The European Industrial Hemp Association has launched an industry consortium to share the burden of Novel Foods applications.
In the face of disparate and inconsistent regulation across the EU governing the production and marketing of CBD-related products, hemp industry body the European Industrial Hemp Association (EIHA) has launched a consortium aimed at streamlining regulation and sharing the financial burden incurred by Novel Foods applications for products derived from hemp and cannabinoids.
President of the EIHA Daniel Kruse said: “We only stand a chance if we jointly bear the exorbitant costs for the necessary toxicological studies and the long procedure ahead of us. This would not be affordable for a single hemp company.”
The EIHA’s Novel Food Consortium has already established a collaborative partnership with independent regulatory affairs consultancy ChemSafe, which will act as service provider and oversee laboratory toxicology analysis of products put forward for approval. Over the next two to three years, the EIHA anticipates investment of around €3.5m in ‘unprecedented’ toxicological studies covering the key cannabinoids CBD and THC, set to begin in August 2020.
Cannabinoids and Novel Foods regulation
Within European legislation, the term ‘Novel Foods’ covers food products which are relatively new to European consumer diets, and which are therefore considered to warrant additional scrutiny before they can be approved for sale in Member States. This can refer to ‘exotic’ or internationally sourced consumables which have only recently made their way to EU markets, such as chia seeds or noni juice; synthetic products with new or artificially altered primary molecular structures; foods derived or extracted from microorganisms, such as algae oil; or foods produced via new or uncommon manufacturing processes, such as the treatment of milk with ultraviolet light.
The European Commission updated its Novel Foods Catalogue in January 2019 to include both extracts of the cannabis sativa L plant and synthetically produced cannabinoids. While the catalogue is not a legally binding document, it is widely used by EU regulators and policymakers to determine which products fall under the EU Regulation on Novel Foods. The inclusion of cannabinoids and cannabis extracts in the Novel Foods Catalogue has meant that these products must be submitted for pre-market authorisation: a process which is both time consuming and expensive, with applications taking around two years and costing up to €500,000 for a single product.
The official position of the EIHA is that cannabinoids extracted from the hemp plant do not technically constitute Novel Foods under the terms of the EU’s Novel Foods Regulation. According to the EU’s definition, a food product is novel if it has not been ‘used for human consumption to a significant degree within the [European] Union before 15 May 1997’; the EIHA contends that, as hemp and hemp-derived products have been widely used around the world for centuries, hemp and its extracts – including cannabinoids – do not fit into this category. Nonetheless, while cannabinoids are officially defined as Novel Foods for regulatory purposes – and while Member States continue to implement widely differing levels of enforcement of the regulations – the association has acted on behalf of the European hemp industry to secure the necessary approvals.
Building the Novel Food Consortium
The Board of the EIHA members first proposed the concept of an industry-wide consortium to navigate the intricacies of Novel Foods applications in June 2019 at a meeting of the association’s annual general meeting (AGM). After establishing a partnership with ChemSafe and designating an expert taskforce, the consortium was officially approved by member vote at the June 2020 AGM. Regular members of the association will automatically be granted membership of the consortium; and, once the consortium has attained approval for its product applications, those members will be able to market their products within the EU with a five-year exclusivity. In order to ensure all its members are appropriately served, the Novel Foods Consortium will submit parallel applications for authorisation to the European Food Safety Authority, for EU approval; and to the UK’s Food Standards Agency.
EIHA Managing Director Lorenza Romanese said: “We will accompany all EU companies that wish to join the consortium and believe in our solution, trust our competences and rely on the professionality of the team behind this project. By covering all the possible range of toxicological studies for both molecules, CBD and THC, this project represents the most comprehensive response that we can give to authorities. It is science-based; and it is the only way in which we can invert the unfair status quo. We cannot guarantee the success of the application, but what we can ensure is that we will put all of our efforts into this project that will change history.”