China Released Draft Regulations on the Registration and Filing of Health Foods Containing Probiotic Ingredients: Key Changes & Industry Impact

On July 24, 2026, China's State Administration for Market Regulation issued the Provisions on the Registration and Filing of Health Foods Using Probiotic Ingredients (Draft for Public Comment) (hereinafter referred to as the Draft), with the deadline for public comments set for August 24, 2026.

This Draft replaces the 20-year-old Regulations on the Declaration and Review of Probiotic Health Foods (Trial). To help clients navigate these updates, CIRS Group has synthesized the core regulatory shifts and what they mean for your compliance strategy.

Detailed Breakdown of the Six Major Changes

1. Clarifying the Definitions: Probiotics vs Health Foods Containing Probiotic Ingredients

The Draft provides clear definitions of probiotics and health foods containing probiotics:

• “Probiotics” refer to “live microorganisms that, when ingested in adequate amounts, confer a health benefit on the host.”
• “Health foods containing probiotic ingredients” refer to “health foods that use probiotics as the primary ingredient, contain an adequate number of live microorganisms, and possess specific claimed health functions when consumed in accordance with the recommended intake and usage instructions.”

Key Takeaways: Probiotics are limited to live microorganisms. Health foods produced using dead bacteria or genetically modified strains do not fall within the scope of these regulations.

2. Strengthening Management Requirements for Strains

Current regulations impose relatively lenient requirements on bacterial strains, whereas the Draft strengthens the management requirements at the strain level. It explicitly states that probiotics used as ingredients in health foods must be identified down to the strain level. The strains used must fall within the scope of bacterial species approved for food use by the national health administration, possess a clearly defined strain designation, and have well-characterized and genetically stable biological properties and functional characteristics. In addition, both the strains and their metabolites must be demonstrated to be non-toxic and safe.

3. Addition of Multiple New Documentation Requirements

Building upon existing filing requirements, the Draft introduces three new documentation requirements:

• Documentation on the genetic stability of the bacterial species and strain: This includes data on the genetic stability of key indicators or characteristics of the bacterial species over at least twice the maximum number of passages within a single production cycle.
• Safety assessment report for the strain: For strains belonging to microbial species approved for food use by the national health administration but for which a specific strain number has not been specified, a safety assessment report—including an antimicrobial resistance test report and a toxin production test report issued by a legally accredited food testing institution—must be provided.
• Scientific basis for the health claims associated with the strain.

Key takeaways: Among the newly published food ingredients, some microorganisms are currently classified only at the strain level. For ingredients where the specific strain is not specified, a safety assessment—including antibiotic resistance testing—must be conducted in accordance with the recently published and implemented National Food Safety Standard: Safety Evaluation Procedures for Microbial Strains Used in Food.

4. New Requirements for Commercial Probiotic Ingredients

The Draft sets forth clear standardization requirements for commercial probiotic ingredients:

• They must be health food ingredients consisting of a single probiotic strain that has been fermented and enriched, with necessary excipients added, and processed through steps such as blending.
• The excipients used must be food additives and/or food ingredients that are essential for maintaining the stability of the strain and meeting formulation requirements. They must not exert any functional effects in the product and must not affect the testing of the product’s technical indicators.
• All types of excipients used must be listed in the application and identified on the label and package insert.

Key takeaways: Current regulations do not impose restrictions on commercial probiotic ingredients, and companies may procure multi-strain premixed composite probiotic powders for health food R&D and registration. The draft for public comment restricts commercial probiotic ingredients to a single strain, so the aforementioned practice will no longer be applicable.

5. Raising the Minimum Live Bacteria Threshold for the Final Product

The Draft imposes stricter requirements on the total number of live bacteria in the final product, stating that “for registered products, the total number of live probiotic bacteria ingested daily within the product’s shelf life shall not be less than 107 CFU/mL(g),” raising the total live bacteria requirement from “106 CFU/mL(g)” in the current regulations to “107 CFU/mL(g)” . Additionally, the draft requires that live bacteria consistent with the declared and labeled bacterial species be isolable from the product.

6. Upgrading the Regulatory Model and Establishing a Filing Channel

Current regulations apply only to the registration of probiotic health foods and do not provide a filing pathway. However, Article 9 of the draft for public comment states: Any entity or individual may submit a proposal to the review authority for inclusion in the Health Food Ingredient Catalog, based on a comprehensive evaluation of the safety, efficacy, and quality control of the strain and commercial probiotic raw materials.

Key takwaways: This provision opens a key pathway for probiotic health foods to transition from a registration system to a filing system. If a strain is successfully included in the Health Food Ingredients Catalog, health foods containing that strain may be submitted via the filing process, significantly shortening the product’s time to market.

Conclusion & Next Steps

This Draft represents a significant modernization of China's probiotic regulatory framework. While stricter strain stability, safety, and potency thresholds will raise initial R&D and filing costs, the introduction of the filing promises a much faster route to market for proven strains. CIRS warmly reminds that companies planning to enter or expand within China's nutraceutical market should audit their current strain portfolios and adjust R&D pipelines accordingly.

What CIRS Can Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.