EU Infant Formula Regulation 2026: Commission Delegated Regulation (EU) 2026/743, Group F Protein Hydrolysates & Compliance Guide

EU Infant Formula Regulation 2026: New Protein Hydrolysate Requirements, Group F Composition, EFSA Assessment & Market Access

The European Union has taken an important step in the evolution of infant formula regulation with the adoption of Commission Delegated Regulation (EU) 2026/743.

Adopted on 30 March 2026 and published in the Official Journal of the European Union on 9 June 2026, the regulation amends Commission Delegated Regulation (EU) 2016/127 concerning the protein-related requirements applicable to infant and follow-on formula manufactured from protein hydrolysates. It enters into force on the twentieth day following publication and is binding and directly applicable in all EU Member States.

The amendment introduces a new “Protein-related requirements group F”, allowing the use of a specific protein hydrolysate that was positively assessed by the European Food Safety Authority (EFSA).

For infant formula manufacturers, food business operators, importers, exporters and regulatory professionals, this represents an important development in EU food regulatory compliance, infant nutrition regulation and formula product development.

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

Commission Delegated Regulation (EU) 2026/743 amends Regulation (EU) 2016/127, the EU framework establishing specific compositional and information requirements for infant formula and follow-on formula.

The amendment specifically addresses formulas manufactured using protein hydrolysates.

Previously, Regulation (EU) 2016/127 contained protein-related requirements for Groups A through E. The 2026 amendment adds Group F following EFSA's scientific assessment of a specific hydrolyzed protein source.

The EU regulation states that the new protein hydrolysate may be used where the formula complies with the specified protein source, processing, protein content, amino acid and L-carnitine requirements.

Key Regulatory Timeline

The amendment therefore converts the scientific assessment into a specific regulatory pathway for marketing formula manufactured from the evaluated hydrolysate.

Why Does the 2026 EU Infant Formula Update Matter?

Infant formulas are subject to highly detailed EU compositional requirements because it may serve as the sole source of nutrition for infants during critical stages of development.

Under Regulation (EU) 2016/127, formulas manufactured from protein hydrolysates must meet defined requirements relating to:

• Protein content
• Protein source
• Protein processing
• Amino acid composition
• L-carnitine
• Other applicable compositional requirements

The 2026 amendment demonstrates that these requirements can evolve when new scientific evidence supports the safety and nutritional suitability of a specific protein hydrolysate.

For manufacturers, the change provides an opportunity to develop and market formulas using a newly recognized hydrolyzed protein source while maintaining compliance with the EU regulatory framework.

New Protein-Related Requirements: Group F

The most significant change introduced by Regulation (EU) 2026/743 is the addition of Protein-related requirements Group F.

Group F establishes specific requirements for formulas manufactured using the newly assessed hydrolysate.

Group F briefly

These requirements are legally incorporated into Annex I of Regulation (EU) 2016/127 by the 2026 amendment.

Approved Protein Source: Whey–Casein Blend

Group F applies to a specific protein hydrolysate manufactured from mixtures of sources of skimmed cow's milk and whey protein concentrates.

The regulation specifies an initial:

Whey protein: Casein ratio = 60:40 w/w

This is important because the authorization is not a general approval for every protein hydrolysate having similar characteristics.

The regulatory requirements are linked to the specific protein source and manufacturing characteristics assessed by EFSA.

Manufacturers therefore need to verify that their hydrolysate and manufacturing process correspond to the regulatory criteria before relying on Group F.

Defined Protein Content: 2.3–2.8 g/100 kcal

One of the most important compliance parameters is protein concentration.

For Group F, the regulation specifies:

Minimum: 2.3 g/100 kcal

Maximum: 2.8 g/100 kcal

This corresponds to:

0.55–0.67 g/100 kJ

The minimum protein concentration reflects the conditions under which EFSA concluded that the specific hydrolysate was nutritionally safe and suitable for infant and follow-on formula.

Manufacturers developing or reformulating products should therefore verify protein concentration using the correct calculation basis and ensure that the finished formula remains within the regulatory range.

Specific Protein Processing Requirements

Group F does not only define the protein source. It also specifies the protein processing conditions.

Under the regulation, the source material is hydrated and heated. Hydrolysis is then carried out:

• At a pH of 6.9–7.6
• At a temperature of 50–55.5°C
• Using a metalloprotease

The food enzyme is subsequently inactivated through heat treatment at 80–85°C for 17 seconds to 10 minutes, with an additional thermal process up to 140°C for 0.5 seconds where required.

