International Chemical Regulation REACH Workshop,2011

Regulations on the Control over Safety of Hazardous Chemicals (Decree No. 591)

The first law that regulated the safety management of dangerous chemicals in China came into being in 1987 when the so-called Regulations of Chemical Dangerous Goods Safety Management took effect on 2 February. After 15 years' constant legal improvement, the State Economic and Trade Commission published on 2nd March 2002 a new regulation Decree No. 344 based on the 1987 law. However, due to the reform of governmental institutions and rapid development of hazardous chemical industry over the first 2010s decade, Decree No. 344 began falling short of the practical situation of Chin's hazardous chemical industry.

In this background, China shifts the main responsibility of managing hazardous chemicals (and dangerous goods) to the State Administration of Work Safety instead of the old triangular ministerial relationship. On 16 February 2011, the Regulations on the Control over Safety of Hazardous Chemicals was officially approved and signed by Premier Wen of the Chinese State Council as the Decree No. 591. The Decree 591 has right taken effect on 1 December 2011, in the hope that problems exposed under previous Decree 344 would be better addressed to and clear-cut solved, such as safe use and transport duties of hazardous chemicals, emergency response to prevent chemical accidents, enhancing the effectiveness of implementation, etc.

 

Main Changes of Decree 591

Compared with Decree 344, Decree 591 has expanded from 74 to 102 articles in content.

Chapters	General rules	Safety of manufacture and storage	Usage safety	Safety of operation	Safety of transport	Registration of hazardous chemicals and emergency rescue	Legal responsibility	Supplemental provisions	Total
Decree 591	10	17	5	10	23	9	22	6	102
Decree 344	6	20		8	12	8	16	4	74

Under the 2011 new law, requirements between safe use and safety storage are differentiated from the safety of manufacturing, which suggests the country is paying more attention on the downstream usage concerns of hazardous chemical products.

The new decree also strengthens the regulation on safety transport of hazardous chemicals. Article 54 of Decree 591 "prohibits the transportation of hyper-toxic chemicals and other hazardous chemicals specified by law through closed inland rivers." Yet, for transport through non-closed inland rivers, the state will identify a special list that defines the range of hazardous chemicals prohibited for inland river transport so it means substances outside this list might be give green light for non-closed inland river transport.

Purchase and transportation of hyper-toxics are streamlined in administrative formalities. In the previous Decree 344, companies have to acquire two kinds of documentation, i.e. the proof of purchase and purchase permit, at the local county public security authority of the destination before purchasing or transporting the product. Decree 591 devises 3 types of permission system for of hazardous chemicals. Companies are allowed to purchase hyper-toxics by virtue of either of the 3 permits, the safe manufacturer permit, the safe use permit or the safe operation (management) permit, and the transport consignee may choose either the origin place or the destination of the purchased chemicals to apply for a road pass issued by the corresponding county bureau of public security.

After all, Decree 591 emphasizes the legal responsibilities of enterprises engaged in hazardous chemicals. The legal representative and main responsible directors should take full responsibility for the safety control of one's own company. Companies engaged in hazardous chemicals should be equipped with the safety conditions satisfying legal, regulatory, national and industrial standards. A system of position safety responsibility must be established and perfected within the company and all staff members on the positions of direct operation must be qualified with sound education and technical training on hazardous chemicals.

The System of hazardous chemicals dissemination —— Seven HC-related lists

1)    Catalogue of Hazardous Chemicals (2002 and new versions)

The Catalogue of Hazardous Chemicals was first published in 2002 by the State Administration of Work Safety (SAWS), which contains over 3800 substances classified in 7 hazard categories (19 divisions/items).

