環境用藥管理法

This Act is formulated to prevent harm from environmental agents, preserve human health, and protect the environment.

“Competent authority” as referred to in this Act means 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.

1The matters designated as the responsibility of the central competent authority

2I. Planning, drafting, supervision and implementation of national environmental agents control policies, programs and plans

3II. Implementation, drafting, deliberation and interpretation of environmental agents control laws and regulations

4III. Environmental agents control research, development and public awareness

5IV. Training and management of national environmental agents control personnel

6V. Supervision of national environmental agents control work

7VI. Coordination or implementation of national environmental agents control work

8VII. International cooperation and technology exchanges in the area of environmental agents control

9VIII. Other matters related to national environmental agents management.

1The responsibilities of special municipality, county and city competent authorities are as follows:

2I Planning and implementation of environmental agents control action programs and plans under jurisdiction.

3II. Implementation of environmental agents control laws and regulations, and drafting, interpretation and implementation of environmental agents control laws and regulations under jurisdiction.

4III. Environmental agents control research, development and public awareness.

5IV. Environmental agents control statistics compilation and reporting tasks under jurisdiction.

6V. Other environmental agents control matters under jurisdiction.

1The terms used in this Act are defined as follows.

2I. “Environmental agents” means the following types of chemical agents or microbial preparations used for environmental sanitation and pollution control, and which are distinguished as technical grade environmental agents, general use environmental agents, and restricted use environmental agents in accordance with use concentration and method of use:

31. Pesticides, miticides, rodenticides, bactericides/fungicides used for environmental sanitation, and other chemical agents used against organisms injurious to environmental sanitation.

42. Synthetic chemical agents used to prevent air, water, or soil pollution, or treat waste, and that have been officially announced by the central competent authority.

53. Microbial preparations produced from natural or artificially-modified microbe organisms or their metabolic products, and used to control air pollution, water pollution, or soil pollution, treat waste, or control environmental sanitation disease vectors.

64. Other environmental agents officially announced and designated by the central competent authority.

7II. “Technical grade environmental agents” means active component raw materials used to manufacture or process general use environmental agents and restricted use environmental agents.

1The counterfeit environmental agents referred to in this Act mean those environmental agents to which one of the following circumstances apply:

2I. Unauthorized manufacturing, processing or import without central competent authority authorization.

3II. Contains intermixed domestic and foreign products or mutual substituted domestic and foreign products without change of packaging.

4III. Alteration or change of validity period markings.

5IV. The active components are not consistent with approved items.

6The validity period labeling referred to Subparagraph 3 of the foregoing paragraph means manufacturing dates, batch numbers and expiration dates stated on the labels of environmental agents.

The prohibited environmental agents referred to in this Act mean environmental agents containing components whose manufacture, processing, import, export, sale, or use has been officially announced as prohibited by the central competent authority.

1The inferior quality environmental agents referred to in this Act mean those environmental agents to which one of the following circumstances applies:

2I. The addition or modification of coloring agents, preservatives, fragrances, solvents or excipients without central competent authority authorization.

3II. The active component content does not comply with allowable error standards.

4III. Has exceeded the validity period.

1Those that intend to manufacture, process, or import environmental agents shall apply to the central competent authority for checking and registration by submitting markings and a sample together with the product’s name, components, performance data, key aspects of the manufacturing process, analytical methods, toxicology report, efficacy (potency) report, and other relevant information or documentation.Manufacture, processing, or import may begin only after the central competent authority has issued a permit.

2When an environmental agent for which a permit has been issued in the foregoing paragraph is a general use environmental agent, the competent authority shall announce information including the manufacturer or importer, product name, permit number, composition, performance data, and product markings on the Internet in order to facilitate public queries.

3Customs shall order those persons obligated to pay tax to return within a limited time period any imported environmental agents that have not received the central competent authority’s permission or approval.

4Passengers or service personnel on transportation vehicles that import small quantities of environmental agents with themselves for personal use are not subject to the restrictions of the foregoing paragraph. Relevant types of environmental agents and permissible amounts shall be determined on the basis of relevant Customs Act regulations.

5The environmental agents in the foregoing paragraph shall be imported solely for personal use, and may not be sold.

1The validity period of the environmental agent permit in Paragraph 1 of the foregoing article shall be five years. Those who wish to continue to manufacture, process, or import an environmental agent after permit expiration shall apply to the central competent authority for an extension within the period between three and six months prior to the permit’s expiration. Each extension may not exceed 5 years. The central competent authority shall determine regulations governing application conditions, approval or rejection, revocation, cancellation, extension, modification, issuance (replacement or renewal), and other binding matters.

