Q&As on Health Food Registration and Filing in China

On July 18, 2023, we hosted a free webinar in Chinese and Japanese on health food registration and filing in China as well as an analysis of the difficulties. A lot of questions were raised during the webinar. CIRS Group has collected questions on health food and made a Q&A summary as follows:

Q: Why is DHA available for import filing?

A: According to Article 76 of the Food Safety Law of the People’s Republic of China, if the first-time imported health food contains nutritional substances such as vitamins and minerals, it shall get filed with the food safety regulatory and administrative department under the State Council. According to the Health Function Directory of Allowed Nutrition Supplement Claims (2023 version), the health function of DHA – supplementing n-3 Polyunsaturated fatty acid – falls under the category of “vitamin, mineral, and other nutrients supplement”, so it can be included in the import filing category.

Q: Is it possible to test the imported health products via overseas self-built methods?

A: Yes, with the exception of those with test methods specified in the regulations excepted. If the testing methods are different from those recorded in the national, local, and industrial standards or technical specifications, methodological research materials need to be provided.

Q: Is there any requirement on the particle size of whey protein powder when processing filing for protein? Is it possible to use the function claims recorded in GB 28050?

A: There is no requirement on the particle size of whey protein itself when it is used as raw material of health food. However, such requirements on particles is set for the health food using whey protein powder as raw materials. Index of particle size are set by reference to the provisions of the Pharmacopoeia of the People’s Republic of China.

GB 28050 is not applicable to health food, therefore the functional claims of proteins recorded in GB 28050 cannot be used as a reference for health food.

Q: How long does it take for the official department to respond after health food materials is submitted?

A: Registration review: The review center shall complete the review of the application materials within 60 working days. If necessary, the review period can be extended by another 20 working days with the approval of the director of the review center.

Filing review: There is no specific provision, but it usually does not take more than 60 working days.

Q: Is it possible to do the stability test of health food by ourselves?

A: Yes, or you can also entrust a legally qualified food inspection agency to carry out the stability test.

Q: I haven’t obtained the production license yet I have to process product filing, what should I do first, product filing or production license?

A: You may obtain the health food production license first as “the variety to be filed” according to the “Health Food Production License Review Rules”, and then apply for health food filing. Specific operating procedures vary from province to province, and it is recommended that factories consult with the market supervision authorities at the provincial level in advance.

Q: We know that it is necessary to provide a qualification certificate covering the name of products to open an account for the imported health food filing. Then, do we have to apply for a new account when we need to file for other products?

A: There is no need to apply for a new account. When applying for the filing of new products, you just need to provide the supporting documents required for filing for the new products.

Q: Do we need to provide additional information for one product in different packaging materials forms? (e.g. aluminum plastic packaging and bottle packaging)

A: If the filer intends to use two or more packaging materials in direct contact with the product, they should indicate specific packing materials in the "Type, Name, and Standard of Direct Contact Product Packaging Materials" section. They should also provide the testing reports for different packing materials respectively if the product is newly applied for filing. But when the products have obtained filing certificates and intend to add extra packaging materials that directly contact the product, filers only need to process the change of filing as per relevant procedures.

Q: Can we paste the registered trademark on the Ingredient List of the health food?

A: No, the ingredient list needs to be consistent with the sample label instructions in the health food approval document, and the registered trademark of the ingredient cannot be added.

Q: When is the functional evaluation method excepted to come out?

A: After the Technical Specifications for Inspection and Evaluation of Health Food (2003 version) was abolished in July 2018, the State Administration for Market Regulation has collected opinions on the new functional evaluation method of health food twice, in November 2020, and January 2022  respectively. It is believed that with the suggestions from the public and the revision of government departments, the official version of the functional evaluation method will soon be implemented, and the registration for products with the 24 specified health functions can then advance smoothly.

It is worth mentioning that currently there are nine functional evaluation methods still valid, these are:

• Antioxidant,
• Assisting the protection of gastric mucosa,
• Assisting blood sugar reduction,
• Alleviating eye fatigue,
• Improving iron-deficiency anemia,
• Assisting blood lipids reduction,
• Alleviating lead excretion,
• Reducing body weight, and
• Clearing the throat.

Throughout 2023, we will launch a series of free webinars of highly concerns. To know more about our free webinars, please click CIRS Food - Upcoming Free Webinars in 2023.

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