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[05] Section 5low risk#10 ADR trigger

History of Use

Only 1 clock-stopped issue across 239 opinions — the rarest standalone ADR trigger. But the 18% inadequacy rate tells a different story: the panel frequently judges history of use claims as weak, even when it does not send a separate ADR for it. History of use contributes to the overall weight of evidence but rarely blocks an assessment on its own.

1Opinions with ADR on this section
1Clock-stopped issues
18%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.

  • 1History of use documentation does not cover 25 continuous years (TFC route)
  • 2Evidence limited to a single country or ethnic group without broader context
  • 3No distinction between traditional preparation and the novel food as produced
  • 4Processing or extraction methods differ substantially from traditional use
  • 5Consumption levels in traditional context not documented
  • 6No evidence of absence of adverse effects in the source population
What EFSA expects

For TFC (Art. 14): documented evidence of safe use for ≥ 25 years in a significant part of the population of a third country. Evidence must cover the product in a form comparable to how it will be marketed in the EU. For standard applications: documented history of the source organism in the food chain, including preparation methods and consumption patterns. The traditional form must be clearly linked to the novel food as proposed.

From the case law

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

“There is no documented history of safe consumption of the NF or its source. According to the applicant, food products containing A. diaperinus larvae have been marketed in certain countries of the European Union for up to ~15 years, but precise consumption figures were not made available.”
ON-7325Frozen and freeze-dried Alphitobius diaperinus larvaeInsect proteinFavorable with conditions7 ADRs
“While canola oil has a pre-1997 history of safe food use, canola protein isolates have not been consumed in the EU in significant quantities.”
ON-3420Rapeseed protein isolate (Isolexx™)Protein isolateFavorable with conditions
“Synthetic zeaxanthin has not previously been available on the European market. No reliable data are available concerning consumption of zeaxanthin-containing food supplements.”
ON-728Synthetic zeaxanthinChemical nutrientUnfavorable
Category-specific notes

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

Plant extracts

History of use is the critical gating factor. The traditional preparation must match the proposed novel food — a concentrated extract of a traditionally eaten leaf is not the same product.

Modified novel foods

History of use cannot be claimed for modified versions of already-authorised novel foods. Only the Art. 10 extension route applies.

Check your dossier against this pattern.

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