China Chemical Regulations

Management of Highly Toxic Chemicals in China

Highly toxic chemicals are defined as chemicals with high acute toxicity (usually GHS Acute Toxicity Category 1). Those chemicals can be lethal even in very small quantities. If illegally used as poisons, they could pose a big threat to public security. Examples of such chemicals include sodium cyanide.

In China, highly toxic chemicals are mainly regulated by the following administrative regulations:

  • Regulations on Safe Management of Hazardous Chemicals (2011) – State Council Decree 591;
  • Catalogue of Hazardous Chemicals (2015);
  • The Measures for the Administration of Licenses for the Purchase and Road Transportation of Highly Toxic Chemicals in China (2005) – Order 77 of the Ministry of Public Security;

The above regulations establish a much tighter regulatory regime for highly toxic chemical than regular hazardous chemicals in China and set additional requirements on the storage, purchase and sales of highly toxic chemicals.

List of Highly Toxic Chemicals in China

The Ministry of Public Security (MPS), the principle police authority in China, used to maintain a separate List of Highly Toxic Chemicals. This list has recently been incorporated into the Catalogue of Hazardous Chemicals (2015). Highly toxic chemicals are now marked as “剧毒” in the note column of the Catalogue.

There are currently 148 highly toxic chemicals in the Catalogue of Hazardous Chemicals (2015). You can search the Catalogue by Chinese name or CAS number.

Regulatory Requirements for Highly Toxic Chemicals in China

Since highly toxic chemicals are also hazardous chemicals included in the Catalogue of Hazardous Chemicals, they are subject to production/operation/safe use license requirements and HazChem registration requirements under Decree 591. In addition to that, they are subject to additional security and reporting requirements on storage, sales and purchase. Here we will only summarize the extra requirements for highly toxic chemicals:

Storage·       Dedicated warehouse, anti-theft system, full-time security guard;

·       Double staff for receiving/delivering chemicals and double staff for safekeeping;

·       Shall declare chemicals stored, quantities and management personnel info to both local work safety authority and local public security bureau;

·       Shall report any loss or theft case immediately;

Sales·       Shall check if buyers possess valid purchase permits before sales;

·       Shall maintain a good sales record including chemicals sold, quantities, uses, buyers’ names, and photo copies of purchase permits and photo identity cards of the handlers; and keep such records for at least 1 year;

·       Shall not sell highly toxic chemicals to private individuals (except pesticides);

Purchase·       Shall provide HazChem production/operation/safe use license or purchase permits issued by local public security bureau before purchase;

·       Shall declare highly toxic chemicals bought, quantities and flow info to local public security bureau (at county level) within 5 days since the purchase;

New Substances

A new substance is defined as a substance other than those listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). China implements a pre-market notification system for new substances.

The Measures for Environmental Administration of New Chemical Substances (China MEP Order 7) requires that manufacturers and importers submit new substance notifications and obtain approvals from the Solid Waste and Chemical Management Centre of China MEP (MEP-SCC) prior to production or importation. This notification requirement not only applies to a new substance on its own, but also applies to a new substance in a mixture.

Hazardous Chemicals

Hazardous chemicals are mainly controlled by State Council Decree 591 Regulations on Safe Management of Hazardous Chemicals issued in 2011 and many department rules.

In Decree 591, hazardous chemicals are defined as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, flammable and do harm to human body, facilities and environment. All chemicals meeting GHS hazard classification criteria may fall within its scope.

Among all hazardous chemicals placed on Chinese market, more than 2,800 chemicals have been added to the Catalogue of Hazardous Chemicals (2015). This Catalogue is an administrative license Catalogue which means that businesses who handle hazardous chemicals in the Catalogue are subject to various license requirements.

In addition to the license requirements, Decree 591 require businesses who handle hazardous chemicals in China to submit HazChem registrations and provide SDSs and labels prepared in accordance with relevant China GHS standards.

Highly Toxic Chemicals

Highly toxic chemicals are defined as chemicals with high acute toxicity (usually GHS Acute Toxicity Category 1). Those chemicals can be lethal even in very small quantities. If illegally used as poisons, they could pose a big threat to public security. Examples of such chemicals include sodium cyanide.

The Ministry of Public Security (MPS), the principle police authority in China, used to maintain a separate List of Highly Toxic Chemicals. This list has recently been incorporated into the Catalogue of Hazardous Chemicals (2015). Highly toxic chemicals are now marked as “剧毒” in the note column of the Catalogue.

Highly toxic chemicals are subject to additional security and reporting requirements on storage, sales and purchase.

Explosive Precursors

Explosive precursors are certain chemicals which can be used in the illicit manufacture of explosives. Those chemicals need to be controlled to reduce the risks of misuse by terrorists and protect public security.

In China, explosives precursors are mainly regulated by State Council Decree 591 Regulations on Safe Management of Hazardous Chemicals. This regulation establishes a much tighter regulatory regime for explosives precursors than regular hazardous chemicals and sets additional requirements on the storage, purchase and sales of explosives precursors.

Toxic Chemicals Severely Restricted from Import and Export (Chinese PIC List)

The list of toxic chemicals severely restricted from import/export in China is promulgated by China MEP based on the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. It is the official PIC list in China.

There are currently 162 types of chemicals in the list of toxic chemicals severely restricted from import/export. Examples include ethylene oxide, sodium cyanide, PFOS and its salts, mercury and Nonyl Phenol, PCBs and PCTs.

List of Toxic Chemicals Severely Restricted from Import/export (2014 Version)

Companies who intend to export or import toxic chemicals on the “List of toxic chemicals severely restricted to be imported into or exported from China” shall apply for registration certificates or custom clearance notification from the Solid Waste and Chemical Management Center of China MEP (MEP-SCC) prior to export and import.

In addition that, most of restricted toxic chemicals are included in the Catalogue of Hazardous Chemicals, they are subject to production/operation/safe use license requirements and HazChem registration requirements under Decree 591.

Drug Precursor Chemicals

Drug precursors are certain chemicals which can be used in the illicit manufacture of narcotic drugs and psychotropic substances. Examples of such chemicals include acetic anhydride, acetone, hydrochloric acid, and sulfuric acid.

China has ratified the UN Convention on Drug Precursors. Precursor chemicals are subject to strict license requirements on production, sales, purchase and transportation in China. In addition to that, China implements a pre-import and pre-export notification system for dual-use precursor chemicals.

Chemical Weapons Precursors

Chemical weapons precursors are certain toxic chemicals and their precursors which can be used in the illicit manufacture of chemical weapons. Examples of such chemicals include sodium cyanide, phosgene and many organic compounds containing the elements Phosphorus, Sulphur or Flourine. In China, those chemical weapons precursors are called controlled chemicals.

China has ratified the Chemical Weapons Convention (CWC) since 1997 and imposed strict license and declaration obligations on companies who produce, trade, use, import and export controlled chemicals.