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Provisions on the Environmental Administration of New Chemical substances (reference translation)
Issued by: The State Environmental Protection Administration of P. R. China
Issued on: 12 September 2003
Effected as of: 15 October 2003
Chapter
1 General
Provisions
Article
1
This Provisions is formulated for the
purpose of enhancing the environmental management on new chemical
substances, preventing environmental pollution, and protecting human health and
safeguarding the ecological environment.
Article
2 This
Provisions is applicable to activities in relation to the manufacture or import
of new chemical substances and their
environmental management undertaken within the territory of the
People¡¯s Republic of China.
Article
3 The State shall, for the purpose of the environmental
management of new chemical substances, establish the systems of
notification and registration applied to any of the manufacture or import of new chemical
substances.
Any
manufacturer or importer of new chemical substances shall, prior to the
manufacture or import of new chemical substances, make notifications and
applications for the registration certificates for the environmental management
on new chemical substances (hereinafter cited as ¡®the registration
certificates¡¯) in accordance with relevant provisions of this Provisions.
The
aforesaid provision shall not be applied to the chemical substances which have
been manufactured or imported before the effective date of this Provisions.
Article
4 The term ¡®new chemical
substance¡¯, as used in this Provisions, means any chemical substance which has not yet been manufactured or
imported in China before the date on which it is notified.
The State Environmental Protection Administration of the
People¡¯s Republic of China (hereinafter cited as ¡®the SEPA¡¯) is
responsible for compiling and timely publicizing the inventory of chemical
substances manufactured or imported in China.
Article
5 The SEPA is empowered to
formulate and promulgate relevant standards and technical requirements for the environmental management of
new chemical substances.
Article
6 The SEPA
shall establish a Expert Committee on the Environmental Management on New
Chemical Substances (hereinafter cited as ¡®The Expert Committee¡¯).
The
main responsibility of the Expert Committee is to evaluate the environmental
impacts on new chemical substances
and, after evaluation, submit reports in written form on the evaluation results
to the SEPA.
Article
7 Any administrative department
or person involved in the environmental management of new chemical substances
shall keep the commercial and technical secrets for the notifiers of new
chemical substances (hereinafter cited as ¡®the notifiers¡¯).
Chapter
2 Notification
Article 8 The notifiers shall, prior to the manufacture or import of new chemical substances, complete and submit the notification forms and the testing reports of new chemical substances, together with a copy of the document on the qualification of the testing entity(ies), to the Chemical Registration Center of SEPA (hereinafter cited as ¡®CRC-SEPA¡¯).
The
contents of the notification form shall include information of the new chemical
substance notified: the name(s) and the molecular structure; the method(s)
applied in measuring; the use(s) of the new chemical substance; the scheduled
annual amount of manufacture or import; the
physi-chemical properties,
toxicological
and eco-toxicological
characteristics; the measures for accident prevention and
emergency responses; and the measures for pollution prevention and elimination
and for waste disposal, etc..
In case that the testing data were completed out of China,
the testing entity(ies) involved shall have been
accredited by qualifications the competent uthorities of the country in which
the entity(ies) is(are) located.
The eco-toxicological data of new chemical substances shall include those obtained through biological tests performed in China by the application of China¡¯s test organisms.
Article 9 The notifiers who provide information materials containing commercial and technical secrets shall give confidential indications at the relevant items in the materials.
The
notifiers who will uncover the secrets which is mentioned in aforesaid
item shall inform CRC-SEPA in written form.
Article 10 The
notifiers may make a serial notification on the new chemical substances with
similarities in molecular constitutions, similarities or sameness in use(s) and
testing data, whereas the registration
certificate shall be applied for each new chemical substance.
Article
11 In case that
two or more notifiers make a joint notification on the same new chemical substance, each notifier shall apply for a
registration
certificate separately.
Article
12 In notifying
a new chemical substance which has been included in the inventories
of existing
chemical substances in at least four countries or regional economic
integration organizations, the notifier is
only required to complete and submit the notification form and the report
of eco-toxicological testing performed in China.
