Chinese regulation guidance

An easy outline
of Chinese Chemical Regulations
A revised version

Special thanks to the contribution of

Cora Knutson

HelpyouKnowit

Mai Fung | Global Chemical Regulatory Consultant

HelpyouKnowit
The file is made by Mai.Fung,
which intends to help you know more
about the content n of Chinese
chemical legislation.

Additional information please let me
know by sending email.

HelpyouKnowit

>> Content
Recent update

> Order 7 by MEP (not applied in Hong Kong neither Macao) Updated on 29 Feb 2012
Notification of New Chemicals

> Decree 591 by State Council (not applied in Hong Kong neither Macao) Updated on 16 Dec 2011
Existing Hazardous Chemicals

> China GHS, and labeling
To be finished

> Hazardous Chemical of Import & Export Updated on 07 Mar 2012
AQSIQ implements inspection and enforcement

> 158 Toxic Chemicals restricted from Import & Export Updated on 06 Mar 2012
MEP released the 2012 version of the catalog of restricted toxic chemicals

> Order 27 by MOH Updated on 16 Mar 2012 (middle way)
Disinfectants Regulation in China

“Linkedin” me What will come soon?
 A topic of label on industrial or consumer products is being planned
Maij1217@gmail.com  Narration is considered to be added in this presentation material

HelpyouKnowit

>> Key updates

Mar 21 12 One point to be noticed
Decree 591;
China GHS inspection
Specific explanation of AQSIQ inspection over Haz. chemicals

Mar 14 12 The catalog added for download (English)
335 extremely toxic chemical substances under Decree 344
Extremely Toxic
Catalog

Many mistakes fixed and format adjusted

Mar 07 12 Newly-added slides
New regulatory added Regulation of toxic chemicals import and export by MEP

HelpyouKnowit

It is complex, but no need to worry
Chemical-regulation related departments

The top rank

State Council
Please be informed:
All the departments would be involved in some
parts of the regulations either New Chemical
The Ministry Notification(Order 7 by MEP) or Decree 591 by
SC

 MEP Ministry of Environmental Protection
 MoH Ministry of Health
 MoR Ministry of Railways
 MoA Ministry of Agriculture
 MIIP Ministry of Industry and Information Technology
 MoT Ministry of Transport
 MPS Ministry of Public Security

The State Administration

State Administration of
 SAWS
Work Safety of State Council
General Administration of
 Customs
Customs of China
General Administration of Quality
 AQSIQ Supervision, Inspection and
Quarantine HelpyouKnowit
Driving Green Chemical

Regulation Releasing and Management Leading
Major Inspection and Enforcement

State Council
Regulation releasing
MIIP MoH

MEP MoR
MEP Local MEP

MoT MoA
SAWS
SEPA(State of Environmental
Protection Agency) became MEP in
2008, and the latter one is short for
MPS
The status of Administration is
Ministry of Environmental Protection lower than Ministry, although they
are in charge of critical specific areas.

Pollution prevention
SAWS
Division(-MEP)
…
Customs
Chemical Registration National Registration AQSIQ
Center (-MEP) Center for Chemical (-SAWS) Local CIQ of AQSIQ

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CHINAREACH
Order 7 by MEP >

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China REACH is not a proper name
China REACH is just a name that helps you to quickly understand

Order 7 by MEP or Environmental Administration of New Chemical
Substances in China should replace the current name as China REACH

Unlike EU REACH: China REACH: Order 7 by MEP for new
… the EU REACH program (where there is pre-registration chemicals
requirements and then submission of dossiers by a certain date, Make an enquiry to the authority for the confirmation whether the
followed by government assessment of a small fraction of chemical substance is new or not; the complaint implementation
would be different dependent on tonnage band or according to
those submitted dossiers, and authorization/substitution of
some detailed requirements. Limited data is required as well
substances deemed to be of concern)
>> By Karen Levins from Intertek Cantox New Chemical
(similar to Non phase-in substance)
Non-Phase-in substance Phase-in substance

Existing chemical (especially hazardous
chemicals)
The management may be involved in data requirements, testing
data r, risk assessment report required, national standard of risk
assessment is being drafted and discussion
>> By Xiao (X) Zhang from Dow Corning

Existing chemical
(similar to phase-in substance)

HelpyouKnowit

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Order 7 by MEP is New

SEPA changed to MEP
Order 17 changed to Order 7 .

Order 7 by MEP
Entered into force 15 Oct 2010
Order 7 by MEP
Issued 19 Jan 2010
Order 7: Revision of Provisions on the
Environmental Administration of New
Chemical Substances in China

X
Order 17 by SEPA 15 Oct 2003
Entered into force
Order 17: Provisions on the
Environmental Management of New
Chemical Substances in China

7 years

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Updates on 05 Dec 2011
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Notification under Order 7 matters to you & your Business

No Notification, No Market
Your new substances shall be prohibited in China without notification

Severe punishment
If a new substance notification failed to be submitted
 The company will be warned, fined and even forced to close
 And not be allowed to submit notifications within next 3 years;

It also matters to the environment
Whether a new substance has been notified is a crucial aspect of environmental
impact assessment, so please do obey the rules

HelpyouKnowit

Updated on 29 Feb 2012
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Step by step
To evaluate if you have been affected by the regulation before
you start your compliance

Who affected What substances Comply
are new
Whether your products Whether those chemicals If you do have been affected,
have be affected because of some chemicals are new in China then learn how to comply with it

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A chemical regulation on New Chemical Substances
The new rule clearly specify what should be regulated and taken under control

What would be regulated in
the scope of Order 7 by MEP

New Chemicals (Not in IECSC)
 A New Substance itself
 New substances in Preparation
 New substances in articles intended to be released
-----------------------------------------------------
New substances used as ingredients or intermediates for producing
 Pharmaceuticals
 Pesticides
 Veterinary drugs Please be informed, we are now confirm TGAI(Technical Grade Active Ingredient) and
technical are not in the scope of Order 7 by MEP, because the use of those products have
 Cosmetics been identified as pesticide products.
 Food additives
 Feed additives

IECSC: Inventory of Existing Chemicals Substances
- 45,602 existing chemical substances (till Dec 7 2010)

Where to find IECSC （in English）
http://www.crc-mep.org.cn/iecscweb/IECSC.aspx?La=1

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A chemical regulation on New Chemical Substances
Some categories of chemicals may benefit from exemption from this law

Exempt from
Chemical substances or related products the Order 7 by MEP

Radioactive substances, military industry products, pyrotechnics, biotic substances,
Category 1: pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods, food additives, feed,
Products subject to other existing regulations feed additives, tobacco and tobacco products.

