Decision No. 3616/2004/QD-BYT on issuing "Regulations on Food Safety Sanitation for Irradiated Foods"

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of "Sanitation Safety Regulations for Irradiated Food Preservation"

food preserved by irradiation method” 

MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government assigning responsibilities for state management over product quality;

Considering the proposal of the Director of the Legal Affairs Department and the Director of the Food Safety and Hygiene Inspection Department of the Ministry of Health,

Pursuant to …;

Article 1. Issued together with this Decision "Sanitation Safety Regulations for Irradiated Food Preservation" are hereby issued together with this Decision. 

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.

Article 3. The Heads of the Office, Inspectorate, Legal Affairs Department, Science and Training Department, Food Safety and Hygiene Inspection Department of the Ministry of Health, Directors of Health Departments of provinces and centrally governed cities, Heads of units under the Ministry of Health, and Heads of health services of relevant sectors are responsible for implementing this Decision.

SANITATION SAFETY REGULATIONS FOR

IRRADIATED FOOD PRESERVATION

(Issued together with Decision No. 3616/2004/QĐ-BYT dated October 14, 2004 of the Minister of Health)

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

These regulations govern sanitation safety for irradiated food circulating on the territory of Vietnam.

Article 2. Applicability

These regulations apply to irradiation facilities, processing facilities, and businesses dealing with irradiated food. 

Article 3. Explanation of Terms

In these regulations, certain terms are defined as follows:

1. Irradiated food means food treated with ionizing radiation from radioactive sources or radiation-emitting machines (hereinafter referred to as radiation sources) for preservation and prevention of food deterioration.

2. Absorbed dose is the ratio between de and dm, where de is the average absorbed energy (measured in joules) that ionizing radiation transmits to a mass of food with a mass of dm (measured in kilograms).

3. Unit of absorbed dose is Gray (symbol Gy), 1Gy=1J/kg, 1kGy=1000 Gy.

4. Radiation source is the energy source from radiation-emitting machines or ionizing radiation from radioactive sources.

5. Irradiated food means food containing five percent or more by weight that has absorbed a dose exceeding the minimum absorbed dose.

6. Irradiation facility are is a facility using radiation sources to irradiate food.

7. Processing facility for irradiated food is a facility processing food that uses irradiated food as raw material or applies irradiation methods to preserve food.

8. Business dealing with irradiated food is a business engaged in the sale of irradiated food.

9. Dose determination system is a system of equipment used to determine absorbed dose, including dosimeters, measuring devices, and procedures for using the dose determination equipment system.

10. Maximum permissible absorbed dose is the absorbed dose value specified for each type of food in Article 9 of these regulations.

11. Minimum absorbed dose is the absorbed dose value for each type of food below which the desired technical objectives will not be achieved when irradiating the food. 

Chapter II
REGULATIONS FOR IRRADIATION FACILITIES

Article 4. General Requirements

1. Irradiation facilities must comply with the provisions of the Radiation Safety and Control Ordinance and other guiding legal documents implementing this Ordinance.

2. Irradiation facilities may only operate irradiation activities after obtaining written approval from the Food Safety and Hygiene Inspection Department.

3. Irradiation facilities must have two separate areas designated for food awaiting irradiation and food that has been irradiated to prevent recontamination or repeated irradiation. These areas must be sufficiently spacious, appropriate to the scale of irradiation, and must meet all corresponding food storage conditions.

4. Irradiation facilities must have sufficient staff trained in specialized knowledge and skills in accordance with the provisions of the Radiation Safety and Control Ordinance and other relevant laws. 

Article 5. Provisions on radiation sources

1. Only radiation sources specified in Technical Regulation TCVN 7247:2003 on Irradiated Foods - General Requirements for Food Irradiation shall be used:

a) X-rays emitted from machines operating at energy levels not exceeding 5 mega electron volts (MeV).

b) Gamma rays from radioactive isotopes ⁶⁰Co or ¹³⁷Cs.

c) Electron beams emitted from machines operating at energy levels not exceeding 10 MeV.

2. In addition to complying with regulations on radiation source management, any increase or decrease in radiation sources, changes in characteristics of the radiation machine, or repairs affecting dose distribution must immediately cease operations and report to the Nuclear Radiation Control and Safety Agency.

Article 6. Management of Irradiation Dose at Food Irradiation Facilities

1. The irradiation process must ensure that the absorbed dose for each type of food does not exceed the permissible limit set forth in Article 9 of this Regulation.

2. If food requires an absorbed dose higher than 10 kGy to achieve technical objectives, it must obtain written approval from the Food Safety Authority.

3. Measurement of absorbed dose must be conducted according to one of the following Vietnamese Standards: TCVN 7248:2003 Practice Standard for Dose Measurement Applicable to Gamma Irradiation Equipment Used for Food Processing or TCVN 7249:2003 Practice Standard for Dose Measurement Applicable to Electron Beam and Bremsstrahlung Irradiation Equipment Used for Food Processing.

4. Food irradiation facilities must retain irradiation reports for each batch of food for one year from the date of irradiation, including the following contents:

a) Information about the batch (type of food, production facility, production date or expiration date).

b) Status of energy source, dose calibration process.

c) Absorbed dose value (determined according to Clause 3 of this Article).

d) Date of irradiation.

Article 7. Provisions on Operation of Food Irradiation Equipment

The operation of food irradiation equipment must comply with Technical Regulation TCVN 7250:2003 Operating Regulations for Food Irradiation Equipment. 

 Chapter III
PROVISIONS FOR IRRADIATED FOOD

Article 8. Requirements for Irradiated Food

1. Food must be processed under sanitary conditions ensuring quality in accordance with corresponding standards before irradiation.

2. Re-irradiation of food is not permitted except for: grains, beans, dried foods, and similar goods irradiated for insect control or sprout inhibition purposes.

Food will not be considered re-irradiated if:

a) The food is processed from raw materials that have been irradiated at an absorbed dose not exceeding 1 kGy;

b) The food contains no more than 5% by weight of components that have been irradiated;

c) Special technological requirements necessitate multiple-stage irradiation to achieve the desired effect through the total absorbed dose during processing.

3. Only irradiated food with complete labeling as prescribed in Article 10 of this Regulation may be circulated in the market. 

Article 9. List of Permitted Irradiated Foods and Maximum Absorbed Dose Limits

Depending on the purpose of irradiation, the irradiation process must ensure that the absorbed dose for each type of food does not exceed the following limits: 

 Article 10. Packaging, Storage, and Labeling

1. Food must be packaged in the same packaging before and after irradiation.

2. Irradiated food must be stored according to regulations applicable to non-irradiated food.

3. On the packaging of irradiated food, in addition to mandatory information required by law for food labeling, there must be a statement: "Irradiated Food" or affix an identifiable label for irradiated food (as specified in the Appendix attached to this Decision).

 Chapter IV
IMPLEMENTING PROVISIONS

Article 11. Handling Violations

Organizations and individuals violating this Regulation shall be subject to disciplinary action, administrative penalties, or criminal prosecution, if damage is caused, they must compensate according to the provisions of the law.

Article 12. Implementation Organization

The National Food Safety Authority, the Inspectorate of the Ministry of Health, and other competent state management agencies are responsible for inspecting and supervising the implementation of this Regulation.