Taiwan REACH: Toxic Chemicals and Concerned Substances Control Act (TCCSCA)

On January 16, 2019, Taiwan ushered in a significant evolution in its regulations governing toxic chemicals. This transformation saw the existing Toxic Chemical Substance Control Act rebranded as the Toxic Chemicals and Concerned Substances Control Act (TCCSCA). With its implementation, companies involved in the production or import of new and existing chemical substances found themselves faced with new mandates, leading to changes in their operational procedures.

Introduction to the TCCSCA

The Toxic Chemicals and Concerned Substances Control Act, also known as TCCSCA, signifies a monumental shift in Taiwan's stance on regulating toxic chemicals. Enacted on January 16, 2019, it has been designed to enhance environmental protection and safety standards through the oversight of chemical substance management. The TCCSCA encompasses several critical components that businesses dealing with chemical substances must grasp to ensure they stay compliant with the law.

Registration of Chemical Substances

One of the foundational aspects of the TCCSCA is the obligatory registration of chemical substances with the Taiwan Environmental Protection Administration (EPA) for companies engaged in their production or import. The registration process is categorized into different types based on the nature of the chemical substance.

• New Chemical Substance Registration

New chemical substances, those not present in the Taiwan Chemical Substance Inventory (TCSI), necessitate registration. This registration is classified into three types, each contingent on factors such as tonnage, substance properties, and usage data:

1. Standard Registration: This category applies to most new chemical substances.
2. Simplified Registration: Companies can opt for this if their substances meet specific criteria.
3. Small Quantity Registration: Reserved for substances with lower tonnage and certain characteristics.

These categories facilitate a more tailored approach to the registration process, accommodating companies with a variety of chemical substances.

The following categories are used to further categorize registration for new chemical substances:

• Novel chemical compounds in general
• Development and research in science
• PPORD stands for process-oriented research and development.
• Isolated intermediates on-site
• Polymer Low-concern polymer
• Chemical compound at the nanoscale
• Carcinogenic, mutagenic, or reproductively harmful substance

Existing Chemical Substance Registration

For substances already in production or import with an annual tonnage of 0.1 tons or more, Phase One Registration is mandatory. The deadline for Phase One Registration was set six months after the commencement of production or importation, beginning from January 1, 2020. This crucial provision ensures that companies dealing with existing chemical substances comply with the new regulations in a timely manner.

Registration by Non-Taiwanese Companies

It's important to note that non-Taiwanese companies are not permitted to directly submit substance registrations or appoint a Third-Party Representative (TPR) for registration. Only Taiwanese importers or manufacturers can designate a TPR for chemical registration. This requirement underscores the significance of understanding and adhering to the TCCSCA's regulations for both local and international businesses.

Phase One Registration for Existing Chemical Substances

Taiwan's EPA introduced the requirement for Phase One Registration for existing chemical substances with annual quantities exceeding 100 kilograms. The deadline for Phase One Registration was set for six months after the start of production or importation, beginning from January 1, 2020. This provision ensures that companies dealing with existing chemical substances comply with the new regulations in a timely manner.

Designated Chemical Substances and Standard Registration

The EPA released an initial list of 106 Designated Chemical Substances subject to standard registration in March 2019. Companies that obtained the Phase I registration number before December 31, 2019, must complete standard registration before specified deadlines. Failing to do so will result in a prohibition on manufacturing or importing these 106 substances into Taiwan. This emphasis on standard registration aims to improve transparency and safety in handling chemical substances.

Exemptions from the TCCSCA Regulations

While the TCCSCA imposes stringent regulations, there are certain exemptions in place. The following categories of substances are exempt from these regulations:

• Naturally Occurring Substances: Chemicals that occur naturally are not subject to TCCSCA regulations.
• Chemical Substances in Machinery or Equipment: Substances contained within machinery or equipment used for test runs are exempt.
• Inseparable Intermediates: Chemical substances produced during chemical reactions in reaction vessels or production processes are not regulated.
• Chemical Substances Related to National Security or Defense: Chemical substances related to national security or national defense fall under exemption.
• Chemical Substances Under Customs Control: Substances under customs control are exempt from TCCSCA regulations.
• Chemical Wastes: Chemical wastes generated or released from industrial processes are not within the scope of TCCSCA.
• By-products or Impurities: By-products or impurities with no commercial value are exempt.
• Mixtures: Mixtures, excluding individual constituents, are not subject to these regulations.
• Polymers Subject to the 2% Rule: Polymers that meet the criteria outlined in the 2% Rule and are listed on the inventory of existing chemicals are exempt.

The Role of GHS in TCCSCA

The implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) plays a crucial role in ensuring chemical safety in Taiwan. Introduced in 2008, GHS was scheduled for full implementation in 2016 for all hazardous chemicals with physical and health hazards. Both the Toxic Chemical Substances Control Act (TCSCA) and the Occupational Safety and Health Act (OSHA) mandate that chemical suppliers label packages and containers containing toxic or hazardous chemicals. They must also provide safety data sheets in compliance with the applicable GHS regulations and standards in Taiwan.

Taiwan TCSCA and EU REACH differences

Regulation and Handling of Controlled Toxic Chemicals

The EPA classifies chemicals into four categories, based on their toxicological properties:

1. Class 1: Chemicals that are not easily biodegradable or that, through bioaccumulation, bioconcentration, or biotransformation, harm human health or the environment.
2. Class 2: Chemicals that result in genetic mutations, teratogenesis, infertility, tumors, or other chronic disorders.
3. Class 3: Chemicals that pose an imminent threat to the survival of living creatures or to human health.
4. Class 4: Chemicals that could potentially harm human health or cause environmental damage.

Businesses handling substances designated as Class 1, 2, 3, or 4 dangerous chemical substances must submit applications for licenses, registration, or approval and adhere to the necessary management procedures, which include periodic record submissions, proper labeling, and restrictions on the sale or transfer of these substances.

Category- All 4 Classes: Management Requirements-

• Periodically submit records on toxic chemical substance management and release quantities (Article 8).
• Ensure proper labelling of containers, packages, and preparation and retention of safety data sheets (Article 17).
• Prohibit the sale or transfer of such substances to entities lacking the necessary permit, registration, or approval (Article 23).

Category- Class 1, 2 & 3 Only Management Requirements-

• Potential handling restrictions or prohibitions (Article 7)
• Option for handlers to request removal of restrictions or prohibitions (Article 7)
• Requirement to submit risk prevention and response plans (Article 10)
• Mandatory permit application (M/I), registration (user or storage company), or approval (for usage below large-scale) (Article 13)
• Necessity to engage professional technical management personnel (Article 18)

Category- Class 4 Only(New requirement): Management Requirements-

• Toxicological data submission and pre-handling approval (Article 7)

Conclusion

The Toxic Chemicals and Concerned Substances Control Act (TCCSCA) plays a pivotal role in regulating and managing the safe handling of toxic chemicals within Taiwan. It imposes various requirements and obligations on businesses and stakeholders to ensure the protection of human health and the environment. Compliance with TCCSCA is essential for anyone involved in the production, import, export, or use of chemicals in Taiwan. Staying updated on any amendments or changes to the legislation is crucial to maintaining regulatory compliance. Overall, the Taiwan TCCSCA serves as a comprehensive framework to safeguard public health and the environment while promoting responsible chemical management practices.