8 Key Facts About Lacto-N-triose II as a Novel Food
What the Positive EFSA Opinion (July 2026) Means – and Does Not Yet Mean – for Functional Food Manufacturers

Regulation (EU) 2015/2283 on novel food establishes a centralised authorisation procedure for ingredients that were not used to a significant degree in the EU before 15 May 1997. Lacto-N-triose II – a trisaccharide from the HMO group, application NF 2024/22930 (EFSA-Q-2024-00142) submitted by Shandong Henglu Biotechnology Co., Ltd – received a positive EFSA scientific opinion on 22 July 2026. That is an important milestone, but not the end of the procedure: formal authorisation still requires an implementing regulation from the European Commission. Below are eight issues worth understanding now, ahead of that authorisation taking effect – and what remains unknown.

1. The Eventual LNT II Authorisation Will Not Be Generic – It Will Cover a Specific Production Source and Manufacturing Method

According to the application documentation (NF 2024/22930), LNT II is manufactured by fermentation using a genetically modified strain of the yeast Kluyveromyces lactis DSM 709-2-02. The future Commission implementing regulation – once adopted – will most likely specify not only the substance itself but also this specific, accepted manufacturing method. This is not a technical detail. A manufacturer wishing to use LNT II obtained by a different method (e.g. a different microorganism, enzymatic chemical synthesis, or extraction from human breast milk) will need to either submit a separate authorisation application or demonstrate that its product is 'substantially equivalent' within the meaning of Article 10 of Regulation (EU) 2015/2283. Enforcement practice shows that national authorities – including the Polish Chief Sanitary Inspectorate (GIS) – verify, during inspections of food supplements, whether the technical specification of an ingredient is consistent with the scope of the authorisation. A discrepancy between a supplier's specification and the scope of the future implementing regulation will constitute a direct basis for challenging the legality of the product.

• Already check in your supplier's documentation whether the LNT II production method matches the one described in application EFSA-Q-2024-00142 (strain K. lactis DSM 709-2-02), and once the implementing regulation is published, the method specified there.
• Request from your supplier a Certificate of Analysis (CoA) and a technical specification – and be ready to compare it against the annex to the implementing regulation once published.
• If the supplier is based outside the EU, verification of the specification is the importer's obligation – not the supplier's.

A failure of the specification to comply with the scope of the future authorisation will not be a formal irregularity – it will constitute the placing on the market of food that is unauthorised as a novel food, which under Article 14 of Regulation (EC) 178/2002 may render the food legally unsafe. Until the implementing regulation enters into force, placing LNT II on the market at all – regardless of specification compliance – is not permitted.

2. The July 2026 EFSA Scientific Opinion Distinguishes Between Population Groups – and That Distinction Will Be Legally Binding Once the Implementing Regulation Is Adopted

In its scientific opinion (EFSA Journal 2026;24(7):10257, EFSA-Q-2024-00142, adopted by the NDA Panel on 1 July 2026, published on 22 July 2026), EFSA assessed the safety of LNT II separately for infants, young children, and the adult population, under the proposed conditions of use submitted by the applicant. This is not an academic distinction – once the Commission adopts the implementing regulation, it can be expected to transpose these categories directly into the conditions of use, as has happened with earlier HMO authorisations. This means the eventual permitted dose for adults and the permitted dose in infant preparations will be two different figures, each supported by different toxicological justifications. A food supplement manufacturer targeting adults will not be able to automatically rely on safety data relating to infants, and vice versa.

• For infants: LNT II is assessed in the context of infant formula – compliance with Regulation (EU) 609/2013 will be required in parallel.
• For adults: EFSA's opinion sets out proposed safe conditions of use (including a maximum level of 0.2 g/day in food supplements, excluding infants and young children) – the final, legally binding values will only appear in the Commission's implementing regulation. Full application reference: NF 2024/22930, EFSA-Q-2024-00142.
• Products intended for pregnant or breastfeeding women require a separate analysis, as EFSA did not treat this group as a priority population in this scientific opinion.

3. Proposed Maximum Levels in the Final Product – Not Yet Binding, But Worth Preparing for Now

Commission implementing regulations on other HMOs (including earlier implementing regulations for 2'-fucosyllactose and lacto-N-neotetraose) consistently specify maximum use levels in mg per kg of product or in mg per day for the consumer, broken down by food category. In its application, the LNT II applicant proposed a similar structure – a table of food categories with maximum levels (including beverages, dairy products, infant cereals, FSMPs, and food supplements capped at 0.2 g/day, excluding infants and young children) – which EFSA assessed as safe in its July 2026 opinion. Importantly, this remains a proposal from the applicant, positively assessed by EFSA – the final, legally binding, exhaustive table of categories will only appear in the Commission's implementing regulation, which may (though need not) differ from the version assessed by EFSA. Once the regulation enters into force, a fundamental principle of novel food law will apply: authorisation is positive and exhaustive, not presumed – if a product category is not listed in the table, LNT II will not be usable in it, even if the dose would otherwise fall within safety limits.

