CHEMICAL MANUFACTURERS

The Committee appreciates the government’s ongoing efforts to foster two-way communication with industry stakeholders. We encourage the relevant agencies to maintain their commitment to open collaboration, ensuring continued progress in chemical management.

This year, the Committee urges the Ministry of Environment (MOENV) to establish a well-balanced policy for PFAS management, enhance the new chemical substance registration framework, and improve the efficiency of downstream use and exposure data collection. Additionally, we call on the central government to strengthen communication on Taiwan’s chemical management strategy and deepen its engagement with industry. A significant focus should be on aligning chemical reporting requirements across ministries and making efficient use of hazard and exposure assessment data.

Suggestion 1: Develop a balanced PFAS management policy based on scientific evidence, international standards, and socioeconomic considerations.

1.1 Establish a science-based regulatory framework for PFAS.
Per- and polyfluoroalkyl substances (PFAS) are highly stable and resistant to acids, bases, and solvents, making them essential to Taiwan’s critical industries, including renewable energy, automotive, healthcare, and technology. However, growing concerns over their environmental persistence and potential health risks have led to increased global regulatory scrutiny.

The Committee urges the Chemicals Administration under the MOENV to ensure that Taiwan’s PFAS regulatory framework is scientifically rigorous and transparent. Clear regulatory objectives, including risk mitigation strategies and compliance expectations, should be established to provide industries with a well-defined path forward. Additionally, businesses should be granted sufficient time to conduct independent assessments and submit informed feedback to regulators. At the regulatory level, the Committee urges the Chemicals Administration to develop PFAS management strategies based on scientific principles, ensuring clarity, consistency, and feasibility for industry compliance.

The Chemical Abstracts Service (CAS) Registry Number system, widely used in the United States, provides a precise and universally recognized framework for chemical classification. By eliminating ambiguities in chemical nomenclature, CAS numbering links all available data and research, facilitating informed regulatory decision-making and compliance. Taiwan has partially integrated the CAS system through the Taiwan Chemical Substance Inventory (TCSI). To further enhance regulatory transparency and efficiency, we recommend strengthening this alignment, thereby providing a more consistent foundation for chemical management, minimizing misclassification risks, and streamlining compliance processes for businesses operating in domestic and international markets.

1.2 Align PFAS regulations with international standards and best practices.
The Stockholm Convention on Persistent Organic Pollutants (POPs), a treaty ratified by over 180 countries to safeguard human health and the environment, has classified certain PFAS compounds, such as perfluorooctanoic acid, perfluorooctane sulfonate, and perfluorohexane sulfonate, as hazardous substances. In response, several advanced economies have launched regulatory investigations and implemented legislative measures, both under international commitments and through independent national policies, to limit PFAS use and encourage the development of safer alternatives.

To facilitate a balanced and evidence-based transition, we recommend adopting an approach similar to that of the European Union or Canada, where regulatory decisions are based on systematic evaluations of their impact on industry-specific value chains. This method ensures that restrictions and phase-out plans consider both environmental and health concerns, as well as the economic feasibility of compliance and the availability of suitable alternatives.

To further align Taiwan’s regulatory framework with international best practices, we encourage the government to incorporate elements of the U.S. Environmental Protection Agency’s PFAS Management Action Plan. This framework offers a structured approach to risk mitigation, industry transition, and environmental protection.

1.3 Support a feasible industry transition and compliance strategy. A survey by the Semiconductor Industry Association (SIA) indicates that replacing PFAS in semiconductor applications requires a minimum of 15 years. Overly ambitious legislation could pose significant compliance challenges for Taiwan, potentially disrupting industries that depend on PFAS and undermining the country’s leadership in advanced technology sectors.

Fluoropolymers, a distinct subset of PFAS, exhibit unique chemical properties that set them apart from other PFAS compounds. These large, stable molecules are insoluble, non-bioavailable, and non-bioaccumulative, with no Globally Harmonized System (GHS) hazards. They play a critical role in semiconductor infrastructure, process equipment, and consumables, making them indispensable to Taiwan’s high-tech industries. Given these distinct characteristics, regulatory frameworks should differentiate fluoropolymers from other PFAS compounds to prevent unnecessary industry disruption.

No viable substitutes currently exist for fluoropolymers that meet the high-performance standards required by Taiwan’s advanced industries. Given their critical role in semiconductor manufacturing, renewable energy, and other high-tech sectors, any regulatory measures must account for the absence of alternatives to prevent unintended disruptions.

To balance sustainability goals with industrial competitiveness, the Committee recommends a differentiated, characteristic-based approach to PFAS regulation. Such an approach would involve distinguishing between PFAS substances based on their chemical properties and risk profiles, such as separating fluoropolymers, hydrofluoroolefins, and other PFAS that do not pose GHS-classified hazards from those that do. This method would allow Taiwan to implement changes to chemical manufacturing processes and regulatory frameworks in a phased and controlled manner. By prioritizing research, industry collaboration, and gradual adaptation, Taiwan can ensure that regulatory advancements support both environmental sustainability and the continued growth of its high-tech economy.

