Cannabidiol Novel Food Assessments Paused Pending New Data
Regulators in the European Union are shelving plans to allow CBD to be freely sold and added to foods and dietary supplements. EFSA scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to lack of data and uncertainties regarding the potential harms of consuming CBD.
The European Commission considers that CBD can be considered a novel food if it meets the conditions of European legislation on novel foods. Following the submission of numerous applications concerning CBD under the Novel Foods Regulation, the Commission has asked EFSA to give their opinion on the safety of CBD consumption for humans.
The European Food Safety Authority said this week that it does not have enough data to comment on the safety of CBD for human consumption.
“There are insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people's psychological well-being,” the health agency said.
The agency had reviewed more than a dozen applications from companies wishing to sell CBD products without prescription in EU member states. This delay means that these companies do not know if and when they will be able to market their products.
The European Union has planned to hold a public meeting on June 28 on CBD consumption and what regulators want to know about it. But officials gave no indication of how long it will take to find the data they seek.
Hemp-derived cannabinoids, including CBD, were added to the EU's Novel Food Catalog in January 2019, meaning CBD foods and supplements must be assessed for consumer safety before being sold. legally.
The EU delay comes after similar delays in the UK, a former EU member who said after leaving the union that he would assess the safety of CBD products himself. This process has dragged on for years, prompting a group of parliamentarians to recommend this week that the UK overhaul its process for evaluating CBD products.
Data gaps and uncertainties
EFSA's Nutrition, Novel Foods and Food Allergens (NDA) Expert Panel has received 19 applications for CBD to be authorized as a novel food, with more being reviewed.
Chairman of the NDA Group, Professor Dominique Turck, said: “We have identified several dangers associated with the consumption of CBD and determined that the many data gaps on these health effects must be filled before these assessments can be made. go forward. It is important to emphasize at this point that we have not concluded that CBD is unsafe as a food. »
Animal studies show significant negative effects, especially with regard to reproduction. It is important to determine whether these effects are also seen in humans.
Ana Afonso, Head of Nutrition and Food Innovation at EFSA, said: “It is not unusual to stop the evaluation of a new food when information is lacking. Applicants are responsible for filling data gaps. We engage with them to explain how additional information can be provided to help remove uncertainties. »
As part of the follow-up, EFSA is organizing an information session, open to applicants and other groups or individuals interested in this issue and in novel foods in general.
- Statement on the safety of cannabidiol as a novel food : data gaps and uncertainties
- Plain language summary: Statement on the safety of cannabidiol as a novel food : data gaps and uncertainties.
- Information session : The safety of cannabidiol as a novel food : data gaps and uncertainties