Businesses today are navigating unprecedented challenges due to rapid shifts in the global economic landscape and mounting disruptions from trade tensions. Although taxpayers are making good-faith efforts to comply with regulations across jurisdictions, the increasing complexity of legal and policy frameworks has heightened uncertainty and exposure to risk.

This year’s recommendations focus on practical solutions for offshore trust compliance, modernizing transfer pricing procedures, and enhancing Taiwan’s competitiveness for global talent. The Committee urges the tax authorities to adopt more flexible and pragmatic approaches to tax compliance. Such measures would enhance taxpayer confidence, encourage compliance with domestic regulations, and foster a more business-friendly environment, laying a stronger foundation for sustaining growth amid heightened economic uncertainty.

Suggestion 1: Extend the deadline and waive penalties for offshore trust tax reporting obligations.

To support the implementation of Taiwan’s Controlled Foreign Corporation (CFC) rules, the Ministry of Finance issued a ruling in July 2024 requiring offshore trustees to report trust income based on the financials of a Taiwan CFC if the trust property includes shares or capital of the CFC held by a Taiwan settlor. The ruling applies retrospectively from 2024, with the first filing deadline set for February 5, 2025. Failure to file by the deadline may result in tax penalties.

Given the retrospective nature of the rule, the complexity of trust structures, and the time required for information gathering and coordination with offshore trustees, the Committee recommends extending the initial reporting deadline and waiving penalties for trust income filings involving Taiwan CFCs related to the 2024 fiscal year. Doing so would provide affected taxpayers with sufficient time to meet compliance requirements and support a smoother transition to the new reporting regime.

Under the new ruling, offshore trustees are required to submit detailed financial information, including books of account, income statements, distribution records, and other documentation, for all trust assets, including both CFC and non-CFC holdings, in accordance with Taiwan’s Income Tax Act. However, fulfilling these obligations may present considerable challenges for foreign trusts due to the following concerns:

• In many jurisdictions, trustees are bound by strict confidentiality obligations under local trust laws and international practice. Disclosure of trust-related information is generally permitted only with the consent of the settlor or as required by local authorities. Unauthorized disclosure may constitute a breach of fiduciary duty and violate contractual obligations. It remains uncertain whether Taiwan’s ruling can be enforced against offshore trustees or whether the required disclosures are legally permissible under the laws governing the trustee’s jurisdiction.
• In some cases, beneficiaries may be unaware of their status under the trust. Disclosure may require explicit consent from both the settlor and the beneficiaries, particularly where the legality of such disclosure under local laws is unclear. These challenges create significant barriers to compliance and may conflict with legal norms in jurisdictions where the offshore trustees are domiciled.

The Committee therefore urges the government to take the following measures:

1. Extend the reporting deadline. Obtaining consent from settlors and beneficiaries may require considerable time, particularly when beneficiaries are unaware of their status or are located across multiple jurisdictions. Extending the reporting deadline would provide offshore trustees with a more reasonable timeframe to secure the necessary consents and fulfill their obligations in compliance with both Taiwan’s requirements and the applicable legal frameworks of other jurisdictions.
2. Reconsider penalty liability. As trustees act solely as intermediaries and are not the beneficial owners of trust property, it would be more appropriate for any penalties related to trust income reporting to fall on the settlors or beneficiaries. To encourage cooperation from offshore trustees while respecting their fiduciary obligations and legal limitations, the Committee recommends that trustees serve primarily as information conduits. Penalty liability should rest with the parties ultimately benefiting from the trust, thereby supporting compliance without placing undue burden on trustees.
3. Permit the use of alternative accounting standards. As CFCs are typically organized under foreign jurisdictions, preparing financial reports under the Taiwan Generally Accepted Accounting Principles may impose undue burden. Allowing financials to be submitted based on International Financial Reporting Standards or other widely accepted international accounting standards would help reduce compliance costs, thereby enhancing offshore trustee willingness to comply and ensure timely reporting.

