By Weisin Chai
The amendment of Taiwan Toxic Chemical Substances Control Act (TCSCA) was published on December 11, 2013 through Regulation No. 10200225131 by the Environmental Protection Administration (EPA). Thirteen articles were revised and four articles added in this amendment. The amendment was effective immediately after the announcement. Exceptions include Article 7-1, Article 7-2, Article 17, Article 35 Part 10, Article 35-1 and Article 41, which will take effect one year after the announcement.
The major changes in the amendment include:,
- adding regulations in regards to registration, evaluation and control of toxic chemical substances;,
- imposing stringent restrictions on Class 4 toxic chemical substances;,
- adding the requirement of publicizing exposure condition of toxic chemical substances;
- granting special permission for emergency response vehicles to be exempt from speed limits, restrictions on road traffic signals, markings and informative signals while performing emergency duties when warning lights and siren are on.
Stipulated in Article 7-1, manufacturers and importers of existing chemicals at quantities above the annual tonnage band shall register to the Taiwan Environmental Protection Administration (EPA), Executive Yuan before the designated deadlines. Existing chemicals refer to chemical substances which have been published on the National Existing Chemical Substance Inventory (NECSI). Any chemicals not available on the NECSI are defined as new chemical substances. Application for registration of new chemicals shall be done 90 days before manufacturing or importing. Handling of Class 1, Class 2 and Class 3 toxic chemical substances are subjected to prohibition or restrictions. Therefore, the new chemicals which conform to the definition of Class 1, Class 2 or Class 3 toxic chemical substances are subjected to prohibition and restrictions as well. The Class 4 toxic chemical substances which previously required notification only to special municipality, county city competent authorities before handling, are now subject to the approval requirement.
Based on the manufacturing or importing quantity, the registration is categorized into standard registration, simplified registration and small-quantity registration. The application shall include information such as condition of manufacturing or importation, physical and chemical properties, toxicology information, exposure information, risk assessment and any other information requested by the EPA. Similar to the European Union regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), joint registrations are accepted in TCSCA. Registrants of the same chemical substance may use information which has already been submitted by previous registrants. This can avoid duplicate testing. The cost of the data may be shared under the agreement of all registrants. EPA will intervene only when requested by the registrants.
In addition to the stipulation on registration on chemical substances, according to Article 41, information about chemical substances registered under TCSCA will be disclosed to the public with the exception of those substances involved in national defense or claimed as business confidential. Industries may file confidential business information (CBI) to EPA. However, if the information is needed for the benefit of the public, for protecting people’s lives, bodies and health, or consented by the manufacturer or importer, the CBI may need to be disclosed. Even with chemical substances that are involved in national defense or covered by CBI, there is certain information that is not subject to confidential protection. This may include information such as chemical identities, physical and chemical properties, toxicological information, classification, labelling and other safety-related information when activities such as investigating, checking, sample-collecting and testing are performed for the execution of this Act.
Except for those chemical substances regulated under the TCSCA, the chemical substances which have been approved after the registration process shall comply with any other relevant and applicable regulations.
As a result of this amendment, other enforcement rules relating to classification of chemical substances, annual tonnage bands, conditions of manufacturing or import, physical and chemical properties, toxicological information, exposure information, risk assessments, term of registration, procedures for different categories of registration, the procedure of approval, rejection, revocation or cancellation of a registration, chemical-handling prohibitions or restrictions, post registration reporting or modification of chemical substances information, recordkeeping, CBI, etc. shall be determined or drafted to align with TCSCA. Industries should stay alert on the progress of chemical control measures in Taiwan throughout 2014.
Readers may consult the listed websites for more details regarding TCSCA, subsequent regulations and the NECSI.
Toxic Chemical Substance Control Act (TCSCA)
The Toxic Chemical Substances List
The Toxic Chemical Substances Search Engine
Other subsequent regulations under TCSCA
National Existing Chemical Substance Inventory (NECSI)