Daily Question on Administrative Licenses [Daily Question 090417]
Thread Content
I see that people on the forum often ask what documents are required and what the basis is for obtaining a certain certificate Today we are summarizing this here for everyone’s convenience in looking it up. What are the various administrative permits related to hazardous chemicals, and what are the relevant legal bases? Everyone is welcome to come together and summarize! The reference format for answering questions is as follows: Serial number, permitted matter, legal basis, required documents
Serial Number | Permit Issued | Legal Basis | Required Documents
1 | Safety Production Permit (Renewal) | Safety Production Law | Business license, safety assessment report
2 | Administrative permit for fire protection related to new hazardous chemical projects; details can be found at http://bbs.hcbbs.com/viewthread.php?tid=445133&page=1#pid2403473. The format in that post is not entirely accurate; please forgive the inconsistency.
1 | Safety Production Permit (Renewal) | Safety Production Law | Business license, safety assessment report
2 | Administrative permit for fire protection related to new hazardous chemical projects; details can be found at http://bbs.hcbbs.com/viewthread.php?tid=445133&page=1#pid2403473. The format in that post is not entirely accurate; please forgive the inconsistency.
License for the Operation of Hazardous Chemicals (I) Scope of Licensing: For enterprises that operate hazardous chemicals within the administrative territory of this city, excluding those engaged in the wholesale (storage) of refined petroleum products and those registered with the Provincial Administration for Industry and Commerce, the Safety Supervision Bureau is responsible for issuing and managing the operation licenses. The license for handling hazardous chemicals is divided into two categories: Type A and Type B. Units that have obtained a Type A business license may engage in the trading and sale of highly toxic chemicals and other hazardous chemicals ； Units that have obtained a Type B business license may only engage in the trading and sale of hazardous chemicals other than highly toxic chemicals. The business license for refined oil is subject to the management of Category A business licenses. (II) Bases for approval: 1. Regulations on the Safety Management of Hazardous Chemicals (Decree No. 344 of the State Council); 2. Measures for the Administration of Licenses for the Operation of Hazardous Chemicals (Former Decree No. 36 of the **Economic and Trade Commission); 3. Measures for the Approval of Safety Permits for Hazardous Chemicals Construction Projects (Decree No. 8 of the **General Administration of Work Safety). (III) Approval requirements: 1. The premises, facilities, and buildings used for operation and storage must comply with standards such as the “Code for Fire Protection Design of Buildings” (GBJ16), “Safety Regulations for Explosive Hazardous Areas,” and “Rules for Fire Safety Management in Warehouses”; the buildings must also pass inspection by the public security fire department ； 2. The operating conditions and storage conditions meet the requirements specified in the \"Requirements and Technical Specifications for the Operation of Hazardous Chemicals Enterprises\" (GB18265) and the \"General Rules for the Storage of Common Hazardous Chemicals\" (GB15603) ； 3. The main persons in charge, supervisors, safety production managers, and operational staff of the unit have received professional training and passed assessments to obtain the qualifications required for their positions ； 4. Have a sound safety management system and safety operation procedures for various positions ； 5. There is an emergency rescue plan for accidents specific to this unit ； 6. Other conditions that meet regulatory requirements, laws, and **standard requirements. (IV) Materials to be submitted 1. For initial applications: (1) 3 copies of the “Application Form for Hazardous Chemicals Business License” (to be filled out and printed from the “Hazardous Chemicals Safety Supervision Government Information System” on the website of the China Academy of Work Safety) ； (2) Copies of the professional training qualification certificates for the main persons in charge and supervisors of the unit, as well as for safety production management personnel and operational staff ； (3) Copies of the fire safety inspection documents for the buildings used for operation and storage ； (4) Copy of the property ownership or lease agreement for the business and storage premises and facilities ； (5) Safety assessment report ； (6) Safety management systems and job-specific safety operating procedures ； (7) Emergency rescue plan for hazardous chemical accidents ； (8) Copy of the business license or notice of business approval (copy) ； (9) Retailers of refined oil must hold the ‘Approval Certificate for Retailing Refined Oil’ issued by the Ministry of Commerce ； Petroleum product storage and retail businesses shall issue, respectively, the \"Approval Certificate for Petroleum Product Storage Operations\" and the \"Approval Certificate for Petroleum Product Retail Operations\", which are printed in a uniform format by the Ministry of Commerce and issued by the Provincial Economic and Trade Commission ； (10) For storage projects, a site selection opinion issued by the planning department, as well as a construction land use planning permit and a construction project planning permit are required ； (11) Review comments from the relevant district.
