Every pattern below is extracted from real EFSA panel minutes, published opinions, and additional data request letters. These are the gaps that cost applicants months.
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.
The second most frequent ADR trigger (84 clock-stopped issues across 44 opinions) and the hardest to recover from: 29% of assessments end inadequate — the highest rate of any section. Missing or flawed toxicological studies are the single most common cause of unfavorable opinions. The 90-day subchronic study and the genotoxicity battery are the most critical requirements.
The third most common ADR trigger with 34 clock-stopped issues across 28 opinions. Almost always recoverable — only 6% of assessments end with an inadequate judgement, the lowest of any section. But production process ADRs are costly: they delay downstream sections because composition and toxicology data depend on the process being finalised.
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.
23 clock-stopped issues across 23 opinions. Exposure modelling errors directly undermine the toxicological assessment: if intake is underestimated, the entire safety evaluation is compromised. The 17% inadequacy rate reflects how often applicants fail to model combined intake from multiple food categories or miss vulnerable population groups.
19 clock-stopped issues across 18 opinions. Specifications define the quality limits every commercial batch must meet. The 17% inadequacy rate is higher than compositional data itself, because specification failures are often design failures: applicants set ranges post-hoc from a single batch rather than designing them during development (Safe by Design principle).
10 clock-stopped issues across 8 opinions overall, but the 21% inadequacy rate — second highest of any section — reveals the real risk: when ADME data is needed and missing, it is rarely recoverable. For chemical-origin novel foods and nutrient sources, ADME is mandatory and its absence is an immediate blocker.
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.
4 clock-stopped issues across 4 opinions — rarely a standalone ADR trigger. But critical when the novel food replaces a conventional food or is a novel protein source. Protein quality (DIAAS) is mandatory for protein sources but frequently missing. Anti-nutritional factors are a recurring gap for insects and legume-derived products.
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.
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