Regulations on Safe Management of Hazardous Chemicals in China(2011)
Updated in Dec 2011
The State Council, China's Cabinet, published the revised version of Regulations on Safe Management of Hazardous Chemicals in China on 11 March 2011. The regulation, which has clauses for the production, storage, import, use, sales and transporting of hazardous chemicals, will come into force on 1 Dec this year and replace the old version issued in 2002.
This regulation is no doubt the most complex chemical legislation in China. There are 102 articles, dozens of supporting measures and numerous national standards for this law. More than 8 government bodies are involved in the implementation of this law. It is the main law regulating existing chemicals in China. It is also the main law for implementing GHS in China.
Scope of The Regulation - Catalog of Hazardous Chemicals
The legislation mainly regulates hazardous chemicals, which are defined as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, flammable and do harm to human body, facilities and environment.
Please note that all chemicals meeting GHS classification criteria will be regulated as hazardous chemicals by decree 591. Hazardous chemicals listed in the Catalog of Hazardous Chemicals will be subject to extra requirements, for example, operating license, registration, etc.
The current Catalog of Hazardous Chemicals (2002) consists of three parts:
There are more than 3,700 chemicals in current Catalog, which is also available online: http://www.chinasafety.gov.cn/whpcx.htm
New! 23 Nov 2011, English Edition of the Catalog of Hazardous Chemicals in China(2002) is Now Available Free of Charge! Click here.
A new catalog of hazardous chemicals that might include more than 5,000 chemicals is expected to be released by the State Administration of Work Safety(SAWS) at the beginning of 2012.
The hazardous chemicals in the Catalog might be further classified into the following categories and each category requires different management measures.
- Catalog of Highly Toxic Chemicals;
- Catalog of Precursors for Explosives;
- Prohibited Chemicals (2005);
- List of Toxic Chemicals Restricted to Be Imported/Exported;
- List of Priority Hazardous Chemicals for Environment Management;
- List of 60 Hazardous Chemicals for Priority Management;
- Catalog of Industrial Products;
- Catalog of Hazardous Waste;
- List of highly toxic chemicals and other hazardous chemicals for which transportation is prohibited on inland waterways;
If you are involved in the production, import, storage, use, sales, marketing and transportation of hazardous chemicals, you shall firstly identify which category your products belong to and then identify your roles and obligations.
Exemptions: explosives for civil use, fire crackers, radio-active substance, other chemicals for national defense.
List of Laws for Hazardous Chemicals
- Decree 591 – The Regulations on Safe Management of Hazardous Chemicals(comes into force on 1 Dec 2011) - Main Law;
- The Measures for the Administration of Production Licenses for Hazardous Chemicals;
- The Measures for the Administration of Operating Licenses for Hazardous Chemicals(revised in 2011);
- The Measures for the Administration of Safe Use Permit for Hazardous Chemicals(new in 2011);
- The Measures for the Administration of Registration of Hazardous Chemicals(revised in 2011);
- The Measures for the Administration of Standardization of Management of Hazardous Chemicals(released in Aug 2011);
- The Catalog of Hazardous Chemicals(to be released in 2012);
- The Measures for the Administration of Safety Clearance on Construction Projects for Hazardous Chemicals;
- The Measures for the Administration of Safety Supervision of Major Sources of Hazard;
- The Measures for the Administration of Safety Management of Transmission Pipeline for Hazardous Chemicals.;
- The Measures for the Administration of Physical Hazard Identification and Classification for Hazardous Chemicals;
- The Measures for the Registration of Environmental Administration of Hazardous chemicals for public consultations (issued by MEP);
How to Comply
Companies who produce, store, use, sell or transport hazardous chemicals in China are subject to different obligations, for example, safety evaluation report, production license, safe use permit, operating license, registration of hazardous chemicals, SDS and chemical labels.
License System
Any legal entities operating and marketing hazardous chemicals in China shall obtain a license from the State Administration of Work Safety (SAWS) and other authorities. There are three types of licenses in China.
- Production license for manufacturers;
- Operating license for companies importing/distributing/selling hazardous chemicals in China;
- Safe use license for companies who use certain hazardous chemicals to manufacture products;
Please note: Only domestic companies can apply for a license. If your are a foreign company exporting hazardous chemicals to China, you do not need a license.
Safe Use License
Companies who use hazardous chemicals to manufacture products (excluding manufacturers of hazardous chemicals) shall obtain a safe use license from the administrative department of work safety at city level when:
- The industry sector of the company is listed in the Catalog of Applicable Industry Sector for the Safe Use Permit of Hazardous Chemicals (for example, production of fertilizer); and
- The used quantity has reached the threshold volume stipulated by the standard usage quantity of hazardous chemicals (for example, for chlorine, the threshold value is 180t/y). So far, the threshold value has been set for 62 hazardous chemicals (60 hazardous chemicals for priority management + 2 chemicals).
Registration of Hazardous Chemicals in China
Chemical substances listed in the Catalog of Hazardous Chemicals shall be registered with both the National Registration Center of Chemicals (NRCC) of SAWS and local environmental protection authorities(MEP). For hazardous chemicals not listed in the Catalog, registration is required if hazard identification test has been carried out and the classification has been confirmed by authorities.
Please note that companies based outside of China do not need to and cannot register those hazardous chemicals.