What does this mean for a manufacturer right now? If you are planning a new product category (e.g. sports food containing LNT II) that does not appear in the conditions of use assessed by EFSA, be prepared for the possibility that, once the implementing regulation enters into force, you will need to submit an application to extend the conditions of use (Article 10 of Regulation 2015/2283) or a new authorisation application. A legal opinion stating that the product 'falls within the spirit' of the future authorisation will not be sufficient.

4. LNT II and 'Substantial Equivalence' Status – A Route That, Once the Authorisation Takes Effect, May Shorten Time to Market for Competitors

Article 10 of Regulation (EU) 2015/2283 provides for a simplified notification procedure for food that is 'substantially equivalent' to an already authorised novel food. Once LNT II (application by Shandong Henglu Biotechnology, NF 2024/22930) is formally authorised via the Commission's implementing regulation, other manufacturers holding LNT II with an identical chemical specification, purity profile, and safety profile will be able to submit a notification of 'substantial equivalence' to the European Commission instead of a full, separate application. This procedure formally takes 4 months (compared to 9 months for a full application, plus the time required for the EFSA scientific opinion, counted from validation of the application). However, the Commission has on multiple occasions rejected 'substantial equivalence' notifications for other HMOs where impurity profiles or production strains differed. The Commission's decision-making practice demonstrates that the 'substantially equivalent' threshold is interpreted restrictively for fermentation-derived HMOs – which will matter for LNT II especially where a competing supplier uses a different microorganism than the reference strain K. lactis DSM 709-2-02.

• Notification route (Article 10): faster, but requires full comparative specification documentation.
• Full application route (Article 10(1) and Article 16): longer, but yields a standalone authorisation – which has value in commercial negotiations and data protection.
• Data protection for new applications: 5 years of data exclusivity under Article 26 of Regulation 2015/2283 – this is an argument in favour of submitting your own application rather than 'free-riding on another party's authorisation'.

graph TD
    A[Intention to use LNT II in a product] --> B{Does LNT II originate
from an authorised production method?}
    B -- NO --> C[Application for new authorisation
or substantial equivalence
Art. 10 Reg. 2015/2283]
    B -- YES --> D{Is the product category
listed in the authorisation table?}
    D -- NO --> E[Application to extend
the conditions of use]
    D -- YES --> F{Does the dose fall within
the maximum levels?}
    F -- NO --> G[Reduce the dose
or submit new application]
    F -- YES --> H[Verify labelling requirements
under the implementing regulation]
    H --> I{Do you intend to make
a health claim?}
    I -- YES --> J[Separate application to EFSA
under Reg. 1924/2006]
    I -- NO --> K[Product ready
for placing on the EU market]
    C --> L[European Commission Implementing Regulation]
    E --> L
    L --> D

5. The Label of a Product Containing LNT II Will Need to Comply Simultaneously With Two Legal Regimes – This Is Where Most Errors Occur With Other HMOs

Food supplement manufacturers using LNT II will be subject simultaneously to: Regulation (EU) 1169/2011 on the provision of food information to consumers (general labelling requirements); Directive 2002/46/EC as implemented into Polish law by the Regulation of the Minister of Health on food supplements (requirements specific to food supplements); and the conditions of use that the implementing regulation authorising LNT II as a novel food will set out, once adopted. Based on experience with earlier HMO authorisations (e.g. LNnT, 2'-FL), that act can be expected to impose an obligation to include specific information on the label – for example, an indication of the maximum daily dose or warnings for certain consumer groups. If the future implementing regulation requires such labelling and the manufacturer omits it, it will be in breach of the conditions of the authorisation – a separate infringement of novel food law, independent of any labelling law violations.

Once the implementing regulation enters into force, the Polish Chief Sanitary Inspectorate (GIS) will compare the label against its conditions during inspections. The absence of required labelling will constitute grounds for issuing a decision ordering the withdrawal of the product from the market – regardless of whether the product itself is safe. Until then, the only lawful state of affairs is for LNT II not to be on the market as a novel food at all.

