Guidance for Notification of New Chemical Substancebjboardingcard.com/english/uploadfile/2015/1113/... · Appendix 1Risk Assessment Report (Requirements to the format) ... cement,

Guidance for Notification of New

Chemical Substance

(Consultation Draft)

Ministry of Environmental Protection of the

People's Republic of China

June, 2015

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Foreword

This Guidance is prepared in accordance with the Article 11 of Measures for Environmental

Management of New Chemical Substances (Order No. 7 of MEP, hereafter referred to as the

Measures) for purposes of normalizing the notification activities of new chemical substance

and guiding the notifiers to complete notification and registration of new chemical

substances.

The Guidance takes notification procedures and notification classification as the main line,

explains and describes management scope, details of notification report, notification format,

requirements for notification data and management requirements after notification, etc.

specified in the Measures with regard to 6 aspects including scope of application,

notification type and format, notification and registration procedures, requirements for

notification information, special provisions on polymers and supervision and management

after notification and registration.

Notifiers shall perform notification work before new chemical substance registration

according to requirements of the Guidance, carry out risk control Measures after new

chemical substance registration and cooperate in supervision and management of new

chemical substances. The requirements of the Guidance must also be referred to by test

organizations providing data for new chemical substance notification, review committees

performing technical review on new chemical substance registration and all provincial

environmental protection departments responsible for supervision of new chemical

substances to cooperate in work concerning environmental management of new chemical

substances. Solid Waste and Chemical Management Technology Center of MEP

(hereinafter referred to as the "SCC-MEP") undertakes the technical inspection, technical

quality specifications and guidance works and so on for the relevant application materials.

This guidance is the first amendment edition of the Guidance for Notification and

Registration of New Chemicals Substance issued by the MEP in 2010 (No.124 [2010] of

Environmental Office).

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Contents

I. The Applicable Scope of New Chemical Substance Notifications…………………………………..……………

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(I) Scope of notified substance………………………………………………………………………………...


(II) Territorial scope……………………………………………………………………………………………


(III) Range of activity………………………………………………………………………………………….


(IV) Notifier and agent…………………………………………………………………………………….…..


II. Type and Format of New Chemical Substance Notification………………………………………….…..…….错

误!未定义书签。

(I) Notification type…………………………………………………………………………………….……. 错


(II) Special formats of regular notification……………………………………………………………….….. 错


III. New Chemical Substance Notification and Registration Procedures……………………………………....….错


(I) Notification preparation……………………………………………………………………………….….. 错


(II) Regular notification and registration procedures……………………………………………………..…. 错


(III) Simplified notification and registration procedures…………………………………………………..… 错


(IV) Scientific research filing notification procedures……………………………………………………..…错


(V) Notification cancellation……………………………………………………………………………..….. 错


IV. Requirements for New Chemical Substance Notification Documents…………………………….……..……错


(I) Format requirements for notification documents………………………………………………..……….. 错


(II) Quality requirements for notification data………………………………………………………..…..… 错

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(III) Requirements for submitting the regular notification data………………………………..……………. 错


(IV) Requirements for risk assessment report……………………………………………………..………… 错


(V) Data requirements of special formats of regular notification………………………………..………….. 错


(VI) Data requirements of simplified notification…………………………………………………..………. 错


(VII) Information confidentiality requirements………………………………………………..……………. 错


V. Special provisions on polymer…………………………………………………….………………….………..错


(I) Denomination of polymer……………………………………………………………..…….…………… 错


(II) Simplified notification conditions of polymers……………………………………..………………….. 错


(III) Regular notification conditions of polymers………………………………………..………………….错


VI. Supervision and management of registered new chemical substance notification………..…………….……错


(II) Information change in registration certificate………………………………………..……………….... 错


(III) Re-notification after registration…………………………………………………..…………………... 错


(IV) Reporting of new information……………………………………………………..……………….….. 错


(V) Information transfer, reporting and data saving…………………………………..……………………. 错


(VI) Site supervision and inspection…………………………………………………..……………….…… 错


(VII) Entry of registered new chemical substances in the Inventory…………………..………….………..错


(VIII) Cancellation and revocation of registration certificate……………………………..……………….. 错

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Appendix 1Risk Assessment Report (Requirements to the format)

Appendix 2 The report table on each activity of new chemical substances

Appendix 3 The table on the annual report of new chemical substances

Appendix 4 The report on the actual activities of the registered new chemical substances for five years

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Guidance for Notification of New Chemical Substance

I. The Applicable Scope of New Chemical Substance Notifications

(I) Scope of notified substance

1. Notified substances

All chemical substances not listed in Inventory of Existing Chemical Substances in China (hereafter

referred to as the Inventory) are new chemical substances.

Production or import of new chemical substances shall be subject to new chemical substance

notification according to the Measures for Environmental Management of New Chemical

Substances (Order No. 7 of MEP, hereafter referred to as the Measures).

The Measures are applicable to raw materials or intermediates for producing medicine, pesticide,

veterinary drug, cosmetic, food, food additive, feed additive and other products, which are new

chemical substances.

The Measures are applicable to new chemical substances contained in intermediate products or

finished products with specific functions, such as surfactant, plasticizer, antiseptic, dispersant and

flame retardant, regardless of their content.

The Measures are applicable to chemical substances with non-unique and uncertain molecular

structure such as variable composition substances and complex reactivity products and polymers

which are new chemical substances.

2. Exclusion

The Measures are not applicable to the following types of finished products, chemicals or chemical

substances.

(1) Finished products subject to other laws and regulations

Medicine, pesticide, veterinary drug, cosmetic, food, food additive, feed and feed additive,

radioactive substance, military product, explosive product, initiating explosive products and tobacco

etc.

(2) Natural substances

1) Substances unprocessed or processed or treated in manual, mechanical, gravity, water dissolving,

water flotation, thermal dehydration and other physical ways;

2) Substances extracted from air in various ways;

3) Natural polymers, except those subject to chemical processing and treatment;

4) Living substances, such as ribonucleic acid, deoxyribonucleic acid, enzyme, protein and other

biomacromolecules, but except the substances through chemical process.

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(3) Classes for noncommercial purposes or non-voluntarily produced.

1) Impurities, which are the chemical substances that do not contribute to product function, may be

from raw material or result from side reactivity or incomplete reactivity during production, are not

desired, but exist in final product and have single content below 10% and total content below 20%

(weight percentage).

2) Chemical products, which refer in particular to:

a) Those produced by reactivity resulting from accidental contact between chemical substances and

other substances or environmental factor (air, vapor, microbe, sunlight, etc.);

b) Those produced by accidental reactivity of chemical substance, mixture or article in storage;

c) Those produced by undesigned reactivity of chemical substances, mixture or article in end use;

and

3) Wastewater, waste gas, solid waste and byproduct produced during reactivity.

But those of above classes in this section put on the market or voluntarily produced as commodities

are excluded.

(4) Other special classes

1) Materials

Glass, frit and ceramic materials, as well as ceramic vessel, steel and its preparation, high alumina

cement, portland cement, etc.

2) Alloys

Homogeneous and heterochronous solid or liquid obtained by mixing two or more metals or a metal

with other nonmetal substances. But intermetallic compound and accurately defined intermetallics

are excluded.

3) Non-separated intermediates

Intermediates refer to chemical substances generated from the last chemical reactivity during the

whole chemical reactivity process and consumed in a process of producing other chemical

substances or products through chemical reactivity, and shall not be present in produced chemical

substances or products, unless as impurity.

Non-separated intermediates refer to those which are not moved from reactivity vessels or reactivity

devices and also include those stored temporally in vessels after reactivity for the next step of

chemical reactivity in the same plant.

The Measures are applicable to intermediates other than non-separated intermediates.

4) Articles

The articles shall meet the following three requirements:

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a) Forming particular shape or pattern during manufacture;

b) Having functions and purposes for end use, all or part of which are dependent on their shapes or

patterns;

c) No chemical reactivity in end use or only chemical change other than commercial value change

of articles.

For example, battery, fiber, film, leather, yarn and the like are articles.

However, articles intentionally releasing new chemical substances used in the following situations

or new chemical substances in articles may expose to the environment and/or human exposure, shall

be subject to notification of new chemical substances in articles according to the Measures:

a) Release of contained new chemical substances from articles is necessary for realizing function of

the articles, that is, intentional release is artificially designed, shape of the articles are only

considered as vessels of new chemical substances, such as pen, ink box and extinguishing agent;

b) Contained new chemical substances will be produced and released during use, which is necessary

for realizing function of the articles and is intentionally and artificially designed, such as

fragrance-containing eraser.

c) During using process, the new chemical substances in articles may lead to environmental and/or

human exposure, such as the surface paint of articles.

(II) Territorial scope

The Measures are applicable to new chemical substances researched, produced, processed and used

in territory of the People's Republic of China or exported (imported) to territory of the People's

Republic of China.

The Measures are applicable to new chemical substances researched, produced and processed for

use and exported to bonded zone and free trade zone or export processing zone (or the imported

new chemical substances).

The Measures are applicable to new chemical substances all exported and not distributed or

processed and used in territory of the People's Republic of China after being produced in the

territory.

The Measures are not applicable to new chemical substances temporarily stored in bonded zone or

free trade area after being imported and all exported without any processing (including repackaging,

selection, arrangement, etc.).

The Measures are not applicable to new chemical substance activities in Hong Kong Special

Administrative Region, Macao Special Administrative Region and Taiwan.

(III) Range of activity

The Measures are applicable to activities of researching, producing, importing, processing and

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using new chemical substances.

Research refers to exploratory activity understanding and using new chemical substances and

relates to scientific research and development research of process and product. Scientific research

refers to exploration process of new knowledge, theory and principle and can be classified as

fundamental research and application research; development research of process and product refers

to research of applying achievements of scientific research to market development and production

practice on the basis of scientific research.

New chemical substances produced by research can be distributed by market behavior and can only

be used for research after distribution, shall not be used for activities beyond research unless the

new chemical substances have been registered.

Production refers to manufacturing activity of producing new chemical substances on the basis of

raw materials and ingredients etc. through a single or combined chemical reactivity process.

Import refers to trade activity of introducing new chemical substance abroad to meet domestic

demand.

Processing and using refer to production activity of subpackaging, preparing or manufacturing with

new chemical substances as raw materials or ingredients through a single or combined process.

Who processes and uses new chemical substances shall require new chemical substance suppliers to

provide certificates of registration of new chemical substances while receiving. Who processes and

uses new chemical substances shall not process and use unregistered new chemical substances.

(IV) Notifier and agent

1. Classes of notifiers

Notifiers are the subjects of new chemical substance notification. Notifiers are classified as

domestic notifiers and overseas notifiers.

For production activity, the notifiers shall be the entities registered within the territory of People’s

Republic of China planning to be engaged in new chemical substance production.

For import activity, the domestic notifiers shall be the legal entities registered within the territory of

People’s Republic of China planning to be engaged in new chemical substance importation; whist

the overseas notifiers refer to the overseas traders (including exporters in Hong Kong Special

Administrative Region, Macao Special Administrative Region and Taiwan) planning to export new

chemical substances to China.

The entities, registered within the territory of People’s Republic of China, planning to change

registered use of hazardous new chemical substances subject to key environmental management

listed in the Inventory, are qualified for notification as the notifiers.

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2. Requirements for notifiers

After the registration, the notifier is the holder of environmental management registration certificate

for new chemical substances (hereinafter referred to as the "registration certificate"), owns the

rights of "Measures" provisions and undertakes the responsibilities and obligations of "Measures"

provisions.

When the notifier is an overseas person, he should entrust a qualified organization as an agent.

When the overseas notifier is unable to perform or does not to perform the responsibilities and

obligations of the registration certificate holder, the agent should perform the responsibilities and

obligations on behalf of the holder.

The commission contract between the notifier and the agent should clearly describe that if the

overseas notifier is unable to perform or fails to perform the responsibilities and obligations,

whatever any reason, the agent should perform on behalf of the notifier and commitment to

undertake the related the responsibilities and obligations. The validity of the commission contract or

the agency agreement should cover the valid of responsibilities and obligations of registration

certificate holder's, or the date of renewal before the expiry.

The overseas notifier can only entrust one agent for dealing with the notification of the same

chemical substance.

A registration certificate holder can only hold a registration certificate for a new chemical

substance.

3. Qualification of agent

The responsibilities and obligations of agent are that he performs on behalf of the notifier the

related the responsibilities and obligations when the notifier is unable to perform or fails to perform

the responsibilities and obligations, whatever any reason, the agent should perform on behalf of the

notifier the responsibilities and obligations as well as the related responsibilities of the certificate

holder The agent shall meet the following requirements:

(1) Institutions registered within the territory of the People's Republic of China and subject to

annual inspection by Industrial and Commercial Bureau as scheduled and it is legal and effective;

(2) Having fixed offices;

(3) Understanding the responsibilities and obligations specified in the “Measures” in the

holder’s registration certificate, and have the ability to perform and bear the responsibilities and

obligations as well as the related responsibilities;

(4) Receiving supervision and inspection by MEP;

(5) No penalty filing resulting from breach of the Measures in 3 years.

(6) The staff shall not be the employees of related parties such as the environmental protection

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department or experts review committee of new chemical substances (hereinafter referred to as the

"experts review committee") members and other related personnel, etc.

The agent for providing technical advisory service should have a sound quality assurance system

and the corresponding technical ability, having professional personnel who familiar with the

environmental management of new chemical substances and the professional personnel should have

the related professional background and working experience for notification of the new chemical

substance.

The agent shall keep the commercial secrets and technical secrets for the overseas notifier.

II. Type and Format of New Chemical Substance Notification

(I) Notification type

The notification of new chemical substances shall be classified into regular notification, simplified

notification and scientific research filing notification types.

Regular notification refers to notification and registration of one or more new chemical substances

submitted by one or more notifiers in accordance with Article 10 of the Measures.

The notifier for regular notification can choose different amount level to declare according to the

specific amount level or the provided amount level in Article 11 of the Measures. It only can choose

the specific amount to notify for Level 4. If it chooses the amount level to notify, the notification

amount should be calculated according to the lower limit of the higher level. If it belongs to a

repeated notification, joint notification, serial notification or joint & serial notification, the

notification amount level is determined by amount accumulation of each notifier and each

notification substance in the repeated / joint / serial notification.

Simplified notification refers to notification and registration of a new chemical substance submitted

by a notifier in accordance with basic conditions specified in Article 12 of the Measures and special

conditions specified in Article 13.

Scientific research filing notification refers to the filing notification of one or more new chemical

substances submitted by a notifier in accordance with Article 14 of the Measures.

In case of notification of new chemical substances in finished products or articles containing the

new chemical substances, it will be calculated by pure content of the new chemical substances.

Order of decreasing requirements for notification conditions is regular notification, simplified

notification and scientific research filing notification. High notification requirement is allowed for

notified substance meeting low notification requirement, corresponding notification documents are

submitted and new chemical substance notification is handled according to corresponding

procedures. For the registration of the obtained high notification conditions, it can carry out the

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activity of the low notification conditions, but the amount of the new chemical substances in all

activities shall not exceed the amount of registration in the high notification conditions.

(II) Special formats of regular notification

1. Serial notification

Serial notification refers to regular notification performed by one notifier for two or more new

chemical substances with similar molecular structures and similar test data as a series for same or

similar purposes according to Article 15 of the Measures.

If approved for registration, the notifier gets an independent registration certificate of each new

chemical substance in serial notification.

After registration, the other new chemical substances not included in the serial notification shall not

be additionally listed in the serial notification and shall be separately notified according to the

Measures.

2. Joint notification

Joint notification refers to regular notification performed by two or more notifiers by

simultaneously and jointly submitting notification documents of the same new chemical substances

according to Article 15 of the Measures.

If approved for registration, the notifiers of joint notification shall get the registration certificate

separately.

After registration, notifier not included in the joint notification shall not be listed in joint

notification and shall separately notify according to the Measures.

The overseas notifiers in joint notification can jointly entrust the same agent or respectively entrust

itself agent during regular notification.

3. Joint serial notification

Joint serial notification refers to regular notification simultaneously performed by two or more

notifiers by jointly submitting notification documents for a series of new chemical substances and

dealt with as per Article 15 of the Measures.

If approved for registration, the notifiers of joint serial notification shall respectively get an

independent registration certificate corresponding to each new chemical substance in serial

notification.

After registration, notifiers and new chemical substance not included in the joint serial notification

shall not be listed in the joint serial notification and the new chemical substance shall be separately

notified according to the Measures.

4. Repeated notification

Repeated notification refers to regular notification performed by latter notifier using test data in

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notification documents of former notifier with written authorization and approval of the former

notifier on the basis of one or a series of new chemical substances notified by the former notifier

according to Article 15 of the Measures.

If approved for registration, the latter notifier shall get the registration certificate of the new

chemical substance.

5. Re-notification of increasing registered quantity level

Re-notification of increasing registered quantity level refers to regular notification performed by

original registration certification holder again in order to increase registered number to exceed the

original registered quantity level according to Article 27 of the Measures.

In case of meeting the requirements of increasing registered quantity level, MEP will take original

registration certificate back and issue new registration certificate.

6. Re-notification for change in registered use

Re-notification of change in registered use refers to regular notification performed by registration

certificate holder of hazardous new chemical substances subject to key environmental management

in order to change new chemical substance use registered in the registration certificate according to

Article 27 of the Measures.

If notification for change in registered use is approved before listing hazardous new chemical

substances subject to key environmental management in the Inventory, MEP takes the original

registration certificate back and issues new registration certificate.

For obtaining change registration uses of hazardous new chemical substances of Key environmental

management listed in the list of "Inventory", the Ministry of Environmental Protection will

announce the increased uses.

III. New Chemical Substance Notification and Registration Procedures

(I) Notification preparation

1. Judging whether notification is required

Before performing new chemical substance notification, whether notification is required is judged

from the following aspects:

(1) The substances to be notified are not listed in Inventory;

(2) Notifier meets requirements of the Measures and the Guidance;

(3) Area of proposed substance notification activity is in the scope specified in the Measures;

(4) Substance proposed to be notified is within the range specified in the Measures or use of

hazardous new chemical substances subject to key environmental management is proposed to be

changed;

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New chemical substance notification shall be performed if all conditions above are satisfied.

Notifiers can search the Inventory or entrust the SCC-MEP to conform whether the substances to be

registered have been listed in Inventory as per the search procedure of new chemical substance. If it

is determined that chemical substance proposed to be notified has been listed in the Inventory, new

chemical substance notification is not needed.

2. Preparation for notification

(1) Select the notification types and formats.

(2) Notifiers shall organize tests on physicochemical properties, toxicological and ecotoxicological

characteristics according to requirements of notification type information, write risk assessment

reports, prepare notification materials and present all held known information about hazard

properties and environment risks in the notification reports or notification documents.

All known information refers to test data of hazard properties of notified substance, estimation

result, literature, thesis data, and environmental risk assessment data etc. currently held by notifiers,

which conform to the principle of truthfulness, reliability, scientificity and relativity. In case the

similar substances of known notified substances are hypertoxic, mutagenic and carcinogenic

chemical substances that are clearly hazardous to the human health or eco-environment, the

information on similar substances shall be submitted simultaneously.

New chemical substances to be tested in China shall be subject to scientific research filing

notification before importing test sample.

3. Submission of notification documents

The notifier should offer the electronic data form according to the notification software released by

SCC-MEP, and upload the first page of electronic notification form and electronic text of accessory

materials in PDF format.

As to the requirements for corresponding data of various notifications, please see the requirements

for the notification materials of new chemical substances in Part 4 in the guidance.

When a notifier can not submit a copy of all new chemical substance notification documents

because the notifier does not hold relevant notification information of new chemical substance, the

notifier can entrust a third party holding relevant information to submit at one time. The notifier

shall submit notification of entrusting the third party organization, clearly list name of the third

party and schedule of documents entrusted to be submitted.

The notifier is responsible fully for all the submitted notification materials, has all the rights for the

submitted notification materials, but except the submitted materials by third parties.

The contact to SCC-MEP is following:

Address: Room 609B, Building A, No. 1 South Yu Hui Road, Chaoyang District, Beijing

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Solid Waste and Chemical Management Technology Center of MEP,

The Registration and Audit Department

Postal code: 100029

E-mail: [email protected]

Website: http://www.mepscc.cn

(II) Regular notification and registration procedures

1. Formal examination

The SCC-MEP performs formal examination on notification report within 5 working days after

SCC-MEP received the new chemical substance notification report and informs notifier of the result

of formal examination.

(1) Content of formal examination

1) Whether notifier and agent meet requirements of the Measures and the Guidance;

2) Whether area of substance notification activity is in the scope specified in the Measures;

3) Whether notified substance is in the range specified in the Measures;

4) Whether notified substance has been listed in the Inventory;

5) Whether all documents such as notification form, risk assessment report and test report as well as

Appendix are ready, whether descriptions of the same content are consistent and mode meet

requirements;

6) Whether notification documents contain documents required by corresponding notification

modes in case of serial notification, joint notification and repeated notification;

7) Whether notification data meet minimum data requirement specified in the Guidance;

8) Whether source of notification data meets requirements of the Guidance;

9) Other content of formal examination.

(2) Result of formal examination

Results of formal examination are as follows:

The unaccepted: for unsuitable scope of the Measures or the notifier does not meet requirements of

the Measures, the SCC-MEP informs the notifier unaccepted and gives the reasons. The SCC-MEP

does not keep the notification documents, and the notification documents shall be destroyed;

2) The accepted: for notification report passes the formal examination, The SCC-MEP shall accept,

informs notifier the acceptance No., acceptance time, etc., and submit regular notification report to

review committee within 5 working days.

