Cellular agriculture: opportunities, regulations and how to get ahead

With pressure mounting to produce more food using fewer resources and with less environmental impact, cellular agriculture (in particular, cell culture and precision fermentation) holds much promise.

As technical challenges surrounding efficient and effective largescale production are addressed, it could become a mainstream food manufacturing technology. However, technical aspects of production are just one part of the equation; there are also significant regulatory hurdles.

What is cellular agriculture?​

Cellular agriculture offers alternative ways to produce commodities traditionally derived from animals or crops. It involves the isolation of cells from target species, which are then grown in bioreactors before harvesting.

According to the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), ‘cellular agriculture’ can describe both cellular and acellular production.

Cellular products, such as cultured meat, are formed by growing cells from a particular animal species and tissue type in vitro. The cells are then assembled on a scaffold to form tissue-like structures for further processing. Plant cells can also be grown in this way and an apple fruit cell culture biomass was authorised for use in the EU at the end of last year.

In contrast, acellular production uses microorganisms like yeast or bacteria to synthesise valuable ingredients such as proteins and fats, and active ingredients like vitamins, via a fermentation process. These advanced fermentation techniques, capable of producing targeted ingredients, are often referred to as ‘precision fermentation’. Genetic modification techniques are often employed in precision fermentation, which presents additional regulatory challenges.

UK regulations impacting cellular agriculture ​

Many experts believe cell culture and precision fermentation have the potential to deliver nutritious food in more environmentally sustainable and efficient ways than traditional farming. Used at scale, they could offer new ways to address the global protein deficit, while lowering requirements for land, energy and water, as well as reducing emissions.

This attractive prospect is stimulating innovation in both techniques, and a high level of market growth is expected over the coming years. However, history tells us that regulations surrounding food production often struggle to keep pace with the sector’s technical developments. This can lead to legislative gaps, grey areas and uncertainties which make it hard to plan commercial strategies or to ensure new products are compliant by design. 

The UK’s legislative landscape for cell culture and precision fermentation is not straightforward, and it is likely to evolve over the coming years. To maximise the chances of getting products to market, manufacturers need to adopt an agile approach that blends solid understanding of current regulations with effective horizon scanning.

Novel food authorisation​

Food and food ingredients produced using cell culture or precision fermentation must be approved before they can be commercialised in the UK. This is because they are considered novel foods.

The UK’s application and authorisation process for novel foods is managed by the Food Standards Agency (FSA). It is lengthy and requires a thorough safety assessment, but the FSA is investigating how the process can be improved and made more business focussed.

A number of human-identical milk oligosaccharides produced by precision fermentation with a genetically modified strain of E.coli have already been assessed and authorised for use in the UK.

GMO food authorisation​

The fact that cellular agriculture techniques often use genetically modified microorganisms (GMMs) further complicates regulatory matters. GM food has its own dedicated approval route separate from the novel food approval route in the UK. Deciding which is the correct route is critical to successful commercialisation of any new ingredient.

Food ingredients that employ GMMs in their production, but which contain no viable cells or DNA of the GMM in the final product are not considered GM. They follow the novel food approval route which, given continued hostility towards GM food in the UK, is likely to be commercially advantageous.

An illustration of this in practice can be seen with the authorisations of human-identical milk oligosaccharides mentioned above. They were produced with a genetically modified strain of E.coli, but production microorganisms are removed during the manufacturing process and no recombinant DNA remains. Therefore, the oligosaccharides did not fall under the remit of the GMO legislation.

Change may be on the horizon​

The passing of the Precision Breeding Act in England last year is a milestone moment which could signal a shift to a commercially focused approach. By differentiating between genetic modification and gene editing, it paves the way for use of new genomic techniques in plants.

With this change in legislation, FSA is developing a new authorisation framework to regulate the use of food and feed products in England. It doesn’t directly impact cellular agriculture, but it could mark a general turning of the tide.

Another development signifying potential change is FSA’s 2023 decision to conduct a review of the novel foods regulatory framework. This exercise was undertaken in recognition of the fact that the pace of innovation in novel foods could render the current framework unfit for purpose.

In a report on the review’s findings, the FSA emphasises that a good regulatory process does not impose unnecessary barriers to innovation. At this stage, the findings are simply intended to develop the FSA’s thinking on reform opportunities, but with many cellular agriculture products classified as novel foods it is an area to monitor closely.  

Separately, the FSA has specifically clarified that novel food tasting trials involving cell-cultivated products are permissible during research and development, under the proviso that there is no publicity or other marketing.

An opportunity to lead?​

In 2023, the University of Bath announced the launch of its Cellular Agriculture Manufacturing Hub. It aims to support the transition to ‘an environmentally, economically, and socially sustainable model in which novel manufacturing systems complement traditional food production’. The hub is being funded by the Engineering and Physical Sciences Council (EPSRC) of UK Research and Innovation (UKRI).

Coupled with the FSA suggestions that changes to novel food regulation may emerge in time, this sets a positive backdrop for cellular agriculture innovation in the UK. The UK could theoretically become more dynamic and supportive of developments in this arena faster than other European markets.

Will the UK become a hotbed for cellular agriculture innovation? That remains to be seen. However, one thing is certain. Manufacturers looking to get ahead in cell culture or precision fermentation need to consider regulatory matters from the outset. This means rooting commercial strategies in a solid understanding of requirements and classifications surrounding novel and GMO foods.

Decisions made during early development phases could determine which regulatory path a product needs to take. Purposeful steps towards compliance by design reduce risk and may accelerate the journey to authorisation, unlocking commercial returns sooner.

Missed the first edition of our Business Leaders’ Forum Newsletter? You can watch the exclusive video and read the article on complying with the new Economic Crime and Corporate Transparency Act, here.​ ​