Serial Number | Permitted Matters | Legal Basis | Required Documents | 1 | Review for the establishment of hazardous chemicals construction projects | Articles 25 of the Work Safety Law of the People’s Republic of China, Article 9 of the Regulations on the Safety Management of Hazardous Chemicals, as well as relevant provisions such as Article 9 of Order No. 8 issued by the State Administration of Work Safety regarding the Implementation Measures for Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for safety review upon establishment of a construction project ； 2. Copy of the project planning permit issued by the competent construction (planning) authority ； 3. Report on the Evaluation of Safety Conditions for the Construction Project ； 4. Safety assessment report for the construction project ； 5. A copy of the business license for corporate entities issued by the administrative department for industry and commerce, or a notice of pre-approval of the company name ； 6**Written materials required by industrial policy ； 7. Other materials required during the review. 2 Review of the safety facility design for hazardous chemical construction projects. Article 26 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 14 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for review of the design of safety facilities for construction projects ； 2. Safety review opinion for the establishment of a construction project (copy) ； 3. Proof of the design qualification of the design unit (copy) ； 4. Special section on the design of safety facilities for the construction project (including a map showing the location of the construction site, a simplified diagram of the process flow, and a map indicating the areas at risk of explosion) ； Plan layout of construction projects, production and storage units or facilities, lightning and static electricity protection grounding, fire protection facilities and equipment, gas detection plan layout ； List of special equipment and main safety accessories involved in the construction project) ； 5. Other materials required during the review. 3 Filing of the trial production (use) plan for hazardous chemical construction projects. **As required by the relevant provisions of Order No. 8 of the State Administration of Work Safety, the \"Implementation Measures for Safety Permits for Hazardous Chemicals Construction Projects\". 1. Trial production (operation) plan for the construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Qualification certificates and approval forms of the construction unit ； 4. Approval form from the design unit for safety facilities; 5. Qualification certificate and approval form of the supervision unit ； 6. Quality supervision procedures for construction projects (copy) ； 7. Written opinion on the rationale provided by the expert group ； 8. Written explanation of the list of personnel participating in trial production (use) and relevant training details ； 9. Fire safety inspection report (copy) for construction projects with fire safety design ； 10. Inspection and testing documents for safety facilities (copies). 4 Review of the completion inspection for safety facilities in hazardous chemical construction projects. Article 27 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 22 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for the acceptance of the completed safety facilities of a construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Proof of the construction contractor’s qualifications (copy) ； 4. Report on the construction of safety facilities for the construction project; 5. Report on funds invested in work safety ； 6. Safety assessment report for the completion acceptance of construction projects. 5 Safety Production License for Hazardous Chemicals Manufacturing Enterprises: In accordance with Article 7 of the Regulations on the Safety Management of Hazardous Chemicals, Article 2 of the Regulations on Safety Production Licenses, as well as relevant provisions such as Article 2 of the Implementing Measures for Safety Production Licenses of Hazardous Chemicals Manufacturing Enterprises, Order No. 10 issued by the State Administration of Work Safety. 1. Application for a Safety Production License for Hazardous Chemicals Manufacturing Enterprises ； 2. Documents issued by the enterprise regarding the safety production responsibility system (scans), as well as the texts of the safety production responsibility system for the main responsible persons, those in charge of specific areas, safety production management personnel, and various functional departments ； 3. List of safety production management rules and regulations (scan) ； 4. List of safety operation procedures for various positions (scan) ； 5. Documents (scans) outlining the establishment of a work safety management organization and the appointment of full-time work safety managers ； 6. Safety qualification certificates and professional qualification