Decree 591 - Regulations on the Control over Safety of Hazardous Chemicals

What is Decree 591

On 1 Dec 2011, the revised “Regulations on the Control over Safety of Hazardous Chemicals” (a.k.a Decree 591) came into force. 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. The implementation of Decree 591 demonstrates the authorities’ intention to strengthen the safety controls governing hazardous chemicals in China, to prevent and reduce accidents, and to protect life, property and the environment. Enterprises involved in the hazardous chemicals industry should be fully aware of a spectrum of key obligations under this regulation, including:

• China GHS-related duties (classification, labelling, SDS and hazard statements, etc.)

• Hazardous chemicals registration under SAWS Order 53

• License and permit required of hazardous chemicals production, use, operation (including distribution, storage and transport)

• Entry-exit legal inspection for hazardous chemical import& export.

History and Future Trends

Fig. 1 - Milestones in China’s HazChem legislation

Decree 591 took effect on December 1, 2011, which is the revised edition of the formal State Council Decree 344 (commenced in 2002). The diagram above illustrates the major milestones in the developmental history of China’s HazChem management (see figure 1). Both Decree 591 and Decree 344 could date back to the 1987 “Regulation on the management of hazardous goods”. Compared with the 1987 version consisting of 42 articles, Decree 591 has been expanded to 102 articles, supported with 4 administrative measures regulating the manufacture, use, operation and dozens of technical standards on GHS implementation. Major updates in Decree 591 have been made in the following aspects:

• Adjusting main competent authorities of HazChem management;

• Redefinition of terminology of HazChem in China;

• Adjusting the management patterns of HazChem production and storage;

• Enhancing the HazChem production license management;

•  Introducing the HazChem safe use permit system;

• Adding measures that address HazChem safety operation;

• Improving the HazChem registration system;

• Improving the safety assessment on HazChem production, storage and use;

• Adding provisions that regulate HazChem safe transportation.

On December 7, 2013, the State Council revised the Decree 591 by Decree 645 of 2013. Article 6 was amended to clarify that the railway department is responsible for the safety management of the railway transport of hazardous chemicals and the methods of transport. The adjustments took effect immediately. Only minor adjustments were made but not change the legal framework, therefore, this regulation is still known as Decree 591.

As China's economy rapidly develops, hazardous chemical management has become increasingly challenging. There is a pressing need to establish a dedicated law for managing hazardous chemicals, building upon the existing regulations. In mid-September 2017, the first draft of the Law on Safety of Hazardous Chemicals was consulted within the emergency management administrations. On January 5, 2020, the Ministry of Emergency Management (MEM) circulated the second draft of the Law to emergency management administrations at various levels to solicit their comments and opinions (Read more). On April 22, 2020, the MEM released the third draft of the Law. Some additions and adjustments made in this draft, and the State Council executive meeting discussed and decided to submit the draft law to the NPCSC for deliberation. On December 21, 2024, the draft law was submitted to the NPCSC for its first reading. On December 26, 2024, the draft law was released for public comments (Read more). 

Following China’s legislation procedure, the Draft Law is now at the deliberation stage (generally requiring three readings), further revisions may be proposed incorporating stakeholders’ opinions. Once deliberation reaches a unanimous agreement among all parties, with no significant issues requiring further study, the legislative process will advance to the voting stage. If a majority supports the draft, the Law will be approved for promulgation. Once officially published, the Law may wield tremendous influence over the chemical sector and replace Decree 591 to reform chemical management systems in China.

Authorities

Hazardous chemicals are administrated through a complex regulatory network in China, with multiple departments or ministries involved (see Fig. 2). Notably, China launched a reform plan of the Chinese governmental branches in March 2018 (Read more). Following the reform plan, new ministries have taken over the responsibilities of the previous ministries.

Fig. 2 - Authorities for the implementation of Decree 591

Legal Framework under Decree 591

Decree 591 serves as the foundation for China's Hazchem Management upon which all supporting legislations are built such as administrative rules on Hazchem registration and Hazchem licensing, China's GHS system, the inventory of  hazardous chemical substances, guidance documents for hazard assessment as well as other department ordinances regulating specific elements in the supply chain. To further visualize the key elements of Decree 591 it can help to broadly categorize its functionalities into six key areas which are graphically represented in the accompanying diagram (see Fig. 3).

