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

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

Q1: When will the Methods for Functional Evaluation of Health Food be officially issued?

A1: After the Technical Regulations for Health Food Inspection and Evaluation (2003 Version) was repealed in July 2018, the State Administration for Market Regulation (SAMR) opened the new functional evaluation methods for health food for public consultation twice – November 2020 and January 2022. It is believed that with the efforts from both sides of related enterprises and government departments, the new methods for functional evaluation will soon come into effect, and the registration of the 24 health functions will then advance smoothly.

However, it is worth mentioning that there are currently nine methods for functional evaluation valid:

• anti-oxidative;
• assisting the protection from gastric mucosal injury;
• assisting blood sugar reduction;
• alleviating eye fatigue;
• improving iron-deficiency anemia;
• assisting blood lipids reduction;
• alleviating lead excretion;
• reducing body weight; and
• clear the throat.

Source: 国食药监保化[2012] No. 107.

Q2: How to ensure compliance with health food formulas?

A2: Health food filing:

To ensure the health food formula is compliant with Chinese health food regulations, the raw material used in filing products shall be included in the catalogue of health food raw materials, and the excipients shall be included in catalogue of health food excipients. The usage amount of raw materials and excipients shall meet relevant requirements.

Health food registration:

To ensure the health food formula is compliant with Chinese health food regulations, the available raw materials for registration-product of health food are limited as follows: general food raw materials, approved new food raw materials, and “substances that are both food and traditional Chinese medicine”. The additives used in health food shall be included in National Food Safety Standard – Standard for the Use of Food Additives (GB 2760), National Food Safety Standard – Standard for the Use of Nutritional Fortification Substances in Foods (GB 14880), or the new food additives approved and released by NHC. New food raw materials used in health food are required to conduct safety assessments.

Furthermore, as a sufficient theoretical basis can be supportive in approving the rationality of a product in the registration procedure, enterprises should pay more attention to the dossier preparation.

Q3: Is an applicant for registration of domestic health food required to be qualified for health food manufacturing?

A3: The applicant for registration of domestic health food shall be a juridical person or other enterprise registered in China, which means that the applicant is not limited to the manufacturer and does not need to be qualified for health food manufacturing. The product can be entrusted to another enterprise for production.

Q4: Can a manufacturer apply for a health food production license without a health food registration/filing certificate?

A4: According to relevant regulations (For example, Measures for the Management of Food Production License, and Examination Rules of Production License for Health Food), applicants for health food production license are required to provide relevant approval documents for health food registration/filing when submitting application materials.

Manufacturers can obtain their health food production license by two means:

• submitting the health food registration certificates of their entrusting party;
• applying for the license in the form of “to-be-filed products”.

Q5: How can new manufacturers without health food production licenses declare their products?

A5: As stated in Q4, applicants for health food production license shall provide relevant approval documents for health food registration/filing when submitting application materials. The procedures for registration and filing products are separately detailed as follows:

For registration of products: a manufacturer can,

(1) register the product as a health food registration applicant according to the registration procedure (entrust a qualified manufacturer to produce samples), and apply for the health food production license after obtaining the registration certificate; or

(2) obtain a health food registration certificate transferred from others and apply for the health food production license.

For filing of products:

The applicant for filing of domestic health food should be the manufacturer, however, a precondition lies in that a health food manufacturer should obtain the health food production license first. To deal with such a “paradox”, enterprises can take the form of “to-be-filed products” into consideration. Considering that the specific procedures may be varied in different provinces, manufacturers can consult the provincial administration for market regulation in advance.

Here is a brief introduction to the procedure (taking enterprises in Anhui province as an example):

1) Submit applications for health food production licenses to obtain the Acceptance Notice of Food Production License;

2) Log in to the file system with an account obtained with the Acceptance Notice;

3) Submit health food filing materials;

4) Enterprises passing the technical review of health food production will be permitted to product health food;

5) Products meeting the technical requirements of the health food filing materials will obtain a health food filing number and a domestic health food filing certificate; and

6) Enterprises meeting the above requirements will be issued the food production license.

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

Further Information

Click here to view more FAQ: Can Health Food Be Applied for Registration or Filing Currently?