Taiwan New and Existing Chemical Substances Registration under TCSCA/OSHA
The year 2015 will witness new changes to the chemical substance management in Taiwan, resulted from the newly amended Toxic Chemical Substances Control Act (TCSCA) and Occupational Safety and Health Act (OSHA).
In accordance with Article 7-1 of TCSCA, Taiwan’s Environmental Protection Administration (EPA) promulgated the Regulation on New and Existing Chemical Substances Registration, which came into force on 11 Dec 2014. As the regulation focused on the bodies responsible for the management of chemical substances, TCSCA assumed control over new and existing chemicals, imposing registration obligations to relevant stakeholders before accessing the market.
Additionally, Taiwan’s Ministry of Labor (Taiwan MOL) offcially announced the “Regulation on New Chemical Substance Registration and Management” based on Article 13 of the OSHA amended in Jul 2013. This regulation entered into force on 1 Jan 2015.
Both TCSCA and OSHA have allocated chemical registration duties upon local manufacturers or importers. By excluding Non-Taiwanese companies as certificate holders, this move has shown the central government’s regulatory emphasis shift to local manufacturers and importers.
*Non-Taiwanese company is not able to submit an application directly or appoint a representative to register the chemicals on their behalf.The application has to be submitted by the domestic importers.
*Non-Taiwanese exporters shall involve in the registration by providing relative information to local importer or TPR.
*Domestic manufacturers or importers can submit an application by themselves or with the help of the third-party representative.
The following conditions have remained unaffected by regulations under TCSCA and OSHA:
New Chemical Substance Registration under TCSCA and OSHA
Under both TCSCA and OSHA, a new chemical substance is defined as any chemical substance that is not included in Taiwan’s Chemical Substance Inventory (TCSI). The regulations require new chemical substances to be registered based on their tonnage bands, annual quantities of manufacture or import and their chemical usage.
The specific registration type is determined both by the properties of the substances as well as the corresponding usage, which is shown in the following chart:
* This chart integrates the requirements under both TCSCA and OSHA.
* Substance of Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) refers to a substance that meets any criteria of carcinogenicity category 1;mutagenicity category 1; reproductive toxicity category 1, based on R.O.C. National Standards (CNS) 15030.
* Generally, a registrant should submit hazard & exposure assessment if the annual quantity of new substance is over 10 tons. However, when the substance turns out to have no designated PC/TOX/ECO-TOX hazard classification, exposure assessment is then exempted. If annual quantity of new substance is over 1000 tons, a registrant should submit both hazard assessment and exposure assessment.
Existing Chemical Substance Registration under TCSCA
Generally, it is a stepwise process for the management of existing chemical substance which splits into Phase 1 and Standard Registration phase.
Companies that fail to comply with the regulation prior to manufacturing or importing chemical substances will be severely penalized.
>> Comprehensive Regulatory Information
>> Local Third Party Representative Service
>> New Chemical Substance search
>> Training and Consultancy Service
>> Overall Registration Proposal (including Exemption Analysis, Data Assessment, Data Gap Analysis, etc.)
>> Business Confidential Information Protection Application
>> Identification and Registration for Polymer of Low Concern
>> Existing Chemical Substance Phase I Registration
>> Existing Chemical Substance Standard Registration
>> New Chemical Substance Registration (Small Quantity, Simplified, and Standard)
>> Test Monitoring Services
>> Non-testing Data Services (QSAR, Read Across, Expert Statement, Testing Proposal )
>> Preparation and Submission of Risk Assessment Report
>> Preparation of Taiwan Safety Data Sheet (SDS) and Label
>> Communication with Competent Authorities/Experts
>> Registration Certificate Renew/Change
>> Registration/CBI extension
>> TCSI listing
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