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.
These terminations, which were made on the 9th and 12th of February 2019, add to the hundreds of CBD novel food applications that have been terminated since 2022 when the regulatory body halted the application process citing data gaps.
But despite this frustration, and despite many industries having collapsed, or pivoting away from CBD, since the stoppage of assessments, European regulators are finally signalling their plans to progress.
The publication by EFSA on February 9, of a preliminary safe intake level for CBD is a long-awaited move. It’s the first time that the agency has set any kind of safety benchmark. 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 EFSA benchmark of 2mg CBD daily for a adult weighing 70 kg would render most existing CBD applications ineffective and make all CBD sold to consumers completely useless.
The following are some of the ways to get in touch with us. MEDCAN24 Yesterday, it was reported that the UK Food Standards Agency was pushing for a ministerial decision in autumn 2026 at 10mg, a controversially low threshold.
Four additional applications are rejected
All four applications that were terminated covered CBD product categories including CBD isolator, CBD distillate and CBD with broad spectrum.
Three out of four applicants are US companies. Sunflora Inc. in Florida, which is the parent company for Your CBD Store and Sunmed (which describes itself the United States’ largest hemp retailer with more than 250 outlets across 39 States), had two applications rejected, for CBD isolates and broad spectrum extracts.
KND Labs of Denver, which is a cannabinoid producer with Europe as one of its main markets, had its application for broad-spectrum distilate withdrawn. It was impossible to confirm the identity of the applicant at the time this article went online.
EFSA stated that in every case, it had identified deficiencies with the dossiers, issued requests for more information and extended time limits for each company to respond. EFSA contacted KND Labs seven times between April 2023 to February 2024, but did not receive a reply. Sunflora, meanwhile, was contacted three times by the regulator on both of its applications.
Both businesses remain well-resourced and active. As in the UK, however, there are many businesses that have disengaged or cut losses. They may also be moving to new markets.
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. This is more of an adjustment than a meaningful advancement.
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’ .
The number of CBD studies has increased dramatically since the initial opinion. But more importantly, regulatory pressure on CBD has intensified. More than 200 CBD food novel applications were submitted to the European Commission. 17 of them are currently 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 . This figure, however cautious it may be, is still a safe intake of 0.0275 mg/kg body weight per day. That’s approximately 2 mg for a 70 kg adult.
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 placebo for 28 days. The primary goal of the study was to control symptoms, but CBD did not outperform placebo on this measure.
There was no significant statistical difference in the total scores of symptom distress between groups. The secondary outcomes of anxiety, depressive disorders, and opioid use reduction also did not show any significant benefits.
To regulators however, it was not the efficacy of the drug that mattered most, but rather its tolerability. The participants received 400mg of CBD daily, some even reaching 600mg. There was no sign of clinically significant hepatotoxicity over the course of 28 days. Participants did not exceed predefined 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 substudy that was published in the late 2025. It pooled MedCan1 data with those from MedCan2 and related MedCan2 trials (287 total). The study reached the same conclusion. Over four weeks, CBD-only or THC/CBD formulations did not cause clinically significant increases in 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, especially in relation to long-term use and variability of humans.
As we examine the contradiction, it becomes clearer. MedCan evaluated the short-term tolerance of patients who had advanced malignancy, under specialist supervision. Exposure lasted just 28 days. Individuals with severe liver disease were excluded. A thorough monitoring program was implemented. The monitoring was intensive.
EFSA has a fundamentally new mandate. Modeling is not done based on the acute spikes of enzymes observed in patients. Instead, it uses subchronic animal toxology, extrapolation between species, and human variability, as well as uncertainty about 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. The study does not address long-term health effects in healthy individuals or questions regarding chronic exposure to CBD, accumulation and reproductive outcomes.
MedCan’s liver results may undermine claims of acute hepatotoxicity when moderate doses are used. The findings do not close all the gaps in evidence that led to EFSA’s cautious assessment.
CBD’s debate is defined now by the difference between food and clinical medicine. Trials can demonstrate tolerance under supervision but EFSA has a mandate to ensure long-term and population-wide health. It is encouraging to see the 2 mg standard, but there’s no way for an industry to function.