What does FDA’s greenlight of cultivated meat mean for Europe? ‘There are worldwide implications’
In what has been described an ‘historic milestone’, the US Food and Drug Administration (FDA) has judged a cultivated meat product – UPSIDE Foods’ cell-based chicken – to be as safe as its animal-based counterpart.
Having received the FDA’s ‘no questions letter’, UPSIDE Foods now edges closer to commercialisation, which, if achieved, would make the US the second country globally to see cultivated meat enter the market, following on from Singapore’s 2020 regulatory approval.
Over in Europe, the situation is somewhat different. As of September 2022, FoodNavigator understands that not one company had even submitted a novel food dossier on cultivated meat to either the European Food Safety Authority (EFSA) or the UK’s Food Standards Agency (FSA).
What implications, if any, will the FDA’s greenlight on the safety of cultivated meat have on Europe’s sector? Could it encourage a more progressive approach to novel foods authorisation? And might European cultivated meat companies now look to favour the US in their market strategies? FoodNavigator investigates.
All eyes on the US
According to Cellular Agriculture Europe, a Brussels-based industry association, the ‘no questions’ letter doesn’t just have implications for Europe, but for the world. "The FDA’s greenlight on the safety of cultivated meat will have worldwide implications,” Robert E. Jones, President, Cellular Agriculture Europe, explained.
Combined with China’s commitment to R&D (the country has pinpointed cultivated meat and related technologies as areas for R&D investment under its five-year plan), the UK exploring the optimisation of its novel food approvals, and cultivated meat being on the menu at COP27 thanks to Eat Just, Inc., Jones believes ‘it’s clear’ that governments worldwide are ‘racing to capitalise on the potential of cellular agriculture’.
Mosa Meat, the Dutch start-up responsible for creating the world’s first cultured meat hamburger (and where Jones serves as Head of Public Affairs), also suggested the greenlight was an exciting development, worldwide.
“The decision by the FDA is an exciting development for the entire cellular agriculture ecosystem including investors, companies and food system reformers,” Maarten Bosch, CEO of Mosa Meat, told FoodNavigator.
“It is no longer just the Singapore Food Agency telling consumers that cultivating meat is a safe alternative to slaughtering animals, and regulators around the world will be paying close attention.”
Are there regulatory lessons to be learnt?
Could the FDA greenlight be a sign that the EU needs to revamp its regulatory framework, so as not to be left behind? Is there anything that EFSA can learn from the FDA in this context?
UPSIDE Foods, the recipient of the ‘no questions’ letter, believes the greenlight could help to validate cultivated meat across the board. “Broadly speaking, we think the FDA’s action will be a hugely legitimising force for cultivation meat regulation across the globe,” a company spokesperson told this publication.
For Mosa Meat’s Bosch, a reworking of the EU’s regulatory framework is unlikely, but the CEO supports healthy competition between geographies. “A sense of global competition is usually helpful in compelling governments to help their domestic industries scale up and thrive. Legislative changes are unlikely in the EU, however there are lessons to be learned from how open the FDA is to robust dialogue with companies before and during the application process,” we were told. “This approach, which is an administrative level decision, can be very helpful in making the safety review as fast and efficient as possible.”
Now that UPSIDE Foods has received a ‘no questions’ letter on its cultivated chicken product, it will now be able to move onto the standard process – which is comparable to what conventional chicken products follow. This aims to ensure the safe production and handling of its chicken, including securing a United States Department of Agriculture (USDA) grant of inspection.
Mosa Meat said it would be keeping an eye on this particular process. “We’ll have to see how the USDA part of the process will develop, in order to assess how the US framework compares to the existing regulatory pathways in Europe and Singapore.”
Whereas Mosa Meat’s Bosch focused on competition, Cellular Agriculture Europe’s Jones is calling for greater collaboration between regulatory agencies in light of the FDA nod. “As this industry is new and evolving rapidly, knowledge sharing between companies and regulators is critical,” he told this publication.
“We encourage EFSA and the FDA to compare notes, and we stand ready to engage in dialogue about making the regulatory approval process as safe and efficient as possible.”
US a major focus for Europe’s cell-based players
Due to Europe’s stringent novel foods regulations, a great number of cultivated meat players had already been eyeing countries further afield for initial market entry.
In France for example, cell-based foie gras maker Gourmey has previously expressed interest in markets with more progressive regulation, such as Asia and the US. Dutch cultivated meat group Meatable says it is interested in the EU, UK, and US, but plans to first launch in Singapore.
