In this post, we will give you an overview of the revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan. English version of TCSCA has also been provided.
The Toxic Chemical Substances Control Act (TCSCA) is the most important chemical control law in Taiwan. It has undergone 6 amendments since its promulgation in 1986. The amended TCSCA was promulgated by Presidential Order on 11 Dec 2013 and fully comes into force on 11 Dec 2014.
The revised TCSCA introduces many concepts of EU REACH regulation into Taiwan. Under the new Act, enterprises manufacturing or importing new substances or a given quantity of existing chemical substances shall register those substances with the Environmental Protection Administration (EPA). Enterprises that manufacture or import new substances or existing toxic chemical substances without the approval of the EPA will be liable to fines in the range of NT$200,000-2 million for manufacturers or NT$30,000-300,000 for importers.
TCSCA also requires enterprises who handle certain controlled toxic chemical substances to apply for permits, registration or approval and comply with relevant management measures. Here "Handling" refers to activities such as the manufacture, import, export, sale, transport, use, storage or discarding of chemical substances.
More info about Taiwan TCSCA can be found at:
http://www.chemsafetypro.com/Topics/Taiwan/Taiwan_Toxic_Chemical_Substance_Control_Act_TCSCA.html
The official English translation of TCSCA(promulgated in 2013) can be found below:
Toxic Chemical Substances
Control Act
29
Articles promulgated by Presidential Order on November 26, 1986
Revisions to Article 3 promulgated by Presidential Order on November 16, 1988
Revisions and promulgation of 44 Articles by Presidential Order on November 19,
1997
Revisions of Articles 3 to 36 promulgated by Presidential Order on December 22,
1999
Revisions of Article 23 and Article 34 promulgated by Presidential Order on
June 12, 2002
Revisions promulgated by Presidential Order on January 3, 2007
Revisions
of Article 1, 3, 7, 8, 17, 23, 25, 32, 34, 35, 36, 41 and 44, and addition of
Article 7-1, 7-2, 24-1 and 35-1 promulgated by Presidential Order on December 11,
2013
Table of Contents
Chapter 1 General Principles
Chapter 2 Risk Assessment and Prevention
Chapter 3 Management
Chapter 4 Penal Provisions
Chapter 5 Supplementary Provisions
Chapter
1 General Principles
Article 1
This Act is enacted to prevent toxic chemical substances from polluting
the environment and endangering human health, and to manage all relevant
information on domestic chemical substances to serve as a basis for toxic
chemical substances screening, selection and assessment.
Article 2
“Competent authority” as referred to in this Act refers to the
Environmental Protection Administration, Executive Yuan, at the central
government level, the municipal government in special municipalities and the
county or city government in counties or cities.
Article 3
Terms used in this Act are defined as follows.
I. “Toxic chemical substances” refers to those chemical substances that
are intentionally produced by human activity or unintentionally derived from
production processes and that have been officially announced by the central
competent authority as having toxicity subject to the following classification
regulations. Toxic chemical substances shall be classified as follows.
A. Class 1 toxic chemical
substances: those chemical substances that are not prone to decompose in the
environment or that pollute the environment or endanger human health due to
bioaccumulation, bioconcentration or biotransformation.
B. Class 2 toxic chemical
substances: those chemical substances that cause tumors, infertility,
teratogenesis, genetic mutations or other chronic diseases.
C. Class 3 toxic chemical substances:
those chemical substances that endanger human health or the lives of biological
organisms immediately upon exposure.
D. Class 4 toxic chemical
substances: those chemical substances for which there is concern of pollution
of the environment or the endangerment of human health.
II. “Handling” refers to such activities as the manufacture, import,
export, sale, transport, use, storage or discarding of chemical substances.
III. “Pollution of the environment” refers to an alteration of the
quality of air, water or soil due to the handling of chemical substances such
that it causes an impact on the normal use of the air, water or soil,
destruction of the natural ecology or damage to property.
IV. “Release quantity” refers to the total quantity of a chemical
substance that is dispersed into the air, water or soil due to handling.
V. “Existing chemical substances” refers to those chemical substances
that are listed in the chemical substance inventory issued by the central
competent authority after consultation with the government authorities in
charge of subject industry.
VI. “New chemical substances” refers to chemical substances that are not
included in the existing chemical substance inventory.
Article 4
The matters designated as the responsibility of the central competent
authority:
I. Planning and drafting of
national toxic chemical substance management policies, programs, and plans.
II. The determination, approval,
and interpretation of national toxic chemical substance management laws and
regulations.
III. Supervision of management of
nationwide transportation of toxic chemical substances.
IV. Supervision, assistance, and
approval of special municipality, county or city management of toxic chemical
substances.
