Nghị định 77/2016/ND/CP

DECREE

SUPPLEMENTING AND AMENDING CERTAIN REGULATIONS ON INVESTMENT AND TRADING CONDITIONS IN INTERNATIONAL TRADE IN GOODS, CHEMICALS, INDUSTRIAL EXPLOSIVES, FERTILIZER, GAS BUSINESS AND FOOD BUSINESS UNDER THE STATE MANAGEMENT OF MINISTRY OF INDUSTRY AND TRADE

Pursuant to the Law on Organization of the Government dated June 19, 2015;

Pursuant to the Commercial Law dated June 14, 2005;

Pursuant to the Law on quality of products and goods dated November 21, 2007;

Pursuant to the Law on Chemicals dated November 21, 2007;

Pursuant to the Law on Food Safety dated June 17, 2010;

Pursuant to the Law on Investment dated November 26, 2014;

Pursuant to the Ordinance on management and use of weapons, explosive materials and combat gears dated June 30, 2011 and the Ordinance dated July 12, 2013 on amendments and supplements to certain articles of the Ordinance on management and use of weapons, explosive materials and combat gears;

At the request of Minister of Industry and Trade;

The Government promulgates a Decree to provide for supplements and amendments to certain regulations on investment and trading conditions in international trade in goods, chemicals, industrial explosives, fertilizer, gas business and food business under the state management of Ministry of Industry and Trade.

Chapter I

INTERNATIONAL TRADE IN GOODS

Article 1. Addition of Clause 11 to Article 9 of the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“11. Import/export of minerals:

a) Importers/exporters of minerals must be traders as referred to by the Commercial Law;

b) With regard to export, import, temporary import for re-export and transit of coals, traders must own or lease business locations, vehicles, loading instruments, warehouses, ports, and measuring instruments to serve the business and meet requirements for technology, safety, environmental hygiene, and fire and explosion prevention in accordance with prevailing laws.”

Article 2. Amendments to Clause 2 and Clause 3 Article 11 of the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“2. Except for the cases where goods are banned from temporary import for re-export or subject to the suspension of temporary import for re-export and goods subject to the cases stated in Clause 1 of this Article, enterprises are only required to carry out procedures for temporary import for re-export at customs agencies and are not required to submit the license to temporarily import goods for re-export. Ministry of Industry and Trade is assigned by the Government to announce the List of goods which are banned from the temporary import for re-export or subject to the suspension of temporary import for re-export as referred to in this clause.

3. The following goods shall be temporarily imported for re-export under certain conditions:

a) Used goods;

b) Frozen foods;

c) Goods subject to special excise duty.

Ministry of Industry and Trade is assigned by the Government to announce the List of goods temporarily imported for re-export under certain conditions as referred to in this clause.”

Article 3. Addition of Article 11a to the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“Article 11a. Conditions for temporary import for re-export of frozen foods

An enterprise implementing the temporary import for re-export of frozen foods in the List promulgated by Minister of Industry and Trade must satisfy all of the following conditions:

1. Have at least VND 10 billion deposited at a credit institution in the province or city where the enterprise’s warehouse is located as referred to in Clause 2 of this Article.

2. Warehouses to serve the temporary import for re-export of frozen foods must be available. To be specific:

a) The warehouse must contain at least one hundred 40ft containers with the minimum area of 1,500 m². The warehouse must be surrounded with a solid fence with minimum height of 2.5m, have way for vehicles transporting containers out and in the warehouse, and have gate and signboard of enterprise usingthat warehouse;

b) The warehouse must have sufficient power (including network electricity and backup generators with equivalent capacity) and accompanied specialized equipment to operate refrigerated containers in corresponding to the warehouse’s capacity;

c) The warehouse must be owned or leased by an enterprise under a lease contract, located in a planning area for warehousing system in service of temporary import for re-export of frozen foods or in an area prescribed by a boundary provincial People's Committee on the basis of an agreement made with General Department of Vietnam Customs, Border Guard High Command and Ministry of Industry and Trade to build warehouses in service of temporary import for re-export of frozen foods;

d) The enterprise is not allowed to lease the partial or entire warehouse which it has declared to apply for code of temporary import for re-export to another enterprise in order to serve the purpose of applying for a code of temporary import for re-export.”

Article 4. Addition of Article 11b to the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“Article 11b. Conditions for temporary import for re-export of goods subject to special excise duty

An enterprise engaging in temporary import for re-export of goods subject to special excise duty in the List announced by Minister of Industry and Trade must have VND 07 billion deposited at a credit institution in the province or city where that enterprise has Certificate of Business Registration or Certificate of Enterprise Registration issued.”

Article 5. Addition of Article 11c to the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“Article 11c. Conditions for temporary import for re-export of used products

An enterprise engaging in temporary import for re-export of used products must have VND 07 billion deposited at a credit institution in the province or city where that enterprise has Certificate of Business Registration or Certificate of Enterprise Registration issued.”

Article 6. Addition of Article 11d to the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“Article 11d. Issuance of Certificate of code of good temporary import for re-export

1. Ministry of Industry and Trade shall issue a Certificate of code of good temporary import for re-export (hereinafter referred to as code of temporary import for re-export) to an enterprise that meets conditions prescribed in Article 11a or Article 11b or Article 11c of this Decree.

2. The code of temporary import for re-export prescribed in this Article is a specific code for each commodity heading. An enterprise may carry out the temporary import for re-export of goods in the commodity heading of which code of temporary import for re-export issued to that enterprise.

3. In case where foreign goods are sent into bonded warehouses for export/re-export through boundary provinces, only enterprises who have code of temporary import for re-export of the commodity heading of those goods may fill their names in customs declarations for putting goods into bonded warehouses and ex-warehousing from bonded warehouses for export/ re-export. Goods sent into bonded warehouses must comply with regulations of the law on customs.

4. The temporary import for re-export and/or sending of goods prescribed in Article 11a, Article 11b and Article 11c of this Decree into bonded warehouses shall not be the conditional temporary import for re-export and shall not require a code of temporary import for re-export provided that the export/re-export of those goods are not made through Northern boundary border gates. In special cases, Ministry of Industry and Trade may request the Prime Minister to adopt regulations on issuance of codes of good temporary import for re-export to enterprises that engage in temporary import for re-export and/or sending goods into bonded warehouses for export/re-export not through Northern boundary border gates.”

Article 7. Addition of Article 28a to the Government’s Decree No. 187/2013/ND-CP dated November 20, 2013 elaborating the implementation of the Commercial Law with regard of international trade in goods and agencies' sale, purchase, processing and in transit of goods for foreign principals

“Article 28a. Conditions for issuance of permit for production/ export processing of military uniforms of foreign armed forces

Ministry of Industry and Trade shall issue permit for production/export processing of military uniforms of foreign armed forces upon a written certification of Ministry of Public Security or Ministry of National Defence after all of the following conditions are satisfied:

1. Have a sales contract or contract for production/export processing which is entered into between the party placing order for production/processing and the agency in charge of purchase/logistics of a foreign armed force, or certification of the agency or entity that is the final user of military uniforms produced/processed in Vietnam as ordered.

2. If the importing country is USA, the application for permit for production/export processing for the first time must be enclosed with certificate of producer identification code (MID code) for exporting garments products to USA issued by Ministry of Industry and Trade.”

Chapter II

CHEMICAL SECTOR

Article 8. Addition of Article 12a to the Government’s Decree No. 108/2008/ND-CP dated October 07, 2008 detailing and guiding the implementation of certain articles of the Law on Chemicals

“Article 12a. Conditions for production/trading of industrial precursors

1. Conditions for production of industrial precursors

Producers of industrial precursors must satisfy all of conditions for production of industrial chemicals referred to in Clause 4 Article 1 of the Government’s Decree No. 26/2011/ND-CP dated April 08, 2011 providing for amendments to certain articles of the Government’s Decree No. 108/2008/ND-CP dated October 07, 2008 detailing and guiding the implementation of certain articles of the Law on Chemicals.

2. Conditions for trading in industrial precursors

A trader in industrial precursors must satisfy all of conditions for trading in industrial chemicals as referred to in Clause 4 Article 1 of the Decree No. 26/2011/ND-CP and the following conditions:

a) Have Certificate of Enterprise Registration, or Investment License, or Certificate of Business Registration or Certificate of Household Business Registration;

b) Persons in direct contact with precursors, including managers, shopkeepers, delivery men and warehouse-keepers, have attended training courses in chemical safety as referred to in Clause 5 Article 1 of Decree No. 26/2011/ND-CP;

c) Business locations and/or locations for displaying industrial precursors for sale must ensure the quality of stored industrial precursors in conformity with the law on quality of goods and products. Warehouses or areas for storing and preserving industrial precursors must satisfy technical requirements on safety and have necessary warnings installed in accordance with the Law on Chemicals;

d) A trader in industrial precursors must meet requirements on firefighting and prevention, and environmental protection as regulated by laws;

dd) Sold industrial precursors must be properly labeled in accordance with the laws. Invoices for purchase and sale of precursors must clearly show the origin, importers or distributors of such precursors. Entities importing precursors from foreign countries into Vietnam must have one of documents relating to the trading in precursors such as sales contract, or sales agreement, or memorandum, or commercial invoice;

e) Record of sales of toxic chemicals certified by the buyer and seller must be presented in conformity with the Law on Chemicals if sulfuric acid and hydrochloric acid are traded.”

Article 9. Amendments to Points c, d, dd, h and i Clause 1 Article 15 of the Government’s Decree No. 38/2014/ND-CP dated May 06, 2014 on management of chemicals governed by the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction

“Article 15. Conditions for production of Schedule 1 chemicals

1. Organizations and individual are not allowed to produce the Schedule 1 chemicals, except for the cases where they are produced to serve the purposes of scientific research, maintenance of national defense and security, prevention and combat of epidemic diseases, and any producer of Schedule 1 chemicals for such purposes must satisfy the following conditions:

c) Have location, area, workshop, machinery, equipment, technological process and warehouse suitable to produce Schedule 1 chemicals with quality standards assured.

