Leading cannabis Lawyer Robert Jappie of law firm Ince reflects on the shifting status of CBD in Europe
THE European Commission has paused consideration of the majority of CBD Novel Food submissions. Its announcement to potentially reclassify CBD as a narcotic is a real concern for the whole European CBD industry.
Businesses that submitted an application to the EC have each received a letter advising them of the decision to pause the validation process on the basis that consideration is being given to reclassifying CBD as a narcotic.
If this reclassification were to take place CBD could be treated in the same way as THC, under the UN Convention on Narcotic Drugs. This would mean that CBD could not be used in foods. It would also impact upon the use of CBD in cosmetics and vape products.
UK FSA Position
Whilst the UK is in the Brexit transition period, the FSA cannot formally (or legally) accept Novel Food dossiers. However the FSA has confirmed it will informally accept dossiers until the end of 2020.
If a company does informally submit their dossier with the FSA before December 31, 2020, then the FSA will review the dossier and provide feedback on where improvements can/should be made.
This will then give companies time to update their dossiers and formally submit a good quality dossier to the FSA in January. A good quality dossier – especially under the guidance of FSA – means that it is possible to speed up the time from submission to approval.
The FSA will not extend the March 31, 2021, deadline for dossiers to be validated. Paul Tossell who heads up the Novel Food department at the FSA has been categorical about this.
As of approximately two months ago, the FSA had already received eight dossiers submissions. Mr Tossell was adamant that the FSA has the capacity to validate dossiers in time for the March 31, 2021, deadline. To help meet this deadline, however, companies should informally submit their dossiers to the FSA by December 31, 2020, and, ideally as soon as possible.
The FSA has advised that there is no likelihood that the UK Home Office will follow the EC route. They have been very clear that CBD (without any psychotropic properties) is not a narcotic and therefore, not a controlled drug.
The MHRA (Medicines and Healthcare products Regulatory Agency) has confirmed that CBD without any medical claims, is not a medicine. This means all that is left is classification as a ‘food’, and because there is no history of use prior to May 1997, CBD is a novel food.
EU EFSA Position
Businesses have invested a great deal of time and money in establishing operations across Europe in the CBD wellness sector.
It would be entirely inappropriate for the EC to now attempt a reclassification, particularly as CBD was deemed a novel food as long ago as January 2019.
However, as the EC has not yet fixed its position, there is no formal legal challenge available at this time. It seems likely that any efforts to reclassify CBD as a narcotic will be strongly resisted by business in Europe, and via litigation if necessary.
To be novel food approved throughout Europe then a dossier must be submitted to the EC. It is a commercial decision as to whether the company makes a submission to the EC now knowing that it will be ‘paused’ whilst the EC determines if CBD is a narcotic or not.
We can still submit to the EC now. The advantage of submitting to the EC now is that your dossier will already be in the queue for validation should they determine CBD is not a narcotic.
CND Session In Vienna
Something else to consider is the UN Commission on Narcotic Drugs (CND) session in Vienna later this year. The World Health Organisation (WHO) has recommended amending Schedule I of the 1961 UN Single Convention on Narcotic Drugs in order to clarify that cannabidiol (CBD) is not a narcotic drug. The WHO proposals read:
Proposal 5.4: Delete extracts and tinctures of cannabis from Schedule I of the 1961 Convention
Proposal 5.5: Add a footnote on cannabidiol preparations to Schedule I of the 1961 Convention to read: “Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9- tetrahydrocannabidiol are not under international control”
This will be considered by the CND in December 2020. There is some debate as to whether these proposals will benefit the CBD industry if adopted. Either way, it should be an interesting end to an eventful year.