On both sides of Channel, CBD has experienced a turbulent couple weeks. Just days after announcing incredibly stringent new safety limitations, the European Food Safety Authority halted the approvals for four novel foods.
On February 9 and December, the terminations added to the hundreds of CBD novel foods applications that have been terminated since 2022. The regulator cited persistent data gaps as the reason for the stoppage.
The European regulator has finally announced plans for moving forward despite continued frustration from the industry. Since the assessment pause, many companies have collapsed or shifted away from CBD.
This long-anticipated move is now underway with the publication on 9 February of a proviso intake limit by EFSA. Seventeen dossiers currently are under scientific review. EFSA also announced a second webinar in April for applicants to address any outstanding data requirements.
The problem is, the benchmark EFSA set at just 2mg CBD per day, for a 70kg person, will not only render the majority of applications moot but also make CBD that has been approved to be sold ineffective.
You can also read about the advantages of using MEDCAN24 Yesterday, it was reported that the UK Food Standards Agency is pushing for a ministerial decision in autumn 2026 at 10mg, a controversially low threshold.
Four more rejections
All four applications that were rejected covered different CBD products, including CBD Isolate, CBD Broad-Spectrum, and CBD Distillate. The submissions for these types of CBD products took place between 2021-2022.
Three out of four applicants are US companies. Sunflora Inc. of Florida, parent company to Your CBD Store, Sunmed and Sunmed USA, describes itself as being the largest hemp retailer within the United States, with over 250 stores in 39 states. Two applications were terminated for Sunflora Inc.
KND Labs in Denver, a manufacturer of cannabinoids that has Europe on its list of active markets, also had their application for a distillate with a wide spectrum revoked. It was impossible to confirm the identity of the applicant at the time this article went online.
According to EFSA in every case, it found significant flaws in the initial dossiers, issued requests for more information and extended the deadlines to both companies. EFSA contacted KND Labs on seven different occasions from April 2023 until February 2024. The company did not respond. Sunflora, meanwhile, was contacted three times by the regulator on both of its applications.
Both are active, well-resourced companies. However, similar to the UK’s long-running process, large numbers of businesses that were in regulatory limbo, waiting for clarity, have disengaged or cut losses. They may also have shifted their focus on other markets, shutting down completely.
Financial burdens for small operators were prohibitive. The commercial calculation of larger companies to pursue a market without a guaranteed result and despite an ever-stricter regulatory environment can be equally discouraging.
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Why Now?
EFSA’s long-awaited update comes four years after the agency first said that it could not establish whether cannabidiol was safe as a food.
On first inspection, it appears that the statement 2026 offers movement, an interim safe intake level and new modelling. It also includes a systematic review of recent literature. The statement is more of an adjustment than any real progress.
Last year, EFSA was formally requested to revisit its 2022 position and ‘prepare an updated Statement to transparently review the current data gaps status identified in the available scientific literature regarding the safety of CBD as a NF’ .
In the years since I first wrote my opinion, CBD research has expanded dramatically, and regulatory pressures have intensified. More than 200 CBD food novel applications were submitted to the European Commission. 17 of them are undergoing risk assessments at EFSA.
While acknowledging that significant amounts of new literature has been published since it’s original opinion, EFSA reiterated its previous position that it still was ‘not sufficient to address the data gaps and uncertainties previously identified’ .
In fact, EFSA notes that requests for additional animal and human data ‘have not been provided by the applicants’ .
Those uncertainty remain broad. The liver toxicity remains the main concern. Animal studies have consistently shown that it is toxic, and human trials show an increase in aminotransferase. Questions about long-term exposure, potential accumulation, reproductive and neurodevelopmental effects, immune system impacts, and drug–drug interactions remain unresolved. Across multiple sections of the report, the regulator reiterates that the original ‘data gap remains’.
Despite this, the report still has great significance. EFSA developed a toxicological benchmark using dose modeling from GLP compliant 90-day rat tests for the first time. From this, applying a total uncertainty factor of 400, the Panel calculated a provisional safe intake of 0.0275 mg/kg body weight per day, approximately 2 mg per day for a 70 kg adult . Even this number is cautious.
EFSA states that ‘the safety of CBD as a novel food cannot be established… until the relevant safety data become available’ . The 2 mg threshold is not an authorisation level; it is a conservative reference point, limited to highly purified (≥98%) CBD supplements, excluding nanoparticles, and not considered applicable to individuals under 25, pregnant or lactating women, or those on concurrent medication .
A new literature and its findings
The MedCan1 study, a Phase IIb double-blind placebo-controlled trial, conducted in five Australian tertiary centers, is one of the strongest recent studies. The trial randomly assigned 144 cancer patients to either receive increasing doses of CBD oil (up to 600mg per day) or a placebo for 28 days. The primary goal of the study was to control symptoms, but CBD did not outperform placebo on this measure.
The total symptom scores increased in both arms, but there was no statistically significant differences between the two. Other outcomes such as anxiety, depression and quality of life, or the reduction in opioids, also showed no significant benefit.
To regulators however, it was not the efficacy of the drug that mattered most, but rather its tolerability. Over the 28 day period there were no signs of clinically relevant hepatotoxicity. Participants took a 400 mg daily median dose, and some reached 600 mg. Participants did not exceed predetermined ALT and AST thresholds (3 times upper limit normal or 5 times for those with liver metastases) nor were there any serious adverse effects.
The ALT/AST trajectories of patients were examined in a sub-study that was published in the late 2025. It pooled information from MedCan1 as well as MedCan2’s THC/CBD study (287 total participants). This study also reached a similar conclusion. It concluded that medicinal cannabis, over a period of four weeks did not result in clinically-significant elevations in the liver enzymes.
At first glance, this appears to sit uneasily beside EFSA’s 2026 update, which reaffirmed the liver as a ‘major target’ of CBD exposure and derived a conservative provisional intake of approximately 2 mg per day for a 70 kg adult based on subchronic rat modelling and a 400-fold uncertainty factor . The agency has also determined that there remain key data gaps, primarily around long-term rat exposure and variability in humans.
The apparent contradiction becomes more pronounced when examined in greater detail. MedCan’s studies assessed short-term tolerability of biochemicals in advanced cancer patients under expert supervision. Exposure lasted just 28 days. Exclusion of individuals with severe liver disease. A thorough monitoring program was implemented. It was a question of whether CBD could be tolerated by a clinical population for x number of weeks.
EFSA has a fundamentally new mandate. Modeling is based not on acute spikes of enzymes observed in patients monitored, but instead on animal subchronic toxicology and inter-species equivalence, variability among humans, and uncertainties around cumulative exposure. The agency notes explicitly that human liver effects over the long term and their pharmacokinetic behavior are not well understood.
It complicates the narrative, but does not refute EFSA. The data suggest that moderate and high CBD doses, under medical supervision, do not cause overt liver toxicity, at least for the short-term. They do not prove long-term safety for healthy consumers or answer questions about chronic exposure, accumulating CBD, reproductive endpoints, and population-wide variation.
MedCan’s liver results may undermine claims of acute hepatotoxicity when moderate doses are used. These findings alone do not fill in the evidence gaps which underlie EFSA’s cautious evaluation.
CBD’s debate is defined now by the difference between food and clinical medicine. Trials can demonstrate tolerance under supervision but EFSA is mandated to ensure long-term, population-wide safety. This 2 mg threshold is a sign of progress, but leaves little room for an active industry.