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

The State Council of China published the revised version of Regulations on Safe Management of Hazardous Chemicals in China (Decree 591) on 11 March 2011. The regulation, which has clauses for the production, storage, import, use, sales and transporting of hazardous chemicals, was implemented on 1 December 2011 and replaced the old version issued in 2002

There are 102 articles, dozens of supporting measures and numerous national standards for this law. More than 8 China 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.

For more Hazardous Chemical Regulations, please find them here.

Scope

Decree 591 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 Hazardous Chemical Inventory Criteria will be regulated as hazardous chemicals by Decree 591. Hazardous chemicals clearly listed in the Inventory(2828 Entries) will be subject to extra requirements, for example, production license, operating license, safe use permit, safety evaluation report per three years, etc.

The current Hazardous Chemical Inventory consists of two parties:

• Criteria of Classification of Hazardous Chemical;
• 2828 Entries

For EN Version of Hazardous Chemical Inventory, please click here.

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. Please also noted that only Hazardous Chemicals are mandatory to provide GHS SDS and Label. Chemicals with some low risk classifications are not required to provide SDS and Label, for example, Flammable liquids category 4, Flammable solids category 3, etc.

Exemptions: explosives for civil use, fire crackers, radio-active substance, other chemicals for national defense.

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.

1. Production license for manufacturers;
2. Operating license for companies importing/distributing/selling/storaging hazardous chemicals in China;

3. 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.

Hazardous Chemical Registration

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 Order No.53 - the measures for the administration of registration of hazardous chemicals, which enters into force on 1 August 2012.

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

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:

1. Declaration of conformity;
2. Licenses: Registration certificate for hazardous chemicals, operating license, safe-use license and business license;
3. SDS in Chinese; sample of hazard communication label;
4. Report on hazard identification and classification.

The following items will be inspected by CIQ:

1. 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;
2. 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.
3. 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.
4. 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.

Any questions and comments, please contact us at Service@cirs-group.com

Updated by David Wan on 28 August 2015