View
3
Download
0
Category
Preview:
Citation preview
Guidance for Notification of New
Chemical Substance
(Consultation Draft)
Ministry of Environmental Protection of the
People's Republic of China
June, 2015
— 2 —
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).
— 3 —
Contents
I. The Applicable Scope of New Chemical Substance Notifications…………………………………..……………
错误!未定义书签。
(I) Scope of notified substance………………………………………………………………………………...
错误!未定义书签。
(II) Territorial scope……………………………………………………………………………………………
错误!未定义书签。
(III) Range of activity………………………………………………………………………………………….
错误!未定义书签。
(IV) Notifier and agent…………………………………………………………………………………….…..
错误!未定义书签。
II. Type and Format of New Chemical Substance Notification………………………………………….…..…….错
误!未定义书签。
(I) Notification type…………………………………………………………………………………….……. 错
误!未定义书签。
(II) Special formats of regular notification……………………………………………………………….….. 错
误!未定义书签。
III. New Chemical Substance Notification and Registration Procedures……………………………………....….错
误!未定义书签。
(I) Notification preparation……………………………………………………………………………….….. 错
误!未定义书签。
(II) Regular notification and registration procedures……………………………………………………..…. 错
误!未定义书签。
(III) Simplified notification and registration procedures…………………………………………………..… 错
误!未定义书签。
(IV) Scientific research filing notification procedures……………………………………………………..…错
误!未定义书签。
(V) Notification cancellation……………………………………………………………………………..….. 错
误!未定义书签。
IV. Requirements for New Chemical Substance Notification Documents…………………………….……..……错
误!未定义书签。
(I) Format requirements for notification documents………………………………………………..……….. 错
误!未定义书签。
(II) Quality requirements for notification data………………………………………………………..…..… 错
— 4 —
误!未定义书签。
(III) Requirements for submitting the regular notification data………………………………..……………. 错
误!未定义书签。
(IV) Requirements for risk assessment report……………………………………………………..………… 错
误!未定义书签。
(V) Data requirements of special formats of regular notification………………………………..………….. 错
误!未定义书签。
(VI) Data requirements of simplified notification…………………………………………………..………. 错
误!未定义书签。
(VII) Information confidentiality requirements………………………………………………..……………. 错
误!未定义书签。
V. Special provisions on polymer…………………………………………………….………………….………..错
误!未定义书签。
(I) Denomination of polymer……………………………………………………………..…….…………… 错
误!未定义书签。
(II) Simplified notification conditions of polymers……………………………………..………………….. 错
误!未定义书签。
(III) Regular notification conditions of polymers………………………………………..………………….错
误!未定义书签。
VI. Supervision and management of registered new chemical substance notification………..…………….……错
误!未定义书签。
(II) Information change in registration certificate………………………………………..……………….... 错
误!未定义书签。
(III) Re-notification after registration…………………………………………………..…………………... 错
误!未定义书签。
(IV) Reporting of new information……………………………………………………..……………….….. 错
误!未定义书签。
(V) Information transfer, reporting and data saving…………………………………..……………………. 错
误!未定义书签。
(VI) Site supervision and inspection…………………………………………………..……………….…… 错
误!未定义书签。
(VII) Entry of registered new chemical substances in the Inventory…………………..………….………..错
误!未定义书签。
(VIII) Cancellation and revocation of registration certificate……………………………..……………….. 错
— 5 —
误!未定义书签。
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
— 6 —
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.
— 7 —
(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:
— 8 —
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
— 9 —
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.
— 10 —
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
— 11 —
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
— 12 —
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
— 13 —
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;
— 14 —
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
— 15 —
Solid Waste and Chemical Management Technology Center of MEP,
The Registration and Audit Department
Postal code: 100029
E-mail: ncn@mepscc.cn
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
— 16 —
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.
— 17 —
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.
— 18 —
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.
— 19 —
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
2) The certificate of legal person or the business license, the entrusted contract or agency agreement,
the letter of authorization;
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
2) The certificate of legal person or the business license, the entrusted contract or agency agreement,
— 22 —
the letter of authorization;
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;
-Strong acid (pH<2.0) or strong base (pH>11.5);
- 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;
-Strong acid (pH<2.0) or strong base (pH>11.5);
- 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;
- Substance rapidly decomposes and information of decomposed products
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.