3) Temporarily unaccepted: for notification that the formal examination: content does not meet the

requirements, it needs to be supplemented, The SCC-MEP shall once inform the notifier the

mailto:[email protected]

http://www.mepscc.cn/

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supplement requirements, list all the items that need to be supplemented and requirements. After the

notifier offer the corrected information, then the SCC-MEP shall decide whether or not to accept the

notification.

The notifier shall correct documents within time limit required in correction notice at one time; the

SCC-MEP shall restart formal examination procedure from the date of receipt of corrected

document. Time for the SCC-MEP to wait for the notifier to correct documents is not included in

the formal examination term.

2. Technical review

Review committee performs technical review on notification materials that review the human health

and environmental risks of new chemical substances within 60 days after receiving accepted regular

notification report.

If the review committee considers that the existing notification documents are insufficient to overall

evaluate and to make conclusions for management category, exposure degree and risk control

Measures of new chemical substances, etc., the SCC-MEP inform the notifier the supplement

requirements, The supplement requirements shall include descriptive data such as illustrative text

and pictures and test data.

The notifier shall correct documents within time limit required in correction notice at one time; The

time that the SCC-MEP waits for the supplement materials from notifier does not include in the

review period.

The review committee shall put forward some review comments for the regular notification

technique of new chemical substances.

The review comments for regular notification technique includes the classification comment for

new chemical substances, review comment for human health and environmental risk, review

conclusion for the appropriateness of risk control Measures, and a suggestion that whether or

not to approve the registration.

3. Registration publication

MEP reviews and publishes new chemical substances approved for registration on official website

of the SCC-MEP after the SCC-MEP receives the comments of technical review on new chemical

substance registration submitted by review committee.

Content of publication includes name of new chemical substances (the class could be made public

in case of the name of new chemical substance being kept confidential), notifier, notification class

and management category of new chemical substances as well as the harm class of new chemical

substances in the key environmental hazardous management class and others information.

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4. Registration and announcement

MEP approves registration application and issues registration certificate if in the presence of proper

risk control measures, and rejects registration application and notifies the applicant in writing and

gives explanations if high risk is involved and there’s no proper risk control measures. MEP

announces registered new chemical substances on the official website of MEP every six months.

Content of announcement includes name of new chemical substances (the class could be made

public in case of the name of new chemical substance being kept confidential), notifier, notification

class and management category of new chemical substances as well as the harm class of new

chemical substances in the key environmental hazardous management class and others information.

(III) Simplified notification and registration procedures

1. Formal examination

The SCC-MEP performs formal examination on simplified notification documents within 5 working

days after the SCC-MEP received simplified notification documents of new chemical substances

and informs notifier of the result of formal examination.

(1) Content of formal examination

For simplified notification, range of notifiers, territorial scope and substance administration range

shall be subject to formal examination as regular notification. Formal examination of simplified

notification also includes the following content:

1) Whether notification cases meet requirements for simplified notification;

2) Whether notification form is completed in accordance with filling requirements.

3) Whether all documents such as notification form and notification reasons or documentation as

well as Appendix are ready, whether descriptions of the same content are consistent and format

meets requirements;

For basic case of simplified notification, it is required to examine whether report of

ecotoxicological test conducted by Chinese test organism in China is provided;

(2) Result of formal examination

Results of formal examination are as follows:

1) Unaccepted, If notified substance is not in the scope of administration of the Measures or notifier

does not meet requirements of the Measures, the SCC-MEP informs the notifier of rejection in

writing, gives reasons and the SCC-MEP does not save notification documents, and the notification

documents shall be destroyed;

2) Accepted, if notification documents pass the formal examination, the SCC-MEP shall accept,

inform notifier of the acceptance No., acceptance time and other situations.

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In basic case of simplified notification, the SCC-MEP shall submit simplified notification

documents to review committee within 5 working days; and in particular case of simplified

notification, the SCC-MEP shall make comments in writing within 5 working days, collect and send

such documents to the MEP

3) Temporarily unaccepted, for notification that the formal examination: content does not meet the

requirements, it needs to be supplemented, The SCC-MEP shall once inform the notifier the

supplement requirements, list all the items that need to be supplemented and requirements. After the

notifier offer the corrected information, then the SCC-MEP shall decide whether or not to accept the

notification.

The notifier shall correct documents within time limit required in correction notice at one time; the

SCC-MEP shall restart formal examination procedure from the date of receipt of corrected

document. Time for the SCC-MEP to wait for the notifier to correct documents is not included in

the formal examination term.

2. Technical review

The simplified notification documents for basic case shall be reviewed by review committee.

Review committee performs technical review on notification documents, identifies environmental

hazards of new chemical substances, proposing technical review comments on simplified

notification of new chemical substances within 30 days after receiving accepted simplified

notification documents for basic case.

Technical review comments on simplified notification include basic information and preliminary

results of ecotoxicological characteristic test and suggestion on whether to register.

The simplified notification documents for specific case shall not be reviewed by review committee.

3. Registration and announcement

MEP registers and issues registration certificate to those meeting requirements, rejects those failing

to meet requirements, informs notifier in writing and gives reasons after receiving technical review

comments on simplified notification for basic case or written disposal opinion for particular case.

For not registered, the same situation notification shall not be carried out again, but a notification

for higher data requirement type may be carried out.

Announcement after simplified notification and registration is the same as that after regular

notification and registration.

(IV) Scientific research filing notification procedures

1. Acceptance and examination

The SCC-MEP performs formal examination within 5 working days after receiving scientific

research filing notification documents of new chemical substances.

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The SCC-MEP accepts notification documents passing formal examination and monthly collects

and sends scientific research filing notification documents to the MEP.

With respect to notification documents which contain incomplete and incorrect information or are

not in correct format and thus fail in the formal examination, the SCC-MEP informs notifiers of

correction.

Scientific research filing notifier can carry out relevant activities of filinged new chemical

substances upon submission of scientific research filing notification documents of new chemical

substances. If the notifier has carried out relevant activities, but receives correction requirements

from the SCC-MEP, the notifier shall correct notification documents according to requirements.

Scientific research filing notifier shall carry out relevant activities according to Article 34 of the

Measures and be subject to supervision and inspection from the MEP.

2. Result announcement

The MEP regularly announces filing notification documents on official website after examining

filing notification documents collected and sent by the SCC-MEP.

Content of announcement includes acceptance No., acceptance time of scientific research filing

notification, notifier and number of filed new chemical substances etc.

(V) Notification cancellation

1. Applying for canceling the notification

Notifiers can submit an application for cancelling new chemical substance notification to the

SCC-MEP and give reasons for cancelling notification after submitting notification documents and

before receiving approval for registration.

Cancellation becomes effective once the SCC-MEP receives the application for cancelling

notification, and the SCC-MEP immediately stops examination process of the notification and

destruct the notification materials.

2. Notifiers for canceling notification

With respect to joint notification, any notifier can put forward application for cancelling notification

on its own, but the application does not affect other notifiers of joint notification.

With respect to serial notification, notifiers can put forward application for cancelling one or more

substances in serial notification, if the cancelled chemical substance provides required data for the

serial notification, the chemical substance can not be cancelled or may be cancelled after

corresponding data are supplemented. The cancellation application does not affect other notified

substances in the serial notification.

With respect to joint serial notification, notification of one or more or the whole series of substances

— 20 —

may be cancelled with written approval of all notifiers. If the cancelled chemical substance provides

required data for the notification, the chemical substance can not be cancelled or may be cancelled

after corresponding data are supplemented. Any notifier can put forward application for cancelling

joint serial notification.

IV. Requirements for New Chemical Substance Notification Documents

(I) Format requirements for notification documents

Notification materials include the notification form and the corresponding accessories materials.

1. Notification forms

The notification forms need to fill and print with the notification software released by the SCC-MEP,

and offer an electronic data. The filled characters should use simplified Chinese GB2312.

The printed paper notification forms are signed by the notifier, legal representative (or responsible

person), then the first page is scanned with a color scanner and made into a non editable PDF file.

The paper notification forms are retained by the notifier self.

2. Appendix to notification forms

Test report, literature and calculation report can be written in Chinese or English, but a copy of

Appendix can be written in only one language, and Chinese abstracts shall be provided. Experts’

description or notifiers’ notification in English shall be attached with corresponding Chinese

translation. Chinese abstracts and Chinese translation shall be consistent with meanings of original

texts, and notifiers shall be responsible for misunderstanding or delay of review experts due to

inconsistence or error. Besides the minimum data requirements, the other information submitted by

the notifers could be written in languages other than Chinese and English; however, the documents

in other language shall have the Chinese abstract.

Appendix No. shall be marked on the upper right of the first page of each Appendix and shall be

clearly indicated in format of “Appendix serial No./corresponding column No./Appendix pages”.

Appendix numbers are arrange according to the sequence presented in the notification forms, and

the Appendix are arranged according to the order.

Each independent Appendix is paged from the first page, and the starting page number is 1.

All Appendix materials should be made into the PDF files that are unable be edited, including the

entrusted contract, the agency agreement or the letter of authorization, the test reports, the expert

statement, the proof materials in special circumstances which all originals have be signed and

sealed with colour scanning.

PDF electronic files should guarantee a clear resolution, especially in spectrum charts of digital files

such as the color scanning files of the signed and sealed originals. PDF electronic files should be

arranged according to the requirements of registration, a bookmark should be inserted into the first

— 21 —

page of each independent Appendix or report and the title is same with the name of the Appendix or

report.

3. Regular notification report

Regular notification report shall be arranged in the following order:

(1) The first page of regular notification form for the new chemical substances;

(2) Appendix of the regular notification form

1) List of Appendix

2) The certificate of legal person or the business license, the entrusted contract or agency agreement,

the letter of authorization;

3) List of test reports or data: includes an information table of the serial number, name of project,

test results, and test organization;

4) Test report or data: arranged according to the order appeared in the list;

5) Testing organizations or experts qualification certificate: arranged according to the order

appeared in the list, the same test organizations or experts may submit a qualification certificate;

6) Label, chemical safety technical specifications etc..

7) Risk assessment report;

8) Others

4. Simplified notification documents

Simplified notification documents shall be arranged in the following order:

(1) The first page of simplified notification forms for new chemical substances;

(2) Appendix to simplified notification forms:

1) List of Appendix



3) The supporting materials and test report meeting the corresponding simplified notification

situation;

4) Others.

5. Scientific research filing notification documents

Scientific research filing notification documents shall be arranged in the following order:

(1) First page of scientific research filing notification forms of new chemical substances;

(2) Appendix to scientific research filing notification forms:

1) List of Appendix


— 22 —


3) Others

(II) Quality requirements for notification data

1. Principles for data quality

Quality of new chemical substance notification data shall conform to the following principles:

(1) Reliability

Notification data shall be from test organization with good practice and good administration;

(2) Scientificity

Notification data shall be from scientific and rational test design and sufficiently show or approach

characterized chemical substance characteristics;

(3) Pertinency

Notification data shall be suitable for determining certain hazard property or feature of the notified

substance.

2. Qualification of test organization

(1) Qualification of domestic test organization

Domestic new chemical substance test organization shall accept and pass inspection of the MEP and

meet the following requirements:

In ecological toxicology, it shall have a qualified laboratory to test chemicals for the MEP. It only

supplies the test data or index of the qualified chemical laboratories for the MEP in the validity

period.

In physical and chemical properties, domestic test organization must own one of the following

qualifications: being authorized by China National Accreditation for Laboratories, accredited by

China Metrology Accreditation and examined by GLP inspection of Ministry of Agriculture before

the MEP publicizes the name list in respect of physicochemical properties (including the

discrimination data such as spectroscopic data and chromatographic data etc., excluding the gel

permeation chromatograph of polymers), but just providing the data of allowable test items or

indexes in terms of its qualifications.

In toxicology, domestic test organization must own one of the following qualifications: GLP

accreditation by State Food and Drug Administration, institutes qualification of Chemicals toxicity

with GLP laboratories of the Ministry of Health and GLP laboratories approved by Certification and

Accreditation Administration of the People’s Republic of China before the MEP publicizes name

list in respect of toxicology, but just providing the data of allowable test items or indexes in terms of

its qualifications. (Note: full name of GLP is Good Laboratory Practice.)

— 23 —

(2) Qualification of overseas test organization

For the test organizations abroad that complete testing of the new chemical substance abroad and

provide test data, it must pass through the check of the competent national authorities or meets the

specifications of a qualified laboratory. It can only supply the data or index of the qualification and

test items in the period of validity.

3. Test method

For domestic test organizations, they shall carry out the notification testing of new chemical

substance in accordance with the requirements in "Measures" of Article 19 and according to the

requirements in "Guidance for of chemical testing " (HJ/T 153), the method can use the Chemicals

Test Method "(Second Edition)" (China environmental press in September, 2013) or the specified

methods in the relevant national standards or guidelines for the testing of chemicals.

Relevant national standards of chemicals test refer to a series of national standards equivalent to

Guidelines for the Testing of Chemicals of Organization for Economic Co-operation and

Development (OECD).

Overseas test organization shall carry out test for new chemical substance notification according to

Guidelines for the Testing of Chemicals of OECD or by other internationally accepted methods and

adhering to the principle of method consistency.

For items without above methods, test can be performed by methods of corresponding national

standards or internationally universal normative methods; and for special item without normative

method, test is allowed to be performed by exploratory research method, and detail method

selection specification and complete laboratory report shall be attached.

4. Test report

The test report shall be issued according to the effective present test method. If the original test

method in notification has been updated for 5 years, it should be tested again according to the

updated test method. The original test report is offered as the known information for reference

during assessment of the expert review committee.

5. Chinese test organism

China test organisms refer to the organisms cultured and reproduced in China, meeting the technical

requirements and used for specific test, the local biological technology. Including Gobiocypris rarus,

activated sludge within China, etc.

6. Sources of data

The notification data should come from the test report. In case of impossible test or in other

particular cases, international universal estimation methods are allowed, for example Quantitative

— 24 —

Structure-Activity Relationships (QSAR) and Read-Across, data can be obtained by reference to

authoritative literatures, the authoritative database or the acquired data from expert statement and

other methods and the reasons, methods or data source, basis, etc., shall be explained thoroughly.

Regardless the data is generated from any manner, it shall be submitted as an Appendix in the

notification materials. If it is derived from the test report, it should be accompanied by the

qualification certification materials of testing agency; if is derived from QSAR estimation, the

estimation model and parameters, the model recommendation or development units as well as the

version and the effectiveness illustration of results and others information should be submitted at

the same time; if it is derived from the published literature, the full text of the original literature of

the data shall be provided, not only the abstracts or citations; if it is derived from the database, the

database name, releasing organization, version and other related information should be submitted at

the same time; if it is derived from expert’s the statement, the expert introduction information, such

as title / position, working units, research field, the main research achievements shall be provided.

During reviewing of the expert review committee, the weight of evidence analysis will be carried

out based on the science for the assessment of the notification substance.

7. Test order

If test data of physicochemical characteristics, toxicology and ecotoxicology are not available for

new chemical substances proposed for regular notification, and corresponding test researches are

required, it is recommended to carry out test on physicochemical characteristics first and then

simultaneously carry out toxicological and ecotoxicological tests with consideration to possible

exposure routes of new chemical substances. If physicochemical characteristic data show hazard

such as flammability and explosibility, corresponding toxicological and ecotoxicological data shall

be excluded by reference to “special requirements”.

(III) Requirements for submitting the regular notification data

1. Basic principles

Quantity of regular notification data of new chemical substances shall conform to the following

principles:

(1) Authenticity

Notifiers shall fully submit all known information about hazard properties and environmental risk

of notified substances authentically;

(2) Level-based increase

The higher notified quantity level, the higher requirement for test data. When notified quantity

reaches higher level, test data to be submitted will increase subsequently;

(3) Data sharing

— 25 —

Notifiers are encouraged to share new chemical substance notification data;

(4) Selective generality

On the premise that general data shall conform to unified requirement, specific test items can be

excluded considering practical conditions of notified substance (see “data exclusion” for details);

(5) Balance consideration

On the premise that risk assessment quality is ensured, take consideration of “3R” of test organism,

that is, reduction, refinement and replacement.

2. Minimum data requirements

For regular notification of new chemical substances, data with different minimum requirements are

submitted according to difference in notified quantity levels. Notified quantity level of new

chemical substances contained in product or article is determined by pure content of new chemical

substances.

(1) Physicochemical properties

Corresponding physical and chemical data are submitted according to physical state of notified

substances at normal temperature and pressure (20℃and 101.3kPa):

Gaseous state: oxidability, self-ignition temperature (℃), flammability, explosive limit and critical

point;

Liquid state: boiling point (℃), density (kg/m3), vapor pressure (kPa,℃), n-octanol/water partition

coefficient (Log Pow), water solubility (g/L), surface tension 1)

(N/m),pH value, flash point2)

(℃),

oxidability, self-ignition temperature (℃), flammability and explosibility;

Solid state: melting point (℃), density (kg/m3), n-octanol/water partition coefficient (Log Pow),

water solubility (g/L), particle size (μm), oxidability, self-ignition temperature (℃), flammability

and explosibility;

Other forms: referring to the above three ones, data of items that can be tested shall be provided. In

addition, stability of organic solvents and properties of degradation products shall be provided

whenever the substance is at the critical state and the critical temperature could be calculated if

necessary.

The spectrum data: for the organic matter, the infrared, nuclear magnetic resonance, mass

spectrometry should be provided at least 2 kinds; for the chiral matter, the information on the

optical rotation should be provided as far as possible. The information about test conditions of data

should be included in providing spectrum data.

Note 1): The data shall only be submitted whenever the surface activity is expected, foreseeable or

— 26 —

the surface activity is the required data based on the structure of notified substance.

Note: 2) the flash point should be tested with a closed cup test. Open cup test only can be accepted

in special circumstances.

(2) Toxicology

See Table 1 for data requirements of toxicology.

Table 1 Minimum data requirements of toxicology

Data requirement Level I Level II Level III Level IV

1≤Q<10t/a 10≤Q<100t/a 100≤Q<1000t/a Q≥1000t/a

Acute toxicity1)

√ √ √ √

28-day repeated dose toxicity 3)

√ √ √ √

Mutagenicity 4)

√ √ √ √

90-day repeated dose toxicity 5)

√6)

√ √

Reproductive/developmental toxicity 7)

√ √ √

Toxicokinetics 8)

√ √ √

Chronic toxicity9)

√

Carcinogenicity 10)

√

Others11)

Note: “Q” refers to notified quantity.

Notes:

1) Acute toxicity data include acute oral toxicity, acute dermal toxicity, acute inhalation toxicity,

skin irritation, eye irritation and skin sensitization.

2) At level 1, the acute oral toxicity, skin irritation, eye irritation, skin sensitization test data shall be

provided, and the corresponding acute dermal toxicity, acute inhalation toxicity test data shall be

provided in combination with physical and chemical properties and main exposure routes.

3) 28-day repeated dose toxicity includes through oral, dermal and inhalation toxicity and at least

one test data of exposure route shall be provided combining the notification use.

4) At level 1, the bacterial reverse mutation test data and chromosome aberration test data in vitro

(or the in vitro micronucleus test data) should be provided. If any test result is positive, and there is

a risk of widespread exposure, the mutagenicity test of higher magnitude shall be provided.

Since level 2, the test data for the following four situations should be provided according to the test

result of level 1:

a) if all results of level 1 tests are negative, the in vitro gene mutation test data it should be provided;

if the in vitro gene mutation test results are positive, the in vivo gene mutation test data should also

be provided (such as non program DNA synthesis of mammalian liver cell in vitro, cell gene

mutation of transgenic rodent animal in vivo)

— 27 —

b) if the bacterial reverse mutation tests are negative, the chromosome aberration tests in vitro are

positive, the in vitro gene mutation test data and the chromosome aberration tests in vivo should

also be provided (such as mammalian erythrocyte micronucleus test, mammalian bone marrow

chromosome aberration test, etc.); if the in vitro gene mutation test results are positive, the in vivo

gene mutation test data shall also be provided;

c) If the cell reverse mutation tests are positive, the in vitro chromosome aberration tests are

negative, the in vivo gene mutation test data shall also be provided;

d) If all test results of level 1 are positive, the in vivo gene mutation test data and chromosome

aberration test data shall also be provided;

5): In combination with the notification purpose, the test data for at least one exposure route should

be provided.

6): At level 2, the repeated dose toxicity data for 90 days should be provided when there are other

data showing that in the repeated dose toxicity test in 28 days, some harmful substance

characteristics cannot be detected, or the toxic kinetics studies show that the substance or its

metabolites are not detected in specific tissues or organs in 28 days the cumulative effect of

repeated dose toxicity test, while in more long term exposure, it can cause harmful effects.

7): At level 2, the reproductive / developmental screening test data should to be provided. If a

notification substance is known harmful effects on reproduction or its chemical structures are

similar with a known reproductive toxic substance, developmental toxicity study should be carried

out; if the notification substance is known to cause developmental toxicity or its chemical structures

are similar with a known reproductive toxic substance, the reproductive toxicity studies should be

carried out.

If known a substance may have potential reproductive or developmental toxicity, the development

toxicity data before birth, two generation reproductive toxicity data or extension of one generation

reproductive toxicity data may replace the screening test.

Since level 3, the prenatal developmental toxicity data and the two generation reproductive toxicity

data should be provided.

8): At level 2, the relevant information of toxicokinetics should be provided.

Since level 3, new chemical substances with hazard classification and labeling of chemicals in

specification healthy index, the test report of a complete toxicokinetics should be provided; if the

new chemical substances without classification, then the related information of toxicokinetics

should be provided.

9) Test data of at least one exposure route shall be provided based on notified use.

— 28 —

10):The notification substance has a widely dispersed uses or may be frequent, long-term exposure

to the human body, and belongs to the germ cell mutagenicity category 2 or there is evidence in a

repeated exposure test shows that the substance can induce proliferation and / or pre neoplastic

lesions, its carcinogenicity data should be provided.

