LNnT in infant foods: what changes with the European correction and what manufacturers must review

Key data

If your company manufactures or markets infant formulas or special food products containing lacto-N-neotetraose (LNnT), this regulatory correction directly affects you. The corrigendum published on 8 September 2026 corrects the Implementing Regulation (EU) 2023/961, which in turn modified the conditions of use of LNnT within the framework of the Implementing Regulation (EU) 2017/2470, the EU list of authorized novel foods.

LNnT is an oligosaccharide naturally present in human milk. Its authorization as a novel food allows it to be incorporated into infant formulas and special products to replicate some of the nutritional benefits of breastfeeding. Any change in its conditions of use—even if it is a technical correction—can have real consequences for the formulation, labeling and regulatory documentation of products containing it.

What does this regulation establish?

This corrigendum is a formal correction to Implementing Regulation (EU) 2023/961, originally published on 12 May 2023 in Official Journal L 129. Its function is to amend technical or administrative aspects of the original text that regulated the conditions of use of LNnT.

EU legislation on novel foods establishes that any ingredient authorized as a "novel food" must comply with specific conditions of use: product categories in which it can be used, maximum permitted doses and labeling requirements. The published correction adjusts the text of those conditions for LNnT.

Economic and operational impact

Although this is a corrigendum—that is, a correction and not a new substantive regulation—its operational implications are not minor for companies that already have products on the market with LNnT.

• Labeling review: If the correction affects the terms in which LNnT must be declared on the label, manufacturers will need to update artwork, legal texts and product technical documentation.
• Dosage review: Any adjustment in authorized maximum levels may require product reformulation or modification of production processes.
• Review of authorized categories: If the categories of products in which LNnT use is permitted change, some products could fall outside the authorization or, conversely, new opportunities for use could open up.
• Regulatory documentation: Compliance files, technical sheets and declarations of conformity must reflect the corrected text, not the original from May 2023.

The cost of not updating documentation can be significant: products that do not comply with the current conditions of use of a novel food may be withdrawn from the market by food control authorities in the Member States.

Who does it affect?

• Manufacturers of infant formulas (starter, follow-on and special formulas) that incorporate LNnT as an ingredient.
• Manufacturers of special food products (foods for special medical purposes, pediatric nutritional supplements) containing LNnT.
• Regulatory Affairs departments of food industry companies with presence in the EU.
• R&D and formulation managers working with human milk oligosaccharides (HMO) as functional ingredients.
• Importers and distributors of products containing LNnT from third countries that market in the European market.
• Regulatory advisors and specialized consultancies in novel food legislation for the food industry.

Practical example

A Spanish manufacturer of starter infant formulas that incorporates LNnT as a functional ingredient currently has its products registered and labeled in accordance with Implementing Regulation (EU) 2023/961 published in May 2023.

With the publication of this corrigendum on 8 September 2026, the Regulatory Affairs department must:

1. Locate the corrected text in the EU Official Journal and identify exactly which paragraphs or conditions have been modified compared to the May 2023 text.
2. Compare the corrected conditions with those currently applied in its product: dose, product category and labeling declarations.
3. If there are discrepancies, initiate the process of updating labeling or formulation before food control authorities can detect non-compliance.

This process, although technically a "correction", can translate into real costs for packaging redesign, label reprinting and updating files with the competent authority.

What should companies do now?

1. Access the corrected text: Download the corrigendum published on 8 September 2026 in the EU Official Journal and identify exactly which conditions of use of LNnT have been modified.
2. Compare with current practice: Review products containing LNnT and compare their labeling, dosage and product category with the corrected conditions.
3. Update regulatory documentation: Modify technical sheets, compliance files and declarations of conformity to reflect the current text, not the May 2023 version.
4. Evaluate the impact on labeling and formulation: If the correction implies changes in mandatory declarations or use levels, initiate the process of updating packaging or reformulation.
5. Inform the supply chain: Communicate to distributors and importers any changes that affect already marketed products, especially if there are batches in circulation with the previous labeling.
6. Consult with the Regulatory Affairs department or a specialized advisor: Since the text does not specify the date of entry into force, it is a priority to determine from when the correction applies to establish adaptation timelines.

Official source

Consult complete regulation in official source

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_202690745