Neighboring Asian countries such as Singapore and Hong Kong do not request offshore trustees to comply with the foregoing reporting requirements. Adopting these suggestions would represent a constructive step forward for all parties involved, helping to preserve essential elements of flexibility and confidentiality in succession planning while also supporting compliance with Taiwan’s evolving tax framework.

Suggestion 2: Streamline Customs’ review of one-time transfer pricing applications.

To reduce compliance uncertainty and align with international best practices, the Committee recommends that Taiwan Customs streamline its review process for one-time transfer pricing (TP) applications. Specifically, the approach should be harmonized with globally accepted TP principles and the OECD Transfer Pricing Guidelines to establish a more consistent, transparent, and predictable review framework. Doing so will facilitate cross-border transactions, reduce administrative burdens, and enhance Taiwan’s overall trade competitiveness.

1. Allow flexibility in Customs’ coding requirements for one-time TP adjustments. Under tax ruling No. 10804629000 and under the “Operation Directions Governing Customs Value Determination of One-Time Transfer Pricing in a Fiscal Year” (the Directions), importers applying for one-time transfer pricing adjustments (TPAs) are required to follow specific procedural steps. The Directions mandate that the importer of record (IOR) include designated codes and statements on each import declaration to identify shipments eligible for one-time TPA treatment. These include:

   ．Code 138 in the “Related to Seller” field, which indicates that the buyer and seller are related parties and that the importer is applying for Customs value assessment under one-time TPAs during the fiscal year.
   ．Code 65 in the “Code of Duty Payment” field, denoting that duty is estimated in advance.
   ．A remark in the “Other Declarations Particulars” field stating the declaration is “subject to one-time TPA for FYXX.”

   Import declarations lacking these specific codes or notations at the time of importation are ineligible for consideration under the one-time TPA procedure. This strict procedural requirement may create operational challenges for importers seeking flexibility and alignment with post-importation transfer pricing adjustments.
   According to the guidance record form released by the Customs Administration, if the IOR flags only a portion of its import declarations for one-time TPA while leaving others unmarked, and if the pricing of the flagged declarations appears abnormally high, suggesting a concentration of annual profits, Customs may view the application as non-compliant and reject the proposed adjustments. These constraints create additional complexity and uncertainty for taxpayers, particularly in situations where the need for TPAs is identified only after year-end financial reviews.

2. Address practical challenges in implementing one-time TPAs under current Customs procedures. Due to the unpredictable nature of year-end TPAs, multinational corporations (MNCs) often cannot determine whether such an adjustment is necessary until after financial results become available, typically at the end of the fiscal year or after a material period has passed. As a result, by the time an MNC identifies the need for a TPA, most related import declarations may no longer be eligible for the one-time TPA application due to procedural requirements. This presents a particular challenge for a Taiwan-based IOR, who at the time of importation is often unaware whether a TPA will be required or which specific shipments should be flagged in advance.
   According to the guidance form issued by the Customs Administration, one-time TPAs may only be applied to import declarations that were pre-identified for one-time TPA treatment using codes such as 138, 65, and fiscal-year-specific wording. However, because many companies only determine the need for a year-end TPA after reviewing mid- or late-year financial outcomes, earlier shipments are often not flagged in advance. As a result, otherwise eligible adjustments may be disallowed, limiting the Taiwan IOR’s ability to accurately reflect the economic value of the goods and creating unnecessary compliance uncertainty.
   This procedural rigidity gives rise to several critical issues:

   ．Misalignment with international best practices. The current requirements diverge from the principles advocated by the World Customs Organization (WCO) and the World Trade Organization, both of which advocate for more practical alignment between transfer pricing policies and customs valuation practices in related-party transactions. For example, the WCO’s 2018 Guide to Customs Valuation and Transfer Pricing encourages Customs administrations to adopt a substance-over-form approach, particularly in evaluating post-import TPAs. The guide notes that strict procedural barriers may undermine the accurate reflection of the transaction’s economic value and recommends practical flexibility in documentation and timing.
   ．Disconnect between declared and actual transaction value. A strict requirement to pre-flag eligible import declarations may result in a significant discrepancy between the customs value declared at the time of importation and the final, transfer price-adjusted transaction value, undermining accuracy in customs valuation.
   ．Increased administrative and audit burden. Customs is tasked with reconciling the full TPA amount against only those shipments pre-identified for one-time TPA treatment.

