Member Blog: Novel Foods Applications Stalled?

Member Blog: Novel Foods Applications Stalled?

The UK CBD market had an estimated value of £300 million in 2020 and by the end of 2022 estimates had doubled that figure. This goes to show that CBD being deemed a “novel” food in January 2019 has had little impact on market growth and if predictions are right will exceed £1 billion by 2025. With the FSA’s March 2021 deadline long behind us and having made submissions by the deadline, many companies will be feeling comfortable. However, it’s worth remembering that the authorization process is still on-going, so while products that are part of a validated application are allowed to remain on the market they are still not authorized as novel foods. And now with the FSA conducting market research to aid in their risk assessment of consumer CBD products, some concerning data has been published.

The FSA commissioned Fera Science Ltd to carry out a survey to obtain a brief overview of current CBD products on sale in England and Wales in order to help FSA’s risk assessment of CBD products. The products selected covered, oils, sprays and edibles (including drinks). The study collected various data on the products. This included testing for CBD content, cannabinoid profiles, heavy metals, pesticides, residual solvents, Polycyclic Aromatic Hydrocarbons (PAHs) & mycotoxins. A summary of the results are shown below:

  • Heavy metals (cadmium, mercury & lead) and arsenic were not detected in the majority of samples, meaning levels were below the limits of quantification of the method. Seven samples contained lead, four samples arsenic and two samples contained cadmium. Mercury was not found in any sample. A definitive statement as to whether products exceed maximum levels cannot be made due to uncertainty as to whether products would be classified as a food (i.e. oil) or a food supplement. 
  • A  low incidence of low levels of mycotoxins, with Fusarium mycotoxins found more frequently than aflatoxins and ochratoxin A, mostly at the methods reporting limit. Three samples were found to contain ochratoxin A at the methods reporting limit.
  • A total of seven pesticide residues were found across all of the products (each product was tested for over 400 pesticides). There are no specific Maximum Residue Limits (MRL) for CBD products.
  • One oil product was found to have PAHs above the regulated levels, if classed as a product for direct consumption. If classed as a food supplement the PAHs were within regulated levels.
  • Three samples contained residual solvents. One product was over the MRL.
  • Most products contained CBD close to the declared value. Two oils had substantially different levels than that declared (one higher and one lower). CBD was not detected in one of the drink products.  These are potentially non-compliant with compositional and standards requirements.
  • Delta 9-THC was detected in 87 % (26) of the samples analysed. Of these 40% (12) were found to have THC+ (the total sum of illicit cannabinoids in the product) above the 1mg threshold.

Although Fera only tested a small number of products, the fact that such a large percentage of products were found to have issues is concerning to say the least. It throws into question how many other products currently on the market that are part of a validated NF application, but aren’t up to spec.

The next question is, are you 100% sure that your current market offerings meet their product specifications? If not then there’s no time like the present to take a closer look at your products and their manufacturing process. It’s also important to remember that if you do need to make changes then these changes need to be updated in your current regulatory filings.

If you would like to discuss this further, please reach out to us at

Author & Company Information

Aaron Farmer

Aaron Farmer is the Head Of Medical Devices for Arcus Compliance.

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