The UK’s novel foods approval process currently matches the EU’s: lengthy and complicated. Could the FSA’s new, Singapore-inspired approach cut red tape and allow British innovation to thrive?
Genuine innovation in food is difficult. Although the huge problems in the global food system mean game-changing innovation is desperately needed, most new products are just slightly reformulated versions of what has gone before. If we want to create a more sustainable food supply and simultaneously address the enormous issues of diet-related disease, slowly inching forward is not going to cut it. The world is crying out for something new.
Yet creating a completely new type of food comes with its own issues. Novel ingredients like those grown by fermentation or derived from new crops are an unknown quantity when it comes to safety. So, in the late 1990s, the EU decided novel foods must pass stringent assessments before being sold to the public. Chia seeds, CBD, and bread treated with UV light to boost vitamin D levels must all go through this process.
It was no doubt a sensible move, but things have gone slightly awry ever since. Applications are expensive, often requiring detailed toxicology and safety testing, and the process is notoriously time-consuming and bureaucratic. Official timelines from application to approval take about 18 months, but most applications stretch on for years and, depending on the required testing, can cost millions of euros.
While the UK is no longer part of the EU, its process is largely the same, having copied across the legislation on to its own statute book. Now, however, may be time for reform as the Food Standards Agency (FSA) looks to improve its process based on superior models exemplified by countries like Singapore and Israel.
In theory, this faster and simpler process should provide one of the elusive ‘Brexit Benefits’ – encouraging energetic young food startups to target the UK for the development of ground-breaking new ingredients. So, as the first batches of post-Brexit UK novel food applications start to work their way through the process, what could the future of novel foods look like in the UK?
Handholders not gatekeepers
Whatever you think of Brexit, evidence from around the world suggests a more efficient novel foods process could provide significant benefits. The EU has lagged behind in novel food technologies, while countries such as Singapore, Israel, Japan, Australia, Canada, UAE and the US employ systems that inspire considerably more investment and innovation.
Singapore, in particular, has a system that is admired around the world. With little agricultural land, it is acutely aware of the need to increase its food security and has invested hugely in agri-tech innovation. The team that regulates novel food applications is well-resourced and as a result, is highly proactive – organising frequent calls with applicants and maintaining a collaborative approach throughout the process.
“Food tech is a global technology race… The EU should be extremely concerned”
Pasi Vainikka, Solar Foods CEO
Pasi Vainikka is CEO of Solar Foods, a Finnish foodtech company that produces Solein protein powder by fermenting single celled organisms. Solein bills itself as the most sustainable protein in the world, as it is created from air and energy alone. Solein submitted novel food application dossiers in the EU and Singapore at the same time – in September 2021 – and found the differences stark.
“The problem with the EU process is that it is slow, but also untransparent,” says Vainikka. “In Singapore there is a contact person, there are frequent meetings.” It means the process there is faster and more efficient, he adds, but not any less strict. Companies must go through a stage of answering to a panel of global experts, just like the UK. “The difference is that in Singapore, the turnover time of that procedure is about one month, rather than one year.”
Where the EU has a team of gatekeepers, Singapore has handholders. As a result, the process there takes between nine and 12 months from the point of application to approval, with no indication of safety or integrity being compromised. Today, Solein is approved in Singapore following a process that took less than 12 months in total. In the EU, its status is still unclear a year-and-a-half after submission, with the EFSA (the scientific advisory committee) still reviewing papers.
Singapore famously became the first country to approve meat grown from cultured cells, enabling a product manufactured by US company Just to go on sale in restaurants in mid-2021. In stark contrast, it is thought not a single novel food application has yet been made for cultured meat within the EU, despite the technology being pioneered there and several of the leading startups hailing from European countries. For this technology at least, the EU is already several years behind.
Issues with the novel foods application process can create barriers to innovation and growth – the very processes that may be needed to fix many of the major problems in our current food system. For example, Impossible Foods, an alternative meat maker, had its entry into the EU market blocked as it tried to get approval for its crucial ‘heme’ ingredient. The heme is produced in a precision fermentation process and, despite having approval in several other territories and a significant history of safe consumption, is still not allowed to be sold within the EU.
This may well have set a precedent, putting off applications for similar innovations by alternative protein companies in the EU, and suggesting cellular meat has little chance of getting through at all.
What is a novel food?
The FSA defines a novel food as any food that has not been widely consumed by people in the UK or EU before 1997.
Some foods that have been consumed outside the EU before 1997 can be considered through a traditional foods application process, which is less onerous that the full novel foods process.
Testing is essential for safety – there may be unknown toxicity and allergen issues with any novel food or process.
