Decree No. 60/2016/NĐ-CP on certain conditions for investment and business operations in the field of natural resources and environment

DECREE

Provisions on certain conditions for investment and business activities

in the field of natural resources and environment

Pursuant to the Law on Natural Resources, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP issued by the Government on June 19, 2015;

Pursuant to the Investment Law dated November 26, 2014;

Pursuant to the Law on Mineralsn ldated July 17, 11 in 2010;

BASED ON THE LAW ON WATER RESOURCES dated June 21, 2012;

Pursuant to the Law on Environmental Protection dated June 23, 202014;

At the proposal of the Ministry trissued by the Ministry of Natural Resources and Environment;

the Government issues this Decreeustipulates certain conditions for investment and business activitiesNo. in the field of natural resources and environment.1. This Decree stipulates certain conditions for investment and business activities in the fields of water resources, minerals, and environmental protection including:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

a) Conditions for obtaining a permit for underground water drilling operations;

b) Conditions regarding the capacity of organizations conducting basic investigations of water resources and consulting on the planning of water resources; conditions regarding the capacity of organizations and individuals consulting on the preparation of projects and reports in applications for water resource permits;

c) Conditions for organizations engaged in mineral exploration;

d) Conditions for the business of biological products in waste treatment;

đ) Conditions for the business of transporting dangerous goods, which are toxic substances and infectious materials classified under category 6 as specified in Clause 1, Article 4 of Decree No. 29/2005/NĐ-CP dated March 10, 2005 of the Government detailing the list of dangerous goods and the transportation of dangerous goods on inland waterways (hereinafter referred to as Decree No. 29/2005/NĐ-CP); Clause 1, Article 22 of Decree No. 14/2015/NĐ-CP dated February 13, 2015 of the Government detailing and guiding the implementation of certain provisions of the Railway Law (hereinafter referred to as Decree No. 14/2015/NĐ-CP) and Clause 1, Article 4 of Decree No. 104/2009/NĐ-CP dated November 9, 2009 of the Government detailing the list of dangerous goods and the transportation of dangerous goods by road transport vehicles (hereinafter referred to as Decree No. 104/2009/NĐ-CP);

e) Conditions for issuing a permit for hazardous waste treatment.

2. In addition to the provisions on investment and business conditions set forth in this Decree, other investment and business conditions in the field of natural resources and environment shall be implemented in accordance with the laws and specific decrees.

1. The conditions for underground water drilling operations apply to organizations and individuals engaged in underground water drilling, surveying, exploration, and exploitation (hereinafter collectively referred to as underground water drilling operations) within the territory of the Socialist Republic of Vietnam.

Article 2. Applicability

2. The conditions regarding the capacity of organizations conducting basic investigations of water resources and consulting on the planning of water resources; conditions regarding the capacity of organizations and individuals consulting on the preparation of projects and reports in applications for water resource permits apply to:

a) Organizations implementing projects and programs for basic investigations of water resources; consulting on the planning of water resources and consulting on the preparation of projects and reports in applications for water resource permits; independent consultants preparing projects and reports in applications for and extensions of water resource permits (hereinafter collectively referred to as organizations and individuals engaged in water resource activities);

b) Organizations and individuals involved in water exploration, utilization, and discharge of wastewater related to the preparation of projects and reports in applications for water resource permits;

c) State management agencies related to basic investigations, planning of water resources, review, issuance, and extension of water resource permits.

3. The conditions for organizations engaged in mineral exploration apply to organizations engaged in mineral exploration; organizations and individuals holding mineral exploration permits; state management agencies for minerals.

4. The conditions for the business of biological products in waste treatment in Vietnam apply to state management agencies; organizations and individuals involved in the assessment of registration files for biological products; production, business, import, and testing of biological products in waste treatment in Vietnam.

5. The investment and business conditions stipulated in Point đ, Clause 1, Article 1 of this Decree apply to state agencies, organizations, and individuals involved in the transportation of dangerous goods, which are toxic substances and infectious materials by road, inland waterway, and railway transport within the territory of the Socialist Republic of Vietnam.

6. The conditions for issuing a permit for hazardous waste treatment apply to state management agencies; organizations and individuals involved in hazardous waste (hereinafter abbreviated as CTNH).

6. Conditions for issuing a permit to handle hazardous waste shall apply to state management agencies; organizations and individuals involved in activities related to hazardous waste (hereinafter referred to as "hazardous waste" or "CTNH").

Article 3. Conditions for Business Investment in the Field of Water Resources

Article 3. Scale of Groundwater Drilling Operations

Article 3. The scale of groundwater drilling operations is defined as follows:

Clause 1. The scale of groundwater drilling operations is defined as follows:

Point a. Small-scale groundwater drilling operations refer to drilling and installing wells with pipe diameter or casing smaller than 110 mm and belong to facilities with flow rate less than 200 m3/day-night.

Point b. Medium-scale groundwater drilling operations refer to drilling and installing wells with pipe diameter or casing smaller than 250 mm and belong to facilities with flow rate from 200 m3/day-night to under 3,000 m3/day-night.

Point c. Large-scale groundwater drilling operations include cases not specified in points a and b of Clause 1 of this Article.

