Since its inception, the UK CBD oil industry has been left to its own devices to self regulate and ensure CBD products are fit for sale.
However, since early last year, it’s been clear that change was around the corner with the official recognition of CBD as a novel food at an EU level.
This categorisation means CBD products now (technically) require pre-authorisation before going on sale and that all current ingestible CBD on the market in the EU needs to be approved.
Still, enforcement is up to each EU member state. To date, the levels of implementation have been less than uniform, with some countries being much more stringent in the process than others.
While the UK has left the European Union it will still comply with the legislation. The Food Standards Agency (FSA), has announced that all current ingestible CBD on the UK market (excluding Scotland) will need to be submitted for addition to the novel foods catalogue by March 31st 2021. After this date, CBD oil is legal in the UK only if it has an accompanying novel food application submitted.
Any consumable CBD products which are not submitted for addition to the novel food catalogue by this date will not be allowed to remain on sale in the UK market…We will dive into what this means for the industry shortly.
But first, what is novel food regulation, and why does it apply to CBD?
Novel foods are EU foods which have not been widely consumed before May 15th 1997 in the EU.
The primary reason a food is classed as novel is that there is a lack of historical use in regard to its consumption and as such little empirical data if that ingredient is stable when used in food products.
The EU novel foods regulation has three primary stipulations, where the food must not:
The regulation is a European Commission mandate which applies to countries within the European Union. Although, the UK will enforce the directive after the Brexit transition period.
Novel foods examples include:
Any product containing a novel food ingredient will need to pass a rigorous safety assessment before being placed on sale.
The work required for the approval of a new novel food is lengthy and costly where the process involves the creation of a dossier of scientific data points, which can take a year to collate.
Add in the cost of legal advice to ensure the application contains what’s required for approval, and the entire process can end up costing in excess of a hundred thousand pounds.
It’s also widely expected that any new application will take 12-18 months before approval and might require revisions prior to being rubber-stamped by the European Commission.
At the date of writing, there is not a single CBD novel food application which has been approved.
With the classification of CBD as a novel food in January 2019, the impending change has been inevitable.
Countries such as Germany have started to exercise more immediate action for new food regulation, whereas others such as the UK have offered a window of grace to submit a novel foods application. This is likely associated with the size of the UK CBD market, with the UK being the largest market in the EU by far.
In the UK this undercurrent of change is technically owned by the Food Standards Authority. Still, it appears to have been spurred on by the creation of the Association of Cannabinoid Industry in late 2019, an affiliated company of the Centre of Medicinal Cannabis.
While it’s true that in the UK any CBD product which is considered an ingestible will require approval, raw CBD material manufactures will be held to the highest levels of compliance.
What does this mean? Depending on where in the chain the business is, different levels of regulatory oversight will apply. For example:
Raw material manufacturers must carry out the most extensive amount of due diligence and work to comply with the Novel Foods regulation. They must gain appropriate levels of safety and stability data. Combined with harmonised CBD testing methods to submit a novel foods application. This tranche of the CBD industry will need to complete this work and submit it before 31st March 2021 to keep their products on the market after that.
Manufactures of finished products must liaise with their raw material suppliers to ensure they are engaging in a novel foods application and that they have the required safety and stability data.
White label brand owners must consult with their suppliers to ensure they are only using raw materials which are being submitted as part of the Novel Foods process. Final products will need to show benchmarked levels of stability for the end user in order to be approved for use.
While the FSA is in charge of the overarching UK regulation when it comes to anything related to foods, enforcement is at the local level.
As a result, it will be up to local trading standards and environmental health officers to engage with brands and retailers in regards to novel foods enforcement.
Disclaimer: Views expressed here do not necessarily reflect those of Nature & Bloom and its staff. This article is not intended to provide medical advice, diagnosis, treatment, cure or prevention for any disease. Nature & Bloom products have not been evaluated by the MHRA.