certificates (scans) issued to the main responsible persons and safety production management personnel after passing the assessment by the safety supervision department ； 7. List of special operation personnel who have passed the assessment (scanned copy), indicating the type of work, qualification certificate number, and date of issuance of the certificate ； 8. Proof of completion of safety production education and training for other employees other than those listed in items 6 and 7 (scanned copy) ； 9. Special tax invoice issued by the tax authorities or other valid proof documents (scans) for paying work-related injury insurance premiums for employees ； 10. In accordance with the provisions of the \"Interim Measures for the Financial Management of Safety Production Expenses in Enterprises in High-Risk Industries\" issued by the Ministry of Finance and the **State Administration of Work Safety (Document No. Caiqi 478), enterprises shall allocate sufficient amounts to safety production expenses on an annual basis. At the same time, in accordance with the provisions of the \"Interim Measures for the Management of Safety Production Risk Deposits by Enterprises\" issued by the Ministry of Finance, the **State Administration of Work Safety, and the People’s Bank of China (Caijian No. 369), enterprises must deposit sufficient amounts of safety production risk deposits in designated accounts. The “Table of Allocation, Use, and Surplus of Enterprise Safety Funds” along with the documents (scans) showing the storage of funds set aside as collateral for work safety risks in dedicated accounts; 11. A description of the measures taken to prevent occupational hazards and a register of the personal protective equipment provided to employees (scans) ； 12. For hazardous chemicals manufacturing enterprises with major hazard sources, provide proof documents (scans) showing that these major hazard sources and the relevant safety and emergency response measures have been registered with the local safety supervision department ； 13. Emergency rescue plan for hazardous chemical accidents and proof documents filed with the safety supervision department (scans) ； 14. Copy of business license (scanned copy) ； 15. For new, modified, or expanded hazardous chemicals-related construction projects, provide a scanned copy of the document issued by the safety supervision department confirming that the safety facilities have passed the completion inspection ； 16. Copy of the registration certificate for hazardous chemicals production units valid within its period, along with the registration form for such units (scanned copy) ； 17. Written commitment regarding planning administrative permits (scan) ； 18. Safety assessment report issued by a safety assessment institution with the required legal qualifications ； 19. Certificates and documents proving other safety production requirements stipulated by laws, regulations, and rules. 6 License for the Operation of Hazardous Chemicals: In accordance with Article 27 of the Regulations on the Safety Management of Hazardous Chemicals, and with reference to relevant provisions such as Article 3 of the Measures for the Administration of Licenses for the Operation of Hazardous Chemicals, Order No. 36 issued by the Ministry of Economy and Trade. 1. Application for a License to Operate Hazardous Chemicals ； 2. Copy of the business license or approval notice (copy) ； 3. Safety assessment report issued by a safety assessment institution with the required legal qualifications ； 4. Fire safety inspection documents for the buildings used for operation and storage (copies) ； 5. Proof of property rights or lease for the business and storage premises and facilities (copy) ； 6. Safety qualification certificates and professional qualification certificates (copies) issued to the main persons in charge of the unit, supervisors, safety production management personnel, and business personnel (such as storage staff and sales staff) after passing the assessment conducted by the safety production supervision and management department ； 7. Documents (copies) establishing a safety management organization or appointing full-time safety management personnel ； 8. List of safety management systems ； 9. List of safety operation procedures for various positions ； 10. Emergency rescue plan for hazardous chemical accidents and copies of the documentation filed with the local work safety supervision and management department ； 11. If the quantity of hazardous chemicals stored by an operating unit constitutes a major hazard source, it shall submit proof materials showing that the storage location has been registered with the local work safety supervision and management department as well as the public security department ； 12. Certifying documents and materials for other work safety requirements stipulated by laws, regulations, and rules. This post was last edited by lyhh9024 on 2009-4-16 21:59.]