Clause 2. The facility referred to in Clause 1 of this Article is a system consisting of one or more wells within a groundwater exploration and extraction area, with the closest distance between them not exceeding 1,000 meters, owned by an organization or individual; the flow rate of a facility is the total flow rate of the wells belonging to that facility.

Clause 3. Organizations and individuals granted a permit for small-scale groundwater drilling operations may also conduct medium and small-scale operations; they can drill and install boreholes, wells for exploration, extraction, investigation, and survey purposes to serve groundwater exploitation, research, evaluation, and monitoring, with diameters equivalent to those specified in Clause 1 of this Article.

Article 4. Conditions for Obtaining a Permit for Groundwater Drilling Operations

Organizations and individuals conducting groundwater drilling operations must meet the following conditions:

Clause 1. They must have a decision on establishment issued by the competent authority or one of the following business registration certificates: business registration certificate and tax registration, enterprise registration certificate for organizations, or business household registration certificate for groups of individuals or households, issued by the competent authority.

Clause 2. The head of the organization (Director or General Director) or the person primarily responsible for technical matters of the organization or individual conducting the operation (hereinafter collectively referred to as the primary technical responsibility holder) must meet the following requirements:

Point a. For small-scale groundwater drilling operations:

Hold a diploma from a vocational college or higher in geological fields (exploration geology, hydrogeological geology, engineering geology, geotechnical geology, drilling) and have at least two years of experience in the field of business or be a drilling worker with skill level 3/7 or equivalent and have at least four consecutive years of experience in the field of business; directly participated in designing, preparing reports, or drilling at least five groundwater drilling projects.

In cases where none of the above-mentioned certificates are available, there must be at least five consecutive years of experience in the field of business, directly drilled at least ten groundwater drilling projects, and must have a certificate of having completed a technical training course on protecting underground water resources during drilling activities organized by the National Water Resources Management Agency or the Department of Natural Resources and Environment.

Point b. For medium-scale groundwater drilling operations:

Hold a bachelor's degree or higher in geological fields (exploration geology, hydrogeological geology, engineering geology, geotechnical geology, drilling) and have at least three years of experience in the field of business or hold a diploma from a vocational college or higher in geological fields (exploration geology, hydrogeological geology, engineering geology, geotechnical geology, drilling) and have at least five years of experience in the field of business; directly participated in preparing exploration proposals, designing exploitation well systems, or directing the construction of at least five groundwater drilling projects with a flow rate of 200 cubic meters/day-night or more;

Point c. For large-scale groundwater drilling operations:

Hold a bachelor's degree or higher in geological fields (exploration geology, hydrogeological geology, engineering geology, geotechnical geology, drilling) and have at least seven years of experience in the field of business; directly participated in preparing exploration proposals, designing exploitation well systems, or directing the construction of at least three groundwater drilling projects with a flow rate of 3,000 cubic meters/day-night or more;

Point d. The primary technical responsibility holder must be a member of the organization or individual conducting the operation or have a labor contract with the organization or individual according to the Labor Law regulations. In the case of a fixed-term labor contract, at the time of submitting the application, the validity period of the labor contract must still be at least 12 months.

Clause 3. Drilling machines and construction equipment must ensure technical capabilities meeting the provisions of Article 10 of this Decree.

Article 5. Qualification Conditions for Organizations Conducting Operations in the Field of Water Resources

Clause 1. Organizations conducting operations in the field of water resources must have one of the following documents:

Point a. A decision on establishment issued by the competent authority, including functions and tasks related to basic investigations, planning of water resource development, and other activities concerning water resources;

Point b. Business registration certificate or business registration certificate and tax registration or enterprise registration certificate issued by the competent authority.

Clause 2. They must have a team of specialized staff participating in projects and reports meeting the following conditions:

Point a. For basic investigation projects and water resource planning projects: having a professional structure and work experience meeting the provisions of Article 6, and the technical supervisor assigned must meet the provisions of Article 7 of this Decree;

Point b. For project proposals and reports in the application for water resource permits: having a professional structure and work experience meeting the provisions of Article 8 of this Decree.

Clause 3. Individuals belonging to the specialized staff team specified in Clause 2 of this Article must meet the following conditions:

Point a. They must be Vietnamese citizens or foreign nationals holding a work permit in Vietnam according to the Labor Law;

Point b. They must hold a degree from a university or higher, with a relevant field of study matching the assigned tasks. These degrees must be issued by educational institutions in Vietnam or abroad according to the law;

Point c. They must have a recruitment decision or a labor contract with the organization according to the law. In the case of a fixed-term labor contract, at the time of establishing the professional capacity certification for water resource operations, the validity period of the labor contract must still be at least six months.

Clause 4. They must have specialized machinery and equipment meeting the provisions of Article 10 of this Decree. If the machinery and equipment are not owned by the organization, there must be a lease agreement with another organization or individual.

Clause 5. If the project, proposal, or report has specific conditions required for implementation, the organization must meet these conditions or have a joint venture, cooperation agreement, or lease agreement with an organization or individual capable of fulfilling these conditions for implementation.

