Specifically, the Commission (EC)closed procedures without approval for products including isolated cannabidiol, synthetic cannabidiol, tinctures, and oils from Cannabis sativa L. It has also rejected claims for broad-spectrum CBD extracts and distillates from hemp.
Dr. Jerome Le Bloch, head of scientific affairs at Foodchain ID told NutraIngredients there has been a spike in terminations since February, most of which were CBD applications submitted between 2020 and 2022. The total sits at 12 so far this year.
CBD applications rejected by the European Commission
A ‘termination’ means the EC can stop dealing with applications that are unlikely to ever be approved.
Le Bloch said the EC frequently uses this mechanism to terminate novel food applications that lack sufficient data. While it terminated only four applications through this process in 2025, it rejected 14 in 2024, 18 in 2023, and more than 60 in 2022.
He argued the recent application closures primarily reflect the applicants’ failure to carry out adequate due diligence.
“For me, these decisions show that many CBD applications have been submitted without pertinent data,” he said.
He also noted that in some rejected cases, companies submitted Novel Food applications for the UK market, where regulators allow applications for finished products, and submitted the same applications to the EU at the same time. However, EU regulators apply stricter criteria and only accept applications for ingredients, rather than finished products, so those submissions were inappropriate.
“CBD is frequently rejected, but this is due to the high number of applications submitted in 2020/2021, with a large part of the applications being incomplete,” Le Bloch said.
Its likely that applicants were given warning prior to the dismissal and opportunity to provide new data.
EFSA has several unresolved safety concerns around CBD consumption, namely around its effect on reproduction, as well as its safety levels in humans.
Why CBD Novel Food applications fail
For companies looking to pursue novel food status, it is imperative that applicants ensure compliance with all requirements for them to be validated by the Commission, Le Bloch noted.
“Some companies think that a novel food application needs to provide only a few data points to get approved,” Le Bloch said. “This is also a reminder that the EC can terminate non-compliant applications before any scientific discussion.”
He added: “For me, the significant delay in approval is due to applicants who cannot or do not want to perform the studies.”
Approval would also require EFSA to first give a positive opinion, including advice on safe daily intake, how the product can be used, and how it should be labelled. So far it has proposed a safe daily intake of 2mg/day which is not legally binding as yet but will be a consideration in novel food evaluations.
