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

 

New Rules of Registration and Filing of Food Supplements in China

Today I publish an excellent new article from our food contributor from China: regulatory specialist and former food law advisor for the Food and Drug Administration of Beijing Kun Hou. Hopefully it will be the first of a new series about food supplements Chinese market and regulations.

The food supplements market in China has become a diamond mine and its market value is estimated to have reached RMB 1 trillion in 2015 and it’s still growing with a continuous 20% pace annually regardless of the dim GDP growth in China. The 12th Five-year Food Industry Development Plan issued by the National Development and Reform Commission has lifted the food supplements manufacturing business to a national strategy yet the market maturity and consumer consciousness are still to be developed and nurtured.

I myself handled dozens of cases when I was in FDA of Beijing. Many senior citizens in Beijing aged 60 to 75 filed reports concerning food supplements violations, food fraud, false propaganda and other problems on a daily basis. The number of people who feel they have been deceived of the quality increases every day, so as the market value, which shows exactly how strong the market is. Seniors aged over 60 in Beijing get up early to attend meetings held in some hotel at 5 am. Of course they are lured and just curious to see what the offer is at the very beginning. It all ends up with them paying a great sum of money for some food supplements which claim to be healthy or even cancer-preventing yet of no functional values. When they go back home and several days later they start to realize that what they bought is not what they want. They go to FDA with a receipt that provides limited clue and FDA can do ‘nothing’ because they think it’s a guerrilla war they can never win. Those who sell food supplements in China like PERFECT and INFINITUS mostly among friends and relatives are still disliked by people around them. What’s more intriguing is that so many people still cry in their heart for high-quality food supplements which can earn their fundamental trust with a grandeur brand image. So the affluent ask their friends or children to buy it in a foreign country and carry with them overseas. The environment pollution and the food crisis have further implanted a distrust in people’s mind which will need decades to be uprooted.

A Few Tips on the Regulation

The Regulation on the Registration and Filing of Food Supplements in China has just come into force on 1st July 2016.

Food supplements first imported into China mainland excluding those vitamins and minerals food supplements shall be registered by CFDA. By first imported, it means food supplement produced by the same manufacturer from the same country using the same formula. Any food supplement which does not fulfill the three conditions simultaneously shall be deemed food supplements first imported into China mainland and thus needs to be registered. For vitamins and minerals food supplements, filing is required instead of registration. Both the registration and filing shall be initiated by the manufacturer itself. Difference however exists between the two process. Registration shall be conducted by a resident representative in China or an agent located in China. Such requirement does not apply to filing, which means the manufacturer can do this all by himself.

Here I will give a brief introduction on the filing of food supplements and I will leave the registration in a subsequent article which will also feature some comparison between the FS regulations of China and EU&UK.

Basic Requirements

(1)The nutrients of vitamins and minerals shall fall within the category of Ingredients Catalogue of Food Supplements;

(2)The product formula, the name and usage of the raw and supplementary ingredients, efficacy, manufacturing technique, etc shall be in conformity to Chinese laws, regulations, compulsory standards and the technical requirements of Ingredients Catalogue of Food Supplements;

Required Filing Materials

(1) Material of the product formula including the name and usage of the raw and supplementary ingredient, manufacturing technique and quality standard; when it becomes necessary, more materials have to be submitted to demonstrate the provisions according to which the raw material is being used, specifications concerning which part of the raw ingredient has been used, inspection certificate and variety identification;

(2) Introduction to the manufacturing process including production diagram and specification, the critical controlling point and illustration;

(3) Material of the assessment for the safety and nutrition function appraisal including the test material for the ingredients, products excluded by the Ingredients Catalogue of Food Supplements and appraisal material of human consumption; test report of the effective composition or primary composition, hygiene, steadiness, bacteria identification and toxicity; test report of stimulant, prohibited medicine component,etc;

(4) The type, name and relevant standards of the package material that directly contact the food;

(5) Template of the product label and instructions; search material proving that the general name of the product does not contradict the name of a registered drug;

(6) Filing form and undertaking paper of the authenticity of the materials submitted;

(7) Copy of the registration certificate of the company who initiates the filing;

(8) Materials of the technical requirements for the products;

(9) Full-item inspection report issued by a legally qualified institution;

(10) Other materials showing the safety and nutrition function of the products;

(11) Witness statement issued by competent government authorities or legal service providers showing that the applicant is the legal manufacturer the marketed food supplement;

(12) Witness letter issued by competent government authorities showing that the product has been in circulation for at least one year or safety report about the sales of the product and human consumption;

(13) Technical regulations or standards of the country/region where the product has been manufactured or of the international organization;

(14) The actual version of the package, label and instruction of the product in the country where it has been manufactured and circulated;

(15) Registration certificate or business license if the application is been conducted by a resident representative in China or an agent located in China.

The saddest thing in China is the power of law does not always exercise as what is stated in agreed terms. So never assume something is predictable just because it is written on paper. The government has so many that need further and absolute disclosure. Under most circumstances, what kills a cat is not curiosity, it’s opacity. Nevertheless I still believe openness and sharing will ease the way of food circulation around the world.