Toxic Chemical Substances Control Act

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$19.99.
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.

Related Laws