| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness |
| No. 6289/2003/QD-BYT | Ha noi, December 9, 2003 |
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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ON ADDITION OF MICRONUTRIENTS TO FOOD
(Promulgated together with the Health Minister's Decision No. 6289/2003/QD-BYT of December 9, 2003)
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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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.
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.
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.
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.
EXAMINATION, INSPECTION, AND HANDLING OF VIOLATIONS
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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.
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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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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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,FeN2: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.
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
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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.
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.
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.-
File gốc của Decision No. 6289/2003/QD-BYT of December 9, 2003, promulgating the regulation on addition of micronutrients to food. đang được cập nhật.
Decision No. 6289/2003/QD-BYT of December 9, 2003, promulgating the regulation on addition of micronutrients to food.
Tóm tắt
| Cơ quan ban hành | Bộ Y tế |
| Số hiệu | 6289/2003/QD-BYT |
| Loại văn bản | Quyết định |
| Người ký | Trần Chí Liêm |
| Ngày ban hành | 2003-12-09 |
| Ngày hiệu lực | 2008-09-06 |
| Lĩnh vực | Thể thao - Y tế |
| Tình trạng | Hết hiệu lực |