Year-End Review of Chinese Health Food Regulations in 2020

In 2020, 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 2020, and made an outlook on the development trend in 2021.

1. Regulation Framework of China Health Food

2. In 2020, What New Regulations were Issued？

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) shall be filed instead of registration in China.

However, relevant supporting documents (e.g., the technical requirements of these products) have not been officially released. In order to ensure that both raw materials and products meet the filing requirements, it is necessary to wait for the formal release of these supporting documents.

Date	Regulations	Key Points (Click the title)
Issue date: 2020.12.01 Implementation date: 2021.03.01	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	Interpretation of CIRS
Issue date: 2020.08.12	Technical Requirements on Health Food Using the 5 Raw Materials Including Coenzyme Q10 (draft)	Interpretation of CIRS
	Main Production Processes on Health Food Using the 5 Raw Materials Including Coenzyme Q10 (draft)

Gelatin candy and powder will be the available dosage forms of filing

At present, only 5 dosage forms are available for health food filing in China: tablet, hard capsule, soft capsule, oral liquid and granule. It is gratifying that gelation candy (gummies) and powder, which are popular dosage forms for nutrition supplements at home and abroad, would be the available dosage forms of health food filing in the near future.

State Administration for Market Regulation (SAMR) issued a series of drafts including the product technical requirements, the available excipients, and main production processes to standardize the filing work of products in the form of gummies or powder.

Date	Regulations	Key Points (Click the title)
Issue date: 2020.08.28	Technical Requirements for the Health Food Filing of Gelatin Candy (2020 version, draft)	Interpretation of CIRS
	Technical Requirements for the Health Food Filing of Powder (2020 version, draft)
	Available Excipients for Health Food Filing and Their Usage Rules (2020 version, draft)
	The Dosage Forms and Main Production Process of Health Food Filing Products (2020 version, draft)

Nutrient supplements can label function interpretation

Health Food Raw Materials Directory of Nutrition Supplement (2020 version) will come into force since March 2021. Compared with the current version, one big change is that β-carotene, as one of the compound sources of vitamin A, will also be used as a new type of nutrient individually. Meanwhile, the interpretations of health functions have been added in the 2020 Health Function Directory. Companies can use one or more corresponding nutrient functional claim(s) on the label, which has a positive significance for product promotion.

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)

The permitted health functions are reduced from 27 to 24, and the evaluation methods of registration products are released one by one

As is known to all, 27 health functions have been available for functional health food in China. According to the new draft, however, 3 functions including “facilitating milk secretion”, “improving child growth”, and “improving skin oil content” will be removed, and the other 24 functions will be revised as well to make the expressions more accurate and more scientific.

By the end of 2020, the regulations related to toxicological tests, hygienic and physicochemical inspection, and safety assessment of strains used for health food have been officially issued and implemented. Meanwhile, the drafts on health food functional assessment methods were released for public comments as well.

Date	Regulations	Key Points (Click the title)
Issue date: 2020.10.31 Implementation date: 2021.10.31	Guidelines for Inspection and Evaluation of Physicochemical and Hygienic Indicators of Health Food (2020 version)	Interpretation of CIRS
	Guidelines for Toxicological Test and Evaluation of Health Food and Its Raw Materials (2020 version)	Interpretation of CIRS
	Guidelines for Safety Inspection and Evaluation of Strains Used as Health Food Raw Materials (2020 version)	Interpretation of CIRS
Issue date: 2020.11.24	List of Health Functions Available for Health Food, Except Nutrition Supplement (2020 version, draft), which includes Methods for Functional Assessments of Health Food (2020 version, draft)	Interpretation of CIRS
	Interpretation on Health Food Function Claims (2020 version, draft)
	Guidelines for Functional Assessment of Health Food (2020 version, draft)
	Guidelines for Ethical Review of Human Feeding Trials on Health Food (2020 version, draft)

Key points of literature on health functions are specified, and on-site inspection of registered products are standardized

Date	Regulations	Key Points (Click the title)
Issue date: 2020.07.23	Key Points on Review of Literatures for Health Food Functions (draft)	Interpretation of CIRS
Issue date: 2020.11.26 Implementation date: 2021.11.26	Rules for On-Site Inspection of Special Food Registration (trial)	/

Data analysis on health food registration/filing products in 2020

• Statistic and analysis on health food registration products in 2020
• Statistic and analysis on health food filing products in 2020

3. Regulatory Trends in 2021

In 2020, new health food policies in China have been released continuously, and Chinese health food industry would have another high speed development since 2021.

Firstly, the scope of health food filing is expanding. As mentioned above, 5 ingredients including Coenzyme Q10 has officially entered the health food filing list, and we believe that the authorities will actively promote the release of corresponding supporting documents to guarantee the implementation of filing of these functional products since March 2021. With more ingredients, label claims, as well as dosage forms being available for health food filing in the future, health food enterprises will open a new market for themselves.

Secondly, 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. In 2020, most test methods have been officially issued, and it is reported that the functional assessment methods would be released recently in 2021. 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. SAMR has issued the draft of Key Points on Review of Literatures for Health Food Functions to specify the literature requirements. Therefore, when preparing the registration dossier, enterprises shall attach importance to the collection of them.

Finally, the Administrative Measures on Health Food Raw Material Directory and Function Directory has come into force on 1 October 2019. According to this regulation, any unit or individual could give advice on new health functions or listing new food ingredients into filing scope in China. After the technical examination and public demonstration by Chinese authorities, those meeting the requirements can be included in relevant directories. However, more in-depth implementation rules have not been released yet. We expect that in 2021, SAMR can further specify the application requirements on it.

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