   To address these challenges and align with international practices, the Committee recommends that Customs relax its current review framework by allowing one-time TPA applications to be evaluated based on the substance of the transfer pricing arrangement, rather than limiting eligibility to declarations flagged with code 138, code 65, and fiscal year-specific wording. A principles-based approach would ease administrative burdens for both Customs and importers and offer greater regulatory flexibility.
   Alternatively, if immediate implementation is not feasible, the Committee suggests permitting retroactive corrections to import declarations to add the required codes and wording. While current policy limits corrections to obvious errors, expanding this scope would offer a practical solution for compliant importers who identify the need for a TPA after importation. This would support policy goals of accuracy, transparency, and trade facilitation without compromising procedural integrity.

Suggestion 3: Ensure continuity of tax incentives for qualified foreign talent.

According to the National Development Council, over 12,000 Employment Gold Cards have been issued since the program’s launch. However, anecdotal feedback indicates that the loss of tax benefits following a job change has contributed to early departures among qualified professionals.

Under current policy, foreign professionals holding an Employment Gold Card or a Foreign Special Professional Visa lose their tax benefits if they change employers, even if they remain within the original five-year eligibility window. In addition, individuals who initially held a standard Alien Resident Certificate (ARC) and later transitioned to an Employment Gold Card or Foreign Special Professional Visa are often excluded from the incentive program, despite otherwise meeting the required criteria.

The Committee encourages the tax authorities to allow eligible Gold Card and Foreign Special Professional Visa holders to retain their tax benefits throughout the full five-year period, regardless of job changes or earlier visa status. This adjustment would align Taiwan more closely with countries like Singapore, which offers tax incentives for up to five years based on continued contribution to strategic sectors.

Many foreign professionals may opt to leave Taiwan once their tax benefits expire. To improve talent retention and support economic growth, we urge the government to consider extending tax benefits for long-term foreign residents who continue to contribute meaningfully to the local economy. Removing penalties for career mobility or residency upgrades would help Taiwan remain competitive in attracting and retaining global talent.

The Committee is grateful to the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), and Ministry of Agriculture (MOA) for their recognition of and support for our previous suggestions. To effectively address climate change and maintain food security, we urge the authorities to consider our latest suggestions and continue to improve relevant management policies in accelerating the introduction of new pesticide products that are highly safe, efficient, and low-intensity, as well as new technologies for promoting breeding innovation. Doing so will help reduce environmental harm and enable agricultural sustainability. Further, we urge the MOA to accelerate the revision schedule for the Agro-pesticides Management Act.

Suggestion 1: Accelerate revision of Article 14 of the Agro-pesticides Management Act and related labeling regulations.

This suggestion has been brought up in every White Paper since 2019, but no progress has occurred. Article 14 of the Act provides that following the MOEA’s approval of changes in a pesticide label, all relevant products must be relabeled within six months. Such a requirement is reasonable for changes potentially affecting the safety of a product. However, if the change has no impact on farmers’ safe use of pesticides, there is no need for a product already on the market to be withdrawn for relabeling.

Following the approval of new labeling, the procedures for either recalling products from the market or replacing labels have become overly complicated and burdensome, leading to significant costs. Moreover, the requirement that labels cannot be updated by merely marking the change, modifying the adhesive label, or affixing a new adhesive label over the old one necessitates that products (such as those in aluminum sacks) be unpacked and then repacked, which in turn raises occupational safety concerns about the repeated exposure of workers to these products during the process.

