From novel to norm: UK businesses are navigating a maze of regulation around alternative proteins

A version of this Insight first appeared in The Grocer.

The UK government is backing innovative technologies that are at the forefront of future food development – and  stepping up support and funding for alternative proteins. But the international regulations surrounding the development of alternative proteins remain stringent. What do businesses need to know about overcoming these barriers?

Global food challenge

Government bodies and agri-food corporations worldwide have long been preoccupied with how the globe's population will continue to feed itself more sustainably and efficiently in the decades to come.

And while current global food systems offer safe and reliable supply, studies suggest there will need to be heightened measures to improve food security and prioritise environmental sustainability in the future. This necessitates innovation through, for example, developing crops that are more resistant to pests and climate change, as well as developing proteins that will ensure sufficient capacity to feed the growing world population.

From cell-cultivated, lab-grown meat and insects to plant-based alternative protein sources, such as beans and mushrooms, and transformative fermented food ingredients, scientists, governments and leaders in the agri-food industry have been mapping out what the food landscape will look like in the future – and how both innovation and regulatory roadmaps will feed into that vision.

Growing consumer acceptance

Consumers, too, are already buying into the need for proteins that will satisfy personal health ambitions, as well as contribute to the wellbeing of the planet, with a growing trend for protein-rich foods in the diet. In the UK, a 2021 consumer survey by Ipsos MORI on alternative proteins, commissioned by the Food Standards Agency (FSA), found that 90% of respondents were more likely to have heard of plant-based proteins compared to edible insects (80%) and lab-grown (cell-cultivated) meat (78%).

Meanwhile, over three-quarters (77%) perceived plant-based proteins as being safe to eat compared to half (50%) for edible insects and only 30% for lab-grown meat.

However, persuading people to eat less meat is difficult. As Archie Mason, partner of Bramble Partners, an investment firm backing innovative food businesses, points out: “Many consumers are positively antagonistic to the idea of government forcing them to do so. Meat eating is intimately bound up with identity. That’s why we need to use every tool at our disposal – backing precision fermentation, cultivated proteins, better beans, and nature-friendly livestock farming – not just one or two of these, but all of them.”

Gene-editing benefits

One tool with great potential is the use of gene editing, a technique that allows for precise modifications in the genetic makeup of organisms. Public opinion has in the past been wary about using genetic modification, which involves adding genes from other species, in protein production. However, new genetic engineering (GE) technology, is becoming more accepted: GE doesn’t use foreign genes and creates products that could naturally exist.

In 2023, for example, a study by Sciencewise concluded that, as negative perceptions ease, people (particularly the younger generation) “might be more open to the use of engineering biology in food” as they are more likely to place higher importance on the increased security and sustainability benefits that this brings to the agri-food system.

Engineering-biology legislation

Beyond consumer perceptions, however, there are considerable legal ramifications around engineering biology in food and feed production.

Alongside public engagement and transparency, international protocols on engineering biology in food and feed products are focused on risk assessment and management, biosafety and biosecurity, and the careful monitoring and evaluation of the risks and long-term impacts of such products.

As a result, food manufacturers and retailers looking to develop an offering in this market – whether it be gene-edited plant-based products or cell-cultivated meats – still need to jump through numerous hoops before they can bring to market products that are acceptable to both the public and within the boundaries of the law – and the regulations vary depending on the country in question.

UK leadership

However, since its exit from the EU, the UK has begun to establish itself as the European leader in cultivated-meat innovation. Mason of Bramble Partners says that science-based regulation, venture capital (VC) and government-enabled sandboxes, such as the FSA's initiative, can help the UK extend this lead. He adds: ”Companies like Meatly – the first company in Europe to be cleared to sell cultivated meat, and the first in the world to sell cultivated pet food – shows what’s possible when innovation meets clear regulatory ambition.”

In a move to achieve a more streamlined process, the latest and somewhat controversial piece of legislation, the Genetic Technology (Precision Breeding) Regulations 2025, provides for the regulation of plant-based precision-bred organisms (PBOs) released or marketed in England.

DNA adaption

Adapting an organism’s DNA to enhance particular characteristics is at the heart of the new legislation, which is due to come into force on 13 November. This amounts to a relaxation of the former commercial development rules, as it only allows for genetic changes that “could have been produced naturally or through traditional cross-breeding programmes already in use today”, according to BBC science correspondent Pallab Ghosh.

