TCSCA in Taiwan

Taiwan’s Toxic Chemical Substances Control Act incorporates aspects of EU REACH

The Toxic Chemical Substances Control Act (TSCA), the most important chemical control law in Taiwan, was revised to introduce many of the EU REACH regulation concepts into Taiwan. Its revision of articles was promulgated by President Order on Dec 11, 2013 and became effective from Dec 11, 2014.

Article 7-1 of the newly amended TCSCA enables the Taiwanese Environmental Protection Agency (EPA) to gather information and screen toxic chemical substances. It stipulates:

  • The sources of management of chemical substances;
  • That existing chemical substances manufactured or imported in given quantities each year must be registered by the designated deadlines after being manufactured or imported;
  • That all new chemical substances must be registered 90 days before being manufactured or imported;
  • And that the registration should be approved by the central competent authority, Taiwan Environmental Protection Administration (Taiwan EPA).

In addition, TCSCA requires companies that manufacture, import, export, sell, transport, use, store or discard certain controlled toxic chemical substances to apply for permits, to register or get approval to operate and comply with the reinforced management measures.

Registration

Under TCSCA, registrants are domestic manufacturers and importers of chemical substances or their appointed third-party representative (TPR). Foreign companies cannot register directly.

Category Registration type Who When
New substance 3 registration types, depending on volumes and uses: standard, simplified or small quantity registration
  • Manufacturer
  • Importer
  • Representative
90 days before manufacturing or exporting
Existing substance Phase 1 registration*
  • Manufacturer
  • Importer
  • Representative
 
All existing substances imported before March 31, 2016 (≥ 0.1 ton/year). Registration deadline: 31 March 2016
Existing substances, manufactured or imported for the first time after Apr 1, 2016 (≥ 0.1 ton/year). Registration deadline: within 90 days after being manufactured or imported
Phase 2 registration
Listed existing substances as defined by EPA. 
Standard registration: grace period to be defined by the EPA

* Phase 1 registration is similar to pre-registration under EU REACH
Source: ChemSafetyPro.com

Phase 1 registration of existing substances

All existing chemicals manufactured or imported in quantities over 0.1 ton (i.e., 100 kg) per year will be subject to Phase 1 registration for approval prior to their manufacture or importation. Registration requires submission of basic information, including:

  • Registrants’ information
  • CAS No. of chemical substance
  • Annual volume band
  • Usage information

From the information collected during phase 1 registration, EPA will assign to a Priority Existing Chemicals (PEC) list substances of concern – with hazardous properties or high exposure potential – or for which information has not yet been fully identified. These will go through phase 2 registration.

Concerning ExxonMobil products, phase 1 registration was carried-out before March 31, 2016. Although we do not expect our fluids, plasticizers or chemical intermediates to be considered as priority chemical substances, we will evaluate the situation when the PEC list is released, end of 2017. Should any phase 2 registration be required for some of our products, we will take appropriate action.

Phase 2 registration: standard registration for priority chemical substances (PECs)

Under the revised TCSCA, PECs are subject to mandatory standard registration. The PEC list will be released at the end of 2017.

Registration files will include physicochemical and toxicological data, exposure and assessment data, etc.

Management of Controlled Toxic Chemical Under TCSCA

EPA usually classifies toxic chemical substances in classes 1 to 4 when the toxicological characteristics of chemical substances conform to the toxic chemical substance classification definitions given in the table below:

Main differences with EU REACH

  • Registration could only be done by a Taiwan Legal Entity. A non-Taiwanese company cannot appoint an Only Representative (OR) based in Taiwan.
  • Only substances listed on the PEC list requires full registration (Phase 2).
  • All information provided for the registration must be in Chinese.
  • The tool used for preparing the data is different from the EU IUCLID tool and a different computer connection is required.
  • Registration for Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB substances) is not clearly defined. For phase 1 registration, a UVCB substance is accounted for as one substance. However, registration is required for each individual constituent if listed as toxic chemicals when produced, imported, exported, purchased, stored or discarded as a UVCB.
  • There is no requirement to include the registration data in the safety data sheets.

Compare REACH, TCSCA and other similar chemical management programs
To see further similarities and differences between EU REACH, TCSCA and the chemical management programs in force in Turkey and South Korea, click here.

For more information on REACH in Taiwan, please click here.
If you need further assistance, please contact your ExxonMobil sales representative.

Page glossary

  • Article
  • CAS
  • Classification
  • Competent Authority
  • EPA
  • EU
  • Existing Substance
  • Exposure
  • IUCLID
  • Only Representative (OR)
  • PEC
  • Plasticizers
  • REACH
  • Regulation
  • Safety
  • Substance
  • TSCA
  • WHO