EDITOR'S SPOTLIGHT: SCIENCE & REGULATION
Cannabis group cites uncertainty in refusal to submit Novel Foods application
In a statement by the UK-based group, members voiced its opposition to submitting an Application covering cannabinoids and extracts of cannabis.
“Embarking on this application process would mean that the products detailed, within any products, would have to come off the market until such a time as an authorisation is granted as the transitional measures to allow the continued sale ended on the 1st Jan 2019,” the CTA states.
Explaining its decision, the Association says cannabis extracts are not novel and there has been no legally binding determinations on the status of cannabis extracts and their Novel Food status.
The Hull-based group, which counts Cibdol, Kanabo Research and MedCan Pharma as members, adds that all statements pertaining to the Novel status made by the European Food Standards Agency (EFSA) and Member States are currently only opinion.
“Any opinions made by the EFSA cannot be legally relied upon to secure a prosecution for breach of the Novel Food Regulations (NFR),” they say.
“The Novel Food Regulations state it is the Food business operator’s responsibility to determine a food falls within the scope of the Regulation.
“We put forward that there is no requirement to submit an application for a Novel Food as it’s our opinion cannabis extract are not Novel.”
Legal clarification required
While there is no need for Novel Foods applications to be made for cannabis extracts, the industry group reiterates the need for legal clarification to determine whether extracts are Novel or not.
In discussions with EFSA and the EU’s Health and Food Safety (SANTE), the CTA proposes a legal route to reach a definitive clarification that has the backing of Member States.
As part of this process, the CTA will ask all committee members of the Novel Foods Working Group to agree to a process that makes any enforcement action against any CTA member unlawful.
As such, ensuring that only products and sellers registered with the Association are proven to be safe and legal by its legal team.
“We will provide data to every EU member state to show that our members are selling compliantly and that their products are fully compliant with what we believe is not a Novel Food,” the CTA says.
“We will also introduce TrustCanna, an independent expert panel regulating and registering sellers and products to the Member States to certify that a product is safe, legal and as described.
“From farmers, to producers, manufacturers and resellers. Any business in the supply chain can register and TrustCanna certify their products as compliant.”
The Novel Foods challenge
“There is the European Industrial Hemp Association (EIHA) and the CTA, which do not think that hemp products containing cannabidiol (CBD) should not be considered Novel. They intend to go down the Article 4 clarification route,” he says.
On the other side is the Centre for Medicinal Cannabis (CMC), another UK industry group, who firmly believe these products are Novel and intend to seek market authorisation from EFSA on behalf of their membership.
There is also the Czech Republic firm Cannabis Pharma, currently the only pending application for the authorisation of a CBD food supplement from EFSA.
“For me, that route is also fraught with risk as getting authorisation is very expensive and time consuming,” Jappie says.
“In addition, by the letter of the law, you are not allowed to sell your product in the meantime whilst you’re waiting for authorisation.
“If the CMC are looking to go down this route, they may have secured a concession from EFSA to allow their membership to continue to sell their products whilst the application is being considered. But that is speculation on my part.”
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