Where is China with protein alternative regulatory approvals?

Editor’s Note: Bits x Bites is China’s leading agrifoodtech venture capital firm with technology investments across the globe ranging from gene editing and drone-based imagery to biosynthesized ingredients and alternative proteins. This article was written by the team with contribution from Wilfred Feng, senior counsel at law firm Dentons Shanghai. 

The US FDA’s recent nod to cellular agriculture was a protein milestone and a global headline, given the US is the leading meat consumer. What about China? Where do its regulators stand for alternative protein products? 

In 2021, China’s 14th five-year plan announced the importance of securing protein supply through cellular agriculture and synthetic dairy. It was the government’s first acknowledgement of these novel production methods to deliver and diversify protein. 

Given China’s desire to reduce reliance on imports and to satisfy the increasing demand for more abundant nutrition for its rising middle class, the recognition of these innovations was not a complete surprise. Though for many in agrifood technology, the endorsement felt like a small triumph. 

But how does this call impact food laws governing these products? Can we expect an easier regulatory path ahead for protein disruptors? What can we project about China’s openness to cellular agriculture and precision fermentation proteins in the near future? Wilfred Feng, senior counsel at Dentons Shanghai shares his views on these questions.

China takes first step to define regulatory frameworks for cell-based meat

In April 2022, the first China Cellular Agriculture Forum was held as the inaugural discussion to engage state-backed institutions like China Meat Research Center and China Meat Association on the future of cultured meat in China. Then in July, China National Center for Food Safety Risk Assessment (CFSA) and the Ministry of Agriculture led a close-door meeting to further deliberate over the viability and management of cell-based meat production. Two months later, CFSA formally commissioned an investigation project focusing on cellular agriculture. 

Wilfred says: “The investigation is intended to inform regulators on the landscape of cell culture development, and give reviewers some directions as to what questions they should ask to validate nutrition and safety, what criteria they should use—a kind of reviewers’ manual.”

This series of events reflect an escalation of the importance China’s leadership places on cultured meat. Such steps are a necessary path for technology development in China. Similar working groups have been commissioned to consider permitting recycled plastics for food contact and HMO human milk oligosaccharides. Today, dossiers from cell-based meat startups have nowhere to go. 

“This is an important step that shows the Chinese government’s willingness to work on the details to bring cell-based products to market,” says Wilfred. “Several years ago when we spoke with Chen Jun Shi (Senior Research Professor at the China National Center for Food Safety Risk Assessment), he considered cellular agriculture a far away possibility. This year he was quite positive.” 

Regulatory hesitancy hinders innovation 

“China has never been the first one in the world to approve novel agrifood technology,” says Wilfred. “It usually waits for approvals to be granted in the EU, US, and Japan—even better if two of the three have cleared approvals.” 

For HMOs, now generally accepted as essential for infant gut and immunity health, China only started accepting petitions in 2021, several years after approvals were granted in the US, EU, and Australia. Single-cell alga Chlamydomonas reinhardtii was granted approval as a safe food ingredient in 2022, three years after the US. 

As of today, none of the mentioned territories have approved cellular agriculture. And even though Singapore broke the standstill and granted the world’s first approval for one company’s cell-based product, it may have little weight on China’s timeline. 

“Singapore’s regulatory structure is quite different from China. The ministry that approved cellular agriculture is the Singapore Food Agency, who has a dual mission to ensure food safety and food security for Singapore. This is in contrast to China’s CFSA (China National Center for Food Safety Risk Assessment) which has a more singular focus to ensure safe food. Singapore Food Agency’s dual mandate is a factor that allows them to be more aggressive and become first in approving cell-based meat.” 

Harmonize innovation and safety agendas to help move protein products to market 

In parallel to these efforts to usher in new technology, China has gradually been stiffening its food safety control. The 14th Five-Year Plan for Food Safety Standard, Monitoring and Evaluation set goals to build more labs and testing facilities, raise the level of risk assessment, and reinforce nutritional monitoring. 

Bolstering food safety and nutrition gatekeeping is an important social and health service. But without considering the needs for promoting novel technology, it can choke innovation. China has a fine line to tread between promoting food technology and ensuring food safety. 

Today, novel ingredients in China have a long approval process. China defines novel foods as foods and ingredients that do not have a recorded history of safe consumption in at least one province for 30 years. In many cases, even if the whole food format has a long history of consumption, if the ingredient in question is extracted or chemically processed, the ingredient is likely subject to novel ingredient regulations in China. For example, getting approval for protein concentrates from plant sources can take between two and three years. 

In comparison, UK and EU average 17 months; Japan takes a year or more; whereas Australia has a tiered approval system where all approval procedures take a year or less. 

Solutions involving genetically modified microorganisms (GMM) are even more complicated.  “Today the regulators’ attitude for GMM in products is still stubbornly cautious. If we’re serious about applying biotechnology to diversify food and feed, we can’t avoid GMM.” 

In 2017, the door swung open for companies to submit enzymes derived from GMM for approvals. In fact, in June 2022, 11 enzymes derived from GMM were approved in China. And in 2021, regulators also opened up for the submission of GMM-derived food additives. But the process is still slow and few products are approved to date. This reservation is in line with consumers’ low perception of the safety of GMM foods.   

Until these mindsets shift, protein companies that use components approved in China’s list of edible microorganisms and without GMM will have an easier path to market. 

Is the 14th five-year plan a regulatory turning point for protein? It’s too early to say

The developments for alternative protein regulations are important to watch. Complex and timely approval processes are a costly burden especially for early-stage companies. Time will tell whether the regulations in China will become friendlier to protein innovations.

At the least, the public support from President Xi for cellular agriculture and synthetic dairy will translate to some direct outcomes. 

For one, it means more VCs will line up to invest along these government priority lines and provide capital across startup lifecycles. This is especially true in seed stages, which have seen a growing share in overall agrifood investing. And we also expect more scientists to heed the call to develop technology to fill the protein performance gaps today. 

When regulations finally catch up, we look forward to a next generation of products that will be unleashed to truly capture the taste buds of Chinese consumers.