Decree No. 123/2018/ND-CP dated September 17, 2018 of the Government amending and supplementing certain Decrees on investment and business requirements in the agriculture sector

THE GOVERNMENT

DecreeNo. 123/2018/ND-CP dated September 17, 2018 of the Government amending and supplementing certain Decrees on investment and business requirements in the agriculture sector

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

Pursuant to the Law on Investment dated November 26, 2014 and the Law on amending and supplementing the Article 6 and Appendix 4 on the List of conditional business lines stipulated in the Law on Investment;

Upon the request of the Minister of Agriculture and Rural Development;

The Government hereby promulgates this Decree amending and supplementing certain Decrees on investment and business requirements in the agriculture sector.

Article 1. To amend, supplement and repeal a number of articles of the Government’s Decree No. 66/2016/ND-CP dated July 1, 2016 on regulations on requirements for investment in protection and quarantine of flora, plant varieties; common wild animals; aquatic animals; foods and husbandry  

1. To amend and supplement Article 3 as follows:

“Article 3.Requirements for production of pesticides

Pesticide formulating facilities shall meet conditions prescribed in Article 61 of the Law on Plant Protection and Quarantine and the following specific conditions:

1. The persons directly managing and operating pesticide plants must obtain at least bachelor degree in one of the following majors, e.g. chemistry, plant protection, biology or agronomy; workers directly participating in producing pesticides shall be provided with training in professional practice and knowledge of pesticides.  

2. Factories and warehouses designed for storage and preservation of pesticides must be located within industrial zones and ensure conformance to Vietnam National Standard TCVN 5507:2002 Hazardous chemicals – Code of Practice for Safety in Production, Commerce, Use, Handling and Transportation.

3. All equipment and production lines for producing active ingredients, technical grade active ingredients, formulation of products from technical grade active ingredients and pesticide packaging must meet manufacturing process and technological standards and satisfy safety requirements defined in the Vietnam National Standard TCVN 5507:2002 Hazardous chemicals – Code of Practice for Safety in Production, Commerce, Use, Handling and Transportation.

4. Solid waste, emission and wastewater treatment systems must comply with legislative regulations and National Technical Regulations, such as the Government’s Decree No. 38/2015/ND-CP dated April 24, 2015 on the management of wastes and scraps; the National Technical Regulation QCVN 19:2009/BTNMT on industrial emission, applicable to dust and inorganic substances and the National Technical Regulation QCVN 20:2009/BTNMT on industrial emission, applicable to certain inorganic substances; the National Technical Regulation QCVN 07:2009/BTNMT on Hazardous Waste Thresholds and the National Technical Regulation QCVN 40:2011/BTNMT on industrial wastewater.

5. Available product quality inspection laboratories must be registered and designated as per laws on conditions for eligibility to obtain the license to provide product conformity assessment and product quality assessment services.   In case there is none of laboratories, they must enter into product quality inspection contracts with laboratories which have already been registered or designated as per laws on conditions for eligibility to obtain the license to provide product conformity assessment and product quality assessment services with regard to each batch. 

6. Pesticide formulating facilities must design their product quality management systems that obtain the ISO 9001 or equivalent certification, issued by certification bodies that have been registered under legislative regulations on conditions for eligibility for license to provide conformity assessment services."  

2. To amend and supplement Article 4 as follows:

“Article 4. Requirements for pesticide trading

Entities and persons trading pesticides shall be required to meet conditions prescribed in Article 63 of the Law on Plant Protection and Quarantine, and the following specific conditions:

1. The person directly managing pesticides and the person directly selling pesticides must hold at least vocational secondary education graduation diploma in one of the following majors, e.g. plant protection, crop cultivation, chemistry, biology or agronomy, or the certificate of completion of a pesticide training program.  

2. Pesticide distribution locations must be separate from food and beverage service areas, schools and hospitals; when building pesticide distribution facilities, it shall be necessary to ensure that they must be at least 20 meters away from water supply sources (e.g. rivers, lakes, canals, ditches or wells).

