The seed and flower markets in the hemp sector have distinct dynamics. For seeds, the market includes food products, cosmetics, and oil extraction sold as food supplements. Understanding the regulatory landscape for seeds, particularly regarding cultivation and sale, is vital. In Europe, a select number of seed producers specialize in dehulling the seeds and processing them into finished products, or alternatively, selling the seeds in their raw form. They are mainly located in Romania, Germany, Estonia, Lithuania.
The flower market, especially for CBD products, is complicated by regulatory challenges. Until recently, most hemp extracts in the EU were domestically produced, with CBD isolates being imported from the US and China. However, regulatory barriers have limited the processing of hemp flowers in Europe, particularly for CBD isolate production due to high costs and insufficient biomass yield. The market primarily focuses on smokable products where legal, but clearer regulations could foster a broader range of uses and stimulate local value chains.
Since the 1st of January 2019, when CBD and hemp extracts were categorised as Novel Foods (NF), requiring authorisation by the EFSA before entering the EU market, the European Industrial Hemp Association (EIHA) has been engaged in helping operators. In November 2019, during EIHA General Assembly, it was decided to establish the Novel Food Consortium. This initiative facilitates the submission of joint Novel Food applications, significantly reducing the financial burden on individual companies. To date, EIHA have invested €3.6 million in comprehensive toxicological studies on CBD and THC, supporting over 200 companies. The studies for NF applications to EFSA include two focused on CBD (Isolate and Full-spectrum hemp extract) and one clinical study on THC combined with CBD. The THC clinical study aim at validating safe exposure levels and potentially challenging EFSA's current unnecessarily low Acute Reference Dose for THC of 1 microgram/kg body weight. Any operator willing to market CBD isolate or full spectrum extracts must have an approved Novel Food application: joining the EIHA consortium is an alternative to pursuing an individual application to EFSA.