Environmental Management on
Chemicals in China

Chemical Registration Center of SEPA
Gao Yingxin
March 30, 2007

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Contents• System of Laws and Regulations of the Management ofChemicals– Laws Concerning the Management of Chemicals– Administrative Regulations Concerning the Management of Chemicals– Departmental Regulations Concerning the Management of Chemicals– Standards Concerning the Management of Chemicals– Industrial List Concerning the Management of Chemicals• Provisions on the Environmental Administration of New
Chemical substances• Regulations for Environmental Management on the First
Import of Chemicals and the Import and Export of Toxic
Chemicals• Management of Discarded Dangerous Chemicals
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System of Laws and Regulations of theManagement of Chemicals
NPC
Laws
The State Council
Administrative Regulations
Ministries and Committees under the State Council

Departmental Regulations
Local Government and Related Agencies
Local Regulations
Related National and Local Departments
National, Industrial and Local Standards

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Laws Concerning the Management of Chemicals• Environmental Protection Law of the People’s Republic of China (Amended
in 1989)• Law of the People’s Republic of China on the Prevention and Control ofAtmospheric Pollution (Amended in 2000)• Law of the People’s Republic of China on the Prevention and Control of
Water Pollution (Amended in 1996)• Law on Prevention and Control of Environmental Pollution Caused by Solid
Waste (Amended in 2004)• Law on Environmental Impact Assessment of the People’s Republic ofChina (2002)• Law of the People’s Republic of China on the Prevention and Treatment ofOccupational Diseases (2001)• Production Safety Law of the People’s Republic of China (2002)• Law on the Promotion of Clean Production of the People’s Republic ofChina (2002)• Food Hygiene Law of the People’s Republic of China (1995) <concerning
food additives>• Fire Control Law of the People’s Republic of China (1998) <concerning
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flammable and explosive chemicals >Administrative Regulations Concerning theManagement of Chemicals• Regulations on Safe Management of Hazardous Chemicals (revised in 2002)- List of Dangerous Goods (GB12268), Catalog of Hazardous Chemicals(2002 edition), List of Highly Toxic Chemicals (2002 edition), List ofHighly Poisonous Chemicals (2003 edition).
• Administrative Regulations of the People’s Republic of China on Pesticides(revised in 2001)• Pharmaceutical Administration Law of the People’s Republic of China(amended in 2001)• Administrative Regulations of the People’s Republic of China on
Veterinary Medicine (revised in 2004)• Regulations of the People’s Republic of China on. the Administration ofControlled Chemicals (1995) - Catalogue of Controlled Chemicals• Regulation on Management of Drug-Making Chemicals (2002) - Catalogueof Drug-Making Chemicals• Regulations on Industrial Product Manufacturing Permission License (2005)
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Departmental Regulations Concerning theManagement of Chemicals• Regulations for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals (1994) - List of
Toxic Chemicals Banned or Severely Restricted in the People’s Republicof China• Provisions on the Environmental Administration of New Chemical
Substances (2003) - Inventory of the Existing Chemical Substances in
China• Measures for the Prevention and Control of Environment Pollution by
Discarded Dangerous Chemicals (2005)• Measures for The Administration of Registration of Hazardous Chemicals(2002)• Measures for the Administration of Operating Licenses for Hazardous
Chemicals (2002)• Measures for the Administration of Designated Production of the Package
and Containers of Hazardous Chemicals (2002)• Measures for the Administration of Licenses for the Purchase and Road
Transportation of Highly Toxic Chemicals (2005)• Regulations for Management of Road Dangerous Freight (2005)
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Standards Concerning the Management of Chemicals• The Guidelines for the Hazard Evaluation of New Substances (HJ/T154-2004)• The Guidelines for the Testing of Chemicals ( HJ/T153-2004)• The Guidelines of Chemical Testing Good Laboratory Practices ( HJ/T1552004)• Classification and Labeling of Commonly Used Dangerous Chemicals (GB13690-92)• General Rules for the Preparation of Chemical Safety Data Sheet (GB164831996)• Rule for Storage of Chemical Dangers (GB15603-1995)• General Specifications for Transport Packages of Dangerous Goods(GB12463-90)• Standard for Pollution Control on Hazardous Wastes Incineration (GB184842001)• Standard for Pollution Control on Hazardous Wastes Storage (GB18597-2001)• Standard for Pollution Control on the Security of Landfill Site for Hazardous
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Wastes (GB18598-2001)