Chemical production line must ensure quality of produced chemicals. Machinery and equipment for producing Schedule 1 chemicals must have clear and legitimate origin. Machinery and equipment must have stringent requirements on safety, and testing and measurement instruments must be verified, calibrated and adjusted in conformity with current regulations on machinery and equipment verification, and correspond to the production capacity and technological process;

Available or leased warehouses must correspond to chemical warehouse technologies and comply with regulations and standards on fire and explosion prevention. The warehouse where chemicals are stored must have a notice board showing regulations on chemical safety, conspicuous danger signs and signaling system in corresponding with the danger level of stored chemicals with all hazards of chemicals are shown;

Stored chemicals must have proper labels in accordance with current laws on labeling. Labels of Schedule 1 chemicals must be chemically and mechanically durable throughout the existence of chemicals.

d) Have testing/ analytical laboratories for managing quality of chemicals. Testing laboratories must be able to carry out analysis of quality norms specified in National technical regulation for output products and quality norms defined in technical standards applied to input materials in order to control product quality;

In cases where testing laboratories are not available or existing testing laboratories are unable to carry out testing for required quality norms, the producer must enter into a contract with a qualified testing institution that has a certificate of testing operation registration issued in conformity with regulations on quality of goods and products and is assigned to control quality of chemicals.

dd) Have a chemical emission and waste treatment system in conformity with regulations of the law on environment and national technical regulations for industrial emissions, hazardous waste threshold and solid wastes;

h) Employ a technical director or deputy director who must possess bachelor’s degree or higher level in chemicals; managerial, technical and production executives must possess bachelor’s degree or higher level in chemicals or have obtained certificates proving their competence in chemicals;

i) Employees in direct contact with chemicals must attend training courses in chemical safety and have certificates of completion of training courses in chemical safety granted by competent agencies.”

Chapter III

INDSUTRIAL EXPLOSIVES

Article 10. Amendments to Points a, b and c Clause 3 Article 11 of the Government’s Decree No. 76/2014/ND-CP dated July 29, 2014 detailing certain articles of the Ordinance on amendments to the Ordinance on management and use of weapons, explosive materials and combat gears

“3. Technical facilities:

a) The warehouse or port where explosive precursors are unloaded must comply with regulations on security and safety; have fire safety equipment and satisfy fire prevention and fighting conditions as prescribed by the Law on fire prevention and fighting; ensure a safe distance to the entities and objects that need protection under applicable standards, regulations of law on chemicals, and relevant regulations. A trader in ammonium nitrate of high content (98.5% or higher) must have a Certificate of conformity with security and public order issued by a competent authority;

b) Containers of explosive precursors must ensure quality of stored explosive precursors and environmental hygiene, must be impervious to water, not leaked, be cleaned and dried before storing explosive precursors; vehicles for transporting explosive precursors must comply with regulations of the law on transport of dangerous goods;

c) A trader in explosive precursors must have a warehouse (or lease a warehouse to store explosive precursors) which must meet requirements on warehouse and quality assurance of traded explosive precursors.”

Article 11. Amendments to Clause 4 Article 11 of the Government’s Decree No. 76/2014/ND-CP dated July 29, 2014 detailing certain articles of the Ordinance on amendments to the Ordinance on management and use of weapons, explosive materials and combat gears

“4. Chemical safety requirements

a) Have adopted measures certified by or plans approved by competent authorities for preventing and responding to events of chemical hazards in accordance with the Law on Chemicals;

b) Have chemical safety datasheet expressed in Vietnamese, issued by trader, attached along with explosive precursors and retained at places where explosive precursors are stored;

c) Have regulations on chemical safety and signaling system in corresponding with the danger level of stored chemicals shown at places where explosive precursors are stored. If stored explosive precursors have different hazards, warning signs must fully show such hazards;

d) Do not store explosive precursors in outdoor condition; do not store explosive precursors together with combustible materials, reducing agents and chemicals/materials which generate heat by absorption of moisture.”

Article 12. Amendments to Clause 6 Article 17 of the Government’s Decree No. 39/2009/ND-CP dated April 23, 2009 providing for industrial explosives

“Article 17. Conditions for production of industrial explosives

6. Managers, workers and employees involved in the production of industrial explosives must satisfy security and order requirements; possess professional qualifications corresponding to their working positions and duties, have been trained in safety techniques, fire prevention and fighting and response to accidents in industrial explosive production activities. To be specific:

a) Persons in direct contact with the production of industrial explosives must satisfy the following conditions:

- Have legitimate personal identification papers and are not prohibited from participating in industrial explosive activities as referred to in Clause 5 Article 5 of the Decree No. 39/2009/ND-CP;

- Possess professional qualifications corresponding to assigned duties and have been trained in safety techniques in industrial explosive activities as referred to Article 29 of the Decree No. 39/2009/ND-CP and regulations in QCVN 01:2012/BCT, QCVN 02:2008/BCT on industrial explosive activities; TCVN 5507:2002 and relevant standards and regulations for explosive precursors, and have certificates of safety techniques for industrial explosives issued by competent authorities;

- Must be fit to meet requirements for each job in accordance with applicable regulations of the labour law;

- Persons in direct contact with the production of industrial explosives and explosive precursors must be trained and obtain professional qualifications corresponding to assigned positions and duties.

b) Apart from conditions in Point a Clause 6 of this Article, foreigners participating in industrial explosive activities in Vietnamese enterprises must obtain work permits from competent employment authorities, and be given training in laws on industrial explosives and relevant laws of Vietnam;

c) Managers, division heads and employees directly involved in industrial explosive and explosive precursor activities in enterprises affiliated to Ministry of National Defence must be given training and have certificates granted by Ministry of National Defence or an agency in charge of managing industrial explosives under the Ministry of National Defence’s assignment. Training contents shall follow requirements in Point a Clause 6 of this Article.

Directors must possess bachelor’s degrees; technical deputy directors and division heads directly involved in the production of industrial explosives must possess bachelor’s degrees in any of the following majors: chemicals, bullet weapons, chemical technology in propellants and explosives, mining, geology, traffic works, irrigational works.”

Article 13. Addition of Article 20a to the Government’s Decree No. 39/2009/ND-CP dated April 23, 2009 providing for industrial explosives

“Article 20a. Conditions for import/export of industrial explosives

1. Conditions for import of industrial explosives

a) An importer of industrial explosives must be licensed to trade industrial explosives;

b) Contracts for purchase of industrial explosives entered into with foreign enterprises and contracts for sale of industrial explosives entered into with domestic enterprises are required.

2. Conditions for export of industrial explosives

a) An exporter of industrial explosives must be licensed to trade industrial explosives;

b) Contracts for sale of industrial explosives entered into with foreign enterprises and contracts for purchase of industrial explosives entered into with domestic enterprises are required;

c) If industrial explosives are exported (or re-exported) by foreign petroleum enterprises, contracts for purchase of industrial explosives from foreign enterprises and contracts for sale of industrial explosives to other foreign enterprises are required.”

Article 14. Amendments to Clauses 2, 3, 4 Article 21 of the Government’s Decree No. 39/2009/ND-CP dated April 23, 2009 providing for industrial explosives

“Article 21. Conditions for use of industrial explosives

2. There are mineral or petroleum activities, or construction or research or testing works requiring use of industrial explosives. Locations for using industrial explosives must ensure security and order conditions, and safety distances required for works and entities in need of protection according to current technical standards and regulations, and relevant regulations. Organizations using industrial explosives must have:

a) Permit for mineral exploration and exploitation if users are mineral enterprises; Permit for petroleum exploration and extraction if users are petroleum enterprises; Bid-winning decision, or building contract, or letter of authorization/assignment to execute the building contract made by governing bodies;

b) Construction designs of construction work items or mining designs with use of industrial explosives, for industrial-scale works; or construction or exploitation plans, for manual construction or exploitation activities or removal of bombs/mines/unexploded ordnance. The designs or plans approved by investors must meet safety requirements prescribed in QCVN 04:2009/BCT or QCVN 05:2012/BLDTBXH or QCVN 01:2011/BCT or QCVN 18:2014/BXD and other relevant construction standards and technical regulations;

c) The blasting plan with contents regulated by Minister of Industry and Trade.

3. Storehouses, technologies, equipment, facilities and tools serving the use of industrial explosives must be available and meet requirements under current standards and technical regulations and regulations in Section 6 of this Decree; if storehouses and means of transport are not available, premises lease contracts must be made with organizations licensed to preserve and transport industrial explosives or notarized copy of principle contract made with organizations licensed to trade in industrial explosives in order to provide industrial explosives to the works under blasting technical instructions.

4. Managers, head of blasting operation, blasting workers and employees involved in the use of industrial explosives must satisfy security and order requirements; possess professional qualifications corresponding to their working positions and duties, have been trained in safety techniques, fire prevention and fighting, and response to incidents in the use of industrial explosives. An organization using industrial explosives must have: Decision made by enterprise’s leader on appointment of blasting commander and the list of blasting workers and employees directly involved in the use of industrial explosives; Work permits of foreigners who participate in the use of industrial explosives (if any).

A head of blasting operation must have an appointment decision signed by a leader of the organization using the industrial explosives and meet the following conditions: Possess an intermediate-level diploma or higher in mining and/or geology, or traffic works or irrigational works, or bullet weapons, or chemical technology in propellants and explosives, and have at least 01 year (if possessing bachelor’s degree or three-year associate degree) or 02 years (if having intermediate level in techniques) of experience in the use of industrial explosives; if a head of blasting operation possesses an intermediate-level diploma or higher in other technical majors, he/she must have at least 02 years (if possessing bachelor’s degree or three-year associate degree) or 03 years (if having intermediate level in techniques) of experience in the use of industrial explosive, and is required to attend improvement courses in blasting techniques and safety rules and regulations in the exploitation of minerals/petroleum or construction in corresponding to the working field with the use of industrial explosives.

Blasting workers or employees directly involved in the use of industrial explosives must be trained and obtain professional competence corresponding to assigned positions and duties as required in Annex C of QCVN 02:2008/BCT.”

Article 15. Amendments to Clause 2 Article 26 of the Government’s Decree No. 39/2009/ND-CP dated April 23, 2009 providing for industrial explosives

 “2. Satisfy all conditions as referred to in this Decree on the use, maintenance and transport of industrial explosives. Facilities, technical infrastructure and personnel must be able to provide services to at least 05 service-hiring organizations.

Have the written request for issuance of permit to provide blasting service issued by provincial people’s committee with respect to blasting services mentioned in Point a Clause 1 Article 25 of this Decree."

Chapter IV

FERTILIZER

Article 16. Amendments to Point a Clause 3 Article 8 and addition of Article 8a to the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizer

1. Point a Clause 3 Article 8 is amended as follows:

“Article 8. Conditions for production of fertilizer

3. Personnel

a) At least one technician possesses bachelor’s degree or higher in any of the following majors: chemistry, physics, biology, agronomy, cultivation, crop science, or agrochemistry – pedology”.

2. Article 8a is supplemented

“Article 8a. Conditions for production of inorganic fertilizer Conditions for production of inorganic fertilizer referred to in Points a, b, c, d Clause 2 Article 8 shall be as follows:

1. The production line must be mechanized and must ensure quality of produced fertilizer. Machinery and equipment for producing fertilizer must have clear and legitimate origin. Machinery and equipment must have stringent requirements on safety, and testing and measurement instruments must be verified, calibrated and adjusted in conformity with current regulations.

2. Production technological process and process for each type of fertilizer must correspond to production, equipment and capacity.