Further complicating matters are sporadic announcements from the government regarding changes in the use pattern or cautionary notes about individual products, as these necessitate re-approval of the label if any license has been submitted for renewal or amendment. This requirement wastes resources and results in additional costs, including the destruction of existing inventory labels and the labor-intensive process of unpacking and repacking recalled products.

Recommendations:

1. Fast-track revisions to Article 14 of the Agro-pesticides Management Act. Since 2019, the Committee has been calling for amendments, such as removal of the mandate to recall products within six months due to minor label amendments that do not affect safety or manufacturing, but has yet to see any substantial action or even receive a formal reply. We urge the Animal and Plant Health Inspection Agency (APHIA) to confirm that our proposed amendment to Article 14 is among the prospective revisions. Furthermore, we urge APHIA to accelerate the drafting process, enabling a bill to be submitted for legislative approval without further delay.
2. Add a positive list in the Enforcement Rules of the Agro-pesticides Management Act specifying the types of changes that do not require relabeling. Changes such as the name of the manufacturer, extension of product shelf life, and modifications to packaging, labeling design, and barcodes have no impact on product safety. The practice of allowing such modifications without relabeling is already common in other industries. To avoid unnecessary costs and waste, and in consideration of industry practice, the sale of products should be allowed to continue until their expiry dates.

Suggestion 2: Expedite the review process for new active ingredients and products with new content or new formulations.

Under APHIA’s 10-year plan to reduce the volume of chemical pesticide usage by half, companies are encouraged to register pesticides with high safety, low dosage, and specificity to reduce the risks of pesticide exposure to farmers, as well as to mitigate negative environmental impact. Achieving that goal will require the approval of products with new active ingredients and new formulations.

Whether for pesticide registration, renewal, or re-registration, however, the proportion of application approvals for new active ingredients and new formulation products has been minimal. Statistics compiled by APHIA’s Agricultural Information Network show that of the 229 certificates issued in 2023, only 3 were for new active ingredients. In 2022, 296 certificates were issued, with a mere 9 dedicated to new active ingredients. Additionally, on the list of active ingredients that have passed the 15-year pesticide re-registration, 20 active ingredients were approved in 2023, much fewer than the 34 approved in 2022.

We urge APHIA to prioritize the allocation of its review and administrative capacities toward innovative products, such as those with new active ingredients and new formulations. This prioritization would spur the launch of innovative products and aid the elimination of high-hazard or high-risk formulation products.

Suggestion 3: Accelerate the administrative process for determining the maximum residue limits for pesticides.

We are grateful to the TFDA and the MOHW for their commendable efforts in increasing the frequency of announcements regarding the maximum residue limits (MRLs) of pesticides. The TFDA has consistently issued official announcements on MRLs at least three times annually, a practice that greatly benefits stakeholders by providing clearer regulatory guidance.

Despite these improvements, several aspects of the administrative procedures for pesticide registration remain unclear. These ambiguities have caused delays in the registration process, significantly impacting applicants who have made substantial investments in Taiwan. Uncertainty regarding the following points has made it challenging for applicants to predict the approval timeline for their applications:

• The timeline for sending cases to APHIA to schedule review by the Pesticide Advisory Committee under the MOA after the cases have passed review by the Agricultural Chemicals Research Institute.
• The timeline for sending cases to the TFDA after they have passed the Pesticide Advisory Committee’s review.
• The timeline for arranging document reviews by experts and comprehensive review by the Food Sanitation, Safety and Nutrition Advisory Committee after the TFDA has received a case.
• Following case reviews, the various required administrative procedures and joint actions involving some 20 functional offices or units. These procedures may take more than one month, not including the time required for subsequent pre-notification and official announcement of related regulations, which may take at least another four months.
• APHIA’s informal pre-notification procedure that, although officially optional, is being enforced as if mandatory. Completing this process can take up to two months. APHIA has advised the Committee that applicants are expected to initiate direct communication with the TFDA, requesting that it notify APHIA about the contents of any forthcoming announcement prior to its public disclosure. In practice, this procedure significantly delays APHIA’s ability to announce the approved use pattern of registration after the TFDA discloses the finalized MRLs. This extended timeline for procedural compliance not only complicates the registration process but also affects the timely introduction and use of registered products, hindering the efficient management and implementation of agricultural practices.
• The requirement that companies await an official announcement from APHIA before proceeding with applications for permits or changes in labeling. This administrative procedure alone can take at least one month.

