China: Master the Ingredient Regulations for Health Foods

With the Chinese government’s “Healthy China 2030 Plan” [1] and consumers’ increasing demands on health and wellness, the food industry is seizing the momentum and actively seeking product approvals. In the first half of 2025, there were 1,900+ health foods approved by China. [2] Entering the booming health food market offers immense potential. However, navigating the local food regulatory landscape is essential for success in China. This article unpacks the key regulatory considerations with respect to the use of ingredients [3] for which health food companies must know to ensure compliance.

What is health food?

The Chinese Food Safety Law (FSL) [4] defines health foods as the type of foods that make claims about health benefits that are supported by scientific evidence and do not cause any acute, subacute, or chronic harm to the human body. The national food safety standard for health food (GB16740-2014) [5] provides a more specific definition, which describes health foods as “the foods claiming to have specific health functions or are intended to supplement vitamins and minerals, which are suitable for consumption by specific groups, help regulate bodily functions, are not intended for the treatment of diseases, and must not cause any acute, subacute, or chronic harm to the human body.” Approved health foods are recognizable by a blue hat logo on the product package as shown below. In practice, they are known as “blue hat” products. 

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Approved health foods are allowed to bear health claims in order to be distinguished from ordinary foods. Examples of health claims [6] include “assist in boosting immunity,” “alleviate physical fatigue,” “assist in digestion,” and “assist in maintaining blood sugar at a healthy level,” etc. [7] 

As you can see from the above definition of health foods, it includes the foods that are intended to supplement vitamins and minerals. Therefore, the products such as food supplements or dietary supplements available in other countries are likely to fall under the purview of health foods in China and be regulated accordingly. “Nutrient supplements” (a subcategory of health food) is the term used by China when referring to those mineral/vitamin supplements. [8]

How is health food regulated? 

The Chinese State Administration of Market Regulation (SAMR) [9] is the food agency overseeing health foods. The FSL introduces a concept of “special foods,” which includes health foods. [10] According to the FSL, health foods in China are subject to pre-market registration or notification. To be specific, 

• Heath foods which, a) use ingredients that are not included in the Inventory of Health Food Ingredients or b) are imported into China for the first time, are subject to registration.
• Health foods that are a type of nutritional substance intended to supplement vitamins or minerals (e.g., nutrient supplements), are subject to notification.
• Other health foods are subject to notification.

As you can see, the use of ingredients in health foods is one of the factors that impacts whether the food is subject to registration or notification. Different data requirements are imposed by SAMR through the regulations for health food registration and notification. [11] 

How to determine the use of ingredients in health food? 

The ingredients used in health food can be determined based on different regulatory sources. SAMR published Inventories of Health Food Ingredients (e.g., calcium, magnesium, vitamin B1, fish oil, CQ10, and melatonin), [12] and accordingly, those ingredients on the inventories can be added to health foods. It should be noted that SAMR’s ingredient inventories may be scattered in different government announcements. For instance, China has separate inventories of permitted probiotics and fungus strains used in health foods. [13] One should conduct a comprehensive review to make sure all inventories have been taken into account when assessing the status of an ingredient.  

In addition, there are other regulatory sources, such as the ones described below, that could establish the status of use for an ingredient in health food. 

• If a substance is considered an ordinary food ingredient in China, it can be used in health food as well. For instance, substances such as sugar, glucose syrup, water, vegetable oils, etc., are commonly known as food ingredients that can be used in food in general, and thereby can be added in health food.
• If a substance is considered both a drug and food, it can be added to health food. Good examples in this regard are traditional Chinese medicines (TCMs). The Chinese National Health Commission (NHC) has compiled a list [14] of the substances that are considered both drugs and foods (e.g., crocus sativus L., ginkgo biloba L., and cannabis sativa L.). One can add these TCMs to health food. 

It is worth noting that there are also substances that are prohibited for use in health food specifically (e.g., aconite root and sulphur [15]) and in food generally (Sudan dyes and sodium thiocyanate [16]). All these lists should be taken into consideration when developing a health food formulation for the Chinese market. Working with your colleagues in China or regulatory professionals who are well-versed in the Chinese health food regulations would be helpful.  

What if an ingredient of possible interest to use is not permitted yet?  

It is likely that after one has conducted thorough research, the substance of interest remains unconfirmed for use in health food. In this regard, one should consider whether it may be a “novel” ingredient in China that triggers approval before its use. 

Novel food ingredients are governed by NHC through the novel food regulations. [17] In recent years, industry has become active in seeking novel food approvals, especially those with certain health benefits (commonly known as functional ingredients). For instance, Sakura polyphenol [18] and Stevia polyphenol [19] were recently approved by NHC in 2025 as novel food ingredients. Once such approval is granted by NHC, the approved novel ingredient not only can be used in health food, [20] but also in food in general, which opens broader marketing opportunities for the ingredient manufacturer.  

