China Proposes New Health Food Registration Rules: Stricter Animal Raw Material Bans, Eased Plant Material Restrictions

On July 24, 2026, China’s State Administration for Market Regulation (SAMR) released two key draft documents for public comment:

• Regulations on the Registration and Declaration Management of Health Foods Using Animal Ingredients (Draft for Comments)
• Regulations on the Registration and Declaration Management of Health Foods Using Plant Ingredients (Draft for Comments)

Public Comments are welcomed before August 24, 2026.

Compared to the current Regulations on the Declaration and Review of Health Foods from Wild Animals and Plants (Trial), the drafts for comments set a clear regulatory red line and refines the market access criteria. They will significantly impact the health food registration process. Below is an expert analysis from CIRS Group, to help businesses conduct compliance assessments in advance.

Key Regulatory Changes

Expanded Scope: Moving Beyond "Wild" Ingredients

Using animals and their products as raw materials means using animals or their extracts as raw or auxiliary materials.

Using plants and their products as raw materials means using plants (including whole plants and specific parts) or their extracts as raw or auxiliary materials.

Red Line Established: Prohibited Ingredients ("3 + 1" Rule)

Under current rules, class one and two nationally protected wild animals and plants, as well as their products, are prohibited from being used as raw materials for health foods. The drafts for comments adjust the scope of prohibited materials, significantly expanding and tightening the restriction on animal materials, while slightly relaxing the restriction on plant materials. See the table below for details.

Table 1. List of Prohibited Plants and Animals

Detailed Access Requirements: Supporting Documents are Critical

Under the drafts for comments, to gain registration approval, applicants must provide detailed supporting and traceability documents depending on the material type. CIRS Group has made the following summary to help enterprises understand more clearly and intuitively.

¹General requirements: When using animals and their products as raw materials or auxiliary materials for health food, relevant documents such as animal quarantine certificates must be provided. It must also comply with the management regulations of relevant laws and documents related to health food.

²General requirements: The use of plants and their products as raw materials or auxiliary materials for health food must comply with the relevant regulations and management provisions of health food. If the plant is a newly discovered species, a safety assessment should also be conducted in accordance with current relevant laws and regulations.

Impact on Currently Approved Products

According to the drafts for comments, products that have been approved but do not meet the new requirements may be re-submitted as new product registrations after adjusting their formulations (including replacing or removing ingredients). For products where ingredients are solely removed, safety evaluation test data may be exempted.

CIRS Opinion

Once officially implemented, these regulations will standardize market supervision for animal- and plant-derived health foods while raising the baseline for documentation and compliance. CIRS warmly reminds that during the early R&D and formula design stages, related enterprises should conduct thorough compliance checks on all intended plant and animal ingredients to avoid regulatory red lines. In addition, establishing a robust supply chain traceability file early on will be vital for smooth market entry.

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.