In January 2019 the UK Food Standards Agency (FSA) classified CBD is a novel food, which categorises food that wasn’t widely consumed in the EU or UK before 1997. Although the UK is no longer an EU member, companies selling CBD to a UK market must still apply.
CBD companies must get their products approved by the European Food Safety Authority (EFSA) by 31 March 2021 in order to sell their products legally.
The Association for the Cannabinoid Industry (ACI) will lead research that will build the evidence base for companies applying for novel food approval.
This comes amid mounting calls from regulators and food safety agencies for more research on the safety of CBD, including whether CBD use increases the risk of liver toxicity and drowsiness, and if it interacts with other drugs.
In response, numerous collaborative efforts have formed to help companies apply for novel food status. They can help companies share the costs of building their evidence base, while limiting the number of animal studies needed to test their products.
Companies in the ACI will be sorted into one of four consortiums. The first will focus on CBD isolate, followed by narrow spectrum, broad spectrum and full spectrum. The ACI says the data generated from each group will be relevant for all of the group’s members. It aims to submit evidence for CBD isolate to regulators by the end of 2020.
Research will look at different modes of delivery and bioavailability, including ingestion, absorption and inhalation, and whether CBD is safe for vulnerable groups including example children and adolescents, and while pregnant or breastfeeding.
Companies will share at least five commercial batches with the ACI, as well as a sample and all their compositional data, which will be signed off by a toxicologist.The ACI will work with Advanced Development & Safety Laboratories, who will help to ensure protocol will meet EFSA requirements.
“It’s crunch time for the CBD industry,” says Parveen Bhatarah, regulatory and compliance unit lead at the ACI.
“The timeline is very ambitious,” she says, and figuring out how it works will be “a big challenge.”
Bhatarah says the bioavailability of CBD products, in particular, needs to be addressed.
Steve Moore, founder and strategic counsel at The ACI, says: “As the industry has struggled to get to grips with the data requirements for a successful novel food submission, our toxicological proposal provides the most comprehensive and cost-effective solution for CBD businesses.”
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