We urge departments within the MOA and the MOHW to establish and clearly define the procedures and precise timings of administrative processes at both the ministerial and departmental levels. Clarifying these procedures would help streamline the administrative process to the benefit of all stakeholders.

Additionally, we ask that these procedural details be made available to the public. Such transparency could significantly enhance horizontal communication across different ministries and departments, leading to a more coordinated and efficient administrative process.

Suggestion 4: Reassess the reasonableness of data requirements for registering generic pesticides to ensure safe and effective use by farmers.

The Committee has raised this issue in the past four White Paper issues, but no progress has been made. Compared to the regulatory frameworks in other countries for registering generic agricultural products, the procedure in Taiwan stands out for its conciseness, requiring only the submission of physical and chemical data. This approach focuses on ensuring that the active ingredients and formulation type of the generic product match those of the originally registered product.

However, other ingredients in the product may differ from what was covered in the original comprehensively evaluated registration. This discrepancy in composition raises concerns about the efficacy of the generic products, as it cannot be guaranteed to fully match that of the original products. As a result, farmers may inadvertently overuse these products or use them in ways that deviate from the government’s pesticide reduction policy.

Recommendations:

1. Revise current legislation to mandate at least one field test assessing the efficacy of generic pesticides on the crops for which registration is sought.
2. Require the submission of comprehensive toxicological data for the registration of generic products. Data should include reports on oral-, dermal-, and inhalation-acute toxicity, as well as eye irritation tests, to unequivocally demonstrate the safety of the generic products for users.
3. Formalize the registration process for generic pesticides. This process should include evaluation by the MOA’s Pesticide Advisory Committee for the generic product’s necessity, efficacy, and safety before approval is granted. Such measures will ensure that generic pesticides introduced into the market meet the expected high standards of performance and safety, thereby protecting users and supporting the goals of pesticide reduction and sustainable agriculture practices.

Suggestion 5: Set up a transparent regulatory frame-work with a predictable timeline and adopt a product-based regulatory approach harmonized with Taiwan’s major trading partners for genome-edited products.

Agricultural innovation has played an essential role in increasing yields and productivity in support of growing, prosperous civilizations. Moreover, considering the rapidly growing world population, climate change, and increasing scarcity of natural resources such as arable land and water, progress in plant propagation has gained unprecedented importance.

High-yielding crops of superior nutritional value that can be grown more resource-efficiently are increasingly becoming the cornerstone of sustainable yet highly productive agriculture. In addition, there is a need to make crops more pest- and disease-resistant as well as more tolerant to adverse conditions such as drought, heat, submergence, and salinity. Innovations in precision biotechnology, such as gene editing, are therefore required to enhance the speed, predictability, precision, and success rate of plant breeding.

As highlighted in the 2023 White Paper, the World Trade Organization released the joint International Statement on Agricultural Applications of Precision Biotechnology, supported by 10 members, urging governments to implement science-based and globally harmonized policies for precision biotechnology. To support agricultural innovation, many of Taiwan’s key trading partners – including Argentina, Australia, Brazil, India, Japan, the Philippines, and the United States – have since implemented well-functioning and proportionate regulatory systems. These markets have exemptions granted certain types of gene-edited crops from their GMO regulations. Furthermore, the exemption by some government agencies can be evaluated and confirmed through a pre-consultation mechanism.

