DECREE NO. 123/2018/ND-CP AMENDING AND COMPLEMENTING SOME DECREES REGULATING INVESTMENT AND BUSINESS CONDITIONS IN THE AGRICULTURE SECTOR

 

DECREE

Amending and supplementing certain Decrees on conditions for investment and business activities in the agricultural sector

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

Pursuant to the Investment Law dated November 26, 2014 and the Law amending and supplementing Article 6 and Appendix 4 on the list of industries and businesses subject to conditional investment and business of the Investment Law dated November 22, 2016;

At the proposal of the Minister of Agriculture and Rural Development;

The Government promulgates the Decree amending and supplementing certain Decrees on conditions for investment and business in the agricultural sector.

Article 1. Amending, supplementing, and abolishing certain provisions of Decree No. 66/2016/NĐ-CP dated July 1, 2016 of the Government stipulating conditions for investment and business activities related to plant protection and quarantine; plant seeds; breeding of common forest animals; animal husbandry; aquaculture; food

1. Clause 3 shall be amended and supplemented as follows:

“Article 3. Conditions for producing plant protection chemicals

Organizations producing plant protection chemicals must meet the conditions prescribed in Article 61 of the Law on Plant Protection and Quarantine and the detailed conditions below:

1. The person directly managing and directing production must have a bachelor's degree or higher in one of the following majors: chemistry, plant protection, biology, agriculture; workers directly involved in producing plant protection chemicals must be trained and educated in their specialized knowledge and about plant protection chemicals.

2. Production workshops and warehouses storing plant protection chemicals must be located within industrial zones and must comply with the requirements set forth in National Technical Regulation TCVN 5507:2002 Hazardous Chemicals - Safety Regulations for Production, Business, Use, Storage, and Transportation.

3. Equipment and production lines for active ingredients, technical products, finished products from technical products, and packaging of plant protection chemicals must meet the production process and technology requirements and satisfy safety standards as prescribed in National Technical Regulation TCVN 5507:2002 Hazardous Chemicals - Safety Regulations for Production, Business, Use, Storage, and Transportation.

4. Systems for treating solid waste, exhaust gas, and wastewater must comply with legal regulations and National Technical Standards: Decree No. 38/2015/NĐ-CP dated April 24, 2015 of the Government on management of waste and scrap materials; QCVN 19:2009/BTNMT on industrial exhaust gases concerning dust and inorganic substances; National Technical Standard QCVN 20:2009/BTNMT on industrial exhaust gases concerning certain organic substances; QCVN 07:2009/BTNMT on hazardous waste thresholds; and National Technical Standard QCVN 40:2011/BTNMT on industrial wastewater.

5. There must be a laboratory for testing product quality that has been registered and designated according to the legal regulations on conditions for operating conformity assessment services and product quality. In cases where there is no such laboratory, a contract for quality testing with a laboratory that has been registered and designated according to the legal regulations on conditions for operating conformity assessment services and product quality must be established for each batch of products being shipped out.

6. Facilities producing plant protection chemicals must have a quality management system according to ISO 9001 or equivalent standards certified by organizations that have been registered according to legal regulations on conditions for operating conformity assessment services."

2. Clause 4 shall be amended and supplemented as follows:

"Article 4. Conditions for trading in plant protection chemicals

Organizations and individuals trading in plant protection chemicals must meet the conditions prescribed in Article 63 of the Law on Plant Protection and Quarantine and the detailed conditions below:

1. The person directly managing and selling plant protection chemicals must have a secondary level education or higher in one of the following majors: plant protection, crop cultivation, chemistry, biology, agriculture, or hold a Certificate of Professional Training in Plant Protection Chemicals.

2. The location of retail stores selling plant protection chemicals must be separate from areas providing dining services, schools, and hospitals; when constructing, they must be at least 20 meters away from water sources (rivers, lakes, canals, streams, wells).

3. Warehouse for plant protection chemicals

a) For wholesale establishments, the warehouse for plant protection chemicals must meet the requirements set forth in National Technical Regulation TCVN 5507:2002 Hazardous Chemicals - Safety Regulations for Production, Business, Use, Storage, and Transportation;

b) For retail establishments, the warehouse for plant protection chemicals must be constructed at least 20 meters away from water sources (rivers, lakes, canals, streams, wells) and must have shelves that are at least 10 centimeters above the floor and at least 20 centimeters away from walls."

