On 9 February the European Food Safety Authority put the first official number on ingestible CBD: a provisional safe intake level of 0.0275 mg per kilogram of body weight per day, roughly 2 mg a day for a 70 kg adult. It is the first meaningful scientific move since EFSA froze every novel food application in 2022 after concluding that cannabidiol safety “cannot currently be established”. Six months on, the European hemp industry is still recalculating product ranges, doses and dossiers around that figure.
What the opinion actually says
The updated EFSA opinion is not an authorisation but a toxicological benchmark. It was derived by applying an uncertainty factor of 400 to the available data — an unusually conservative approach that reflects the remaining gaps in the science around nervous and reproductive system effects.
The level applies only to formulations using CBD isolate of at least 98 % purity, free of nanoparticles, with a production process assessed as safe and genotoxicity ruled out. The agency also leaves several groups outside the umbrella: under-25s, pregnant and breastfeeding women and anyone on concurrent medication. For them, safety simply could not be established.
Two milligrams is not ten
The commercial impact lies in the comparison. The UK reference the industry has worked with since 2023 was 10 mg per adult per day; the European figure is five times lower. Much of today’s catalogue of oils and capsules sits between 10 and 50 mg per serving, well above the ceiling EFSA now marks. Aligning with the European criterion means revisiting concentrations, dosing devices and directions for use — not just the label.
Still no authorisation, still the core problem
An opinion is not a permit. Cannabidiol remains off the Union list of authorised novel foods, so selling it as a food or food supplement still has no legal basis at EU level. Changing that requires the European Commission and the Member States to vote it onto the list, an administrative step with no date attached.
Meanwhile the funnel stays clogged: of the more than two hundred applications filed since 2018, barely twenty remain under active assessment, and the Commission has been closing files through 2026 on procedural grounds rather than safety rejections. In Spain and several neighbouring markets, ingestible CBD is sold under a de facto administrative tolerance — no firm cover, and exposed to any shift in official enforcement.
Business implications
- Reformulation: high-dose ranges fall outside the European criterion. Lowering concentration or repositioning the product are the two realistic exits.
- Analytical quality: ≥ 98 % purity, absence of nanoparticles and genotoxicity data move from selling point to dossier requirement. Without solid certificates of analysis there is no defensible file.
- Portfolio segmentation: topicals, cosmetics and non-ingestible uses stay outside the novel food perimeter and gain appeal as a short-term commercial shelter.
- Uneven regulatory risk: until there is a Union list, each country enforces its own way. Exporting within the EU calls for a per-market risk map, not a single strategy.
- Live dossiers: anyone with an open application needs new, high-quality toxicological data; EFSA has said it will revisit the provisional level as soon as it arrives.
A table conversation, not a headline
The underlying read, also picked up by the specialised food industry press, is that ingestible CBD is entering a phase of forced professionalisation: less volume, more paperwork. Companies already working to pharmaceutical standards start ahead; those that grew in the legal vacuum face a genuine overhaul.
That is exactly the kind of conversation that belongs at Spannabis B2B Bilbao 2027, the International Cannabis Business Forum held on 11 March 2027 at the BEC VIP Hall in Bilbao. Producers, laboratories, distributors and investors cover in one day what otherwise takes months of diary work. Check the available tickets or book your B2B table to close deals with the regulation already on the table.