Over the past 12 months, some countries and regions have made further noteworthy progress in developing policies for the management of genome-edited products. For example, the European Commission released its New Genomic Techniques (NGT) proposal for new regulation on plants produced by certain new genomic techniques (for example, gene-editing technology) on July 5, 2023. The Commission also proposed that Category 1 NGT plants should be exempted from the requirements of GMO legislation, affirming the Commission’s position that plants derived from these technologies have safety profiles comparable to conventional counterparts and may contribute to sustainable agriculture and the European Union’s Farm to Fork Strategy, as concluded in the NGT study published on April 29, 2021.

On December 20, 2023, the Singapore Food Agency released a policy document for public consultation on the regulatory framework for genome-edited crops for food and feed. This document proposed that plants that do not contain foreign DNA should be exempted from pre-market safety assessment. On January 18, 2024, Thailand’s Technical Biosafety Committee approved the Guidelines for Consideration of Genome Editing, stipulating that products lacking novel genetic combinations or foreign genetic sequences should be exempt from GMO regulation.

These recent policy developments have demonstrated the importance of precision biotechnology such as gene editing to address challenges in agricultural production as well as to support food sufficiency and achieve sustainability goals.

Taiwan is a key global trading partner for agricultural products, including seed and plant products. To help Taiwan maintain a competitive and secure food and feed supply, we urge the government to establish a transparent regulatory framework with predictable timelines and adopt a product-based regulatory approach for gene-edited products to ensure harmonization with Taiwan’s major trading partners.

The Committee is grateful to the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), and Ministry of Agriculture (MOA) for their recognition of and support for our previous suggestions. To effectively address climate change and maintain food security, we urge the authorities to consider our latest suggestions and continue to improve relevant management policies in accelerating the introduction of new pesticide products that are highly safe, efficient, and low-intensity, as well as new technologies for promoting breeding innovation. Doing so will help reduce environmental harm and enable agricultural sustainability. Further, we urge the MOA to accelerate the revision schedule for the Agro-pesticides Management Act.

Suggestion 1: Accelerate revision of Article 14 of the Agro-pesticides Management Act and related labeling regulations.

This suggestion has been brought up in every White Paper since 2019, but no progress has occurred. Article 14 of the Act provides that following the MOEA’s approval of changes in a pesticide label, all relevant products must be relabeled within six months. Such a requirement is reasonable for changes potentially affecting the safety of a product. However, if the change has no impact on farmers’ safe use of pesticides, there is no need for a product already on the market to be withdrawn for relabeling.

Following the approval of new labeling, the procedures for either recalling products from the market or replacing labels have become overly complicated and burdensome, leading to significant costs. Moreover, the requirement that labels cannot be updated by merely marking the change, modifying the adhesive label, or affixing a new adhesive label over the old one necessitates that products (such as those in aluminum sacks) be unpacked and then repacked, which in turn raises occupational safety concerns about the repeated exposure of workers to these products during the process.

Further complicating matters are sporadic announcements from the government regarding changes in the use pattern or cautionary notes about individual products, as these necessitate re-approval of the label if any license has been submitted for renewal or amendment. This requirement wastes resources and results in additional costs, including the destruction of existing inventory labels and the labor-intensive process of unpacking and repacking recalled products.

Recommendations:

1. Fast-track revisions to Article 14 of the Agro-pesticides Management Act. Since 2019, the Committee has been calling for amendments, such as removal of the mandate to recall products within six months due to minor label amendments that do not affect safety or manufacturing, but has yet to see any substantial action or even receive a formal reply. We urge the Animal and Plant Health Inspection Agency (APHIA) to confirm that our proposed amendment to Article 14 is among the prospective revisions. Furthermore, we urge APHIA to accelerate the drafting process, enabling a bill to be submitted for legislative approval without further delay.
2. Add a positive list in the Enforcement Rules of the Agro-pesticides Management Act specifying the types of changes that do not require relabeling. Changes such as the name of the manufacturer, extension of product shelf life, and modifications to packaging, labeling design, and barcodes have no impact on product safety. The practice of allowing such modifications without relabeling is already common in other industries. To avoid unnecessary costs and waste, and in consideration of industry practice, the sale of products should be allowed to continue until their expiry dates.