3. Article 5 shall be amended and supplemented as follows:

"Article 5. Conditions for organizations engaged in pest control activities subject to plant quarantine

Organizations engaged in pest control activities subject to plant quarantine must meet the conditions prescribed in Article 37 of the Law on Plant Protection and Quarantine and the detailed conditions below:

1. The person directly managing and directing the organization engaged in pest control activities subject to plant quarantine must have a university degree or higher in the specified field as defined in National Technical Standard QCVN 01 - 19:2010/BNNPTNT on fumigation disinfection procedures or Vietnamese standards and basic standards on pest control activities subject to plant quarantine; the person directly performing pest control activities subject to plant quarantine must hold a Practice License issued by the Plant Protection Department.

2. There must be a location for pest control activities, workshops, storage facilities, and equipment suitable for the scale, methods, and type of pest control activities as prescribed in National Technical Standards on pest control activities subject to plant quarantine.

3. There must be equipment for each method of pest control as prescribed in Appendix I attached to this Decree."

4. Article 6 is amended and supplemented as follows:

"Article 6. Conditions for organizations conducting trials of plant protection chemicals

Organizations conducting trials of plant protection chemicals must meet the conditions prescribed in Article 59 of the Law on Plant Protection and Quarantine and the detailed conditions below:

1. The person directly managing and directing the organization conducting trials of plant protection chemicals must have a bachelor's degree or higher in one of the following majors: plant protection, crop cultivation, biology, chemistry, agriculture, and hold a Certificate of Training in Trials of Plant Protection Chemicals.

2. Workers must have a professional background in one of the following majors: plant protection, crop cultivation, biology, chemistry, agriculture, and must have been trained in trials of plant protection chemicals.

3. There must be equipment as prescribed in Appendix II attached to this Decree."

4. For organizations conducting tests to determine the quarantine period for plant protection products, there must be an analytical residue laboratory that has been registered and designated in accordance with the provisions of the law on business conditions for conformity assessment services and product quality. In cases where there is no such laboratory, they must have a contract with an analytical residue laboratory that has been registered and designated in accordance with the provisions of the law on business conditions for conformity assessment services and product quality.

5. Clause 2 of Article 11 shall be amended and supplemented as follows:

“2. For lures and bird nest farming: The sound emission equipment for luring must not exceed 70 decibels A during the period from 6:00 AM to 9:00 PM; it is prohibited to use sound emission equipment for luring birds from 9:00 PM to 6:00 AM the next day.”

6. Some clauses and points of Article 19 shall be amended and supplemented as follows:

a) Clause 1, Clause 2 of Article 19 shall be amended and supplemented as follows:

“1. The facility must maintain a safe distance from waste treatment areas.

2. There must be a water supply system for food production that complies with the technical regulations set forth in the National Technical Regulation QCVN 02:2009/BYT regarding drinking water quality.”

b) Clause 3 of Article 19 is abolished.

7. Some clauses and points of Article 20 shall be amended and supplemented as follows:

a) Point a, b of Clause 2 of Article 20 shall be amended and supplemented as follows:

“2. Regarding slaughterhouse location

a) Slaughterhouses for livestock and poultry must maintain a safe distance from residential areas, schools, hospitals, places frequently crowded with people, national highways, rivers, streams, sources of drinking water supply, breeding farms, livestock and poultry markets, and other pollution sources;

b) When operating, slaughterhouses for livestock and poultry must comply with the requirements of veterinary hygiene conditions, animal disease safety, and food safety as stipulated by law;”

b) Clause 1; Point c, d of Clause 2; Clause 3 of Article 20 are abolished.

8. Some clauses and points of Article 21 shall be amended and supplemented as follows:

a) Clause 2; Point a and Point e of Clause 3; Point a and Point b of Clause 4 of Article 21 shall be amended and supplemented as follows:

“2. The facility must maintain a safe distance from waste treatment areas.

