The EU’s food safety authority EFSA published on 9 February 2026 a provisional safe intake level for cannabidiol (CBD) of 0.0275 mg per kg body weight per day — about 2 mg per day for a 70 kg adult. The number is published in an update to EFSA’s earlier 2022 statement (EFSA Journal 2026, 10.2903/j.efsa.2026.9862) and signals that the long pause since June 2022 is now partially lifted.
But the figure says less about CBD than many think, and more about how EU regulation of hemp has drifted far from its original intent. This piece untangles three things: what EFSA actually said in February, how the Novel Food definition has shifted since 1997, and why the pause should never have applied to hemp foods to begin with.
What EFSA said in February 2026
The ~2 mg/day provisional intake level is derived using a highly conservative approach. EFSA took the available toxicological data and applied an uncertainty factor of 400 to cover remaining data gaps. That’s higher than the standard factor (typically 100 for animal-to-human extrapolation) and reflects continuing uncertainty rather than proven toxicity.
The level applies only to:
- CBD isolate with ≥98% purity
- No nanoparticles
- Verified non-genotoxic production process
- As a food supplement — not as an ingredient in foods
This is not a general approval of CBD as a food ingredient. It is a provisional figure for a specific form of CBD isolate in capsule or drop form, and only as long as the applicant can document their production process. EFSA itself emphasises that the level does not constitute a formal authorisation of CBD as a novel food.
Why the Epidyolex data was a legitimate concern
EFSA’s original 2022 worry was largely based on liver effects observed in clinical trials with Epidyolex, a medicine for rare epilepsies containing highly purified CBD at pharmaceutical doses (10–20 mg/kg/day — that is, 700–1400 mg/day for an adult). Elevated transaminases were noted in the registration trials.
That’s a relevant signal at that dose — but the dose is 350–700 times the intake level being discussed for foods. Extrapolating risk from drug doses to food doses requires large uncertainty margins (hence EFSA’s factor of 400). It’s not fair to claim the problem is “made up” — but neither is it fair to claim that a drug for severe epilepsy and a food supplement dose are the same thing. The distinction is central, and it’s spelled out in EFSA’s own 2022 statement.
The bigger issue: the Novel Food definition
This is where the deeper question sits. Regulation (EU) 2015/2283 defines in Article 3 a “novel food” as something “that was not used for human consumption to a significant degree within the Union before 15 May 1997”. The logic is reasonable — substances without a consumption history should be safety-assessed before market entry.
Hemp does not meet that definition. Archaeological finds show hemp use in Europe from the Bronze Age (2700–1700 BC), and hempseed, hempseed oil and hempseed flour have documented consumption in Sweden, Germany, Italy, Poland and Lithuania since the Middle Ages. One of Europe’s earliest printed cookbooks — Platina’s De Honesta Voluptate Et Valetudine (1475) — contains a recipe for a cannabis-nectar health drink. Hempseed oil was one of the most-consumed vegetable oils in European diets before industrialisation.
Despite this, in January 2019 the European Commission published an update to its Novel Food Catalogue in which extracts from industrial hemp containing cannabinoids were classified as novel foods — as if they had never been consumed before 1997. This happened without new scientific data, through a reinterpretation of the definition.
EIHA, the European Industrial Hemp Association, then reminded the EU that in November 1998 it had received written confirmation from the PAFF Standing Committee that hemp flowers and leaves were permitted as food precisely because hemp had been consumed in Europe for millennia. That confirmation still stood — but the new catalogue status for extracts effectively overruled it.
What the change cost the industry
Classification as a novel food means every individual product needs an application with toxicological studies. EIHA estimates the cost at €350,000 – €500,000 per product. That locks small-scale European growers and hemp processors out of the market, and forced industry organisations to form joint data consortia to even afford the applications.
The result was a market where thousand-year-old European food traditions were replaced with a regulatory logic built for entirely new synthetic ingredients. The logic fits Epidyolex — a pure pharmaceutical with specific doses and production standards. It does not fit a plant-based food with documented history.
Hemp’s return as traditional food
It took until 2 June 2023 for the European Commission to acknowledge that hemp leaves — like the seed — are a traditional food not covered by the Novel Food Regulation’s authorisation requirement. That meant hemp tea and hemp leaf products can again be marketed freely within the EU without an application.
Still classified as novel food after June 2023:
- CBD isolate (extracted and concentrated)
- CBD distillate and CBD extracts
- Products to which these are added as ingredients
Not classified as novel food:
- Hempseed, hempseed oil, hempseed flour, hemp protein
- Hemp leaves and hemp tea
- Whole hemp flower (Premium Hemp Powder and similar whole-flower products sit in a grey zone that varies by member state — France’s Conseil d’État ruled in 2022 that whole flower is a traditional food, other countries do not always follow)
What this means for Swedish operators in 2026
Three practical takeaways:
1. Hempseed and whole-hemp foods remain free to sell. None of this is covered by the Novel Food requirement — before or after the 2019 reclassification. Livsmedelsverket follows EFSA’s line but has historically prioritised enforcement on products making explicit health claims (which violate Regulation (EC) No 1924/2006) rather than the presence of hemp itself.
2. CBD extract added to foods still requires authorisation. EFSA’s February 2026 statement applies specifically to high-purity CBD isolate as a food supplement. A business selling CBD-added foods as food still carries regulatory risk until specific applications are approved.
3. The Kanavape ruling stands. The EU Court of Justice’s judgment in C-663/18, Kanavape (19 November 2020) established that CBD is not a narcotic under the 1961 UN Convention. That means free movement of goods under TFEU Article 34 applies — a member state cannot prohibit CBD legally produced in another member state except on documented public health grounds.
The bigger picture
EFSA’s work on CBD as a novel food is not wrong in itself — it’s a natural consequence of the Commission classifying the extracts as novel in 2019. The error sits one step earlier: in a reinterpretation of the 1997 definition that turned a plant with thousand-year food tradition into a novel food without new data, without public consultation, and against earlier Commission guidance.
The 2 mg/day EFSA set in February does not solve that. It shows that a conservative safety assessment of pure CBD isolate yields a very low acceptable intake — but says nothing about hemp’s wholeness as a food, or whether extracts should be subject to the same logic as synthetic food additives.
That’s where the conversation needs to land during 2026–2027.
Sources
- EFSA. Update of the statement on safety of cannabidiol as a novel food. EFSA Journal 2026. doi:10.2903/j.efsa.2026.9862
- EFSA. Provisional safe level for cannabidiol as a novel food. Press release 9 February 2026.
- EFSA NDA Panel. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties. EFSA Journal 2022;20(6):7322.
- European Parliament and Council Regulation (EU) 2015/2283.
- Court of Justice of the EU, judgment 19 November 2020, Kanavape, C-663/18.
- EU Novel Food Catalogue — Cannabis sativa L.
- EIHA — Industrial Hemp History and Novel Food Consortium.
- FoodTimes. EU, hemp leaves do not qualify as “novel food” (2 June 2023).
- Hemptoday. Hemp extracts in EU history — EIHA paper.
Daniel Johansson founded Helsama OÜ. See Ownership and transparency for our editorial principles.