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THE MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 18/2011/TT-BYT
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Hanoi, May 30, 2011
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CIRCULAR
PROMULGATING NATIONAL TECHNICAL REGULATION ON MICRONUTRIENT
FORTIFIED FOOD
THE MINISTER OF HEALTH
Pursuant to the Law on
Technical Regulations and Standards dated June 29, 2006 and the Government's
Decree No. 127/2007/ND-CP dated August 01, 2007 on elaboration of some Articles
of the Law on Technical Regulations and Standards;
Pursuant to the
Ordinance on Food Safety dated August 07, 2003 and Government’s Decree No.
163/2004/ND-CP dated September 07, 2004 on elaboration of the Ordinance on Food
Safety;
Pursuant to the
Government’s Decree No. 188/2007/ND-CP dated December 27, 2007 defining
functions, tasks, powers and organizational structure of the Ministry of
Health;
At the request of
Director General of Vietnam Food Administration, Director General of Science
and Education Department and Director General of Department of Legal Affairs.
HEREBY DECIDES:
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QCVN 9-2:2011/BYT
National technical regulation on micronutrient fortified food.
Article
2. This Circular comes into force from December 01, 2011.
Article
3. Director General of Vietnam Food Administration,
heads of units owned by and affiliated to the Ministry of Health; Directors of
Departments of Health of provinces and central-affiliated cities and
organizations and individuals concerned are responsible for the implementation of
this Circular.
PP. THE MINISTER
THE DEPUTY MINISTER
Trinh Quan Huan
Foreword
QCVN 9-2:2011/BYT is
developed by the Drafting Committee for National technical regulation on
micronutrient fortified food, submitted by the Vietnam Food Administration
for approval and promulgated together with the Circular No. 18/2011/TT-BYT
dated May 30, 2011 of the Minister of Health.
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NATIONAL TECHNICAL REGULATION ON MICRONUTRIENT FORTIFIED
FOOD
I.
GENERAL PROVISIONS
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for technical and managerial requirements for fortification of food
with micronutrients.
2. Regulated entities
This Regulations applies
to:
2.1. Importers,
exporters, producers and traders of micronutrient fortified food.
2.2. Relevant regulatory
bodies.
3. Definitions and
abbreviations:
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3.2. KQĐ means
Unspecified.
II.
TECHNICAL REQUIREMENTS
1. Technical
requirements applicable to micronutrient fortified fish sauce
- Micronutrient fortified
fish sauce must satisfy the technical requirements applicable to fish sauce
laid down in the corresponding Regulation or relevant regulations of law.
- Type and content of the
micronutrient for fish sauce fortification are specified as follows:
Micronutrient
Content
(mg/100ml)
Substance added
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Maximum
Iron (Fe)
30,0
50,0
- EDTA iron(III) sodium
salt hydrate.
(Characteristics of
EDTA iron(III) sodium salt hydrate are specified in QCVN 3-3:2010/BYT).
- Ferrous sulfate,
Ferrous fumarate
2. Technical
requirements applicable to micronutrient fortified flour
- Micronutrient fortified
flour must satisfy the technical requirements applicable to flour laid down in the
corresponding Regulation or relevant regulations of law.
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Micronutrient
Content (mg/kg)
Substance added
Minimum
Maximum
Iron (Fe)
27,80
51,60
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(Characteristics of
ferrous sulfate are specified in QCVN 3-3:2010/BYT).
Zinc (Zn)
70,90
131,70
Zinc oxide
(Characteristics of
Zinc oxide are specified in QCVN 3-1:2010/BYT).
Vitamin A
1,33
4,80
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Vitamin B12
0,02
KQĐ
Cyanocobalamin
(solubility in water: 0,1%)
(Characteristics of
Cyanocobalamin are specified in Vietnamese Pharmacopoeia)
Folic acid
2,04
8,16
Folic acid
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3. Technical
requirements applicable to micronutrient fortified edible oil
- Micronutrient fortified
edible oil must satisfy the technical requirements applicable to edible oil
laid down in the corresponding Regulation or relevant regulations of law.
- Type and content of the
micronutrient for edible oil fortification are specified as follows:
Micronutrient
Content (mg/100g)
Substance added
Minimum
Maximum
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2,75
5,50
Retinyl palmitate
4. Technical requirements
applicable to micronutrient fortified sugar
- Micronutrient fortified
sugar must satisfy the technical requirements applicable to sugar laid down in
the corresponding Regulation or relevant regulations of law.
- Type and content of the
micronutrient for sugar fortification are specified as follows:
Micronutrient
Content (mg/kg)
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Minimum
Maximum
Vitamin A
15,0
30,0
Retinyl palmitate
III.
TEST METHODS AND SAMPLING
1. Test methods
The micronutrients specified
in this Regulation may be tested using the following methods or equivalent
methods:
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1.2. Zinc: determined
according to AOAC 999.11: Lead, Cadmium, Copper, Iron, and Zinc in foods Atomic
Absorption Spectrophotometry after dry ashing;
1.3. Vitamin B1:
determined according to AOAC 957.17: Thiamine (Vitamin B1)
Fluorometric method;
1.4. Vitamin B2: determined
according to AOAC 970.65: Riboflavin (Vitamin B2) in foods and
vitamin preparations fluorometric method;
1.5. Vitamin A:
determined according to AOAC 2002.06: Retinyl palmitate (Vitamin A) in
Fortified fluid milk – Liquid chromatography;
1.6. Folic acid:
determined according to AOAC 992.05: Total folate (Pteroylglutamic acid) in
Infant formula – Microbiological methods.
2. Sampling:
Sampling shall comply
with the guidance specified in the Circular No. 16/2009/TT-BKHCN dated June 02,
2009 of the Ministry of Science and Technology and other relevant regulations
of law.
IV.
MANAGERIAL REQUIREMENTS
1. Labeling
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- In addition, the
Vietnamese text: “Thực phẩm bổ sung vi chất dinh dưỡng” (“Micronutrient
fortified food”) must be written on the product label.
2. Declaration of
conformity
Conformity of
micronutrient fortified food shall be declared in accordance with regulations
of this document.
1.2. Conformity
declaration procedures and methods shall comply with the Regulation on
certification of standard conformity, certification of technical-regulation
conformity, declaration of standard conformity and declaration of
technical-regulation conformity enclosed with the Decision No. 24/2007/QD-BKHCN
dated September 28, 2007 of the Minister of Science and Technology and
regulations of law.
3. Inspection of
micronutrients for food fortification
The inspection of quality
and safety of micronutrient fortified food shall be conducted in accordance
with regulations of law.
IV. RESPONSIBILITIES OF
ORGANIZATIONS AND INDIVIDUALS
1. Producers of micronutrient fortified food are only allowed
to fortify each certain type of food with micronutrients and substances in
accordance with this Regulation.
2. Producers, importers and traders of micronutrient
fortified food must declare conformity in accordance with the technical
requirements set forth in this Regulation, apply for the declaration of
conformity at the Vietnam Food Administration and ensure quality and safety of
such food as declared.
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V. ORGANIZATION OF
IMPLEMENTATION
1. The Vietnam Food Administration is assigned to preside
over and cooperate with relevant competent authorities in providing guidelines
for and organize the implementation of this Regulation.
2. According to managerial requirements, the Vietnam Food
Administration shall propose amendments to this Regulation to the Ministry of
Health.
3. If international guidance on test methods, standards and
regulations referred to in this Regulation are amended or replaced, the newest
ones shall prevail.