Food Supplement Regulation of China – Vitamins and Minerals list compared to EU

 

Thanks as usual to my guest writer KUN HOU (kunhou2016@gmail.com) for the valuable insights of China. This comparative article will be most useful to many readers.

Regulations concerning the nutrients used as ingredients of food supplements are under constant change and revision in China.

CFDA put forward its first official positive list of vitamins and minerals that might be present in food supplements in the beginning of 2016.

The list has not come into force yet and it is slightly different from the current rules which were brought into effect in 2005 by then SFDA.

Before the list is legally introduced, let’s look at first how the rules for vitamins and minerals differ between China and EU presently. It will help international food supplements manufacturers gain a clearer clue on Chinese regulation and avoid pitfalls when exporting vitamin and minerals supplements to China.

Vitamins and Minerals in General

Name CN EU
Minerals Ca Calcium
Mg Magnesium
K Potassium
Fe Iron
Zn Zinc
Se Selenium
Cr3+ Chromium
Cu Copper
Mn Mangnese
Mo Molybdenum
Lodine
Sodium
Fluoride
Chloride
Phosphorus
Vitamins Retinol Equivalent(Vitamin A or Vitamin A+b-Carotene) Vitamin A
Vitamin C Vitamin C
Vitamin D Vitamin D
Vitamin E Vitamin E
Vitamin k Vitamin k
Vitamin B1 Vitamin B1
Vitamin B2 Vitamin B2
Vitamin PP Niacin Niacin
Niacinamide
Vitamin B6 Vitamin B6
Vitamin B12 Vitamin B12
Folic acid Folic acid
Pantothenic acid Pantothenic acid
Biotin Biotin
b-Carotene
Choline

 

Mineral Substances

Name CN EU
Ca Calcium carbonate Calcium carbonate
Calcium chloride Calcium chloride
Calcium gluconate Calcium gluconate
Calcium lactate Calcium lactate
Calcium glycerol phosphate Calcium glycerophosphate
Calcium malata
Calcium monophosphate
(Calcium phosphate,Secondary)
Calcium phosphate,monobasic
(Calcium phosphate,Primary)
Calcium phosphates
Calcium sulfate
CalciumLascorbate
Calcium acetate
Calcium caseinate
Calcium citrate
Calcium citrate malate
Calcium salts of citric acid
Calcium salts of orthophosphoric acid
Calcium hydroxide
Calcium oxide

 

 

Name CN EU
Mg Magnesium carbonate Magnesium carbonate
Magnesium chloride Magnesium chloride
Magnesium gluconate Magnesium gluconate
Magnesium lactate Magnesium lactate
Magnesium glycerol phosphate Magnesium glycerophosphate
Magnesium citrate
Magnesium phosphate,dibasic
Magnesium phosphates
  Magnesium acetate
Magnesium salts of citric acid
Magnesium salts of orthophosphoric acid
Magnesium hydroxide
Magnesium oxide
Magnesium sulphate

 

 

Name CN EU
Fe Ferric carbonate Ferrous carbonate
Ferrous citrate Ferrous citrate
Ferrous fumarate Ferrous fumarate
Ferrous gluconate Ferrous gluconate
Ferrous sulfate Ferrous sulphate
Ferrous lactate Ferrous lactate
Ferric pyrophosphate Ferric diphosphate (ferric pyrophosphate)
Ferric ammonium citrate
Ferric chloride
Ferric citrate
Heme iron(Ferrous porphyrin)
Hemin (ferriheme)
Ferrous succinate
Ferric ammonium citrate
Ferric sodium diphosphate  
Ferric saccharate
Elemental iron (carbonyl+electrolytic+hydrogen reduced)

 

 

 

 

 

Name CN EU
Copper Copper carbonate Cupric carbonate
Copper citrate Cupric citrate
Copper gluconate Cupric gluconate
Copper sulfate Cupric sulphate
Copper lysine complex

 

 

Name CN EU
Potassium Potassium carbonate Potassium carbonate
Potassium chloride Potassium chloride
Potassium citrate Potassium citrate
Potassium gluconate Potassium gluconate
Potassium lactate Potassium lactate
Potassium glycerol phosphate Potassium glycerophosphate
Potassium phosphate dibasic  
Potassium Sulphate
Potassium iodide
Potassium iodate
Potassium bicarbonate
Potassium hydroxide
Potassium salts of orthophosphoric acid
Potassium fluoride

 

 

Name CN EU
Zinc Zinc acetate Zinc acetate
Zinc carbonate Zinc carbonate
Zinc chloride Zinc chloride
Zinc citrate Zinc citrate
Zinc gluconate Zinc gluconate
Zinc lactate Zinc lactate
Zinc sulfate Zinc sulphate
Zinc oxide Zinc oxide

 

 

 