6. Health Claims for LNT II: Even a Future Novel Food Authorisation Will Not Automatically Confer the Right to Make Any Health Claim

This is one of the most common errors in the industry, so it is worth addressing now, ahead of formal authorisation. Manufacturers confuse two distinct legal regimes: novel food authorisation (Regulation 2015/2283) and the authorisation of health claims (Regulation (EC) 1924/2006). The eventual authorisation of LNT II as a novel food will mean solely that the ingredient may be lawfully placed on the market in specified products and at specified doses. It will not mean that any health benefit may be attributed to it on the label or in advertising. As of the date of publication of this article, no health claim for Lacto-N-triose II appears in the EU register of authorised health claims (Regulation (EU) 432/2012 and the 'on hold' list). Marketing communications suggesting a beneficial effect of LNT II on the gut microbiota, immune function, or infant health – in the absence of an authorised health claim – are incompatible with Article 10 of Regulation 1924/2006. In addition, until formal novel food authorisation is granted, any marketing communication about LNT II as a food ingredient in the EU is premature for an entirely separate reason: the mere presence of the ingredient in the product would itself be unlawful.

• General claims about 'supporting gut health' without authorisation: infringement of Article 10(1) of Regulation 1924/2006.
• Claims about reduction of disease risk without authorisation: infringement of Article 14 of Regulation 1924/2006 – higher sanction threshold.
• Health claims on food supplements are monitored by the Polish Chief Sanitary Inspectorate (GIS), not the Office of Competition and Consumer Protection (UOKiK) (although UOKiK may investigate market practices in advertising).

The only lawful route to communicating the health benefits of LNT II is to submit an application for authorisation of a health claim to EFSA, or to rely on general claims relating to categories of ingredients (e.g. prebiotics) – but the latter must satisfy the conditions of Article 13(1) of Regulation 1924/2006 and appear in the approved register.

7. The LNT II Supply Chain and Future Importer Liability – Worth Starting Supplier Due Diligence Now

The applicant in the EFSA procedure is Shandong Henglu Biotechnology Co., Ltd (China) – a strong indicator of where most LNT II is likely to originate once it reaches the European market following formal authorisation. Under Regulation (EU) 2015/2283 and Regulation (EC) 178/2002, an importer placing LNT II on the EU market will be responsible for the ingredient's compliance with the conditions of the authorisation – irrespective of any assurances given by the supplier. This means that the importer will need to: hold documentation confirming that the production method used by the supplier corresponds to the method specified in the implementing regulation (by reference, the K. lactis DSM 709-2-02 strain described in the application); verify batch-by-batch specifications against the contaminant limits set out in the authorisation; and maintain traceability documentation in accordance with Article 18 of Regulation 178/2002. Until the authorisation takes effect, no import of LNT II as a novel food is lawful, regardless of the supplier's documentation.

Enforcement practice with other HMOs shows that the Polish Chief Sanitary Inspectorate (GIS), when inspecting food supplements, requests documentation of the ingredient's origin and the supplier's specification. The absence of such documentation is not merely a procedural issue – it means the manufacturer is unable to demonstrate the legality of the ingredient used. Where LNT II originates from a production process outside the future authorised pathway, the product may be classified as containing an unauthorised novel food, triggering a withdrawal procedure under Article 138 of Regulation (EU) 2017/625.

8. Combinations of HMOs in a Single Product – Each Combination Is a Separate Legal Issue (and LNT II Does Not Yet Have Its Own Authorisation)

The HMO market is moving towards products containing mixtures of several human milk oligosaccharides – for example, LNT II + 2'-fucosyllactose (2'-FL) + lacto-N-tetraose (LNT). 2'-FL and LNT already have their own novel food authorisations; as of the date of publication of this article, LNT II only has a positive EFSA opinion, without a Commission implementing regulation. Once LNT II is formally authorised, each of these ingredients will have a separate novel food authorisation with a separate scope of use and maximum levels. There is no mechanism for 'combining authorisations'. If a product is to contain three HMOs, the manufacturer will need to demonstrate compliance with the conditions of each of the three implementing regulations separately – including the maximum levels for each individual ingredient – and, crucially, must assess whether the combined intake does not exceed safety levels. Until LNT II is authorised, any mixture containing it is not permitted on the EU market.

In its scientific opinions on individual HMOs, EFSA indicated that the safety assessment of mixtures requires a separate analysis of interactions. The European Commission has not yet issued a general implementing regulation authorising 'HMO mixtures' as a category – each combination, if not covered by an existing application, may require a new authorisation. Manufacturers planning multi-ingredient HMO products should obtain a legal opinion before placing the product on the market, not after the first inspection.

• Check the scope of each implementing regulation for each HMO in the product individually.
• Verify that your product category (e.g. food supplement for adults) appears in each of the food category tables.
• If you are using HMOs in an infant preparation: Regulation (EU) 609/2013 imposes additional requirements that are independent of the novel food authorisation.
• Document your maximum level calculations for each ingredient – this is material that the Polish Chief Sanitary Inspectorate (GIS) may request during an inspection.