Solid Waste and Chemicals Management Center, MEE

Environmental Management Policy for
New Chemical Substances in China
Division of Chemical Management
Solid Waste and Chemicals Management Center,MEE
Liu Xiaojian
2022.2.17

CONTENTS
I. Overall policies on environmental managementof new chemical substances
II. Requirements for registration of new
chemical substances
III. Requirements for post-registration tracking
management21Overall policies on environmental
management of new chemical substances3

I. Overall policies
1. History
Measures for Environmental Measures for Environmental
Management of New
Management of New
Chemical Substances
Chemical Substances（SEPA Order No.17）（MEP Order No.7）

Measures for Environmental
Management Registration of
New Chemical Substances（MEE Order No.12）

Measures on
Measures on
Environmental
Environmental
Management ofManagement ofFirst Amendment
New Chemical
New Chemical Second Amendment
Substances
Substances

Measures on
Environmental
Management
Registration of
New Chemical
Substances

Order No. 17
of SEPA

Order No. 7
of MEP

Order No. 12
of MEE

Establish

Development

Optimize

2003

2010

2020

4

I. Overall policies
2. Management System
1. Inventory of Existing Chemical Substances in China
2. Guidance for Environmental Management Registration of New Chemical Substancesand supporting forms and filling instructions (Announcement No. 51 [2020] of the MEE )policies

3. Announcement on Transition Matters Concerning Environmental Management
Registration of New Chemical Substances(Announcement No. 46 [2020] of the MEE )4. Announcement on Standardizing the Management of Chemical Testing Institutions(Announcement No. 85 [2016] of the MEP )5. Guidelines for Approval of New Chemical Substances Environmental Management

Order
NO.12

Registration Certificate (Published on the Ministry of Government Affairs Service
platform)

Technical
Documents5

I. Overall policies
2. Management System
policies

Order
NO.12

Technical
Documents

1. Testing Guidelines of Chemicals，Testing Methods of Chemicals andrelevant national standards for chemical testing
2. Technical Requirements for Identification of substances for New
Chemicals Notification and Registration；
3. Framework Guideline on Environmental Risk Assessment Techniques for
Chemical Substances (Trial)
4. Technical Guideline for Environmental and Health Hazard Assessment ofChemical Substances (Trial)；
Technical Guideline for Environmental and Health Exposure Assessment ofChemical Substances (Trial)
Technical Guideline for Environmental and Health Risk Characterization ofChemical Substances (Trial)

6I. Overall policies
3. Measures for Environmental Management Registration of New
Chemical Substances（MEE Order No.12）
Chapter 1 General Provisions （Articles 1 to 9）
Chapter II Basic Requirements（Articles 10~14）

Chapter III Regular Registration, Simplified Registration
and Filing（Articles 15~37）
Chapter IV Tracking Management（Articles 38~45）
Chapter V Legal Liability（Articles 46~51）

Chapter VI Supplementary Provisions（Articles 52~55）

7

I. Overall policies
4. Guidance for Environmental Management Registration of New Chemical
Substances (Announcement No. 51 [2020]，MEE )Implementing guidance of Order No.12，which
support to guide enterprises to apply for theenvironmental management registration of new
chemical substances and fulfill their responsibilities
and obligations under the Measures.
Clarify the specific requirements for notification
dossiors, data requirements, quality of test data ,environmental risk assessment reports, tracking
management, etc..

8

I. Overall policies
5. Supporting forms and filling instructions (Announcement No. 51[2020]，MEE )Supporting Applications form for Registration and Management• Application Forms for Regular Registration, Simplified Registration, and New Use Environmental
Management Registration• Record application form
• Certificate Change Application Form for Regular Registration and Simple Registration• Notification Withdrawal Application Form
• Certificate Cancellation Application Form
• Application Form for Addition of Chemical Substances to the Inventory• Application Form for Identification Information Disclosure Extension• New Hazard Information Reporting Form
• First activity report form
• Annual report form
• List of Chemical Substance Use Code9

I. Overall policies
6. Announcement on Transition Matters Concerning Environmental
Management Registration of New Chemical Substances (Announcement
No. 46 [2020] of the MEE )❖ Implementation of environmental risk control measures❖ Information transfer, Information reporting and Record keeping

Regular❖ Application for cancellation of registration certificate
Registration❖ New use environmental management registration for Key environmental management
hazardous new chemical substances, and specify permitted uses when listed in theInventory.