V. Coordination of toxic chemical
substance management matters involving relevant agencies, two or more counties
(and/or cities), a special municipality and a county or city, or two special
municipalities.
VI. National toxic chemical
substance management research, development, and training of implementation
personnel.
VII. International cooperation and technology exchanges involving toxic
chemical substance management.
VIII. National toxic chemical substance management public awareness work.
IX. Assistance with the
establishment of a toxic chemical substance joint prevention organization by
toxic chemical substance handling enterprises.
X. Management of other national
matters involving toxic chemical substances.
Article 5
The responsibilities of special municipality, county and city competent
authorities are as follows:
I. Planning and implementation of
toxic chemical substance management programs and plans within its jurisdiction.
II. Implementation of toxic
chemical substance management laws and regulations, and determination,
interpretation, and implementation of autonomous toxic chemical substance
management laws and regulations within its jurisdiction.
III. Research, development, and
public awareness work concerning toxic chemical substance management within its
jurisdiction.
IV. Survey and determination of
toxic chemical substance dispersal during handling within its jurisdiction.
V. Implementation of toxic
chemical substance management survey work and compilation and reporting of
statistical data within its jurisdiction.
VI. Management of other matters
involving toxic chemical substances within its jurisdiction.
Article 6
The competent authority may appoint a subordinate agency or commission,
another agency or group to perform research, personnel training, risk
assessment, and prevention work in connection with toxic chemical substance
management.
Chapter
2 Risk Assessment and Prevention
Article 7
The central competent authority shall officially announce toxic chemical
substances as Class 1, Class 2, Class 3 or Class 4 when the toxicological characteristics
of chemical substances conform to the toxic chemical substance classification
definitions prescribed in Article 3 of this Act.
The central competent authority may restrict or prohibit the handling of
Class 1, Class 2 and Class 3 toxic chemical substances.
Handlers may apply for the removal of the restrictions or prohibitions
prescribed in the foregoing paragraph when they can prove that prevention and
control methods employed in the toxic chemical substance use process can
prevent or avoid pollution of the environment or the endangerment of human
health. The applicant may submit an appeal when an application is rejected, but
only one appeal may be made. The central competent authority shall determine
regulations governing documents to be attached to the appeal application,
rejection, the deadline for submission of an appeal, and other binding matters.
Prior to handling of Class 4 toxic chemical substances, toxicity and
relevant information of the toxic chemical substances shall be reported to special
municipality, county or city competent authorities. Such handling shall be
performed upon permission of the competent authorities in accordance with
authorized items.
The central competent authority shall determine regulations governing
application for permission, review procedure, permits issuance (replacement and
re-issue), validity time period, change, extension, cancellation, revocation,
and other binding matters.
Article 7-1
For the purpose of compiling necessary information of chemical substances
for national sound chemical management, those that manufacture or import
existing chemical substances with quantities reaching specific amount each year
shall apply to the central competent authority for chemical substances
information registration by the designated deadlines; those manufacturing or
importing new chemical substances shall
apply to the central competent authority for chemical substances information
registration 90 days prior to commencement of manufacturing or import.
Manufacturing or import of said existing and new chemical substances shall only
be allowed when the registration is approved.
The information to be registered of the chemical substances specified in
the preceding paragraph includes manufacturing or import status, physical, chemical,
toxicity, exposure and hazard assessment of chemical substances, or other
necessary items designated by the central competent authority. Based on annual
manufacturing or import quantity, and the classification of the substances, the
registration shall be divided into the standard registration, simplified
registration, and small quantity registration.
The central competent authority shall attach conditions in granting
permission of registration, impose a ban or restriction on handling and require
handling reports as determined by the central competent authority that there is
a concern over the toxicological characteristics of new chemical substances
conforming to definitions of Class 1, Class 2, or Class 3 toxic chemical
substances pursuant to Article 3 in the Act; for those new chemical substances
where the central competent authority determines there is a concern of
environmental pollution or endangerment to human health, the central competent
authority shall attach conditions in granting permission of registration,
restrict handling and require submission of exposure and risk assessment
reports. Pursuant to Article 7, Paragraph 1, the central competent authority
shall officially announce toxic chemical substances as Class 1, Class 2, or
Class 3 toxic chemical substances when the central competent authority confirms
the toxicological characteristics of new chemical substances conform to the
toxic chemical substance classification definitions prescribed in Article 3 of
this Act.
Joint registrants or the early and late registrants of the same chemical
substance may utilize information registered in the first paragraph under
agreement. There is no need for duplication of testing. The central competent
authority may decide the cost of accessing said information to be equally
shared at the request of the late registrants when there is no agreement of
cost sharing methods reached among all registrants. Afterwards, utilization of
registered information shall be accepted after the shared cost has been made.
