The Committee appreciates the government’s efforts to maintain constructive dialogue with industry stakeholders over the past year.

As Taiwan’s chemical regulatory framework continues to evolve, the Committee encourages the government to strengthen scientific rigor, regulatory consistency, and international alignment. In particular, we recommend establishing a risk-based PFAS (per- and polyfluoroalkyl substance) management policy grounded in scientific evidence, international standards, and socioeconomic considerations; addressing gaps in data requirements, exemptions, and review consistency in chemical registration; and further amending the “Regulations for the Labeling and Hazard Communication of Hazardous Chemicals” to simplify compliance, reduce costs, and promote alignment with international practice.

Suggestion 1: Establish a risk-based and internationally aligned PFAS management policy grounded in scientific evidence, international standards, and socioeconomic considerations.

Per- and polyfluoroalkyl substances play important functional roles in a range of critical industries, including semiconductors, electronics, renewable energy, automotive manufacturing, and medical applications. At the same time, certain PFAS chemicals have raised environmental and human health concerns due to their resistance to degradation and potential to accumulate in the environment, prompting jurisdictions worldwide to develop regulatory frameworks.

The Committee recognizes the Ministry of Environment’s (MOENV) efforts to advance PFAS management, including the release of the PFAS Management Action Plan in 2024 and the alignment of restrictions on substances such as perfluorooctanoic acid, perfluorooctane sulfonate, and perfluorohexane sulfonate with international conventions. Ongoing work on monitoring, risk assessment, and interministerial coordination represents meaningful progress toward a more structured regulatory framework.

However, the current regulatory approach raises several concerns. The proposed designation of 269 PFAS substances as chemicals of concern, combined with disclosure requirements for products containing PFAS levels above specified concentration thresholds, has increased compliance costs for importers and downstream users and created uncertainty regarding the protection of confidential business information. These impacts are particularly significant for fluoropolymers, which do not carry hazard classifications under the Globally Harmonized System (GHS) for the classification and labeling of chemicals and have risk profiles that differ from those of other PFAS substances, yet are subject to the same disclosure requirements. This approach does not fully reflect the principle that regulatory requirements should be proportionate to the level of risk posed by a substance.

Internationally, PFAS regulatory frameworks generally adopt risk-based, phased, and use-oriented approaches. In the European Union, regulatory decisions continue to be evaluated through scientific and socioeconomic assessment processes, and key sectors such as electronics and semiconductors have not yet been subject to broad restrictions. In the United States, regulatory efforts focus on data collection and risk assessment rather than class-wide restrictions. Canada has proposed managing fluoropolymers separately, while Japan and South Korea have limited controls to a small number of substances for which there is established international consensus.

Compared to those jurisdictions, Taiwan’s current approach differs in terms of scope, disclosure requirements, and implementation timelines. This discrepancy has raised concerns among international suppliers regarding compliance burdens and supply chain risks. In some cases, suppliers have raised the possibility of adjusting or withdrawing certain products from the Taiwan market, which could affect the stability of supply for high-tech industries.

The Committee urges the MOENV to prioritize the following actions:

1.1   Adopt a risk-based and use-specific approach to PFAS management. Regulatory measures should differentiate among PFAS substances based on scientifically established risk profiles, including their hazard characteristics and potential exposure levels, rather than applying uniform requirements across all substances. A risk-based and use-oriented approach would better reflect differences in hazard and exposure and ensure that regulatory controls are proportionate.

1.2   Align PFAS regulatory frameworks with international practices and timelines. Taiwan’s PFAS management policies should be developed in line with approaches adopted in major jurisdictions, including phased implementation and ongoing scientific and socioeconomic evaluation. Greater alignment would reduce regulatory divergence and support supply chain stability.

1.3   Provide differentiated regulatory treatment for fluoropolymers. Fluoropolymers that do not exhibit hazardous properties and do not meet GHS classification criteria should be assessed separately from other PFAS substances. Applying the same disclosure and management requirements does not reflect their distinct risk profiles and could create unnecessary compliance burdens, and avoid uncertainties related to the protection of confidential business information and the associated supply chain risks. Based on current international practices, approximately 20 commonly used and nonhazardous fluoropolymers such as polytetrafluoroethylene (PTFE) could be excluded, thereby further clarifying the regulatory scope and reducing compliance burdens on industry.

1.4   Incorporate socioeconomic considerations into PFAS policy design. Regulatory measures should take into account the availability of alternatives, technological feasibility, and potential impacts on supply chains and key industries. A balanced approach would support environmental and health objectives while maintaining industrial competitiveness.

Suggestion 2: Close gaps in data requirements, exemptions, and review consistency for chemical registration.

The Committee recognizes the efforts of the Ministry of Environment’s Chemicals Administration to strengthen Taiwan’s chemical registration framework. However, several aspects of the current system reduce regulatory predictability and increase compliance burdens, particularly for industries that depend on rapid material innovation. Addressing these gaps will be essential to maintaining Taiwan’s competitiveness in the semiconductor and other high-tech sectors.

2.1   Expand the use of existing scientific evidence for new chemical substance registration and clarify rules for the adaptation of the standard information requirements due to the properties of the substance. Under the current framework, registrants face limitations in using existing scientific literature, international databases, and the weight-of-evidence approach in which multiple sources of existing scientific data are evaluated together rather than relying on a single test. Guidance documents are often interpreted as determinative rather than indicative, which restricts the use of credible existing data and leads to duplicative and time-consuming testing.