3. Regarding processing and manufacturing workshops

a) Production lines must be arranged in a unidirectional manner from raw materials at the input to the final product; separate channels must be established for products, additives, packaging materials, and waste;

e) There must be a water supply system for processing and manufacturing food that complies with the technical regulations set forth in the National Technical Regulation QCVN 01:2009/BYT regarding drinking water quality; water for cleaning the workshop, equipment, and tools must meet the standards set forth in the National Technical Regulation QCVN 02:2009/BYT regarding drinking water quality;

4. Regarding equipment and tools

a) There must be personal hygiene facilities for workers;

b) There must be food processing equipment that meets the National Technical Regulation QCVN 12-1:2011/BYT on safety and hygiene for plastic packaging and utensils in direct contact with food, National Technical Regulation QCVN 12-2:2011/BYT on safety and hygiene for rubber packaging and utensils in direct contact with food, and National Technical Regulation QCVN 12-3:2011/BYT on safety and hygiene for metal packaging and utensils in direct contact with food;”

b) Clause 1; Point b, d, đ, g, h of Clause 3; Point c, d, đ of Clause 4 of Article 21 are abolished.

9. Some clauses and points of Article 22 shall be amended and supplemented as follows:

a) Clause 1; Point c of Clause 2 of Article 22 shall be amended and supplemented as follows:

“1. Wholesale agricultural markets must maintain a safe distance from waste treatment areas.

2. Zoning within wholesale markets

c) There must be a water supply system for washing and preliminary processing of products that complies with the technical regulations set forth in the National Technical Regulation QCVN 02:2009/BYT regarding drinking water quality.”

b) Clause 3 of Article 22 is abolished.

10. Some clauses and points of Article 23 shall be amended and supplemented as follows:

a) Point a of Clause 2; Point b of Clause 3 of Article 23 shall be amended and supplemented as follows:

“2. Selling locations

a) The facility must maintain a safe distance from waste treatment areas;

3. Equipment and tools

b) There must be equipment and tools for storing, packaging, and displaying products that meet the National Technical Regulation QCVN 12-1:2011/BYT on safety and hygiene for plastic packaging and utensils in direct contact with food, National Technical Regulation QCVN 12-2:2011/BYT on safety and hygiene for rubber packaging and utensils in direct contact with food, and National Technical Regulation QCVN 12-3:2011/BYT on safety and hygiene for metal packaging and utensils in direct contact with food.”

b) Clause 1; Point b of Clause 2; Point a, c of Clause 3 of Article 23 are abolished.

Article 2. Amend, supplement, and abolish certain provisions of Decree No. 35/2016/NĐ-CP dated May 15, 2016 detailing certain provisions of the Law on Animal Health

1. Certain clauses and points of Article 12 shall be amended and supplemented as follows:

a) Clause 1; point a, c, e of Clause 2 of Article 12 shall be amended and supplemented as follows:

"1. Location: Must maintain a safe distance from residential areas, public works, hospitals, veterinary clinics, animal disease diagnostic facilities, and pollution sources.

2. Factory buildings:

a) Must have designs suitable for the scale and type of drugs produced, preventing the intrusion of insects and other animals; must have positions isolated from external infection sources;

c) The floor must not absorb water, be easy to clean and disinfect; walls and ceilings must be made of durable and easy-to-clean materials;

e) Must have systems for supplying and treating water and air to ensure production; must have drainage, wastewater treatment, exhaust gas treatment systems;"

b) Point c, d of Clause 3 of Article 12 shall be amended and supplemented as follows:

"3. Raw material storage areas, auxiliary material storage areas, finished drug storage areas must have appropriate sizes according to the production scale and meet the following conditions:

c) Prevent the intrusion of insects and other animals;

d) Floors, walls, and ceilings as specified in point c of Clause 2 of this Article;"

c) Point c of Clause 5 of Article 12 shall be amended and supplemented as follows:

"5. Drug quality inspection

c) Must have appropriate equipment."

d) Abolish point b, c of Clause 1; point b, d, đ, g of Clause 2; point đ, e of Clause 3 of Article 12.

2. Certain clauses of Article 17 shall be amended and supplemented as follows:

a) Clause 2, Clause 3 of Article 17 shall be amended and supplemented as follows:

"2. Must have sufficient counters, cabinets, shelves to store and display products ensuring stability, ease of cleaning, and protection against adverse effects of light, temperature, humidity, mold, rodents, and harmful insects.

