Provisions on Declaration and Review of Health Food Applications for Amino Acid Chelates, etc. (Trial)

(Draft for Comments)

Article 1: These Rules are formulated to standardize the evaluation of health food in accordance with the "Food Hygiene Law of the People's Republic of China" and the "Administrative Measures for Registration of Health Food (Trial)".
Article 2: Applications for registering health foods produced using amino acid chelates must, in addition to submitting the required materials as per general health food regulations, also provide the following documents:
(I) Provide clear chemical structures of the product, physicochemical properties, ligand-to-metal ion ratios, and free element-to-total element ratios.
(II) Provide qualitative and quantitative testing methods for amino acid chelates (including raw materials and finished products), along with validation reports issued by a testing agency recognized or approved by the National Medical Products Administration.
(3) Histopathology report from an FDA-recognized testing agency, including acute toxicity studies with a fasting period of 16 hours prior to a single gavage (with detailed gross anatomical and pathological observations of the gastrointestinal tract at 2 and 4 hours post-gavage), and a 30-day feeding study covering the liver, kidneys, and gastrointestinal tract (including duodenum, jejunum, and ileum).
(IV) Literature on the consumption of this amino acid chelate domestically and internationally.
Article 3: For applications to register health foods directly produced via microbial fermentation, in addition to submitting the required materials as per general health food regulations, the following documents must also be provided:
(1) Source of the microbial strain and a strain identification report issued by an inspection agency recognized or approved by the National Medical Products Administration.
(II) Virulence test report for the bacterial strain.
(3) Safety Evaluation Report on the Microbial Strain.
(4) Literature on the use of this strain in food production domestically and internationally.
(5) Quality standards for final fermentation products (including purity, impurity composition, and content).
Article 4: Health food products manufactured using melatonin as an ingredient must meet the following requirements:
(1) The product formula shall not contain any ingredients other than melatonin, necessary excipients, and vitamin B6.
(2) The applicant shall submit a test report for the melatonin raw material, which must have a purity of at least 99.5%.
(3) The recommended daily intake of melatonin is 1-3mg/.
(4) The declared health function is temporarily limited to improving sleep.
(5) Precautions: Individuals engaged in driving, operating machinery, or performing hazardous tasks should not consume this product before or during operation. Patients with autoimmune disorders (e.g., rheumatoid arthritis) and hyperthyroidism should use with caution.
Article 5: Health food products manufactured using soybean lecithin as the raw material must comply with the following requirements when applying for registration.
(1) The applicant must submit a test report on the acetone-insoluble and ether-insoluble content of soy lecithin raw material.
(2) The soy lecithin raw material used shall meet the Grade I requirements specified in "General Technical Conditions for Lecithin" (SB/T10206-94).
Article 6: Health food products manufactured using aloe as an ingredient must comply with the following requirements:
(1) The applicant must submit an aloe vera variety identification certificate issued by a professional appraisal institution at the provincial level or above.
Report.
(2) Aloe vera (Aloe barbadensis Miller) and Aloe ferox are the only aloe species permitted as raw materials for health food. For other aloe species, a toxicological safety evaluation report and relevant literature on edible safety must be submitted in accordance with Article 63 of the "Interim Measures for the Registration of Health Food."
(3) Daily consumption of aloe should be limited to under 2 grams (based on dry raw material), except when using aloe gel as the raw material.
(4) Aloe raw materials shall comply with the requirements of "Edible Aloe Products" (QB/T2489).
(5) Not suitable for pregnant women, nursing mothers, and individuals with chronic diarrhea.
(6) Precautions: If you experience significant diarrhea after consuming this product, stop using it immediately.
Article 7: Health food products produced using ants as raw materials must comply with the following requirements:
(1) Applicants must submit an ant species identification report issued by a professional appraisal institution at or above the provincial level, along with proof of the source of ant raw materials.
(2) Ant species approved as raw materials for health foods include Polyrhachis vicina, Polyrhachis dives, Coptotermes formosanus, Macrotermes barneyi, and Odontotermes formosanus. For other ant species, a toxicological safety evaluation report on the raw material and relevant literature on edible safety must be provided in accordance with Article 63 of the "Measures for the Administration of Health Food Registration (Trial)."
(3) During product processing, the temperature shall generally not exceed 80°C.
(4) Provide a formic acid content determination report.
(5) Precautions: Use with caution if you have allergies.

