In January 2019, the entries Cannabis sativa L. and Cannabidiol/ Cannabinoids were clarified in the Novel Food catalogue available on the website of the European Commission. 

Novel Food is a food that was not used for human consumption to a significant degree in the European Union before 15 May 1997, irrespective of the date of accession of Member States to the Union. According to EU rules, anyone wishing to sell food containing a novel food ingredient must first obtain a license from the European Food Safety Authority (EFSA).

As regards the plant for any use, it is recalled that in the European Union, the cultivation of varieties of Cannabis sativa is authorized provided that they are registered in the Common Catalogue of varieties of agricultural species of the European Union and that the tetrahydrocannabinol (THC) content does not exceed 0.2% (w/w). 

Can I produce or market products containing CBD?

All kinds of products containing CBD can be produced and marketed, as long as they are not intended for human consumption.

This possibility is based on the fact that CBD is considered a “Novel Food” in the EU Catalogue, and this consideration means that the human ingestion of these foods is not allowed in the EU for safety reasons. 

According to the Novel Food catalogue, some products derived from Cannabis sativa plants or plant parts, such as seeds, seed oil, defatted hemp seed meal, have a history of consumption in the European Union and are therefore not new. 

In mid-July 2020, it was announced that the EU was suspending the publication of new food guidelines for CBD-containing foods and was considering labelling such foods as narcotic. We thought the US policy on CBD in food was bizarre, but the EU is trying to reach the heights of absurdity.

On 19 November 2020, the Court of Justice of the European Union concluded that CBD (cannabidiol) extracted from the Cannabis sativa plant does not constitute a “narcotic drug” because it does not appear to have a psychotropic effect or a harmful effect on human health on the basis of the available scientific data.

This judgment (Case C 663/18) follows a reference for a preliminary ruling concerning French legislation restricting the industrialisation and marketing of hemp to fibre and seeds only (Order of 22 August 1990).

This ruling is not specific to food and does not alter the fact that CBD (Cannabis sativa extract or synthetic) is considered a novel food under Regulation (EU) 2015/2283, and that CBD can only be used in food with a specific authorisation granted under Regulation (EU) 2015/2283. 

However, this opinion of the European Court of Justice should be a good argument for the European Commission to reconsider its preliminary opinion and agree to send the CBD novel food applications extracted from Cannabis sativa to EFSA for scientific evaluation.

The criminal lawyer specializing in CBD, Joan Bertomeu, of the Brotsanbert law firm, points out that “the recognition of the first Novel Food licenses” would take the conflict from the “regulatory” to a question of “direct application of EU law”.

 

Each EU state must decide whether each CBD product is sold as medicine or food

Under current EU legislation and in light of the case law of the European Court of Justice, the national authorities of the member states, acting under the supervision of the Courts, are responsible for assessing the characteristics of the product in question on a case-by-case basis to determine whether a product is considered medicinal or edible,” explains Health and Food Safety Commissioner Stella Kyriakides in the response on behalf of the European Commission. “Where CBD products are considered edible, additional conditions apply to their placing on the market, in line with the EU acquis [binding laws],” which amount to the New Food requirements as detailed below.

“This includes the requirements detailed in the Novel Food Regulation, according to which Novel Foods must be assessed by the European Food Safety Authority and authorised by the Commission before being placed on the EU market. The Commission has received several applications for authorisation of CBD as a Novel Food”.

“Until such authorisation is given, unauthorised novel foods cannot be imported into the EU to be placed on the EU market as such or used in meals”, leaving room for other operations that would be limited for drugs but not for CBD, such as storage or transfer.

“In short, the recognition of the first Novel Food licenses would turn a conflict that is currently one of regulatory interpretation into one of direct application of EU law by the states,” concludes Bertomeu. 

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