The Committee appreciates the government’s positive response to our 2024 White Paper recommendations, particularly the decision to lift the ban on electronic sign-up agreements in the direct selling industry.

The below suggestions aim to enhance regulatory transparency and administrative efficiency, consistent with the principles of openness and reform championed by the Lai Ching-te administration. These proposals are intended to reduce trade barriers, promote innovation, and deliver tangible benefits to both Taiwan’s consumers and retail sector.

Suggestion 1: Promote trade facilitation through clearer customs and food safety regulations.

1. Enhance clarity in the application of Article 13 of the Regulations Governing the Implementation of Automated Cargo Clearance Procedures. Taiwan’s implementation of Article 13 leverages digital tools to classify imports into three categories: Channel One (C1), Channel Two (C2), and Channel Three (C3), determining whether cargo is subject to document review or physical inspection.
   However, there are no consistent, publicly accessible guidelines outlining how the Customs Administration under the Ministry of Finance (MOF) determines these classifications or what importers can do to achieve fast-track clearance through C1. The absence of clear criteria hinders predictability and undermines trust in the system.
   The Committee recommends that the MOF publish detailed guidance on the classification process and eligibility criteria. Doing so would enable businesses to adopt practices that support customs compliance and allow qualified importers to benefit from expedited clearance, ultimately enhancing trade efficiency and reducing supply chain delays.
2. Remove the requirement for overseas sales evidence or trial reports in infant and follow-on formula registrations. All ingredients used in infant and follow-on formulas (except those for special medical purposes) must meet the safety, nutrition, and compositional standards set by the Taiwan Food and Drug Administration (TFDA). Non-traditional food ingredients must be reviewed and approved by the TFDA’s Food Safety and Nutrition Advisory Committee. Prior to manufacturing, processing, preparing, repacking, importing, or exporting, products must undergo inspection, registration, and licensing by the TFDA to ensure compliance with nutrient content limits and applicable sanitation standards prescribed by the agency.
   The TFDA also requires applicants to submit overseas sales evidence or trial reports for infant and follow-on formula registrations. However, this requirement does not apply to nutritionally complete and balanced foods for special medical purposes (formulas designed to be the sole source of nutrition for patients with specific medical conditions), for which the TFDA removed the sales/trial report requirement in 2019.
   The Committee recommends extending this policy to infant and follow-on formulas that comply with TFDA compositional standards. As breast milk substitutes already undergo rigorous safety evaluations by the TFDA, the requirement for overseas sales or trials does not enhance consumer safety. Instead, it imposes unnecessary administrative burdens, delays market access for innovative products, restricts consumer choice, and inhibits trade.
3. Increase transparency in the food additive review process. This issue was raised in the 2024 White Paper and discussed during last year’s meeting with the National Development Council. The Committee reiterates its recommendation that the TFDA adopt a more transparent and participatory approach when reviewing new food additives or considering modifications to their permitted scope of use.
   The Committee recommends that the TFDA engage industry experts early in the process to ensure regulatory decisions reflect operational needs and scientific evidence. Greater transparency and stakeholder involvement would enhance regulatory predictability, reduce miscommunication, and ensure technically sound, operationally feasible regulations. We look forward to supporting the TFDA in developing a structured and inclusive review framework.
4. Adjust avian influenza import restrictions and diversify poultry supply sources. Avian influenza outbreaks threaten poultry and poultry product supplies, often leading to shortages and price increases in Taiwan. The Committee urges the government to adopt more targeted risk management strategies to safeguard food security and consumer interests.
   We recommend revising Taiwan’s blanket import restrictions by adopting a county-level ban, following practices in Canada, Hong Kong, New Zealand, and Singapore. These jurisdictions limit import bans to the affected counties rather than suspending poultry imports from an entire state, thereby minimizing disruption to trade while still protecting animal and public health.
   Additionally, we suggest that the government proactively diversify poultry import sources. A more diversified sourcing policy would mitigate overreliance on a limited number of countries and enhance Taiwan’s resilience against future disease outbreaks. As part of this effort, the government should consider permitting the import of poultry and poultry products from additional qualified sources, such as Thailand, to ensure poultry availability, reduce price volatility, and support food security.