1. Chemical substances unprocessed or only processed in the ways below
Category 2: 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6)
Substances exist in nature Heat dehydration.
2. By any means, substances extracted from the air
3. Natural polymer with no chemical modification
4. Biomacromolecule like RNA, DNA or protein

Chemicals for Non-commercial purpose or chemicals unintentionally produced
Category 3: 1. Impurity, produced from raw materials or secondary reactions. One single of those
Substances of noncommercial purpose or unintentionally produced impurities in final products should not be over 10% w/w, all impurities in final products
should not occupy over 20% w/w
2. Chemical produced from reactions 1) new chemicals from random reactions 2) new
chemicals produced from random reactions between chemicals, mixtures or articles in
storage 3) new chemicals produced from random reactions between chemicals,
mixtures or articles in final use (unintentionally)
3. Waste water, gas or solid waste or other by-products

Category 4: 1 Material: Glass; .Frit; Pottery raw materials and ceramic ware; Steel and steel
products; High-alumina cement; Portland cement;
Substances of special categories
2. Homogeneous and heterogeneous alloys, except for metal compounds and precisely
defined intermetallic compounds
3. Non-isolated intermediates
4. New chemicals in Articles expect 1) new chemicals intentionally released from the
final articles 2) new chemicals intentionally released from the final articles in use (quite
the same as the definition under EU REACH)

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Notification body – like EU REACH, only within China
Who shall and who is not obligated

Out of China Mainland China Mainland

Hong Kong & Macao are not affected
by this law
Chinese NA*

Subsidiary
1 of Foreign Companies

Foreign Companies Manufacturers
Selling new substances to China of New Chemicals

Importer
of New Chemicals or

Companies hope to change the
registered uses of New Chemicals

Notification not required Notification required

* Notification Agent= NA
Notify on behalf of Foreign companies
http://www.cirs.ie/China_Chemical_Regulation/IECSC_China_REACH_China_Ne
w_Chemical_Registration.html

The uses under “Priority hazards for environmental
management” on IECSC

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What the notification Process looks like?

Different Roles
Process

MEP MEP issued Order 7
MEP decides the results
Catalog of Hazardous
Chemicals (SAWS)
Ministry of State Council MEP takes charge of management
New hazardous chemicals classified Hazardous
and Priority Environmental Management of MEP
Would likely be included Catalog of Hazardous
Chemicals of SAWS
Technical evaluation
Taskforce for Evaluation provide Feedbacks

Receive Registration Application
CRC-MEP Formal Check of materials （CRC）

Notification Result –Every 6-month reported
New chemical classified:
- General (5 years before included in IECSC)
- Hazardous (Pending and Evaluation) +86 10 8491 765 6
- Priority Environmental Management Call for technical supports from CRC
Local MEP
Inspection
Submit related dossier and data
9 qualified labs in China for eco-toxic

 Search through IECSC portal
Notification Body to find your substance in the list or not
 Make enquiry for 3166 confidential
Substances (22Euro or 30USD)

 Confidential substance: another database to help define substance

Updates on 29 Nov 2011
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Foreign companies – choosing notification bodies strategically

Please be advised: choose the notifier carefully
be careful if you choose your Chinese customer(importer) as the
notifier instead of you, you may lose your upper hand because you
have to rely on them because of their notification certificates in China.

Out of China Mainland China Mainland

Role A : *
Parent Companies
Role B : Assigned by A
NA Company 1
1 Service Providers playing as NA will serve Foreign companies
* better. They are not involved in real business, but offer Belongs to A: Importer
Predominant technical supports and keep confidentiality. Factory Plant & Subsidiary 2
2 The Factories or Subsidiary Companies applying for certificate
as importer will benefit more themselves when they sell or Belongs to A: Notification Agent
make purchase . Factory Plant & Subsidiary 3
3 The Factories or Subsidiary Companies assigned as NA will be
Predominant allowed to notify on behalf of their Parent companies(Role A)
But they have to meet NA requirements* as Role B. Role C: Notification Body
Importer and Manufacturer 4
4 Your business partners, Importers or Manufacturers , as (business partner)
notification body would hold predominant positions and
Role D: Unqualified
more say throughout supply chains.
Distributor X 5
5
If Distributors are not the direct importers of the substance,
they are unobligated to complete notification . Who is the Certificate Holder?
NA’s name is Certificate Holder
1 3 Role A’s name is Applicant

*Predominant: - This is more about what Role A may benefit
*NA requirements: - approx. 330,000euro registered capital (for more, please make requests) Importer(Manufacturer)’s name is both
2 4 Certificate Holder & Applicant

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Implementation- before notification

Preparation Notification Post-notification

Preliminary Stage Necessary Certificate
Steps Management
What information needed during inquiry
 Company information
 Substance profile (CAS# | molecular formula etc.)
IECSC
- CIRS will help you with information collection and make inquires. Inquiry Typical Notification
For confidential substances
Some more information helps to decide
 3 types of Notification (next page) No need for other information here Simplified Notification
The inquiry is submitted online, after
payment. The result would be sent back as
Scientific Research Record
paper copy.

