A MEMBER survey of Europe’s largest hemp and CBD trade group shows there is still has some way to travel to ensure market compliance in time for next year’s Novel Food deadline.
The UK-based Cannabis Trades Association (CTA) asked its 400 members to respond to an in-house survey designed to gauge their approach to market compliance for CBD products.
The key takeaways from the 100-or-so replies are as follows:
-Four members have made Novel Food applications with a further 16 thinking about it and 13, at this stage, opting not to proceed.
-Of the base ingredient and product manufacturers, 25% use solely isolates, with the rest using either distillates or whole plant extracts.
-Over four-fifth of members may be able to proceed to Novel Food compliance through an application by their raw ingredient supplier.
Switch To CBD Isolates
Siân Phillips, Managing Director of the CTA, told BusinessCann: “While the feedback was mainly from the new members of the CTA, and was just a portion of our total membership, we are seeing a shift towards CBD isolate.
“However, there are still three-quarters of members using distillate, or whole plant extract, as their base ingredients.
“We have had discussions with the FSA; it’s much easier to secure compliance with an isolate rather than the broad and full spectrum products, and this is the way forward say the regulators.”
The hemp plant, which is the source ingredient of CBD, contains over 100 cannabinoids and hundreds of additional compounds.
This makes producing a consistent CBD products from one batch to another a manufacturing challenge, consequently regulators have indicated the most secure path to compliance is to use an isolate as a base ingredient.
UK regulators the Food Standards Agency (FSA) have asked companies to comply with its Novel Food regulations by March 31, next year, or face enforcement action against their products.
CTA Members Fall Into 5 Categories
To help with compliance the CTA has split its membership into five categories as follows:
-Manufacturers who produce raw ingredients such as isolate, distillate and raw extracts
-Primary producers who buy ingredients to blend or formulate products
-Secondary producers who buy finished product to decant or bottle
-White Label or Own Brand (buy sealed finished product and rebrand)
-Resellers (including wholesalers) of pre-branded products or ingredients.
Following a recent meeting with the FSA the CTA understands the Novel Food applications need to completed by those who fall into either of the first two categories.
Whilst those in categories three to five; those who make no alterations to the base ingredient, can rely on the Novel Food applications of their suppliers.
In relation to those in this first two categories the CTA is awaiting further FSA feedback on a submission which outlines a route to compliance for these.
Animal Testing Deemed Essential
The key sticking point in this regulatory process is the need to undertake in-vivo – rodent – tests to determine the safety profile of CBD products.
However, the industry is wary of starting these until it has secured further guidance from the FSA on exactly what they need to test for.
In February this year the FSA first raised concerns over the safety of CBD when it advised pregnant women, and those breastfeeding or taking any medication not to consume CBD products.
It warned of its potential to damage the liver, as well as possible negative reactions with other drugs, in particular the blood-thinner Warfarin, and recommended no more than 70mg a day (about 28 drops of 5% CBD).
Potential For Black Market in 2021?
Ms Phillips added: “At the moment we are working on this day-to-day as the FSA has yet to determine its final position on CBD safety.
“Our members need to talk to their supply chain and ensure they are doing all they can to secure compliance.”
However, the survey highlights the reluctance of some in the supply chain to comply with the Novel Food pathway.
Ms Phillips added: “Unfortunately I see a huge black market emerging, and Trading Standards seem to lack the resources to police it effectively.”
The survey comes as the UK looks set to become Europe’s CBD powerhouse after doubts recently emerged over its regulatory status on the Continent.