In the aftermath of the FSA’s announcement relating to CBD regulation and precautionary health advice, the ACI’s Regulatory Lead, Dr Parveen Bhatarah, has compiled the following answers to some of the common questions being posed to the ACI.
Please note: We are also in the process of compiling a more indepth FAQ which we will publish early next week.
Gather appropriate safety data, with suitable standardised testing methods, and submit a Novel Food application as soon as possible. The ACI can support you with this.
Novel Foods applications need to be made by raw material suppliers (the CBD ingredient, for example isolate or distillate). Any end user of this raw material (such as a brand) also needs to show their product stability when using this raw material in their finished product. Brands don’t necessarily need to make a full Novel Foods application (although they can if they see the commercial value in doing so) but must they ensure that their raw materials are sourced from raw material manufacturers who have submitted applications. The ACI will assist brands to decide what is the most economical approach to be fully compliant.
These rules outlined by the FSA apply to all products being sold as foods. Every category needs to show stability data so that there is no degradation of key raw materials.
As a part of a raw material supplier’s Novel Foods application your extraction techniques need to be detailed. It is about safety, to show you have full understanding of the process, you understand the stability of the product and there is full traceability of supply chain so consumers are never misinformed.
Responsible suppliers of CBD industry should have all the process and stability data already. If they do not have this then they can generate six month accelerated stability data. They can send it for initial genotoxicity studies which takes about eight weeks.
The longest time required is to generate a safety study for dose evaluation and the amount of bilirubin produced during these trials. This will require a 90 day study and could take up to 8-9 months. These can happen concurrently. However, we are re-confirming this with our safety labs.
Also, companies can submit a Novel Foods application while safety studies are still going in parallel. This means by the time your application is reviewed safety data will already be in place.
It is likely to standardise the testing methods and initiate safe dose evaluation. This is the best outcome for consumers as well as the suppliers, as the responsible suppliers are already working on this.
More information on this topic will be shared by the ACI at the upcoming CBD Summit event 16-17 March 2020. On this date the ACI will officially release our kitemark audit process for companies within the CBD industry.
Should you have any more questions please do not hesitate to contact the ACI. One of our experts will be in touch. We will also be publishing a more in depth FAQ on our website early next week.