Navigating Food Approvals in China: From Ingredients and Additives to Finished Foods

The Chinese Government has a comprehensive framework for regulating food sold to consumers. In recent years, officials have been proactive in amending existing regulations and developing new requirements to keep up with industry innovation and consumer demands. Foreign food companies often find it challenging to navigate the local regulatory landscape when entering the Chinese market. Since pre-market food approval is one of the common challenges for companies to tackle, this article uncovers various types of food applications (e.g., novel food) in China to help companies gain a better understanding.

New food ingredients

Food ingredients are the basic substances used in food, such as sugar, starch, and water. China does not have a ‘positive list’ of food ingredients. However, pre-market approval is required if a food ingredient is ‘new’ in accordance with the Chinese National Health Commission’s (NHC’s) novel food regulations [1]. Typically, ‘new’ here means a substance that does not have a history of traditional consumption in China. That means even if an ingredient is commonly used in other jurisdictions, it may still be considered ‘new’ in China if it lacks a history of consumption by the Chinese population. One can seek approval for a new food ingredient via the so-called ‘novel food application’ process. The subjects of novel foods could be, for example, newly developed plant extracts, edible bacterial strains, cultured meat, insect-based ingredients, or fermentation-derived proteins. The NHC will review each application and make an announcement on its website once approved [2].

New food additives

Food additives in China are primarily regulated by the national food additive standard GB2760 [3]. Only permitted food additives can be used in food. That means non-permitted additives, i.e., ‘new’ food additives, must obtain pre-market approval before their use in China. The NHC is also the food agency in charge of reviewing and approving new additives in accordance with the food additive regulations [4]. It has set out the specific data requirements for new food additives. The subjects of food additives not only include the typical ones, such as preservatives, colour additives, and antioxidants, but also nutritional fortification substances (e.g., vitamins and minerals), enzymes, chewing gum base ingredients, and processing aids (e.g., solvents and filtration agents). Thus, one should first assess whether a substance used in food is considered a food additive or food ingredient in China before applying for approval, as they are subject to different application procedures.

Finished foods for consumers

The substances used in food may be subject to pre-market approval, and the finished foods sold directly to consumers also may require pre-market approval in China. Health foods are one such example. When a company intends to communicate certain health benefits of a food to consumers through product labelling, such food may be deemed a ‘health food’ that can only be marketed in China after receiving approval from the State Administration of Market Regulation (SAMR). For instance, making the claim that a food has the function of boosting the body’s immune system would transform the product into a health food, meaning it would require pre-market approval. It should be noted that in practice only the health claims approved by Chinese regulators can be used for health foods sold in the country. Therefore, even if one can demonstrate the scientific relationship between the food and the stated health claim and has already obtained approval in other regions, such as from the European Food Safety Agency or Japanese Consumer Affairs Agency, it needs to go through the SAMR’s health food application process [5] by submitting the required data. Notably, the SAMR’s approval is product-specific and company-specific.

Other than health foods, there are other special foods [6] in China that require pre-approval by the SAMR before being placed on the market, such as infant formula and foods for special medical purposes, for which there are separate sets of detailed requirements. Therefore, one should always assess the regulatory status of a food in its entirety (e.g., food composition and labelling) when considering its export to China.

Over the years, China has continued to optimise its food regulatory environment, which provides foreign food companies with a more transparent, rules-based gateway to a market of 1.4 billion consumers. Should you wish to learn more details about China’s requirements for foods or have questions on the above, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.

Keller and Heckman LLP represents the food industry on regulatory matters around the world. Please sign up for our newsletters here.

Note: A version of this article appeared in EURObiz magazine’s July/August edition [7].

[1] Administrative measures for the safety review of new food raw materials, National Health Commission, 26th December 2017, viewed 13th August 2025, <https://www.nhc.gov.cn/wjw/c100221/202201/0bbea384f540430485b886edba385559.shtml>

[2] Updates, National Health Commission, 2nd July 2025, viewed 13th August 2025, <https://www.nhc.gov.cn/sps/c100087/new_list.shtml>

[3] Latest Announcements, National Center for Food Safety Risk Assessment, 16th March 2025, viewed 13th August 2025, <https://sppt.cfsa.net.cn:8086/db?type=2&guid=6CA1489A-9570-4906-8CE8-CC86FBFB1941>

[4] Regulations on the Application and Acceptance of New Food Additive Varieties, National Health Commission, 25th May 2010, viewed 13th August 2025, <https://zwfw.nhc.gov.cn/kzx/zcfg/sptjjxpzsp_236/201005/t20100525_1311.html>

[5] Health Food Registration, State Administration for Market Regulation, viewed 13th August 2025, <https://zwfw.samr.gov.cn/guideDetail?id=22d18e7b4dc749fa9d1a52d172c2b3f8>

[6] Article 74 of the Chinese Food Safety Law refers to special foods. See: Food Safety Law, State Administration for Market Regulation, 29th April 2021, viewed 13th August 2025, <https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_6bff4ef87291497fa72949e1fc88efb5.html>

[7] https://europeanchamber.oss-cn-beijing.aliyuncs.com/upload/documents/documents/EURObiz_2025_J_A%5b1332%5d.pdf