This means manufacturers cannot assess compliance solely because of the finished product's protein content.

The source material and manufacturing process are also central to Group F eligibility.

L-Carnitine Requirement

Regulation (EU) 2026/743 also maintains a minimum L-carnitine requirement of 1.2 mg/100 kcal for Group F formulas.

L-carnitine is involved in fatty-acid metabolism and energy metabolism.

For regulatory purposes, however, the key consideration is not the physiological role alone. Manufacturers must demonstrate that the finished formula satisfies the applicable compositional requirement.

EFSA Scientific Basis Behind the Amendment

The regulatory change follows an EFSA scientific opinion adopted on 29 January 2025 concerning a specific protein hydrolysate derived from sources of skimmed cow's milk and whey protein concentrates.

EFSA assessed the nutritional safety and suitability of the hydrolysate for use in infant and follow-on formula.

The assessment considered the characteristics of the hydrolysate and evidence including a clinical intervention study.

EFSA reported that an infant formula containing the evaluated hydrolysate at 2.3 g protein/100 kcal, used as the sole source of nutrition for three months, resulted in growth like a comparator formula based on intact cow's milk protein at 1.9 g protein/100 kcal. No concerns were identified from the reported adverse-event and tolerance data.

EFSA concluded that the hydrolysate was a nutritionally safe and suitable protein source for infant and follow-on formula when the formula contains at least 2.3 g protein/100 kcal and complies with the applicable compositional and amino acid requirements.

What Does This Mean for Infant Formula Manufacturers?

The new regulation creates both compliance obligations and product-development opportunities.

Manufacturers using or considering the Group F hydrolysate should conduct a structured regulatory assessment covering:

1. Product Formulation Review

Review:

• Protein concentration
• Protein source
• Whey-to-casein ratio
• Amino acid profile
• L-carnitine
• Other mandatory nutrients

2. Manufacturing Process Assessment

Confirm that the manufacturing process corresponds to the conditions established for the Group F protein hydrolysate.

3. Regulatory Gap Assessment

Compare the existing product against the amended requirements of Regulation (EU) 2016/127.

4. Technical Documentation

Maintain evidence supporting:

• Raw material identity
• Protein source
• Hydrolysate characterization
• Manufacturing process
• Analytical results
• Finished product composition
• Compliance with amino acid requirements

Impact on Existing Infant Formula Products

Companies already marketing hydrolyzed-protein infant formula should not assume that the introduction of Group F automatically changes the status of their existing products.

Instead, manufacturers should determine:

Does the existing formula use a protein hydrolysate covered by Group F?

If yes, the manufacturer should verify compliance against every applicable Group F criterion.

If no, the manufacturer should continue assessing the product against the protein-related requirements applicable to its existing hydrolysate category.

This distinction is important because Regulation (EU) 2026/743 adds Group F to the existing framework rather than replacing all existing hydrolysate categories.

EU Infant Formula Compliance Checklist 2026

Implications for EU Exporters and International Manufacturers

The amendment is also relevant to companies outside the EU that export infant formulas or follow-on formula into the European market.

International manufacturers should evaluate whether their products meet the amended EU requirements before placing products on the EU market.

Attention should be given to:

• Ingredient specifications
• Protein hydrolysate documentation
• Manufacturing process records
• Nutritional composition
• Analytical testing
• Scientific substantiation
• Product labeling
• EU regulatory documentation

An ingredient or formula that complies with requirements in another jurisdiction may not automatically comply with EU Regulation (EU) 2016/127 as amended by Regulation (EU) 2026/743.

Key Challenges for Regulatory Teams

The Group F amendment may create several practical challenges.

1. Complex Ingredient Qualification

Protein hydrolysates are not interchangeable. The regulatory criteria relate to specific protein sources and processing characteristics.

2. Formulation Control

Small changes in protein concentration or raw material composition can affect regulatory compliance.

3. Supplier Management

Manufacturers should ensure that suppliers provide sufficiently detailed specifications and change notifications.

4. Scientific Documentation

Companies developing new hydrolysates may need substantial scientific evidence to support safety and nutritional suitability.

5. Regulatory Change Management

Regulatory teams should ensure that product databases, specifications and compliance assessments reflect the amended EU framework.

