The company that makes 13% of all CBD food supplements permitted to sell in the UK, are now one step closer to validation and full authorisation.
BRITISH CANNABIS™ has received news that novel foods applications RP126 and RP127 have been validated by the Food Standard’s Agency (FSA).
Formal notification from the FSA was received this week that the applications by the Association for The Cannabinoid Industry (ACI) for the authorisation of CBD isolate and distillate ‘fall within the scope of the novel foods’ as set out in Regulation (EU) 2015/2283. These primary CBD ingredients thus fulfil the requirements set out in Article 10(2) of that Regulation.
The ACI’s applications are now regarded as valid and will move on to a risk assessment stage for further assessment. This allows BRITISH CANNABIS‘ own proprietary product applications to move onto the next stage of authorisation.
The BRITISH CANNABIS™ in-house Science and Regulatory department has confirmed expectation that their own finished product toxicology studies will now be updated in the very near future, leading to completion of 15 submitted application dossiers. As a consequence, over 1,200 products in the BRITISH CANNABIS™ portfolio are set to move through validation and on towards full authorisation, via their own risk assessment.
BRITISH CANNABIS’ primary applications (15 out of 74), make up 20% of all novel food applications in the UK, which total an estimated 320 brands).
In 2022, BRITISH CANNABIS™, as part of an ACI consortium, was included in a toxicological study and the related toxicology and bioavailability data was submitted to the FSA to support their applications.
This included a dose range finding study and the OECD408 rodent toxicity study to determine a No Observable Adverse Effect Level (NOAEL), to cover the safety implications of not only CBD, but also the minor cannabinoids and other plant matrices present in these plant-derived products.
Two years on from the novel food application deadline, this week’s FSA update comes around a year after the food safety body published its first public list of ingestible CBD products deemed temporarily compliant, pending the submission of toxicology data, its risk assessment and acceptance to progress to validation.
BRITISH CANNABIS™ CEO, Tom Whettem, celebrated:
“This is yet a further milestone for BRITISH CANNABIS™ and we look forward to the next stage of the specific product validations in the coming months. Further securing our regulatory position should be encouraging to our customers and consumers who rely on having safe, accurate CBD supplements for the long term”.
This resulting 13% share of CBD food supplements (1,200+) currently permitted to remain on the UK market by choice of products includes 75 of the company’s own-brand portfolio, from the CBD by BRITISH CANNABIS™ (FKA Canabidol™), ACCESS CBD® and CBD HEALTH™ ranges, as well as CBD food supplements manufactured under license to Elixinol Wellness. Also validated are hundreds of individual products across several leading brands ‘Powered by BRITISH CANNABIS™’ under the company’s white label manufacturing services.