The regulatory challenges ahead for academics developing cutting-edge foods

Academic researchers are making significant strides in developing innovative products and processes that could be commercialised as food.  Many such products potentially have significant benefits to health and could allow us to have much more sustainable diets or allow food to be produced in areas impacted by climate change. 

What academics do not always understand is the path to commercialisation as a food is highly regulated, especially for foods developed using cutting-edge science. This includes alternative proteins, cultivated meats, fermentation-based dairy alternatives, precision bred gene edited plants and other food tech.  

Navigating the regulatory landscape for such foods is complex and may involve obtaining a novel foods authorisation or consideration of the new rules for gene edited plants and obtaining other authorisations. The first step is an assessment of what authorisations may be needed to commercialise and if there are any other regulatory issues such as compliance with ionisation or fortification regulations.

In practice at least this step will likely be needed to satisfy potential partners before they agree to collaborate or invest. They may want a formal legal opinion before progressing. 

If an authorisation is required, this process typically requires submitting a comprehensive dossier to the Food Standards Agency (FSA) or Food Standards Scotland (FSS) to demonstrate the product’s safety. This process can be both lengthy and complex. But exactly what is entailed is very fact specific both in terms of the innovation itself and how it could be commercialised. For instance, the approval process for animal feed, in contrast to food designed for humans, is less stringent and is typically relatively fast process normally taking months rather than the years needed for a novel food authorisation.

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