This document provides an overview of chemical legislation in China through the introduction of main regulations, including the China New Chemicals regulation (MEP Order 7). It summarizes the key aspects of MEP Order 7, including the types of chemicals subject to the regulation, competent authorities, statistics on past notifications, and details on the notification procedures and requirements, which include preparation, notification, and post-notification stages. The presentation emphasizes that chemical legislation in China has a different framework than Western countries and provides helpful context, links, and tips for navigating the regulatory process.

1. CHINA CHEMICAL
LEGISLATION PRESENTATION
Feb 27 | GLOBALCHEM 2013
Gaylord National Resort & Convention Center
Mai Fung
REACH24H Consulting Group

2. About my presentation
This is a presentation tells what chemical legislation system
looks like in China through the introduction of main regulations.
Useful links
This is a presentation giving you the knowledge and providing
you with tips, useful links as well as additional information
for practical your use in compliance with Chinese regulations. Additional information
REACH24H Consulting Group GlobalChem 2013

3. China New Chemicals (MEP Order 7- Revision of Provisions on the Environmental Administration of New Chemical
Substances)
China Hazardous Chemicals (State Council Decree 591 | SAWS Order 53 | MEP Order 22 | SAWS Order 55)
& China GHS SDS + Labeling (National standards | AQSIQ Inspection Letter [2012] NO.30)
PRESENTED BY MAI FUNG OF REACH24H
SPECIALLY FOR GLOBALCHEM 2013

4. Chemical legal framework
Different from the western developed countries, chemical legislation
framework in China could be shown as the chart below in general.
Class in legislation system
From top to lower level
Top level 2nd level 3rd level 4th level
Law: Administrative Law: Measures: GB & GB/T
On this level, the laws was On this level, the laws was On this level, the laws was Known as National Standard; usually be
legislated through the legislated through the state legislated by each functional divided into GB(/T)
People’s Congress Council Ministry GB: National Standard (Compulsory)
GB/T: Recommended Standard
For example For example For example
Constitution State Council Decree 591 MEP Order 7 For example
MEP Order 22 GB 15258-2009
SAWS Order 53 GB 20584 – GB 20586 (CN GHS
Classification)
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5. Competent authorities
This page is just for your reference.
Ministry Administration
MEP Ministry of Environmental Protection 環保部 SAWS State Administration of Work Safety 安監局
(Replacing SEPA)
MOR Ministry of Railways 鐵道部 CUSTOMS General Administration of Customs of 海關總署
(GAC) P.R.C.
MOA Ministry of Agriculture 農業部
AQSIQ General Administration of Quality 品質監督檢驗檢
Supervision, Inspection and Quarantine 疫總局
MIIT Ministry of Industry and Information 工信部 SAIC State Administration for Industry and 工商總局
Technology Commerce
MPS Ministry of Public Security 公安部 SDPC National Development and Reform 國家發展和改革
Commission 委員會
MOT Ministry of Transport 交通運輸部
MOH Ministry of Health 衛生部
Responsible institutes
NRCC-SAWS National Registration Center For 化學品登記中心
Chemicals of SAWS
CRC-MEP Chemical Registration Center of MEP 環保部化學品登
記中心
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6. Chem-environmental
Management in China
• General new chemical substances
• New hazardous chemical substances
45,000+ • New hazardous chemicals of priority
environmental concern (NHCPEC)
• General hazardous chemicals
3,800+ Existing Chemical substances with no
particular management MEP Order
• HCPEC (list to be released).
• Toxic chemicals restricted to be
7,000+ 7
imported or exported Catalog of Hazardous Chemicals (to be re-
issued) + extremely toxic chemicals + …
“Revision of Provisions on the
MEP Order 22 Environmental Administration of
State Council Decree 591
SAWS Order 53(registration system)
New Chemical Substances”
SAWS Order 41 55 57…(License system)
Existing chemicals New chemicals
Ministry of State Ministry of
Environmental Administration Environmental
Protection of Work Safety Protection
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7. China New Chemicals
Never call me “China REACH”
Overview of MEP Order 7 Preparation | Notification | Post-notification Roadmap of MEP Order 7
The key part
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8. China New Chemicals
Order 17 by SEPA Order 7 by MEP
Overview of Order 7 Provisions on the Environmental
Management of New Chemical
Substances in China
Revision of Provisions on the
Environmental Administration of
New Chemical Substances in China
“Revision of Provisions on the Environmental Administration
of New Chemical Substances”. It is administered by the MEP
Invalid Issued Came into force
and implemented by Chemical Registration Center (CRC- 2002 2010 Oct 15 2010
MEP). SEPA has replaced by MEP.
What chemical substances Exemption from notification X
are subject to it
• Finished products subject to other existing regulations
• New chemical substance out of IECSC • Substances exist in nature
• New substance in preparation/mixtures • Substances of noncommercial purpose or unintentionally produced
(surfactants, plasticizers, preservatives etc.) (Impurity <10% w/w | Chemical produced from reactions | Waste water, gas or solid waste or other by-products)
• Article with intended release of new substance • Substances of special categories
• UVCB (Substances of Unknown or Variable (Material: glass materials, ceramics, etc. | Homogeneous and heterogeneous alloys | Non-isolated intermediates
Composition, Complex) New chemicals in Articles: intended release chemical in article excluded)
• Polymer
Applicable
Applied to a Chinese entity Territories • Within Chinese Customs
Boundary
Who will be affected • Affiliate of a foreign company in China • Bonded areas & Export
• Manufacturers of new chemicals Processing Zones
Territories • Importer of new chemicals
under the regulation • Representative agent in China assigned by a foreign company Inapplicable
(A representative agent shall meet some requirements) • Hong Kong, Macau, Taiwan
• Cargos temporarily stored in
A notifier could be a foreign entity; the applicant and holder of a certificate will processing zones or to be
be Chinese entity. exported with no processing

