21 Sep, 2020

 

Critical novel foods update: FSA Confirms that Valid CBD Novel Foods Applications Must Include Toxicology Safety Study Data

Updated 25 September

With just 6 months remaining, for CBD companies to have a valid novel foods application for each of their products, the ACI has received confirmation from the FSA that these dossiers must include toxicology safety study data and literature-based information is not sufficient. This is to address concerns expressed by the Committee on Toxicology.

This means:

  • Novel foods applications will not be validated without the inclusion of toxicology safety data*.
  • This data does not exist and must be generated. Relying on data in the public domain is not sufficient.
  • The cost of generating this data will be hundreds of thousands of pounds. Depending on the complexity of the finished product could cost between £300k to £1M.
  • ACI Safety Study Consortium will generate this data allowing companies to share the costs.

*FSA clarified this further in their guidance issued on 24 September.

The ACI hosted a panel discussion outlining the implications of this recent confirmation. 

This is essential viewing for any CBD company wanting to sell CBD as a food in the UK post 31 March 2021.

Join us for a free Safety Study Webinar 4pm Friday 25 September – register and submit your questions here.

Related content : ACI Safety Study Consortium FAQ