To obtain a work safety license, an enterprise must meet the following work safety requirements: (1) Establish and improve a work safety responsibility system, as well as comprehensive work safety rules and procedures； (II) Safety investments meet the requirements for safe production ； (III) Establish a work safety management organization and assign full-time work safety management personnel ； (IV) The principal persons in charge and safety production management personnel have passed the assessment ； (5) Special operation personnel who pass the assessment by the relevant competent authorities obtain a special operation qualification certificate ； (VI) Employees have passed safety production education and training ； (7) Participate in work-related injury insurance in accordance with the law, and pay insurance premiums for employees ； (8) The factory buildings, work areas, as well as safety facilities, equipment, and processes comply with the requirements of relevant laws, regulations, standards, and procedures regarding work safety ； (IX) There are measures in place to prevent and control occupational hazards, and labor protection equipment that meets ** standards or industry standards is provided for employees ； (10) Conduct safety assessments in accordance with the law ； (11) Measures for the detection, assessment, monitoring of major hazard sources, as well as emergency response plans ； (12) Have an emergency rescue plan for production safety accidents, an emergency rescue organization or emergency rescue personnel, and be equipped with necessary emergency rescue equipment and apparatus ； (13) Other conditions stipulated by laws and regulations. Article 7: Before commencing production, enterprises shall apply to the authority responsible for issuing safety production licenses in accordance with the provisions of these regulations, and submit the relevant documents and materials specified in Article 6 of these regulations. The authority responsible for issuing safety production licenses shall complete the review within 45 days from the date of receipt of the application; if the requirements for safe production stipulated in these regulations are met, a safety production license shall be issued ； If the safety production conditions stipulated in these regulations are not met, a safety production license will not be issued; the enterprise shall be notified in writing along with the reasons. Coal mining enterprises shall, on a mine (shaft) basis, obtain a work safety license in accordance with the provisions of these regulations before applying for a coal production license.
Permitted activities: License for the installation of pressure pipelines. Legal basis: Detailed rules for the accreditation of units engaged in the installation of pressure pipelines. Required documents: 1. Table of minimum requirements for personnel responsible for the quality management system in the installation unit; 2. Table of minimum requirements regarding the human resources of the installation unit; 3. Table of minimum equipment requirements for the installation unit; 4. Requirements regarding the qualification level of the installation unit; 5. Application form for a license to install pressure pipelines; 6. Basic information sheet of the unit engaged in pressure pipeline installation; 7. Quality management system documents; 8. Documentation related to representative projects; 9. Various technical documents related to pipeline installation, as well as data on welding process evaluations
Regarding the various administrative permits for hazardous chemicals, they can be summarized as the \"three simultaneities,\" which include four aspects: safety, fire protection, environmental protection, and occupational health. The procedures for the four aspects of \"simultaneous implementation\" are generally similar; they usually involve steps such as establishment review or preliminary evaluation, design review, acceptance review, and the issuance of approval documents or opinions. The specific implementation methods or regulations outline clear procedures that can be followed as a guide. The various documents required for submission are clearly specified in the specific implementation measures or regulations; each province may formulate corresponding rules based on its own circumstances, so please refer to those guidelines. Regarding safety permits, I agree with the opinion from the 4th floor; it should be added that for hazardous chemical projects, a \"Safety Conditions Assessment Report\" must be prepared prior to the application for approval.
To obtain a work safety license, an enterprise must meet the following work safety requirements: (1) Establish and improve a work safety responsibility system, as well as comprehensive work safety rules and procedures； (II) Safety investments meet the requirements for safe production ； (III) Establish a work safety management organization and assign full-time work safety management personnel ； (IV) The principal persons in charge and safety production management personnel have passed the assessment ； (5) Special operation personnel who pass the assessment by the relevant competent authorities obtain a special operation qualification certificate ； (VI) Employees have passed safety production education and training ； (7) Participate in work-related injury insurance in accordance with the law, and pay insurance premiums for employees ； (8) The factory buildings, work areas, as well as safety facilities, equipment, and processes comply with the requirements of relevant laws, regulations, standards, and procedures regarding work safety ； (IX) There are measures in place to prevent and control occupational hazards, and labor protection equipment that meets ** standards or industry standards is provided for employees ； (10) Conduct safety assessments in accordance with the law ； (11) Measures for the detection, assessment, monitoring of major hazard sources, as well as emergency response plans ； (12) Have an emergency rescue plan for production safety accidents, an emergency rescue organization or emergency rescue personnel, and be equipped with necessary emergency rescue equipment and apparatus ； (13) Other conditions stipulated by laws and regulations. Article 7: Before commencing production, enterprises shall apply to the authority responsible for issuing safety production licenses in accordance with the provisions of these regulations, and submit the relevant documents and materials specified in Article 6 of these regulations. The authority responsible for issuing safety production licenses shall complete the review within 45 days from the date of receipt of the application; if the requirements for safe production stipulated in these regulations are met, a safety production license shall be issued ； If the safety production conditions stipulated in these regulations are not met, a safety production license will not be issued; the enterprise shall be notified in writing along with the reasons. Coal mining enterprises shall, on a mine (shaft) basis, obtain a work safety license in accordance with the provisions of these regulations before applying for a coal production license.
