Circular No. 28/2010/TT-BCT provides detailed regulations on certain provisions of the Chemical Law and Decree No. 108/2008/NĐ-CP dated October 7, 2008, guiding the implementation of certain provisions of the Chemical Law.

CIRCULAR

Regulations on certain provisions of the Law on Chemicals and Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals.

Detailed regulations and guidance on implementing certain provisions of the Law on Chemicals and Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government.

___________________________________

THE MINISTER OF INDUSTRY AND TRADE

Pursuant to Decree No. 189/2007/ND-CP dated December 27, 2007, issued by the Government, detailing the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

The Government issues this Decree amending and supplementing the list of narcotic substances and precursors promulgated together with Decree No. 57/2022/NĐ-CP dated August 25, 2022 of the Government stipulating the lists of narcotic substances and precursors.

Pursuant to Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals;

The Ministry of Industry and Trade hereby provides detailed regulations on certain provisions of the Law on Chemicals and Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular stipulates on:

a) Conditions for material and technical infrastructure ensuring safety in chemical production and business in the industrial sector;

b) Documents and procedures for issuing Certificates of Compliance with Conditions for Production and Business of Chemicals listed in the Catalogue of Conditionally Produced and Traded Chemicals in the Industrial Sector;

c) Documents and procedures for issuing Licenses for Production and Business of Chemicals listed in the Catalogue of Restrictedly Produced and Traded Chemicals in the Industrial Sector;

d) Preparation and review of applications for permission to produce, import, and use prohibited chemicals in the industrial sector;

đ) Measures for prevention and response to chemical accidents and establishment of Emergency Response Plans for chemical accidents in the industrial sector;

e) Purchase and sale control forms for toxic chemicals; construction of Safety Data Sheets for chemicals; registration files and organization of evaluation of new chemicals; confidentiality of chemical information.

2. The issuance of Certificates of Compliance with Conditions for Production and Business of Chemicals listed in the Catalogue of Conditionally Produced and Traded Chemicals in the Industrial Sector; Licenses for Production and Business of Chemicals listed in the Catalogue of Restrictedly Produced and Traded Chemicals in the Industrial Sector as stipulated in this Circular shall not apply to explosive precursors, gasoline, oil, and liquefied petroleum gas.

Article 2. Applicability

This Circular applies to organizations and individuals engaged in chemical production, business, and use in the industrial sector and those related to chemical activities within the territory of the Socialist Republic of Vietnam.

Article 3. Explanation of terms and abbreviations

In this Circular, the following terms are understood as follows:

1. Catalogue of Conditionally Produced and Traded Chemicals in the Industrial Sector is the catalogue of chemicals specified in Appendix 1 attached to this Circular.

2. Catalogue of Restrictedly Produced and Traded Chemicals in the Industrial Sector is the catalogue of chemicals specified in Appendix II of Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals.

3. Catalogue of Prohibited Chemicals is the catalogue of chemicals specified in Appendix III of Decree No. 108/2008/NĐ-CP.

4. Chemical Business means the implementation of one, several, or all stages of the investment process from production to consumption or provision of chemical services in the market for profit-making purposes.

5. Certified copy is a certified copy by a competent authority.

6. CAS Number of a chemical is a unique sequence of digits assigned to each chemical according to the rules of Chemical Abstracts Service (a division of the American Chemical Society, abbreviated as CAS).

7. Number UN (United Nations) is a four-digit number defined by the United Nations for identifying hazardous chemicals.

Chapter II

Article 1. MATERIAL AND TECHNICAL CONDITIONS FOR SAFETY IN THE PRODUCTION AND BUSINESS OF CHEMICALS IN THE INDUSTRY

Article 4. Ensuring Safety in Chemical Production and Business

Organizations and individuals producing and trading chemicals in the industry shall comply with conditions regarding factory buildings, warehouses, equipment, transportation means, and safe operation as stipulated in the Law on Chemicals; Articles 5, 6, and 7 of this Circular; Vietnam Standard TCVN 5507:2002 Dangerous Chemicals - Safety Regulations for Production, Trading, Use, Storage, and Transportation; and other relevant laws, standards, and technical regulations currently in force.

Article 5. Conditions Regarding Factory Buildings and Warehouses

1. Place

a) Factory buildings and warehouses must be located at sites suitable for planning conditions;

b) The location of chemical production factory buildings must ensure convenient access to electricity supply, water supply, drainage, pollution treatment, and traffic;

c) Chemical production factory buildings and chemical storage warehouses shall not be placed adjacent to residential areas. For warehouses storing chemicals within factory buildings for production purposes, the warehouse location must meet technological requirements for chemical preservation. Chemical storage warehouses must be situated outside the production factory building;

d) Warehouse locations must ensure sufficient space for easy entry and exit of transport vehicles and fire trucks;

2. Layout of Factory Buildings and Warehouses

The layout of factory buildings must meet design standards based on current Vietnamese Construction Standards and Building Standards concerning climatic conditions, geological hydrological conditions, meteorological and hydrological conditions, earthquake zoning, fire prevention and explosion control, environmental protection, and workplace safety;

a) The layout of factory buildings must reasonably arrange construction components with clear functions;

b) The area of factory buildings must comply with current regulations to accommodate production equipment;

c) Factory buildings for production must be designed to ensure indoor working environmental conditions meet health standards set by the Ministry of Health regarding temperature, humidity, and wind speed;

d) Internal traffic systems must be rationally arranged to ensure safe transportation within the factory building and firefighting operations. Factory buildings must have perimeter walls separating the facility from the outside;

đ) For chemical storage warehouses, designs must adhere to principles minimizing fire and spill risks and must separate substances capable of causing chemical reactions;

e) Warehouse designs depend on the type of chemicals to be stored, classified according to explosion and fire risks as specified in Vietnam Standard TCVN 2622:1995. Designs must follow Vietnamese Construction Standards and related Vietnam Standards. In addition to general structural requirements, chemical warehouse designs must implement fire and explosion prevention standards, such as fire resistance; fire separation; escape routes; fire alarm systems; fire suppression systems; and fire watch stations;

