By Roland Sebestyén
Whereas the UK CBD market has grown into a £300 million business, there are still some crucial questions regarding its safety and benefits. Furthermore, confusing regulation often prevents patients from enjoying the positive impacts that CBD may have to offer. To further address this issue, a group of organisations has now launched an initiative to lead the way in research.
In February 2020, the UK Food Standards Agency set out a new deadline for the industry to apply for European Union safety evaluations as a “novel food” and also provided consumption guidelines to consumers.
Over the past year, the Government Committee on Toxicity (COT) has been undertaking an ongoing review of CBD safety, highlighting the need for new toxicology data.
Today, the Association for the Cannabinoid Industry (ACI), in partnership with Advanced Development and Safety Laboratory (ADSL), is announcing a landmark study with a consortium of CBD companies to build a sustainable, safe, and fully compliant industry in the UK.
Dr. Parveen Bhatarah, Head of Regulation and Compliance, ACI, said: “To have a sustainable CBD industry in the UK, we need to generate new toxicology data as per EFSA’s guidance and in line with the Government’s Committee on Toxicity requirements.
“This study, which includes a rodent study according to OECD 408 parameters, will meet these demands support novel foods applicant needs in a cost-efficient way that also minimises animal testing.”
Mark Bowes-Cavanagh, Managing Director, ADSL, added: “ADSL will be supporting the ACI with all its technical services, including regulatory compliance, analytical studies, cannabinoid stability and collation of the risk dossier to meet the Food Standards Agency (FSA) guidelines on the Novel Food Application (NFA).
“The establishment of the consortium to meet the safety requirements, economical and ethical criteria is a significant step forward in cooperative development of ‘new’ consumer products.”
This study will address the existing gaps in data identified by COT (including whether CBD causes potential drowsiness, liver toxicity, or has any interaction with other drug substances) and generate analytics accordingly. It will also provide the safety information mandated by the novel foods application process.
It is reported that any company that does not have such original derived data will not have their novel foods dossier validated by the FSA. Only products with this validation will be allowed on the market after 31st March 2021.
ACI, an industry body committed to nurturing a safe, legal and well-regulated CBD market in the UK, claimed that by bringing together this group of companies, “we are leading the way not just for the industry in the UK but across the world.”
They said no other country had provided a clear regulatory framework for compliance that exists in the UK. Moreover, they announced that the safety information generated in this study would respond to future demands of regulatory authorities in the US and EU.