THE MINISTER OF HEALTH

DECIDES:

Article 1.- To issue together with this Decision the Regulation on conditions for ensuring food hygiene and safety in the production of, trading in, and use of, food additives.

Article 2.- The director of the Department for Food Quality, Hygiene and Safety Control shall have to guide and inspect the implementation of this Decision.

Article 3.- This Decision takes effect 15 days after its signing for issuance.

Article 4.- The director of the Office, the chief inspector and the directors of the departments of the Ministry of Health, the director of the Department for Food Quality, Hygiene and Safety Control, the director of the Vietnam Pharmaceutical Management Department, the heads of the units attached to the Ministry, the directors of the Health Services of the provinces and centrally-run cities, and the heads of the health agencies of the branches shall have to implement this Decision.

For the Minister of Health
Vice Minister
LE VAN TRUYEN

Article 1.- Scope of regulation: This Regulation prescribes the conditions for ensuring food hygiene and safety in the production of, trading in, and use of, food additives.

Article 2.- Subjects of application: This Regulation applies to domestic organizations and individuals and foreign-invested establishments engaged in the production of, trading in, and use of, food additives.

Article 3.- For the purposes of this Regulation, the following terms shall be construed as follows:

1. Food additives are substances which are not regarded as food or food components. Food additives are of little or no nutritious value, deliberately added in order to meet the technological requirements in the food production, processing, treatment, packaging, transportation and preservation. Food additives shall not include contaminated substances or substances added to food for the purpose of increasing the nutritious value of food.

2. Food additive-producing establishments are establishments which produce, prepare, package and/or preserve food additives.

3. Food additive-trading establishments are establishments which trade in, export and/or import food additives.

4. Food additive-using establishments are establishments which use food additives for food processing.

Article 4.- The production of, trading in, and use of, food additives in food processing must ensure the following principles:

1. Food additives are on the lists prescribed by the Ministry of Health.

2. Food additives ensure the purity required for food.

3. Food additives are used within the prescribed amounts.

4. Food additives have labels as prescribed, or their names printed on the food labels (for foods containing such additives).

Chapter II

CONDITIONS FOR ENSURING FOOD HYGIENE AND SAFETY IN THE PRODUCTION OF, TRADING IN, AND USE OF, FOOD ADDITIVES

Article 5.- The establishments producing, trading in and/or using food additives must comply with the regulations on business registration, publicization of food quality, hygiene and safety standards according to the provisions of law; ensure the publicized registration contents, and submit to the supervision and inspection by the agencies performing the State management over food quality, hygiene and safety.

Article 6.- Conditions required for establishments trading in, exporting and/or importing food additives:

1. The establishments must make business registration and have clear addresses.

2. They must have signboards clearly showing the trade names: Shops or stalls for trading in, exporting and/or importing food additives.

3. Salespersons must go through training courses on food additive trading, organized by competent medical agencies.

4. The establishments may only trade in, export and/or import food additives on the list permitted by the Ministry of Health.

5. Food additives must be of the right kinds usable for food, of a clear origin or source.

6. Food additives must have Vietnamese-language product labels showing use instructions and other contents as prescribed. Where they divide and re-package the food, the shops must comply with the regulations on food labeling.

7. Conditions for exporting and importing food additives: The establishments must have adequate documents, including the original purchase invoices, the import permit (for imported goods), the export permit (for exported goods); the paper acknowledging the publicization of the food quality, hygiene and safety standards of each kind of food additive, issued by the agency performing the State management over food hygiene and safety.

8. Food additives for sale must be arranged separately in stalls or boxes, not together with other merchandise or foods.

Article 7.- Conditions required for establishments producing and packaging food additives

1. Conditions for the establishments:

a/ Environmental sanitation: The location of grounds for the production and packaging of food additives must ensure the environmental sanitation conditions and be isolated from toilets and other polluting sources.

b/ Design: Food additive-producing and -packaging workshops must be designed and organized on the one-direction principle: The area for gathering, preserving and treating raw materials, followed by the area for processing, packaging and preserving food additives.

c/ Hygiene requirements:

- Ceilings, floors and walls must be made of non-absorbent materials, easy to clean.

- Equipment and containing tools such as trays, buckets, basins must be made of materials permitted for use in the food production such as stainless steel, aluminum, epoxy-coated material, etc., but neither color nor recycled plastic; there must be gauging devices up to standards.

- Equipment and tools must be cleaned after each production shift.

- Only detergents permitted for household use and food processing can be used, but not industrial detergents.

- The packaging areas, storehouses, and the food additive-preserving places must be kept clean and hygienic, free from insects and rats.

- Garbage bins must have lids, not letting litters scatter around and waste water leak out. Rubbish must be gathered at places far from the processing areas and taken away everyday.

- Sewage must be unchoked with no stagnant water and must not be open-air.

- There must be toilets up to standards.

d/ Requirements for the water-supplying sources:

- The used water must meet the criteria set by the Ministry of Health.

- There must be adequate clean water for normal operations of the establishments, water for workers to wash their hands before taking part in production and processing. If well water is used, it must be treated according to regulations and tested periodically.

e/ Hygiene for production workers:

- They must have pre-recruitment medical checks, annual post-recruitment medical checks and excrete tests at least once a year.

- They must have the knowledge about food hygiene and safety and firmly grasp the technological process and their responsibility.

- They must not leave their clothes and personal belongings in the production and packaging areas.

- They must keep personal hygiene, wash their hands with soap before taking part in producing and packaging food additives.

