We recently got to ask Kai-Friedrich Niermann of KFN+ Law Office some questions about EU Novel Food authorizations. His answers are a must-read for cannabis food businesses interested in the EU market.
1. What is an EU Novel Food authorization?
Novel foods are regulated in the European Union by the so-called Novel Food Regulation (Regulation (EU) 2015/2283). In principle, all foods that were not consumed to any significant degree in the European Union before 1997 are considered novel foods.
A novel food catalog is maintained in which the status of a food can be reviewed. With this catalog, the EU Commission summarizes the information it receives from member states on the status of a food. In January 2019, the catalog was amended to classify extracts from industrial hemp containing cannabinoids as a novel food.
2. What are the main challenges for a hemp/cannabis/CBD businesses seeking a Novel Food authorization?
The purpose of the Novel Food Regulation is to ensure a high level of protection in food safety. An application for approval as a novel food therefore requires extensive toxicological studies to confirm the safety of the product. In the case of industrial hemp extracts, the focus is particularly on cannabinoids such as CBD and THC.
Most recently, the European Food Safety Authority (EFSA) informed applicants that more data was needed on the interaction of CBD with the liver. But also the allowed content of THC in hemp foods has been controversial for years and previous guideline, the so-called acute reference dose or ARfD (1 µg Delta 9 THC/kilogram body weight), is much too low. Hardly any hemp food manages to comply with this guideline value.
Through extensive toxicological studies with animal experiments and human exposure, a limit value must now be determined that is realistic, enables the legally secure and economical marketing of hemp foods, and still offers a sufficient level of protection.
3. What is the European Industrial Hemp Association’s Novel Food Consortium and how does it help address the issues described above?
The EIHA is the representative body of the European hemp industry in Brussels. A total of 250 members have joined forces and raised an amount of EUR 4 million to submit a joint application for approval as a novel food to the European Commission for a quartet of different CBD product formulations (Isolate, Gold, Regular, and Raw).
Toxicological studies are already underway, with approval for CBD isolates expected in one year, and for full spectrum products in two years. The enormous costs involved in the application for approval therefore do not have to be borne by one company alone, but are thus spread over many shoulders.
4. How can businesses join the consortium?
Any company can join the consortium. Membership in EIHA is required, as well as the conclusion of a project contract with EIHA projects GmbH. The fees are graduated according to the turnover of the company. The annual fee for membership in the association in the lowest level (annual turnover under EUR 1 million) is EUR 2500, and for participation in the consortium EUR 25,000. This sum can be paid in three installments. For members with turnover that exceeds EUR 50 million, the annual membership fee is EUR 25,000, and the consortium participation fee is EUR 413,000. These fees increase every six months.
5. Are there relevant Novel Food laws and regulations at the national level in EU countries, which businesses need to bear in mind?
The classification of a food as a novel food often starts with one EU member state alone, which then convinces other EU members and the EU Commission to also classify it as a novel food. In this respect, the market must always be monitored very closely. In Germany, for example, hemp leaves as tea products are classified as a novel food by some authorities. Poland’s Supreme Administrative Court overruled a lower court that had sided with the country’s Chief Sanitary Inspectorate’s finding that unprocessed hemp products are novel. Ireland, for its part, classifies cold-pressed hemp oils as non-novel, although they contain cannabinoids. NCBFAA In such a case, one can then resort to the EU regulations on mutual recognition of goods, which of course does not make the matter any easier.