- Substance rapidly decomposes and information of decomposed products
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
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.
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
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
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:
Risk Assessment Report ——Substance name
— 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:
Average value and range of
molecular weight: Average value (lower limit – upper limit)
Structural formula:
Average value and range of
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
……
Risk Assessment Report ——Substance name
— 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
……
Risk Assessment Report ——Substance name
— 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
……
Risk Assessment Report ——Substance name
— 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
……
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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;
□ Explosive stated in
item 1.2;
□ Explosive stated in
item 1.3;
□ Explosive stated in
item 1.4;
□ Explosive stated in
item 1.5;
□ Explosive stated in
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;
□ Can’t be categorized
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;
□ Can’t be categorized
Risk Assessment Report ——Substance name
— 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;
□ Can’t be categorized
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;
□ Can’t be categorized
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;
□ Can’t be categorized
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;
□ Can’t be categorized
Risk Assessment Report ——Substance name
— 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;
□ Can’t be categorized
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;
□ Can’t be categorized
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;
□ Can’t be categorized
Risk Assessment Report ——Substance name
— 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;
□ Can’t be categorized
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;
□ Can’t be categorized
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;
□ Can’t be categorized
Risk Assessment Report ——Substance name
— 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;
□ Can’t be categorized
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
Risk Assessment Report ——Substance name
— 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:
Risk Assessment Report ——Substance name
— 77 —
The division rationale:
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
The kind of danger The categorization
standard
The categories The categorization
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;
Risk Assessment Report ——Substance name
— 78 —
The kind of danger The categorization
standard
The categories The categorization
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
Rules for classification
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;
Risk Assessment Report ——Substance name
— 79 —
The kind of danger The categorization
standard
The categories The categorization
rationale
□ Can’t be
categorized
Serious eye damage/eye
irritation
GB 30000.20-2013
Rules for classification
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
Rules for classification
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
Rules for classification
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
Rules for classification
and labeling of
chemicals—Part
23:Carcinogenicity
□ Not applicable;
□ Category 1A;
□ Category 1B;
□ Category 2;
□ Not in this
categorization;
Risk Assessment Report ——Substance name
— 80 —
The kind of danger The categorization
standard
The categories The categorization
rationale
□ Can’t be
categorized;
Reproductive toxicity GB 30000.24-2013
Rules for classification
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
Rules for classification
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
Rules for classification
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
Rules for classification
and labeling of
chemicals—Part
□ Not applicable;
□ Category 1;
□ Category 2;
Risk Assessment Report ——Substance name
— 81 —
The kind of danger The categorization
standard
The categories The categorization
rationale
27:Aspiration hazard □ Not in this
categorization;
□ Can’t be
categorized;
Note: Only the selected categories will be remained.
6.3.2 The division of the management categories
The management categories:
The division rationale:
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
method of persistent,
bioaccumulative and toxic
substances, and very
persistent and very
bioaccumulative substances
□ Very
bioaccumulative
substances
□ The
bioaccumulative
substances
□ The substance
without biological
accumulation
□ Can’t be
assessed
3 Toxicity GB/T 24782-2009 Decision □ The toxic
Risk Assessment Report ——Substance name
— 82 —
The kind of danger The categorization standard The categories The categorization
rationale
method of persistent,
bioaccumulative and toxic
substances,and very
persistent and very
bioaccumulative substances
substance
□ The non-toxic
substance
□ Can’t be
assessed
4 PBT and vPvB
assessment
GB/T 24782-2009 Decision
method of persistent,
bioaccumulative and toxic
substances, and very
persistent and very
bioaccumulative substances
□ PBT substance
□ vPvB
substance
□ Non-PBT and
non-vPvB
substance
□ Can’t be
assessed
Note: Only the selected categories will be remained.
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
Risk Assessment Report ——Substance name
— 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
□ The short-term aquatic
harm 2 or the long-term
aquatic harm 3
□ The short-term aquatic
harm 3 or the long-term
aquatic harm 4
Note: Only the selected grading results and grading marks will be retained.
