There are over 40,000 chemical substances being produced and used in China, approximately 3000 are earmarked for stringent regulatory control measures due to their high risks to safety, human health and the environment. China’s first legislation comprehensively controlling the production, storage, operation and use of hazardous chemicals was enacted in 1987, and the first new chemical substance notification regime was established in 2003. The current regulatory framework in China has developed in phases without a clear development roadmap and is widely considered as overly complicated and inconsistent. China is now emphasizing development of sound chemical management based on risk assessment in the wake of a number of recent disastrous chemical safety accidents and environmental issues. Over the last several years China has attempted to plug legislative loopholes, bring about regulatory reforms and build law enforcement capacities.
Major effective chemical regulations are listed as follows:
- Regulations on the Control over Safety of Hazardous Chemicals
Regulations on the Control over Safety of Hazardous Chemicals was promulgated on Mar 2, 2011 via State Council Decree 591 and entered into force on Dec.1, 2011.
As the key piece of legislation on management of hazardous chemicals, it regulates hazardous chemicals through the entire supply chain, ranging from manufacture and importation to distribution and storage, transportation and use. Chemicals classified to the following categories are subject to prioritized controls under the regulation:
- Hazardous chemicals (including hazardous chemicals listed in “Inventory of Hazardous Chemicals” and those not listed but classified to certain hazard categories according to GHS);
- Highly toxic chemicals; and
- Explosive precursors.
There is a spectrum of obligations under this regulation, mainly including:
- Identification of hazardous chemicals and GHS-related duties (classification, labelling & SDS)
- Hazardous chemicals registration
- License/permit required of hazardous chemicals production, use, operation (including distribution, storage and transport)
- Entry-exit legal inspection for hazardous chemical import& export
Since the regulatory framework under Decree 591 is very convoluted, the major subordinate regulations (department rules, etc.) are listed as follows: (but not limited to)
Date of Issuance
Date of Entry into Force
Interim Provisions for the Supervision and Administration of Major Hazard Installations of Hazardous Chemicals
State Administration of Work Safety (SAWS)
SAWS Order 40
Measures for the Administration of Hazardous Chemicals Safe Production Permit
SAWS Order 41
Measures for the Administration of Hazardous Chemicals Registration
SAWS Order 53
Measures for the Administration of Hazardous Chemicals Operation Permit
SAWS Order 55
Measures for the Administration of Hazardous Chemicals Safe Use Permit
SAWS Order 57
Measures on the Management of Physical Hazard Identification and Classification for Chemicals
SAWS Order 60
Measures on the License Management of the Purchase and Road Transportation of Highly Toxic Chemicals
Ministry of Public Security (MPS)
MPS Order 77
Specifications on the Inspection and Supervision over Entry-Exit Hazardous Chemicals and their Packages
General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)
AQSIQ Announcement 30 of 2012
Ministry of Environmental Protection (MEP)
*Repealed by MEP Order 40 on July 13, 2016
- Measures for the Environment of New Chemical Substances
Measures for the Environmental Management of New Chemical Substances was published as MEP Order 7 on Jan 19, 2010 and came into force on Oct 15, 2010.
The regulation requires new substances manufactured or imported in China to be notified to China Solid Waste and Chemicals Management Center under Ministry of Environmental Protection (SCC-MEP) prior to entering the Chinese market. New chemical substances are substances not listed in the Inventory of Existing Chemical Substances in China (IECSC), of which the latest version was published in 2013. Finished products (e.g. cosmetics, pharmaceuticals, etc.), naturally occurring substances, impurities (<10% w/w), alloys, non-isolated intermediates and materials (e.g. glass materials, ceramics, etc.) are excluded.
There are three types of notification under NCSN, depending on the purpose of manufacturing/export/import and the quantities, namely 1) Scientific Research Record Notification, 2) Simplified Notification (further classified to General Case and Special Case), and 3) Regular Notification. For different types the data requirements and the cost generated from testing are different.
- Notice on the Issuance of List of Toxic Chemicals Severely Restricted for Import and Export in China (2014)
To implement Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade and in accordance with the adjustment of the Import and Export Tariff of People’s Republic of China, MEP and General Administration of Customs jointly issued “List of Toxic Chemicals Severely Restricted for Import and Export in China”. The list was first published in 2005 and updated annually or biennially. This latest version has been effective since Jan 1, 2014.
Importers of the listed chemicals shall obtain “Environmental Registration Certificate for Importing Toxic Chemicals” and “Notification for Customs Clearance for Importing Toxic Chemicals” from MEP. Exporters of the listed chemicals shall obtain “Notification for Customs Clearance for Exporting Toxic Chemicals”.
- Regulations on the Administration of Precursor Chemicals
Regulations on the Administration of Precursor Chemicals was published on Aug 26, 2005 as State Council Decree 445 and entered into force on Nov 1, 2005. It was slightly amended by State Council Decree 653.
The regulation classifies precursor chemicals into 3 categories namely Cat. I – major materials that are essential for producing drugs, and Cat. II & III - chemical agent that can be used for producing drugs.
Business activities related to drug precursor chemicals are subject to different administration and licensing systems. Entities engaging in the production, distribution, purchase, transportation or importation/exportation of the chemicals in the Category I shall apply the licenses from different authorities. For the precursor chemicals in the Category II, transporters, importers/exporters shall apply the licenses and manufacturers, distributors and purchasers of the precursors shall file a record with authorities. Importers and exporters of the Category III listed chemicals shall apply for permits of importing or exporting of the precursor chemicals, while the manufacturers, distributors, transporters and purchasers shall file a record with competent authorities.
- Regulations on the Administration of Ozone Depleting Substances
Regulations on the Administration of Ozone Depleting Substances was published on Apr 8, 2010 as State Council Decree 573 and entered into force on Jun 1, 2010. It was enacted to fulfill China’s commitment under The Vienna Convention for the Protection of the Ozone Layer and Montreal Protocol on Substances that Deplete the Ozone Layer.
China will gradually phase out ODSs used as refrigerants, foaming agents, extinguishing agents, solvents, detergents, processing agents, pesticides, aerosols and expansion agents. For this purpose, the List of Ozone Depleting Substances under National Control was published on Sep 27, 2010.
Manufacturers, users, importers and exporters of the listed ODSs shall be licensed (in accordance with Decree 591, as all the ODSs are hazardous chemicals) and are subject to quota control. Other traders of ODCs are subject to record-filing at MEP.
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