CBD in Europe: EFSA wants to restrict consumption to 2 mg/day

L’European Food Safety Authority (EFSA) launched a public consultation in its updated opinion on the safety of the cannabidiol (CBD) as novel food. Published on September 9, the proposal recommends a daily intake limit of 2 milligrams per day for a 70-kilogram adult, a threshold that many stakeholders consider excessively restrictive.

The public consultation (PC 1597), titled «Update to the Safety Opinion on Cannabidiol (CBD) as a Novel Food,» is open until October 14, 2025. It invites companies, experts, public authorities, and citizens to submit their contributions, provided they are submitted via EFSA’s online platform in the required format. Following the consultation, EFSA may revise its opinion before publishing a final version.

For context, the United Kingdom sets a limit of 10 mg/day (previously set at 70 mg/day), Australia at 60 mg/day, while in the Canada, the limit is 200 mg/day, which is 100 times higher than the EFSA’s provisional figure.

According to the Union of Industrialists for the Promotion of Hemp Extracts (UIVEC), nearly a decade of CBD use in Europe has not been linked to any major public health issues, making the suggested limit «difficult to justify.».

Scientific uncertainties and safety concerns

EFSA’s updated statement is based on an analysis of scientific literature published since 2021. Despite the influx of new data, the agency emphasizes persistent shortcomings, particularly with regard to the effects of CBD on the liver, the endocrine system, the nervous system and the reproductive health.

Animal studies consistently show signs of liver toxicity at very high doses, while clinical trials in humans confirm the risk of liver toxicity when the CBD interacts with other medications. Concerns also remain regarding the reproductive toxicity and effects on neurological development during prenatal exposure.

In order to establish a provisional safe intake level, EFSA applied a uncertainty factor of 400, which is twice as strict as the standard limit of 200, resulting in the proposed limit of 2 mg/day. This value was derived from dose-response modeling of subchronic studies, focusing on liver parameters.

In its report, EFSA further concluded that the safety of CBD cannot be established for people under the age of 25, pregnant or breastfeeding women, or people taking medication concurrent.

Industry stakeholders are challenging EFSA’s methodology

This restrictive figure has already sparked strong reactions from the scientific community. Jérôme Le Bloch, PhD, head of scientific affairs at FoodChain ID, told NutraIngredients:

«As in previous assessments, EFSA does not clearly explain which studies were included or excluded, nor does it provide sufficient justification for rejecting a large portion of the reviewed literature.»

He also criticized the reliance on a single safety criterion and the unusually strict safety margin:

«The value of 2 mg/day is derived from a BMDL [lower limit of the reference dose] based on a single safety criterion, which is questionable. The proposed limit is extremely low and could discourage consumers.»

Dr. Le Bloch and other consultants are calling on companies to share their safety data during the consultation period, in the hope of influencing EFSA’s final position.

CBD Regulations in Europe and Beyond

Currently, none CBD product intended for oral consumption is authorized in the European Union under Regulation on Novel Foods, which each Member State may choose to follow or not.

The The only approved medication is the’Epidyolex, prescribed for rare forms of epilepsy. By the end of August, the European Commission had received more than 200 inquiries regarding CBD, 17 of which were undergoing a risk assessment by EFSA.

Visit France, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) went a step further by proposing, earlier this year, to classify CBD as substance suspected of being toxic to human reproduction under the European chemicals regulations. In Switzerland, authorities recommend a maximum daily dose of 12 mg, while in the United Kingdom, regulators have recently reduced the recommended daily dose from 70 mg to 10 mg/day.

In this fragmented landscape, the EFSA consultation is seen as an important opportunity to shape the future of European CBD market. Industry representatives warn that without a more proportionate approach, the proposed threshold could undermine consumer confidence and hinder the sector’s sustainable development.