3. Pesticide warehouses or storage facilities

a) As regards pesticide wholesaling facilities, pesticide warehouses must conform to requirements set out in the Vietnam National Standard TCVN 5507:2002: Hazardous chemicals – Code of Practice for Safety in Production, Commerce, Use, Handling and Transportation;

b) As regards pesticide retailing facilities, pesticides must be stored in pesticide warehouses which are built at the distance of at least 20 meters away from water supply sources (e.g. rivers, lakes, canals, ditches or wells), and must be placed onto pallets as high as at least 10 cm from the floor and must be 20 cm distant from the walls.”  

3. Amending and supplementing Article 5 as follows:

“Article 5. Requirements for quarantine service providers

Organizations practicing quarantine service shall be required to meet conditions prescribed in Article 37 of the Law on Plant Protection and Quarantine and the following specific conditions:

1. The person directly running and managing an organization providing quarantine service must hold at least bachelor degree as provided in the National Technical Regulation QCVN 01 - 19:2010/BNNPTNT on procedures for fumigation or the Vietnam Standards, fundamental standards for the quarantine service; the person directly carrying out the quarantine service must hold the practicing card issued by the Plant Protection Department.

2. These organizations must locate sites for handling of such articles, build premises, warehouses and equipment commensurate with the handling scale, method and form according to national technical regulations on quarantine service.

3. These organizations must provide equipment suitable for each handling method as provided for in Appendix I to this Decree.”

4. To amend and supplement Article 6 as follows:

“Article 6. Requirements for pesticide testing organizations

Pesticide testing organizations must meet conditions prescribed in Article 59 of the Law on Plant Protection and Quarantine, and the following specific conditions:

1. The person directly running and managing an pesticide testing organizations must obtain at least bachelor degree in one of the following majors, e.g. plant protection, crop cultivation, chemistry, biology or agronomy, and the certificate of completion of the pesticide field trial training program.  

2. These organizations’ employees must hold relevant qualifications in the following majors, e.g. plant protection, crop cultivation, chemistry, biology or agronomy, and attain the certificate of completion of the pesticide field trial training program.  

3. These organizations must provide means and equipment specified in Appendix II to this Decree.

4. The pesticide testing organizations to determine the wait time between pesticide applications must have pesticide residue analysis laboratories which have already been registered or designated as per laws on eligibility conditions for the license to provide product conformity assessment and product quality assessment services. In case where there are none of such laboratories, the organization must enter into a contract with residue testing and analysis laboratories which have already been registered or designated as per laws on eligibility conditions for the license to provide product conformity assessment and product quality assessment services.” 

5. To amend and supplement Clause 2 Article 11 as follows:

“2. As for attraction, breeding and raising of swallows, bird call devices with the intensity of sound not exceeding 70 dBA shall be permitted for use during the period from 6 a.m. to 9 p.m.; use of bird call devices shall not be allowed during the period from 9 p.m. to 6 a.m. in the next morning.”   

6. To amend and supplement cl a number of clauses and points of Article 19 as follows:

a) To amend and supplement Clause 1 and 2 Article 19 as follows:

“1. These establishments must be placed at the safe distance from waste disposal sites.

2. There must be water supply systems for manufacturing of foods that meet technical specifications prescribed in the National Technical Regulation QCVN 02:2009/BYT regarding quality of water for domestic use.”

b) To repeal Clause 3 Article 19.

7. To amend and supplement a number of clauses and points of Article 20 as follows:

a) To amend and supplement Point a, b clause 2 Article 20 as follows:

“2. Slaughtering places

a) Livestock and poultry slaughter houses must be located at the safe distance from residential areas, schools, hospitals, regularly crowded places, national highways, rivers, streams, water supply sources for domestic use, animal farms, market places where livestock and poultry are sold, and contamination sources;

b) Livestock and poultry operating slaughter houses must meet requirements concerning veterinary medicine hygiene and animal disease safety, and ensure food safety in accordance with laws;"

b) To repeal Clause 1; Point c, d Clause 2; Clause 3 Article 20.

8. To amend and supplement a number of clauses and points of Article 21 as follows:

a) To amend and supplement Clause 2; Point a and e Clause 3; Point a and Point b Clause 4 Article 21 as follows:

“2. Food processing establishments must be placed at the safe distance from waste disposal sites.

