CIRS FAQ: Do Health Foods Sold on Cross-border E-commerce Platforms Need to Apply for Registration or Filing? Vol. 08, 2023

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food and common food to help you understand the current requirements in China.

Q1: What is the legal basis supporting the exemption of health foods sold on cross-border E-commerce platforms from registration or filing?

A1: According to the Notice on Improving the Supervision of Cross-border E-commerce Retail Imports (MOFCOM Notice of No. 486, 2018), cross-border E-commerce retail imports are regulated as imported goods for personal use, and not required to apply for the first-import certificate, registration, or filing for relevant commodities.

Q2: Can the formula of probiotic health food be combined with other raw materials (e.g., substances that are regarded as both food and medicine) with the same functions?

A2: Yes. But it needs to be noted that the formula compatibility of such functional health food should be scientific and reasonable. Applicants must also provide sufficient relevant scientific data to support the safety and functionality of the formula.

Q3: How do you apply for raw materials lacking relevant legal basis to be considered health food?

A3: There are mainly two ways:

• Applying for the new food raw material first. Once the raw material is approved, it can be legally used in health food. And then, the enterprise can apply for health food registration.
• Registering the health food containing the health food new raw material directly. When registering the health food, enterprises can conduct a safety evaluation of the raw material by reference to the relevant requirements to the safety review of new food raw materials, submit the R&D report, international research and utilization status materials, manufacturing processes, quality standards, toxicology test reports, inspection reports, and other materials necessary for safety evaluation.

Q4: Can food additives that have been listed in GB 2760 and have existing national standards be used as active ingredients in health food?

A4: It needs to be noted that GB 2760 is the standard for the use of food additives and cannot be regarded as a legal basis for the use of health food raw materials, unless the food additive included in GB 2760 has an acceptable basis for use as a health food raw material, or is traditionally used in health food needed for registration.

Q5: Without consideration of food additives included in GB 2760 (e.g., food flavor substances), what amino acids are allowed for use in foods for special dietary uses?

A5: There are lots of categories included in foods for special dietary uses, among which, the following are permitted to use amino acids as nutrients:

• According to the General Rules of Infant Formula for Special Medical Purposes (GB 25596-2010) and the General Rules of Food for Special Medical Purposes (GB 25522-2013), amino acids are allowed to be used in infant FSMP and FSMP consumed by people over one-year-old. The source of amino acids must meet the requirements of relevant standards and/or GB 14880.
• According to the Food Safety National Standard for Infant Formula (GB 10765-2021) and the Food Safety National Standard for Older Infant Formula (GB 10766-2021), amino acids are permitted for use in infant formula and older infant formula. The source of amino acids must meet the requirements of relevant standards and/or GB 14880.
• According to the General Rules of Sports Nutritious Foods (GB 24154-2015), amino acids are permitted for use in sports nutritious foods for recovery from exercises and speed and strength. The source of amino acids shall meet the requirements of Table 2 in relevant standards.

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Further Information

Vol. 01, 2023 FAQs on Health Food Registration and Filing in China

Vol. 02, 2023 The Precondition to Health Food Application in China

Vol. 03, 2023 Applicants’ Qualifications for the Registration of New Food Raw Material (Novel Food) in China

Vol. 04, 2023 Technical Requirements for New Food Additives Applications in China

Vol. 05, 2023, Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production?

Vol. 06, 2023, Is There Any Protection Period for Newly Approved New Food Additives?

Vol. 07, 2023, Is it Possible to Keep the Health Food Formula Secret during Compliance Applications?