3. Structure and Architectural Layout of Construction Projects

a) Enclosed and spacious areas must have two-way emergency exits clearly marked (with signs, diagrams, etc.) and designed for ease of use in emergencies. Emergency exits must be easily opened in darkness or thick smoke;

b) Warehouses must be ventilated through openings in the roof, walls below the roof, or near the floor;

c) Warehouse floors must be impermeable to liquids, flat without slippery surfaces, and free of cracks that could hold leaking water, spilled liquids, or contaminated firefighting water, and should have curbs or edges around them;

d) Construction materials for warehouses and insulation materials must be non-flammable, and the building frames must be reinforced with concrete or steel;

Article 6. Conditions regarding equipment

1. Production equipment

a) Production equipment must meet general safety requirements as stipulated in current Vietnam Standards;

b) Regular maintenance and cleaning schedules for production equipment must be established;

c) Technical parameters of production equipment must be checked, and safety protection systems for users must be installed;

2. Safety Equipment and Means

a) Lighting fixtures and other electrical equipment must be installed at necessary locations and cannot be temporary installations. All electrical equipment must be grounded and equipped with circuit breakers for leakage protection and overload protection;

b) Fire-resistant equipment must be used in areas storing low ignition temperature solvents or fine chemical dust;

c) Full emergency response equipment must be provided at chemical production and trading facilities. Fire alarm and suppression systems must be installed in appropriate locations and regularly inspected to ensure they are ready for use;

3. Emission and Waste Treatment Systems

a) Factory buildings and chemical warehouses may not release harmful substances, noise, or other harmful factors into the air beyond current environmental hygiene standards. Exhaust gases from factory buildings and chemical warehouses must comply with National Technical Regulations: QCVN 19:2009/BTNMT - National Technical Regulations on Industrial Emissions for Dust and Inorganic Substances; QCVN 20:2009/BTNMT - National Technical Regulations on Industrial Emissions for Certain Organic Substances; QCVN 21:2009/BTNMT - National Technical Regulations on Industrial Emissions for Chemical Fertilizer Production;

b) Factory buildings and chemical warehouses must have wastewater treatment systems. Treated wastewater must meet National Technical Regulations: QCVN 07:2009/BTNMT - National Technical Regulations on Hazardous Waste Thresholds; QCVN 24:2009/BTNMT - National Technical Regulations on Industrial Wastewater; QCVN 25:2009/BTNMT - National Technical Regulations on Wastewater from Solid Waste Landfills;

c) Solid waste from factory buildings and chemical warehouses must comply with the Government's Decree No. 59/2007/NĐ-CP dated April 9, 2007, on solid waste management. Factory buildings and chemical warehouses must have tools to collect and transport solid waste out of the production area after each shift; storage areas for solid waste must be sealed off and isolated from the production area.

Article 7. Conditions for transportation means and safe operation

1. Transportation means for chemicals must meet current technical standards for hazardous goods being transported and ensure the following requirements:

a) Be designed to prevent leakage or release of chemicals into the environment. During transportation, do not mix chemicals that can react chemically with each other and cause danger;

b) Chemicals must be contained in appropriate packaging and transported by specialized means;

c) Have warning signs on the transportation means. If there are different types of chemicals on one transportation means, the labels of each type of chemical must be affixed on both sides and at the rear of the transportation means.

2. Safe operation at chemical warehouses

a) Chemical production facilities and chemical storage warehouses must establish Measures or Plans to prevent and respond to chemical accidents;

b) Chemical production facilities must establish internal rules on chemical safety and appropriate warning systems according to the level of danger of the chemicals. In cases where chemicals have multiple dangerous characteristics, the warning labels must fully reflect these dangerous characteristics;

c) Operations at chemical warehouses must ensure strict safety and hygiene, avoiding potential risks such as fire, leakage...;

d) Warehouse staff must apply all Safety Data Sheets for all stored and transported chemicals; instructions on safety work and hygiene work; instructions when accidents occur;

đ) Chemicals in the warehouse must be separated from hazardous areas frequently visited by people; there must be space between the wall and the nearest stored chemical packages, and there must be clear pathways inside for ventilation and unobstructed access for rescue equipment during inspection and firefighting activities.

Chapter III

RECORDS AND PROCEDURES FOR ISSUING CERTIFICATES OF QUALIFICATION AND LICENSES FOR CHEMICAL PRODUCTION AND DISTRIBUTION IN THE INDUSTRY

PART 1. RECORDS AND PROCEDURES FOR ISSUING CERTIFICATES OF QUALIFICATION FOR PRODUCTION AND DISTRIBUTION OF LISTED CHEMICALS WITH CONDITIONS IN THE INDUSTRY

Article 8. Organization for Issuing Certificates of Qualification for Chemical Production and Distribution

Provincial Departments of Industry and Trade (hereinafter referred to as Departments of Industry and Trade) are responsible for issuing Certificates of Qualification for production and distribution of listed chemicals with conditions in the industry (hereinafter referred to as Certificate of Qualification).

Article 9. Application Documents for New Certificate of Qualification for Organizations and Individuals Producing Listed Chemicals with Conditions

1. Legal Documents

a) Application form for Certificate of Qualification according to the model attached as Appendix 2 to this Circular;

b) A certified copy of the Business Registration Certificate;

c) A certified copy of the Decision approving the investment project for construction of production works in accordance with laws on management and investment in construction;

d) A certified copy of the Decision approving the Environmental Impact Assessment Report attached to the proposal or the Registration Confirmation of Environmental Protection Commitment attached to the proposal issued by the competent authority;

đ) A certified copy of the Fire Prevention and Control Certificate or the Inspection Record ensuring fire prevention and control safety by the competent police authority.

2. Technical Condition Documents

a) Declaration of factory and warehouse systems of hazardous chemical production facilities;

b) Declaration of labor protective equipment and safety equipment according to the model attached as Appendix 3 to this Circular;

c) Announcement of conformity declaration and periodic quality monitoring plan for chemicals based on chemical testing equipment or a joint agreement with a unit having recognized chemical testing capacity;

d) Safety Data Sheets for all hazardous chemicals in the production facility.

3. Personnel Condition Documents

a) Declaration of personnel according to the model attached as Appendix 4 to this Circular, including managerial and technical staff, and employees directly involved in the production, storage, and transportation of hazardous chemicals;

b) Certified copies of bachelor's degrees in chemical fields of the General Director or Deputy General Director for Technology; certificates of participation in chemical vocational training courses for technical staff, employees, and workers of the chemical production facility;

c) Health qualification certificate issued by a district or county health agency for individuals specified in point a of this clause.

