THE European Food Standards Agency (EFSA) issued a statement last week announcing that its scientists ‘cannot currently establish the safety of cannabidiol (CBD) as a novel food’.
EFSA said they were effectively ‘stopping the clock’ on the 19 European novel foods applications currently under consideration until ‘many data gaps’ on the health effects of CBD in humans have been filled.
While technically the ruling does not impact the sale of CBD products in the UK, with the national Food Standards Agency (FSA) acting independently of EFSA following Brexit, the ramifications could still be felt across the UK industry.
Some have suggested that it is merely a matter of time before these same data gaps come into play in the upcoming ‘risk assessment’ stage of the UK’s novel foods process, but others believe this could simply be a move by European authorities to ‘reposition themselves’ in the driving seat of CBD regulation after the FSA carved their own separate path.
What Have EFSA Said?
After receiving 19 CBD novel food applications, with more on the way, the European Commission asked the EFSA to give its opinion on whether CBD consumption is safe for humans as a novel food.
The EFSA’s expert panel on Nutrition, Novel Foods and Allergens (NDA) have now said there is ‘insufficient data’ to make a decision.
Chair of the NDA Professor 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.”
According to one industry source, the EFSA have essentially ruled that the CBD toxicity data which has so far been carried out on rodents, which many CBD companies have spent considerable amounts of money and time carrying out, are not enough to establish safety in humans.
EFSA’s statement suggests that ‘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.’
Now studies into the effects of CBD on the ‘liver, gastrointestinal tract, endocrine system, nervous system and on psychological function’ need to be conducted with humans.
The statement refers to the ‘many human studies’ carried out into the effects of Epidyolex, GW Pharmaceuticals’ NHS-prescribed CBD treatment for refractory epilepsies, but states that these studies are unsuitable for analysing CBD as a novel food.
Furthermore EFSA says that no NOAEL, the highest dose of a drug that does not produce a significant increase in adverse effects, has yet been established for CBD.
The European Industrial Hemp Association (EIHA) are currently working on toxicological studies to establish a NOAEL for CBD, alongside a ‘fair and scientifically correct TDI’ (Tolerable Daily Intake).
EIHA’s managing director Lorenza Romanese informed BusinessCann that the results from the studies relating to CBD isolate are due to be published in July or August this year, while full spectrum will be due between October and November.
While they hope to fill many of these ‘data gaps’, it is understood that further human studies will now be needed to satisfy EFSA, and it’s not yet clear how these can or will be structured.
How Will This Impact This UK’s Novel Foods Process?
The FSA are due to publish their final version of the UK public list on June 30, which will then see them move towards the ‘risk assessment’ phase.
Executive Director of the Cannabis Trades Association Marika Graham-Woods told BusinessCann that ‘were going to encounter the same problems in the risk assessment phase without a doubt’.
She added: “There’s a lot of companies who are currently, if you like, in the running because they’re on the public list, that would now have to commission toxicology studies.
“And there probably is going to be a need for a consortia to be bolted together to test in humans, because that sort of study is a lot of money.”
However, according to The Canna Consultant’s (TCC) who recently published a breakdown of EFSA’s detailed statement, this decision could be driven more by political reasons than medical.
In a statement published on Friday, the TCC suggested that pre-Brexit the UK FSA was an ‘integral part of European Food Safety Regulation’, but its move to carve its own regulatory path in England and Wales post-withdrawal is seen as ‘unacceptable’ by many in the EU.
“The EU Commission, the EMA and the EFSA cannot be seen to be allowing GB to be driving the policy on CBD as they must consider the voices of 27 countries.
“The FSA upset many on the Continent when it first provided the 70mg (or 1mg per kg) limit on CBD. The EFSA had not declared such a limit. It further enraged the elite when Emily Miles stated in early May that, “There is little evidence of significant harm.” Another statement not supported by the EFSA.
“There is brinkmanship at play here. The EFSA statement is without doubt an EMA-driven statement which seeks to take back control and reposition itself in the driving seat.”
TCC concluded that they believe the EFSA will, set a daily limit for CBD consumption at around 40-50mg, and therefore forgo the need for new data to fill these ‘gaps’.
According to statements from the FSA, they do not plan to remove any products on sale or halt novel foods applications unless they find ‘credible evidence’ that CBD risks harm to the public.