Q&A: Cannabis and Novel Food Authorizations in Europe

Kai-Friedrich Niermann, KFN+ Law Office, was kind enough to answer some questions regarding EU Novel Food Authorizations. For cannabis food businesses that are interested in the EU market, his answers are a must-read.
1. What is an EU Novel Food Authorization?

The EU’s Novel Food Regulation (Regulation EU 2015/2283) regulates novel foods. All foods that were not consumed in any significant amount in the European Union prior to 1997 are considered novel foods.
A new food catalog is maintained that allows for the review of the current status of a food. The EU Commission compiles information from member states about the status of food with this catalog. The catalog was updated to include extracts from industrial hemp containing cannabis as a novel food in January 2019.

2. What are the main obstacles for CBD/Cannabis/Hemp businesses looking to obtain a Novel Food approval?

The Novel Food Regulation’s purpose is to provide high levels of food safety protection. To confirm the safety of a novel food, a request for approval must be supported by extensive toxicological studies. The focus in industrial hemp extracts is on cannabinoids like CBD and THC.
The European Food Safety Authority (EFSA), recently informed applicants that more data is needed about the interaction between CBD and the liver. The allowed amount of THC in hemp foods is controversial. In fact, the previous guideline, or acute reference dose (ARfD) (1 ug Delta9 THC/kilogram weight), was not enough. This guideline value is not met by any hemp food.
Extensive toxicological studies involving animal experiments and human exposure have now led to the determination of a limit value that is both realistic and allows for legal and economical marketing of hemp foods while still providing sufficient protection.

3. What is the European Industrial Hemp Association’s Novel Food Consortium? How does it address the above-mentioned issues?

The EIHA, the representative body for the European hemp industry in Brussels, is the EIHA. 250 members joined forces to raise EUR 4 million to submit a joint request to the European Commission to approve a novel food. The four different CBD product formulations (Isolate/Gold, Regular, and Raw) were submitted.
Toxicological studies have already begun. CBD isolates are expected to be approved in one year and full spectrum products in two. The immense costs associated with the application for approval are not only borne by one company, but are spread across many companies.

4. How can businesses join the consortium

Any company can join this consortium. EIHA membership is required. The fees are based on the company’s turnover. For membership at the lowest level (annual turnover below EUR 1 million), the annual fee is EUR 2500. Participation in the consortium costs EUR 25,000. This sum can be paid in three installments. The annual membership fee for members with a turnover exceeding EUR 50 million is EUR 25,000. The consortium participation fee costs EUR 413,000. These fees are subject to an increase every six months.

5. Are there any relevant Novel Food laws and regulations at national level in EU countries that businesses should be aware of?

A food is often classified as a novel or unusual food by one EU member state. This convinces the EU Commission and other EU members to classify it as such. This is why the market must be closely monitored. Some authorities in Germany have classified hemp leaves as tea products as novel foods. The Supreme Administrative Court of Poland overturned a lower court’s decision to support the Chief Sanitary Inspectorate’s conclusion that unprocessed hemp products were novel. Ireland, on the other hand, considers cold-pressed hemp oils non-novel even though they contain cannabinoids. NCBFAA In such cases, one can resort to EU regulations on mutual reconnaissance of goods. This is of course not an easy solution.