Registration of Hazardous Chemicals with NRCC
Manufacturers and importers shall register chemicals listed in the Catalog of Hazardous Chemicals with the National Registration Center of Chemicals (NRCC) of SAWS prior to manufacture or importation for the first time. The validity of registration certificate is 3 years and has to be renewed 3 months prior to the certificates expiry date.
Unlike new chemical registration which requires expensive toxicology data, eco-toxicology data and risk assessment, this registration only requires the following information:
- legal entity information
- classification and labeling
- physiochemical properties
- main uses
- hazard classes
- conditions for safe storage, use and transport
- emergency responses
Please note that importers are not required to register those under the old law. Foreign companies based outside of China do not need to and cannot register.
Registration of Hazardous Chemicals with MEP
New! Manufacturers and companies who use hazardous chemicals to manufacture products in China shall submit an environmental administration registration to local environmental protection authorities and obtain a registration certificate, which is then valid for three years.
The following documents are required for the registration with MEP:
- Environment administration registration form including legal entity information, name, category, volume, uses, operational method, aquatic toxicity data and risk management measures;
- Operating licenses and business license;
- Environment emergency responses
For priority hazardous chemicals for environmental management, there are extra requirements:
- Companies must prepare an environmental risk assessment report;
- Companies must pass on-site inspection before a registration certificate is granted;
- Companies must report the information regarding release and migration of the hazardous chemicals to environmental protection authorities before 31st Jan of each calendar year.
Please note that this is a new requirement for manufacturers and users in China. The list of priority hazardous chemicals for environmental management will be promulgated and updated by MEP. Hazardous chemicals meeting either one of the following criteria could be added to the list.
- chemicals that are not easily degradable, bio-accumulative and can cause serious harm to human health and living beings after long-term exposure;
- chemicals that are extremely un-degradable and extremely bio-accumulative;
- chemicals that can cause acute toxicity or chronic toxicity to aquatic environment;
- chemicals that can serious hazards to human health or the environment;
- chemicals subject to any international environment conventions;
- chemicals liable to accidents and causing severe hazards to the ecological environment;
- other chemicals for which risks need to be reduced;
Please note: New chemicals substances shall be registered with the Chemical Registration Centre(CRC) of MEP.
The Relationship Between the Regulation and China GHS
This regulation has given legal forces to China GHS national standards for the first time. Companies who fail to classify, label and package hazardous chemicals in accordance with those standards would face a maximum penalty of 50,000 yuan or a ban on production or import.
Even though this regulation will not come into force until 1 Dec 2011, companies shall adopt China's GHS national standards before 1 May 2011, which is the official deadline.
Supervision of Import and Export of Hazardous Chemicals
General Administration of Quality Supervision, Inspection and Quarantine(AQSIQ) or CIQ is responsible for performing inspection of imported & exported hazardous chemicals and their packages.
Chinese companies who export hazardous chemicals abroad by sea or air need to obtain hazard identification and classification report from designated testing lab in China(for example, Shanghai Chemical Industry Testing Centre for Shanghai Port) to determine if those chemicals belong to dangerous goods. If those chemicals belong to dangerous goods, manufacturers of the dangerous goods and packages need to apply for an inspection from local Inspection and Quarantine authorities and get certified by CIQ. Otherwise, the goods cannot be exported.
If foreign companies export hazardous chemicals in China, Chinese importer shall apply for inspection from local Inspection and Quarantine authority at the port of entry.
The following documents shall be provided (at least) when applying for an inspection:
- Declaration of conformity;
- Licenses: Registration certificate for hazardous chemicals, operating license, safe-use license and business license;
- SDS in Chinese; sample of hazard communication label;
- Report on hazard identification and classification;
The following items will be inspected by CIQ:
- Identify whether the composition/constituent information of goods, physical and chemical properties, hazard class, packaging category meet the requirements of relevant standards, and whether they are consistent with the hazard identification and classification report, SDS and chemical safety label provided when applying for an inspection;
- Identify whether a Chinese SDS has been provided along with the goods, whether a Chinese label has been affixed on the packaging of goods; whether the contents in SDS and label meet the requirements of relevant standards and are consistent with the goods.
- Identify whether the models, category, specification, unit quantity and mark of packaging meet the standard requirements and whether the packaging has been adapted to the properties and uses of the inspected goods.
- Identify whether the packing method meets standard requirement and whether the use of package is appropriate, whether the packaging is sealed tightly and whether the goods inside the package have leaked.
If hazardous chemicals and packaging materials pass inspection, CIQ will issue a certificate of inspection and quarantine of imported commodities and the chemical products can now be sold and used in China.
Please note that sending a small quantity of sample by delivery service provider does not require CIQ inspection.
Our Services
- Free regulatory advice;
- New! Free chemical inventory search service;
- IECSC 2010;
- Catalog of Hazardous Chemicals;
- Catalog of Highly Toxic Chemicals;
- Prohibited Chemicals (2005);
- List of Toxic Chemicals Restricted to Be Imported/Exported;
- List of 60 Hazardous Chemicals for Priority Management
- Catalog of Industrial Products;
- Chinese SDS and chemical safety label;
- CIQ inspection assistance;
- Safety evaluation report;
- Application of operating license/safe use permit;
- Registration of hazardous chemicals;
About Us
Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.
Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, food additives, pesticides and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China.We also deliver the most up-to-date regulatory information about chemical control laws in China.
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