Novel Food Deadline Looms
The CBD industry is about to experience the biggest legal shakeup since the first products entered the UK back in 2017. Monumental changes in the UK & European law will support regulation demand from the Food Standards Agency (FSA) and the European Food Standards Agency (EFSA) to finalise applications for Novel Foods, which is a vigorous process ensuring any manufacturing, distribution, or retailing of CBD complies with all FSA, MHRA and Trading Standard requirements by March 31st, 2021.
The Purity Wellness Group have been advocating regulatory change since 2016 and applied significant time, effort, and investment to reach this point. We are now incredibly proud to announce that we have submitted our Novel Food Licence application, allowing us to continue to deliver pharmaceutical-grade CBD Oil, Beverages, Edible and Topical product collections across the UK and European markets.
“I am very pleased to inform you that our Novel Food Application has been submitted and accepted.”
Application Validation Reference Number #48**
Dr. Vanesa Fernandez Chief Scientific Officer – Director FBS Biosciences Europe BV
“CBD products to enter the UK market will soon require a Novel Foods application submitted and validated by the FSA (Food Safety Authority) including a cover letter, a dossier, and a summary of the dossier.”
WHAT ARE NOVEL FOODS?
“Novel foods” are defined as foods that have limited consumption history in the UK and EU prior to May 1997.
These foods do not have an established safety profile.
- The UK and EU regulatory bodies, FSA and EFSA, respectively, recognize that any food considered to be a novel food should be evaluated on toxicological, chemical, microbiological and stability parameters, prior to market approval and sale to the general public.
- 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.
UK NOVEL FOODS REQUIREMENTS
CBD products to enter the UK market will soon require a Novel Foods application submitted and validated by the FSA (Food Safety Authority) including a cover letter, a dossier, and a summary of the dossier.
Beginning April 1, 2021, regulatory authorities will initiate enforcement action: CBD products without a validated application will be removed from retail shelves and non-compliant distributors can be issued fines.
New products cannot enter the market until the application is authorized by the FSA.
” By submitting our application Purity Hemp Company remains the Gold Standard, as recognised by the Banned Substance Control Group (BSCG). “
UK & EU NOVEL FOODS APPLICATION REQUIREMENTS
The application must include administrative, scientific and safety data that demonstrably outlines the toxicological, microbiological and chemical parameters of the food and packaging materials.
Like the FDA’s GRAS requirements, the toxicological requirements include the core areas of:
- Kinetics – to understand the metabolism and bioavailability of CBD and CBD products.
- Genotoxicity – to validate that CBD does not cause harmful DNA damage.
- 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 does not cause unwanted developmental changes.
Purity Hemp Company joined FBS Bio-Science Novel Foods Consortium – total cost £1.3M
This membership allows continuity in the supply chain for CBD ingredients through a sharing of costs and data that meet the requirements of the FSA (or EFSA, respectively, on each slide) which ensures that Purity Hemp Company and its partner brands will continue commercially after the established deadlines.
” There were many cowboys in the industry selling CBD products which were false advertising the amount of CBD in the products, which of course, is not good for business. “
A statement from CBD Industry Experts ACI, Alpha Green & the MHRA
Enforcement for Novel Food compliance – what can we expect?
There were many cowboys in the industry selling CBD products which were false advertising the amount of CBD in the products, which of course, is not good for business. The idea of the Novel Food regime was to push these cowboys out of the sector, and this can only be done with enforcement.
New product restrictions Novel Food compliance will be devolved to local authority Trading Standards and environmental health but there is also a national organisation called the National Trading Association. These organisations revolve around consumer protection and safety, which as explained, has been a problem for the CBD industry in recent times.
From the 1st of April 2021, here is how they are planning to enforce brands and manufacturers who are not Novel Food compliant:
- Retailers can be forced to remove non-compliant products from the shelves.
- E-Commerce platforms can be forced to remove products from sale.
- Stocks can be seized from warehouses if non-compliant.
The future for Novel Food
Many of us did not want to see Novel Food regulations come in as it essentially brings another barrier to trade. At first glance, this regulation seems unnecessary considering long-term use of cannabinoids has been safe so far and that we have seen how CBD products positively affect a user’s health and well-being. But while this is a major inconvenience to the industry, we do believe that things will become much easier eventually.
Once the Novel Food application deadline has passed and consumers see products being removed from retailers there will be a broader understanding of the safety to use CBD products and the role the Government plays in ensuring only quality products are sold to the public.