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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.