Article 6. Conditions for the professional staff of organizations participating in implementing basic investigation projects and advisory planning of water resources

1. For organizations implementing basic investigation projects on water resources:

a) Professional structure: Must have at least five officers trained in relevant fields such as surface water and marine water (hydrology, oceanography, engineering hydrology, environmental hydrology, water resources engineering), groundwater (geology, hydrogeology, geotechnical engineering, drilling exploration, geophysics, geotechnology), environment (environmental science, environmental technology, environmental engineering, environmental management), water resources management, or other related fields. The professional structure must be appropriate to the specific content of each basic investigation project on water resources;

b) Work experience: Must have at least three years of experience related to basic investigation activities, water resources planning, or directly participated in at least two basic investigation projects and water resources planning.

2. For organizations implementing water resources planning projects:

a) Professional structure: Must have at least seven officers trained in relevant fields such as surface water and marine water (hydrology, oceanography, engineering hydrology, environmental hydrology, water resources engineering), groundwater (geology, hydrogeology, geotechnical engineering, drilling exploration, geophysics, geotechnology), environment (environmental science, environmental technology, environmental engineering, environmental management), water resources management, or other related fields. The professional structure must be appropriate to the specific content of each water resources planning project;

b) Work experience: Must have at least four years of experience related to basic investigation activities, water resources planning, or directly participated in at least three basic investigation projects and water resources planning.

Article 7. Conditions for technical supervisors of basic investigation projects and water resources planning projects

1. For basic investigation projects on water resources:

a) Field of study: Trained in one of the fields of hydrology, oceanography, hydrogeology, environmental engineering, water resources engineering;

b) Work experience: Must have at least five years of experience in basic investigation activities on water resources, water resources planning, or participated in at least three basic investigation projects and water resources planning;

c) At the same time, can only take charge of a maximum of three basic investigation projects on water resources.

2. For water resources planning projects:

a) Field of study: Trained in one of the fields of hydrology, hydrogeology, environmental engineering, water resources engineering;

b) Work experience: Must have at least seven years of experience in basic investigation activities on water resources, water resources planning, or participated in at least five basic investigation projects and water resources planning;

c) At the same time, can only take charge of a maximum of two water resources planning projects.

Article 8. Conditions for the team of specialized staff of organizations preparing projects and reports in the application dossier for water resources permits

1. Number of specialized staff:

a) For projects and reports within the licensing authority of the Ministry of Natural Resources and Environment: At least three staff members trained in the fields specified in Clause 2 of this Article;

b) For projects and reports within the licensing authority of the Provincial People's Committee: At least two staff members trained in fields appropriate to the provisions set out in Clause 2 of this Article.

2. Fields of training:

a) For projects and reports on the exploitation and utilization of surface water and seawater: Including fields related to surface water and seawater (hydrology, oceanography, engineering hydrology, environmental hydrology, water resources technology);

b) For projects and reports on exploration, exploitation, and utilization of groundwater: Including fields related to groundwater (geology, hydrogeology, engineering geology, drilling exploration, geophysics, geotechnical engineering);

c) For projects and reports on discharging wastewater into water sources: Including fields related to the environment (environmental science, environmental technology, environmental engineering, environmental management).

3. Work experience:

a) For projects and reports within the licensing authority of the Ministry of Natural Resources and Environment: At least three years of experience in the field of water resources and the environment, or having directly participated in at least three projects and reports. Among them, the technical supervisor of the project and report must have at least five years of experience or have directly participated in at least five projects and reports;

b) For projects and reports within the licensing authority of the Provincial People's Committee: At least two years of experience in the field of water resources and the environment, or having directly participated in at least one project and report. Among them, the technical supervisor of the project and report must have at least three years of experience or have directly participated in at least three projects and reports.

4. At any given time, the technical supervisor of a project or report may only be responsible for the technical supervision of a maximum of three projects or reports.

Article 9. Conditions for independent consultants undertaking the preparation of projects and reports in the application dossier for water resources permits

Independent consultants undertaking the preparation of projects and reports in the application dossier for water resources permits must meet the conditions stipulated in point a and point b of Clause 3 of Article 5 of this Decree and the following conditions:

1. The field of training must be appropriate to the type of project or report as provided for in Clause 2 of Article 8 of this Decree.

2. Work experience:

a) For the preparation of projects and reports in the application dossier for water resources permits within the licensing authority of the Ministry of Natural Resources and Environment, there must be at least fifteen years of experience and having been the technical supervisor of at least seven projects and reports;

b) For the preparation of projects and reports in the application dossier for water resources permits within the licensing authority of the Provincial People's Committee: At least eight years of experience in the field of water resources and having been the technical supervisor of at least five projects and reports.

3. At any given time, an independent consultant may only undertake the preparation of one project or report in the application dossier for water resources permits.

Article 10. Conditions for machinery and specialized equipment

1. Existing or rented machinery and specialized equipment must ensure quantity, quality, and technical performance suitable for the content of the project items.

2. In cases where machinery and equipment require quality inspection according to regulations, they must have a quality inspection certification issued by the competent authority.

3. In cases where the project includes drilling groundwater construction items, the drilling machines and construction equipment must meet the requirements for scale of operation and labor safety as stipulated.

