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, 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, set out in EFSA's statement of 9 February 2026 and published in full in the EFSA Journal, 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
  • Not for people under 25, pregnant or breastfeeding women, or people taking other medication, for whom EFSA concluded that safety cannot be established

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. As the testing firm Complife points out, the level does not represent 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 to food-level intakes requires large uncertainty margins; EFSA's factor of 400 was applied to a reference point derived from subchronic animal studies. 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. According to the European Industrial Hemp Association, hemp has been a traditional food in Europe for centuries, its culinary use can be traced back to the Middle Ages, and countries including Sweden, Germany, Italy, Poland and Lithuania have documented hemp dishes. One of Europe's earliest printed cookbooks, Platina's De Honesta Voluptate Et Valetudine (1475), contains according to EIHA a recipe for a cannabis-nectar health drink, and Food Times reproduces Platina's recipe for hemp soup. EIHA also states that hemp oil was one of the most-consumed vegetable oils in the pre-industrial European diet.

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, responded in May 2019 with a collection of historical evidence intended to show that hemp leaves, flowers and extracts had been consumed in Europe to a significant degree before May 1997, and called for them to be exempted from the catalogue. The catalogue status for extracts nonetheless stood.

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 to €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, according to EIHA's position (this is the association's view, not an established classification; whole-flower products sit in a grey zone whose treatment varies by member state)

What this means for Swedish operators in 2026

Three practical takeaways:

1. Hempseed foods remain free to sell. Hempseed and products made from it are not covered by the Novel Food requirement, before or after the 2019 reclassification. Whether foods made from the whole plant or the flower are covered is disputed; EIHA argues they are not (see above).

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.

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.

Daniel Johansson founded Helsama OÜ. See Ownership and transparency for our editorial principles.

Updated 7 October 2026.