FEARS the European Commission will once more change its position on the status of CBD have receded after it Validated its first Novel Food applications for natural plant extracts.
BusinessCann understands at least five companies have been informed by the EC that their applications to sell CBD products have made it through to the final stage of the Novel Food process.
The companies – Czech-based CBDepot, PharmaHemp of Slovenia, Swiss firm Linnea, French company Spectrums Europe and the UK arm of Brains Bioceutical were notified and their details later posted on its Novel Food portal (see here).
The EC would not confirm whether there would be further imminent additions – it would only confirm it had validated Novel Food applications from a ‘number of companies’.
This progress has been welcomed as excellent news by the industry as many of the EC’s 130-plus CBD Novel Food applications have been in the pipeline for over two years, prompting concern over the delay.
As BusinessCann reported in Autumn 2021 some of these concerns stemmed from the International Narcotics Control Board’s determination that all parts of the cannabis pant fall under the international drug laws.
And, this had followed the EC changing its position in July 2020 when it deemed CBD a narcotic – a decision it reversed a few months later following the European Court of Justice (ECJ) KanaVape decision.
In December 2020, the EC said it was resuming the CBD Novel Food process and now – almost 14 months later – the CBD validations have been welcomed by one of the successful applicants Boris Baňas, founder and Chief Sales Officer of CBDepot.
He told BusinessCann: “This is a milestone for the industry. Finally, after more than a year the EC has formally recognised the decision of the ECJ in the KanaVape case.
“The validation of plant-based applications implies these extractives are not in breach of the definition of the European Commission’s definition of a food – which confirms that it no longer views CBD as a narcotic.
“The EC has finally formalised hemp extractives with negligible content of THC do not fall under the scope of the United Nations Single Convention on Narcotic Drugs. This is despite several UN agencies – such as the INCB – still claiming the opposite.”
Next Stage After Validation
With validation now complete the applications in question will now be examined by the European Safety Authority (EFSA).
It will deliver its scientific opinion ‘within nine months from the date of receipt, noting however that extensions are possible if further data are requested’, an EC official told BusinessCann.
The official continued: “After publication of the EFSA opinion, and in case the outcome is favourable, the Commission has seven months to submit a draft act authorising its’ marketing to the Standing Committee (represented by Member States).
“The draft act foresees not only the placing on the market of the novel food but also updates the Union list (of novel food).”
Adding that if the ‘EFSA opinion is not favourable or for any other legitimate reason(s), the Commission may terminate the procedure for the authorisation’.
In Step With The UK
In progressing these applications to the validation phase the EC is catching-up with the UK where three Novel Food applications for plant-based applications have made it thus far.
In 2020, the EC validated five synthetic CBD applications – see here – with the UK having validated three such applications.
All European and UK applications are now being examined by the relevant scientific experts as part of a comprehensive risk assessment before final Authorisation is determined.
Although many of the products allied to these applications are already on sale across the continent final Novel Food Authorisation will be a significant milestone of the CBD industry.
In the minds of regulators and Governments it will finally remove all doubts around the legitimacy of CBD products.
INCB Cannabis Initiative
Following the disclosure of the INCB’s Cannabis Initiative the EC told BusinessCann it believed that it is ‘important to maintain the coherence and compatibility of international law with the EU acquis’.
Going on to say ‘it was taking into account the work carried out by INCB’.
BusinessCann has approached the EC to see if it has reached a final determination on the narcotic CBD issue and is awaiting a response. Likewise we have reached out to Spectrums Europe, Linnea and PharmaHemp and are awaiting a response. BusinessCann will be publishing an article from Brains on its Novel Food progress over the coming days.