2The central competent authority may cancel the permit in the foregoing paragraph when necessary to maintain citizens’ health or protect the environment or ecology.

3If an environmental agent permit has been cancelled pursuant to the regulations of the foregoing paragraph, the original applicant may reapply to the central competent authority for a permit after submitting scientific or technical data or on-site survey results verifying that the original cause of cancellation is no longer present.

1Environmental agent vendors and pest control operators shall apply to the local competent authority for a permit, and may engage in business only after the review and approval of registration and receipt of a license. However, those environmental agent manufacturing enterprises that concurrently engage in the export, wholesale, or retail sale of self-produced products, or in the import of technical grade products for self-use on the company or factory premises stated on the environmental agent permit are not required to apply for an environmental agent vendor license. The central competent authority shall determine regulations governing application conditions, procedures, approval or rejection, revocation, cancellation, modification, suspension of business, resumption of business, termination of business, and other binding matters.

2When environmental agent vendors or pest control operators receive a permit as in the foregoing paragraph, the competent authority shall announce information including the company name, name of statutory responsible person, and permit number on the Internet in order to facilitate public queries.

Those enterprises that hold an environmental agent manufacturing or import permit or environmental agent vendor or pest control operator license shall engage in approved items only.

Environmental agent manufacturing enterprises shall apply for factory registration in accordance with relevant regulations, and factory equipment and health and safety conditions shall comply with environmental agent factory establishment standards. The central competent authority in conjunction with the relevant industry competent authority shall determine the foregoing standards.

Environmental agents manufacturing enterprises may not manufacture or process environmental agents using technical grade environmental agents that have not been checked and registered.

1Those technical grade environmental agents approved by the central competent authority may be transferred.

2The central competent authority shall determine application condition, review, and approval regulations.

1Environmental agent manufacturing enterprises may manufacture or process environmental agents exclusively for export in accordance with foreign buyers’ order requirements after receiving central competent authority approval, and the restrictions of Article 9, Paragraph 1 shall not apply. The central competent authority shall determine regulations governing application conditions, review, approval, and other binding matters.

2The environmental agents approved by the central competent authority in the foregoing paragraph may not be domestically sold or used for other purposes.

1Environmental agents manufacturing enterprises may not commission the manufacture of environmental agents or manufacture environmental agents under commission without the approval of the central competent authority.

2The central competent authority shall determine regulations governing application conditions, review, approval, and other binding matters with regard to the commissioning or being commissioned in the foregoing paragraph.

1The mixing and packaging of environmental agents may be performed only after receiving central competent authority approval.

2The central competent authority shall determine regulations governing application conditions, review, approval, and other binding matters with regard to the commissioning or being commissioned in the foregoing paragraph.

3“Mixing”, as mentioned in the first paragraph, means the mixture of different components or environmental agent products to create environmental agents; separate packaging means to change for the purpose of sale the package capacity of an environmental agent that has been issued a permit.

4The packaging of environmental agents in the first paragraph may be performed only in environmental agents factories possessing unitary dosage form equipment.

1Environmental agents manufacturing enterprises, environmental agents vendors, and pest control operator shall establish positions for professional technical personnel.

2The central competent authority shall determine regulations governing the number of personnel, employment, training, qualifications, work responsibilities, acquisition, revocation, and cancellation of licenses, in-service training, retraining, reporting of vacancies or commissioned filling of vacancies, and other binding matters with regard to the professional technical management personnel in theforegoing paragraph.

Environmental agents vendors and general use environmental agents wholesaler suppliers and retailers may not store or sell unmarked environmental agents or sell environmental agents after opening the original packaging.

1Restricted use environmental agents may be sold solely to health/environmental protection competent authorities or their subordinate agencies, licensed environmental agent vendors, pest control operators, and other buyers approved by the local special municipality, county, or city competent authority.

2Restricted use environmental agents may be used solely by health/environmental protection competent authorities or their subordinate agencies, licensed pest control operators, and other buyers approved by the local special municipality, county or city competent authority.

The work performed by pest control operators shall meet the regulations the central competent authority. The central competent authority shall determine regulations governing environmental agent use safety, operations, and safeguards, training of application personnel, environmental agent use, reporting and preservation of application records, application plans, and other binding matters.

1Environmental agents provided exclusively for experimental research, educational demonstrations, special control projects, or for license application shall not be subject to the restrictions designated in Article 9, Paragraph 1 and Article 15 after central competent authority approval has been obtained. The central competent authority shall determine regulations governing application conditions, review, approval, and other binding matters.

