Robert Jappie Partner - Life Science & Cannabis Regulation
CBD and Novel Foods: ACI provides more information
More information on how the FSA Novel Food application procedure is going to work has been provided by the ACI. In particular they have provided further clarity on the application timetable and the likely cost burden on SMEs.
As previously discussed, the deadline for submission of a “valid” novel food application is the 31st March 2021. The ACI says that “valid” should actually mean “validated”. The FSA (or the European Commission, if you submit pre-1st January) will review the application and within one month, validate the application. Validation means you have submitted all the required data in the correct format and your application can proceed to full consideration.
Once validated the FSA aims to consider the full application within 18 months. In the event that your application does not have sufficient information, the application will not be rejected. Rather a ‘Request for Further Information’ (“RFI”) will be issued and the applicant will have an opportunity to fill in any gaps.
The ‘validation’ requirement should be a warning to anyone considering submitting an application as late as possible. However, if it is correct that opportunities will be provided to rectify any deficiencies in an application, then this should be considered relatively positive news.
The procedure is set to mirror that of the EU, however the FSA may have an easier job in approving submissions as under EU regulations all 27 member states have to agree to the approval. Post 2020, the FSA won’t have to worry about this.
The Cost Burden
There is still more information required on who needs to apply, but the ACI seem sure that the majority of the costs burden should fall on the big wholesalers. Effectively, those at the top of the supply chain should be doing most of the work as they are providing the active CBD ingredient. SMEs which are producing brands may still have to make submission in relation to complex formulations, but they will be able to include their supplier data as part of their submission.
Ultimately, it will be the company that is selling the product to the consumer that will need to carry out the necessary due diligence to avoid regulatory intervention. Shops like Holland & Barrett will have to satisfy themselves that the brands they stock are novel food compliant. Brand producers will have to be sure that their active ingredients and formulations have been included in a novel food submission, to be able to assert compliance.
Do all finished products need to have their own novel food submission? The ACI says No. If you have a submission made for one formulation, and then you produce another product that is very similar then you may be able to avoid a further submission if you can justify to the FSA that your new product has the exact same qualities. Provided the stability and safety data of your new product matches the previous one then no new submission will be required.
EIHA decision in Germany
The European Industrial Hemp Association achieved a good decision with the German regulators which confirmed that a full plant extract would not be considered novel. This makes perfect sense as the FSA has repeatedly confirmed that the hemp plant itself is not novel. If I was to squeeze the juice out of the plant then common sense would dictate that juice could not be novel either.
Does this impact on the FSA’s position? It appears that a full spectrum product could avoid the need for a novel food submission. The FSA has been clear that once a full plant extract is put through other processes, its composition is changed and it becomes a new product. Any efforts to remove the controlled drug content out of a full plant extract could then place you back in Novel Food territory.
Of course there will be many different circumstances which will require clarification from the FSA. What is really extraordinary at moment is that the information being provided isn’t being delivered to the public directly by the FSA. It appears that the FSA is quite happy to hand over full control of the process to a private organisation (The ACI), which is something they always denied that they would do.