Category 1 - Explosives 第1类 爆炸品

1.1 Substances and articles that have a hazard of mass detonation 1.1 项  具有整体爆炸危险的物质和物品

1.2  Substances and articles that have a hazard of fire and of either a minor blast or minor projection or both, but of no mass explosion hazard 1.2项  具有燃烧危险和较小爆炸或较小抛射危险，或两者兼有、但无整体爆炸危险的物质和物品

1.3 Substances and articles that present no significant hazard 1.3项  无重大危险的爆炸物质和物品

Category 2 - Compressed gases and liquefied gases 第2类 压缩气体和液化气体

2.1  Flammable gases 2.1项 易燃气体

2.2  Non-flammable gases 2.2项  不燃气体

2.3  Toxic gases 2.3项  有毒气体

Category 3 - Flammable liquids 第3类 易燃液体

3.1  Liquids of low flash point 3.1项  低闪点液体

3.2  Liquids of medium flash point 3.2项  中闪点液体

3.3  Liquids of high flash point 3.3项  高闪点液体

Category 4 -  Flammable solids, spontaneous combustible substances and substances which in contact with water emit flammable gases 第4类 易燃固体、自燃物品和遇湿易燃物品

4.1  Flammable solids 4.1项  易燃固体

4.2  Articles liable to spontaneous combustion 4.2项  自燃物品

4.3  Articles which in contact with water emit flammable gases 4.3项  遇湿易燃物品

Category 5 - Oxidizing substances and organic peroxides 第5类 氧化剂和有机过氧化物

5.1  Oxidizing substances 5.1项  氧化剂

5.2  Organic peroxides 5.2项  有机过氧化物

Class 6 - Toxic and infectious substances 第6类 毒害品和感染性物品

6.1 Toxic substances 6.1项  毒害品

Category 8 - Corrosive substances 第8类 腐蚀品

8.1  Corrosives presenting acidic properties 8.1项  酸性腐蚀品

8.2  Corrosives presenting alkalinous properties 8.2项  碱性腐蚀品

8.3  Other corrosives 8.3项  其他腐蚀品

The 2002 catalogue listed a substance with its corresponding code of dangerous goods, the CAS number, UN number plus Chinese chemical name and synonyms (most but not all substances were provided with English names). View bilingual versions of the Catalogue of Hazardous Chemicals.

With the establishment of Decree 591, China has made the decision to expand and revise the 2002 Catalogue. Stated in Article 3 of the decree, new Catalogue should be compiled and adjusted, based on standards for hazard classification and identification of the inherent properties of substances. Authorities responsible for the new catalogue preparation are a group of SAWS-led multi-departments, including MIIT (Ministry of Industry and Information Technology), MPS (Ministry of Public Security), MEP (Ministry of Environmental Protection, MOH (Ministry of Health), AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), MOT (Ministry of Transport), MOR (Ministry of Railway), CAAC (Civil Aviation Administration of China) and MOA (Ministry of Agriculture).

The new catalogue is said to consist of three parts: 1) hazardous chemicals listed in national standard GB 12268-2005 (List of Dangerous Goods) (download) ; 2) chemicals listed in the List of Hyper-toxic Chemicals (about 150 chemicals); 3) other hazardous chemicals not listed in GB 12268 but identified and announced by relevant national departments (NETC, MEPS, MEP, MOH, AQSIQ, MOT, etc.)

According to the REACH24H chaired 3rd International Chemical Regulation REACH Workshop, the new catalogue has currently completed the main body and is expected to be made public early next year. The 2012 catalogue has included several new information tabs such as the hazard category, risk phrase (H-Phrase) or precautionary Statement, the pictogram and signal word, which will substantially enhance the corporate understanding and practice of a China-GHS-based labeling and MSDS preparation.

the Revised Catalogue of Hazardous Chemicals

2)    List of First 60 Hazardous Chemicals for Priority Management - published

Considering the nation's chemical accidents over the past 40 years and the variety of chemical hazards subject to priority control at home and abroad, the SAWS carried out the hazard screening on the 3800+ substances listed in 2002 Catalogue and issued in June 2011 a first list of 60 hazardous chemicals to which priority environmental management should be applied.

