CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Heath Food Filing? Vol. 3, 2024

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

Q1: Do samples for toxicological tests of health food need to be from the same batch as those for hygiene tests?

A1: According to the Technical Guidance for Toxicological Tests and Evaluation of Safety of Health Food and Its Raw Materials (2020 Edition), samples used in toxicological tests should have the same batch number as those used in function tests and should be one of the three batches of samples used in hygiene tests, excluding products with a shelf life shorter than the entire test cycle, such as probiotics and dairy products. If additional tests are required based on technical review opinions and the original batch of samples has expired, new batch samples can be used, but a full inspection report should be provided in accordance with the technical requirements of the product.

Q2: Are health food raw materials Ginseng radix et rhizoma, Panacis quinquefolii radix and Ganoderma only applicable for domestic health food filing?

A2: Yes. According to Article 76 of the Food Safety Law of the People’s Republic of China, Article 9, and Article 45 of the Administration Measures for Health Food Registration and Filing, health food products using raw materials not listed in the health food raw material directory, and first-time imported health foods should apply for registration to the State Administration for Market Regulation (SAMR). However, for first-time imported health foods that supplement vitamins, minerals, and other nutrients, filing can be applied. The health functions of the above-mentioned three health food raw materials do not fall under supplementing vitamins, minerals, and other nutrients. Therefore, the filing is only applicable to domestic health food and does not include first-time imported ones.

Q3: Can different companies apply for health food filing using the same formula?

A3: It is feasible in terms of application since there are no restrictive regulations. But companies should be held accountable for the potential commercial disputes and other issues.

Q4: If an unapproved raw material is used in health food, is it mandatory to first apply for a new food raw material before applying for health food?

A4: There is no prescribed sequence for application. It can be divided into the following two scenarios:

• If the applicant first applies for the new food raw material, it can be used in health food once it is officially approved.
• If the applicant does not apply for a new food raw material first, when applying for health food registration containing that raw material, the applicant must, following the relevant regulations for the safety review of new food raw materials, provide safety assessment materials such as research and development reports, information on its research and utilization both domestically and internationally, toxicological test reports, production processes, quality requirements, and inspection reports. Following approval of registration, the raw material is permitted for use only in the specific health food.

Q5: Is it mandatory to list the food additives that comply with the carryover principle on product labels as stipulated in GB 2760?

A5: If there are existing national, industry, or local standards for the compound ingredients directly added to the food, and their quantity is less than 25% of the total food mass, then the food additives contained in such compound ingredients do not need to be labeled if they comply with the “carryover principle” as specified in the GB 2760 - Food Additive Use Standards and do not serve a technical function in the final product.

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Further Information

CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024