DECISION

PROMULGATING THE REGULATION ON ADDITION OF MICRONUTRIENTS TO FOOD

THE MINISTER OF HEALTH

Pursuant to the Government's Decree No. 49/ 2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government's Decree No. 86/ CP of December 8, 1995, on the assignment of state management responsibilities for goods quality:

At the proposal of the director of the Food Safety and Hygiene Department, the director of the Legal Department and the director of the Science and Training Department under the Ministry of Health,

DECIDES:

Article 1.- To promulgate together with this Decision the Regulation on addition of micronutrients to food.

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Article 3.-The director of the Office, the chief inspector, and the directors of the Science and Training Department and the Legal Department of the Ministry of Health: the director of the Food Safety and Hygiene Department, directors of provincial/municipal Health Services, and heads of units attached to the Ministry of Health shall implement this Decision.

FOR THE MINISTER OF HEALTH

VICE MINISTER

Tran Chi Liem

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REGULATION

ON ADDITION OF MICRONUTRIENTS TO FOOD

(Promulgated together with the Health Minister's Decision No. 6289/2003/QD-BYT of December 9, 2003)

Chapter I

GENERAL PROVISIONS

Article 1.- This Regulation governs the addition of micronutrients to food.

Article 2.- This Regulation applies to Vietnam-based producers, processors and traders of food added with micronutrients.

Article 3.- In this Regulation, the terms below are construed as follows:

1. Micronutrients include vitamins and minerals of a very small quantity (weighed in microgram or milligram) which are essential for the growth, development and maintenance of life of human bodies.

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Chapter II

REQUIREMENTS ON MICRONUTRIENTS AND SOME KINDS OF FOOD TO BE ADDED WITH MICRONUTRIENTS

Article 4.- Micronutrients to be added to food are subject to state inspection of their quality, hygiene and safety.

Article 5.- Micronutrients to be added to food must satisfy the following conditions:

1. Not affecting the nature of food (color, smell, taste, structure or processing characteristics):

2. Not reducing products* use duration.

Article 6.-

1. The addition of micronutrients to food must comply with regulations applicable to each kind of food:

a/ Baby food must comply with the regulations in Appendix 1.

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c/ Wheat flour must comply with the regulations in Appendix 3.

d/ Cooking oil must comply with the regulations in Appendix 4.

e/ Edible sugar must comply with the regulations in Appendix 5.

2. The addition of vitamins and minerals to
baby food and wheat flour must comply with the regulations in Appendix 6.

Chapter III

REQUIREMENTS ON PRODUCERS. PROCESSORS AND TRADERS OF FOOD ADDED WITH MICRONUTRIENTS

Article 7.- Before putting products into circulation on the market, producers, processors and traders of food added with micronutrients shall carry out procedures for food quality, hygiene and safety standard announcement with the Ministry of Health (the Food Safety andl Hygiene Department).

Article 8.- Producers and processors of food added with micronutrients shall satisfy food hygiene and safety conditions specified by law.

Establishments producing and processing food added with micronutrients are encouraged to apply Hazard Analysis and Critical Control Points (HACCP) or Good Manufacture Practices

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Article 9.- Producers and processors of food added with micronutrients are responsible for the quality, hygiene and safety of their food products and shall conduct periodical inspectionsaccording to regulations to ensure the quality and quantity of micronutrients as announced.

Chapter IV

REQUIREMENTS ON LABELING. PACKING. PRESERVATION AND TRANSPORTATION OF FOOD ADDED WITH MICRONUTRIENTS

Article 10.- The labeling of products must comply with the Prime Minister's Decision No. 178/1999/QD-TTg of August 30. 1999. promulgating the Regulation on labeling of domestically circulated, imported and exported goods, and guiding legal documents. In addition, a product label must bear the phrase "Thuc pham bo sung vi chat dinh duong " (Food added with micronutrients).

Article 11.- Containers of food added with micronutrients must ensure food hygiene and safety so as not to denature the food, and suit preservation and transportation conditions.

Article 12.- The preservation and transportation of food added with micronutrients must satisfy food hygiene and safety conditions prescribed by law and must not reduce the quantity of micronutrients in food.

Chapter V

EXAMINATION, INSPECTION, AND HANDLING OF VIOLATIONS

Article 13.-

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2. Provincial/municipal Health Services shall coordinate with concerned agencies in examining and inspecting the implementation of this Regulation in their localities.

Article 14.- Organizations or individuals that violate this Regulation shall, depending on the nature and severity of their violations, be administratively handled or examined for penal liability and. if causing damage, pay compensation therefor in accordance with law.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 15.-

1. Producers, processors and traders of food added with micronutrients shall implement this Regulation.

2. The Food Safety and Hygiene Department shall assume the prime responsibility for, and coordinate with functional Departments and Bureaus under the Ministry' of Health, the National Institute of Nutrition and concerned agencies in. guiding and directing the implementation of this Regulation.

