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.

Thông tư 18/2011/TT-BYT về Quy chuẩn kỹ thuật quốc gia đối với thực phẩm bổ sung vi chất dinh dưỡng do Bộ trưởng Bộ Y tế ban hành