EFSA assessed a mixture consisting mainly of lacto-N-triose II, produced by fermentation with genetically modified Kluyveromyces lactis DSM 709-2-02. Identity, manufacturing, composition and specifications raised no safety concern.

Proposed uses span several foods, infant and follow-on formula, supplements and foods for special medical purposes. The Panel compared estimated exposure with natural exposure in breastfed infants and with previously assessed HiMOs.

For regulatory and ingredient-scouting teams, the opinion is a useful precedent. Final Commission authorisation, definitive conditions of use and labelling still require separate verification, while safety alone does not authorise functional claims.

Why it matters

The opinion widens the regulatory landscape for human-identical milk oligosaccharides and provides a concrete reference for identity, process and exposure.

Evidence limit

This is a scientific safety opinion, not final European Commission authorisation and not evidence of efficacy or prebiotic benefit.

Editorial note. This content is intended for industry professionals. It does not constitute medical advice, therapeutic guidance or regulatory advice. Read our editorial method.

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