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EFSA’s scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake. Low-THC cannabis products in Europe An increase in the open sale of cannabis products in Europe has raised questions around the possible legal and commercial status of these products. The

Cannabidiol novel food evaluations on hold pending new data

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods. Following the submission of numerous applications for CBD under the novel food regulation, the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.

Data gaps and uncertainties

EFSA’s expert Panel on , Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”

There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.

Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans.

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Support to applicants

Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated: “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”

As part of the follow-up, EFSA is holding an info-session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally. The online event takes place on 28 June – register to attend!

Low-THC cannabis products in Europe

An increase in the open sale of cannabis products in Europe has raised questions around the possible legal and commercial status of these products. The products are marketed for their low THC (tetrahydrocannabinol) content, which sellers claim exempt them from control by drug laws, or as sources of CBD (cannabidiol). This publication presents an initial overview of the situation, covering the types of low-THC product available, user profiles, associated harms and regulatory responses in Europe. Low-THC products that take forms similar to illicit cannabis products, such as smoking mixtures, oils and edibles, are a primary focus of this study. The report highlights the challenges facing policymakers and suppliers of low-THC products, including the legal status of the products and the regulatory frameworks that may apply to their sale.

Notes on translations:
Czech: translated and produced by the Czech national monitoring centre for drugs and addiction.