Cannabinoids and EU Novel Food Regulations
If your business could be affected by the recent changes to the EU Novel Foods Catalogue entry for cannabis and its derivatives, Hanway Associates would like to hear from you.
The European Union’s Novel Food Regulations ((EU) 2015/2283) state that any product considered to be ‘novel’ in food requires authorisation from the European Commission before it can be sold as a foodstuff in the EU. A food is considered ‘novel’ if it was not consumed in the EU to any significant degree before May 1997. This includes newly-developed food (eg Antarctic krill oil), food produced using new technologies (such as UV-treated food), and food with a history of consumption in countries outside of the EU (such as chia seeds). This applies to all foodstuffs, including food supplements, food ingredients, and substances intended to be incorporated into food.
Recent updates to the European Union’s Novel Foods Catalogue have occurred regarding the use of CBD, other cannabinoids and hemp-derived products in food. A recently-added submission for the term ‘Cannabinoids’ reads (emphasis added):
“Without prejudice to the information provided in the novel food catalogue 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.”
While the Novel Food Catalogue is non-exhaustive and carries no legal power, it is frequently updated and amended with input from Member States, and is used as reference by authorities in EU countries to aid enforcement of Novel Food Regulations. It has been reported that the UK was one of a group of countries which requested an update to the catalogue, due to a previous lack of clarity of the status of CBD and other hemp-derived products. The change has been followed by news that the UK Food Standards Agency will now seek to have CBD food products removed from shelves while the current application to authorise its use is considered. This may leave consumers unable to access CBD, and producers unable to sell products for up to 18 months.
Ongoing novel food application
Before a food considered ‘novel’ can be sold in the EU it must be authorised for use, following submission of an authorisation application to the European Commission. A foodstuff will be authorised only if it can be demonstrated that the product is safe, does not mislead the consumer, and is not nutritionally disadvantageous.
At present, a novel food application for CBD is under consideration with the European Food Safety Agency (ESFA), to authorise the use of CBD in food supplements for adults with a daily intake of up to 130 mg. The opinion of the ESFA is expected from March 2019. If the application is successful, the European Commission must draft an implementing act authorising the use of the product within seven months.
Until a further update from the EU, consumers, vendors and manufacturers may find that the sale of CBD oils, supplements and food is disrupted.
Please get in touch with Hanway Associates at firstname.lastname@example.org if your business could be affected by the recent changes to the Novel Food Catalogue.