3. Must have equipment to ensure storage conditions indicated on product labels; must have thermometers and hygrometers to monitor product storage conditions. For vaccine and biological product retail establishments, there must be refrigerators, coolers, or cold storage rooms; there must be thermometers to check storage conditions; there must be backup generators, transportation equipment to ensure product storage conditions indicated on labels during distribution."

b) Abolish Clause 1, Clause 4, Clause 5 of Article 17.

3. Certain clauses of Article 18 shall be amended and supplemented as follows:

a) Clause 2 of Article 18 shall be amended and supplemented as follows:

"2. Must have ventilation fans and air conditioning systems to ensure storage conditions indicated on product labels; must have thermometers and hygrometers to monitor product storage conditions. For establishments importing vaccines and biological products, there must be separate storage areas, backup generators, and equipment, transportation means to ensure product storage conditions indicated on labels during transportation and distribution."

b) Abolish Clause 3, Clause 4 of Article 18.

4. Clause 1, Clause 2, Clause 5, Clause 6 of Article 19 shall be amended and supplemented as follows:

"1. The location must be separated to ensure safety from residential areas and public works.

2. Must have a laboratory that ensures biosafety when working with microorganisms or products that may contain microorganisms capable of causing infectious diseases to humans and animals as prescribed by laws on prevention and control of infectious diseases. There must be a separate room for analyzing physical and chemical indicators.

5. Must have a system for treating waste, water, and exhaust gases; there must be a separate area for disposing of experimental animals used for vaccine testing, microorganisms.

6. Must have refrigerators, deep-freeze units to preserve microorganism strains for testing purposes."

5. Certain clauses and points of Article 20 shall be amended and supplemented as follows:

a) Point d, point đ of Clause 1 of Article 20 shall be amended and supplemented as follows:

"1. Livestock and aquaculture sites must meet the following conditions:

d) Must have animal housing, ponds, tanks with areas ensuring density according to trial procedures;

đ) Must have a number of animals meeting the requirements for trials as prescribed by the Ministry of Agriculture and Rural Development; there must be a separate area for raising experimental animals, with a system for treating waste and wastewater, and an area for disposing of animal carcasses and diseased samples;"

b) Clause 2 of Article 20 shall be amended and supplemented as follows:

"2. Must have or lease a drug testing facility that meets the conditions stipulated in Article 19 of this Decree."

c) Abolish point a of Clause 1 of Article 20.

6. Supplement Article 19a as follows:

"Article 19a. Responsibilities of organizations and individuals importing and trading in animal health drugs

1. Organizations and individuals importing animal health drugs must have record books and standard operating procedures to ensure the storage, monitoring, and tracking of each batch of animal health drugs.

2. Organizations and individuals trading in animal health drugs must establish and retain records and invoices regarding the purchase and sale of animal health drugs."

Article 3. Amend, supplement, and abolish certain provisions of Decree No. 39/2017/NĐ-CP dated April 4, 2017 of the Government on the management of animal feed and aquatic feed:

1. Certain clauses and points of Article 7 shall be amended and supplemented as follows:

a) Clause 1; points a, c, d, đ, e, g of Clause 4 of Article 7 shall be amended and supplemented as follows:

"1. The production and processing sites must be located in areas not contaminated by waste or harmful chemicals; the production site must be separated from other areas.

4. Requirements for workshops and equipment:

a) The production area must be designed and equipped according to a one-way principle, with separation between incoming raw materials and outgoing products.

c) There must be storage facilities for various types of animal feed and aquatic feed raw materials as recommended by the manufacturer.

d) Production and processing facilities for animal feed containing antibiotics must have measures and procedures to control production and processing to prevent the spread and cross-contamination of antibiotics.

đ) There must be measuring devices to monitor quality.

e) There must be solutions regarding equipment and tools to control sand, gravel, and metal.

g) There must be solutions to prevent and control mice, birds, and other harmful animals; there must be dust extraction and waste treatment equipment."

b) Abolish Clause 2, Clause 3, and point h of Clause 4 of Article 7.