Article 11. Qualification Documents of Organizations and Individuals Participating in Implementing Projects and Reporting in the Water Resources Sector

1. Organizations and individuals engaged in business when implementing basic investigation projects, consulting on planning, preparing proposals, and reporting in applications for water resources permits must have qualification documents proving their capacity in accordance with this Decree.

2. Qualification documents for organizations engaged in business in the water resources sector:

a) Certified copies or copies accompanied by original documents for identification of various types of documents specified in Clause 1, Article 5 and other documents, materials, contracts to prove compliance with requirements for project items with conditions when implemented (if applicable) as stipulated in Clause 5, Article 5 of this Decree;

b) List of professional staff and persons assigned to technical management; certified copies or copies accompanied by original documents for identification of identity cards, citizen identification cards, passports, educational certificates, professional licenses (if applicable), employment contracts or recruitment decisions; materials and documents to prove individual work experience meeting the requirements stipulated in Articles 6, 7, and 8 of this Decree;

c) List of specialized machinery and equipment used to implement projects and documents proving compliance with the requirements stipulated in Article 10 of this Decree.

3. Qualification documents for independent consultants who prepare proposals and reports in applications for water resources permits:

a) Certified copies or copies accompanied by original documents for identification of identity cards, citizen identification cards, passports, educational certificates;

b) Materials and documents to prove individual work experience meeting the requirements stipulated in Clause 2, Article 9 of this Decree.

4. Organizations and individuals engaged in business must submit qualification documents to the competent authority assigning tasks, placing orders, tendering, or individuals and organizations hiring to prepare proposals and reports as a basis for selecting organizations and individuals with the necessary qualifications to implement projects, proposals, and reports.

Chapter III

CONDITIONS FOR PROFESSIONAL MINERAL EXPLORATION ORGANIZATIONS

Article 12. Professional Mineral Exploration Organizations

Professional mineral exploration organizations when contracting to implement mineral exploration project plans with organizations or individuals holding mineral exploration permits must comply with the provisions set forth in Article 35 of the Minerals Law and the regulations stipulated herein, including:

1. Enterprises established in accordance with the Enterprise Law.

2. Scientific and technological organizations established in accordance with the Science and Technology Law.

3. Cooperatives and cooperative unions established in accordance with the Cooperative Law.

4. Specialized geological public institutions established by competent state authorities with functions and tasks related to mineral exploration.

Article 13. Professional Documents for Mineral Exploration

1. Professional mineral exploration organizations as prescribed in Article 12 of this Decree when implementing mineral exploration project plans must have professional documents for mineral exploration, including:

a) A certified copy of the decision on establishment or certificate of scientific and technological activity or business registration certificate issued by the competent authority;

b) The contract for implementing the mineral exploration project plan with organizations or individuals permitted to conduct mineral exploration, accompanied by the mineral exploration permit issued by the competent authority;

c) List of staff and workers participating in the implementation of the mineral exploration project plan; labor contracts (or equivalent documents) of technical managers and technical workers directly involved in the implementation of the project plan as prescribed;

d) Documentation of individuals participating in the implementation of the mineral exploration project plan (certified copies or copies with original documents for verification) including: Decision assigning tasks to the technical manager (hereinafter referred to as the project leader for mineral exploration), along with relevant certificates and academic credentials, scientific curriculum vitae of the project leader; labor contracts or recruitment decisions; appointment decisions or task assignments; relevant certificates and academic credentials corresponding to assigned tasks; copies of identity cards, citizen identification cards, or passports;

đ) List of specialized equipment and tools suitable for implementing mineral exploration works in accordance with the mineral exploration project plan.

2. In cases where the mineral exploration project plan is implemented directly by organizations holding mineral exploration permits, they must have documents meeting the requirements stipulated in points c, d, and đ of clause 1 of this Article.

3. The professional documents for mineral exploration as prescribed in clause 1 of this Article shall be managed and retained by organizations or individuals holding mineral exploration permits and professional mineral exploration organizations.

Article 14. Conditions for Project Leaders for Mineral Exploration

1. Project leaders for mineral exploration must comply with the provisions set forth in point b of clause 1 of Article 35 of the Minerals Law and the following provisions:

Point a. They must be Vietnamese citizens or foreign nationals holding a work permit in Vietnam according to the Labor Law;

b) Hold a bachelor's degree or higher in geology for mineral exploration or a comparable field; for water mineral exploration projects, it should be in hydrogeology and engineering geology;

c) Have at least five years of experience participating in the implementation of geological survey and mineral exploration project plans; hold a project leader certificate for mineral exploration issued by the Ministry of Natural Resources and Environment;

d) Project leaders for mineral exploration who undertake the task of implementing mineral exploration project plans must meet the time experience conditions stipulated in point b of clause 1 of Article 35 of the Minerals Law, and for hazardous mineral exploration project plans, they must have participated in at least one hazardous mineral exploration project plan as a geological technical officer; for other mineral exploration project plans, they must have participated in at least one mineral exploration project plan as a geological technical officer.

2. Project leaders for mineral exploration may only perform their duties when assigned tasks by organizations permitted to conduct mineral exploration or professional mineral exploration organizations.

3. At the same time, project leaders for mineral exploration may only take responsibility for a maximum of two mineral exploration project plans. When preparing reports on mineral exploration results, project leaders for mineral exploration must spend at least 25% of the implementation time specified in the mineral exploration permit on directing the implementation of the project plan.