3. Food processing premises

a) Production lines must be arranged according to the principle of single-flow direction from input materials to finished products; channeling of products, additives, packing materials and wastes;

e) There must be the system for supply of water for processing of foods that meets technical specifications prescribed in the National Technical Regulation QCVN 01:2009/BYT regarding quality of potable water; the system for supply of water used for cleaning premises, equipment and tools that meets the National Technical Regulation QCVN 02:2009/BYT regarding quality of water for domestic use;

4. Equipment and tools

a) These establishments must have personal hygiene equipment designed to meet the needs of production workers;

b) These establishments must have food processing equipment and tools that meet the National Technical Regulation QCVN 12-1:2011/BYT regarding sanitary safety for synthetic plastic packaging and tools in direct contact with foods; the National Technical Regulation QCVN 12-2:2011/BYT regarding sanitary safety for rubber-made packaging and tools in direct contact with foods; the National Technical Regulation QCVN 12-3:2011/BYT regarding sanitary safety for metal packaging and tools in direct contact with foods;"   

b) To repeal Clause 1; Point b, d, dd, g, h Clause 3; Point c, d, dd Clause 4 Article 21.

9. To amend and supplement a number of clauses and points of Article 22 as follows:

a) To amend and supplement Clause 1; Point c Clause 2 Article 22 as follows:

“1. Wholesale markets must be placed at the safe distance from waste disposal sites.

2. Zoning of a wholesale market

c) There must be the system for supply of water for cleansing and primary processing of foods that meet technical specifications prescribed in the National Technical Regulation QCVN 02:2009/BYT regarding quality of water for domestic use.”

b) To repeal Clause 3 Article 22.

10. To amend and supplement a number of clauses and points of Article 23 as follows:

a) To amend and supplement Point a Clause 2; Point b Clause 3 Article 23 as follows:

“2. Trading venues

a) Food trading establishments must be placed at the safe distance from waste disposal sites;

3. Equipment and tools

b) These establishments must have food containing, packing and display equipment and tools that meet the National Technical Regulation QCVN 12-1:2011/BYT regarding sanitary safety for synthetic plastic packaging and tools in direct contact with foods; the National Technical Regulation QCVN 12-2:2011/BYT regarding sanitary safety for rubber-made packaging and tools in direct contact with foods; the National Technical Regulation QCVN 12-3:2011/BYT regarding sanitary safety for metal packaging and tools in direct contact with foods."  

b) To repeal Clause 1; Point b Clause 2; Point a, c Clause 3 Article 23.

Article 2. To amend and supplement a number of articles of the Decree No. 35/2016/ND-CP dated May 15, 2016 detailing a number of articles of the Law on Animal Health

1. To amend and supplement a number of clauses and points of Article 12 as follows:

a) To amend and supplement Clause 1; Point a, c, e Clause 2 Article 12 as follows:

“1. Location: Manufacturing of veterinary drugs must be safely separated from residential areas, public facilities, hospitals, veterinary infirmaries, establishments providing diagnosis of animals, and other sources of pollution.

2. Workshops:

a) The workshops must be designed to ensure they are appropriate to the scale and product types, to avoid invasion of pests and other animals; must be separated from the external sources of contamination;

c) The workshop’s floor is waterproof, easy to clean, sterilize or disinfect; walls and ceilings are made of durable, solid and easy-to-clean materials;

e) There must be water and air supply and treatment systems to meet manufacturing requirements; water drainage, emission and waste treatment systems;”

b) To amend and supplement Point c, d Clause 3 Article 12 as follows:

“3. Raw material, ingredient and finished product storage facility must cover an appropriate area of land to meet manufacturing needs and satisfy the following conditions:

c) Prevent pests and other animals from getting inside;

d) Floors, walls and ceilings shall be subject to Point c Clause 2 of this Article;”

c) To amend and supplement Point c Clause 5 Article 12 as follows:

“5. Inspection of quality of veterinary drugs

c) Proper equipment must be available for use.”

d) To repeal Point b, c Clause 1; Point b, d, dd, g Clause 2; Point dd, e Clause 3 Article 12.

2. To amend and supplement a number of clauses of Article 17 as follows:

a) To amend and supplement Clause 2 and 3 Article 17 as follows:

“2. Provide the adequate number of counters, cabinets, shelves and racks for handling and display of products and ensure that they are rigid, easy to clean and avoid any adverse impact of light, temperature, moisture, fungi, rodents and pests.