Thank you to all the friends from LS for their participation. To summarize briefly, there may be some differences in the implementation details among different provinces and cities; for specific information, one can check and consult the local work safety supervision agency’s website. Guidelines for handling procedures are usually available on the safety supervision bureau’s website. You can go inside and look for it. lyhh9024 has already provided a very detailed summary, which everyone can refer to. Additionally, related discussions can be found in past Daily Question posts, so you can check those as well! Safety procedures for handling chemical engineering construction projects [Daily Question 20090108] http://bbs.hcbbs.com/thread-367967-1-1.html I will only add here the \"Registration Certificate for the production (Categories II and III) and distribution (Category II) of non-pharmaceutical precursor chemicals\"! Serial Number | Permitted Matters | Legal Basis | Required Documents
1 | Approval for the establishment of hazardous chemicals construction projects | Articles 25 of the Work Safety Law of the People’s Republic of China, Article 9 of the Regulations on the Safety Management of Hazardous Chemicals, as well as relevant provisions in Article 9 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Safety Licensing of Hazardous Chemicals Construction Projects. 1. Application for safety review upon establishment of a construction project ； 2. Copy of the project planning permit issued by the competent construction (planning) authority ； 3. Report on the Evaluation of Safety Conditions for the Construction Project ； 4. Safety assessment report for the construction project ； 5. A copy of the business license for corporate entities issued by the administrative department for industry and commerce, or a notice of pre-approval of the company name ； 6**Written materials required by industrial policy ； 7. Other materials required during the review. 2 Review of the safety facility design for hazardous chemical construction projects. Article 26 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 14 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for review of the design of safety facilities for construction projects ； 2. Safety review opinion for the establishment of a construction project (copy) ； 3. Proof of the design qualification of the design unit (copy) ； 4. Special section on the design of safety facilities for the construction project (including a map showing the location of the construction site, a simplified diagram of the process flow, and a map indicating the areas at risk of explosion) ； Plan layout of construction projects, production and storage units or facilities, lightning and static electricity protection grounding, fire protection facilities and equipment, gas detection plan layout ； List of special equipment and main safety accessories involved in the construction project) ； 5. Other materials required during the review. 3 Filing of the trial production (use) plan for hazardous chemical construction projects. **As required by the relevant provisions of Order No. 8 of the State Administration of Work Safety, the \"Implementation Measures for Safety Permits for Hazardous Chemicals Construction Projects\". 1. Trial production (operation) plan for the construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Qualification certificates and approval forms of the construction unit ； 4. Approval form from the design unit for safety facilities; 5. Qualification certificate and approval form of the supervision unit ； 6. Quality supervision procedures for construction projects (copy) ； 7. Written opinion on the rationale provided by the expert group ； 8. Written explanation of the list of personnel participating in trial production (use) and relevant training details ； 9. Fire safety inspection report (copy) for construction projects with fire safety design ； 10. Inspection and testing documents for safety facilities (copies). 4 Review of the completion acceptance of safety facilities for hazardous chemical construction projects. Article 27 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 22 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for the acceptance of the completed safety facilities of a construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Proof of the construction contractor’s qualifications (copy) ； 4. Report on the construction of safety facilities for the construction project; 5. Report on funds invested in work safety ； 6. Safety assessment report for the completion acceptance of construction projects. 5. Safety production license for hazardous chemicals manufacturing enterprises: In accordance with Article 7 of the Regulations on the Safety Management of Hazardous Chemicals and Article 2 of the Regulations on Safety Production Licenses, as well as relevant provisions such as Article 2 of the Implementation Measures for Safety Production Licenses of Hazardous Chemicals Manufacturing Enterprises, Order No. 10 issued by the State Administration of Work Safety. (1) Documents issued by the enterprise regarding the safety production responsibility system, as well as copies of various safety production responsibility system texts ； (2) List of safety production management rules and regulations ； (3) List of safety operation procedures for each position ； (4) Documents (copies) establishing the work safety management organization and appointing full-time work safety management personnel ； (5) Safety qualification certificates and professional qualification certificates (copies) issued to the principal persons in charge and safety production management personnel after passing the assessment conducted by the safety production supervision and management department ； (6) The list of special operation personnel who have passed the assessment should indicate the type of work, the certificate number, and the date the certificate was issued ； (7) Proof of completion of safety production education and training for other practitioners ； (8) A special invoice (copy) issued by the tax authorities for paying work-related injury insurance premiums on behalf of employees, or other valid supporting documents ； (9) Proof of investment in work safety in the 3 years prior to the date of application ； (10) Explanation of measures taken to prevent occupational hazards and registration list of personal protective equipment provided to employees ； (11) Safety assessment report issued by a safety assessment institution with the required legal qualifications ； (12) Hazardous chemical manufacturing enterprises with major hazard sources shall provide certified documents (copies) showing that the major hazard sources and relevant safety measures and emergency response measures have been filed with the local work safety supervision and management department ； (13) Emergency rescue plan for hazardous chemical accidents and certified documents (copies) filed with the work safety supervision and management department of the provincial-level city ； (14) Copy of the business license ； (15) New, revised, or expanded hazardous chemicals manufacturing enterprises shall provide a copy of the approval letter issued by the work safety supervision and management department at the prefecture-level city or above ； (16) Other documents and materials required by laws, regulations, and rules (such as planning procedures, fire safety inspection reports for construction projects, etc.). 6 Hazardous Chemicals Business License (divided into Type A and Type B). In accordance with Article 27 of the Regulations on the Safety Management of Hazardous Chemicals, as well as relevant provisions such as Article 3 of the Measures for the Administration of Hazardous Chemicals Business Licenses issued by the Ministry of Economy and Trade under Order No. 36. 1. Application for a License to Operate Hazardous Chemicals ； 2. Copy of the business license or approval notice (copy) ； 3. Safety assessment report issued by a safety assessment institution with the required legal qualifications ； 4. Fire safety inspection documents for the buildings used for operation and storage (copies) ； 5. Proof of property rights or lease for the business and storage premises and facilities (copy) ； 6. Safety qualification certificates and professional qualification certificates (copies) issued to the main persons in charge of the unit, supervisors, safety production management personnel, and business personnel (such as storage staff and sales staff) after passing the assessment conducted by the safety production supervision and management department ； 7. Documents (copies) establishing a safety management organization or appointing full-time safety management personnel ； 8. List of safety management systems ； 9. List of safety operation procedures for various positions ； 10. Emergency rescue plan for hazardous chemical accidents and copies of the documentation filed with the local work safety supervision and management department ； 11. If the quantity of hazardous chemicals stored by an operating unit constitutes a major hazard source, it shall submit proof materials showing that the storage location has been registered with the local work safety supervision and management department as well as the public security department ； 12. Certifying documents for other work safety requirements stipulated by laws, regulations, and rules. 7. Registration certificate for the production (Categories II and III) and operation (Category II) of non-pharmaceutical precursors for drug manufacture. “Regulations on the Management of Precursors for Drug Manufacture” (Decree No. 445 of the State Council); “Measures for the Licensing of the Production and Operation of Non-pharmaceutical Precursors for Drug Manufacture” (Decree No. 5 of the Work Safety Supervision Bureau). (I) When registering as a producer of Category II or III non-pharmaceutical precursors for drug manufacture, the following documents must be submitted: 1. Application form for registration of non-pharmaceutical precursors for drug manufacture (2 copies) ； 2. Management System for Precursor Chemicals ； (See the table of requirements for manufacturing enterprises in the application form) 3. Product packaging instructions and user manual ； 4. Copy of the business license. For enterprises that produce hazardous chemicals, they must also submit a safety production license for such enterprises as well as a registration certificate for hazardous chemicals (copies). (II) When applying for registration as a business dealing with Category II and III non-pharmaceutical precursor chemicals, the following documents must be submitted: 1. Application form for registration of business dealing with non-pharmaceutical precursor chemicals (2 copies) ； 2. Management System for Precursor Chemicals ； (See the table of operating conditions for entities dealing in precursor chemicals in the application form) 3. Product packaging instructions and user manuals ； 4. Copy of the business license. If it is an entity engaged in the handling of hazardous chemicals, a copy of the hazardous chemicals handling license must also be submitted.