Except the above situation, the carcinogenicity test data or carcinogenicity assessment report should

be provided, but the conclusions of the assessment still need to further test, the carcinogenicity test

data shall be provided.

Widely dispersed uses refer to the trained professional personnel use the chemicals in scattered site

or use in many public or in daily life, resulting in uncontrolled exposure or disperse release

activities. For example, the new chemical substances or products containing new chemical are used

for paint, pesticide spraying, textile printing and dyeing and other occupation exposure related

activities or used as a detergent, cleaning agent, disinfectant, cooling liquid, cosmetics, perfume, air

spray products, household paint, coating, adhesive, lubricant and other related exposure with

consumers and the environment.

11): In case that it is proved by relevant data that notified substance may have obvious target organ

toxicity, corresponding toxicity data shall be submitted, and neurotoxicity data shall be submitted in

case of organic phosphorus substance.

(3) Ecotoxicology

See Table 2 for data requirements of ecotoxicology.

Table 2 Minimum data requirements of ecotoxicology

Data requirement Level I Level II Level III Level IV

1≤Q<10t/a 10≤Q<100t/a 100≤Q<1000t/a Q≥1000t/a

Algal growth inhibition toxicity √ √ √ √

Daphnia acute toxicity √ √ √ √

Fish acute toxicity √ √ √ √

Activated sludge respiration inhibition

toxicity

√ √ √ √

Adsorption/desorption √ √ √ √

Degradability 1)

√ √2）

√ √

Earthworm acute toxicity test √3）

√3）

√ √

Daphnia reproductive test √ √ √

Bioaccumulation √ √ √

Fish chronic toxicity test4)

√ √

Seed germination/root elongation toxicity

test

√ √

— 29 —

Enchytraeids reproduction test or

earthworm reproduction test5）

√

Note: “Q” refers to notified quantity.

Notes:

1) Submit rapid biodegradability test data, and such data shall be obtained by using test method

suitable for properties of notified substance.

2) Starting from Level II, In case that test result shows notified substance has no rapid

biodegradability, submit original biodegradability test data; In case that test result shows notified

substance has no biodegradability, submit hydrolysis test data related to pH value.

3) Water solubility is less than 1mg/L and logKoc is more than 3.5.

4) Select any test from the following tests: fish early-life stage toxicity test, fish short-term toxicity

test on embryo and sac-fry stages or fish juvenile growth test.

5): When the results of terrestrial organism acute toxicity test have harm classification, it is required

to provide.

3. Special requirements

(1) Requirements for data of special substances

For notified substances specified below, descriptive or evidential data concerning relevant attributes

shall be submitted and data can be submitted according to special requirements.

1) Self-ignitable chemical substances

Providing density test data, the test data must not be provided for the toxicological and

ecotoxicological data, providing the data derived from estimation, analogue cross reference data or

documents data.

2) Explosive, flammable or self-reactive chemical substances

For chemical substances resulting in explosion, ignition or self-reactivity in routine test at normal

temperature and pressure, test data of toxicology and ecotoxicology are excluded but data originated

from estimate, analogue cross reference, literature, etc are included.

3) Chemical substances emitting flammable gas in case of contact with water

Ecotoxicology test data are excluded if chemical substance reacts vigorously with water at ambient

temperature and generates gas with self-ignition orientation, or reacts with water at ambient

temperature and generates gas at the maximum speed more than or equal to 1L/kg per hour.

4) Inorganic compounds and metals

Biodegradability test data are excluded.

5) Chemical substances decomposing or reacting in case of contact with water/light (excluding

chemical substances emitting flammable gas in case of contact with water)

— 30 —

Decomposition in case of contact with water/light refers to half-life period DT50<12h under normal

temperature and pressure

Requirements for physicochemical properties are the same as “physicochemical properties in

minimum data requirements”.

Test report specifying names and contents of hydrolytic and photolytic products, or the products

with reactivity and whether those products are new chemical substances are required, and new

chemical substances are respectively treated according to the following classifications:

——Ecotoxicology data are excluded if all products generated in decomposition or reactivity in

case of contact with water/light is existing chemical substances;

——Ecotoxicology data of notified substance or its hydrolysate corresponding notified quantity are

required if all products generated in decomposition or reactivity in case of contact with water/light

contain new chemical substances (single substance content >10%). Data submitted shall be test data

if notified substance is taken as an object; and data submitted can be those originated from test,

estimate, analogue cross reference, literature, etc. if its hydrolysate is taken as an object.

6) Insoluble compounds

Insoluble compounds refer to chemical substances with water solubility less than 100mg/L.

Maximum dose/concentration of its aquatic ecotoxicology test shall be saturated solution of such

substance in test medium. Preparation method of saturated solution shall conform to relevant

technical specifications.

(2) Requirements for data of other special cases

1) Ecotoxicology test completed in the territory of China

——Aquatic toxicity data. Submit the toxicity test data of at least one item at Level I (fish is

preferred); and at least select one item in newly added data requirements for increasing one quantity

level starting from Level II.

——Biodegradability data. Rapid biodegradability test is preferred. In case that such test has been

completed abroad, the rapid biodegradability or inherent biodegradability could be selected for test.

In case rapid biodegradability test has been completed abroad and test result shows that the notified

substance has no rapid biodegradability, the inherent biodegradability shall be selected.

——Terrestrial organism toxicity data. For soil environmental risk substances that need to pay

attention, it is recommended to provide.

2) Test sample

The test data of physicochemical properties, toxicological and ecotoxicological properties should be

obtained from the pure substance, namely, the test sample shall be a pure substance (the total

amount of impurity <20%). In case the purity could not be obtained, the test data could be got from

— 31 —

the self-made product, and the evidence for inability of purity extraction shall be provided

simultaneously. Test data of toxicology and ecotoxicology can be obtained from pure substance or

compound containing notified substance, but sample purity shall be identified in test report.

3) Impurity

In case that it is proved that some impurity contained in notified substance is of high toxicology and

ecotoxicology hazard, and its content is within a range of variation (<10%), sample with highest

content of such impurity shall be taken as test sample and its content shall be identified in test

report.

4. Data exclusion

See Table 3 to Table 5 for exclusion conditions of notification data.

Table 3 Exclusion conditions of data of physicochemical properties

Data Exclusion conditions and description a

Melting point (℃) -Melting point/condensation point is below -20℃.

Boiling point (℃) - Gaseous substance; - Solid with melting point above 300℃ or decomposed

before boiling. In this case, estimate or measure the boiling point of such

substance through decompression; - Substance decomposing before boiling.

Density (kg/m3) - Gaseous substance; - Substance stable only in solution containing special

solvent, and its solution density is similar with solvent density. In this case, it

shall be identified that whether solution density is higher or lower than solvent

density; - Gaseous substance.

Vapor pressure (kPa,℃) - Melting point is higher than 300℃ ;

- If melting point is between 200℃ and 300℃, limit value obtained by

measurement or accepted calculation method can be provided.

Surface tension (N/m) - Water solubility at 20℃ is lower than 1mg/L.

Self-ignition temperature (℃) - Explosive or self-flammable in air at room temperature; -

- Gas without flammable range;

- Non-flammable liquid in air, For example, the substance does not belong to

the inflammable liquid or the liquid flash point is greater than 200℃;

Solid with melting point lower than 160℃, or solid which only generates

spontaneous heating at 400℃ as proved by initial result.

Flash point (℃) - Inorganic substance;

-Substance only containing volatilizable organic component with flash point

above 100℃ in aqueous solution;

- Estimated flash point is higher than 200℃;

- Accurately expectable based on existing material with certain characteristics.

— 32 —

N-octanol/water partition

coefficient (Log Pow)

- Inorganic substance.

Water solubility (g/L) - Substance hydrolyzing in case that pH value is 4, 7 or 9 (half-life period is

shorter than 12h);

- Readily oxidizable in water;

- If substance shows “insolubility” in water, limit test shall be taken till

minimum detectability of analysis method.

Oxidability -Explosive;

- Highly flammable;

- Organic peroxide (classified by test);

- the compounds do not contain the high-electronegative atom;

-Unable to proceed exothermic reactivity with flammable substance, For

example, the substances with chemical structure as basis (such as organic

matter that not including oxygen and halogen atoms and these elements are not

chemically bonded with nitrogen or oxygen, or inorganic matter that not

including oxygen and halogen atoms).

Flammability - Explosive or self-flammable solid;

- Self-ignition occurs in case of contact with air.

Explosibility -No explosibility-related chemical group in molecule;

- Substance containing explosibility-related chemical group and containing

oxygen, but calculated oxygen balance is less than -200;

- Substance containing explosibility-related chemical group, but its pyrolytic

energy is less than 500J/g or initial pyrolytic temperature is lower than 500℃.

Particle size (μm) - Sale or use in non-solid or non-particle type.

Stability in organic solvent and

characteristics of degradation

products

- Inorganic substance.

Note: If several exclusion conditions are listed, it is sufficient only if one condition is fulfilled (unless otherwise

specified).

Table 4 exclusion conditions of toxicology data

Data Exclusion conditions and description

Acute oral toxicity - Gaseous state at normal temperature and pressure;

- Skin corrosive.

Acute dermal toxicity - Gaseous state at normal temperature and pressure;

- Difficult to pass through skin barrier.

- Skin corrosive;

— 33 —

Acute inhalation toxicity -The vapor pressure is less than 10-1

Pa when the substance is at 20℃;

-The part that can be drawn in the particle size distribution of substance

( micro particle with particle size ＜100μm) <1% (weight percent), and

when use, the produced aerosol particles , micro particles or droplets

MMAD>100μm.

Skin irritation or skin corrosion - Gaseous state at normal temperature and pressure;

-Flammable in air at room temperature;；

- No skin irritation reactivity occurred in acute dermal toxicity test with

limit dose of 2000mg/kg body weight;

-Strong acid (pH<2.0) or strong base (pH>11.5);

- Acute dermal toxicity is virulent;

- Highly irritant or corrosive demonstrated by structure-effect analysis

result (considered as skin irritant or skin corrosive).

- Skin corrosive demonstrated by existing data (considered as skin irritant

or skin corrosive).

Eye irritation -Flammable in air at room temperature;


- above skin irritation toxicity of class 2 (inclusive 2);

- Skin corrosive demonstrated;

- It has shown in data that it is an irritant to the eye (considered as eye

irritation).

Skin sensitization - Gaseous state at normal temperature and pressure;

- Flammable in air at room temperature;


- Highly irritant or corrosive at expected contact concentration;

- similar chemical structure with that of known sensitizer (considered as

skin sensitization)

28-day repeated oral toxicity - Gaseous state at normal temperature and pressure;

- Substance rapidly decomposes and information of decomposed products

is sufficient;

- Reliable 90-day repeated dose oral toxicity or chronic oral toxicity

research data are available.

- Skin corrosive;

— 34 —

28-day repeated dermal toxicity - Gaseous state at normal temperature and pressure;

-The physical and chemical properties and toxicological properties have

shown that it is difficult to be absorbed by the skin;


is sufficient;

- Reliable 90-day repeated dose dermal toxicity or chronic dermal toxicity

research data are available.

- Skin corrosive;

28-day repeated inhalation toxicity -The vapor pressure is less than 10-1

Pa when the substance is at 20℃.

-The part that can be drawn in the particle size distribution of substance

( micro particle with particle size ＜100μm) <1% (weight percent), and

when use, the produced aerosol particles , micro particles or droplets

MMAD>100μm.


is sufficient;

- Reliable 90-day repeated dose inhalation toxicity or chronic inhalation

toxicity research data are available.

90-day repeated dose toxicity - Substance rapidly decomposes and information of decomposed products

is sufficient;

- Reliable chronic toxicity research data are available and same test animal

and Exposure route.

-The toxicity effect have been observed in a repeated exposure toxicity

tests with the same test animal and exposure route for 28 days, or "non

observable effect level" is very low2.

-1 or 2 class of carcinogens.

Mutagenicity - Carcinogen Class I or Class II: reproductive/developmental toxicity Class

I or Class II (considered as reproductive cell mutagenicity, carcinogenicity,

reproductive/developmental toxicity).

-Having the in vivo genetic toxicity test, the in vitro genotoxicity tests with

the same genetic toxicity endpoints can be exempted.

Reproductive/developmental

toxicity

--Embryonic developmental toxicity data or two-generation reproductive

toxicity data are available (reproductive/developmental screening data can

be excluded);

- Carcinogen Class I or Class II;

- Mutagenic substance Class I or Class II;

-It has been known that the substance meets the standard of reproductive

toxicity Class I and Class II and the latter three conditions are considered as

— 35 —

reproductive cell mutagenicity, carcinogenicity,

reproductive/developmental toxicity.

Carcinogenicity -Substance belongs to the 1A or 1B of germ cell mutagenicity ;

-Having joint chronic toxicity and carcinogenicity test.

Chronic toxicity -Having joint chronic toxicity and carcinogenicity test.

1: If several exclusion conditions are listed, it is sufficient only if one condition is fulfilled (unless otherwise

specified).

2: No observable effect and very low level refers to the lowest observable effect level for 28 days repeated dose

toxicity test is less than 100mg/kg (oral), 200mg/kg (percutaneous), 0.25mL/L (inhalation, gas), 1mg/L

(inhalation, steam), and 0.2mg/L (suction, dust / smoke).

Table 5 Exclusion conditions of ecotoxicology data

Data Exclusion conditions and description1

Algal growth inhibition toxicity -Water solubility is lower than 1mg/L and impossible to

penetrate the biomembrane2.

Daphnia acute toxicity -Water solubility is lower than 1mg/L and impossible to

penetrate the biomembrane2;

- Chronic toxicity data of same species are available, such

as, daphnia reproductive test.

Fish acute toxicity -Water solubility is lower than 1mg/L and impossible to

penetrate the biomembrane2;

- Chronic toxicity data of same species are available, such

as, fish 14-day toxicity test data, fish chronic toxicity test,

etc.

Daphnia reproductive test -Water solubility is lower than 1mg/L and impossible to

penetrate biomembrane2.

Terrestrial

organism

toxicity

Earthworm acute toxicity - Lower absorption of the soil (such as logKoc >1.5);

- Long-term test shall be considered to be used for replacing

short-term test if soil adsorption is high (such as

logKoc >4.5).

Earthworm chronic toxicity

Seed germination/root elongation

toxicity

Terrestrial plant chronic test

Soil microorganism effect

— 36 —

Activated sludge respiration inhibition toxicity - Impossible to produce microorganism toxicity as

demonstrated by relevant data, for example, solubility is

quite low;

- Can be replaced by nitrification inhibition effect test if it

is microorganism inhibitor (especially for nitrobacteria).

Adsorption/desorption - Substance and its degradation products rapidly

decompose, for example hydrolysis half-life <12h.

Degradability Non-biodegradation -Rapid biodegradation;

- Hydrolysis test is not required if solubility is quite low.

Rapid biodegradation - Inorganic substance.

Inherent biodegradation - Inorganic substance;

- Rapid biodegradation.

Bioaccumulation Fish accumulation - Low possibility of accumulation in organism (e.g. log

Kow<3);

- Impossible to penetrate biomembrane;

- Rapid biodegradation

1: If several exclusion conditions are listed, it is sufficient only if one condition is fulfilled (unless otherwise

specified).

2: Provide the test report of biological membrane permeability for the notification substance or its analogues; if it

is unable to carry out the test to obtain the membrane permeability data of notification substance, the reasons that

it is unable to carry out the test as well as the prediction report of biological membrane permeability software

and summary or description of literature data should also be provided at the same time

(IV) Requirements for risk assessment report

1. Principles for report preparation

The risk assessment report is prepared adhering to the principle of “scientific basis, factualism,

accurate statement, full demonstration, graded assessment and focus on doubt”.

The risk assessment report shall be prepared in accordance with the relevant technical specifications

issued by the MEP. Based on the number levels of notification substances, the hazardous nature and

notification uses and other specific conditions, the hazard classification and identification are

carried out and environmental risk assessment and health risk assessment are developed.

The notifier may prepare the risk assessment report by himself or entrusted the relevant

organizations. The preparation organization should have the specialized technical personnel with the

relevant professional knowledge. The preparation staff should follow the occupation ethics, have

professional background or work experience for new chemical risk assessment.

2. Requirements for report preparation

(1) General requirements

— 37 —

For level 1 of notification substance, the environmental risk assessment should be carried out

qualitatively, but also may be quantitatively environmental risk assessment; for level 2 or above of

notification substance, the quantitative risk assessment should be carried out.

The risk assessment report should accurately describe the hazard assessment, exposure assessment

and risk characterization process and conclusion of the notification substance. The cited data and

information in the risk assessment report should have the relevance, accuracy, adequacy and

traceability, the data processing is standardized and the measurement units meet the relevant

national standards. The known hazardous information of notification substances, regardless of

whether it belongs to the requirements of the minimum data in the level of amount, it should be

reflected in the risk assessment report, no deliberately is concealed.

(2) Special requirements

According to the classification and labelling specifications of chemicals (GB 30000), a new

chemical substance is in non hazard classification, the classification results, the basis and simple

exposure description shall be provided in the risk assessment report..

A series of notification substances as a group of chemical substances with similar molecular

structure, the same or similar use, similar test data, in addition to the chemical substance

identification and physicochemical properties, the risk assessment is carried out on the principles of

data sharing with in the series, strict and tight classification, accumulation of notification number,

and preparing a risk assessment report. Namely, the data of identification and phys chemical

properties is not shared, the information of the related substance should be listed separately; the data

of environmental fate, pollution, health hazard, exposure information are shared. In identification

and assessment, the hazard classifications are carried out for the minimum or maximum toxicity

data, and derivation of the predicted non effective concentration (PNEC). In exposure assessment,

accumulation of notification number of various substances, and the quantitative or qualitative

assessment are carried out.

The risk assessment report shall have complete contents, with clear and objective and fair

conclusions, the risk control Measures are feasible, concise and accurate, consistent, complete

reference chart, and pay attention to the timeliness of references.

3. Report format

Risk assessment report includes a cover page, contents, text and the list of references and Appendix.

The cover of risk assessment report includes the title, name and CAS number of the notification

substance, name of notifier, name of report preparation organization, and time of r report

preparation. The cover should have the official seal of the preparation organization.

— 38 —

The report preparation organization and staff shall be described in the title page of the risk

assessment report, including professional background, work experience and the received relevant

training etc. The numbers of the report preparation staff should be signed with handwritten in the

title page. For risk assessment report is prepared through an entrusted related organization, the

entrusted letters between the notifier and the report preparation organization, the related

qualification documents of the report preparation organization should be listed in accessory parts

The contents of risk assessment report should include the detailed titles and the corresponding page,

the serial number, title and page number of chart.

The test of risk assessment report should include the contents of background, environmental

management category and risk control Measures, substance identification, attribute data,

applications, harm classification, identification of persistent bioaccumulative and toxic (PBT) or

high persistent bioaccumulative (vPvB), hazard assessment, exposure assessment, risk

characterization, assessment conclusion, and other parts.

As to the format requirements of risk assessment report, please see Appendix 1.

4. The contents of the report

(1) Background

Explaining the basis of the assessment, brief describing the assessment process, briefly introducing

the preparation organization and personnel, including professional knowledge and training situation

(2) Environmental management category and risk control Measures

According to the relevant technical documents issued by the MEP, the environmental management

categories of the notification substance are explained. An overview of the risk control Measures for

the notification substance.

(3) Substance identification

Chinese and English name, CAS number, molecular formula, structural formula, material

composition, impurities, product identification information, etc. of the notification substances are

listed.

(4) Attribute data

List data summary of physical and chemical properties (such as melting point, boiling point, vapor

pressure, water-solubility, octanol water partition coefficient, etc.), degradation data summary (such

as hydrolysis, biodegradation, etc.), bioaccumulation data summary (such as fish bioaccumulation,

etc.), data summary of the acute/chronic environment toxicity (such as algae, daphnia, fish,

earthworm and other organisms), and data summary of mutagenicity of health toxicity and acute /

chronic oral/percutaneous/inhalation toxicity of notified substances.

The data summary of physical and chemical properties such as melting point, boiling point, vapor

— 39 —

pressure, water solubility, octanol water partition coefficient, etc. degradation data summary such as

hydrolysis, biodegradation, bioaccumulation data summary such as fish bioaccumulation, the data

summary of the acute toxicity/chronic environmental toxicity such as algae, daphnia, fish,

earthworms and other organisms and data summary of mutagenicity of health toxicity and acute /

chronic toxicity such as oral and skin, inhalation of notification substances are listed from the

aspects of the main results, test conditions, test method, and test organization, data summary should

include main result, test condition, test method, test agency and so on.

(5) Use

Explaining use and expected effect of notification substances. For use may result in a greater risk, it

should be listed as not recommend use. Use classification and code thereof should be filled out

according to the use code table of chemicals. Refer to the Appendix 2 for the use code table of

chemicals (Appendix 2).

(6) Risk classification and management category and physical risk control

According to the classification and label specifications of chemicals, the classifications of physical

hazards, environmental hazards and health hazard of the notification substances are carried out,

respectively; and the environmental management categories are divided, respectively, in accordance

with the relevant technical specifications issued by the MEP from the physical hazards,

environmental hazards and health hazards of the notification substance.

Describing the oxidation, flammability, explosion, ban complex materials, packaging and storage

conditions, leakage treatment Measures, suitable extinguishing equipment, and physical risk control

Measures of notification substance.

(7) Identification of persistent, bioaccumulative and toxic substances or high persistent high

bioaccumulation

According to the "The identification methods of persistent, bioaccumulative and toxic substances,

and very persistent and bioaccumulative substances " (GB/T 24782) in combination with the

degradation and biological accumulation, environmental hazards and health hazard of notification

substance, the substances are judged whether they belong to PBT or vPvB substances.

(8) Hazard assessment

According to the relevant technical specifications issued by the MEP, the risk assessment of the

notification substance is carried out.

