NOVEL FOOD · EVIDENCE GAP COMPARISON · 22 SEPTEMBER 2026
CBD Novel Food evidence gaps: three EFSA dossiers, three different records.
Ingredient name alone cannot explain an EFSA conclusion. Production, purity, final formulation, particles, dose and the submitted evidence package all remain dossier-specific.
Compare gaps—do not predict EFSA.
Two opinions published on 21 September concluded that safety could not be established after requested information was not supplied. A separate opinion published on 18 September reached a positive safety conclusion for a narrowly defined synthetic CBD material and use. None of these facts, by itself, is EU market authorisation.
The outcome follows the assessed material and evidence—not the word “CBD”.
Synthetic ≥98% CBD in MCT oil, maximum 2 mg/day, adults over 25; pregnancy, lactation and concurrent medication excluded.
Plant-derived ≥98% isolate proposed at 60 mg/day. EFSA named gaps across identity, process, composition, specifications and safety evidence.
Extract with 57–65% CBD and 9–17% other cannabinoids, proposed at 30 mg/day. The uncharacterised fraction and requested evidence remained material.
A useful preflight asks which evidence category is open.
The two 21 September opinions explicitly report requests covering identity, production, composition, specifications, genotoxicity, reproductive and developmental toxicity, and human data. The full opinions also show why final-formulation and particle evidence matter. A mapper can turn those historical observations into evidence requests; it cannot determine that a new dossier will succeed.
Evidence coverage is not a safety conclusion.
A percentage can describe whether documents have been mapped to expected categories. It cannot validate study design, test-item equivalence, exposure assumptions, data quality or EFSA’s future scientific judgment. A positive EFSA opinion also remains separate from the European Commission’s authorisation and the Union-list entry required for market access.
Map supplier evidence to the dossier record.
See coverage, historical blockers and a prepared supplier request—while keeping EFSA prediction and market authorisation explicitly out of scope.
Three opinions and the separate authorisation gate.
EFSA Journal e10154 · 18 September 2026Positive safety opinion for a defined synthetic CBD material and use ↗EFSA Journal e10318 · 21 September 2026≥98% plant-derived CBD isolate; safety could not be established ↗EFSA Journal e10319 · 21 September 202657–65% CBD extract; safety could not be established ↗European Commission · Novel Food authorisationsRisk assessment and Commission decision remain separate ↗Educational, source-backed comparison—not a dossier sufficiency opinion, safety assessment, authorisation or legal advice.