The permitted chemical substances registration information shall be
provided for government authorities in charge of subject industry to manage
chemicals used for the purposes of management of subject industries, as well as
for the central competent authority to serve as a basis of assessing, screening
and official announcement of toxic chemical substances pursuant to Article 7
Paragraph 1.
The central competent authority shall determine regulations governing
classification of chemical substances, quantity tonnage, conditions of
manufacturing or import, physical, chemical, toxicity, exposure and risk
assessments, and related information of the chemical substances; other
necessary documents, deadlines of registration, standard, simplified, small
quantity registration, and joint registration, review procedure; permission or
rejection decisions; revocation or
cancellation of permitted registration; ban or restriction on handling; post
registration report or modification of chemical substances information; records
keeping; information disclosure, confidential business information protection,
and other binding matters.
Article 7-2
The handling and management of substances registered and approved by this
Act, that are officially announced as toxic chemical substances, shall comply
with this Act. The other chemical substances shall comply with regulations of
the central competent authorities in charge of other subject industry when
applicable.
In granting permission of foregoing registration of the existing and new
chemical substances and other related matters, the central competent authority
may commission juridical associations funded by the central competent
authority, administrative corporations and professional groups. The central
competent authority shall determine regulations governing the commissioning.
Article 8
The handler shall produce reports and regularly report records concerning
the handling of toxic chemical substances and their release quantities; such
records shall be preserved properly for future reference.
The central competent authority shall determine regulations governing the
production, format, and preservation of the records in the foregoing paragraph,
the content, frequency, and method of reports, and other binding matters.
The competent authority shall provide the release quantities records
on-line pursuant to the foregoing 1st Paragraph to the public for reference, on
a stage-by-stage basis.
Article 9
The central competent authority may control the handling of Class 1 and
Class 2 toxic chemical substances by means of total release quantity control
methods.
Article 10
The handlers of Class 1, 2, and 3 toxic chemical substances shall submit
risk prevention and response plans concerning the toxic chemical substances at
issue to the special municipal, county, or city competent authority to be filed
for future reference, and shall implement measures in accordance with the
content of the risk prevention and response plans.
The competent authority shall provide Class 3 toxic chemical substance
risk prevention and response plans in the foregoing paragraph to the public for
reference.
The central competent authority shall determine regulations governing risk
prevention and response plan production, content, reporting, implementation,
disclosure for public reference, and other binding matters with regard to the
toxic chemical substance risk prevention and response plans in the foregoing
two paragraphs.
Chapter
3 Management
Article 11
Unless other regulations apply, the handling of toxic chemical substances
shall be conducted in accordance with methods officially announced or approved
by the central competent authority.
The central competent authority may, based on management requirements,
officially announce control concentration standards and large-scale handling
standards for toxic chemical substances.
Article 12
When it is verified through scientific techniques or field testing and
research of a toxic chemical substance that original officially announced
management items fail to meet requirements, the central competent authority
shall promptly issue an official announcement of modification or cancellation.
Article 13
A manufacturer, importer or seller of Class 1, 2 or 3 toxic chemical
substances shall apply to the competent authority for a permit, and shall
operate in accordance with the content of the permit.
An enterprise using or storing Class 1, 2 or 3 toxic chemical substances
shall apply to the special municipal, county, or city competent authority for
registration, and shall operate in accordance with the content of the
registration document.
An enterprise disposing of or exporting Class 1, 2 or 3 toxic chemical
substances shall apply by the batch or shipment to the special municipality,
county or city competent authority for registration, and may only begin
handling after doing so.
With regard to the handling of Class 1, 2 or 3 toxic chemical substances
mentioned in Paragraphs 1 or 2, when the total quantity handled is lower than
the large-scale handling standard officially announced pursuant to Article 11,
Paragraph 2, the handler shall, after receiving the approval of the special
municipality, county or city competent authority and obtaining an approval
document, not be subject to the restrictions of Paragraph 1, Paragraph 2,
Article 10, Article 18, and Article 19.
The central competent authority shall determine regulations governing
permit, registration, and approval application, review procedures, issuance
(replacement or renewal), change, extension, revocation, cancellation, and
other binding matters in the foregoing four paragraphs.
Article 14
The permit mentioned in Paragraph 1, the registration document mentioned
in Paragraph 2, and the approval document mentioned in Paragraph 4 of the
foregoing article shall have a validity period of five years. Those who must
continue handling the toxic chemical substances after permit/document
expiration shall apply for an extension within the period between three and six
months prior to the expiration of the permit/document; each extension may not
exceed 5 years.
The competent authority may modify or cancel the permit, registration
document or approval document in the foregoing paragraph when necessary to
prevent Class 1, Class 2, and Class 3 toxic chemical substances from polluting
the environment and endangering human health.
