A British trade group says it has formed a consortium that may spend up to £1million (€1 million; $1.27 million) to carry out trials aimed at demonstrating the safety of CBD. The Association for the Cannabinoid Industry (ACI) said the research intends to answer questions posed by the UK’s Food Standards Agency (FSA).
FSA has expressed concerns about CBD including its potential to induce drowsiness, liver toxicity and negative interactions with other drugs. The trials, to be carried out on rodents, will look at broad spectrum CBD, according to ACI. FSA issued further clarification on the importance of generating new toxicology data for CBD this week.
The ACI effort is a response, at least in part, to FSA having set a March 31, 2021 deadline for extract makers to apply for European Union safety evaluations under Novel Food guidelines, rules created as a food safety mechanism to control new, genetically or synthetically produced food products before market entry. While the UK is poised to leave the European Union, authorities there apparently intend to follow the model being set under EU Novel Food rules so their products have access to EU markets.
‘Largest trial ever’
Under the guidelines, Novel Foods are defined as those that were not consumed to a significant degree in the EU before May 15, 1997. If a food is considered novel it must undergo a pre-market safety assessment under the hurting European Food Safety Authority (EFSA) before it can be legally marketed in the EU.
Fifteen of a total 25 members ACI claims to represent are reported to be members of the consortium. The group, which formed earlier this year, called the effort “Europe’s largest ever trial designed to establish the safety of CBD products.”
Safety questions unanswered
UK-based Advanced Development and Safety Laboratories (ADSL), which ACI said would coordinate the trials, said discussions with the FSA include a proposed variance of 5% in cannabinoid profile that would be allowed from the base ingredient chosen for the tests.
“There still remain some fundamental unanswered questions regarding its safety for human consumption,” ACI noted in a press relase.
“This study will help fill the missing gaps in the key toxicology data,” said Steve Moore, an ACI representative. “It’s been clear since CBD has been designated a Novel Food last year that there is a need for more safety data and this must come from this emerging industry.”
“No other country has provided the clear regulatory framework for compliance that exists in the UK. The safety information generated in this study will respond to future demands of regulatory authorities in the U.S. and EU,” Moore said.
15 consortium members
The ACI consortium includes primarily UK firms but also some North American companies, including: B3 Labs, Britannia Bud, CBD Capital, Echo Pharmaceuticals, Herbotany Health, iX Syrnix, Jersey Hemp, MGS Pure Extracts, Natuera, Naturecan, Sativa Group, The House of Green, Vana Labs, Columbia Care and Gencanna.
The European Industrial Hemp Association (EIHA) also formed a consortium earlier this year that will carry out toxicology and other studies as part of its efforts to get approval for CBD products under Europe’s Novel Food rules. EIHA, which said it has already filed a Novel Food application for a CBD isolate on behalf of members participating in its consortium, estimated it may spend as much as €3.5 million in that effort.
That effort could become moot if the European Commission proceeds with its intentions to declare CBD a narcotic across the EU, as proposed in a surprising “preliminary conclusion” issued last month. That decision, if finalized, would not necessarily affect the situation regarding CBD and other extracts in the UK market itself under a Brexit scenario, but UK companies would need to meet EU standards to sell their products in European Union member states.