FSA Published a List of CBD Products With Credible Novel Food Applications

Today, the Food Standards Agency (FSA) published a list of CBD products that have credible applications for authorization with the FSA.

The listed products are now one step closer towards being authorized, said the FSA in their press release.

The Agency called on local authorities and industry to help bring the CBD market into compliance by prioritizing the removal of products from the sale that are not on the public list that the FSA published today.

CBD products are ‘novel’ and therefore need to be assessed by the FSA for safety before being placed on the market in England and Wales. In Scotland, Food Standards Scotland (FSS) is responsible for the regulation of CBD products. Currently, no CBD products have been authorized for sale in the UK. The CBD public list shows which products have a credible application for authorization with the FSA.

“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 prioritize 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 authorization.

“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 emphasize that the FSA is not endorsing products on the public list, and inclusion on the list is no guarantee that they will be authorized 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, ” said Emily Miles, Chief Executive of the FSA.

Local authorities which enforce the novel food legislation have been advised to encourage food businesses whose products are not on the public list to voluntarily withdraw their products from the market and to consider more formal measures where this is not the case.

Validated applications will now 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 the authorization.

Authorization of any CBD products is unlikely to happen before 2023.

EIHA applications awaiting evidence, Ilesol Pharmaceuticals granted market authorization

As a member of the European Industrial Hemp Association’s (EIHA) Novel Food Consortium since its foundation, Ilesol Pharmaceuticals is now confirmed to be awaiting evidence for novel food application and looks forward to the full registration in England and Wales.

EIHA projects GmbH, together with the scientific provider ChemSafe, has submitted applications to FSA for natural CBD isolate and Full Spectrum. The EIHA’s applications are now included in the list of the applications awaiting evidence and can move towards the full risk assessment.

Ilesol Pharmaceuticals has implemented the Hazard Analysis Critical Control Points (HACCP) management system; and HRN EN ISO 22000:2018 Food Safety Management system.

Following the positive outcome of the Novel Food applications both to the FSA and the European Food Safety Authority (EFSA), our company’s products should be allowed to be marketed in the EU and UK with exclusivity on the Consortium’s study that will last five years.

The Consortium has agreed to invest up to €3,5 million for financing all relevant and unprecedented toxicological studies on CBD and THC, including the largest ever study on the impact of trace levels of THC.

“I think the UK has understood the importance for European operators of having both forms of CBD extracts secured on the market, and that is why it is ready to study science-based results. A legal market for CBD extracts with the associated clarity that brings will guarantee the quality of these products and facilitate a more professional savoir faire. On this special day, I’d like to thank ChemSafe, EIHA service provider, that supported this project since 2019″, said Lorenza Romanese, EIHA’s managing director.

However, the EIHA notes that there are also some inaccuracies, inconsistencies, and a few surprising absences on this list. They will review these over the coming days and continue our open discussions with the FSA.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.