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Taiwan - Regulation

On 16 January 2019, Taiwan 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.

Companies manufacturing or importing chemical substances in Taiwan will need to comply with the TCCSCA with following procedures: 

 

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.

 

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). 

Registration for New Chemicals

New Chemical Substances can be registered in three types: Standard registration (above 1 TPA), Simplified registration (between 100 kilograms to 1 TPA) and Small quantity registration (less than 100 kilograms). Application needs to be submitted 90 days before manufacturing and importing. 

Non-Taiwanese manufacturers not willing to disclose product compositions to their Taiwanese clients can nominate a TPR to submit substance information and fulfil the obligation of annual reporting. 

 

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. 

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. 

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