Article 15. Conditions for the workforce of technical workers implementing mineral exploration projects

1. The workforce of technical workers in cadastral, geological, hydrogeological, engineering geological, geophysical, construction works (excavation, drilling), and other related fields must meet the quantity requirements suitable to the mineral exploration project that has been appraised when issuing the mineral exploration permit.

2. Each group of technical workers in various fields during construction must appoint a person responsible who meets the professional requirements and experience time as follows:

a) For hazardous mineral exploration projects, there must be a minimum of five years of work experience for those with a vocational intermediate level or three years for those with a bachelor's degree; among which, at least one year of participation in construction of geological investigation projects or hazardous mineral exploration projects.

b) For the remaining mineral exploration projects, there must be a minimum of three years of work experience for those with a vocational intermediate level or two years for those with a bachelor's degree.

Article 16. Conditions for specialized equipment and tools for construction of mineral exploration projects

1. Specialized equipment and tools for construction of mineral exploration projects must ensure the quantity, quality, and technical performance suitable to the items and tasks in the mineral exploration project that has been appraised when issuing the mineral exploration permit.

2. Radioactive and rare earth mineral exploration must have specialized equipment and tools, and a team of technical staff operating them, meeting the safety requirements for radioactive materials according to the laws on nuclear radiation safety.

Chapter IV

INVESTMENT AND BUSINESS CONDITIONS IN

ENVIRONMENT PROTECTION FIELD

Section 1

CONDITIONS FOR BIOLOGICAL PREPARATION BUSINESS IN WASTE TREATMENT

Article 17. Conditions for biological preparation business in waste treatment

1. Organizations and individuals engaged in business, import of biological preparations in waste treatment (hereinafter referred to as biological preparations) must be granted a certificate of circulation of biological preparations issued by the General Department of Environment, Ministry of Natural Resources and Environment, in accordance with this Decree.

2. Biological preparations that have been granted a certificate of circulation of biological preparations but have changes in their components or active substance concentrations affecting the treatment efficiency and safety for human health and living organisms must re-register for a certificate of circulation of biological preparations in accordance with Article 20 of this Decree.

Article 18. Certificate of Circulation of Biological Preparations

The certificate of circulation of biological preparations for waste treatment specifies the following contents:

1. Name of registered biological preparation.

2. Quantity of biological preparation allowed to circulate.

3. Components of active substances, microorganisms (scientific name, concentration, density) in the preparation.

4. Production facility (name of facility, address, contact phone number).

5. Registration facility (name of facility, address, contact phone number).

6. Usage method, validity period of biological preparation.

7. Packaging specifications of biological preparation.

Article 19. Application Documents for Circulation of Biological Preparations

1. A request for registration of circulation of biological preparations in the format prescribed in Appendix I attached to this Decree.

2. Copy of Business Registration Certificate (if applicable).

3. Production process of biological preparations.

4. Certified copy or original copy for comparison (in case organizations or individuals submit applications directly) test result report or quality analysis of biological preparations from domestic or foreign units with testing functions.

5. Introduction of biological preparations in the format prescribed in Appendix II attached to this Decree.

6. Certified copy or original copy for comparison (in case organizations or individuals submit applications directly) evaluation record of the scientific council management body for biological preparations that are research results (if applicable).

7. Test results of biological preparations (if applicable).

8. Label, formal packaging proposed for circulation along with the storage and usage guide of biological preparations and warnings about risks to human health and living organisms.

9. Certified copy or original copy for comparison (in case organizations or individuals submit applications directly) patent protection document or commitment not to violate intellectual property regulations for domestically produced preparations proposed for registration.

10. Certified copy or original copy for comparison (in case organizations or individuals submit applications directly) circulation permit of biological preparations issued by the competent authority of the producing country for imported biological preparations.

11. Detailed testing plan including main contents: testing content, time, location, and testing agency for biological preparations without recognized testing results.

Article 20. Procedures and formalities for issuing certificates of circulation for biological products

1. Organizations and individuals specified in Article 17 of this Decree shall prepare seven sets of registration files for the circulation of biological products in accordance with the provisions of Article 19 of this Decree and submit them directly or through postal service to the General Department of Environment for examination, evaluation, and issuance of certificates of circulation for biological products.

2. Within five working days from the date of receipt of the file, the General Department of Environment shall be responsible for examining the completeness and validity of the file. In cases where the file is incomplete or invalid, a written notice must be issued to the organization or individual applying for registration to make corrections and supplements.

3. Within ten working days from the date of completion of the examination of the completeness and validity of the file, for biological products that have not yet obtained testing results, the General Department of Environment shall issue a written notification regarding the monitoring and inspection program according to the detailed testing plan contents submitted by the organization or individual applying for the circulation of biological products.

4. Within twenty working days from the date of receiving a complete file as stipulated in Clause 2 of this Article or the testing results of the product as stipulated in Clause 3 of this Article, the General Department of Environment shall establish and organize a specialized scientific council meeting to evaluate the registration file for the circulation of biological products (hereinafter referred to as the Council).