As one of the regulatory authorities involved alongside the Department for Environment, Food and Rural Affairs (Defra), the FSA has said that precision-bred products will only be authorised if they are judged not a risk to health, not to mislead consumers and not to have lower nutritional value than their traditionally bred counterparts.

Accelerating innovation

To support innovation and reduce the barriers of red tape, last year the UK’s Department of Science, Innovation & Technology (DSIT) set up the Regulatory Innovation Office (RIO) to ensure safety and speed up regulatory decisions. Within this, engineering biology is one of the main areas of focus.

And, to further the cause of novel food innovation, in March this year the DSIT granted £1.4m in funding to the FSA to open an innovation hub, designed to help develop and expand specialist expertise in regulating innovative technologies such as precision fermented foods and ensure these are safe to eat before they are sold, as well as give greater clarity on regulatory requirements to innovators and investors.

In the same month, the FSA launched a pioneering two-year regulatory programme for cell-cultivated products (CCPs) as part of the DSIT’s Engineering Biology Sandbox Fund. This will aim to gather rigorous scientific evidence about CCPs and how they are made to inform future regulation on these products and enable the FSA to assess applications more efficiently, with safety for consumers a priority.

Regulatory minefield

While the new legislation will be welcomed by UK manufacturers keen to be at the forefront of food and feed biotechnology, achieving compliance could prove a regulatory minefield.

The Genetic Technology (Precision Breeding) Act 2023 heralds a new era for precision-bred organisms in England as it allows for a streamlined regulatory framework to facilitate their use in food and feed. But it highlights the complexity of the process, particularly in light of the recently proposed sanitary and phytosanitary (SPS) agreement between the current Labour Government and the EU.

By advancing ahead of the EU, the UK positions itself as a leader in genetic technology, offering a favourable regulatory environment for businesses and investors. However, businesses will be looking to stay informed about potential divergence between the UK and EU regimes.

Businesses will want to monitor the progress of the regulations and guidance to ensure compliance and leverage the opportunities presented by this new framework, especially in the wake of the announcement of a new UK-EU SPS agreement.

EU clarification

While details of the SPS agreement are still being hashed out, the EU’s current regulatory position on gene-edited products still needs clarification and this could complicate the issue for companies keen to gain acceptance of their alternative protein submissions on both the UK and EU markets.

For example, from 13 November, UK businesses will be able to start applying for release and marketing authorisations for PBOs – in a two-tier process that involves both a release notice and marketing authorisation through Defra and the FSA. However, in the EU, it’s likely the process will be more convoluted until the European Parliament and Council reach agreement on the detail of authorisations, and other elements such as patents – and, given the involvement of 27 member states, this could take at least six to 12 months or longer to achieve.

Other regulatory issues that will need to be taken into account include pre-market authorisation of novel foods in the EU and UK that apply to categories of protein beyond PBOs, currently coming under the jurisdiction of the European Food Safety Authority and the FSA respectively.

Window of opportunity

However, as the UK-EU SPS agreement is also not yet fleshed out, UK companies interested in developing alternative proteins under the terms of the newly agreed legislation will be looking to forge ahead and aim for authorisation on this side of the Channel as quickly as possible. This could stand them in good stead when it comes to regulatory approval and eventual acceptance on the EU market.

UK companies have a small window of opportunity to get their applications in to the FSA and Defra and, will also be looking for advice on how to navigate the process and put together the documentary evidence they will need, this should help to smooth the process with the regulator. Alternative protein development is an exciting and fast-moving area and, as expected, comes with many legal considerations.

Osborne Clarke comment

UK food companies and manufacturers are increasingly seeking out technical advice relating to food law and novel products. This advice could be in the shape of forming legal arguments for lobbying, interpreting the regulations or simply helping to guide manufacturers and present persuasive arguments to regulators on why a newly developed protein should be permitted. Intellectual property and patent expertise are also highly relevant for businesses focused on alternative protein.

Technical advice can also be sought to help identify new or additional food safety hazards, support product labelling and marketing and secure VC financing to help manufacturers grow their operations or commercialise their alternative protein products on a scalable basis – while international legal expertise can be vital for businesses as they look to navigate complex regulatory landscapes in multiple markets.

The future of food is changing rapidly and alternative proteins are at the cutting edge. Government policies to support the development of lab-grown meats and gene-edited plants, alongside VC investment in future food-tech, will continue to make this an exciting area for manufacturers, helping them to ensure food safety and sustainability for a growing global population in years to come.

Please contact our specialists to find out more about ways to achieve compliance in the alternative proteins arena or visit our preparing future of foods webpage.