Food Technology Needs a Regulatory Revolution

Our global food system is more fragile than we might think. Many of us have enjoyed a boom of eating what we want, when we want it, and are only now starting to face the consequences. After energy, food is the second-largest contributor to greenhouse gas emissions, yet it took 27 COP meetings for it to feature on the main agenda of the conference. The recent Covid-19 pandemic has alerted us to the risk of zoonotic disease, and the ongoing conflict in Ukraine has highlighted the risks and rewards of an international supply chain.

The good news is that new technologies, such as precision fermentation and cultivated meat, provide an exciting opportunity to address these challenges while boosting global growth and creating jobs.

For these products to hit the shelves, they need to be regulated. Yet global food regulation is playing catch-up and currently frustrates economic growth, acting as a cost-and-time sink for industry and regulators. But with some simple changes to the regulatory system, countries can unlock the potential of the fledgling novel-food industry while maintaining high safety standards. The introduction of a system for provisional approval, allowing companies to manufacture and sell limited quantities, can provide the regulatory kickstart that the industry needs. Here’s what needs to happen:

1. Design and implement a provisional novel-food authorisation (pNFA) process.

2. Carve out a team at the regulator dedicated to pNFAs, providing expert upfront guidance and ongoing support to food-tech companies as they prepare their pNFA submissions.

3. Target timelines of three months to review and decide on a pNFA submission, providing either approval or feedback that allow food-tech companies to make progress.

4. Prioritise pNFA applications based upon their potential to contribute to net-zero targets, in line with government policy and regulator strategy.

Countries that embrace novel foods can expect an economic boost. And those that ignore the opportunity should expect an exodus, as companies shift operations to more favourable environments. In some cases, the exodus has already started.

With a rising population, our planet is at breaking point. Half of all habitable land is used for agriculture, and this figure is set to increase. Growing demand for meat has led to irreversible deforestation that is destroying animal habitats and damaging the planet’s lungs. The Covid-19 pandemic has shone a light on the growing risk of zoonotic diseases, and the overuse of antibiotics threatens our ability to safely perform the simplest of surgeries in the years to come.

Around the world, governments have set ambitious net-zero targets, implementing policies that encourage the use of renewable energy and a switch to electric cars. Yet food, one of the biggest opportunities to cut carbon emissions, has received little attention to date. A third of greenhouse-gas emissions come from our food, with 18 per cent from animal agriculture alone, largely driven by the conversion of feed to meat and the gases released by livestock.

But the news isn’t all bad. Over recent years, new companies have been furiously developing novel-food technologies that, if widely adopted, can help us reach net-zero targets. And the benefits aren’t only green. These technologies promise economic growth, improved food security, enhanced biodiversity through reduced land use, and better health, with the reduction of intensive animal farming and the overuse of antibiotics. Many of these benefits are aligned with published policies, so their adoption should really be a slam-dunk (see Figure 3).

Examples of these novel technologies include precision fermentation and cultivated meat. Precision fermentation uses cells as minuscule factories to turn a feedstock, such as sugar, into edible products. We already consume products made through traditional fermentation, such as tempeh, yoghurt and cheese. In precision fermentation the cell factories can be used in a continuous manufacturing process, with the end product regularly siphoned off, ready to be sold.

Cultivated meat also uses biological cells. A small biopsy of muscle and fat is taken from a farm animal, such as a pig, and the cells are multiplied to make more muscle and fat. It’s real meat, just grown differently, as the end product has the same biological and nutritional profile as meat from the slaughterhouse. The overall process is similar to that of plant cultivation, where a small sample is grown in ideal conditions to create the end product (see Figure 1).

A Missed Opportunity

Both technologies promise breweries of the future, with large steel tanks strategically positioned to reduce food miles and enhance food security. If adopted, they show potential to boost a country’s economy, with a report indicating that the UK would unlock £2.1 billion of GDP growth, create 16,000 jobs and boost tax receipts by over £500 million from cultivated meat alone.

