The agency recently published the latest public list which includes 12,000 products – up from 6,000 in March – and said it was grateful for “the help and cooperation of the CBD industry”.
The FSA’s Director of Policy, Rebecca Subworth, commented that the initial list prompted a number of companies to come forward with new evidence linking large numbers of individual products to existing applications.
As a result, the agency made a final call for evidence to support businesses in achieving compliance for their products.
“We think it is important we get this right, and it is encouraging that so many companies want to get their CBD products on the path to authorisation,” she said.
Although the list is now closed, businesses can continue to apply for authorisation of CBD food products through the regulated products process (for Great Britain) or via the European Commission for those wanting to sell products in Northern Ireland.
However, new applications will not be eligible for the public list and should not be put on sale until they have been authorised, according to the agency.
Market regulations
CBD extract acquired novel food status in January 2019. Under novel food regulations, any food or food ingredient with no history of consumption before May 1997 should be evaluated and authorised before they can be sold to the general public.
Authorisation is required to demonstrate products comply with legal, safety and content standards, to protect public health. Products need to be correctly labelled and not considered as being controlled substance.
To evaluate product credence, FSA requested submissions from the CBD industry to draw up a public list of products with credible applications for market authorisation, and to help local authorities and retailers prioritise products to be removed from sale.
Local authorities are responsible for enforcing regulations and were advised by FSA to encourage food businesses not on the list or marked as ‘removed’ to withdraw products voluntarily from the market, and to consider more formal measures is they refused.
A product is generally removed from the list when “an application has not made sufficient progress towards validation in the agreed time”, or simply not made it to the next stage.
Assessment
Validated applications are subject to a full risk assessment and those deemed of low enough risk must go through a further risk management process before a recommendation can be made to ministers on authorisation.
This stage can take up to nine months, with the clock being stopped if further information is required. Where the risks are low enough then the subsequent risk management stage has to be completed within seven months. This means it is unlikely any applications will be considered for authorisation before early to mid-2023.
FSA recommendations
CBD extract is non-toxic and found naturally in the cannabis plant. It is used in a range of products, including oils, confectionery, bakery products, and drinks, but there are currently no authorised CBD products on the market in the UK.
FSA recommends no more than 70mg per day of CBD (or 28 drops of 5% CBD) should be consumed without medical supervision and suggests consumers to consult its precautionary ‘consumer advice’ (based on recent findings from the government’s Committee on Toxicity (COT)) before taking any CBD products.
The agency does not endorse products on the public list and there is no guarantee that those on the list will be authorised; all applicants are fully assessed for safety before approval is given.
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