Article 10. Documents for requesting issuance of a new Chemical Product Registration Certificate for organizations and individuals engaged in chemical business activities listed in the Conditional Production and Business Chemical List.

1. Legal Documents

a) Application form for Certificate of Qualification according to the model attached as Appendix 2 to this Circular;

b) A certified copy of the Business Registration Certificate;

c) A certified true copy of the Fire Prevention and Control Certificate or a record of fire safety inspection issued by the competent police authority.

d) The environmental protection commitment registration confirmation certificate issued by the competent authority.

2. Technical Condition Documents

a) An inventory of production facilities and warehouses of each hazardous chemical business establishment.

b) Declaration of labor protective equipment and safety equipment according to the model attached as Appendix 3 to this Circular;

c) An inventory of dedicated transportation equipment and a certified true copy of the Dangerous Goods Transport Permit.

d) An inventory of business locations; if a hazardous chemical business establishment has multiple business points dealing with the same type of chemical, each point must prepare its own separate application according to this Article and be issued a shared Chemical Product Registration Certificate.

đ) Safety data sheets for all hazardous chemicals within the business establishment.

3. Documents regarding conditions for business operators

a) A personnel inventory according to Model 4 attached to this Circular, including: management and technical staff, and employees directly involved in hazardous chemical business operations, storage, and transportation.

b) A certified true copy of a bachelor's degree in chemical fields or a bachelor's degree in technical economics of the General Director or Deputy General Director for Technology; certificates showing participation in chemical business training courses for technical staff, employees, and workers of the hazardous chemical business establishment.

c) Health qualification certificate issued by a district or county health agency for individuals specified in point a of this clause.

Article 11. Documents for requesting issuance of a Chemical Product Registration Certificate for organizations and individuals simultaneously producing and trading in chemicals listed in the Conditional Production and Business Chemical List.

For organizations and individuals simultaneously producing and trading in chemicals listed in the Conditional Production and Business Chemical List, the application documents for the Chemical Product Registration Certificate include:

1. Application form for issuance of a Chemical Product Registration Certificate for conditional production and business of chemicals.

2. A certified true copy of the Business Registration Certificate.

3. Safety data sheets for all hazardous chemicals within the production and business establishment.

4. A personnel inventory according to Model 4 attached to this Circular, including: management and technical staff, and employees directly involved in hazardous chemical production, business operations, storage, and transportation.

5. A certified true copy of a bachelor's degree in chemical fields or a bachelor's degree in technical economics of the General Director or Deputy General Director for Technology; certificates showing participation in chemical business training courses for technical staff, employees, and workers of the hazardous chemical production and business establishment.

6. Health qualification certificate issued by a health authority at district or county level for the subjects specified in Clause 4 of this Article.

7. Documents stipulated in Points c, d, đ of Clause 1; Points a, b, c of Clause 2 of Article 9 and Points c, d of Clause 2 of Article 10 of this Circular.

Article 12. Cases of amendment and supplementation

1. In cases where there are changes to the contents of the already issued Chemical Product Registration Certificate, organizations and individuals must submit an application to the Department of Industry and Trade requesting amendments and supplements to the Chemical Product Registration Certificate.

2. Documents for requesting issuance of an amended and supplemented Chemical Product Registration Certificate include:

a) A request for amendment and supplementation;

b) The original Certificate;

c) Supporting documents proving the need for amendment and supplement.

Article 13. Cases of reissuing

1. In cases where the Certificate is lost, burned, or destroyed, organizations and individuals must prepare a dossier to submit to the Department of Industry and Trade requesting reissue of the Certificate. The dossier includes:

a) A request for reissuance;

b) A certified true copy of the Certificate (if available).

2. In cases where the Certificate has expired, at least 30 (thirty) working days before the expiry date of the Certificate, organizations and individuals must prepare a dossier to submit to the Department of Industry and Trade requesting reissue. The dossier includes:

a) A request for reissuance;

b) The Certificate or a certified true copy of the previously issued Certificate;

c) A report on the operation of chemical production and business during the period covered by the previous Certificate, specifying the name of the chemicals, their intended use, quantities produced, imported, and used; import, export, inventory levels, and storage locations; implementation of safety measures; and other relevant information (if any).

Article 14. Procedures for Issuing Certificates

1. Organizations and individuals requesting issuance of a Certificate must submit one set of the dossier to the Department of Industry and Trade.

2. Within twenty (20) days from the date of receipt of a complete and valid dossier as stipulated in Articles 9, 10, 11, 12, and 13 of this Circular, the Department of Industry and Trade shall be responsible for reviewing, examining, and issuing the Certificate according to the model attached as Appendix 5 to this Circular to organizations and individuals.

In cases where the issuance of the Certificate is refused, the Department of Industry and Trade must provide a written response stating the reasons.

3. If the dossier is incomplete or invalid, within five (5) days from the date of receiving the dossier, the Department of Industry and Trade must issue a written request for supplementation.

4. Organizations and individuals who have been issued a Certificate must pay the prescribed fee as stipulated by the Ministry of Finance.

5. For businesses currently engaged in chemical production and business that need to change their business name without changing the conditions for production and business, they must submit to the Department of Industry and Trade a certified true copy of the decision allowing the name change and a request to reissue the Certificate.

Article 15. Validity Period of the Certificate

The Certificate has a validity period of five (5) years from the date of issuance. For organizations and individuals with multiple business locations, each business location must be clearly specified in the Certificate as having met the required conditions.

PART 2. Dossier and Procedures for Issuing Permits for the Production and Business of Chemicals Listed in the Restricted Chemicals List in the Industry Sector

Article 16. Organization Issuing Permits for the Production and Business of Restricted Chemicals

The Ministry of Industry and Trade issues Permits for the production and business of chemicals listed in the Restricted Chemicals List in the industry sector (hereinafter referred to as the Permit).