3. Fertilizer producer must have testing laboratories eligible to carry out analysis of quality norms specified in National technical regulation for output products and quality norms defined in technical standards applied to input materials in order to control product quality.

Inorganic fertilizer producer that has no testing laboratory or has testing laboratories which are unable to carry out analysis of all required quality norms as specified in National technical regulation, a contract must be signed with an designated or accredited testing institution to control quality of produced fertilizer.

4. The entity hiring another entity to manufacture inorganic fertilizer must make a written agreement and meet all conditions for business subject as referred to in Clause 1 Article 8 of Decree No. 202/2013/ND-CP The entity that are hired to manufacture inorganic fertilizer must meet conditions for business subject as referred to in Clause 1 Article 8 of Decree No. 202/2013/ND-CP and requirements on technical infrastructure and technical documents as referred to in Clauses 1, 2 and 3 of this Article. The entity that hires another entity to manufacture inorganic fertilizer shall submit the application for issuance of a License to manufacture inorganic fertilizer in accordance with regulations of Ministry of Industry and Trade.”

Article 17. Addition of Article 8b to the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizer

“Article 8b. Conditions for production of organic fertilizer and other types of fertilizer Conditions for production of organic fertilizer and other types of fertilizer are provided for in Points a, b, c, d Clause 2 Article 8 in national technical regulation for production of organic fertilizer and other types of fertilizer. If the national technical regulation is not available, the production of organic fertilizer and other types of fertilizer must comply with the following regulations:

1. Production capacity

Fertilizer production capacity must be conformable with the production line, machinery, equipment and production technological process.

2. Area for production

a) Having or leasing workshop, warehouse for raw materials and warehouse for finished products with the area in line with the production capacity;

b) Having or leasing premises whose area must meet the requirements for internal traffic, operation house, testing laboratory or other requirements as referred to by applicable laws.

3. Warehouses for finished products and raw materials

a) Having warehouse or entering into a contract for leasing warehouse whose area must be consistent with the production capacity or production planning;

b) Warehouse must have firm roof and walls, waterproof floor and other means of preservation, except for warehouse of organic materials;

c) Having rules of warehouse to ensure the quality of products and labor safety.

4. Production machinery and equipment

a) Having production line, machinery and equipment from the processing of materials to the final products in conformity with the production capacity and technological process. The stages and systems require motorized and automated machinery and equipment: Shoveling and mixing materials when producing root fertilizer; crushing and screening when producing solid or powder fertilizer; stirring and filtering when producing liquid fertilizer; transportation line; drying and granulating for fertilizer in the form of grains or tablets, or drying system for powder fertilizer, where necessary; weighing and packaging system of finished products;

b) In case of self-production of yeast strains to produce microbial organic fertilizer or microbial fertilizer, equipment for preparation of environment and culture of microorganisms consist of: technical balance, shaker, sterile autoclave, incubator, drier, peristaltic shaker, microwave, microbiological safety cabinet, refregerator, fermenter or fermentation equipment for production of microbial fertilizer and microbial organic fertilizer;

c) In case of self-fermentation for production of bio-organic fertilizer or bio-fertilizer, there must be a hydrolyzed fermentation equipment system with the line from raw materials to finished product.

6. Production technological process

Production technological process must be available for each type of fertilizer and correspond to production machinery and equipment, and production capacity.

7. Quality control

Having certificate of quality control system according to TCVN ISO 9001:2008 or above or equivalent. New producers must have this certificate within 01 year from the date of establishment.

8. Raw materials and additives for production of fertilizer

a) Having the list of input raw materials and additives for each type of produced fertilizer in consistent with the production technology;

b) Raw materials and additives must have obvious origin.

9. Testing laboratories

a) Having testing laboratory which is unable to carry out analysis of quality norms according to standards announced for application and as specified in corresponding national technical regulation or signing contract with an designated or accredited testing laboratory to control quality of each produced batch of fertilizer;

b) If the producer has a testing laboratory available to carry out the testing, certificate of periodical calibration and verification of testing and measuring machinery and equipment is required.”

Article 18. Amendments to Clause 8 Article 15 of the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizer

“Article 15. Conditions for sale of fertilizer

8. If an entity sells inorganic fertilizer, organic fertilizer and other types of fertilizer at the same time, that entity must satisfy conditions for sale of fertilizer in this Article and those stated in Article 15a and Article 15b.”

Article 19. Addition of Article 15a to the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizer

“Article 15a. Conditions for sale of inorganic fertilizer

Conditions for sale of inorganic fertilizer referred to in Clauses 2, 3, 4, 5 Article 15 shall be elaborated as follows:

1. Stores or business locations where inorganic fertilizer is sold must have signs, public price lists for each type of fertilizer, listed in a noticeable and legible place. Fertilizer displayed for sale must be arranged separately, not be confused with other types of goods, must be stored in a dry place in order to keep the quality of fertilizer and environmental hygiene condition.

2. Packaging, instruments and/or equipment for containing, storing and transporting fertilizer must guarantee the fertilizer's quality and environmental hygiene, and must not be leaked to spread fertilizer affecting the surrounding environment. Measures for handling fertilizer packaging, bottles, jars and expired fertilizer products must be taken.

3. Warehouses must meet requirements on building location and design in conformity with the traded fertilizer, and requirements for environmental protection, fire fighting and prevention. In a warehouse, fertilizer must be arranged separately and not be confused with other types of goods.

4. Imported fertilizers must have labels and origin in accordance with the law, and the notice of results of state inspection of the quality of imported fertilizer shipment before they are sold. Domestic fertilizers must have invoices or legal documents proving their origin of manufacturing, importer or distributor.
5. If a retail store of inorganic fertilizer does not have warehouse, devices and equipment for containing fertilizer must guarantee the fertilizer’s quality, and be conformable with requirements on environmental hygiene and firefighting and prevention.”

Article 20. Addition of Article 15b to the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizers

“Article 15a. Conditions for sale of organic fertilizer and other types of fertilizer

Regulations in Clauses 2, 3, 4, 5 Article 15 with respect to conditions for sale of organic fertilizer and other types of fertilizer are guided for implementation as follows:

1. Stores or business locations where organic fertilizer and/or other types of fertilizer are sold must have signs, and public price lists displayed in a noticeable and legible place. Organic fertilizer and/or other types of fertilizer displayed for sale must be arranged separately, not be confused with other types of goods, must be stored in a dry place in order to keep the quality of fertilizer and environmental hygiene condition.
2. Packaging, instruments and/or equipment for containing, storing and transporting fertilizer must guarantee the fertilizer's quality, and must not be leaked to spread fertilizer to the outside and affect the surrounding environment. Measures for handling fertilizer packaging, bottles, jars and expired organic fertilizer and/or other types of fertilizer must be taken.
3. Having or leasing a warehouse for storing organic fertilizer and/or other types of fertilizer, which must meet requirements on building location and design in conformity with the traded fertilizer, and requirements for environmental protection, fire fighting and prevention. In a warehouse, organic fertilizer or other types of fertilizer must be arranged separately, not be confused with other types of goods, or in direct contact with rain, sunlight or wind, must comply with environmental hygiene requirements and not be leaked to cause pollution to surrounding environment.

4. If a retail store of organic fertilizer and/or other types of fertilizer does not have warehouse, devices and equipment for containing organic fertilizer and/or other types of fertilizer must guarantee the fertilizer’s quality, and be conformable with requirements on environmental hygiene.

5. Having invoices or legal documents showing the origin, importer or distributor of each type of organic fertilizer and/or other types of fertilizer.”

Article 21. Addition of Clause 1a to Article 20 of the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizers

“Article 20. Experiments on fertilizer

1a. Entities that meet all of the following conditions shall be eligible to carry out fertilizer experiments:

a) Conditions to be satisfied by a fertilizer experiment facility: Have functions or duties to carry out fertilizer experiments or research on fertilizer in the establishment decision granted by a competent authority; personnel requirement: have at least 03 technicians who are permanent employees or employees with 01-year or above contracts, possess bachelor's degree or higher in agrochemistry – pedology, or agronomy, or cultivation, or in other relevant majors such as chemistry, or biology, or environment, and have at least 02 years of experience in experiment or research on fertilizer;

b) Conditions to be satisfied by a fertilizer producer or importer that itself carries out the fertilizer experiments: Have a license to producer fertilizer (for fertilizer producer) or Certificate of enterprise registration or Investment Certificate or Business registration certificate (for importer of fertilizer for trading); personnel requirement: as referred to in Point a of this Clause.”

Chapter V

GAS BUSINESS

Article 22. Addition of Article 18a to the Government’s Decree No. 19/2016/ND-CP dated March 22, 2016 providing for gas business

“Article 18a. Conditions for issuance of Certificate of eligibility for LPG bottle testing

1. A LPG bottle test station that meets the following conditions shall be eligible to have a Certificate of eligibility for LPG bottle testing granted:

a) Have legal status;

b)Have regulations on safety and process for LPG bottle testing approved by the station’s leader as regulated;

c) Have necessary equipment to serve the testing. To be specific:

- Equipment for recovering residual LPG in bottles;

- Devices for measuring metal thickness, weld ultrasonic flaw detector;

- Equipment for assembling and disassembling bottle valves;

- Equipment for testing durability and tightness;

- Water remover;

- Equipment for checking the inside of bottle;

- Surface cleaning equipment;

- Scales;

- Stamping equipment;

- Vacuum suction equipment.

All equipments mentioned above must have technical parameters and output in conformity with the testing capacity of LPG bottle test station.

d) Have qualified personnel to serve the testing: Employees who directly carry out the testing must be trained in professional skills and safety in bottle testing with certificates thereof granted, and have at least 02 years of working experience;

dd) Have plans for firefighting and prevention approved, and fire equipment equipped in accordance with applicable laws.

2. Certificates of eligibility for LPG bottle testing are issued by Ministry of Industry and Trade”.

Article 23. Addition of Article 18b to the Government’s Decree No. 19/2016/ND-CP dated March 22, 2016 providing for gas business

“Article 18b. Conditions for issuance of Certificate of eligibility for production/ repair of LPG bottles

1. An establishment producing/repairing LPG bottles may have a Certificate of eligibility for production/repair of LPG bottles if all of the following conditions are satisfied:

a) Have legal status;

b) Have regulations on safety, LPG bottle manufacturing process and processes for quality control of manufactured products approved by the establishment’s head;

c) Have testing equipment which meets requirements on control of safety and quality of manufactured LPG bottles. To be specific:

- Pressure testing system: creating a pressure of not less than 3MPa;

- Gas tightness testing system;

- Non-destructive testing equipment: weld quality testing equipment and ultrasonic thickness gauges;

- Equipment for testing components and mechanical properties of materials used to manufacture LPG bottles;

- Scales;

- Tightening torque measuring tools.

d) Have testing equipment operators and welders who must meet the following requirements:

- Testing equipment operators must be trained in professional skills and safety techniques as regulated;

- LPG bottle welders must possess Certificates of pneumatic tools welding as regulated.

dd) Have plans for firefighting and prevention approved, and fire equipment equipped in accordance with applicable laws.