3. Provincial/municipal Health Services shall organize the implementation of this Regulation in their localities.

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APPENDIX 1

REGULATIONS ON ADDITION OF MICRONUTRIENTS TO BABY FOOD

Baby food means additional food for infants aged 6 months or older, which are produced from such main cereals as rice, wheat, soybeans, green peas and powdered milk, added with vitamins and minerals in a quantity estimated to satisfy around 30-50% of daily needs of infants.

Added substances

Content/100 Kcal

Minimum

Maximum

1. Vitamin A (RE)

250 IU

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2. Vitamin D

40 IU

80 IU

3. Vitamin C

8 mg

40 mg

4. Vitamin Bl

40 mg

200 mg

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60 mg

300 mg

6. Folic acid

4 mg

20 mg

7. Vitamin B12

0.15 mg

1.5 mg

8. Vitamin K

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40 mg

9. Calcium (Ca)

50 mg

250 mg

10. Iron (Fe)

0.5 mg

2.5 mg

11. Zinc (Zn)

0.3 mg

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APPENDIX 2

REGULATIONS ON ADDITION OF IRON TO FISH SAUCE

Usable form of iron: NaFeEDTA Added dose:

- Minimum: 30 mg of element iron/100 ml of fish sauce

- Maximum: 50 mg of element iron/100 ml of fish sauce Allowable NaFeEDTA standard:

Scientific name: Sodium Iron (III) Ethylene Daminte Tra Acetate, trihydrate Chemical formula: C₁0H₁₂,FeN_2:NaO3, 3H₂0

Molecular weight: 421,09 (trihydrate)

Characteristics

Allowable content

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12.5 - 13.5%

EDTA component

65.5 - 70.5%

pH of 1%-solution

3.5-5.5

Water-Insoluble rate

Maximum 0.1%

Nitrilotriacetic acid

< 0.1 %

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Maximum 1 mg/kg

Lead (Pb)

Maximum 1 mg/kg

Purity: according to JECFA standard.

APPENDIX 3

REGULATIONS ON ADDITION OF MICRONUTRIENTS TO WHEAT FLOUR

Added substances

Added quantity

1. Iron (Fe)

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2. Zinc (Zn)

30 mg/kg

3. Thiamine (vitamin Bl)

2.5 mg/kg

4. Riboflavin (vitamin B2)

4 mg/kg

5. Folic acid

2 mg/kg

APPENDIX 4

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Usable form of vitamin A: vitamin A palmitate Added dose:

- Minimum: 50 IU/gram of oil

- Maximum: 100 IU/gram of oil Preservation conditions:

- Cooking oil added with vitamin A must be preserved in colored cans to avoid direct sunlight.

- 50% of the quantity of vitamin A can be preserved within 6-9 months.

APPENDIX 5

REGULATIONS ON ADDITION OF VITAMIN A TO EDIBLE SUGAR

Usable form of vitamin A: vitamin A palmitate Added dose:

- Minimum: 15 mg/gram of sugar

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- Sugar added with vitamin A must be preserved in airtight boxes to avoid direct sunlight.

- 50% of the quantity of vitamin A can be preserved within 6 months.

APPENDIX 6

REGULATIONS ON ADDITION OF VITAMINS AND MINERALS TO BABY FOOD AND FLOUR

Vitamin

Form of vitamin

Purity

1. Vitamin A

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USP, BP. Ph.Eur, FCC

USP, BP, Ph.Eur. FCC

USP. BP. Ph.Eur. FCC FAO/WHO. FCC

2. Vitamin D

Ergocalciferol (vitamin D2) Cholecalciferol (vitamin. D3)

USP. BP. Ph.Eur. FCC USP. FCC

3. Vitamin C

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USP. BP. Ph.Eur FAO/WHO. FCC USP. FAOAVHO. FCC

4. Vitamin Bl

Thiamine chloride hydrochloride

Thiamine mononitrate

USP. BP, Ph.Eur, FCC-US P. FCC

5. Vitamin B2

Riboflavin

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USP. BP. Ph.Eur. FAO/WHO. FCC

6. Folic

Folic acid

USP. BP

7. Vitamin B12

Xyanocolbalamin Hydroxocobalamin

USP. BP. Ph.Eur NT, BP

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8. Vitamin K

Phytylmenaquinone

USP. BP

9. Calcium (Ca) sources

Calcium carbonate

FCC, FAO/WHO

Calcium citrate

FCC. FAO/WHO

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Calcium lactate

FCC. FAO/WHO

Calcium phosphate, tribasic

FCC. FAO/WHO

10. Iron (Fe)

Ferrous fumate

FCC

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FCC. FAO/WHO

Ferrous lactate

MI

Ferrous sulfate

FCC

11. Zinc <ZN) sources

Zinc acetate

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Zinc oxide

MI

Zinc sulfate

FCC

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Notes:

- USP: United States Pharmacopoeia

- NF: United States National Formulary

- BP: British Pharmacopoeia

- BPC: British Pharmaceutical Codex

- Ph.Eur: European Pharmacopoeia

- MI: Merck Index

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- DAB: Deutsches Arzneibuch 7

- FCC: Food Chemicals Codex.-