Article 15
Those handlers of a toxic chemical substance whose permit, registration,
or approval has been revoked or cancelled, or that have been ordered to
terminate business, pursuant to the regulations of this Act may not apply for a
permit, registration or approval for the handling of the toxic chemical
substance at issue within two years.
Those handlers that have partially or completely suspended work or
business pursuant to the regulations of this Act shall submit explanations and
verification documents concerning the completion of improvements before the
resumption of work or business, and may resume work or business only after
verification and approval by the competent authority. This also applies to
those that have been ordered by the competent authority to make improvements
within a limited period and that voluntarily report the suspension of work or
business.
Article 16
Handlers of Class 1, Class 2, and Class 3 toxic chemical substances shall
adopt measures necessary to protect third parties, and shall, pursuant to
regulations, purchase liability insurance to cover handling risks.
The central competent authority shall determine regulations governing the
handlers required to purchase liability insurance and insurance targets, insurance
contract items, minimum insurance amount, insurance content, and document
preservation and relevant document content in the foregoing paragraph.
Handlers of Class 1, Class 2, or Class 3 toxic chemical substances shall
actively prevent the occurrence of accidents, and shall bear responsibility for
adopting necessary protective, response, and disposal measures when an accident
occurs.
An enterprise manufacturing, using, storing or transporting Class 1, Class
2, or Class 3 toxic chemical substances shall establish a nationwide toxic
chemical substance joint prevention organization, which shall assist
protective, response, and disposal measures adopted in the event of an accident
in the foregoing paragraph.
Article 17
The handler shall mark matters related to toxicity and pollution control
measures pursuant to regulations on Class 1, Class 2, Class 3, and Class 4
toxic chemical substance on containers, packaging, handling sites, and
facilities, and shall keep safety data sheets for the corresponding toxic
chemical substances.
The central competent authority shall determine regulations governing the
marking of containers, packaging, handling sites, and facilities, the
preparation, classification, pictograms, contents, formats, and establishment
of safety data sheets, and other binding matters in the foregoing paragraph.
Article 18
An enterprise manufacturing, using, storing or transporting Class 1, Class
2, and Class 3 toxic chemical substances shall employ professional technical
management personnel pursuant to regulations for the performance of toxic
chemical substance pollution control and risk prevention and response work.
The central competent authority shall, with regard to the professional
technical management personnel in the foregoing paragraph, determine
regulations governing qualifications and training; issuance, revocation or
cancellation of qualification certificates; employment grade; number of
personnel; work responsibilities; deputies; changes; and other binding matters.
Article 19
The normal operation of discharge and leakage prevention facilities shall
be maintained and response equipment shall be kept available while toxic
chemical substances are in the process of being handled.
The central competent authority shall determine regulations governing
installation, construction, operation, inspection, maintenance, service,
calibration, record-keeping, record preservation, and other binding matters
with regard to the response equipment and detection and alarm equipment in the
foregoing paragraph.
Article 20
For those circumstances in which the handling of Class 1, Class 2, or
Class 3 toxic chemical substances is to be suspended for a period that exceeds
one month, the statutory responsible person shall, within thirty days from the
day handling is suspended, submit a list of the remaining toxic chemical
substances to the competent authority for approval and handle the remaining
toxic chemical substances in accordance with the following methods.
I. Return to the original
manufacturer of vendor.
II. Sale or transfer to others.
III. Return to overseas exporter.
IV. Disposal pursuant to relevant
waste disposal regulations.
V. Other methods officially
announced or approved by the central competent authority
Article 21
The following circumstances in which Class 1, Class 2, and Class 3 toxic
chemical substances are handled shall be deemed as the suspension of handling:
I. Those circumstances in which
handling is suspended for one year or more without the approval of the
competent authority.
II. Those circumstances in which
handling is suspended for six months or more and the competent authority
determines there is concern of pollution of the environment or the endangerment
of human health.
III. Those handlers of a toxic
chemical substance whose permit, registration, or approval has been revoked or
cancelled, or that have been ordered to terminate business, pursuant to the
regulations of this Act.
Article 22
Owners of Class 1, Class 2, and Class 3 toxic chemical substances shall,
prior to transport, submit a transport manifest to the special municipality,
county or city competent authority at the place of dispatch, and shall send a
copy of the authorized transport manifest to the special municipality, county
or city competent authority at the destination.
Vehicles transporting Class 1, Class 2, and Class 3 toxic chemical
substances shall, pursuant to regulations, be installed with real-time tracking
systems, which shall be kept in normal operation.
The central competent authority in conjunction with the Ministry of
Transportation and Communications shall determine regulations governing
transport manifest reporting and preservation, real-time tracking system
installation, transport markings, documents to be carried, safety equipment,
accident handling, and other binding matters in the foregoing paragraph.
