Decision No. 6289/2003/QD-BYT on issuing "Supplementary Nutrient Fortification in Food"

Pursuant to …;

Regarding the issuance of "Regulations on Supplementing Micronutrients to Food"

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/ND-CP dated May 15, 2003 of the Government on the Provision of Functions, Tasks, Authorities, and Organizational Structure of the Ministry of Health;

Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government on the Allocation of Responsibilities for State Management of Product Quality;

At the proposal of the Director of the Food Safety Agency, the Head of the Legal Department, and the Head of the Science and Training Department of the Ministry of Health,

Pursuant to …;

Article 1. Issued along with this Decision are "Regulations on Supplementing Micronutrients to Food".

Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 3. The Heads of the Office, Inspectorate, and Departments of Science and Training, Legal Affairs of the Ministry of Health; Directors of the Food Safety and Control Bureau; Directors of Health Departments of provinces and centrally-administered cities; and Heads of units under the Ministry of Health shall be responsible for implementing this Decision.

REGULATIONS

Supplementing Micronutrients to Food
(issued together with Decision No. 6289/2003/QD-BYT dated December 9, 2003 of the Minister of Health)

PART I
GENERAL PROVISIONS

Article 1. These regulations govern the supplementation of micronutrients to food.

Article 2. These regulations apply to organizations and individuals producing, processing, and trading food supplemented with micronutrients in Vietnam.

Article 3. In these regulations, the following terms are understood as follows:

1. Micronutrients are vitamins and minerals with very small amounts (measured in micrograms or milligrams) necessary for growth, development, and maintenance of human life.

2. Supplementing micronutrients to food means adding a certain amount of one or more micronutrients to food.

Chapter II
REQUIREMENTS FOR MICRONUTRIENTS AND CERTAIN TYPES OF FOOD SUPPLEMENTED WITH MICRONUTRIENTS

Article 4. Sources of micronutrients used to supplement food must be subject to state inspection for quality and safety.

Article 5. Micronutrients added to food must meet the following conditions:

1. Not affecting the characteristics of the food (color, smell, taste, structure, processing features).

2. Not reducing the shelf life of the product.

Article 6.

1. The supplementation of micronutrients to food must comply with the provisions for each type of food:

a. Infant nutrition powder as stipulated in Appendix 1;

b. Fish sauce as stipulated in Appendix 2;

c. Wheat flour as stipulated in Appendix 3;

d. Edible oil as stipulated in Appendix 4;

e. Sugar as stipulated in Appendix 5;

2. The addition of vitamins and minerals to infant nutrition powder and wheat flour must be carried out according to the provisions in Appendix 6.

Chapter III
REQUIREMENTS FOR ORGANIZATIONS AND INDIVIDUALS PRODUCING, PROCESSING, AND TRADING FOOD SUPPLEMENTED WITH MICRONUTRIENTS

Article 7. Organizations and individuals producing, processing, and trading food supplemented with micronutrients must complete procedures to announce food quality and safety standards with the Ministry of Health (Food Safety and Control Bureau) before circulating products on the market.

Article 8. Organizations and individuals producing and processing food supplemented with micronutrients must ensure food safety and hygiene conditions as prescribed by law.

It is encouraged to apply the Hazard Analysis and Critical Control Points (HACCP) system or Good Manufacturing Practices (GMP) at production and processing facilities for food supplemented with micronutrients.

Article 9. Organizations and individuals producing and processing fortified food must be responsible for the quality and safety of their products and organize regular self-inspection in accordance with regulations to ensure the quality and content of the nutrients as declared.

Chapter IV
REQUIREMENTS FOR LABELING, PACKAGING, STORAGE AND TRANSPORTATION OF FORTIFIED FOOD

Article 10. Labeling of products must comply with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister on the issuance of the Labeling Regulation for goods circulating domestically and exported/imported goods; and guiding legal documents implementing this Regulation. Additionally, the product label must include the phrase in Vietnamese "Fortified Food".

Article 11. Packaging containing fortified food must ensure hygiene and safety for the food, not alter the nature of the food; it must be suitable for storage conditions and transportation.

Article 12. Storage and transportation of fortified food must ensure hygiene and safety conditions for food as prescribed by law and must not reduce the amount of nutrients in the food.

Chapter V
INSPECTION, AUDIT AND VIOLATION HANDLING

Article 13.

1. The Food Safety Agency shall take the lead and coordinate with the Ministry of Health's Inspectorate, relevant Departments and Agencies under the Ministry of Health, and related agencies to organize inspections and audits of the implementation of this Regulation nationwide.

2. Provincial Health Services under centrally governed cities shall cooperate with related agencies to organize inspections and audits of the implementation of this Regulation within their respective jurisdictions.

Article 14. Organizations and individuals violating this Regulation will be subject to administrative penalties or criminal prosecution, depending on the nature and severity of the violation, and if damage is caused, they must compensate according to the provisions of the law.

Chapter VI
IMPLEMENTING PROVISIONS

Article 15.

1. Organizations and individuals producing, processing, and trading in fortified food have the responsibility to implement this Regulation.

2. The Food Safety Agency shall take the lead and coordinate with relevant Departments and Agencies under the Ministry of Health, the Institute of Nutrition, and related agencies to guide and direct the implementation of this Regulation.

3. Provincial Health Services under centrally governed cities shall organize the implementation of this Regulation within their respective jurisdictions.