The first batch contains hazardous chemicals that are listed on 2002 Catalogue and meet the following conditions at the temperature of 20℃ and normal atmosphere pressure of 101.3 kPa:

a. Flammable gases, Category 1　(lower explosive limit ≤ 13% or explosion limit range ≥ 12%);

b. Flammable liquids, Category 1 (Flash point < 23℃ and initial boiling point ≤ 35℃);

c. Liquids liable to spontaneous combustion, Category 1 (liable to combustion when in contact with gas for no more than 5 minutes);

d. Solids liable to spontaneous combustion, Category 1 (liable to combustion when in contact with gas for no more than 5 minutes);

e. Substances when in contact with water emit flammable gases, Category 1 (When reacting violently with water at ambient temperature, the produced gas is usually susceptible to spontaneous combustion, Release of flammable gas is equal to or greater than the rate per kilogram of substance release within 1 minute in any 10 liters of any substance or mixture);

f. Phosgene derivates like triphosgene, etc.

Download the List of First 60 Hazardous Chemicals for Priority Management in Chinese.

Recently, SAWS is urging domestic Chinese companies to report at the city authority of work safety before 20 December if they engage in the production or manufacture of substances on the first batch list.

3)    List of Hazardous Chemicals susceptible to explosion – to be approved

Article 23 of Decree 591 specifies that entities if engaged in production or storage of any chemicals in this list shall record faithfully the information on product identity, production volume and the substance flow chart. Necessary safety measures are required should the chemicals be lost or stolen.

In October 2011, the Ministry of Public Security released the draft proposal of the List of Hazardous Chemicals Susceptible to Explosion for public consultation. This list contains in total 69 hazardous substances, or in specific, 7 perchlorates, 12 nitrates, 17 nitro compounds, 14 peroxides and hyperoxides, 16 fuel reducers and 3 other substances.

