The Ministry of Industry and Information Technology recently promulgated the revised Implementing Rules for the Regulations of the People’s Republic of China on the Control of Monitored Chemicals, which set forth clear provisions on the construction and production management, the management of trade and use, import and export controls, data reporting and retention, international inspections, and domestic supervision and inspection of monitored chemicals. The new rules will take effect on January 1, 2019, and the original implementing rules issued by the former Ministry of Chemical Industry in 1997 shall be repealed simultaneously.

Order of the Ministry of Industry and Information Technology of the People’s Republic of China

No. 48

The “Detailed Rules for the Implementation of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals” were reviewed and approved at the third ministerial meeting of the Ministry of Industry and Information Technology on June 20, 2018, and are hereby promulgated, entering into force on January 1, 2019. The “Detailed Rules for the Implementation of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals” previously promulgated by the former Ministry of Chemical Industry on March 10, 1997 (Order No. 12 of the former Ministry of Chemical Industry) is hereby repealed simultaneously.

Minister Miao Wei

July 2, 2018

Attachment: Implementing Rules of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals

Detailed Rules for the Implementation of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals

Article 1 　In order to strengthen the supervision and administration of monitored chemicals, fulfill the obligations under the Chemical Weapons Convention, ensure the personal safety of citizens, and protect the environment, these Detailed Rules are hereby formulated in accordance with the Regulations of the People’s Republic of China on the Administration of Monitored Chemicals.

Article 2 　Any entity engaging in the production, operation, use, or import and export of controlled chemicals within the territory of the People’s Republic of China shall comply with these Detailed Rules.

Article 3 　The Ministry of Industry and Information Technology is responsible for the nationwide administration of monitored chemicals.

The industrial and information technology authorities of local people’s governments at or above the county level, or the departments designated by such local people’s governments to oversee monitored chemicals, shall be responsible for the administration of monitored chemicals within their respective administrative jurisdictions.

Article 4 　The funds required for the industrial and information technology authorities at all levels, or the chemical‑monitoring administrative departments designated by local people’s governments, to carry out their duties under the Chemical Weapons Convention shall, in accordance with law, be included in the budgets of the respective levels of government.

Article 5 The State strictly controls the production of Category I monitored chemicals.

Any entity that intends to produce Category I monitored chemicals for scientific research, medical purposes, pharmaceutical manufacturing, or protective applications shall obtain approval from the Ministry of Industry and Information Technology and conduct such production at small-scale facilities designated by the Ministry.

The production of Category I monitored chemicals in facilities not designated by the Ministry of Industry and Information Technology is strictly prohibited.

Article 6 For the construction, expansion, or reconstruction of facilities used to produce Category II and Category III monitored chemicals, as well as specific organic chemicals containing phosphorus, sulfur, or fluorine that fall under Category IV monitored chemicals, the applicant shall complete the “Application Form for the Construction, Expansion, or Reconstruction of Monitored Chemical Production Facilities” and submit the relevant materials required by the form to the industrial and information technology authority of the province, autonomous region, or municipality directly under the central government where the facility is located. The provincial, autonomous regional, or municipal industrial and information technology authority shall, within 20 working days from the date of receipt of all application materials, complete the review and provide its opinion, and then submit the case to the Ministry of Industry and Information Technology for approval.

The Ministry of Industry and Information Technology shall, within 20 working days from the date of receipt of the materials submitted by the industrial and information technology authorities of provinces, autonomous regions, and municipalities directly under the central government, render a decision. If approved, it shall issue an approval document; if not approved, it shall notify the applicant in writing and provide the reasons therefor.

Article 7 Upon completion of new construction, expansion, or renovation projects involving production facilities for Category II and Category III monitored chemicals, as well as specific organic chemicals containing phosphorus, sulfur, or fluorine among Category IV monitored chemicals, the relevant authorities shall, within 40 working days from the date of completion, submit an application to the industrial and information technology administrative department of the province, autonomous region, or municipality directly under the central government where the facility is located for completion acceptance. If the acceptance is passed, the local provincial, autonomous regional, or municipal industrial and information technology administrative department shall issue a review opinion certifying successful acceptance and submit it to the Ministry of Industry and Information Technology for approval.

