EU Regulations on Cannabis and Novel Food Authorizations

Home | Canna Law Blog | Cannabis and Novel Food Authorizations in the EU: Q&A Table of Contents Toggle 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. Check Out Our Cannabis Law Services Share Twitter Facebook LinkedIn E-mail Comment Fred Rocafort Fred leads Harris Sliwoski’s intellectual property practice and is the coordinator of the firm’s international team. Much of Fred’s practice consists of helping cannabis businesses protect their brands. He also works with entrepreneurs and companies entering the Web3 space, a new frontier for IP law. Prior to joining Harris Sliwoski, Fred worked overseas for more than a decade, in both government and private sector roles. Fred is a regular contributor to the award-winning China Law Blog and Canna Law Blog. Fred began his career overseas as a U.S. consular officer in Guangzhou, China, where he advocated for fairer treatment of American companies and citizens in China and for stronger intellectual property rights enforcement. After entering the private sector, Fred worked at a Shanghai law firm as a foreign legal advisor and later joined one of the oldest American law firms in China, helping foreign companies navigate the Chinese legal environment. He also led the legal team at a Hong Kong-based brand protection consultancy, spending most of his time out in the field, protecting clients against counterfeiters and fraudsters in Greater China, Southeast Asia and Latin America. In addition to his IP work, as a native Spanish speaker, Fred works closely with different Harris Sliwoski teams on Latin America and Spain matters. Fred also provides advice to cannabis industry participants and other businesses on import and export transactions. Fred is an ardent supporter of FC Barcelona—and would be even in the absence of Catalan forebears who immigrated to Puerto Rico in the mid-1800s. Harris Sliwoski Attorney Read more posts [email protected] Read More Hemp/CBD, International Cannabis Law Related Posts September 25, 2026 DEA Enforcement in a Changing Cannabis Landscape: Rescheduling, Hemp, and What Comes Next September 17, 2026 The Supreme Court May Decide if Cannabis-Related Residency Requirements are Unconstitutional September 16, 2026 A $31.8 Million Cannabis-Related Verdict That a Federal Court Wouldn’t Enforce September 15, 2026 Jason Adelstone Moderates Federal Cannabis Policy Discussion at IgniteIt Denver September 11, 2026 Medical Marijuana in Schedule III Survives Its First Major Challenge September 10, 2026 How to Acquire a Colorado Cannabis License September 4, 2026 The Intoxicating Hemp Products Ban Was Delayed a Month. Now What? August 31, 2026 Is the Global Shift to the Right Threatening International Cannabis Reforms? August 28, 2026 Oregon Cannabis Roundup: Fall 2026 August 26, 2026 Five Bills Every California Cannabis Operator Needs to Track in 2026 August 14, 2026 California Cannabis Contracts After Rescheduling: Why Your Contracts Need a Second Look August 4, 2026 DCC License Conversions After Rescheduling: How and When to Split A/M Licenses in California August 3, 2026 The Contradictions of Cannabis Law: From the United States to International Treaties July 28, 2026 What California Operators Must Do After Rescheduling: DEA Registration, License Restructuring, and 280E July 24, 2026 Medical Marijuana Schedule III Litigation: The D.C. Circuit's First Major Test Leave a comment Cancel reply