Progress on novel food authorisations for non-synthetic cannabinoids will be paused until European regulators decide whether extracts from hemp flowers constitute a drug under narcotics laws, CBD-Intel has learned.
If CBD is considered to be a narcotic it cannot legally be considered a food, and therefore cannot go through the EU novel food approval process.
The European Commission (EC)’s Directorate-General for Health (DG Santé) told CBD-Intel that authorities were unsure how a hemp flower extract should be interpreted under the 1961 UN Single Convention on Narcotic Drugs.
It appears that the convention, as originally written, included cannabis extractions without anticipating the rise of CBD. It is now unclear for some European authorities whether CBD should be considered a cannabis extraction and therefore a narcotic.
A decision on this could be made as early as September. However, that is not guaranteed. The EC could wait until the UN has voted on the re-scheduling of hemp extracts or the European Court of Justice (CJEU) makes an official ruling in the French Kanavape case, which has implications for the qualification of extracts.
Safety of CBD ‘unproven’
Until a decision is made all novel food applications for non-synthetic cannabinoids – including CBD – have been frozen and will not be reviewed by the European Food Safety Authority (EFSA).
While the process is on hold, the EC says agencies will no longer have to meet suggested deadlines for the processing of applications – though these were only voluntary to start with and could have been paused at any point. Most applications are paused unless the data submitted is perfect, the EC added.
Altogether this means that it is now unclear when, if at all, a successful non-synthetic cannabinoid novel food application will be approved at the European level.
Safety of CBD has also still not been demonstrated in the eyes of European regulatory authorities. Most current applications for CBD have been found wanting, the DG Santé said, adding that it appears some companies thought that merely by submitting some sort of application they would be allowed to remain in the market.
The hidden danger of chocolate
Authorities would still need to see proof of absolutely no safety concerns before allowing CBD into any foods. Manufacturers must prove the safety of potential exposure levels for different population groups. For example, questions remain on what happens if a child or a pregnant woman accidentally ingests a couple of chocolate bars containing CBD.
This implies that a general CBD-as-an-ingredient novel food application may not be enough and that separate applications would be needed to cover different CBD processing methods as well as, potentially – depending on other ingredients – different end products.
It also implies that cannabinoids as isolates are more likely to be approved than cannabinoids in a spectrum extract due to the extra complexities and variables a spectrum would yield.
Due to this, the DG Santé sees CBD as fitting more into a wellness supplement category than a general food ingredient category.
– Freddie Dawson CBD-Intel staff
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