's-milk-derived whey and skimmed milk protein sources with a 60:40 whey-to-casein ratio.

4. Does the amendment affect all infant formulas?

No. The new requirements specifically concern infant and follow-on formula using the protein hydrolysate covered by the amended provisions.

5. What is the L-carnitine requirement?

For infant formula containing the Group F hydrolysate, the applicable requirement establishes a minimum L-carnitine level of 1.2 mg/100 kcal.

6. What should manufacturers do now?

Companies should determine whether their products use the relevant hydrolysate and then review formulation, ingredient specifications, manufacturing conditions, technical documentation and labelling against the amended EU requirements.

Conclusion

Commission Delegated Regulation (EU) 2026/743 represents another development in the EU's science-based approach to infant and follow-on formula regulation.

By introducing Group F requirements for a specific protein hydrolysate, the EU provides a defined compositional framework for products using this newly assessed protein source.

For manufacturers and exporters, compliance should not be limited to checking the final protein concentration.

Companies should evaluate the complete regulatory chain:

Protein source → Hydrolysis process → Composition → Nutritional adequacy → L-carnitine → Finished formula → Documentation → Labelling → EU market compliance

Early regulatory assessments can help companies identify formulation gaps, update technical documentation and prepare products for EU market requirements.

As infant nutrition regulations continue to evolve alongside new scientific assessments, manufacturers should maintain active monitoring of European Commission, EFSA and EU food-composition developments.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support infant formula manufacturers, ingredient suppliers, exporters and regulatory teams with:

• Infant formula regulatory assessments
• EU Regulation (EU) 2016/127 compliance review
• Group F formulation assessment
• Protein hydrolysate regulatory evaluation
• Ingredient and formulation review
• Nutritional composition assessment
• Regulatory gap analysis
• Technical dossier review
• Labelling compliance assessment
• Supplier documentation review
• Market-entry strategy
• EU regulatory intelligence
• Product registration and notification support

Our approach helps infant nutrition companies align formulation, ingredient specifications, technical documentation and EU regulatory requirements as the European regulatory framework continues to evolve.