- They must wear labor protection clothes (caps, gauze-masks�) and gloves when packaging food additives.

- They must not eat, drink nor smoke in the production and packaging areas.

2. Requirements for production materials:

a/ Materials and food additives purchased for preparation and packaging must be accompanied with adequate dossiers explicitly showing the origin and quality of food additives.

b/ They must have explicit labels, enclosed with the cards showing the serial numbers of the goods lots already warehoused and delivered for sale.

c/ Material purchase invoices must clearly show the addresses of the sellers.

d/ Additives put into processing, bottling, packaging or for retail must have their use duration remaining at least six months and the use duration of the processed and packaged products must coincide with the use duration of original materials.

3. Product labeling requirements:

a/ The produced and packaged products must bear food additive labels.

b/ Ensuring that labels are inscribed with at least the following contents:

- The name of the food additive, its international index.

- The address of the producer.

- The net weight.

- Use duration (or the date of manufacture and use duration).

- Ingredients.

- Use and preservation instructions.

For imported additives put on sale, they must have additional labels with the above contents in Vietnamese.

4. The following must be fully recorded daily for monitoring:

- The name of the food additive.

- The origin.

- The technological process.

- The production lot and use duration.

- Accompanied invoices showing clearly the addresses of purchasers and buyers of the establishments.

Article 8.- Conditions for food-processing establishments using food additives

a/ They must not use materials being color dyes, synthetic sweeteners, preservatives and other additives not on the list of food additives prescribed by the Ministry of Health for food processing.

b/ They must use only food additives which are packaged and labeled according to the provisions in Article 7 of this Regulation.

c/ Food additives must ensure the purity required for use in food.

d/ Food additives must be used within the prescribed amounts and according to the prescribed formula, and have instructions for use with each kind of food.

e/ For packaged products using food additives, their labels must clearly show the names of all the used food additives.

Chapter III

RESPONSIBILITIES OF ESTABLISHMENTS PRODUCING, TRADING IN AND USING FOOD ADDITIVES

Article 9.- Responsibilities of the establishments producing, packaging, exporting and/or importing food additives

1. To make business registration with the managing agencies.

2. To publicize the food quality, hygiene and safety standards at the medical agencies according to the provisions of law.

3. To comply with the technological process; to produce products of constant quality standards, ensuring food hygiene and safety.

4. To package food additives within the prescribed amounts. Tools, packages and labels for packaging each kind of food additive must be separately kept to avoid confusion, which may affect the quality of each kind of food additive.

Article 10.- Responsibilities of trading establishments

1. To make business registration with the managing agencies.

2. To trade in and put for sale only food additives with their quality, hygiene and safety standards already publicized at the medical agencies.

3. To adopt the servicing modes ensuring food hygiene and safety and a cultured and civilized style of trading.

4. To post up prices, use instructions and to sell products at the posted prices.

5. To introduce fully to the customers the origin and use instructions of each kind of food additive for use in each goods item or dish.

6. Not to commit the following acts: trading in fake and inferior-quality food additives, exchanging fraudulently food additives, cheating in payment with customers.

7. The establishments exporting and/or importing food additives must meet all conditions prescribed in Clause 7, Article 6 of this Regulation.

Article 11.- Responsibilities of customers

1. To buy only food additives with their quality standards already publicized at the medical agencies.

2. To read the labels of food additives carefully before buying and using them.

3. To buy only food additives in packages with clear labels having all the contents as prescribed.

4. To use food additives in right amounts as prescribed.

5. To detect and inform the managing agencies of the establishments producing and/or trading in food additives at variance with regulations.

Article 12.- Regulations on the reporting regime and investigation of food additive poisoning

1. When detecting or doubting that food poisoning cases have occurred (due to the use of food additives), those who are present at the places of their occurrence must immediately report them to the nearest medical agencies and keep the samples of food additives doubted to cause poisoning for investigation and verification.

2. The owners of the establishments using and/or trading in food additives related to food poisoning cases must be responsible for their wrong doings and violations and pay material indemnification (medical treatment charges) to the poisoned persons.

Chapter IV

RESPONSIBILITIES TO MANAGE THE PRODUCTION OF, TRADING IN, AND USE OF FOOD ADDITIVES

1. The Food Quality, Hygiene and Safety Control Department, the Ministry of Health, shall be responsible for:

a/ Guiding, instructing and coordinating with the authorities and branches to supervise and monitor the producing and trading establishments to ensure that their food additive production and trading comply with this Regulation on the national scale.

b/ Managing, receiving dossiers of publicization of food quality, hygiene and safety standards from the establishments producing and/or processing food additives, the establishments trading in, exporting and/or importing food additives; managing exported and imported food additives in the whole country.

2. The provincial/municipal Health Services shall be responsible for guiding the producing and trading establishments to comply with the current law provisions and for managing the establishments trading in and/or using food additives in their respective localities.

Chapter V

COMMENDATION AND HANDLING OF VIOLATIONS

Article 14.- Commendation

If organizations and individuals producing, trading in and/or using food additives well implement the provisions of this Regulation, they shall be commended and/or rewarded according to the general regimes of the State.

Article 15.- Handling of violations

If organizations and individuals trading in and/or using food additives violate the provisions of this Regulation, they shall, depending on the seriousness of their violations, be administratively sanctioned; if causing any damage, they shall have to pay compensation therefor according to the provisions of law.

For the Minister of Health
Vice Minister
LE VAN TRUYEN