Article 17. Dossier for New Permit Applications by Organizations and Individuals Producing Restricted Chemicals

1. Legal Documents

a) An application form for the Permit according to the model attached as Appendix 6 to this Circular;

b) A certified copy of the Business Registration Certificate;

c) A certified copy of the Decision approving the investment project for construction of production works in accordance with laws on management and investment in construction;

d) A certified copy of the Decision approving the Environmental Impact Assessment Report attached to the proposal or the Registration Confirmation of Environmental Protection Commitment attached to the proposal issued by the competent authority;

đ) A certified copy of the Fire Prevention and Control Certificate or the Inspection Record ensuring fire prevention and control safety by the competent police authority.

2. Technical Condition Documents

a) Declaration of factory and warehouse systems of hazardous chemical production facilities;

b) Declaration of labor protective equipment and safety equipment according to the model attached as Appendix 3 to this Circular;

c) Announcement of conformity declaration and periodic quality monitoring plan for chemicals based on chemical testing equipment or a joint agreement with a unit having recognized chemical testing capacity;

d) Safety Data Sheets for all hazardous chemicals in the production facility.

3. Documentation regarding the conditions for producers.

a) A personnel declaration form according to the model attached as Appendix 4 to this Circular, including: management and technical staff, and employees directly related to the production, storage, and transportation of dangerous chemicals;

b) Certified copies of bachelor's degrees in chemical fields of the General Director or Deputy General Director for Technology; certificates of participation in chemical vocational training courses for technical staff, employees, and workers of the chemical production facility;

c) Health qualification certificate issued by a district or county health agency for individuals specified in point a of this clause.

Article 18. Dossier for New Permit Applications by Businesses Engaged in the Business of Restricted Chemicals

1. Legal Documents

a) An application form for the Permit according to the model attached as Appendix 6 to this Circular;

b) A certified copy of the Business Registration Certificate;

c) A certified true copy of the Fire Prevention and Control Certificate or a record of inspection ensuring fire safety by the competent police authority;

d) The environmental protection commitment registration confirmation certificate issued by the competent authority.

2. Technical Condition Documents

a) A statement of the need for restricted chemical business;

b) A declaration of the factory and warehouse system of each business engaged in dangerous chemical business;

c) A declaration of labor protection equipment and safety facilities according to the model attached as Appendix 3 to this Circular;

d) A declaration of dedicated transport vehicles and a certified true copy of the Dangerous Goods Transport Permit;

đ) A declaration of each business location, if the business has multiple business locations dealing with the same type of chemical, each location must prepare a separate dossier according to the provisions of this Article and be issued a common Permit;

e) A safety data sheet for all dangerous chemicals in the business premises.

3. Documents regarding conditions for business operators

a) A personnel declaration form according to the model attached as Appendix 4 to this Circular, including: management and technical staff, and employees directly related to the business, storage, and transportation of dangerous chemicals;

b) A certified true copy of a bachelor's degree in chemical fields or a bachelor's degree in technical economics of the General Director or Deputy General Director for Technology; certificates showing participation in chemical business training courses for technical staff, employees, and workers of the hazardous chemical business establishment.

c) Health qualification certificate issued by a district or county health agency for individuals specified in point a of this clause.

Article 19. Application Documents for Issuing a Permit for Organizations and Individuals Producing and Trading Restricted Chemicals Listed in the Restricted Chemicals Catalogue

For organizations and individuals producing and trading restricted chemicals listed in the Restricted Chemicals Catalogue, the application documents for issuing a permit include:

1. An application form for issuing a permit to produce and trade restricted chemicals listed in the Restricted Chemicals Catalogue.

2. A certified true copy of the Business Registration Certificate.

3. Safety data sheets for all hazardous chemicals within the production and business establishment.

4. A personnel inventory according to Model 4 attached to this Circular, including: management and technical staff, and employees directly involved in hazardous chemical production, business operations, storage, and transportation.

5. A certified true copy of a bachelor's degree in chemical fields or a bachelor's degree in technical economics of the General Director or Deputy General Director for Technology; certificates showing participation in chemical business training courses for technical staff, employees, and workers of the hazardous chemical production and business establishment.

6. Health qualification certificate issued by a health authority at district or county level for the subjects specified in Clause 4 of this Article.

7. The documents specified in point c, d, đ clause 1; point a, b, c clause 2 Article 17 and point a, d, đ clause 2 Article 18 of this Circular.

Article 20. Cases of Amending and Supplementing the Permit

1. In cases where there are changes to the contents of the already issued permit, organizations and individuals must prepare an application dossier to be sent to the Ministry of Industry and Trade requesting amendments and supplements to the permit.

2. The application dossier for amending and supplementing the permit includes:

a) A request for amendment and supplementation;

b) The original permit that has been issued.

c) Supporting documents proving the need for amendment and supplement.

Article 21. Cases of Reissuing the Permit

1. In cases where the permit is lost, burned, or destroyed, organizations and individuals must prepare an application dossier to be sent to the Ministry of Industry and Trade requesting reissue of the permit. The dossier includes:

a) A request for reissuance;

b) A valid copy of the permit (if available).

2. In cases where the permit expires, thirty working days before the expiration date of the permit, organizations and individuals must prepare an application dossier to be sent to the Ministry of Industry and Trade (Chemical Administration Department) requesting reissue. The dossier includes:

a) A request for reissuance;

b) The permit or a valid copy of the previously issued permit;

c) A report on the operation of chemical production and trading during the period covered by the previous permit, specifying the name of the chemical, purpose of use, quantity of chemical produced, imported, and used; import, export, inventory, and storage location of the chemical; implementation of safety measures; other information (if any).

Article 22. Procedures for Issuing the Permit

1. Organizations and individuals applying for a permit must submit one set of application documents to the Ministry of Industry and Trade (Chemical Administration Department).

2. Within twenty (20) days from the date of receipt of complete and valid application documents as stipulated in Articles 17, 18, 19, 20, and 21 of this Circular, the Ministry of Industry and Trade (Chemical Administration Department) shall be responsible for reviewing, assessing, and issuing the permit according to the model attached as Appendix 7 to this Circular to the organization or individual.

In cases where the permit is refused, the Ministry of Industry and Trade (Chemical Administration Department) must provide a written response stating the reasons.

3. If the application dossier is incomplete or invalid, within five (5) days from the date of receipt of the dossier, the Ministry of Industry and Trade (Chemical Administration Department) shall issue a written request for supplementation.