2. Clause 1 and Clause 2 of Article 8 shall be amended and supplemented as follows:

"1. The display and storage areas for animal feed and aquatic feed must be separated from plant protection chemicals, fertilizers, and other harmful chemicals.

2. There must be equipment and tools to store animal feed and aquatic feed."

3. Point a of Clause 2 of Article 10 shall be amended and supplemented as follows:

"a) Must have or lease locations, facilities, and specialized equipment that meet the requirements for testing each type of feed on each target species.

For aquatic feed testing facilities, they must have sufficient water meeting quality requirements; separate water supply and drainage systems, and a pond for wastewater to ensure environmental index testing and disease indices for aquatic species."

4. Certain clauses of Article 12 shall be amended and supplemented as follows:

a) Clause 1 of Article 12 shall be amended and supplemented as follows:

"1. Animal feed and aquatic feed permitted for circulation in Vietnam are those that meet the applicable standards and national technical regulations (if any) and are published on the Ministry of Agriculture and Rural Development's electronic portal, including:

a) For complete mixed feeds and concentrated feeds produced domestically: Organizations and individuals self-declare the product ensuring compliance with the file requirements stipulated in point a of Clause 4 of this Article (excluding the registration application for animal feed and aquatic feed permitted for circulation in Vietnam) and are responsible for the declaration file and the product's quality.

b) For animal feed and aquatic feed not covered by point a of Clause 1 of this Article: Organizations and individuals submit the registration file as prescribed in Clause 4 of this Article and are confirmed by the Ministry of Agriculture and Rural Development to comply with the applicable standards and national technical regulations (if any). The circulation period of the product in Vietnam is five years from the date of confirmation. Six months before the end of the circulation period, organizations and individuals wishing to continue circulation must re-register with the Ministry of Agriculture and Rural Development."

b) Clause 3 of Article 12 shall be amended and supplemented as follows:

"3. Animal feed and aquatic feed produced for internal consumption or according to custom and single ingredients do not need to register for circulation in Vietnam, but must comply with the relevant national technical regulations.

The Ministry of Agriculture and Rural Development publishes products of animal feed and aquatic feed according to custom and single ingredients permitted for circulation in Vietnam, including minimum quality levels and relevant national technical regulations (if any) to apply in production."

c) Supplement Clause 5a of Article 12 as follows:

"5a. For animal feed and aquatic feed specified in point a of Clause 1 of this Article: Organizations and individuals submit the product declaration file as prescribed in point a of Clause 4 of this Article to the Ministry of Agriculture and Rural Development for publication on the Ministry of Agriculture and Rural Development's electronic portal and permission to circulate the product.

For animal feed and aquatic feed specified in point b of Clause 1 of this Article, the procedure for handling the registration file for animal feed and aquatic feed permitted for circulation in Vietnam is carried out in accordance with the provisions of Clause 6 of this Article."

d) Point a of Clause 7 of Article 12 shall be amended and supplemented as follows:

"a) Changes in information about animal feed and aquatic feed already permitted for circulation in Vietnam can be made by the organization or individual holding the permit, including:

The name of the producer, the main office address, the production facility address, the phone number, and fax number of the registering organization or individual; the name of the animal feed and aquatic feed; the standard announcement code, trademark name, color, size, form, packaging specifications of the product for animal feed and aquatic feed specified in point a of Clause 1 of this Article.

The address, phone number, and fax number of the registering organization or individual; the importer's name; the color, size, and form of the product; packaging specifications for animal feed and aquatic feed specified in point b of Clause 1 of this Article.

When making changes to the above information, the organization or individual must notify the Ministry of Agriculture and Rural Development for publication on the Ministry of Agriculture and Rural Development's electronic portal.