200RMB + (service charge by 3rd party consultant)
No obligation under the law

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3 Notification types based on different cases

Typical Notification > Simplified Notification > Scientific Research Record

Tonnage band At or Above Annual Volume of New Chemicals Annual Volume of New Chemicals
Criteria the Annual Volume of 1 ton of New Chemicals Between 0.1 Ton to 1 Ton Less than 0.1 Ton

(4 tonnage level) Divided into 2 parts Used for scientific research
Other Criteria
1-10 ; 10-100; 100-1000; over 1000tpa Basic condition and Specific condition or the sample is to be lab tested in China

Time for 4-18 Months  3-10 Months(basic condition) 14 workdays
Notification (largely dependent on testing arranged and  4-5 Months (specific condition)
conducted)

Remark For polymers containing less than 2% new  Basic :
chemical substance (w/w), if the polymer is planned to  Specific: * Please be informed that:
be included in the IECSC, then typical notification is a) New chemicals for export lower than 1tpa Scientific Research Record is the necessary work
required (not recommended) b) For scientific research with tonnage between 0.1 before Typical Notification and basic condition
to 1 ton per year of Simplified Notification because samples need
c) For technological research with tonnage less to be tested in China
Low concern Polymer:
than 10 ton per year
Only chem-physic data for typical notification
d) For polymer consisting of monomers already
Not Low-concern polymer: listed in IECSC
Full tests for typical notification e) for polymers containing less than 2% new
chemical substance weight by weight
Low concern condition:
（no quantity limit of such polymer imported）
No Heavy metal
a) for low concern polymers (if the polymer itself
Not Soluble in water
is not listed in IECSC);.
Not Soluble in organic solvent
Unstable in different PH solutions

For Chemicals used for PPORD * to be notified, and Scientific Research Record could be started once
specific case notification maintained valid within 2 years afterward the notification form submitted (other 2 not)

Where you may find the required data for Notification:
http://www.cirs.ie/China_Chemical_Regulation/Data_Requirements_New_Chemical_Notification_in_China_REACH.html

• Specific condition: A specific report for new chemicals (now developed by notification bodies on their own)
• PPORD: Product and Process Oriented Research and Development HelpyouKnowit

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Implementation- Compliant guidance

Typical Notification


Preliminary Necessary Steps Data & Dossier Certificate
Stage
The body of notification

4 Special formats of typical notification
Management
IECSC
Tonnage level unrelated

 Serial Notification
Inquiry 
-Similar substances notification at same time
Joint Notification
- Co-notification(data or cost-share policy needed to be talked
between co-notification bodies)
 Repeated Notification
- Notification by referring to the data owned by previous
notification bodies.

HelpyouKnowit
 Re-notification
- Notification for amount increased or uses changed; additional
data required; old notification certificate replaced by the new Driving Green Chemical
one
Find more by contacting Mai.fung@cirs.ie or mai.fung1217@gmail.com

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Preliminary Necessary Steps Data & Dossier Submission Certificate
Stage Management
The body of notification

IECSC
Data gap analysis You need more attention to this work; it affects cost and time

Inquiry Testing Proposal Largely dependent on the capacity of the contracted lab

Testing arrangement Largely dependent on the capacity of the contracted lab

Dossier generation Dossier template decided by CRC,
some information needed from company (like uses of new chemical)

 Spectrum  Toxic data  Eco-toxic data HelpyouKnowit
1  Chem-physic data 2 3 Driving Green Chemical

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Data & Lab- Must all data be generated in China?

Typical Notification The data of 1st and 2nd category is
preferred being generated from GLP labs,
following OECD methods if outside China

Mostly Not
 Spectrum  Toxic data  Eco-toxic data
1  Chem-physic data 2 3

Part of data in the 3rd category is strictly required to be
generated by 9 MEP-approved eco-toxic labs in China.
We suggested more tests be carried out in China.
 Many companies would be worried about
whether data generated outside China Minimum tests
accepted. conducted 1-10tpa Around 3 Months
in China (At least )One Toxicity test for aquatic organism
It turns out that the data acceptance is not so & (At least) one study on Degradation
exclusive as its political system of this country
showed in front of the western nations. Most
10-100tpa Around 3-5 Months
studies may be referenced if they were performed
to accepted standards by a lab meeting MEP
14 days extended toxicity study in fish (about 3Months)
requirements. Or Daphnia magna Reproduction study (about 4-5Months)
Or Bioaccumulation (about 4-5Months)
 Please be informed again: Please be advised, at least one test must be picked between
all above 3 tests
Scientific Record is needs here for the sample of
the substance to be tested in China
100+tpa- Around 6 Months
Chronic toxicity test for fishes

9 Eco-toxic labs approved by the MEP
http://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm

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Preliminary Necessary Certificate Management
Stage Steps  MSDS and hazardous information General New Chemicals

IECSC Notify
communicated to downstream users
 Risk management measures conducted
Inquiry  First-activity report submission Hazardous
 Registered information to be updated New Chemicals
(tonnage level, uses, activity, the Authorized
Approved
by MEP holder of the notification certificate) Priority hazardous new
 Keep documents on file for over 10 chemical substances for
years environmental
 New hazard to be updated if needed be management
 Only downstream users who are Restricted
capable of the implementation of risk For those 2, more
measures allowed to buy products obligations added
from the certificate holders.

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5-year
Notification completed

New chemicals
Added in IECSC

First activity

Using (sale) or Manufacturing of the Hazardous New Chemicals(Authorization)

+
new chemical for the first time after its - 1st activity report + annual activity report
notification in China
Priority hazardous new chemical substances
1st
The activity should be reported to for environmental management (Restricted )
- 1st activity report + each activity report +
the MEP as the first date of 5-year

5-year
annual activity report for the last year +
period. (Report template given by MEP) annual activity plan for this year

This period decided by the MEP is more like a
transitional time after the first activity date before
new chemicals allowed to be added in IECSC

 For general new chemicals, after 5 years, they would
triggered the action of being added in the IECSC automatically.
 For other 2 categories, Hazardous new chemicals, Priority hazardous
new chemical substances for environmental management would
be evaluated from multi-aspect during the 5 years. So the process
could be much more complex.

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Simplified Notification > Basic Condition Studies required Notification duration: 5-10 Months


Preliminary Data & Dossier & Doc
Development
Submission
Annual Report to the authority:
Stage 

Scientific Record Form
Simplified Notification Form
Before 01 Feb
 The figures of the production of
 Test report notified new chemical substance
IECSC  Other information: ES, production process
(annual tonnage, production days ); or
Inquiry tonnage imported etc.
 Chem-physic data  Eco-toxic data
1 2  The transfer information of the notified
 melting point within China
 water-solubility  Ready biodegradation new chemicals, including the overall
 Partition coefficient  Acute toxicity test for fishes tonnage of transfer and major
n-octanol/water  Acute toxicity test for recipients etc. in last year
earthworm
Test duration: 4-6 Months  The updated or renewed information
9 Eco-toxic labs approved by the MEP of the notified new chemical
http://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm substances during last year.

