Decree No. 26/2011/ND-CP Amending and Supplementing Certain Provisions of Decree No. 108/2008/ND-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals

Article 1. Amending and supplementing certain Articles 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 as follows:

1. Amending and supplementing Article 4, Clause 1, Point b, and adding Point d of Article 4

"Article 4. List of chemicals for production and business with conditions; List of restricted chemicals for production and business; List of prohibited chemicals and List of toxic chemicals"

1. Issuing along with this Decree the lists of chemicals as prescribed in Article 14, Article 15, Article 19, and Article 23 of the Law on Chemicals, including:

b) The list of restricted chemicals for production and business amended and supplemented (Annex II);

d) The list of toxic chemicals that must establish a Purchase and Sale Control Form for toxic chemicals (Annex VI)."

2. Amending and supplementing Article 5

"Article 5. List of dangerous chemicals that must establish Measures; Emergency Prevention and Response Plans for chemical accidents and establish safety distances.

1. Attached hereto:

a) Organizations and individuals producing, trading, storing, preserving, and using dangerous chemicals listed in this Article must establish Emergency Prevention and Response Plans for chemical accidents as stipulated in Article 38 of the Law on Chemicals and establish safety distances amended and supplemented (Annex IV);

b) Organizations and individuals producing, trading, storing, preserving, and using dangerous chemicals listed in this Article must establish Measures to prevent and respond to chemical accidents (Annex VII).

2. In accordance with management requirements at different periods, the Ministry of Industry and Trade shall take the lead and coordinate with relevant ministries managing industries and sectors to review and submit to the Government for amending and supplementing the Lists of chemicals prescribed in Clause 1 of this Article."

3. Adding Clause 1 of Article 6

"Article 6. List of chemicals that must be declared. Issuing along with this Decree the List of chemicals that must be declared amended and supplemented (Annex V)."

4. Amending and supplementing Article 7

"Article 7. Conditions for producing and trading chemicals included in the List of chemicals for production and business with conditions in the chemical industry

1. Conditions for producing chemicals

a) The Director or Deputy Director of Technical Affairs or technical staff responsible for chemical production activities at chemical production facilities must have a bachelor's degree or higher in chemical engineering;

b) Full-time staff responsible for chemical safety management must be trained or instructed in chemical safety technology;

c) Workers directly exposed to chemicals at production facilities must be trained or instructed in chemical safety technology;

d) The infrastructure and technical equipment at chemical production facilities must meet the requirements as stipulated in Article 12 of the Law on Chemicals;

đ) Must have appropriate equipment or contracts with units having sufficient capacity recognized by competent authorities to test chemical content and components;

e) Must have Measures to prevent and respond to chemical accidents confirmed by competent authorities or Emergency Prevention and Response Plans for chemical accidents approved by competent authorities;

g) Must have fire prevention and extinguishing safety equipment in accordance with the Fire Prevention and Fighting Law; have equipment to control, collect, and treat hazardous waste or contracts for transporting, treating, and disposing of hazardous waste in accordance with the Environmental Protection Law.

2. Conditions for trading chemicals

a) The person in charge of chemical safety at chemical trading facilities must have a secondary level or higher education in chemical engineering;

b) Workers directly exposed to chemicals at trading facilities must be trained or instructed in chemical safety technology;

c) The infrastructure and technical equipment at chemical trading facilities must meet the requirements as stipulated in Article 12 of the Law on Chemicals;

d) Must have Measures to prevent and respond to chemical accidents confirmed by competent authorities or Emergency Prevention and Response Plans for chemical accidents approved by competent authorities;

đ) Must have fire prevention and extinguishing safety equipment in accordance with the Fire Prevention and Fighting Law; have equipment to control, collect, and treat hazardous waste or contracts for transporting, treating, and disposing of hazardous waste in accordance with the Environmental Protection Law."

5. Adding Article 7a after Article 7

"Article 7a. Training and instructing on chemical safety technology

1. Organizations and individuals engaged in chemical activities must be responsible for sending leaders, managers, and workers in their facilities to training courses on chemical safety technology.

2. The subjects to be trained and instructed on chemical safety technology include: leaders and managers of departments directly related to chemical activities; persons directly involved in producing, trading, transporting, storing, preserving, and using chemicals.

3. The content of training and instructing on chemical safety technology in chemical activities must be suitable for job positions and types of chemicals, including:

a) For leaders and managers of departments directly related to chemical activities, they must be trained and instructed on legal knowledge about managing chemical activities; legal knowledge related to fire prevention and fighting; regulations on safety distances; implementing Measures and Emergency Prevention and Response Plans for chemical accidents;

b) For persons directly involved in producing, trading, transporting, storing, preserving, and using chemicals, they must be trained and instructed on safety contents in production, trading, use, preservation, and transportation of chemicals as prescribed in current standards, regulations, and legal documents;

c) Ministries managing industries and sectors shall specify the training and instructing programs and contents on chemical safety technology in chemical activities for the subjects prescribed in Clause 2 of this Article.

