World’s Largest THC Toxicology Study Shows ‘Very Positive’ Signs So Far

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Since the Kanavape case in 2020, the European hemp industry has continued to grow at a rapid pace.

At the forefront of this development is the European Industrial Hemp Association (EIHA), which is conducting major toxicological studies on THC that could bring even more change to this burgeoning industry.

Upstream Cannabis Europa London 2022Lorenza Romanese, the organization’s chief executive, spoke to BusinessCann about the current state of European hemp and what needs to be done to keep it evolving.

Thank you for joining us Lorenza, could you start by telling us a bit about yourself and the work you do at EIHA?

My name is Lorenza Romanese, I am the General Director of EIHA. We are a small team of five people based in Brussels, and we represent and defend the three main players in the hemp supply chain: growers, manufacturers and processors, and traders.

We are a business-run association, which means businesses pay a membership fee to receive benefits, including receiving regular industry updates. They receive information from us, and our members are our source of information.

Our goal is to take information from the sector and translate it into political messages, and try to solve the problems of companies in the market. We also collect information from the main DGs (Directorates General of the European Commission), which are like a ministry for the rest of the Member States. That’s what we do.

Last month saw the publication of the UK FSA’s public list of novel foods. You must have been happy to see a number of members of the EIHA consortium included?

The EIHA is very, very happy with the publication of the list. Of course, we regret the delay, we have been waiting for the list for a year.

But we welcome the publication of the list and we are very happy that our two applications are now on their waiting list. Remember that the waiting list is intended for companies and requests for which toxicological studies are still in progress, as in our case.

Once the toxicological studies have been completed, we will upload the report attesting to the safety of our products on the FSA portal. We should then be able to move on to the validated list.

It is certain that the waiting list and the validated list give the possibility of operating and remaining in the market.

The safety assessment of these products will be carried out, as will the risk assessment, at a later stage within the FSA as well as with EFSA in Europe. Today, it is therefore more about administration and the will to invest in toxicological studies, and risk assessment will come later.

You mentioned in a press release “inaccuracies, inconsistencies and even some surprising absences on the list”, can you explain what you mean by that?

Let me re-emphasize that we really welcome the FSA’s approach and willingness to regulate this market. We have probably all, even as a trade association, underestimated the size of the market.

Nevertheless, the project was very, very ambitious. The FSA decided to monitor, verify and display the marks, and by displaying the marks, it multiplied the number of products and the collection of data that was needed to compile this list.

It is therefore more than human to have a few errors. 10 days after the publication of our press release, we are very happy that all errors have been corrected and that all of our members are now displayed on the list, with one exception. We are still awaiting some clarification on the documentation to be submitted to show that the last member was compliant.

Can you tell us about your toxicological studies?

We are embarking on a major project that goes beyond the usual public affairs work that we do here. We understood that the sector was facing a common challenge, very complex, very costly, very ambitious. We have therefore decided to join forces and prepare a common response to this challenge.

So we built that spec, we decided what products they wanted to bring to the UK and European market, and once we agreed on the spec, we did a simple assessment of how many studies already available for these products.

We found some shortcomings and decided to raise 3.5 million euros to invest in toxicological studies, which were divided into three main costs. The first are toxicological studies dedicated to the CBD isolate, therefore all the studies necessary to ensure the safety of this product and to define the correct TDI (tolerable daily intake).

We performed the same set of toxicology studies with a bit more complexity for full-spectrum extracts, and the third major expense was running the largest clinical trials for THC.

The purpose of this clinical trial is to make sure that we might be able to increase the level and the precise reference dose for THC.

There are many things we need to clarify, we need to define a NOAEL (No Observed Adverse Effect Level), a LOAEL (Lowest Observed Adverse Effect Level) appropriate, and an appropriate measurement of the uncertainty factor for THC.

When it comes to CBD, there are also shortcomings. So we need to set a correct TDI. The FSA guidelines suggest a TDI of 7mg, we would like to increase this. Another is the level of THC and other minor cannabinoids in full-spectrum extracts.

Our goal is to define the values ​​that are still missing and to identify higher values ​​than those that have been proposed by the authorities.

Can you provide an update on your preliminary results and let us know when you expect them to be complete?

Toxicological studies are a complex set of studies, some are shorter, some longer, some must be carried out in parallel, others are large. The most important are the 90-day studies.

They give us the possibility to follow the rats for a long period, followed by a recovery period, in order to be able to measure the parameters liveand then measure things like toxicity in the liver.

As for the CBD isolate, the 90-day studies have been completed. We are in the process of drafting the report to submit to the FSA, and I expect that report to be submitted by July this year. As for the full spectrum, the results will be known by the end of the year. As for THC on humans, the results will be known in 2023.

All studies on the isolate and the full spectrum of CBD are therefore complete. And so far I can just say that there is nothing to worry about. There were no values ​​above or even close to the limit. So this product, according to the level we tested, can be considered safe.

We found that all the tests were negative, which in toxicology is a very good thing because it means that there is no negative effect for the parameters that we tested at the level that we tested.

The European Commission recently announced its decision to establish a new maximum level of THC in hemp food products, what does this mean for the European hemp industry?

The EIHA advocated for a common approach regarding the maximum level of THC in foods [ndlr : 7,5mg/kg de THC pour l’huile de chanvre et 3g/kg pour les aliments secs à base de chanvre]. We therefore welcome the new European regulations which will be directly applicable in all Member States.

Until a few weeks ago in Europe, there was no maximum level, no regulation, no provision, there were only guidelines drawn up by EFSA.

This is a great achievement for the sector, because finally, from Lisbon to Warsaw, all the products will be the same, because all the limits will finally be European limits.

There are still a few points that could be clarified. But let’s wait for our toxicological studies on THC which may support other changes later.

During the controversial Kanavape case in 2020, which threatened to classify CBD as a narcotic throughout Europe, it was suggested that this galvanized support for increased THC limits across the sector. Do you think this has had an impact on recent developments?

The court case came when the industry needed it most. Let’s do a little recap. In 1997, the European Commission declared that the leaves and flowers extracted from hemp did not constitute a new food, which led to numerous investments in the sector.

In 2016, some cannabinoid-containing products were considered novel foods for the first time, but basically low-level products were still salable as foods.

In 2019, all products were considered novel foods. In 2020, hemp was considered a narcotic. Then came the Kanavape case, which, as I said, came at the right time for the industry.

The judge of the Court of Justice made it clear that hemp should not be considered a narcotic, and that all parts of the plants should be marketable because none of them should be considered a narcotic.

It was a game-changer from that point of view. We cannot measure the real impact today, because when it comes to cannabis, it always takes a little time.

Since the adoption of the 2020 decision, we have not seen a major change in Europe. I know that the European Commission is still working on the integration of this principle within the EU. So, again, let’s wait for the results of our toxicology studies.

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