The Food and Agriculture Organization of the United Nations (FAO) recently published a report on the food safety aspects of precision fermentation, covering nomenclature issues, the production process, and regulatory frameworks. Its conclusions are based on findings from a systematic literature search and consultations with regulators.

The report explains that, although precision fermentation processes has existed for some time, the term “precision fermentation” is relatively new, and does not have an internationally harmonized definition. Generally, precision fermentation refers to specific fermentation processes for a targeted and efficient production of food ingredients, and is increasingly used to describe the production of food compounds traditionally sourced from animals; for example, egg white protein, milk proteins (i.e., casein, whey, lactoferrins, and beta-lactoglobulin), muscle proteins (i.e., collagen and gelatin), human-identical milk oligosaccharides, and honeys. Precision fermentation is also being explored for the production of biological substances to be used as media components for cell-based food production.

Fermentation-based technologies convert organic substrates into food products using various microorganisms, including bacteria, yeasts, filamentous fungi, and microalgae. Although traditional fermentation has been used for millennia to produce foods and beverages like yogurt, miso, beer, and other items, it is now being applied to the production of large quantities of microbial biomass that can be used as a whole—as a food product on its own or further processed to isolate specific food-ingredient compounds (i.e., lipids, proteins, and pigments).

The perception that precision fermentation is a novel process may come from its association with the use of modern genetic tools to target the efficient production of food products, ingredients, and additives. It often contributes to cellular agriculture efforts (i.e., cell-based food production) and other future food production systems that do not rely heavily on conventional agriculture practices.

This perception of novelty may lead various authorities to question whether existing food safety regulatory frameworks are adequate for ensuring the safe production of precision-fermented foods. FAO asserts that the appropriateness of adapting or developing regulatory frameworks for precision-fermented foods can be determined through formal risk assessment, beginning with comprehensive hazards identification that requires a full understanding of the precision fermentation production process. Although precision fermentation generally uses established fermentation processes, precision fermentation may differ from traditional fermentation in the use of various production hosts, the scale of production, processing modes, and types of food applications.

In the U.S. and Hong Kong, precision-fermented beta-lactoglobulin has already been commercialized for use in ice creams and baked goods. Soy leghemoglobin produced via precision fermentation has been commercialized as a meat flavor additive in Canada, Australia, New Zealand, and the U.S. In India, Israel, and Singapore, precision-fermented milk proteins have been approved as food ingredients.

Since precision fermentation-derived food products have been commercialized and marketed in some countries, FAO suggests that regulatory authorities in other countries may benefit from the experience that these countries have gained through their regulatory processes. For example, in some countries and jurisdictions, pre-market approval of precision-fermented foods, including a food safety assessment, is required. Additionally, some countries apply labeling requirements to precision-fermented foods, for the purpose of distinguishing the precision fermentation derived products, or for the purpose of allergen indications.