❖ Information reporting and Record keeping

Simplified❖ Application for cancellation of registration certificate
Registration❖ Validity period of R&D Simplified registration certificate: two years after the start of thefirst activity.
10

I. Overall policies
7. Inventory of Existing Chemical Substances in China
Adjusted and published by MEE
Chemical substances produced, sold, processed, used orimported in China before October 15, 2003, could be
supplemented into the Inventory.

Inventory

Chemical substances registered under regulations onenvironmental management of new chemical substances

Dynamic
updates(Order No. 17, No. 7, or No. 12) after October 15, 2003, would
be included into the Inventory according to the regulations.
112

Requirements for registration of
new chemical substances

12II. Requirements for registration
1. Scope of registration➢ “new chemical substances” as stated in the Measures refer tothose chemical substances not listed in the Inventory of Existing
Chemical Substances in China(IECSC).

➢ Chemical substances that are subject to environmental managementof new uses as stipulated in the Inventory(IECSC) and are used forindustrial purposes other than the permissible use, they shall be
subject to environmental management as new chemical substances.

13

II. Requirements for registration
1. Scope of registration
Non-applicable
categories• Medicines (including active pharmaceutical ingredients), pesticides(including

technical materials), veterinary drugs (including active pharmaceutical ingredients),
cosmetics, food, food additives, feed, feed additives, fertilizers and other products;• Radioactive material➢ However, where the above products are altered to other industrial uses and the raw
materials or intermediates used to produce the above products belong to new
chemical substances, the Measures shall apply.
14

II. Requirements for registration
Exemption Category

Naturallyoccurring
substances

Non-commercial or
non-intentionallyproducedcategories

Other special
categories

4 Categories

3 Categories

7 Categories

15II. Requirements for registration
2. Management principles and key points of control
sourcecontrol

licensingrisk
prevention

Hazard Identification
environmental risk assessmentclassified
management

Tracking
Management

key points of control
管控重点• new chemical substances that would cause persistent, bioaccumulative
or severe harm to the environment or health• new chemical substances that may stay in the environment for a longtime, and may pose rather high risks to the environment and health16

II. Requirements for registration
3. Registration Type
Regular
Registration
Annual production
or import of new
chemical substances> 10 tons/year
New UseEnvironmental
Management
Registration

Simplified
Registration
Annual production or
import volume of new

chemical substances is
1 to 10 tons/year

Record
1. Annual production or import volumeof new chemical substances is less than
1 ton per year;
2. The new chemical monomer or
polymer contains no more than 2% of
the reactants or polymerS of low
concern

Substances are used for industrial purposes other thanthe permitted uses, they shall be subject toenvironmental management as new chemical substances.
17

II. Requirements for registration
4. Applicant and Agent•Enterprises and institutions that arelegally registered within China, able toindependently bear legal responsibilities,
Manufacture and engaged in the production or
import of new chemical substances.

• Import• Processing
and use

Production or trading enterprises that
intend to export new chemical
substances to China may also serve asapplicants. However, enterprises andinstitutions that are legally registered
within the territory of China and able toindependently bear legal responsibilities
shall be designated as their agents

New chemical substances such as
medicines, pesticides specified in Article 2of the Measures, where intended for otherindustrial uses, the producer, importer orprocessor and user of relevant products
may act as the Applicant.
For chemical substances that have been
listed in the Inventory and been subject
to environmental management for newuses, and are intended for industrial
purposes other than permissible uses,
the producer, importer or processor anduser of relevant chemical substances may
act as the Applicant.
18

II. Requirements for registration
4. Applicant and AgentEnterprises and institutions thatare legally registered within
China and able to independently
bear legal responsibilities shallbe designated as their agentsThe contents need to be clearly definedin the contract or agreement between
applicant and agent
The applicant and the agent per form the
new chemical substance environmental
management registration and postregistration obligations jointly, and bear the
responsibilities
Relevant responsibilities and obligationsof changing agents;