9. China New Chemicals
Statistics recap of Order 7
Recap notification cases under MEP Order 7 in 2012
Source: Chemlinked.com | CRC-MEP (Jan 30 2013)
406 1,474 11
Jan-Jun2012
Jan-Jun 2012 Jan-Jun 2012
484 3,402 30
Jul-Dec2012 Jul-Dec 2012
Jul-Dec2012
47.9% 42.7% 95.3%
890/1,854 3402/7,969 41/43
Scientific Research Record Notification Simplified Notification Regular Notification
Special case | General case 14 submission in 2012 left to be approved
(3,009) (393) Approved 14 general hazardous substances | 21 NHCPEC

10. China New Chemicals
Notification Preparation
Details of notification procedures will be unfolded at each stage.
5+ years
before listed in IECSC
Preparation Notification Post-notification
42,436 (200M software)
It additionally includes
42,436 Online (Free) 3,166 Confidential substances
IECSC inquiry 8,175 with no CAS# included
IECSC since 2003 Search with one of 3 identities: Not easy for some products with
English name | Chinese name | CAS# same generic name but different CAS#
• To get to know whether your
PC version of IECSC
chemical substance is new or not It returns with either of 2 results:
8,500CNY (1,400USD)
…listed in IECSC
• No need for additional information …is not found in IECSC
at this stage
42,436 (10 work day)
It additionally includes
3,166 confidential substances
Up-to-date database
CRC-MEP has its own internal identification
method for substances with no CAS#
Formal inquiry
Useful link: Additional information: 600CNY (100USD)
Different IECSC version on CRC-MEP Valued tips for applying IESCE inquiry

11. China New Chemicals
IECSC 2013 was published
PDF of IECSC has come out and been kept updated.
IECSC database 2010 IECSC database 2013
What is new?
42,436 42,342 • Minor mistakes of chemical name
8,175 with no CAS# included and molecular formula fixed;
Updated
on Jan 30 • Some new chemicals notified under
2013 SEPA Order 17 (2002) included;
• Chemicals through IECSC
3,166 confidential chemical 3,270 confidential chemical
supplementation (Supplementation
substances substances should be submitted before Dec 01
2011) during Nov. 2010 & Nov.2011
in accordance with MEP Notice
[2011] No. 1366
45,602 in total 45,612 in total
IECSC Ver. 2010 IECSC Ver. 2013
• Online database (free) • PDF
• Pc version • Online database updated in
early Feb.
• Pc version (2010 ver.
purchasers get updated for
free) released in early Feb.
Additional information:
IECSC (2013) PDF download

12. China New Chemicals
Notification implementation
Details of notification procedures will be unfolded at each stage.
5+ years
before listed in IECSC
Preparation Notification Post-notification
IECSC inquiry Existing Substances
not subject to MEP Order 7
X
New substances (SRRN): for testing sample
Subject to MEP Order 7 (Risk Assessment): for regular (Review): for regular
notification notification &
general case of simplified
Regular Notification • Data gap analysis notification
• Testing proposal
• (Scientific Research Record) CRC-MEP Certification or
Simplified Notification
• Testing execution Submission & (Review) Public announcement
• (Risk Assessment )
Scientific Research Record • Dossier generation
(SRRN)
3 types of Dossier and Submission and
notification submission material certification
1 2 3