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Simplified Notification > Specific Condition No Studies required Notification duration: 3-4 Months


Preliminary Annual Report to the authority:
Stage Dossier and Document
Development
Submission Before 01 Feb
 The figures of the production of
notified new chemical substance
IECSC
 Scientific Record Form
 Simplified Notification Form (annual tonnage, production days ); or
Inquiry 

Documents as proof of specific condition
Other information: ES, production process
tonnage imported etc.

Polymer: GPC –  The transfer information of the notified
Gel Permeation Chromatography new chemicals, including the overall
tonnage of transfer and major
recipients etc. in last year

 The updated or renewed information
of the notified new chemical
substances during last year.

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Bring your doubts after reading the following pages

Simplified Notification > Specific Condition No Studies required

Case Study
A Special case
to know new substances in polymer

Please remember, Polymer product Sep 2010
polymers containing less than 2% exempted from notification under Order 17
each new chemical substance weight by weight. ( later replaced by Order 7 by MEP )

Simplified Notification(Specific Condition) is enough
Order 7 by MEP
entered into force Oct 2010

1 year

2%
<
A new substance in Polymer
Monomer is less than 2% (w/w)
Aug 2011
Simplified Notification
Please be advised:
No tonnage limit on the import of such polymer product is required,
so please consider about higher tonnage band during notification
“Please be noticed:
One year of exemption transitional time has passed.”

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Scientific Research Record

Scientific
Preparation Post-notification
Research Record

Preliminary For scientific

Stage
research use only  Scientific project starts
Notification Material Submission
Development to be conducted
Typical notification  Laboratories conduct
IECSC Documents to be prepared:
 The Record Form (template offered)
related tests for new

Inquiry
substances
Simplified notification  Attachments including license of
basic condition notification companies and scientific
research institutions (apply substances
directly; test proposal
The above 2 types of
notification demand  More than one substances notified
scientific record because together allow to be covered in one
a sample is asked for scientific research record
testis
2 weeks

Updates on 17 Feb 2012
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About notification cost- you need to know
To help you understand the structure of notification cost, and make it cost-effective

Cost breakdown

 MEP not charge for notification |
Administrative fee  IECSC search will be charged for a small amount of fee
 Companies who want to register new chemicals but located
Local agent fee outside China need to appoint local service provider as notifier
 Test fee would take the largest part of your cost especially when
3%
Test fee the cases fall into typical notification

17%
Smart-cost tips

Try saving test cost
Be sure your notification type is correct: Test cost
More information please refer to previous pages 3 Notification types based on different cases
80%
Reasonable data source is a key point: 80% (Dependent on specific cases)
 Avoiding unnecessary testing by taking advantage of referring to literature,
some database or data resulted from QSAR, reading-across reference etc.
 Consider the lowest-required tests according to different notification types.
 Foreign companies may use GLP-generating data for notification using
More information please refer to previous pages Data & Lab- Must all data be generated in China?

Strategic arrangements of studies: basic studies first, then come the advanced
 Finish basic or compulsory studies, and then higher-level studies to be carried out; In some
cases, based on the results from previous studies, higher-level studies would benefit from waiving. Administrative Local agent service fee Test fee Source:
 Case- the applicant could firstly conduct skin corrosive study and if the result is positive, then 28- Eric Xiong from CIRS
day repeated oral toxicity study could be waived, by which hundreds of thousands RMB for testing
can be saved (from Eric Xiong from CIRS)

HelpyouKnowit
Special formats of typical notification may save you much money:
 Serial Notification -Similar substances notification for avoiding unnecessary tests on group substances.
 Joint Notification - Data or cost-sharing between co-notification bodies of the same substances. Driving Green Chemical
(like Joint-submission of registration dossier under REACH)
 Repeated Notification - Notification by referring to the data owned by previous notification bodies (Like
the game rule of LOA purchase under REACH)

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How we offer our help
Not just providing compliance work, we are also well known to your suppliers in China

Preparation 1
1. Typical Notification
Preliminary Stage IECSC Search & Decide 2. Simplified Notification
3. Scientific Record

Notification 2
Scientific Record
 Information collection The easiest notification
 document preparation
Basic or Specific Condition?
Basic Condition Specific Condition Simplified Notification
+ Scientific Record  Information collection
 Forms and documents and document
 Studies analysis and tests preparation
proposal  Notification dossier
 Eco-toxicology properties submission and follow
tests arrangement & up
follow up
 Dossier develop and
submission; progress
report

+ Scientific Record Typical Notification
 Forms and documents preparation
 Data valuation, literature review, tests proposal
 Tests arrangements and follow up
 Dossier develop and submission; progress report

Post-Notification 3
& follow up 1. Preparation and Updating of information
2. Keep contacting the local authorities, reporting
necessary issues to fulfill obligation

NEXTSECTOR >
Please be advised-Way of Simplified Notification has changed

Transitional Time Till 31 Dec 2011 Online Simplified Notification Started 2012

Alternative 1: Alternative 1:
Paper Notification Material （SEAL） Paper Notification Material （SEAL） CRC-MEP

Alternative 2:
Email Notification Material （SEAL） Ok X
Notification
Body On test: Alternative 2:
Web-based Notification System Web-based Notification System CRC-MEP
Client-side Download:
http://www.crc-
mep.org.cn/news/NEWS_DP.aspx?TitID=379&T0=01000&Lan
guageType=CH&Sub=125

Contact：
Ma Xin - Max@crc-mep.org,cn
IT Support：
Deng Qing- Dengq@crc-mep.org,cn

Simplified Notification Material

Basic condition: Specific condition:
Limited Information & 3 Studies needed Very Limited information needed

DECREE591by
State Council >

HelpyouKnowit

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Decree 591 is revised

State Council State Council[2002] Decree 344
replaced by Decree 591 by SC Substance + Mixture
regulated at same time

Decree 591 by SC
Will Enter into force The 1st Regulation replaced by 01 Dec 2011
State Council[2002] Decree 344
Decree 591by SC 02 Mar 2011
Issued
X China GHS started on 1 May 2011
(both Substance + Mixture
Decree 344 by SC regulated at same time)

15 Mar 2002
Entered into force
X
1st Regulation by SC
17 Feb 1987
Issued & Entered into force

1987: Regulation Decree 344: Regulation Decree 591: Regulation
On the safe on the Control over on Safe Management of
Management of Safety of Hazardous Hazardous Chemicals
Hazardous Goods Chemicals

HelpyouKnowit

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What the registration looks like?

