Czech firm’s push to register synthetically made CBD advances

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The European Food Safety Authority (EFSA) has green-lighted the “suitability check” of an application from Czech-based phytocannabinoids maker CBDepot for synthetically manufactured Cannabidiol (CBD) as a Novel Food ingredient, the company announced.

CBDepot said it expects the EU Commission to declare its dossier valid and return it to EFSA for a risk assessment as soon as possible. If that assessment is positive, the compound’s use as an ingredient in food supplements still needs to be approved by EU Member States.

One step in process

The application was submitted last October. It’s approval is an important step in the process of clearing CBD for use as an ingredient in food supplements in European Union states, CBDepot has said.

Cannabis Pharma (one of mother companies of CBDepot) has also submitted a second, previous application for non-synthesized hemp-derived Cannabidiol isolate as a Novel Food ingredient. That application has been before EU officials since 2016, and was re-filed in early 2018. The dossier was declared as suitable under risk assessment by EFSA last July, but the EU Commission has not declared the application valid as of today, CBDepot said.

Push for exemption

CBDepot is guiding its CBD ingredients through various regulatory channels in the EU and on several export markets. The company is among several European stakeholders pushing for low potency hemp extracts to be exempt from the definition of Novel Food rules, which are essentially consumer safety guidelines. Under those rules, foods and food ingredients not commonly consumed in the European Union before 1997 must undergo a lengthy, expensive risk assessment process.

Covering both versions of Cannabidiol — isolated and synthesized — to be approved as authorized Novel ingredients for food supplements should give the company an edge in the fast-evolving CBD sector, CBDepot said.

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