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How the FSA may change novel food regulation

By Katrina Anderson and Stefanie Lo

- Last updated on GMT

Change is coming but which direction will novel food regulations go? Credit: Getty/amanalang
Change is coming but which direction will novel food regulations go? Credit: Getty/amanalang
Following publication of its review of the approvals process for novel foods commercialisation, Katrina Anderson and Stefanie Lo of Osborne Clarke explain the proposals under consideration.

The Food Standards Agency​ (FSA) has published its long-awaited review​ of the approvals process for placing novels food on the market in the UK. This is known as the novel food regulation and governance. This is the process by which innovations such as lab grown meats, products using specific fermentation and more unusual ingredients such as insects can be placed on the market.

The review was triggered by the government's commitment to promote innovation in food, particularly in relation to sustainable alternative proteins and dairy as part of its Benefits of Brexit policy agenda.  The report considers a range of different options on how to facilitate getting innovative new food products to market in the UK more quickly.

Proposals for UK novel food regulations

There are a number of different possible proposals that could be adopted by the UK Government. These include:

1. Modest proposals to make the existing novel food approval process more efficient by removing pain points, such as delays caused by the need for the government to pass a statutory instrument before there is final approval for a food to be placed on the market.  There are also suggestions that applications could be triage-based on risk level and there could be a priority lane for applications that meet certain criteria – this would most likely be based on the government's policy agenda around bringing sustainable plant-based alternatives to market and other government objectives. The report also endorses the industry's calls for more guidance and early engagement particularly to support SMEs and start-ups who do not have the in-house regulatory support to facilitate applications.

2. More radical suggestions ranging from changing the definition of what constitutes ‘safe’ to adopting more of a risk-benefit approach. This would mean that the threshold for what a company needs to demonstrate in order to establish their product is safe might be more aligned to the US standard of ‘reasonably certain of no harm’ rather than the legacy EU precautionary principle which is a higher standard.  It would also mean that when applying the novel foods authorisation, companies who could demonstrate the real consumer benefits such as sustainability of products, would be able to have these factored into the overall assessment of whether the product was authorised or not.

3. There is also a suggestion that we could move to more of a conditional authorisation, which would mean allowing products to be placed on the UK market and monitored for a period of time for safety. This would be instead of requiring full authorisation before any sales were possible.  This would obviously have significant commercial benefits as it would allow companies to initially sell their products during at least some of the authorisation period rather than needing to wait for final approval before making any sales in the UK. 

4. The final suggestion is to do away with novel foods regulation in its current form entirely. Instead this could either be replaced by regulation for specific types of novel food i.e., you could end up with one framework for cultivated meat and another for precision breed gene edited products.  Or there could be an entirely new system of approvals for all foods (regardless of whether they are novel or not) based on their risk to consumers.

Next steps

Before any decisions are taken on which of the possible proposals to adopt as government policy, the FSA will need to review the report and the government will need to officially respond. The report also makes it clear that there will be no regulatory changes without public consultation. All of this means that it is likely to be some time before it is clear which route the government intends to pursue. 

What is clear is that we can expect significant overhaul of the novel foods regulation in the next few years – most likely to make it more streamlined and faster. This will be good news for food business operators looking to bring applications.

You may also be interested in reading Katrina Anderson’s Legal Brief on bringing an alternative protein product to market. Read for free here.

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