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Clifford Chance

Clifford Chance

Healthcare, Life Sciences & Chemicals

German Government confirms classification of CBD as novel food

More and more food manufacturers are trying to place cannabis-based products on the EU market, and many such products contain cannabinoids such as tetrahydrocannabinol or cannabidiol ("CBD"). However, CBD-containing foodstuffs are classified as novel food under the Novel Food Regulation (EU) 2015/2283. "Novel food" means any food (including food supplements) that was not used for human consumption to a significant degree within the European Union before 15 May 1997. It can only be placed on the EU market after prior authorisation by the European Commission.

In January 2019, the European Commission included CBD in its so-called "Novel Food Catalogue". According to the Novel Food Catalogue, there was no significant human consumption of CBD before 15 May 1997. Until today, CBD or CBD-containing products have not yet been authorised as novel food.

In Germany, the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, "BVL") recently published a (non-binding) press release according to which it is not aware of any case where CBD could be legally marketed in foodstuffs. Upon a formal request by various delegates of the German Bundestag and the parliamentary group of the Free Democratic Party (Freie Demokratische Partei, "FDP"), the German federal government has now also confirmed, through an official reply dated 25 July 2019, that CBD is to be classified as novel food. According to the German federal government, there is – in general – no evidence for any significant human consumption of isolated cannabinoids or extracts enriched with cannabinoids before 15 May 1997.

Moreover, the German federal government also clarified in its official reply that a previous publication of the European Commission, according to which foodstuffs containing specific parts of the hemp plant might not qualify as novel food, was repeatedly mistaken and, in particular, does not mean that all food derived from the hemp plant is legally marketable. As pointed out by the German federal government, it must always be assessed, on a case-by-case basis, whether a specific product has already been used to a significant degree as a foodstuff in the European Union before 15 May 1997. Otherwise, as in the case of CBD-containing foodstuffs, related products must be classified as novel food and then require a formal marketing authorisation before they can be placed on the EU market.

As set out in its official reply, the German federal government obviously shares the approach taken by the European Commission, which is to classify foodstuffs containing cannabinoids (and, in particular, CBD) as novel food so that related products will presumably not be marketable in Germany and the wider EU market without a previous marketing authorisation under the Novel Food Regulation (EU) 2015/2283.