4. Organizations and individuals who have been granted the permit must pay the fee as prescribed by the Ministry of Finance.

5. For production and trading facilities that were operating before the effective date of this Circular but have not yet obtained a permit and wish to continue operations, they must follow the procedures for obtaining a permit as stipulated herein.

6. In cases where production and trading facilities for restricted chemicals cease operations or change their business locations, they must submit a written report to the Ministry of Industry and Trade (Chemical Administration Department).

Article 23. Validity Period of the Permit

The permit has a validity period of three (3) years from the date of issuance. For organizations and individuals with multiple trading points, each trading point that meets the conditions must be clearly stated on the permit.

Chapter IV

ESTABLISHING AND REVIEWING APPLICATIONS FOR PERMITTING THE PRODUCTION, IMPORT, AND USE OF BANNED CHEMICALS IN THE INDUSTRY

Article 24. List of Prohibited Chemicals

Organizations and individuals producing, importing, using prohibited chemicals listed in the List of Prohibited Chemicals stipulated in Clause 3, Article 3 of this Circular for special purposes serving national security, defense, disease prevention and control, and other special cases in the industry (hereinafter referred to as production, importation, and use of prohibited chemicals) must be approved by the Prime Minister.

Article 25. Documents for Requesting Permission to Produce Prohibited Chemicals

Organizations and individuals producing prohibited chemicals shall submit two (2) sets of documents, one set to the Prime Minister and one set to the Ministry of Industry and Trade (Chemical Administration Department). The documents include those specified in Article 17 of this Circular and the following documents:

1. Application for permission to produce prohibited chemicals sent to the Prime Minister and simultaneously to the Ministry of Industry and Trade (Chemical Administration Department) according to the form attached as Appendix 8 to this Circular.

2. Commitment statement on the implementation of prohibited chemical production.

3. Explanation of the need for prohibited chemical production.

Article 26. Documents for Requesting Permission to Import Prohibited Chemicals

Organizations and individuals importing prohibited chemicals shall submit two (2) sets of documents, one set to the Prime Minister and one set to the Ministry of Industry and Trade (Chemical Administration Department). The documents include the following:

1. Application for permission to import prohibited chemicals specifying the needs and import time, sent to the Prime Minister and simultaneously to the Ministry of Industry and Trade (Chemical Administration Department) according to the form attached as Appendix 9 to this Circular.

2. A valid copy of the Production and Business License for chemicals under the Restricted Chemicals List.

3. Report on the quantity of chemicals imported in the planning year.

4. A valid copy of the Sales Contract for chemicals with foreign enterprises.

Article 27. Documents for Requesting Permission to Use Prohibited Chemicals

Organizations and individuals using prohibited chemicals shall submit two (2) sets of documents, one set to the Prime Minister and one set to the Ministry of Industry and Trade (Chemical Administration Department). The documents include the following:

1. Application for permission to use prohibited chemicals specifying the purpose, scope, and location of use, sent to the Prime Minister and simultaneously to the Ministry of Industry and Trade (Chemical Administration Department) according to the form attached as Appendix 10 to this Circular.

2. A certified true copy of the Business Registration Certificate.

3. A valid copy of the Decision approving the Environmental Impact Assessment Report or the Registration Confirmation of Environmental Protection Commitment issued by the competent authority.

4. A valid copy of the Confirmation of Compliance with Security and Public Order Conditions and Fire Prevention and Control Review Document or Inspection Record ensuring fire safety issued by the competent fire prevention and control authority.

5. Construction design of projects involving the use of prohibited chemicals.

6. Inventory of preventive and emergency response equipment for chemical incidents and emergency response force.

7. Inventory of personal protective equipment and safety equipment according to the form attached as Appendix 3 to this Circular.

8. Inventory of factory buildings and warehouses of the facility using prohibited chemicals.

9. Inventory of dedicated transport vehicles and a valid copy of the Dangerous Goods Transport Permit.

10. Safety Data Sheets for all hazardous chemicals at the facility using prohibited chemicals.

Article 28. Examination of application dossier for permission to produce, import, and use prohibited chemicals.

1. Examine the conditions for production, business of chemicals as stipulated in Articles 11, 12, and 13 of the Chemicals Law and the documents in the application dossier of organizations and individuals as stipulated in Articles 25, 26, and 27 of this Circular.

2. Within no more than twenty (20) working days from the date of receiving a complete and valid application dossier as stipulated in Articles 25, 26, and 27 of this Circular, the Ministry of Industry and Trade (Chemical Administration Department) shall conduct inspection and examination. The examination document of the Ministry of Industry and Trade shall be attached to the dossier submitted to the Prime Minister.

3. In cases where organizations and individuals supplement, adjust, or change activities at existing facilities, they must submit detailed reports and explanations regarding such supplements, adjustments, or changes to the Ministry of Industry and Trade for review and examination before submitting to the Prime Minister for approval.

Article 29. Management of production, import, and use of prohibited chemicals.

1. When requested, organizations and individuals engaged in the production, import, and use of prohibited chemicals must comply with the regulations on verification of production, import, and use data conducted by the Ministry of Industry and Trade in coordination with relevant agencies.

2. Organizations and individuals producing, importing, and using prohibited chemicals listed in the Prohibited Chemicals List must submit annual reports on production, import, and use of prohibited chemicals to the Ministry of Industry and Trade (Chemical Administration Department) by January 31 each year.

The content of the report on the situation of production, import, and use of chemicals listed in the Prohibited Chemicals List shall be carried out in accordance with Clause 2 of Article 52 of the Chemicals Law.

Chapter V

MEASURES AND PLANS FOR PREVENTION AND RESPONSE TO CHEMICAL INCIDENTS IN THE INDUSTRY

Article 30. Measures for prevention and response to chemical incidents.

1. Investors of projects producing, trading, using, storing, and preserving hazardous chemicals not included in the list specified in Clause 1 of Article 38 of the Chemicals Law must develop measures for prevention and response to chemical incidents suitable to the scale, production conditions, and characteristics of the chemicals.

2. Investors of projects producing, trading, using, storing, and preserving hazardous chemicals have the responsibility to report the implementation of measures for prevention and response to chemical incidents to the Department of Industry and Trade where the operating facility is located in accordance with Clause 1 of Article 48 of this Circular.

