EU Commission – CBDs has to be considered novel food

For those who are still trying to find “alternative” routes to the EU market for CBDs, the following Q&A of the EU Parliament and EU Commission shall clarify the situation once and for all.

QUESTIONS In its ruling of 19 November 2020, the Court of Justice of the European Union ruled that cannabidiol (CBD) ‘does not appear to have any psychotropic effect or any harmful effect on human health’(1). In the following week, the Commission stated that ‘in light of the comments received from applicants and of the recent Court’s judgment in case C-663/184, the Commission has reviewed its preliminary assessment and concludes that cannabidiol should not be considered as drug within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 in so far as it does not have psychotropic effect. As a consequence, cannabidiol can be qualified as food, provided that also the other conditions of Article 2 of Regulation (EC) No178/2002 are met. 1. Does the Commission have information about why the Irish Government has not acted on these developments? 2. Why is it that small businesses are still being raided and harassed(2) even though they are selling items such as raw hemp and CBD, which can both be qualified as food?

(1)1.C-663/18, B S and C A (Commercialisation du cannabidiol- CBD)2020 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62018CJ0663 (2)https://www.irishexaminer.com/news/munster/arid-40226360.html

EU COMMISSION ANSWERS

Member States have the primary responsibility for transposing, applying and implementing EU law correctly. The Commission assists Member States in this task and ensures that the EU law is applied correctly.

In particular, the products the Honourable Member refers to may be considered as medicinal ones in accordance with the rules laid down in the Medicinal Products Directive. In light of the jurisprudence of the Court of Justice of the EU, Member States are responsible for assessing the characteristics of the product in question on a case-by-case basis to determine whether a product qualifies as a medicinal product or not.

If not, the Commission considers that cannabidiol (CBD) can be qualified as food provided that also the other conditions of Article 2 of Regulation (EC) No 178/20022 are met.

Additional conditions for its placing on the market apply, in line with the EU acquis.

Foods which were not used for human consumption to a significant degree within the Union before 15 May 1997 and fall under at least one of the listed categories are subject to the Novel Foods Regulation.

In 2019, Member States considered that no history of human consumption for cannabidiol as food before 15 May 1997 could be demonstrated, and that it should be regarded as ‘novel’, and thus be subject to the novel food Regulation. Such products must therefore go through a pre-market authorisation process, which includes a safety assessment by the European Food Safety Authority (EFSA). To date, no CBD product has been authorised as a novel food in the European Union.