For the quantitative risk assessment, the environmental PNEC of notification substances should be

derived; for qualitative environmental risk assessment, classification of environmental hazards of

the notification substances should be carried out.

— 40 —

For health hazard assessment, classification of health hazard of the notification substances should

be carried out.

(9) Exposure assessment

According to the relevant technical specifications issued by the MEP, exposure assessment of the

notification substances is carried out.

For the quantitative risk assessment, the different exposure scenarios are set to describe the detailed

exposure scenarios according to the stage of life, mode of production, use, yield / consumption

amount, situation, etc.

In the description of exposure scenario, the following circumstances shall be stated:

1) Short title and No.: decide a short title and No. for exposure scenarios:

2) Overview: the stages of the life cycle (production/preparation/industrial use/ consumption

use/recycling use/disposal), application fields, application mode, etc. of notification substances

involved in the exposure scenarios. In referring foreign exposure scenarios, the corresponding

conditions are indicated;

3) Basic characteristics of chemicals: in this scenario, the physical state, particle size, concentration

of the notification substance in chemicals or chemicals containing the notification substance etc.

4) Production / use quantity and time: the annual yield and /or use amount, frequency and duration

time of the notification substances or chemicals containing the notification substance etc.

5) Production process: names of production and / or use process, process flow, reactivity conditions,

chemical reactivity of the notification substances; providing the process flow chart, and the inlet

and exit location and quantity of the notification substance and / or containing its waste are

indicated as far as possible in the process flow diagram.

6) Operating environment and operating conditions: the main equipment and its closed or open and

automation control, clean production, temperature, ventilation, ground seepage, working

environment, personal protection requirements and other conditions;

7) Three waste generations: the generation conditions of three wastes (waste gas, waste water, solid

waste) containing the notification substances in production and / or use including the production

link, generation amount and the notification substance concentration, and explaining the use method

and basis; if the application of raw material balance method, the material balance table should be

listed; three wastes emission amount is directly calculated by using the emission factors without

calculating the production amount of three wastes, and this part can be simplified appropriately.

8) Treatment and emissions of waste gas: recovery, utilization and disposal conditions of waste gas

containing the notification substance in the production and / or use; illustrating emission amount /

day of waste gas containing the notification substance; for use of the emission factor method, the

— 41 —

sources basis of emission factors should be fully stated;

9) Treatment, emissions and fate of wastewater: recycling, utilization and disposal of wastewater

containing the notification substance in production and / or use; illustrating emission amount /day

of waste water containing the notification substance, and illustrating whether the wastewater is

discharged into the municipal sewage treatment plant or sewage treatment plant of industrial park

and associated processing conditions; for use of the emission factor method, the sources basis of

emission factors should be fully stated.

10) Storage and fate of solid waste: storage, discharge and fate/ or use of solid waste containing the

notification substances in the production and / or use; for use of the emission factor method, the

sources basis of emission factors should be fully stated.

11) Surrounding environment: illustrating the flow of natural water body such as river, lake, sea and

others receiving the waste water, and (if possible) the surrounding environmental function zoning

and environmental sensitivity

12) Exposure of consumption link indicates the environmental exposure information such as the

maximum consumption volume of reported substances in the representation areas, and meanwhile

indicates health exposure information of notified substances such as consumption mode, and

maximum consumption volume per capita.

The emission amount and other important parameters should be listed in the form for each exposure

scenario, and the environmental prediction concentration in the sewage treatment plant, surface

water, sediments, soil and other environmental media (PEC) should be estimated in accordance with

the relevant technical specifications issued by the MEP.

For qualitative environmental risk assessment or health risk assessment, the environmental exposure

or health exposure of to notification substances should be classified.

(10) Risk characterization and uncertainty analysis.

According to the relevant technical specifications issued by the MEP, the risk characterization and

uncertainty analysis of the notification substance are carried out.

For quantitative environmental risk assessment, the ratio of PEC and PNEC should be compared for

sewage treatment plant, surface water, sediments, soil and other environmental media in different

exposure scenarios to obtain the risk quotient (RCR).

For qualitative environmental risk assessment and health risk assessment, a qualitative risk rank

environmental or health risk level should be obtained in combination with environmental or health

hazards classification and exposure classification,

The risk characterization and uncertainty are analyzed from factors involved in both the hazard

— 42 —

assessment and exposure assessment.

(11) Assessment conclusions

An overview of physical risk, physical risk control Measures and risk assessment conclusions of

physical risk of the notification substances.

An overview of the environmental hazards, environmental risk control measures and environmental

risk assessment conclusions of the notification substances.

An overview of the health hazards, health risk control Measures and health risk assessment

conclusions of the notification substance

According to the relevant technical specifications issued by the MEP, the environmental

management category of the notification substances is carried out in combination with physical

danger division, environmental hazard division, health hazard division and PBT or vPvB

identification.

(12) References

Main references used in the risk assessment process of the notification substances are listed.

(13) Appendix

According to the order existing in the risk assessment report, the lists of various appendixes are

listed. These appendixes are attached in order after risk assessment report.

(V) Data requirements of special formats of regular notification

Handling procedures for special formats of regular notification are the same as regular notification

procedures. Additional data requirements are as follows:

1. Serial notification

The notifier shall submit an Appendix in tables for describing that all new chemical substances meet

serial notification conditions in serial notification against the tables. The Appendix cover at least

identifications including Chinese and English names, CAS number, molecular formula, molecular

weight and structural formula, and physicochemical characteristic data, use and notified quantity of

all new chemical substances, etc.

For serial notification, test data of one or more new chemical substances in the serial notification

can form the minimum test data requirements under the quantity level. The notified quantity level of

the serial notification is determined by the total notified quantity of all serial substances in this

serial notification.

In respect of the new chemical substances in serial notification, in case certain property (such as

toxicity) could not explain the similar testing result of the serial substance, the test data of each

substance shall be submitted respectively.

— 43 —

2. Joint notification

All notifiers in the joint notification shall fill the home page of notification form, basic information

pages, and shall respectively sign home pages of regular notification form.

The notified quantity level of joint notification is determined by the total notified quantity of

various notifiers in this joint notification.

3. Joint serial notification

In joint serial notification, data shall be simultaneously submitted according to requirements for

joint notification and serial notification. The notified quantity level of joint serial notification is

determined by the total notified quantity of all notified substances by various notifiers in the joint

serial notification.

4. Repeated notification

The latter notifier of repeated notification shall submit the signed original of power of attorney of

notification data that are used by the latter notifier with the approval of the former notifier. The

power of attorney shall clearly list item name and data/Appendix No. of notification materials used

with approval.

The notified quantity level of the latter notifier is determined by the sum of notified quantity or

registered quantity of the former notifier and notified quantity of the latter notifier.

Where notification is submitted based on the same test report, the notified quantity level is

determined according to provisions in the preceding paragraph.

The former notifier obtains registration certificate for producing new chemical substances, the

registered substances are exported outside the customs territory after production and then imported

into the customs territory after processing and preparation, the latter notifier can transact

notification formalities of imported new chemical substances based on noncumulative notified

quantity level, but shall provide evidence issued by the registration certificate holder of domestic

new chemical substances at the same time.

5. Re-notification for increase in registered quantity level

In case of increase in registered quantity level, the registration certificate holder shall submit the

corresponding test data and relevant information of this quantity level before quantity level increase

and transact re-notification according to test data requirements specified in the Guidance. Data that

have been submitted for the original notification registration can not be resubmitted.

6. Re-notification for change of registered use

For change in registered use on the registration certificate of hazardous new chemical substances

subject to key environmental management, changes are classified as three cases and subject to

— 44 —

re-notification.

(1) Before registered substances are listed in the Inventory, the registration certificate holder shall

submit risk assessment report of change in registered use and outline data of functions, desired

effect, etc. of new use different from those of registered use before changing registered use. Data

that have been submitted for the original notification registration can not be resubmitted.

(2) After registered substances are listed in the Inventory, the original registration certificate holder

shall submit risk assessment report of change in registered use and outline data of functions, desired

effect, etc. of new use different from those of registered use before changing registered use. Data

that have been submitted for the original notification registration can not be resubmitted.

(3) After registered substances are listed in the Inventory, who processes and uses the chemical

substances shall submit exposure prediction assessment data, and functions and desired effect of

changed use before changing registered use.

(VI) Data requirements of simplified notification

1. Basic cases of simplified notification

As for basic cases of simplified notification of the new chemical substance with the annual yield or

imported amount less than 1 ton, the report on ecotoxicological test by Chinese local test organisms

within China also shall be submitted in addition to meeting completion requirements of notification

form.

If notified substances are organic substances, rapid degradation test report shall be provided. If

notified substances are not easily subject to rapid biological degradation, report on acute toxicity

test of aquatic organisms (fish is preferred) also shall be submitted.

If notified substances are inorganic substances, report on acute toxicity test of aquatic organisms

(fish is preferred) shall be submitted.

Where notified substances have water solubility less than 100mg/L and are toxic to aquatic

organisms at saturated concentration, the corresponding median lethal concentration or effect shall

be given; and where notified substances are non-toxic to aquatic organisms at saturated

concentration, report on acute toxicity test of terrestrial life (earthworm is preferred) shall be

provided.

Particular requirements for submitting simplified notification data and data exemption with

requirements for the regular notification data

2. Special cases of simplified notification

In different special cases of simplified notification, the following information shall be submitted in

Appendix forms in addition to meeting completion requirements of notification form:

(1) Intermediates with annual output or import volume less than 1t.

— 45 —

Evidence or statement (signed and sealed original) of intermediates contain functions, effect,

application field and basic situation of intermediates, etc.

(2) Substances only for export with annual output or import volume less than 1t.

Statement (signed and sealed original) for substances only for export without domestic sales or

processing and use after production or import in China contains enterprises and countries where the

substances are only exported after production and import, export use and foreign customization

(3) Substances for scientific research with annual output or import volume more than 0.1t but less

than 1t.

Evidences or statement (signed and sealed original) of scientific research contain research and

development institution information, scientific research project name, research content description,

functions and effects of notified substances in research and main application fields.

(4) Polymers containing new chemical substance monomer less than 2% or low concern polymers.

See special provisions on polymers.

(5) Substances for process and product research development with annual output or import volume

less than 10t but production and import not more than 2 years.

Evidences or statement (signed and sealed original) of process and product research development

contain research and development institution information, research and development project name,

research content description, functions and effects of notified substances in research and main

application fields.

(VII) Information confidentiality requirements

The notifier can set the corresponding check boxes in columns “confidential” in the notification

form that are permitted for keeping confidential. In case that confidentiality is required, the notifier

shall check the corresponding column. For columns without check boxes, confidential information

shall not be required.

Where information items of registration certificate, and publication and/or announcement shall be

confidential, the notifier shall also provide the corresponding alternative information.

Unless otherwise stipulated by laws and regulations, Environmental Protection Department and the

SCC-MEP shall not reveal the approved confidential information without written approval of the

notifier.

When the notifier or registration certificate holder decrypts confidential content or hopes to disclose

it, they shall present a written statement for declassifying confidentiality to the SCC-MEP. The

written statement shall clearly list declassified items and shall be signed and officially sealed by the

legal representative of the notifier/ registration certificate holder. In respect of the documents

— 46 —

provided by third party for joint notification and joint serial notification, the written statement for

declassifying confidentiality shall be signed or/and officially sealed by the legal representatives of

notifier/ registration certificate holder (including the third party providing the documents) or the

authorized signatory of the legal representatives.

V. Special provisions on polymer

(I) Denomination of polymer

1. Definition of polymer

Polymer is considered as a chemical substance. For polymers not listed in the Inventory, new

chemical substance notification shall be transacted according to the Measures.

While manufacturing the polymers in China, the monomers or reactants shall be regularly registered

new chemical substances, excluding the existed substance by nature and non-separated

intermediates in conformity with the waiving category in this Guidance.

Polymer is a chemical substance consisting of one or more than monomeric units in sequence and

the molecular weight of such molecules shall be arranged within the certain scope and the

differences of molecular weight mainly depends on number of monomeric units. Polymers shall

simultaneously meet the following three conditions:

(1) Molecular weight is not a fixed value but dispersedly distributed;

(2) Molecules with weight percentage more than 50% at least contain three monomeric units which

are connected with at least one of other monomeric units or other reactants in covalent bonding;

(3) Molecules with same molecular weight shall not exceed 50% (weight percentage) of all

molecules.

The above terms are defined as follows:

——Monomer refers to a chemical substance capable of forming covalent bonds with two or more

same or different molecules under specific polyreactivity conditions.

——Monomeric unit refers to a form of monomers in polymers after reactivity.

——Sequence refers to one form of successive monomers of monomeric units connected by

covalent bonds in molecules. Units of sequence can not be broken by units other than monomeric

units.

——Reactant refers to a molecule that is connected to one or more sequences of monomeric units.

Reactants can not be repeating units in polymer structures under specific reactivity conditions.

——Weight percentage refers to charge weight ratio of monomers or reactants in polyreactivity or

content ratio (by weight) of monomeric units or reactants combined in molecules after

polyreactivity.

— 47 —

2. Denominating rules of polymer

For polymers, Chinese name shall be denominated according to the Principles of Denominating of

Macromolecular Chemistry (2005 Edition) and English name shall be denominated according to

rules of IUPAC or CAS. The Chinese name and the English name shall be corresponding.

Polymers with determined molecular structure shall be denominated based on the determined

molecular structures, such as polyethylene, polystyrene, siloxane and polysiloxane.

Polymers without determined molecular structure shall be denominated based on initial monomers

and reactants. For example, monomers in polyreactivity are A, B, C, D and E respectively, thus the

polymer name can be presented as an polymer of A, B, C, D and E.

3. Rule of 2% polymer

The rule of 2% polymer refers to a denominating rule which is applicable to denomination based on

initial monomers and reactants:

(1) Names of all monomers and reactants with weight percentage more than 2% shall be listed in

the polymer name;

(2) Names of monomers and reactants with weight percentage less than or equal to 2% can not be

listed in the polymer name.

For example, weight percentage of monomers in polyreactivity: M1 (35%), M2 (28%), M3 (15%),

M4 (12%), M5 (5%) and M6 (1.5%); weight percentage of initiators or blocking agents: R1 (2.2%)

and R2 (1.3%); and additives of polymers: A1 and A2. The polymer name can be the three

conditions as follows:

1) Polymer name 1: initiating/blocking polymer of R1 and R2 of M1, M2, M3, M4, M5 and M6;

2) Polymer name 2: initiating/blocking polymer of R1 and R2 of M1, M2, M3, M4 and M5;

3) Polymer name 3: initiating/blocking polymer of R1 of M1, M2, M3, M4 and M5.

Description:

——Weight percentage of M6 and R2 is less than 2% so that their names can be listed in the name

list as necessary;

——The three names can be taken as polymer names, but the notifier can use only one name for

polymer notification and the polymer can be treated as another chemical substance in case of

changing name.

——Additives that are not combined into polymer structure shall not be listed in the name list, but

shall be listed in the monomer list;

——Changing content of monomers or reactants in the registered polymer name is allowed;

——Names of monomers or reactants in the registered polymer name shall not be changed or added

— 48 —

and reduced.

(II) Simplified notification conditions of polymers

1. Polymers with less than 2% monomer content of new chemical substance

Where the polymer is not listed in Inventory, but all monomers or reactants with weight percentage

less than or equal to 2%, simplified notification can be transacted on the polymers.

If the polymer itself is not in the " Inventory ", but all its the monomer / polymer reactants are in the

"Inventory", or the weight percentage is greater than 2% of all new chemical monomer / reactants

have obtained routine declaration registration certificate, the simple declaration of polymer can be

carried out.

2. Low concern polymers

Low concern polymers shall meet one of the following requirements:

(1) When average molecular weight of polymers is 1,000-10,000 daltons, oligomers with molecular

weight less than 500 daltons have less than 10% content, and oligomers with molecular weight less

than 1000 daltons have less than 25% content, but low concern polymers shall not contain high

concern or high activity groups, such as heavy metal, cyan group, acrylic ester, aziridine, isocyanate,

thio-isocyanate and vinyl sulphone.

(2) When average molecular weight of polymers is not less than 10,000 daltons, oligomers with

molecular weight less than 500 daltons have less than 2% content, and oligomers with molecular

weight less than 1000 daltons have less than 5% content.

(3) The low concern polymers belong to polyester polymers which contain at least two carboxylic

ester bonds in polymeric molecules and at least one carboxylic ester bond is combined with internal

monomers.

3. Simplified notification requirements for polymers

Simplified notification form of polymers shall provide the following information for characterizing

polymer identification:

(1) Monomer /reactant list, containing name, CAS number and content (charge weight ratio/weight

percentage) of monomers /reactant, and listing of monomers /reactant in the Inventory.

(2) Molecular weight distribution diagram, containing Gel Permeation Chromatography (GPC) of

polymers or other characterized molecular weight of polymers and their distribution results, such as

weight-average molecular weight, number average molecular weight and molecular weight

distribution.

Molecular weight and molecular weight distribution diagram are information necessary for judging

whether polymers conform to polymer definition or belong to low concern polymers.

(3) Polyreactivity mechanism process, containing description of polyreacted monomers by words or

— 49 —

diagrams, process, conditions and mechanisms.

4. Notification amount of polymer simplified notification

The notification amount of polymer simplified notification does not be limited.

5. Polymers that do not meet the conditions of the simplified application

(1) Polymer that the degradation or it unstable

For the polymers that is easy degradation, decomposition and depolymerization, the simplified

notification can be carried out; for the polymers that decomposition in production or use, the

simplified notification also can be carried out.

(2) Water absorbent polymer.

The simplified notification also can be carried out for the water absorbent polymers with number

average molecular weight greater than or equal to 10000.

(III) Regular notification conditions of polymers

In regular notification of polymers, the notifier shall not submit risk assessment report.

In regular notification of polymers, the notifier shall submit identification information of

characterization polymer (requirements are the same as “simplified notification requirements for

polymers”), polymerization monomers residues, distinguished by the following procedures in order:

1. Containing of heavy metals or cations in polymer structures

If yes, list the heavy metals or cations and perform notification based on data requirements of the

corresponding quantity level in regular notification; and if no, perform the next test.

2. Water solubility of polymers

If yes, perform notification based on data requirements of the corresponding quantity level in

regular notification; and if no, perform the next test.

3. Solubility of polymers in organic solvents

Lipotropy solvents: n-octanol and n-heptane;

General solvents: isopropanol, 1,2-dichloroethane, toluene, tetrahydrofuran, methyl isobutyl ketone

and dimethyl formamide.

If it is soluble in either of the lipotropy solvents, stop this test and perform notification based on

data requirements of the corresponding quantity level in regular notification; and if no, perform

solubility test on general solvents. If it is soluble in over two (not included) general solvents, stop

this test and perform notification based on data requirements of the corresponding quantity level in

regular notification; and if no, perform the next test.

4. Stability of polymers under acidic-alkalinic conditions

Stability test is performed on polymers under conditions of pH 4, 7, 9 and 12 (if it is important

— 50 —

physiologically) respectively. If polymers are unstable under any of the conditions, perform

notification based on data requirements of the corresponding quantity level in regular notification;

and if no, judge low concern polymers.

5. Category of low concern polymers

If not, perform notification based on data requirements of the corresponding quantity level in

regular notification.

If a polymer belongs to the low attention one, it is not affected by the limit of amount, the

requirements for toxicology and ecological toxicology data are free from the amount requirements

of routine declaration data for this guidance, the polymer declaration may be carried out. In such

cases, the declaration amount does not be limited.

Where the polymer with less than 1 ton of annual yield or imported, in case of selecting the regular

notification procedure, the relevant information is required to be submitted via the above judgment

procedures as per the minimum data requirement.

VI. Supervision and management of registered new chemical substance notification

(I) Valid period of registration certificate

Registration certificate holder shall perform activities for producing or importing new chemical

substances based on scope and requirements specified in the registration certificate. Registration

certificate shall not be transferred and authorized to others.

Validity period of regular notification registration certificate is calculated from the issue date to the

date of listing new chemical substances into the Inventory.

Validity period of simplified notification registration certificate is calculated from the issue date to

the date when the registration certificate holder takes initiative to apply for cancellation or the

registration certificate is legally cancelled for other reasons, but the registration certificate of

simplified notification of process and product research development shall be effective two years

after the first activity and the same notifier shall not re-notify after expiration. The same notifier

shall not apply for simplified notification for the purpose of process and product research

development after expiration.

After notifier obtains the registration of high notification conditions, the registration certificate of

low notification conditions has been obtained will be automatic failure, it should be returned to the

SCC-MEP.

(II) Information change in registration certificate

When the registration certificate holder is an overseas notifier, for change of registration

information, it requires put forward by the registration certificate holders and agents together, the

— 51 —

responsibilities and obligations of the parties in change materials shall be defined clearly after the

registration information changes.

1. Change in registered uses

The hazards new chemical substances that have obtained the regular notification registration

certificate (not including the key environmental management hazards class), for change of uses,

the registration certificate holder should be prepared and provided the risk assessment report, and

put forward an application to the SCC-MEP. After the SCC-MEP receives the application materials,

they are submitted to the Review Committee for reviewing, then send to the MEP for approval. A

Receipt of change is issued for the acceptable risk, marked the change items. The registration

certificate holder can develop activity by using the Receipt and the original registration certificate;

no longer change the registration certificate for the unacceptable risk.

For general class of new chemical substances that have obtained the regular notification registration

certificate, it does not need to make the formalities of alteration for changing the registration uses.

For the new chemical substances that have obtained the simplified notification registration

certificate, it do not need to make the formalities of alteration for changing the registration uses, but

the use change should be indicated in the annual report.