Name CN EU
Manganese Manganese sulphate Manganese sulphate
Manganese gluconate Manganese gluconate
Manganese chloride Manganese chloride
Manganese citrate Manganese citrate
Manganese glycerol phosphate Manganese glycerophosphate
Manganese carbonate

 

 

Name CN EU
Chromium Chromium trichloride Chromium (III) chloride
Chromium nicotinate
Chromium picolinate
Chromium yeast
Chromium (III) sulphate

 

 

 

Name CN EU
Molybdenum Ammonium Molybdate Ammonium molybdate (molybdenum (VI))
Sodium Molybdate Dihydrate Sodium molybdate (molybdenum (VI))

 

 

 

Name CN EU
Selenium Sodium selenate Sodium selenate
Sodium selenite Sodium selenite
Selenium carrageenan  
Selenium cysteine
Seleniumrich yeast
Selenomethionine
Sodium hydrogen selenite

 

Vitamin Substances

 

Name CN EU
VITAMIN A All trans Retinol Retinol
Vitamin A acetate Retinyl acetate
Retinyl palmitate Retinyl palmitate
All trans beta—Carotene Beta-carotene

 

 

Name CN EU
VITAMIN D Vitamin D2 Ergocalciferol
Vitamin D3 Cholecalciferol

 

 

Name CN EU
VITAMIN E D—alpha—tocopherol D-alpha-tocopherol
DL—alpha—tocopherol DL-alpha-tocopherol
DL—alpha tocopheryl acetate D-alpha-tocopheryl acetate
D—alpha—tocopheryl acid succinate D-alpha-tocopheryl acid succinate
Mixed tocopherols  
Dalphatocopheryl acetate
DL-alpha-tocopheryl acetate

 

 

Name CN EU
VITAMIN K Vitamin K1(Phytonadione)  
Vitamin K2(Menaquinones)
  Phylloquinone (phytomenadione)

 

Name CN EU
VITAMIN B1 Thiamin hydrochloride Thiamin hydrochloride
  Thiamin mononitrate Thiamin mononitrate

 

Name CN EU
VITAMIN B2 Riboflavin Riboflavin
Riboflavin—5’—phosphate,sodium Riboflavin 5’-phosphate, sodium

 

 

 

Name CN EU
NIACIN Nicotinic acid Nicotinic acid
Nicotinamide Nicotinamide

 

 

Name CN EU
PANTOTHENIC ACID D—pantothenate,sodium D-pantothenate, sodium
D—pantothenate,calcium D-pantothenate, calcium
Pantothenic Acid
Calcium pantothenate
Dpanthenol
  Dexpanthenol

 

Name CN EU
VITAMIN B6 Pyridoxine hydrochloride Pyridoxine hydrochloride
  Pyridoxine 5’—phosphate Pyridoxine 5’-phosphate

 

 

Name CN EU
FOLIC ACID Pteroylmonoglutamic acid (Folic Acid) Pteroylmonoglutamic acid

 

 

Name CN EU
VITAMIN B12 Cyanocobalamin (Vitamin B12) Cyanocobalamin
  Hydroxocobalamin Hydroxocobalamin

 

Name CN EU
BIOTIN D—biotin D-biotin

 

Name CN EU
VITAMIN C L—ascorbic acid L-ascorbic acid
  Calcium—L—ascorbate Calcium-L-ascorbate
  Potassium—L—ascorbate Potassium-L-ascorbate
  Sodium—L—ascorbate Sodium-L-ascorbate
  Ascorbyl palmitate
  L-ascorbyl 6-palmitate

 

FDA Releases Final Guidance for Voluntary Qualified Importer Program

The U.S. Food and Drug Administration is announcing final guidance for industry for a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. The final guidance is in question-and-answer format to explain how this program will work.

In particular the document address the following points:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

The Food Safety Modernization Act (FSMA), indeed, required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see FDA’s third-party certification regulations at 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

Speaking of benefits for companies, they will be the following:

• FDA will expedite entry into the United States for all foods included in an approved VQIP application (VQIP foods). FDA will set screening in its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of food which are the subject of an approved VQIP application to expedite the entry of such food. The system is designed to recognize the information and release the shipment immediately after the receipt of entry information, unless examination and sampling are necessary for public health reasons. (See Question A.5.)

• FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP. (See Question A.5.)

• In the examination and/or sampling circumstances identified in the previous bullet, FDA will attempt, to the extent possible, to examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.

• FDA will expedite its laboratory analysis of “for cause” or audit samples of VQIP entries, to the extent possible in accordance with public health priorities.

• FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document. The VQIP Importers Help Desk will be available for assistance with completing the VQIP application and facilitating review of VQIP food that does not receive an immediate release.

• FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP Web page. VQIP importers may choose not to be listed on the VQIP importers list. A VQIP importer’s decision to opt out of being listed on the publicly available list of approved VQIP importers will not have any effect on its participation.

Additional Information