CIRS FAQ: Can We Claim New Health Functions for Products Now? Vol. 09, 2023

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

Q1: What sweeteners can be used for health food filing? And what are their usage limits?

A1: According to the Available Excipients for Health Food Filing Products and Their Usage Requirements (2021 Version), sweeteners that can be used in health food filing products and their limited usage is shown in the table below:

No.	Name of the sweetener	Maximum level of use (g/kg)
		Solid preparation	Liquid preparation
1	Erythritol	Appropriate level	Appropriate level
2	D-mannitol	Appropriate level	Appropriate level
3	Maltitol	Appropriate level	Appropriate level
4	Maltitol syrup	Appropriate level	Appropriate level
5	Xylitol	Appropriate level	Appropriate level
6	Neotame	0.33	0.05
7	Lactitol	Appropriate level	Appropriate level
8	Sucralose	1	1
9	Sorbitol and sorbitol syrup	Appropriate level	Appropriate level
10	Sodium saccharin [1]	0.15	0.15
11	Steviol glycosides	10; 3.5[3]	10
12	Aspartame	3	3

Note: [1] cannot be used as an excipient for gel candies; [3] refers to the amount allowed for gel candies production.

Q2: Can we claim n ew health functions for products now?

A2: Currently, the Administrative Measures for the Catalogue of Health Food Raw Materials and Health Function Catalogues has been implemented, while the Implementation Rules for New Functional Technology Evaluation of Health Foods (Trial) (Draft for Comment) has not yet been officially released. Food-related enterprises may prepare in advance for the application of new functions in accordance with the regulatory requirements that are now in place, and then apply after detailed implementation rules are published.

Regulations	Status	Date of implementation/release
Administrative Measures for the Catalogue of Health Food Raw Materials and Health Function Catalogues	Effective	Implemented on 2019.10.01
Implementation Rules for New Functional Technology Evaluation of Health Foods (Trial) (Draft for Comment)	Draft	Released on 2022.08.02

Q3: What materials are required for a new health function claim?

A3: According to the Implementation Rules for New Functional Technology Evaluation of Health Foods (Trial) (Draft for Comment), applicants can apply for new functions and registration of health food with new functions simultaneously.

(1) Materials required for a new health claim:

• Table of contents of the new health function claim;
• Letter of commitment for authenticity;
• Copy of the ID card or registration certificate of the applicant;
• Name, explanation, mechanism of action, and supporting evidence of the new health function claim;
• R&D reports of the new health function claim;
• Evaluation and verification materials of the new health function claim;
• Same or similar health function application status in China and other countries;
• Other scientific supporting evidence;
• Materials related to the ethics of health function claim;
• Technical evaluation for the samples;
• Other materials related to the function evaluation;
• Other materials related to clinical studies; and
• Other issues that need to be mentioned.

(2) Materials required for the registration of health products with new functions

The materials required for the registration and application of new functional health products shall be prepared according to theImplementation Rules (Draft) and relevant regulations of health food registration.

Q4: Is there any divergence in the filing requirements for domestic health food in different provinces?

A4: The filing of domestic health food in each province is carried out in accordance with the Guidelines for Health Food Filing (Trial) and relevant regulations, therefore, the requirements for filing materials and testing must also comply with the above-mentioned regulations. As a result, there is no difference in the filing requirements among different provinces. The particular procedures and review standards, however, might be slightly different.

Q5: We know that the Chinese labels are printed on the back of the product packaging, yet the information of the distributors/importers is not printed directly onto the product packaging. So can I stick this information on the back of the packaging in the follow-up steps?

A5: (1) For imported common food: yes.

(2) For imported health food and food for special dietary purposes: the answer would be no. According to the Administrative Measures for Import and Export Food Safety (GACC Decree No. 249), the Chinese label of imported health food and food for special dietary purposes must be directly printed on the packaging of the smallest sales unit, and it is not allowed to stick on extra information.

Q6: Since the filing of imported products that supplement DHA is now available, are the raw material source of the products restricted to algae only? Will fish oil work?

A6: Only raw materials derived from algae sources are allowed, and fish oil is not permitted to be used.

Regulatory basis: According to the Health Food Raw Materials Directory of Nutrient Supplement (2023 Version), the available compound source of the nutrient DHA is docosahexaenoic acid oil and it needs to comply with the technical requirements of DHA algae oil raw materials.

Q7: Is there any required dosage form for the registered health food in pills?

A7: Yes, there is.

Regulatory basis: (1) According to the Health Food Production License Review Rules, the dosage form of pills is included in the Catalog of Health Food Production Licenses. (2) It can be seen from the recorded registered health food that over 200 registered health food in the form of pills have been approved.

Q8: Is the Directory of Imported Health Food Fling Raw Materials and the Directory of Domestic Health Food Fling Raw Materials the same?

A8: Directory of Raw Materials for Health Food subject to Filing include: (1) Health Food Raw Materials Directory of Nutrition Supplements; (2) Functional health food raw materials (currently includ ing coenzyme Q10, melatonin, spirulina, broken ganoderma lucidum spore powder, fish oil, soy protein isolate and whey protein).

Directory (1) is applicable for domestic and imported filing health food while Directory (2) is now applicable for domestic filing health food only.

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

Further Information

Vol. 01, 2023 FAQs on Health Food Registration and Filing in China

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

Vol. 03, 2023 Applicants’ Qualifications for the Registration of New Food Raw Material (Novel Food) in China

Vol. 04, 2023 Technical Requirements for New Food Additives Applications in China

Vol. 05, 2023, Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production?

Vol. 06, 2023, Is There Any Protection Period for Newly Approved New Food Additives?

Vol. 07, 2023, Is it Possible to Keep the Health Food Formula Secret during Compliance Applications?

Vol. 08, 2023, Do Health Foods Sold on Cross-border E-commerce Platforms Need to Apply for Registration or Filing?