European Novel Food Regulation – What’s It All About?

September 10, 2019

Makers and sellers of CBD products should be conforming to the European Union’s Novel Food regime introduced in January this year.

But, as things stand, just one firm Cannabis Pharma, a Czech Republic company, has made an application to the European Food Safety Authority (EFSA), with a handful of others said to be in the pipeline.

The Centre for Medicinal Cannabis in the U.K., is currently working on an industry kitemark scheme – The Cannabinoid Industry Quality Charter – which will conform with Novel Food Regulations. 

Minimum Cost Of £200,000

A spokesperson for the CMC explained how the Novel Food authorisation process works: “We estimate that there will be a minimum cost of £200,000 in putting together a credible Novel Food application, but that could be a lot more depending on whether EFSA request animal studies and, or toxicology studies. 

“A company would submit their application which will then enter a 16-month review process. This timeline is paused whenever EFSA requests further information which will prolong the time and increase expenses.”

With the process being so costly and time-consuming it will be out of the financial reach of many smaller CBD retailers, and may pose a threat to the livelihoods of many small and medium size manufacturers. 


One for the CBD Manufacturers

The CMC spokesperson added: “Manufacturers of raw materials are in a prime position to apply for Novel Foods authorisation as they will be able to compliantly sell to companies further downstream. 

“So companies from this category will be applying, more likely so, than retailers, and this will allow the CBD retailers, who use their extracts in their products, to conform to the Novel Food regime. So, the smart approach for a smaller operator would be to source from a supplier who already has a Novel Food licence.”

CBD Testers has spoken to some retailers who are being asked to contribute to the cost of a Novel Food authorisation by larger companies.

But the CMC spokesperson believes this will ‘most likely’ not happen, adding: “There will be a huge commercial advantage to these suppliers, so the cost of the application pales in comparison to the size of the opportunity.” 

The E.U. Novel Food Regulations

Under European Union law, food that has not been consumed to a significant degree by humans in the E.U. before May 15, 1997, when the first Regulation was introduced, is considered as Novel Food. These are controlled in a stricter manner than regular foods and in January this year the EFSA classified CBD as a Novel Food.

This prompted outrage from the CBD industry and many examples of the use of cannabis and hemp, as foods, have subsequently been highlighted by the cannabis community.

Food producers can only sell a Novel Food in the 28-member E.U. market following a successful authorization process. There are three routes by which an apparently novel food may be approved or authorized under the Novel Food regulation:

  • By showing significant history of use in the EU prior to 1997
  • Demonstrating the food is a ‘traditional’ one from a third country, where a history of safe food use for at least 25 years can be demonstrated. For example; chia seeds, and noni fruit juice.

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