Probiotics are a well-established segment in the global health and nutrition market, widely used in supplements, functional foods, beverages, and snacks. Overseas markets such as Europe, the United States, Japan, and South Korea have long recognized the health benefits of probiotics, with consumers seeking gut health, immune support, and other functional benefits. This article gives an overview of the probiotic market and its compliance requirements in China.
In recent years, China's probiotic market has also experienced rapid growth. Although the industry started relatively late — in the late 1990s — strong policy support, growing consumer demand, and advances in scientific research have fueled this expansion.
According to Euromonitor, the Chinese probiotic market exceeded RMB 100 billion in 2022, growing at an annual rate of 11–12%. The International Probiotics Association (IPA) predicts that China will become the world's second-largest probiotic market, with market size expected to approach RMB 200 billion by 2028.
This rapid growth has attracted both domestic and overseas companies to enter the Chinese market. However, success in China not only depends on consumer demand but also on understanding and complying with local regulatory requirements. Different categories of probiotic foods — from dairy products and beverages to snacks — are subject to specific rules regarding strain approval, product quality, and labeling.
This category includes dairy products, meal replacements, confectionery, probiotic solid beverages, and lactic acid bacteria drinks. Overseas companies entering China must pay attention to three key compliance areas:
In China, edible probiotic strains are regulated under a "positive list + administrative approval" system, which clearly defines the strains allowed for use in foods in China. The National Health Commission (NHC) of China oversees all food-grade strains. The current positive list system includes three main directories:
List of Cultures Available in Food
List of Cultures Available in Infants and Young Children's Food
List of Cultures Available in Health Food
For general foods, probiotics must either be included in the first two lists (food or infant food) or undergo a New Food Ingredient application and obtain approval from the China NHC.
Products must meet Chinese requirements for the live bacteria count and microbiological safety indicators throughout their shelf life.
Strain name and amount must be declared if highlighted.
Health or disease prevention claims are not allowed for general foods.
For live lactic acid bacteria drinks, live bacteria count must be ≥ 10⁶ CFU/g (mL) and indicated on the label.
Solid beverages must be labeled as "固体饮料" (solid beverage) in a prominent font and include a mandatory warning statement covering at least 20% of the panel: "This product cannot replace foods for special medical purposes, infant formula, or health foods."
Special probiotic foods in China mainly include health foods (“blue hat” products) and infant formula products. This section focuses on health foods.
Probiotic health foods must be registered according to the Declaration and Review of Probiotic Health Food(Draft). Common approved health functions include: "Helps enhance immunity" and "Helps regulate intestinal flora."
For health foods, probiotics used could be from any of the three positive lists or go through New Food Ingredient application and obtain approval from the China NHC. But genetically modified strains are not permitted for health food registration.
Each strain must maintain a live count of at least 10⁶ CFU/mL (g) throughout the shelf life.
Products must include:
Blue-hat logo
Functional ingredients
Suitable/unsuitable population groups
Consumption instructions
The State Administration for Market Regulation (SAMR) of China is actively working to include 9 probiotic strains into the Health Food Raw Materials Directory. This will reduce development costs, shorten R&D timelines, and facilitate more innovative products.
China's probiotic market presents significant opportunities for overseas companies; however, navigating the country's complex regulatory landscape is crucial for success. Understanding the compliance requirements for both general foods and special foods — from strain approval and quality standards to labeling rules — can help ensure smooth market entry and avoid potential enforcement risks.
At ZMUni Compliance Centre, we provide end-to-end support for international food companies entering the Chinese market, including applications for new food ingredients and food additives, health food registration and notification, pre-packaged food compliance, regulatory strategy consulting, and customs clearance. For any related service requests, feel free to reach out at info@zmuni.com.
