Deep dive: Cultured club

The technologies producing cultivated meat are gaining momentum worldwide but, as yet, regulatory approvals are not keeping apace. David Burrows investigates who will be next in line to join Singapore and Israel at this new lab-grown dinner party?

It was in December 2020 that Singapore approved the first sale of a cultivated meat product for human consumption. Having such a prominent regulator green light this new technology should have produced ‘ripple effects’ throughout the region, experts said. They were right: US$62 million of investment flooded into cultivated meat and fish companies based in Asia Pacific last year, double the amount in 2020. Investment globally more than trebled to almost US$1.4 billion, according to The Good Food Institute.

Those uplifts can’t be directly linked to the Singapore Food Agency’s (SFA) approval of Eat Just’s chicken, of course. But serving poultry that was cultivated rather than caged and slaughtered made the technology “real” to investors, notes GFI. “Not a week goes by that we aren’t in touch with either a new cultivated meat start-up in Asia that has their eyes on the regional market, or an international company that has put Singapore into their plans for the first time because of the friendlier regulatory climate,” says a spokesperson for GFI.

There can be no doubt that, mentally, the historic approval has had a big impact. Indeed, those in this space are using it to press other countries into following suit. But will they? And, if so, how quickly? That’s the US$1.4 billion question.

“The question of approval is primarily a question of time,” suggests Didier Toubia, Co-founder & CEO at Israeli start-up Aleph Farms, which is preparing for the commercial launch of its cultivated beef in Singapore. A number of companies have said publicly that they expect approval for their products by the end of 2022 or 2023, but as yet there hasn’t been one.

“The industry is trying to speed up regulatory clearance of cultured meat,” adds Kantha Shelke, Senior Lecturer in Food Safety Regulations at Johns Hopkins University and Principal at food science firm Corvus Blue, but regulators are “cognizant of the fact that cultured meat is more than just replicating the organoleptic, nutritional, and compositional characteristics of meat tissue harvested from food-producing animals. They also need to confirm that the harvested cells have no unintended consequences”.

All this takes time – and how much depends on where the application is made. The approval process for such novel foods is around nine months in Singapore but can be as long as three years in the EU (which has an average of 28 months), according to research by Amgen Consulting, a regulatory specialist focused on the alternative proteins sector.

Europe: More taste, less speed

It is no secret that the European Union has the most demanding regulatory framework and the longest novel food approval timelines, but it’s worth the pain: a go-ahead gives market access to 27 countries and a population of 447.7 million consumers. Europe, too, is the birthplace of cultivated meat – Dutch food-tech company Mosa Meat unveiled the first lab-grown burger in 2013 – but others have joined the chase since that very pricey patty.

It has just begun picking up the pace again though. In March 2022, the Dutch House of Representatives voted (strongly) in favor of cultured meat being used in ‘tastings’ (these are allowed in France and Germany too), which are “of great importance for the taste of cultured meat and public perception”, MPs noted. Producers are now working with the Ministry of Health and the Netherlands Food and Consumer Product Safety Authority on the details. “The fact that we can now start with the tastings will benefit the product that we will offer to EFSA [the European Safety Authority] for approval,” Daan Luinin, Meatable CTO & Co-founder told foodnavigator.com.

Earlier this year, the Netherlands government also announced €60 million (US$59.5 million) to support the creation of a national cellular agriculture ecosystem as part of the country’s national growth fund. Others are looking on enviously at what ProVeg, an NGO, reported as the largest-ever investment in cell ag by a national government in Europe (globally, GFI notes, private investment in cultivated meats is dwarfed by that for climate tech more widely, despite food being responsible for around a third of global emissions).

The UK is another government seemingly supportive of a technology that boasts of far lower environmental impacts than traditional meat. The country has the richest landscape of cell ag companies in Europe, according to ProVeg, with 12 companies that are working on cultured meat, cultured fat, cell-line developments, or bioreactor systems. One of those, Roslin Technologies based in Scotland, last year become the first cultivated meat company to win a UK government grant (£1 million from UK Research and Innovation in 2021). “Singapore and the USA are viewed as the fast track [for cultivated meat],” insists John Clinkenbeard, COO at Roslin Technologies, but there is an opportunity on the back of Brexit for the UK to “lead the way in food-tech”.

Cultivated meat has been the topic of debates this summer in both the UK and European parliaments. Concerns at both were raised that Europe is being left behind. To “get ahead of the game” the UK government was urged by MPs to examine carefully its investment in R&D and make sure that its regulation “does not get in the way of the introduction into the market of cultivated meat”.

Some countries, such as France, present a far more hostile environment to this technology but there is little doubt that a number of governments are looking closely at the opportunities thanks to Singapore’s approval. However, start-ups are “a bit cautious” about going for the European route first, says Harini Venkataraman, Senior Analyst in the Agrifood team at Lux Research, based in the Netherlands.

Nicolas Carbonnelle, Partner at law firm, Bird & Bird, says the cultivated meat sector was lucky to have a bold regulatory body like the SFA willing to invest the time and resources into that first approval. “Not all authorities are going to do that,” he says, but there is still a sense the “game is changing”.

Asia is hot right now

Singapore offers a fraction of Europe’s market (5.7 million people) but its new and comparatively flexible novel food framework makes up for it. “Start-ups may be incentivized to establish their manufacturing bases in locations that have established regulatory approval processes for cultivated meats,” explains Waverly Eichhorst, from the University of Colorado Boulder, who has been studying the state of cultivated meat in Thailand.