Different Roles
Process

State Council
Regulation issued by State Council
Regulation releasing

SAWS SAWS takes charge of management
State Administration of Work SAWS plays as leader role in Decree 591
Safety of State Council & releases Catalog of Hazardous Chemicals

… Catalog of Hazardous Chemicals (2002)
To be renewed

Check catalog: www.chinasafety.gov.cn/whpcx.htm

Receive Registration Application +86 532 8378 659 3
NRCC-SAWS Formal Check of materials （NRCC） Registration Call-in
Submit information (easier than China REACH)
for 3-year-valid certification & Renew 3
Registrant months before expiry

Importer &
Manufacturer in CHINA  Search through the Catalog to see if registration
needed;
 Obligation: safety evaluation report, production
license, safe use license, operating license, registration
of hazardous chemicals, SDS and chemical labels
(China GHS)

Other government bodies involved in implementation of the law
HelpyouKnowit
MIIP | MoH | MEP | MoR | MoT | MoA | MPS Administration of Custom | AQSIQ

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2 Major catalog of chemicals under Decree 591

Over 7,000
in new version

Likely to be merged

Catalog of Hazardous Chemicals Catalogue of Extremely Toxic Chemicals(2002rev.)
Pure Substance

Over 3,800 335 This is a domestic rule, import and
export of those toxic chemicals
are not in the scope

Version 2002 came up with Decree 344, Version 2002, substances majorly came from
and the new Catalog is to be published early Catalog of Hazardous Chemicals , but some
next year chemical substances were borrowed from
“List of Dangerous Goods (GB12268-90)” or
Manufacturers, Importer, other roles (distributors, even other lists.
warehousing and storing companies ) chemicals
within Chinese territory need to be sure whether If purchase or transport of chemicals in the
any of their chemical products are listed in the inventory of toxic chemicals happens, companies
Catalog, especially sensitive to the newest version will be required to apply for some licenses before
upcoming. actions.
But as we believe, the new version firstly comes
up as a draft before it become the decided one. Download
HelpyouKnowit

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You may feel less interested,
You will also find information of
because
If your company is located outside of mainland
China, it will not be directly affected by Decree
591.
China GHS
However,
your suppliers, business partners, importers,
or customers likely to have obligations under
the Decree which may affect your business.

Be sure
those companies are fully
understanding their requirements
so that your business
Stays Out of Trouble

HelpyouKnowit

NEXTPAGE >

Under Decree 591,
registration is the responsibility of
Importer & Manufacturers in China

But,
If you are the roles below,
what are your obligations?
Key words found in next several pages
Manufacturer in China

Importer in China
Distributor and warehouse, storage obligation, registration, license, implementation,
company enforcement authorities
Transportation company in China
Manufacturer (chemical user)
in China

You should pay more attention to under 591
Companies located outside China GHS compliant, SDSs and labels are necessary
You may have your contracted suppliers or partners in
China be aware of this law

NEXTPAGE >
Obligation: Registration & License Led by SAWs

Roles Registration Main License Chemical List

Manufacturer Registration Certificate License of Manufacturing Safety
1 China

Importer Registration Certificate License of Operation Safety
2 China Classification & labels SDS

Distributor License of Operation Safety
3 Warehousing X
Transportation License of Transportation on Road
4 Companies X License of Transportation in Water

Manufacturer License of Using Safety
5 Chemical User X
Roles
Chinese Manufacturers
Distributors
1 Bulk Chinese producers of Hazardous Chemicals
2 Hazardous Chemicals importers within Chinese territory Chemicals (Ver.2002 to be
updated)
3 Hazardous Chemicals Distributor s or warehousing service providers
Chinese Manufacturers
4 Bulk Chinese producers of Hazardous Chemicals Distributors Inventory of Toxic Chemicals

Chinese Manufacturer
5 Companies using Hazardous Chemicals to produce some chemical- Chemical User
The Directory of Industries
based goods in certain industries (follow the link by clicking here)
Criteria for Limit Volume

NEXTPAGE >
Your roles decide your obligations under Decree 591
Different roles mean different obligations and enforcement authorities

Manufacturers in China Obligation Responsible Authorities
What to be prepared
(different forms and documents usually)
 In case that a company
using hazardous chemicals Submit Registration  NRCC of SAWS  Registration Form
in its production and the - (final check)  Technical Safety Instruction of
final product still a  Local registration chemicals (Important)
hazardous chemicals in the offices(province)  Label (Important)
Catalog of Hazardous - (receive registration and check)  Emergency call (or contracted service)
Chemicals, this company NRCC registration platform:
 Business license issued by Industrial and
needs to do registration and http://register.nrcc.com.cn/
apply for the License of
Commercial Bureau
Manufacturing Safety.  Documents and Application
 Manufacturing Safety rules
This company should be
considered as a Manufacturer Routine Practice
rather than a Manufacturer License of Manufacturing Safety State Administration of Work Stewardship Documents
(Chemical User) Information changed Safety of State Council (SAWS)  Safety Management personnel document
 Safety Assessment Report by 3rd party
 If new hazardous chemicals  Emergency Rescue Plan & Record
are being manufactured after  Emergency Rescue Checklist
acquiring registration …
certificate and license, the
manufacturer needs to Safety License of Occupational NA NA
update both certificate as Hygiene
well as License of
Manufacturing Safety

SAWS: http://www.chinasafety.gov.cn/newpage/
NRCC: http://www.nrcc.com.cn/
TEL: +86 (0)532 83 8891 91
Local Registration office: HelpyouKnowit
http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=243&ChannelID=180 Driving Green Chemical

NEXTPAGE >

Importer in China Obligation Responsible Authorities
What to be prepared

Submit Registration  NRCC of SAWS  Registration Form
- (final check)  Technical Safety Instruction of
 Local registration offices(province) chemicals (Important)
- (receive registration and check  Label (Important)
 Emergency call (or contracted service)
NRCC registration platform:  License issued by Industrial and
http://register.nrcc.com.cn/
Commercial Bureau

