EIHA versus BVL: Cannabidiol (CBD) not necessarily subject to registration as a novel food

CBD-containing products are not generally covered by the Regulation for novel foods subject to authorisation
In the opinion of the Federal Government and the Federal Ministry of Food and Agriculture (BMEL) only CBD isolates and CBD-enriched hemp extracts are obviously novel

The European Industrial Hemp Association (EIHA) has achieved a groundbreaking success in the discussion about the generally permissible trade and sale of CBD-containing products. According to the report, the German Federal Government and the Federal Ministry of Food and Agriculture (BMEL) have clearly endorsed the view of the EIHA: Foodstuffs containing parts of the hemp plant are in principle not “novel” foods within the meaning of Regulation (EU) 2015/2283. However, this does not automatically also apply to isolated CBD (cannabidiol) or extracts enriched with CBD “Thus, hemp food products made from traditionally produced extracts with the natural full spectrum of the cannabinoids contained in the hemp plant are not novel foods. For the German hemp food industry this statement by the government and the ministry is an important milestone”, says Daniel Kruse, President of the EIHA.

The controversy was triggered by a publication of the Federal Office of Consumer Protection and Food Safety (BVL) on its homepage on the subject of “Food supplements with cannabidiol (CBD)” of 20.03.2019:

“The BVL is currently not aware of any case in which cannabidiol (CBD) could be found in foodstuffs, i.e. also in food supplements.”

The BVL will continue to publish information on its homepage at another location:

“In the view of the BVL, for products containing CBDs, either an application for authorisation of a medicinal product or an application for authorisation of a novel food must be submitted before the products are placed on the market. In the context of these procedures, the safety of the product shall be demonstrated by the applicant.”

The EIHA considers the above general assessment made by the BVL regarding the alleged lack of marketability of food supplements containing CBDs to be factually and legally incorrect and inaccurate. From the point of view of the EIHA, this assessment by the BVL would mean that all hemp foodstuffs would fall under the Novel Food Regulation and would therefore be subject to authorisation.

“This is so not right. CBD is a completely natural, non-psychotic ingredient of industrial hemp and has been consumed for thousands of years via the hemp seeds, flowers and leaves and processed into high-quality food, including through traditional extraction techniques,” says EIHA President Kruse. “The BVL must differentiate between extracts with the natural full spectrum of cannabinoids contained in the hemp plant on the one hand and products enriched with isolates or with cannabinoids on the other. Otherwise there will be even more uncertainty for the hemp food industry and consumers in Germany”.

The BVL does not take the following facts into account in the generalised statements made so far:

– Cannabidiol (CBD) is a natural substance contained in the crop Cannabis sativa L., which is from EU-certified cultivation and which has always been and still is mainly found in the flowers and leaves of this plant, along with other cannabinoids.

– The aforementioned plant Cannabis sativa L. (“hemp”) and its parts, namely its seeds as well as its processed flowers and leaves, are, in the opinion of the Federal Government, “foodstuffs” within the meaning of Section 2(2) of the LFGB in conjunction with Article 2 of Directive (EU) 178/2002 and thus not medicinal products and therefore do not require a marketing authorisation as medicinal products.

– The consumption of CBD-containing parts of the plant Cannabis sativa L., in particular hemp leaves or flowers or their extracts, was already taking place to a considerable extent within the EU or its member states before the Novel Food Regulation came into force on 15.05.1997. Therefore, cannabis products containing CBDs are not “novel” and therefore do not require prior authorisation under Article 6 of Regulation (EU) 2015/2283 (so-called “Novel Food Regulation”).

– Plant products containing CBD can therefore be marketed both as foodstuffs and as food supplements.