For aquatic feed, in cases where the importer's information is changed or supplemented, before importation, the organization or individual must notify the Ministry of Agriculture and Rural Development of the changed information along with the purchase and sale contract or documentation (from the manufacturer) proving the right to distribute the product in Vietnam."

d) Amend the phrase specified in point b, Clause 7, Article 12 "Changes to information about feed and aquatic feed products that have been permitted for circulation in Vietnam by the Ministry of Agriculture and Rural Development include: manufacturer's name, production facility address; product name, standard number published for application, product code (trade name)" to read "Changes to information about feed and aquatic feed products that have been permitted for circulation in Vietnam by the Ministry of Agriculture and Rural Development include: manufacturer's name, production facility address; product name, standard number published for application, product code (trade name) as stipulated in point b, Clause 1 of this Article."

e) Point c, Clause 7, Article 12 shall be amended and supplemented as follows:

"c) Changes to information about feed and aquatic feed products according to custom and single ingredients, the Ministry of Agriculture and Rural Development shall change based on national technical standards and market requirements."

Article 4. Amend and abolish certain provisions of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms:

1. Article 37 shall be amended and supplemented as follows:

"Organizations and individuals producing and trading genetically modified organisms for intentional release (cultivation, breeding, release) into the environment, in addition to complying with laws on production and trade, must ensure that the genetically modified organisms have been issued a Biosafety Certificate or listed in the Catalogue of Genetically Modified Organisms Issued a Biosafety Certificate, except as provided for in Article 24 of this Decree."

2. Article 38 shall be amended and supplemented as follows:

"Organizations and individuals producing and trading genetically modified organisms, products derived from genetically modified organisms used as food, in addition to complying with laws on production and trade of food, must ensure that the genetically modified organisms have been issued a Food Safety Compliance Certificate or listed in the Catalogue of Genetically Modified Organisms Issued a Food Safety Compliance Certificate; products derived from genetically modified organisms where the genetically modified organisms have been issued a Food Safety Compliance Certificate or listed in the Catalogue of Genetically Modified Organisms Issued a Food Safety Compliance Certificate, except as provided for in Article 29 of this Decree."

3. Article 39 shall be amended and supplemented as follows:

"Organizations and individuals producing and trading genetically modified organisms, products derived from genetically modified organisms used as animal feed, in addition to complying with laws on production and trade of animal feed, must ensure that the genetically modified organisms have been issued an Animal Feed Safety Compliance Certificate or listed in the Catalogue of Genetically Modified Organisms Issued an Animal Feed Safety Compliance Certificate; products derived from genetically modified organisms where the genetically modified organisms have been issued an Animal Feed Safety Compliance Certificate or listed in the Catalogue of Genetically Modified Organisms Issued an Animal Feed Safety Compliance Certificate, except as provided for in Article 34 of this Decree."

4. Article 40 shall be amended and supplemented as follows:

a) Clause 3, Article 40 shall be amended and supplemented as follows:

"3. Genetically modified organisms and products derived from genetically modified organisms imported into Vietnam for the purpose of intentional release must meet the conditions stipulated in Article 37 of this Decree. Genetically modified organisms and products derived from genetically modified organisms imported into Vietnam for the purpose of use as food or animal feed, or processing into food or animal feed, must meet the conditions stipulated in Articles 38 and 39 of this Decree."

b) Abolish Clause 4, Clause 5 of Article 40.

Article 5. Amending and supplementing Clause 1 of Article 12 of Decree No. 181/2013/ND-CP dated November 14, 2013 of the Government detailing the implementation of certain provisions of the Advertising Law

“1. The advertising of special products, goods, and services specified from Article 3 to Article 11 of this Decree (excluding feed advertisements) shall only be carried out after being confirmed by the competent state agency regarding the content of the advertisement.”

Article 6. Repealing Circular No. 48/2015/TT-BNNPTNT dated December 16, 2015 of the Minister of Agriculture and Rural Development guiding detailed conditions for pest control service activities.

Article 7. Transitional Provisions

1. For warehouses and storage facilities for plant protection chemicals built outside industrial zones before the effective date of this Decree, they may continue operations but must comply with environmental laws.

2. Domestic complete mixed rations and concentrated feeds that were permitted for circulation prior to the effective date of this Decree shall continue to be permitted for circulation. Organizations and individuals must update the standard declaration applicable to these products on the Ministry of Agriculture and Rural Development's electronic portal in accordance with the regulations.

Article 8. Effective Date

This Decree takes effect from the date of issuance.

Article 9. Responsibility for implementation

Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial and centrally-administered city People's Committees shall be responsible for guiding and implementing this Decree./.