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In a major setback for the European CBD industry, the European Food Safety Authority (EFSA) has set a sharply restrictive daily intake benchmark of just 2 milligrams a day — a level that could leave most CBD products too weak to have any meaningful effect.
The decision raises the bar for companies seeking to stay in the legal market, which will now require stronger long-term evidence that higher limits are safe – and a bet that the doses regulators feel comfortable permitting will match the doses consumers want.
EFSA, however, said it had established a preliminary safe intake level at only 0.0275 micrograms/kg of bodyweight for a 70 kg adult.
A wide gap
This level is well below the maximum daily consumption limit of 17.5 milligrams proposed by the European Industrial Hemp Association. It highlights the difference between EFSA’s precautionary toxicology standard and higher thresholds that industry has argued to be commercially viable.
“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.
Nevertheless, the Association stated that “we remain committed to work with EFSA to close the data gaps to reach this level of scientifically-supported standards.”
The backlog in Novel Food
CBD does not make you high, and it is well known for having potential therapeutic properties, like reducing inflammation, pain, and anxiety. CBD products are sold primarily as health supplements that are blended with hemp oil and other oils. The CBD-containing food and drinks include candy, cookies, honey, cake and cakes, coffee, tea and many other products.
EFSA has around 200 novel CBD food applications. A few of these are already under assessment. In June 2022, the agency put evaluations on hold due to unresolved gaps in data analysis. The publication by EFSA of a risk assessment updated with a benchmark of 2 milligrams per day this month signals a move into a more active phase of evaluation.
The shift in the EU Novel Food Regulation could change the future of applicants, like the EIHA Projects GmbH consortium. It has filed dossiers for CBD isolates as well synthetic CBD forms.
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.
Comparative studies of 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. The Food Standards Agency in Britain recommends healthy adults to limit their CBD intake from food products at 10 milligrams per day. This is a precautionary measure. Swiss regulatory commentaries often refer to a benchmark of 12 mg per day. Health Canada’s advisory panel concluded in Canada that CBD oral dosages of up to 200 mg per day are generally tolerable and safe for short-term use (up to thirty days), provided it is discussed with pharmacists about the use of other medications.
The divergence in the risk assessments raises serious questions as to their proportionality, consistency and fairness.
EFSA’s method
EFSA has said that they have applied a safety margin to CBD due in part to the lack of evidence and exclude people who are under 25 or pregnant, breastfeeding or taking medication.
The agency emphasized that there are still unanswered questions regarding the long-term effects of CBD on the immune system, the reproductive, and neurological systems, as well as the liver. EFSA emphasized the benchmark isn’t final, and it could be modified as data improves.
EIHA’s recommended CBD threshold will keep products safe, but still contain enough CBD for positive health benefits. Therefore they can be used as food and supplements.
Efficacy questions
The commercial CBD market has built itself around everyday health benefits. Closing this gap is essential to its success.
The industry has long maintained that CBD supplementation levels between 10 and 20 milligrams a day correspond better with the way CBD is actually consumed by consumers.
Commercial stakes
EFSA’s developments come at a time when the CBD sector is suffering from a post-bubble malaise.
The European CBD market is not well-represented by official sales data. Many products are sold under regulatory grey zones and fragmented regimes.
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 nearly €3 million on studies to support the consortium’s CBD novel food authorizations in the EU and the UK’s separate approval system. According to Mirizzi, the group will not be discouraged.
“The hemp sector invested heavily to generate robust toxicological data, precisely in support of a science based Novel Food Authorization. “We will move ahead within the 2-milligram per day framework but remain committed in strengthening the evidence by additional peer reviewed and proprietary studies,” said he. “Our goal remains the same: aligning the EU-safe intake level to what scientific data objectively justifies.”