Upon completion and acceptance, and following approval by the Ministry of Industry and Information Technology, an application for a special permit for the production of monitored chemicals shall be submitted in accordance with Article 10 of these Detailed Rules.

Article 8 For production facilities of Category II and Category III monitored chemicals, as well as specific organic chemicals containing phosphorus, sulfur, or fluorine within Category IV monitored chemicals, if any of the following circumstances apply to new construction, expansion, or reconstruction projects, the project shall not pass completion acceptance, and the industrial and information technology authorities of the province, autonomous region, or municipality directly under the central government shall issue a review opinion stating that acceptance is not approved:

(1) For production facilities of Category II and Category III monitored chemicals, as well as for specific organic chemicals containing phosphorus, sulfur, or fluorine within Category IV monitored chemicals, where the certified production capacity reaches or exceeds 150% of the design production capacity;

(2) Concealing relevant information or submitting false documents and materials in applying for completion acceptance, where the circumstances are serious;

(3) Other circumstances as prescribed by the Ministry of Industry and Information Technology.

If the completion acceptance is not approved, the applicant shall complete the rectification within six months and reapply for completion acceptance.

Article 9 The State implements a special licensing system for the production of Category II and Category III monitored chemicals, as well as certain organic chemicals containing phosphorus, sulfur, or fluorine that fall under Category IV monitored chemicals.

Article 10 　Applicants for a special permit to produce monitored chemicals shall meet the following conditions:

(1) The applicant is a legal person or an unincorporated organization;

(2) Possess the funds and facilities necessary for the production of monitored chemicals;

(3) Possess technical capabilities and production facilities suitable for the manufacture of monitored chemicals, and comply with the requirements of the local environmental protection and work safety supervision authorities.

(4) Possess qualified technical personnel and management systems appropriate for the production of monitored chemicals;

(5) Possess the capacity to implement the Chemical Weapons Convention;

(6) No record of illegal production, operation, or use of controlled chemicals within the past five years.

Article 11 　Applicants seeking a special permit for the production of monitored chemicals shall complete the “Application Form for a Special Permit for the Production of Monitored 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 12 　The industrial and information technology authorities of provinces, autonomous regions, and municipalities directly under the central government shall organize experts to conduct on-site assessments of applicants in accordance with the requirements set forth in the “On-site Assessment Form for Special Licenses for the Production of Monitored Chemicals,” and, within 20 working days from the date of receipt of all application materials, shall submit their assessment opinions together with the complete set of application documents to the Ministry of Industry and Information Technology.

Article 13 　Upon receipt of the materials submitted by the industrial and information technology authorities of provinces, autonomous regions, and municipalities directly under the central government, the Ministry of Industry and Information Technology shall review whether such materials comply with the conditions set forth in Article 10 of these Detailed Rules, and shall render a decision within twenty working days from the date of receipt. If approved, it shall issue a Special Production License; if not approved, it shall notify the applicant in writing, stating the reasons therefor.

Article 14 　The Special Permit for the Production of Monitored Chemicals is valid for a period of five years. If, upon expiration of the permit, the holder intends to continue producing monitored chemicals, they shall, six months in advance, submit an application for renewal to the Ministry of Industry and Information Technology through the industrial and information technology authorities of the province, autonomous region, or municipality directly under the central government where the facility is located. Upon review and confirmation that the conditions set forth in Article 10 of these Detailed Rules are met, the permit shall be renewed prior to its expiration.

Article 15 　Where a change in the enterprise name or other particulars necessitates the replacement of a Special Permit for the Production of Monitored Chemicals, the relevant provincial, autonomous region, or municipality‑level department of industry and information technology shall submit to the Ministry of Industry and Information Technology, through its local authority, both the original Special Permit and a copy of the amended business license. Upon review and confirmation that the conditions set forth in Article 10 of these Detailed Rules are met, the Ministry shall approve the replacement of the Special Permit for the Production of Monitored Chemicals.

Article 16 　Producers of Category II controlled chemicals shall not sell such chemicals to any entity or individual that has not obtained a business license or a use license for Category II controlled chemicals.