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[10] Section 10medium risk#8 ADR trigger

Allergenicity

4 clock-stopped issues across 4 opinions in the overall dataset, but the 16% inadequacy rate masks category-specific risk. For insects and fungal proteins, allergenicity is the primary bottleneck — cross-reactivity with crustaceans must be systematically addressed. For lipid-fraction products (e.g. DHA-rich oils), allergenicity risk is lower but not absent: residual proteins from the source organism may contain recognised allergens.

4Opinions with ADR on this section
4Clock-stopped issues
16%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.

  • 1No cross-reactivity assessment with known allergens (crustaceans for insects, moulds for fungi)
  • 2Protein characterization insufficient to assess allergenic potential
  • 3Missing bioinformatic analysis (sequence homology with known allergens)
  • 4Pepsin resistance test not performed or not according to EFSA protocol
  • 5No serum screening with allergic patient sera
  • 6Labelling implications for cross-reactive allergens not addressed
What EFSA expects

Systematic allergenicity assessment following a tiered approach depending on the source: (1) for novel foods from known allergenic sources — full assessment against the source allergens; (2) for foods from sources not subject to allergen labelling — sequence homology search and pepsin resistance; (3) for foods with unknown allergenic potential — comprehensive assessment including bioinformatics (AllergenOnline, WHO/IUIS), pepsin resistance test, and serum screening with sera from patients allergic to taxonomically related species.

From the case law

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

“The Panel notes that the intermediate product contains a recognised allergen (triosephosphate isomerase) whose structure is shared with other taxa, among which Crangon crangon (Cra c 8), a shrimp species.”
ON-8072Ethanolic extract of Phaeodactylum tricornutumMicroalgaeUnfavorable6 ADRs
“The Panel considers that there is no sufficient basis to conclude on the risk of allergenicity for the NF and, given the protein content, some risk is present.”
ON-7380Freeze-dried mycelia of Antrodia camphorataBiomass fermentationFavorable with conditions2 ADRs
“Considering these inconclusive analytical results, the applicant agreed, in accordance with the Labelling Directive 2003/89/EC, that all products containing krill oil would be labelled as containing crustacean.”
ON-938Krill oil (Euphausia superba)LipidFavorable with conditions
Category-specific notes

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

Insects

Allergenicity is the primary bottleneck. Cross-reactivity with crustaceans/shellfish (tropomyosin, arginine kinase) must be explicitly addressed. Labelling requirements for crustacean-allergic consumers are mandatory.

Fermentation

For fungal proteins: cross-reactivity with common mould allergens must be assessed. Residual host-cell proteins may also need allergenicity evaluation.

Algae

Even lipid-fraction algae products may contain residual protein allergens from the source organism. ON-8072 (Phaeodactylum tricornutum extract) contained a recognised shrimp allergen (triosephosphate isomerase).

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