NutraIngredients-USA spoke with Dr Mark Tallon, managing director of European food law consultancy, Legal Foods Ltd, via video to find out more. Legal Foods represents a number of companies in relation to the lawful sale of products across the EU and is working on novel foods dossiers regarding Cannabidiol.
Dr Tallon is also the author of a recent paper in the Journal of Dietary Supplements, titled Cannabis sativa L. and Its Extracts: Regulation of Cannabidiol in the European Union and United Kingdom.
In Europe, there is a Novel Foods Catalogue. Anything is considered novel if there is no history of use prior to May 1997.
“Outside of cold pressed seeds from Cannabis sativa, anything else that’s extracted – so if it’s an alcohol extraction or a CO2 extraction – those are considered novel and from that you need to submit a dossier for them to place that product on the market legally in Europe,” explained Dr Tallon.
“If you’ve got a specific extract, so that could be high in CBD, or other cannabinoids like CBG or CBN, or even terpenes, then they would also need a novel foods submission.”
The FSA’s approach
There’s a divergent view between what’s happening at European level and what’s happening in the UK, said Dr Tallon. At the European level, the assessor is EFSA (the European Food Safety Authority) and the equivalent in UK is the FSA (the Food Standards Agency). As the UK navigates the Brexit transition period the FSA is accepting the same information as EFSA for novel foods approval.
“In all Member States, CBD is considered novel and therefore shouldn’t be placed on the market until there’s an authorization,” explained Tallon, “but that horse has already bolted, and CBD is everywhere.
“So, the way the FSA is handling this is to say it’s impossible to enforce and remove all of those products, and ultimately damage business. They’re trying to take more of a pragmatic approach and any products that were on the market prior to March of this year can stay on the market, but they need to have submitted a valid novel food submission. So that means you submit your dossier to them and they have, say, a month to assess that dossier and say it’s got all the bits and pieces in that demonstrate that there’s enough for them to assess and decide is something is novel.
“If all the information is not in there and it’s rejected, or you don’t get it in before that end of March period [March 31st, 2021] then you cannot put any products on the market that contain CBD, so you need the novel foods validation.”
The UK FSA has also settled on a safe limit of CBD intake of 70 mg per day.
“There’s still some conflict within the actual data to suggest that the 70 mg is still too high, but businesses are quite happy with that. Most companies don’t put 70 mg in a product anyway, so it’s not a concern.”
April 1st, 2021 – what does the market look like?
So what will the market look like in the UK once we pass that key March 31st deadline?
“From the UK side, I think a lot of the dossiers that have been submitted, simply because of cost of investing in the process, have probably gone down the route of a critical review of the literature,” said Dr Tallon.
“I don’t think there’s enough data to fill those gaps in terms of safety. I think a lot of those dossiers will be rejected or be found wanting, so I think that will be one result of the process.
“I think the larger companies, the ones that have invested in actual full trials will be in a much better position as being able to say they have robust data to prove safety and then they just need to build on that.
“I think we’ll end up with a small number of companies that can get approval and they’ll then license out that to other companies. So maybe you’ll only have [a small number] that hold the license, they’ll end being distributors to 20, 30, 40, 50 other companies. So instead of just being a finished products companies, they’ll end up being a raw ingredient supplier by chance and that opens up other avenues, especially for the bigger CBD companies that are publicly floated.”