2. Certificates of eligibility for production/ repair of LPG bottles are issued by Ministry of Industry and Trade”.

Chapter VI

FOOD BUSINESS SECTOR UNDER THE STATE MANAGEMENT OF MINISTRY OF INDUSTRY AND TRADE

Section 1. GENERAL REGULATIONS

Article 24. Conditions for investment and trading in food sector under the state management of Ministry of Industry and Trade

1. Food production and trading establishments that are required to have Certificates of conformity with food safety regulations under the management of Ministry of Industry and Trade must:

a) Have Certificate of enterprise registration, Certificate of household business registration or other papers of equivalent legal effect;

b) Have conditions for ensuring food safety in conformity with each type of production or trading in foods as referred to in Sections 2, 3, 4, 5, 6, 7 Chapter VI of this Decree.

2. Food production and trading establishments that are not required to have Certificates of conformity to food safety regulations as referred to in Clause 1 Article 12 of the Decree No. 38/2012/ND-CP under the management of Ministry of Industry and Trade must satisfy the following conditions:

a) Have conditions for ensuring food safety in conformity with each type of production or trading in foods as referred to in Section 8 Chapter VI of this Decree;

b) Make commitments with competent authorities appointed by provincial people’s committees to manage foods safety in provincial areas.

Article 25. Conditions for appointment of testing establishment and reference testing establishment in food safety under the state management of Ministry of Industry and Trade

1. Conditions for appointment of food testing establishment:

a) Must be established under the law or assignment decision of a competent authority;

b) Have quality management system that must meet regulations in TCVN ISO/IEC 17025:2007 or ISO/IEC 17025:2005;

c) Have equipment and facilities that meet requirements on testing methods;

d) Have at least 02 testers who must be technicians possessing bachelor’s degrees in testing;

dd) Have testing methods updated with value certified;

e) Have criteria/assays complying with regulations or corresponding technical regulation and other relevant requirements adopted by supervisory ministries.

2. Conditions for appointment of food reference testing establishment:

a) Must be appointed by Ministry of Industry and Trade as referred to in Clause 1 of this Article;

b) Have quality management system certified to be conformable with TCVN ISO/IEC 17025:2007 or ISO/IEC 17025:2005, and that certification of conformity must be valid for at least 01 more year from the application for registration of appointment;

c) Have results of proficiency testing or interlaboratory comparison conformable with requirements on criteria/assays registered for reference testing.

Section 2. GENERAL FOOD SAFETY CONDITIONS TO BE SATISFIED BY FOOD PRODUCTION ESTABLISHMENT

Article 26. Conditions to be satisfied by food production establishment

1. Location and environment:

a) Production location must have enough area for the placement of food production area and auxiliary areas in order to facilitate the food production, storage and transportation;

b) No standing water or pooled water is present in the manufacturing and storage areas;

c) Pests and other contaminants are prevented from affecting the manufacturing facility;

d) The food safety is protected from the pollution by dust, toxic chemicals chemicals and other sources of pollution.

2. Workshop design:

a) Production workshop and auxiliary areas must have enough area for arranging the food production line and be conformable with its design use;

b) The food manufacturing process shall be designed according to one-way rule from raw materials to finished products;

c) The following areas shall be designed to be situated separately: raw materials storage, finished products storage; preparation, processing and packaging areas; restrooms; protective clothing change rooms and relevant auxiliary areas. Raw materials, finished foods, packing materials and waste must be separately placed;

d) Internal roads shall be constructed to ensure hygienic standard; drainage system must be covered closely to ensure hygienic standard;

dd) The waste collection and treatment area must be outside the food manufacturing area and ensure hygienic standards.

3. Workshop structure:

a) The workshop must have a firm structure suitable to the nature, scale and process of food production technology;

b) Materials in direct contact with foods must have a smooth surface, be impervious to water, not release harmful substances into the foods, not be eroded by detergents, disinfectants, and be easily cleanable and sterilized;

c) Walls must be flat, in bright color, impervious to water, not cracked, not adhered by dirty substances and be easily cleanable; ceilings must be flat, in bright color, not leaked, impervious to water, not cracked, not adhered by dirty substances and easily cleanable;

d) Floors must be flat, smooth, load-bearing, not slippery, well-drained without pooled or standing water, and easily cleanable;

dd) Front door and windows must be smooth, tight, convenient for cleaning and not be penetrated by pests or domestic animals;

e) Stairs, flight of steps and shelves must be not slippery, be easily cleaned and located at places suitable to the manufacturing process.

4. Air ventilation system:

a) The ventilation for areas of the production establishment must be ensured and correspond to the type of food production; the air ventilation system must be easily maintainable and cleanable;

b) The air flow direction of the air ventilation system must be ensured in a manner of not blowing from the contamination-prone areas to area where the cleanness is a must.

5. Lighting system:

a) Lighting system must be constructed as regulated in order to meet requirements on the production, quality control and food safety;

b) Lamps must be safely covered by boxes or grids in order to avoid lamp break and ensure that broken lamps may not fall into foods.

6. Water supply system:

a) Clean water must be sufficiently provided to serve the food production and conformable with regulations on the quality of edible and drinkable water;

b) Clean water must be sufficiently provided to clean equipment, devices, clean the production establishment and must be conformable with regulations on the quality of edible and drinkable water;

c) Water sources exploited, treated and used by the production establishment must be inspected and conformable with regulations on the quality of edible and drinkable water; the inspection of hygiene must be carried out for every 6 months.

7. Steam and compressed air:

a) Steam and compressed air used for the food production must be clean, safe, and must not contaminate foods;

b) Water used for food production shall be run in different pipes with different color from the water pipeline system for the purposes of production of steam, chilling, firefighting or for other purposes.

8. Waste treatment system:

a) Waste and garbage containers must be available; such containers must be made of firm materials, closely covered and may be locked (where necessary). Containers of dangerous waste must have a specialized design to be easily differentiated from others, and may be equipped with locks to prevent pollution;

b) The waste treatment system must be operated on a regular basis and the waste must be treated in conformity with standards referred to in the regulations on hygiene and environment.

9. Restrooms, protective-clothing change rooms:

a) Restrooms must be constructed far away from the food production area; the restroom door is not opened towards the food production area; at least 01 restroom is available for 05 persons;

b) The air ventilation is constructed in a manner that the air flow does not blow from the restrooms to the food production area; the drainage system works well and ensure sanitary conditions. The board “Rửa tay sau khi Di vệ sinh” (“Wash your hands after using the restroom”) must be hung at a noticeable place in the restroom;

c) There is a room to change the protective clothing before and after working.

10. Food raw materials and food packing materials:

a) Food raw materials, food additives, food processing aids and preservative substances used in the food production must have clear origin and ensure safety as regulated;

b) Food packing materials must be reliable and safe; the chemical contaminants from the food packaging materials do not migrate into foods and those materials are not contaminated that affect to the food safety and quality.

Article 27. Equipment and device requirements

1. Equipment and devices in direct contact with foods must be manufactured in a such manner as to satisfy production technology requirements; be safe and not pose a food contamination issue, and easily assessable for cleaning, sterilization and maintenance. Mobile production equipment and devices must be durable, easily movable, assemble and cleanable.2. Hand wash and sterilization stations:

a) Provide with equipment for hand washing, sterilization of hands, boots, and footwear before entering into the food production areas;

b) The hand wash stations must have sufficient clean water, disinfectants, disposable towels or paper towels or hand dryers;

c) The food workshop must have hand wash sinks for employees.

3. Food production equipment and devices:

a) Equipment and devices serving the food production must be sufficient and suitable for the processing of materials, food processing and packing;

b) Materials of equipment and devices must be non-toxic, corrosion-resistant, non-rusty; not to release toxic substances into foods, and not to cause strange smell or food changes;

c) Equipment and devices must be easily cleanable and maintainable; and lubricants and metal debris thereof do not contaminate foods;

d) Equipment and devices of the production line must have proper sanitary and operational procedures.

4. Pest control:

a) Pest control devices must be made of stainless, easy to disassembly for cleaning, and be designed in a manner to prevent the pest infestation;

b) No drug or animals is used to destroy rats and pests in the food production area.

5. Monitoring and measuring instruments:

a) Instruments must be available for the purposes of monitoring the food quality and safety and able to assess basic food quality and safety criteria. Measuring instruments must ensure the accuracy in the course of use, be inspected, calibrated and tested as referred to by the law on measurement;

b) Monitoring and measuring instruments must have guaranteed accuracy, be maintained and inspected on a periodical basis as regulated.

6. Detergents and antiseptics:

a) Only permitted detergents and antiseptics are used;

b) Detergents and antiseptics must be contained in recognizable packages with guidance for use and must not be dropped in the food production area.

Article 28. Conditions to be satisfied by persons directly participating in the food production

1. The production establishment's owner and persons who directly participate in the food production must have Certificates of competence in food safety according to the training program adopted by Ministry of Industry and Trade.

2. The production establishment's owner and persons who directly participate in the food production must satisfy health conditions when participating in the food production process; for areas having diarrhea epidemic as announced by competent authorities, persons directly participating in the food production must be performed stool culture and must be tested negative for pathogens causing this diarrhea epidemic and cholera, dysentery, bacillus and typhoid; the medical testing are performed by health facilities of urban/suburban district or equivalent or higher level. With regard to food manufacturing facilities that are required to have Certificates of conformity to food safety regulations, the production establishment's owner and persons directly participating in the food production must come under the health check and obtain certificate of good health as referred to by law.

3. Persons suffered from diseases such as developed tuberculosis, acute diarrhoea, cholera, dysentery, bacillus, typhoid, hepatitis A or E, acute respiratory tract infection, or acute dermatitis or skin infection may not directly take part in the course of food production and processing.

4. Persons directly participating in the food production must dress separate protective clothing, wear specialized hats, gloves and mark.

5. Persons directly participating in the food production must obey provisions on practice for hygiene assurance: Keeping fingernails short and clean and not to wear rings, jewelry or wrist-watches; not eating, drinking, smoking and spitting in the food production area.

Article 29. Conditions on food preservation in food production

1. Raw materials, packages and finished foods must be preserved in separate storing area or warehouse for each type with suitable area.

2. Warehouse must be designed in conformity with requirements on preservation and delivery of each type of foods and food raw materials; ensure safety, ventilation, easy to cleanse and prevent from penetration and habitation of insects and harmful animals.

