A French hemp industry trade association believes the consortium approach applied during the initial European novel food application process could again be the solution to the requests for additional data that have stalled the assessment process.
The Union of Industrialists for the Valorisation of Hemp Extracts (UIVEC) is calling for CBD firms to come together to form a consortium and share scientific data in an effort to clear the backlog of applications stemming from the halt on the process brought about by the European Food Safety Authority (Efsa) over questions on available data regarding the safety of CBD as an ingestible ingredient.
Associations such as the European Industrial Hemp Association (EIHA) and the Association for the Cannabinoid Industry (ACI) have already attempted to apply consortium approaches to novel food applications in the EU and UK. But the UIVEC believes that creating more consortiums is the only way the industry will be able to address the data concerns that have led Efsa to pause assessments, given the potentially enormous costs involved.
UIVEC president Ludovic Rachou (pictured, left) told CBD-Intel: “There’s an opportunity for companies to work together to supply the necessary data, and we’re sure there are firms that would be willing to engage in a consortium approach. We already have some ingredients manufacturers on board, and we’re reaching out to more firms and discussing the opportunity at industry events.”
The association plans to launch the consortium this autumn but admits that getting the industry on side and establishing consortium rules will be a long and complex process. The UIVEC has been consulting on the specifics, such as pricing and the levels of legal agreements that would need to be in place to ensure confidentiality.
Bonus benefits for consortium members
“Firms would obviously not want to share data with their competitors and would be working with independent contractors,” said Rachou. “Everything would remain confidential – it would be about making sure that the data provided is strong enough to meet the requirements for all the dossiers.”
Rachou admits that the novel food process has, thus far, been lengthy and burdensome for the industry but argues that many firms have already invested hundreds of thousands of euros on product development, and that this was really the only way to open up the market.
“We had an exchange with the European Commission a few days ago about how the process would work,” he said. “For example, how data could be shared between suppliers and what kind of non-disclosure agreements would need to be in place to ensure confidentiality. It’s a lengthy process and there are costs involved.”
The UIVEC says that firms could be grouped together according to the substance they are required to study – such as 95% CBD isolate, for example. Companies could share the cost of conducting a study and the resulting data.
“It doesn’t mean that Efsa would necessarily validate the dossier submitted, but it would share the cost of filling the data gaps and help everyone to achieve a consistent standard of data,” said Rachou. “No one wants to spend millions of euros on a new study with no guarantee of positive results, but at least this way the risk is shared.”
Waiting on the Supreme Court
Rachou predicts it will take at least two years to start clearing Efsa’s dossier backlog. In the meantime the association is also attempting to influence events at a national level. The UIVEC is looking to lobby French authorities ona variety of issues as the country looks to implement further regulations on CBD products.
“CBD products are everywhere in France, and we have a duty to the French people to ensure that products on the market are safe,” he said. “So we’ve been talking with the authorities in a bid to establish some guidelines for a transition period, such as lower dosage levels, appropriate instructions on labels and packaging, and recommendations for mixing CBD with other medication.”
French CBD firms face further uncertainty as they await the decision of the Supreme Court on the ban of the sale of hemp flower, which was temporarily overturned at the start of the year. UIVEC general delegate Zoé Demange (pictured, right) predicts that the industry will have the final decision from the courts this autumn.
“The uncertainty has been painful for the industry,” she said. “Shops are still selling flower, but the market seems to be slowing. The market in France is very crowded. There are a lot of CBD shops and now that tobacconists have started to sell CBD products as well, they’re making competition even tougher for the specialist shops. Prices are being cut, which could potentially impact quality.
“If the courts allow flowers to remain on the market in France, they’ll be treated in the same way as a tobacco product, which means tobacconists could be the only outlets allowed to sell them. I don’t believe the ban will become permanent, but there will be some new legal proceedings as a result.”
- Ludovic Rachou and Zoé Demange will be speaking at the CBD Hemp Business Fair in Barcelona on 7th October.
- The UIVEC is launching, via the International Bureau for Analytical Studies (BIPEA), an inter-laboratory ring test designed to compare analytical methods and results from various labs within the EU, with the goal of validating a preferred and harmonised method for testing hemp extracts.
– Lorraine Mullaney CBD-Intel staff