A dropper of CBD oil, the kind of product this opinion is about, not a specific brand named in the story
elsaolofssonCC BY 2.0
Illustrative. This is a stock photograph of a CBD oil dropper, not the Chanelle McCoy product the EFSA opinion actually covers.
Europe Approved Its First CBD Supplement Ever, and Capped It at 2 Milligrams a Day
Since 2022, every application to sell a CBD product as a regulated novel food in the European Union has gone the same way: nowhere. The European Food Safety Authority kept asking for safety data nobody had submitted, mainly on reproductive effects and long term human use, and one applicant after another fell short. This year that changed. EFSA's expert panel issued its first ever positive safety opinion on a CBD novel food, from a company called Chanelle McCoy UK Ltd. The milestone is real. The number attached to it is the part worth reading closely.
- Europe's food safety regulator, EFSA, has issued its first ever positive safety opinion on a CBD novel food application, after putting every other CBD dossier on hold since 2022.
- The applicant asked for 25 milligrams a day and ended up accepting 2 milligrams, the provisional safe level EFSA had already set for the whole CBD category.
- The dose is small because the safety data is thin. EFSA applied an uncertainty factor of 400 to cover missing reproductive toxicity and human trial data, and excluded anyone under 25, pregnant, breastfeeding, or on medication.
- The UK's food regulator looked at the same company's dossier and set a provisional daily intake of 10 milligrams, five times higher than EFSA's number.
What the applicant asked for
Chanelle McCoy's original submission to EFSA.
What EFSA approved
The provisional safe intake level for a 70 kilogram adult, backed by an uncertainty factor of 400.
What the UK's FSA set
The same company's dossier, reviewed independently, landed at five times EFSA's figure.
Same molecule, same applicant, two regulators, and a five times spread in what each one called safe.
A yes that is smaller than almost any bottle on a shelf
Chanelle McCoy originally asked EFSA to clear a cannabidiol isolate from Cannabis sativa at 25 milligrams a day. EFSA said yes, but only at 2 milligrams a day for a 70 kilogram adult, the provisional safe intake level the regulator had already set for the whole CBD category in a separate statement adopted in December 2025. That is the number that actually matters here. Practically every CBD supplement sold on a European shelf right now is dosed well above it, some by twenty times or more. If this opinion becomes the authorized standard, the legal product and the product people actually buy could end up being two very different things.
Why the number is so small
EFSA capped the dose this low because the safety picture is still thin, not because 2 milligrams is some proven effective amount. The regulator applied an uncertainty factor of 400 to cover the gaps in the evidence base. The company submitted a 90 day toxicity study in rats, but no reproductive or developmental toxicity data and no human clinical trial, which is exactly the evidence EFSA had already told earlier applicants it needed. The opinion also comes with real exclusions: it does not apply to anyone under 25, to anyone who is pregnant or breastfeeding, or to anyone taking medication, and it only covers CBD purity of 98 percent or higher with no nanoparticles present. Meanwhile, the UK's Food Standards Agency reviewed the same company's dossier and landed on a provisional acceptable daily intake of 10 milligrams, five times EFSA's figure. Same molecule, same applicant, two regulators, a five times spread. That gap is a useful, honest look at how much of a safe dose is science and how much is how cautious a given regulator decided to be.
Honest caveat
This is a safety opinion, not an effectiveness one. EFSA said nothing about whether CBD actually does anything at 2 milligrams a day, and industry commentators have argued bluntly that a dose this low will deliver no meaningful physiological benefit. The opinion is also contested inside the industry on consistency grounds: at least one competitor dossier reviewer has publicly questioned why this application cleared without the reproductive toxicity and human data EFSA required of others, and another has noted that excluding nanomaterials rests on a theoretical basis rather than a measured one. Those are interested critics, but their objection is specific and checkable. And this is a single regulatory opinion. The European Commission and its member states still have to decide whether to actually authorize the product, so nothing here is final yet.
What this means for you
If you take CBD, or you are thinking about starting, the honest takeaway is not that your usual dose is suddenly dangerous. It is that the phrase safe dose means something much narrower and more provisional than most labels suggest, and that the exclusions in this opinion, under 25, pregnant or breastfeeding, or on medication, are the most actionable part of a document your bottle will never quote to you. If a product ever advertises itself as EFSA approved at a much higher dose than 2 milligrams a day, that claim is getting ahead of what the regulator actually said.
Primary sources
- Safety of cannabidiol isolate from Cannabis sativa L. as a novel food. EFSA Journal 2026;24(5):e10124, published May 27, 2026.
- Update of the statement on safety of cannabidiol as a novel food. EFSA Journal 2026, adopted December 16, 2025.
- Turning point for CBD as EFSA publishes first positive safety opinion. NutraIngredients, September 21, 2026.
- FSA signals major milestone in CBD novel food process. NutraIngredients, September 14, 2026.
Common questions
Does this mean CBD is now approved for sale in the EU?
Not yet. EFSA's opinion is a positive safety finding, the first the CBD category has ever received, but the European Commission and EU member states still have to vote on whether to actually authorize the product as a novel food. Until that happens, this is a scientific opinion, not a market authorization.
Why did the UK set a different safe dose than the EU?
The UK's Food Standards Agency reviewed the same company's application independently and set its own provisional acceptable daily intake at 10 milligrams a day, five times EFSA's 2 milligram figure. Both regulators looked at largely the same underlying data and reached different conclusions about how cautious to be, which is a useful reminder that a safe dose is partly a scientific calculation and partly a judgment call.
Is 2 milligrams a day actually enough to do anything?
Nobody knows, and that is the point. This opinion is about safety, not effectiveness. EFSA did not test or claim that 2 milligrams produces any particular effect, and several industry critics have said publicly that a dose this small is unlikely to deliver a noticeable physiological benefit.
Stay Curious.
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