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[03] Section 3high risk#1 ADR trigger

Compositional Data

The most frequent ADR trigger across all 239 analysed opinions. 102 clock-stopped issues in 61 cases — more than any other section. Most are recoverable (13% inadequacy rate), but they are costly: each round means new lab work, new batches, new analysis. The ≥5 independent batches requirement is the single most predictable ADR trigger.

61Opinions with ADR on this section
102Clock-stopped issues
13%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.

  • 1Fewer than 5 independent batches analysed — EFSA’s 2024 guidance requires ≥5 and this is the most consistent first-round ADR trigger
  • 2Missing contaminant analysis (heavy metals, PAHs, dioxins, pesticides)
  • 3Analytical methods not validated or not described
  • 4No stability data under proposed storage conditions
  • 5Microbiological criteria missing or not aligned with Reg. (EC) 2073/2005
  • 6Minor constituents or impurities above 1% not identified and quantified
What EFSA expects

Full compositional analysis of ≥ 5 independently produced batches using validated analytical methods. Proximate analysis (protein, fat, carbohydrate, ash, moisture). Contaminant analysis according to EU maximum levels. Microbiological criteria. Stability data under proposed storage conditions and shelf life. All analytical methods described with LOD/LOQ. For complex mixtures: all fractions above 1% characterised.

From the case law

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

“A substantial fraction (between 20% and 30% w/w) of the NF remains uncharacterised.”
ON-10004Carbon dioxide extract from Cannabis sativa L.Plant extractUnfavorable1 ADR
“Results revealed high microbial counts regarding total aerobic microbial count, coliforms, Enterobacteriaceae, yeasts and moulds, highlighting excessive variability in the hygiene conditions along the production process.”
ON-9467Grain and flour from perennial intermediate wheatgrassWhole foodUnfavorable3 ADRs
“EFSA therefore asked the applicant to provide compositional data (i) on a current lot of the Novel Food, (ii) elaborated by the certified laboratory and (iii) covering all analyses contained in the specification.”
ON-3954Arracacha roots (Arracacia xanthorrhiza)Whole foodInconclusive1 ADR
Category-specific notes

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

Algae

Heavy metal contamination (arsenic, cadmium, lead, mercury) is a particular focus. Iodine content must be quantified if relevant.

Insects

Pesticide residues from feed. Heavy metals. Microbiological safety (Salmonella, Listeria). Chitin quantification.

Plant extracts

Characterization of active constituents and marker compounds. Solvent residues if extracted — Directive 2009/32/EC limits apply (e.g. hexane ≤1 mg/kg).

Check your dossier against this pattern.

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