Suggestion 2: Adopt measures to improve efficiency in the food import process.

1. Replace paper-based requirements with electronic procedures to advance digital governance and efficiency. The Committee again recommends eliminating paper-based requirements in the organic import permit application process. This issue was raised in the 2022, 2023, and 2024 editions of the White Paper. Despite prioritizing digital transformation and net-zero goals, the government has made little progress in this regard. Hard-copy documents and postal money orders burden importers, slow trade, and contradict policy goals. Although the Ministry of Agriculture (MOA) cites restrictions under the U.S.-Taiwan Organic Equivalence Arrangement, no provision prevents Taiwan from adopting a digital permit system.
   We urge the MOA to modernize the application and review system by introducing electronic submissions and digital payment mechanisms. This step would reduce paper use, improve efficiency, and support digital government and sustainability goals.
2. Allow multiple packers to be listed as manufacturers of fresh produce to improve inspection efficiency and reduce redundancy. Under the TFDA’s 2024 Regulations of Inspection of Imported Foods and Related Products, importers are required to declare the “actual packer/manufacturer” for all imported food products, except for fresh produce. In the case of fresh produce, which is often sourced from multiple packers by large exporters, the exact packer may not be identifiable at the time of import. The current policy allows importers to instead declare the “foreign responsible exporter” under such circumstances. However, in practice, border inspectors have asked importers to amend this information during product inspections, resulting in the splitting of a single declaration into multiple filings. This practice has significantly increased the administrative burden on importers, led to repetitive inspections, and raised operational costs.
   The Committee recommends allowing more than one packer per inspection filing when products come from the same country and meet uniform safety and quality standards. This change would streamline inspections, reduce duplication, and improve resource allocation.
3. Adjust tariff rates on dietary supplements to support preventive health. The Healthy Taiwan initiative, a core policy under President Lai Ching-te, emphasizes prevention and sustainable health, for which dietary supplements play a critical role.
   At present, imported dietary supplements face a 30% tariff, which is notably higher than the rates imposed by key trading partners such as the United States, Japan, and South Korea, where tariffs range between 6.4% and 14.56%. In a misalignment with national health priorities, the supplement tariff is also higher than the 27% tobacco tariff.
   The Committee recommends a gradual reduction of the import tariff on dietary supplements to 10%. Lowering the tariff would be aligned with Taiwan’s trade norms and improve consumer access to health products.
4. Refine regulatory handling of carried-over natural substances. The Committee recommends revising the checklist of common supplementary document requirements for imported food and related product inspection applications to clarify procedures when unlisted substances such as preservatives or antioxidants are detected during inspection. In such cases, literature-based background values should be recognized as the sole compliance criterion. Providing clear guidance on this point would reduce ambiguity for importers, minimize unnecessary documentation requests, and improve overall inspection efficiency. To that end, we propose the following refinements:
   2.4.1 Address new raw materials and advanced processing methods. Public data may not reflect regional or proprietary ingredient variations. The TFDA should allow scientific documentation to explain differences.

   2.4.2 Establish standardized carryover management. The TFDA should adopt guidelines or accept raw material testing under finished products to confirm naturally occurring substances (such as salicylic acid and benzoic acid).

   2.4.3 Align with international standards. We urge the TFDA to differentiate additives from flavorings (such as rosemary extract) in accordance with Codex Alimentarius standards to avoid ingredient misclassification and support global trade consistency.

5. Accept electronic health certificates for imported compound food additives at Customs. The Committee notes that since 2021, the TFDA has accepted health certificates with electronic signatures for the registration of food additives. However, the port of entry still requires original hard copies for imported compound additives in accordance with Customs guidance last updated in 2017.
   Electronic signatures are already accepted by the TFDA in other processes. Allowing electronic certificates at the port would enhance consistency, streamline clearance, and support digital governance and trade facilitation.