5. Issuance of certificates of circulation for biological products

a) Within seven working days from the date the Council approves the results without requiring any corrections or supplements, the General Department of Environment shall examine and decide to issue the certificate of circulation for biological products;

b) If the Council approves with required corrections or supplements, the General Department of Environment shall issue a written notice to the organization or individual to perfect the file. Within seven working days from the date of receipt of the completed file from the organization or individual, the General Department of Environment shall examine and decide to issue the certificate of circulation for biological products;

c) If the Council does not approve, within two working days from the date of conclusion of the Council meeting, the General Department of Environment shall issue a written notice to the organization or individual applying for the circulation of biological products informing them of the rejection and specifying the reasons.

6. For biological products that have already been granted certificates of circulation, organizations and individuals wishing to continue trading or importing such products shall notify the General Department of Environment and the Ministry of Natural Resources and Environment at least fifteen working days before the circulation period. Within five working days from the date of receipt of the notification from the organization or individual, the General Department of Environment shall be responsible for replying in writing to the organization or individual. The organization or individual may only circulate the product upon approval by the General Department of Environment.

Article 21. Revocation of certificates of circulation for biological products

1. Certificates of circulation for biological products shall be revoked in the following cases:

a) The certificate of circulation for biological products was issued in violation of regulations;

b) Changes in the composition of the biological product;

c) There is confirmation from the competent authority regarding the infringement of industrial property rights on the registered biological product.

2. Organizations and individuals whose certificates of circulation for biological products have been revoked shall be responsible for recalling and disposing of the biological products they have produced, imported, and circulated in accordance with the law.

3. When the certificate of circulation for a biological product is revoked, the General Department of Environment shall be responsible for removing the biological product from the list of biological products for waste treatment in Vietnam and publishing it on the General Department of Environment's website and the Ministry of Natural Resources and Environment's website.

Article 22. Biological Product Testing Facilities

1. A testing facility is an organization with the function of researching and transferring biotechnology or environmental technology (as decided upon establishment or certified by the competent authority for scientific and technological activities) that has sufficient equipment, raw materials, and human resources to implement field applications according to biological product usage guidelines.

2. Organizations or individuals proposing to register the circulation of biological products may choose the agency and location for testing and must pay the costs of conducting the tests as agreed in the contract.

3. The testing facility selects the cooperating agencies during the testing process on its own; it is responsible for storing the results file for at least 60 months after the completion of the testing.

Article 23. Content, Methods, and Reporting of Biological Product Testing Results

1. The content of testing for each type of biological product includes:

a) Composition and quality of the biological product according to published standards;

b) Effectiveness of using the biological product according to the biological product usage guidelines;

c) Safety for human health and living organisms during the use of the biological product.

2. Testing methods are carried out according to relevant technical standards or other methods ensuring objectivity and scientific accuracy.

3. The report of the testing results from the testing facility must include the following contents:

a) Name of the testing facility and name of the organization or individual requesting the test;

b) Name of the tested biological product along with the file on composition, effectiveness, storage, usage, labeling, and packaging;

c) Condition of the biological product before testing;

d) Testing requirements;

đ) Location, time, scale, and method of testing;

e) Testing results, conclusions, and recommendations.

Article 24. Supervision and Inspection of Biological Product Testing

1. The General Department of Environment is responsible for supervising and inspecting or delegating local Environmental Protection Agencies to carry out supervision and inspection of the use of biological products according to the notification document specified in Clause 3, Article 20 of this Decree.

2. The inspection team consists of representatives from the General Department of Environment or local Environmental Protection Agencies and experts in biotechnology.

3. The results of supervision and inspection must be documented in writing together with discussion opinions and recommendations with the presence and confirmation of the members of the inspection team and representatives of the biological product testing facility.

Article 25. List of Biological Products for Waste Treatment in Vietnam

1. Biological products granted a certificate for circulating biological products must establish a list of biological products for waste treatment in Vietnam and publish it on the electronic information website of the Ministry of Natural Resources and Environment and the General Department of Environment's electronic information website.

2. Every six months, the General Department of Environment is responsible for reviewing, amending, and supplementing the list of biological products for waste treatment in Vietnam.

Section 2

CONDITIONS FOR OPERATING DANGEROUS GOODS TRANSPORTATION

INCLUDING TOXIC SUBSTANCES AND INFECTIOUS MATERIALS

Article 26. Requirements for Dangerous Goods Transportation Permit for Toxic Substances and Infectious Materials

1. Organizations and individuals must have a permit for transporting dangerous goods, including toxic substances and infectious materials, in the following cases:

a) When transporting dangerous goods, including toxic substances and infectious materials, by road transport vehicles with a quantity equal to or exceeding the threshold requiring a transportation permit as stipulated in Column 6 of Appendix III issued together with this Decree;

b) When transporting each type of dangerous goods with a quantity not exceeding the threshold requiring a transportation permit as stipulated in Column 6 of Appendix III issued together with this Decree, but the total quantity of toxic substances and infectious materials transported on the same road transport vehicle exceeds one ton per trip (excluding packaging weight).

