The Committee appreciates the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), and Ministry of Agriculture (MOA) for considering our recommendations in the 2024 Taiwan White Paper. We commend their commitment to open dialogue and the adoption of science-based regulations, which are essential to the continued growth and advancement of our industry.

As we confront the complexities of agriculture, it is critical to address the numerous challenges faced by farmers, affecting not only productivity and competitiveness but also agricultural sustainability and food security. To mitigate negative impacts, we encourage the authorities to strengthen regulatory management, streamline the registration process for new pesticides, and accelerate the revision of the Agro-pesticides Management Act.

Additionally, we strongly urge the establishment of a practical regulatory framework that adopts a product-based approach for gene-edited products. Implementing such a framework would foster innovation in plant breeding and enhance food security by enabling the development of more resilient and sustainable agricultural solutions.

Suggestion 1: Broaden and clarify amendments to Article 14 of the Agro-pesticides Management Act and related labeling regulations.

Under current regulations, approved labeling updates must be implemented within six months. This requirement applies not only to products in production or storage but also to those already distributed through market channels. After the six-month window, products bearing outdated labels must be recalled and relabeled with the most recently approved version, creating significant logistical and financial burdens for businesses, particularly when managing high-volume or long-shelf-life products.

During a closed-door consultation with the Animal and Plant Health Inspection Agency (APHIA) by representatives from the pesticide industry in January 2025, the APHIA proposed a draft amendment to the regulations on pesticide labeling management (the Regulations). This amendment would allow pesticide companies applying for changes to their foreign manufacturing facilities, commissioned packaging facilities, or processing plants to continue using existing labels after the change is approved, provided the label information remains consistent with the updated facility details.

However, we continue to recommend the inclusion of an expanded and comprehensive positive list in the Regulations that clearly defines the circumstances under which product recall for label replacement is not required. In addition to changes in foreign manufacturing facilities, commissioned packaging factories, or processing facilities, we urge the inclusion of modifications such as product shelf-life extensions, updates to packaging design, and corrections of typographical errors or other label adjustments that do not impact product safety. Establishing such a list would enhance regulatory clarity, reduce unnecessary administrative burdens, improve overall efficiency, and allow companies to respond more flexibly to operational and market changes.

For years, the practice has been well-established in other industries of allowing products to remain on the market without recall and applying new labels only after a label amendment. To minimize unnecessary resource waste and costs, and in alignment with industry best practices, we strongly recommend that changes unrelated to product safety be permitted without requiring immediate relabeling. Instead, products already on the market should be allowed to retain their original labels and continue being sold until the expiration of the respective batch.

Suggestion 2: Ensure consistent and predictable pesticide registration and review management.

In many developed countries, the information and standards required for pesticide registration are clearly defined through laws, regulations, or published technical specifications, providing industry with a transparent and predictable compliance framework. In Taiwan, however, the absence of a consolidated and consistently published set of standards has resulted in persistent uncertainty for registrants. Despite years of discussion, progress on resolving this issue has been significantly delayed, and the timeline for establishing the relevant draft regulations remains unclear. As a result, companies continue to operate without a stable regulatory reference, hindering planning and investment.

The MOA introduces new measures or standards annually at its business registration symposium. However, pesticide registration information must be compiled several years in advance of submission, making it challenging for applicants to comply immediately with newly issued requirements. As a result, companies frequently receive multiple requests for supplemental documents or additional information during the review process, leading to prolonged delays or, in some cases, failure to obtain registration approval. This uncertainty hinders industry planning and disrupts the timely introduction of safer, more effective, and more innovative pesticide products.

For instance, regarding the scope of extended use of an already-registered pesticide, applicants were previously only required to conduct an efficacy evaluation on representative crops to obtain approval. However, recent administrative updates have introduced additional requirements outlined in the guidelines for pesticide extended use applications, including the submission of a written justification of extended use and a form describing the intended method of pesticide application.