3. The storing area or warehouse for preserving foods must have sufficient name boards; internal rules, process, hygiene regulations; for raw materials and finished foods requiring a special preservation, books for monitoring temperature, humidity and other conditions must be equipped.

4. Raw materials and food products must be packed and preserved at position with distance from the floor of not less than 12m, distance from the walls of not less than 30cm and distance from the ceiling of not less than 50cm.

5. Having specialized equipment for adjusting temperature, humidity, air ventilation and elements affecting the food safety; specialized equipment must be suitable and ensure it is able to monitor and control mode of preservation with respect to each type of foods/ materials at the request of producers; must be easily maintained and cleaned.

6. Equipment/ tools must be available to monitor temperature, humidity and elements affecting the food safety during the course of food production.

7. Ice water used in the food preservation must be produced from clean water sources in according to national technical regulation.

Section 3. GENERAL CONDITIONS ON FOOD SAFETY TO BE SATISFIED BY FOOD TRADING ESTABLISHMENTS

Article 30. Conditions for food trading establishments

1. There must have enough area at the trading establishment for displaying foods for sale, storing and maintaining foods, and facilitating the transport of materials and food products.

2. No standing water or pooled water is present in the trading establishment.

3. Pests and other contaminants are prevented from affecting the trading establishment.

4. The food safety is protected from the pollution by dust, toxic chemicals chemicals and other sources of pollution.

5. Food selling area, restroom, protective clothing change room and other auxiliary areas must be designed separately from each other and in conformity with requirements on each type of traded foods. The restroom door is not opened towards the food storing area.

6. The trading establishment’s structure must be conformable with the nature and scale of each type of traded foods; it must be constructed of materials that meet hygiene conditions and can prevent the penetration of pests, insects and animals.

7. The floor of the trading establishment must be flat and smooth with firm and load-bearing surface; the floor must be not slippery, be well-drained without pooled or standing water, and easily cleanable.

8. Walls and ceiling must be flat, in bright color, made of firm and durable materials, not leaked, not cracked, and not adhered by dirty substances.

9. Front door and windows must be smooth, flat and convenient for cleaning. Protective net should be installed at necessary places to prevent the penetration of pests or animals.

10. Lighting system and luminous intensity must conform to the food producer’s requirements on food preservation; Lights must be protected by lampshades or protective nets.

11. The air ventilation system must be conformable with food preservation requirements and ensure that all areas shall be ventilated.

12. Waste and garbage containers must be available; such containers must be made of firm materials, closely covered and cleaned on a regular basis.

13. Devices, soap and detergents for cleaning and washing hands must be available at the hand wash area. The board “Rửa tay sau khi Di vệ sinh” (“Wash your hands after using the restroom”) must be hung at a noticeable place.

14. Clean water must be sufficiently provided to clean equipment, devices, and clean the trading establishment in conformity with the national technical regulation on domestic water quality.

15. Books or software for management of food safety must be maintained during the business operation. Traded foods and food materials must have clear origin and unexpired shelf life, and ensure food safety standards as regulated.

16. Cleaning process and diary reports on hygiene must be maintained by the trading establishment's owner.

Article 31. Equipment and device requirements

1. Equipment serving the food trading and storage must be conformable with requirements by each type of foods and those of food producer (food display cases and cabinets, equipment for adjusting temperature, humidity, air ventilation in food sale and storage areas); regulations on hygiene processes must be available.

2. Equipment for adjusting temperature, humidity, air ventilation and elements affecting the food safety must be available in conformity with technical requirements for each type of foods and those of food producer during the food trading process.

3. Equipment for preventing the penetration of insects and harmful animals must be stainless, easy to disassembly for maintenance and cleaning, and must ensure effective operation in preventing the penetration of insects and harmful animals. Chemicals and animals shall not be used to destroy rats and insects in food sale and storage areas.

4. Instruments and equipment for monitoring and measuring the food quality and safety must have guaranteed accuracy, be maintained and inspected on a periodical basis as regulated.

Article 32. Conditions to be satisfied by persons directly selling foods

1. The food trading establishment’s owner and persons directly selling foods must satisfy all of conditions referred to in Clauses 1, 2, 3 Article 28 of this Decree.

2. Persons directly selling foods must dress separate protective clothing in conformity with hygienic regulations.

Article 33. Requirements on preservation and transportation of foods for sale

1. Apart from regulations in Article 29 of this Decree, the food preservation must meet the following food safety conditions:

The food preservation area must be equipped with sufficient shelves or cases which must be made of firm and hygienic materials. Foods must be packed and preserved at position of not less than 15 cm, 30 cm and 50 cm far away from the floor, the wall and the ceiling respectively. Foods must be stacked in the warehouse in conformity with stacking height instructed by the food producer.

2. Food safety conditions in course of food transportation:

a) Instruments for storing foods must be separated from the surroundings, avoid the intrusion of dirt and insects, and be appropriate for the transported amount of foods;

b) The specialized transport equipment and instruments in direct contact with foods during the transportation must be made of materials that do not contaminate the foods or the food wrappings, and are easily cleanable;

c) Equipment for adjusting temperature, humidity, air ventilation and elements effecting the food safety must be available in conformity with technical requirements for preserving each type of foods and those of food producer during the transportation of foods;

d) Regulations on the conditions for ensuring the food safety during the transport must be adopted; food preservation conditions must be maintained and controlled during the food transportation; with respect to foods requiring special preservation, specific procedures for delivering and receiving foods must be carried out;

dd) Instruments and equipment must be cleaned before, during, and after the transportation of foods; foods must not be transported together with goods that are harmful or may cause cross-contamination and affect on the food safety and quality.

Section 4. FOOD SAFETY CONDITIONS TO BE SATISFIED BY PROCESSED MILK PRODUCTION ESTABLISHMENT

Article 34. Food safety conditions to be satisfied by processed milk production establishment

1. The processed milk production establishment must have a production site which meets the following requirements:

a) The production site must be situated far from sources of pollution or hazards and not be affected by pollutants from the surrounding environment on the quality and safety of processed milk products;

b) The production site’s area must be enough for arranging the production line in conformity with the establishment’s design capacity, ensuring that production stages comply with technology requirements and industrial sanitation measures.

2. The processed milk production establishment must have the workshop design which meets the following requirements:

a) The production line shall be located in an area not affected by sources of pollution such as boiler, wastewater treatment station, solid waste collection site and toilet area;

b) The workshop shall be designed according to the one-way rule from input materials to final products which are processed milk of all kinds;

c) Raw material warehouse, supplies and packaging warehouse, final product warehouse, production areas (material preparation, processing, filling and packaging and product finishing, clean-in-place system (CIP), mechanical and power system), chemical warehouse, solid waste collection site, wastewater collection and treatment system, and other auxiliary works must be separated from one another to avoid the cross-contamination;

d) Internal roads shall be designed and built in a way that ensures the solidity, durability and suppression of dust; overhead walkways shall be installed with handrails or partitions which facilitate the observation and ensure occupational safety;

dd) Water drainage system (for wastewater generated from the production and daily-life activities and rainwater) shall be designed and built separately, have covers and a suitable slope to ensure a complete drainage.

3. The workshop structure must meet the following requirements:

a) The ground of production areas must facilitate the water drainage and shall be built of durable, difficult-to-peel-off, anti-slip and easily cleanable materials. The water drainage system in production areas must have covers;
b) Catch pits must have traps to prevent sewer odor and insects, and restrict the penetration of microorganisms from sewer systems into the workshop;

c) Pipe systems must be painted in different colors and must have distinguishable characteristics.

4. The air ventilation system must meet the following requirements:

a) The workshop must have ventilation doors to ensure the air circulation and facilitate the dissipation of heat and exhaust generated from production activities; in case of forced ventilation, air conditioning equipment must provide sufficient fresh air and ensure air circulation;

b) The area where the filling line is installed must always be kept dry, well ventilated and clean.

5. The water supply and storage system must meet the following requirements:

a) To supply sufficient quality water;

b) There must be sufficient pump systems, water treatment systems, water tanks and water pipe systems which are always in good condition and regularly inspected to prevent backflow or blockage;

c) Water supply systems must be separate, have noticeable signs, and be easily cleanable so as to ensure safety of the clean water source and avoid the contamination;

d) Water storage, settlement and filtration tanks must fit water treatment technology and shall be cleaned according to regulations or when necessary;

dd) Upon occurrence of an incident related to the water quality, the production shall be immediately stopped and products produced during the occurrence of the incident shall be isolated;

e) There must be standby electricity generators and water pumps so as to ensure uninterrupted production in case of power outage or water pump failures;

g) After being treated up to standards applicable to milk production, water shall be stored and preserved so as to avoid the contamination from sources of pollution.

6. Steam, heat and compressed air supply systems must meet the following requirements:

a) Steam boilers shall be designed and installed in places separated from production areas and regularly inspected according to current regulations;

b) Steam and compressed air pipe systems shall be designed and securely installed, easily distinguished from other pipe systems, and regularly inspected according to current regulations.

7. Waste, wastewater and exhaust gas collection and treatment systems must meet the following requirements:

a) Solid waste

- Solid wastes shall be collected in suitable tanks or containers put in places convenient for waste collection and treatment without causing adverse impacts on the production process;

- Scrap containers shall be clearly labeled or have signs for distinction from containers of raw materials, semi-finished products and finished products; be made of waterproof and corrosion-resistant materials; be tight and easy to clean (for reusable containers) or easy to destroy (for disposable containers);

- Solid wastes shall be treated by organizations or individuals licensed to operate in the field of environmental treatment by competent state management agencies.

b) Industrial and daily-life wastewater

- Wastewater treatment facilities shall be located separately from production areas;

- Wastewater treatment capacity and technologies must suit the peak discharge so as to ensure that treated wastewater is up to prescribed environmental standards;

- It is not permitted to directly discharge untreated wastewater into the surrounding environment; drains in production areas must run from clean to less clean areas and ensure complete drainage when the water flow stops;

- Catch pits must have lids; drains and catch pits in production areas shall be cleaned at the end of each workday and regularly dredged according to regulations.

c) Exhaust gas from a production area and steam boilers shall be treated so as to cause no adverse impacts to other production areas.

d) Hazardous wastes

- Hazardous wastes shall be collected, stored, transported and treated separately according to current regulations;

- Hazardous wastes shall be managed and treated by organizations and individuals licensed to operate in environmental treatment with respect to treatment of hazardous wastes by competent state agencies.

