Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Controlled Chemicals (2018)

Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Controlled Chemicals (2018) Order of the Ministry of Industry and Information Technology (No. 48) The Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Controlled Chemicals , as deliberated and adopted at the 3rd executive meeting of the Ministry of Industry and Information Technology on June 20, 2018, are hereby issued, and shall come into force on January 1, 2019, upon which the Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Controlled Chemicals (Order No. 12, former Ministry of Chemical Industry) issued by the former Ministry of Chemical Industry on March 10, 1997 shall be repealed. Minister: Miao Wei July 2, 2018 Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Controlled Chemicals Chapter I General Provisions Article 1 For the purposes of strengthening the supervision and management of controlled chemicals, implementing the Chemical Weapons Convention, guaranteeing the personal safety of citizens and protecting environment, these Detailed Rules are developed in accordance with the Regulation of the People's Republic of China on the Administration of Controlled Chemicals . Article 2 The production, business operation, use, import and export and other activities of controlled chemicals in the territory of the People's Republic of China shall be carried out according to these Detailed Rules. Article 3 The Ministry of Industry and Information Technology (“MIIT”) shall be responsible for the management of controlled chemicals. The competent departments of industry and information technology of the local people's governments at or above the county level or the management departments of controlled chemicals determined by the local people's governments shall be responsible for the management of controlled chemicals within their respective administrative regions. Article 4 The funds required by the competent departments of industry and information technology at all levels or the management departments of controlled chemicals determined by the local people's governments for implementing the Chemical Weapons Convention shall be included in the government budget at the same level according to the law. Chapter II Construction and Production Management Article 5 The state shall strictly control the production of the Schedule I controlled chemicals. Where the Schedule I controlled chemicals need to be produced for the purposes of scientific research, medical treatment, manufacturing of drugs or protection, it shall be reported to the MIIT for approval and production shall be carried out in small-scale facilities designated by the MIIT. It is strictly prohibited to produce the Schedule I controlled chemicals in facilities that are not designated by the MIIT. Article 6 For new construction, expansion or reconstruction of the facilities for producing the Schedule II and Schedule III controlled chemicals and specific organic chemicals containing phosphorus, sulfur, and fluorine in the Schedule IV controlled chemicals, the applicant shall complete the Application Form for New Construction (Expansion or Reconstruction) of Production Facilities for Controlled Chemicals, with the relevant materials as required in the Application Form attached, and file an application with the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where it is located. The competent department of industry and information technology of the province, autonomous region or municipality directly under the Central Government shall, within 20 working days of receipt of all the application materials, complete the examination and sign the opinions, and report to the MIIT for approval. The MIIT shall make a decision within 20 working days of receipt of the materials submitted by the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government. Where approval is granted, an approval document shall be issued; and where approval is not granted, the applicant shall be notified in writing and the reasons shall be given. Article 7 After the completion of a new construction, expansion or reconstruction project of the production facilities for the Schedule II and Schedule III controlled chemicals and the specific organic chemicals containing phosphorus, sulfur, and fluorine in the Schedule IV controlled chemicals, an application for completion acceptance shall be filed with the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where the project is located within 40 working days from the date of completion. Where the project passes the acceptance, the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where the project is located shall issue examination opinions on passing the acceptance and submit them to the MIIT for approval. After the completion acceptance is approved by the MIIT, an application for a special production license for controlled chemicals shall be filed according to the provisions of Article 10 of these Detailed Rules. Article 8 A new construction, expansion or reconstruction project of the production facilities for the Schedule II and Schedule III controlled chemicals and the specific organic chemicals containing phosphorus, sulfur, and fluorine in the Schedule IV controlled chemicals falling under any of the following circumstances shall not pass the completion acceptance, and the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government shall issue examination opinions on failing the acceptance: (1) The rated production capacity of the production facilities for the Schedule II and Schedule III controlled chemicals and specific organic chemicals containing phosphorus, sulfur, and fluorine in the Schedule IV controlled chemicals reaches or exceeds 150% of the designed production capacity. (2) An application for completion acceptance is filed by concealing the relevant information or providing false documents and materials, and the circumstances are serious. (3) Other circumstances as prescribed by the MIIT. Where completion acceptance is not passed, the applicant shall complete rectification within six months and re-apply for completion acceptance. Article 9 The state shall implement a special licensing system for the production of the Schedule II and Schedule III controlled chemicals and specific organic chemicals containing phosphorus, sulfur, and fluorine in the Schedule IV controlled chemicals. Article 10 To apply for a special production license for controlled chemicals, the applicant shall meet the following conditions: (1) The applicant is a legal person or an unincorporated organization. (2) The applicant has the funds and places needed for producing controlled chemicals. (3) The applicant has the technical conditions and production facilities that are commensurate with the production of controlled chemicals, and satisfy the requirements of the local environmental protection and work safety supervision and administration departments. (4) The applicant has the professional technicians and management systems that are commensurate with the production of controlled chemicals. (5) The applicant has the capability of implementing the Chemical Weapons Convention. (6) The applicant has no records of illegal production, business operation or use of controlled chemicals within five years. Article 11 To apply for a special production license for controlled chemicals, an applicant shall complete the Application Form for the Special Production License for Controlled Chemicals, with the relevant materials as required in the Application Form attached, and file an application with the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where it is located. Article 12 The competent departments of industry and information technology of provinces, autonomous regions and municipalities directly under the Central Government shall organize experts to conduct on-site assessment of applicants under the requirements of the On-site Assessment Form for Special Production License for Controlled Chemicals, and shall, within 20 working days of receipt of all application materials, submit the assessment opinions and all application materials to the MIIT. Article 13 The MIIT shall, upon receipt of the materials submitted by the competent department of industry and information technology of a province, autonomous region, or municipality directly under the Central Government, conduct examination on whether the application materials meet the conditions set out in Article 10 of these Detailed Rules, and make a decision within 20 working days of receipt of the materials. Where approval is granted, a special production license shall be issued; and where approval is not granted, the applicant shall be notified in writing and the reasons shall be given. Article 14 A special production license for controlled chemicals shall be valid for five years. Where the production of controlled chemicals needs to be continued upon expiry of the validity period of a special production license, the license holder shall file an application for extension with the MIIT through the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where it is located six months in advance. Where the conditions set out in Article 10 of these Detailed Rules are met upon examination, extension shall be approved prior to the expiry of the validity period. Article 15 Where a special production license for controlled chemicals needs to be replaced due to change in the enterprise name or any other item, the photocopies of the special production license and the business license of the enterprise after change shall be submitted to the MIIT through the competent department of industry and information technology of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located. Where the conditions set out in Article 10 of these Detailed Rules are met upon examination, the replacement of the special production license for controlled chemicals shall be approved. Article 16 A producer of the Schedule II controlled chemicals shall not sell the Schedule II controlled chemicals to any entity or individual that has not obtained a business operation permit or use permit for the Schedule II controlled chemicals. Chapter III Management of Business Operation and Use Article 17 The state shall implement a licensing system for the business operation of the Schedule II controlled chemicals and the use of the Schedule I and Schedule II controlled chemicals. Article 18 To apply for a business operation permit for the Schedule II controlled chemicals, an applicant shall meet the following conditions: (1) The applicant is a legal person or an unincorporated organization. (2) The applicant has the capability to manage the entire process of the purchase, transportation and storage of the Schedule II controlled chemicals. (......