The full table of List of Hazardous Chemicals susceptible to explosion

Order	Chemical Name (CN)	Chemical Name (EN)	Hazard Category of explosiveness and flammability	UN No.
1 高氯酸、高氯酸盐及氯酸盐 Perchlorates
1.1	高氯酸[含酸50%-72%]	PERCHLORIC ACID	Oxidizing liquids ，Category 1	1873
1.2	氯酸钾	POTASSIUM CHLORATE	Oxidizing solids ，Category 1	1485
1.3	氯酸钠	SODIUM CHLORATE	Oxidizing solids ，Category 1	1495
1.4	高氯酸钾	POTASSIUM PERCHLORATE	Oxidizing solids ，Category 1	1489
1.5	高氯酸锂	LITHIUM PERCHLORATE	Oxidizing solids ，Category 1
1.6	高氯酸铵	AMMONIUM PERCHLORATE	Explosives，Division 1.1 Oxidizing solids，Category 1	1442
1.7	高氯酸钠	SODIUM PERCHLORATE	Oxidizing solids ，Category 1	1502
2 硝酸及硝酸盐类 Nitrates
2.1	硝酸[含硝酸≥70%]	NITRIC ACID	Substances of metal corrosive properties，Category 1 Oxidizing liquids，Category 1	2031
2.2	硝酸钾	POTASSIUM NITRATE	Oxidizing solids，Category 3	1486
2.3	硝酸钡	BARIUM NITRATE	Oxidizing solids，Category 2	1446
2.4	硝酸锶	STRONTIUM NITRATE	Oxidizing solids，Category 3	1507
2.5	硝酸钠	SODIUM NITRATE	Oxidizing solids，Category 3	1498
2.6	硝酸银	SILVER NITRATE	Oxidizing solids，Category 2	1493
2.7	硝酸铅	LEAD NITRATE	Oxidizing solids，Category 2	1469
2.8	硝酸镍	NICKEL NITRATE	Oxidizing solids，Category 3	2725
2.9	硝酸镁	MAGNESIUM NITRATE	Oxidizing solids，Category 3	1474
2.10	硝酸钙	CALCIUM NITRATE	Oxidizing solids，Category 3	1454
2.11	硝酸锌	ZINC NITRATE	Oxidizing solids，Category 2	1514
2.12	硝酸铯	CAESIUM NITRATE	Oxidizing solids，Category 3	1451
3 硝基类化合物 Nitro Compounds
3.1	硝基甲烷	NITROMETHANE	Flammable liquids，Category 3	1261
3.2	硝基乙烷	NITROETHANE	Flammable liquids，Category 3	2842
3.3	硝化纤维素
3.3.1	硝化纤维素[干的或含水(或乙醇)＜25%]	NITROCELLULOSE,DRY OR WETTED WITH WATER(OR ALCOHOL)	Explosives，Division 1.1	0340
3.3.2	硝化纤维素[含增塑剂＜18%]	NITROCELLULOSE WITH PLASTICIZING SUBSTANCE	Explosives，Division 1.1	0341
3.3.3	硝化纤维素[含乙醇≥25%]	NITROCELLULOSE WITH ALCOHOL	Explosives，Division 1.3	0342
3.3.4	硝化纤维素[含水≥25%]	NITROCELLULOSE WITH WATER	Flammable solids，Category 1	2555
3.3.5	硝化纤维素[含氮≤12.6%,含乙醇≥25%]	NITROCELLULOSE WITH ALCOHOL,NOT MORETHAN 12.6% NITROGEN	Flammable solids，Category 1	2556
3.3.6	硝化纤维素[含氮≤12.6%,含增塑剂≥18%]	NITROCELLULOSE WITH PLASTICIZING SUBSTANCE, NOT MORETHAN 12.6% NITROGEN	Flammable solids，Category 1	2557
3.4	硝基萘类化合物	NITRONAPHTHALENES
3.5	硝基苯类化合物	NITROBENZENES
3.6	硝基苯酚（邻、间、对）类化合物	NITROPHENOLS(O-,M-,P-)
3.7	硝基苯胺类化合物	NITROANILINES
3.8	2，4-二硝基甲苯	2，4-DINITROTOLUENE		2038
	2，6-二硝基甲苯	2，6-DINITROTOLUENE		1600
3.9	二硝基(苯)酚[干的或含水＜15%]	DINITROPHENOL	Explosives，Division 1.1	0076
3.10	二硝基(苯)酚碱金属盐[干的或含水＜15%]	DINITROPHENOLATES	Explosives，Division 1.3	0077
3.11	二硝基间苯二酚[干的或含水＜15%]	DINITRORESSORCINOL	Explosives Division 1.1	0078
4 过氧化物与超氧化物 Peroxides and hyperoxides