Article 13 In
one of the following cases, the notifier may apply for exemption from the
notification:
(a)
The annual amount of manufacture or
import of the new chemical substance does not exceed 100
kilograms and they are only used for scientific
research purpose;
(b)
A polymer containing a new chemical
substance monomer less than 2% (w/w);
(c)
The total amount of the manufacture or
import of a new chemical substance does not exceed 1,000
kilograms and they are specifically used for technologies
research and development. In this case, the manufacturer or importer may apply for
one-year exemption from notification and no extension will be granted;
(d)
Samples of new
chemical substances imported for the purpose of performing the eco-toxicological
tests in China as required by this Provisions.
Any
notifier intending to apply for the exemption from notification shall submit the
application form for exemption from
notification to CRC-SEPA and provide the necessary documents
demonstrating the conformities to the aforesaid provision and s/he is obliged to
keep a record of the information on the scientific research of the substance,
the research and development of relevant technologies, the quantities of the
substance manufactured or imported, the names of the customers, and others.
Chapter 3 Registration
Article
14 CRC-SEPA
shall, within 15 days after recepting notification materials,
complete the format check on the notification materials in accordance with relevant
provisions of this Provisions, inform the notifiers in written form that their
notification materials are in conformity with the format requirements provided
for in this Provisions and thus accepted; or inform the notifiers in written
form that their notification materials are not in conformity with the format
requirements provided for in this Provisions and thus rejected.
CRC-SEPA
shall, if finding the notification materials incomplete
or not in conformity with the format requirements provided for in this
Provisions, inform the notifier in written form, in one time, all components
which shall be supplemented or corrected.
CRC-SEPA
shall submit the accepted notification materials, within 5 days after they were
accepted, to the Expert Committee.
Article
15 The
Expert Committee shall, within 60 days after received the notification
materials, proceed the evaluation on the
environmental impacts of the new chemical substances in accordance with
relevant standards and technical requirements for the environmental management
on new chemical substances adopted or issued by the SEPA and then submit the
evaluation reports in written form to the SEPA.
Article 16 The SEPA shall, within 30 days after received the evaluation reports from the Expert Committee, make the decisions on whether to approve the application for notification. Those whose applications for notification have been approved will be awarded the Registration Certificates and those whose applications for notification were rejected will be given explanations.
The
SEPA shall inform CRC-SEPA its decisions and CRC-SEPA is responsible for
forwarding the decisions in written form to notifiers.
Article
17 CRC-SEPA
shall, within 15 days after received the application for the exemption from
notification, make suggestions on decisions and submit them to the SEPA for
review and audit.
The
SEPA shall, within 15 days after received the application materials and the
suggestions on decisions, make decisions on whether to approve the application
for exemption from notification and inform CRC-SEPA its decisions. CRC-SEPA is
responsible for forwarding the decisions to the notifiers in written form.
Article
18 The SPEA
shall, after having made decisions on the registration or the exemption from
notification in accordance with Artical 16 and Article 17 respectively, inform
its decisions and transmit the notice on the supervision and inspection over environmental
impacts of new chemical substances to the environmental protection
administrative departments at the provincial
level where the manufacturers or importers concerned are located.
The
provincial environmental protection administrative departments shall transmit the
decisions and the notices aforesaid to the environmental protection
administrative departments of the counties or municipalities where the
manufacturers or importers of the new chemical substances are located.
Chapter 4
Supervision and Management
Article
19 Any holder of the registration certificates shall, within 5 days after
each batch actually manufactured, imported or transferred new
chemical substances to users, fill in and submit a record form on manufacture,
import or circulation of new chemical substances
to the environmental protection administrative department of the county where the manufacturer or
importer is located.
The environmental protection administrative
department at county level
shall,
within 5 days after received the
record form, report to the municipal environmental protection administrative
department; the latter shall, within 5 days after received
the record form, report to the environmental protection administrative
department at the province level; the provincial environmental protection
administrative department shall, within 5 days after receiving the record form,
report to the SEPA.
