I have spoken to numerous CBD brands who are aware of the 31st March 2021 deadline to submit a valid novel food authorisation application, yet have failed to do so. This made me curious to find out more about what is required, how they complete the dossier and what the punishment might be if they fail to do so.
I therefore got in contact with the Food Standards Agency and received a friendly response from Lisa Nelson, the Senior Communications Manager. After a week of discussions with the policy team, the answers were all gathered and detailed below.
It should also be highlighted that I labelled my original questions to Lisa as ‘forms that need to be completed’, however she highlighted that, for clarity, businesses need to complete a dossier, or collection of documents, rather than a form/forms to apply for authorisation. The dossier will normally include information such as administrative, technical and safety information about the product being submitted for authorisation, including how it’s manufactured and what it will be used in.
Have any CBD brands in the UK filled in the dossier yet? There were stories a few months ago that none had completed it yet, but I wasn’t sure if that was out of date.
To date (beginning of June 2020), no company has successfully completed the authorisation process. There are currently a number of applications with the European Commission, of which one has been fully validated by the Commission. The FSA’s deadline is for businesses to reach this validated stage with us by the end March 2021.
What will happen to brands if they don’t meet this deadline? There is talk that they could be taken off shop shelves, but what about brands selling online? Could they be fined?
Local authorities enforce the novel food legislation (both for traditional retail and online). They have been advised that businesses should be able to sell their existing CBD products until 31 March 2021, provided they are not incorrectly labelled, are not unsafe to eat and do not contain substances that fall under drugs legislation.
From 1 April 2021, only products which have submitted a valid novel food authorisation application will be allowed to remain on the market. The authorisation process ensures novel foods meet legal standards, including on safety and content. All other products will be required to obtain the necessary authorisation before being placed on the market, and no new products will be allowed onto the market with prior authorisation.
From the moment they complete the dossier, how long does it take till they find out if they’re approved?
The exact time varies and is dependent on if the applicant provides all the needed information from the start. In total, the European Commission and the European Food Safety Authority (EFSA) have 17 months to process the application, but this time is extended if the applicant needs to provide more information. The initial validation stage takes one month if all the needed information is provided.
Please can you provide details you have about the dossier and what is required from CBD brands
The application for authorisation needs to provide detailed information about production of the novel food, including compositional and stability information. The application also needs to include details of the proposed end uses of the food, although these tend to be broad categories (e.g. bakery goods). Both the legislation (EU Regulation 2015/2283 and EU Regulation 2017/2469) and associated guidance provide further detail. Businesses can also consult our guidance on CBD products and novel foods on our website.
We are discussing potential applications with several businesses and are confident that a number will reach the validated application standard by the deadline, so we would strongly encourage businesses to act now to ensure they are able to supply products in the UK after the deadline.