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CIRCULAR

PROMULGATING NATIONAL TECHNICAL REGULATION ON SUBSTANCES THAT MAY BE ADDED FOR IRON FORTIFICATION IN FOOD

THE MINISTER OF HEALTH

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006 and the Government's Decree No. 127/2007/ND-CP dated August 01, 2007 elaborating some Articles of the Law on Standards and Technical Regulations;

Pursuant to the Ordinance on Food Safety dated August 07, 2003 and Government's Decree No. 163/2004/ND-CP dated September 07, 2004 elaborating some Articles 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 the Director of the Vietnam Food Administration, the Director of the Science and Education Department and the Director of the Department of Legal Affairs,

HEREBY DECIDES:

Article 1. QCVN 3-3:2010/BYT – National technical regulation on substances that may be added for iron fortification in food is promulgated together with this Circular.

Article 2. This Circular comes into force from January 01, 2011.

Article 3. The Director of the Vietnam Food Administration, heads of units affiliated to the Ministry of Health, units affiliated to the Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities and relevant organizations and individuals are responsible for the implementation of this Circular./.

Foreword

QCVN 3-3:2010/BYT is developed by the Drafting Board for National technical regulation on micronutrient fortified food, submitted by the Vietnam Food Administration for approval and promulgated together with the Circular No. 16/2010/TT-BYT dated May 20, 2010 of the Minister of Health.

NATIONAL TECHNICAL REGULATION

ON SUBSTANCES THAT MAY BE ADDED FOR IRON FORTIFICATION IN FOOD

I. GENERAL

1. Scope

This National technical regulation (hereinafter referred to as the “document”) provides for specifications and regulatory requirements for quality, hygiene and safety of substances that may be added for iron fortification in food.

2. Regulated entities

This document applies to:

2.1. Importers, exporters, producers, traders and users of substances that may be added for iron fortification in food (hereinafter referred to as “entities”).

2.2. Relevant regulatory agencies.

3. Interpretation of terms and acronyms:

3.1. “substances that may be added for iron fortification in food” refer to those intentionally added to food for the purpose of iron fortification.

3.2. “International Pharmacopoeia 2006” refers to the International Pharmacopoeia that is developed by World Health Organization. Its fourth edition was published in 2006.

3.3. JECFA monograph 1 - Vol. 4: JECFA monographs 1 - Combined compendium - JECFA monograph 1 - Vol. 4 (JECFA monographs 1 - Combined compendium of food additive specifications; Joint FAO/WHO expert committee on food additives; Volume 4 - Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications; FAO, 2006) is developed by JECFA and was published by FAO in 2006.

3.4. “C.A.S number” (Chemical Abstracts Service) refers to registry numbers of chemical substances identified by the American Chemical Society.

3.5. “TS” stands for test solution.

3.6. “AsTS” stands for Test solution of suitable purity for use in the limit tests for arsenic.

3.7. “PbR” stands for reagent of suitable purity for use in the limit tests for lead.

3.8. “PbTS” stands for test solution of suitable purity for use in the limit tests for lead.

3.9. “R” stands for reagent.

3.10. “VS” stands for volumetric solution.

3.11. “ADI” stands for acceptable daily intake.

3.12. “INS” stands for international numbering system.

II. SPECIFICATIONS, TESTS AND SAMPLING

1. Specifications and tests for substances that may be added for iron fortification in food are provided in annexes to this document:

Annex 1: Specifications and tests for sodium iron (iii) ethylenediaminetetraacetate and trihydrate.

1.2. Annex 2: Specifications and tests for ferrous gluconate.

1.3. Annex 3: Specifications and tests for ferrous sulfate.

1.4. Annex 4: Specifications and tests for ferrous fumarate.

2. Sampling adheres to the guidelines in the Circular No. 16/2009/TT-BKHCN dated June 02, 2009 by the Ministry of Science and Technology and relevant regulations of law.

III. REGULATORY REQUIREMENTS

1. Declaration of conformity

Declarations of conformity of substances that may be added for iron fortification in food shall be submitted in accordance with regulations laid down in this document

1.2. Methods and procedures for submission of declarations of conformity shall comply with the Regulation on certification and declaration of conformity and conformance under the Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology and regulations of laws.

2. Inspection of substances that may be added for iron fortification in food

The quality, hygiene and safety of substances that may be added for iron fortification in food must be inspected in accordance with the regulations of law.

IV. RESPONSIBILITIES OF ENTITIES

1. Entities must declare conformity of substances that may be added for iron fortification in food with the specifications mentioned in this document, register their declarations of conformity at the Vietnam Food Administration and ensure the quality, hygiene and safety of such substances as declared.

2. Entities are only entitled to import, export, produce, sell and use substances that may be added for iron fortification in food as declared after their completion of registration of declarations of conformity and their compliance with regulations on quality, hygiene, safety and labeling.

V. IMPLEMENTATION

1. The Vietnam Food Administration shall take charge and cooperate with authorities concerned to provide guidance on and organize the implementation of this document.

2. The Vietnam Food Administration shall, according to its managerial duties, suggest amendments to this document to the Ministry of Health.

3. In the cases where any of the international guidelines for tests and regulations of law referred to in this document is amended or replaced, the newest one shall apply.

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