In addition, adaptations to standard testing or omissions of information requirements arising from the intrinsic properties of the substance are accepted in a narrowly limited manner. Existing criteria that allow waivers are often interpreted inflexibly, limiting their practical effectiveness.

The Committee recommends clarifying that data requirements should be applied based on scientific merit and allowing broader use of internationally recognized data sources. Exemption criteria should also be expanded to account for substance characteristics, with accredited laboratories permitted to provide justifications based on technical infeasibility.

2.2   Improve review consistency and reduce overlapping regulatory requirements for new chemical substance registration. Inconsistent review standards and overlapping requirements across regulatory authorities continue to create uncertainty for registrants. In some cases, previously accepted data is subject to re-evaluation, and identical submissions by different registrants may receive differing assessments. Further, the additional requirements sometimes duplicate existing regulations governing the handling and storage, and transportation of hazardous substances.

The Committee recommends establishing a more unified and transparent review mechanism to ensure consistency in regulatory decisions. The authorities should also assess whether existing regulatory frameworks already address certain risks and avoid introducing duplicative requirements unless clearly justified.

2.3 Align new chemical substance registration requirements for low-volume substances with international practices. Current registration requirements for new chemical substances apply even at low annual volumes, increasing compliance costs and the administrative burden. In many jurisdictions, including the European Union and several Asian markets, substances below certain thresholds are subject to simplified notification mechanisms or are exempt from registration altogether.

The Committee recommends aligning Taiwan’s approach with international practices by introducing simplified requirements or exemptions for low-volume substances, meaning chemicals manufactured or imported in small annual quantities, particularly those below one ton per year. Such adjustments would reduce unnecessary regulatory burden while maintaining appropriate oversight.

2.4   Enhance transparency in hazard-assessment and substance selection processes for following batches of existing chemical substance standard registration. Greater transparency is needed regarding prioritization criteria, assessment methodologies, and opportunities for stakeholder engagement in the hazard assessment of existing chemical substances. At the same time, uncertainty remains regarding how data gaps are addressed, including whether registrants will be required to generate additional data, cost sharing mechanism for authority-initiated testing, and whether the resulting data will be accepted internationally. The implementation of the new mechanism in the coming batches must respect the cost sharing and cost recovery rights of lead registrants and co‑registrants in the first batch.

The Committee recommends establishing clear and publicly available procedures, including disclosure of prioritization approaches, candidate lists, and opportunities for stakeholder input at key stages of the assessment process. The authorities should also clarify data gap requirements and cost-sharing mechanisms, while allowing registrants to submit supplementary information where appropriate. In addition, prioritizing non-animal testing methods in line with international guidelines and supporting domestic capacity for alternative testing would facilitate implementation.

Suggestion 3: Amend the “Regulations for the Labeling and Hazard Communication of Hazardous Chemicals” to improve clarity, reduce the compliance burden, and align with international practices.

The Committee recognizes the ongoing efforts of the Occupational Safety and Health Administration (OSHA) to update Taiwan’s regulatory framework for safety data sheets (SDS) and the GHS. However, several aspects of the current and proposed requirements may create unnecessary compliance burdens and diverge from international practice. Addressing these issues would improve regulatory clarity and facilitate more efficient implementation across supply chains.

3.1   Provide a sufficient transition period for implementation of revised SDS and GHS requirements. Regulatory amendments to SDS and GHS labeling will require manufacturers and suppliers to update documentation and communicate changes throughout upstream and downstream supply chains.

The Committee recommends providing a minimum transition period of three years to allow sufficient time for compliance and ensure orderly implementation.

3.2   Align SDS content requirements with international standards. Certain SDS requirements in Taiwan are inconsistent with international practice. For example, the requirement to include “Person who prepared the SDS” and related data fields in Section 16 is not commonly required in other jurisdictions. In addition, the absence of a clearly specified edition of CNS 15030 (Taiwan’s national standard for chemical classification, labeling, and safety data sheets under the GHS framework) creates uncertainty for suppliers preparing SDS and labels.

The Committee recommends removing non-standard SDS content requirements and clearly specifying the applicable version of CNS 15030 to ensure consistency and reduce ambiguity.

3.3   Align hazard classification and disclosure requirements with the global GHS framework. Current requirements for hazard classification and disclosure may not fully reflect internationally adopted GHS practices. For mixtures that present only physical hazards such as flammability, rather than health or environmental hazards, requiring disclosure of individual ingredients is unnecessary when classification can be based on mixture testing results. In addition, certain low-severity health hazard categories, such as Acute Toxicity Category 5, Skin Irritation Category 3, and Aspiration Hazard Category 2, are not widely adopted in other jurisdictions. Under the UN GHS Building Block Approach (GHS 1.1.3.1.5), competent authorities may selectively adopt hazard classes and categories based on regulatory needs.

The Committee recommends aligning classification and disclosure requirements with international GHS guidance by focusing on substances relevant to health and environmental hazards and reviewing the necessity of including lower-severity categories.

3.4   Remove requirements that create unnecessary administrative burdens without clear safety benefits. Under Taiwan’s current framework, SDS must be renewed every three-year. This unique requirement is not found in the EU, United States, and South Korea, where SDS updates are prompted by newly available data, classification revisions, or regulatory amendments.

The three-year renewal compels chemical manufacturers or suppliers to repeatedly engage upstream suppliers to secure timely SDS revisions, yet it doesn’t enhance safety outcomes. The Committee recommends abolishing the three-year renewal requirement to align Taiwan’s requirement with prevailing international practice.

The Committee recommends reviewing and removing such requirements where appropriate to reduce compliance costs while maintaining effective hazard communication.