Article 8: Applications for registering health foods using alcohol as a carrier must meet the following requirements:
(1) The product's alcohol content must not exceed 38% ABV.
(2) Do not exceed 100 ml per day.
(3) Applications for auxiliary lipid-lowering and chemically induced liver injury protection functions are not permitted.
Article 9: Applications for registration of unsaturated fatty acid health foods must meet the following requirements:
(1) The recommended daily intake of the product shall not exceed 20 ml.
(2) Do not heat or cook before consumption.
(3) Product is packaged in daily serving sizes.
Article 10: Health food products manufactured using chitin as a raw material must meet the following requirements:
(1) The applicant shall submit a deacetylation degree test report for the chitin raw material.
(2) The degree of deacetylation of chitin raw materials shall be greater than 85%.
Article 11: Health food products produced using superoxide dismutase (SOD) as an ingredient must comply with the following requirements:
(1) Superoxide dismutase (SOD) must be extracted from the edible parts of natural foods, and its extraction and processing must comply with food production standards.
(2) Health food products manufactured using superoxide dismutase (SOD) as a raw material are currently limited to antioxidant functions for registration.
(3) When applying for a health food using superoxide dismutase (SOD) as the sole ingredient, provide domestic and international research data on SOD's oral absorption rate and in vivo metabolism to demonstrate that SOD can be absorbed orally.
(4) Application for health food registration using superoxide dismutase (SOD) in combination with other functional ingredients
When added, functional ingredients should have antioxidant properties. Products must not be named after superoxide dismutase (SOD) and must not claim SOD-related benefits.
Article 12: For health food products produced using the following raw materials, in addition to submitting the declaration documents required for health foods, the following shall also be provided:
(1) For animal-derived ingredients (including placentas, bones, etc.), provide proof of ingredient source and a quarantine certificate issued by a county-level or higher livestock quarantine agency.
(2) For products using plant raw materials from different varieties, such as Rhodiola, pollen, or spirulina, a variety identification report issued by a provincial-level or higher professional appraisal institution must be provided.
(3) For Dendrobium use, a species identification report issued by a professional appraisal institution at the provincial level or above and an on-site cultivation inspection report issued by the provincial food and drug administration are required.
Article 13: In principle, the same product shall not be manufactured in two dosage forms or as separately formed entities. Products meeting the following conditions may apply for registration of two dosage forms or separate formation:
(1) Sufficient evidence indicates that, under current production technology conditions, the product cannot be processed into a single dosage form; or even if it can be processed into a single dosage form, doing so would compromise product shelf life, resulting in a shelf life of less than 6 months.
(II) A single dosage form alone cannot constitute a distinct health function.
(3) Health food products in two dosage forms must indicate both forms in the product name. The minimum packaging unit should correspond to a single daily or per-serving amount.
Article 14: Sublingual dosage forms and sprays shall not be used as health food formulations.
Article 15: Specific regulations for the review of sustained-release health food preparations are as follows:
(1) Applicants must provide sufficient evidence to justify the necessity of the sustained-release formulation (including literature and experimental data).
(II) The product's raw materials shall consist of monomeric components with a purity of 90% or higher.
(3) Ensure the food safety of ordinary formulations converted to sustained-release products and submit relevant toxicological evaluation data.
(4) The applicant shall submit test reports for comparative dissolution studies of immediate-release and sustained-release formulations, as well as human bioavailability and bioequivalence studies, conducted in accordance with the "Guiding Principles for Sustained-Release and Controlled-Release Preparations," "Dissolution Test Methods," and "Guiding Principles for Human Bioavailability and Bioequivalence Studies of Pharmaceutical Preparations" in the Chinese Pharmacopoeia.
Article 16: For health food products where the raw materials and main excipients are identical, and only differ in flavor or color, toxicological safety evaluation tests and functional efficacy evaluation tests may be waived (a copy of the original product's test report must be provided). However, testing methods, evaluation indicators, and judgment criteria must comply with current regulations. The product name shall include the flavor or color designation.
Article 17: For products with additional dosage forms, applicants shall explain the necessity and basis for adding the new form. The raw materials, active ingredients, and daily consumption amount must match those of the original product. The physical appearance should be similar (e.g., both solid or both liquid), and the production process must not undergo qualitative changes that affect safety or efficacy. In such cases, toxicological safety evaluations and functional efficacy trials may be waived by providing copies of the original product's test reports. However, testing methods, evaluation indicators, and acceptance criteria must comply with current regulations.
Article 18: Creatine and bear bile powder shall not be used as raw materials for health food applications. Applications for health foods using metallothionein as a raw material are currently not accepted or approved.
Article 19: The food additives used in health foods shall be limited to those listed in the "Hygienic Standards for the Use of Food Additives" or in the list of new food additive varieties announced by the Ministry of Health.
Article 20: The target population, non-target population, and precautions for health food shall be determined based on the declared health functions and the characteristics of the product.
(1) Health functions and their corresponding suitable and unsuitable populations must comply with the requirements in the Appendix. If a health food has multiple health functions, determine the product's suitable and unsuitable populations based on those for its primary function, while taking all functions into account.
(2) If a product contains an ingredient unsuitable for specific populations, those populations must be added to the "Not Suitable For" section. For example: products using safflower should list pregnant and breastfeeding women, as well as individuals with heavy menstrual bleeding, as not suitable; health supplements containing lingzhi, ginseng, American ginseng, or hormone-containing items (such as royal jelly) should also list children and adolescents as not suitable.
Article 21: These regulations shall be interpreted by the State Food and Drug Administration.
Article 22: These regulations shall take effect on [date]. Any prior regulations that conflict with these regulations shall be superseded by them.

Attachment:

Health functions and corresponding suitable and unsuitable populations

 Health Functions | Suitable for | Not Suitable for