 Application form of business license of
hazardous chemicals
 Catalog of relevant production safety
documents
License of Operation Safety Local Work Safety Department  Work safety standards and manual
(Same required as Distributor – (province )  Safety training and training materials
Warehousing & Storing)  Budget raised for manufacturing safety
of hazardous chemicals and budget
report
FIND MORE IN NEXT PAGE

 The Record of Hazardous  General Administration of  The Record is Optional (suggested)
Chemicals Imported Quality Supervision, Inspection  The Application composed with
 The Application for quarantine and Quarantine - self-declaration
inspection  Local CIQ (for direct - SDS and label document
implementation - If the Record completed, submit it
（to be confirmed）

SAWS: http://www.chinasafety.gov.cn/newpage/ AQSIQ: http://www.aqsiq.gov.cn/
NRCC: http://www.nrcc.com.cn/
TEL: +86 (0)532 83 8891 91
HelpyouKnowit
Local Registration office:
http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=24
3&ChannelID=180

NEXTPAGE >

Distributor Obligation Responsible Authorities
What to be prepared
Warehousing & Storing
Local Work Safety Department  Application form of business license of
– (City-level) hazardous chemicals
 Catalog of relevant production safety
Responsible for the management of documents
 Specialized in hazardous sales and  Work safety standards and manual
warehousing business  Safety training and training materials
 Budget raised for manufacturing safety
of hazardous chemicals and budget
License of Operation Safety report
(Same required as Importer )  Injury Insurance for employees or
Local Work Safety Department production liability insurance proof
– (County-level )  Business license issued by Industrial and
Commercial Bureau
Responsible for the management of  Property or leasing documents of
 Sales of toxic chemicals * business venues and facilities equipped
 Explosive chemicals * with
 Storing and sales of hazardous  Emergency Rescue Plan & Record
chemicals(gas station etc.)  Extra documents required when a
company is equipped with storage
facilities(gas station for example)
*Extremely toxic chemicals – a list of chemicals
issued in 2002 (335 chemicals up till now)
*Explosive chemicals - also a separated list of
chemicals

 Please be informed that you may find the contact information of Local
Work Safety Departments, however we do not believe that is necessary,
simply ask for help from your local distributors or consultants , they have
HelpyouKnowit
ways. Driving Green Chemical
 All documents to be shown to city-level or county-level Work Safety
Department dependent on the business your companies are running.

NEXTPAGE >

Transportation Companies Obligation Responsible Authorities
Implementation

 “TDG business” Application Form
 Daft report of dangerous goods,
Transport License of Dangerous Goods Ministry of Transport of P.R.C classification and operation plan
on Road  Special vehicles used for transport
(GB12268-2012 *) Transport of Dangerous  Identification documents and copies of
(GB6944-2012P *) Goods on Road Investor and personnel in charge
 Testimonial documents of parking area
for special vehicles, capabilities of safety
protection, environmental protection and
fire fighting device equipped
…

NA NA NA

Transport of Dangerous
Goods by Water
 Report of toxic chemicals and quantity to
be transported
Transport License of Toxic Chemicals Public Security Bureau  The details of transport, plan, destination,
on Road (County-level) route, fixed date
(Inventory of Toxic Chemicals *)  Purchase license or import license issued
Transport of Toxic Chemicals by the Customs
on Road  The qualification of drivers and other
certificates

* GB12268-2012: (here in Chinese) the inventory of dangerous goods MoT: http://www.mot.gov.cn/
(Be advised: some chemicals also found in the Catalog of Hazardous Chemicals ver.2002)
* GB 6944-2012: (here in Chinese) the classification of dangerous goods

* Inventory of Toxic Chemicals - English version please follow the link below
http://issuu.com/mai.fung/docs/inventory_of_toxic_chemicals__for_transport_and_pu?mode=window&backgroundColor=%23222222

NEXTSECTOR >

Manufacturers in China Obligation Responsible Authorities
Implementation
Chemical User
 Emergency Rescue Plan & Record
A Company using  Emergency Rescue document
hazardous chemicals as  Technical Safety Instruction of
major materials or even Chemicals
additives in its production
License of Using Safety Local Work Safety Department  Emergency response (people equipment
– (City-level) and checklist)
 Safety assessment report by 3rd party
 Manufacturing Safety document and
rules
…

 Please be noticed, hazardous chemicals need to apply for this license under Decree 591
only meet two descriptions below:
- The Directory of Industries
- Criteria for Limit Volume
Find the copies for your information :
http://issuu.com/mai.fung/docs/the_directory_of_industries_for_the_application_of
?mode=window&backgroundColor=

 Also please be informed that you may find the contact information of Local Work Safety
Departments, however we do not believe that is necessary, simply ask for help from your
local distributors or consultants , they have ways. HelpyouKnowit

NEXTPAGE >

You will also find information of

China GHS

 The comparison of differences between China and other areas.

 GB15258-2009
General Rule for Preparation of Precautionary Label for Chemicals

 GB16483-2008
Instruction of Safety Data Sheet, Content and Section

HelpyouKnowit

Regulation on Import & Export of AQSIQ
Hazardous Chemicals >
Specific implementations
since 01 Feb 2012

HelpyouKnowit

NEXTPAGE >
Import & export of Hazardous chemical products
The vehicle has been rolling since o1 Feb 2012

DECREE591 by State Council
Catalog of
 01 Dec 2011 …
Entered into force Hazardous
Chemicals
 Catalog of Hazardous Chemicals to be Ver.2002
The ver.2002 is to be updated under the
updated from Ver.2002 to a new version Decree 591
 SAWS is responsible for the Inspection
and enforcement of the Decree 591
within China;
 taking care of the new version of the
Catalog new version

AQSIQ + Customs
Selected from the
Chemicals Ver.2002
 Importer or exporter of the chemicals in Part of Statutory Inspection Catalogue

160*
the Statutory Inspection Catalogue 2012 2012
should fulfill the obligations under AQSIQ is responsible for the hazardous
related regulations issued by the AQSIQ chemical products import and export;
 Local CIQ implements inspection and currently focused mainly on the Statutory
management of compliance work of Inspection Catalog ; for other chemicals in
import & export of hazardous chemicals the Catalog of Hazardous Chemicals, they
will not be taken as top priority of AQSIQ’s
and packaging
inspection work for now