Suggestion 2: Expedite the review process for new active ingredients and products with new content or new formulations.

Under APHIA’s 10-year plan to reduce the volume of chemical pesticide usage by half, companies are encouraged to register pesticides with high safety, low dosage, and specificity to reduce the risks of pesticide exposure to farmers, as well as to mitigate negative environmental impact. Achieving that goal will require the approval of products with new active ingredients and new formulations.

Whether for pesticide registration, renewal, or re-registration, however, the proportion of application approvals for new active ingredients and new formulation products has been minimal. Statistics compiled by APHIA’s Agricultural Information Network show that of the 229 certificates issued in 2023, only 3 were for new active ingredients. In 2022, 296 certificates were issued, with a mere 9 dedicated to new active ingredients. Additionally, on the list of active ingredients that have passed the 15-year pesticide re-registration, 20 active ingredients were approved in 2023, much fewer than the 34 approved in 2022.

We urge APHIA to prioritize the allocation of its review and administrative capacities toward innovative products, such as those with new active ingredients and new formulations. This prioritization would spur the launch of innovative products and aid the elimination of high-hazard or high-risk formulation products.

Suggestion 3: Accelerate the administrative process for determining the maximum residue limits for pesticides.

We are grateful to the TFDA and the MOHW for their commendable efforts in increasing the frequency of announcements regarding the maximum residue limits (MRLs) of pesticides. The TFDA has consistently issued official announcements on MRLs at least three times annually, a practice that greatly benefits stakeholders by providing clearer regulatory guidance.

Despite these improvements, several aspects of the administrative procedures for pesticide registration remain unclear. These ambiguities have caused delays in the registration process, significantly impacting applicants who have made substantial investments in Taiwan. Uncertainty regarding the following points has made it challenging for applicants to predict the approval timeline for their applications:

• The timeline for sending cases to APHIA to schedule review by the Pesticide Advisory Committee under the MOA after the cases have passed review by the Agricultural Chemicals Research Institute.
• The timeline for sending cases to the TFDA after they have passed the Pesticide Advisory Committee’s review.
• The timeline for arranging document reviews by experts and comprehensive review by the Food Sanitation, Safety and Nutrition Advisory Committee after the TFDA has received a case.
• Following case reviews, the various required administrative procedures and joint actions involving some 20 functional offices or units. These procedures may take more than one month, not including the time required for subsequent pre-notification and official announcement of related regulations, which may take at least another four months.
• APHIA’s informal pre-notification procedure that, although officially optional, is being enforced as if mandatory. Completing this process can take up to two months. APHIA has advised the Committee that applicants are expected to initiate direct communication with the TFDA, requesting that it notify APHIA about the contents of any forthcoming announcement prior to its public disclosure. In practice, this procedure significantly delays APHIA’s ability to announce the approved use pattern of registration after the TFDA discloses the finalized MRLs. This extended timeline for procedural compliance not only complicates the registration process but also affects the timely introduction and use of registered products, hindering the efficient management and implementation of agricultural practices.
• The requirement that companies await an official announcement from APHIA before proceeding with applications for permits or changes in labeling. This administrative procedure alone can take at least one month.

We urge departments within the MOA and the MOHW to establish and clearly define the procedures and precise timings of administrative processes at both the ministerial and departmental levels. Clarifying these procedures would help streamline the administrative process to the benefit of all stakeholders.

Additionally, we ask that these procedural details be made available to the public. Such transparency could significantly enhance horizontal communication across different ministries and departments, leading to a more coordinated and efficient administrative process.

Suggestion 4: Reassess the reasonableness of data requirements for registering generic pesticides to ensure safe and effective use by farmers.

The Committee has raised this issue in the past four White Paper issues, but no progress has been made. Compared to the regulatory frameworks in other countries for registering generic agricultural products, the procedure in Taiwan stands out for its conciseness, requiring only the submission of physical and chemical data. This approach focuses on ensuring that the active ingredients and formulation type of the generic product match those of the originally registered product.

