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  • Regulatory House

The safety of Cannabidiol as a novel food – regulatory update

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. However pure CBD or hemp extracts containing other cannabionoids do not have a proved history of consumption to a significant degree by humans in the EU before 15 May 1997, and therefore fall within the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, and they are considered by the European Commission as a novel food, where the approval process precedes placing on the market.

Currently, 19 applications are under risk assessment at EFSA and its scientists cannot establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.

According to the statement of the Ministry of Agriculture of the Czech Republic, these foods (synthetic CBD or CBD obtained from hemp plants by different production methods, hemp extracts) cannot be placed on the market now until the approval process is completed.

Following the gradual development and expected changes in this area, the supervisory authorities will always assess individual products on an individual basis and on a case-by-case basis during official controls.

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