By This is the second part of a four-part series on cannabis regulation in Europe. Click here for Part 1. Part 2 analyzes the differences between the UK, EU and US. Part 3, coming out next week, will go into more detail on dosages, approvals, and more. Please look forward to future updates.
EU regulatory environment
We Europeans look at the American market with envy and wonder why we can’t be more like that. The differences between the US market, the UK and the EU economies could not be more different, but change seems to be on the horizon. The UK and EU both have novel food laws, but their implementation differs significantly.
In the EU, the application is submitted to the EU Commission and approval can take up to 9 months just for approval of the application. No further testing is required. Also, there is no charge for the application, but collecting the data needed just to create the application is expensive, and can cost upwards of six figures. Even if the application is approved, there may still be data gaps and uncertainties, there are toxicology tests that can take years to complete, and finally approval and verification by EFSA (European Food Safety Authority) is required. becomes. The required toxicology tests are very expensive, with both the EIHA (European Industrial Hemp Association) and his EFSA estimating a cost of around €3.5 million.
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has so far received 19 applications for CBD as a novel food, with more on the way. According to the NDA’s website, NDA chair Professor Dominic Turk reports that it has “identified several risks associated with CBD consumption,” and many data gaps need to be filled before the evaluation can proceed. reported. However, she concluded, “It is important to emphasize that we have not concluded that CBD is not food safe.”
As always, in food and drug reviews, it is the applicant’s responsibility to demonstrate that the product is safe for human consumption. And for the European Commission, EFSA is decisive. And while the first trials were in animals, they also included trials in humans, which helps explain the high cost.
At present, EFSA is not satisfied with the applications submitted so far and does not want further information on the effects of CBD on the liver, the gastrointestinal tract, the endocrine system, the nervous system, and on the psychological health of people, as well as on its effects on health. looking for data. human reproduction.
Therefore, in 2019, EIHA established a German corporation, EIHA Projects GmbH, with the aim of pooling funds to partners for the cost of application and toxicity testing. New Food Applications (NFAs) for CBD isolates and synthetic CBD were filed on November 4, 2022, with full coverage expected to follow in April-May 2023. Please note that the synthetic CBD application was completely withdrawn as it was not tested. done so far.
This application should be bolstered by a series of toxicity studies under the auspices of EFSA and, in the UK, the FSA. EFSA will initiate a risk assessment as soon as a conformity check has been carried out. A suitability check is a process carried out by EFSA to ensure that there is sufficient data to carry out a risk assessment. According to their webpage, a risk assessment can take nine months.
For applications submitted by EIHA Projects GmbH, the CBD isolation dossier will be submitted to EFSA in September to enter the risk assessment stage. At this stage, EFSA can examine the data and request further data if it feels it is necessary. They will have nine months to complete this task and submit their recommendations to the EU Commission for a vote of the 27 members. The EIHA Projects GmbH application is now valid and legally binding. The EIHA project GmbH expects verification to be completed in 2024. This is a big change.
Applications for full-spectrum distillates should be ready by the end of 2023 and EFSA should complete a risk assessment near the end of 2024. Full-spectrum is more complicated because it allows for small amounts of cannabinoids and limited THC. It should be noted that testing full-spectrum distillates at the 0.2% THC limit tests the limit of how much THC humans can consume without side effects. This research is unprecedented and could have enormous implications for the THC issue and possible future legalization. Implementation will cost another million euros.
UK regulatory approach
Novel Food’s approach in the UK is very different from that of the EU, which has both strengths and weaknesses. The reason his CBD market in the UK has been so strong is because the FSA has been on the market before 13th February 2020 and is associated with applications filed before 31st March 2021. is authorized to sell the product. As a result, the FSA was inundated with applications, many of which were later rejected for technical reasons, largely because these conditions were not met. Currently, around 11,000 products, worth an estimated £1 billion in revenue, remain on the FSA’s list and have passed pre-verification while the FSA awaits its final toxicology report. Only 400 CBD products were selected from the list, but to date, none have been approved. Toxicology reports are required to have pre-verified status, and it is not yet known how many companies will be able to produce such reports.
An important point to note is that due to Brexit, if UK validation actually takes place, it will be invalid in the EU, but any product whose EU application is accepted on the European Union list will be valid in the UK. is.
With a £1 billion crisis still expected, it’s easy to see why UK CBD makers would try to appease the FSA despite the regulatory hurdles. By keeping its doors open, the UK has managed to maintain investor interest in the CBD market and protect the public from unmonitored products.
This is by no means the case in the EU. The EU market remains thin in comparison, despite a small number of products still eluding authorities in the EU. Their approach hinders growth compared to the UK, where strong novel food regulations are in place, but the approach is different.
At the moment, the market comparison between the EU and the UK and North America looks bleak, at least for now, but sales across the EU could be very profitable in the future after approval. As we move closer and closer to Novelfood’s list, the European market could prove to be one of the largest markets for the safest CBD products in the world.
american market
Still, it’s the American market that whets our appetite. Oils, tinctures, candies, cakes and drinks containing every cannabinoid from CBD to Delta 9, Delta 8 and HHC are available here and producers are on their way to becoming millionaires. The current market size is estimated at $6 billion and is projected to reach over $16 billion by 2026.
What about health-related concerns and testing requirements? Will these be limited to the UK and EU? Find out more! The U.S. cannabis market has been alarmed by producers and lawmakers alike calling for tougher laws and enforcement.
In the United States, the FDA (Food and Drug Administration) has warned the public about CBD’s potential harmful side effects on its website and wants to force Congress to address the issue.
Many of their concerns echo those of the FSA and EFSA. For example, the FDA mentions on his website that he has only one approved CBD product. It’s a drug called Epidiolex. The FDA reviewed the Epidiolex application in 2018, noting that it identified certain safety risks, including the potential for liver damage. EFSA requires testing on the same issue.