Article 23
Handlers of Class 1, Class 2, Class 3, and Class 4 toxic chemical
substances shall not sell or transfer the toxic chemical substances at issue to
those that have not obtained a permit, registration or approval pursuant to
Article 13, Paragraphs 1 through 4.
However, those that receive prior approval from the competent authority
shall not be subject to this restriction.
Article 24
For those toxic chemical substances for which one of the following circumstances
applies, the handler shall promptly adopt emergency control measures and,
within no more than one hour, notify the local competent authority.
I. Those circumstances in which
the environment surrounding the handling site suffers pollution due to leakage,
chemical reaction or other unexpected accident.
II. Those circumstances in which an
unexpected accident occurs during transport and for which there is concern of
pollution of the environment or the endangerment of human health.
For the circumstances in the subparagraphs of the foregoing paragraph, the
special municipality, county or city competent authority, in addition to
ordering the adoption of necessary measures, may also order the partial or
complete suspension of handling related to the accident at issue.
If an unexpected accident occurs during transport in Paragraph 1,
Subparagraph 2, the handler or owner shall, within no more than two hours, send
professional response personnel to the site of the accident in order to bear
responsibility for accident response and clean-up matters.
The handler in Paragraph 1 shall, in addition to being required to bear
responsibility for clearance and disposal pursuant to relevant regulations
after the occurrence of an accident, also submit a report to the special
municipality, county, or city competent authority for reference. The central
competent authority shall determine standards governing the format, content,
items to be recorded, and other binding matters of said report.
Article 24-1
Emergency response vehicles dispatched by the central, municipality,
county and city competent authorities, or the handlers in responding to a toxic
chemical substance disaster or accident, are not subject to speed limit when on
duty; emergency vehicles may not be subject to the limit of road traffic
signals, markings and informative signals, while the vehicle’s warning lights
and siren are operating for performing emergency duty.
For emergency response vehicles for a toxic chemical substances disaster
pursuant to the foregoing paragraph, the central competent authority in
conjunction with the Ministry of Transportation and Communications shall
determine regulations governing vehicles signals, color in vehicles
identification, equipment standards, function, qualification of drivers,
handler permission, supervision and management for duty performance, and other
related matters.
Article 25
The competent authority may send personnel bearing documents verifying
their duties or markings providing sufficient identification to enter public or
private premises and check the handling of toxic chemical substances and
related articles and sites and order the provision of relevant information. In
order to check toxic chemical substances, distributions, orders can be issued
for submission of relevant data for receiving, production, sales, stock
inventory receipts, account books, and other relevant statements, and other
production, sales, shipping or import and export information. When necessary,
the personnel may collect samples of toxic chemical substances or related
articles, for which receipts shall be issued, and perform testing, and may
provisionally seal the premises, which shall be put under the safekeeping
temporarily of the statutory responsible person.
Samples collected pursuant to the foregoing paragraph shall be tested as
quickly as possible, and an analysis laboratory that has been issued a permit
by the central competent authority may be commissioned to perform testing; the
period for testing shall not exceed one month. However, those that receive the
approval of the central competent authority shall not be subject to this
restriction.
The environmental analysis and testing organization in the foregoing
paragraph shall perform work consistent with the testing and analysis categories
on its permit. The central competent authority shall determine regulations
governing the required conditions and facilities; the qualifications and
in-service training of analysis personnel; permit application, review
procedures, period of validity, issuance, replacement, revocation, and
cancellation; suspension and resumption of business; checking and evaluation
procedures; information reporting; and other binding matters in connection with
the organizations.
The central competent authority shall officially announce the methods and
quality control items for the testing of toxic chemical substances.
Article 26
Toxic chemical substances or related articles checked pursuant to
Paragraph 1 of the foregoing article shall be handled as follows depending on the
outcome of checking:
I. Violations of the regulations
of this Act shall be punished pursuant to the regulations of this Act; the
handler of toxic chemical substances or related articles may be ordered to
perform clearance and disposal pursuant to the regulations of the Waste
Disposal Act within a limited period.
II. The handler of those sealed
toxic chemical substances and related articles that have been determined to be
waste may be ordered to perform clearance and disposal pursuant to the related
regulations of the Waste Disposal Act within a limited time period. Those
sealed toxic chemical substances and related articles that have been determined
to be appropriate for the making of improvements or conversion into other
substances shall be unsealed and returned to the handler and the handler shall
be supervised in making improvements or performing conversion within a limited
time period; a handler that fails to make improvements by the deadline may be
ordered to perform clearance and disposal pursuant to the regulations of the
Waste Disposal Act within a limited period.
III. Those sealed toxic chemical
substances and related articles that are not in violation of the regulations of
this Act shall be promptly unsealed and returned to the handler.