2. Organizations and individuals do not need a permit for transporting dangerous goods, including toxic substances and infectious materials, in the following cases if they meet the conditions stipulated in this Decree:

a) When transporting dangerous goods, including toxic substances and infectious materials, by road transport vehicles with a quantity below the threshold requiring a transportation permit as stipulated in Column 6 of Appendix III issued together with this Decree, but must have a plan for preventing and responding to environmental emergencies during dangerous goods transportation (according to the model prescribed in Appendix IV issued together with this Decree) and must comply with the transportation conditions stipulated in Articles 27, 28, and Article 29 of this Decree;

b) When transporting dangerous goods, including toxic substances and infectious materials, by inland waterway or rail transport, but must comply with the corresponding regulations under Decree No. 29/2005/ND-CP or Decree No. 14/2015/ND-CP and must comply with the transportation conditions stipulated in Articles 27, 28, and Article 29 of this Decree.

Article 27. Conditions regarding packaging, containers, labeling, and hazardous substance warning signs

1. Requirements for packaging, containers, and labeling of dangerous goods that are toxic substances and infectious materials:

a) The packaging of dangerous goods and the use of materials for packaging and containers must comply with the provisions of National Standard TCVN 5507:2002 - Dangerous Chemicals - Safety Regulations for Production, Business, Use, Storage, and Transportation (hereinafter referred to as TCVN 5507:2002) or other replacement documents, and be consistent with technical requirements and standards corresponding to the type of goods (if applicable).

b) Packaging and containers for dangerous goods must be resistant to corrosion, rust, and chemical reactions with the contents; they must be waterproof, sealed, and secure to ensure no leakage during normal transportation and minimize leakage into the environment in case of accidents.

c) In cases where organizations or individuals transporting dangerous goods use packaging and containers to self-package such goods, they must conduct tests and bear responsibility for the test results of these packaging and containers before use to prevent falling out or leakage during transportation.

b) After use, packaging and containers for dangerous goods must be stored separately in accordance with the provisions of National Standard TCVN 5507:2002.

2. Labeling requirements:

Labeling of dangerous goods shall be carried out in accordance with the regulations on product labels and chemical labeling.

3. Requirements for hazard symbols and warning signs:

a) Hazard symbols and warning signs must be affixed to the outside of packaging and containers for dangerous goods.

b) Transport vehicles must have hazard symbols of the type or group of goods being transported. If multiple types of dangerous goods are transported simultaneously in the same vehicle, all relevant hazard symbols must be affixed to the vehicle. These symbols should be placed on both sides of the vehicle and at the rear, with sufficient durability to withstand weather conditions and common handling during loading, unloading, and transportation. Hazard symbols and warning signs must not be present on transport vehicles unless they are transporting dangerous goods.

c) Hazard symbols and warning signs for the type or group of goods being transported must comply with the provisions set forth in Article 6 of Decree No. 29/2005/NĐ-CP, Article 24 of Decree No. 14/2015/NĐ-CP, or Article 9 of Decree No. 104/2009/NĐ-CP.

d) For road and rail transport vehicles carrying bulk dangerous goods exceeding the permitted weight threshold as specified in Column 6 of Appendix III issued together with this Decree, in addition to hazard symbols and warning signs, there must be an emergency information board placed at the end of the transport vehicle, with the bottom edge of the board at least 450 mm above ground level.

4. Requirements for stacking, unstacking, and storage of dangerous goods:

a) Organizations and individuals involved must strictly follow instructions for storing, stacking, unstacking, and warehousing each type of dangerous goods in accordance with the provisions of National Standard TCVN 5507:2002 or notifications from the owners of dangerous goods or transport vehicles.

b) Stacking, unstacking, and warehousing of dangerous goods must be carried out in accordance with the provisions of Article 9 of Decree No. 29/2005/NĐ-CP, Article 29 of Decree No. 14/2015/NĐ-CP, or Article 12 of Decree No. 104/2009/NĐ-CP.

5. Dangerous goods that are toxic substances and infectious materials must be accompanied by a chemical safety data sheet in accordance with current regulations.

Article 28. Conditions for vehicles transporting hazardous goods that are toxic substances and infectious materials

Road motor vehicles, railway vehicles, and inland waterway vessels transporting hazardous goods that are toxic substances and infectious materials must meet the corresponding conditions for each type of vehicle as stipulated in Article 13 of Decree No. 104/2009/ND-CP, Article 30 of Decree No. 14/2015/ND-CP, Article 10 of Decree No. 29/2005/ND-CP, and the following conditions:

1. Not to transport hazardous goods together with passengers, animals, foodstuffs, or food products, or to transport hazardous goods that can react with each other causing fire, explosion, or producing new harmful substances to the environment and human health on the same vehicle.

2. To have equipment to cover and completely seal the cargo compartment. The covering equipment must be suitable for waterproofing, fireproofing, and not being destroyed upon contact with the transported goods; it must withstand impact and ensure safety, minimizing leakage of toxic and infectious substances into the environment in case of accidents.

3. To ensure sufficient emergency response equipment and materials during transportation as described in the environmental accident prevention and response plan for hazardous goods transportation according to the model attached as Appendix IV to this Decree.

4. To comply with regulations, standards, and norms for transporting dangerous chemicals or hazardous goods, safety fire prevention and firefighting conditions as prescribed by law, and implement mandatory fire and explosion insurance as prescribed by law.

