Last month, the UK government announced the launch of its Regulatory Innovation Office (RIO), a new initiative promising to trim the lengthy and often tangled legal pathway to market for new products in high-growth sectors.
In a statement to the press, secretary of state for science, innovation & technology, Peter Kyle, described how the department would speed up approvals, provide regulatory certainty and reduce unnecessary delays across high-growth industries - including engineering biology - helping to make food production more efficient and sustainable.
Why is change needed?
The UK’s current approvals process for food products derived from such methods is recognised as unacceptably lengthy, complex and inconsistent, taking as long as two years for many applications. For food products involving synthetic biology or genetically engineered ingredients, companies must comply with several layers of regulation, including approval from the FSA and, in many cases, adherence to genetically modified organism (GMO) regulations, which can be stringent and slow-moving.
These regulatory hurdles can be especially challenging for start-ups and smaller companies in the food space, many of which lack the resources necessary to wait out a prolonged approval process. It also makes the UK unattractive as a market, and uncompetitive as a venue to launch an innovative product. As a result, many of these companies prioritise launching in markets with simpler or faster regulatory paths, such as the US or Singapore, where approvals for novel food products like lab-grown meat have already been granted.
Will this new novel foods approval approach work?
To address these concerns, the UK Government has also committed funding to the Food Standards Agency (FSA), including a £1.6m award as part of the Engineering Biology Sandbox Fund, which aims to test more innovative regulatory approaches. This initiative could expedite the approval process for products like cultivated meat, allowing innovative food products to reach consumers more quickly and cost-effectively, while maintaining safety standards.
With all this in mind, the Government should certainly be commended for setting out a pathway for reform and for recognising the novel foods industry as a potential growth market - but will it be enough? Are the issues inherent to the current approval system, in particular institutional reluctance to authorise innovative products without an enormous amount of scrutiny, so deep-seated that there will need to be a major cultural shift within the FSA, as well as a significant injection of funding if we are to see the level of reform required to give businesses the support they need?
The approach by ministers suggests that the intent is to steer applicants through the process, but in our experience the problem is rarely with applications per se; it is the process itself, which is overly cumbersome and inherently risk averse. This is antithetical to innovation and the necessary agility to react to market demand.
In order to really make an impact, one of the first challenges the RIO will need to focus on is how it can foster greater willingness among regulators to give indicative and advisory feedback early in a process, given that the process currently requires significant scientific - and therefore capital - investment.
Too often UK regulators are perceived to delay approval decisions until they have an overwhelming weight of positive scientific evidence, despite the absence of evidence generating concern. This has an anti-competitive effect, as already observed, because start-ups and innovators are often unable to raise capital until they achieve regulatory approval, with returns on investment then not seen until years later. Furthermore, the Covid-19 pandemic has surely taught us that often there is very little science or scientific agreement to be found.
Lessons from Singapore
Learning from the Singapore Food Agency (SFA) could provide a useful model. The SFA has streamlined its approval process for products like cultivated meat by offering real-time feedback during product development, enabling companies to address regulatory requirements proactively.
Singapore has achieved its leadership in regulatory innovation for novel foods through a combination of targeted initiatives.
Pilot programmes, such as Shiok Meats' world-first cultivated crustacean meat facility, have provided platforms for pre-commercial testing and compliance evaluation. While collaboration hubs like the Singapore Institute of Food and Biotechnology Innovation (SIFBI) streamline efforts by uniting research institutions, regulatory bodies, and start-ups to provide clear guidance on navigating regulations.
Additionally, workshops and training programs have equipped industry professionals with the skills needed to meet safety standards and expedite product readiness.
The SFA further supports innovation by offering feedback during product development and not simply when the application process is completed. Complementing these efforts, significant government investment, such as the S$144m allocated through the Singapore Food Story R&D Program, has bolstered research and development in alternative proteins, positioning the country as a global leader in food technology innovation.
How can the Regulatory Innovation Office succeed?
As the UK establishes the RIO, its ultimate success will hinge on its ability not only to streamline approval processes but also to foster a cultural shift within the FSA. The challenges are significant, but so too are the opportunities.
If the RIO can draw on best practices from global leaders in this field, while addressing the systemic inefficiencies and risk aversion that have long plagued UK regulators, it has the potential to position the UK as a global competitor in novel food development and approval.
