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Taiwan - Regulation

On 16 January 2019, Taiwan has amended the country’s toxic chemical law from Toxic Chemical Substance Control Act and renamed it to Toxic Chemicals and Concerned Substances Control Act (TCCSCA). On March 11 2019, Taiwan’s Environmental Protection administration (EPA) published the amended regulation on New and Existing Chemical Substances. Under the new Act, manufacturers or importers of new substances or existing chemical substances must apply to the Environmental Protection Administration (EPA) for chemical substances registration.

 

 

From 1 January 2020, manufacturers or importers who manufacture or import Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacturing/importing. 

For New Chemical Substances, companies should submit application before manufacturing or importing. 

According to TCCSCA, Taiwanese manufacturers, importers and Third-Party Representatives (TPR) based in Taiwan can register substance information. 

Non-Taiwanese companies are not allowed to submit substance registrations directly and they cannot appoint a TPR to register substances on their behalf. The regulations only authorize Taiwanese importers or manufacturers to appoint a TPR to assume their chemical registration responsibilities.

Non-Taiwanese manufacturers not willing to disclose product compositions to their Taiwanese clients can ask the importers to nominate a TPR to do the annual reporting on behalf of the importers without disclosing product composition to the importers. 

 

Chemical Inventory in Taiwan

Taiwan’s Chemical substance Inventory (TCSI), was compiled jointly by two competent authorities, the Environmental Protection Administration and Ministry of Labor. The inventory contains more than 100,000 substances that have been circulated or placed in Taiwan. The Inventory Chemical Substance Nomination and Notification (CSNN) is available online and one can search for chemical substances via CAS no., English name or Chinese name. Chemicals in the inventory are considered Existing Chemical Substances in Taiwan. Chemicals outside the inventory are considered New Chemical Substances

 

Registration of Existing Chemical Substance

Phase One Registration

Manufacturers / Importers, who manufacture/import existing chemical substances in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacture/import.

Information required for Phase One Registration: 

  • Name of substance, CAS No.​
  • Tonnage band in a calendar year (estimated)​
  • Information on use​
  • Use information of this chemical (Product type)

 

Standard Registration

Taiwan's EPA announced the first batch of Priority Existing Chemical (PEC) in which contains 106 substances. Companies manufacturing/importing PECs with a quantity above 1 TPA need to submit Standard Registration: 

  • Before December 31, 2024 (if the Phase One Registration Number received before January 1, 2020)
  • Before December 31, 2025 (if the Phase One registration Number received after January 1, 2020). 

Data requirement for Standard Registration: 

  • Information of the registrant and basic identification of the substance​
  • Information on manufacture, use and exposure of the substance
  • Hazards classification and labelling​
  • Physical and chemical properties​
  • Safe use information​
  • Toxicological information​
  • Ecotoxicological information​
  • Hazard assessment​
  • Exposure assessment​

 

 

 

Substance Type

Deadlines

Existing Substance

Registration within 6 months of manufacture/import (M/I) tonnage exceeding 100 kg per year

Existing Substance (106 PECs)

Phase One Registration within 6 months 

Standard Registration, if Phase One Registration Number obtained before 1 Jan 2020:

December 31, 2024

Standard Registration, If Phase One Registration Number obtained after 1 Jan 2020:

December 31, 2025

 

New Substance

Registration is required 90 days before M/I

All Substance after Registration

Annual Reporting of the last year to the EPA between 1 April to 30 September every year

 

The Regulations shall not apply to any of the following substances or articles:

  • Substances which occur in
  • Chemical substances in machines or equipment for test run
  • Inseparable intermediates from chemical reactions in the reaction vessel or production
  • Chemical substances for national security or national defense
  • Chemical substances under customs
  • Chemical wastes produced or released from industrial
  • By-products or impurities that are of no commercial
  • Mixtures; but individual constituents of mixtures shall not be applied to the
  • Polymers that the 2% Rule is Applicable and listed on the inventory of existing chemical

In addition, the regulation is not applicable to substances or articles that are regulated by following Acts:  

  • Agro-pesticides, as defined by the Agro-pesticides Management Act 
  • Feeds and feed additives, as defined by the Feed Control Act 
  • Fertilizers, as defined by the Fertilizer Management Act 
  • Veterinary drugs, as defined by the Veterinary Drugs Control Act 
  • Medicaments, as defined by the Pharmaceutical Affairs Act 
  • Controlled drugs, as defined by the Controlled Drugs Act 
  • Cosmetic(s), as defined by the Statute for Control of Cosmetic Hygiene 
  • Foods, food additives, food utensils, food containers or packaging, and food cleansers, as defined by the Act Governing Food Safety and Sanitation 
  • Tobacco products, as defined by the Tobacco Hazards Prevention Act 
  • Tobacco and alcohol, as defined by the Tobacco and Alcohol Administration Act 
  • Radioactive materials, as defined by the Atomic Energy Act and the Ionizing Radiation Protection Act 
  • Industrial use explosive materials, as defined by the Industrial Explosives Administrative Act 
  • Chemicals regulated by the Montreal Protocol under the Air Pollution Control Act 
  • Environmental agents, as defined by the Environmental Agents Control Act 
  • Toxic chemical substances, as defined by the Act

 

In Taiwan, GHS has been implemented for selected chemicals since 2008. Full GHS implementation for all hazardous chemicals including their physical and health hazards at workplace has been enforced since 2016. Both Toxic Chemical Substance Control Act (TCSCA) and Occupational Safety and Health Act (OSHA) require chemical suppliers to label the packages and containers of hazardous or toxic chemicals and provide Safety Data Sheets (SDS) with relevant GHS regulations and standards in Taiwan.

Labeling and SDS requirements under the Ministry of Labor's Regulations: 

Standard  GHS Format and Content Yes
Language Traditional Chinese
Substance Name Traditional Chinese & English
Labeling of the small package (<= 100 ml) Product Identifier, pictogram and signal word
Review of SDS Every 3 years 
Exemption consumer products, etc. 

New Chemical Substances (refers to those not listed in the inventory) can be registered in three types under the TCCSCA:

  • Standard registration: at 1 ton or more
  • Simplified registration: at 100 kilograms or more, but less than 1 ton
  • Small quantity registration: less than 100 kilograms

Registration for New Chemical Substances is further divided into the following categories:  

  • General new chemical substances
  • Scientific research and development
  • Process orientated research and development, PPORD.
  • On-site isolated intermediates
  • Polymer
  • Polymer of low concern
  • Nano scale chemical substance
  • Substance of carcinogenic, mutagenic or toxic for reproduction (CMR)

 

New Chemical Substances need to be registered before manufacturing and importing. 

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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. 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. 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

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