The ACI have received clarification from the FSA on several points concerning novel foods dossier applications that have been raised by our members.
Please see below these questions and FSA responses.
ACI Question: The FSA will not require a novel food submission for each individual finished food product, is this correct? Obviously, the finished product manufacturer is making their product, as per the novel foods dossier submitted by the CBD ingredient supplier.
FSA Response: All finished products need to be covered by a validated novel food application.
However, several products may fall within the scope of a single application. What’s needed is that the finished product is made with the applied for substance (e.g. a CBD extract made by x manufacturer), and that the end use / presentation of the finished products is within the ‘uses’ identified by the application (e.g. as a 5% CBD extract in oil).
It is also worth commenting that bioavailability in different foodstuffs may help support their application. All data/studies etc. need to relate to your specific product or one that is produced in exactly the same way with the same specification ranges, same raw ingredients from the same place etc.
ACI Question: Assuming the above is correct, the FSA does not require a novel food submission for each individual food product, are the following approaches acceptable?
ACI Question: Should the food product manufacturers compile any further information with regards to the individual formulations & submit separate novel foods application or addendum to novel foods application of their CBD ingredient supplier? For example, all the dossier info should come from the key CBD supplier and brands need to risk assess if their finish product formulation is different from the CBD supplier, generate stability data, physico-chemical information, biochemical, microbial, ADME (absorption, distribution, metabolism and excretion), bio availability, toxicology and safety info on the other formulation ingredients, target population and proposed dose.
FSA Response: The applicant must provide the information as per the EFSA guidance and the legislative requirements. This will include much more than the specific examples you give above and I would suggest to refer to the guidance, etc. for further information. As highlighted above you should ensure you consider bioavailability in the different foods, etc.