Tuesday, December 17, 2013

New Taiwan TCSCA - Toxic Chemical Substances Control Act (TCSCA)

The revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan was officially promulgated by President Ma Ying-jeou on 11 December 2013. The revised TCSCA requires enterprises to register new substances 90 days prior to production or importation and register designated existing substances manufactured or imported above a given quantity. 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 are expected to come into force on 11 Dec 2014 while other provisions will come into force at the date of promulgation.  

What is New? Taiwan EPA Releases the English version of the Regulation on New and Existing Chemical Registration in Feb

The regulation has set out detailed chemical registration requirements under TCSCA and it can be accessed here. It is recommended that you also read our summary of TCSCA registration requirements first.

Background of Revision

TCSCA was firstly issued in Nov 1986 and has gone through 5 revisions with the latest amendment done in 2007. It is the main legislation for industrial chemicals in Taiwan and its primary focus is on the control of toxic chemical substances, requiring business operators to apply for handling permits for designated toxic chemical substances from Environmental Protection Administration (EPA).
The main reason for amendment is that there is no chemical registration scheme in Taiwan. After so many countries (Korea, China, Japan) have implemented REACH-like chemical legislation and required risk assessment of chemical substances, Taiwan may become a test ground for new substances if not having a chemical registration scheme in place. In addition to that, the food plasticizer contamination incident in 2011 made authorities realize that they do not have sufficient power under current TCSCA (i.e, request for toxicology data or requiring license) to control chemical substances for which there is concern of pollution of the environment or the endangerment of human health (Class 4 toxic chemical substances).

Chemical Substance Registration

The following substances require registration

Category
Comments
  • New Substance
  1. New substance shall be registered 90 days prior to production or import;
  • Designated Existing Substance at a given quantity or above
  1. The list of designated substances subject to registration will be announced by authorities;
  2. Grace period will be given;

A new substance is defined as a substance that is not listed in Taiwan national existing substance inventory
Registration information includes manufacturing or importing details, the physical, chemical, and toxicology data, exposure and hazard assessment data and other information designated by the central competent authority. According to substance type and the quantities of manufacturing or importing, there are 3 types of registration: standard registrationsimplified registration andsmall volume registration.

What is New? Top 10 Differences between Taiwan TCSCA and EU REACH Compared


Taiwan TCSCA is another new important REACH-like chemical regulation that imitates EU REACH regulation. Despite many similarities, Taiwan TCSCA and EU REACH are different in many aspects. In this article, we have summarized the top 10 differences between Taiwan TCSCA and EU REACH to help you comply with TCSCA.

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