3. Have equipment to ensure conformity with storage conditions inscribed on product labels; keep thermometers and hygrometers in place to keep track of product storage conditions.   Traders of vaccines and/or biological preparations must have refrigerators, cooler freezers or cold storage warehouse; must install thermometers for checking the storage conditions; must equip standby generators, utilities and vehicles for transportation and distribution of vaccines to satisfy storage conditions inscribed on product labels.”

b) To repeal Clause 1; Clause 4, Clause 5 Article 17.

3. To amend and supplement a number of clauses of Article 18 as follows:

a) To amend and supplement Clause 2 Article 18 as follows:

“2. Have air ventilators and air conditioners to ensure conformity with storage conditions specified on product labels; have thermometers and hygrometers to keep track of product storage conditions.   Importers of vaccines and/or biological preparations must have separate warehouses, standby generators, equipment and vehicles to conform to the storage conditions indicated on product labels during transportation and distribution.”

b) To repeal Clause 3; Clause 4 Article 18.

4. To amend and supplement a Clause 1, 2, 5, 6 Article 19 as follows:

“1. These establishments must be separate and keep a safe distance from residential areas and public utility facilities.

2. These establishments must have testing laboratories that meet biosafety standards for working with microorganisms or products likely to contain microbes that may cause infectious diseases for humans and animals in accordance with laws on prevention and control of infectious diseases. Separate laboratory rooms must be available for analysis of physicochemical indicators.

5. They must have waste, wastewater and emission treatment systems; must establish a separate area for disposal of animals used for testing of vaccines and microorganisms.

6. They must have refrigerators and/or deep freezers for retention and preservation of various microbial breeds for testing purposes.”  

5. To amend and supplement a number of clauses and points of Article 20 as follows:

a) To amend and supplement Point d and Point dd Clause 1 Article 20 as follows:

“1. Animal husbandry and aquaculture areas must satisfy the following conditions:

d) Have cages, ponds and aquariums for culture of animals of which size may be chosen depending on the stocking density following testing procedures;  

dd) Have the adequate number of animals to serve the testing purposes under regulations promulgated by the Ministry of Agriculture and Rural; establish separate sites for raising of animals used in tests, waste and wastewater treatment systems, as well as areas intended for disposal of animal corpses and pathology specimens;”

b) To amend and supplement Clause 2 Article 20 as follows:

“2. Own or hire establishments performing veterinary drug tests that comply with conditions as per Article 19 of this Decree."  

c) To repeal Point a Clause 1 Article 20.

6. To insert Article 19a as follows:

“Article 19a. Responsibilities of entities and persons importing and trading veterinary drugs

1. Veterinary drug importers must maintain a system of books, records and standard manuals in order to meet the requirements concerning storage, control and monitoring of receipt and dispatch of each veterinary drug batch.

2. Veterinary drug traders must keep logbooks and deposit receipts or evidencing documents relating to sale and purchase of veterinary drugs.”

Article 3. To amend, supplement and repeal a number of Articles of the Government’s Decree No. 39/2017/ND-CP dated April 4, 2017 providing the regulatory framework for animal feeds and aqua feeds:

1. To amend and supplement a number of points and clauses of Article 7 as follows:

a) To amend and supplement Clause 1; Point a, c, d, dd, e, g Clause 4 Article 7 as follows:

“1. Animal and aqua feed manufacturing and processing sites must be placed in the vicinity of areas which are not affected by hazardous wastes and chemicals; manufacturing sites must be isolated from other areas.

4. Requirements concerning workshops and built-in equipment:

a) A production site must be designed and furnished with equipment items according to the single-direction rules, and must keep input materials and products separate.

c) Its warehouse or storage facility must be designed to store animal and aqua feed ingredients according to the manufacturer’s recommendations.

d) With respect to a facility manufacturing and processing animal feeds containing antibiotics, it must adopt measures and procedures for prevention of spreading of antibiotics resulting in cross-contamination.

dd) Measurement devices or instruments must be available for use in product quality surveillance.

e) Measures regarding equipment and tools must be implemented to control the presence of impurities and metals in products.

g) Adopt measures to prevent and control rats, birds and other harmful animals; provide vacuum cleaners and waste treatment equipment.”

b) To repeal Clause 2; Clause 3, Point h Clause 4 Article 7.