1 | Approval for the establishment of hazardous chemicals construction projects | Articles 25 of the Work Safety Law of the People’s Republic of China, Article 9 of the Regulations on the Safety Management of Hazardous Chemicals, as well as relevant provisions in Article 9 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Safety Licensing of Hazardous Chemicals Construction Projects. 1. Application for safety review upon establishment of a construction project ； 2. Copy of the project planning permit issued by the competent construction (planning) authority ； 3. Report on the Evaluation of Safety Conditions for the Construction Project ； 4. Safety assessment report for the construction project ； 5. A copy of the business license for corporate entities issued by the administrative department for industry and commerce, or a notice of pre-approval of the company name ； 6**Written materials required by industrial policy ； 7. Other materials required during the review. 2 Review of the safety facility design for hazardous chemical construction projects. Article 26 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 14 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for review of the design of safety facilities for construction projects ； 2. Safety review opinion for the establishment of a construction project (copy) ； 3. Proof of the design qualification of the design unit (copy) ； 4. Special section on the design of safety facilities for the construction project (including a map showing the location of the construction site, a simplified diagram of the process flow, and a map indicating the areas at risk of explosion) ； Plan layout of construction projects, production and storage units or facilities, lightning and static electricity protection grounding, fire protection facilities and equipment, gas detection plan layout ； List of special equipment and main safety accessories involved in the construction project) ； 5. Other materials required during the review. 3 Filing of the trial production (use) plan for hazardous chemical construction projects. **As required by the relevant provisions of Order No. 8 of the State Administration of Work Safety, the \"Implementation Measures for Safety Permits for Hazardous Chemicals Construction Projects\". 1. Trial production (operation) plan for the construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Qualification certificates and approval forms of the construction unit ； 4. Approval form from the design unit for safety facilities; 5. Qualification certificate and approval form of the supervision unit ； 6. Quality supervision procedures for construction projects (copy) ； 7. Written opinion on the rationale provided by the expert group ； 8. Written explanation of the list of personnel participating in trial production (use) and relevant training details ； 9. Fire safety inspection report (copy) for construction projects with fire safety design ； 10. Inspection and testing documents for safety facilities (copies). 4 Review of the completion acceptance of safety facilities for hazardous chemical construction projects. Article 27 of the Work Safety Law of the People’s Republic of China, with reference to relevant provisions such as Article 22 of Order No. 8 issued by the State Administration of Work Safety, namely the Measures for the Implementation of Safety Permits for Hazardous Chemicals Construction Projects. 1. Application for the acceptance of the completed safety facilities of a construction project ； 2. Review opinion on the design of safety facilities for the construction project (copy) ； 3. Proof of the construction contractor’s qualifications (copy) ； 4. Report on the construction of safety facilities for the construction project; 5. Report on funds invested in work safety ； 6. Safety assessment report for the completion acceptance of construction projects. 5. Safety production license for hazardous chemicals manufacturing enterprises: In accordance with Article 7 of the Regulations on the Safety Management of Hazardous Chemicals and Article 2 of the Regulations on Safety Production Licenses, as well as relevant provisions such as Article 2 of the Implementation Measures for Safety Production Licenses of Hazardous Chemicals Manufacturing Enterprises, Order No. 10 issued by the State Administration of Work Safety. (1) Documents issued by the enterprise regarding the safety production responsibility system, as well as copies of various safety production responsibility system texts ； (2) List of safety production management rules and regulations ； (3) List of safety operation procedures for each position ； (4) Documents (copies) establishing the work safety management organization and appointing full-time work safety management personnel ； (5) Safety qualification certificates and professional qualification certificates (copies) issued to the principal persons in charge and safety production management personnel after passing the assessment conducted by the safety production supervision and management department ； (6) The list of special operation personnel who have passed the assessment should indicate the type of work, the certificate number, and the date the certificate was issued ； (7) Proof of completion of safety production education and training for other practitioners ； (8) A special invoice (copy) issued by the tax authorities for paying work-related injury insurance premiums on behalf of employees, or other valid supporting documents ； (9) Proof of investment in work safety in the 3 years prior to the date of application ； (10) Explanation of measures taken to prevent occupational hazards and registration list of personal protective equipment provided to employees ； (11) Safety assessment report issued by a safety assessment institution with the required legal qualifications ； (12) Hazardous chemical manufacturing enterprises with major hazard sources shall provide certified documents (copies) showing that the major hazard sources and relevant safety measures and emergency response measures have been filed with the local work safety supervision and management department ； (13) Emergency rescue plan for hazardous chemical accidents and certified documents (copies) filed with the work safety supervision and management department of the provincial-level city ； (14) Copy of the business license ； (15) New, revised, or expanded hazardous chemicals manufacturing enterprises shall provide a copy of the approval letter issued by the work safety supervision and management department at the prefecture-level city or above ； (16) Other documents and materials required by laws, regulations, and rules (such as planning procedures, fire safety inspection reports for construction projects, etc.). 6 Hazardous Chemicals Business License (divided into Type A and Type B). In accordance with Article 27 of the Regulations on the Safety Management of Hazardous Chemicals, as well as relevant provisions such as Article 3 of the Measures for the Administration of Hazardous Chemicals Business Licenses issued by the Ministry of Economy and Trade under Order No. 36. 1. Application for a License to Operate Hazardous Chemicals ； 2. Copy of the business license or approval notice (copy) ； 3. Safety assessment report issued by a safety assessment institution with the required legal qualifications ； 4. Fire safety inspection documents for the buildings used for operation and storage (copies) ； 5. Proof of property rights or lease for the business and storage premises and facilities (copy) ； 6. Safety qualification certificates and professional qualification certificates (copies) issued to the main persons in charge of the unit, supervisors, safety production management personnel, and business personnel (such as storage staff and sales staff) after passing the assessment conducted by the safety production supervision and management department ； 7. Documents (copies) establishing a safety management organization or appointing full-time safety management personnel ； 8. List of safety management systems ； 9. List of safety operation procedures for various positions ； 10. Emergency rescue plan for hazardous chemical accidents and copies of the documentation filed with the local work safety supervision and management department ； 11. If the quantity of hazardous chemicals stored by an operating unit constitutes a major hazard source, it shall submit proof materials showing that the storage location has been registered with the local work safety supervision and management department as well as the public security department ； 12. Certifying documents for other work safety requirements stipulated by laws, regulations, and rules. 7. Registration certificate for the production (Categories II and III) and operation (Category II) of non-pharmaceutical precursors for drug manufacture. “Regulations on the Management of Precursors for Drug Manufacture” (Decree No. 445 of the State Council); “Measures for the Licensing of the Production and Operation of Non-pharmaceutical Precursors for Drug Manufacture” (Decree No. 5 of the Work Safety Supervision Bureau). (I) When registering as a producer of Category II or III non-pharmaceutical precursors for drug manufacture, the following documents must be submitted: 1. Application form for registration of non-pharmaceutical precursors for drug manufacture (2 copies) ； 2. Management System for Precursor Chemicals ； (See the table of requirements for manufacturing enterprises in the application form) 3. Product packaging instructions and user manual ； 4. Copy of the business license. For enterprises that produce hazardous chemicals, they must also submit a safety production license for such enterprises as well as a registration certificate for hazardous chemicals (copies). (II) When applying for registration as a business dealing with Category II and III non-pharmaceutical precursor chemicals, the following documents must be submitted: 1. Application form for registration of business dealing with non-pharmaceutical precursor chemicals (2 copies) ； 2. Management System for Precursor Chemicals ； (See the table of operating conditions for entities dealing in precursor chemicals in the application form) 3. Product packaging instructions and user manuals ； 4. Copy of the business license. If it is an entity engaged in the handling of hazardous chemicals, a copy of the hazardous chemicals handling license must also be submitted.