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[02] Section 2high risk#3 ADR trigger

Production Process

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.

28Opinions with ADR on this section
34Clock-stopped issues
6%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.

  • 1Missing or incomplete process flow diagram
  • 2No identification of critical control points (CCPs) or missing HACCP plan
  • 3Process changes between pilot and commercial scale not addressed
  • 4Insufficient description of purification or extraction steps
  • 5No process contaminant monitoring data
  • 6GMO status of production organism not declared or not substantiated
What EFSA expects

Complete process flow diagram from raw materials to final product. Identification of all CCPs with corresponding monitoring parameters. Evidence that the commercial-scale process produces the same product as the batches tested. For fermentation: full description of the production organism, fermentation conditions, and downstream processing. Any process changes during development must be documented with impact assessment.

From the case law

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

“In order to monitor the efficiency of the heat treatment and to guarantee that there are no viable Y. lipolytica cells remaining in the dried biomass thereafter, testing for the presence of viable yeast cells has to be carried out immediately after the heat treatment.”
ON-5594Yarrowia lipolytica yeast biomassBiomass fermentationFavorable with conditions1 ADR
“The applicant was requested to provide information on the hazard analysis and quality control measures (HACCP) in place. The applicant did not reply to these requests.”
ON-9413Dried biomass powder of Chlamydomonas reinhardtiiMicroalgaeUnfavorable1 ADR
“Considering that the description of the production process has changed without justification several times over the course of the risk assessment period, the Panel has doubts regarding the robustness, consistency and credibility of the data submitted by the applicant.”
ON-7449Calcium, magnesium and sodium salts of beta-hydroxybutyrateChemical nutrientUnfavorable2 ADRs
Category-specific notes

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

Fermentation

Genetic stability of the production strain across fermentation cycles. Antibiotic resistance marker status. If GMM: full molecular characterization and GMO Panel co-adoption required. Genotoxicity testing on the culture supernatant is a separate requirement (see Section 9).

Insects

Feed substrate composition and controls. Rearing conditions. Kill step validation. Processing (drying, milling) impact on product.

Chemical nutrients

Synthetic route must be fully described. Process impurities from reagents or intermediates must be identified and quantified.

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