Several major developments have all happened at the same time for novel foods. Perhaps most importantly, one of the European Commission (EC)’s departments – the Directorate-General for Health and Food Safety – has said it is holding sending any further non-synthetic CBD applications to the European Food Safety Authority (EFSA) for evaluation until it has determined whether CBD technically falls under the definition of a narcotic according to the 1961 UN Single Convention on Narcotic Drugs.
This is a massively important decision and will apparently come down to the formation of some sort of political consensus among member states. An upcoming decision from the Courts of European Justice (CJEU) on the French Kannavape case and an expected vote by the UN in December could both be important. But it is unclear whether the Kannavape case will have any sort of binding impact specifically on the issue of CBD as a narcotic. It is also unclear when the UN vote will happen.
Either way, the EC says it expects to forge ahead and hopes to have a decision on the issue by sometime in the autumn – though that is not a guaranteed timeline. Until that point, non-synthetic CBD applications will remain stalled.
That has not stopped industry bodies from moving forward. The European Industrial Hemp Association (EIHA) will submit four applications to both European and UK authorities on behalf of a consortium of members. The Association for the Cannabinoid Industry (ACI), meanwhile, will proceed with a series of studies that involved members can use to push forward their own applications to EFSA, the UK Food Standards Agency (FSA) or other agencies requiring safety data on CBD products elsewhere in the world.
For those looking to sell in the UK and submit applications to the FSA, the agency has provided further details on its timelines and the situations for which it believes a new novel food application would be required. It wants companies to have applications submitted by the start of 2021 so that it has time to validate them and certify that the involved products can stay on the market past its 31st March 2021 deadline. It believes this should be enough time for it to get through incoming applications – though this depends on the amount it receives.
The FSA technically cannot take in applications until that time as part of its agreement for leaving the EU. However, it is informally advising companies on their applications in the meantime. It laid out some examples of when it believed a separate novel food application would be required.
This included when a primary ingredient involved different ingredients, different mixtures, concentrations and functions. The end conditions of use must also be covered in the application from the start or would require a new application if a manufacturer wanted to use it in a new product.
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