2The environmental agents approved by the central competent authority in the foregoing paragraph may not be domestically sold or used for other purposes.

3The central competent authority may cancel its approval of environmental agents in the first paragraph for use in experimental research or educational demonstrations if necessary to maintain public health or protect the environment or ecology.

1Environmental agents manufacturing enterprises, environmental agents vendors, and pest control operators shall record the quantities of environmental agents manufactured, processed, exported, imported, sold, and used each month.

2The recorded data in the foregoing paragraph shall be preserved for three years. When necessary, the competent authority may order an enterprise to submit said records.

1The central competent authority shall officially announce the allowable error margins for the active component content of environmental agents.

2Changes in the allowable error margins in the foregoing paragraph shall be officially announced six months prior to the day the changes are to take effect.

The central competent authority shall determine regulations governing storage, placement, quantities, and locations of environmental agents, types of environmental agents used, personnel safety equipment, pollution control measures, and other binding matters.

1The prior approval of the central competent authority is required for environmental agents markings usage or changes.

2The central competent authority shall determine regulations governing the markings, methods, and other binding matters in the foregoing paragraph.

The clearance and disposal of waste environmental agents and environmental agents containers shall be performed pursuant to the Waste Disposal Act and relevant laws and regulations.

Environmental agent microbial preparations may be used in ecological and water source conservation or protection areas. The central competent authority shall determine regulations governing use applications, records, and other binding matters concerning such use.

Applications for the use of microbial organisms or their metabolic products modified by means of genetic engineering or other technologies in experimental research for the purpose of developing environmental agent microbial preparations shall be made to the central competent authority. The central competent authority shall determine regulations governing application conditions, procedures, emergency response, records, and other binding matters.

1If environmental agents microbial preparations pollute the environment, or harm the ecology or human health, the statutory responsible person or actual operator shall promptly adopt emergency control measures, and shall notify the local special municipality, county, or city competent authority within a maximum of two hours.

2Under the circumstances in the foregoing paragraph, the special municipality, county or city competent authority may promptly prohibit handling activities connected with said pollution, including manufacturing, processing, separate packaging, blending, import, export, transport, sale, storage, use, experimental research, and educational demonstration.

Those enterprises that do not hold an environmental agent permit or environmental agent vendor or pest control operator license may not advertise environmental agents.

1Environmental agents manufacturing enterprises, environmental agents vendors, and pest control operator may not overstep the content of their registration, and may not publish or broadcast false, exaggerated, or illicit advertising.

2The central competent authority shall determine regulations governing promotional methods in the foregoing paragraph, the content of explanatory information, and other binding matters.

The competent authority may send personnel to enter public or private premises bearing documents verifying their duties or markings providing sufficient identification and inspect the circumstances of environmental agent manufacturing, processing, separate packaging, blending, sale, storage, use, experimental research, and educational demonstration. In those circumstances in which the personnel deem there is concern of the violation of this Act, environmental pollution or harm to the ecology or human health, they may provisionally seal the premises, which shall be put under the safekeeping of the statutory responsible person. When necessary, the personnel may collect samples, for which a receipt shall be issued, and perform testing.

1When environmental agents or related articles have been sealed pursuant to the foregoing article, the following actions shall be taken in accordance with the results of checking and testing:

2I. When there is a violation of this Act, in addition to penalties designated in this Act, those sealed environmental agents and articles that the competent authority has determined to be waste shall be disposed of pursuant to relevant waste disposal regulations.

3II.The premises shall be promptly unsealed if there is no violation of this Act.

1Environmental analysis and testing organizations may perform analysis and testing work pursuant to this Act only after obtaining an approved permit from the central competent authority.

2The 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 organization’s required conditions and facilities; license application, review procedures, issuance (replacement), revocation, and cancellation; suspension and resumption of business; checking and evaluation procedures; instruments and equipment; in-service training and technical skills assessment; blind testing, testing methods, quality control items, basic quality system standards, testing report signing, data reporting, and other binding matters.

When an environmental agent manufacturing or import permit has been revoked pursuant to Article 10, Paragraph 2, the enterprise engaged in the manufacture, processing, or import of environmental agents shall compile a lists of goods in stock and a list of recalled on-sale goods by the deadline designated by the central competent authority, and shall individually submit the lists to the special municipality, county or city competent authority for inventory and future reference.

If the competent authority discovers counterfeit or prohibited environmental agents, the enterprise engaged in the manufacture, processing, import, or sale of the environmental agents shall be notified to compile a list of goods in stock within seven days of the day after receipt of the notice, and compile a list of recalled on-sale counterfeit or prohibited environmental agents within 15 days of said date. Said lists shall be individually submitted to the special municipality, county or city competent authority for inventory and future reference.