Interest has also spilled over into neighboring countries including Japan, China, South Korea, as well as Thailand. “Things have certainly heated up [in Asia],” adds Toubia. Aleph has partnerships with food companies Thai Union and CJ CheilJedang, as well as with Mitsubishi in Japan.

Asia is not just a hotbed for food-tech innovation either: it is also seeing some of the largest increases in demand for meat as the middle classes grow. Some forecasts suggest beef consumption across the continent will grow faster than any other region in the next few years. Governments are “making it clear that they are open to approving and accepting cultivated meat as a complement to more environmentally friendly practices in conventional agriculture”, Toubia notes.

It’s all very exciting. Speak to those involved in cultivated meat and there is much talk of collaboration, communication and dialog between regulators and the industry. This is new ground for both parties, of course. “Singapore’s regulatory approval of cultivated meat depended on meat producer Eat Just working with the Singapore Food Agency to prove that the company could meet food safety requirements for novel foods and manufacture a high-quality product consistently and dependably,” noted Boston Consulting Group in a recent research paper. Others can “take inspiration” from this.

Industry is eager to launch products and scale up and regulators will need to keep pace, notes BCG. “Advances are happening quickly: by the time a company receives approval for their cultivated product, technology might have moved to a new level – with new considerations and requirements. By establishing a suitable approach to regulation that takes into account the rapid pace of innovation, the burden on both industry and regulator can be reduced.”

Japan’s Health, Labor & Welfare Ministry now has a research team dedicated to cultivated meat. At the start of this year, China’s five-year agricultural plan included cultivated meat as a component of food security. Companies in South Korea such as TissenBio have also been able to raise significant early rounds of funding, notes GFI, as the government indicated its intention to evaluate the safety and manufacturing processes of cultivated meat and seafood.

Singapore has been “sharing” its approach to cultivated meats with other countries, according to GFI, with the likes of Japan looking to craft its own novel food regulatory frameworks. Lux’s Venkataraman says regulatory bodies the world over are trying to understand what a streamlined process looks like – and nowhere more so than the USA, which is her bet for “something happening” next in the space.

USA – the sweet spot

President Joe Biden recently signed an Executive Order directing the whole of the US government to explore the potential of biotechnology, including “cultivating alternative food sources”. At the press briefing, a senior official said the initiative will look at how to “improve food security and drive agricultural innovation, including through new technologies that protect crops from disease, enhance seeds and fertilizers and foods made with cultured animal cells”.

Eat Just CEO, Josh Tetrick, told PlantBasedNews that this was a “bold move” by the USA. The country could indeed provide a sweet spot for cultivated meat companies – a flexible and open regulator that provides valuable pre-submission advice, plus a market of 329.5 million people. “The USA has moved at record pace to develop a framework for these novel products,” suggests Brian P. Sylvester from law firm Covington & Burling.

The two regulators involved – the US Department of Agriculture (USDA) and the US Food and Drug Administration (FDA) – developed a Memorandum of Understanding in 2019 and inter-agency working groups are focused on topics such as pre-market safety and labeling, Sylvester explains. “The regulators have also engaged with industry – they’ve been very welcoming,” he adds.

For novel foods, it is the manufacturers’ responsibility to make sure the food is safe to consumers, notes Canadian cell-cultured start-up Future Fields. With cultivated meat, each product will be assessed on a case-by-case basis for their safety and toxicity. Overall, the regulatory threshold will “likely be higher” than that of “regular” foods, explains a spokeswoman. “Regulators will be strictly analyzing every parameter of this product development process to avoid the associated risks and safety concerns.”

The main areas on product safety tend to be related to the cells and their genetic stability, the growth medium and its potential residuals, and the standard of production. There are several things to iron out, suggests Shelke from Johns Hopkins, as regulators look to ensure consumer safety as a preventive approach rather than having to react to adverse events. “This all takes time,” she adds.

Professor Tom MacMillan, who is leading a project at Royal Agricultural University in the UK to understand the implications of cultured meat for farmers, says there are “murmurs” from the industry about regulatory barriers, but “when you dig into it the issue really seems to boil down to wanting the regulatory requirements translated into terms that make sense for their sector. Last I heard, folks are already working on that”, he says. “Most businesses recognize the huge importance of regulation in underpinning consumer confidence and the social licence for cultured meat.”

Indeed, research by the UK Food Standards Agency shows that of the consumers not keen to try cultivated meat, 27% could be persuaded if they knew it was safe to eat and 23% would be swayed if they could trust that it was regulated properly.

“It’s not just about how [these products] will be approved now,” suggests Anne Marie Taylor, Director at law firm DWF, “but how they will be regulated going forward”.

Taylor is among those remaining hopeful about the benefits of cultivated meats but cautious about the forecasts. Saskia Hoebée, Senior Associate at European food-tech VC, Five Seasons Ventures, says there are usually one or two hurdles facing investors but in the case of cultivated meats there are four – and the regulatory environment is only one of them. Question marks remain over scalability, price parity and consumer perception, too, she says.

Just 1,000 people have been able to buy cultivated meat in Singapore. Still, that first approval serves as a proof of concept, says GFI. It demonstrates that “cultivated meat can deliver all of the tastes and flavors that mainstream meat-eating consumers expect, without industrially farming animals and chopping down the rainforest to get it”.

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