Validity period of the agency relationship.
19

II. Requirements for registration
5. Dossier requirements for registration
Simplified Registration Dossier requirements• Regular Registration Application Forms• Legal entity certificate or business license, agency contract or agreement, letterof attorney;• Test reports or data on physical and chemical, and ecotoxicology properties• Conclusion and basis for determination of persistence, bioaccumulation andtoxicity• Explanator y Materials on the necessity of information protection• Commitment letters to implementing or transmitting environmental risk control
measures;• Qualification of testing agency• Other avaliable information on the environmental and health hazard
characteristics and environmental risks
20II. Requirements for registration
5. Dossier requirements for registration
Regular Registration Dossier requirements• Regular Registration Application Forms• Legal entity certificate or business license, agency contract or agreement, letter ofattorney;• Test reports or data on physical and chemical, toxicology and ecotoxicology
properties• Environmental risk assessment report• Social and economic benefit analysis report (for highly -hazardous new chemical
substances)• Explanator y Materials on the necessity of information protection• Commitment letters to implementing or transmitting environmental risk control
measures and environmental management requirements;• Qualification of testing agency• Other avaliable information on the environmental and health hazard characteristics
and environmental risks21II. Requirements for registration
5. Dossier requirements for registration
Unable to test

Minimum required
data

Basic data
From test report

Special data
Should be submitted for
those with P, B
properties
Mainly from test report

Other data
Should be submitted
where minimum
required data is
insufficient to make acomprehensive
environmental risk
assessment for
regular registrations .
Data from test reports
is preferred

QSAR
Cross reference
Authoritative
published literature
Authoritative
database(Adequate explanationof reasons, methods ordata sources, basis,
etc.)

22

II. Requirements for registration
5. Dossier requirements for registration
The ecotoxicology test report shall include test data completed
in accordance with relevant standards by using organisms of
China offered for test.

Gobiocypris rarus

Test Organisms in
China refer to native
organisms bred andpropagated in China thatmeet the technicalrequirements of standard
testing methods or test
guidelines and are used
for specific tests .

Activated sludge
in China

23

II. Requirements for registration
5. Dossier requirements for registration

1
•
•

•

•

Environmental
risk assessment

In a quantitative approach;
Clarified specific requirements
for hazard assessment,
exposure assessment, and risk
characterization;网上登记系统
Build scenarios based on thelife cycle stages and uses in
China;
Carried out based on technicalguidelines.

2
1.

Socio-economic benefit
analysis

填写、提交电子数据；

Description of the activity scenarios of
new chemical substance and chemical
2. 需签字盖章材料，彩色扫描；substances for application uses;
Analyze and evaluate environmental,
3. • 分别上传附件。
health, economic, and social impacts;• Economic and social benefits outweigh
the risks to human health and theenvironment, and have considerable orobvious advantages in both aspects.
•24II. Requirements for registration
5. Dossier requirements for registration

3

Application for identification information
protection•

Chinese and English name, CAS number,molecular formula and structural formula, etc.;•

Information protection statement and othernecessity explanatory materials.
When the registered substance is included in
the Inventory, postponement of disclosure ofidentification information can be applied forthe chemical substance subject to information
protection，necessity explanatory materials•

Necessity explanatory materials include:•

Specific information column andcorresponding protection period;•

A description of whether the
information is known to the public;•

A description of whether the
information has commercial value;•

Whether relevant measures have been
and will be continuously taken toprotect the information applied forprotection from disclosure, and thespecific measures.

25

II. Requirements for registration
5. Dossier requirements for registration

4

Chemical substances that cannot be tested•

If it is not possible to carry out toxicology or ecotoxicology tests, data
derived from estimates, analogue cross-references or literature can besubmitted.

