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) as well as the

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

On January 5, 2020, the Ministry of Emergency Management (MEM) circulated the second draft of the Law on Safety of Hazardous Chemicals to emergency management administrations at various levels to solicit their comments and opinions (see ChemLinked news). Later on April 22, the MEM released the third draft of the Law. Some additions and adjustments made in this draft, once adopted in the future, may wield a tremendous amount of influence over the chemical sector. The Law, once published officially, will replace Decree 591 and set the tone for the reform of chemical management systems in China.

History

图1.png Fig. 1 - Milestones in China’s HazChem legislation

Decree 591 is the revised edition of the formal State Council Decree 344, which came into effect in 2002. The diagram on the left 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.

Authorities

Hazardous chemicals are administrated through a complex regulatory network in China, with multiple departments or ministries involved (see Fig. 2).

Department	Supply Chain	Management Scope
MIIT (Ministry of Industry and Information Technology)	N/A	Leading authority for GHS implementation
SAWS (State Administration of Work Safety	Manufacture, use, storage, operation	Enforcing authority for HazChem safe production, use, operation and HazChem facility construction; competent agency for HazChem registration
MEP (Ministry of Environmental Protection)	Manufacture, use, import & export	Enforcing authority for HazChem environmental registration (manufacture &use, and import & export)
MOT (Ministry of Transport)	Transport, packaging	Enforcing authority for HazChem inland & inner waterway transport and packaging
GAC (General Administration of Customs)	Import & export, declaration	Enforcing authority for HazChem entry-exit inspection and customs declaration
AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine)	Sale, entry-exit inspection	Enforcing authority for HazChem sale and distribution
SAIC (State Administration of Industry and Commerce)	Business registration, advertising	Enforcing authority for HazChem enterprises’ business registration
MOA (Ministry of Agriculture), (former) MOH (Ministry of Health)	N/A	Cooperating authority for HazChem listing consultation

Fig. 2 - Authorities for the implementation of Decree 591

Legal Framework under Decree 591

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Fig. 3 - Regulatory diagram of HazChem management 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 various inventories of 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).

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.

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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 (a.k.a. Catalog of Hazardous Chemicals or Chinese C&L Inventory) 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 1st, 2015. (Read more in CL expert article: Interpretation of China Inventory of Hazardous Chemicals (2015))

On Aug 19th, 2015, SAWS issued the Guidance for the Implementation of China Inventory of Hazardous Chemicals (Trial), which further specifies the implementation rules under SAWS's jurisdiction and provides the official classification results of the listed chemicals. (See CL news)

Other substance lists

Based on the Inventory of Hazardous Chemicals, the authorities involved in hazardous chemical management have also formulated different substance 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 (by SAWS)

· Catalog of Hazardous Chemicals of Priority Environment Concern (by MEP)

Import & Export

· List of Severely Restricted Toxic Chemicals in China

· Catalogue of Entry-Exit Commodities Inspected and Quarantined by the Competent Entry-Exit Inspection and Quarantine Authority (Adjusted on a yearly basis, see 2014 adjustment and 2012 adjustment related to hazardous chemicals)

Transportation:

· GB 12268-2012 List of Dangerous Goods

· List of Air Transport Dangerous Goods (2019)

· List of Hazardous Chemicals Prohibited from Inland Waterway Transport (2019 Version)

For more detailed introduction of China’s chemical lists, please refer to CL expert article: Overview of Hazardous Chemicals Management in China

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 explainations, please refer to Chempedia - China GHS.

Hazard classification

Details of the China GHS classification criteria can be referred to in 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) published by SAWS, 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.

图4.png Fig. 5 - Sample of a China GHS label in Chinese

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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.

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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

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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. The eight official registration-related documents were released in the SAWS Notice 144 issued in Dec 2012.

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

图8.png

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 recently 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

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

On 29 Dec 2011, China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and General Administration of Customs (GAC) jointly issued the “Adjustment of 2012 Catalogue of Entry-Exit Commodities Inspected and Quarantined by the Competent Entry-Exit Inspection and Quarantine Authorities” (hereinafter referred to as the “ Legal Inspection Catalog”), also known as AQSIQ Notice 1466-2011. This AQSIQ Notice adds 160 hazardous chemicals listed in the Catalog of Hazardous Chemicals (2002 version) to the Legal Inspection Catalog. However, the AQSIQ Announcement 30 published on 29 Feb 2012 further expanded the inspection scope to cover all the hazardous chemicals listed in the Catalogue of Hazardous Chemicals.

Since 29 February 2012 companies are required to produce a range of documents to apply to the CIQ for such inspections (see Fig. 10). Chinese companies exporting hazardous goods overseas must have a hazard identification and classification report produced by a Chinese accredited laboratory [4]. Meanwhile, the CIQ will check the composition/constituent information, physical and chemical properties, hazard class etc. to confirm that they meet the requirements (see the yellow box in Figure 4). A strong emphasis is placed on China GHS-aligned SDS and Precautionary Labels.

Please note that the obligations discussed above does not make the complete list, detailed consultation with the regulatory specialists from the REACH24h is strongly recommended.