Article 31. Development of plans for prevention and response to chemical incidents.

1. Investors of projects producing, trading, using, storing, and preserving hazardous chemicals listed in Appendix IV of Decree 108/2008/NĐ-CP exceeding the corresponding threshold must develop plans for prevention and response to chemical incidents and submit them to the competent authority for approval as stipulated in Clause 1 of Article 34 of this Circular.

2. Investors of projects producing, trading, using, storing, and preserving hazardous chemicals may develop plans for prevention and response to chemical incidents themselves or hire consulting units to develop such plans.

3. Guidelines for presenting plans for prevention and response to chemical incidents shall be carried out according to the model in Appendix 11 attached to this Circular.

Article 32. Content of plans for prevention and response to chemical incidents.

1. The content of plans for prevention and response to chemical incidents shall be carried out in accordance with Article 39 of the Chemicals Law.

2. Specific requirements for the content of plans for prevention and response to chemical incidents shall be carried out in accordance with Appendix 12 attached to this Circular.

Article 33. Documents for Requesting Approval of the Chemical Accident Prevention and Response Plan

1. The application form of the project investor for production, business, use, storage, and preservation of dangerous chemicals according to the model attached at Appendix 13 to this Circular.

2. The Chemical Accident Prevention and Response Plan comprising ten (10) copies. In cases where more copies are required due to the needs of the review process, the project investor must provide additional copies as requested by the reviewing authority.

3. Any accompanying documents (if any).

Article 34. Review and Approval of the Chemical Accident Prevention and Response Plan

1. Reviewing and Approving Authority

a) The Chemicals Administration shall be the authority receiving and reviewing the Chemical Accident Prevention and Response Plan for projects investing in production, business, use, storage, and preservation of dangerous chemicals classified under Groups A and B, and shall submit to the Minister of Industry and Trade for approval;

b) The Department of Industry and Trade shall be the authority receiving, reviewing, and approving the Chemical Accident Prevention and Response Plan for projects investing in production, business, use, storage, and preservation of dangerous chemicals classified under Group C;

c) Projects investing in production, business, use, storage, and preservation of dangerous chemicals are classified according to the scale and nature of the project as prescribed in Decree No. 12/2009/NĐ-CP dated February 12, 2009 of the Government on management of investment construction projects.

2. Review of the Chemical Accident Prevention and Response Plan

a) Pursuant to Clause 3, Article 40 of the Chemical Law, the time limit for reviewing and approving the Chemical Accident Prevention and Response Plan is thirty (30) days from the date the receiving authority receives complete and valid documents;

b) Within seven (7) days from the date of receipt of the documents, the receiving authority must notify in writing the project investor about the incomplete or invalid status of the documents, the requirements for rectification and supplementation, and the deadline for completing the documents;

c) Within fifteen (15) days from the date of receipt of the conclusion and evaluation of the Review Board, the receiving authority is responsible for:

- Submitting the plan for approval by the competent authority when the content of the plan is appropriate;

- Notifying the project investor that the approval of the Chemical Accident Prevention and Response Plan is not accepted and stating the reasons for non-approval;

- In case the plan needs to be redrafted, the receiving authority must inform the project investor of the requirements for completion, the deadline for completion, and follow the initial procedures for review and approval.

The decision to approve the Chemical Accident Prevention and Response Plan is made according to the model attached at Appendix 13 to this Circular.

3. After the Chemical Accident Prevention and Response Plan has been approved, the project investor is responsible for submitting the plan to the state management agency for fire prevention and fighting, local authorities, sectoral management agencies, and the Industrial Park Management Board, Export Processing Zone Management Board, and Economic Zone Management Board if the facility is located within an industrial park, export processing zone, or economic zone.

Article 35. Activities of the Review Board

1. The Review Board for the Prevention and Response Plan for Chemical Accidents shall be established by the head of the competent authority that approves the Plan. The Review Board consists of the Chairman, the Secretary of the Board, and other members who are representatives of relevant state management agencies, fire prevention and firefighting agencies, local authorities, and experts from related fields. The total number of Review Board members must be at least nine (9) people. The Review Board for the Plan is responsible for conducting an assessment and review of the Plan and drafting a conclusion report.

The conclusion of the Review Board shall be carried out according to the model attached as Appendix 15 to this Circular.

2. The Review Board operates on the principle of collective discussion. The Review Board ceases its activities and dissolves itself after the Prevention and Response Plan for Chemical Accidents has been approved.

Article 36. Meeting of the Review Board

1. The Chairman of the Review Board is responsible for organizing the review meeting. The review meeting can only be held if at least two-thirds (2/3) of the total number of members are present.

2. In case a member of the Review Board cannot attend the review meeting, they must submit their opinion in writing to the Chairman of the Review Board.

3. Documents serving the meeting of the Review Board must be sent by the competent authority that reviews and approves the Prevention and Response Plan for Chemical Accidents to the members of the Review Board no later than five (5) working days before the meeting is organized.

4. Members of the Review Board discuss the contents of the Prevention and Response Plan for Chemical Accidents and other issues related to the content of the Plan. The Chairman of the Review Board concludes whether the Prevention and Response Plan for Chemical Accidents meets the requirements based on the agreement of two-thirds (2/3) of the members present.

5. The Secretary of the Review Board is responsible for recording the minutes of the meeting. The minutes of the meeting must be signed by the Chairman and the Secretary of the Review Board.

Article 37. Review Fee

1. The investor of a project producing, trading, using, storing, and preserving dangerous chemicals must pay the review fee for the Prevention and Response Plan for Chemical Accidents. The review fee is paid once and simultaneously with the submission of the Plan application documents.

2. The level of the review fee, collection, payment, and management and use of the review fee shall be implemented in accordance with the guidelines of the Ministry of Finance.

Article 38. Management of Measures or Plans for Preventing and Responding to Chemical Accidents

1. During the implementation of projects producing, trading, using, storing, and preserving dangerous chemicals, the project investor must ensure compliance with all requirements stipulated in the Measures or Plans for Preventing and Responding to Chemical Accidents that have been approved.

2. In cases where changes occur during investment and construction that alter the safety requirements already approved and confirmed, the project investor must report to the competent authority that approves the Prevention and Response Plan for Chemical Accidents for consideration and decision.