8. The warehouse system must meet the following requirements:

a) Raw material and additive warehouses:

- Raw material and additive warehouses shall be separated from production areas;

- Raw materials and additives shall be placed in shelves or stands and kept away from direct sunlight;

- Raw material and additive warehouses must satisfy temperature, moisture, storage duration requirements and other storage conditions as instructed or required by producers;

- Raw materials and additives which have their sacks opened but have not yet been used up shall be securely closed after each use and stored according to regulations;

- Raw materials and additives stored in warehouses must have information on their names and use duration;

- Raw milk warehouses: Milk purchasing stations must have chilling systems and equipment, devices and chemicals to test the quality of raw milk, and must keep samples of purchased milk; raw milk tanks must have a heat- resistant layer and inner layer made of contamination-resistant materials that can maintain the temperature of 4^oC-6^oC; the storage period of raw milk, counting from the time of milking till the time of processing, must not exceed 48 hours; immediately after being used, milk tanks shall be cleaned to be free of microorganisms and chemical detergent residues according to regulations;

- Raw material and additive warehouses shall be regularly maintained and cleaned according to internal regulations.

b) Supplies, packaging and chemical warehouses

- Supplies, packaging and chemical warehouses shall be located separately from production areas;

- Supplies and packaging shall be kept away from direct sunlight;

- Packaging in direct contact with products shall be stored according to regulations of producers;

- The storage duration and other preservation conditions must comply with the instructions or regulations of producers;

- Supplies, packaging and chemical warehouses shall be regularly maintained and cleaned according to internal regulations.

c) Finished product warehouse

- Finished product warehouse shall be located separately from production areas and must be convenient for warehousing and ex- warehousing activities;

- Finished product warehouse shall always be kept at a certain temperature as required, be dry, clean and well ventilated and stored products shall be kept away from direct sunlight so as to avoid changes in their quality, appearance and safety;

- There must be a separate space for keeping substandard quality products pending disposal;

- Finished product warehouse shall be regularly maintained and cleaned according to internal regulations;

- Products stored in the finished product warehouse must have information on their name, lot number, date of manufacture, production shift and use duration;

- For products which require cold preservation:

+ Products shall be stored in refrigerated warehouse, ensuring that cold air is always distributed to every corner of the warehouse;

+ Refrigerated warehouse shall always be kept at a certain temperature as required for each type of product.

9. Production area must meet the following requirements:

a) Raw material preparation area

- Raw materials shall be sorted by type and put in shelves or stands;

- Flavorings shall be prepared separately so as to avoid the cross-contamination;

- Measuring devices must operate accurately and properly;

- The production area shall be regularly cleaned to avoid dust and stagnant water;

- Only responsible or authorized persons may enter the area where raw materials are handed over for production.

b) Processing area

- Processing equipment shall be cleaned before each production cycle every day;

- Rubbish shall be collected in plastic bags placed at designated places;

- Persons working in the material mixing or blending area, who are in direct contact with products, must wear waterproof, durable, light-colored and food-safe gloves;

- The processing area shall be cleaned every day or after each production cycle of each type of product;

c) Filling and packaging area

- The chambers where filling lines are located must be closed, aseptic and kept at 20^oC-28^oC with a positive air pressure relative to the outside;

- Filling equipment must be aseptic during the filling process;

- The inner surface of the pipes conducting products to filling equipment must be disinfected according to regulations;

- Filling equipment shall be cleaned every day or after each production cycle of each type of product;

- Only responsible or authorized persons may enter the filling and packaging area to avoid cross-contamination.

d) Finished product area

- The area where milk products are packaged must be cleaned before the packaging takes place and always kept dry;

- Devices and equipment for packing finished milk products (thin-film packaging machines, use duration printers, carton filling conveyors) shall be well cleaned.

10. The production establishment must have internal transport system to ensure that processed milk products may not be transported in the same tanks or vehicles with supplies, raw materials and chemicals as this might cause cross contamination affecting the quality and safety of the products. The production establishment’s owner shall specify (in writing) requirements on vehicles for, and mode of, internal transportation of processed milk products as well as preservation conditions and food safety management during internal transportation.

11. The raw material and product quality control system must meet the following requirements:

a) Quality control areas shall be situated separately and conveniently for quality control during the production process; be equipped with essential machinery, equipment and instruments to measure and inspect basic quality criteria of major raw materials and finished products. Microorganism testing sections must be aseptic and isolated from other testing sections;

b) If the quality control section is unavailable, the processed milk production establishment must sign a contract with an outside qualified organization to carry out the inspection of basic criteria of main raw material and finished product;

c) There must be places for preserving samples and keeping dossiers of preserved samples. Establishments shall comply with regulations on sample preservation and destruction applicable to each type of sample.

12. Management of records

a) A processed milk production establishment shall keep sufficient management records (contracts, invoices, documents, quality testing slips, dossiers for declaration of conformity or declaration of conformity with food safety regulations, and other relevant documents) for raw materials, auxiliary materials, additives, processing aids, supplies packages and chemicals to serve origin tracing and food safety and quality control;

b) A processed milk production establishment must have sufficient food safety management records according to regulations (Certificate of satisfaction of food safety conditions, Certificate of declaration of conformity or Certificate of declaration of conformity with food safety regulations) for its processed milk products.

13. The processed milk production establishment’s owner and persons directly participating in production:

The processed milk production establishment’s owner and persons directly produce milk products must satisfy all of conditions mentioned in Article 28 of this Decree.

Article 35. Instruments, equipment and packages storing processed milk

1. Instruments and packages in direct contact with processed milk products must comply with the national regulations on hygiene safety for packages and instruments in direct contact with foods.

2. Machinery, equipment and utensils in contact with milk and raw materials shall be synchronously designed and manufactured, made of rustless materials, do not cause harms when being used for the intended purpose, and can be easily cleaned, disinfected and maintained whenever necessary so as to avoid contamination.

3. Equipment for heat-treating, cooling, chilling, and refrigerated storage of milk shall be designed in a way that can quickly reach and maintain the necessary temperature; and ensure the monitoring and control of temperature as required.

4. Air blown directly to products (if any) must be aseptic.

5. An alarming system must be installed in case processing parameters (temperature, pressure) exceed permissible limit.

6. Waste and hazardous chemical containers shall be designed in a suitable manner to ensure safety, and be made of durable materials.

7. Production, processing and testing equipment and devices must be regularly maintained and replaced when they are damaged or show signs of damage.

Testing and measuring devices and equipment subject to strict safety requirements must be calibrated and inspected according to regulations.

8. The repair and maintenance of machinery and equipment shall be conducted outside production areas or when production activities have been stopped. In case of on-site repair or regular maintenance, machinery, equipment and surrounding areas shall be cleaned upon the completion of such repair or maintenance;

9. Lubricant oils and greases used for equipment and machinery in direct contact with products must be those permitted for use in food production.

Section 5. FOOD SAFETY CONDITIONS FOR BEER PRODUCTION ESTABLISHMENT

Article 36. Conditions to be satisfied by beer production establishment

1. Production site

a) To be built under the current plan approved by a competent state authority;

b) To be situated far from sources of pollution or hazards and other pollutants in the surrounding environment in order to avoid causing adverse impact on the quality and safety of beer products;

c) To have sufficient space for arranging production lines suitable to the establishment’s design capacity, ensuring that technology requirements are satisfied and industrial sanitation measures are applied at all production stages.

2. Workshop layout and design

a) The arrangement of production lines shall take into account wind directions so as to avoid adverse effects of sources of pollution such as steam boilers, wastewater treatment facilities, solid waste collection sites, toilet area and other pollutants;

b) Warehouses (raw material, auxiliary material, processing aid and product warehouses); production areas (areas for material preliminary processing, cleaning and processing; areas where malting equipment, yeast propagation equipment, fermentation tanks, whirlpools, filtration tanks and filling and product finishing lines are located); clean-in-place (CIP) systems; mechanical and power systems; solid waste collection sites and wastewater collection and treatment systems; and other auxiliary works shall be separated from one another to avoid the cross-contamination;

c) Internal roads shall be designed and built in a way that ensures solidity, durability and suppression of dust; overhead walkways shall be installed with handrails or partitions which facilitate observation and ensure occupational safety;

d) Water drainage systems (for wastewater generated from daily-life and production activities and rainwater) shall be designed and built separately, have covers and a suitable slope to ensure complete drainage.

3. Workshop structure:

a) The area where material grinding and crushing machines are located must neither generate dust to the surrounding environment nor affect other production stages;

b) The area where mashing coppers are located shall be adequately lit and ventilated so as to maintain a temperature as required;

c) The area where yeast propagation equipment is located must ensure sanitation conditions and meet technological requirements and be easily cleanable and disinfectable.

d) The area where fermentation tanks are located:

- The ground of the area shall be built of durable, anti-slip and difficult- to-peel-off materials, and have a suitable slope to ensure complete drainage;

- In case fermentation tanks are located in a workshop, the ceilings and walls of the workshop shall be built of waterproof, easily cleanable and anti- mold materials;

- In case yeast is produced right in the production area, the workshop where the yeast propagation equipment is located shall be designed in a way that can ensure asepsis, equipped with a disinfection system and placed under constant control to ensure yeast quality;

- In case the yeast is produced outside the production area, there must be devices and equipment to ensure yeast safety and avoid contamination during the process of yeast delivery and receipt.

dd) The area where filtration tanks and filing systems are located:

- The area shall be situated isolatedly in order to ensure asepsis and avoid insects and cross-contamination from nearby sources of pollution;

- The grounds of workshops shall be built of durable, anti-slip and difficult-to-peel-off materials and must ensure complete drainage. Water drainage systems must have covers.

4. Air ventilation system:

- The workshop must have ventilation doors to ensure the air circulation and facilitate the dissipation of heat and exhaust gas generated from production activities;

- The area where material grinding and crushing machines are located must have ventilation and air filtration systems to prevent the pollution to other production stages;

- The area where mashing coppers are located shall be designed in a way that can ensure air ventilation, quick dissipation of heat, moisture and odor and maintenance of a temperature and occupational safety as required.

5. Water supply system:

a) To supply sufficient quality water;

b) There must be sufficient pump systems, water treatment systems, water tanks and water pipe systems which are always in good condition and regularly inspected to prevent backflow or blockage;

c) Water supply systems must be separate, have noticeable signs, and be easily cleanable so as to ensure safety of the clean water source and avoid the contamination;

d) Water storage, settlement and filtration tanks must fit water treatment technology and shall be cleaned according to regulations or when necessary;

dd) Upon occurrence of an incident related to the water quality, the production shall be immediately stopped and products produced during the occurrence of the incident shall be isolated;

e) There must be standby electricity generators and water pumps so as to ensure uninterrupted production in case of power outage or water pump failures;

g) After being treated up to standards applicable to beer production, water shall be stored and preserved in separate devices so as to avoid the contamination from sources of pollution.

6. Steam, heat and compressed air supply systems

a) Steam boilers shall be designed and made of suitable materials, installed in places separated from production areas and regularly inspected according to current regulations;

b) Steam and compressed air pipe systems shall be designed and made of suitable materials, securely installed, easily distinguished from other pipe systems, and regularly inspected according to current regulations.

