HempToday® May 5, 2020

Euro consortium will submit consolidated Novel Food application

A consortium led by the European Industrial Hemp Association (EIHA), will resort to the current EU food safety approval process for hemp foods and extracts while continuing to challenge those rules.Stakeholders in the consortium, which is being organized as a limited liability company, EIHA projects GmbH, disagree with changes made in January 2019 to the EU’s Novel Food catalogue which re-classified hemp leaves and flowers as well as extracts derived from those plant parts – including CBD – as Novel Foods.But with EU officials and some Member States failing to give any signals that the rules change will be reversed, the consortium has formed to help participating stakeholders get their products on the market legally by going through the Novel Foods approval process.

About the rules

Europe’s Novel Food rules were created as a food safety mechanism to control new, genetically or synthetically produced food products before market entry. Under the guidelines, Novel Foods are defined as those that were not consumed to a significant degree in the EU before May 15, 1997.If a food is considered novel it must undergo a pre-market safety assessment under the European Food Safety Authority (EFSA) before it can be legally marketed in the EU, an expensive and lengthy process which stakeholders say is hurting Europe’s hemp food and CBD producers.

How the consortium works

A consortium task force within EIHA is creating a list of 4 product formulations to cover every possible CBD related product, which will be consolidated into one Novel Food application, thereby reducing costs to producers.EIHA estimates that an individual company registering a single product under Novel Food guidelines would pay around €300,000. Depending on their size, companies may join the consortium for around €10,000 – €50,000. Those fees will rise over time, with initial founding members getting preferred membership rates, according to EIHA.The consortium will need a minimum €2 million in financing, with estimates that the required lab analysis of CBD and THC toxicology studies alone will cost €1.8 million. EFSA estimates 18-24 months for an application to be considered under Novel Food rules, but EIHA said the process could take longer.

Previous rules ‘workable’

EIHA has argued that hemp-specific Novel Food rules which existed before the changes in 2019 were “workable” for stakeholders, and have encouraged a return to those guidelines. Not doing so leaves Europe at a disadvantage in the rapidly growing global hemp food marketplace where big players such as China, Canada, the United States and Switzerland are aggressively competing, the Association has said.EIHA has a stated position that Novel Food categorization for hemp should apply only to genetically designed food products or enriched/isolated cannabinoids – and not to hemp leaves and flowers extracted using traditional extraction means and respecting the naturally occurring level of cannabinoids.

It’s just food

Those derivatives, including CBD, should be treated as any other food product or food supplement, EIHA contends. The Association carried out extensive research last year to prove that those parts of the cannabis plant, and extracts derived from them, have been in the European diet going back centuries.Hemp seeds, leaves and flowers, which have similarly shown up throughout European history as a common food, do not fall under Novel Food rules. EIHA said it will stick to its position on this, “while at the same time leading the hemp industry into the future by a sound and well-prepared Novel Food application process.”All business operators working with CBD-related biomass, extracts, oils, isolates and finished products, who are regular members of EIHA are automatically and mandatorily members in the consortium. The consortium will be executed thru the EIHA projects GmbH which in turn is wholly owned by EIHA. Companies who are not current members of EIHA must first join the Association to become consortium participants.

EIHA’s position on hemp extracts

• Leaves and flowers of industrial hemp plants are not Novel Foods, and should be regulated by the existing rules on food and food supplements. Extracts, from traditional extraction technologies, from hemp plants legally grown in Europe are not Novel Foods
• Whole-plant extracts, so called full spectrum extracts with naturally occurring level of cannabinoids are not Novel Foods. As long as a similar level of cannabinoids is maintained in final product, the product is not Novel Food.
• For consumers’ safety, EIHA proposes a maximum daily intake of 100 mg food and/or food supplements for an average adult.
• Genetically modified plants and synthetic material should be considered Novel Foods.