13. 1
3 types of notification
Regular Notification Simplified Notification Scientific Research Record (SRRN)
Applied Tier 1: 1-10t/a Tier 2: 10-100t/a
tonnage band 0.1 – 1t/a <0.1t/a
Tier 3: 100-1000t/a Tier 4: 1000+t/a
Supplemental Special cases of regular notification General case For the scientific research purpose
information • Serial Notification
Similar substances notification once
• Joint Notification Special case
Joint notification(data or cost-share) • Intermediate, <1t/a
Testing samples imported for
• Repeated Notification • only for export, <1t/a
compulsory eco-toxicological tests
Notification by referring to the data • for scientific research 0.1 to 1t/a
SRRN is necessary for regular notification
owned by previous notifiers. • for polymer with new monomer
and general case of simplified
• Re-notification (<2%w/w) (no volume limited)
notification because of sample needed
Tonnage increase; registered use change • new polymer of low concern (No volume
for tests.
• Joint Serial Notification limited) PPORD: Process and Product
• for PPORD,1-10t/a (2-year validity) Orientated Research & Development
Notification 8-18 Months 5-10 Months(general case) 14 workdays
Duration (largely dependent on testing arrangements: 2-3 Months (special case)
Tier 4 may need much more time)
Complication indicator
documents | data | procedures

14. 2
Complication indicator Dossier and submission material
documents | data | procedures
Regular notification Simplified notification SRRN
Notification Application Form Notification Application Form Notification Application Form
+ Research information
Compliance statement (special case) English and Chinese chemical name
Scientific Record Form
Scientific Record Form (general case)
+ • Test reports/data (Phyiso-chemical, Eco-toxic test reports (general case)
Testing institute information
toxicology & eco-toxicology) (1-3 tests)
• C&L for hazardous substances (China
Phyiso-chemical data
GHS)
 Melting point
• Risk Assessment Report(since 1t/a)
 Water-solubility
• SDS…
 Partition coefficient noctanol/water
 Tests required according to different Data acceptable indicator
Data could be secured from testing Data sources acceptance by MEP
tiers;
institutes out of China but preferred being
 Phyiso-chemical and toxic data could be Accreditation proof of lab
generated from GLP labs, following OECD Laboratory test report
secured from testing institutes out of provided
methods (preferred): Data from SDS could
China but preferred being generated
be also acceptable
from GLP labs, following OECD methods Full official document will be
Publish literature
 Some eco-toxic data must be generated Eco-toxic data within China accepted only
by MEP-accredited Chinese testing  Ready biodegradation (only for organic)
institute* with Chinese organism  Acute toxicity test for fishes Details on the database required Database
 Acute toxicity test for earthworm name, publish institute, edition
etc.
 Eco-toxic data generated by MEP- Models, parameter, developing QSAR
accredited Chinese testing institute with unit, edition, effectiveness provided
Chinese organism;
 No data requirement for special case Profile of expert is a must; statement Expert
only as supplemental support
Useful link: 10 (8+2) MEP-accredited testing institutes
The list of MEP-accredited Eco-toxic testing institutes

15. 3
Submission and certification
Regular notification Simplified notification SRRN
• Application form &Hazardous • Online submission software • Online submission software
Email or CD classification form (only in simplified Chinese) is (only in simplified Chines) is
the only accepted submission the only accepted submission
or • Test reports required and risk method since Jan 2012 Online
method since May 2012
assessment report, SDS & label
+
• Printed Application form with
stamp and signature • Original copy printed through • Original copy printed through
Hard • Other necessary documents the submission software shall the submission software shall Hard
copy be submitted with stamp and copy
(POA, authorization letter if a be submitted with stamp and
foreign company appoints 3rd signature as well signature as well
party to carry out notification)
Submit to CRC-MEP Submit to CRC-MEP Submit to CRC-MEP 1
Regular notification through General case through
2 Expert Committee review Expert Committee review
Reviewed by MEP and decided to approve (much time consumed) 3
• Notification number
• Notification type • Regular notification- Valid since date of issue till
• Certificate holder (Foreign Notification Certificate being listed in IECSC after 5 years.
company is presented) Issued by MEP for Simplified and • Simplified notification – Valid since date of issue
• Notifier regular notification till the certificate cancellation applied for or
• EN & CN chemical substance name repealed by the holder.
• CAS# • Post-notification obligation shall be fulfilled to
remain the validity of the certificate.
Online
Public Announcement
For Scientific Research Record
Notification (SRRN)

16. China New Chemicals
Post-notification obligation
Details of notification procedures will be unfolded at each stage.
Preparation Notification Post-notification
IECSC inquiry Submission & Notification Certificate
Obligation will be fulfilled according to 3
different management categories based on
“Guidance for Hazardous Identification of
new chemical substances” HJ 154-201* to
replace HJ/T 154-2004
Obligation indicator General new chemical
substances
More obligations put on
New hazardous chemical
substances
New hazardous chemicals of priority
environmental concern (NHCPEC)
Useful link: HJ/T 154-201* (Chinese ver.)
Guidance for Hazardous Identification of new chemical substances

