The UK has recently become the first country to regulate orally consumed CBD products. Currently, CBD has been touted as a novel food group item or supplementary, but the new move to regulate CBD hopes to “de-risk” CBD (Cannabidiol) to spur innovation. With a clear set of guidelines for orally consumed CBD products, there is a growing likelihood of improvement in the sort of products offered.
In response to this move, the FSA (Food Standards Agency) and the ACI (Association for the Cannabinoid Industry) has created a list featuring CBD products. These products have been given the green light to remain on shelves in line with the UK’s new novel foods regulations. Products that do not appear on the list can no longer be sold.
Ensuring these guidelines are met by CBD products not only helps to ensure the quality and safety of products in England and Wales, but also for investors looking to take part in the CBD industry. Trading Standards will also be enforcing the new rules with immediate effect on retailers selling CBD products.
Regulating orally consumed CBD products
From February 13th, 2020, no new CBD extracts, isolates or associated final products using the novel ingredient CBD, are allowed to be sold until they receive the necessary authorisation. Products that were available beforehand were required to send an application for assessment by the FSA. The complete process of evaluation can take around a year to complete. One month is allowed for the validation process, then up to nine months for the risk assessment, and up to seven months for any subsequent risk management and authorisation decisions.
Most applicants will be manufacturers of CBD brands including us here at Xyfil. A detailed dossier must be provided for existing and new orally consumed CBD products.
There are three parts involved. Firstly, part one should contain all administrative data such as information relating to the applicant. Part two should contain information specific to the novel food (along with a list of references) such as:
- identity of the novel food
- production process
- compositional data
- the history of use of the novel food and/or its source
- proposed uses and use level and anticipated intake
- absorption, distribution, metabolism and excretion
- nutritional information
- toxicological information and allergenicity
Part three should include the glossary or abbreviations of terms quoted in the dossier, certifications (on the accreditation of laboratories, certificates of analyses), full copies/reprints of all pertinent scientific data (published and unpublished), full study reports and scientific opinion of national/international regulatory bodies.
Ensuring the quality of the dossier, and the information provided significantly affects the time needed for assessment and authorisation.
Xyfil makes the process simpler for you
Brands can apply for authorisation of CBD extracts and isolates via our compliance and White Label service. We will guide you through the process and secure your products ready for sale. Here at Xyfil, we have worked on countless successful applications for CBD-based products. Our market-ready approach means less paperwork and less hassle in getting your business off the ground.
By working with us you can benefit from our purpose-built analytical laboratory, including patent-pending equipment for generating accurate emissions samples. Work with our dedicated scientists and let us handle your brand compliance from end to end. Get in touch today to get started on your CBD brand.