We can all agree that fermentation is having a moment. From probiotic products and prebiotic fibres to emerging postbiotic ingredients and precision-fermented proteins, advances in microbial science are creating new possibilities for manufacturers.
But even as innovation accelerates, the rules governing how these ingredients are classified, substantiated and marketed are struggling to keep pace.
For companies hoping to turn scientific advances into commercial products, the challenge extends beyond proving that an ingredient works. They must also establish how it will be regulated, what evidence will be required, which claims can be made and whether those claims will be accepted in every market they want to enter.
Peter Berry Ottaway, a food scientist and regulatory consultant whose career spans more than five decades, believes businesses too often leave questions of regulation until it is too late.
He told FoodNavigator that his consultancy regularly receives enquiries from companies seeking to establish whether a product is viable only after development has progressed substantially. In some cases, the regulatory obstacles prove insurmountable.
“So far this week, we’ve had five people apply to us for information on whether their start-up will work. It’s only Wednesday.”
The probiotic precedent
Probiotics illustrate how regulatory uncertainty can affect an established area of functional food innovation.
Defined by the International Scientific Association for Probiotics and Prebiotics (ISAPP) as live microorganisms that confer a health benefit when administered in adequate amounts, probiotics have attracted extensive scientific and commercial interest. However, the ability to communicate their benefits varies between jurisdictions.
In the UK, for example, the Department of Health talks openly about prebiotics in public advice leaflets and the like, but the word is banned on commercial food labels, classified as an unauthorised health claim on food packaging and marketing.
Businesses must navigate the distinction between describing an ingredient – “Contains Live Cultures”, is a common one – and making a health claim that requires authorisation.
For companies developing unfamiliar microbial ingredients or novel fermentation processes, the evidence required can represent a substantial investment before commercial returns are assured.
Berry Ottaway warns that the cost of generating the necessary evidence can be prohibitive for smaller businesses. He estimates that some regulatory programmes such as that for novel foods authorisation may require hundreds of thousands of pounds, depending on the product and the studies needed.
“Lots of firms baulk at the cost. If your evidence holds together, and you have a market ahead of you that’s going to repay one-third of a million pounds in a hurry – then it’s worth going ahead.”
The UK layer
The UK is proving to be a particular headache for the food industry, where post-Brexit divergence has created differences from EU rules in some areas of food law.
A proposed UK–EU sanitary and phytosanitary agreement could bring closer alignment across a broad range of agrifood requirements, including food safety, regulated products, nutrition and health claims, and labelling. The UK government intends for the agreement to take effect in mid-2027, although negotiations and implementation details remain ongoing. The government has published guidance urging businesses to prepare for potential changes.
For manufacturers, closer alignment could ultimately simplify trade, but the transition raises practical questions. Depending on the final arrangements, businesses may need to review ingredients, authorisations, product formulations and labels to ensure they remain compliant.
Berry Ottaway argues that regulatory change can carry substantial costs for businesses managing large product portfolios, particularly where packaging and printed materials need to be replaced.
The Asia challenge
Approaches to functional ingredients vary even more widely between Asian markets. China and Japan have substantial research and development activity in probiotics, while regulatory approaches across Southeast Asia remain more conservative and fragmented.
Wai Mun Poon of Wong SJ Asia, a specialist in regulatory affairs, says one underlying problem is that regulatory frameworks can struggle to keep pace with emerging science.
“At present, there are international standards and guidelines for probiotics (WHO) and, to some extent, prebiotics. However, postbiotics remain an emerging field, and there is still a lack of clarity on how these products should be defined, classified and regulated,” she explains.
In many Asian markets, newer functional ingredients are assessed under existing regulations for conventional foods or health supplements, even when their characteristics and scientific considerations differ from those of more established products. China is also developing frameworks and standards covering probiotics, prebiotics and postbiotics, but approaches are not uniform across the region.
“Differences in regulatory requirements across markets can affect the selection of strains and ingredients, product formulation and the feasibility of launching a product in individual markets. Companies should assess the regulatory requirements and potential regulatory hurdles when selecting their target markets and right from the start of product development,” Poon advises.
She believes clearer definitions and classification criteria would help regulators and businesses establish how emerging products should be assessed. This is particularly relevant to postbiotics and fermented foods, some of which have long featured in traditional Asian diets but have not always been clearly defined from a regulatory perspective.
Evidence does not guarantee an approved claim
Classification is only part of the challenge. Even where an ingredient can be used, manufacturers must establish that the evidence supports the claims they intend to make.
“Having scientific evidence does not necessarily mean that the health claim will be accepted by regulatory agencies,” adds Asia regulatory specialist Poon.
She points to a potential mismatch between research conducted in clinical settings and the intended use of the finished product as a conventional food or health supplement. Studies may focus on disease prevention or treatment, for example, while the proposed product and its marketing fall within a different regulatory context.
For the industry, the challenge is not simply to generate more research. It is to understand what evidence is needed to demonstrate a particular benefit and how that evidence will be assessed by the relevant authorities.
Precision fermentation adds another dimension
The regulatory conversation is taking place against a wider backdrop of food innovation. Precision fermentation uses microorganisms to produce specific ingredients, including proteins and fats. It is distinct from conventional food fermentation and from the use of probiotic or postbiotic preparations, but it raises related questions about how novel technologies are assessed and communicated.
The European Institute of Innovation and Technology (EIT) Food’s October 2026 Consumer Observatory report explores how perceptions may influence the success of precision-fermented ingredients and highlights the importance of communicating tangible benefits such as flavour, texture and nutritional value, while clearly explaining the production process.
The study found that while many of its participants were not yet convinced by the technology, they were curious enough to want to try a product before deciding what they thought of it. This creates, the authors say, an opportunity for food businesses but also puts pressure on the first experience.
Some participants struggled to understand how microorganisms are used in the production process, whether the resulting ingredients should be considered “real” or alternatives.
“Curiosity gives precision fermentation an opening, but consumers still have very basic questions about what the technology is and what it means for the food they eat,” says Klaus G. Grunert, Professor of Marketing at Aarhus University, the study’s lead. “If those questions are left unanswered, novelty can quickly turn into suspicion.”
One particular challenge was explaining the role of microorganisms clearly enough. Participants said vague descriptions could make precision fermentation sound almost like “magic”, leading some to wonder whether information was being withheld.
The findings suggest that communicators need to strike a balance between making the science accessible and providing enough detail to be transparent.
Where does this leave the food industry?
Regulatory planning, scientific substantiation and consumer communication should not be treated by food businesses as separate stages of innovation.
For companies developing functional ingredients, the first step is to identify the intended product category, target markets and benefits they want to communicate. That can help determine which ingredients are viable, what research may be needed and whether the proposed claims are realistic.
The next step is to consider how the evidence will translate into a finished product and its marketing. A biological effect observed in research may be scientifically interesting, but manufacturers need to establish what it means for the intended consumer and whether that benefit can be communicated within the relevant regulatory framework.
Finally, of course, businesses must assess whether the proposition is commercially compelling. Consumers may be interested in gut health, nutrition or new production technologies, but they still expect products to meet familiar standards for quality, taste, convenience and value.
The next generation of functional foods will depend on scientific progress. Whether those innovations become successful products, however, may depend just as much on whether companies understand the rules before they invest.