17. Obligation indicator
More obligations put on
General new chemical New hazardous chemical NHCPEC
substances substances
1 1 2 1 2 3
• Communicate MSDS to downstream users • Submit Annual Report (for previous • Submit report on disposal information
year, submitted before Feb 01 each year)
• Implement risk management measures • Submit substance flow chart
• Comply with <<Measures for The
• Do not sell chemicals to downstream users Administration of Registration of • Submit annual plan (for next year)
who are not capable of implementing risk Hazardous Chemicals>> SAWS order 53
management measures
• Submit first-activity(manufacture or import)
2 3
report
• Keep documents on file for over 10 years
The categories of “new hazardous chemical substances” and “new hazardous
chemicals with priority environmental concern” are decided according to
• Submit updates if new hazard arises
evaluation of substances through regular notification or simplified notification
(general case) given by expert committee based on HJ/T 154-201.
1
General substances will be listed in IECSC after 5 years Hazardous chemicals (with priority concern) will be decided to be included by
since the first activity. the 5-year activity report submitted 6 months before the 5-year duration.
Substances through SRRN or Simplified notification will In pursuant of Decree 591, new chemicals with hazardous properties shall be
NOT be listed in IECSC automatically. registered, and the competent authority is NRCC-SAWS .
Additional information: Annual Report
Guidance on Annual Report of New Chemical Substances (Trial | En)

18. China New Chemicals
Roadmap of Order 7
It will be a long way before stricter enforcement
implemented, but you have to remain alert on that. Last
Page of MEP Order 7
Fully inspection &
MEP Order 7 published Improving and progressing
enforcement
Currently
The authority is now being much stricter
with assessment and verification of
notification submitted.
What is the focus for now? Enforcement
Milestone • Improve the internal work flow MEP, CRC-MEP, local
MEP Order 7 came into • Consolidate the communication with active notifiers for better mutual understanding Environmental Protection Bureaus.
force on 15 Oct. • Erase the unclear points in the regulation, and make it “applicable” and “unambiguous”
2010, replacing SEPA Order • Guidance and supportive documents like: Short in man power and
17 in 2003 Guidance on Risk Assessment Report experience, that will need more
Guidance for Hazardous Identification of new chemical substances time to be changed.
Measures on Expert Management for Chemical Environmental Management Notice
Case 1: Generic name of a serial products Penalty:
• 10,000CNY-30,000CNY
Case 2: Plant extract – whether a plant • Repeal certificate
extract shall be notified only for itself (but “Mild” punishment
purification seems difficult); or notification of
plant extract in a solvent is allowed

19. China Hazardous Chemicals
Overview of the legislation framework SAWS Order 53 and MEP Order 22 (Comes into force Mar 2013) SAWS Order 57
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20. China Hazardous Chemicals
Overview of Hazardous
Chemical legislation
Catalog of Hazardous Chemicals (China Classification & Labeling (C&L) inventory)
Registration System SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113)
State Council Decree 591 Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57)
Regulations on the Control over Safety of Permit & License Manufacturer | Importer | Operation | Distributor & storage | Transporting | User
Hazardous Chemicals (top law)
China GHS Leave to the 3rd part
Dec 2011 SAWS Order 41
Measures for the
Administration of Hazardous Aug 2012 SAWS Order 53 May 2013 SAWS Order 57
Chemicals Safe Production Measures for the Measures for the
Permit Administration of Registration administration of Hazardous
of Hazardous Chemicals Chemicals Safe Use Permit
Feb 1987 Mar 2002 Decree 344 2011 Decree 591 Sep 2012 SAWS Order 55 Mar 2013 MEP Order 22
Regulation on the Safe Regulation on the Control Regulation on Safe Measures for the Measures for Environmental
Management of over Safety of Hazardous Management of Hazardous Administration of Hazardous Management of Registration
Hazardous Goods Chemicals Chemicals Chemicals Operation Permit of Hazardous Chemicals
Invalid Invalid Issued Came into force Came into force Came into force Come into force Come into force
1986 2002 2011 Dec 01 2011 Aug 01 2012 Sep 01 2012 Mar 01 2013 May 01 2013

21. China Hazardous Chemicals
State Council Decree 591
Hazardous chemicals are administrated through a complex
regulatory network in China, with more than ten ministries
involved. As the key legal document, Decree 591 sits at the
top of this structure. English ver. available on
Chemlinked.com
Who will be the enforcement The specific responsibilities
? bodies?
SAWS:
• Implementation of registration of hazardous chemicals;
MIIT (Primary authorities) • License system (Order 41 Order 55 Order 57 –
manufacturing; operation; use)
NRCC-SAWS + SAWS
MEP
AQSIQ:
MOT • Implementation of registration of hazardous chemicals;
Each enforcement body • Implementation of enforcement actives over packaging and
SAIC will be responsible for storing of hazardous chemicals; also the QS license(license
specific part. for industrial product manufacturing)
MOA
MPS
MPS:
AQSIQ • License of purchase of extremely toxic chemicals ;
• Permit of transport of extremely toxic chemicals on road;
SDPC

