China Nutrient Supplement Regulation
Nov 03, 2015
Rachel Shen
Tags : China
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CONTENTS

In China, nutrient supplements are regulated as one category under the umbrella term health food. Nutrient supplements refer to products whose purpose is to supplement nutrients such as vitamins and minerals rather than energy supply. The functions of nutrient supplements include supplement of insufficient dietary intakes, prevention of nutritional deficiency and disease risk reduction.

There are single-ingredient and multi-ingredient nutrient supplements. Supplements can only carry claims purporting to supplement normal vitamins and/or minerals intake and cannot bear any functional claims.

1. Current laws and regulations


Overarching law

Food Safety Law of the P. R. China (2015)

Main supporting regulations

GB 16740-2014 National Food Safety Standard Health Food

Administrative Measures for Registration and Filing of Health Foods (draft)

Administrative Measures on Health Food Raw Material Directory and Health Function Directory (draft)

Administrative Measures on Health Food Labeling (draft)

Administrative Provisions on Nutrient Supplements (draft)

Requirements on Nutrient Supplements Dossiers (draft)

2. Categories of nutrient supplements and their permitted compound sources



Nutrients

Compound sources

Ca

Calcium carbonate

Calcium gluconate

Calcium citrate

Calcium lactate (cannot be the compound source for the foods for infants and young children)

Calcium salts of orthophosphoric acid

Dicalcium phosphate (secondary calcium phosphate)

Calcium acetate (cannot be the compound source for the foods for infants and young children)

Calcium chloride

Calcium sulfate

Calcium ascorbate (cannot be the compound source for the foods for infants and young children)

Calcium dihydrogen phosphate (primary calcium phosphate) (cannot be the compound source for the foods for infants and young children)

Fe

Ferrous sulfate

Ferrous gluconate

Ferrous fumarate

Ferrous lacate (cannot be the compound source for the foods for infants and young children)

Ferrous succinate (cannot be the compound source for the foods for infants and young children)

Zn

Zinc sulfate

Zinc gluconate

Zinc oxide

Zinc citrate

K

Potassium citrate

Potassium carbonate (cannot be the compound source for the foods for infants and young children)

Potassium lactate (cannot be the compound source for the foods for infants and young children)

Dipotassium hydrogen phosphate

Potassium chloride

Mg

Magnesium chloride

Magnesium carbonate

Magnesium oxide

Cu

Cupric sulphate

Se

Sodium selenite

Cr

Chromium trichloride

Chromium nicotinate

Chromium picolinate

Chromium yeast

Mo

Ammonium Molybdate

Sodium Molybdate Dihydrate

Mn

Manganese sulfate

Vitamin A

Vitamin A acetate

Vitamin A palmitate

β-carotene

β- Carotene

Vitamin D

Vitamin D2 (Ergocalciferol)

Vitamin D3 (Cholecalciferol)

Synthetic Vitamin E

DL-α- tocopheryl acetate

DL-α-tocopherol

Natural Vitamin E

Natural Vitamin E (D-α- tocopheryl acetate)

D-α- tocopherol

Natural Vitamin E (D-α-tocopheryl acid succinate)

Vitamin C

L- ascorbic acid

L-ascorbyl 6-palmitate

Sodium ascorbate

Calcium ascorbate

Vitamin B1

Thiamine hydrochloride

Vitamin B2

Riboflavin

Riboflavin-5’-phosphate, sodium

Vitamin B6

Pyridoxine hydrochloride

Vitamin B12

Cyanocobalamin

Pantothenic acid

D-pantothenate, calcium (cannot be the compound source for the foods for infants and young children)

Folic acid

Pteroylmonoglutamic acid (folic acid)

Choline

Choline bitartrate

Biotin

Biotin

Vitamin K

Vitamin K1 (Phylloquinone, plant menadione)

Niacin

Nicotinic acid (Niacin)

Nicotinamide

Nicotinamide

N/A

3. Management of imported nutrient supplements in China


After the new Food Safety Law was formally implemented from Oct. 1, 2015, the procedure for nutrient supplements entering Chinese market has been greatly simplified from rigorous registration system to filing system. Imported nutrient supplements are only required to be filed with SAMR before sale in Chinese market.

3.1 Qualification of the filing applicant

The applicant of imported nutrient supplements should be the legitimate holder of products and provide legal qualifications issued by local country.

3.2 Dossier requirements for filing of nutrient supplements

(1) Application form for health food filing;

(2) Qualification certificate of the applicant and its copies;

(3) Product formula, production process, labels, users’ directions, quality standard as well as the materials proving the product safety and health functions.

The following materials in addition to the materials mentioned above (except Item 2) as well as the following supplementary materials should be submitted for filing of imported health foods:

(1) Qualification certification of the applicant issued by the competent authority of the producing country (district) proving the applicant is the legal owner of listed products, and relevant valid period;

(2) The documents granted by relevant institutions in the producing country (district), proving the conformity of the manufacturer to relevant local production quality standards;

(3) Foreign manufacturers which are represented by a permanent representative office in China for registration purposes should provide the Registration Certificate for Permanent Chinese Representative Agency of Foreign Companies and its copies;

(4) The documents issued by the competent authority of the producing country (district) proving that the products have been sold for more than one year;

(5) Analytic report of overseas sales and consumer’s feedback on the products;

(6) Product standard of the producing country (district) or international organizations;

(7) Full item testing report of three batches of products issued by health food inspection institute;

(8) The samples of package, label and users‟ directions of the products used in producing country (district).

3.3 Testing of nutrient supplements

A full testing report generated from testing of three samples batches is also required for filing of nutrient supplements. The testing items have been simplified to only include hygiene test, stability test, and effective ingredients or iconic composition test.

Time scale for the testing items required for nutrient supplements

Testing item

Time scale

Hygiene testing

120 days

Stability testing

Testing on substances that characterize product

There are 58 testing agencies accredited by former CFDA. However in Oct 2017, China CFDA (former) unveiled the “Specification for Special Food Evaluation Technical Institution” , saying that any legally qualified food testing agency filed with the competent authority could provide the testing services to enterprises. 

3.4 Procedure for filing of imported nutrient supplements:

nutrient_supplements0313.png

3.5 Notify any changes in filed information

If there is any change to the filing information and product technical requirements, the applicant should submit relevant documentary evidence supporting the change, and provide new filing information to the original filing department. If the filing materials are legally relevant, the changes will be kept on record.

4. Labeling and packaging


The following information should be included on the label and user’s directions:

  • All the raw materials and additive materials

  • Active substances and corresponding contents

  • Claims (can only carry claims purporting to supplement normal vitamins and/or minerals intake)

  • Suitable and unsuitable groups

  • Intake amount and instruction for use

  • Product specification

  • Shelf life and product storage

Nutrient supplements should indicate “nutrient supplements” on the label and indicate “XX nutrient supplement” in the function item. Nutrition facts shall be indicated as nutrients based on the smallest serving unit;

There should be a declaration “the product is not a substitute for medicine”. Consumers should not exceed the recommended intake or should not be taken with other nutrient supplements of the same kind. Products subject to filing should further indicate that “this product has not been evaluated by CFDA”.

Tags : China