Industrial List Concerning the Management ofChemicals Catalogue for the Guidance of Industrial Structure
Adjustment (2005)

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Management of New Chemical Substances-- Provisions on the Environmental Administrationof New Chemical substances• The Provisions is the No. 17 Decree in 2003 of SEPA. It wasenacted on September 12 of 2003 and took effect on October
15 of the same year. The promulgation of the Provisions
serves as a milestone in the field of environmental
management of chemicals in China.
• Background– Honoring the commitment China has made following its
accession into the WTO– Getting compatible with international standards– Filling in the cap in the filed of environmental managementof chemicals in China
9Management of New Chemical Substances-- Provisions on the Environmental Administrationof New Chemical substances• Inventory of Existing Chemical Substances in China (IECSC)
was initiated in December of 1994 and was supplemented
upon application five times in 1996, 1999, 2001, 2002 and2003 respectively. Presently the IECSC covers around over
45,000 kinds of chemical substances.
• A range of guidelines were issued including the Guidelines for
the Testing of Chemicals, the Guidelines for the Hazard
Evaluation of New Substances and the Guidelines of Chemical
Testing Good Laboratory Practices, all taking effect from June
1 of 2004.

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Management of New Chemical Substances-- Provisions on the Environmental Administrationof New Chemical substances• The New Chemical Substance Notification Guideline
has been formulated.
• An Expert Committee on the Environmental
Management on New Chemical Substances isestablished to take charge of the registration andreview of new chemical substances. The Committee
so far has a pool of 39 experts from related sectors.
• 7 qualified domestic eco-testing laboratories were
publicized.
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Applicable Scope• Territorial– Within the customs territory of P.R.C.
– Excluding Hongkong, Macau, Taiwan– Excluding the confines of bonded areas andexport manufacturing trade zones within P.R.C.

• Substances– New Chemical Substances, not listed in IECSC– Despite the concentration of new chemical
substances inside the preparations
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Activities and Notifiers• Activities• Production within the customs territory of P.R.C.
– Importation into the customs territory of P.R.C.
– Exportation to the customs territory of P.R.C.
– Transfer into the customs territory of P.R.C. frombonded areas and export manufacturing trade zones• Notifiers– Domestic producer– Domestic importer– Foreigner exporter (Incl. those located in Hongkong,
Macau, Taiwan, bonded areas and trade zones)
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Substance Scope--Exemptions•

Chemicals Under the Management of Other
Existing Laws and Regulations
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–
–
–
–
–
–
–
–
–
–
–

Radioactive substances
Military industry products
Pyrotechnics
Biological substances
Pesticides
Veterinary drugs
Pharmaceuticals
Cosmetics
Foods
Food additives
Feed
Feed additives
Tobacco and tobacco products

14Substance Scope—Exemptions Con’t 1•

Substances That Exist in Nature–

Substances that are unprocessed, or that are processedor treated only through the methods listed below:
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•

–
–

ManualMechanicalGravitational
Water soluble
Floatation
Heat dehydration

Extracted from the atmosphere through various means
Natural polymers, except for ones that are processed
through physical or chemical processing
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Substance Scope—Exemptions Con’t 2•

Special Categories
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Glass
Frit
Pottery raw materials and ceramic ware
Steel and steel products
High-alumina cement
Portland cement
ArticlesHomogeneous and heterogeneous alloys, except for
metal compounds and precisely defined intermetallic
compounds
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Substance Scope—Exemptions Con’t 3• Categories that have noncommercial objectives or that are
produced unintentionally, except when they are put
directly onto the market as commodities– Impurities– Products of random reactions that occur when a certain chemical
substance accidentally comes into contact with another substanceor when an article comes into contact with an environmental factor(such as air, steam, a microorganism, or sunlight)– Products of random reactions that occur when a chemical
substance, mixture, or article is in storage– Products of reactions that occur when a chemical substance,
mixture, or article is in final use– Waste water, waste gas, solid waste, and by-products