7. Waste, wastewater and exhaust gas collection and treatment systems

a) Solid waste:

- Solid wastes shall be collected in suitable tanks or containers put in places convenient for waste collection and treatment without causing adverse impacts to the production process;

- Scrap containers shall be clearly labeled or have signs for distinction from containers of raw materials, semi-finished products and finished products; be made of waterproof and corrosion-resistant materials; be tight and easy to clean (for reusable containers) or easy to destroy (for disposable containers);

- Brewing grains shall be collected once every 48 hours;

- Reusable papers, labels, broken bottles, used or damaged bottle caps shall be collected, sorted at source and stored in distinguishable bags or bins according to internal regulations before being transported to recycling facilities;

- Solid wastes shall be treated by organizations or individuals licensed to operate in the field of environmental treatment by competent state management agencies.

b) Industrial and daily-life wastewater:

- Wastewater treatment facilities shall be located separately from production areas;

- Wastewater treatment capacity and technologies must suit the peak discharge so as to ensure that treated wastewater is up to prescribed environmental standards;

- It is not permitted to directly discharge untreated wastewater into the surrounding environment; drains in production areas must run from clean to less clean areas and ensure complete drainage when the water flow stops;

- Catch pits must have lids; drains and catch pits in production areas shall be cleaned at the end of each workday and regularly dredged according to regulations;

- Beer production establishments located in industrial parks shall discharge wastewater into centralized drainage systems of industrial parks according to current regulations on environmental management in industrial parks.

c) Exhaust gas from a production area and steam boilers shall be treated so as to cause no adverse impacts to other production areas.

d) Hazardous wastes:

- Hazardous wastes shall be collected, stored, transported and treated separately according to current regulations;

- Hazardous wastes shall be managed and treated by organizations and individuals licensed to treat hazardous wastes by competent state agencies.

8. Warehouse system

a) General requirements on warehouses (raw material, additive, processing aid, supplies, packaging and finished product warehouses):

- Having a storage capacity suitable to design capacity of the production line;

- Being periodically maintained and cleaned according to internal regulations;

- Meeting preservation conditions according to instructions or regulations of producers;

- Being capable of preventing the penetration of insects, rodents and other harmful elements;

- Having information for identifying each type of raw material, additive, processing aid, supplies, packaging and finished product; having warehousing and ex-warehousing records;

b) Chemical warehouses must meet preservation requirements and conditions according to producers’ instructions or regulations and current regulations on chemical preservation.

c) Finished product warehouse

Apart from regulations in Clauses 2, 3, 4, 5 of Article 29, finished product warehouses must meet the following conditions:

- The warehouses shall always be kept at a certain temperature and moisture as required in internal regulations for each type of beer;

- Products stored in finished product warehouses must have information on their name, lot number, date of manufacture, production shift and use duration according to internal regulations;

- There must be a separate space for keeping substandard quality products pending disposal.

9. Raw material and product quality control systems

a) Quality control areas shall be situated separately and conveniently for quality control during the production process; be equipped with essential machinery, equipment and instruments to measure and inspect basic quality criteria of major raw materials and finished products. Microorganism testing sections must be aseptic and isolated from other testing sections;

b) If no quality control section is available, beer production establishments shall outsource the control of basic quality criteria of major raw materials and finished products to inspection and analysis organizations that have suitable professional capacity and qualifications;

c) There must be places for preserving samples and keeping dossiers of preserved samples. Establishments shall comply with regulations on sample preservation and destruction applicable to each type of sample.

10. Internal transportation

a) Establishment owners shall specify (in writing) requirements on vehicles for, and mode of, internal transportation of beer products as well as preservation conditions and food safety management during internal transportation;

b) Beer may not be transported in the same tanks or vehicles with supplies, raw materials and chemicals as this might cause cross contamination affecting the quality and safety of the products.

11. Management of records

a) A beer production establishment shall keep sufficient management records (contracts, invoices, documents, quality testing slips, dossiers for declaration of conformity or declaration of conformity with food safety regulations, Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations and other relevant documents) for raw materials, auxiliary materials, additives, processing aids and packages to serve origin tracing and food safety and quality control;

b) A beer production establishment must have sufficient food safety management records according to regulations (Certificate of satisfaction of food safety conditions, Certificate of declaration of conformity with regulations or Certificate of declaration of conformity with food safety regulations and records of periodical testing results) for its beer products.

12. The beer production establishment’s owner and persons directly produce foods must satisfy all of conditions mentioned in Article 28 of this Decree.

Article 37. Equipment and device requirements

1. Instruments and packages storing beer are instructed in the national regulations on hygiene safety for packages and instruments in direct contact with foods.

2. Containers of raw materials and finished products must be made of materials which do not contaminate products.

3. Grinding and crushing machines must be suitable to technologies applicable to each type of material and be thoroughly cleaned before and after use.

4. Mashing, malting and lautering equipment:

a) These equipment must have safety valves in good condition and shall be periodically maintained and repaired so as to ensure safe operation under high pressure and temperature;

b) Mashing coppers must ensure a heating rate suitable to applied technologies and designed capacity and ensure even heating on their surface;

c) These equipment shall be cleaned with chemical detergents and disinfected according to the internal industrial cleaning process. The lids of mashing coppers must have edges so as to prevent contamination of water used to clean the outer side of the tanks.5. Filtration tanks shall be made of contamination-resistant materials and must be easy to install, clean and maintain. They must also be tight so as to avoid loss of CO₂ and penetration of oxygen and microorganisms.

6. Fermentation tank:

a) The ends of hoses connecting yeast propagation stations shall be hung on a rack and sterilized before use;

b) Fermentation tanks shall be cleaned with chemical detergents and disinfected according to the internal industrial cleaning process;

c) Lids of fermentation tanks must have edges so as to avoid contamination of water used to clean the outer side of the tanks.

7. Deaeration and carbonation equipment shall be made of stainless material.

8. Filling equipment must be capable of filling exactly a set volume into a bottle so as to prevent frothing; shall be cleaned and disinfected before use according to a set process.

9. Product-conducting pipe systems shall be cleaned with chemical detergents and disinfected according to the internal industrial cleaning process.

10. Vehicles for internal transportation (lift trucks) shall be kept clean before, during and after use. These vehicles must be specialized lift trucks made of materials which do not cause pollution to beer products so as to ensure food safety.

11. Supporting facilities:

a) Steam boilers, heating systems, steam supply systems shall be designed in conformity with food safety requirements. Hot air and steam must not cause pollution to products;

c) Measuring and testing equipment, and equipment subject to strict safety requirements shall be calibrated and inspected according to current regulations.

12. Other regulations:

a) Production equipment and devices shall be regularly maintained, inspected, repaired or replaced when they are damaged or show signs of damage;

b) Waste and hazardous chemical containers shall be designed in a suitable manner to ensure safety, be made of durable materials and lockable in order to avoid contamination;

c) The repair and maintenance of machinery shall be conducted outside production areas or when production activities have been stopped. In case of on-site repair or regular maintenance, machinery/ equipment and surrounding areas shall be cleaned as soon as the repair or maintenance finishes;

d) Lubricant oils and greases used for equipment and machinery in direct contact with products must be those permitted for use in food production.

Section 6. FOOD SAFETY CONDITIONS TO BE SATISFIED BY VEGETABLE OIL PRODUCTION ESTABLISHMENT

Article 38. Conditions to be satisfied by vegetable oil production establishment

1. Production site

a) To be built under the current plan approved by a competent state authority;

b) To be situated far from sources of pollution or hazards and other pollutants in the surrounding environment, which may cause adverse affect on the quality and safety of beer products;

c) To have sufficient space for arranging production lines suitable to the establishment’s design capacity, ensuring that technology requirements are satisfied and industrial sanitation measures are applied at all production stages.

2. Workshop design

a) Layout of production line must be arranged to appropriate wind direction to avoid adverse effects of solid waste, waste oil, sanitary facilities and other pollutants;

b) The workshop shall be designed according to the one-way rule from input materials to final products which are vegetable oil products;

c) Warehouses (raw material, auxiliary material, processing aid and product warehouses); production areas (preliminary processing, cleaning, drying, pressing, extraction, refining, filling and product finishing, clean-in-place (CIP), mechanical and power systems); solid waste collection sites, wastewater and waste oil collection and treatment systems; and other auxiliary works shall be separated from one another to avoid the cross-contamination;

d) Internal roads shall be designed and built in a way that ensures the solidity, durability and suppression of dust; overhead walkways shall be installed with handrails or partitions which facilitate the observation and ensure occupational safety;

dd) Water drainage system (for wastewater generated from the production and daily-life activities and rainwater) shall be designed and built separately, have covers and a suitable slope to ensure a complete drainage.

3. Workshop structure:

a) The ground of production areas must facilitate the water drainage and shall be built of durable, difficult-to-peel-off, anti-slip and easily cleanable materials. The water drainage system in production areas must have covers;b) Manholes and catch pits must have traps to prevent sewer odor and insects, and restrict the penetration of microorganisms from sewer systems into the workshop;

c) Piping system (pipes of vegetable oil, pipes for directing and recovering solvents, cleaning equipment) must be designed and made of appropriate materials, painted in different colors and distinguishable instructions.

4. Air ventilation system:

a) The workshop must have ventilation doors to ensure the air circulation and facilitate the dissipation of heat and exhaust gas generated from production activities in order to ensure ambient temperature at workplace and labour safety as regulated;

b) Area of drying and extraction must be well-ventilated to ensure suitable ambient temperature at the workplace and labor safety as regulated;

c) Raw material pressing area must be designed with a dust collector and an appropriate ventilation system to ensure proper operation and no generation of pollution to other production stages;

d) Oil refining area must be designed in a way that can ensure air ventilation, quick dissipation of heat and odor, and guarantee of a temperature and labour safety as regulated;

dd) The area where the filling line is installed must always be kept dry, well ventilated and clean.

5. Steam, heat and compressed air supply systems

a) Steam boilers shall be designed and installed in places separated from production areas and regularly inspected according to current regulations;

b) Steam and compressed air pipe systems shall be designed and securely installed, easily distinguished from other pipe systems by signs or instructions, and regularly inspected according to current regulations.

