Lacto-N-triose II, a Novel Food Update and Zinc-L-Carnosine

Three developments directly relevant to regulatory affairs, product development and scale-up

EFSA considers Lacto-N-triose II safe as a novel food under the proposed conditions. The EU authorisation of Rhizomucor pusillus mycelium is in force, with specific conditions of use and five years of data protection. For zinc-L-carnosine, the Authority still finds insufficient evidence of safety and bioavailability.

Executive summary:

EFSA has assessed the human milk oligosaccharide Lacto-N-triose II as safe under the proposed conditions of use—a positive scientific opinion, but not yet a market authorisation. The novel food development concerning Rhizomucor pusillus reported in July has now taken effect as an EU authorisation with specific use limits and data exclusivity. The zinc-L-carnosine assessment demonstrates where a food supplement dossier remains scientifically inadequate despite a clearly intended use.

Lacto-N-triose II: a positive EFSA opinion on another human milk oligosaccharide

On 22 July 2026, EFSA assessed Lacto-N-triose II (LNTri II) as a novel food. This human milk oligosaccharide is produced by fermentation using a genetically modified strain of Kluyveromyces lactis. In the relevant EFSA Panel’s view, the information on identity, manufacturing process, composition and specifications raised no safety concerns. [1]

Proposed uses include infant formula, follow-on formula, food supplements and foods for special medical purposes. EFSA concludes that LNTri II is safe under the proposed conditions of use. For manufacturers, this is a significant scientific milestone, but it does not replace the subsequent EU authorisation and inclusion in the Union list of novel foods. [1]

For product development, the question therefore shifts from the fundamental safety assessment to conditions of use, specification, labelling and the timing of possible inclusion in the Union list. Particularly for infant nutrition and special medical purposes, the distinction between a scientific opinion and actual permission to place a product on the market remains crucial.

Follow-up: Rhizomucor pusillus becomes eligible for marketing under EU law

The earlier news article of 28 July 2026 discussed the possible product categories and the significance of authorisation for Rhizomucor pusillus mycelium. [2] The legal act is now operationally relevant: Implementing Regulation (EU) 2026/1507 has applied since 26 July 2026 and adds the fermentation-derived mycelium to the Union list of novel foods. [3]

The specific use limits are now decisive for manufacturers. Intended uses include cereals and snacks, biscuits, bars, milk alternatives, non-alcoholic drinks, flatbreads and steamed bakery products, chocolate products, cocoa-based spreads, meal replacements and food supplements. For adult food supplements, the maximum is 6 g per day; pregnant and breastfeeding women and people under 18 must be excluded. The required designation is ‘Rhizomucor pusillus mycelium’. [3]

The authorisation is subject to data protection for five years from 26 July 2026 and is initially restricted in principle to The Protein Brewery B.V. For potential customers, the question therefore shifts from general permissibility to specification, entitlement to supply, dosage, target group and technical validation in the final product. [3]

Zinc-L-carnosine: EFSA finds insufficient evidence of safety and bioavailability

On 17 June 2026, EFSA published its assessment of zinc-L-carnosine as a novel food and as a zinc source for food supplements. The intended use was for the general population aged 12 and over, excluding pregnant and breastfeeding women, at a maximum daily intake of 112.5 mg zinc-L-carnosine—equivalent to approximately 25 mg zinc and 87.5 mg L-carnosine. [4]

The Authority concluded that the substance was insufficiently characterised and that neither bioavailability nor safety under the proposed conditions of use could be established. For developers, this is more than an isolated negative opinion: where a substance is intended both as a novel food and as a source of a vitamin or mineral in food supplements, identity, specification, solubility, release, bioavailability and safety data must align. A plausible product idea or use in other markets does not replace this evidence. [4]

For the German, Austrian and Swiss markets, this primarily implies a clear sequence in project planning. Before developing the formulation, claims or packaging, it must be established whether the specific substance is authorised under EU law and can be used as a nutrient source. EFSA’s opinion is not a general statement against zinc-L-carnosine as a subject of research; it is, however, a clear signal that market entry cannot be planned without a robust dossier.

Possible product concepts—subject to authorisation

From a development perspective, possible applications—subject to subsequent authorisation and specific conditions of use—could include infant and follow-on formula, medical nutrition or food supplements with targeted HMO positioning. These examples describe potential applications, not products currently eligible for marketing.

Wishing you a pleasant weekend, Andreas Gebhart

Sources

All sources last checked and accessed on 13 August 2026.

1. VO (EU) 2026/196, Art. 1–4.
2. VO (EU) 2026/1507, Rhizomucor pusillus.
3. Essential Signals: TFA, neue Novel Foods und Fermentation im Scale-up, 28. Juli 2026.
4. EFSA: Zink-L-Carnosin als Novel Food und Zinkquelle, 17. Juni 2026.

Note: This article provides professional information and does not constitute legal advice. The specific product, target market and legislation in force at the time of the decision are decisive. Image: AI-generated.