Taiwan Toxic Chemical Substance Control Act (TCSCA)

Little Pro on 2015-12-31

Toxic Chemical Substances Control Act (TCSCA) is the most important chemical control law in Taiwan. It has undergone 6 amendments since its promulgation in 1986. The amended TCSCA was promulgated by Presidential Order on 11 Dec 2013 and fully comes into force on 11 Dec 2014.

Main Requirements of Taiwan TCSCA

The revised TCSCA introduces many concepts of EU REACH regulation into Taiwan. Under the new Act, enterprises manufacturing or importing new substances or a given quantity of existing chemical substances shall register those substances with the Environmental Protection Administration (EPA). Enterprises that manufacture or import new substances or existing toxic chemical substances without the approval of the EPA will be liable to fines in the range of NT$200,000-2 million for manufacturers or NT$30,000-300,000 for importers.

TCSCA also requires enterprises who handle certain controlled toxic chemical substances to apply for permits, registration or approval and comply with relevant management measures. Here "Handling" refers to activities such as the manufacture, import, export, sale, transport, use, storage or discarding of chemical substances.

To understand the impact of TCSCA on your businesses, you need to:

  • Check if your products or raw materials are within the scope of TCSCA;
  • Check if you need to do any registrations;
  • Check if you handle certain controlled toxic chemicals announced by the EPA;

Scope of Taiwan TCSCA

  • Substance on its own or in mixture- new substance(1) & existing substances;
  • Substance intended to be released from an article(2); and
  • Certain toxic chemical substances annouced by the EPA;
Out of Scope
  • Naturally occurring substances;
  • Finished chemical products subject to other laws: cosmetics, pesticides, pharmaceuticals, food additivies, etc.;

1.'New substance' is a substance that is not listed on national existing chemical substance inventory. More info about this inventory can be found here.

2."Article" means a manufactured item formed to a specific shape or design during the manufacturing process(i.e., cups, toy cars, etc.). Articles that do not contain any substances intended to be released are exempt from registrations. However, articles may need meet certain restriction or prohibition requirements of TCSCA if they contain controlled toxic chemical substances annouced by the EPA.

Chemical Substance Registration under TCSCA

Under TCSCA, registrants are domestic manufacturers(M) and importers(I) of chemical substances. Domestic manufacturers and importers can appoint third-party representatives to handle substance registrations via notarized appointment letters. Forein companies cannot directly submit substance registrations. Registration numbers will be issued to registered substances.

Category Registration Type Who/When
New Substance
  • Standard registration, simplified registration or small quantity registration;
  • Depending on volume and uses;
  • Who: M/I/representative
  • When: 90d prior to M/I;
Existing Substances
  • Phase I registration(*): All existing substances(>=0.1t/y);
  • Post Phase I registration: An existing chemical substance manufactured or imported, for the first time, with volume >=0.1t/y, after 31 March 2016;
  • Standard registration: Designated existing substances(>=1t/y) annouced by the EPA;
  • Who: M/I/Representative
  • Phase I registration deadline: 31 March 2016
  • Standard registration: Grace period will be designated by the EPA.

* Phase I registration is equivalent to pre-registration under EU REACH regulation and the information required is very simple. The first list of 106 designated prioritized existing substances has been published in March 2019. 

Read more: Chemical substance registration under TCSCA

Annual Reporting

Obtaining registration numbers for new substances and >=1t/y prioritized existing chemical substances (PEC) is not the end of TCSCA. Registrants are required to report the production or import volume of registered chemical substances to EPA on annual basis. This is a new requirement added in March 2019 via the revision of Regulations of New and Existing Substance Registration [Update: March 2019].

Management of Controlled Toxic Chemicals under Taiwan TCSCA

EPA usually announce toxic chemical substances as Class 1, Class 2, Class 3 or Class 4 when the toxicological characteristics of chemical substances conform to the toxic chemical substance classification definitions given below.

Classs 1
  • Chemical substances that are not prone to decompose in the environment or that pollute the environment or endanger human health due to bioaccumulation, bioconcentration or biotransformation.
Class 2
  • Chemical substances that cause tumors, infertility, teratogenesis, genetic mutations or other chronic diseases.
Class 3
  • Chemical substances that endanger human health or the lives of biological organisms immediately upon exposure;
Class 4
  • Chemical substances for which there is concern of pollution of the environment or the endangerment of human health.

Once a substance has been annouced as Class 1, 2, 3, or 4 toxic chemical substance, enterprises who handle it will need to apply for permits, registration or approval and comply with relevant management measures.

Category Management Requirements
All 4 classes
  • Regularly report records concerning the handling of toxic chemical substances and their release quantities(Article 8);
  • Marking and labelling of containers, packages and preparation/keeping of safety data sheets(Article 17);
  • Handlers shall not sell or transfer them to those that have not obtained a permit, registration or approval(Article 23);
Class 1, 2 & 3 Only
  • May face restriction or prohibition from handling(Article 7);
  • Handlers may apply for the removal of the restrictions or prohibitions(Article 7);
  • Submission of risk prevention and response plans(Article 10);
  • Apply for a permit(by M/I), registration(by user or storage company) or approval(usage below than large-scale usage)(Article 13);
  • Employ professional technical management personnel(Article 18).
Class 4 Only(New requirement).
  • Submission of toxicological information and obtaining an approval prior to handling(Article 7).

To download all 4 classes of toxic chemicals, please click here. When a toxic substance is annouced, the EPA will also annouce whether the toxic substance is restricted or prohibited from handling. From example, Polychlorinated biphenyls is prohibited from all handling and uses except for research, testing or education purpose.

Reference & Resources

Click here to access all references and resources for Taiwan including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities.

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 Tags: Topics - TaiwanREACH-like Regulation and Registration