Regulatory sandbox
Israel is another country with a more collaborative approach. ‘The Kitchen’ Food Tech Hub, heavily backed by the Israel Innovation Authority, is arguably the global centre of sustainable food innovation.
A regulatory sandbox approach allows research and testing of novel foods within The Kitchen space, and the possibility of licences for small-scale test launches of novel products. It means The Kitchen has rapidly attracted a group of disruptive startups to set up operations there. In contrast, just last year the Dutch FSA confiscated and destroyed samples from cellular agriculture pioneer Mosa Meats because it was still illegal to taste products within the EU, even within controlled conditions at the company laboratories.
Canada, Australia, Japan, the UAE and New Zealand all encourage novel food applications through streamlined and efficient application processes. The common factor is adequate resourcing of teams, allowing a collaborative approach to applications. In the better-performing regions, 12 to 14 months is a standard period from application to approval, compared with two to four years in the EU.
Despite having some of the best food tech researchers and institutes in the world, onerous regulations and member state resistance has meant the EU has fallen behind when it comes to fostering novel foods startups.
There can be little doubt this has had a measurable negative impact on investment and growth. “Food tech is a global technology race,” says Vainikka. “The EU has several of the leading companies, but all of them will end up going to market in other continents. The longer the delays to the process, the more likely it is that investment in business and factories will happen elsewhere. The EU should be extremely concerned.”
There is clearly a post-Brexit opportunity to attract companies and investment, but also to foster a culture of innovation. Much like Singapore is currently seen as a food tech gateway to Asia, the UK has an opportunity to position itself as a globally recognised gateway to European and US markets. So how are we doing on this front?
In truth, it is too early to tell, as the first wave of post-Brexit applications is only just making its way through the system. But there are encouraging noises from within the FSA, which sensibly has been looking towards the rest of the world for inspiration after recently commissioning a review of novel food regulations.
Peter Quigley, the FSA’s director of regulatory services, was part of an official delegation that visited Singapore to learn about best practise, including adequate resourcing of teams and the importance of preapplication engagement with businesses.
“Although food safety is the absolute priority of the FSA, the broader strategy of the organisation is about promoting healthier, more sustainable foods,” he says. “Enabling innovation is definitely part of delivering this.”
Also integral to success in other regions has been the prioritisation of applications based on their importance. In Singapore, this has resulted in a focus on sustainable protein technologies. By comparison, the FSA is currently considering 165 novel food applications, 133 of which are for CBD products – arguably of questionable benefit to population and planetary health.
The role of the FSA has traditionally only been to assess the safety and transparency of foods. But within its recent five-year strategy announcement, the organisation made its first-ever commitments to improving the health and sustainability of our food system. Professor Robin May, the FSA’s chief scientific advisor, is currently looking at a variety of approaches to help smooth the application process, and says he is keen to keep these new priorities in mind.
The unspoken issue, however, is adequate resourcing of regulatory teams, which is essential for a well-managed, speedy process. The FSA has considerably increased responsibilities post-Brexit, and if it wants to position itself as a collaborative regulatory partner rather than a bureaucratic gatekeeper, it will need a big enough team to do so. Whether or not this investment will happen within the current financial climate remains to be seen.
Policy Exchange, the UK’s largest and arguably most influential political think tank, is currently lobbying for such regulatory reform. Its ‘Unleashing Capital’ report, published last year, advocates for sites such as the Sheffield Olympic Legacy Park to trial a regulatory sandbox approach, similarly to Israel’s The Kitchen.
The Sheffield-based technology park is home to the National Centre of Excellence for Food Engineering and is developing its own food industry accelerator based on the Israel model, looking to attract startups and investment from around the world.
“Our view is that economic growth is not limited by too much regulation, but rather that growth is impeded by regulators not having the resources to get alongside innovators early enough to help guide them through the regulatory process to commercialisation,” says Chris Low, the park’s CEO.
He’s hoping to speed up the slow process that has dissuaded some of the world’s most innovative startups from coming to the EU. Many global companies and investors will be watching closely, in the hope the UK will become a more attractive destination. Proximity to the European market and close links to the US are a tempting combination and would be far more compelling if the regulatory framework was improved.
“Navigating the complexities and regulations within the EU has become a hurdle for many companies,” says Irina Gerry, chief marketing officer at Change Foods, a US-based precision fermentation startup looking to manufacture dairy proteins. “The UK has a unique ability to take on the leadership role within greater Europe by inviting, nurturing, and developing sustainable food technologies.”
This would fall in line with the ambitions of PM Rishi Sunak, who this week created a new department for science, innovation and technology. The question is whether novel foods can pitch themselves as part of his vision for the UK to become a true “science and technology superpower”.
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