In both the United States of America and the U.K. there’s a lack of sufficient reliable evidence in favor of products that have been infused with full-spectrum hemp extract.
EU Novel Food Catalogue & The Reclassification of Derived Products Comprising Cannabinoids
However, in the year 2019, the European Union (EU) launched their Novel Food Catalogue and reclassified the Sativa L. extracts and derived products comprising cannabinoids as the “Novel Food.” This reclassification was primarily based on the lack of adequate history regarding the human consumption of such extracts and of any product that might have been infused with cannabinoids.
Just as you’d naturally predict, the process of Novel food Application is quite expensive and time-consuming. Each item undergoing the process has to go through three primary stages: Application Assessment, Safety Assessment, and Market Authorization. These stages take an estimated time period of 3 to 4 years and often require hefty budgets varying from €350,000 to €500,000.
Foundation of Novel Food Consortium in Europe
With the objective of alleviating the huge budget burden of individual Novel Food application, the European Industrial Hemp Association (EIHA), which is popular for advocating and representing an interest in the hemp growers and processors of all the European states, has come up with the Novel Food Consortium. This consortium aims to submit joint applications for the Novel Food and divide the cost of applications amongst members. Therefore, the Novel Food Consortium mostly comprises small-scale and medium-sized enterprises that couldn’t bear the cost of individual applications.
Do The Products Infused with Full-Spectrum Hemp Extracts Qualify for Safe Human Consumption?
Until now, the European Industrial Hemp Association (EIHA) has submitted an estimated three applications, each for synthetic CBD-based products, CBD-isolate-based products, and for products infused with full-spectrum hemp extracts, respectively. For each application, the EIHA is obligated to submit separate toxicological studies highlighting that these products are pure and safe for consumption. However, the organization tends to be highly concerned about providing evidence for the third application only— the products infused with full-spectrum hemp extracts.
The managing director of EIHA, Lorenza Romanesque, has explained in her recent interview that “they are facing a massive challenge in providing evidence for the safe human consumption of products infused with full-spectrum hemp extracts because of the presence of tetrahydrocannabinol (THC) in the full-spectrum hemp extracts”.
Similar to the United States, Europe has also not conducted enough research to definitively say with sufficient, reliable evidence that could prove the safety of products infused with full-spectrum hemp for human consumption, and THC products, one of the very few cannabinoids found excessively within cannabis plants. Therefore, considering the lack of information, EIHA tends to conduct quick research and surveys, which could help gather sufficient evidence. Despite it being a collective requirement for effort, EIHA contributes immensely to the study, all individually. They have invested in conducting the largest human trial in history to determine and prove the safety of products infused with full-spectrum hemp extracts with a traceable amount of THC.
The Largest Human Trial in The History by EIHA
This human trial by the EIHA is expected to assess an estimated sample of 200 participants during a trial period of thirty days. The trial is meant to make the regulators comfortable in accepting the concept of full-spectrum hemp extracts and to facilitate legal continuation of products infused with full-spectrum hemp in the markets of European states and worldwide.
However, there are chances that the European regulators might reject the authenticity and reliability of this largest human trial during the assessment phase. EIHA seems to be prepared to make an appeal in the Novel Food Consortium in case that happens.
Once this toxicological study has been carried through and submitted by the European Industrial Hemp Authority (EIHA), the Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) will have an estimated period of nine months to carry through the safety analysis and assessment of submitted study’s outcomes and determine their verdict.
What’s Next? Will The European Regulators Legalize Products Infused with Full-Spectrum Hemp Extracts or Not?
In case of a favorable verdict, the European Union Commission will have to submit a draft to implement approved regulations that state that the products infused with full-spectrum hemp extracts are safe for human consumption and could be legally grown and sold across the states of Europe and worldwide. Thus, the products would then be added to the EU Novel Food Catalogue as well.
Contrarily, suppose the verdict is against the EIHA’s toxicological study. In that case, the EU will have to submit a draft for the non-implementation of such regulations, which states that the products infused with full-spectrum hemp extracts are safe for human consumption and allows their legal production and selling.
Needless to say, if the outcomes are favorable, this would be a massive game-changer for the hemp industry. It would help to expand the production and sales of hemp-infused products – maximizing sales, consumption, and revenue at most.
Get Your Florida Medical Marijuana Card Now!
Until the time products infused with full-spectrum hemp extracts are under assessment and critique, you can always get medical marijuana products if you meet the qualifications and an adequate consultation from a medical marijuana doctor in Florida..
Wondering how? Well, that’s simple!All you need to do is complete this patient qualification test, and you’ll be matched with an adequate doctor based on your answers and medical history. This qualification test is simple and asks you a few basic questions about your medical background, why you think you need medical marijuana, and so on. Then, your doctor will further assess your needs and issue you a Florida medical marijuana card based on your requirements. This card can enable you to legally purchase all your favorite medical marijuana products legally without hassle. Take the test and schedule your appointment at MMJ Health to see if you qualify today!