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[01] Section 1medium risk#4 ADR trigger

Identity of the Novel Food

23 clock-stopped issues across 16 of 239 opinions. Less frequent than compositional or toxicological ADRs, but when identity issues arise, 64% lead to a clock stop — the highest conversion rate of any section. The panel needs unambiguous identification: what exactly is the novel food, and how is it distinguished from similar products.

16Opinions with ADR on this section
23Clock-stopped issues
9%End inadequate or partially adequate
Common gaps

The specific issues EFSA most frequently flags in this section. Each of these has caused a clock stop in at least one published case.

  • 1Taxonomic identification insufficient or outdated (wrong nomenclature, no culture collection deposit)
  • 2Molecular structure or structural characterization not provided for chemical substances
  • 3No clear definition of what the novel food is versus the source organism or raw material
  • 4Production strain not identified at species and strain level
  • 5Novel food not unambiguously distinguished from similar authorised products
  • 6Missing information on physical form (powder, oil, suspension) and its impact on identity
What EFSA expects

Unambiguous identification of the novel food. For chemical substances: IUPAC name, CAS number, molecular formula, structural formula. For organisms: full taxonomic classification, strain designation, and deposit in a recognised culture collection. For complex products: clear definition of what constitutes the novel food versus the source. Physical form and any processing that affects identity must be described.

From the case law

Real findings from EFSA panel opinions. Each quote is verbatim from a published assessment.

“During the assessment of this NF, EFSA requested the applicant to identify the strain ‘TKD‑1’ at the species level.”
ON-8414DHA-rich oil from Schizochytrium limacinumMicroalgaeFavorable with conditions3 ADRs
“The Panel considered that the analytical data provided by the applicant do not fully support the identity of the material as a complex between OSA and vanillin.”
ON-5086Orthosilicic acid-vanillin complexChemical nutrientFavorable with conditions2 ADRs
“Upon EFSA’s request, the applicant provided the results of size exclusion chromatography (SEC) analysis under denaturing and reducing conditions and sodium dodecyl sulfate‑polyacrylamide gel electrophoresis (SDS‑PAGE) analysis.”
ON-7204Beta-lactoglobulin from precision fermentationProtein isolateFavorable with conditions2 ADRs
Category-specific notes

How this section plays out differently depending on your novel food type.

Algae

Most commonly flagged section for algae applications. Strain identification at species level required, with deposit in a recognised culture collection.

Fermentation

Production strain must be fully characterised including genetic stability data. If GMM-derived: whole genome sequencing and detailed molecular characterization expected.

Cell culture

Cell line identity and provenance. Absence of adventitious agents. Origin and characterization of the cell line must be fully documented.

Insects

Species identification including life stage at harvest. Distinction between whole insect, defatted powder, protein isolate, etc.

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