5. Road motor vehicles transporting hazardous goods must have a cab large enough for at least two people to sit, including one person to operate the vehicle and one person to escort the hazardous goods.

Article 29. Conditions for drivers and escorts of vehicles transporting hazardous goods that are toxic substances and infectious materials

1. Drivers must hold a valid driving license appropriate to the type of vehicle specified in the hazardous goods transportation permit.

2. Drivers and escorts of hazardous goods must satisfy one of the following conditions:

a) Having been trained and issued a training certificate for transporting hazardous goods that are toxic substances and infectious materials by the Ministry of Natural Resources and Environment;

b) Having been trained and issued a valid training certificate for chemical safety or other hazardous goods transportation by a competent state agency;

c) Graduating from a specialized chemical program at a college level or higher.

Article 30. Hiring for the transportation of hazardous goods that are toxic substances and infectious materials

In cases where the owner of hazardous goods hires the owner of a vehicle to transport hazardous goods, they must comply with the following provisions:

1. For road motor vehicles:

a) For hazardous goods, the owner must have an economic contract or a written agreement regarding transportation with the owner of the hazardous goods transportation vehicle holding a valid hazardous goods transportation permit appropriate to the type of goods to be transported;

b) If the owner of the hazardous goods transportation vehicle does not have a valid hazardous goods transportation permit appropriate to the type of goods to be transported, the owner of the hazardous goods must meet all transportation conditions as stipulated in Articles 27, 28, and 29 of this Decree and submit an application for a hazardous goods transportation permit by road motor vehicle for each shipment as prescribed.

2. For inland waterway vessels and railway vehicles: For hazardous goods, the owner must have an economic contract or a written agreement regarding transportation with the owner of the hazardous goods transportation vehicle, which includes a clause requiring the owner of the hazardous goods transportation vehicle to meet transportation safety and environmental protection conditions appropriate to the type of goods to be transported as stipulated in Article 27, Clause 1, 2, 3, and Clause 4 of Article 28 and Article 29 of this Decree.

3. The hiring of transportation for hazardous goods must comply with current laws.

Section 3

CONDITIONS FOR GRANTING PERMITS TO TREAT HAZARDOUS WASTE

Article 31. Conditions for granting permits to treat hazardous waste

Organizations and individuals applying for a permit to treat hazardous waste (HW) must meet the conditions stipulated in Article 9 of Decree No. 38/2015/NĐ-CP dated April 24, 2015 of the Government on management of waste and scrap materials, and technical requirements and management procedures related to the conditions for granting permits to treat HW including:

1. Means and equipment for storing, transporting, and treating HW (including preliminary processing, recycling, co-processing, energy recovery from HW) must comply with the technical requirements and management procedures specified in Appendix V attached to this Decree.

2. Means for transporting HW must have a satellite positioning system (GPS) connected to an online information network to determine location and record the transportation route of HW.

3. One means or equipment may only be registered for one HW treatment permit, except for sea, rail, and air transport means.

4. Environmental protection facilities at the HW treatment facility and intermediate transfer stations (if any) must comply with the technical requirements and management procedures specified in Appendix V attached to this Decree.

5. Organizations and individuals applying for a HW treatment permit must develop all contents regarding safe operation procedures for systems, means, and equipment; plans for pollution control and environmental protection, occupational safety and health protection, accident prevention and response, regular annual training, pollution treatment and environmental protection upon cessation of operations; environmental monitoring programs, operational treatment monitoring, and assessment of treatment effectiveness of HW.

6. Organizations and individuals applying for a HW treatment permit must prepare simplified or schematic guidance charts regarding safe operation procedures as stipulated in Clause 5 of this Article with appropriate sizes and install them in convenient locations for observation on transport means, within the treatment facility, and intermediate transfer stations (if any).

Chapter V

IMPLEMENTATION RESPONSIBILITY

Article 32. Effectiveness

1. This Decree takes effect from July 1, 2016.

2. Transitional Provisions

a) Organizations and individuals who have been granted a permit to operate groundwater drilling before the effective date of this Decree shall continue to use it. Applications for permits to operate groundwater drilling received by competent authorities before the effective date of this Decree shall be processed according to the laws in effect at the time of receipt.

Organizations and individuals with decisions approving, assigning tasks, or signing contracts to conduct basic investigations of water resources, consulting on planning water resources, preparing proposals, and reports in applications for water resource permits before the effective date of this Decree shall continue to implement them;

b) Organizations and individuals who have been granted a permit to circulate biological products before the effective date of this Decree shall continue to use them unless revoked. Applications for circulating biological products received by competent state agencies before the effective date of this Decree to process under administrative procedures for registering biological product circulation shall be handled according to the laws in effect at the time of receipt;

Permits for transporting dangerous goods that are toxic substances and infectious substances with validity periods before the effective date of this Decree shall continue to be used, except in cases of revocation and reissue. The acceptance and handling of applications for permits to transport dangerous goods that are toxic substances and infectious substances before the effective date of this Decree shall be carried out according to the laws in effect at the time of receipt.

Article 33. Responsibility for Implementation

1. The Minister of Natural Resources and Environment shall be responsible for guiding the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, and Chairpersons of provincial People's Committees within their respective functions and duties shall be responsible for implementing this Decree./.