Fig. 3 - Regulatory diagram of HazChem management under Decree 591

Regulatory Scope

Under Decree 591, hazardous chemicals are defined as highly toxic chemicals or chemicals with toxic, corrosive, explosive, flammable and other properties, which result in harms to human bodies, infrastructures and the environment". All hazardous chemicals are subject to Decree 591 except explosives for civil uses, fireworks and crackers, radioactive articles, nuclear substances, and hazardous chemicals for military research and industry which are regulated by other legislations. Decree 591 should also be referred to in terms of safety management of monitored chemicals and hazardous chemicals used as pharmaceuticals and/or pesticides.

Fig. 4 - Hazardous chemicals of different risk levels

Different hazardous chemicals pose different level of risks. From a regulatory perspective, hazardous chemicals of higher risk levels are distinguished from others by substance lists. (See Fig.4)

• High risk level - Chemicals specifically listed in the Inventory of Hazardous Chemicals and other relevant lists, subject to strict controls

• Medium risk level - Chemicals classified to hazardous categories adopted by the Inventory of Hazardous Chemicals, subject to regular supervision

• Relatively low risk level - Chemicals with GHS classifications, requiring the industry to make best efforts to ensure the hazard communication along the supply chain

Inventory of Hazardous Chemicals

The Inventory of Hazardous Chemicals (2015) is the primary reference for regulation of well-recognized hazardous chemicals in China. It is an essential supporting document of Decree 591 as it helps guide law enforcement authorities as well as clarifying industry obligations.

Originally issued in 2002, the list has gone through many revisions and the latest version is scheduled to enter into force from May 1, 2015. (Read more in ChemLinked expert article: Interpretation of China Inventory of Hazardous Chemicals (2015))

On August 19, 2015, the Guidance for the Implementation of China Inventory of Hazardous Chemicals (Trial) was issued, which further specifies the implementation rules and provides the official classification results of the listed chemicals. 

On November 7, 2022, the MEM issued a notice to update Entry 1674 in the 2015 Inventory, i.e., deleting the condition “[closed cup flash point ≤ 60 ℃]” for diesel oil, which took effect on January 1, 2023. It means that all types of diesel oil shall be subject to obligations under the Decree 591 from 2023 regardless of flash point, e.g., hazchem registration, GHS compliance (classification, labeling and SDS), etc. Although an entry in this inventory was updated, it is still called Inventory of Hazardous Substances (2015) so far (Read more).

Other lists

Based on the Inventory of Hazardous Chemicals, the authorities involved in hazardous chemical management have also formulated different lists under their own jurisdictions or across multiple sectors according to practical requirements. Some examples are shown below (but not limited to):

Production

· List of Hazardous Chemicals under Priority Management (1st Batch)

· List of Hazardous Chemicals under Priority Management (2nd Batch)

Import & Export

· Inventory of Severely Restricted Toxic Chemicals

Transportation:

· GB 12268-2012 List of Dangerous Goods

· List of Air Transport Dangerous Goods

· List of Hazardous Chemicals Prohibited from Inland Waterway Transport

Industry Obligations

I. GHS compliance

One major responsibility under Decree 591 is to comply with China GHS requirements. There is no single piece of legislation called “China GHS”: instead, the UN GHS model is being implemented with reference to Decree 591 through a series of measures and national standards. For example, the Measures for the Administration of the Registration of Hazardous Chemicals (SAWS Order 53), states that companies must provide a safety data sheet (SDS) and label according to SDS standard GB/T 16483-2008, labeling standard GB 15258-2009, etc. in order to obtain a registration certificate from the NRCC. Articles 15 and 79 of Decree 591 state that companies handling hazardous chemicals must comply with China GHS obligations, including those related to classification, labeling and SDSs, according to the specific national standards.

The following sections provide breif introduction to China GHS. For more detailed explanations, please refer to Chempedia - China GHS.

