Provisions on the Declaration and Review of Nutritional Supplement Additives (Trial)

Provisions on the Declaration and Review of Nutritional Supplement Additives (Trial)
(Draft for Comments)

Article 1: These Regulations are formulated to strengthen the management of nutrient supplements in accordance with the "Food Hygiene Law of the People's Republic of China" and the "Measures for the Registration of Health Food (Trial)."

Article 2: Nutritional supplements are products designed to provide vitamins and minerals rather than energy. Their purpose is to fill dietary gaps, prevent nutrient deficiencies, and reduce the risk of certain chronic degenerative diseases.

Article 3: Nutritional supplements must meet the following requirements:
(1) Intended solely for the supplementation of vitamins and minerals. The types of vitamins and minerals must comply with the "Specifications for Types and Dosages of Vitamins and Minerals."
(2) Items listed in the "List of Vitamin and Mineral Compounds" may be used as sources for nutrient supplements. Vitamins and minerals extracted from edible parts of foods must not contain other bioactive substances at levels that reach active doses.
(3) Auxiliary materials shall be used solely to meet process requirements or improve the product's color, aroma, and taste, and must comply with applicable national standards.
(4) For adults, the daily recommended intake of vitamins and minerals shall comply with the "Vitamins, Minerals: Types and Dosages" regulations. For pregnant women, lactating mothers, and individuals under 18 years of age, the daily recommended intake of vitamins and minerals shall be maintained within the range of 1/3 to 2/3 of China's Recommended Nutrient Intake (RNI) for that specific nutrient in these populations.
(5) The recommended daily intake for the product should be small. It is primarily available as tablets, capsules, granules, or oral liquid. Daily consumption of granules must not exceed 20 grams, and daily consumption of oral liquid must not exceed 30 milliliters.

Article 4: Items listed in the "List of Vitamin and Mineral Compounds" generally do not require toxicological safety reports if their production raw materials, processes, and quality standards comply with national regulations. For items outside this list, applicants must submit scientific literature on nutritional effects, metabolic pathways in humans, and safe intake levels for humans, as well as a toxicological safety evaluation report prepared in accordance with new food resource safety assessment requirements.

Article 5: The applicant shall provide quantitative testing methods for the nutrients in the dietary supplement.

Article 6: The declared value for nutrient supplements refers to the specific numerical amount of a nutrient indicated on the product label and instructions. Range values are not permitted.
The vitamin content range in the product quality standard is 0.8×labeled value to 1.8×labeled value, and the mineral content range is 0.75×labeled value to 1.25×labeled value. The measured value of each nutrient in the product must fall within this specified range.
The nutrient content ranges in the product quality standard shall comply with the "Types and Amounts of Vitamins and Minerals" requirements.

Article 7: A nutritional supplement containing three or more vitamins and minerals may be referred to as a multivitamin and mineral supplement.

Article 8: Products shall be packaged in sealed containers to facilitate consumption and maintain stability. Packaging materials that come into direct contact with the dietary supplement must comply with applicable hygiene standards or requirements.

Article 9: Labels and instructions for nutrient supplements shall comply with national regulations and must also include the following information:
(1) "Nutrient Supplement" label.
(II) Main Raw and Auxiliary Materials
(3) Nutritional information must be declared for the minimum consumption unit.
(4) Target Audience
(5) Unsuitable for
(6) Usage and Dosage: Clearly specify recommended intake levels for different population groups.
(VII) Specifications
(VIII) Shelf Life
(IX) Storage Instructions
(10) Important: This product is not a substitute for medication. Do not exceed the recommended dosage or take it simultaneously with other similar nutritional supplements.

Article 10: The "Types and Dosages of Vitamins and Minerals" and the "List of Vitamin and Mineral Compounds" shall be formulated and published by the National Medical Products Administration.

Article 11: These regulations shall be interpreted by the China Food and Drug Administration.

Article 12: These regulations shall take effect on [date].Implement. Previously published regulationsshall prevail over any inconsistent provisions.

Attachment 1: "Types and Dosages of Vitamins and Minerals";
Attachment 2: "List of Vitamin and Mineral Compounds".

Attachment 1:

Types and Dosages of Vitamins and Minerals

Note: Dosages in this table are for adults.

Attachment 2

List of Vitamin and Mineral Compounds