• The Statutory Inspection Catalogue 2012 (over 200 products) –
• But now only including 160 chemical products from the Catalog of Hazardous Chemicals Ver.2002
Please find the Statutory Inspection Catalogue 2012 in Chinese here (http://www.box.com/s/vged6ilflnv285x1no5x)

NEXTPAGE >
The obligations of import & Export of Hazardous chemical goods
CHINA GHS | SDS | LABELLING

Related Rules
Import into China Export from China
& Inventory
- SDS & Labeling preparation - SDS & Labeling preparation National laws and standards;
1 Following the newest version of UN GHS(Ver. 4th) Documents should be translated in Chinese if the
Industrial standards
Documents should be prepared in Chinese
original copies written in foreign language
(follow the local regulations where your products are
about to be shipped to ) China TDG & GHS

2 - The report of hazard profile prepared - Sample required to be tested in local CIQ approved Special requirements agreed
by the approved labs labs between national
including classification report of TDG & - The report of hazard profile prepared governments
GHS by local CIQ approved labs including classification
report of TDG & GHS
- Packing decided by the exporter according to the
classification report of TDG
- Exporter requires test reports of packaging and
containers from packing suppliers
Food additives
3 - Conformity Declaration of Hazardous-chemical - Conformity Declaration of Manufacturer of
Hazardous chemicals used in
importer (Template offered by the authority in Chinese) Hazardous-chemical imported (Template offered by the
authority in Chinese) food as additives is supposed to
meet the requirements of food
hygiene and product inspection
4 The authority will be responsible for as well as food safety
- Ensuring all information of components in the products to be imported or exported are the same inspection accordingly.
as reported in the information included Conformity Declaration for inspections
- Checking hazards classification information on the packing; checking if labeling is designed to be complied
with TDG(or IMDG, IATA DGR) and GHS
- Ensuring Chinese SDS provided affixed on packaging; checking if the SDS, labeling are correct
- Identify whether the packing method meets standard requirements and whether the use of packaging is
appropriate; check whether the packaging is sealed tightly; ensure whether the goods inside the packaged is HelpyouKnowit
not leaked. Driving Green Chemical

Updates on 2 Mar 2012
NEXTPAGE >
Inspection on chemical substances only, or chemicals in mixtures
The inspection is an extension of the implementation of Decree 591

Decree 591 >>

Decree 591 by SC Catalog of Hazardous Chemicals (2002) to be updated

CIQ inspection Inspection of CIQ on 160 hazardous chemical products ( Statutory Inspection
Catalogue 2012 ) imported or exported is part of the implementation of Decree 591

CIQ inspections are
only responsible
According to
for Export & Import
CN GHS

Both hazardous chemical substances or chemicals in mixtures CN Lab-
should be complied with hazardous chemical control law. SDS el

Notice
Emergency call should be Chinese
domestic phone number and the
contact also located in China.
24h
Emergency Call

Outside China Inside China

National Standards help you with your SDS, labeling under China GHS
- GB/T 22234-2008 labelling for chemical products under China GHS HelpyouKnowit
- GBT16483-2008 Content and each section in SDS Driving Green Chemical
- GB 15258_2009 General rules for SDS development
- GB 13690-2009 General principles of hazard classification and profile under CN GHS

NEXTPAGE >
Inspection list & Catalog of Hazardous Chemicals Ver.2002
2 lists but quite closely related

Decree 591 >>

How 2 lists are linked 160 chemicals
Catalog of Hazardous Chemicals (updated regularly)
The Statutory Inspection Catalogue 2012
(Ver.2002 currently still works)

Chemical
Chemical products
substances Ingredients are
already listed in the chemical substances
China Catalog Ver.2002 listed in the Catalog
Existing hazardous REACH Ver.2002
chemical
New chemicals identified
as hazardous chemicals

NEXTPAGE >
The inspection has been implemented
We list the areas where inspection is quite strict.

Shandong Shandong
Zhejiang Province
Province Province

Fujian Province Jiangsu Province City Shanghai

Guangdong
More & more…
Province

The authorities of the above areas
have started the inspection & enforcement already

Find out whether your business has been affected • Ensure your implementation of compliance will be • Cooperate with your service agents or your
Check the catalog | Have news from the local partner or your consultant initiated with no delay business partners, get material well papered

HelpyouKnowit

NEXTSECTOR >
One point to be noticed

AQSIQ (local CIQ) Only inspect Chemicals in
the Catalog of Haz. Chemicals

Imported chemical products are allowed to
be put on with GHS label after clearance
but in special warehouse
Catalog of Hazardous Chemicals
(Ver.2002 currently still works)

AQSIQ

X
AQSIQ shall not put any inspection upon
Chemicals with GHS
label but not in the
Catalog
chemicals out of the Catalog of Haz.
Chemicals even with GHS label
GHS label could be referred to GHS rules of
exporting countries.

Toxic Chemicals
MEP
Severely restricted from import & export>

HelpyouKnowit

NEXTSECTOR >
Learning steps – it is about restricted toxic chemicals
What would be the key issues you need to know?

Who Restricted Comply
May be affected Chemicals Strategy

Who might be Whether those chemicals If you do have been affected,
affected because of some chemicals have been or will be restricted in China then learn how to comply with it

The purpose of restriction regulation of toxic chemical import & export
+ Toxic chemicals should be strictly under control. The authority will have clear minds of what toxic
chemicals imported or exported, the amount, where the chemicals transported , who will be
responsible people, and impacts against the environment caused by the toxic chemicals

HelpyouKnowit

NEXTPAGE >
Who may be affected ? What responsibilities?
Who will be affected | what would be the main responsibilities?