Article 27
Each industry competent authority shall provide guidance for pollution
abatement work for toxic chemical substances.
Article 28
The handling of toxic chemical substances by government agencies and
academic organizations may be managed in accordance with the following
regulations:
I. The central government agency
with jurisdiction over the government agency or academic organization shall, in
conjunction with the central competent authority, separately determine
regulations governing management authority over and use of the handled toxic
chemical substances; the employment of professional technical management
personnel; transport; record production, reporting, and length of preservation;
marking, storage, checking; and other binding matters.
II. The central government agency
with jurisdiction over the government agency or academic organization shall
submit management methods for individual handling circumstances to the central
competent authority for approval.
Chapter
4 Penal Provisions
Article 29
The convicted perpetrator cause human death shall be punished by life
imprisonment or a minimum of seven years imprisonment, and may be fined a
maximum of NT$10 million; cause serious
injuries shall be polished by
imprisonment a minimum of three years and maximum of ten years, and may be
fined a maximum of NT$5 million; cause hazards to human and diseases shall be
polished by imprisonment a maximum of three years and maximum of three years,
and may be fined a maximum of NT$4 million, when any of the following circumstances
occurred:
I. A violation of restrictions or
prohibitions officially announced pursuant to Article 7, Paragraph 2.
II. Unauthorized handling without
obtaining a permit pursuant to Article 13, Paragraph 1, or the failure to
perform handling in accordance with listed permit items.
III. Unauthorized handling without
registration pursuant to Article 13, Paragraph 2 or 3, or the failure to
perform handling in accordance with listed registration items.
IV. The failure to comply with an
order issued by the competent authority pursuant to Article 24, Paragraph 2
Article 30
Those in one of the following circumstances shall be punished by a maximum
of three years imprisonment, detention and/or a fine of a maximum of NT$5
million.
I. A violation of restrictions or
prohibitions officially announced pursuant to Article 7, Paragraph 2 that
causes serious pollution of the environment.
II. The failure to obtain a permit
pursuant to Article 13, Paragraph 1, unauthorized handling or the failure to
perform handling in accordance with listed permit items that causes the serious
pollution to the environment.
III. Unauthorized handling without
registration pursuant to Article 13, Paragraph 2 or 3, or the failure to
perform handling in accordance with listed registration items, that causes
severe pollution of the environment.
IV. The failure to comply with an
order issued by the competent authority pursuant to Article 24, Paragraph 2,
causing severe pollution to the environment.
V. Those circumstances in which
those that have reporting obligations pursuant to the regulations of this Act
knowingly report false information or keep false records of their operations.
Article 31
For those circumstances in which a statutory responsible person of a
juridical person, or an agent, employee or other working personnel of a
juridical person or natural person, violates, due to the performance of
business activities, Article 29 or the previous article, in addition to the
perpetrator being punished, said juridical person or natural person shall also
be fined pursuant to the regulations of each article violated.
Article 32
Those in one of the following circumstances shall be fined NT$1 million to
NT$5 million and shall be ordered to make improvements within a limited time
period. Those that have failed to complete improvements by the deadline may be
ordered to suspend work or suspend business. When necessary, the competent
authority may issue orders for the termination of business, the revocation or
cancellation of registration or the revocation or cancellation of permits.
I. A violation of restrictions or
prohibitions officially announced pursuant to Article 7, Paragraph 2.
II. Failure to obtain a permit
pursuant to Article 13, Paragraph 1 and the performance of unauthorized
handling.
III. Failure to purchase liability
insurance to cover handling risks pursuant to Article 16, Paragraph 1.
IV. A violation of management
regulations prescribed in Article 19, Paragraphs 1 or 2 governing the
installation, construction, operation, inspection, maintenance, service, or
calibration of emergency response equipment and detection and alarm equipment
that causes pollution of the environment.
V. A violation of the regulations
of Article 20.
VI. A violation of the regulations
of Article 24, Paragraphs 1 or 2; a violation of the regulations of Article 20,
Paragraph 3 that causes pollution to the environment; failure to bear
responsibility for clearance and disposal pursuant to the regulations of
Paragraph 4 of the same article.
VII. For those that have been ordered by the competent authority pursuant
to Article 26, Subparagraph 1 or 2 to perform clearance and disposal within a
limited period, failure to perform clearance and disposal by the deadline.
Article 33
Those that evade, obstruct or refuse checking, orders, the collection of
samples and testing, or sealing and safekeeping work performed by the competent
authority pursuant to Article 25, Paragraph 1 shall be fined NT$1.5 million and
may be fined per violation.
