What does the FDA’s green light on cultured meat mean for Europe? “There are global consequences”

It was a “historic milestone” that the US Food and Drug Administration (FDA) recognized a cultured meat product – UPSIDE Foods Cell Chicken – as safe as its animal-derived counterpart.

After receiving a “no question letter” from the FDA, UPSIDE Foods is now moving closer to commercialization, which, if achieved, would make the US the second country in the world to bring cultured meat to market after Singapore regulatory approval in 2020.

In Europe, the situation is a little different. As of September 2022, FoodNavigator understands this no company has even submitted a new nutritional profile for cultured meatto the European Food Safety Authority (EFSA) or the UK Food Standards Agency (FSA).

What implications, if any, will the FDA’s green light on cultured meat safety have for the European sector? Could this contribute to a more progressive approach to the authorization of new food products? And could European meat companies now favor the US in their market strategies? FoodNavigator is investigating.

All views on the US

According to Cellular Agriculture Europe, an industry association based in Brussels, the “no questions asked” letter has implications not only for Europe but for the world. “The FDA’s green light on the safety of cultured meat will have implications around the world.” ​Robert E. Jones, president of Cellular Agriculture Europe, explained.

Coupled with China’s commitment to research and development (the country has clearly identified cultured meat and related technologies as areas for R&D investment in its five-year plan), the UK is exploring the possibility of streamlining authorizations for new food products and cultured meat on the COP27 menu thanks to Eat Just, Inc.’s Jones says it’s “clear” that governments around the world are “racing to capitalize on the potential of cellular agriculture.”

Mosa Meat, the Dutch start-up responsible for creating the world’s first cultured meat burger (and where Jones is head of public affairs), also suggested the green light was an exciting event worldwide.

“The FDA’s decision is an exciting development for the entire cellular agriculture ecosystem, including investors, companies and food system reformers,” ​Marten Bosch, CEO of Mosa Meat, told FoodNavigator.

“It’s no longer just the Singapore Food Agency that is telling consumers that meat farming is a safe alternative to animal slaughter, and regulators around the world will be paying close attention.”

Can lessons be learned from regulation?

Could the FDA’s green light be a sign that the EU needs to review its regulatory framework to avoid being left behind? Can EFSA learn something from FDA in this context?

UPSIDE Foods, the recipient of the “no questions asked” letter, believes the green light can help validate cultured meat across the board. “Broadly speaking, we believe the FDA’s actions will be an extremely legitimate force to regulate meat farming worldwide.” The press secretary of the company informed the publication about this.

For Mosa Meat’s Bosch, a reworking of the EU regulatory framework is unlikely, but the CEO supports healthy competition between regions. “A sense of global competition usually helps to force governments to help their national industries expand and prosper. Changes in EU law are unlikely, but there are lessons to be learned from how open the FDA is to having a robust dialogue with companies before and during the application process.” we were told. “This approach, which is an administrative-level solution, can be very helpful in making security checks as fast and efficient as possible.”

Could the FDA’s green light be a sign that the EU needs to review its regulatory framework to avoid being left behind? GettyImages/Rimma_Bondarenko

Now that UPSIDE Foods has received a “no questions asked” letter for its cultured chicken products, it will now be able to move to a standard process comparable to that followed by conventional chicken products. This is aimed at ensuring the safe production and handling of chicken, including obtaining an inspection permit from the United States Department of Agriculture (USDA).

Mosa Meat said it will monitor the process. “We will have to see how the USDA portion of the process evolves to assess how well the US framework compares to existing regulatory pathways in Europe and Singapore.”

While Mosa Meat’s Bosch focused on the competition, Cellular Agriculture Europe’s Jones is calling for more cooperation between regulators in light of the FDA nod. “As this industry is new and rapidly evolving, knowledge sharing between companies and regulators is critical,” he told the publication.

“We encourage EFSA and FDA to compare notes, and we stand ready to engage in dialogue about making the regulatory approval process as safe and efficient as possible.”

The US is the focus of European mobile players

Due to strict regulations in Europe regarding new food products, a large number of meat players have already looked to distant countries for their initial market entry.

In France, for example, the cell-based foie gras producer Gourmey used to expressed interest​ in markets with more progressive regulation, such as Asia and the US. Dutch Cultured Meat Group Meatable says it is interested in the EU, UK and US, but plans to launch in Singapore first.