4. After being trained and instructed on chemical safety technology, those who meet the requirements will be issued a Certificate."

5. The sectoral management agency shall guide and authorize specialized agencies under provincial People's Committees to organize training courses on chemical safety technology in accordance with the contents and programs prescribed in Clause 3 of this Article, and issue Certificates of Training on Chemical Safety Technology to organizations and individuals engaged in chemical activities within their jurisdiction.

6. Before December 31 each year, the agency issuing the Certificate as prescribed in Clause 5 of this Article shall be responsible for reporting to the sectoral management agency; before January 15 each year, the sectoral management agency shall submit to the Ministry of Industry and Trade the situation of training and instruction on chemical safety technology within its jurisdiction.

7. The sectoral management agency shall inspect the training and instruction activities on chemical safety technology of the agencies issuing certificates within its jurisdiction.

6. Supplement Article 7b following Article 7

"Article 7b. Documents, Procedures, and Authorities for Confirming Preventive and Response Measures for Chemical Accidents

1. Organizations and individuals producing, trading, storing, preserving, and using dangerous chemicals must establish preventive and response measures for chemical accidents in accordance with the provisions of Clause 2 and Clause 3 of Article 36 of the Law on Chemicals.

2. The application documents for confirming preventive and response measures for chemical accidents include:

a) An application form from organizations and individuals producing, trading, storing, preserving, and using dangerous chemicals;

b) Preventive and response measures for chemical accidents;

c) Supporting documents (if any).

3. The competent authority confirming preventive and response measures for chemical accidents shall be responsible for inspecting the actual conditions of production, trading, storage, preservation, and use of dangerous chemicals before issuing the confirmation certificate. The confirmation period for preventive and response measures for chemical accidents shall not exceed twenty (20) working days from the date of receipt of complete and valid application documents as prescribed in Clause 2 of this Article.

4. Organizations and individuals applying for confirmation of preventive and response measures for chemical accidents must pay fees as prescribed by law.

5. The sectoral management agency shall be responsible for:

a) Taking the lead and coordinating with state management agencies on fire prevention and fighting, and other relevant agencies in organizing the confirmation of preventive and response measures for chemical accidents;

b) Organizing regular or spot checks on the management and implementation of preventive and response measures for chemical accidents within its jurisdiction;

c) Specifying detailed requirements regarding the content and organization of issuing confirmation certificates for preventive and response measures for chemical accidents."

7. Supplement Article 7c following Article 7

"Article 7c. Registration for Using Chemicals.

1. Organizations and individuals using chemicals as prescribed in Chapter V and Articles 63 and 64 of the Law on Chemicals must carry out registration for using chemicals.

2. The sectoral management agency shall specify in detail the procedures for registering the use of chemicals within its jurisdiction; it shall conduct regular or spot inspections on the organization and registration for using chemicals."

8. Amend and supplement Article 8

"Article 8. Conditions for Producing and Trading Conditionally Controlled Chemicals in the Health Sector

1. Conditions for Producing and Trading Chemicals in the Pharmaceutical Field. A facility producing and trading chemicals for use in the pharmaceutical field must have a professional manager, facilities, technical equipment, and personnel as prescribed by the Drug Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing certain provisions of the Drug Law.

2. Conditions for Producing Insecticides, Disinfectants Used in Household and Medical Purposes. A facility producing insecticides, disinfectants used in household and medical purposes must meet the following conditions:

a) The person directly managing the production activity must have a bachelor's degree or higher in chemistry;

b) The physical infrastructure and technical equipment in the production facility must comply with the requirements set forth in Article 12 of the Law on Chemicals;

c) Must have sufficient testing equipment or enter into a contract with a unit capable of testing quality to ensure product quality;

d) Must have measures to manage fire prevention, explosion prevention, chemical accident prevention, waste treatment, and environmental protection in accordance with the law.

3. Conditions for Trading Insecticides, Disinfectants Used in Household and Medical Purposes. A facility trading insecticides, disinfectants used in household and medical purposes must meet the following conditions:

a) The person responsible for chemical safety must have a high school diploma or higher in chemistry, except in cases where trading common insecticides and disinfectants including mosquito repellent incense, insect spray, insect repellent cream, electric mosquito repellent sheets, electric mosquito repellent solution, mosquito netting treated with insecticide, and ant and fly baits;

b) The physical infrastructure and technical equipment in the trading facility must comply with the requirements set forth in Article 12 of the Law on Chemicals;

c) Must have measures to manage fire prevention, explosion prevention, chemical accident prevention, waste treatment, and environmental protection in accordance with the law.

4. Conditions for Producing Chemicals Used in Medical Equipment. A facility producing chemicals used in medical equipment must meet the conditions specified in Clause 2 of this Article.

5. Conditions for Trading Chemicals Used in Medical Equipment. A facility trading chemicals used in medical equipment must meet the trading conditions for medical equipment as prescribed by law."