Mosa Meat is similarly looking at commercialisation through a global lens, and confirmed Europe is on the agenda – at least in the long-term. “The fact that Europe’s safety regulations are robust is exactly why Europeans trust their food, so we welcome a thorough review of our non-GMO and animal serum-free beef,” Bosch told FoodNavigator.
“We pioneered cultivated meat in 2013, set up our company in the Netherlands, and will absolutely bring it to market in Europe. We are a mission-driven company and you cannot make a global impact on the climate crisis without having a presence in Europe as well.”
The company is currently in talks with regulators in ‘multiple’ geographies around the world, including North America, Europe and Asia. While the FDA’s recent greenlight doesn’t directly impact Mosa Meat’s plans, the CEO said it will ‘undoubtedly’ re-energise the conversation around cultivated meat and generate more consumer interest in the benefits of its beef.
Perhaps unsurprisingly, UPSIDE Foods’ plans similarly remain unchanged. “Our current focus is on the US, but our mission is global,” a company spokesperson explained. “Ultimately, we want our products to be available wherever meat is sold across the world.”
We couldn’t help but ask why, in UPSIDE Foods’ opinion, its cell-based chicken product was the first to receive the FDA greenlight in the US. The company puts it down, at least in part, to ‘open dialogue’ between relevant stakeholders.
“Since our earliest days, UPSIDE has maintained an open dialogue with regulators at both the FDA and the USDA. Our top priority has always been to ensure the safety and quality of our products, and we’re incredibly grateful for the agency’s rigorous and thoughtful process to ensure the safety of our food supply,” we were told.
What about the UK? ‘Industry is held back by anachronistic EU red tape’
Currently, the UK and EU Novel Foods regimes are closely aligned. The FSA has maintained the same application criteria and evaluation standards as the Commission and EFSA, as per EU law Regulation 2017/2469, which has been retained after Brexit.
As Jessica Burt, a specialist lawyer in food regulatory, marketing, and product liability at UK law firm Mills & Reeve explained, this means a lengthy application process that, even without further requests for information, would take some 18 months.
“Cultured meat would require a pre-market authorisation and approval…However it is unclear what type of nutritional and toxicological evidence would be required to approve it. Novel foods must be safe for human consumption, labelled appropriately so as not to mislead consumers, and must not differ from the food it intends to replace in such a way that its normal consumption would be nutritionally disadvantageous for consumers,” she told this publication.
Now that the UK has withdrawn from the UK, however, is there potential for the FSA to rework its framework for cultivated meat authorisation?
The Government has, indeed, indicated that a ‘new approach’ will be taken to novel foods, we were told. “We have already seen some divergence between the UK and EU in the approach taken to gene editing with the Genetic Technology (Precision Breeding) Bill that is currently in the House of Lords.
“In the same way that innovation is supported with an emphasis on environmental benefits, there is a real chance for the UK to promote strategic advantage in existing and novel technologies, including in cultured meat.”
In addition, under the Retained EU Law (Revocation and Reform) Bill – under which the vast majority of this retained law would fall away on 31 December 2023, unless specific measures are taken before then to preserve it – would similarly pave the way for a divergence from the EU strict processes of approval for cultured meat.
Challenges that might stand in the FSA’s way are at least three-fold, believes Burt.
From a practical perspective, it will take time and resources to pass any updated legislation and to scrutinise processes outside of EFSA and the UK. From a political standpoint, there may be consumer concerns that will not be allayed by the UK diverging from the EU approach, she suggested. “However, there does appear to be a real political will to gain advantages from Brexit.”
And finally, the application and intersection of regulations concerning technical definitions of what constitutes meat, country of origin, added ingredients, and certain ‘formed’ meat products, could also prove challenging.
While hurdles are inevitable, the willingness for change – at least from those within the sector – is undeniable.
Jeremy Coller, chair of trade association Alternative Protein Association (APA) and of private equity house Coller Capital, believes the UK has ‘all the right ingredients’ to be a world leader in alternative proteins in the future.
For cultivated meat, however, the UK’s ‘small yet growing’ industry is ‘held back by anachronistic EU red tape’ created when the technology and techniques being used today ‘didn’t’ even exist’.
Now that the UK is no longer part of the EU, Coller sees potential for the UK to take a more progressive approach to regulation. “Singapore is already well ahead and even the US, the world’s most carnivorous country, recently gave approval to a lab-grown meat product for the first time ever.
“If we get moving now, it can be the UK that secures the thousands of jobs, the massive export market, the unrivalled security of food supply.”