Furthermore, even when applicants adhere to the implementation methodology prescribed by the competent authority, they are still required to restate representative efficacy and, in some cases, conduct additional domestic trials. These new requirements not only increase administrative burdens but also prolong the approval process, delaying farmers’ access to more advanced and reliable pesticide solutions. We urge the MOA and the APHIA to streamline the regulatory framework and eliminate redundant requirements to make the registration process more efficient and predictable.

We recommend that the MOA amend the Agro-pesticides Management Act and its associated sub-laws, including the Guidelines for the Physicochemical and Toxicological Studies of Agro-Pesticides and Article 4, Paragraph 1, Subparagraph 2 of the guidelines for pesticide field trials. These provisions should clearly define the extended scope of use for grouped crops or pest species, the criteria for representative crop selection, and the implementation methods for extrapolation. Incorporating these elements into the formal regulatory framework would reduce ambiguity, ensure more consistent application, and improve predictability for applicants.

Additionally, we urge the MOA to revise the review schedule and compliance standards to establish a more transparent and predictable process. These adjustments would improve regulatory efficiency, reduce unnecessary delays, and facilitate the timely introduction of innovative and effective agro-pesticide products.

Suggestion 3: Establish administrative procedures to accelerate the approval of pesticide residue tolerances.

The Committee acknowledges the authorities’ commitment to improving the inquiry system and appreciates the TFDA’s efforts to provide timely updates on the status of domestic maximum residue limit (MRL) applications submitted by the MOA. These efforts have contributed to greater transparency.

The TFDA issued two rounds of pesticide residue tolerance announcements in 2024. The first, on March 29, included the deletion of three active ingredients (AIs) covering 23 crops and the addition of 22 AIs for 101 crops. The second, on November 18, added 21 AIs for 135 crops. While these announcements reflect continued progress, the frequency and volume of updates are lower than in prior years.

Despite the number of meetings convened by the Food Sanitation, Safety, and Nutrition Advisory Committee and the fact that most cases reviewed involved pesticide tolerances, there has been no increase in the number of announcements issued nor a noticeable improvement in review timelines. The Committee therefore recommends that the TFDA align the announcement schedule with the frequency of pesticide technology committee meetings and aim to issue at least three pesticide residue tolerance announcements per year.

Additionally, the Committee notes that administrative processing by the APHIA to transfer cases to the TFDA following pesticide technology committee approval often exceeds one month. It is recommended that this period be limited to 30 days.

Further, the Committee urges the TFDA to clarify the expected timelines for both documentary and committee meeting reviews once cases have been submitted. The entire process from submission to pre-announcement and final announcement should be expedited to achieve a publication frequency of no fewer than three announcements per year.

Accelerating the approval of pesticide residue tolerances would enhance public food safety, support diversified and resilient food import channels, and facilitate the introduction of high-efficiency, low-toxicity pesticides. The Committee encourages the MOHW and MOA agencies to continue publishing review timelines and streamlining administrative procedures to improve efficiency in the announcement process.

Suggestion 4: Strengthen intellectual property protection for new active ingredient registration, label expansion, and extrapolations.

Article 10 of the Agro-pesticides Management Act provides for a 10-year data protection period for new AIs, with the relevant amendments promulgated on May 23, 2018. However, the provision has not yet entered into force. As stipulated in Article 59, the effective date must be separately announced by the Executive Yuan and is to be coordinated with Taiwan’s negotiations for accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

The Committee has consistently urged that this link to the CPTPP be lifted and calls on the authorities to finalize the implementation date of the provision as soon as possible. Taiwan formally submitted its application to join the CPTPP on September 22, 2021, and has since taken proactive steps to align relevant legal frameworks with the agreement’s standards. Intellectual property regulations are among the critical areas of reform and should continue to advance accordingly.

Article 10 also specifies the inclusion of “extrapolation registration” within the scope of data protection. Implementing the data protection mechanism would create a more predictable and investment-friendly environment for pesticide development, encouraging the introduction of safer and more effective active ingredients. This would, in turn, support Taiwan’s efforts to improve agricultural outcomes and enhance its competitiveness in global agricultural policy.

