Revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan

The revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan was officially promulgated by President Ma Ying-jeou on 11 December 2013.

The English version of the full text of the revised TCSCA (Non-official translation) can be downloaded here free for charge


Regulation Requirements

The revised TCSCA requires enterprises to register (submit the dossier) new substances 90 days prior to production or importation, pre-register (Phase I Registration) existing substance and register(Phase II Registration) designated existing substances manufactured or imported above a given quantity.

Pre-registration (Phase I registration)

All manufactured or imported existing substances with tonnage 0.1t/y shall be pre-registered before 31th, March, 2016. Company information, basic substance identification information, produced or imported volume and use information shall be provided via IT system. In order to keep confidential business information (CBI), a manufacturer outside Taiwan may appoint a Taiwan local agent (TPR, Third Party Represent) to finish pre-registration. 

Late pre-registration will be applicable after 1st March 2016 for first production and importation after that.

Registration (Phase II registration)

All manufactured or imported new substance with tonnage 0.1t/y shall be registered 90 days prior to production or import. For existing substances, similar to K-REACH, some designated substances are required to be registered. They shall be registered before different deadline according to hazard and volume in Taiwan. However, the first batch of designated substances is not released till now. Non Taiwan manufacturer can also appoint a TPR to complete registration. 


New or Existing

A new substance is defined as a substance is not listed in Taiwan Chemical Substance Inventory (TCSI) published by Authority. More information could be found here.


Registration Type

There are three types of registration:  standard registrationsimplified registration and small volume registration. Standard registration includes four ties and data requirements increase by degrees.

Annual

PPORD

 R&D

CMR+1

Standard

on-site isolated intermediate

Polymer

PLC

1000t

St. reg. I

St. reg. IV

St. reg. IV

St. reg. I

Sm. reg. + pre evaluation

100t

St. reg. IV

St. reg. III

10t

St. reg. III

St. reg. II

1t

Sim. reg.

St. reg. II

St. reg. I

Sim. reg.

100kg

Sm. reg.

NA

St. reg. I

Sim. reg. or Sm. reg.

Sm. reg.

NA


Management of Toxic Chemical Substance

Download the toxic chemical substance inventory here.

The Act also strengthens the management of Class 4 toxic chemical substances. Enterprises are required to declare relevant toxicological information and obtain approval from competent authorities for Class 4 toxic chemical substances prior to handling. The provisions pertaining to chemical registrations have come into force on 11 Dec 2014. CIRS summaries major points of the rules.

The table below shows the definitions of Class 1, 2, 3 & 4 toxic chemical substances and how they are regulated under TCSCA.

Category

Class 1

Class 2

Class 3

Class 4

Hazard

Hard to break down in the environment and easily to pollute the environment and endanger human beings health because of the bioaccumulation, bioconcentration, or biotransformation.

Has the ability to cause cancer, infertility, birth defects, genetic mutations, or other chronic diseases.

Human beings health and environment will be endangered immediately after exposure to chemicals.

There is a risk to endanger human beings health and the environment.

Management

1. Obtain the permit(manufacture, import or sell toxic substances more than the large scale handling standard)
2.Obtain the registration(use, store and dispose toxic chemical substance more than the large scale handling standard) - like reporting;
3.Obtain approval(manufacture, import, sell, use, store or dispose toxic chemical substance less than the large scale handling standard)

Toxicological information concerning the toxic chemical substances should be submitted and approved.

Label and SDS

yes

yes

yes

yes

Note 1: The validity period of the permit, the registration document and approval is 5 years.

Note 2: Only domestic enterprises in Taiwan can apply for handling permits.


SDS and Label under TCSCA

Under revised TCSCA, the handler shall, pursuant to regulations, mark matters related to toxicity and pollution control on Class 1 to Class 4 toxic chemical substance containers, packaging, handling sites, and facilities, and shall keep safety data sheets for the corresponding toxic chemical substances. GHS SDSs and labels are compulsory for Class 1 to Class 4 toxic chemical substances and mixtures containing them.


Penalty

The table summarizes the penalties for failing to register substances under revised TCSCA.

Category

Comments

Failure to notify new substance;

  1. Fine: NT$200,000 to NT$2,000,000;
  2. Repeated infringement: business suspension or returned export.

Failure to register designated existing substance.

  1. Fine:  NT$30,000 to NT$300,000;
  2. Repeated infringement: business suspension or returned export.


Our Service

  • General consultancy & training;
  • Search and confirm if a substance is new in Taiwan;
  • Pre-registration and TPR service;
  • Dossier preparation and submission of new substance notification and existing substance registration (full, simplified, small volume);
  • Test monitoring/translation of study reports;
  • Preparation of SDS and label in compliance with Taiwan GHS;
  • Regulatory update monitoring.


About us and contact

We have provided one-stop chemical notification and GHS services for many companies doing business in/with Asia (for example, China, Japan, Korea, Taiwan, Malaysia, and Philippine). We help them find out how their chemicals are regulated in those countries or regions and offer free initial consultations about how to comply. If notification is required, we help them submit chemical registrations (sometimes via our local partners). We also prepare or translate GHS compliant SDS and label in accordance with their national chemical legislation at affordable prices.

If you have any questions about chemical compliance in the Asia-pacific region, please contact: Service@cirs-reach.com