Taiwan Region TCCSCA/OSHA
Taiwan’s industrial chemicals are currently managed by the Toxic and Concerned Chemical Substance Control Act (TCCSCA) and the Occupational Safety and Health Act (OSHA). The two laws fall under the remit of two different authorities, namely the Environmental Protection Administration (EPA) and the Ministry of Labor (MOL).
The associated registration obligations required for chemicals are stipulated in the subordinate regulations under TCCSCA and OSHA, namely the Regulation on New and Existing Chemical Substances Registration (EPA’s regulation, revised on 11 Mar 2019) and the Regulation of New Chemical Substances Registration (MoL’s regulation, revised on 19 Aug 2015).
Companies outside Taiwan are not allowed to submit registration applications directly nor appoint a TPR based in Taiwan to register substances on their behalf. Both regulations only authorize importers and manufacturers in Taiwan to appoint a third party representative (TRP) based in Taiwan to assume their chemical registration responsibilities.
New Chemical Substance Registration under TCCSCA and OSHA
Substances not listed in Taiwan’s existing chemical substance inventory (TCSI) are regarded as new chemical substances subject to new chemical substance registration. Based on the tonnage band, substance properties and usage information, three registration types will be adopted, including standard registration, simplified registration, and small quantity registration.
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:
a: Substances classified as Carcinogenic, Mutagenic, or toxic for Reproduction (CMR) refers to those that meet the criteria of carcinogenicity category 1; mutagenicity category 1; reproductive toxicity category 1, based on “CNS 15030”.
b: Generally, a registrant should submit a hazard & exposure assessment if the annual quantity of new substance is exceeds 10 tons. However, when the substance turns out to have no designated PC/TOX/ECO-TOX hazard classification, exposure assessment is exempted.
Existing Chemical Substance Registration under TCCSCA
Step-wise registration is applied to Taiwan’s existing chemical registration.
* ECN: Existing Chemical Nomination
** Transitional Registration: Registration measure for chemical substances manufactured or imported in Taiwan before the regulation came into effect
The exemptions are identical under TCCSCA and OSHA.
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 Consulting Services
- 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)
- Registration platform and Consortium Management
- Test Monitoring Services
- Non-testing Data Services (QSAR, Read Across, Expert Statement, Testing Proposal )
- Preparation and Submission of Risk Assessment Report
- Communication with Competent Authorities/Experts
- Registration Code Renewal/Change
- Registration/CBI Extension
- TCSI Listing
- Annual Reporting