2. Change in activity types

For the new chemical substances that have obtained the regular notification registration certificate,

in order to its activity types change from production into import, the registration certificate holder

should put forward a change filing to the SCC-MEP. After the SCC-MEP receives the change filing

materials and confirmation, a Receipt of change filing is issued, indicating the change items. The

registration certificate holder may participate in various activities by using the Receipt and the

original registration certificate, no longer renewal of registration certificate.

For the new chemical substances that have obtained the regular notification registration certificate,

in order to its activity types change from import into production, the risk assessment report should

prepared again and submitted to by the registration certificate holder, a change application is put

forward to the SCC-MEP. After the SCC-MEP receives the change filing materials and they are

sent to the review committee for reviewing, and after approval by the MEP, a Receipt of change

filing is issued, indicating the change items. The registration certificate holder may participate in

various activities by using the Receipt and the original registration certificate, no longer renewal of

registration certificate. For the unacceptable risk, not need change.

For the new chemical substances that have obtained the simplified notification registration

certificate, in order to its activity types, it does not need to make the formalities of alteration for the

— 52 —

change, but should indicate the type of altered activities in the annual report.

3. Change in registered substance identification

For the new chemical substances that have obtained the notification registration certificate, in

order to change identification information such as names of Chinese and English or CAS number,

the registration certificate holder shall specify the scientific reason and evidence of the change,

providing identification information after the change, proposing change filing to the SCC-MEP.

After the SCC-MEP receives the change filing materials and confirmation, a Receipt of change



registration certificate.

4. Name change of registration certificate holder and / or the agent

For the name change of the registration certificate holder and / or agent, the registration certificate

holders and agents shall jointly put forward change filing to the SCC-MEP, showing change name,

merger, split, merger or acquisition of assets and other specific changes of the company, and put

forward the certification materials.

After SCC-MEP receives the change filing materials and confirmation, a Receipt of change filing is

issued, indicating the change items. The registration certificate holder may participate in various

activities by using the Receipt and the original registration certificate, no longer renewal of

registration certificate

After the name change of the registration certificate holder and / or agent, the new registration

certificate holders and / or agent shall bear all the responsibilities within the valid registration

certificate.

5. Change of registration agent

For the registration certificate holder change the agent, the registration certificate holders and

agents shall jointly submit to change filing to the SCC-MEP, provide the agreement between the

registration certificate holder and former agent about the agent relationship, and the agreement

between the registration certificate holder and new agent about the agent relationship, and other

materials.

After the SCC-MEP receives the change filing materials and confirmation, a Receipt of change



registration certificate

The agent responsibility before changing shall be borne by the former agents, except otherwise

agreed by the parties.

— 53 —

6. Change in quantity within registered quantity level

For the new chemical substances that have obtained the regular notification registration

certificate(Grade 2 to Grade 4), in order to increase the registration amount in the registration scale,

the risk assessment report should be prepared again and submitted to the SCC-MEP by the

registration certificate holder, and put forward a change application. After the SCC-MEP receives

the application materials, it is sent to the review committee for reviewing, and sent to the MEP for

approval. A Receipt of change filing is issued, indicating the change items for the acceptable risk.

The registration certificate holder may participate in various activities by using the Receipt and the

original registration certificate, no longer renewal of registration certificate. For the unacceptable

risk, it does not need change.

Except the new chemical substances that have obtained the regular notification registration

certificate, in order to increase the registration amount in the registration scale, or have obtained the

simplified notification registration certificate, the registration certificate holder should put forward a

change filing to the SCC-MEP, describing the registration change reason. After the SCC-MEP

receives the change filing materials and confirmation, a Receipt of change filing is issued,

indicating the change items. The registration certificate holder may participate in various activities

by using the Receipt and the original registration certificate, no longer renewal of registration

certificate.

(III) Re-notification after registration

1. Change in name of registration certificate holder

The new chemical substances that have obtained the regular notification registration certificate, in

order to increase production or import amount in the registration scale, the registration certificate

holder should put forward additional materials according to the routine reporting procedures for

re-notification. After registration, the registration certificate holder may produce or import in

accordance with the approved quantity or magnitude. The original registration certificate shall

expire automatically and be returned to the Center of Solid Waste and Chemical Management

Technology.

2. Change in quantity within registered quantity level

For the new chemical substances that have obtained the registration certificate but did not listed in

the "Inventory" of hazardous key environmental management, in order to change the registration

uses, the registration certificate holders need to submit additional materials according to the

routine reporting procedures for re-notification. After obtaining registration, the production or

activity may be carried out according to the approved use. The original registration certificate shall

— 54 —

expire automatically and be returned to the Center of Solid Waste and Chemical Management

Technology.

After the new chemical substances obtain the registration certificate are listed in the "Inventory" of

hazardous key environmental management, in order to change the registration uses, the registration

certificate holders need to submit additional materials according to the routine reporting procedures

for re-notification. After announcement of additional uses, the production or activity may be carried

out according to the approved use. The original registration certificate shall expire automatically

and be returned to the Center of Solid Waste and Chemical Management Technology.

(IV) Reporting of new information

According to Article 26 in the Measures, the registration certificate holder shall submit SCC-MEP

the new information of hazard properties of chemicals within 30 days and meanwhile perform data

saving and management work if new hazard properties of registered substances are discovered.

New information of hazard properties includes unconformity of information of new chemicals in

actual activities to the original notification information or new hazard properties.

The SCC-MEP shall submit the new information of hazard properties received to review committee

for technical review, and then reports the technical review advice to Environmental Protection

Department.

The technical review advice includes respective influences of new information of hazard properties

on management category of registered substances, the original risk assessment, technical review

advice at registration and appropriateness of the existing risk control Measures.

The Receipt shall be issued to the registration certificate holders who are capable of risk control or

only are capable of risk control by enhancing risk control measures, with renewal items such as new

hazard classification, management category, risk control measures, administrative requirements of

such registered substances marked. The registration certificate holders shall implement

corresponding risk control measures, and may carry out activities by strength of the Receipt and the

original registration certificate, without need of renewal of registration certificate. The registration

certificate of such new chemical substance shall be withdrawn if the applicant has no proper risk

control measures, and announcement shall be made.

(V) Information transfer, reporting and data saving

1. Transfer of registration information to processors and users

According to provisions in Article 30 in the Measures, the registration certificate holder of regular

notification shall list the recognized hazard properties of the registered new chemicals into Material

Safety Data Sheet (MSDS), transfer the Material Safety Data Sheet and other information in writing

when processors and users transfer the registered substances and shall ensure that the processors

— 55 —

and user obtain such information.

The registration certificate holder is responsible for providing statement including new chemical

substances without notification registration or the registered new chemical substances in products to

processors and user.

Before registered new chemical substances are transferred to processors and user, the registration

certificate holder of regular notification shall assess risk control ability of processors and user on

the new chemical substances according to provisions in Article 33 in the Measures and shall not

transfer the new chemical substances to the processors and user who are not capable of adopting the

risk control Measures.

Whenever the registered substances are transferred in the form of preparations or articles, the

registration certificate holder of regular notification shall assess risk control ability of processors

and user on preparations or articles and shall not transfer the preparations or articles containing the

new chemical substance to the processors and user who are not capable of adopting the risk control

Measures.

2. Initial case report

Holder of registration certificate for regular notification shall report initial activity to the SCC-MEP

according to Clause 1 of Article 35 in the Measures.

As for production activity, holder of registration certificate for regular notification shall submit

Initial Activity Report Form of New Chemical Substance to the SCC-MEP within thirty (30) days

after initial production activity. Commencement date of initial production activity is the date when

new chemical substance product is firstly produced.

As for import activity, holder of registration certificate for regular notification shall submit Initial

Activity Report Form of New Chemical Substance to the SCC-MEP within thirty (30) days after

initial import activity. Commencement date of initial import activity is the date of customs entry of

new chemical substance.

As for activities of import and transfer to the first processing and using person, holder of

registration certificate for regular notification shall submit Initial Activity Report Form of New

Chemical Substance to the SCC-MEP within thirty (30) days after import and transfer to the first

processing and using person. Commencement date of transfer is the delivery date of initial transfer

to the first processing and using person. In this case, initial report as specified in previous clause is

not required.

3. Report of each condition

For key environmental management of hazardous new chemical substances, after the registration

— 56 —

certificate holders produce or import in accordance with the "Measures" of the second provisions of

Article 35, more than 10kg of hazardous new chemical substance of key environmental

management is transferred to different processing users each time, the new chemical substance

event must declare to the SCC-MEP in activity event report form within 30 days from the date of

transferring.

As to the report form of each activity event for new chemical substance, please see appendix 3.

4. Annual report and annual plan

According to the provisions of "Measures" of Article 36, the registration certificate holder of the

simplified notification and hazardous new chemical substances (including the key environmental

management of hazardous new chemical substances) shall submit an annual report for former year

to the SCC-MEP before 1 February each year (January 1st to December 31st), reporting the

information about the annual yield and /or import amount for registration new chemical substances.

The annual report of hazardous new chemical substances (including the key environmental

management of hazardous new chemical substance) shall also include the implementation of risk

control measures, environmental exposure and release and causing the actual effect on human

health, and other risks associated with environmental information.

The annual report of hazardous new chemical substances shall also include the production or import

plan and risk control measures of the new chemical substances in this year.

As to the annual report form of new chemical substances, please see Appendix 4.

5. Data storage

Holder of new chemical substance registration certificate shall properly store documents including

notification data of new chemical substance, actual situations of production and import activities,

information transmitting to processing and using person, etc. for at least ten (10) years.

(VI) Site supervision and inspection

Research, production, import or processing and using unit of new chemical substance shall conform

to tracking control requirements in the Measures, implement risk control Measures and

administrative management requirements specified in registration certificate of new chemical

substance, accept and coordinate with new chemical substance supervision and management

inspection carried out by local environmental protection department, timely and accurately submit

relevant data of new chemical substance, completely and clearly answer relevant questions about

new chemical substance and positively implement agreed inspection results and requirements after

supervision and inspection.

— 57 —

(VII) Entry of registered new chemical substances in the Inventory

1. Procedures for entry of general new chemical substances in the Inventory

The MEP shall list general new chemical substances announcement into the Inventory by

arrangement of SCC-MEP after five years from the date of the registration certificate holder firstly

producing or importing the general new chemical substance.

2. Procedures for entry of hazardous new chemical substances in the Inventory

The registration certificate holder of hazardous new chemical substances (including the key

environmental management of hazardous new chemical substances) shall submit the actual

activities status to the SCC-MEP at 6 months in advance for 5 years since the first production or

import, indicating the production, transferring, risk control measures, and its implementation during

the period as well as the actual effect on the environment and human health and other information

related to actual activities.

After the SCC-MEP receives the actual activity reports, it shall be sent to the review committee.

The review committee assesses retrospectively for the practical activities of registration new

chemical substances and puts forward the retrospective assessment opinions.

The MEP will list registered new chemical substances announcement in the Inventory based on

assessment comments.

As to the practical activities report of registration new chemical substances in five years, please see

Appendix 5.

3. Management of registered new chemical substances listed in Inventory

Registered substances listed in the Inventory are not applicable to the Measures according to

existing chemical substances management, with an exception of change in use of new chemical

substances subject to key environmental managements.

(VIII) Cancellation and revocation of registration certificate

1. Cancellation of registration certificate

For the regular registration new chemical substances before listing in the "Inventory" and the

simplified registration new chemical substances, if the cancellation of registration, they are divided

into the following two situations:

(1) Where the registration certificate holder does not engage in production and import activity, the

holder can submit cancellation application, explain reasons and return registration certificate to the

SCC-MEP.

(2) Where the registration certificate holder ceases production and import activity, the holder can

submit cancellation application, explain reasons and return registration certificate to the SCC-MEP.

— 58 —

After the SCC-MEP receives the application for cancellation, they are regularly collected and

submitted to the MEP to announce cancellation.

2. Revocation of registration certificate

As stipulated in Article 43 of the Measures, where the registration certificate holder is found to hide

relevant information or provides false data, etc during notification, the MEP may revoke the

registration certificate of the new chemical substances.

As stipulated in Article 26 of the Measures, where there are no proper Measures to control

hazardous properties of registered new substances, the MEP may revoke registration certificate of

new chemical substances and give announcement.

3. Management requirements after cancellation and revocation

The registration certificate will be invalid from the date of cancellation and revocation, and the

registration certificate holder will not bear responsibilities stipulated in laws any more. However,

validation cancellation and revocation will not exempt the holder from liabilities that shall be

undertaken before validation of cancellation and revocation.

For joint notification, each registration certificate holder may cancel registration at own discretion,

but this does not affect rights and duties of other holders in joint notification.

For serial notification, the registration certificate holder may cancel registration certificates

corresponding to one or more substances registered. The cancelled registration certificate shall not

affect the production or import of other registered new chemical substances in the serial

notification.

For repeated notification, cancellation activity of the registration certificate holder shall not affect

other registration certificate holders.

The original registration certificate holder shall not re-notify the same new chemical substance

within five years after cancellation.

— 59 —

Appendix 1

Risk Assessment Report (Requirements to the format)

Substance name:

CAS No.:

Business Name:

Prepared by:

Date:

Prepared by:

Contact person:

Tel:

Email:

Main preparation personnel:

Name

(Manual signature) Professional title Faculty

Note

(Experience and training)

— 60 —

CONTENTS

1 Background ......................................................................................................................................................... 64

1.1 Assessment basis ....................................................................................................................................... 64

1.2 A brief introduction to the assessment procedure ...................................................................................... 64

2 The kinds of environmental management and the risk controlling measures .............................................. 64

2.1 The kinds of environment management ..................................................................................................... 64

2.2 The general description to the risk preventing and controlling measures .................................................. 64

3 The substance indications .................................................................................................................................. 64

3.1 The chemical substance 1 .......................................................................................................................... 64

3.1.1 The basic information of the chemical substances .......................................................................... 64

3.1.2 The substance composition ............................................................................................................. 65

3.1.3 Commodity information ................................................................................................................. 65

3.1.4 The registration and management in other countries ...................................................................... 66

3.2 Chemical substance 2 (being applicable for the serial notification) .......................................................... 66

3.3 Chemical substance (being applicable for the serial notification) ............................................................. 66

4 Usage……… ........................................................................................................................................................ 66

4.1 Notification usage ...................................................................................................................................... 66

4.2 Non-recommended usage .......................................................................................................................... 66

5 Property data ...................................................................................................................................................... 67

5.1 Physical and chemical properties ............................................................................................................... 67

5.1.1 Chemical substance 1...................................................................................................................... 67

5.1.1.1 The data on the physical and chemical properties ............................................................... 67

5.1.1.2 The summarization of the physical and chemical properties and the assessment of the data

quality ………….. ........................................................................................................................... 67

5.1.2 Chemical substance 2 (being applicable for the serial notification) ............................................... 67

5.1.3 Chemical substance … (being applicable for the serial notification) ............................................. 67

5.2 The data on the degradation and biological accumulation ......................................................................... 67

5.2.1 The summarization of the degradation and the data quality assessment......................................... 68

5.2.2 The summarization of the biological accumulation and the data quality assessment ..................... 68

5.3 The data on the environmental toxicity ..................................................................................................... 68

5.3.1 The data on the microbiological toxicity and the data quality assessment ..................................... 68

5.3.2 The data on the aquatic environmental toxicity and the data quality assessment ........................... 68

5.3.3 The data on the terrestrial environmental toxicity and the data quality assessment ....................... 68

5.4 The health toxicity ..................................................................................................................................... 68

5.4.1 The data on the health toxicity ........................................................................................................ 68

5.4.2 The summarization on the acute toxicity and the data quality assessment ..................................... 69

5.4.3 The summarization on the irritation/corrosivity and sensitization as well as the data quality

assessment …………… ........................................................................................................................... 69

— 61 —

5.4.4 The summarization on the repetitive infectious toxicity and the chronic toxicity as well as the data

quality assessment……. .......................................................................................................................... 69

5.4.5 The summarization on the inherited toxicity and the data quality assessment ............................... 69

5.4.6 The summarization on the reproductive and developmental toxicity and the data quality

assessment……………. ........................................................................................................................... 69

5.4.7 The summarization on the carcinogenicity and the data quality assessment .................................. 69

5.4.8 The summarization on the toxicokinetics and the data quality assessment .................................... 69

6 The categorization of the harms and the division of the management categories......................................... 69

6.1 The categorization of the physical danger, the division of the management categories and the risk

control.….. ....................................................................................................................................................... 69

6.1.1 The categorization of the physical danger ...................................................................................... 69

6.1.2 The division of the management categorization ............................................................................. 74

6.1.3 The comprehensive description on the physical danger and the controlling measures ................... 74

6.1.3.1 The comprehensive description on the physical danger ...................................................... 74

6.1.3.2 The controlling measures for the physical danger ............................................................... 74

6.2 The categorization of the environment harm and the division of the management categorization ............ 74

6.2.1 The categorization of the environment harm .................................................................................. 74

6.2.2 The division of the management categories .................................................................................... 75

6.3 The categorization of the health harm and the division of the management categories ............................ 76

6.3.1 The categorization of the health harm ............................................................................................ 76

6.3.2 The division of the management categories .................................................................................... 80

7 The PBT and vPvB authentication .................................................................................................................... 80

7.1 The results of the PBT or vPvB authentication ......................................................................................... 80

7.2 The assessment of the PBT or vPvB authentication .................................................................................. 81

8 The harm assessment .......................................................................................................................................... 81

8.1 The environmental harm assessment (quantitative) ................................................................................... 81

8.1.1 The deductive results of PNEC ....................................................................................................... 81

8.1.2 The brief introduction to the deduction procedure of PNEC .......................................................... 82

8.2 The environmental harm assessment (qualitative) ..................................................................................... 82

8.2.1 The results of the grading on environmental harm ......................................................................... 82

8.2.2 The brief description to the procedure of environmental harm grading ......................................... 83

8.3 The assessment on the harm to health ....................................................................................................... 83

8.3.1 The results of the grading on the harm to health............................................................................. 83

8.3.2 The brief introduction to the grading on harm to health ................................................................. 85

9 The exposure assessment……. ........................................................................................................................... 85

9.1 The assessment on the environmental exposure (quantitative) .................................................................. 85

9.1.1 The sketch on the scenery of exposure ........................................................................................... 85

9.1.2 The environmental exposure scenery 1 ........................................................................................... 85

— 62 —

9.1.2.1 The description of the exposure scenery 1 ........................................................................... 85

9.1.2.2 The assessment parameters of the environmental exposure of exposure scenery 1 ............. 86

9.1.2.3 The PEC estimation of the environment of sewage treatment plant of exposure scenery 1 88

9.1.2.4 The PEC estimation of the environment of surface water of exposure scenery 1 ................ 88

9.1.2.5 The PEC estimation of the environment of surface water sedimentation of exposure scenery

1…………………. .......................................................................................................................... 88

9.1.2.6 The PEC estimation of the environment of soil environment of exposure scenery 1 .......... 88

9.1.3 Exposure scenery 2 ......................................................................................................................... 88

9.1.4 Exposure scenery… ........................................................................................................................ 88

9.2 The environmental exposure assessment (qualitative)............................................................................... 88

9.2.1 The description and grading of environmental exposure assessment ............................................. 88

9.2.2 The brief introduction to the procedure of environment exposure assessment and the discussion of

the results…………….. ........................................................................................................................... 89

9.3 The assessment of the health exposure ...................................................................................................... 89

9.3.1 The description and grading of the health exposure assessment ..................................................... 89

9.3.2 The brief introduction to the procedure of health exposure evalution and the discussion to the

results………………… ........................................................................................................................... 93

10 The risk characterization….. ........................................................................................................................... 93

10.1 The environmental risk characterization (quantitative) ............................................................................. 93

10.1.1 The results of the environmental risk characterization (quantitative) ........................................... 93

10.1.2 The uncertainty assessment of the environmental risk characterization (quantitative) ................. 94

10.2 The environmental risk characterization (qualitative) ............................................................................. 94

10.2.1 The results of the environmental risk characterization (qualitative) ............................................. 94

10.2.2 The uncertainty assessment of the environmental risk characterization (qualitative) ................... 95

10.3 The health risk characterization ............................................................................................................... 95

10.3.1 The results of the health risk characterization .............................................................................. 95

10.3.2 The discussion of the uncertainty of health risk characterization ................................................. 96

11 The assessment conclusions ........................................................................................................................... 96

11.1 The physical risk ...................................................................................................................................... 96

11.1.1 The brief introduction to the physical risk .................................................................................... 96

11.1.2 The controlling measures of the physical risk .............................................................................. 96

11.1.3 The assessment conclusions of the physical risk .......................................................................... 96

11.2 The environmental risk ............................................................................................................................ 96

11.2.1 The brief introduction to the environmental risk .......................................................................... 96

11.2.2 The controlling measures of the environmental risk ..................................................................... 96

11.2.3 The conclusions of the environmental risk assessment................................................................. 96

11.3 The health risk ......................................................................................................................................... 96

11.3.1 The brief introduction to the health risk ....................................................................................... 96

— 63 —

11.3.2 The controlling measures of the health risk .................................................................................. 96

11.3.3 The assessment conclusions of the health risk .............................................................................. 96

11.4 The general conclusion of the risk assessment ........................................................................................ 96

11.5 The divison of the environmental management categories ...................................................................... 96

11.5.1 The conlusion of PBT or vPvB ..................................................................................................... 96

11.5.2 The results of the category devision of environment management ............................................... 96

12 The references……………………………… ................................................................................................... 96

13 The appendixes……………………. ................................................................................................................. 96

Chart

Table 1 The basic information of the chemical substance 1 ................................................................................... 7

Table 2 The information on the composition of the chemical substance .................................................................. 8

Table 3 The information of impurities of the chemical substance 1 ......................................................................... 8

Table 4 The commodity information of the chemical substance 1 ........................................................................... 8

Table 5 The registration and management of the chemical substance 1 in other countries 1 ................................... 9

Table 6 Notification usage ...................................................................................................................................... 9

Table 7 Non-recommended usage ............................................................................................................................ 9

Table 8 The summarization to the data of the physical and chemical properties of the chemical substance 1 ...... 10

Table 9 The summarization on the data on the degradation and biological accumulation…..10

Table 10 The summarization of the data on the environmental toxicity................................................................. 11

Table 11 The summarization on the data on the health toxicity ............................................................................. 11

Table 12 The categorization of the physical danger ............................................................................................... 12

Table 13 The categorization of the environment hard ............................................................................................ 17

Table 14 The categorization of the health harm ..................................................................................................... 19

Table 15 The PBT or vPvB authentication ............................................................................................................. 23

Table 16 PNEC (quantitative) .............................................................................................................................. 24

Table 17 The grading on environmental harm (qualitative) ................................................................................. 25

Table 18 The grading on the harm to health ........................................................................................................... 26

Table 19 The table on the sketch on the scenery of exposure (quantitative) ........................................................ 28

Table 20 The assessment parameters of the environmental exposure of exposure scenery 1 (quantitative) ........ 29

Table 21 The description of environmental exposure assessment (qualitative) ................................................... 31

Table 22 The grading on environmental exposure (qualitative) ........................................................................... 32

Table 23 The description of the health exposure .................................................................................................... 32

Table 24 The grading of health exposure ............................................................................................................... 36

Table 25 The results of the environmental risk characterization (quantitative) .................................................... 36

Table 26 The environmental risk characterization (qualitative) ........................................................................... 37

Table 27 The health risk characterization ............................................................................................................... 38

Table 28 The table on the usage and codes of the chemicals ................................................................................. 40

— 64 —

Risk Assessment Report ——Substance name

— 65 —

1 Background

1.1 Assessment basis

1.2 A brief introduction to the assessment procedure

2 The kinds of environmental management and the risk controlling

measures

2.1 The kinds of environment management

2.2 The general description to the risk preventing and controlling measures

3 The substance indications

3.1 The chemical substance 1

3.1.1 The basic information of the chemical substances

Table 1 The basic information of the chemical substance 1

Chinese category name:

English category name:

Chinese name:

IUPAC name:

CAS name:

CAS number:

Other name:

Molecule formula:

Average value and range of

molecular weight:

Smiles code:

Status under normal temperature and

pressure:

Color:

Odor:

Substance categorization:

口 With unique and defined molecule structure

口 Without unique and defined molecule structure

口 Polymer

Average value and range of purity:


— 66 —

Note:

Structural formula:

3.1.2 The substance composition

Table 2 The information on the composition of the chemical substance 1

Component 1

Chinese name:

IUPAC name:

CAS name:

CAS number:

Molecular formula:


molecular weight: Average value (lower limit – upper limit)

Structural formula:


content % (w/w): Average value (lower limit – upper limit)

Note:

NOTE: Required to fill out if the notified substance is mixture.

