Tapping into China’s Booming Novel Food Market – A Regulatory Glance
As the global food industry races ahead with innovations of new foods such as cultured meat, plant-based alternatives, fermentation-derived proteins, and insect-based ingredients, companies are increasingly eyeing international expansion. Among the most promising, but complex, markets is China. With its vast consumer base and growing appetite for food innovation, China is a critical destination for any forward-thinking food brand. This article provides a regulatory glance at the novel food approval in China and offers practical guidance for navigating the path to market entry.
The concept of novel food has been incorporated into the Chinese food legislation since the Food Sanitation Law (repealed) in 1983. While the novel food definition has evolved over the years, pre-market approval has always been the requirement. Under the current novel food regulation (amended in 2017) [1], novel foods refer to those foods that do not have the consumption history (typically at least 30 years) in China, such as the structure of the original components in food has been altered or it involves the use of new manufacturing technology. It could capture a broad scope of food ingredients, e.g., bacterial strains, extracts from plants, and algae protein. Microorganisms using genetic engineering may also be the subject of novel food ingredients in China [2].
The Chinese National Health Commission (NHC) [3] is the governing agency in charge of approving novel foods. China National Center for Food Safety Risk Assessment (CFSA) [4] is the institute (affiliated with NHC) handling the food safety assessment of novel foods. NHC has published data requirements for a novel food application, including toxicity tests, product specification, manufacturing process, product labeling, etc. It is worth noting that, unlike some jurisdictions where safety may be demonstrated through a comprehensive and thorough literature review, China expects companies to conduct the actual toxicity testing to justify the safety of the ingredient. Moreover, local toxicology testing may be additionally required during the expert review despite the acceptance of such data generated outside China. Furthermore, NHC does not offer an official pre-filing consultation. Therefore, it is crucial for a company to work with reliable regulatory professionals to understand the local application requirements and communicate with the authorities throughout the process.
For instance, the first step to consider a novel food application is to determine whether the ingredient falls under the scope of novel food defined by China. Under the framework of novel food, the principle “substantial equivalence” is recognized by NHC. However, one cannot merely rely on such a principle to circumvent an application. A company still needs to put together an application dossier to demonstrate that the ingredient it produces is substantially equivalent to the novel food already approved [5]. If NHC agrees with the company, it will issue a notice to discontinue their review, which, in practice, may be considered proof to show the ingredient is acceptable for use in China.
In 2025, NHC thus far has accepted in total 26 novel food applications [6] which include four applications filed by overseas companies seeking approvals of Bifidobacterium bifidum BGN4, Procyanidins, Glycosylated form of hesperidin, and Tuna Anserine [7]. The remaining applications involve the novel ingredients such as fermented mycelium, L-ergothioneine, krill oil, and coffee bean extract, etc. While some countries already have approved cultured meat under their novel food framework, no application has been submitted to NHC for cultured meat in China. NHC, however, is working on some guidelines in this regard.
After NHC starts its review on a novel food application, industry will be given an opportunity to submit comments on the application.
Should you wish to learn more details about China’s novel food application or have any questions on the above, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
Keller and Heckman LLP represents the food industry on regulatory matters in China and across the Asia Pacific region. Please sign up for our newsletters here.
[1] https://zwfw.nhc.gov.cn/kzx/zcfg/xspylsp_237/202107/t20210707_2132.html
[2] https://cfsa.net.cn/zxdt/tzgg/2024/14077.shtml
[3] https://www.nhc.gov.cn/sps/new_index.shtml
[4] https://www.cfsa.net.cn/
[5] Please reach out to the author if you would like to discuss further on substantial equivalence of novel food.
[6] As of June 18, 2025.
[7] https://zwfw.nhc.gov.cn/kzx/slgs/xspylsp/