With the deadline for novel food authorisation on the horizon for UK CBD companies, Shomi Malik, Development Director at The Association for the Cannabinoid Industry (ACI), outlines the steps that must be taken to ensure dossiers meet the required standards.
On 13 February 2020, the UK Foods Standards Agency (FSA) provided long awaited further guidance relating to CBD and Novel Foods with an announcement that all companies selling CBD as a food must have a fully validated novel food dossier for each of their products by 31 March 2021.
In an unequivocal statement, they made clear that: “Businesses need to submit, and have fully validated, novel food authorisation applications by 31 March 2021. After this date, only products for which the FSA has a valid application will be allowed to remain on the market.”
The time is now for CBD companies operating in a grey zone to start the process towards ensuring they can hit the deadline to get their CBD dossier validated and become legally compliant.
Many CBD businesses had ignored previous guidance from the FSA, issued in early 2019, that were in line with updates to the European Food Safety Authority (EFSA) Novel Foods Catalogue classifying all cannabinoids as unauthorised novel foods. The following year was filled with conjecture as to whether CBD should be a novel food or not. Meanwhile, consumer demand for CBD branded products continued to soar. The Centre for Medicinal Cannabis now estimates the UK market to be worth £450 million.
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Encouragingly, companies operating in this space are now acting on the new FSA guidance with a YouGov poll indicating 74 percent of the general public in agreement with the FSA’s approach.
The FSA confirmed last month that high quality CBD novel food dossiers have already been submitted. One of those is from the US firm Mile High Labs who have submitted dossiers to EFSA and FSA for their CBD isolate and finished products. Christian Hendriksen, VP of International Expansion, Mile High Labs said: “Our novel food application is a key step in ensuring continued compliance for our customers, as well as our products, in the European market.”
Recent calls from some in the sector requested that the FSA postpone their deadline, given the current pandemic, but the FSA has since confirmed they have no plans to do this.
If companies do not have appropriate stability data or toxicological data then time is running out.
Dr Andy Yates, Pharmacy Lead for The Association for the Cannabinoid Industry (The ACI), a body set up to foster a legally compliant, sustainable and safe CBD industry in the UK points out: “The FSA has always been clear they expect UK CBD companies to work towards Novel Foods authorisation. Their deadline may seem a long way off, particularly with things that are happening around us right now. However, it is approaching fast given the work that needs to be done. The time is now for CBD companies operating in a grey zone to start the process towards ensuring they can hit the deadline to get their CBD dossier validated and become legally compliant.”
Experts for The ACI recently compiled a timeline to guide CBD companies in this process. They identified key data sets a company must compile to submit a credible dossier with a high likelihood of gaining validation by EFSA. These include a toxicology assessment, stability assessment, manufacturing data for at least five batches and other necessary assessments.
Dr Parveen Bhatarah, who heads up The ACI’s Regulatory and Compliance Unit explains: “The FSA expects all companies operating in the UK CBD industry to demonstrate that their products are safe for human consumption. Getting a Novel Foods dossier validated is the way a company does this. In particular, CBD raw material suppliers need to ensure they have made an appropriate risk assessment and can supply the relevant safety data.”
The ACI is concerned that many companies are going to struggle to comply if they have not started the process already.
This data can be gathered in parallel, but the clock is ticking and compiling the necessary data for a full toxicology assessment could take up to nine months. In addition, it will take time for EFSA to review and validate the dossier, which is estimated to be two-three months.
Only products with a validated dossier can remain on the market after the 31 March 2021 deadline. The ACI is concerned that many companies are going to struggle to comply if they have not started the process already. Dr Bhatarah continues: “Although the 31 March 2021 is the deadline for Novel Food application validation, if companies do not have appropriate stability data or toxicological data then time is running out. The ACI will support companies that do not have the relevant in-house regulatory expertise.”
For smaller brands, ensuring their suppliers are in the process of submitting novel foods applications is a critical step to ensure they have the data they need for their own dossiers.
The ACI will be hosting a symposium for CBD brands in the final week of May. Representatives of the FSA, trading standards, analytical testing laboratories and other key stakeholders will be presenting to CBD brands giving them a clear understanding as to what they need to know to stay on the UK market on 1 April 2021.