The main legislation governing the new chemical substances market in Taiwan is the Toxic and Concerned Chemical Substances Control Act (TCCSCA) and its subordinate regulation, Regulations for Registration of New and Existing Chemical Substances, administered by the Chemical Substance Management Administration, Ministry of Environment (MOENV). The current regulatory framework came into force on 16 January 2019, replacing the former Toxic Chemical Substances Control Act and unifying the environmental and occupational safety management systems.
In 2014, Taiwan formally established its dedicated new chemical substance regulatory system by issuing the Regulations for Registration of New and Existing Chemical Substances, which came into effect on 11 December 2014. This regulation introduced a tiered registration system and officially launched the Taiwan Chemical Substance Inventory (TCSI) on 31 December 2014, initially listing approximately 93,000 substances. Finally, in 2019, the overarching law was comprehensively revised and enacted as the Toxic and Concerned Chemical Substances Control Act (TCCSCA), which fully implemented a mandatory registration regime for both new and existing chemical substances and transferred inventory management to the Ministry of Environment.
The TCCSCA and related regulations impose registration obligations on:
Chemicals already regulated under other specialized laws are exempt from new chemical registration under the TCCSCA, including:
Radioactive substancesPharmaceuticals (including Active Pharmaceutical Ingredients (API))Pesticides (including technical material)Veterinary drugsCosmeticsFood and food additivesFeed and feed additivesFertilizers
Also exempted are:
(As of 2026, the TCSI is dynamically maintained by the MOENV and contains over 108,000 chemical substances.)
Legal basis and the Authority
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.
Definition of Pesticide under PMA
Finished Pesticides refers to the following drugs or biological product:
those used to regulate the growth of agricultural and forestry crops or affect their physiological effects
for regulating the growth of beneficial insects
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.
Pesticide License
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.
Pesticide License application takes between 90 to 150 days.
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.
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.
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.
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.
Pesticides are legally approved and available to farmers, used in accordance with the "Plant Protection Manual”.
Responsible agency: county and city governments
Monitor and control pesticide residues through sampling of agricultural products
Sampling points: field before harvest, warehouse, store, market
Valid Time for Pesticide License and Permit
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:
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.
Field Trial Permit
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
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