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Authorised UK CBD products expected by 2023

Home » Authorised UK CBD products expected by 2023

As the UK makes moves to be the world’s first regulated CBD market, the Food Standards Agency (FSA) has now published the anticipated list of credible CBD Novel Food applications.

The published list features a total of 3,500 CBD products for oral consumption that are considered to be attached to a credible Novel Foods application. The products included represent a variety of application types, including synthetic, isolate and full spectrum.

These products will be able to remain on the market as they progress towards final authorisation. The FSA has stated that although these products are classed as “credible”, it does not guarantee they will be authorised for sale.

With a lengthy process still to go, it is unlikely that any applications will be considered for authorisation before early to mid-2023. Any further authorisations may take another few years.

Emily Miles, Chief Executive of the FSA, commented: “The CBD market is growing rapidly. The FSA has been working to move the CBD industry into compliance. Today we have taken the next step in our pragmatic approach to making sure CBD products are safe and what they say they are.  

“We have created the public list to help local authorities and retailers prioritise products to be removed from sale. If a product is not on the list, it should be removed from sale because it is not attached to a credible application to us for market authorisation. 

Read more: FSA gives update on Novel Foods progress

“But being on the list means that the application is credible and the FSA has, or is shortly expecting to receive, significant scientific evidence from the applicant with which to judge safety.  

“I want to emphasise that the FSA is not endorsing products on the public list, and inclusion on the list is no guarantee that they will be authorised as they have not yet been fully assessed for safety. But we have taken the step of publishing the list so that local authorities, retailers and consumers can make informed judgments about what they stock and buy, as we gradually bring this growing market into compliance with the law.” 

Novel Foods application process

CBD products were classed as a ‘novel’ food product by the European Union (EU) in 2019, and now need to be assessed by the FSA for safety before being permitted for sale. CBD businesses were given a deadline of March 31 to submit any Novel Food application and since 1 January 2021, the FSA has reviewed over 900 applications. A total of 680 of those applications were rejected and a further 42 were withdrawn by the applicant. 

The FSA has confirmed that there are currently 182 live applications, with 175 at the pre-validation stage, 7 at the risk assessment stage.

The 3,500 featured products are linked to 70 applications that have provided enough evidence or completed toxicological studies, 65 of which are in the “awaiting evidence” category and five are in the validated category. For those that remain in the awaiting evidence section, companies will be required to supply more information this year in order to be assessed for validation.

Validated applications will move on to a full risk assessment. Those that are shown to be of a low enough risk must also go through a risk management process before a recommendation can be made to Ministers on authorisation.

Products will be assessed for safety, which the FSA has stated could take up to nine months. However, if further information is needed, “the clock can be stopped” for this process. The organisation could not confirm a timeframe for the requirement to provide this extra information, but has said this will be done “in a timely manner”.

For those applications that did not make it through the checks, applicants may reapply if they can provide the additional information needed to pass validation. 

This will be specified in the FSA’s feedback on original applications, but the orgainsation highlights that these products will not be added to the public list and could not be reintroduced into the market until an authorisation is granted.

CBD compliance

To ensure consumer safety, the FSA has called on local UK authorities and retailers to help bring the market into compliance. Following today’s publication of the list, local authorities will be able to play a role by prioritising the removal of products from sale that are not included. 

Miles commented: “If a product is not on the list, it should be removed from sale because it’s not attached to a credible application for market authorisation.

“I do want to emphasise that the FSA is not endorsing products on the public list, and inclusion on the list is no guarantee that those products will be authorised as they have not yet been fully assessed for safety.”

Local authorities, retailers and consumers can use the list to make informed judgments about what they stock and what they buy.

Miles continued: “We’ve been working with local authorities throughout this process to make sure that they’ve been fully informed about the approach that we’re taking. So the guidance that we’re issuing is going to help local authorities take a proportionate approach to their enforcement activity. 

Read more: FSA says authorities will need to step up CBD enforcement

“We don’t expect enforcement to be a big bang so they will be considering these products alongside all of the other responsibilities that they have – we expect them to prioritise appropriately. 

“They have been very close to the development of this policy, and we will be providing further guidance to them if needed. Our request is for retailers, in particular, to be responsible and make sure that they are not selling products that aren’t on the list. 

“This is as much about voluntary compliance that we’re asking for as it is about enforcement.” 

The FSA is advising local authorities which enforce the novel food legislation to encourage food businesses whose products are not included to voluntarily withdraw their products from the market. 

The UK’s CBD sector trade body, The Association for the Cannabinoid Industry (ACI) has been working closely with the FSA for two years and with companies to help them meet the requirements for their Novel Foods applications.

ACI founder, Steve Moore, commented: “The FSA public list represents a major milestone for the UK’s CBD category. 

“It demonstrates the progress the sector has made to meet compliance requirements and creates greater regulatory certainty which, in turn, will increase levels of consumer trust, encourage investment in the sector, and promote innovation. 

“ACI is immensely grateful for the work that our members and the FSA have put in to take this momentous step.”

Jeremy Willcocks, partner at law firm Arnold & Porter, said: “The release by the Food Standards Agency of the list of cannabinoid (CBD) products permitted for sale to consumers in England and Wales is an important milestone for the CBD sector in the UK. We welcome the release.

“CBD foods on the list can now be sold legally in England and Wales. Other CBD foods products need to be removed from sale. Today’s announcement brings welcome legal certainty which will encourage investment in the CBD foods sector. The ACI has played an important role in this process and we congratulate the ACI for its terrific work.”

View the list here.

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