New protein requirements in infant formula milk: what manufacturers must do in 2026

Key data

Manufacturers of infant formula and follow-on formula prepared from protein hydrolysates have a new compliance obligation in the EU. The Delegated Regulation (EU) 2026/743, published on 9 June 2026, amends Delegated Regulation (EU) 2016/127 and updates the protein requirements that these products must meet before they can be marketed in the European market.

The change is significant: it affects product composition, labeling and all technical documentation that supports it. Companies that do not start the adaptation process now risk being unable to comply on time and, in the worst case, having their products withdrawn from the European market.

What does this regulation establish?

Delegated Regulation (EU) 2026/743 amends Delegated Regulation (EU) 2016/127, which is the framework regulation governing infant formula and follow-on formula in the European Union. The amendment focuses specifically on protein-related requirements for products made from protein hydrolysates.

The changes respond to new scientific assessments of infant nutritional needs and the safety of these products. In practice, this translates into the following elements that companies must review:

The regulation establishes a transitional period for companies to adapt, although its exact duration is not specified in the published text. In any case, reformulation and analytical validation processes require time, so the recommendation is to begin adaptation immediately.

Economic and operational impact

This regulation generates direct and indirect costs for companies in the sector. This is not just a label update: it involves a complete product review process that can affect multiple business lines simultaneously.

• Reformulation costs: If the current formulation does not meet the new protein thresholds, it will be necessary to modify the product recipe, with the R&D, ingredient and validation costs that this entails.
• Analytical costs: The regulation requires new composition analyses to demonstrate compliance. Depending on the number of affected references, this can represent a significant cost per product.
• Labeling costs: Updating artwork, printing new labels and managing old label inventory.
• Documentation costs: Review and update of technical documentation and records associated with each affected reference.
• Risk of market withdrawal: Non-compliance may result in withdrawal of products from the European market, with the economic and reputational impact that this entails.

The impact will be greater the broader the range of products made with protein hydrolysates that the company markets. Companies with multiple references in this category will need to manage the adaptation process as a cross-functional project involving R&D, quality, regulatory and marketing.

Who does it affect?

This regulation directly affects:

• Manufacturers of infant formula made from protein hydrolysates marketed in the EU.
• Manufacturers of follow-on formula made from protein hydrolysates marketed in the EU.
• Distributors of these products in the European market, who must ensure that the products they market comply with the new regulation.
• Regulatory, Quality and R&D departments of affected companies, who are directly responsible for managing the adaptation process.
• Importers of infant formula with protein hydrolysates from third countries wishing to access the European market.

Products made with non-hydrolyzed proteins are not affected by this specific amendment, although they remain subject to the rest of Regulation (EU) 2016/127.

Practical example

A European infant formula milk manufacturer that markets three references of infant formula with protein hydrolysates (for example, a hypoallergenic starter formula, a follow-on formula and one specialized for intolerances) will need to address the following process for each of them:

1. Review the current formulation against the new protein thresholds of Regulation (EU) 2026/743.
2. If the formulation does not comply, initiate the reformulation process with the R&D team.
3. Commission new composition analyses to demonstrate compliance with updated thresholds.
4. Update the labeling of the three references and associated technical documentation.
5. Manage the transition period to ensure there is no stock on the market with non-compliant labeling or formulation once the deadline expires.

If the company does not start this process with sufficient advance notice before the end of the transitional period, it risks having to withdraw product from the market or being unable to launch new batches until the adaptation is complete, with the consequent impact on sales and relationships with distributors and customers.

What should companies do now?

1. Identify all affected references: Make an inventory of all infant formula and follow-on formula made with protein hydrolysates that the company manufactures or distributes in the EU.
2. Review current formulations: Compare the current protein composition of each reference with the new thresholds established by Regulation (EU) 2026/743 to determine if reformulation is necessary.
3. Plan composition analyses: Commission the new analyses needed to demonstrate compliance, especially if reformulations are carried out.
4. Update labels and technical documentation: Begin the process of updating labeling and all affected records and technical documentation.
5. Establish an adaptation timeline: Set internal milestones to complete adaptation before the end of the transitional period, taking into account R&D, analysis, printing and inventory management times.
6. Consult with the regulatory department or a specialized advisor: Verify the interpretation of the new thresholds and documentation requirements with experts in European food regulation to avoid errors that could lead to non-compliance.

The risk of not acting is clear: non-compliance may result in withdrawal of products from the European market, with the economic, reputational and logistical impact that this entails.

Official source

Consult complete regulation in official source — EUR-Lex OJ:L_202600743

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202600743