Article
20 The
environmental protection administrative
department at the county level shall, within 5 days
after received the record forms from manufacturers or importers who
transferred new chemical substances out of the county, inform
environmental protection administrative
departing
another county where the users are located and transmit the information on the
circulation of new chemical substances, relevant decisions and the notices
on the supervision and inspection over environmental impact of new chemical
substances .
The
environmental protection administrative
department of the county where the
users are located shall, within 5 days after they received the information on
the circulation of new chemical substances, relevant decisions and the notices
on the supervision and inspection over
environmental impact of new chemical substances, report to the
municipal
environmental
protection administrative
departments at the next upper level; the latter shall, within 5 days after
received the reports, report to the environmental
protection administrative
departments at the provincial level.
Article
21 The holders of the registration
certificates shall keep the materials for notification, record of the
manufacture or import and the
environmental impacts of new chemical substances until the date when the
chemical substances are publicized.
Article
22 Environmental protection administrative departments shall,
in reviewing documents of environmental impact assessment of
any project of new construction, renovation or expansion in relation to the manufacture or use of new chemical
substances, check the registration certificates and take them as one of the
important for decisions.
Article 23 The
environmental protection administrative department at the county level
or above is empowered to exercise supervision
and inspection over activities in relation to new chemical substances
under its jurisdiction and, in finding the facts that the environment is
endangered by new chemical substances, shall order the manufacturers or
importers or users to take emergent measures to eliminate harms and report
directly to the SEPA and the environmental protection administrative department
at its next higher level simultaneously.
The
SEPA shall check and investigate the facts after received the reports and may
withdraw the registration certificates of new chemical substances from relevant
manufacturers or importers.
Chapter
5 Legal
Liabilities
Article
24 Any notifier who, in violation
of this Provisions, made falsifications in the application
for the registration certificates shall be subject to a fine of RMB10,000 at
least and RMB30,000 at most, by the SEPA. In this case, the SEPA is empowered to
order the violator to rectify the wrongful acts, record and publicize the fact
of violations and refuse any notification submitted by the aforesaid violator in
the following 3 years.
Article
25 Any organization or person
who, in violation of this Provisions, conducted one of the following
acts shall be subject to a fine not exceeding RMB30,000, by the local
environmental protection administrative department at the county level or above,
and the department is empowered to order the violator to rectify the wrongful
acts and submit a report on the violation to the SEPA. The SEPA will record and
publicize the facts of violations and refuse any notification of new chemical
substances made by the violator in the following 3 years.
(a)
Refusing field inspections by the competent environmental
protection administrative
department or conducting falsifications when inspected;
(b)
Having
not filled in and/or submitted the record form providing information
on the manufacture, import and circulation of new chemical substances as
required;
(c)
Having not kept the materials for the notification, manufacture, import
and environmental impacts of new chemical substances as required;
(d)
Manufacturing or importing new chemical substances without application
for or being awarded the registration certificates.
Article
26 In
case of misusing authorities, neglecting duties or disclosing the commercial and
technical secrets of notifiers, the relevant department and the responsible
person(s) involved in the environmental management on new chemical substances
shall be subject to administrative
punishments in accordance with relevant laws and regulations;
In cases of a crime committed, criminal penalties shall be imposed in
accordance with relevant laws and regulations.
Chapter
6 Supplementary
Provisions
Article
27 The standardized formats and contents of the following
documents shall be stipulated by
the SEPA:
(a)
Notification form of new chemical substances;
(b)
Application form for exemption from notification of new chemical
substances;
(c)
Registration certificate on
new chemical substance;
(d)
Notice on the supervision and
inspection over environmental impact of new chemical substances;
(e)
Record form of the manufacture, import and circulation of
new chemical substances.
Article
28
Charges for notification and registration of new chemical substances
shall comply with the relevant state stipulations.
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