As noted above, health food is subject to pre-market registration/notification in China, under which SAMR would review the details of ingredients used to ensure safety and verify efficacy. Therefore, instead of filing a novel food ingredient application with NHC, an alternative is to clear the use of the new ingredient together with the application of filing for approval of the finished health food [21] with SAMR. Once SAMR approves the health food, the new ingredient used therein becomes acceptable as well. Companies should analyze this on a case-by-case basis to determine an appropriate approach to seek clearance when strategizing the market-entry plan in China. 

What is the specification requirement for ingredients used in health food?

The Chinese government has developed food standards to regulate almost every aspect of food to ensure safety. According to the government data as of October 2024 [22], there were 1,610 food safety national standards promulgated in the last five years. Therefore, once an ingredient is confirmed to be acceptable for use in health food, the next step is to ascertain whether an applicable standard has been developed by China for the ingredient. While China typically would make reference to international food standards and the standards adopted by other jurisdictions during the standard-drafting process, stricter limits are adopted from time to time due to local circumstances. Therefore, one should never assume that the ingredients following the rules in the home country would automatically be acceptable in China. CQ10 was noted above as an example of a permitted ingredient for health food. Specification requirements have been established for CQ10 in China which address product form, technical parameters, adjuvants, etc. [23] 

Summary 

Health food in China overall is heavily regulated; however, given the increasing demands of healthier and more nutritious foods by Chinese consumers, industry has been advocating to reform the existing system and create a more industry-friendly environment. [24] The current dual-track system, i.e., registration and notification for health food, is one of the successful outcomes after years of effort. Previously all health foods were subject to registration without flexibility. The use of ingredients in health food is closely related to the evaluation and approval of the finished health foods. A holistic approach should be taken when considering the Chinese market, as this article only focuses on the ingredients and there are other aspects of health food one must consider, such as selecting health claims to use [25], preparing scientific data to justify the claims, arranging clinical trials, etc. 

Should you have any questions on the above or overall food law questions in China, 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 in China and across the Asia Pacific region. Please sign up for our newsletters here.

This article was first published by The World of Food Ingredients [26] with minor edits. 

[1] https://www.gov.cn/zhengce/2016-10/25/content_5124174.htm 

[2] https://www.163.com/dy/article/K43LCQ230514EAHV.html. The approved products include health foods subject to notification and registration. 

[3] Ingredients discussed in this article do not include the substances such as food additives and processing aids that may be used in health food for technological functions or facilitating the manufacturing process of the food.

[4] https://flk.npc.gov.cn/detail2.html?ZmY4MDgxODE3YWIyMmUwYzAxN2FiZDhkODVhMjA1ZjE 

[5] https://sppt.cfsa.net.cn:8086/db?type=2&guid=C9648171-BCB6-49B3-8287-1C7D6CE94391 

[6] https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_bfffccd97e6e4dfaa9d353318487e670.html 

[7] Please reach out if you are interested in the details of approved health claims in China. 

[8] For instance, there is an inventory of substances referring to the ingredients used as “nutrient supplements” at https://www.samr.gov.cn/cms_files/filemanager/samr/www/samrnew/samrgkml/nsjg/tssps/202012/W020201201528791482791.docx 

[9] https://www.samr.gov.cn/tssps/kpxc/bjsp/index.html 

[10] Other special foods include infant formula and foods for special medical purposes. 

[11] https://www.gov.cn/gongbao/content/2016/content_5074083.htm 

[12] https://www.samr.gov.cn/tssps/zcwj/art/2023/art_ff0298388ff5401094fa6fedd8f64f44.html 

[13] https://www.cfe-samr.org.cn/zcfg/bjsp_134/gsgg/zc/202207/t20220729_4388.html 

[14] http://www.nhc.gov.cn/wjw/c100175/202111/aac61b41730f4062bee4eefcf51933f4.shtml 

[15] https://www.cfe-samr.org.cn/zcfg/bjsp_134/qt_bjsp/202208/t20220802_4458.html

[16] https://www.gov.cn/zhengce/zhengceku/202401/content_6927335.htm and http://www.nhc.gov.cn/zwgkzt/spaqxx/201406/38e5c8a53615486888d93ed05ac9731a.shtml

[17] https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm

[18] http://www.nhc.gov.cn/sps/c100087/202505/427e4d6f342d40c199c137a39629a1cd.shtml

[19] http://www.nhc.gov.cn/sps/c100088/202502/943dcc40bc45486cbcda67859bf1fddb/files/1741760236048_98505.pdf

[20] Please keep in mind that a health food using the approved novel food ingredients should first be approved by SAMR before it can be placed on the market. 

[21] Under this approach, the company should include the safety data of the new ingredient in the application dossier of the health food using the new ingredient for government review. 

[22] https://www.gov.cn/lianbo/bumen/202410/content_6983075.htm

[23] https://www.beijing.gov.cn/zhengce/zhengcefagui/qtwj/202204/t20220412_2674378.html

[24] http://www.ce.cn/xwzx/gnsz/gdxw/202503/10/t20250310_39314809.shtml

[25] https://www.khlaw.com/insights/china-calls-submissions-new-health-claims

[26] https://www.foodingredientsfirst.com/theworldoffoodingredients.html