9. Supplement the name of Article 12

10. Amend and supplement Article 13

"Article 13. Responsibilities for Establishing Safe Distances"

1. Projects for investment in production, business, storage, preservation, and use of hazardous chemicals listed in Appendix IV of this Decree must establish safe distances from the areas of production, business, storage, preservation, and use of hazardous chemicals to residential areas, public works, historical and cultural sites, scenic spots, natural reserves, national parks, biosphere reserves, species and habitat conservation areas, marine protected areas, and sources of potable water, in accordance with the provisions of this Decree, and must comply with technical standards on safe distances.

2. The Ministry of Industry and Trade shall take the lead and coordinate with relevant ministries managing industries and sectors, and provincial People's Committees to organize inspections and evaluations of the current status of areas that need to maintain safe distances for existing facilities engaged in production, business, storage, preservation, and use of hazardous chemicals which have not met the requirements for safe distances as stipulated in this Decree. In cases where existing facilities engaged in production, business, storage, preservation, and use of hazardous chemicals have not established safe distances, they must develop a timeline to determine safe distances and report on the implementation of such timelines to the relevant ministries managing industries and sectors and provincial People's Committees. The establishment of safe distances must be completed before December 30, 2012."

11. Amend and supplement Article 18

"Article 18. Procedures for Chemical Declaration

1. For organizations and individuals producing chemicals

a) Provincial Departments of Industry and Trade shall accept declaration files for organizations and individuals producing chemicals listed in the Chemicals Declaration List within their jurisdictional areas;

b) Organizations and individuals declaring chemicals shall prepare one set of declaration files including the following documents: Chemical Declaration Form; Safety Data Sheet (SDS) in Vietnamese according to the model prescribed by the Ministry of Industry and Trade for hazardous chemicals. If the chemicals have been previously declared at the Department of Industry and Trade and the chemical components have not changed, organizations and individuals producing hazardous chemicals are not required to resubmit the SDS;

c) Organizations and individuals producing chemicals listed in the Chemicals Declaration List shall be responsible for declaring the chemicals produced annually in writing to the Department of Industry and Trade before January 31 each year;

d) The confirmation period for chemical declarations by the Department of Industry and Trade is five working days, counted from the date of receipt of complete and valid files as stipulated in point b, Clause 1 of this Article.

2. For organizations and individuals importing chemicals

a) The Ministry of Industry and Trade shall accept declaration files for organizations and individuals importing chemicals listed in the Chemicals Declaration List;

b) Organizations and individuals declaring chemicals shall prepare one set of declaration files including the following documents: Chemical Declaration Form; Purchase Invoice for chemicals; other relevant documents (if any). For hazardous chemicals listed in the Chemicals Declaration List attached as Appendix V to this Decree, the declaration file must include the Safety Data Sheet (SDS) in Vietnamese according to the model prescribed by the Ministry of Industry and Trade and the English version for comparison purposes. If the chemicals have been previously declared at the Ministry of Industry and Trade and the chemical components have not changed, organizations and individuals importing hazardous chemicals are not required to resubmit the SDS. This provision does not apply to organizations and individuals declaring imported chemicals through electronic means;

c) Before clearing customs for chemicals, organizations and individuals importing chemicals shall be responsible for declaring the chemicals to the Ministry of Industry and Trade;

d) The confirmation period for declarations of imported chemicals by the Ministry of Industry and Trade is seven working days, counted from the date of receipt of complete and valid files as stipulated in point b, Clause 2 of this Article.

3. The Ministry of Industry and Trade shall specify the models of the Chemical Declaration Form, the Confirmation Certificate for Chemical Declarations, and the procedures for declaring imported chemicals and reporting chemicals through electronic means.

4. Exemptions from chemical declarations for chemicals produced or imported once for security, defense, and urgent disaster response and epidemic control purposes.

5. Fees for chemical declarationsOrganizations and individuals declaring chemicals produced and imported chemicals must pay declaration fees in accordance with the provisions of the law."

12. Add Article 18a after Article 18

"Article 18a. Confirmation of Safety Data Sheets for Exported ChemicalsBefore exporting chemicals, organizations and individuals must fully record the information of the chemicals as required in the Safety Data Sheet (SDS) and must have the Ministry of Industry and Trade evaluate and confirm the Safety Data Sheet (SDS)."

13. Amend Clause 2 of Article 20

"2. The Ministry of Industry and Trade shall take the lead and coordinate with relevant ministries managing industries and sectors, and localities to develop a National Chemical Database Project and a National Chemicals List to submit for approval."

14. Amend Clause 2 of Article 22 as follows:

"2. This Decree replaces Government Decree No. 68/2005/NĐ-CP dated May 20, 2005 on chemical safety."

Article 2. Effectiveness

This Decree takes effect from June 1, 2011.

Article 3. Responsibility for Implementation

Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial People's Committees directly under the Central Government, and related organizations and individuals are responsible for implementing this Decree./.