The Association for the Cannabinoid Industry (ACI) is the UK’s membership organization for businesses committed to nurturing a safe, legal and flourishing commercial cannabis extract market. “Novel foods” are defined as foods that have limited consumption history in the UK prior to May 1997. These foods do not have an established safety profile and therefore must be evaluated on toxicological, chemical, microbiological and stability parameters, prior to market approval and sale to the general public.
GenCanna Has Submitted Several Applications for Consideration
For a company to sell a novel food, a dossier and application (collectively “Application”) must be submitted to FSA and EFSA for validation and under certain instances, authorized by the regulatory body before the novel food can be offered for sale to the general public. ACI’s application included administrative, scientific and safety data that demonstrably outlines the toxicological, microbiological and chemical parameters of the food and packaging materials.
Core Areas of Toxicological Requirements for CBD Products
Like the FDA’s Generally Accepted As Safe (“GRAS”) requirements, toxicological requirements include the core areas of:
- Kinetics – to understand the metabolism and bioavailability of CBD and CBD products
- Genotoxicity – to validate that CBD doesn’t cause harmful DNA changes
- Repeated dose toxicity testing (sub-chronic, chronic toxicity and carcinogenicity) — to confirm safe consumption levels and understand any physiological changes from prolonged use
- Reproductive and developmental toxicity — to ensure consuming CBD doesn’t cause unwanted developmental changes
Leading the CBD Industry in Novel Foods
On February 15, 2021, ACI submitted its novel food application on behalf of its CBD Safety Study Consortium.
“I am delighted to submit these dossiers on behalf of the ACI-ADSL CBD safety consortium and support an industry on the cusp of …a fully legally compliant market,” explains Dr. Parveen Bhatarah, Regulatory and Compliance Associate, ACI, who led this collective effort. “Well done to our consortium members who have delivered on the substantial data requirements that were asked of them. We’re very pleased to lead the way to a sustainable cannabinoid industry.”
Safety Information to Support the Industry Globally
The study also generates the safety information mandated by the FSA’s novel foods application process. …
“The FSA has always had an ethical responsibility to gain evidence to prove that CBD is safe for human consumption. With the submission of the ACI and ADSL CBD consortium safety study ACI is well on the way to providing FSA this evidence,” says Dr Paul Duffy, Toxicology Associate, ACI.
This submission is the culmination of months of work from members like GenCanna.
No other country has provided the clear regulatory framework for compliance that exists in the UK, and data being generated through this process will be useful to meet demands from US and EU regulatory authorities, further supporting the industry globally.