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Types of Notification• Typical Notification• Serial Notification: similar molecular structure,same or similar usage, and similar test data
• Joint Notification: two or more notifiers• Simplified Notification: already listed in fouror more existing inventories in the world• Notification Exemption• Polymer Notification
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Notification Exemption• manufactured or imported annually for scientificresearch purposes does not exceed 100 kg;• polymer containing a new chemical substancemonomer of less than 2 percent, and some special
catalogs of polymers• manufactured or imported for technologicalresearch and development does not exceed 1,000kg, apply for a one-year notification exemption,
but no extensions will be granted;• imported for new chemical substanceecotoxicology testing in China
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Polymer Notification• Not required: in IECSC already• Notification Exemption– All of their monomers are already included in IECSC– Two or more monomers/reactants with the highest content in thepolymer already exist in one or more other polymers in theInventory, and other new chemical substance monomer of less than
2 percent– All of their blocks are already included in the block
copolymerization in IECSC– Their precursors and branched chains are already included in thegraft polymers in IECSC– of low concern

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•
•
•

Simplified Notification
Typical Notification
Serial Notification
Joint Notification

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Data Requirements• Environmental
protection and Safety• Notifier and substanceidentity– Recommended safe
usage
– Emergency measures– Pollution prevention andabatement methods– Waste disposal measures– Notifier information– Substance identity– Determination method– Manufacture process– Usage and Exposure• Inherent Characteristics– Physiochemical properties– Toxicology– Ecotoxicology• Non-compellent– MSDS– Commodity label
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Requirement on Materials-Principle
 The quality and quantity of the information should be
sufficient for the Expert Committee to make an objective
assessment of the environmental and public healthimpact of the notified substance.
 The notifier may make an independent pre-assessment of
the new chemical substance that is to be notified withreference to the Guidance for the Hazard Assessment of
New Chemical Substances that was promulgated by
SEPA
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Requirement on Materials-Physichemical property, at minimum• Solid• Liquid– relative density– flash point– self-ignition
temperature– explosive limit– particle size
– water solubility– Kow– relative density– oxidbillity/causticity– vapor pressure– Flammability– water solubility
– Kow
– pH

• Gas
– explosive limit– oxidbillity

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Requirement on Materials-Toxicological data, at minimum• Basic level (Q<104kg)− Acute toxicity: acute peroral toxicity, acuteinhalation toxicity, acute dermal toxicity, skinirritation, eye irritation, and skin sensitization− Short-term repeated dose toxicity: peroral toxicity,dermal toxicity, and inhalation toxicity− Mutagenicity: bacterial back mutation test andmammalian extracellular chromosome aberration
test
24Requirement on Materials-Toxicological data, at minimum• Level 1 (104kg<Q<106kg), upon the basic
level– QSAR result– Mutagenicity– Reproduction/development toxicity– Repeated dose toxicity (90 days)• Level 2 (Q > 106kg), depend on thejudgement of expertise– Acute and/or repeated dose toxicity– Reproduction/development toxicity (second
generation)

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Requirement on Materials-Ecotoxicological data, at minimum Basic level• algal growth inhibition test
• daphnia 24h acute immobilization test
• fish acute toxicity test
• activated sludge respiration inhibition test
• biodegradation test (or abiotic degradation test)• adsorption/desorption screening test

 Level 1 & 2: as basic level. Bioconcentration test isrequested if non-biodegradable
 More test data might be requested when theCommittee cannot make evaluation

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China Test Organisms• Definition: bred and cultivated in China, accord withtechnique criteria, used for designated test, including
China domestic species and these commonly usedinternationally• Species– Gobiocypris rarus– Xiphophorus helleri– Zebra fish
– Active sludge

