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).
The specific issues EFSA most frequently flags in this section. Each of these has caused a clock stop in at least one published case.
Pre-set specifications covering identity, purity, composition, and contaminant limits, with justified acceptance ranges derived from data across ≥ 5 independently produced batches. Specifications must be tight enough to ensure batch-to-batch consistency and to guarantee that commercial product matches the material used in safety studies. For contaminants: limits must be set at achievable levels, not just at regulatory maximum levels.
Real findings from EFSA panel opinions. Each quote is verbatim from a published assessment.
“The test materials used in the toxicological studies contained 2% of related compounds of the synthetic crystalline lycopene, whereas the specifications indicate that this should be no more than 9%. An explanation of this discrepancy between what is tested and what is in the specifications is needed.”
“Concentrating the unsaponifiable matter via molecular distillation is accompanied by an increase in the levels of polycyclic aromatic hydrocarbons.”
“The Panel considers that the specification limit of 10 meq O/kg fat for peroxide value in the dried forms is too high and considers a limit of 5 meq O/kg fat to be appropriate for the novel food in the dried and powder forms.”
How this section plays out differently depending on your novel food type.
Specifications must account for metabolic variation between fermentation runs. Residual host-cell protein and DNA limits if applicable.
Purity specifications critical. Process impurity limits must be set and justified. Polymorphic forms must be specified if relevant.
Specifications for heavy metals must reflect environmental variability in cultivation conditions.
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