FAQ 

1. What is Commission Delegated Regulation (EU) 2026/743?
Commission Delegated Regulation (EU) 2026/743 amends EU Regulation 2016/127 by introducing new protein-related requirements for infants and follow-on formulas containing a specific protein hydrolysate.

2. What is Group F protein hydrolysate under EU infant formula regulations?
Group F is a new protein-related category covering a specific hydrolyzed protein derived from skimmed cow’s milk and whey protein concentrates and assessed by EFSA.

3. What is the Group F protein requirement for infant formula?
The Group F protein requirement is 2.3–2.8 g/100 kcal, equivalent to approximately 0.55–0.67 g/100 kJ.

4. What is the whey-to-casein ratio for Group F infant formula?
The required initial whey-to-casein ratio is 60:40 w/w for the protein source specified under Group F.

5. What are the hydrolysis conditions for Group F protein?
The specified hydrolysis process uses a metalloprotease, with processing parameters including pH 6.9–7.6 and temperature 50–55.5°C, followed by enzyme inactivation.

6. What is the L-carnitine requirement for Group F formula?
Group F formulas must contain at least 1.2 mg L-carnitine per 100 kcal, in accordance with the applicable EU compositional requirements.

7. Did EFSA approve the Group F protein hydrolysate?
EFSA assessed the specific hydrolysate for nutritional safety and suitability. Its scientific opinion formed the basis for the subsequent EU regulatory amendment establishing Group F requirements.

8. When does EU Regulation 2026/743 apply?
Regulation (EU) 2026/743 was published in the Official Journal on 9 June 2026 and enters into force 20 days after publication.

9. Does EU Regulation 2026/743 affect all hydrolyzed infant formulas?
No. Group F applies to the specific protein hydrolysate and conditions defined in the regulation. Other hydrolyzed formulas remain subject to their applicable requirements under Regulation (EU) 2016/127.

10. How can manufacturers comply with EU infant formula Regulation 2026/743?
Manufacturers should review protein content, protein source, whey-to-casein ratio, hydrolysis conditions, amino acids, L-carnitine, specifications, documentation and labeling against the amended EU requirements.

How Manufacturers Can Prepare

A proactive compliance strategy should include:

1. Identify affected products using protein hydrolysates.
2. Map protein sources and suppliers to the applicable regulatory group.
3. Verify Group F eligibility where relevant.
4. Confirm the 2.3–2.8 g/100 kcal protein range.
5. Review manufacturing and hydrolysis parameters.
6. Verify amino acid requirements.
7. Confirm L-carnitine levels.
8. Update technical documentation and specifications.
9. Review product labeling and regulatory information.
10. Establish ongoing EU infant nutrition regulatory monitoring.

This approach can help manufacturers reduce regulatory gaps while supporting efficient product development and market access.

Conclusion

Commission Delegated Regulation (EU) 2026/743 represents an important development in the EU regulatory framework for infant formula and follow-on formula manufactured from protein hydrolysates.

By adding Protein-related requirements Group F, the European Commission has created a regulatory pathway for a specific hydrolysate that was positively evaluated by EFSA for nutritional safety and suitability.

For manufacturers, the key requirements include a 2.3–2.8 g/100 kcal protein range, a 60:40 initial whey-to-casein ratio, specified hydrolysis conditions, applicable amino acid requirements and a minimum L-carnitine level of 1.2 mg/100 kcal.

The amendment demonstrates the EU's continuing approach of linking scientific evidence, compositional standards and regulatory market access.

Manufacturers and exporters should therefore review their hydrolyzed-protein portfolios, technical specifications and manufacturing processes to determine whether the new Group F requirements affect their products.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions supports food and infant nutrition companies with regulatory strategy, compliance assessment and technical documentation for evolving global requirements.

Our support can include:

• EU Infant Formula Regulatory Assessment
• Regulation (EU) 2016/127 Compliance Review
• Regulation (EU) 2026/743 Impact Assessment
• Protein Hydrolysate Regulatory Assessment
• Formula Composition Review
• Nutritional Compliance Assessment
• Ingredient and Supplier Documentation Review
• Label and Claims Compliance Review
• Regulatory Gap Assessment
• EU Market Access Support
• Scientific and Regulatory Documentation Review
• Ongoing Regulatory Monitoring

Whether you are launching a new hydrolyzed-protein formula, reformulating an existing product or preparing an international product for the EU market, Maven Regulatory Solutions can help you identify regulatory gaps and build a structured EU infant formula compliance strategy.