Fears that the European Commission (EC) may once again change its position on the status of CBD have faded after it validated its first Novel Food applications for natural Cannabis extracts.
At least five companies have thus been informed by the EC that their Novel Food dossiers relating to CBD have reached one of the last stages of the Novel Food process.
The companies – CBDepot, based in the Czech Republic, PharmaHemp, based in Slovenia, the Swiss company Linnea, the French company Spectrums Europe and the UK branch of Brains Bioceutical – have been informed and their contact details published on the Novel Food portal.
The EC would not confirm if any other imminent additions were planned. She only confirmed that she had validated Novel Food’s claims from “a number of companies.”
A two-year delay
This breakthrough was welcomed as great news by the industry, as many of the EC’s 130 Novel Food Authorization applications have been in process for more than two years, raising widespread concerns about what delay.
Some of these concerns stemmed from the International Narcotics Control Board’s determination that all parts of cannabis pants fall under international drug laws.
This followed the EC’s change of position in July 2020 when it wanted to consider CBD as a narcotic, a decision it reversed a few months later following the KanaVape decision of the Court of Justice of the Union. European (CJEU).
In December 2020, the EC declared that it was resuming the CBD Novel Food process and, almost 14 months later, these CBD validations were welcomed by one of the successful applicants Boris Baňas, Founder and Chief Sales Officer of CBDepot .
He told BusinessCann, “This is an important milestone for the industry. Finally, after more than a year, the EC officially recognized the CJEU’s decision in the KanaVape case.
“The validation of the herbal applications implies that these extracts are not in breach of the European Commission’s definition of a food – confirming that it no longer considers CBD to be a narcotic. »
“The EC has finally made it official that hemp extracts with negligible THC content do not fall under the United Nations Single Convention on Narcotic Drugs. This despite the fact that several UN agencies – such as the INCB – still claim the opposite. »
Next step after validation
The validation having been completed, the applications in question will now be examined by the European Food Safety Authority (EFSA).
The latter will deliver its scientific opinion “within nine months from the date of receipt, noting however that extensions are possible if additional data is requested,” an EC official told BusinessCann.
The official continues: “After the publication of the opinion of the EFSA, and in the event of a favorable result, the Commission has seven months to submit to the permanent committee (represented by the Member States) a draft act authorizing its marketing. . The draft act provides not only for the placing on the market of the novel food but also for the updating of the Union list (of novel foods). »
Adding that if “EFSA’s opinion is not favorable or for any other legitimate reason, the Commission may terminate the authorization procedure”.