Risk Assessment Report ——Substance name
— 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
The kind of harm The assessment
standard
The grading
results
The marks
given in
grades
The rationale for grading
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
□ Category of the acute
oral toxicity 3
□ Category of the acute
oral toxicity 4 or 5
The acute dermal
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
dermal toxicity 1
□ Category of the acute
dermal toxicity 2
□ Category of the acute
dermal toxicity 3
□ Category of the acute
dermal toxicity 4 or 5
The acute inhalation
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
inhalation toxicity 1
□ Category of the acute
inhalation toxicity 2
□ Category of the acute
inhalation toxicity 3
□ Category of the acute
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
Risk Assessment Report ——Substance name
— 85 —
The kind of harm The assessment
standard
The grading
results
The marks
given in
grades
The rationale for grading
(consultative draft) harm
□Low harm
irritation 2
□Category of skin
irritation 3
Eye irritation The guideline on
the risk assessment
of the chemical
substances
(consultative draft)
□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
(consultative draft)
□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
(consultative draft)
□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
(consultative draft)
□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
(consultative draft)
□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
Risk Assessment Report ——Substance name
— 86 —
The kind of harm The assessment
standard
The grading
results
The marks
given in
grades
The rationale for grading
the risk assessment
of the chemical
substances
(consultative draft)
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
Risk Assessment Report ——Substance name
— 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
chemical substances of local part (point source)
(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
Risk Assessment Report ——Substance name
— 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
chemical substances of local part (point source)
(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)
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
□0, not applicable
2
A5 The eye irritation
□3, low eye irritation
□2, mediate eye irritation
□1, high eye irritation
□0, not applicable
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
Risk Assessment Report ——Substance name
— 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
□0, not applicable
3
Technique procedure
B4 The controlling
method of the
technique procedure
□2, intermittent production
□1, continual production
□0, not applicable
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
Risk Assessment Report ——Substance name
— 93 —
□0, effective treatment
B10 The treatment of
wasted water
□2, no treatment
□1, mediate treatment effect
□0, effective treatment
2
B11 The disposal of
the solid waste
□2, no treatment
□1, mediate treatment effect
□0, effective 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
□0, not applicable
2
C2 With package
(solid)
□2, no package
□1, with package
□0, not applicable
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
□0, not applicable
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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
sewage treatment plant
The environment of
surface water
The environment of
sedimentation in
surface water
The soil environment
The other environment
……. The environmental of
sewage treatment plant
The environment of
surface water
The environment of
sedimentation in
surface water
The soil environment
The other environment
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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 99 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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)
Risk Assessment Report ——Substance name
— 100 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 101 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Stabilizer (such as antioxidant, thermal
stabilizer, ultraviolet ray absorbent,
anti-setting agent, anti-gelling agent)
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
Bactericide 2 (excluding the
pesticide and non-medicine
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
Bactericide 3 (excluding the
pesticide and non-medicine
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,
Risk Assessment Report ——Substance name
— 102 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 103 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 104 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Stabilizer (such as antioxidant, thermal
stabilizer, ultraviolet ray absorbent,
anti-setting agent, anti-gelling agent)
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
Stabilizer (such as antioxidant, thermal
stabilizer, ultraviolet ray absorbent,
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)
Risk Assessment Report ——Substance name
— 105 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
compound, friction material
39b Additives for grinding wheel, lapping
compound, friction material
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
Risk Assessment Report ——Substance name
— 106 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 107 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 108 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 109 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 110 —
No. Usage categorization Detailed usage categorization
Code Name of detailed usage categorization
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
Risk Assessment Report ——Substance name
— 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
registration certificate.
— 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
II. The summarization of the registration certificates
The total number of the
registration certificates
Risk Assessment Report ——Substance name
— 2 —
The total number of the
registration certificates of
simplified notification
The certificates
with actual
activities
The total number of the
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
… …
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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
registration certificate.
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.
Risk Assessment Report ——Substance name
— 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.
The registration certificate number: The registration certificate number on the
registration certificate should be filled in.
— 9 —
The filling instruction to Table 2-The information of simplified notification with
actual activities
The registration certificate number: The registration certificate number on the
registration certificate should be filled in.
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
chemical substances of the whole year in this annual report.
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
The registration certificate number: The registration certificate number on the
registration certificate should be filled in.
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
Risk Assessment Report ——Substance name
— 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
chemical substances of the whole year in this annual report.
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
chemical substances of the whole year in this annual report.
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
chemical substances of the whole year in this annual report.
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
Risk Assessment Report ——Substance name
— 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
Risk Assessment Report ——Substance name
— 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.
Risk Assessment Report ——Substance name
— 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.
Recommended