2. To amend and supplement Clause 1 and 2 Article 8 as follows:

“1. Animal feed and aqua feed selling points and storage facilities must be isolated from pesticides, fertilizers and other hazardous chemicals.

2. These facilities must have equipment and instruments to preserve animal and aqua feeds.”

3. To amend and supplement Point a Clause 2 Article 10 as follows:

“a) Have or rent locations, premises or dedicated equipment necessary to meet testing needs with respect to each feed for a single fish or animal.

Establishments testing aqua feeds must have the adequate water supply that meets quality standards; must install separate water supply and drainage systems and wastewater retention basins to meet the requirements concerning inspection of environmental indicators and others relating to aquatic diseases.”

4. To amend and supplement a number of clauses of Article 12 as follows:

a) To amend and supplement Clause 1 Article 12 as follows:

“1. In order to obtain authorization for sale in Vietnam, animal and aqua feeds must meet quality requirements in conformance to the applicable standards and relevant technical regulations (if any), and must be published on the Portal of the Ministry of Agriculture and Rural Development, including:

a) Completely mixed feeds and concentrated feeds which are domestically manufactured, organizations or individuals announcing products on their own shall be required to submit the application documentation specified in point a Clause 4 of this Article (except the application form for authorization to sell animal feeds and aqua feeds in Vietnam), and shall be held responsible for product announcement and quality dossiers.

b) With respect to animal feeds and aqua feeds other than those defined in Point a Clause 1 of this Article, organizations and individuals shall submit application documents for registration under Clause 4 of this Article, and shall be certified by the Ministry of Agriculture and Rural Development as conformable to applied standards and equivalent national technical regulations (if any).  Period of market authorization of a product in Vietnam shall be 5 years from the certification date. 6 months before expiration of that period, organizations and individuals wishing to renew their registration shall register with the Ministry of Agriculture and Rural Development.”

b) To amend and supplement Clause 3 Article 12 as follows:

“3. Animal and aqua feeds manufactured for internal consumption or according to convention, and single materials, shall not be subject to the requirement concerning application for approval for sale in Vietnam, but must meet regulations set out in relevant national technical regulations.

The Ministry of Agriculture and Rural Development shall be responsible for making a public statement about animal and aqua feeds formulated according to convention, and single materials, which are approved for sale in Vietnam, including provisions on the minimum quality level and provisions set forth in relevant national technical regulations (if any) in order to be applied to the livestock and aquatic production.”

c) To insert Clause 5a into Article 12 as follows:

 “5a. With respect to animal feeds and aqua feeds prescribed in Point a Clause 1 of this Article, requesting organizations and individuals shall submit application documents for registration as per Point a Clause 4 of this Article to the Ministry of Agriculture and Rural Development in order for these documents to be posted on its Portal, and shall obtain the market authorization for the products in question.

As for animal feeds and aqua feeds defined in Point b Clause 1 of this Article, procedures for processing of application documents for registration of market authorization for animal feeds and aqua feeds shall be subject to provisions in Clause 6 of this Article.”

d) To amend and supplement Point a Clause 7 Article 12 as follows:

“a) Any change in information about animal and aqua feed products approved for sale in Vietnam shall be made by organizations and individuals owning these products at their discretion. Information subject to such change shall include the followings:

Name of the manufacturer, main office’s address, workshop’s address, telephone or fax number of the organization or person applicant; name of animal feeds or aqua feeds; number of the applied standard, symbol (trade name), color, size, type, packing specifications of the products referred to Point a Clause 1 of this Article.  

Address, telephone number, fax number of the organization or person applicant; name of the importer; color, size and type of the product; packing specifications of the products specified in Point b Clause 1 of this Article.

If the abovementioned information is changed, organizations and individuals must inform the Ministry of Agriculture and Rural Development in order for changed information to be posted on the Portal of the Ministry of Agriculture and Rural Development.