Hazard classification

Details of the China GHS classification criteria can be referred to in GB 30000.1-2024 (replacing GB 13690-2009) and GB 30000.2-2013 ~ GB 30000.29-2013 series standards.

In addition, in the Guidance for the Implementation of China Inventory of Hazardous Chemicals (Trial), official classification results are provided for all the chemicals listed in the Inventory of Hazardous Chemicals (2015). While following these classification results are generally taken as a mandatory requirement, the "lowest classification" and "incomplete classification" principles allow the industry to make their own decisions to a certain extent.

• Lowest Classification: only the lowest applicable hazard classification results are specified for the listed chemicals; Companies can assign higher sub-categories under the same hazard category based on the available and reliable data.

• Incomplete Classification: The guidance does not include the complete hazard categories of the chemicals; companies should supplement other hazard categories by consulting the data of their own, without changing the hazard categories listed in the guidance.

In case there is any disagreement with the official classification and which is not applicale to the principles stated above, companies can submit their opinions and source data to NRCC for expert review.

Labeling and Packaging

Manufacturers and importers of hazardous chemicals are required to provide precautionary labels for their products and attach the label to the product package (including the outer packaging). The content of this precautionary label should be prepared consistent with the national mandatory standard GB 15258-2009, according to which, the label (see Fig. 5 and Fig. 6) should at least include:

1. Product name and components

2. Signal word

3. Pictogram that indicates the hazard(s)

4. Hazard statements

5. Other precautionary statements that may cover prevention, emergency response/rescue, and storage and handling information

6. Producer/supplier information

7. Emergency telephone number* for potential chemical accident

* For detailed requirements of emergency telephone number please see the section of SAWS Order 53.

Fig. 5 - Sample of a China GHS label in Chinese

Fig. 6 - Sample of a regular China GHS label translated in English

If the volume of container or package of a hazardous chemical product is smaller than 0.1 L, a simplified precautionary label (see Fig. 7) can be adopted in which the precautionary statements can be omitted.

Fig. 7 - Sample of a simplified China GHS label

Hazardous chemical companies may also refer to GB/T 22234-2008 Labelling of chemicals based on GHS (recommended national standard) for detailed requirements on Chinese pictograms, symbols, signal words and hazard statements, etc. This Chinese standard is the identical equivalent (IDE) of its Japanese counterpart of JIS Z 7251: 2006, Labelling of chemicals based on GHS.

Packaging and transporting of dangerous goods must comply with three primary mandatory national standards, GB 190, GB 12268 and GB 6944. GB 190-2009 Packing symbol of dangerous goods specifies the pictogram, size, color and usage of the packing symbols for corresponding categories of dangerous goods. The latter two standards were revised and put into effect in 2012 to regulate the classification and packing of dangerous goods for their commercial transport, storage, sale and operation. GB 12268-2012 presents the whole list of dangerous goods under control in China and specifies the criteria and rules for classifying dangerous articles containing impurities or additives. GB 6944-2012 stipulates the classification, precedence of hazards and Code (UN number) of dangerous goods.

SDS preparation and communication

Safety Data Sheet (SDS) helps enterprises to communicate the basic hazard information of the hazardous chemicals. In addition to the basic hazard properties, information on its transportation, handling, storage and emergency response/rescue (including emergency telephone number*) are contained in SDS so that it also has significant value of guidance to all public/private service agencies and other relevant parties of the concerned chemical product.

* For detailed requirements of emergency telephone number please see the section of SAWS Order 53.

As stipulated in Decree 591, the manufacturer or producer is obliged not only to provide a corresponding SDS for the chemical product, but also to promptly report any new hazard information to authorities and correspondingly amend the SDS without delay.

Companies should refer to  GB/T 16483-2008 and GB/T 17519-2013 for preparation of the safety data sheet. SDS suppliers should note that the recorded chemical data in SDS must be kept accurate, consistent and coherent.