3. The Measures or Plans for Preventing and Responding to Chemical Accidents must be kept at the production, trading, usage, storage, and preservation facilities for dangerous chemicals, serving as the basis for developing chemical safety management plans in production, trading, usage, storage, and preservation activities.

4. Annually, investors of projects producing, trading, using, storing, and preserving dangerous chemicals must develop and organize drills of preventive and response measures included in the Measures or Plans for Preventing and Responding to Chemical Accidents.

Chapter VI

CHEMICAL POISON PURCHASE AND SALE CONTROL FORM; CONSTRUCTION OF A CHEMICAL SAFETY SHEET; REGISTRATION AND EVALUATION FILE FOR NEW CHEMICALS; INFORMATION SECURITY

Article 39. Control Certificate for Toxic Chemicals

1. In accordance with Clause 1 and Clause 3 of Article 23 of the Chemical Law, the purchase and sale of toxic chemicals must be accompanied by a Control Certificate and must be retained by both the seller and the buyer, and must be presented upon request.

2. The Control Certificate for purchasing and selling toxic chemicals shall follow the model provided in Appendix 16 attached to this Circular.

Article 40. Construction of Safety Data Sheets for Chemicals

1. Chemicals classified as hazardous substances under Clause 1 of Article 29 of the Chemical Law and Articles 16 and 17 of Decree No. 108/2008/NĐ-CP must establish a Safety Data Sheet.

2. Pursuant to Clause 2 of Article 29 of the Chemical Law, organizations and individuals producing or importing hazardous chemicals must prepare a Safety Data Sheet before putting them into use or circulating on the market. The Safety Data Sheet must be transferred free of charge to the organization or individual receiving hazardous chemicals at the time of initial delivery and whenever there is any amendment or supplementation to the contents of the Safety Data Sheet as stipulated in Clause 3 of this Article.

3. In cases where scientific evidence shows changes in the hazardous characteristics of chemicals, organizations and individuals engaged in hazardous chemicals must amend and supplement the Safety Data Sheet within 15 (fifteen) working days from the date of receipt of new information. The amended and supplemented Safety Data Sheet must be immediately provided by the organizations and individuals specified in Clause 2 of this Article to those related to the chemicals. The date and content of amendments and supplements must be clearly marked to alert users of the Safety Data Sheet.

4. Organizations and individuals producing or importing hazardous chemicals must retain the Safety Data Sheet for all hazardous chemicals currently present in their premises and must present it when requested, ensuring that all relevant parties can access the information contained in the Safety Data Sheet of such hazardous chemicals.

5. Form and Content of the Safety Data Sheet

a) The Safety Data Sheet must be in Vietnamese and the original language of the manufacturer, in printed form;

b) If the Safety Data Sheet consists of multiple pages, each page must be consecutively numbered from the first to the last page. Each page number includes the page sequence number and the total number of pages of the entire Safety Data Sheet, and must bear the stamp of the manufacturer or importer;

c) The Safety Data Sheet must include the contents as prescribed in Clause 3 of Article 29 of the Chemical Law;

d) The Safety Data Sheet must be constructed according to the model provided in Appendix 17 attached to this Circular.

Article 41. Registration Dossier and Organization for Evaluation of New Chemicals

1. Registration Dossier for New Chemicals

a) New chemicals may only be put into use or circulated on the market after obtaining the evaluation results from the organization evaluating new chemicals;

b) The registration dossier for new chemicals must comply with the provisions of Clause 2 of Article 44 of the Chemical Law. Organizations and individuals producing or importing new chemicals must submit two (2) copies of the registration dossier for new chemicals to the Ministry of Industry and Trade (Chemical Administration Department);

c) In cases where new chemicals are listed in at least two foreign chemical lists, organizations and individuals producing or importing new chemicals must submit the registration dossier including:

- Application for registration of new chemicals;

- Summary report of chemical evaluation along with the CAS number or UN number of the new chemicals in two foreign chemical lists;

d) Organizations and individuals producing or importing new chemicals must submit the dossier and documents specified in points b and c of this clause to the Ministry of Industry and Trade (Chemical Administration Department) within at least thirty (30) working days.

2. Organization for Evaluation of New Chemicals

a) The evaluation of new chemicals shall be conducted by scientific organizations in chemistry, medicine, and environmental toxicology with sufficient expertise designated by the Minister of Industry and Trade;

b) The outcome of the evaluation process is comprehensive information about the characteristics of the chemicals and the information necessary to construct the Safety Data Sheet for new chemicals with hazardous characteristics.

Article 42. Management of Activities Related to New Chemicals

1. Organizations and individuals engaging in chemical activities related to new chemicals as prescribed in Article 46 of the Law on Chemicals shall report to the sectoral management agency, relevant field management agency, and the Ministry of Industry and Trade (Chemical Administration Department).

The report on new chemicals shall be made according to the form attached as Appendix 18 to this Circular.

2. After five (5) years from the date of registration of new chemicals, if such new chemicals do not generate serious impacts or impacts with a different level of danger compared to the initial assessment conclusion, they will be added to the National List of Chemicals.

3. The Ministry of Industry and Trade (Chemical Administration Department) shall organize inspections and supervision of compliance with regulations concerning conditions for new chemical activities; handle according to the law or organize additional assessments when there is evidence showing that new chemicals have serious impacts different from the initial assessment conclusion; notify customs authorities and other relevant agencies about the assessment results after completing the new chemical assessment.

Article 43. Confidentiality of Information

1. Organizations and individuals engaged in chemical activities shall comply with regulations on information confidentiality as stipulated in Article 19 of Decree No. 108/2008/NĐ-CP.

2. Agencies and persons receiving declarations, registrations, and reports on chemicals shall keep confidential information secret at the request of the declarant, registrant, or reporter, except in cases provided for in Clause 1 of Article 51 of the Law on Chemicals.

3. Agencies and persons receiving declarations, registrations, and reports on chemicals shall not transmit confidential information over wide-area networks.

4. Officials and civil servants assigned to work on information confidentiality must sign a commitment to protect confidential information to be kept in personnel files. The commitment must clearly state the responsibilities of officials and civil servants assigned to work on information confidentiality when violations occur, they will be handled according to current regulations.

