The future of food: regulatory challenges for biotechnology and cellular agriculture

Having recently attended the 2025 Australian Institute of Food Science and Technology Convention and the Made and Grown: The Future of Food conference hosted by Cellular Agriculture Australia, it is clear that certain technologies and innovations are leading the pack in terms of answering the global challenge of: how to sustainably feed more people using fewer resources? This article explores how ready Australia’s laws and regulations are to embrace this future.

What is the future of food currently predicted to be?

As a lawyer (and not a scientist or futurist), it is hard to be certain whether the technologies currently at a tipping point here in Australia will in fact be the future they claim to be. However, the cases put forward by industry, investors, government and academia are compelling.

The technologies that are already attracting investment and approaching viable product in Australia are:

• Precision fermentation: a technology that has been used by the food and pharmaceutical industries for decades, but are now reaching a scale and application that can have a wider impact on the food supply. Simply put, precision fermentation is the identification or development of a specific living organism which secretes specific (usually high value) ingredients, from insulin to milk proteins.
• Cell cultivation: similar to precision fermentation except, instead of feeding an organism to obtain a by-product, the organism being grown is itself the product. Australia’s first cell-cultivated meat product obtained regulatory approval in June this year, but the cells that can be grown are not limited to animal products. KHQ has advised on both cell-grown meat and plant products that are now on the Australian market, as well as advising on how human tissue regulations can impact the growth of human milk components.
• Molecular agriculture: imagine growing a canola crop that (when squeezed) produces a fish oil. Or imagine growing a plant that (when harvested) produces a bovine milk protein. While this technology requires much more time than the previous two and may require more upstream processing to produce a refined output, plants are incredible factories that provide their own carbon and energy, in contrast to the previous two technologies.

Both the AIFST Convention and Made and Grown conference discussed the challenges facing broader adoption of these technologies while also pointing to their potential: technologies that can be used in urban environments; that require less land; that could require fewer resources; that need not impact the welfare of animals; and which could – at the right scale – be price equivalent to traditional agriculture.

The challenges are significant. Vast investment is required for these technologies to reach the requisite scale to be sustainable and competitive. That same scale is a barrier to wider use of these technologies outside of pharma and high value ingredients (as food commodities generally have small margins on high volume of production).

However, the opportunities are also tangible. One of the biggest shifts since the retail explosion (and subsequent contraction) of “alternative proteins” during the peak of the COVID pandemic is that these new technologies are focused on complementing traditional agricultural produce, not supplanting or replacing it. Using these technologies to produce high value ingredients which are currently causing bottlenecks in traditional agriculture (such as enzymes and milk components) will, if they fulfil their potential, result in growth of both cellular and traditional agriculture.

Australia is also uniquely positioned to take advantage of these technologies. We are currently home to cutting edge research as well as successful start-ups developing this technology. We are rich in the inputs these technologies require (land, sunshine, sugar). We currently have a political drive to mature our economy to further develop refining and manufacturing, not just “dig and ship” our commodities to other economies to be developed into higher value goods (and profited from) overseas.

Finally, following national defence weaknesses exposed by the COVID pandemic and recent uncertainty in global trade and security, these technologies could elevate Australia from being food secure to food sovereign.

Beyond investment in the infrastructure to make these industries a reality, what are the regulatory barriers to these food applications actually reaching consumers in Australia (aka going to market and making some actual revenue)?

What are the regulatory barriers?

In Australia, there is a significant difference in regulating how a food substance is made and whether the food substance itself requires approval. In other words, is the process or the output regulated … or both?

For example, cell-grown meat products are genetically identical to the animal from which the original cell line was taken. And yet the process of growing animal cells without the animal has been held by Food Standards Australia New Zealand (FSANZ) to trigger the definition of “novel food”. This means that any cell-grown product (meat or otherwise) will need regulatory pre-approval from FSANZ.

However, importantly, in approving Australia’s first cell-grown meat product, FSANZ created a new regulatory pathway for all cell-grown food products. This new pathway should, as the industry matures and regulators become more comfortable with the controls required to safely produce the food, lead to these approvals becoming quicker and quicker. It is the first time since I have been practising law that the Food Standards Code appears to ready for a new technology as it arrives, rather than holding new technologies back. FSANZ should be commended on the development of this regulatory pathway, although there are no doubt some quirks in the new Standard 1.5.4 that still need to be ironed out.

However, not all new technologies or new ingredients might require regulatory pre-approval. Many of these high value food ingredients have specifications listed in Schedule 3 of the Food Standards Code. If cellular agriculture manages to produce an ingredient that meets the same specification that is prescribed for production from traditional agriculture, then perhaps no regulatory pre-approval of the output is necessary.  If the process of making the food ingredient is already approved (such as is the case for many precision fermentation applications), then perhaps no regulatory pre-approval is required at all (so long as the product is safe, of course).

Key takeaway: build regulatory assessment into development plans (and budget)

Given the food approval process can take anywhere from 9 months to several years, whether such an approval is necessary to bring your innovation to the Australian market is a vital assessment to make as early as possible.

This is a particular challenge for start-ups, as any safety assessment by FSANZ requires a settled process and consistent output. While R&D into new ingredients and scale-up improvements can continue as a company awaits regulatory approval, there may be no revenue until such an approval in place, only costs.

In KHQ’s experience, there are many start-ups that have had funding to develop an incredible innovation that garners significant market interest – but then not have sufficient funding to last the years required to move from R&D to commercialisation. While of course this is an argument for regulatory approval timelines to be shortened, no stakeholder (industry, government or consumer) wants untested and potentially unsafe food in the market. Timeframes can only be shortened so much to be confident in the in the safety of brand-new product or technology.

A much larger legislative review required to embrace the future of food

Regardless as to whether an individual product or process requires regulatory approval, if the Australia government wishes to encourage the development of these technologies, then many pieces of legislation and regulation need to be updated, not just the Food Standards Code.

For example, many import and export regulations define “meat” in relation to an animal carcass or a slaughtered animal. Biosecurity restrictions should be amended to reflect that lab-grown products pose almost zero risk of transmitting animal disease. While all of these ingredients will have been grown and made in Australia, the legal definition of “grown in” includes “materially increased in size or materially altered in substance in that country by natural development”. While many food scientists could easily argue that bioreactors harnesses natural development processes, would a judge agree?

Given that a policy paper has only just been released to acknowledge the existence of the internet is an issue our food regulations have yet to adapt to, a much quicker and more targeted review of our laws is required for Australia to become a cellular agriculture powerhouse.

Author’s note: KHQ sat on the Food Policy & Regulation Panel at the 2025 AIFST Convention and acts for two prominent Australian biotechnology companies.

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