II. Hazardous Chemicals Registration

SAWS Order 53

Measures for the Administration of Hazardous Chemicals Registration

Under Decree 591, hazardous chemicals and the enterprises involved are identified through the hazardous chemicals registration system. Manufacturers and importers of hazardous chemicals are obliged to submit registrations to the NRCC prior to the first time manufacture and import, according to the provisions set out in the 2012 revised Measures for the Administration of Registration of Hazardous Chemicals (SAWS Order 53), which has entered into force on 1 August 2012. Unlike its predecessor, SAWS Order No.53 extends the registration obligation to the hazardous chemicals importers for the first time, while enterprises storing or using the substance remain exempt.

Potential registrants must provide more detailed information, including classification, label, physical and chemical properties, main uses, hazardous properties and the safety requirements of storage, use and transport, plus emergency response measures. 

Emergency telephone number

Registering enterprises shall provide emergency telephone consulting service or entrust an accredited third-party service provider. The emergency telephone number should be included on label, SDS and registration documents. In accordance with Article 22, SAWS Order 53, the following requirements on the emergency telephone number have to be met, including

· 24/7 available

· Landline telephone within the territory of China

· Professional work staff responding

III. HazChem Licensing System under Decree 591

Fig. 9 - Licensing Systems under Decree 591

Decree 591 controls the various activities of hazardous chemicals through the supply chain by implementing a license system. Different actors in the supply chain must apply to different departments or ministries for different licenses (see Fig. 9).

With the release of Decree 591, separate measures on the administration of specific licenses crucial to different types of HazChem companies have been promulgated or enacted. Companies dealing with hazardous chemicals should be mindful of the specific licensing systems under Decree 591.

Besides the revised measures for the implementation of work safety licenses for hazardous chemical production enterprises (SAWS Order 41), which was published in July 2011, separate measures for the administration of operation licenses (SAWS Order 55) and safe use licenses (SAWS Order 57) for hazardous chemicals were released in 2012. Note that only domestic companies can apply for the licenses.

IV. Entry-Exit Inspection on Hazardous Chemicals

The General Administration of Customs of China (GACC) is the component authority for inspection and quarantine for imported and exported hazardous chemicals, and their packaging. Companies are required to produce a range of documents for the import/export inspections. Chinese companies exporting dangerous goods overseas must have a hazard identification and classification report produced by a Chinese accredited laboratory. Meanwhile, the check on the composition/constituent information, physical and chemical properties, hazard class etc. to confirm that they meet the requirements (see the yellow box in Fig. 4). A strong emphasis is placed on China GHS-aligned SDS and Precautionary Labels. In recent years, refroms of the inspection on the import and export of hazardous substances have been carried out (see Fig. 10).

Fig. 10 - China's Entry-Exit Inspection and Quarantine

GACC implemented the Announcement on Questions Regarding the Inspection on Imported and Exported Hazardous Chemicals and Their Packaging (a.k.a. GACC Announcement No. 129 of 2020) from January 10 of 2021. It is considered the guiding document for customs agencies to fulfill their duties concerning the inspection on imported and exported hazardous chemicals and their packaging. However, in practice, some problems weren't solved. For example, all the imported hazardous chemicals gathering at the port of discharge may be risky, and different inspection requirements at different customs ports may lead to low efficiency of customs clearance.

For import inspection, in late 2022, to standardize the operational requirements and prevent false declaration or concealment, GACC decided to reform inspections and pilot in Shanghai. Shanghai piloted the new inspection mode from 1 December 2022 to 31 March 2023. Other cities in China such as Nanchang, Changsha, and Guangzhou also carried out the pilot project in early 2023. Given the pilot experience and promising achievements, the GACC decided to implement the new inspection mode - "Document Review + Port Inspection or Destination Inspection" for each batch of imported hazardous chemicals nationwide from April 13, 2023 (Read more). 

For export inspection, reform plan has been piloted in certain cities like Ningbo, Shanghai, etc. form October 2023 and significant success have been achieved. Therefore, the GACC decided to roll out the export inspection reform pilot nationwide from July 8, 2024. The export inspection reform pilot targets changes to the declaration and customs clearance for companies exporting hazardous chemicals (Read more).