Sativa Group Plc [AQSE:SATI], the UK’s leading quoted CBD wellness and medicinal cannabis Group, has confirmed it is working on its Novel Food application in partnership with Stillcanna Inc, and is committed to meeting the requirements of the Food Standards Agency concerning the safe use of CBD products and the timetable for Novel Food authorisation.
CBD extract and isolate products were confirmed as novel food products in January 2019. Under the novel food regulations, foods or food ingredients which do not have a history of consumption before May 1997 should be evaluated and authorised before they can be placed on the market.
The FSA is giving the CBD industry a deadline of the 31st March 2021 to submit valid novel food authorisation applications. After 31st March next year, only products which have submitted a valid application will be allowed to remain on the market. The authorisation process ensures novel foods meet legal standards, including on safety and content.
With the novel food’s authorisation, it will mean that there is a two-step process in applications. Step one, the manufacturers of the CBD ingredient, (extract or isolate) of which genotoxicity and toxicology testing are part of that process, and step two, the manufacturer of the end consumer product who will need to conduct stability testing and apply for novel foods authorisation.
Once a CBD product is authorised that authorisation applies to that product only. This means using the same detailed production methods, for the exact same uses as described within the authorisation and using the same safety evidence base. Where a business buys CBD product from others, they must ensure these products are correctly authorised, and that they only use them in ways described in the authorisation. The Sativa Group PLC will continue to support white label customers with novel food regulatory approved products.
The proposed combination of the Sativa Group PLC and StillCanna Inc will allow the merged company to offer a consistent seed to consumer supply from one single company. They manufacture both the CBD ingredient as well as manufacturing the end consumer product delivered to shelves. On that basis, Sativa Group PLC and StillCanna will be submitting a joint application for all combined products to provide a wide range within their portfolio of brands including Goodbody Botanicals and Goodbody Wellness for novel foods approval.
Henry Lees-Buckley, Chief Executive Office of Sativa, said: “We welcome and embrace the clarity of the regulatory framework as an important step to leading the development of a safe and legal market in the UK. We are taking seriously the guidance from the FSA to reassure our customers and distribution partners that Sativa and StillCanna are at the forefront of building a sustainable CBD wellness industry. We have invested in our infrastructure to ensure that we are fully compliant with industry regulation for each step of the manufacturing process of our CBD products. By owing each step of that process we can ensure that compliance is maintained throughout”
Sativa Group PLC is committed to manufacturing and selling the highest quality CBD wellness products in the market. The Group have already begun the process of gaining the approvals. Sativa have hired consultancy support with GRS (Global Regulatory Services) and are in the process of delivering the required product testing. Additionally, to ensure compliance with the necessary regulations the group is working with regulators via trade bodies such as the Association for the Cannabinoid Industry (ACI).