#32026R0397Commission Implementing Regulation (EU) 2026/397 authorising lacto-N-tetraose produced by a derivative strain of Escherichia coli K-12 MG1655 as a novel food
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This regulation authorises Inbiose N.V. to place on the EU market lacto-N-tetraose (LNT) produced via microbial fermentation using a genetically modified derivative of E. coli K-12 MG1655 (ATCC 700926) as a novel food. It grants five years of data exclusivity from 16 March 2026, allowing only Inbiose (or applicants with their agreement or independently obtained data) to use the submitted proprietary studies on identity, production process, composition, ADME, toxicology and allergenicity. The LNT is authorised for the same food categories and maximum levels as previously approved versions, except food supplements for young children are excluded. A specific labelling requirement is imposed on food supplements containing this LNT: they must state that the product should not be consumed on the same day as other foods containing added LNT.
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Key Changes
- Authorises LNT produced by E. coli K-12 MG1655 derivative strain as novel food from 16 March 2026
- Grants 5-year data protection period exclusively to Inbiose N.V. until 16 March 2031
- Excludes use of this LNT in food supplements intended for young children
+ 3 more changes with Pro
Obligations
What this law requires
Only Inbiose N.V. may place lacto-N-tetraose produced by E. coli K-12 MG1655 (ATCC 700926) on the EU market for five years from the entry into force of this Regulation (16 March 2026), unless other applicants obtain independent legally obtained data or have Inbiose's agreement
Food supplements containing lacto-N-tetraose produced by E. coli K-12 MG1655 (ATCC 700926) must include labelling stating 'the product should not be consumed on the same day as other foods containing added LNT'
Food supplements containing lacto-N-tetraose produced by E. coli K-12 MG1655 (ATCC 700926) are prohibited from being marketed for young children
Lacto-N-tetraose produced by E. coli K-12 MG1655 (ATCC 700926) may only be used in the same food categories and at the same maximum levels as previously authorized LNT versions (from Implementing Regulation (EU) 2020/484), excluding food supplements for young children
Inbiose N.V. holds exclusive rights to proprietary scientific studies and data (identity, production process, composition, ADME, toxicology, allergenicity assessment) for five years from entry into force, preventing other applicants from referencing these protected studies