Latest Updates of China Health Food (Dietary Supplement) Regulations

In 2021, Chinese authorities issued a series of health food regulations to support the implementation of the dual-track system of health food registration and filing. CIRS has comprehensively summarized the key points of health food regulations issued in 2021, and made an outlook on the development trend in 2022.

1. Regulation Framework of China Health Food (Dietary Supplement)

2. Filing: What New Regulations were Issued or Implemented in 2021？

• 5 functional ingredients can be used in filing products since March 2021

Since March 2021, health food made of coenzyme Q10, fish oil, broken ganoderma lucidum spore powder, spirulina, or melatonin as single raw materials (vitamin B6 can be added in product made of melatonin) can be filed instead of registration in China.

However, subject to relevant provisions of the Food Safety Law, the filing of the above five functional raw materials is only applicable to domestic products, and imported products still need to apply for registration. Find CIRS interpretation on the differences between registration and filing of imported health food here.

Date	Regulations
Issue date: 2020.12.01 Implementation date: 2021.06.01	Health Food Raw Material Diretory - Coenzyme Q10 Health Food Raw Material Diretory - Broken Ganoderma Lucidum Spore Powder Health Food Raw Material Diretory - Spirulina Health Food Raw Material Diretory - Fish Oil Health Food Raw Material Diretory - Melatonin
Issue date: 2021.02.01 Implementation date: 2021.06.01	The Dosage Forms and Technical Requirements on Health Food Using the 5 Raw Materials Including Coenzyme Q10

• Six Raw Materials Including DHA are expected to be added into Filing Scope

On 20 December 2021, SAMR issued three drafts related to health food filing. The biggest change in these drafts is that “DHA” is added into the “Directory of Nutrition Supplement”. As the function of this nutrient ("supply n-3 polyunsaturated fatty acids") is within the scope of “supply nutrients”, CIRS expects that overseas enterprises can also apply for the filing of DHA products in the future.

In addition, soybean protein isolate and whey protein are expected to be the available raw materials for health food filing, and the health function is enhancing immune. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials only includes the domestic products in China, and overseas products still need to apply for health food registration.

Date	Regulations	Key Points (Click the title)
Issue date: 2021.12.20	Health Food Raw Materials Directory of Nutrition Supplement (2022 version, draft)	Interpretation of CIRS
	List of Health Functions Available for Nutrition Supplement (2022 version, draft)
	Health Food Raw Material Directory of Protein (draft)

• Gelatin candy and powder become available dosage forms of filing

Since 1 June 2021, gelation candy (gummies) and powder, which are popular dosage forms for nutrition supplements at home and abroad, are available for health food filing. Based on CIRS’s data analysis, up to the end of 2021, 40 domestic products in gummies and 22 domestic products in powder have got the filing approval.

Date	Regulations	Key Points (Click the title)
Issue date: 2021.02.20 Implementation date: 2021.06.01	The Dosage Forms and Technical Requirements of Health Food Filing Products (2021 version)	Interpretation of CIRS
	Available Excipients for Health Food Filing and Their Usage Rules (2021 version)

• Nutrient supplements can label function interpretation

The interpretations of health functions have been added for 15 nutrients in the 2020 Health Function Directory. Since 1 June 2021, companies can use one or more corresponding function interpretation on the label. For example, products used to supplement vitamin E can be labeled with "vitamin E has antioxidant effect".

Date	Regulations	Key Points (Click the title)
Issue date: 2020.12.01 Implementation date: 2021.03.01	Health Food Raw Materials Directory of Nutrition Supplement (2020 version)	Interpretation of CIRS
	List of Health Functions Available for Nutrition Supplement (2020 version)

• Since 1 March 2021, additional materials are required for products suitable for special groups

From 1 March, 2021, the new health food filing system is officially putted into operation. Compared with the old system, there are 2 additional materials in the new system.

If the suitable crowds of the product include	Additional materials required for the filing application
People at the age of 1 to 3, pregnant women and lactating women	1) The product safety evaluation for the suitable crowds and the R&D materials developed for these people; 2) Scientific evidence of the necessity and safety of these people to eat this product.
People under the age of 4 to 17	The product safety evaluation for the suitable crowds and the R&D materials developed for these people

3. Registration: Functional Assessment Methods are Second Opened for Public Comments

According to the new drafts issued on 13 January, 2022, 3 functions including “facilitating milk secretion”, “improving child growth”, and “improving skin oil content”, and 4 old functions which were no longer approved by former Ministry of Health (including “tumor suppression”, “assisting tumor suppression”, “anti-mutation”, “delaying senescence”) will be removed from health food registration. The other reserved 24 functions will be revised as well to make the expressions more accurate and more scientific.

Meanwhile, the drafts on health food functional assessment methods were second released for public comments on 13 January, 2022.

Date	Regulations	Key Points (Click the title)
Issue date: 2022.01.13	List of Health Functions Available for Health Food, Except Nutrition Supplement (2022 version, draft)	Interpretation of CIRS
	Guidelines for Functional Assessment of Health Food (2022 version, draft)
	Guidelines for Ethical Review of Human Feeding Trials on Health Food (2022 version, draft)
	Methods for Functional Assessments of Health Food (2022 version, draft)
	Interpretation on Health Food Function Claims (2022 version, draft)

4. New Requirements on Imported Health Food

According to the regulations issued by GACC in 2021, imported health food will face the two major changes, Firstly, the Chinese labels for imported health foods shall be directly printed on the package since 2022. Secondly, all overseas food manufacturers shall register the factory at GACC before entering China market since 2022, and the registration way for health food manufacturers is “be recommended to GACC by the exporting country’s competent authority”.

Date	Regulations	Key Points (Click the title)
Issue date: 2021.04.13 Implementation date: 2022.01.01	Administrative Measures on Import and Export Food Safety	Interpretation of CIRS
Issue date: 2021.04.13 Implementation date: 2022.01.01	Administration Measures on the Registration of Overseas Manufacturers of Imported Food	Interpretation of CIRS
Issue date: 2021.11.05	Official Interpretation of GACC Decree No.248	Interpretation of CIRS

5. Data analysis on health food registration/filing products in 2021

1. Statistic and analysis on health food registration products in 2021

2. Statistic and analysis on health food filing products in 2021

6. Regulatory Trends in 2022

In 2021, the scope of health food filing was expanded. In addition, according to the drafts issued by SAMR on 20 December, 2021, 6 ingredients including DHA, soybean protein isolate, whey protein, etc., will be added into the health food raw material directory, which means, more ingredients will be available for health food filing in the future.

On the other hand, after the abolishment of Technical Standards for Testing & Assessment of Health Food (2003 version), the registration tests of new products in China have been suspended. At present, most test methods have been officially issued, and it can be expected the functional assessment methods would be released in 2022. Meanwhile, China authorities will pay great attention to the R&D materials during the technical review of product registration dossiers, and sufficient scientific literature support is a focus of the review. Therefore, when preparing the registration dossier, enterprises shall attach importance to the collection of them.

CIRS Food Technical Team has prepared a guideline on health food exportation to China to help related enterprises better understand the management trends of food regulations in China. If you are interested, do not hesitate to know more information.

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