Largest Human Trial to Date Reviews Safety of Full Spectrum Hemp Products

In January 2019, the European Union (EU) reclassified extracts of Cannabis sativa L. and derived products containing cannabinoids, including CBD, as “Novel Food” under the EU Novel Food Catalogue. The reclassification was based on the lack of demonstrated history of human consumption of these extracts and of any product to which they might be added.

As one would naturally suspect, the Novel Food Application process is time consuming and expensive. Every successful Novel Food Application goes through three phases (the “Application Assessment,” the “Safety Assessment” and the “Marketing Authorization”), which lasts 3 to 4 years and require a hefty budget of €350,000 to €500,000.

To alleviate to burdensome cost of an individual Novel Food Application, the European Industrial Hemp Association (EIHA), which represents and advocate for the interest of European hemp producers and processors, launched a Novel Food Consortium (the Consortium). The Consortium was established to submit joint Novel Food applications and share the costs between its members, the majority of which are small and medium-sized enterprises (SMEs) that could not bear the cost of an individual application.

To date EIHA has submit three categories of Novel Food applications, including one for CBD-isolate-based products, another for synthetic-CBD-based products and a

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