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 Administration of Controlled Chemicals, which set forth clear provisions regarding the construction and production management, the management of trading and use, import and export controls, data reporting and retention, international inspections, and domestic supervision and inspection of controlled 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1, 2019, and the original implementing rules issued by the former Ministry of Chemical Industry in 1997 shall be repealed simultaneously.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Ministry of Chemical Industry on March 10, 1997 (Order No. 12 of the former Ministry of Chemical Industry) is hereby repealed simultaneously.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 scheduled 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 Scheduled 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 administration of monitored chemicals nationwide.

The industrial and information technology authorities of local people’s governments at or above the county level, or the departments designated by such 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 competent departments of industry and information technology at all levels, or the monitoring chemical management authorities 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 controlled chemicals for scientific research, medical purposes, pharmaceutical manufacturing, or protective applications shall obtain approval from the Ministry of Industry and Information Technology and carry out 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 renovation 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, an application form titled “Application Form for the Construction, Expansion, or Renovation of Monitored Chemical Production Facilities” shall be completed and accompanied by the relevant materials specified in the form. Such applications shall be submitted to the industrial and information technology authorities 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 authorities shall, within 20 working days from the date of receipt of all application materials, complete the review and provide their opinion, after which the application shall be submitted 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 reasons.

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 parties shall, within 40 working days from the date of completion, apply to the industrial and information technology authorities 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 industrial and information technology authority shall issue an official review opinion certifying successful acceptance and submit it to the Ministry of Industry and Information Technology for approval.

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

Article 8 For new construction, expansion, or renovation projects of production facilities for Category II and Category III monitored chemicals, as well as for specific organic chemicals containing phosphorus, sulfur, or fluorine within Category IV monitored chemicals, if any of the following circumstances apply, 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 among 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 the application materials meet 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, a Special Production License shall be issued; if not approved, the applicant shall be notified in writing with an explanation of the reasons.

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 renewal shall be approved prior to the expiration date.

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 issuance of a replacement 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 usage permit for Category II controlled chemicals.