The European Food Safety Authority (EFSA) has put CBD Novel Food applications on hold as scientists are unable to establish the safety of CBD.
Scientists have been unable to establish the safety of CBD as a Novel Food due to “data gaps and uncertainties about potential hazards related to CBD intake.”
The EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has so far received a total of 19 CBD Novel Foods applications. Only applications that are approved will legally be able to be sold in any EU Member States.
It has stated that data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological wellbeing is currently insufficient, and that animal studies have shown significant adverse effects, especially in relation to reproduction.
The organisation has now put applications on hold as it says it must be determined if these effects are also seen in humans.
Chair of the NDA Panel, Professor Dominique Turck, commented: “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.”
Speaking to Cannabis Wealth, representatives of the European hemp industry, the European Industrial Hemp Association (EIHA) commented: “European Food Safety Authority (EFSA) confirms that a Novel Food application for CBD products should foresee solid scientific data.
“Definitely not a surprise and 100 per cent in line with our approach: we decided in 2021 to pool the resources of more than 100 companies and work with Chemsafe Srl on a serious and solid submission, anticipating the scientific gaps indicated today by EFSA. Unity makes strength (and foresight).”
The UK’s Food Standards Agency (FSA) earlier this year published a public list of the country’s own CBD Novel Foods applications that are deemed as potentially safe for human consumption. However, so far, no CBD applications have gone through a full risk assessment, and validated applications on the FSA’s public list are now progressing to the risk assessment stage. The organisation recently confirmed that final approvals are not expected until 2023 as more safety and toxicology data is gathered.
To demonstrate product safety, any company in the UK making a CBD Novel Food application has to conduct an extended 96-day, repeat dosing, rat toxicity study for each individual product on the application.
In a statement to Cannabis Wealth, deputy director of Regulatory Services at the Food Standards Agency, Peter Quigley, said: “We note with interest the European Food Safety Authority’s (EFSA) statement on the safety of cannabidiol as a novel food.
“EFSA has reached the same conclusions as the Committee on Toxicity did two years ago: there are still evidence gaps relating to CBD as a food and relevant data is needed to prove a safety case for CBD foods.
“It also mirrors the approach we have been taking of requiring applicants to submit toxicological data to prove the safety of CBD products instead of relying on literature reviews of existing evidence.”
Head of Nutrition and Food Innovation at EFSA, Ana Afonso, 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.”
The EFSA will be holding an information session, open to applicants and other groups or individuals with an interest in this issue and novel food. The online event will take place on 28 June.