22. China Hazardous Chemicals
Whose obligation?
Who will be affected by the
? Decree 591? What actions shall be subject to
? the Decree 591
Manufacturer in China
Production Use
Importer in China
Sales and storage Transportation
Only Chinese companies
Distributor and storage company
will be affected directly.
Transportation company in China It will affect the whole
supply chain
Chemical user in China

23. China Hazardous Chemicals
Why Decree 591 also matters
to foreign companies?
On one hand, even though your company is located far away from China Mainland, the
suppliers or importers of hazardous chemicals listed in the catalogue in China will have to
1
face even stricter inspection of the enforcement authorities. So get to know whether
your business partners have been aware of the responsibilities they shall
fulfill in pursuant of SAWS Order 53.
It is a domestic law, then why it
? matters to overseas enterprises?
One the other hand, because the implementation of China GHS draws extremely high
2 attention of the competent authorities, companies outside China shall pay much more
attention to their preparation of GHS compliance, especially
classification, labeling, SDS and packaging instead of roughly doing translation
or simply ignoring differences of standards applied from area to area.

24. China Hazardous Chemicals
Catalog of Hazardous Chemicals
The to-be-released new Catalog of Hazardous Chemicals 7000+ Inventory of Hazardous Chemicals
(China C&L Inventory) is the spirit of China GHS. (China C&L Inventory), first batch of
4,000 chemicals might be released around Jun.
(But with no classification this time…)
To be updated
3800+ 335+ Extremely Toxic chemicals
(2002ver.) synthetic substances & mixtures(agrochemicals)
• came from Catalog of Hazardous Chemicals
(2002).
• This is a domestic rule, import and export of
What are the hazardous The current Catalog of Hazardous those toxic chemicals are not in the scope
? chemicals under Decree 591? Chemicals came up with Decree
344
+ • Under Decree 591, Art (23) (24) (25) (35)
(38) (39) (40) (48) (50) has regulated the
Those chemicals have been defined as
production, use, sell and
“highly toxic chemicals” or other chemicals
purchase, transporting of extremely toxic
with toxic, corrosive, explosive, flammable
chemicals
and other properties, which will do harm to
people , facilities and environment. C&L Inventory from EU, Japan will also be
Out of scope (under specific control laws) referred to for the update of the new Catalog
- explosives for civil use ;
- fire cracker, fireworks; Hazardous chemicals or those with priority environmental concern under MEP Order 7 may
- radio-active substances; likely be one source where the new Catalog of Hazardous Chemicals come from
- dangerous chemical for national defense; in the future
Additional information: Additional information: 335 toxic chemicals: Company holding safe
3800+ Catalog of Hazardous Chemicals (2002rev.|EN) 335 Extremely Toxic Chemicals(2002rev.| EN) production, operation, use permit (SAWS Order 41 55 57) to
conducting purchase.

25. China Hazardous Chemicals
What new Catalog looks like?
The new catalog(China C&L Inventory) will be specific, more elements
introduced.
“In the new version of Catalog, the chemicals will come
with the information and hazardous properties .”
New Version to be
New Catalog of Hazardous Chemicals
published
(China C&L Inventory)
Product name
Other name
English name
Other EN name
CAS# UN# Hazardous
classification
GHS pictogram Signal word Hazardous
statement
Remark
7000+
Current version 2002
Current Catalog of Hazardous Chemicals
3800+

26. China Hazardous Chemicals
Emergency Response Call
A question everyone will ask. ER call has been a must for registration
of hazardous chemicals (Art.22 SAWS Order 53), China GHS-compliant Keep these in mind
SDS and label. Last page of overview of Decree 591
1) For companies those are planning ER Unit on their own
• ER call should be a Chinese landline; 24h on-duty
• designated staffer as 24h supporter; Chinese
• staffer should be well trained with competent capabilities
of hazardous chemicals handling;
Landline
+
2) Other companies shall appoint accredited agent to handle
ER responsibilities.
Importers of hazardous chemicals shall set up ER unit or commit the preparation of Designated-&
ER work to import agent or registration institutes. As we have noticed there is only -trained staff
one qualified 24h ER call institute (NRCC- SAWS Order 53 Art.6(4)) located in China
so far till now.
Or
3) Penalty: <30,000CNY for failure in preparation of ER call.
We have been aware that NRCC will take random inspection over the ER call installation.
Hand this to
service provider
Useful link: NRCC emergency response call
http://er.nrcc.com.cn | t: (+86) 0532 8388 9090

