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UK CBD industry body becalmed after novel foods applications clarification

CBD manufacturers will have to submit a Novel Food application to be legally sold in the UK market after Brexit. The FSA has set a deadline for submissions of 31 March 2021. 

Toxicology studies will be required

However, industry body the Association for the Cannabinoid Industry (ACI) had complained there was a lack of clarity from the FSA on the issue of whether companies would need to carry out their own toxicity studies or rely on the results from publicly available studies to support their applications.

The Advisory Council for Novel Foods and Processes (ACNFP), an advisory committee to the FSA, has since said that relying on publicly available data will not be sufficient for a novel foods dossier to be authorised.

The most recent ACNFP meeting minutes noted “there are still gaps in the toxicological data package around systemic toxicity and human bioavailability.”

According to the FSA, applicants will therefore need to include details of the toxicological studies they have undertaken or propose to undertake with clear details of the reasoning for these particular tests.

Finished products are required to have their own dossiers

Further confusion had related to whether all finished products need to be included in the primary ingredient manufacturer’s application.

In response, the ACI noted it had been contacted by dozens of brands asking for clarity on what the responsibility of a brand is in regard to their products. It said it was now clear from the ACNFP minutes “that individual finished products will potentially require further bioavailability studies to prove their safety and will be required to be included in a novel foods dossier.”

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