Precision Fermentation is coming

Ben Sutherland, Principal Food Technologist | Standards & Surveillance, FSANZ

Precision fermentation has come to the fore of late here at FSANZ. Otherwise known as microbial fermentation or precision biomanufacturing, this innovative approach produces various foods via genetically modified (GM) microorganisms. Specialised bacteria, yeast, or fungi are engineered to produce proteins, flavours, or other components traditionally obtained from animal or plant sources. Foods produced via fermentation can be further categorised into precision fermentation, where a filtration/separation process yields a final food, or biomass production, where the entire ferment forms the final food. Made without the need to raise and slaughter animals, they may be able to address supply volatility in instances where foods from animals may be compromised by disease or other factors like those currently creating egg shortages here. FSANZ is assessing applications we’d consider to be true precision fermentation, such as oligosaccharides for infant formula products, enzymes and also one considered biomass, Impossible Food’s soy leghemoglobin.

FSANZ considers we’d likely see multiple applications to amend the Australia New Zealand Food Standards Code (the Code) for precision fermentation products, such as animal comparator proteins and specialty ingredients, such as flavour compounds, used to enhance the taste, texture, and nutritional profile of various foods. The use of genetically engineered organisms in food production requires thorough testing to ensure the safety of the final foods. And whilst there is an onus on the manufacturer to supply safe and suitable food, a FSANZ pre-market assessment would still be required.

In preparation, we are collaborating with Cellular Agriculture Australia (CAA) and the CSIRO in Australia. FSANZ has observer status on the CAA’s Industry working group which includes regulators, companies, and researchers as part of its membership. The aim is to foster a commercial Australian cellular agriculture sector and ensure a fit for purpose regulatory framework is in place. With the CSIRO, we are discussing the issues that might be experienced by the sector, how our risk assessments might develop, and ways to engage with stakeholders. This includes developing brochures for industry, along with a practical resource guide and targeted communication for these stakeholder groups. We are also collaborating with and advising various overseas regulators who realise the precision fermentation wave is coming. So once industry have optimised their strains, tackled the challenges of factory design, ingredient sourcing, scaling production, filling the talent pool or gaining access to expertise, we aim to make the path to regulation a little less daunting.

Stakeholders are always welcome to contact FSANZ with any enquiries on these types of foods, as we can advise on the application process and provide expert advice in certain circumstances from our great team here, many who have worked in the precision fermentation area.

“But what about GM status?"

One common question is around the GM status of such products as industry move closer to their manufacturing phase. To answer this, when coming from GM microorganisms, the resultant product may be considered a “food produced from gene technology”. And while FSANZ doesn’t have a philosophical view on the benefits or otherwise of GM foods, noting there are around 90 currently in the Code, there are labelling implications. Section 1.5.2-4 of the Code requires labelling as ‘genetically modified’ where novel DNA or novel protein is present in the food for sale. Additionally, foods listed in S26-3(2) ‘Food produced using gene technology’, subsections (2A) and (3) must also be labelled with the words ‘genetically modified’, as well as any other additional labelling required by that schedule, regardless of the presence of novel DNA or novel protein in the foods. These foods are considered to have an altered characteristic, such as an altered composition or nutritional profile, when compared to the existing counterpart food that is not produced using gene technology. The requirement to label as ‘genetically modified’ also applies to a food for sale that consists of, or has as, a component that is a GM food. Sometimes GM labelling does not apply, such as if the food has been highly refined (other than food that has an altered characteristic), where the refining process removes novel DNA or novel protein e.g. a highly refined oil from a GM crop. It depends on whether it is a substance used as a processing aid or a food additive, where novel DNA or novel protein from the substance does not remain present in the food for sale, whether a flavouring substance is present in the food in a concentration of no more than 1 g/kg (0.1%); or whether unintentionally present in the food in an amount of no more than 10 g/kg (or 1%) of each ingredient.

We understand that labelling is only one aspect of the precision fermentation journey, there are no doubt many other questions stakeholders have. FSANZ is willing to provide advice on the regulatory process during industry’s development phase, so please reach out and we’d be happy to help.