The updates, which now sets 31 March 2021 as the date for finished products to be covered by a validated Novel Foods application, is among changes that have caused uncertainty for ACI’s members.
While the FSA confirmed that all finished products need to be covered by a Novel Foods application, several products could fall within the scope of a single application.
Responding to the query, the Agency says, “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).
The FSA adds that bioavailability in different foodstuffs may help support a firm’s application with all data/studies etc. needing to relate to a specific product or one produced in the same way with the same specification ranges, same raw ingredients from the same place etc.
Clarification came on the 13 February 2020, when the FSA confirmed that after 31 March 2021 only CBD products with a validated Novel Foods dossier would be allowed to be sold online and in shops in the UK.
The Agency also highlighted dossiers submitted to the European Food and Safety Authority (EFSA) and FSA would take 2-3 months for validation, meaning firms would need to submit dossiers to both authorities by October 2020 or by December 2020 at the very latest to be validated by 31 March 2021.
The issue is further complicated by Brexit, in which the FSA says “If your product or process has been authorised by the European Commission and the necessary legislation is in place and applies by the end of the transition period, that authorisation will remain valid in the UK.”
CBD isolate or ingredient
Further clarification concerns the use of a CBD isolate or ingredient extract in an application, with the FSA confirming that products must be within the specification of the application, and as such there will be minimum / maximum levels (as per the application itself).
“It is for the applicant to ensure the product is safe, and to identify which contaminants, etc. must be controlled,” the guidance says.
“Controls also apply to the transport and storage conditions, to avoid mycotoxin production for example.”
When asked if shelf stability should be established by the food product manufacturer for each food product, the FSA commented that stability was important and must be included.
“This may be by the manufacturer or other applicant – what’s key is that it’s included whoever the actual applicant is,” they say.
“The finished product must only be prepared, marketed and sold in accordance with the validated application,” says the FSA in response to a question asking if the daily dose should be consistent with the novel food application.
“The exception being ‘new’ products which must have full authorisation before marketing – in which case they adhere to the authorisation itself).”
One final query asks if food product manufacturers need to compile any further information concerning individual formulations, which then require submitting a separate Novel Foods application or addendum to Novel Foods application of their CBD ingredient supplier.
The query is relevant since all dossier info should come from the key CBD supplier. Brands need to risk assess if their finish product formulation is different from the CBD supplier.
Brands would also need to take into account 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.
“The applicant must provide the information as per the EFSA guidance and the legislative requirements,” the FSA says in response.
“This will include much more than the specific examples and the FSA suggests firms to refer to the guidance, etc. for further information. As highlighted above firms should ensure they consider bioavailability in the different foods, etc.”