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The European Industrial Hemp Association (EIHA) has announced the largest-ever study on the impacts of trace levels of THC on human health. The trial is due to start in the next couple of weeks and will cost 1.6 million euros.
The laboratory analyzing the results will be Eurofins, after the Association members voted so in June 2019. There will be 200 participants in the trial.
The study could change the face of cannabis across the planet, EIHA Managing Director Lorenza Romanese told BusinessCann.
‘This is the only way we can proceed if we want to demonstrate to regulators that it is safe for businesses to make and sell – and for consumers to take – real, full-spectrum, hemp food supplements, containing all of the cannabinoids, and their acid forms. If we were to stick to the guidelines on THC in Europe at the moment then there will never be a future for whole plant extracts – which are considered illegal – and this needs to change. This will bring stability; it will be referenced worldwide, and it will allow all governments to, at last, make science-based guidelines for all hemp foods and derivates’, she said.
EIHA believes that trace levels of THC in a recommended daily dose will never produce extracts with any potential harm to human health. Ms. Romanese said EIHA believes that the current permissible THC limits are inadequate, so the Association presses for higher levels based on scientific research. ‘No one is getting high on CBD or hemp oil, and our aim is to prove it’s safe, even at higher doses, like elsewhere in the world’, she pointed out. Ms. Romanese also said that the study would allay regulatory concerns and end the ‘vendetta on whole hemp plant oil’.
The EIHA demonstrated that hemp extracts have been used across Europe for centuries and that whole-plant extracts – especially when mixed into hemp seed oil or initially extracted from hemp seed and leaves – are full of nutrients and support overall health. ‘This voice needs to be heard, said Ms. Romanese.
The results of this study will be included in the EIHA’s application to the European Food Safety Authority and the UK Food Standards Agency under their Novel Food pathways. It will be submitted for a ‘Regular’ – full spectrum, traditional, hemp food supplement.
BusinessCann reports that EIHA is currently spending €2m on two Consortium Novel Food applications for a CBD isolate and synthetic CBD. It says the findings from the THC study will dovetail with the CBD toxicology data in these applications.
The EIHA’s THC study serves a double purpose. On the one hand, it aims to increase the permitted level of THC in hemp-derived food – dry food and oil derived from seeds. On the other hand, the goal is to obtain the approval of full-spectrum extracts which inevitably contain higher levels of THC than the ones stated in the EFSA guidelines.
EIHA believes that the current values are outdated and unnecessarily strict and are based on a biased consideration of past studies.
In Europe, the permitted levels of one microgram per kg of body weight – 0.001 mg/kg BW – are particularly striking if compared to international competitors, like Canada (0.014 mg/kg BW), Switzerland (0.007 mg/kg BW), or Australia and New Zealand (0.006 mg/kg BW). Ms. Romanese has outlined.
The guidance value for THC recommended by EFSA, upon which the European Council will most probably base its decision on THC limits in food, is based on faulty conclusions of the data, she claims.
EFSA’s guidelines are based on three large clinical trials on HIV patients (Beal et al. 1995 and 1997, Struwe et al, 1993) to determine the LOAEL (Lowest Observable Adverse Effects Level), and one very small study – on 11 subjects – which was the only one to specifically and systematically investigate the psychoactive effects of delta9-THC.
In the UK, there is no limit set per kg/bodyweight for hemp foods, but instead an arbitrary amount of 1mg per product, irrespective of the product size. This was set 50 years ago and has no relation to ordinary hemp foods that have been safely consumed for millennia, therefore EIHA advocates for reasonable guidance values, Ms. Romanese added.
“It’s important to note that only members of the EIHA Consortium will be able to sell products with higher levels of THC if the Novel Food application is approved. Consortium partners will own the intellectual property of this study for the following five years”, she said.