The Novel Food regulation aims to establish a food safety mechanism to control newly developed, synthetic, or genetically produced food in the EU.
If a food is considered novel, it must be authorized by the EU Commission and undergo a pre-market safety assessment by the EFSA before it can be legally marketed in the EU.
In January 2019, Member States’ representatives updated the Novel Food Catalogue with “Cannabis sativa L.” and “Cannabinoids.”
CBDepot’s commitment to Novel Food compliance began in early 2016, shortly after the CBDex® brand was launched by Cannabis Pharma, the JV partner in CBDepot. Their EU application NF 2019/1371 was the first-ever CBD-specific dossier to have reached valid status on March 27th, 2020.
In early January 2021, CBDepot filed two Regulated Product applications with the UK Food Standards Agency (FSA) to grant access, post-Brexit, for its two grades of Cannabidiol to the most significant legal CBD food supplement market worldwide: application RP70, for Pure Cannabidiol with 4MP®- branded secondary products in the forms of carrier oils, measured dose spray, and chewable tablets, and application RP85, for Isolated Cannabidiol and CBDex®-branded secondary products in the form of carrier oils linked to this dossier.
In April 2021, the Regulated Products applications with the UK FSA are declared validated. Twelve Secondary Food Supplementary Products linked to the primary dossiers may remain on the UK market for legal sale while undergoing the final Risk Assessment Period.
“For CBDepot, the filling of the pre-submission dossier with EFSA for CBG as a Novel Food is a natural next step towards bringing the next non-psychoactive cannabinoid closer to food applications. Along with the dossier, CBDepot made the notification of related studies in line with the new Transparency Regulation having entered into force on March 27th, 2021,” says Boris Baňas, the co-founder and CSO of CBDepot.
CBDepot is a pioneer in the manufacture of high-quality natural and synthesized cannabinoids. With roots dating back to 2014, the company has been a leader in helping to establish legal and quality standards for cannabinoid-specific ingredients that have a fast-growing presence in sectors including foods, cosmetics, medical devices, and magistral formulas.