The revised “Detailed Rules for the Implementation of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals” have been promulgated.
Release Date:
2018-07-04
Chapter III: Operation and Usage Management Article 17 The State shall implement a licensing system for the operation of Category II controlled chemicals and for the use of Category I and Category II controlled chemicals. Article 18 Applicants seeking a license to operate Category II controlled chemicals shall meet the following conditions: (1) The applicant must be a legal entity or an unincorporated organization; (2) The applicant must possess end-to-end management capabilities over the procurement, transportation, and storage of Category II controlled chemicals; (3) The applicant must have operational facilities that comply with safety requirements and technical personnel familiar with the products’ performance; (4) The applicant must maintain a sound management system for the operation of controlled chemicals; (5) The applicant must have personnel who are well-versed in the statistical reporting of controlled chemical data.
Chapter 3: Operation and Usage Management
Article 17 The State implements a licensing system for the trade of Category II controlled chemicals and for the use of Category I and Category II controlled chemicals.
Article 18 Applicants for a business license to handle Category II monitored chemicals shall meet the following conditions:
(1) The applicant is a legal person or an unincorporated organization;
(2) Possesses end-to-end management capabilities for the procurement, transportation, and storage of Category II controlled chemicals;
(3) Possess business facilities that meet safety requirements and technical personnel who are familiar with the product’s performance;
(4) Possesses a sound management system for the operation of monitored chemicals;
(5) Possess management personnel and management systems that are familiar with the statistical reporting of monitored chemical substances and with the requirements for implementing the Chemical Weapons Convention.
(6) No record of illegal production, operation, or use of controlled chemicals within the past five years.
Article 19 Applicants seeking a business license for the trade of Category II controlled chemicals shall complete the “Application Form for the Trade of Category II Controlled Chemicals,” attach the relevant documents required by the form, and submit their application to the competent department of industry and information technology of the province, autonomous region, or municipality directly under the central government where they are located.
Article 20 The industrial and information technology authorities of provinces, autonomous regions, and municipalities directly under the central government shall review the application materials and conduct on-site verification, and shall render a decision within 20 working days from the date of receipt of all application materials. If approved, they shall issue a license for the operation of Category II monitored chemicals; if not approved, they shall notify the applicant in writing and provide the reasons therefor.
Article 21 Operators engaged in the trade of Category II controlled chemicals shall not sell such chemicals to any entity or individual that has not obtained a license for the trade or use of Category II controlled chemicals, nor shall they purchase Category II controlled chemicals from any entity or individual that has not obtained a special production license or a trade license for such chemicals.
When purchasing Category II controlled chemicals, the purchaser shall verify the seller’s special production license and business license for Category II controlled chemicals and retain copies thereof. When selling Category II controlled chemicals, the seller shall verify the buyer’s business license and use license for Category II controlled chemicals and retain copies thereof.
Article 22 Operators engaged in the trade of Category II controlled chemicals shall maintain original records and statistical ledgers for purchase, storage, and sales, with a retention period of no less than three years. Such operators shall submit sales records for the preceding six months to the industrial and information technology authorities of the province, autonomous region, or municipality directly under the central government where they are located, in January and July each year.
Article 23 Anyone who needs to use Category I monitored chemicals for scientific research, medical purposes, pharmaceutical manufacturing, or protective measures shall complete the “Application Form for the Use of Category I Monitored Chemicals,” attach the relevant documents required by the form, and submit the application to the Ministry of Industry and Information Technology. Upon approval, the Ministry shall issue an official approval document. The applicant shall, on the basis of this approval document, enter into a contract with a production unit designated by the Ministry of Industry and Information Technology and submit a copy of the contract to the Ministry for record‑keeping.
Article 24 Applicants for a license to use Category II controlled chemicals shall meet the following conditions:
(1) The applicant is a legal person or an unincorporated organization;
(2) Possesses end-to-end management capabilities for the procurement, transportation, storage, and use of Category II controlled chemicals;
(3) Possesses a sound management system for the use of monitored chemicals;
(4) Possess the capacity to implement the Chemical Weapons Convention;
(5) No record of illegal production, operation, or use of controlled chemicals within the past five years.
