EIHA conducts hemp THC tolerability study in Portugal

If you are in Portugal and live in Porto, you could be one of 400 selected for a study to assess the tolerability of residual THC from industrial hemp formulations. The European Industrial Hemp Association (EIHA) is promoting the test as part of the CBD submission processes as a “new food” to the European Union (EU) and a clinic in Porto was chosen to do so. The information was confirmed to Cannareporter by Lorenza Romanese, Managing Partner at EIHA.

EIHA is making progress on “novel food” applications to the EU, with full spectrum formulations posing more challenges for the consortium. Tests are needed to prove that CBD from industrial hemp can finally appear as a food ingredient, namely studies that prove the absence of CBD toxicity and the tolerability of THC present in hemp in residual proportions.

In 2019, EIHA moved into the novel food market by submitting an application to use CBD (cannabidiol) as a food in products for consumption in the EU. Lorenza Romanese confirmed this week to Cannareporter that EIHA has to carry out a THC tolerability study and that EIHA has chosen a clinic in Porto to do so.

Full Spectrum has more submission challenges like “novel food”

Lorenza Romanese told Cannareporter that EIHA “gathered the data and described the processes according to the information submitted by its members”. Regarding the EIHA submissions (one for full-spectrum CBD formulations, another for formulations with hemp-derived isolate CBD and another for synthetic CBD), the group spokesperson assumes that “it is the full-spectrum products that present the most challenges. in terms of submission”. Regarding CBD isolate, these questions do not arise because “it is an ingredient”.

Lorenza Romanese shared some details regarding the trial that will take place in Porto: it will host 400 people and will take place in a private health institution. The 400 participants will be divided into four groups in a 30-day study. Recruitment will be carried out “on the basis of blood samples and other analyses”, with study participants having to be 'healthy' according to certain health parameters.

The EIHA Consortium in response to the Novel Food regime

The Novel Foods Scheme, which includes hemp and other cannabinoids, is an extensive procedure for assessing the food safety of products, foods and ingredients which, according to the EU, do not have a significant past consumption history (before from 1997). Although hemp foods are allowed, namely with hemp seeds or other parts of the plant, hemp-derived cannabinoids, namely CBD from industrial hemp, are considered a novel food by the EU.

EIHA has joined the efforts of several members across Europe and in 2019 raised €3,5 million to submit an application for hemp-derived CBD as a novel food. The various EIHA members who decided to join the consortium contributed “15 euros, through a 3-year installment payment scheme”, which Lorenza considers “very fair”. The THC study was “designed from day one,” according to Romanese.

Through this consortium, EIHA aims to expand industrial hemp to include industrial hemp-derived CBD as a food ingredient. The various participants in this consortium will enjoy 5 years of intellectual property protection, being able to market products based on the products tested and approved in the order placed.