Worlds Largest THC Toxicological Study Shows ‘Very Positive’ Signs
Ahead of Cannabis Europa London 2022, BusinessCann spoke to the organization’s managing director Lorenza Romanese about the current state of European hemp, and what needs to be done for its evolution to continue.
BC: Thanks for joining us Lorenza, could you start by telling us a bit about yourself and the work you do over at the EIHA.
My name is Lorenza Romanese, I’m the managing director of the EIHA. We are a small team of five based here in Brussels, and we represent and defend the three main actors along the supply chain of hemp, the producers, the manufacturers and processing companies, and the traders.
We are a company-driven association, meaning that companies pay a membership fee to enjoy benefits, including receiving industry updates on a regular basis. They get the information from us, and our members are our source of information.
We aim to grasp information from the sector and translate it into policy messages and try to solve the problems of the companies on the market. We also collect information from the main DGs (Directorate-Generals for the European Commission), which is like the ministry for the rest of the member states. This is what we do.
BC: Last month saw the publication of the UK FSA’s Novel Foods Public List, you must have been pleased to see a number of the EIHA consortium members included?
The EIHA is very, very happy about the publication of the list. Of course, we regret the delay, we were waiting for the list for one year.
But we definitely welcome the publication, we are very happy that both our applications are now displayed on their on-hold list. Let’s recall that the on-hold list is for the companies and applications that still have some toxicological studies going on, as in our case.
Once the toxicological studies are concluded, then we will upload the report to support the safety of our products into the FSA portal. Then we should be able to move to the validated list.
Surely the on-hold list and the validated list gives the possibility to operate and stay on the market.
The safety evaluation of these products will be done, as will the risk assessment, at a later stage within the FSA as well as with EFSA in Europe. So today it’s more about administration and the willingness to invest in toxicological studies, and then the risk assessment will come later.
BC: You mentioned in a press release ‘inaccuracies, inconsistencies and indeed a few surprising absences on the list’, can you explain what you meant here?
Let me underline again, that we really welcome the approach and the willingness from FSA to regulate this market. Probably all of us, even us as a trade association, underestimated the size of the market.
Nevertheless, the project was very, very ambitious. The FSA has decided to control, check and display the brands, and by displaying the brands, they have multiplied the number of products and the collection of data that was needed to come up with this list.
Therefore, it’s more than human to have some mistakes. 10 days after the publication of our press release, we are very pleased that all the mistakes were corrected and all our members are now displayed on the list, with one pending. We are still waiting on some clarifications on documentation to be submitted to show that the last member was compliant.
BC: Can you walk us through your toxicological studies?
We’re jumping into a big project that goes beyond the usual public affairs work we are doing here. We understood that the sector was facing a common challenge that was very complex, very costly, very ambitious. Therefore, we have decided to join forces and to prepare a common reply to this challenge.
So we have built this specification, we decided which were the products that they want to trade in the UK and European market, and once we have agreed on the specification we did a simple assessment of how many studies were already available for these products.
We noticed some gaps and decided to collect €3.5m to invest into toxicological studies, which have been divided into three main costs. The first are toxicological studies dedicated to isolate CBD, so all studies necessary to ensure the safety of this product and to define the correct TDI (Tolerable Daily Intake).
We have done the same toxicological package with a little more complexity for full spectrum extracts, and the third main expense has been conducting the biggest clinical trials for THC.
The scope of this clinical trial is to make sure that we might be able to increase the level and the accurate reference dose for THC.
There are many things that we need to clarify, we need to define a NOAEL (No Observed Adverse Effect Level), an appropriate LOAEL (Lowest Observed Adverse Effect Level), and an appropriate uncertainty factor measurement for THC.
When it comes to CBD, there are gaps here as well. So we need to define a correct TDI. The FSA guidelines propose a 7mg TDI, we would like to increase this.
The level of THC and other minor cannabinoids in full spectrum extracts is another.
We’re aiming to define the values that are still missing and to identify higher values than the ones that have been proposed by the authorities.
BC: Can you give us an update on your preliminary findings and when you think they’ll be completed?
Toxicology studies are a complex package of studies, some are shorter, some are long, some must be conducted in parallel, others are consequential. The most important are 90-day studies.
These give us the possibility to monitor the rats for a long period, followed by a recovery period, so we can measure the parameters in vivo, then measure things like toxicity in the liver.
When it comes to isolate CBD, the 90 day studies have been completed. We are now drafting the report to be submitted to the FSA, so I expect the submission on this at the latest July this year. When it comes to full spectrum, the results will come by the end of the year, when it comes to THC on human beings, the results will come in 2023.
So all the studies both for isolate and full spectrum CBD are concluded. And so far, I can simply say that there is nothing to worry about. There were no values beyond or even near to the limit. So this product, according to the level that we have tested, can be considered safe.
When what we have been seeing is that all the text tests were negative, which in toxicology is very good because it means that there is no adverse effect for the parameters that we have been testing at the level that we have been testing.
BC: The European Commission recently announced a decision to establish a new maximum level of THC in hemp food products, what does this mean for the EU’s hemp industry?
The EIHA have been advocating for a common approach when it comes to a maximum level of THC in food, so we welcome the new regulation coming from Europe that will be directly applicable in all member states.
Until a few weeks ago in Europe, there was no maximum level there were no regulation, no provision, there were only a guidelines drafted by EFSA.
This is a huge achievement for the sector, because finally from Lisbon to Warsaw, all products will be will be the same because all the limits will finally be European limits.
There are still some more points that might be clarified. But let’s wait for our toxicological studies on THC that might support further changes later on.
BC: During the controversial Kanavape case in 2020, which threatened to class CBD as a narcotic across Europe, it was suggested that this galvanised support for a rise in THC limits across the sector. Do you think this has had an impact on recent developments?
The court case arrived in the most needed moment for the sector. Let’s do a small recap. In 1997 the European Commission said that hemp extract leaves and flowers were not a novel food, leading to lots of investment in the sector.
In 2016 certain products containing cannabinoids were considered novel foods for the first time, but basically low concentration products were still sellable as food.
In 2019 all products were considered a novell food. In 2020, hemp was considered a narcotic. And then came the Kanavape court case, as I said it arrived in the in a good moment for the sector.
The Judge of the Court of Justice clearly clarified that hemp should not be regarded as a narcotic, and all parts of the plants should be marketable as none of them should be considered a narcotic.
It was a game changer from this point of view. We cannot measure a real impact today, because when it comes to cannabis, it always takes a little bit of time.
Since the adoption of the ruling 2020, we have not seen any major change in Europe. I know that the European Commission is still working on integrating this principle within the EU. So again, let’s wait for the results of our toxicological studies.
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