Table 3 The information of impurities of the chemical substance 1

No. Chinese name CAS number Average value and range

of content % (w/w): Note

1

2

3

……

3.1.3 Commodity information

Table 4 The commodity information of the chemical substance 1

No. Commodity name Commodity

appearance

Average value and range

of content % (w/w): Note

1

2

3

……


— 67 —

3.1.4 The registration and management in other countries

Table 5 The registration and management of the chemical substance 1 in other

countries 1

Country and

region Directory name

Number in this

directory

Management

requirements Note

3.2 Chemical substance 2 (being applicable for the serial notification)

3.3 Chemical substance … (being applicable for the serial notification)

4 Usage

4.1 Notification usage

Table 6 Notification usage

No.

Code of

usage

(general

category)

Name of

usage

(general

category)

Code of usage

(sub-category)

Name of usage

(sub-category)

Expected

effect

Note

(Including the

corresponding

foreign usage and

categorization)

1

2

3

……

4.2 Non-recommended usage

Table 7 Non-recommended usage

No.

Code of

usage

(general

category)

Name of

usage

(general

category)

Code of usage

(sub-category)

Name of usage

(sub-category)

Note

(Including the

corresponding foreign

usage and

categorization)

1

2

3

……


— 68 —

5 Property data

5.1 Physical and chemical properties

5.1.1 Chemical substance 1

5.1.1.1 The data on the physical and chemical properties

Table 8 The summarization to the data of the physical and chemical properties

of the chemical substance 1

No. Property

item

Main

testing

conditions

Results Data

type

Testing

method

Testing

organization Note

1

2

3

……

5.1.1.2 The summarization of the physical and chemical properties and the

assessment of the data quality

5.1.2 Chemical substance 2 (being applicable for the serial notification)

5.1.3 Chemical substance … (being applicable for the serial notification)

5.2 The data on the degradation and biological accumulation

Table 9 The summarization on the data on the degradation and biological

accumulation

No. Property

item

Inoculu

m/tested

creature

Calibratio

n index

Resul

ts

Data

type

Testi

ng

meth

od

Testing

organiza

tion

Note

(Including the

corresponding

serial name of

notified

substance )

1

2

3

……


— 69 —

5.2.1 The summarization of the degradation and the data quality assessment

5.2.2 The summarization of the biological accumulation and the data quality

assessment

5.3 The data on the environmental toxicity

Table 10 The summarization of the data on the environmental toxicity

No. Property

item

Tested

creatu

re

The most

sensitive

index of

observation

Resu

lts

Data

type

Testin

g

metho

d

Testing

organiza

tion

Note

(Including the

corresponding

serial name of

notified

substance)

1

2

3

……

5.3.1 The data on the microbiological toxicity and the data quality assessment

5.3.2 The data on the aquatic environmental toxicity and the data quality

assessment

5.3.3 The data on the terrestrial environmental toxicity and the data quality

assessment

5.4 The health toxicity

5.4.1 The data on the health toxicity

Table 11 The summarization on the data on the health toxicity

No. Property

item

Tested

creature

The most

sensitive

index of

observation

Results Data

type

Testing

method

Testing

organization

Note

(Including the

corresponding

serial name of

notified

substance)

1

2

3

……


— 70 —

5.4.2 The summarization on the acute toxicity and the data quality assessment

5.4.3 The summarization on the irritation/corrosivity and sensitization as well

as the data quality assessment

5.4.4 The summarization on the repetitive infectious toxicity and the chronic

toxicity as well as the data quality assessment

5.4.5 The summarization on the inherited toxicity and the data quality

assessment

5.4.6 The summarization on the reproductive and developmental toxicity and

the data quality assessment

5.4.7 The summarization on the carcinogenicity and the data quality

assessment

5.4.8 The summarization on the toxicokinetics and the data quality assessment

6 The categorization of the harms and the division of the management

categories

6.1 The categorization of the physical danger, the division of the

management categories and the risk control

6.1.1 The categorization of the physical danger

Table 12 The categorization of the physical danger

Kind of danger Classification

standard Categorization

Rationale for

classification


— 71 —

1 Explosive GB 30000.2-2013

Rules for

classification and

labelling of

chemicals—Part

2:Explosives

□ Not applicable;

□ Unstable explosive;

□ Explosive stated in

item 1.1;


item 1.2;


item 1.3;


item 1.4;


item 1.5;


item 1.6;

□ Not in this

categorization;

□ Can’t be categorized

2 Flammable gas

(including the gas

with instable

chemical

property)

GB 30000.3-2013

Rules for

classification and

labelling of

chemicals—Part

3:Flammable gases

□ Not applicable;

□ Category 1;

□ Category 2;

□ The gas with instable

chemical property –

category A;

□ The gas with instable

chemical property –

category B;

□ Not in this

categorization;


3 Aerosol GB 30000.4-2013

Rules for

classification and

labelling of

chemicals—Part 4:

Aerosols

□ Not applicable;

□ Category 1;

□ Category 2;

□ Not in this

categorization;



— 72 —

4 Oxidizing gases GB 30000.5-2013

Rules for

classification and

labelling of

chemicals—Part 5:

Oxidizing gases

□ Not applicable;

□ Category 1;

□ Not in this

categorization;


5 Gases under

pressure

GB 30000.6-2013

Rules for

classification and

labelling of

chemicals—Part 6:

Gases under

pressure

□ Not applicable;

□ Compressed gases;

□ Liquefied gas;

□ Frozen and liquefied

gas;

□ Dissolved gas;

□ Not in this

categorization;


6 Flammable

liquids

GB 30000.7-2013

Rules for

classification and

labelling of

chemicals—Part 7:

Flammable liquids

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Not in this

categorization;


7 Flammable solids GB 30000.8-2013

Rules for

classification and

labelling of

chemicals—Part

8:Flammable solids

□ Not applicable;

□ Category 1;

□ Category 2;

□ Not in this

categorization;



— 73 —

8 Self-reactive

substance and

mixtures

GB 30000.9-2013

Rules for

classification and

labelling of

chemicals—Part

9:Self-reactive

substances and

mixtures

□ Not applicable;

□Type A;

□Type B;

□Type C;

□Type D;

□Type E;

□Type F;

□Type G;

□Not in this

categorization;


9 Pyrophoric

liquids

GB 30000.10-2013

Rules for

classification and

labelling of

chemicals—Part

10:Pyrophoric

liquids

□ Not applicable;

□ Category 1;

□ Not in this

categorization;


10 Pyrophoric solids GB 30000.11-2013

Rules for

classification and

labelling of

chemicals—Part

11:Pyrophoric

solids

□ Not applicable;

□ Category 1;

□ Not in this

categorization;

□Can’t be categorized

11 Self-heating

substance and

mixture

GB 30000.12-2013

Rules for

classification and

labelling of

chemicals—Part

12:Self-heating

substances and

mixtures

□ Not applicable;

□ Category 1;

□ Category 2;

□ Not in this

categorization;



— 74 —

12 Substances and

mixtures which,

in contact with

water, emit

flammable gases

GB 30000.12-2013

Rules for

classification and

labelling of

chemicals—Part

13:Substances and

mixtures which, in

contact with water,

emit flammable

gases

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;

□Can’t be categorized

13 Oxidizing liquids GB 30000.14-2013

Rules for

classification and

labelling of

chemicals—Part

14:Oxidizing

liquids

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;


14 Oxidizing solids GB 30000.15-2013

Rules for

classification and

labelling of

chemicals—Part

15:Oxidizing solids

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;


15 Organic peroxides GB 30000.16-2013

Rules for

classification and

labelling of

chemicals—Part

16:Organic

peroxides

□ Not applicable;

□Type A;

□Type B;

□Type C;

□Type D;

□Type E;

□Type F;

□Type G;

□ Not in this

categorization;



— 75 —

16 Corrosive to

metals

GB 30000.13-2013

Rules for

classification and

labelling of

chemicals—Part

17:Corrosive to

metals

□ Category 1;

□ Not in this

categorization;


Note: Only the selected categorizations will be retained

6.1.2 The division of the management categorization

The management categorization:

The division rationale:

6.1.3 The comprehensive description on the physical danger and the

controlling measures

6.1.3.1 The comprehensive description on the physical danger

The relevant information:

The assessment results:

6.1.3.2 The controlling measures for the physical danger

The prohibited assorted substances:

The conditions for packaging and storage:

The leakage-processing measures:

The suitable fire extinguishers:

6.2 The categorization of the environment harm and the division of the

management categorization

6.2.1 The categorization of the environment harm

Table 13 The categorization of the environment hard

The kind of danger The categorization

standard

The categories The categorization

rationale

1 The short-term

harm to the

aquatic

environment

GB 30000.28-2013

Rules for

classification and

labelling of

chemicals—Part

28:Hazardous to

the aquatic

environment

□ Not applicable;

□Category 1;

□Category 2;

□ Category 3;

□ Not in this

categorization;

□Can’t be

assessed


— 76 —

2 The long-term

harm to the

aquatic

environment

GB 30000.28-2013

Rules for

classification and

labelling of

chemicals—Part

28:Hazardous to

the aquatic

environment

口 Not applicable;

口 Category 1;

口 Category 2;

口 Category 3;

口 Category 4;

口 Not in this

categorization;

□ Can’t be

assessed

3 The short-term

harm to the

environment of

sewage-processing

factory

The guidelines for

the authentication

of the harm to new

chemical

substances

(exposure draft)

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;

□ Can’t be

assessed

4 The short-term

harm to the soil

environment

The guidelines for

the authentication

of the harm to new

chemical

substances

(exposure draft)

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;

□Can’t be

assessed

5 Hazardous to the

ozone layer

GB 30000.29-2013

Rules for

classification and

labelling of

chemicals—Part

29:Hazardous to

the ozone layer

□ Not applicable;

□ Category 1;

□ Not in this

categorization;

□ Can’t be

assessed

Note: Only the selected categories will be remained.

6.2.2 The division of the management categories

The management categories:


— 77 —


6.3 The categorization of the health harm and the division of the

management categories

6.3.1 The categorization of the health harm

Table 14 The categorization of the health harm


standard


rationale

The acute oral toxicity GB 30000.18-2013

Rules for classification

and labelling of

chemicals—Part

18:Acute toxicity

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;

□Not in this

categorization;

□ Can’t be

categorized

The acute dermal toxicity □ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;

□ Not in this

categorization;

□ Can’t be

categorized

The acute toxicity (gas

inhalation)

□ Not applicable;

口 Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;


— 78 —


standard


rationale

□ Not in this

categorization;

□ Can’t be

categorized

The acute toxicity (vapour

inhalation)

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;

□ Not in this

categorization;

□ Can’t be

categorized

The acute toxicity (dust and

smog inhalation)

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;

□ Not in this

categorization;

□ Can’t be

categorized

Skin corrosion/irritation GB 30000.19-2013


and labeling of

chemicals—Part

19:Skin

corrosion/irritation

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Category 4;

□ Category 5;

□ Not in this

categorization;


— 79 —


standard


rationale

□ Can’t be

categorized

Serious eye damage/eye

irritation

GB 30000.20-2013


and labeling of

chemicals—Part

20:Serious eye

damage/eye irritation

□ Not applicable;

□ Category 1;

□ Category 2A;

□ Category 2B;

□ Not in this

categorization;

□ Can’t be

categorized

Respiratory or skin

sensitization

GB 30000.21-2013


and labeling of

chemicals—Part

21:Respiratory or skin

sensitization

□ Not applicable;

□ Category 1A;

□ Category 1B;

□ Not in this

categorization;

□ Can’t be

categorized

Germ cell mutagenicity GB 30000.22-2013


and labeling of

chemicals—Part

22:Germ cell

mutagenicity

□ Not applicable;

□ Category 1A;

□ Category 1B;

□ Category 2;

□ Not in this

categorization;

□ Can’t be

categorized;

Carcinogenicity GB 30000.23-2013


and labeling of

chemicals—Part

23:Carcinogenicity

□ Not applicable;

□ Category 1A;

□ Category 1B;

□ Category 2;

□ Not in this

categorization;


— 80 —


standard


rationale

□ Can’t be

categorized;

Reproductive toxicity GB 30000.24-2013


and labeling of

chemicals—Part

24:Reproductive

toxicity

□ Not applicable;

□ Category 1A;

□ Category 1B;

□ Category 2;

□ Not in this

categorization;

□ Additional

category;

□ Can’t be

categorized;

The specific target organ

toxicity (single exposure)

GB 30000.25-2013


and labeling of

chemicals—Part

25:Specific target

organ toxicity—Single

exposure

□ Not applicable;

□ Category 1;

□ Category 2;

□ Category 3;

□ Not in this

categorization;

□ Can’t be

categorized;

The specific target organ

toxicity (repeated exposure)

GB 30000.26-2013


and labeling of

chemicals—Part

26:Specific target

organ

toxicity—Repeated

exposure

□ Not applicable;

□ Category 1;

□ Category 2;

□ Not in this

categorization;

□ Can’t be

categorized;

Aspiration hazard GB 30000.27-2013


and labeling of

chemicals—Part

□ Not applicable;

□ Category 1;

□ Category 2;


— 81 —


standard


rationale

27:Aspiration hazard □ Not in this

categorization;

□ Can’t be

categorized;


6.3.2 The division of the management categories

The management categories:


7 The PBT and vPvB authentication

7.1 The results of the PBT or vPvB authentication

Table 15 The PBT or vPvB authentication

The kind of danger The categorization standard The categories The categorization

rationale

1 Persistent GB/T 24782-2009 Decision

method of persistent,

bioaccumulative and toxic

substances, and very

persistent and very

bioaccumulative substances

□ Very persistent

substance

□ Persistent

substance

□ The substance

without persistent

□ Can’t be

assessed

2 The biological

accumulation

GB/T 24782-2009 Decision




persistent and very


□ Very

bioaccumulative

substances

□ The

bioaccumulative

substances

□ The substance

without biological

accumulation

□ Can’t be

assessed

3 Toxicity GB/T 24782-2009 Decision □ The toxic


— 82 —

The kind of danger The categorization standard The categories The categorization

rationale



substances,and very

persistent and very


substance

□ The non-toxic

substance

□ Can’t be

assessed

4 PBT and vPvB

assessment

GB/T 24782-2009 Decision




persistent and very


□ PBT substance

□ vPvB

substance

□ Non-PBT and

non-vPvB

substance

□ Can’t be

assessed


7.2 The assessment of the PBT or vPvB authentication

8 The harm assessment

8.1 The environmental harm assessment (quantitative)

8.1.1 The deductive results of PNEC

Table 16 PNEC (quantitative)

Environmental

item

Deductive

standard

Assessment

coefficient

method/Distribution

balancing method

Evaluation

coefficient PNEC

Rationale of

deduction

The

environment of

the sewage

treatment plant

The guideline

on the risk

assessment of

the chemical

substances

(consultative

draft)

The

environment of

the surface

water

The guideline

on the risk

assessment of

the chemical


— 83 —

substances

(consultative

draft)

The

environment of

the surface

water sediment

The guideline

on the risk

assessment of

the chemical

substances

(consultative

draft)

The soil

environment

The guideline

on the risk

assessment of

the chemical

substances

(consultative

draft)

The other

environment

8.1.2 The brief introduction to the deduction procedure of PNEC

8.2 The environmental harm assessment (qualitative)

8.2.1 The results of the grading on environmental harm

Table 17 The grading on environmental harm (qualitative)

The kind of harm The assessment

standard

The grading

results

The marks

given in

grades

The rationale for grading

The

environmental

harm

The guideline on

the risk

assessment of the

chemical

substances

(consultative

draft)

□High

harm

□Middle

harm

□Low harm

□3

□2

□1

□ The short-term aquatic

harm 1 or the long-term

aquatic harm 1, 2



aquatic harm 3



aquatic harm 4

Note: Only the selected grading results and grading marks will be retained.


— 84 —

8.2.2 The brief description to the procedure of environmental harm grading

8.3 The assessment on the harm to health

8.3.1 The results of the grading on the harm to health

Table 18 The grading on the harm to health


standard

The grading

results

The marks

given in

grades


The acute oral

toxicity

The guideline on

the risk assessment

of the chemical

substances

(consultative draft)

□Extremely

high harm

□High

harm

□Middle

harm

□Low harm

□4

□3

□2

□1

□Category of the acute

oral toxicity 1

□ Category of the acute

oral toxicity 2


oral toxicity 3


oral toxicity 4 or 5

The acute dermal

toxicity

The guideline on

the risk assessment

of the chemical

substances


□Extremely

high harm

□High

harm

□Middle

harm

□Low harm

□4

□3

□2

□1

□Category of the acute

dermal toxicity 1


dermal toxicity 2


dermal toxicity 3


dermal toxicity 4 or 5

The acute inhalation

toxicity

The guideline on

the risk assessment

of the chemical

substances


□Extremely

high harm

□High

harm

□Middle

harm

□Low harm

□4

□3

□2

□1


inhalation toxicity 1






inhalation toxicity 4 or 5

Skin

corrosion/irritation

The guideline on

the risk assessment

of the chemical

substances

□High

harm

□Middle

□3

□2

□1

□Category of skin

corrosion 1A-1C

□Category of skin


— 85 —


standard

The grading

results

The marks

given in

grades


(consultative draft) harm

□Low harm

irritation 2

□Category of skin

irritation 3

Eye irritation The guideline on

the risk assessment

of the chemical

substances


□High

harm

□Middle

harm

□Low harm

□3

□2

□1

□Category of eye

irritation 1

□Category of eye

irritation 2A

□Category of eye

irritation 2B

Breath and skin

sensitization

The guideline on

the risk assessment

of the chemical

substances


□High

harm

□Middle

harm

□3

□2

□Category of breath

sensitization 1

□Category of skin

sensitization 1

Mutagenicity The guideline on

the risk assessment

of the chemical

substances


□Extremely

high harm

□High

harm

□4

□3

□Category of

mutagenicity of

reproductive kind 1

□Category of

mutagenicity of

reproductive kind 2

Reproductive toxicity The guideline on

the risk assessment

of the chemical

substances


□Extremely

high harm

□High

harm

□4

□3

□Category of

reproductive toxicity 1

□Category of

reproductive toxicity 2

The toxicity of

repetitive contact and

the chronic toxicity

The guideline on

the risk assessment

of the chemical

substances


□High harm

□Middle

harm

□3

□2

□The specific target

organ toxicity of repetitive

contact 1

□The specific target

organ toxicity of repetitive

contact 2

Carcinogenity The guideline on □Extremely □4 □The category of


— 86 —


standard

The grading

results

The marks

given in

grades


the risk assessment

of the chemical

substances


high harm

□High

harm

□3 carcinogenity 1

□The category of

carcinogenity 2

Note: Only the selected grading results and grading marks will be retained.

