UK clarifies post-Brexit novel foods applications criteria for CBD industry
04 Nov 2020 --- The UK’s Food Standards Authority (FSA) has put the CBD industry at ease after clarifying criteria for safety certifications in novel foods. CBD manufacturers in the UK will need to submit applications before March 31, 2021.
Applications detailing toxicity reports will need to be made to the Advisory Council for Novel Foods and Processes (ACNFP), an advisory body to the FSA.
Toxicology reports can be chosen at a manufacturer’s discretion but must be submitted with justifications on why they opted for a particular test.
The clarification of standards and procedures lends a further advantage to the UK CBD industry as EU policy remains restrictive.
Confusion surrounding applications
Previously, frustration was mounting over the FSA’s unclear stance on CBD. Producers were unsure whether toxicity reports would need to be defined and submitted by each company or if there would be a standardized testing procedure.
The Committee on Toxicology (COT) advised the ACNFP on how this could be done with CBD.
The COT noted that the primary source of data on toxicology for CBD was produced by studies used to support the authorization of a particular CBD-based epilepsy remedy named Epidiolex.
However, this data was branded insufficient for generalization to food products. “The committee noted that medical trials are not designed to support food products’ safety since exposure patterns, co-consumption, purity of the CBD and recorded outcomes differ.”
Concerns were raised over whether CBD could interact with other drugs or if it could cause consumers drowsiness. Both possibilities could have dangerous consequences.
“Therefore, results from these studies may only be useful in supporting novel food applications for CBD in certain circumstances,” reads the ACNFP’s meeting minutes.
“The ACNFP noted that there are still gaps in the toxicological data regarding systemic toxicity and human bioavailability,” it continues.
Due to the insufficiency of publicly available data and the fact that existing data is derived from studies supporting a single medicinal product, individual toxicity reports will need to be produced, the COT concludes.
The UK CBD industry has received long awaited clarity on application criteria for novel foods.Collective applications
To lessen the load on individual companies and share the burden of costs associated with conducting toxicity studies, industry body Association for Cannabinoid Industry (ACI) has launched a safety study consortium.
The consortium will conduct studies on products for FCA approval on behalf of the entire industry.
The ACNFP approves this approach, saying, “a shared package of toxicology studies would be acceptable in circumstances that could be scientifically justified.”
The ACI says it is confident the consortium can fulfill this requirement. “We have built internal scientific, toxicology and regulatory expertise, from the pharmaceutical and food industry, and are working with established external partners to ensure that the highest science and regulatory standards are applied.”
UK capitalizes on EU confusion
With Brexit looming over industry bodies, the FCA’s clarification of CBD regulations presents a national advantage for cannabidiol manufacturers.
This year, the European Commission (EC) announced it would be freezing all applications of hemp extracts and natural cannabinoids under novel food regulation, considering them to be drugs.
While EU companies are allowed to continue selling their products, for the time being, proper regulation on the matter will not be set in stone until the UN votes.
This presents a significant opportunity for UK businesses trading in the hemp sector, a representative of the Cannabis Trades Association previously told NutritionInsight.
By Louis Gore-Langton