Mosa Meat similarly sees commercialization through a global lens, and has confirmed that Europe is high on the agenda – at least in the long term. “The fact that European safety regulations are robust is exactly why Europeans trust their food, so we welcome the thorough inspection of our non-GMO and serum-free beef.” Bosch told FoodNavigator.

“In 2013, we started growing meat, created our company in the Netherlands and will definitely bring it to the European market. We are a focused company and you cannot have a global impact on the climate crisis without also having a presence in Europe.”

The company is currently in talks with regulators in “several” regions around the world, including North America, Europe and Asia. Although the recent FDA approval does not directly affect Mosa Meat’s plans, the CEO said it will “undoubtedly” reinvigorate the conversation around cultured meat and spark more consumer interest in the benefits of beef.

Perhaps unsurprisingly, UPSIDE Foods’ plans also remain unchanged. “Right now we’re focused on the US, but our mission is global,” – explained the representative of the company. “Ultimately, we want our products to be available wherever meat is sold around the world.”

meaty visual space

Due to strict regulations in Europe regarding new food products, a large number of meat players have already looked to distant countries for their initial market entry. GettyImages/visualspace

We couldn’t help but ask why UPSIDE Foods thought its cellular chicken product was the first to get the FDA green light in the US. The company puts this down, at least in part, to an “open dialogue” between relevant stakeholders.

“From its earliest days, UPSIDE has maintained an open dialogue with FDA and USDA regulators. Our top priority has always been to ensure the safety and quality of our products, and we are incredibly grateful to the agency for their rigorous and thoughtful process to ensure the safety of our food supply.” we were told.

What about the UK? “Industry held back by anachronistic EU red tape”

Currently, the UK and EU novel food regimes are closely aligned. The FSA has retained the same application criteria and assessment standards as the Commission and EFSA under EU Regulation 2017/2469, which has been retained post-Brexit.

As explained by Jessica Burt, a specialist food regulatory, marketing and product liability lawyer at UK law firm Mills & Reeve, this means a lengthy application process which, even without further requests for information, will take around 18 months.

“Culturized meat will require prior market authorization and approval…However, it is unclear what type of nutritional and toxicological evidence will be required for its approval. New foods must be safe for human consumption, labeled appropriately so as not to mislead consumers, and must not differ from the foods they are intended to replace in such a way that their normal consumption would be nutritionally disadvantageous to consumers “, – she told the publication.

However, now that the UK has left the UK, is there an opportunity for the FSA to overhaul its cultured meat permit system?

We are told that the government has indeed indicated that a “new approach” to new foods will be taken. “We have already seen some divergence between the UK and the EU in the approach to gene editing in the Genetic Technology (Precision Breeding) Bill which is currently in the House of Lords.

“Just as innovation is supported with a focus on environmental benefits, there is a real chance for the UK to advance strategic advantages in existing and new technologies, including meat farming.”

Furthermore, under the EU Retained Law (Repeal and Reform) Bill, which will see the vast majority of this retained law stand down from 31 December 2023, unless concrete steps are taken to preserve it by then, it will also open way to deviate from the EU’s strict approval processes for cultured meat.

The challenges that could stymie the FSA are at least three-fold, according to Burt.

From a practical perspective, it will take time and resources to adopt updated legislation and to scrutinize processes beyond EFSA and the UK. From a political perspective, there may be consumer concerns that will not be allayed by the UK’s departure from the EU approach, she suggested. “However, there seems to be real political will to get the benefits of Brexit.”

Finally, applying and crossing regulations regarding technical definitions of what constitutes meat, country of origin, added ingredients, and some “formed” meat products can also prove challenging.

cage of meat Firn

However, now that the UK has left the UK, is there an opportunity for the FSA to overhaul its cultured meat permit system? GettyImages/Firn

While obstacles are inevitable, the readiness for change – at least on the part of those in the sector – is undeniable.

Jeremy Coller, chairman of the Alternative Protein Association (APA) trade association and private equity house Coller Capital, believes the UK has “all the right ingredients” to become a world leader in alternative proteins in the future.

However, when it comes to cultured meat, the UK’s “small but growing” industry is “held back by anachronistic EU red tape” created when the technology and methods used today “didn’t even exist”.

Now that the UK is no longer part of the EU, Koller sees the potential for the UK to take a more progressive approach to regulation. “Singapore is already way ahead, and even the USA, the most carnivorous country in the world, recently gave permission for the first time in history to grow meat products in the laboratory.

“If we start moving now, the UK can provide thousands of jobs, a huge export market, unrivaled food security.” What does the FDA’s green light on cultured meat mean for Europe? “There are global consequences”

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