Precision Fermentation

Precision fermentation refers to the use of microorganisms — often genetically modified — as cell factories to produce specific target compounds such as proteins, fats, flavours, or vitamins. The microorganism is engineered or selected to produce a desired substance, which is then isolated and purified from the fermentation broth.

Under the EU novel food regulation, precision fermentation products typically fall under the category of foods produced using a new production process, or foods consisting of or isolated from microorganisms. If a genetically modified microorganism (GMM) is used in production, additional requirements apply regarding the characterisation of the production organism, even if the organism itself is not present in the final product.

EFSA's assessment of precision fermentation products focuses on several specific areas: characterisation of the production strain (including any genetic modifications), evidence that the final product is free from viable GMOs and newly introduced DNA, process contaminant analysis, and demonstration that the target compound is identical to its conventionally produced counterpart where a comparison is possible.

EFSA's 2025 guidance on characterisation of microorganisms used in food and feed production provides the current framework for GMM safety assessment in this context.