If the competent authority discovers inferior quality environmental agents, the enterprise engaged in the manufacture, processing, import, or sale of the environmental agents shall be notified to compile a list of goods in stock within seven days of the day after receipt of the notice, and compile a list of recalled on-sale inferior quality environmental agents within one month of said date. Said lists shall be individually submitted to the special municipality, county or city competent authority for inventory and future reference.

The environmental agents of those environmental agents manufacturing enterprises, environmental agent vendors, and pest control operators that have terminated operations, suspended operations, or have had their permit or license revoked or cancelled shall be subject to appropriate disposal. The central competent authority shall determine the disposal method.

The original manufacturer, processor, importer, or seller shall bear the cost of the appropriate disposal of environmental agents seized or confiscated pursuant to this Act.

Those that manufacture, process, or import counterfeit or prohibited environmental agents thereby causing human death shall be punished by a maximum of 10 years imprisonment and may be fined a maximum of NT$3 million; those that cause severe injury shall be punished by a maximum of five years imprisonment and may be fined a maximum of NT$2 million; those that cause harm to human health such that it leads to illness shall be punished by a maximum of three years imprisonment and may be fined a maximum of NT$1 million.

Those that knowingly sell, transfer, display with the intent of selling, store, mix, or package counterfeit or prohibited environmental agents thereby causing human death shall be punished by a maximum of seven years imprisonment and may be fined a maximum of NT$3 million; those that cause severe injury shall be punished by a maximum of three years imprisonment and may be fined a maximum of NT$2 million; those that cause harm to human health such that it leads to illness shall be punished by a maximum of one years imprisonment and may be fined a maximum of NT$1 million.

If a representative of a juridical person, agent of a juridical person or natural person, employee, or other working personnel commits a violation of Article 42 or the foregoing article in the course of work, in addition to punishing the perpetrator pursuant to each relevant regulation, the juridical person or natural person shall be punished with the fines designated in each relevant article.

(Deletion)

1When an enterprise manufactures, processes, or imports counterfeit or prohibited environmental agents, the statutory responsible person shall be fined NT$300,000 to NT$1.5 million.

2When an enterprise knowingly sells, transfers, displays with the intent of selling, stores, mixes, or packages counterfeit or prohibited environmental agents, the statutory responsible person shall be fined NT$90,000 to NT$450,000.

3When an enterprise processes or imports the inferior quality environmental agents in Article 8, Subparagraphs 1 and 2, the statutory responsible person shall be fined NT$60,000 to NT$300,000.

4When an enterprise sells, transfers, displays with the intent of selling, or stores the environmental agents in Article 6, Paragraph 1, Subparagraph 1, Article 7, or Article 8, Subparagraph 3, has been ordered to make improvements within a limited time period, but has failed to make improvements by the deadline, the statutory responsible person shall be fined NT$30,000 to NT$150,000.

Those that violate Article 16, Paragraph 2 or Article 23, Paragraph 2 shall be fined NT$90,000 to NT$450,000.

1When one of the following circumstances applies, the violator shall be fined NT$60,000 to NT$300,000, and may be ordered to make improvements within a limited time period; serious violators and those that fail to make improvements by the deadline shall have their permit or license revoked or cancelled, and may be ordered to suspend work, suspend business, or terminate business when necessary:

2I. A violation of Article 14, Article 15, Paragraph 1, Article 17, Paragraph 1, Article 18, Paragraph 1, Article 19, Paragraph 1, Article 20, Article 24, Paragraphs 1 and 2, Article 31, Paragraphs 1 and 2, Article 32, or Article 33, Paragraph 1.

3II. A violation of the management regulations of Article 26 governing the quantities and locations of environmental agent storage or placement, types of environmental agents used, personnel safety equipment, or pollution control measures.

4III. A violation of the management regulations of Article 29 governing use applications, use quantity restrictions, records, and record preservation for environmental agent microbial preparations.

5IV. A violation of the management regulations of Article 30 governing environmental agent microbial preparation applications, physical and biological protective measures and emergency response measures at experiment sites, records and record preservation, and record reporting.

6V. A violation of the management regulations of Article 36, Paragraph 2 governing instruments and equipment, analysis personnel, technical skills assessment, blind sample testing, testing methods, quality control items, basic quality system standards, testing report signing, data reporting, and work responsibilities.