5Chemical substances used only as pesticide intermediates,
pharmaceutical intermediates or veterinary intermediates

Only basic data could be submitted for the minimum required
data for toxicology and ecotoxicology. Detailed information on theintermediates use of chemical substances should also be submitted.
26

II. Requirements for registration
5. Dossier requirements for registration⚫ High-hazard chemical substances
High-hazardous chemical substances are those withpersistence, bioaccumulation and toxicity, and with very
persistence and very bioaccumulation at the same time, or
those with equivalent environmental or health hazard
High-hazardous chemical substances with equivalentenvironmental or health hazards include but are notlimited to endocrine disruptors (EDCs) and highly toxic(acute or chronic) substances

PBT/vPvB assessment:
Tiered Testing and Assessment
Judgment Criteria +Screening methods and Criteria27

II. Requirements for registration
6.Registration process and timeline

Regular Registration/Simplified Registration

SubmitDossiers

Acceptance
5 workingdays

Technical
Review

60 days forRegular
Registration

Publicity

Registration
DecisionIssuance ofregistration certificate，Registration decision
Announcement

20 workingdays

30 days for
Simplified
Registration28

II. Requirements for registration
6.Registration process and timeline
Approval qualification
forunreasonable
Regular Registration
No

environmental risks arefound, registration shallbe approved.
For high-hazardous
chemical substances, therequirements for thenecessity of application
activity shall also be met

Approval qualificationfor Simplified
RegistrationFor
new chemical

substances those notfound to be persistent,
bioaccumulative andtoxic, and not found tohave any accumulated
environmental risks,registration shall beapproved29

II. Requirements for registration
7. Information change of Registration certificate

Dossier requirements

Re-registration•

01

Activity type:
import change to production

03

Change the uses ofchemical stustances

05

Other situations
leading to increased
environmental risk

02 The production or import
volume exceed theregistration volume

04 Change theenvironmental risk
control measures

•
•

•
•
•

Resubmission of the registration
application form and a statementof reasons for the change;
New environmental risk
assessment reports;
New environmental risk control
measures to be taken anddescription of suitability ;New test report or data;
Socio-economic benefit analysis
report (if required);
New commitment letters30

II. Requirements for registration
7. Information change of Registration certificate

1Change ofRegular•Chang of Applicant/Agent name
•Change of registered agent•Activity type: change from production to import, or increaseimports activity•Change of identification information such as chemical names,
CAS NO., molecular formulas and structural formulas

Change ofSimplified
Registration

Registration
Certificates2•Registration volume•Activity type
•Application use•Environmental Risk Control Measures•Change of Applicant/agent name
•Change of registered agent•Change of chemical names, CAS NO., molecular formula andstructural formula and other identification information

Certificates31II. Requirements for registration
8. Dossier requirements for Record Notification

Record Notification

Record Notification for Polymers

I. The annual production or import volume of
new chemical substances is less than 1 Ton/a

Meets the definition of polymer
in the guideline

II. The polymer contains no more than 2% of
new monomers or reactants, or belongs to apolymer of low concern

Meets one of the two polymer
Record conditions
Doesn’t meet any polymer record
exclusions

32

II. Requirements for registration
Polymer Record Exclusions
1

Cationic polymers, or those polymers that are anticipated to become cationicpolymer in natural aquatic environment (such as polymer containing amine groupand isocyanate).

2

Degradable or unstable polymers, including those that are easy to degrade,
decompose and depolymerize, and those that decompose after production or use.

3

Water absorbing polymers with a number-average molecular weight of 10,000
or more.

4

Fluorine-containing polymers that contain the structure fragment ofperfluoroalkyl sulfonate group and perfluoroalkyl carboxylic acid group or fluorine
telomeres, or; that contain the structure fragment of perfluoroalkyl
groups covalently bonded with carbon or sulfur atoms in polymer molecules.

5

Elemental Composition Restrictions

33

II. Requirements for registration
8. Dossier requirements for Record Notification
Dossier requirements for Polymer Record
List of monomers/reactants: Including the chemical name, CAS NO., content of
the monomers/reactants, whether listed in the IECSC or not
Molecular weight distribution data: including Gel Permeation Chromatography（GPC）of polymers, or other results of characterization of polymer molecularweight and its distribution
The mechanism and process of polymerization
The explanation which indicates the applicated polymer does not meets any
polymer record exclusions
34

II. Requirements for registration
9. Record process
After the Applicant submitscomplete Record materials,
the online registration
system automatically sends
a Record receipt.
The new chemical substance
related activities may be
carried out by the Applicant
base on the Record content.

A

MEE shall organize its
affiliated technicalagencyto conduct
random inspections ofcompliance of the filed
materials.

