Decision No. 3616/2004/QD-BYT of October 14th, 2004, on the issuance of the regulations on safety and sanitation of foods preserved by irradiation

DECISION

ON THE ISSUANCE OF THE REGULATIONS ON SAFETY AND SANITATION OF FOODS PRESERVED BY IRRADIATION

THE MINISTER OF HEALTH

Pursuant to the Decree No. 49/2003/ND-CP, dated on 15 May 2003, specifying functions, responsibilities, authorities and organization structure of the Ministry of Health;
Pursuant of the Decree No. 86/CP issued by the Government, dated on 8 December 1995, on responsibilities in the State management of goods quality;
Considering the proposal by the Directors of Legal Department and Food Sanitation and Safety Agency, the Ministry of Health:

DECIDES:

Article 1.To issue Regulations on sanitation and safety of foods preserved by irradiation attached to this Decision.

Article 2.This Decision shall enter into force 15 days after the date of the announcement of this Decision in the Official Gazette.

Article 3.The Chief Secretariat, the Chief Inspectorate, the Director of Legal Department, the Director of Science and Education Department, the Director General of Food Sanitation and Safety Agency - the Ministry of Health, Directors of Provincial Health Departments and health officials in agencies under the Ministry of Health shall be responsible to implement this Decision.

REGULATIONS

ON THE SAFETY AND SANITATION OF FOODS PRESERVED BY IRRADIATION
(in accordance with Decision No. 3616/2004/QD-BYT issued by the Minister of Health dated on 14 October 2004)

Chapter I

GENERAL REGULATIONS

Article 1. Scope

This Regulations stipulates the sanitation and safety of foods that are preserved by irradiation and distributed in Vietnam.

Article 2. Subjects of application

This Regulations applies to food irradiation facilities, and facilities that process and trade irradiated foods.

Article 3. Definitions:

The following definitions apply for the purpose of this Regulations:

1. Foods preserved by irradiation are foods processed by ionising radiation from radioactive sources or generators (hereinafter referred to as radioactive sources) to preserve and protect foods from degradation.

2. Absorbed dose is the ratio of de to dm, where de is the average absorbed energy (in jun) that the ionising radiation transmits to a food of weight of dm (in kilogram).

3. The unit of absorbed dose is Gray (Gy), 1 Gy = 1j/kg, 1kGy=1000 Gy.

4. Radiation source is the source that emits energy from radiation generator or ionising radiation from radioactive source.

5. Irradiated food is the food that has 5% of its weight absorbed a dose greater than the minimum absorbed dose.

6. Food irradiating facility is the facility that uses radiation sources to irradiate foods.

7. Irradiated food processing facility is the facility that uses irradiated food as materials or applies irradiation for food preservation.

8. Irradiated food trading facility is the facility that trades in irradiated foods.

9. Dose measuring system is the system of equipment used for measuring absorbed dose, including: dosimeter, measuring instruments; and procedures using the dose measuring system.

10. Maximum allowable absorbed dose is the highest absorbed dose that is allowed to apply for a kind of the food prescribed in Article of this Regulations.

11. Minimum absorbed dose is the absorbed dose that is necessary for a kind of food to meet expected technical requirements.

Chapter II

PROVISIONS ON FOOD IRRADIATING FACILITIES

Article 4. General requirements

1. Food irradiating facilities shall comply with the Ordinance on radiation safety and control and other legal documents detailing the implementation of the Ordinance.

2. Food irradiating facilities may conduct food irradiating activities only after obtaining permission from the Food Sanitation and Safety Agency.

3. Food irradiating facilities shall have 02 separate areas, one for food for irradiating and the other for irradiated food so as to prevent the food from being re-infected or re-irradiated. These areas shall be large enough in accordance with irradiation scales and in compliance with standards for preservation.

4. Food irradiating facilities must have a sufficient number of qualified staff in accordance to provisions of the Ordinance on Radiation Safety and Control and other relevant legal regulations.

Article 5. Provisions on radioactive sources

1. Only radioactive sources prescribed in TCVN 7274:2003 Irradiated foods General requirements for food irradiation shall be used:

a) X-ray is emitted from generator operating at power equal to or lower than 5 mega electron von (MeV).

b) Gamma-ray is emitted from radioactive isotopes 60Co or 137Cs.

c) Electron beams are emitted from generators operating at power equal to or lower than 10 MeV.

2. In addition to compliance with regulations on radiation source management, if it is planned to alter specifications of generators or to repair the equipment for which dose distribution can be affected, the operation shall be ceased and any changes shall be reported to the Vietnam Agency for Radiation and Nuclear Safety and Control.

Article 6. Management of radiation doses at food irradiating facilities

1. The procedure for food irradiation must ensure that absorbed doses for each kind of food shall not be greater than the limits specified in Article 9 of this Regulations.

2. In case the absorbed dose is required to be greater than 10 kGy to meet other technical objectives, written permission from Agency of Food Sanitation and Safety shall be obtained.

3. Measurement of absorbed doses shall be conducted in compliance with one of the following Vietnam Standards: TCVN 7248:2003 Standards in conducting dose measurement for gamma irradiation equipments used for food processing, or TCVN 7249:2003 Standards in conducting dose measurement for electron-beam irradiation and bremsstranhlung equipment used for food processing.

4. Food irradiating facilities shall keep records of irradiation results of each batch of food for every year. The following information shall be included:

a) Information of the batch (type of food, manufacturer, and date of manufacture and expire);

b) Power conditions, dose adjustment procedure;

c) Absorbed doses (determined as specified in Para. 3 of this Article).

d) Irradiation date.

Article 7. Provisions on operation of food irradiating equipment

Operation of food irradiating equipment shall comply with TCVN 7250:2003 Standards on operation of irradiating equipment used for food processing.

Chapter III

PROVISIONS ON IRRADIATED FOODS

Article 8. Requiremens for irradiated foods

1. Before being irradiated, foods must be processed to meet sanitary and quality requirements.

2. Re-irradiation is prohibited, except for foods such as: cereal, beans, dry foodstuff and other similar goods that are irradiated to control insects or to inhibit germination.

Foods shall not be considered as to be re-irradiated if:

a) The food is processed from materials irradiated at a dose equal to or less than 1 kGy;

b) The food contains less than 5% of its weight irradiated;

c) Due to special technical requirements, the food are required to be multi-irradiated to achieve the desired results.

3. Only irradiated foods with adequate labels as specified in Article 10 of this Regulation are allowed to be distributed.

Article 9. List of foods that can be irradiated and Dose limits

Depending on purposes of irradiation, process of irradiation must ensure absorbed dose of each kind of food not to exceed limitations as following:

Article 10. Packaging, Storaging and Labelling

1. The same package shall be used for food before and after irradiated.

2. Irradiated foods shall be preserved in accordance with regulations specified for un-irradiated foods.

3. There shall be the sign Irradiated food or label of irradiated foods (as indicated in the Appendix of this Regulations) on the package of irradiated foods, in addition to other information in compliance with legal regulations.

Chapter IV

IMPLEMENTATION

Article 11. Handling violation

Organisations, individuals who violate this Regulations shall be subject to administrative sanctions or criminal prosecution, depending on the nature and scope of the violation and its consequences; and bear compensation if there is damage.

Article 12. Implementation

The Agency of Food Sanitation and Safety, the Inspectorate of the Ministry of Health, and other state regulatory authorities are responsible for conducting inspection on the implementation of this Regulations.