Cannabidiol (CBD) guidance for England and Wales
Business guidance on cannabidiol (CBD) as a novel food.
CBD is one of many chemicals called cannabinoids. It is found within hemp and cannabis and can be produced synthetically.
CBD extracts can be derived from most parts of hemp or 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. That is why CBD food products require authorisation before they can be sold legally in Great Britain (GB).
There are currently no authorised CBD extracts or isolates on the market.
Applying for authorisation
Food businesses must apply for authorisation of their CBD extracts, isolates and associated products to be placed on the GB market using our regulated product application service.
In most cases the applicant will be the manufacturer, but others such as trade bodies and other suppliers may also apply.
Once a CBD ingredient is authorised that authorisation applies to that ingredient only. This means using the same detailed production methods, for the exact same uses as described within the authorisation, and using the same safety evidence base.
The applicant may request that the newly developed scientific evidence or scientific data supporting their application is not used in subsequent applications for five years from the date of the authorisation of the novel food without their permission.
You need to apply for authorisation of your CBD extracts and isolates using the procedure for full novel food applications.
An important part of any CBD novel food application is a consideration of the product’s safety. Without such information or a justification for the delay in providing the necessary information, we will not be able to validate an application.
Meeting the validation standard does not mean the product will necessarily be authorised. Each application will be considered on its own merits. Applications will be progressed and potentially authorised only if directly relevant safety information is included.
For developing toxicological testing of CBD products, we recommend considering the EFSA guidelines on novel food applications. The guidelines suggest a repeated dose 90-day oral toxicity study following the OECD TG 408 protocol. The protocol should be modiﬁed to include assessment of additional parameters. These parameters are described in the more recent guideline on repeated-dose 28-day oral toxicity studies in rodents (OECD TG 407).
The Committee on Toxicity’s view is that there are several data gaps for CBD in the literature. These gaps and any indications from the literature, such as with repro-toxicology where there may be areas of concern, would provide a useful basis to further development of your testing plans. There is also the requirement for genotoxicity testing. This normally includes a bacterial reverse mutation assay (AMES test), an in vitro mammalian cell micronucleus test, and a chromosome aberration test.
We suggest the test items used to generate studies are carefully chosen to ensure all novel ingredients being applied for are covered. Where safety is not demonstrated in the tests further studies may be required to explore specific issues identified. We encourage applicants to provide all studies at submission to allow for a complete risk assessment.
We cannot accept literature only to evidence safety of a CBD novel ingredient.
CBD food products linked to novel food applications
The list of CBD products linked to novel food applications contains CBD food products which meet the following criteria:
- they were on the market at the time of our announcement on CBD (13 February 2020)
- we received an authorisation application for the products by 31 March 2021
- we validated the application or agreed that it is sufficiently progressing towards validation
All CBD products must comply with other legislative requirements and should not be:
regarded as controlled substances
Any products which do not appear on the list or are marked as ‘Removed’ must be withdrawn from the market, as the related novel food application has been deemed unsuitable for progressing to authorisation.
Search the list of CBD products
This list applies to England and Wales. You can find more information about CBD products in Northern Ireland in our CBD guidance for Northern Ireland. Novel foods regulations in Scotland are covered by Food Standards Scotland.
Other CBD food products
From the date of our announcement (13 February 2020), no new CBD extracts, isolates or associated final products using this novel ingredient, including new brands, should be put on the market until they have the necessary authorisation. A validated application is not sufficient to put new products on the market. We expect all other CBD products not on the list to be voluntarily withdrawn. Local authorities are responsible for enforcement and may remove these products from the market.
All applicants with invalidated CBD product applications have been requested to voluntarily remove their products from the market. You can find more information on our page on invalidated CBD authorisation applications.
Safety of CBD products
We have issued consumer advice on the consumption of CBD for healthy adults and vulnerable groups.
Sellers of CBD should be aware of this information and be able to inform consumers on the recommended maximum daily limit for healthy adults We advise that those who are pregnant, breast-feeding or taking medication should refrain from taking CBD as a precaution.