CBD products and “Novel Food” authorisation

The past few years have seen the rise of CBD products on the market. Cannabidiol (CBD) is a cannabinoid and its extracts can be obtained from hemp or cannabis plants. Boasting benefits of wellness, claims of reducing anxiety and bestowing a calming effect through use, everything from shampoo to tea to chocolate has been infused with CBD and is being widely sold over the counter. Its meteoric success has meant that controls and regulation surrounding CBD products is now playing a game of catch-up.

The FSA's approach

Of particular focus are products where CBD is being consumed and a pathway for regulatory compliance in the UK is being paved by the Food Standards Agency (FSA), an authority on food safety in England and Wales. The FSA (now that the EU Transition Period has ended) is continuing to align itself with the European Commission’s (EC) confirmation in 2019 of CBD extracts as a “Novel Food”.

The Novel Food Regulation (Reg 2015/2238) states that a “Novel Food” is a food that has not been consumed to a significant degree by humans in the EU before 15 May 1997. Unlike the related product Hemp, which is not considered a Novel Food given its history of consumption before 1997, CBD’s lack of consumption before this date means it falls within the “Novel Food” category. Where a food has been classified as “novel”, it can only be put on the EU market where the EC has:

  • processed an application for the authorisation of the novel food;
  • has adopted an implementing act authorising its placing on the market; and
  • updated the EU list of novel foods.

Following Brexit, the FSA announced, in February 2020, that businesses selling CBD products in the UK for consumption must have submitted relevant novel food authorisation applications by 31 March 2021. This is the first step towards Novel Foods authorisation for products containing CBD for consumption to be sold in the UK. This is the only route for compliance for such products in the UK. In most cases the applicant will be the manufacturer but others such as trade bodies and other suppliers may also apply. The application requires businesses selling these products to detail the way in which they are manufactured as well as data to prove the safety and compliance of the product. If authorisation is granted, the authorisation applies to that specific product only and to it being manufactured in the way specified in the application.

Where businesses have submitted applications to the EC, they were also required to submit an application to the FSA by the March deadline. The FSA previously confirmed that after 31 March 2021, only businesses that were already selling CBD products for consumption before the FSA’s announcement of the deadline in February 2020, may continue selling in England and Wales provided they have submitted a validated application to the FSA. A validated application is an application that has been received and includes all the data the FSA (or FSS) requires with full authorisation taking at least a year after validation has been granted. The position for newcomers to the market after February 2020 differ as they may only sell their product on the market provided they have received full authorisation, not simply just submitted a validated application.

The position in Scotland

Novel Foods in Scotland are regulated by Food Standards Scotland (FSS) which has been working closely with the FSA encouraging businesses selling CBD products for consumption to get a novel foods application into the FSS (via the FSA) by the March deadline.

On 17 December 2020, as the Transition Period was coming to an end, the FSS clarified their position in Scotland in a statement to the Association for the Cannabinoid Industry and its members:

“All businesses intending to sell food items containing CBD should not place their products on the market until they have applied for, and received, authorisation from the EU or, from 1 January 2021, Food Standards Scotland.

We urge businesses with products already on the market to lodge an application for authorisation of a novel food without undue delay”.

The approach in Scotland differs from that being taken by the FSA in England and Wales in a key way: a validated application alone is now no longer sufficient in Scotland following the passing of the March ddeadline. Having said this, the FSA has made clear that in terms of enforcement, it has recommended Scottish Local Authorities (who are responsible for the enforcement of food safety measures), take a “proportionate approach”. This means Local Authorities should take into account whether a business has taken steps towards becoming compliant when deciding whether products are to be removed from shelves in Scotland.

How can we help?

At MacRoberts, we understand that the CBD market shows no signs of slowing down and instead is a quickly growing market with huge potential. We are here to assist you and your businesses in navigating through the regulatory compliance. Please contact our Food and Drink team if you have any related queries and we would be happy to help.

This article was co-written by Anita Dhesi, Trainee Solicitor.

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