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Taiwan TCCSCA Registration

Taiwan,TCCSCA,toxic,substance,registration

Taiwan's industrial chemicals are currently managed by the Toxic and Concerned Chemical Substance Control Act (TCCSCA) and the Occupational Safety and Health Act (OSHA). Under TCCSCA, enterprises manufacturing or importing new substances or a given quantity of existing chemical substances shall register those substances with the Environmental Protection Administration (EPA).

On 11 Mar 2019, EPA revised the Regulation on New and Existing Chemical Substances Registration This regulation has set out detailed information requirements for chemical registrations under TCCSCA.

Who Shall Register

  • Manufacturers of chemical substances in Taiwan;

  • Importers of chemical substances in Taiwan;

The Registrants must be the legal entities or natural person in Taiwan. Registrants may entrust a third party representative (TPR) to complete registration, and representatives must be the legal entities or natural person in Taiwan.

New Chemical Substance Registration

Substances not listed in Taiwan Chemical Substance Inventory (TCSI) are regarded as new chemical substances subject to new chemical substance registration. Based on the tonnage band, substance properties and usage information, three registration types will be adopted, including standard registration, simplified registration, and small quantity registration.

Existing Chemical Substance Registration

All manufactured or imported existing substances with tonnage 0.1t/y shall be pre-registered (Phase 1 registration) before 31th, March, 2016. After 2016, existing chemical substance manufactured or imported, for the first time, with volume >=0.1t/y can still submit post pre-registration.

EPA announced the lists the first batch of 106 Designated Chemical Substances subject to standard registration in March 2019. The Data requirement for existing chemicals standard registration is the same as standard registration of new substances. For the substances that obtained the phase I registration number before Dec 31, 2019, the company should finish standard registration before the deadlines and will be forbidden to manufacture or import these 106 substances into Taiwan after the deadline, unless they finish the registration. The deadlines for standard registration are as follows:

Situation of Phase I Registration

Deadline for Standard Registration

Complete Phase I Registration before 31 Dec. 2019

Annual tonnage exceeding 1 ton, yet no more than 100 ton;

Before 31 Dec. 2022;

 

Annual tonnage exceeding 100 ton;Before 31 Dec. 2021;

Complete Phase I Registration after 1 Jan. 2020

 

Annual tonnage exceeding 1 ton, yet no more than 100 ton;

Within 3 years from 1 Jan. of the second year of Phase I Registration;

Annual tonnage exceeding 100 ton;Within 2 years from 1 Jan. of the second year of Phase I Registration;

The annual tonnage is less than 1 ton when the Phase I Registration is completed

The actual annual tonnage exceeds 1 ton before 31 Dec. 2019

Before 31 Dec. 2022;

The actual annual tonnage exceeded 1 ton after 1 Jan. 2020

Within 3 years from 1 Jan. of the second year of Phase I Registration;

Note: Taiwan is revising the Regulation on New and Existing Chemical Substances Registration and the deadline for standard registration of the designated existing substance  is expected to be extended by 1-2 years.

Our Service

  • General consulting & Training

  • Search and confirm if a substance is listed in TSCI

  • Existing substance Pre-registration (Phase I registration)

  • Existing substance standard registration

  • Local Third Party Representative Service

  • New substance notification (Small volume, Simplified, and Standard)

  • Test monitoring/translation of study reports

  • Preparation and Submission of chemical safety report

  • Preparation of SDS and label in compliance with Taiwan GHS

  • Regulatory update monitoring