First CBD novel food application headed for EU risk assessment

A cannabinoid producer in the Czech Republic is the first to have a CBD novel food application declared “valid” by EU authorities and move forward for a risk assessment.

CBDepot’s application for the authorization of synthetic cannabidiol was sent to the European Food Safety Authority (ESFA) for a risk assessment on March 27, agency spokesman Edward Bray told Hemp Industry Daily. CBDepot reported the news on its website last week.

Across the European Union’s 27 member states, cannabinoid extracts such as CBD are subject to a 1997 provision called the Novel Food Regulation, a set of guidelines for evaluating consumer safety before putting new ingredients in food.

EU food regulations are enforced by member states, leading to a patchwork of enforcement landscapes across the continent, as well as a thriving illicit market for CBD products. Only 45 “novel foods” applications for CBD authorization have been received.

Application Process

All novel food applications must be declared “valid” by the European Commission before they can undergo an EFSA risk assessment. During this review period, the commission may consult with EFSA officials about the scientific data provided by the manufacturer.

The EFSA has nine months to carry out a risk assessment on a “valid” novel food application, though the window can be paused for addition questions from the agency.

After that, the application is handed back to the European Commission, which then has seven months to review it and up to three months for adoption.