B

The information on Recordand cancellation of Recordof new chemical substances
shall be published on thegovernment website of MEE

C35

II. Requirements for registration
10. Dossier Submission
Application on New Chemical Substance Online Registration System
Online Application path: log in to the Ministry of
Ecology and Environment“National Integrated
Online Government Affairs Service Platform”>
select“New Chemical Substances”>select“Item
Notification”in the column of “13002 New
Chemical Substance Environmental Management

Registration Certificate Issue and Approval Items”

地址：http://zwfw.mee.gov.cn/ecdomain/#/commonPage_1
363Requirements for post-registration
tracking management37

III. Tracking Management
1. Post-registration Information Report

Regular/Simplified Registration

First activity
reportAnnual report

Submit the first activity repor t within 60 days since the dateof the first production activity or the first impor t and transfer
to the processing user

Regular Registration(stipulated the submission ofannual report requirements on certificate )Submit the annual repor t before April 30 of each year
since the year of the registration date

Application on New Chemical Substance Online Registration System
38

III. Tracking Management
2. Management requirements••

For Regular Registration, Simplified Registration, Record
Information to be transfered: cer tificate number orrecord receipt number, uses, environmental and healthhazard characteristics and environmental risk control
measures, environmental management requirements•

For Regular Registration：Producers and processing users
should disclose the implementation of environmental risk
control measures and environmental management
requirements after the first activity

Information
Tr a n s f e r

Information
Publicity

Dossier
keeping•••

Establish a new chemical activity recording system；
Regular and simplified registration dossiers and activity
records shall be kept for at least 10 years
Record Notification dossiers and activity records shall be kept
for at least 3 years
39III. Tracking Management
3. New Hazard Information and Environmental Risk Tracking

health hazard characteristics orenvironmental risks timely;• Take measures to eliminate or
reduce environmental risks timely

For new chemical substances whoseenvironmental risks may continue toincrease, relevant researchers, producers,
importers and processing users may berequired to further submit relevant
environmental or health hazards andenvironmental exposure data
information

Environmental
Risk Tracking

New Hazard
Information• Report new environmental or40

III. Tracking Management
4. Supervision Management
Supervision mode
• Environmental super visionand spot check ;• Random selection of bothinspectors and inspection
entities and the prompt
release of results;• Included in the annual
environmental enforcement
work plan;

Supervision content• Whether to apply forenvironmental management
registration of new chemical
substances as required;• The authenticity of theregistration, whether toimplement the requirements
stated in the registration
cer tificate and other relevant
requirements of the Measure.
41

III. Tracking Management
5. Inventory Supplement
Inventory (IECSC)

Registered substances
listed into inventory*

化学物质增补

Registered under
Order No.17

Registered under
Order No.7

Registered under
Order No.12

All substances
have been listed
into IECSC

5 years since thefirst activity or the
implementation of
the Order No.12

5 years since theRegistration
approved*Refer to regular registeredsubstances, new chemical
substances that are simply
registered and recorded are
not listed in the Inventory42

III. Tracking Management
5. Inventory Supplement
For chemical substances produced, sold, processed, used or imported in China
before October 15, 2003, the applicant may submit a supplement application
form and relevant evidence materials to apply for adding them to the Inventory.
ApplicantSupplement conditions
1. The applied substance is not listed in
the Inventory;

1. Enterprises producing, importing,

2. Meet the Scope of registration in the
Measure.

substances;

processing and using related chemical

2. Relevant industry associations;
3. Other related entities.
43

III. Tracking Management
5. Requirements for Inventory Supplement
Accurate and standardized identification

Supplement application form

information of chemical substances:
Chinese and English chemical name, alias, CAS
number, molecular formula, structural formulaand other information

Annex to application

Substantiation materials that can prove that thechemical substance has been produced, sold, processedor imported in China before October 15, 2003, including
but not limited to Distribution invoice, Customs export
declaration,Industry
statistics,Chemicalindustry
yearbook,Documents
issuedbymanagement
departments, Publications.
44

Thanks
Division of Chemical Management，MEESCC
Liu Xiaojian
Phone：010-84665574
E-mail：liuxiaojian@meescc.cn
Address：NO.1，YuHui S Road, Chaoyang District，Beijing45