CBD Novel Food: EFSA sets the EU’s first safe limit

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The European Food Safety Authority (EFSA) has, for the first time, set a provisional safe level for cannabidiol (CBD) as a novel food: 0.0275 mg per kilogram of body weight per day, or roughly 2 mg a day for a 70 kg adult. The figure is low, but it ends years of scientific uncertainty and brings order to a market that had been stuck in regulatory limbo. For the CBD industry, it is the first reference point to start working with seriously.

What EFSA actually decided

The opinion, published on 9 February 2026 by EFSA’s NDA panel, establishes a provisional safe intake level. It is not a marketing authorisation, but the scientific piece that was missing to unblock the novel food applications pending in the European Union. The limit also includes an added uncertainty factor, because EFSA acknowledges the evidence is still incomplete and anticipates revising the figure once it receives new toxicological data and human studies.

The fine print is decisive for business: the safe level applies only to food supplements containing CBD with a minimum purity of 98%, no nanoparticles, a production process deemed safe, and genotoxicity excluded. Anything outside those conditions will still lack a clear route to market.

Populations left uncovered

EFSA is explicit: it could not establish CBD safety for several groups. The safe level does not cover people under 25, pregnant and breastfeeding women, or those taking medication. It is a restriction with direct labelling and marketing consequences, and it sharply narrows the audience a CBD supplement can legally target in Europe.

What it means for the CBD business

The decision raises the documentary bar and separates serious operators from the rest. These are the most immediate implications for ingredient makers, formulators and brands:

  • High-purity isolates gain the edge. Only CBD reaching 98% purity comes close to compliance; full-spectrum and broad-spectrum products face a much harder path.
  • More demanding dossiers. Applicants must provide dose-response profiles, impurity control and long-term effect data (liver, endocrine, nervous and reproductive systems).
  • Reformulation driven by dose. A ceiling of ~2 mg/day forces a rethink of concentrations, formats and dosing messaging on the pack.
  • The UK is ahead. Britain’s FSA is moving faster with its parallel process, while EFSA’s queue remains congested: a commercial window worth watching.
  • Traceability as a market filter. Testing, labelling and production process become requirements, not selling points.

Spain: from limbo to framework

The European move comes at a key moment for Spain, where CBD is still caught between the cosmetic and the food categories and is not authorised as a novel food. With medical cannabis regulation already under way via the hospital route, the hemp and CBD sector needed exactly this European reference to plan investment and standardise product. EFSA’s figure does not solve the market, but it finally gives producers, laboratories and distributors a verifiable starting point.

This is precisely the kind of debate that will be on the table at Spannabis B2B Bilbao 2027, the international cannabis business forum bringing producers, laboratories, distribution and investment together at the BEC on 11 March 2027. If your company works with CBD or hemp, understanding the European novel food roadmap will be decisive: book your B2B table to connect with the players shaping the market. Sources: EFSA and Food Safety Magazine.


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