The Food and Agriculture Organization of the United Nations (FAO) published an insightful report providing a comprehensive review of scientific evidence and regulatory practice in the precision fermentation sector.

From production processes to regulations from around the world, the report outlines how different jurisdictions approach safety for precision fermentation – and where greater clarity is still needed. We’ve captured the key takeaways to help guide regulators in their work in this space.

About the report

Drawing on a systematic review of scientific literature and insights from more than 100 regulatory experts across 35 jurisdictions, the FAO report presents a comprehensive overview of food safety considerations for precision fermentation-made food products. It includes case studies, identifies common production steps and potential related hazards, and highlights how countries are currently assessing the safety of precision fermentation-made foods.

The report offers a roadmap to support regulators, particularly in countries where precision fermentation is gaining momentum but formal guidance is still evolving. It also calls for improved alignment on terminology to avoid confusion and strengthen consumer confidence.

Precision fermentation and its applications in food products

The report recognises that the ongoing quest for more sustainable and cost-effective ways of producing food has recently led to a growing interest in fermentation-based technologies. It highlights that precision fermentation is expected to play a significant role in future food systems, especially by supporting sustainable food security in the context of climate change or in regions where agricultural land use is limited. One rapidly growing area of application of precision fermentation is the production of animal-specific components, offering the potential to deliver nutritious food ingredients more sustainably.

Precision fermentation uses microorganisms to produce specific functional ingredients, such as proteins, enzymes, flavour molecules, vitamins, and fats. While many processes involve editing the genes of these microorganisms so that they produce the desired ingredients, the report notes that some companies avoid genetic modification altogether. In either case, the resulting ingredients are typically highly purified, with no – or at most trace levels of — modified microorganisms present in the final product.

The report highlights several long-commercialised examples of precision fermentation, such as chymosin (rennin), an enzyme used in cheese production. Originally sourced from animals, it is now widely produced via precision fermentation. These examples show that precision fermentation is already a well-established part of global food production, with products approved via long-standing and robust regulatory pathways. 

The importance of clearly defined terminology

One of the key challenges highlighted in the FAO report is the lack of a universally agreed-upon definition of precision fermentation. While the underlying technology is decades old, the term itself has only recently gained widespread use, leading to diverse interpretations across sectors. The report points out that this diversity in terminology can cause confusion and uncertainty, in particular for regulatory bodies.

“No country or jurisdiction has an official or legal definition of the term “precision fermentation”, although many of them have informally been using the term, even in regulatory contexts.”

FAO Report on Precision Fermentation with a focus on Food Safety, p28

The report suggests that a clear and consistent definition will be important for effective communication and regulation across global food safety frameworks. As a starting point, it recommends that national authorities review how the term is currently used within their regulatory context and consider establishing a formal definition at the local level.

Food safety considerations for precision fermentation

The central finding of the report is clear: precision fermentation does not pose fundamentally new safety challenges. In most cases, existing food safety systems can be applied effectively, requiring only slight adaptations to reflect the novelty of target ingredients where needed.

“In the literature, there are few mentions of potential new hazards in the process of precision fermentation and they mostly [focus] on the concern that input materials for the fermentation process might remain in the final products.”

FAO Report on Precision Fermentation with a focus on Food Safety, p26

The report outlines that most food safety risks associated with precision fermentation are well known from conventional fermentation and biotechnology applications. While the technology is advancing rapidly, the underlying processes and associated hazards are well understood and already covered by established safety tools like Good Manufacturing Practices (GMP), hygienic facility design, and comprehensive food safety assessment methodologies outlined in Codex Alimentarius guidelines.

While production methods vary depending on the target ingredient, such variations are not unusual in food manufacturing and are addressed through standard risk assessment practices. Specific attention may be needed for potential allergens or trace residues. 

Potential risks are manageable with existing frameworks

The report maps the fundamental stages of precision fermentation production, which typically include technology development, upstream fermentation, and downstream processing, and assesses the risks and hazards associated with each stage.

Key takeaways include:

• The microbial production host significantly influences the risk profile. A lower risk example is baker’s yeast (Saccharomyces cerevisiae), which is used in precision fermentation to produce milk and egg proteins.
• Areas for consideration include microbial residues, allergens, and chemical inputs – all of which are considered as manageable within existing frameworks.
• No fundamentally new hazard types were identified that fall outside the scope of current assessment tools.

While most precision fermentation-made ingredients are highly purified and free from the production organism, there may be exceptions. The report therefore strongly recommends that authorities familiarise themselves with the production process and conduct case-by-case safety assessments, particularly when novel compounds or genetically modified organisms are involved.

International coordination can improve regulation

A core message of the report is that regulators don’t need to start from scratch when assessing the safety of precision fermentation products. The findings of the two consultations with more than 100 regulatory experts from 35 jurisdictions confirm that most countries already apply similar existing food safety frameworks to precision fermentation-made foods, even though the terminology and assessment approaches differ.

Some regulators focus on the end product, others on the production process, and a few assess both. The report also highlights gaps and inconsistencies, such as variations in allergen labelling rules and the absence of precision fermentation-specific provisions in many jurisdictions. It highlights that inconsistent terminology can lead to regulatory ambiguity, delay product approvals, and create consumer confusion.

To address these challenges, the report recommends fostering broader dialogue among competent authorities at the international level. For example, greater coordination through Codex Alimentarius could help streamline assessments and increase global consumer confidence.

Conclusion

The FAO’s new report confirms what many in the field have long known: precision fermentation itself is not new – nor are the food safety principles used to evaluate it. What is new is the term’s rapid emergence and the growing diversity of its applications.

As more precision fermentation-made products seek market entry, this comprehensive review provides more clarity for regulators and policymakers. It finds that many existing food safety systems are already being applied to precision fermentation products, with more similarities than differences across jurisdictions, while highlighting the need for clearer terminology and global coordination. 

The ball is now firmly in the regulators’ court. While innovators are advancing the application of precision fermentation for alternative proteins with significant potential to contribute to sustainable food systems and food security, regulatory uncertainty risks delaying progress. Regulators must act now to provide the clarity needed to realise these benefits while maintaining consumer safety and public confidence.

Author

Lea Seyfarth Policy Officer

Lea engages with EU policymakers to advance alternative proteins and create a better European food system.