Regulatory Requirements for Probiotics, Prebiotics and Postbiotics in China

Human intestine is a crucial organ for digestion and immunity. It harbors approximately 70% of the body's immune cells, highlighting its essential role in maintaining the overall health. As people's awareness of intestinal health increases, probiotics have gained immense popularity as an ingredient in various products, offering a well-established and effective approach to promoting the growth of beneficial bacteria through microbial regulation.

It is reported that 87.6% of individuals suffered from intestinal health problems in 2019 in China, which prompts many Chinese to modify their habits to improve their intestinal health, providing hope for tackling this issue.¹ Probiotics have become increasingly popular in China, with frequent use in food, drugs, and health supplements. The 2022 Chinese Probiotics Market Analysis Report highlights the sustained growth of the probiotics market in recent years, with a growth rate exceeding 16% during 2017-2020, and an expected value of 106.5 billion yuan in 2022.²

The burgeoning probiotics industry, coupled with ongoing research on intestinal microbiota, has paved the way for prebiotics, postbiotics, and their derivatives to enter the market. In this article, ChemLinked examines the regulatory requirements for probiotics, prebiotics and postbiotics products in China and explore their development in the Chinese market.

1. Probiotics 

Probiotics are the most widely used and established product among the three in the Chinese market. However, China does not yet have a national-level standard or regulation specifically targeted at probiotics. Even the official definition of probiotics in Chinese regulations remains unclear.

Thankfully, regulatory supervision on probiotics has been increasingly emphasized and improved in China, with related draft regulations and industry standards have been released. For instance, in 2019, the State Administration for Market Regulation (SAMR) issued a draft of the Probiotics Health Food Filing and Reviewing Provisions, defining probiotics as living microorganisms that are beneficial to the health of the host when ingested in sufficient quantities. Moreover, the Group Standard for Probiotic Foods released by China Food Industry Association in 2021 and the General Rules for the Use of Probiotics in Foods released by China Food Science and Technology Association in 2022 offer similar definitions of probiotics.

China has a list of probiotic strains that can be used in general food and health supplement, with a total of 39 strains as of now. Furthermore, China has established a list of strains for use in baby food, which includes 14 strains. To gain the approval of the use of new strains, the requirements of the Regulations on the Filing and Acceptance of New Food Raw Materials must be met.

Likewise, the use of probiotics in the Chinese food market is primarily divided into three food categories, including general food (primarily dairy products), health supplement, and baby food. The use of probiotics must also meet the requirements stipulated in the corresponding final product standards, which are primarily reflected in probiotic's labeling and claims. For related requirements, please refer to Decoding Probiotic Regulations for Food & Health Supplements (China).

While there are some guidelines and recommendations from industry associations and scientific organizations, the lack of a formal regulatory framework has led to concerns about the quality and safety of probiotic products on the market. At the recent 2023 "Two Sessions", the National People's Congress proposed promoting the construction of probiotic laws and regulations.³ It is believed that China's regulation of probiotics will enter a more complete stage in the near future.

2. Prebiotics 

Prebiotics are generally defined by international standards as "non-digestible food ingredients that selectively stimulate the growth and/or activity of a limited number of bacteria in the colon, leading to beneficial effects on host health." However, in China, there is currently no clear definition of prebiotics at the food regulation level, and no national standards or regulations have been established for prebiotics.

To address this issue, the Chinese Nutrition Society released an "Expert Consensus on Prebiotics and Health" in 2021, defining prebiotics as food components that are generally not digestible or absorbable by the human body, but can be selectively utilized by human microbiota to improve the composition and/or activity of the intestinal microbiota, thereby promoting human health. This definition is quite similar to international standards. Additionally, the Chinese Nutrition Society has identified five primary health benefits of prebiotics: intestinal flora balance improvement, intestinal function regulation, immune regulation, weight regulation, and glycemic regulation.

Unlike probiotic strains, prebiotic classifications are more diverse. There are numerous types of prebiotics that are permitted for use in the Chinese food market, and many of which fall under the category of dietary fiber, including inulin, fructooligosaccharides (FOS), galactooligosaccharides (GOS), xylooligosaccharides (XOS), isomaltooligosaccharides (IMO), soybean oligosaccharides (SBOS), and resistant dextrin. All of the prebiotics must meet respective standard requirements, for example, FOS shall comply with GB 1903.40-2022 Fructooligosaccharide. Products that claim to contain prebiotics must clearly indicate the specific type of prebiotic used in the ingredient list.

3. Postbiotics 

As research on the relationship between probiotics and human health deepens, scientists have discovered that inactivated bacterial bodies, bacterial components, and metabolic products also have health benefits for the human body. This has led to the emergence of the concept of "postbiotics," which has gained significant attention from the industry in recent years. While postbiotics is a new concept that lacks a unified definition, the International Scientific Association for Probiotics and Prebiotics (ISAPP) defines it as preparations of non-living microorganisms and/or their components that are beneficial to the host's health.

Although the industrialization of postbiotics in China is still in its early stages, the industry has taken the first step in the standardization of regulations. In February of 2023, the group standard titled Postbiotics from Lactic Acid Bacteria was unveiled (see the draft version here), mainly applying to the production, testing, and sales of postbiotics products. The release of this standard has epoch-making significance for the high-quality development of China's postbiotics industry.

In the group standard, postbiotics are defined as preparations of inactivated microorganisms and/or bacterial components with clear genetic backgrounds that are beneficial to the host's health, including or excluding their metabolic products. Chemical synthetic components as well as viruses/bacteriophages and their products are excluded. In short, postbiotics is a collective term for beneficial ingredients of probiotics that have been inactivated. Unlike traditional active probiotics, postbiotics do not have the problem of activity weakening because they do not have activity in nature. In contrast, they also retain a large amount of nutrients and effective ingredients.

In addition, the standard particularly emphasizes the requirements for raw materials of postbiotic products, and the strains should meet several major conditions, e.g., the strains must be included in the list of permitted bacterial cultures in food. It also specifies the requirements for production, labeling, packaging, transportation and storge of postbiotics from lactic acid bacteria.

In conclusion, China's regulatory framework for probiotics, prebiotics, and postbiotics is still burgeoning, with a lack of clear definitions and national standards. As people's awareness of intestinal health continues to grow, the regulations of these products are expected to become more comprehensive and standardized. As such, it is essential for manufacturers to stay up to date with the latest regulatory requirements to ensure the safety and quality of their products in the Chinese market.