CBD, Europe, Regulatory

First food safety applications for CBD advance in UK

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Three CBD brands may remain on the market in the United Kingdom after three food safety applications were approved under Novel Foods rules. The Food Standards Agency (FSA) on Monday validated applications for products from Pureis CBD, Galway, Ireland, and Cannabis Pharma s.r.o. of the Czech Republic.

The applications approval means the products may remain on sale in England and Wales until a final decision on their authorization has been made, FSA said in a press release. CBD companies that had products on the market as of Feb. 13, 2020 had until the end of March to file Novel Food applications or remove their products from the market.

FSA said it continues to validate CBD Novel Food applications and will be adding products weekly. A final full list of valid applications is expected to be complete in June, the agency said.

‘No guarantee’

“Inclusion on the list is no guarantee of eventual authorization; that will be determined on the strength of evidence of safety submitted by the companies,” FSA said.

“This is about bringing the CBD industry into compliance with the law,” Emily Miles, FSA Chief Executive, said of the authorization process that ensures newly introduced foods meet standards for safety and advertised levels of CBD content. “Consumers need to be able to trust that these products are safe and are what they say they are,” Miles said.

When complete, the UK list of approved CBD products can be used by suppliers and retailers to confirm the status of particular products and to help inform local enforcement decisions, Miles said.

The companies

Pureis, led by pharmaceuticals veterans Chanelle McCoy, CEO, and Caroline Glynn, CSO, makes a range of own-brand CBD capsules and oils.

Cannabis Pharma s.r.o is the supplier and manufacturer of the CBDex brand – all natural CBD oils made from isolated CBD. Cannabis Pharma, daughter company CBDepot, and 4MP Technologies, Chichester, England, are co-applicants within the UK food safety process. CBDepot makes cannabinoid-specific ingredients for foods, cosmetics and medical devices sectors.

Cannabis Pharma and CBDepot said in a press release that Monday’s listings means 12 secondary food supplements under the CBDex and 4MP brands that are linked to the Novel Food applications remain on the market while they continue to undergo final risk assessment. Cannabis Pharma indicated that process is well advanced for its products.

“Our battery of proprietary Tier 1 and Tier 2 studies on genotoxicity, subchronic toxicity and toxicokinetics of cannabidiol, already presented to the UK and EU authorities, give us solid grounds for the future of our UK and EU operations,” said Boris Baňas, founder and CSO of CBDepot.

CBDepot submitted the first ever CBD-specific dossier to be validated by the European Commission; that approval came one year ago, with the application now undergoing risk assessment by the European Food Safety Authority.

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