1.4 Strengthen industry-government engagement for effective regulation. The Committee urges the Chemicals Administration to collaborate with relevant ministries, including the Ministry of Economic Affairs (MOEA) and the MOENV, to conduct a comprehensive assessment of the safety, environmental, and economic impacts of PFAS. To facilitate ongoing dialogue, we recommend expanding industry-government engagement through additional meetings modeled on the PFAS Management Action Plan by the 2023 National Chemical Substance Management Board, which successfully enhanced inter-ministerial coordination on hazardous chemical management. According to the action plan, stakeholder meetings are to be held at least once annually and convened as needed based on circumstances, serving as a platform to coordinate and guide the overall promotion strategy of the initiative. Regular stakeholder consultations will enable a more transparent and informed decision-making process, ensuring that regulations reflect both scientific evidence and industry realities.

1.5 Enhance public health protections without disrupting industry. Public health concerns, particularly regarding food safety and consumer products, require both source control and post-market oversight. The Committee urges the Ministry of Health and Welfare (MOHW) to strengthen regulatory measures for PFAS in food packaging and cosmetics to mitigate potential health risks.

The Committee urges collaboration with the Ministry of Economic Affairs (MOEA) to enhance research and development capabilities, ensuring the industry receives the necessary support to develop viable PFAS alternatives. We also encourage the Chemicals Administration to integrate insights from academia and industry into regulatory strategies that protect Taiwan’s environment and public health while sustaining economic growth.

Suggestion 2: Optimize new chemical substances registration mechanisms and measures to promote innovation and align with international practices.

Taiwan plays a pivotal role in the global semiconductor and electronics industry, making innovation in chemical research and development essential. As regulatory authorities impose increasingly stringent requirements and advance green chemistry initiatives under sustainability goals, manufacturers are actively seeking viable safe alternatives to existing formulas. Many of these newly developed substances fall under the category of new chemical substances.

Although the Regulations of New and Existing Chemical Substances Registration have been in place since 2014 and have undergone multiple amendments and guideline revisions, there remains a gap between regulatory requirements and the practical challenges faced by industry. The current procedures impose significant administrative burdens, which can delay innovation and hinder the transition from research and development to production. For example, for new chemical substances under 100 kg, the registration process typically takes around one month to complete. Given the high volume of daily sample shipments in the industry, the time and administrative burden required for small quantities (often just a few kilograms) pose a substantial barrier to innovation in Taiwan.

In contrast, South Korea, a key industry competitor, amended its regulations in January to streamline the new chemical substance registration process. The amendments raised the notification threshold from 0.1 tons per year to 1 ton per year and replaced the registration requirement with a simplified notification process, enabling approvals within seven days.

To improve regulatory efficiency while maintaining manageable risks, the Committee recommends that the Chemicals Administration periodically review and adjust Taiwan’s new chemical substance registration threshold. Regulations should be relaxed for substances imported or manufactured below 1 ton per year by transitioning from a registration system to a notification process. Simplifying submission requirements and administrative procedures while replacing comprehensive reviews with completeness checks would reduce compliance burdens, support industrial innovation, and better align Taiwan’s regulatory framework with international best practices.

Additionally, while the regulations include provisions for joint registration of new chemical substances, no supporting measures have been implemented in recent years. Maintaining flexibility in the chemical supply chain is essential. Once the original registrant has completed the registration of a new chemical substance, foreign manufacturers and their domestic importers should be allowed to engage in joint registration when customers seek to import the substance or formulations containing it directly, provided the original registration tonnage is not exceeded.

Allowing joint registration would prevent redundant dossier reviews, reduce the administrative workload for regulatory authorities, and significantly ease compliance burdens on the chemical industry. Implementing this measure would improve regulatory efficiency while ensuring continued oversight.

Suggestion 3: Streamline downstream use and exposure information collection to enhance industry compliance efficiency.

Over the past two years, an increasing number of industry players have reported receiving requests from regulatory authorities to provide use and exposure information on downstream customers. These requests stem not only from the standard registration process for existing and new chemical substances but also from cases requiring supplementary information.

The Committee acknowledges the Chemicals Administration’s need to understand the domestic operation and flow of substances. However, registrants cannot compel downstream customers or secondary value chain participants, such as the customers of distributors, to disclose detailed usage and exposure data, nor can they verify its accuracy.

To address this challenge, we recommend that the Chemicals Administration refine its data collection approach in registration cases by allowing registrants to provide only next-tier customer information and product names. This method would enable regulatory authorities to obtain necessary data directly from downstream entities while safeguarding trade secrets and reducing the administrative burden on the industry.

