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Cannabidiol novel food evaluations on hold due to data gaps and uncertainties about potential hazards related to CBD intake

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Cannabidiol is a substance that can be obtained from Cannabis sativa plant and can be synthesised chemically as well.

In its ruling of 19th of November 2020, the Court of Justice of the European Union ruled that cannabidiol (CBD) does not appear to have any psychotropic effect or any harmful effect on human health. This was followed by statement issued by the European Commission concluding that cannabidiol should not be considered as drug within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 in so far as it does not have psychotropic effect. Therefore, cannabidiol can be qualified as food, provided that also the other conditions of Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety are met.

Following the submission of numerous applications for CBD under the novel food regulation, the European Commission asked European Food Safety Authority (EFSA) to give its opinion on whether CBD consumption is safe for humans. EFSA is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (Commission, Council, Parliament) and EU Member States. After review of several application EFSA 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. More on the topic can be found on EFSA official website including official Statement on the safety of cannabidiol as a novel food: data gaps and uncertainties.

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 28th of June 2022register to attend.

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