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.
1. Can I apply for health food registration renewal and change of registration at the same time?
Yes. According to the Guidelines for Health Food Registration Application, applicants are allowed to submit multiple change of registration applications simultaneously, including those for renewal registration.
2. Can the registration certificates of filing products be transferred?
No. It’s specified in the Guidelines for Health Food Filing (Trial) that health food filing products registration certificates cannot be transferred.
3. Is it true that new health food products cannot be sold during the registration and evaluation period in China, even if this process takes 1-2 years?
Yes. Health food products must obtain approval certificates before they can be legally marketed and sold.
4. Can imported products be imported as special dietary foods first, and then, after obtaining health food registration/filing approval, be imported as health foods?
Yes, if the product meets the requirements for special dietary foods. However, it’s important to note that special dietary foods and health foods have different labeling requirements. When importing as health food, it will be necessary to redesign the labels to comply with relevant regulations.
5. How should the shelf life of health food be determined and what should be considered?
According to the Guiding Principles for Stability Testing of Health Food, the shelf life of health food should be determined based on specific products and stability testing results.
- For samples evaluated for quality stability using short-term or long-term tests, the overall evaluation period should cover the anticipated shelf life. The reference point should be the longest time point where there is no significant change compared to the 0-month data. The shelf life should be determined based on test results and specific product characteristics;
- For samples evaluated using accelerated testing for quality stability, the shelf life is generally set at 2 years based on the accelerated test results; and
- For samples subjected to both accelerated and long-term tests, the shelf life is primarily determined based on the long-term test results.
6. If health food undergoes a 3-month accelerated stability test and the shelf life is set at 2 years, is it still necessary to conduct long-term tests afterwards?
No. In this case, a long-term test will not be required.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024
CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Health Food Filing? Vol. 3, 2024
