Regulations on Safe Management of Hazardous Chemicals in China

Share |

China

Regulations on Safe Management of Hazardous Chemicals in China - Decree 591

Updated in April 2014

The State Council, China's Cabinet, published the revised version of Regulations on Safe Management of Hazardous Chemicals in China on 11 March 2011(Decree 591). The regulation, which has clauses for the production, storage, import, use, sales and transporting of hazardous chemicals, was implemented on 1 Dec 2011 and replaced 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.

What is New?

16 July 2014, CIRS is going to hold a free webinar about hazardous chemicals operating license in China. For more info please click here.

24 April 2014, CIRS to hold a joint workshop with NRCC: Registration of imported hazardous chemicals in China. Click here for more info.

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, product license, operation license, safe use permit, etc.

The current Catalog of Hazardous Chemicals (2002) consists of three parts:

- the List of dangerous goods (GB12268-2005);

- Catalog of highly toxic chemicals(~150 chemicals);

- other chemicals announced by authorities;

New! 27 Sept 2013, a revised draft version of Catalogue of Hazardous Chemicals(2013) was released by China SAWS. More info about the changes can be found here.

Both the Catalogue of Hazardous Chemicals(2012) and the Catalogue of Hazardous Chemicals(2013 Draft) is available for online search at: http://cciss.cirs-group.com/

If you would like to get the English version of the new Catalog of Hazardous Chemicals(2013 draft) and find out all the differences between Catalog(2002) and Catalog(2013 Draft),please complete this order form and send it to service@cirs-reach.com.

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.

hazardous chemicals China

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 2012);
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 in 2012);

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).

More info can be found here.

Registration of Hazardous Chemicals with SAWS

Manufacturers and importers of hazardous chemicals in China shall register hazardous chemicals with the National Registration Center of Chemicals (NRCC) of SAWS prior to manufacturing or importation. The validity of registration certificate is 3 years and has to be renewed 3 months prior to the certificates expiry date.

The detailed registration requirement can be found in SAWS's order 53 - the measures for the administration of registration of hazardous chemicals, which enters into force on 1 Aug 2012.

Please note that companies based outside of China do not need to and cannot register those hazardous chemicals.

More info about SAWS's order 53 can be found here.

Registration of Hazardous Chemicals with MEP

New! 17 Oct 2012, The Chinese Ministry of Environmental Protection has released the trial Measures (MEP’s order No. 22) for Environmental Administration Registration of Hazardous Chemicals. This new measures will enter into force on 1st March 2013.

There are two requirements in the new measures:

Manufacturers of hazardous chemicals and companies who use hazardous chemicals to manufacture products shall submit an environmental administration registration to environmental protection authorities. Only chemicals listed in the Catalog of Hazardous Chemicals will be affected. Those hazardous chemicals will be further classified into two categories: general hazardous chemicals and priority hazardous chemicals for environmental management (PHCs). There are more stringent requirements for the registration of PHCs.
Companies which deal with import and/or export of chemicals on the “List of toxic chemicals severely restricted to be imported into or exported from the People Republic of China” need to register with the Chemical Registration Centre (CRC) of MEP and apply for relevant registration certificates or custom clearance notification.

More info can be found here.

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.

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.

Contact Us

CIRS China
11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
Email: service@cirs-reach.com