THE MINISTRY OF
HEALTH
|
SOCIALIST
REPUBLIC OF VIETNAM Independence
- Freedom - Happiness
|
No.
6289/2003/QD-BYT
|
Ha
noi, December 9, 2003
|
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,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.
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.-