27. Registration system
Overview of SAWS Order 53 (I) Registration online
Measures for the Administration of Registration of Hazardous Chemicals. This
new regulation specifies the procedures of registration of hazardous
chemicals, and stresses the implementation of China GHS. English ver. is
available on chemlinked.com
• Manufacturer of hazardous chemicals in China
• Phyiso-chemical and hazardous properties; • Importer of hazardous chemicals in China
Focus • Classification and labelling; Who
Chemical users or storage companies of hazardous chemicals
on • Storage condition, safe use &transport; affected have been released from registration obligation under this new
• Protection and emergency response; order.
• Main uses & restricted uses
Competent
NRCC-SAWS | SAWS
Authority
Oct 2002
Measures for the Administration of 2012 SAWS Order 53
Registration of Hazardous Chemicals by Measures for the
the former State Economic Trade Administration of Registration
Commission (now integrated in the of Hazardous Chemicals
Ministry of Commerce)
Invalid Issued Came into force
2002 2012 Aug 01 2012

28. China Hazardous Chemicals
Registration system
Overview of SAWS Order 53 (II)
• Catalog of Hazardous Chemicals • Build files for hazardous chemicals;
What 3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory Registrant • Register hazardous chemicals & accept inspection;
• Designate staff to be responsible for registration;
chemicals obligation • Entrust qualified institutes to conduct hazard
• Chemicals not subject to the Catalog but with hazardous classification
identification;
by accredited institutes
• Set up 24h emergency telephone consultation.
Specific guidance will be published later for hazardous identification and
classification
1) List of chemicals of required for hazard identification and • A Company producing and importing same hazardous
classification(unavailable) chemicals shall register as manufacturer, providing the
2) Measures for the Administration of hazardous identification and classification Notice information of the imported hazardous chemicals.
update: Measures on the Management of Physical Hazard Identification • An importer importing same hazardous chemicals from
and Classification for Chemicals and more practical guidance will be given different manufacturers shall register chemicals of the
3) Accredited institutes manufacturers for its first trade , and furthermore provide
• For physical hazards identification: 2 Labs (one attached to NRCC) the information of such chemicals from other
• For toxic hazards identification: 20 MOA-accredited labs manufacturers.
• For eco-toxic hazard identification: 9 MEP-accredited labs • Manufacturers and importers importing same hazardous
chemicals from the same manufacturers for many times
shall only register the chemical once.
Useful link:
Measures for the Management of Physical Hazard Identification Source: officer from NRCC-SAWS
and Classification for Chemicals (chemlinked.com)

29. China Hazardous Chemicals
Registration of Manufacturer
under SAWS Order 53 Content of registration
Key points of registration to be carried out by a manufacturer • Information of manufacturer (the registrant)
of hazardous chemicals 1) Extremely toxic chemicals (the list of 335 substances)
2) Hazardous Chemicals under Priority Management (2
batches, 13 chemicals in the 2nd batch have been published
formally on 10 Feb 2013)
Prior to the final acceptance of a  List of produced chemicals (all chemicals in one certificate)
When newly-built chemical plant  Identification of source of major hazards
to register  Identification of priority-management process of hazardous
chemicals
Manufacturer: • 2 original copies of Registration form of • Information of each hazardous chemical (core)
Companies make concentrated hazardous hazardous chemical producer/manufacturer; 1) information of chemical
• Business license of registrant; What to be 2) the manufacturer of hazardous chemicals imported
chemicals. However, hazardous chemical
• 1 copy of SDS and China GHS-compliant 3) composition
purchasers, repacking or dilute it with non- submitted 4) classification & labeling (hazard category, pictogram,
Precautionary Label (GB 15258-2009);
hazardous solvents are not considered as • Emergency response call number (Art.22 SAWS warning signals, hazard statements, precautionary statements)
manufacturer Order 53) or 1 copy Emergency service contract; 5) physic and chemical properties
• Product standard of the hazardous chemicals to 6) main uses and advised uses against
be registered (national standard-GB or industrial 7) hazardous properties (physical hazards, health hazards &
standard to be provided) environmental hazards)
8) occupational exposure limits in working place
9) storage conditions and transportation information
10) protection measures and emergency response
Useful link:
Useful link:
The interpretation of registration form for manufacturer and importer
List of Hazardous Chemicals under Priority Management (2nd Batch) (chemlinked.com)
of hazardous chemicals in China