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Test Methods• Toxicological & Ecotoxicological tests– Testing in China• Guidelines for Testing of Chemicals (HJ/T153-2004), and• Guidelines for the Testing of Chemicals (China Environ. Science
Press, 2004)– Testing outside China• Guidelines for Testing of Chemicals (HJ/T153-2004)• OECD, ISO and other internationally universal test methods• Physi-chemical property– Guidelines for Testing of Chemicals (HJ/T153-2004)– National or Industry Standards– OECD, ISO and other internationally universal test
methods
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Test Institution Qualification• China and other countries:—National Laboratory Accreditation; or—Recognition by MOH; or—GLP recognition by the State Food and Drug Administration—Measurement attestation at State level (limited to physical and chemical
property tests)• Other countries;—Certification or accreditation by its national authorities concerned with new
chemical substance management; or—Authenticated or accredited by the authorities concerned with quality
inspection, customs, public health, or agriculture of one's own country, when
the national authorities concerned with new chemical substance managementof one's home country to provide test data for new chemical substance
notifications has not yet make authentication or accreditation• If the test agency is not recognized by the national authorities concerned withenvironmental protection of one's own country, the CRC will not recognize it
as test data provided for new chemical substance notifications either.
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Evaluation Method• Guidance for the Hazard Assessment of New Chemical
Substances (HJ/T 154-2004)• Four health hazard levels according to complex toxicity
evaluation and human exposure evaluation: extremelyhigh(++++), high(+++), media(++), low(+).
• Five environment hazard levels according to complex
toxicity evaluation and exposure to environment:
extremely high(++++), high(+++), media(++), low(+),
non(-).
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Evaluation Result• Hazard classification• Health and zoology evaluation– For extremely high hazard substances, recommend not toapprove, and prohibit production, selling, usage– For high hazard substances, recommend to approve, withlimitation on production, selling, usage and clear
recommendations– For media hazard, recommend to approve, with clear
requirements on proper protections for production, selling,usage– For low/non hazard substances, recommend to approve,
without (special) requirements
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Environmental Management on the Import and Export of Toxic Chemicals-- Regulations for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals• The Regulations was issued by the former National
Environmental Protection Agency, the former Ministry ofForeign Trade and Economic Cooperation and theGeneral Administration of Customs and took effect fromMay 1 of 1994.
• Background– Implementing the voluntary prior informed consent
procedure (PIC) contained in the London Guidelines
for the Exchange of Information on Chemicals inInternational Trade– Practicing the Regulations on Safe Management ofHazardous Chemicals
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Environmental Management on the Import and Export of Toxic Chemicals-- Regulations for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals• List of Toxic Chemicals Banned or Severely Restricted in the
People’s Republic of China (the First Group) (including 27
types)• In a bid to intensify the management over the import of mercury,
SEPA and the General Administration of Customs jointly issued
the Announcement on Mercuric Sulphide Being Listed in the
List of Toxic Chemicals Banned or Severely Restricted in China(SEPA Document No. 166[2003]), and the Announcement was
put into effect from October 15 of 2003.
• Regarding the implementation of the PIC Convention, SEPA
and the General Administration of Customs jointly released theNo. 29 Announcement in 2005 for the supplement of the List of
Toxic Chemicals Banned or Severely Restricted in the People’s
Republic of China (the Second Group) (including 7 types), and33
the Announcement was put into effect from July 10 of 2005.

Environmental Management on the Import and Export of Toxic Chemicals-- Regulations for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals• At the end of 2005, SEPA, together with the General Administration ofCustoms made some adjustment to the list of imported and exported
chemicals under restriction by enacting the new edition of the Catalogue for
Severe Restriction of Imported and Exported Toxic Chemicals of China,
which was effective on January 1 of 2006.
• At the end of 2005, SEPA, the Ministry of Commerce and the General
Administration of Customs jointly adjusted the list of banned chemicals forimport and export by releasing the Catalogue of Commodities Forbidden toImport (the Sixth Batch) and the Catalogue of Commodities Forbidden to
Export (the Third Batch), both taking effect from January 1 of 2006.
• SEPA and the General Administration of Customs jointly issued the No. 80
Announcement in 2006 for the revision of the Catalogue for Severe
Restriction of Imported and Exported Toxic Chemicals of China, which tookeffect from January 1 of 2007. This revision is mainly for revising the custom
code of the chemicals included in the said Catalogue based on the
Harmonized Commodity Description and Coding System (HS) (2007 Edition)of the World Customs Organization (WCO) and further includes three new 34
compounds in the Rotterdam Convention into the Catalogue.