1When one of the following circumstances applies, the violator shall be fined NT$30,000 to NT$150,000, and may be ordered to make improvements within a limited time period; serious violators and those that fail to make improvements by the deadline shall have their permit or license revoked or cancelled, and may be ordered to suspend work, suspend business, or terminate business when necessary:

2I. A violation of Article 9, Paragraph 5, Article 12, Article 21, Paragraphs 1 or 2, or Article 27, Paragraph 1.

3II. Refusal, evasion or obstruction of inspection, sampling, testing or sealing and safekeeping pursuant to Article 34.

4III. A violation of the management regulations of Article 13 governing factory establishment standards concerning factory environment, process equipment, and testing equipment.

5IV. A violation of the management regulations in Article 19, Paragraph 2 governing the establishment, number of personnel, employment, in-service training, and reporting of vacancies or commissioned filling of vacancies regarding professional technical personnel.

6V. A violation of the management regulations of Article 22 governing the training of application personnel, environmental agent use, safety equipment, notification of customer of application plans, reporting of application records, and preservation of records.

7

Those that conduct operations without having obtained permits pursuant to Article 11 shall be fined NT$30,000 to NT$150,000.

Professional technical personnel that violate the regulations of Article 19, Paragraph 2 governing retraining, work responsibilities, or reporting of resignation shall be fined NT$4,000 to NT$20,000; when necessary, their qualification certificates shall be revoked or cancelled.

1The competent authority shall variously take the following disciplinary actions if it discovers counterfeit or prohibited environmental agents:

2I. The local competent authority shall seize or confiscate the discovered environmental agents, or shall order the enterprise engaged in the manufacture, processing, import, or sale of environmental agents to take appropriate action.

3II. If an enterprise has manufactured, processed, or imported counterfeit or prohibited environmental agents, or is using a permit or license under false pretenses, the original issuing agency shall revoke or cancel the permit or license, and shall officially announce the company’s name and address, the name of its statutory responsible person, the names of the counterfeit or prohibited environmental agents, and the circumstances of the violation.

4III. If an enterprise sells, displays with intent to sell, or uses counterfeit or prohibited environmental agents, the original issuing agency shall revoke its license, and officially announce the manufacturer’s name, address, the name of the statutory responsible person, the names of the counterfeit or prohibited environmental agents, and the circumstances of the violation.

1When the competent authority sends personnel to perform counting of inferior quality environmental agents pursuant to Article 39, the personnel may, when necessary, seize said environmental agents.

2If the inferior quality environmental agents in the foregoing paragraph have been domestically manufactured or processed, and can still be altered for use after testing, the original manufacturer may submit an alteration plan to the central competent authority within two months of the date of inventory. Upon approval of the plan, alteration may be performed within a limited time period under the supervision of the special municipality, county or city competent authority. If the inferior quality environmental agents cannot be altered, no alteration plan has been submitted by the deadline, or no alteration has been performed by the deadline, the local competent authority may confiscate the inferior quality environmental agents or order the manufacturer to take appropriate action. If the inferior quality environmental agents have been imported with approval, the local competent authority shall order the original importer to send back the environmental agents out of the country within two months of the date of inventory. If the importer has not complied by the deadline, the local competent authority may confiscate the inferior quality environmental agents or order the importer to take appropriate action.

3If an enterprise has manufactured, processed, or imported the inferior quality environmental agents defined in Article 8, Subparagraphs 1 and 2, or has used technical grade environmental agents that have exceeded their validity period, the local competent authority shall officially announce the company’s name and address, the name of its statutory responsible person, the names of the environmental agents, and the circumstances of the violation; if the violation is serious or repeated, the local competent authority may revoke or cancel relevant permits or licenses or terminate the enterprise’s operations.

The competent authority shall enforce suspension of work, suspension of business, or revocation or cancellation of permit or license imposed pursuant to this Act; the industry competent authority, following imposition of punishment and notification by the competent authority, shall enforce orders for the termination of business.

After an enterprise’s permit or license has been revoked or canceled, that enterprise may not re-apply for the same permit or license within one year, and may not re-apply to use the product items on its original permit within two years.

The central competent authority shall determine the standards of fees collected by competent authorities at all levels pursuant to this Act.

Standard testing methods for environmental agents shall conform to national standards when national standards exist. The central competent authority shall officially announce standard testing methods when no relevant national standards exist.

The improvement period may not exceed 30 days then an enterprise has been notified to make improvements within a limited period pursuant to this Act. Those unable to complete improvements by the improvement deadline due to natural disaster or other force majeure shall, within 15 days after the reason ends, apply to the competent authority for the approval of an improvement deadline by submitting a written explanation of cause and relevant information.

The central competent authority shall determine the enforcement rules of this Act.

This Act shall take effect on the date of promulgation.