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From Hundreds Of CBD Suppliers To A Dozen – Potential Impact Of UK Regulator’s Novel Food Move

cbd novel food
Written by Peter McCusker

There are thousands of CBD brands in the U.K. and Europe, and tens of thousands of products.

These brands and their white-label wholesalers are served by hundreds of global suppliers varying in size from small family farms to large corporate outfits delivering in bulk. However, this market is set for a major shake-up as a result of the U.K.’s decision to enforce the European Union’s classification of CBD as a Novel Food.

Come March 31, 2021, the number of companies able to meet the high U.K. regulatory bar required by Novel Food is estimated to be in the region of around ten to a dozen.

For more articles about Europe, Novel Food and CBD Regulations, subscribe to the CBD Business Weekly Newsletter.

300-Page Novel Food Submission

One such company is set to be Colorado-Based Mile High Labs which currently supplies U.S.-grown CBD from its base in Northern Ireland – a European bridgehead it established 2019.

It supplies a range of isolates and distillates to a wide range of European wholesalers and brands. Over the last nine months its pharmaceutically-focused, regulatory team have assembled its Novel Food submission, not an easy task; its application currently totals over 300 pages of data and analysis.

London-based Christian Hendriksen, Vice President of International Expansion for Mile High Labs, sees the Novel Food pathway for CBD as a crucial step in delivering safe and compliant product.

CBD Isolate Only

Mile High Labs’ application will provide the data to prove its product is safe and stable when formulated into food products. At this stage Mile High is solely submitting a Novel Food application for its CBD isolate.

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Mr Hendriksen elaborated: “It’s not a trivial task. It takes time to generate the relevant data and also to assemble it into the actual form that is required. The application process means you have to characterise your products in very great detail.

“Our isolate is more than 98% pure, but with distillate or broad spectrum extracts you will have to account for every individual compound, all of the other cannabinoids and terpenes, and assemble the associated data to demonstrate their safety.

Inherent Variability Of Extracts

“With extracts, there will be inherent variability from batch to batch, as CBD levels vary, but to secure a Novel Food authorisation it is necessary to demonstrate a high-degree of manufacturing consistency.

“Isolates are products which are easier to characterise, so in the short term this is where the focus will be – until people have more time to generate data for their broad-spectrum product. There is a chance that isolate will dominate the CBD food segment in the short term until companies, including ourselves, have had time to generate data.”

Mile High expects to submit its Novel Food application later this year and this will also include recommendations on a suggested daily dose. The recent recommendation from the U.K. Food Standards Agency (FSA) is 70mg a day.

Many estimate the cost of securing a Novel Food application as being in the region of £250,000 to £300,000. This, and the onerous quantity of analysis and data required will squeeze many existing suppliers out of the market.

Just A Dozen Suppliers – Initially

Mr Hendriksen believes there will be no more than a dozen validated U.K. CBD suppliers come next spring.

cbd novel food

“Many will simply not have capacity and resources to get through the Novel Food process and the FSA is effectively saying ‘you have to do it or you are out’. From a small business perspective it is not a good thing, it makes it extremely tough to compete.” 

While acknowledging the challenges this throws up for the industry Mr Hendriksen is 100% with the FSA. 

“Novel Food is designed to protect consumers, and you should only be should selling a new ingredient in Europe if you can demonstrate it is safe. This is what other food manufacturers have to do, they are used to it, so why should CBD be any different?”

The Fight Will Go On

A Novel Food, in the eye of the European and U.K. regulators, is a food that has not been eaten to any significant degree in domestic markets before May 15, 1997.

Mile High’s view is that, although humans have consumed hemp for much longer, hemp-derived CBD is a relatively new product.

This view is shared by the recently-created trade group the Association for Cannabinoid Industry (ACI), which has been spun-out of leading industry body the Centre For Medicinal Cannabis.

It is working with it members such as Mile High, Dragonfly Biosciences, Sativa Investments and others to achieve Novel Food benchmarks. It has issued guidance on how to secure this which can be found here: https://www.theaci.co.uk/regulations/

ACI Regulatory Expert Dr Parveen Bhatarah Gather said there is still time for raw material suppliers to gather all of the necessary data and complete an application between now and the end of March, next year.

For CBD brands, they will need to demonstrate their raw materials are sourced from manufacturers with submitted applications, and if necessary, demonstrate ‘product stability when using this raw material in their finished product’. 

Brand Support

Thierry Way is director and brand manager at U.K firm Ultra Sports Europe. He is fully supportive of the Novel Food pathway as a means of delivering a regulated U.K. market 

European Novel Food Regulation – What’s It All About?

Ultra Sports sells imported CBD products from publicly-listed U.S. brand cbdMD which sponsors leading sports stars such as golfer Bubba Watson.

He said: “This new regulation is no doubt going to cause some disruption in the industry. However, we really feel this a great step forward to making the industry a safe, more trustworthy place for consumers. We are working with our American partners to submit a Novel Food application by the end of March, next year.”

While the FSA’s move has crystallised the U.K’s CBD position it has by no means secured universal support. Industry bodies such as the Cannabis Trades Association (CTA) and CannaPro, whose members helped create the industry, are still contesting the Novel Food designation.

Heading To The Law Courts?

They maintain that CBD is not novel – that it has been used in European foods for hundreds of years. There are many in the industry who will recoil at the thought of the market becoming solely one of isolates, with many users said to favour the entourage effect of broad and whole spectrum products.

There is still plenty of fight left in these bodies and they will continue to take it to the regulators and maybe even the courts.

While also maintaining its position that CBD in whole plant extracts is not a Novel Food, the European Industrial Hemp Association acknowledges that isolates are novel, and it’s taking forward a joint Novel Food application on behalf of its members for isolate.

The growth of the U.K CBD market over the last few years has been phenomenal and on the whole it has been driven by the hundreds of members of the CTA and CannaPro.

Uncertainty For Smaller Suppliers

Both of these have established their own self-regulatory bodies which have clamped down hard on those making medical claims, which the rules do not allow.

However, the FSA has now decided its time to take a firmer grip on the market following new guidance on potential health risks and concerns over CBD product content.

The U.K. CBD market is already worth over £300 million and is estimated to treble in size within the next few years. While these new regulations may destabilise the market initially, it looks like the FSA’s Novel Food pathway will mean its next phase of U.K. CBD market growth could be controlled by a dozen-or-so larger CBD suppliers.

@The FSA’s stance on Novel Foods applies only to food additives, not vaping products or cosmetics which are governed by separate regulations.

For more articles about Europe, Novel Food and CBD Regulations, subscribe to the CBD Business Weekly Newsletter.

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About the author

Peter McCusker

Peter McCusker is an experienced news and business editor, who believes it’s time to fully embrace the multiple, proven, medical benefits of the cannabis plant.

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