The FSA has set a deadline for CBD businesses to provide more information about cannabidiol (CBD) products and their contents. It also advises vulnerable groups not to take CBD, and healthy adults to take no more than 70mg a day.
CBD is one of many chemicals called cannabinoids. It is found within hemp and cannabis.
CBD extracts can be derived from most parts of hemp / cannabis plants. They are selectively extracted, concentrating CBD and removing or reducing other chemical components. This process means the final product is different from hemp.
Hemp and related products, such as cold-pressed oils, are not novel because there is evidence to show a history of consumption before May 1997. This is not the case for CBD extracts.
CBD status as a novel food
The novel food status of CBD extracts was confirmed in January 2019, and the FSA has updated the Novel Foods Catalogue to reflect this change.
The Novel Foods Catalogue is a way of recording decisions made on the novel food status of foods and food supplements. The catalogue itself does not have legal status. The European Commission uses this tool to show the decisions made on novel food status and it is these decisions that have legal status. This makes it clear that CBD extract and isolate products are legally novel foods.
There are currently no authorised CBD extracts or isolates on the market.
Food businesses should apply for authorisation of their CBD extracts and isolates. This is the only route to compliance for these CBD products. No separate arrangement has been made with any specific business or industry sector.
Applications can be made by following the links on the FSA’s Novel Foods page. In addition to submitting them to the European Commission as usual, it strongly recommends businesses also send them to the Agency to allow it to consider them. It says it can then give businesses guidance and answer any queries it may have, in order to ensure they progress at pace through oits UK authorisation process from 1st January 2021. They can be contacted at firstname.lastname@example.org
Deadline for businesses to have CBD applications validated
Businesses need to submit, and have fully validated, novel food authorisation applications by 31st March 2021. After this date, only products for which the FSA has a valid application will be allowed to remain on the market.
The Agency says it has advised local authorities that businesses can continue to sell their existing CBD products during this time, provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under drugs legislation. However, no new CBD extracts or isolates should be sold until they have the necessary authorisation.
The deadline applies in England, Wales and Northern Ireland. Novel foods regulations in Scotland are covered by Food Standards Scotland.
Article 4 applications
Article 4 of the Novel Food Regulations provides a consultation process for a business to check if their product is novel or not. An Article 4 submission is not a route to compliance for any novel food, including CBD.
Submitting an Article 4 request does not mean unauthorised novel products are permitted on the market. If a business submits an Article 4 request, they are expected to have not placed the products on the market until an answer is formed. This is not what has happened with CBD extract products as there are hundreds of products on the market without authorisation.
Submitting an Article 4 request will not alter any enforcement position and offers no protection against enforcement for unauthorised novel foods placed on the market.
If any business believes they have a significant history of consumption for their CBD extracts from before May 1997, they should follow the consultation process on the novel food page.
Safety of CBD products
The FSA has issued consumer advice on the consumption of CBD for healthy adults and vulnerable groups.
The Agency says it has discussed CBD with various trade bodies and many other organisations involved in the novel food and CBD industry and it will continue to do so. FSA says while it is important that it understands their views, it will not in any way endorse any specific trade body’s approach to the route to compliance for CBD extract products. There are no specific agreements with individual trade bodies and all businesses marketing novel CBD products are treated the same.
Although the Cannabis Trades Association (CTA) said it welcomes a Route to Compliance for the industry and its members, it says it is still of the opinion that natural (not isolates or synthetic forms) CBD products do not fall under the scope under the Novel Food schedule.