Effective May 15, the French General Directorate for Food (DGAL) prohibited the sale of CBD gummies, tinctures and supplements under EU Novel Food regulation without prior consultation with industry representatives.
Outlining the impact for the local hemp industry, the Union of Industries for the Valorization of Hemp Extracts (UIVEC), said this will affect nearly 2,000 hemp producers, 20,000 pharmacies, 1,500 CBD shops and several major retailers and independent stores, representing an estimated turnover of around €100 million for CBD-based food supplements alone.
“France, the historical European leader in hemp cultivation area, risks destroying its own competitive advantage at a time when other countries are actively structuring their markets,” it stated when the proposed ban was first announced.
The ban follows ECHA‘s agreement with an opinion proposed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) that CBD should be classified as a reproductive toxicant.
Jerome Le Bloch, head of scientific affairs at FoodChain ID, described the ban as a significant blow for the CBD industry.
“This is a major development, which represents another significant negative signal for the CBD sector,” he said. “The industry has already faced major challenges linked to novel food authorization requirements, EFSA’s inability so far to confirm CBD safety and uncertainty around toxicological data. Against this backdrop, the proposed classification of CBD as a reproductive toxicant would add further pressure on an already fragile and highly uncertain European CBD supplements market.”
Is CBD legal across Europe?
In the EU, CBD used in food or dietary supplements is classified as a novel food, meaning it requires pre‑market authorization from the European Food Safety Authority (EFSA). However, no supplements have yet received full approval.
At the same time, enforcement varies across the bloc, as each Member State implements the legislation differently, with some more tolerant than others.
More accepting countries include Germany, Netherlands, Poland, Czech Republic, Austria, Switzerland and the UK, although that market is looking less and less optimistic. Spain, Ireland and the Nordics have a more restrictive approach, and France, in particular, had been adopting an increasingly strict stance in response to EFSA’s recently proposed reduced safe daily intake for CBD of just 2 mg per day.
‘Excessive requirements by EFSA’
Commenting on the rationale behind the ban, Mark Tallon, PhD, managing partner of food law firm Legal Foods, highlighted that the safety of CBD products depends entirely on the dose, as with all chemicals.
“Vitamin A, selenium, boric acid and iodine are all food ingredient but also reproductive toxicants—they are not banned,” he said. “Alcohol has reproductive and development adverse effects at X dose, as can caffeine. The issue is what dose and what labeling mitigates the risk of harm.”
As such, he noted that food supplements often carry warnings such as “Keep out of reach of young children” or “Not suitable for pregnant and breast-feeding women” and that it is important in these cases to be proportionate and consider all the safety data.
“The ANSES opinion sent to ECHA already omits significant evidence and misrepresents the data,” he said. “EFSA has already stated 2 mg is acceptable so there is no defect ban. The battleground remains ‘dose’—What is the safe level of exposure?”
EFSA previously rejected CBD novel food applications due to a lack of full identity characterization (notably particle size and nanoparticle presence), stability data, genotoxicity studies, reproductive and developmental toxicity data, and human clinical safety data.
Le Bloch noted that three ongoing applications under EFSA evaluation were withdrawn on May 19, “probably due to the complexity to fulfil EFSA requirements.”
For Tallon, the biggest issue with CBD submissions is not CBD’s potential classification as a reproductive toxicant but rather the “excessive requirements by EFSA for characterization of hemp extracts and possible presence of nano materials.”
“What we see is EFSA taking a position that they will simply ignore evidence if we don’t believe a novel food is characterized to the degree now expected,” he said. “Proportionality is out of the window, and we won’t see EFSA explain in such opinions why the believe extracts could contain nano materials, simply that they might.”
In this scenario, applications may be withdrawn to avoid a non-assessment and a default rejection, such as “We cannot assess on the basis of poor characterization.”
Tallon warns that the unprecedented strict stance—one that departs from the approach historically applied to similar extracts—has led, and will continue to lead, to a loss of engagement with the authorities and increased risk of illegal products on the market.
“As with health claims, the result will be a commercial decision to simply place products on the market and not engage with safety assessment, as it is often lower cost to pay the fines or defend cases in court that to pursue an unpredictable novel foods submission,” he said.
