The pace of innovation is extremely rapid. Food tech is now akin to software development, with some of the best engineers and scientists migrating from traditional jobs into this promising sector. Advances are made every few months, improving yields, reducing costs and enhancing taste and texture. Just like a software update on your phone or computer, changes can be relatively minor yet they come through frequently.
By contrast, around the world, the process to authorise new foods is opaque and painfully slow. It isn’t designed to work with the recent significant advances in food technology, or to accommodate frequent improvements. Thus it frustrates economic growth and becomes a cost-and-time sink for both industry and regulators.
A recent report, focusing on the UK, outlined the critical path that cultivated meat must follow for it to be widely adopted by consumers. The first step is a suitable regulatory framework that maintains high standards but works with industry.
The Current Regulatory Process
Today, in the UK and EU, new foods must undergo an approval process known as a novel-food authorisation. Companies must compile and submit a lengthy dossier outlining the process to manufacture the product and providing evidence that it is safe to eat. This evidence varies by product type and can include detailed scientific analysis such as toxicology reports and shelf stability tests.
Some guidance is provided by the authorities, but it is down to the company submitting the application to provide the information they believe to be appropriate to obtain approval. Compiling this dossier takes several months, if not years. And once it is submitted, the review process takes at least 18 months, and often double that due to requests for additional data and clarifications.
Other countries follow a similar process, although some markets have a more supportive approach. For example, in Singapore regulators engage in the process of compiling the dossiers, providing guidance and feedback on individual chapters, allowing them to make a swift decision once the full dossier is submitted. This iterative feedback approach helps companies develop a process that regulators can support, and reduces the risk of wasted time and effort on both sides of the table. However, the process is still demanding and time-consuming, with an “all-or-nothing” approach to approval.
We Need Change Now
The novel-food authorisation legislation in the UK and EU was established 25 years ago. Significant advances in food technology over the past ten years means it is no longer fit for purpose and a rethink is required.
No matter the market or approach, one thing must remain consistent. Any food that is approved for consumption must be safe. It is the job of the independent regulator to ensure this, and it is in a company’s best interest for standards to stay high. Nobody wants the approval of food that is detrimental to human health.
However, with such a cumbersome process, and without change, both regulators and food-tech companies are set to be bogged down with dossier submissions and reviews over the years to come. No one will benefit: not the consumer, the planet or the economy.
Countries that offer the most attractive regulatory environment can expect companies to flock to their cities, pursuing early market validation that will allow them to secure further investment. For a country like the UK, with the third-highest concentration of cultivated-meat startups, there is a lot at stake (Figure 2). For now, an attractive talent pool is keeping the UK industry buoyant, but it won’t take much for the bubble to burst.
So how do we embrace advances in food technology as quickly as possible, realising their potential while maintaining the high food standards that benefit us all?
It’s Time for a Regulatory Revolution
The novel-food authorisation process is designed to ensure that there is no detrimental effect on human health once a product is approved for mass consumption. It is a highly robust process because once approval is given, that’s it: a company starts mass manufacturing and consumers start mass consuming.
The stakes are high and warrant the high level of scrutiny. But what if we were to reduce the stakes? What if there were a different type of approval, where the risk was lower and so the process could be faster?
A Provisional Licence to Eat
In the UK a teenager can obtain a provisional driving licence, allowing them on the road to learn and refine their driving skills. We accept that there is inherent risk in allowing a complete novice behind the wheel of a vehicle that weighs a tonne and can reach 100 miles per hour, but we also accept that the risk has been mitigated, with a fully qualified driver sitting next to them who is ultimately responsible for the new driver’s actions. There is also an incentive for the new driver to get better – if they want to drive on their own, with a full licence, they must pass both a theory test and a practical test, demonstrating that they can be a safe user of the road.
This risk-based approach to licensing can be applied to novel foods. Regulators could provide two levels of approval: a provisional authorisation and a full authorisation, with the former requiring a less detailed dossier and providing small-scale market access in return.
A provisional authorisation would allow a company to manufacture and sell a novel food, with limitations set by the regulator designed to mitigate the risk to the wider population. A review of the food’s safety would be completed, ensuring that consumption would not have a negative impact on health, but the dossier requirements would be reduced, knowing that there would not be long-term or mass exposure to the product until a full authorisation is given.
The regulator would need to provide guidance, outlining the dossier requirements for a provisional authorisation versus a full authorisation, allowing them to make an appropriate judgement on safety. Example limitations from the regulator could include: a cap on the number of products that can be sold; a minimum selling price; and a specification on the type of sales channels permitted.
These examples of limitations reduce risk because they either limit exposure of the novel food to the wider population, or increase the controls around how it is made and sold. A cap on the number of products that can be sold would prevent the novel food from being consumed by a the mass market.
A minimum selling price could be set that discourages multiple purchases, helping to limit high exposure to one individual. Specifying sales channels, for example by permitting sales in restaurants only, can help ensure that the product is prepared and cooked in the correct way by a professional. The limitations are designed to make the risk to the population acceptable.
The regulator would review each provisional dossier and determine whether appropriate limitations can be devised and implemented that mitigate the risk appropriately. The provisional authorisation would also be time-limited – for example, two years – requiring review after being initially granted.
And just like a provisional driving licence, we can expect food companies to adhere strictly to the limitations: they would not want to risk their opportunity of securing a full authorisation further down the line.
A Recipe for Success
This risk-based approach to authorisation would provide the foundation for a food-tech industry to flourish. Companies could sell products and get consumer feedback, showing demand for different formats in different channels and at different price points. This would give food-tech companies the confidence to invest, raise capital from investors to build production facilities, recruit teams and form partnerships, all ahead of being granted full approval.
Without a provisional authorisation, companies have two options: either to invest in expansion “at risk”, hoping that full regulatory approval will swiftly follow, or to wait for the full approval first, placing the company in a zombie-like state while it awaits its fate. Or there is option three: to move operations to a different geography with a more attractive regulatory process, something for which Singapore in particular is well positioned.
The provisional authorisation process benefits the regulator, too. With increased engagement, regulators can more easily assess the new expertise they need in-house to make sound safety decisions, giving them time to upskill their team in new technologies before full authorisation dossiers are submitted. Furthermore, provisional applications give an indication about the future volume and timing of full applications, allowing regulators to grow their team alongside a growing industry and prevent a backlog of assessments.
A dedicated in-house team could review provisional authorisation applications, fast-tracking those that are best aligned with government policy and regulator strategy. For example, a novel food that promises a reduction in greenhouse gases would be prioritised over others.
The provisional authorisation team can be tasked with triaging the food-tech “software updates” too: that is, the relatively minor, frequent advances that improve the manufacturing process of a novel food. Categorising changes as substantial or non-substantial, this expert team can estimate the level of information needed to form an opinion on safety and guide companies appropriately. This initial assessment helps the regulator prepare for the incoming submission and helps the company to plan their commercial strategy.
At the heart of a provisional authorisation approach is a process that recognises the huge potential of the rapidly growing and changing food-tech industry, and understands the benefit of nimble, risk-based regulation. The country that adapts first has the potential to make food technology a cornerstone of their economy, attracting the world’s best companies and talent to their doorstep.
About the Author: Russ Tucker is the founder of Ivy Farm Technologies, a cultivated-meat company based in Oxford, UK. Prior to Ivy Farm, he advised supermarkets around the globe with Boston Consulting Group, after completing his DPhil in Biomedical Engineering at Oxford University.