Article 34
Those in one of the following circumstances shall be fined NT$100,000 to
NT$500,000 and shall be ordered to make improvements within a limited time
period. Those that have failed to complete improvements by the deadline may be
ordered to suspend work or suspend business. When necessary, the competent
authority may issue orders for the termination of business, the revocation or
cancellation of registration or the revocation or cancellation of permits.
I. Failure to keep, declare,
preserve, or report records on the part of those that have record-keeping,
declaration, record preservation or reporting obligations pursuant to Article
7, Paragraph 4, Article 8, Paragraph 1, Article 22, Paragraph 1, or Article 24,
Paragraph 4.
II. A violation of the regulations
of Article 10, Paragraph 1, Article 17, Paragraph 1, Article 18, Paragraph 1 or
Article 23.
III. Unauthorized handling and
failure to apply for registration in violation of the regulations of Article
13, Paragraph 2 or Paragraph 3.
IV. Violation of the management
regulations of Article 16, Paragraph 2 concerning insurance targets, insurance
contract items, minimum insurance amount, insurance content, and document
preservation, or violation of Paragraph 3 by failure to take preventive action,
thereby causing an accident.
V. A violation of management
regulations prescribed in Article 19, Paragraphs 1 or 2 governing the
installation, construction, operation, inspection, maintenance, service, and
calibration, records and records preservation of response equipment and
detection and alarm equipment.
VI. A violation of management
regulations prescribed in Article 22, Paragraphs 2 or 3 governing transport
manifest reporting and preservation, real-time tracking system installation,
transport markings, documents to be carried, safety equipment, and accident
handling.
VII. A violation of management regulations prescribed in Article 25,
Paragraph 3 governing permit testing and analysis categories or a violation of
management regulations prescribed in the same paragraph governing the required
conditions and facilities; the qualifications and in-service training of
analysis personnel; testing and analysis permit period of validity; information
reporting; and work responsibilities.
Article 35
Those in one of the following circumstances shall be fined NT$60,000 to
NT$300,000 and shall be ordered to make improvements within a limited time
period; those that have failed to complete improvements by the deadline may be
ordered to suspend work or suspend business; when necessary, the competent
authority may issue orders for the termination of business, the revocation or
cancellation of registration or the revocation or cancellation of permits.
I. A violation of the management
regulations of Article 7, Paragraph 5 concerning permission, permits issuance
(replacement and renewal), and change.
II. Failure to complete improvement
by the deadline after being ordered by the central competent authority to make improvement within a limited time
period due to missing content or format of the records produced and reported pursuant
to Article 8 Paragraph 2.
III. A violation of management
regulations of Article 8, Paragraph 2 concerning frequency, method, and
preservation of records report.
IV. Handling in violation of the
total release quantity control methods of Article 9.
V. A violation of management
regulations prescribed in Article 10, Paragraph 3 governing risk prevention and
response plan production, content, reporting, and implementation.
VI. A violation of Article 11,
Paragraph 1.
VII. The failure to perform handling in accordance with the listed items
of a permit issued pursuant to Article 13, Paragraph 1 or handling in violation
of registration items pursuant to Paragraphs 2 or 3 of the same article.
VIII. Unauthorized handling without obtaining approval or failure to
perform handling in accordance with approved items in violation of Article 13,
Paragraph 4.
IX. A violation of management
regulations prescribed in Article 13, Paragraph 5 governing
permit/registration/approval application, replacement or renewal, and change.
X. A violation of Article 16,
Paragraph 4.
XI. A violation of management
regulations prescribed in Article 17, Paragraph 2 governing the marking of
containers, packaging, handling sites, and facilities, and the preparation,
classification, pictograms, contents, formats, and establishment of safety data
sheets.
XII. A violation of management regulations prescribed in Article 18,
Paragraph 2 governing the qualifications, training, and employment grade of
professional technical management personnel; number of personnel; work
responsibilities; deputies; and changes.
XIII. A violation of management regulations prescribed in Article 28,
Subparagraph 1 governing the management authority of relevant government
agencies and academic organizations and their use of toxic chemical substances;
the employment of professional technical management personnel; transport;
record production, reporting, and length of preservation; marking, storage, and
checking, or the failure to perform handling in accordance with the management
methods prescribed in Subparagraph 2 of the same article.
Article 35-1
A fine of NT$200,000 to NT$2 million shall be imposed on those who fail to
obtain approval of registration pursuant to Article 7-1, Paragraph 1, prior to
manufacturing or importing new chemical substances. In addition, correction
shall be ordered to be made within a given time period; those that do not make
the correction by the deadline may be fined per violation, and be ordered to
suspend work, suspend business or return export when failing to make the
correction within a given time period for more than 2 times.
