Taiwan TCCSCA and OSHA Chemical Substance Registration

Overview of Taiwan Chemical Regulations

Chemical substances in the Taiwan region are primarily regulated by two key legislative frameworks: the Toxic and Concerned Chemical Substances Control Act (TCCSCA) and the Occupational Safety and Health Act (OSHA). These regulations aim to manage the environmental and occupational health risks associated with chemical exposure throughout the supply chain.

The Environmental Protection Administration (EPA) oversees TCCSCA, which focuses on the environmental management of toxic and concerned chemical substances. Meanwhile, the Ministry of Labor (MOL) administers OSHA, prioritizing the safety and health of workers handling hazardous chemicals in the workplace. Compliance with both acts is mandatory for any enterprise manufacturing or importing chemical substances into Taiwan.

Navigating these dual requirements is essential for smooth market operations. Proregulations offers comprehensive support to help companies determine their registration obligations and complete the necessary filings under both TCCSCA and OSHA.

Compliance Strategies and Substance Categories

The registration requirements in Taiwan are determined by whether a substance is classified as "new" or "existing" and its annual tonnage.

Existing Chemical Substances

Substances already listed in the Taiwan Chemical Substance Inventory (TCSI) are considered existing chemicals. These substances are subject to:

• Phase 1 Registration: Mandatory for substances manufactured or imported in volumes exceeding 100 kg per year.
• Standard Registration: Required for specific existing substances designated by the EPA when they exceed 1 ton per year.

New Chemical Substances

Any substance not listed in the TCSI is classified as a new chemical substance. Under both TCCSCA and OSHA, new substances must undergo registration before being placed on the market. The type of registration—Small Volume, Interim, or Standard—depends on the tonnage and the specific use of the substance.

New Chemical Substance Registration Types

Taiwan's registration system for new substances is tiered based on the annual quantity and the nature of the chemical application.

• Small Volume Registration
  Applicable for substances manufactured or imported in quantities between 0.1 and 1 ton per year.
• Interim Registration
  Typically used for substances in quantities between 1 and 10 tons per year, or for specific categories like polymers with low concern.
• Standard Registration
  Mandatory for substances exceeding 10 tons per year. This process is the most comprehensive, requiring detailed toxicological and ecotoxicological data.

For substances used exclusively for scientific research and development (SRD) or product and process-orientated research and development (PPORD) in volumes under 1 ton, simplified notification procedures may apply.

Proregulations' Taiwan Chemical Registration Services

Our team provides specialized compliance solutions to help international and local enterprises manage their TCCSCA and OSHA obligations in Taiwan.

• Third-party representative (TPR) service
  We can act as the authorized TPR for foreign manufacturers, handling all registration procedures and protecting confidential business information.
• Inventory search and substance identification
  Our experts verify whether your substances are listed in the TCSI to confirm their regulatory status as new or existing chemicals.
• Dossier preparation and submission
  We manage the entire application process, from data gap analysis to the final submission of registration dossiers for all levels of registration.
• Testing coordination and risk assessment
  Proregulations coordinates with qualified laboratories to generate necessary testing data and performs comprehensive environmental and health risk assessments.
• Post-registration support
  We provide ongoing assistance with annual reporting, registration maintenance, and updates to ensure continued compliance.

If you need to navigate the complexities of Taiwan's TCCSCA and OSHA regulations and ensure your products meet all legal requirements, please contact us.