Countries that drive forward these technologies have the potential to establish themselves as science superpowers, championing innovation and attracting the best companies and talent from around the world. And those that don’t will miss out. Companies based in the UK and EU are already looking to more attractive markets such as Singapore, where policy has encouraged regulators to be forward-thinking, providing guidance on how to prepare an application, with open and iterative dialogue on draft submissions.

As of January 2023, cultivated chicken is authorised for sale in Singapore and has been given the provisional green light for sale in the US. These approvals are for early-stage processes at individual companies, so we can expect further applications and modifications before mass manufacture and sale.

Regulation That Gets in the Way

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?

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.

Design and Implement a Provisional Novel-Food Authorisation (pNFA) Process

• A transparent process is required, outlining the key steps towards approval. Technology-specific advice sheets (for example, for cultivated meat, cultivated seafood, precision fermentation with yeast and precision fermentation with bacteria) should outline evidence expectations, providing guidelines for companies to work within. A framework should be designed, outlining the example limitations that the regulator may decide to impose (such as limits on sales quantities or on sales channels), and how this provisionally links to evidence expectations.

• The full novel-food authorisation (fNFA) process should be modified, demonstrating how a pNFA dossier can be leveraged as companies look to upgrade their authorisation from provisional to full.

• The regulator should charge the company for each pNFA and fNFA submission. The cost should be set at a level that does not deter applications, but also recognises the investment required by the regulator to appropriately review the novel food. Controls would need to be designed and implemented to prevent coercion and undue influence.

Carve Out a Team at the Regulator Dedicated to pNFAs, Providing Expert Upfront Guidance and Ongoing Support to Food-Tech Companies as They Prepare Their pNFA Submissions

• A faster process requires a dedicated team that stays close to the industry. The regulator does not necessarily need to secure new resource, but instead can refocus part of their team to ensure the objectives of a provisional authorisation system are met.

• Regular industry webinars and consultations should be run, advising new food-technology companies on the differences between pNFA and fNFA submissions, allowing them to understand trade-offs and make decisions.

• A regulator with close ties to industry can stay up to date on developments, allowing them to upskill their team accordingly as new technologies and approaches are established.

• The regulator should provide frequent ongoing company-specific advice, reviewing draft dossier chapters and outlining trade-offs. To avoid conflicts of interest, the advice can be provided without prejudice, with a separate team reviewing and formally deciding on pNFA submissions.

Target Timelines of Three Months to Review and Decide on a pNFA Submission, Providing Either Approval or Feedback that Allow Food-Tech Companies to Make Progress

• For a pNFA process to be valuable, the decision needs to be quick. From the point of submission, a turnaround time of three months should be feasible, especially given the upfront guidance from the regulator.

• Companies should receive a partial fee refund if the review of their submission takes longer than three months.

Prioritise pNFA Applications Based Upon Their Potential to Contribute to Net-Zero Targets, in Line With Government Policy and Regulator Strategy

• The regulator should avoid a first-in, first-out approach to submission review, and instead prioritise novel foods that align with government and regulator objectives, such as net zero or healthy eating.

• A framework should be developed that allows companies to declare their alignment to key policies as part of their submission. As a result of this declaration, a target-review timeline should be shared with the company, for example, three months or six months.

With a risk-based approach to regulation, governments and regulators can unleash the potential of the fledgling precision fermentation and cultivated-meat industries. A simplified pNFA can maintain safety standards, speed up approvals, and upskill both the regulator and the industry in their understanding of new technologies. Once granted, a provisional approval can provide small-scale market access that is key to new companies securing funding and maintaining their growth.

For those that act now, the opportunity is huge. A welcoming regulatory environment can attract companies, create jobs, bolster national food security and help deliver on net-zero pledges. But not every country will win. Those that are slow to act will become late adopters, missing out on the economic growth, highly skilled jobs and tax receipts from companies that choose to headquarter elsewhere. The opportunity is there for the taking.

Lead Image: TBI