European food safety panel sets ultra-low daily limit for CBD, tightening approvals

“While we welcome the fact that a safety threshold for CBD has finally been identified, the level set is disproportionately low and does not, in our view, reflect the reality of the available scientific evidence and the studies we conducted,” said Francesco Mirizzi, EIHA’s managing director.

“EFSA has applied a highly conservative methodology, which drives the safe level downward. While consumer protection must remain paramount, risk assessment of novel foods should also be evidence-based, balanced and efficient,” he said.

Nonetheless, “we are committed to working with EFSA and the European Commission’s to address the outstanding data gaps in order to achieve this scientifically supported level,” the Association said in a statement.

Novel food backlog

Unlike marijuana, CBD is not intoxicating and is known for its potential therapeutic effects, such as reducing anxiety, pain and inflammation. CBD formulations are mainly sold as health supplements, which are mixed with hemp oil or other oils. Food and drink items containing CBD have been produced in the form of candy, honey, cakes and cookies, tea, coffee and other niche products.

EFSA is believed to be sitting on roughly 200 CBD novel food applications, with a handful already under scientific assessment. The agency put the evaluations on hold in June 2022 due to what it said were unresolved data gaps in safety analysis. This month’s publication of an updated risk assessment with the 2-milligram-a-day benchmark signals EFSA is opening a new phase of active evaluation.

That shift could reshape the prospects for applicants seeking authorization under the EU’s Novel Food Regulation, including an EIHA consortium, EIHA Projects GmbH, which has submitted dossiers covering CBD isolate and synthetic forms of CBD.

EFSA’s ultra-low benchmark means applicants proposing higher daily intakes must either lower their requested conditions of use or supply substantially stronger long-term safety evidence to justify a higher threshold — particularly on liver effects and chronic exposure.

International comparisons

EIHA noted that the provisional safe intake EFSA proposed — about 2 milligrams of CBD a day — sits well below other jurisdictions that have offered practical daily guidance. In Britain, the Food Standards Agency recommends that healthy adults limit CBD consumption from food products to 10 milligrams of CBD a day as a precautionary limit. In Switzerland, regulatory commentary often cites a 12 mg-per-day benchmark used by authorities. In Canada, Health Canada’s advisory panel has concluded that oral CBD is generally safe and tolerable at doses between about 20 milligrams and up to 200 milligrams a day for short-term (up to 30 days) use, contingent on discussion with a pharmacist about other medication use.

“This divergence raises legitimate questions about proportionality and consistency in risk assessment approaches,” Mirizzi said.

EFSA’s methodology

EFSA said it applied an additional safety margin because of incomplete evidence about CBD usage and excluded people under 25, pregnant or breastfeeding women, and individuals taking medication from its assessment.

The agency pointed to unresolved questions about the effects of long-term CBD consumption on the liver, neurological function, and the reproductive and immune systems. EFSA emphasized that the benchmark is not final and could be revised as more robust data becomes available.

EIHA said its recommended threshold would keep CBD products safe but contain enough CBD to deliver positive health effects, and therefore remain viable as foods and supplements.

Efficacy questions

Closing the gap between 2 milligrams a day and higher intake levels supported by industry is critical to the commercial CBD market, which has been built around the idea of everyday wellness benefits.

Industry stakeholders have long argued that intake levels in the range of 10 to 20 milligrams per day are more consistent with how CBD supplements are actually used and more likely to align with consumer expectations.

Commercial stakes

The developments at EFSA come during a period of post-bust malaise for the CBD industry worldwide.

Official audited sales figures for the European CBD category are scarce because the industry has operated under fragmented regulatory regimes and many products have sold in a regulatory gray zone.

Industry analysts estimated the broader European cannabidiol market at roughly €347.7 million in 2023, down from modeled valuations that reached as much as €1.6 billion in 2020. One of the few national market benchmarks comes from France, where the CBD market was estimated to have generated about €600 million in revenue in 2023.

Resetting the bar

For Europe’s CBD sector, EFSA’s new benchmark may provide the clearest scientific reference point yet — but it also sets a high bar for any applicant seeking approval at doses the market has historically supported.

EIHA Projects GmbH has already spent several million euros (early estimates were € 2.5 – €3.5 million) on studies to support the consortium’s CBD novel food authorizations in the EU and the UK’s separate approval system. That means the group won’t be dissuaded, according to Mirizzi.

“The hemp sector has invested heavily in generating robust toxicological data precisely to support a science-based Novel Food authorization. We will now move forward within the 2-milligram-a-day framework, but we remain committed to strengthening the evidence base through additional peer-reviewed and proprietary studies,” he said. “Our objective remains clear: to align the EU safe intake level with what the scientific data objectively justify.”