CBD and the EU Novel Food Catalogue: A Deep Dive
Cannabidiol, commonly known as CBD, has gained significant attention in recent years due to its potential therapeutic benefits. However, its status as a novel food in the European Union has raised questions and concerns among consumers, manufacturers, and regulators alike.
EFSA's assessment of CBD: from the 2022 pause to 2026
In June 2022, the European Food Safety Authority (EFSA) paused its evaluations of CBD as a novel food because of data gaps. In February 2026 it published an updated statement with a provisional safe level of 0.0275 mg of CBD per kg of body weight per day (about 2 mg a day for a 70 kg adult), and it has since resumed issuing opinions on individual applications. The reason given in 2022 was data gaps and uncertainties about potential hazards of CBD intake.
EFSA's provisional level applies only to food supplements with CBD at least 98% pure and without nanoparticles. For people under 25, pregnant or breastfeeding women and people taking medication, EFSA says the safety of CBD cannot be established.
What Qualifies as a Novel Food?
CBD can be derived from Cannabis sativa L. plants or can be chemically synthesised. The European Commission has determined that CBD qualifies as a novel food, provided it aligns with the conditions set out in EU legislation on novel foods. The Commission sought the opinion of EFSA on the safety of CBD consumption for humans, given the influx of applications for CBD under the novel food regulation.
Data Gaps and Concerns
By June 2022, EFSA's expert Panel on Nutrition, Novel Foods, and Food Allergens (NDA) had received 19 applications for CBD as a novel food. In 2022, the Chair of the NDA Panel at the time, Prof. Dominique Turck, said the panel had identified several hazards and data gaps, and stressed that it had "not concluded that CBD is unsafe as food".
EFSA's 2026 statement still lists concerns about the liver, gastrointestinal tract, endocrine, nervous and reproductive systems. It found consistent liver effects in animal studies, and signs of liver effects in human trials, particularly when CBD was combined with medication.
Animal studies have shown adverse effects, especially concerning reproduction. It remains crucial to determine if these effects are also observed in humans. This concern is further elaborated in a published study.
Support for Applicants and Future Directions
In 2022, Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated that pausing a novel food assessment is not uncommon when there is missing information. Since then, EFSA has issued opinions on individual applications. Several concluded that safety "cannot be established" because applicants did not supply the requested data, including two published on 21 September 2026. On 18 September 2026, EFSA gave its first positive opinion. It concerns a synthetic CBD (at least 98% pure) in MCT oil at no more than 2 mg a day for adults over 25, and found it safe except for people taking medication.
EFSA's opinion is advice: the European Commission and Member States decide whether a CBD novel food can be sold, and none has been authorised yet.
Sources: EFSA news, June 2022; EFSA Journal 2026, 9862 (updated statement); EFSA Journal 2026, 10154; EFSA Journal 2026, 10318; EFSA Journal 2026, 10319; EFSA: novel food.
CBD and cannabis rules in selected European countries
The novel food rules apply across the EU, but national rules on hemp, CBD and cannabis still differ. The overview below summarises the situation described in our earlier country reports.
France
A 2022 survey by Santé publique France of adults aged 18 to 75 in metropolitan France found that 16.4% had tried CBD at least once and 10.0% reported use in the previous 12 months. The ministerial order of 30 December 2021 authorised the cultivation and specified uses of registered Cannabis sativa L. varieties with a delta-9-THC content no higher than 0.3%. On 29 December 2022, the Conseil d’État annulled the order’s general ban on selling low-THC flowers and leaves; this does not mean every CBD oil, cream or edible meets all applicable product rules.
Spain
It is not accurate to describe every CBD product as entirely legal in Spain. Requirements depend on the product, its composition, intended use and presentation. Regulation (EU) 2015/2283 on novel foods has applied since 1 January 2018, and Spain’s food authority AESAN explains that a novel food needs authorisation and an entry in the Union list before it can be marketed. Earlier estimates of around 20 million euros for Spain’s CBD oil market were not accompanied by a named dataset or methodology. Medical cannabis in Spain is covered by its own rules.
Italy
Italy has rules covering the production and sale of hemp-derived products, but its regulatory environment for cannabinoid products has been changing, and illicit sales continue alongside the legal market. Euromonitor tracks the Italian cannabis market in three segments (medical cannabis, adult-use cannabis and CBD), broken down by product format and distribution channel. These are research categories covering both legal and illicit sales, so they do not mean that every segment or format is legally available in Italy.
The Netherlands
Under the Closed Coffee Shop Chain Experiment, the first pilot trials began in Breda and Tilburg in December 2023. The experimental phase began on 7 April 2025 and lasts four years; during this phase, coffee shops in the ten participating municipalities must sell only regulated cannabis products. An independent team of researchers analyses the impact on public safety, crime, nuisance and community well-being.
Greece
Greece legalised medical cannabis in 2017. In parliamentary questions, Greek MEP Stelios Kouloglou described restrictions on imports introduced in 2021 and raised concerns about patients’ access and the free movement of goods. In its written response, the European Commission stated that Member States may allow patients access to cannabis-based medicinal preparations and that it had no plans for further harmonisation at that time.
Read more in our guide: Is your CBD oil legal?