4.1	过氧化氢[含过氧化氢≥27.5%]	HYDROGEN PEROXIDE	Oxidizing liquids，Category 3	2014
4.2	过乙酸	PERACETIC ACID	Flammable liquids，Category 3 Organic peroxides type D	2131
4.3	过氧化钾	POTASSIUM PEROXIDE	Oxidizing solids ，Category 1	1491
4.4	过氧化钠	SODIUM PEROXIDE	Oxidizing solids ，Category 1	1504
4.5	过氧化锂	LITHIUM PEROXIDE	Oxidizing solids，Category 2	1472
4.6	过氧化钙	CALCIUM PEROXIDE	Oxidizing solids，Category 2	1457
4.7	过氧化镁	MAGNESIUM PEROXIDE	Oxidizing solids，Category 2	1476
4.8	过氧化锌	ZINC PEROXIDE	Oxidizing solids，Category 2	1516
4.9	过氧化钡	BARIUM PEROXIDE	Oxidizing solids，Category 2	1449
4.10	过氧化锶	STRONTIUM PEROXIDE	Oxidizing solids，Category 2	1509
4.11	过氧化氢尿素	UREA HYDROGEN PEROXIDE	Oxidizing solids，Category 3	1511
4.12	过氧化二异丙苯[工业纯]	DICUMYL PEROXIDE	Organic peroxides type F	2121
4.13	超氧化钾	POTASSIUM SUPEROXIDE	Oxidizing solids，Category 1	2466
4.14	超氧化钠	SODIUM SUPEROXIDE	Oxidizing solids，Category 1	2547
5燃料还原剂类 Fuel reducers
5.1	环六亚甲基四胺[乌洛托品]	HEXAMETHYLENETETRAMINE	Flammable solids，Category 3	1328
5.2	甲胺[无水]	METHYLAMINE	Flammable gases，Category 1	1061
5.3	乙二胺	ETHYLENE DIAMINE	Flammable liquids，Category 3	1604
5.4	硫磺	SULPHUR	Flammable solids，Category 2	1350
5.5	铝粉[未涂层的]	ALUMINIUM POWDER UNCOATED	Substances when in contact with water emit flammable gases，Category 3	1396
5.6	金属锂	LITHIUM	Substances when in contact with water emit flammable gases，Category 1	1415
5.7	金属钠	SODIUM	Substances when in contact with water emit flammable gases ，Category 1	1428
5.8	金属钾	POTASSIUM	Substances when in contact with water emit flammable gases，Category 1	2257
5.9	金属锆粉[干燥的]	ZIRCONIUM POWDER，DRY	1．Fire：Solids susceptible to spontaneous combustion，Category 1； Substances when in contact with water emit flammable gases，Category 1 2．Non-fire：Self-heating substances，Category 1	2008
5.10	锑粉	ANTIMONY POWDER		2871
5.11	镁粉或镁合金粉	MAGNESIUM POWDER or MAGNESIUM ALLOYS POWDER	Self-heating substances，Category 1； Substances when in contact with water emit flammable gases，Category 1	1418
5.12	锌粉或锌尘	ZINC POWDER or ZINC DUST	Substances when in contact with water emit flammable gases，Category 3	1436
5.13	硅铝	ALUMINIUM SILICON POWDER	Substances when in contact with water emit flammable gases，Category 3	1398
5.14	硼氢化钠	SODIUM BOROHYDRIDE	Substances when in contact with water emit flammable gases，Category 1	1426
5.15	硼氢化锂	LITHIUM BOROHYDRIDE	Substances when in contact with water emit flammable gases，Category 1	1413
5.16	硼氢化钾	POTASSIUM BOROHYDRIDE	Substances when in contact with water emit flammable gases，Category 1	1870
6其他 Others
6.1	苦氨酸钠[含水≥20%]	SODIUM PICRAMATE	Flammable solids，Category 1	1349
6.2	高锰酸钠	SODIUM PERMANGANATE	Oxidizing solids，Category 2	1503
6.3	高锰酸钾	POTASSIUM PERMANGANATE	Oxidizing solids，Category 2	1490