8.3.2 The brief introduction to the grading on harm to health

9 The exposure assessment

9.1 The assessment on the environmental exposure (quantitative)

9.1.1 The sketch on the scenery of exposure

Table 19 The table on the sketch on the scenery of exposure (quantitative)

The number of the

scenery of

exposure

The short topic of the

scenery of health A brief introduction to the scenery of health

9.1.2 The environmental exposure scenery 1

9.1.2.1 The description of the exposure scenery 1

The short topic and number:

The brief introduction:

The basic feature of the chemicals:

The amount and time of production/using:

The production technique:

The operation environment and conditions:

The generation of the wastes:

The processing and emission of the waste gas:

The processing, emission and/or flow direction of wasted water:

The storage, emission and/or flow direction of the wasted solid:

Surrounding environment

Consumption mode, maximum consumption volume per capita


— 87 —

9.1.2.2 The assessment parameters of the environmental exposure of exposure

scenery 1

Table 20 The assessment parameters of the environmental exposure of exposure

scenery 1 (quantitative)

Topic

Short topic and number

The relative parameters of the chemical substances

The amount of notification of the chemical

substances (t/y)

The annual production/using amount proportion

of the chemical substances of local part (point

source) (%)

The annual production/using amount of the

chemical substances of local part (point source)

(t/y)

The relative parameters of the wasted gases

The annual production amount of the wasted gas

of chemical substances of local part (point

source) (kg/y)

The processing technique and effects of wasted

gas of chemical substances of local part (point

source)

The annual emission amount of the chemical

substances of local part (point source) (kg/y)

The number of emission days of the chemical

substances of local part (point source) (d)

The emission amount of the wasted gas of


(kg/d)

The relative parameters of the waste water

The annual production amount of the waste

water of the chemical substances of local part

(point source) (kg/y)

The processing technique and effects of wasted

water of chemical substances of local part (point

source)

The annual emission amount of the chemical


— 88 —

substances of local part (point source) (kg/y)

The number of emission days of the chemical

substances of local part (point source) (d)

The emission amount of the wasted water of


(kg/d)

The flow direction of the waste water of local

part (point source)

口 Sewage-processing plant of zone

口 Municipal sewage-processing plant

口 Directly discharged surface water

口 Directly discharged to sea

口 Directly discharged to soil

The relative parameters of the soild waste

The production amount of the solid waste (kg/y)

The processing and/or direction of the soild

wastes

The relative parameters of the zone or municipal sewage-processing plant

The processing technique and effects of the

processing technique of the zone or municipal

sewage processing water

The daily water generation amount of the zone

or municipal sewage processing water (L/d)

The daily slurry generation amount of the zone

or municipal sewage processing water (kg/d)

The relative parameters of the natural parameters

The kind of the receiving water body

□ river;

□ lake;

□ ocean;

The flow of the receiving water body (m3/d)

The diluting factor of the receiving water body

The slurry of the municipal sewage treatment

plant used in the agricultural soil (kg/y·m2)


— 89 —

9.1.2.3 The PEC estimation of the environment of sewage treatment plant of

exposure scenery 1

9.1.2.4 The PEC estimation of the environment of surface water of exposure

scenery 1

9.1.2.5 The PEC estimation of the environment of surface water sedimentation

of exposure scenery 1

9.1.2.6 The PEC estimation of the environment of soil environment of

exposure scenery 1

9.1.3 Exposure scenery 2

9.1.4 Exposure scenery…

9.2 The environmental exposure assessment (qualitative)

9.2.1 The description and grading of environmental exposure assessment

Table 21 The description of environmental exposure assessment (qualitative)

Situation/grading Marks

Exposure

factor

Production

amount/import

amount (t/a)

□Amount < 10

□ 10 ≤ amount < 100

□ 100 ≤ amount < 1000

□ ≥1000

□1

□2

□3

□4

Using amount □Only in the closed system

□Industrial use

□Specialized use

□Consumer use

□0

□1

□2

□3

Half-life period

(d)

□Half-life period ≤ 16

□ 16 ≤ amount <50

□ 50 ≤ amount < 150

□ amount ＞ 150

□1

□2

□3

□4

Or degradation □ Can be biologically

degraded rapidly

□Meet the requirements of

the rapid biological

degradation excluding

during the window period

□ Can be biologically

degraded in natural mode

□1

□2

□3

□4


— 90 —

□ Can’t be biologically

degraded

Table 22 The grading on environmental exposure (qualitative)

Situation/grading Marks

Total mark of environmental

exposure

□ Total mark of

environmental exposure ≤3

□ 4≤Total mark of

environmental exposure ≤6

□ Total mark of

environmental exposure ≥7

Grading of environmental

exposure and marks

□Low exposure

□Middle exposure

□High exposure

□1

□2

□3

9.2.2 The brief introduction to the procedure of environment exposure

assessment and the discussion of the results

9.3 The assessment of the health exposure

9.3.1 The description and grading of the health exposure assessment

Table 23 The description of the health exposure

Exposure factor Contributed marks for exposure (Ai Bj Ck，) Weight

(pi)

Mark of

exposure

factor

Physical and chemical properties

A1 gas/liquid/solid □3, the sublimation of gas or solid\

□0, not applicable 3

□3, the organic matter with boiling point < 50

□2, the organic matter with 50≤ boiling point ＜

260

□1, the organic matter with 260≤ boiling point ＜

400

□0, other

Or

□3, the organic matter with vapour pressure >

1.33×10-2

kPa

□2, the organic matter with 1.33×10-4

kPa≤ vapour

pressure＜1.33×10-2

kPa


— 91 —

□1, the organic matter with 1.33×10-6

kPa≤ vapour

pressure＜1.33×10-4

kPa

□0, other

□3, the dry solid with grain diameter ≤10μm

□2, the dry solid with 10μm＜ grain diameter

≤100μm

□1, the dry solid with grain diameter > 100μm or

the wet solid

口 0, not applicable

A2 Solubility in

water

□3, solubility in water > 1000mg/L

□2, 100 mg/L≤ solubility in water ＜1000 mg/L

□1, 0.1 mg/L≤ solubility in water ＜100 mg/L

□0, solubility in water < 0.1mg/L

3

A3 The cleanability

during overflow or

discharging

□3, not easy to be cleaned

□2, easy to be cleaned

□1, very easy to be cleaned

□0, not applicable

3

The toxicology property which is beneficial to reduce the exposure

A4 The skin irritation

□3, low skin irritation

□2, mediate skin irritation

□1, high skin irritation


2

A5 The eye irritation

□3, low eye irritation

□2, mediate eye irritation

□1, high eye irritation


2

A6 Odor □1, no odor

□0, with odor 2

Testability

A7 The effectivity of

the testing method

(the testing methods

for the possible

emission ways)

□2, no testing methods

□1, the testing method is not accurate enough

□0, the method is effective

1

The exposure during the industrial procedure


— 92 —

B1 The frequency of

chemical substance

inhalation

□3, dispersing in the air

□2, dispersing in the air intermittently

□1, can be smelt

□0, not tested or not applicable

4

B2 The frequency of

the worker’s skin

contacting the

chemical substances

□3, constant contact

□2, intermittent contact

□1, occasional contact

□0, no contact

4

B3 The constant

exposure time

□3, constant exposure time＞6 h

□2, 4 h≤ constant exposure time ≤6 h

□1, constant exposure time＜4 h


3

Technique procedure

B4 The controlling

method of the

technique procedure

□2, intermittent production

□1, continual production


2

B5 The working

condition of

operation

□3, used directly

□2, used in local ventilation

□1, used for separation

□0, not applicable or used in the closed system

2

The pollution source in the operation place

B6 The loading

(overflow) of the

chemical substance

□2, tend to overflow

□1, not tend to overflow

□0, not tend to overflow or not applicable

2

B7 The waste gas,

waste water or solid

wastes

□2, discharging

□1, almost no discharging

□0, no discharging

2

B8 The leakage

□3, large leakage amount

□2, mediate leakage amount

□1, low leakage amount

□0, no leakage amount or not applicable

2

The prevention and treatment measures

B9 The purification

of wasted gas

□2, no treatment

□1, mediate treatment effect

2


— 93 —

□0, effective treatment

B10 The treatment of

wasted water

□2, no treatment



2

B11 The disposal of

the solid waste

□2, no treatment



2

B12 The contingency

planning

□2, no planning

□1, mediate planning effect

□0, effective planning

2

Transportation

C1 Vessel (liquid and

gas)

□2, vessel ≤1000 kg

□1, vessel ＞1000 kg


2

C2 With package

(solid)

□2, no package

□1, with package


2

Storage

C3 Pressure

□2, with pressure

□1, with reduced pressure

□0, with normal pressure

2

C4 Storage

conditions

□3, open field

□2, shed

□1, warehouse


2

C5 The security

distance of storage

tank

□2, don’t meet requirements

□1, meet requirements basically

□0, meet requirements or not applicable

2

Using

C6 Using method

□3, consumer

□2, specialized usage

□1, industrial usage

□0, used in the closed system or not applicable

2

Disposal


— 94 —

C7 The diffused of

the wasted material

□3, tend to diffuse

□2, not tend to diffuse

□1, no diffusion or not applicable

2

C8 Processing

method such as

burning, storage,

recycling/crushing,

etc.

□3, no rational disposal

□2, improper disposal

□1, mediate disposal

□0, easy to be disposed

2

The mark of exposure factors (SHE)

The largest mark of exposure factors (SHEmax) 149

The exposure factors RE=SHE/ SHEmax

Table 24 The grading of health exposure

Exposure Grading

Exposure factor

RE

□RE≥0.70

□0.40≤RE＜0.70

□RE＜0.40

□High

□middle

□low

Quantity factor □amount≥1000 t/a

□100 t/a≤amount＜1000 t/a

□10 t/a≤amount＜100 t/a

□amount＜10 t/a

□

extremely

large

□large

□middle

□small

Qualitative

health exposure

grading

□Extremely high exposure

□High exposure

□Middle exposure

□Low exposure

□4

□3

□2

□1

9.3.2 The brief introduction to the procedure of health exposure evalution and

the discussion to the results

10 The risk characterization

10.1 The environmental risk characterization (quantitative)

10.1.1 The results of the environmental risk characterization (quantitative)

Table 25 The results of the environmental risk characterization (quantitative)

Serial number and

name of exposure

scenery

Environmental medium PEC PNEC

Environmental risk

characterization

CRC=PEC/PNEC


— 95 —

1 The environmental of

sewage treatment plant

The environment of

surface water

The environment of

sedimentation in

surface water

The soil environment

The other environment

2 The environmental of


The environment of

surface water

The environment of

sedimentation in

surface water



……. The environmental of


The environment of

surface water

The environment of

sedimentation in

surface water



10.1.2 The uncertainty assessment of the environmental risk characterization

(quantitative)

10.2 The environmental risk characterization (qualitative)

10.2.1 The results of the environmental risk characterization (qualitative)

Table 26 The environmental risk characterization (qualitative)

The level of

environmental

harm

The mark of

environmental

harm

The level of

environmental

exposure

The mark of

environmental

exposure

The level of

environmental

risk

Environmental

risk

characterization

□High risk

□Middle risk

□9-6 points

□5-3 points


— 96 —

□Low risk □2-1 points

10.2.2 The uncertainty assessment of the environmental risk characterization

(qualitative)

10.3 The health risk characterization

10.3.1 The results of the health risk characterization

Table 27 The health risk characterization

The level of

health harm

The

mark of

health

harm

The level of

health exposure

The mark

of health

exposure

The level of

health risk

Health risk

characterization

□extremely high

risk

□high risk

□middle risk

□low risk

□16-12 points

□11-8 points

□7-4 points

□3-1 points


— 97 —

10.3.2 The discussion of the uncertainty of health risk characterization

11 The assessment conclusions

11.1 The physical risk

11.1.1 The brief introduction to the physical risk

11.1.2 The controlling measures of the physical risk

11.1.3 The assessment conclusions of the physical risk

11.2 The environmental risk

11.2.1 The brief introduction to the environmental risk

11.2.2 The controlling measures of the environmental risk

11.2.3 The conclusions of the environmental risk assessment

11.3 The health risk

11.3.1 The brief introduction to the health risk

11.3.2 The controlling measures of the health risk

11.3.3 The assessment conclusions of the health risk

11.4 The general conclusion of the risk assessment

11.5 The division of the environmental management categories

11.5.1 The conclusion of PBT or vPvB

11.5.2 The results of the category division of environment management

12 The references

13 The appendixes


— 98 —

Table 28 The table on the usage and codes of the chemicals

No. Usage categorization Detailed usage categorization

Code Name of detailed usage categorization

1 Used for export 01a Used for export

2

Intermediate (synthetic raw

material, poly-raw material and

poly-initiator, etc)

02a Intermediate (synthetic raw material,

poly-raw material and poly-initiator, etc.)

3 Used for testing and researching 03a Used for testing and researching

4 Reagent 04a Reagent

5

Food additives, vessel package,

toy and detergent (the detergent is

only used for tableware and

foods)

05a

Food additives, vessel package, toy and

detergent (the detergent is only used for

tableware and foods)

6 Pesticide 06a Pesticide

7 Fertilization 07a Fertilization

8 Feed additives 08a Feed additives

9 Medicine (including that used for

animals) 09a Medicine (including that used for animals)

10 Cosmetics 10a Cosmetics

11

Solvent for painting, varnish and

surface coating; solvent for

printing ink and duplicating;

solvent for bactericide

11a Solvent for painting, painting diluent, paint

remover

11b Solvent for varnish, solvent for insulating

varnish

11c Solvent for surface coating, solvent for

coating-prevention

11d Solvent for printing ink, ink remover, solvent

for duplicating

11e Solvent for bactericide

11z Others

12 Solvent for adhesive, sticker and

sealed materials

12a Solvent for adhesive and sticker, adhesive

remover, glue remover

12b Adhere with the solvent

12c Solvent for the sealed materials

12z Others


— 99 —



13 Solvent for cleaning

13a

Non-aqueous (used for degreasing and

cleaning), quasi-aqueous (used for cleaning

with scaling powder)

13b Solvent for photoresist developing,

anti-stripping agents

13z Others

14

Cleaning agent for cloth cleaning

(mainly used in the cleaning

industry)

14a Reagent for dry cleaning

14b Detergent

14z Others

15 Industrial solvents (excluding the

solvents above)

15a Solvent for synthetic reaction

15b Solvent for texture and membrane

manufacturing (including carbon disulfide)

15c Solvent for extraction and purification

15d Solvent for dilution

15z Others

16 Used for spray 16a Gas spray (Freon gas, etc), diluent

16z Others

17 Other solvents 17a Other solvents

18 Chemical procedure modulator

18a Catalyst, catalyst carrier

18b Dispersant, emulsifier

18c Polymerization regulator, polymerization

inhibitor, stabilizer

18z Others

19

Colorant (dye, painting, pigment,

coating, printing ink and leather;

excluding primer for fabric and

primer for paper and pulp

solvent)

19a Primer (dye, painting, pigment)

19b Color former, color fixative aids

19c Fluorescer

19z Others

20

Aqueous detergent, wax 1

(industrial use, fabric primer and

the reagent for paper and pulp are

excluded)

20a Soap, detergent (surface active agent)

20b Inorganic and organic alkali, bleach

20c Agent for re-adhesion, chelating agent (buider

and additive)


— 100 —



20d Inorganic acid, organic acid (rust and aqueous

rust detergent for metal surface)

20e Rust preventing agent

20f Wax (used for automobile and leather, etc)

20z Others

21 Aqueous detergent, wax 2 (Used

for furnitures and others)

21a Soap, detergent (surface active agent)

21b Inorganic and organic alkali, inorganic and

organic acid, bleach

21c Agent for re-adhesion, chelating agent (buider

and additive)

21d Softener

21e Wax (used for floor, automobile and leather,

etc.)

21z Others

22

Painting (painting and raw

material for lacquer), auxiliaries

for the surface coating (including

primer)

22a Colorant (dye, painting, pigment)

22b Plasticizer

22c

Stabilizer (such as antioxidant, thermal

stabilizer, ultraviolet ray absorbent,

anti-setting agent, anti-gelling agent)

22d Filler agent (filler)

22e Corrosion inhibitor, rust preventing agent,

corrosion remover, antifoggant

22f Emulsifier, dispersant, anti-blocking agent

22g Skinning agent, tackifier, defoamer

22h

The ingredients of cross linking agent, curing

agent, photopolymerization inhibitor and

adhesive

22i The monomer and oligomer of photocuring

painting

22j The drying accelerator, wetting agent, fire

retardant and waterproof agent

22z Others


— 101 —



23

The agent for printing ink and

photocopying and the

colorblender (including those

used for writing utilities and

anti-ink)

23a

Colorant (dye, painting, pigment),

thermal-sensitive pigment, pressure-sensitive

pigment, color agent

23b Platicizer

23c




23d Emulsifier, dispersant, anti-blocking agent

23e Skinning agent, tackifier, defoamer

23f

The monomer and oligomer for the solidified

ink against ultraviolet ray and electronic ray,

emulsion

23g The drying accelerator, wetting agent

23z Others

24 Antifoulant (used for fishing net

and painting at boat bottom)

24a Antifoulant for fishing net

24b Antifoulant for the painting at boat bottom

25

Bactericide 1 (excluding the

pesticide and non-medicine

products)

25a

Bactericide, pesticides, corrosion remover,

antifoggant, wooden corrosion remover and

anti-termite agent

26



products; for industrial

use/working sequence, not

included in the products)

26a

Anti-trouble pesticides (pesticide, insect-resist

agent, insect attractant, potentiating agent,

etc)

26b Gaseous bactericide, fumigate and smoke

agent

26c Bactericide, disinfectant, corrosion remover

26d Wetting agent, emulsifier

27



products; used in families)

27a

Anti-trouble pesticides (pesticide, insect-resist

agent, insect attractant, potentiating agent,

etc.)

27b fumigate and smoke agent, fibre insect-insist

agent

27c Bactericide, disinfectant, corrosion remover,


— 102 —



smoke agent

27d Herbicide used for non-agricultural land

27e Termite expellant, anti-termite agent

27f Wetting agent, emulsifier

27z Others

28 Gunpowder, dynamite (including

fire crackers)

28a Gunpowder, dynamite

28b Ignition inhibitor

28z Others

29 cyclamate

29a Spice, air freshener, deodorant

29b Deodorant

29z Others

30

Adhesive, bonding agent, sealant,

sealing material (including

primer)

30a Ingredients of adhesive (including couplant),

curing agent

30b Plasticizer, filler

30c Stabilizer (inhibitor, etc)

30d Corrosion remover, anti-smoker agent

30e Fire retardant, conductive agent

30z Others

31 The materials for photos,

photoresist and printing plate

31a emulsion

31b Monomer and oligomer of photosensitive

resin; photosensitive resin

31c Pigment formation coupler (provided for

photochrome)

31d Fixing agent, stabilizer

31e Sensitizer, desensitizer, crosslinking density

increaser, anti-additive

31f Contrast agent (water-soluble processing

agent)

31z Others

32 Fibre primer 32a Oiling agent for spinning

32b Detergent and extracted detergent (soaping


— 103 —



agent)

32c Chelating agent

32d Bleach

32e

Levelling agent, penetrating agent,

accelerating agent, mordant (auxiliaries for

printing and dyeing)

32f Dispersant and defoamer

32g Mercerizing agent

32h Fixing agent

32i softener

32j Degumming agent

32k Colorant (dye and painting), fluorescent

brightener

32l Dipping enhancer

32m Fire-proofing agent, fire retardant

32n Water proofing agent and oil-proofing agent

32o Morph stabilizer and processing agent

32p Antistatic agent

32q Processing material of anti-odor and

anti-pollution, discoloration preventing agent

32z Others

33 Agent for paper and pulp

33a Control for viscosity substances

33b Bleach

33c Dispersant and defoamer (surfactant)

33d Yield enhancer

33e Colorant (dye and painting), fluorescent

brightener

33f Intensity improver for paper, dipping

enhancer

33g Sizing

33h Fire-proofing agent, fire retardant


— 104 —



33i Water proofing agent and oil-proofing agent

33j Agent for surface coating

33z Others

34

Synthesized resin (plastic)

material and additives (used for

the allocation of the formation

material/formation processing)

34a Platicizer

34b




34c Fire retardant

34d Antistatic agent

34e Antifoggant, antidrip agent

34f Filler, diluent

34g Foaming agent (organic foaming agent,

inorganic foaming agent)

34h Casting and foaming injection molding

materials (monomers in the prepolymers, etc)

34i Curing agent, cross linking agent (styrene

monomer used for FRP, etc.)

34j Curing accelerator

34k Crystal nucleating agent

34l Lubricant, release agent

34z Others

35 Additives used for rubber

35a Sulfuration acceleration

35b Sulfuration agent, de-sulfuration agent

35c



emulsifier, anti-gelling agent, anti-precipitant,

inhibitor)

35d Plasticizer, enhancer

35e Foaming agent (organic foaming agent,

inorganic foaming agent)

35f Burning-preventing agent, peptizer, regulator

(auxiliaries for processing)


— 105 —



35g Antistatic agent, fire retardant

35h Latex coagulant

35z Others

36 Leather primer

36a Agent for preparation (before tanning)

36b Tanning agent (chromium sulfate, methanol,

synthesized tannic acid, etc)

36c

Finishing (colorant, coloring auxiliaries,

water-proofing agent and oil-proofing agent,

etc)

36z Others

37 Glass, enamel, cement

37a Raw material for glass and enamel

37b Additives for glass and enamel

37c Raw material for cement

37d Additives for cement

37z Others

38 Ceramic, fireproof material, fine

ceramic

38a Raw material for ceramic, fireproof material,

fine ceramic

38b Additives ceramic, fireproof material, fine

ceramic, etc.