Environmental Management on the Import and Export of Toxic Chemicals-- Regulations for Environmental Management on the First Import ofChemicals and the Import and Export of Toxic Chemicals• The competent department for dealing with theexamination and approval of the import and export of
toxic chemicals under SEPA has formally networked
with the electronic port system of related custom
department from October 1 of 2005.
• A new edition of the Delivery Note for theEnvironmental Management on the Imported or
Exported Toxic Chemicals and registration
application form were publicized to support theelectronic networking.
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Registration Application• Applicant: Foreign companies• Documents: Application Form, Contract• Registration fee: US$10,000/certification• Payment: Guidance• Evaluation period: 30 days
• Valid period of certification: 2 years• Amount per certification: no limit but
reasonable36Declaration Notification Application• Domestic Importer• Documents: Application form, Copy ofregistration certificate, Qualification document,
Contract, Downstream buyer• Registration fee: None
• Evaluation period: 10 days
• Valid period: 6 months
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Special Catalogue• Chemicals listed in PIC convention• Chemicals listed in POPs convention• Export of Arsenic compounds• Export of Sodium Cyanide• Mercury– Import: Quota control, designated users and usages– Export: Comments from provincial EPB
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Relevant Materials• Detailed Rules on Implementing theRegulations• Directions for the Registrations• Document requirements• Application flow chart• Application form
• Form sample, Instruction to fill in
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Other information
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All materials are available from CRC-SEPA’s website
Application process is availble from the website
CRC-SEPA website: http://www.crc-sepa.org.cn
Phone: (+86-10) 84915286
Fax: (+86-10) 84913897
E-mailweihua@crc-sepa.org.cn
Mail address: Chemical Registration Center of SEPA
Beiyuan, Anwai, Beijing 100012, PRC• Visiting: Room 801, Building 1, CRAES
8# Dayangfang, Anwai, Chaoyang District,
Beijing• Application on Internet will be accessible soon
– Both paper documents and electronic data are required in testrun– Only electronic data when formally running

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Contact
Post address: Division of New Chemical Substance Management
Chemical Registration Center of SEPA
No. 8, Dayangfang, Beiyuan, Andingmenwai
Chaoyang District, Beijing, P. R. China
Zip Code: 100012
E-MailNotification of New Chemical Substance: ncn@crc-sepa.org.cn
Service of New Chemical Substance Affirmance: ncncheck@crc-sepa.org.cn
IECSC: inventory@crc-sepa.org.cn

Reception Office: No.804, 8th Floor, Building 1
Dayangfang No. 8, Anwai, Beijing, 100012, P.R. China
Tel: (+86-10) 8491-7656; 8491-5287
Fax: (+86-10) 8491-7656
Website: http://www.crc-sepa.org.cn
41Management of Discarded
Dangerous Chemicals• Measures for the Prevention and Control ofEnvironment Pollution Caused by Discarded
Dangerous Chemicals (2005)• Measures for the Administration of Registration ofHazardous Waste (2004)• Measures for the Administration of Duplicate Formfor the Transfer of Hazardous Waste (1999)• The National Catalogue of Hazardous Wastes (1998)

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Management of Discarded
Dangerous Chemicals•••

Operation of discarded dangerous chemicals– The environmental protection bureaus above the provincial level taking charge of issuing
the operational license of discarded dangerous chemicals– Encouraging the units producing dangerous chemicals to recycle and dispose thediscarded chemicals of the same kind as their products
Disposal requirements to enterprises being closed down, suspended of operation, merging
with other enterprises or switching to other products– Properly handling the discarded, warehoused dangerous chemicals and equipment– Checking the soil and groundwater of the premise and compiling the environmental risk
assessment report– Compiling and performing the environmental restoration plan if any pollution of thepremise has been made and entrusting professional checkup organs to do the checkup
after the environmental restoration
Collecting or paying the fees for the disposal of discarded dangerous chemicals and bearing
the responsibility for the disposal– Submitting the discarded dangerous chemicals taken over to professional organs for
disposal– The department responsible for taking over the chemicals shall take charge of collecting
the disposal fees. In case there is no clearly identified person for the chemical or thechemical is submitted by the public, the receiving department of the chemical should
apply for the disposal fee to the financial department at the same level.
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