On Dec. 15,2003, the Republic of China promulgated the Act and implemented it from the date of promulgation. On March 10, 2021, the Authority amended and promulgated Article 6, Annex 1, Annex 3, and Annex 4.

The competent authority in charge of pesticide management in Taiwan is the Agricultural Committee of the Executive Yuan at the central level; the municipal government at the municipal level; and the county (city) government at the county (city) level.

Finished Pesticides refers to the following drugs or biological product: 

1. those used to control pests of agricultural and forestry crops or their products

2. those used to regulate the growth of agricultural and forestry crops or affect their physiological effects

3. for regulating the growth of beneficial insects

4. others that have been announced by the central competent authority and listed as plant protection agent

Pesticide Ingredients refer to the raw materials of active ingredients required to process the finished pesticides of the items in the preceding paragraph. However, after being announced by the central competent authority that it can be directly supplied to the users of the items in the preceding paragraph, it is regarded as a finished pesticide.

Who is affected? 

Pesticide manufacturers engage in the manufacture, processing, and repackaging of pesticides, and importers of pesticides in Taiwan need to comply with the Pesticide Management Act and apply for licenses. 

Timeline 

Pesticide License application takes between 90 to 150 days. 

Key Requirements 

• The applicant applies enclosing attachment of various pesticide-related toxicology, environmental distribution, and field test data to Agricultural Chemicals and Toxic Substances Research Institute (ACTSRI)
• The use or modification of pesticide labels shall be approved by the central competent authority in advance. After the label is changed, the original label should be replaced within 6 months.
• When pesticide manufacturers or dealers apply for approval and registration in accordance with the preceding article, they shall fill in an application form, and attach the certificate of conformity to the inspection of pesticide standard specifications, physicochemical and toxicological tests, field test data and other relevant data.
• The application for import of pesticide ingredients is exclusively limited to the pesticide manufacturers, and the pesticide ingredients that have been approved for import are limited to their self-use only and cannot be transferred. However, those approved by the central competent authority are not subject to this limitation.

After the fee is paid within 30 days starting from the application and the information has been checked, the case is included in the review process for the preliminary review of pesticide registration information. If there is any information omission, the application process can be restarted again after the applicant is notified to make corrections; if the application is not completed twice within the 3-month period, a new fee must be paid to restart the application process. After the preliminary examination is passed, the applicant shall prepare all application materials after receiving the notification to the Toxicology Section and the Applied Technology Section of the Pesticide Expert Group at Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ).

If the applicant wish to approve the imported sample, the applicant must prepare backup physicochemical data on passing the preliminary review of pesticide registration data to carry out the specification inspection of the applicant's application. Applicant is allowed to send the prepared application materials to the Toxicology Section and the Applied Technology Section of Pesticide Expert Group at BAPHIQ after having passed the specification inspection or upon having passed on re-submission of sample and its back-up data after failing to pass the first specification inspection.

Responsible agency: Pesticide Expert Group of BAPHIQ

BAPHIQ ​​​conducts pesticide safety review and drug efficacy review. After passing the case review, the applicant will be notified to check the documents for registration, or if the notification fails to meet the requirements, the applicant will be notified for re-submission of data or the case will be withdrawn.

​​​​​​​Responsible agency: Food and Drug Administration, Ministry of Health and Welfare (MOHW) and BAPHIQ

1. Food and Drug Administration conducts residue tolerance verification and announcement

   • • After 60 days notice of the residual standard, if there is no objection during the period, it will be officially announced; if there is any objection, it will be open to opinion submission, and the amendment will be announced after 60 days.

2. BAPHIQ issues registration permission of Pesticide License

   • • After the preliminary review of the registration document, if the information is not complete, the preliminary review of the registration document will be carried out again after supplementing the information.

     • After approval, the pesticide license will be issued upon the payment of license fee being made by the applicant.

Official Approval

• Pesticides are legally approved and available to farmers, used in accordance with the "Plant Protection Manual”.

1. 1. 1. Responsible agency: county and city governments

         • • Monitor and control pesticide residues through sampling of agricultural products

           • Sampling points: field before harvest, warehouse, store, market

The validity period of the pesticida License is five years. Within 6 months before the expiry date, the concerned individual may apply for an extension to the central competent authority; each extension shall not exceed 5 years.

The application for extension in the preceding paragraph may be exempted from the inspection of pesticide standard specifications.

For pesticides that have been approved and registered for 15 years, after 5 years from the date of implementation of hereby amended provisions of this Act on Dec. 9, 2014, the application for license extension shall be re-attached with toxicological tests, which shall be handled in accordance with the provisions of Article 10. However, those who have already attached data of toxicological tests when applying for the approval and registration of the pesticide are not subject to this limitation.

Regulations on the characters used in the pesticide labeling in the preceding paragraph, the matters to be recorded, the style of warning and caution signs, and the matters to be followed shall be prescribed by the central competent authority.

Permitted exceptions: pesticides that fall under any of the following circumstances, which have been approved by the central competent authority, are not subject to the restrictions stipulated in Article 9:

1. 1. It is specially used for experimental research, educational demonstration or emergency prevention and control.
   2. After the input, the relevant processing procedures such as manufacturing, processing, and sub-assembly are carried out for the purpose of output.
   3. It is manufactured or processed exclusively for output.
      • The pesticides mentioned in the preceding paragraph shall not be sold in the country or used for other purposes. However, it is not limited to domestic sellers for emergency prevention and control purposes.

Regulations on the application, review and other matters to be complied with for pesticides under the first exception description shall be prescribed by the central competent authority.

On November 07, 2019, the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) announced the Guidelines for Field Trials of Pesticides.

The applicants (Pesticide manufacturers and dealers) should submit an application for field trial design to Agricultural Chemicals and Toxic Substances Research Institute (ACTSRI).

After paying the application fee and passing the review of the expert group, revised, if necessary, the applicants should include other relevant information of field trial permit application to ACTSRI, which is forwarded to BAPHIQ.

BAPHIQ will approve the input drug dose for the field trial permit and notify the applicant

A testing unit approved by the central agency to conduct field efficacy, phytotoxicity, and residue disappearance tests, this includes forming an inspection team of BAPHIQ to conduct test spot check