Out of China
In China

Foreign Companies Domestic Companies
Located outside China Located in China
Export toxic chemicals into China Importer & Exporter of toxic chemicals

Who will be affected Who will be affected

>
>

Importer Exporter
Registration Certificate for the
Environmental Management on the  Import Clearance Notification Export Clearance
Import of Toxic Chemicals CRC  Registration Certificate for the Notification
of MEP Environmental Management on
Responsibilities the Import of Toxic Chemicals
>

Responsibilities

>
 Foreign companies that export toxic chemicals listed in the
“Catalog of toxic chemicals severely restricted to be
imported or exported(the newest version is 2012)” shall  An Export Clearance is
 An Import Clearance Notification
apply one Registration for each type of toxic chemicals Notification with a valid
is with a valid period of 6 Months
 Chinese importer should apply for import clearance period of 6 Months
 Import Clearance Notification
Notification by the Registration Certificate during import of  Export Clearance Notification
shall be applied for each time
each batch of same toxic chemicals shall be applied for each time

Please be informed
>

Please be informed
>

 Registration Certificate shall be applied each type of chemicals exported  Importer could apply for Registration Certificate instead of a foreign
+ to China once with a valid period of 2 years. + companies, but we recommend foreign companies should take the
responsibilities on your own or assign Chinese representative to do so.
 Import Clearance Notification shall be applied for each batch of each
toxic chemical to be imported into China with a valid period of 6 months
by providing Registration Certificate for this chemical.

NEXTPAGE >
Let’s review who would be responsible for application
Under different regulations

Toxic chemical import & export Order 7 & Decree 591
Business players
Under toxic chemical
Under Order 7 & Decree
import and export

X
Foreign company 591, foreign companies
regulation, foreigners are
are not qualified for
recommended to finish
Chinese manufacturer notification of registration
application

Chinese importer
Out of China
Chinese representative
In China
Subsidiary of Foreign
Under toxic chemical Decree 591 | Order 7
Companies but in China
import and export
regulation, importers are Decree 591 | Order 7
qualified for registration
but not preferred Order 7

Notice: Order 7*
Importers could apply for
registration certification on * - if a subsidiary of a foreign companies in
behalf of foreign companies China is acting as manufacturer or importer of
hazardous chemicals under Decree 591, it shall
apply for registration certificate.

Registration body under Order 7 & Decree 591 | Order 7 >> Decree 591 >>

NEXTPAGE >
The Catalog of restricted toxic chemicals
Check the catalog before export chemical products to China

2012 version Replaced
Catalog of toxic chemicals severely 2010 version of catalog 2012 version of catalog
by
restricted to be imported or exported

158
Pure substances
Chinese version

English version
>

>
http://www.box.com/s/illcyl3i95p0e1me04jd

http://www.box.com/s/3jbg9g1tn69o6pk48r6r

& Chemicals

China MEP and Customs jointly issued the 91 statement on
2012 version of the “Catalog of Toxic Chemicals severely restricted to be imported or exported”
News source in Chinese
HelpyouKnowit
http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=387&T3=10&LanguageType=CH&Sub=12 Driving Green Chemical

NEXTPAGE >
The Registration Certificate application process

Different Roles 30 work days
Process

a) Discussion
MEP b) Publicity for comments (3 days)
c) Final approval MEP Publicity board:
Ministry of State Council d) Certificate issued
http://www.mep.gov.cn/zhxx/gsq/
Division of pollution
prevention Failure in
approval，
CRC notifies
the applicant
X Technical evaluation
Taskforce for Evaluation provide Feedbacks

X Fail in approval

Invoice or notify Receive Registration Application
CRC-MEP application failure Formal Check of materials (5 work days)

Inspection and
management after
certificate issued • CRC software for some Fail in preparation

Local MEP •
•
materials
Other materials (hard copy)
Registration fee
X of registration materials

Inspection

 Check 2012 version Catalog of toxic chemicals severely
Registration restricted to be imported or exported
applicant
Online registration:

！
http://www.crc-mep.org.cn/A107/A107_R17.aspx
Certificate could be applied by either side of the business, a
foreign company or its Chinese importer
(3 roles played by importer: chemical user, trader, or representative of foreign
companies )

NEXTSECTOR >
What to be prepared for Regulation Certificate application
Help your with compliant work

Type 1 Foreign companies

+ Necessary materials to be submitted

Application form of Registration Certificate (template avail.)
Business Contract (Original Copy)
The source of toxic chemicals; hazardous profile; C&L;
emergency response & fist aid ; disposal; environmental CRC
effects; chemical control laws of countries where the source of MEP
located etc.
CRC supports
+ 10,000USD or equivalent RMB Tel: + 86 10 4915286 (hazardous chemical only)
Email: weihua@crc-mep.org.cn

Type 1 Chinese importers
Not all materials listed
FC = Foreign companies

Importers of toxic chemicals Importers of toxic chemicals Importers of toxic chemicals
as user as trader as representative of FC*
• Application form • First 6 points are same • Include all materials of importer as
• Toxic chemical profile • License of Operation Safety trader
• Business license (Decree 591) of both importers • First and second grade
• Original business contract & Downstream trader downstream roles’ License of
• Copy of import & export approval • Annual record of toxic chemicals Operation Safety (trader) and

HelpyouKnowit
certificate sales Environment report for each
• Environment report for each • Sales information of toxic chemicals and comments from the
authorities (users) required
chemicals and comments from the chemicals within recent 2 years Driving Green Chemical
authorities • DU inventory(only applied to some • Business license of importer and
certain chemicals) first grade DU required
+ 10,000USD or equivalent RMB
+ 10,000USD or equivalent RMB + 10,000USD or equivalent RMB

SFDA license and label

Cosmetics
Regulations >

HelpyouKnowit

MOH license and label

Disinfectant
Regulations >

HelpyouKnowit

NEXTPAGE >
Order 27 by MOH since 2002

Order 22 changed to Order 27
by MEP

Order 27 by MOH
Entered into force 01 Jul 2002
Order 27 by MOH
Issued 28 Mar 2002
Order 7: Revision of Provision on
Administration of Disinfection in China

X
Order 22 by MOH 31 Aug 1992
Issued
Order 22: Provision on Administration
of Disinfection

10 years

Order 27 by MOH
http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsjdj/pgz/200804/16529.htm HelpyouKnowit

NEXTPAGE >

Be Noticed

Afterwards, we talk mainly about
Disinfectant

HelpyouKnowit

Pesticide & Agrochemical

Pesticide
Regulations >

HelpyouKnowit

Will be updated by Mai SOON

HelpyouKnowit

Chinese regulation guidance

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