Dr Paul Duffy, Toxicology Associate, at the ACI, elaborates on its Novel Food applications and the significance of these development for the the CBD industry
THIS week marks a significant milestone for the Association for the Cannabinoid Industry (ACI), and our members, as we submit their scientific dossiers to the Food Standards Agency (FSA) for their products.
This is to gain a Novel Foods validation to allow them to sell legally in the UK. It’s a momentous milestone for a relatively new industry and positions the UK at the heart of a responsible, regulated and innovative cannabinoid sector.
Not everyone in the industry is on board with the framework that was outlined by the FSA. Which was in accordance with guidelines from the European level.
As much of the discussion was centred around what the data requirements were, who should do a novel foods application, and a myriad other issues, the ACI’s engagement with the UK FSA elucidated on many of these points.
CBD Is ‘No Normal Novel Food’
Cannabinoids, and in this instance CBD, are no normal novel food. Most novel foods do not have the batch-to-batch variability throughout the supply chain that comes with plant-derived CBD.
Most items in the novel food catalogue have reams of data in the public domain, making an authorisation a relatively simple case of a literature review, CBD does not.
These points lead to a challenging environment to achieve compliance in time for the FSA’s March 31 deadline.
We have maintained that generating the required data would do more for the industry than ‘just’ achieve compliance; in the absence of any data on cumulative exposure, the opportunity to generate this data would have far-reaching implications.
Namely, the first of its type of data to categorically deem CBD safe. An important factor, especially when considering the Committee on Toxicity’s (COT) preliminary assessment on the safety of CBD.
The COT report has nothing to do with novel foods, but a convenient overlap in the data requirements as set out by the European Food Safety Authority (EFSA), meant that these safety concerns would be addressed.
Is CBD Safe?
This is no easy topic, as evidenced by the number of differing views in the industry. If you look at the EFSA guidelines on data, a number of questions arose:
- Would all product-types need to undergo all the tests?
- If not, which materials need to be tested, and how do finished products fit in that?
- Would a consortium-approach work?
- What’s the mechanism by which suppliers, manufacturers and brands can work together to achieve novel foods compliance?
- What’s the most ethical way to undertake the necessary tests, without repeating multiple rodent studies?
Through our industry-leading team of experts, and our partnership with ADSL, we were able to come up with an innovative strategy, reducing the financial burden, whilst allowing companies to maintain their IP and allow for flexibility in supply chains.
Our proposal was accepted by the FSA to allow our joint submission on a CBD isolate and CBD broad-spectrum distillate.
Toxicology Study Will Fill Data Gaps
Once regulatory clarity existed the ACI worked with our members to identify the data gaps to demonstrate the safety of CBD as a food ingredient.
Putting together a novel foods application is an expensive undertaking, even the big companies working in the CBD sector did not have the resources to fund their own studies so ACI created a consortium approach to generate this data.
ACI consulted frequently with the FSA to ensure that this approach would be acceptable and our members would not get a nasty surprise on submission. They verified that this was an appropriate route to take.
We are now six weeks aways from FSA’s deadline and this week marks the cut off point for companies to submit their novel foods dossiers for each of their products.
ACI are delivering on the promise to our members that we’d help them gain full legal compliance in the UK market and we are in the process of submitting the novel foods applications – which includes an on-going 90-day (OECD 408) rodent study – on behalf of our CBD safety study consortium.
After April 1, 2021 there will be fully legally compliant CBD products on the market in the UK for the very first time. It will allow retail chains to identify what to stock and give them the confidence that they have undertaken the necessary due diligence in selecting legal and safe products.
This is the first step in a developing sector with huge potential. By engaging in this process it opens up a wealth of opportunities for the industry. The future for this industry looks bright.
Dr Paul Duffy, Toxicology Associate, ACI