30. China Hazardous Chemicals
Registration of importer
under SAWS Order 53 Content of registration
Key points of registration to be carried out by an importer • Information of downstream user of chemicals imported
of hazardous chemicals or Information of trader of chemical imported
1) Extremely toxic chemicals (the list of 335 substances)
When 2) Hazardous Chemicals under Priority Management
Prior to any importing activities
to register  List of imported chemicals (all chemicals in one certificate)
 Identification of source of major hazards
 Identification of priority-management process of hazardous
• 2 original copies of Registration form of hazardous chemicals (only for downstream user or companies with storage
chemical producer/manufacturer; facilities)
• Business license of registrant and 1 copy of any
Importer (trader or downstream of following document or certificate: What to be • Information of each hazardous chemical (core)
 Foreign trader registration certificate or submitted 1) Information of chemical
chemical user)  Import and export enterprise qualification certificate 2) the manufacturer of hazardous chemicals imported
• Companies have secured business or 3) composition
licenses and the certain documents  Foreign investment approval certificate; or 4) classification & labeling (hazard category, pictogram,
or certificates, being allowed to  Hong Kong and Macao and overseas Chinese warning signals, hazard statements, precautionary statements)
conduct importing activities of investment enterprise approval certificate. 5) physic and chemical properties
hazardous chemicals. • 1 copy of SDS and China GHS-compliant Precautionary 6) main uses and advised uses against
• For chemical user after importing Label (GB 15258-2009); 7) hazardous properties (physical hazards, health hazards &
activities, company will put • Emergency response call number (Art.22 SAWS Order environmental hazards)
hazardous chemicals into industrial 53) or 1 copy Emergency service contract; 8) occupational exposure limits in working place
• Product standard of the hazardous chemicals to be 9) storage conditions and transportation information
production.
registered (national standard-GB or industrial standard 10) protection measures and emergency response
to be provided)

31. China Hazardous Chemicals
Registration procedure
under SAWS Order 53
In this section, let’s go through the registration procedure for importer of
hazardous chemicals under Order 53.
Legal liabilities
Step1 Step2
Fail Fail • Fail in registering
Notice of rejection of registration Notice of rejection of registration • Fail in updating information of
application application hazardous chemicals or new hazards
Fine:<50,000 or
Registration Registration 50,000-100,000CNY
Apply through online office Submit hardcopies of office NRCC
registration software (provincial registration materials (provincial level) Final check
Registration Certificate
(NRCC) level) to registration office format check Validity period: 3 years • Fail to provide ER number or
format check at provincial level • Remain the information on the certificate unqualified ER service
up-to-date (update online within 15 days • Fail to update information of
when changes occur) registrant, ER number, company seat
• Extend the certificate after 3 years (apply • Fail to apply for extension as
3 work days 20 work days 15 work days for verification of extension of certificate certificate expires
online 3 months before it expires) • Forge certificate etc.
• Illegally obstruct enforcement
activities and inspection
Useful link: Fine:<30,000 CNY
Online registration software (NRCC-Chinese only)
Chrome “Adblock plus” may block the pop-out tab

32. China Hazardous Chemicals
Supportive documents
This page is just for your reference. SAWS Notice [2012] No. 144
Registration form of hazardous chemical
1 producer/manufacturer
2 major supportive
8 Registration form of hazardous chemical importer
documents
Doc. 2 (Sections to be finished by trader & downstream user
separately)
Oct.17 2012
• Application form of subject registrant
3-8 • Application form of registration modification
• Evidential document of registration modification
(no registration certificate to be re-issued after
modification)
• Application form of registration certificate
renewal (certificate expires)
• Notice of rejection of registration application
• Notice of requesting supplementary materials
Useful link:
NRCC Consults on 8 Supporting Documents for SAWS Order 53 (chemlinked.com)

33. China Hazardous Chemicals
Roadmap of Order 53
Brief the plans of the authority for the registration and
management of hazardous chemicals. Last Page of
SAWS Order 53
Currently Look into future
Supportive documents, tons of guidelines Registration officers to be trained with necessary Complete the procedure of registration and post-
to be published (8 documents and more) knowledge – GHS, data evaluate, procedure (Mar registration (review and renewal)
2013)
Heavy workload of online registration Guidance for the registration of substances & New database of hazardous chemicals is planned
system optimization mixtures with unknown hazardous properties to be established within 3 years in the future
The registration of hazardous chemicals is promoted The implementation of hazardous identification for
mainly amongst Chinese importers at the 1st stage chemicals with unknown hazardous properties
Source: officer from NRCC-SAWS
No clear timeline for the
implementation of plan
above specifically
SAWS Order 53 is different from