Suggestion 5: Adopt a product-based regulatory approach for gene-edited products to ensure harmonization with Taiwan’s major trading partners.

Plant breeding is a science-driven, product-oriented discipline aimed at improving crops to meet the evolving demands of the entire value chain, from farmers to consumers. Advances in breeding technologies, including targeted mutagenesis and genome editing, have significantly enhanced breeders’ ability to introduce novel traits with greater precision and efficiency. Unlike traditional methods that rely on random genetic variation, these innovative techniques allow for targeted gene edits, enabling more predictable and desirable outcomes.

These plant breeding innovations can generate genetic changes comparable to those occurring naturally through spontaneous mutations or conventional breeding techniques. With these advancements, breeders can accelerate the development of high-performing, resilient crops, contributing to sustainable agriculture and a more secure global food supply.

The latest breeding innovation tools, such as genome editing, offer transformative solutions to the climate and agronomic challenges faced by farmers. These technologies enable the development of crops with enhanced resistance to diseases and pests, improved agronomic performance, and greater tolerance to abiotic stresses such as drought, salinity, and extreme temperatures. Plant breeding innovations can play a crucial role in strengthening global food security and fortifying the agricultural system.

Beyond agricultural productivity, these advancements also benefit end users by enabling the development of crops with specific quality and nutritional characteristics. For example, genome editing allows for the enhancement of healthier oil profiles and other nutritional improvements, catering to consumer demand for healthier and more sustainable food options while bolstering public health.

As noted in the 2023 and 2024 editions of the Taiwan White Paper, breeding innovation tools have been instrumental in the development of new gene-edited products. To support agricultural innovation through these advanced breeding techniques, Taiwan’s key trading partners (including Argentina, Australia, Brazil, Canada, India, Japan, the Philippines, and the United States) have established well-functioning and proportionate regulatory systems that follow a product-based approach. These markets have also introduced exemptions for certain types of gene-edited crops from their GMO regulations, recognizing that genome editing can produce genetic changes comparable to those occurring naturally or through conventional breeding methods.

In 2024, Thailand introduced a new regulation titled “Certification of Organisms Developed from Genome Editing Technology for Agricultural Use, B.E. 2567,” aimed at positioning the country as a global leader in agricultural innovation. This regulatory framework aligns Thailand with other nations that have embraced science-based approaches to plant breeding advancements.

Similarly, the Singapore Food Agency has established a science-based and risk-proportionate regulatory framework for gene-edited crops used in food and animal feed. Under this framework, gene-edited crops that are equivalent to conventionally bred crops are not required to undergo a pre-market safety assessment. This approach facilitates the adoption of genome editing technology while maintaining rigorous safety standards and ensures that agricultural innovation can progress without unnecessary regulatory barriers.

Furthermore, other countries in the region, including Indonesia, Malaysia, and New Zealand, have made significant progress in developing policies for managing gene-edited products. In New Zealand, the Ministry of Business, Innovation and Employment has introduced the Gene Technology Bill, marking a significant step toward establishing a science-based regulatory framework for gene technology.

By adopting this framework, New Zealand aims to unlock the broad benefits of biotechnology, including advancements in healthcare and solutions to climate change. These policies also aim to enhance environmental protection, increase agricultural productivity, and strengthen export competitiveness. The development of such policies reflects a growing global consensus on the need for proportionate, science-driven policies that support innovation while maintaining safety and sustainability.

Considering the effective adoption of genome editing policies by many of Taiwan’s trading partners to support agriculture innovation, address climate change, and enable sustainability, we continue to urge the TFDA and MOA to establish a workable regulatory framework and adopt a product-based regulatory approach for gene-edited products.

Implementing such a framework is essential not only for maintaining Taiwan’s competitiveness in agricultural innovation and the seed industry but also for ensuring a stable food and feed supply. Additionally, aligning Taiwan’s regulatory approach with that of its major trading partners will facilitate international trade harmonization, enhance market access, and support long-term agricultural development.