A fine of NT$30,000 to NT$300,000 shall be imposed on those who fail to
gain approval of registration pursuant to Article 7-1, Paragraph 1, prior to
manufacturing or importing existing chemical substances. In addition,
correction shall be ordered to be made within a given time period; those that
do not make the correction by the deadline may be fined per violation, and be
ordered to suspend work, suspend business or return export when failing to make
the correction within a given time period for more than 2 times.
A fine of NT$100,000 to NT$500,000 shall imposed on those that violate
issued attaching conditions pursuant to Article 7-1, Paragraph 3. In addition, correction shall be ordered to
be made within a given time period; for those that do not make the correction
by the deadline, the approval of registration may be cancelled. Recall and destruction of such chemical
substances, their compounds and articles shall be carried out by its
manufacturer or importer. When necessary, the competent author can recall,
destroy such chemical substances on behalf of the manufacturer or the importer
and collect necessary handling expenses.
A fine of NT$30,000 to NT$300,000 shall be imposed on those who fail to
comply with the registration requirements pursuant to Article 7-1, Paragraph 6,
on registering conditions of manufacturing or import, registration timeline,
joint submission, reporting of chemical substances after registration or
registered information modification, record keeping in accordance with the
enforcement rules issued by the central competent authority. In addition,
correction shall be ordered to be made within a given time period; those that
do not make the correction by the deadline may be fined per violation, and be
ordered to suspend work, suspend business or return export when failing to make
the correction within a given time period for more than 2 times.
Article 36
Toxic chemical substances or related articles checked pursuant to Article
25 shall be handled as follows depending on the outcome of checking:
I. Toxic chemical substances or
related articles may be confiscated when in violation of the regulations of
this Act.
II. Sealed toxic chemical
substances and related articles that have been determined to be appropriate for
the making of improvements or conversion into other substances but have not
been subjected to improvement or conversion by the deadline may be confiscated.
Article 37
The period for making improvements, reporting or performing conversion for
those notified pursuant to this Act to make improvements, report or perform
conversion within a limited period may not exceed thirty days unless there are
actual needs and the central competent authority grants approval.
Chapter
5 Supplementary Provisions
Article 38
After the official announcement by the central competent authority of
those toxic chemical substances that are already being handled prior to
official announcement, the handler shall, within the officially announced
period, complete improvement with regard to matters that must be declared,
reported or implemented in accordance with regulations, and shall obtain a
permit, complete registration or obtain approval pursuant to this Act, and may
only continue handling after doing so.
Article 39
Those enterprises that have obtained a registration document or approval
document in accordance with law prior to the implementation of revisions to
this Act shall apply to the special municipality, county or city competent
authority for an extension within five years of the implementation of revisions
to this Act; the registration or approval document shall lose its validity if
no application has been made by the deadline or no extension has been obtained.
Article 40
The central competent authority shall determine the standards of fees
collected by competent authorities at all levels pursuant to this Act.
Article 41
Chemical substance registration information pursuant to this Act shall be
disseminated to the public. However, the central competent authority possesses
the authority to maintain confidentiality of information involving national
defense, industrial or commercial confidentialities subject to the application
submitted by the manufacturer or importer and received approval by the central
competent authority.
When one of the following circumstances occurs, information
confidentiality in the foregoing paragraph shall not be subjected to this
restriction pursuant to the authority of the central competent authority.
I. It is necessary for
benefitting the public.
II. It is necessary for protecting
people’s lives, bodies, health.
III. It is consented by the
manufacturer or importer.
Confidentiality shall be maintained concerning reviews, checking, and the
collection of samples and testing performed pursuant to this Act that involve
national defense, industrial or commercial secrets. However, identities,
physical, chemical, toxicity, classification, labeling and relevant safety
information of chemical substances shall not be subjected to this restriction.
The Freedom of Government Information Law shall apply to application to
the central, municipality, county and city competent authorities for provision
of government information pursuant to the regulations in the foregoing three
paragraphs.
Article 42
The competent authority may grant incentives to enterprises that comply
with one of following conditions:
I. The handler has not violated
the regulations of this Act for ten consecutive years.
II. The handler has achieved
outstanding results in its toxic chemical substance risk prevention and
equipment improvement efforts.
III. Those that invent or improve
methods for the reduction of dangers or pollution created through the
manufacture, transport, storage or use of toxic chemical substances that are
appropriate for promotion.
The competent authority shall determine regulations governing applicable
targets, selection, incentive methods, and other binding matters with regard to
the incentives in the foregoing paragraph.
Article 43
The central competent authority shall determine the enforcement rules of
this Act.
Article 44
This Act shall take effect on the date of promulgation.
Except for Article 7-1, Article 7-2, Article 17 and Article 35-10, Article
35-1 and Article 41 revised on November
22, 2013, which shall take effect one year after promulgation; the other
amendments shall take effect on the date of promulgation.