34. another registration regulation
MEP Order 22
Registration system
Overview of MEP Order 22
(I)
Measures for Environmental Management of Registration
of Hazardous Chemicals. Taking existing hazardous chemicals • Manufacturer and user of hazardous chemicals in China
Focus the managementis available on chemlinked.com
of general hazardous
under control. Englishtoxic chemicals and chemicals with
ver. Who • Importer and exporter of toxic chemicals in China (foreign
chemicals,
companies qualified under MEP Notice [2009] No. 113)
on higher hazardous properties against human health affected Application scope is to be confirmed. However, in Art.2 of MEP Order 22, it
and environment. Some content may be also
indicates that only companies located in China will be subject to the law;
shared with SAWS Order 53
Useful link:
Competent
MEP Order 22 vs SAWS Order 53 (chemlinked.com) CRC-MEP | MEP
Authority
1994 SEPA Order [1994] 140 1994 SEPA Order [1994] No.140 2009 MEP Notice [2009] No.113 2012 MEP Order 22
Regulation of Environmental Revision of Regulation of Notice of the Environmental Measures for Environmental
Management on the First Import Environmental Management on the Administration of Registration of the Management of Registration of
of Chemicals and the Import and First Import of Chemicals and the Import and Export of Toxic Hazardous Chemicals
Export of Toxic Chemicals Import and Export of Toxic Chemicals (practical guidance on Order 140 and Notice 113 to be
Chemicals toxic import & export registration) incorporated into MEP Order 22
41 items revised
May 01 1994 ]= Valid No regulations for
Valid Issued (Trail) Come into force
production or use of
SEPA replaced by MEP Jan 2 2003 toxic chemicals SEP 2009 Oct 2012 Mar 2013

35. China Hazardous Chemicals
Registration system
Overview of MEP Order 22 (II)
What Refer to extremely toxic chemicals Only the regulation of MEP Order 22 has
Supportive been published, other guidance or
and other chemicals listed in Catalog
chemicals of Hazardous Chemicals. documents supportive documents are still absent.
Manufacturer and user of
Importer and exporter of toxic chemicals
hazardous chemicals
Catalog of Hazardous Chemicals List of Toxic Chemicals Severely Restricted to
• General hazardous chemicals be Imported into or Exported from China
3800+ chemicals (version 2002) to be re-issued 158 chemicals (version 2012) for 2009 MEP
or know as China C&L Inventory but not listed in Notice [2009] 113 “Notice of the Environmental
HCPEC list. Administration of Registration of the Import and
• Hazardous Chemicals of High Priority Export of Toxic Chemicals”
Concern （Currently more important)
Chemicals listed in the New Catalog will be Notice:
through assessment according to the certain Under SAWS Order 53, before import of these 158
benchmark of hazardous and environmental toxic chemicals, a Chinese importer should be
risk level and later be decided as HCHEC or not. register them by submitting application to NRCC-
Chemicals like PBT, vPvB, EDC or seriously SAWS as well. CRC-MPE is mainly taking in charge
environmentally-hazardous chemicals with of the management of those 158 toxic chemicals
solid evidential proof will mostly be treated as
HCHEC (This list will be published by MEP)
Useful link: Additional information: 158 chemicals
Chinese Official Clarifies Must-Know Issues on MEP Order 22 List of Toxic Chemicals Severely Restricted to be Imported into or
Exported from China
(chemlinked.com)

36. China Hazardous Chemicals
Obligation of each role in one table
Under MEP Order 22
Role Chemicals Registration & License Materials prepared Related Responsible
regulation authorities
Application form of registration certificate;
registrant information; produced or used EIA: MEP will issue guidance
Manufacturer & General hazardous Registration Certificate of hazardous chemicals including quantity; MEP Order 22(Trial) Local environmental
for EIA operation
User of hazardous chemicals (in Catalog environmental management of classification; SDS; prevention and control under Decree 591 protection authorities
Environmental monitoring
of hazardous hazardous chemicals measures; emission of the typical pollutants; (County level)
chemicals report: shall be generated
chemical) Environmental Impact Assessment(EIA);
contingency plans for emergency; disposal; by the applicant or the
annual report (Jan each year) to public on hazards, qualified environmental
emission of pollutants, protection measures; monitoring agency
Environmental monitoring report
Annual report: For
Addition to the material required from general manufacturer or user of
Manufacturer & Registration Certificate of hazardous chemicals; Environmental Risk MEP Order 22(Trial) Local environmental HCPEC to submit before Jan
User of hazardous HCPEC environmental management of Assessment(ERA) conducted by qualified under Decree 591 protection authorities 31 each year to the
hazardous chemicals institutes; Annual report of emission, migration (provincial level) administration of
chemicals
and monitoring result of particular pollutants, and Environmental Protection at
protection measures against pollutants and
county level.
environmental risks
Importer and exporter of
• Registration Certificate for • Application through CRC software + other toxic chemicals
Importer and Toxic Chemicals environmental management on documents submission MEP Notice [2009] CRC-MEP (a foreign company could
exporter of toxic Severely Restricted to Import (and export) of Chemicals • Materials are different according to foreign NO. 113 & MEP do registration on their own
be Imported into or & Import release permit for importer companies; importer as user; importer as In future MEP Order or appoint Chinese
chemicals
Exported from China • Export release permit for exporter trader; importer as representative of foreign 22 importers to finish it on
companies: their behalf)
Useful link:
MEP Order No 22: A Big Step but Long Way Ahead (chemlinked.com)