Article 25 Applicants seeking a license for the use of Category II controlled chemicals shall complete the “Application Form for the Use of Category II Controlled Chemicals,” attach the relevant documents specified in the form, and submit their application to the competent department of industry and information technology of the province, autonomous region, or municipality directly under the central government where they are located. In addition, they shall submit supporting documentation in accordance with their annual usage volume.
Article 26 The industrial and information technology authorities of provinces, autonomous regions, and municipalities directly under the central government shall review the application materials and conduct on-site verification, and shall render a decision within 20 working days from the date of receipt of all application materials. If approved, they shall issue a License for the Use of Category II Monitored Chemicals; if not approved, they shall notify the applicant in writing and provide the reasons therefor.
Article 27 Anyone who has obtained a license for the use of Category II monitored chemicals shall, upon presentation of such license, purchase Category II monitored chemicals from entities or individuals holding a special production license and an operating license for Category II monitored chemicals.
Article 28 The validity period of the operating license and the usage license for Category II monitored chemicals is five years, and the format of these licenses is uniformly prescribed by the Ministry of Industry and Information Technology.
Where the validity period of a license has expired and the holder intends to continue operating or using monitored chemicals, they shall submit an application for renewal to the industrial and information technology authority of the province, autonomous region, or municipality directly under the central government where they are located, at least six months in advance. Upon review, if the applicant is found to meet the conditions stipulated in these Detailed Rules, the license shall be renewed prior to the expiration of its current term.
Chapter 4: Import and Export Management
Article 29 The State implements a licensing system for the import and export of Category I monitored chemicals, as well as Category II and Category III monitored chemicals, their production technologies, and specialized equipment.
Article 30 The import and export of Category I monitored chemicals, as well as Category II and Category III monitored chemicals and their production technologies and specialized equipment, shall be conducted by designated entities in accordance with the Regulations of the People’s Republic of China on the Administration of Monitored Chemicals. Such designated entities shall submit import and export applications to the Ministry of Industry and Information Technology.
For applications for import, the following documents shall be submitted: the “Application Form for Import of Monitored Chemicals”; the “Application Form for Import‑Related Business Operations Involving Monitored Chemicals” or the “Application Form for Import‑Related End‑Use of Monitored Chemicals,” duly certified by the competent department of industry and information technology of the province, autonomous region, or municipality directly under the central government; and the original import contract.
For applications for export, the following documents shall be submitted: the “Application Form for the Export of Monitored Chemicals”; a certificate issued by the government of the importing country or an agency authorized by that government, certifying that the imported monitored chemicals, as well as the related production technologies and specialized equipment, will not be used for the production of chemical weapons nor re-exported to third countries, together with details specifying the name, quantity, intended end-use, and the name and address of the ultimate user of the monitored chemicals; and the original export contract.
Article 31 With respect to applications for the import or export of Category I monitored chemicals, the Ministry of Industry and Information Technology shall, within 20 working days from the date of receipt of all application materials, complete its review and issue its opinion, which shall then be submitted to the State Council for approval. The designated entity shall, on the basis of the State Council’s approval document, apply to the Ministry of Commerce for an import or export license.
With respect to applications for the import or export of Category II and Category III monitored chemicals, as well as their production technologies and specialized equipment, the Ministry of Industry and Information Technology shall render a decision within 20 working days from the date of receipt of all application materials. If approved, it shall issue an approval document; the designated entity shall, on the strength of such document, apply to the Ministry of Commerce for an import or export license. If not approved, the applicant shall be notified in writing, with reasons provided.
Article 32 Where an amendment to the import or export license is required, in addition to the materials specified in Article 30 of these Detailed Rules, the applicant shall also submit the original documents approving the import or export and the corresponding license.
Article 33 The designated entity shall submit the following information in writing to the Ministry of Industry and Information Technology:
(1) List of the principal leaders responsible for this work;
(2) The name of the specialized agency responsible for this business;
(3) Photocopies of the identity cards and work permits of full-time personnel who sign import and export contracts on behalf of the entity.
If the information specified in the preceding paragraph undergoes any changes, it shall be reported to the Ministry of Industry and Information Technology within ten working days.
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