UK FSA releases initial validated novel food application list

The long-anticipated UK Food Standards Agency (FSA) initial list of products supported by a validated CBD novel food application has been released.

However the list only contains 23 total products arising from three brands. And those three brands are controlled by just two companies that have thus far managed to complete what is really only the first large step in the full novel food application approval process.

Validation requires checking that an application contains all information required by law to allow it to proceed to the authorisation process. This information includes evidence of a risk assessment. If any of this information is missing, the application cannot be legally validated, the FSA said.

“It is important to note that validation is not the same as authorisation. There is no guarantee that a validated application will be authorised. Addition of a CBD product to this list does not mean it is authorised or approved, only that the applicant is seeking authorisation,” it added.

This means that these would have been the only products technically permitted on the UK market if the FSA had not made a change in policy to allow products with a submitted application to stay on the market – as opposed to only those supported by an application that had been validated by the FSA – pending full approval of the application.


List can ‘inform enforcement decisions’


As the FSA works through the backlog of applications submitted before the 31st March 2021 deadline more products will be added to the list, which the FSA said will be updated regularly.

There was a flurry of announcements from companies saying their applications had passed the administrative check (essentially that they had been successfully submitted) following the FSA’s change in policy leading up to the 31st March deadline. It had been thought that the FSA might also produce a list of the applications that had gone through that initial step but were still awaiting validation.

However this has proved to not be the case, with the inference being that such a list would be premature given the differences between being administratively accepted and being validated. Such a list could also lead to potential confusion about what products are permitted to remain on the market.

The FSA added that local authorities are responsible for enforcing legislation and that, by the letter of the law, CBD-containing food products should not be on the market at all even though the FSA was permitting them to remain while the retroactive approval process took place. It said it had asked the local authorities to take into account the suppliers on the list that had shown an interest in moving towards compliance.

“We expect companies which have not applied for authorisation or those rejected from the process to withdraw their products from the market voluntarily,” the FSA said. “If this does not happen, local authorities can use the list to inform their enforcement decisions. It is also available for retailers to know the status of their suppliers.”


Two successful validations


Chanelle McCoy, co-founder of the company behind the Pureis CBD brand, said that she was proud her company was one of the only two to successfully have its application validated. She told CBD-Intel that being the first through the gate was the result of years of hard work on the sidelines. The company undertook tasks such as clinical studies to ensure products were safe, coupled with an immediate embracing of regulation in its entirety rather than wasting time trying to fight elements as others had done.

“The minute novel food regulation for CBD was announced we never queried or questioned the regulation, we embraced it. Ethically we wouldn’t put a product on the market without having conducted safety clinical studies, it would be against the moral compass of our company,” she said.

Pureis hopes that regulation will lead to greater connectivity with other institutions and service providers that have taken a conservative line on CBD in the UK, including the UK Home Office, providers of financial services, banking companies, social media firms and other digital platforms.

McCoy comes from a pharmaceutical background and the Pureis CBD is a synthetic production – both likely aiding the speed of validation, though this still took the FSA some months to complete given that McCoy told CBD-Intel the company had submitted its application as soon as it could on 1st January 2021.

Meanwhile the other company to see its CBD novel food application successfully validated by the FSA also said it had been working on it for some time. 4MP Technologies was the UK company behind the application but had been working with Czech firm CBDepot, which was the first firm to successfully get an EU CBD novel food application validated and passed to the European Food Safety Authority (EFSA) for further assessment.

4MP and CBDepot said they filed their UK novel food CBD applications in early January 2021. These covered two brands – CBDex and 4MP – and also covered primary isolated CBD and secondary CBD-containing products such as chewable tablets and CBD in carrier oils.

“CBDepot’s battery of proprietary Tier 1 and Tier 2 studies on Genotoxicity, Sub-chronic Toxicity and Toxicokinetics of Cannabidiol, already presented to the UK and EU authorities, give us solid grounds for the future of our UK and EU operations,” said Boris Baňas, founder of CBDepot.

CBDDepot’s European and UK application are both also for a synthetic CBD ingredient – likely helping with its passage through validation. However the inclusion of secondary edible products – and not just pure CBD isolate in an ingestible form – marks another milestone in the ongoing saga of CBD as a novel food ingredient in the UK.

“This is an outstanding joint achievement by CBDepot’s and 4MP’s regulatory, scientific and product development teams,” said Scott Cooper, product and business development director of 4MP Technologies.

 Freddie Dawson CBD-Intel staff

Photo: Roman Wisdom Naturopathy

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