CBD opinion overview
- EFSA issued its first positive CBD food opinion application
- CBD deemed safe for adults over 25 under conditions
- Assessments were paused after data gaps raised safety concerns
- More than 100 CBD applications lacked previous positive opinions
- European Commission and Member States now decide approval outcome
Cannabidiol (CBD) just got closer to approval in the EU.
The European Food Safety Authority (EFSA) has delivered its first ever positive opinion for the use of CBD in food. In its opinion, EFSA considered CBD safe for those over 25, except for people taking medications and pregnant or lactating women.
EFSA’s opinion is in response to a novel food application by Irish supplements company Chanelle McCoy, which intends to use CBD in an an oil-based food supplement.
While the ingredient must still be approved by the European Commission, EFSA’s opinion could be extremely consequential.
CBD assessments have been restricted
CBD only contains traces of the psychoactive component of the cannabis plant, tetrahydrocannabinol (THC), and is largely considered non-intoxicating.
Yet it remains a novel food in the EU, meaning that it was not consumed significantly in the bloc before May 1997.
The ingredient has faced significant barriers in achieving approval in the EU. Since 2010, more than 2,000 novel food assessments of ‘botanicals’, which include CBD, have been paused, and in 2022, EFSA also paused all CBD assessments due to insufficient data. In December 2025, the previously identified data gaps were confirmed.
A safe level of 0.026 mg per kg of body weight per day, or 2 mg per day for a 70-kg adult, was also established, taking into account the existing data gaps. This applies to food supplement formulations with CBD purity ≥ 98%, for people over 25.
More than 100 applications have been submitted for CBD, yet prior to this not a single one has been approved. Now, EFSA’s opinion may represent a watershed moment in European CBD.
EFSA’s judgement
Despite all of this, EFSA gave a positive opinion on Chanelle McCoy’s product. It did not identify any concerns related to genotoxicity or consider CBD nutritionally disadvantageous.
EFSA’s opinion was given in spite of existing data gaps. How did this happen?
In order to address these gaps, the applicant was asked to provide reproductive and developmental toxicity studies, as well as a human clinical study on CBD consumption. Proposed uses were also limited, as was the targeted population to those over 25. EFSA’s panel considered this sufficient.
The panel considered the safe intake level of 0.026 mg per kg of body weight per day, corresponding to 2 mg CBD per day, appropriate for Chanelle McCoy’s product.
Now that EFSA has issued a positive opinion for the CBD product, responsibility falls to the European Commission, along with Member States, to decide whether or not to approve it.
So CBD hasn’t yet been approved. But EFSA’s opinion significantly improves the likelihood of CBD products hitting the EU market.