Although cases requiring incidental provision remain relatively uncommon in Taiwan, the Committee recognizes the increasing regulatory burden on industry. Under the current system, registrants often become aware that a substance they are registering has suspected toxic properties only at the final stage, when the Chemicals Administration informs them of potential restrictions and the need for incidental provision. This late-stage notification limits companies’ ability to plan effectively, increasing administrative costs and regulatory uncertainty.

To address this issue, we recommend that the Chemicals Administration establish clearer and more transparent guidelines on the characteristics of substances subject to incidental provision. Making this information available at the outset would allow industry players to evaluate administrative and compliance costs early in the registration process, enabling more informed decision-making on market entry for new products in Taiwan.

Suggestion 4: Strengthen Taiwan’s chemical management strategy through improved communication, industry engagement, and regulatory harmonization.

Regarding the formulation of the National Policy on Chemicals Management, the Committee recognizes the growing complexity of global chemical consumption and production patterns in the post-SAICM (Strategic Approach to International Chemical Management) era. Given these challenges, we urge the relevant authority to draw on international and industry best practices, strengthen engagement with the chemical sector, and enhance coordination of cross-departmental chemical management strategies.

Although the government plans to establish a consultation mechanism for chemical substance management involving government agencies, industry, academia, and the public, industry participation in these discussions remains limited. Ensuring meaningful engagement from industry stakeholders is essential to developing practical and effective regulations that balance environmental protection with economic sustainability.

Furthermore, variations in chemical management frameworks across different countries underscore the need for competent authorities to actively gather international best practices. Multinational corporations possess valuable insights into global regulatory trends and compliance strategies, which could help Taiwan refine its chemical management policies.

In recent years, government agencies have established a cross-departmental platform to consolidate chemical policies and data across various ministries. While this system integrates chemical substance declaration data, significant gaps remain in policy communication and implementation.

For example, the Chemicals Administration designated sulfuric acid and toluene on the “Designated List of Existing Chemical Substances Subject to Standard Registration” as early as 2019. Once registration is completed, a local Hazard and Exposure Assessment Report is required. However, in the second half of 2024, the Occupational Safety and Health Administration (OSHA) of the Ministry of Labor proposed listing these substances among the top 10 candidates for inclusion in Category A workplaces. This proposal was based on a study by the Institute of Labor, Occupational Safety and Health titled A Study on the Appropriateness of the Types and Quantities of Hazardous Substances in Category A Workplaces.

This case highlights the ongoing issue of fragmented policy communication. While different agencies assess and regulate hazardous chemicals, the lack of coordination creates uncertainty for industry stakeholders. Ensuring timely and consistent information-sharing across agencies would mitigate compliance challenges and improve regulatory transparency.

Hazard and exposure assessment reports derived from the registration of existing chemical substances should serve as the primary reference for assessing local conditions. Situational assessments should be based on these reports rather than outsourced research. The current chemical substance registration policy has been in place for many years, yet policies from different ministries remain parallel with little coordination. The proposal to recommend new listings based on an outsourced research report underscores the need for stronger inter-agency collaboration.

Committee members have observed that several major and lethal factory fires in the past two years have been partly attributed to factories’ failure to declare or update records on the chemicals they used and stored. Inaccurate reporting led to miscalculations in risk assessments during emergencies, increasing the severity of incidents.

For example, the Regulations Governing the Report of Factory Dangerous Objects require regular reporting in January and July, while dynamic reporting must be completed within 10 days of any changes. Meanwhile, the Regulations for Governing Designating and Handling of Priority Management Chemicals require regular reporting between April and September or in January and July, depending on the chemical category and properties. Dynamic reporting under this regulation is only required when a certain threshold is exceeded, with a 30-day deadline.

While the Committee acknowledges the efforts of various ministries to regulate chemical management across manufacturing, import, handling, and use, we note that inconsistent reporting timelines across different regulations create an unnecessary burden on frontline personnel responsible for compliance. To improve efficiency and reduce administrative strain, the Committee recommends that relevant authorities establish a unified national chemical declaration system that allows companies to submit all required reports on a single platform and at a standardized time rather than across multiple platforms with varying deadlines.

Furthermore, the Committee urges the government to strengthen inter-ministerial cooperation and establish a more effective cross-ministerial coordination mechanism. This would ensure that industries receive appropriate guidance when engaging with different regulatory authorities. We also recommend that the government create a more open communication channel and actively involve the chemical industry in discussions. By leveraging global industry expertise and enhancing international engagement, Taiwan can ensure that its chemical management policies align with global best practices.

The Committee encourages the government to take proactive measures and collaborate closely with industry stakeholders to enhance Taiwan’s chemical management strategies. Strengthened coordination will not only improve regulatory clarity but also provide robust protection for the environment and public health.