5. Agencies and persons receiving declarations, registrations, and reports on chemicals, when transmitting confidential information of organizations and individuals engaged in chemical activities that require confidentiality, must comply with the following provisions:

a) Maintain a logbook for tracking confidential information sent out. The logbook for tracking confidential information sent out must include all columns and items: serial number, day, month, year, recipient location, summary of content, degree of confidentiality, urgency, signature of the recipient and full name. Confidential information sent out must be placed in sealed envelopes.

b) Confidential information sent out shall not be mixed with regular documents. Outside the envelope, it must be stamped with symbols indicating the degree of confidentiality.

6. Upon receipt of confidential information, the recipient must inform the sender.

7. Confidential information received must be entered into the logbook for incoming confidential information for tracking and transferred to the person responsible for handling.

8. Confidential information must be strictly stored and preserved in a place ensuring absolute safety as specified by the head of the unit. It shall not be taken outside the agency without authorization. During non-working hours, confidential information must be placed in locked cabinets, desks, or safes.

9. All cases of destroying confidential information must be approved by the competent authority.

Chapter VII

IMPLEMENTING PROVISIONS

Article 44. Responsibilities of the Chemical Administration Department

Popularize, guide, monitor, and inspect the implementation of this Circular. Regularly inspect production and business conditions of production and business establishments of hazardous chemicals as specified in the Production and Business License for chemicals listed in the Restricted Production and Business Chemicals List in the industry.

Article 45. Responsibilities of the Bureau of Safety Technology and Industrial Environment

Guide and inspect the implementation of safety technology in production, business, use, storage, and preservation of hazardous chemicals in the industrial sector.

Article 46. Responsibilities of the Department of Industry and Trade

1. Popularize and guide organizations and individuals engaged in the production, business, and use of chemicals within their jurisdiction to comply with the provisions of this Circular.

2. Organize inspections and checks on conditions for producing and trading hazardous chemicals as stipulated in the Certificate of Eligibility for Production and Business of Chemicals under the List of Conditionally Produced and Traded Chemicals in the Industrial Sector, and impose administrative penalties for violations in chemical activities according to regulations against organizations and individuals engaged in chemical activities within their jurisdiction.

Article 47. Responsibilities of Organizations and Individuals Engaged in Chemical Activities

1. Organizations and individuals engaged in the production and business of chemicals as specified in Chapter III of this Circular must ensure material and technical conditions appropriate to the scale of operation and characteristics of chemicals as prescribed in Article 12 of the Law on Chemicals and this Circular.

2. Organizations and individuals engaged in chemical activities may only produce and trade hazardous chemicals when they meet the required conditions and have Certificates or Licenses issued by competent state authorities as stipulated in this Circular.

3. Ensure the maintenance of production and business conditions as certified or licensed during the process of producing and trading chemicals.

4. Fully and accurately implement all contents related to prevention and response to chemical accidents that have been approved.

5. Facilitate conditions for competent authorities to verify production and business conditions for chemicals as prescribed.

6. Comply with inspection and supervision regulations of competent authorities.

Article 48. Periodic Reporting

1. Organizations and individuals engaged in chemical activities shall be responsible for:

a) Submitting periodic reports every six months and annually to the Department of Industry and Trade before June 10 for the six-month report, and before December 10 for the annual report:

- The situation of production and business activities of chemicals listed in the List of Conditionally Produced and Traded Chemicals;

- The situation of chemical safety at the location of the operating facility;

- The situation and results of implementing preventive measures or plans for responding to Group C chemical accidents;

b) Submitting periodic reports every six months and annually to the Ministry of Industry and Trade (Chemical Administration) before June 1 for the six-month report, and before December 1 for the annual report:

- The situation of production and business activities of chemicals listed in the List of Restrictedly Produced and Traded Chemicals;

- The situation and results of implementing plans for preventing and responding to Group A and B chemical accidents.

2. The Department of Industry and Trade shall be responsible for compiling and reporting to the Ministry of Industry and Trade (Chemical Administration) the situation of chemical activities within its jurisdiction according to the content prescribed in point a, Clause 1 of this Article before June 15 for the six-month report, and before December 15 for the annual report.

3. Report on chemical safety according to the form attached as Appendix 19 to this Circular.

Article 49. Handling of Violations

1. During the production and business activities, organizations and individuals engaging in chemical activities without ensuring the conditions stipulated in the Certificate of Conformity or Permit shall be deemed to be engaging in illegal production and business activities.

2. In cases where the conditions for production and business operations as prescribed in the Law on Chemicals, Decree No. 108/2008/ND-CP and this Circular are violated and not promptly rectified, the issuing authority shall revoke the Certificate of Conformity or Permit in accordance with Clause 2 of Article 18 of the Law on Chemicals. For violations of regulations on chemical activities, depending on the nature and extent of the violation, they will be handled according to the provisions, and if damage is caused, compensation must be provided in accordance with the law.

3. If the responsible authorities or individuals who issue Certificates of Conformity or Permits commit violations, they will be subject to administrative penalties in accordance with Decree No. 90/2009/ND-CP dated October 20, 2009 of the Government on administrative penalties for violations in chemical activities, or may be held criminally liable, depending on the severity of the violation.

Article 50. Effective Date

1. This Circular takes effect from August 16, 2010.

2. This Circular replaces Circular No. 12/2006/TT-BCN dated December 22, 2006 of the Ministry of Industry (now the Ministry of Industry and Trade) guiding the implementation of Decree No. 68/2005/NĐ-CP dated May 20, 2005 of the Government on chemical safety.

3. From January 1, 2011, organizations and individuals producing and trading dangerous chemicals must follow the procedures to obtain Certificates of Conformity or Permits as prescribed in this Circular. Organizations and individuals without or failing to meet the conditions for production and trade of chemicals listed in the List of Conditionally Produced and Traded Chemicals and Restricted Production and Trade Chemicals as stipulated in the Law on Chemicals, Decree No. 108/2008/ND-CP and this Circular must cease production and trade of chemicals until all conditions are fully met.

4. During the implementation process, if there are any difficulties or issues arising, organizations and individuals should promptly report them to the Ministry of Industry and Trade for appropriate amendments and supplements./.