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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. 16/2010/TT-BYT
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Hanoi, May 20, 2010
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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:
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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./.
PP. THE MINISTER
THE DEPUTY MINISTER
Trinh Quan Huan
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.
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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:
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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.
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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
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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.
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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.