4)    List of the standard minimum use tonnage for hazardous chemicals – published

This List has recently been released accompanying the Measures on the Management of Hazardous Chemicals Safe Use Permit on 10 October 2011. With the measures on safe use permit taking effect since this December, chemical companies must make clear that they have to reach the specified annual tonnage limit before applying for their HC safe use permit.

The list contains the first batch of 60 hazardous chemicals of priority management plus two additional substances, 2,2'-Azodi-(2,4-dimethyl valeronitrile) and 2,2'-Azobis(2-methylpropionitrile), due to their inherent explosive or combustible properties.

In the determination of minimum use tonnage limits, the authorities have referred to national standard GB 18218-2009, Identification of major hazard installations for dangerous chemicals, which has come into force since December 2009.

Download the List of the standard minimum use tonnage for hazardous chemicals (in Chinese)

5)    List of hyper-toxic chemicals and other hazardous chemicals prohibited for transporting on inland rivers – to be established

This list is expected to identify the range of hazardous chemicals prohibited for inland river transport. Screening factors like chemical hazards, the potential exposure to human and aquatic environment and the difficulty level in eliminating the hazard consequences are called to take into account for main responsible authorities of MOP, MEP, MIIT and SAWS.

6)    List of hazardous chemicals to which priority environmental control applies

(This part will be updated in the near future.)

7)    List of toxic chemicals severely restricted to be imported into or exported from China

Companies if engaged in the import or export of any substance listed in this catalogue should apply with the MEP for a certificate on environmental management of imported toxic chemicals and a letter of permission notice for environmental management of imported (or exported) toxic chemicals.

The 2011 catalogue contains 158 hazardous substances, each marked with a CAS number and a Chinese HS Code (10-digit numbers). However, it should be noticed that the HS Code that China customs adopted on the basis of WTO system (Harmonized Commodity Description and Coding System) is identical with HTS code of US only for the first 6 digits.

Download the 2011 Catalogue of toxic chemicals strictly prohibited from import and export (in Chinese)

English version of the Catalogue is available for the 2006 version, in which a 6th batch for imported toxics and a 3rd batch for exported toxics.

On 31 December 2011 the Chinese MEP published the 2012 new version of the List. The new list which consists still of 158 substances is coming into force as of 1 January 2012. Modifications to the 2012 version can be founded in our news release: 2012 List of Restricted Toxic Chemicals for Import and Export.

Four Types of Hazardous Chemicals Record Systems

Decree 591 establishes four types of record systems for hazardous chemicals.

1)    Record on fulfillment of the safety assessment report and the reform proposals (Article 22)

2)    Record on hyper-toxic chemicals and other hazardous chemicals of with the storage tonnage would constitute major hazard installations (Article          25)

3)    Record on the sale of hyper-toxic chemicals and chemicals susceptible to explosion (Article 41)

4)    Emergency proposals in response to hazardous chemical accidents (Article 70)

Fifteen Types of Hazardous Chemicals Review and Approval systems

1)    The safe production licensing of hazardous chemicals

2)    The safe use permit licensing of hazardous chemicals

3)    The hazardous chemicals operation licensing

4)    The prohibition and restriction system of hazardous chemicals

5)    The review and justification system for the safe conditions of hazardous chemicals construction projects

6)    The safety warning system of the safety of workplaces, facilities and equipment

7)    The qualification system of personnel training, examination and certification

8)    The permission system for the purchase and transportation of hyper-toxic chemicals and hazardous chemicals susceptible to explosion

9)    The certification system for companies engaged in transportation of hazardous chemicals

10)  The registration system of hazardous chemicals

11)  The registration system for the environmental management of hazardous chemicals and new chemicals

12)  The information reporting system on the environmental release of hazardous chemicals

13)  The system of the identification of chemical hazards

14)  The system of emergency rescue management in response to chemical accidents

15)  The system of the enforcement of legal responsibilities

Supporting regulations on Hazardous chemicals under Decree 591

1)    Catalogue of Hazardous Chemicals (revised)

2)    Measures on the Safe Production License for Hazardous Chemical Manufacturers (published as SAWS order 2011-41)

3)    Measures on the Operation License of Hazardous Chemicals (revised)

4)    Measures on the Safe Use Permit of Hazardous Chemicals (draft)

5)    Measures on the Permit of Safe Construction Project of Hazardous Chemicals ( revised)

6)    Measures on Hazardous Substances Registration (draft)

7)    Interim Provisions for the Supervision and Administration of Major Hazard Installations of Hazardous Chemicals (published as SAWS order 2011-40)

8)    Provisions on the Safety Management of the Pipelines of Hazardous Chemicals

9)    Measures on the Identification and Classification of Physical Risks of Chemicals