As for aqua feeds, if information about the importer is subject to change or supplementation, before commencement of importation, organizations and individuals must inform the Ministry of Agriculture and Rural Development of changed information together with the sales contract or materials (of the manufacturer) proving the right to distribute products in Vietnam.”

dd) Substitute the quote in Point b Clause 7 Article 12 “Changes to information about animal and aqua feed products approved for sale in Vietnam that may be allowed by the Ministry of Agriculture and Rural Development, including such information as the manufacturer’s name and address; name and number of the applied standard, product code (trade name)” with “Changes to information about animal and aqua feed products approved for sale in Vietnam that may be allowed by the Ministry of Agriculture and Rural Development, including such information as the manufacturer’s name and address; name and number of the applied standard, code (trade name) of animal feeds and aqua feeds prescribed in Point b Clause 1 of this Article."

e) To amend and supplement Point c Clause 7 Article 12 as follows:

“c) Changes in information about animal and aqua feeds formulated according to convention, and single materials shall be made by the Ministry of Agriculture and Rural Development, based on standards, national technical regulations and market requirements.”

Article 4. To amend and repeal a number of Articles of the Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms:

1. To amend and supplement Article 37 as follows:

“In addition to complying with laws on manufacturing and trade, organizations and individuals manufacturing and trading genetically modified organisms for purposeful release (culture, growing or release) into the environment must ensure that genetically modified organisms have obtained the certificate of biosafety or have appeared in the Nomenclature of genetically modified organisms obtaining the certificate of biosafety, except those subject to Article 24 of this Decree."

2. To amend and supplement Article 38 as follows:

“In addition to complying with laws on food production and trading, organizations and individuals manufacturing and trading genetically modified organisms or products of genetically modified organisms for food purposes must ensure that genetically modified organisms that have obtained the certificate of fulfillment of food conditions or those that have been present in the Nomenclature of genetically modified organisms are eligible to obtain that certificate; products of genetically modified organisms that have obtained the certificate of fulfillment of food conditions or those that have been present in the Nomenclature of genetically modified organisms are eligible to obtain that certificate, except those subject to Article 29 of this Decree."

3. To amend and supplement Article 39 as follows:

“In addition to complying with laws on animal feed production and trading, organizations and individuals manufacturing and trading genetically modified organisms or products of genetically modified organisms for food purposes must ensure that genetically modified organisms that have obtained the certificate of fulfillment of animal feed conditions or those that have been present in the Nomenclature of genetically modified organisms are eligible to obtain that certificate; products of genetically modified organisms that have obtained the certificate of fulfillment of animal feed conditions or those that have been present in the Nomenclature of genetically modified organisms are eligible to obtain that certificate, except those subject to Article 34 of this Decree."

4. To amend and supplement Article 40 as follows:

a) To amend and supplement Clause 3 Article 40 as follows:

“3. Genetically modified organisms and products of genetically modified organisms that are imported into Vietnam for release purpose must meet conditions specified in Article 37 of this Decree.  Genetically modified organisms and products of genetically modified organisms that are imported into Vietnam for food, animal feed, food or animal feed processing purposes must meet conditions specified in Article 38 and Article 39 of this Decree.”

b) To repeal Clause 4; Clause 5 Article 40.

Article 5. To amend and supplement Clause 1 Article 12 of the Decree No. 181/2013/ND-CP dated November 14, 2013 detailing a number of articles of the Law on Advertising

“1. Advertisement of particular products, goods or services regulated in Article 3 through Article 11 of this Decree (except animal feed advertisement) shall be allowed only if the competent authority approves the advertisement contents.”

Article 6.To repeal the Circular No. 48/2015/TT-BNNPTNT dated December 16, 2015 of the Minister of Agriculture and Rural Development detailing the guidance on conditions for provision of plant protection services.

Article 7. Transitional provisions

1. Any workshop or warehouse storing plant protection drugs that is built outside of an industrial park before the entry into force of this Decree shall be allowed to continue its operation so long as its operations comply with the environmental legislation.

2. Completely mixed feed and concentrated feed products which are domestically manufactured and obtain market authorization prior to the entry into force of this Decree may continue to obtain the market authorization. Organizations and individuals shall be obliged to post the updated announcement of applied standards in accordance with relevant regulations on the Portal of the Ministry of Agriculture and Rural Development.

Article 8. Effect

This Decree takes effect on the signing date.

Article 9. Implementation

Ministers, Heads of Ministry-level agencies, Heads of Governmental bodies, and Chairpersons of People’s Committees of centrally-affiliated cities and provinces, shall be responsible for guiding and implementing this Decree./.

For the Government

Prime Minister

Nguyen Xuan Phuc