CBD and Novel Foods. Navigating regulation

[Updated 31.03.22]
We are happy to confirm that APOTHEM products have been endorsed and added to the FSA’s published list of CBD products linked to novel food applications. The Novel Foods process is a rigorous one, ensuring the safety of consumable products and this new legislation brings welcome regulation to the CBD industry. It means that consumers can know and trust that what they are using is safe and of quality.
The process is lengthy, as with any new regulation, so it is broken down into phases starting with this list of all products linked to an accepted application. These products will then move through to a validation stage and finally approval. Our team has worked hard to deliver a detailed application and demonstrate that our award-winning products meet the legal requirements to remain on sale in the UK.
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[03.04.2021] APOTHEM’s founder and CEO discusses navigating the changes with CBD supplement regulation and what’s next with the ‘Novel Food Act’ in the UK.
How do you feel about the new ‘Novel Food Act’ coming into place for CBD supplements?
In a word, relieved.
APOTHEM has always championed the need for CBD product regulation in the UK because it was like the Wild West only two years ago with unregulated CBD products flooding the market. Fortunately, since then we’ve seen a number of credible CBD brands launch and grow alongside us which is super positive for the category.
However, it has been challenging at times to understand the detail behind what’s required but with the right advice and working with the right partners we are now in a position where all is clear, and we are happy to say we are compliant.
CBD was classed as a novel food by the European Commission last January. What does this actually mean?
CBD sold as a ‘food supplement’ (i.e. any form of edible CBD based products) in the UK and Europe was classed as a novel food in January 2020 by The European Commission, meaning it has to comply with ‘The Novel Food Act’ which requires an approved application to sell.
Further to this, on the 13th February 2020 the EFSA (European Food Safety Association) announced that timings for this new regulation to come into effect was 31st March 2021. As the UK left the EU following this announcement, the UK’s FSA (Food Standards Association) are now managing the application process and guidelines under which they will be governed separately.
The FSA has introduced a pre-approval stage stating that the first deadline is for all CBD brands to have a novel foods application submitted by the 31st March 2021. This is not the deadline for a fully approved application because the time for this is said to be around 24-36 months and they appreciate the market size for CBD in the UK is huge and growing exponentially.
What is a ‘novel food’?
A ‘novel food’ refers to any food without a history of widely documented consumption before May 1997. These can still be things we are familiar with, for example a food consumed elsewhere in the world like chia seeds or certain probiotic bacteria.
Is APOTHEM covered by a novel food application to sell CBD in the UK?
Our CBD supplier was one of the first to submit their novel foods application to EFSA in April 2020 and a follow up application with FSA (as a result of Brexit) confirming APOTHEM is a customer and covering our entire CBD supplement product range.
Only products on sale in the UK before the 13th February 2020 announcement and covered by a novel foods application are compliant to remain on the market through this process. No new products or brands can be launched until a fully approved application has been granted.
We’re in a good place as APOTHEM’s main collection of CBD supplement product formulations were on sale in the UK before 13th February 2020 – which is a requirement for product compliance while the applications are under review.
How does legislation differ with ‘CBD isolate’, ‘full spectrum’ CBD oil and ‘broad-spectrum’ CBD oil products?
CBD products can be produced in three forms: full-spectrum (contains small amounts of all components of the cannabis plant), broad-spectrum (contains CBD plus other cannabinoids), and CBD isolate (the purest form of CBD and contains no other cannabis plant compounds / cannabinoids).
In the UK, the cannabinoids THC (Tetrahydrocannabinol) and CBN (Cannabinol) are currently classed as controlled substances.
CBD (Cannabidiol) is legal in the UK as long as the CBD products contain 0% THC. All APOTHEM products are produced using the highest quality CBD isolate and are 100% THC free.
What is APOTHEM doing to keep up with regulation?
We took the decision at the end of last year to enter a formal and direct relationship with Trading Standards, who are working with the FSA, to ensure we are fully compliant.
Compliance and transparency have always been at the forefront of everything we do so we welcome and support these changes in an industry that has had little regulation to date.
What does all of this mean to consumers buying CBD oil in the UK?
The main takeaway is that this legislation is a really positive step and consumers now have a signpost to navigate the CBD landscape. It will be easier to identify the good from the bad and to know what to look for. Compliant brands can stand by the quality of their products knowing that they have FSA approval and consumers can trust that they are buying CBD from a reputable company.
Enforcement will be key to the success of the legislation, so we’re looking forward to seeing how that shapes up. That’s why it’s still important that consumers buy CBD directly from a credible brand or retailer.
Compliant brands won't come with a visible certification like the food assurance stamps you see on some products such as "Fair-trade" or "Non-GMO Verified". If consumers are looking for some assurance they can always reach out to the company and ask them to verify their novel foods status and / or request to see the brand’s independently tested analytics for all CBD products (batch by batch) detailing the full cannabinoid profile and confirming purity and strength of the product.
What should retailers look for when taking on CBD brands after March 31st?
Retailers can follow the same process as Trading Standards who will be enforcing the regulation after 31 March 2021 by asking CBD brands to confirm that each product formulation was on the market before 13 February 2020 and that they have a valid application in place either directly or with their CBD supplier.
Read more about what APOTHEM's co-founder and CEO, Amelia, has to say about CBD and novel foods in her interview with Cannabis Health Magazine.