EFSA Updates EU Novel Food Catalog for Cannabinoids

The European Union updated its novel food catalog, and cannabinoids regulation now falls under novel food. A novel food is a foodstuff or ingredient that has not been sold as a foodstuff or ingredient in the European Union before May 15, 1997. The Novel Food Regulation (EU) no. 2015/2283 has entered into force on January 1, 2018. It contains an authorization procedure for food additives, food enzymes, food flavorings, and sources of food flavorings used or intended for use in or on foodstuffs and novel foods. A novel food may not be brought onto the European market without prior authorization.

New Cannabinoids Regulation Requires Verification

The new Regulation on novel foods replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017. Article 4 of the novel food Regulation (EU) 2015/2283 requires food companies to verify if the food or food supplements they intend to place on the EU market falls within the scope of the novel food Regulation (EU) 2015/2283.

Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested the European Food Safety Authority (EFSA) to update and develop scientific and technical guidance for the preparation and presentation of applications for authorization of novel foods.

In January 2019, the EFSA changed the entry in the EU Novel food catalog with a new entry on Cannabinoids. Before it may be placed on the market in the EU as a food or food ingredient, any product containing Cannabinoids requires a safety assessment under the Novel Food Regulation.

The EU Novel Food Catalog Guidelines for Cannabinoids

The catalog provides the following description of Cannabinoids: “The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9- tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9- THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8- THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalog for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.

Cannabinoids Regulation: Some Hemp Products Are Not Novel

Regarding Cannabis sativa L. the Novel Food Catalogue mentions: “In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities.

Products Excluded from New Novel Food Regulation

The new Novel Food regulation does not apply in the following cases:
• Food enzymes within Regulation (EC) No 1332/2008.
• Food additives within Regulation (EC) No 1333/2008.
• Flavorings for use in foods within Regulation (EC) No 1334/2008.
• Extraction solvents used in the production of foods within Directive 2009/32/EC approximating EU countries’ laws.
• GMOs for food and feed, covered by Regulation (EC) No 1829/2003.
• If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require authorization under the Novel Food Regulation e.g. food fortification requires authorization.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.