EIHA-led consortium to submit 4 Novel Food applications for CBD

Consortium led by the European Industrial Hemp Association (EIHA) to file 4 applications Novel Food for CBD, while continuing to question the need for these rules for natural, traditional hemp extracts.

To this end, EIHA has set up a limited liability company, EIHA Projects GmbH, which will bring together different members to submit joint Novel Food applications. It intends to submit 4 product formulations to cover all possible CBD-related products, which will be grouped into a single Novel Food application, reducing costs for producers.

EIHA estimates that an individual company registering a single product under the Novel Foods guidelines would have to pay around €300,000. Depending on their size, companies can join the consortium for around €10,000 to €50,000, a fee that will increase over time. All EIHA members already working with CBD biomass, extracts, oils, isolates and finished products are automatically and compulsorily members of the consortium. Companies that are not currently EIHA members must first join the Association to join the consortium.

The consortium will need a minimum of 2 million euros in funding, with the required laboratory analysis of CBD and THC toxicology studies alone estimated at 1.8 million euros. The European Food Safety Authority (EFSA) estimates that it takes 18 to 24 months to review an application. The first Novel Food application for CBD was filed in 2016 and has been validated March 31, 2020.

EIHA's position on hemp extracts

For the EIHA, leaves and flowers from industrial hemp varieties, as well as extracts derived from traditional extraction technologies, should not be classified as Novel Food, the underlying rule being that as long as a natural level of cannabinoids is contained in the final product, the product is not a novel food.

Conversely, synthetic extracts should be considered Novel Food.

«According to a survey we conducted among our members, 66% of EU companies are SMEs that probably can't afford their own toxicity studies. We are creating this NF application to protect the European Union's industrial hemp sector. It goes beyond a simple safety principle,» says Lorenza Romanese, EIHA General Manager.

EIHA's position is shared by the Syndicat Professionel du Chanvre (SPC). For Aurélien Delecroix, its President, «Cannabinoid isolates and concentrates have only very recently been obtained and marketed in Europe, unlike raw products (leaves and flowers) or those obtained by traditional extraction methods with concentrations relatively equivalent to those naturally present in the plant. This strategy therefore seems coherent to us.»