However, other ingredients in the product may differ from what was covered in the original comprehensively evaluated registration. This discrepancy in composition raises concerns about the efficacy of the generic products, as it cannot be guaranteed to fully match that of the original products. As a result, farmers may inadvertently overuse these products or use them in ways that deviate from the government’s pesticide reduction policy.

Recommendations:

1. Revise current legislation to mandate at least one field test assessing the efficacy of generic pesticides on the crops for which registration is sought.
2. Require the submission of comprehensive toxicological data for the registration of generic products. Data should include reports on oral-, dermal-, and inhalation-acute toxicity, as well as eye irritation tests, to unequivocally demonstrate the safety of the generic products for users.
3. Formalize the registration process for generic pesticides. This process should include evaluation by the MOA’s Pesticide Advisory Committee for the generic product’s necessity, efficacy, and safety before approval is granted. Such measures will ensure that generic pesticides introduced into the market meet the expected high standards of performance and safety, thereby protecting users and supporting the goals of pesticide reduction and sustainable agriculture practices.

Suggestion 5: Set up a transparent regulatory frame-work with a predictable timeline and adopt a product-based regulatory approach harmonized with Taiwan’s major trading partners for genome-edited products.

Agricultural innovation has played an essential role in increasing yields and productivity in support of growing, prosperous civilizations. Moreover, considering the rapidly growing world population, climate change, and increasing scarcity of natural resources such as arable land and water, progress in plant propagation has gained unprecedented importance.

High-yielding crops of superior nutritional value that can be grown more resource-efficiently are increasingly becoming the cornerstone of sustainable yet highly productive agriculture. In addition, there is a need to make crops more pest- and disease-resistant as well as more tolerant to adverse conditions such as drought, heat, submergence, and salinity. Innovations in precision biotechnology, such as gene editing, are therefore required to enhance the speed, predictability, precision, and success rate of plant breeding.

As highlighted in the 2023 White Paper, the World Trade Organization released the joint International Statement on Agricultural Applications of Precision Biotechnology, supported by 10 members, urging governments to implement science-based and globally harmonized policies for precision biotechnology. To support agricultural innovation, many of Taiwan’s key trading partners – including Argentina, Australia, Brazil, India, Japan, the Philippines, and the United States – have since implemented well-functioning and proportionate regulatory systems. These markets have exemptions granted certain types of gene-edited crops from their GMO regulations. Furthermore, the exemption by some government agencies can be evaluated and confirmed through a pre-consultation mechanism.

Over the past 12 months, some countries and regions have made further noteworthy progress in developing policies for the management of genome-edited products. For example, the European Commission released its New Genomic Techniques (NGT) proposal for new regulation on plants produced by certain new genomic techniques (for example, gene-editing technology) on July 5, 2023. The Commission also proposed that Category 1 NGT plants should be exempted from the requirements of GMO legislation, affirming the Commission’s position that plants derived from these technologies have safety profiles comparable to conventional counterparts and may contribute to sustainable agriculture and the European Union’s Farm to Fork Strategy, as concluded in the NGT study published on April 29, 2021.

On December 20, 2023, the Singapore Food Agency released a policy document for public consultation on the regulatory framework for genome-edited crops for food and feed. This document proposed that plants that do not contain foreign DNA should be exempted from pre-market safety assessment. On January 18, 2024, Thailand’s Technical Biosafety Committee approved the Guidelines for Consideration of Genome Editing, stipulating that products lacking novel genetic combinations or foreign genetic sequences should be exempt from GMO regulation.

These recent policy developments have demonstrated the importance of precision biotechnology such as gene editing to address challenges in agricultural production as well as to support food sufficiency and achieve sustainability goals.

Taiwan is a key global trading partner for agricultural products, including seed and plant products. To help Taiwan maintain a competitive and secure food and feed supply, we urge the government to establish a transparent regulatory framework with predictable timelines and adopt a product-based regulatory approach for gene-edited products to ensure harmonization with Taiwan’s major trading partners.