6. Waste, wastewater and exhaust gas collection and treatment systems

a) Solid waste:

- Waste oil, after pressing and extraction, must be collected into a separate area with an area appropriate with design capacity of the production line, cleaned every 48 hours for avoidance of cross-contamination during the production;

- Papers, labels, empty bottles, cans, barrels, damaged caps and other solid waste generated during the production must be collected and stored in suitable containers located in a noticeable position to facilitate the collection and treatment and cause no adverse effect on the production;

- Waste generated in the auxiliary areas and domestic waste must be collected, classified and stored in a separate area for treatment;

- Solid wastes must be treated by organizations or individuals licensed to operate in the field of environmental treatment by competent state management agencies.

b) Industrial and daily-life wastewater

- Wastewater treatment facilities shall be located separately from the production area and located upwind;

- Wastewater treatment capacity and technologies must suit the peak discharge so as to ensure that treated wastewater is up to prescribed environmental standards;

c) Exhaust gas from the production area and steam boilers shall be treated so as to cause no adverse impacts to other production areas;

d) Hazardous wastes

- Hazardous wastes shall be collected, stored, transported and treated separately according to current regulations;

- Hazardous wastes shall be managed and treated by organizations and individuals licensed to treat hazardous wastes by competent state agencies.

7. Warehouse system

a) General requirements on warehouses (raw material, preservation of crude vegetable oil, food additives, processing aids, materials, packages and finished products):

- Having a storage capacity suitable to design capacity of the production line;

- Being periodically maintained and cleaned according to internal regulations;

- Meeting preservation conditions according to instructions or regulations of producers;

- Being capable of preventing the penetration of insects, rodents and other harmful elements;

- Having information for identifying each type of raw material, preservation of crude vegetable oil, food additives, processing aids, materials, packages and finished products; having warehousing and ex-warehousing records;

b) Chemical warehouses must meet preservation requirements and conditions according to producers’ requirements and current regulations on chemical preservation;

c) Finished product warehouse

Apart from regulations in Clauses 2, 3, 4, 5 of Article 29, finished product warehouses must meet the following conditions:

- Ensure humidity and temperature suitable for each type of vegetable oil, avoidance of direct exposure of products to sunlight;

- Have all information about name of product, production batch, production date, production shifts and other information as stipulated by the establishment;

- Have separate area to temporarily store unsatisfactory products pending treatment.

8. Crude vegetable oil production area

a) Raw material must be preserved in warehouses or silos to ensure quality and safety of raw materials;

b) Chemicals used to preserve raw materials and produce vegetable oil must be defined in the list of licensed chemicals according to applicable regulations and imposes no negative effect on quality and food safety of the product;

c) Phase of cleaning and temporarily processing raw materials

- Any raw material prior to being put into production must be inspected for residues of pesticides, toxic molds and fungi, heavy metals; Only raw material meeting requirements for quality and food safety is used for vegetable oil production;

- Raw material must undergo complete removal of dirt, stone, sand, metals and other impurities before it is put into pressing and extraction.

d) The phase of pressing, extraction and recovery of crude vegetable oil must ensure no contamination and cross-contamination with insects, dirt, waste oil and other pollutants. Quality and residual solvents must be controlled.

9. Finished vegetable oil production area

a) Refining must ensure removal of harmful substances dissolved in crude oil in order not to degenerate nutrients and quality of vegetable oil;

b) Filtration of vegetable oil

- Filling area must be separate from other production areas; equipment control shall be carried out prior to each production shift to ensure the equipment constantly works well;

- Filling process must be observed by equipment or human to ensure quantity, quality and food safety.

c) Product finishing stage

- Finished vegetable oil shall be recorded and divided into production shifts or cycles. Each batch must be inspected for quality, organoleptic properties, packaging and labels before receipts or dispatches from stores to ensure food quality and safety before distribution and circulation in the market;

- Finished vegetable oil must be stored at a temperature suitable for characteristics of each kind and ensure avoidance of direct exposure to sunlight.

10. Internal transportation

a) During internal transport of vegetable oil, the vegetable oil production establishment’s owner shall provide specific instructions (in writing) for each vehicle, method and conditions for storage and management of food safety;

b) Vegetable oil may not be transported in the same tanks or vehicles with supplies, raw materials and chemicals as this might cause cross contamination affecting the quality and safety of the products.

11. Raw material and product quality control systems

a) Quality control areas shall be situated separately and conveniently for quality control during the production process; be equipped with essential machinery, equipment and instruments to measure and inspect basic quality criteria of major raw materials and finished products. Microorganism testing sections must be aseptic and isolated from other testing sections;

b) If the quality control section is unavailable, vegetable oil production establishment must sign a contract with an outside organization that has appropriate qualification and profession to carry out the inspection of basic criteria of main raw material and finished product;

c) Ensure availability of sample storage area and documents, ensure capability to store and destroy sample according to storage requirements for each sample.

12. Management of records

a) A vegetable oil production establishment must keep sufficient management records (contracts, invoices, documents, quality testing slips, dossiers for declaration of conformity or declaration of conformity with food safety regulations, and other relevant documents) for raw materials, auxiliary materials, additives, processing aids, supplies packages and chemicals to serve origin tracing and food safety and quality control;

b) A vegetable oil production establishment must have sufficient food safety management records according to regulations (Certificate of satisfaction of food safety conditions, Certificate of declaration of conformity or Certificate of declaration of conformity with food safety regulations) for its vegetable oil products.

13. The vegetable oil production establishment’s owner and persons directly produce foods must satisfy all of conditions mentioned in Article 28 of this Decree.

Article 39. Conditions for instruments, equipment and packages storing vegetable oil

1. Instruments and packages storing vegetable oil are instructed in the national regulations on hygiene safety for packages and instruments in direct contact with food.

2. Neutralizer (free fatty acid separator) is capable to control temperature and stirring speed to completely separate detergent residues for ensuring quality of vegetable oil as regulated.

3. Sedimentation equipment must be designed and manufactured with sufficient capacity to control the sedimentation process of each product.

4. Filling and capping equipment must be arranged in a way to prevent alien objects or insects from penetrating into the product.

5. Production equipment/ devices must be regularly maintained, inspected, repaired or replaced upon detection of damage or any sign of damage.

6. Any measuring, testing instrument or any instrument under strict safety requirements must be calibrated and inspected according to the regulation.

7. An alarming system must be installed in case processing parameters (temperature, pressure) exceed permissible limit.

8. Containers of waste and toxic chemicals must be designed in a special way for easy identification, appropriately structured and made of durable materials and be lockable to avoid contamination.

9. The machinery repair and maintenance must be carried out outside of the production area or when there is no production activity at all. Cleaning equipment and surrounding area must be carried out after on-site repair or regular maintenance is completed.

10. Lubricant oils and greases used for equipment and machinery in direct contact with the product must be listed as permissible for food production.

Section 7. FOOD SAFETY CONDITIONS TO BE SATISFIED BY SMALL-SCALE FOOD PRODUCTION ESTABLISHMENT

Article 40. Food safety conditions to be satisfied by small-scale food production establishment

1. The food production area must have no standing water or pooled water, be not polluted by dust or toxic chemicals, be not affected by animals, insects or pests, and be located far away from other pollutants.

2. The food manufacturing process shall be designed according to the one-way rule from input materials to final products.

3. The floor of the production area must be flat and smooth, well-drained without pooled or standing water, easily cleanable and not slippery; the ceiling is impervious to water, not leaked and adhered by dirty substances and pooled water.

4. The food production establishment’s owner and persons directly produce foods must satisfy all of conditions mentioned in Article 28 of this Decree.

Article 41. Raw materials, additives, processing aids and water used to produce/ process foods, and environmental protection

1. Raw materials for foods production and processing:

a) Raw materials must have obvious origin. Information concerning the purchase of raw materials must be retained to serve the origin tracing;

b) Raw materials must be stored according to storage conditions, standards and instructions of providers.

c) Raw materials must not be stored together with goods, chemicals and other devices which may cause the cross-contamination or affect the food safety.

2. Food additives and processing aids must be in the list of licensed food additives and processing aids announced by Ministry of Health.

3. The small-scale food production establishment must provide enough clean water to serve the food production/ processing in conformity with the national technical regulations on the quality of edible and drinkable water.

4. Solid waste and wastewater generated from the food production area must be treated in accordance with regulations on environmental protection and local regulations.

Article 42. Food preservation conditions

Food preservation area:

1. Maintain the satisfaction of conditions on temperature, humidity, lighting, air valentiation and elements affecting the food safety as referred to by the food producer’s regulations on food preservation.

2. Implement measures for preventing pests and harmful animals.

3. Do not store food products together with goods, chemicals and other devices which may cause the cross-contamination or affect the food safety.

Article 43. Food transportation conditions

1. The small-scale food production establishment’s owner must post at the production establishment requirements on vehicles and mode of internal transportation of food products as well as preservation conditions and food safety management during the internal transportation.

2. Food products may not be transported in the same tanks or vehicles with supplies, raw materials or chemicals as this might cause the cross-contamination affecting the quality and safety of the products.

Section 8. FOOD SAFETY CONDITIONS TO BE SATISFIED BY SMALL-SCALE FOOD TRADING ESTABLISHMENTS

Article 44. Food safety conditions at food trading area

1. The food trading establishment must be located at a place which must have no standing or pooled water, be not polluted by dust or toxic chemicals, or other pollutants which cause effect on food safety.

2. Pests and other contaminants are prevented from affecting the trading establishment.

3. The floor of the trading establishment must be well-drained without pooled or standing water, and be easily cleaned; the ceiling is impervious to water, and not leaked.

4. The food trading establishment must provide enough clean water to serve the food trading in conformity with the national technical regulation or local regulations on domestic water quality.

5. Equipment or measures must be available to maintain the satisfaction of food safety conditions according to food producers’ regulations on food preservation; and information concerning the food trading must be retained to serve the tracing of food origin.

6. Waste must be collected and treated in accordance with regulations of the law on environmental protection.

Article 45. Food safety conditions at warehouses

1. The storing area or warehouse for preserving foods must maintain the satisfaction of conditions on temperature and humidity, lighting, air ventilation and elements affecting the food safety as referred to by the food producer’s regulations on food preservation.

2. Measures for pest control must be adopted.

3. Food products must not be stored together with other commodities, chemicals and devices that may affect the food safety.

Article 46. Conditions to be satisfied by the small-scale food trading establishment’s owner and persons directly selling foods

1. The trading establishment’s owner and persons directly selling foods must satisfy all of conditions referred to in Clause 1 Article 32 of this Decree.

2. Persons directly participating in the delivery of processed and unpacked foods must use personal protective equipment (gloves and mask).

Chapter VII

IMPLEMENTATION

Article 47. Effect and implementation

1. This Decree takes effect as of July 01, 2016.

2. This Decree makes articles/clauses/points in the following documents null and void:

a) Clause 4 Article 15 of the Government’s Decree No. 38/2014/ND-CP dated May 06, 2014 on management of chemicals governed by the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction;

b) Point dd Clause 2, Clause 4 Article 8, Clause 7 Article 15 of the Government’s Decree No. 202/2013/ND-CP dated November 27, 2013 providing for management of fertilizer.

3. Ministers, heads of ministerial-level agencies, heads of affiliates of the Government and Chairpersons of people’s committees of central-affiliated cities or provinces shall be responsible for guiding and implementing this Decree./.