38c Thickening material, adhesives

38d Release agent

38z Others

39 Grinding wheel, lapping

compound, friction material

39a Raw material for grinding wheel, lapping


39b Additives for grinding wheel, lapping


39c Thickening material, adhesives

39z Others

40 Raw material and casting material

for metal and alloy

40a Raw material and casting material for metal

40b Adhesives and curing gent for casting

40c Flux, inoculant


— 106 —



40d Release agent

40z Others

41

Surface primer (agent for

electroplate and non-electrolyte

electroplate, etching agent)

41a Electrolyte agent (ingredient of coating)

41b Additives for electroplate pool (gloss

enhancer, smoke-resisting agent)

41c

Primer for non-electrolyte electroplate,

cathode oxidation, thermal spraying and

surface solidification

41d Agent for vacuum electroplate (vacuum

evaporation, spraying, etc.)

41e Gas used for evaporation and cleaning

(semiconductor manufacturing, etc.)

41f Agent for etching processing

41z Others

42 Welding bar, welding

42a Flux for welding bar

42b Antioxidant for welding

42z Others

43 Hydraulic oil (AT hydraulic oil,

etc), insulation oil

43a Crude oil of hydraulic oil

43b Crude oil of insulation oil

43c Extreme pressure agent, antifriction

43d Emulsifier, cleaning dispersant

43e Viscocity adjusting agent

43f Antioxidant, rust preventing agent

43z Others

44 Grinding oil (cutting oil),

lubricant oil

44a Crude oil for grinding oil

44b Crude oil for lubricant oil

44c Extreme pressure agent, antifriction

44d Emulsifier, cleaning dispersant

44e Viscocity adjusting agent

44f Antioxidant, fire retardant, rust preventing

agent


— 107 —



44z Others

Ele45 Electric and electronic material

45a

Magnetic material (excluding storage

medium), piezoelectric material, conduction

material and superconduction material

45b Semiconductor, diode (including LED),

material for solar battery

45c Material for capacitor and resistance

45d Phosphor, liquid crystal and material of

organic EL

45e Sealing material, insulation material

45f

Electronic medium (auxiliary storage device)

(magnetic substance, light-absorbing pigment,

etc)

45z Others

46 Cell (including battery)

46a Electrolyte, bath solution, conductive agent

46b Electrode material

46z Others

47 Water primer

47a Corrosion remover and rust preventing agent

(can cleaner)

47b Softener for hard water

47c Flocculant, PH value modifier (neutralizer)

47d Sealing agent for metal ion (chelating agent,

etc)

47z Others

48 Desiccant, absorbent

48a Absorbent

48b Absorbent (deoxidizing agent, etc.)

48c Desiccant

48z Others

49 Thermal medium

49a Cold medium and coolant

49b Thermal medium and heating agent

49z Others


— 108 —



50 Anti-freezing solution

50a Anti-freezing solution (LLC, etc.)

50b Anti-rusting agent and corrosion remover

50z Others

51

Additives for construction

materials (cement mixture and

soaking agent for wooden

strengthening)

51a Surface curing agent

51b Enhancer and water reducer

51c Release agent and defoaming agent

51d Reinforcing solvent

51e

Stain-proofing agent (water-proofing agent

used excluding for fishing net and boat

bottom coating, etc.)

51z Others

52 Dispersant and primer used

before burial processing

52a Antifreezing agent (snow melting agent)

52b Soil improving material

52c Fire eliminating agent

52d Artificial rainfall agent

52e Dust binder, pulverized coal primer

(suppressing the digestion of heavy metal)

52z Others

53 Separating medium, refining

agent, extracting agent

53a Floatation agent, floatation suppressing agent,

flocculant

53b Metal capturing agent

53c Optical splitting agent

53z Others

54 Fuel and fuel additives

54a Fuel

54b Cleaning dispersant, antioxidant, viscocity

index adjuster, antirust agent

54c Combustion improver, cetane value enhancer,

antiknock

54d Deicer

54z Others

55 Other raw material and additives 55a Other raw material and additives


— 109 —



56

The chemical substances in the

furniture, cleaning and personal

nursery products

56a Floor covering

56b Foam chair and beddings

56c Furniture and decoration utilities (the other

listed categories are excluded)

56d Texture and leather products (the other listed

categories are excluded)

56e Cleaning and furniture maintenance product

56f Cloth and tableware cleaning utilities

564g Water treatment products

564h Personal nursery products

56i Air cleaning products

56j Cloth and shoe maintenance products

56z Others

57

The chemical substances in

building, lacquer, electric

appliances and metal products

57a Adhesives and sealant

57b Lacquer and painting

57c

The material for building/structure – the

wooden material and wooden products used

for engineering

57d Other materials in building/structure

57e Electrical appliances and electronic products

57f Other metal products

57g Battery

57z Others

58

The chemical substances in the

packaging materials, paper and

plastic products, toys and

entertainment utilities

58a Packaging material for food

58b Paper products

58c

The plastic without other covering layer and

the rubber products and plastic products

(excluding the other listed categories)

58d Toys, playground and sport equipment

58e Painting, handcrafts and other amateur

products


— 110 —



58f Ink, carbon dust and colorant product

58g Photographic apparatus, film and optical

chemical products

58z Others

59

The chemical substance used in

automobile, fuel, agricultural and

outdoor products

59a Automobile maintenance products

59b Lubrication grease

59c Anti-freezing and deicing products

59d Fuel and relative products

59e Explosives

59f Agricultural products (other than pesticides)

59g Lawn and garden nursery products (other than

pesticides)

59z Others

60 Others 60a Others

— 1 —

Appendix 2

The report table on each activity of new

chemical substances

Receiving number:

Receiving time:

1 The information in the new chemical substance registration certificates

Registration certificate holder:

Registration certificate number:

2 The information of processer and user

Name: Legal representative:

Address: Zip code:

Contact person: Telephone number: E-mail:

Transferring date: Transferring amount

(ton):

Commodity name during

transferring:

3 The transferring of the risk controlling measures

Whether the obtained information on the

risk controlling measures has been delivered

to the processer and user

□ Yes □No

Table filler (signature):

(Seal of the reporting unit)

Telephone number of the table filler: Table filling date: YY/MM/DD


— 2 —

The instruction on filling the report table on each

activity of new chemical substances

For the report table on each activity of new chemical substances, the registration

certificate holder should fill according to the actual type of activities. The symbol of

“”， “X”or “■” can be written in the selection box occurring in the table for “yes”,

and “□”. The receiving number and receiving time should be written by SCC-MEP.

1. The information of the registration license for new chemical substance

Registration certificate holder: Fill the name of the holder of the registration license

for new chemical substance

Registration certificate number: Fill the number of the registration certificate of

new chemical substance

2 The information of the processer and user

Name: The full name of the processor and user where the new chemical substance is

transferred to (registered in industrial and commercial department);

Legal representative: Fill the name of legal representative of processer and user

(registered in industrial and commercial department); if it is not an organization with

legal representative, the name of principal should be filled in.

Address: Fill in the detailed address of processor and user, which should include

the zip code of the area, as well as the detailed information of the relative province,

city, district, street and house numbering.

Contact person: Fill in the name of the contact person of the processor and user;

Telephone number: Fill in the telephone number (including district number) of

the contact person above)

Transferring date: Fill in the date of each transferring of new mechanical

substances (the format is YY/MM/DD).

Transferring amount: Transferring the amount of the new chemical substances

of the new chemical substance transferred for processing and using each time, and

unit is ton. For the products containing new chemical substances or products

transferring, the amount converting from the amount of pure new chemical substance

should be filled in.

The commodity name during transferring: The commodity name during the

transferring of the new chemical substance should be filled in.

— 3 —

3 The transferring of the risk controlling measures: Select according to

whether the risk controlling measure information indicated in the registration

certificate has been transferred to the processor and user.

Seal: The table filler of the reporting unit should fill in according to the actual

activities, at the same time, the public seal of the unit should be stamped on the seal

column of the reporting unit; it should be signed by the table filler at the place of

signature manually, and the submission time (with the format of YY/MM/DD) should

be filled at the place of reporting date. The reporting unit should be the holder of the


— 1 —

Appendix 3

The table on the annual report of new

chemical substances (trial)

Receiving number:

Receiving time:

Announcement on filling

I make an announcement that:

(I) I am familiar with the requirements in The Measures for Environmental

Management of New Chemical Substances (No.7 Order of the Ministry of

Environment Protection) and The Guideline for Notification and Registration

of New Chemical Substance (HB No.(2010) 124), and I will abide by the

relative regulations strictly.

(II) All the information submitted in the report table are real and reliable, and they

have legal source, and the rights and benefits of other people are not offended.

If there are any false statements, I will hold all the legal responsibilities

caused by this.

The signature of the legal representative:

(Public seal of the holder of the registration certificate)

Date of table filling:

Year of

reporting

□□□□Year

I. The information of the holder of the registration certificate

Holder name

Contact

person

Telephone

number

Cell phone

number

E-mail

II. The summarization of the registration certificates

The total number of the

registration certificates


— 2 —


registration certificates of

simplified notification

The certificates

with actual

activities


registration certificates of

regular notification

The certificates

with actual

activities

III. Note

— 3 —

Table 1 The information of registration certificate without actual activities

The information of the registration certificates of simplified notification

No. Registration Certificate No. No. Registration Certificate No.

1 2

3 4

5 6

7 8

9 10

11 12

13 14

15 16

17 18

19 20

… …

The information of the registration certificates of regular notification

No. Registration Certificate No. No. Registration Certificate No.

1 2

3 4

5 6

7 8

9 10

11 12

13 14

15 16

17 18

19 20

… …


— 4 —

Table 2 The information of simplified notification with actual activities

No.

Number of

registration

certificate

Total

amount of

actual

activities

(ton)

Total

importing

amount

(ton)

Total

production

amount

(ton)

Changes of registration

information and the instruction

to other conditions

1

2

3

4

5

6

7

8

9

10

11

12

…

— 5 —

Table 3 The regular notification information with actual activities

1 The information of the registration certificate

Registratio

n certificate

number

X.C.D. □-□□□□

□

New chemical substance with the danger of

important environment management: □Yes □

No

2 The situation of actual activities

Total amount of

actual activities

(ton)

Existing

form

□pure substance; □preparation; □

articles

Total importing

amount (ton)

Times of

importing

Total production

amount (ton)

Number of

production

batches

Total amount of

transferring (ton)

Times of

transferrin

g

3 Exposure and releasing

The instruction to exposure:

The instruction to releasing in environment:

4 The actual effect caused to the environment and body health

5 The realization of the risk controlling measures


— 6 —

6 The other information relating to the environmental risk

7.The production of the next year or the preparation of the importing plan and risk

controlling measures (the danger of important environment management)

7.1 The production or importing plan of the next year

Predicted

production

amount (ton)

Predicted importing

amount (ton)

7.2 The preparation of implementing the risk controlling measures

— 7 —

The instruction on filling the annual report table of new

chemical substances (trial)

The filling statement

The holder of the registration certificate and the contact person should read the

statement carefully and they should abide by the relative regulations strictly.

The signature of the legal representative: The name of the legal representative must

be printed with the signature of the legal representative; for the non-legal

representative organization, the name of the principal should be printed with the

signature of the principal.

The public seal of the holder of the registration certificate: The public seal of the

unit of the registration certificate holder should be stamped at the place of the

paper-based printed document.

Date of table filling: The concrete date of table filling should be written with the

numerical digits regularly.

Year of reporting: It means the concrete number of last year, for example, 2012.

I. The information of the holder of the registration certificate

The name of the holder: It should be consistent with the name of the holder on the


The contact person: It should be name of the contact person being responsible for

the annual report of the new chemical substances.

Telephone number: It should be the telephone number of the contact person and the

format should be: area number-telephone number-extension number, for example:

010-84915287-1234.

Cell phone number: it should be the cell phone number of the contact person.

E-mail: It should be the email address of the contact person.

II. The summarization of the registration certificate

The total number of the registration certificates: It refers to the total number of the

registration certificates in the annual report which should be submitted by the holder

of the registration certificate in this year, and it should be the sum of the total number

of the regular notification registration certificate for the new chemical substances in

the annual report to be submitted, the total number of the simplified notification

registration certificate for the new chemical substance and the total number of the

registration certificates without actual activities.


— 8 —

The total number of the simplified notification registration certificates: It refers

to the total number of the registration certificates with the notification type of

simplified notification in this annual report (including two kinds of situations – with

actual activities and without actual activities). With actual activities: It means the

total number of the registration certificates with actual activities among the total

number of the simplified notification registration certificates.

The total number of the regular notification registration certificates: It refers to

the total number of the registration certificates with the notification type of regular

notification in this annual report (including two kinds of situations – with actual

activities and without actual activities). With actual activities: It means the total

number of the registration certificates with actual activities among the total number of

the regular notification registration certificates.

III. Notes

If there are changes in the information of the registration certificate holder and the

usage of the registration certificate, they should be indicated in detail.

If there are other instructions, they should be filled precisely.

The filling instruction of Table 1-The information of registration certificate

without actual activities

The relative information on the registration certificate without actual activities should

be filled.

The information on the registration certificate with simplified notification: It

should be the relative information on the registration certificate of new chemical

substances with simplified notification without actual activities. The filler can add

new rows for this item.

The registration certificate number: The registration certificate number on the

registration certificate should be filled in.

The information on the registration certificate with regular notification: It should

be the relative information on the registration certificate of new chemical substances

with regular notification without actual activities. The filler can add new rows for this

item.



— 9 —

The filling instruction to Table 2-The information of simplified notification with

actual activities



The total amount of the actual activities: It refers to the total amount of importing

and production of the new chemical substance in this annual report. If both importing

and products exist, it should be the sum of the two numbers.

The total importing amount: It should be the total importing amount of the new

chemical substances of the whole year in this annual report.

The total production amount: It should be the total production amount of the new


The instruction on the changing of the registration information and other

situations: It is the instruction of the inconsistency between the actual activities (such

as the usage changing and the information of the transporting countries/regions) and

the notification information, or other contents which should be explained, etc..

The filling instruction to Table 3-The regular notification information with

actual activities

For the joint notification, serial notification or joint serial notification, all the

registration certificates of the holder of the corresponding registration certificates

should be filled in the Report Table, and each annual report on the regular notification

of the new chemical substances should be numbered by time sequences of the

registration certificates of the new chemical substances, such as 001/100, which

means the first of the total 100.

1 The information of the registration certificates



Management category: Selected according to the “management category stated in

the registration certificate. If “the danger of important environment management” is

selected, the Item No.7 of this table “the production of the next year or the preparation

of the importing plan and risk controlling”.

2 The situation of the actual activities

The corresponding part should be filled according to the actual activities. If both

importing and products exist, the content of the two parts should be filled in

separately; if the amount of activities of new chemical substances is related, the pure


— 10 —

amount of the new chemical substance should be counted, and the unit should be ton.

The total amount of the actual activities: It refers to the total amount of importing

and production of the new chemical substance in this annual report. If both importing

and products exist, it should be the sum of the two numbers.

Existing form: The existing form of the new chemical substance during the actual

activities of this report, if it exists in many forms, multi items can be selected.

Total amount of importing: It refers to the total amount of importing of the new


Times of importing: It refers to the times of importing of the new chemical

substances of the whole year in this annual report.

Total amount of production: It refers to the total amount of production of the new


Number of production batches: It refers to the number of production batches of the

new chemical substances of the whole year in this annual report.

Total amount of transferring: It refers to the total amount of transferring of the new


Times of transferring: It refers to the times of transferring of the new chemical

substances of the whole year in this annual report.

3 The situation of exposure and releasing

The instruction to the situation of exposure: It should precisely state the actual

exposure in the working environment (the information such as exposure and exposure

density in the actual production environment), the exposure density of the air in the

working environment (actually measured value or assessed value, and the exposure

density in the air of the working environment during the production), the source of the

data such as exposure source and exposure density of the new chemical substances

during the actual production, the testing conditions or estimation rationale, etc..

The instruction to the discharging in the environment: It should precisely describe

the following aspects of the new chemical substances during the production: the

discharging, discharging way and discharging measures of the wastes, the discharging

medium, the generation amount of the new chemical substance in the waste, the

discharging amount and density; the measurement and calculation rationale of the

corresponding value should be provided.

4 The actual effects caused to the environment and human body

It should be the affects of the new chemical substances caused to the environment and

— 11 —

human body during the actual production/processing.

5 The realization of the risk controlling measures

The filler should indicate the implementation of the various risk-controlling measures

regulated in the registration certificate during the actual activities.

6 The other information relating to the environmental risk

The filler should indicate the controlling measures taken for improving the exposure

and releasing of the new chemical substances, as well as the other situation relating to

the risk controlling of the new chemical substances.

7 The production of the next year or the preparation of the importing plan and

risk controlling measures (the danger of important environment management)

This item is the content filled for the annual report on the new chemical substance of

the danger of important environment management.

7.1 The production or importing plan of the next year: It should be filled

according to the activity plan of the next year of the corresponding new chemical

substances.

Predicted production amount: The estimated value in the production planning of the

next year.

Import production amount: The estimated value in the import planning of the next

year.

7.2 The preparation of the implementation of the risk controlling measures

The filler should indicate the preparation of the risk controlling measures for

warranting the security of the activities of new chemical substances in this year.

— 1 —

Appendix 5

The report on the actual activities of the

registered new chemical substances for five years

Receiving

number:

Receiving

time:

1.The report announcement

I make an announcement that:

(III) I am familiar with the requirements in The Measures for Environmental

Management of New Chemical Substances (No.7 Order of the Ministry of

Environment Protection) and The Guideline for Notification and Registration

of New Chemical Substance, and I will abide by the relative regulations

strictly.

(IV) All the information submitted in the report table are real and reliable, and they

have legal source, and the rights and benefits of other people are not offended.

If there are any false statements, I will hold all the legal responsibilities caused

by this.

The signature of the legal representative:

(Public seal of the holder of the registration certificate)

Reporting date: YY/MM/DD

2. The information on the registration certificate

Name of

registration

certificate

Name of chemical

substance (Chinese)

Registration

certificate

number

Registration

amount

Registered


— 2 —

usage

Management

category □Danger; □ Danger of important environment management

3. The information of the contact person of the reporting unit

Name of

contact

person

Telephone

number

Cell phone

number Email

4.The situation of actual activities

Type of

activities □Importing; □Production

Date of first

activity

Amount of activity

(ton_))

Productio

n

Importing

Total amount

of activities

for five years

(ton)

Produc

tion The usage of the

main actual

activities

Importi

ng

Whether the new information on

the hazard-properties of the

substance has been discovered

□No; □Yes Appendix

number

Whether the information protection

has been applied after it is listed in

the Inventory

□No; □Yes Appendix

number

Where there are the changes in the

substance indication information □No; □Yes

Appendix

number

4.1 The transferring activities records after importing/production

No. Name of receiving

unit Address of receiving unit

Total amount of

transferring (ton)

— 3 —

1

2

3

4

5

5. The implementation of the risk controlling measures

6. The actual effects caused to the environmental and human body health

7. The situation of accepting the penalty of environmental protection department

8.There are _______ pages for all the report material (including appendixes) and

________ pages of appendixes


— 4 —

— 5 —

The instruction on filling the report on the actual activities of the registered new

chemical substances for five years

1 The filling statement

The holder of the registration certificate and the contact person should read the

statement carefully and they should abide by the relative regulations strictly.

The signature of the legal representative: The name of the legal representative must

be printed with the signature of the legal representative; for the non-legal

representative organization, the name of the principal should be printed with the

signature of the principal.

The public seal of the holder of the registration certificate: The public seal of the

unit of the registration certificate holder should be stamped at the place of the

paper-based printed document.

Date of table filling: The concrete date of table filling should be written with the

numerical digits regularly

2 The information on the registration certificate

Fill the relative content according to the registration certificate

3 The information of the holder of the registration certificate

The name of the contact person: It should be name of the contact person being

responsible for the annual report of the new chemical substances.

Telephone number: It should be the telephone number of the contact person and the

format should be: area number-telephone number-extension number, for example:

010-84915287-1234.

Cell phone number: it should be the cell phone number of the contact person.

E-mail: It should be the email address of the contact person.

4 The situation of the actual activities

The type of activities: select the type of activities, if there include importing and

production, both of them should be selected

The date of the first activity: There should fill the date of the first production or

importing of the new chemical substance, and the format should be YYMM/DD.

The amount of the first activity: There should fill the amount of the first production

or importing of the new chemical substances.

The total amount of the activities in five years: There should fill the total amount of

production and importing of the new chemical substances from the date of the first

activity to the date of submitting the actual activity report.


— 6 —

The usage of the main actual activities: Fill according to the actual usage of the new

chemical substance.

Whether the new information on the hazard-properties of the substance has been

discovered: The fact of whether the new information on the hazard-properties of the

substance has been discovered should be filled, the new information of the harmful

property includes the inconsistency with the original notification information

discovered during the actual activities of the new chemical substances, or the newly

discovered harmful property. If “yes” is checked, the relative materials should be

submitted by appendixes.

Whether the information protection has been applied after it is listed in the

Inventory: select whether the information protection (including CAS number,

Chinese name and structural formula) is necessary for the substance after it has been

listed in The Inventory of Existing Chemical Substances in China. If “yes” is checked,

the reason for the information protection should be submitted in appendix. For the

substance of which the information protection is not applied during the notification

registration, the information protection is not allowed.

Where there are the changes in the substance indication information: There

should indicate where there are the changes in the substance indication information. If

there is the change, “yes” should be checked, and the relative information should be

submitted in appendixes.

4.1 The records on the transferring activities after importing/production: Fill the

information of the receiving unit and the transferring amount in the rank of top five in

terms of the total transferring amount within five years.

5 The implementation of the risk preventing measures

It should indicate the implementation of the various risk controlling measures

regulated in the registration certificates in five years during the actual activities.

6 The actual affect caused to the environment and human body health

There should fill the effect caused to the environment and human body health of the

new chemical substance during the actual production/processing, for example,

whether are the environmental pollution events caused by the registered substances or

the harm done to the workers in the workplace.

7 The accepted penalty of the environmental protection department

There should indicate the penalty of the enterprise made by the environmental

protection department within five years.