Suggestion 3: Improve regulatory transparency and efficiency in the review of food ingredients and additives.

1. Enhance the transparency and timeliness of the TFDA review of non-traditional food ingredients and food additives. The TFDA’s current review process for non-traditional food ingredients and food additives lacks clearly defined timelines and offers limited visibility into review progress. As a result, the process delays market entry and discourages businesses seeking to introduce innovative products to the Taiwan market.
   The Committee recommends that the TFDA establish a standard review period for applications, particularly for ingredients already approved in peer markets such as those listed under the U.S. FDA’s Generally Recognized as Safe designation or the Codex food additive list. For such cases, the total review period should not exceed one year. Additionally, applicants should be able to track the status of their submissions through a transparent and regularly updated mechanism.
   Enhancing clarity and predictability in the regulatory process would support greater innovation, promote trade, and foster a more open and efficient regulatory environment.
2. Modernize online alcohol transaction regulations for a digitally driven and responsible marketplace. Article 30 of the Tobacco and Alcohol Administration Act (TAAA) prohibits the sale and delivery of alcohol through digital platforms. While the prohibition was originally intended to prevent underage access, this continued limitation increasingly contradicts Taiwan’s digital transformation goals and hinders retail and logistics innovation.
   Taiwan’s establishment of the Ministry of Digital Affairs (MODA) reflects the government’s commitment to advancing the digital economy. However, regulatory restrictions under the TAAA have not kept pace with digital innovation. While the Committee acknowledges the MOF’s responsibility for consumer protection, its concurrent role in overseeing financial systems built on secure digital verification positions it to recognize the reliability of such tools in enabling regulated, safe transactions.
   Several economies, including Australia and the United Kingdom, have adopted regulatory frameworks permitting online alcohol sales while maintaining robust safeguards against underage access. In Taiwan, digital platforms do not serve as the seller of record but function as intermediaries capable of embedding age verification technologies at multiple stages, from transaction to delivery. The challenge lies not in technological readiness but in the absence of an updated regulatory framework.
   The Committee recommends that the MOF initiate structured discussions with MODA and relevant industry stakeholders to evaluate a feasible and secure model for regulated online alcohol sales. This dialogue should be anchored in three core principles:

   ．Defining effective identity verification mechanisms suitable for online commerce.
   ．Requiring additional safeguards such as delivery-based age checks and digital consumption warnings.
   ．Enabling short-term pilot programs through a regulatory sandbox, with clear pathways to broader implementation.

Such a collaborative approach would allow Taiwan to modernize its regulatory landscape while preserving its commitment to consumer safety and public health.

Suggestion 4: Enhance regulatory clarity and international alignment for dual-use substances in food and traditional Chinese medicine.

The Committee appreciates the TFDA’s inclusion of select ingredients with dual use in food and traditional Chinese medicine (TCM) in the Food Ingredient Integration Query Platform. However, regulatory uncertainty persists during the import process, particularly regarding the final classification of products. In some cases, ingredients originally classified as food are reassessed at the point of entry by the Ministry of Health and Welfare’s Department of Chinese Medicine and Pharmacy (DCMP) and deemed to require additional fees and procedures. This lack of transparency delays customs clearance, disrupts supply chains, and exposes companies to reputational risk and unnecessary operational costs.

To address these concerns, the Committee urges the TFDA to improve regulatory transparency and harmonize standards with international practices. Taiwan can build a clearer, science-based regulatory framework that facilitates trade while maintaining public health safeguards.

1. Enhance transparency of administrative procedures. We recommend that the government form a working group that brings together representatives from both the TFDA and the DCMP. This group should be tasked with clarifying regulatory principles for dual-use substances and developing guidance based on science and risk assessment.
2. Align regulations with international standards. Taiwan should benchmark its regulatory practices against those of peer economies in Asia. For example, China has gradually expanded its list of dual-use ingredients to over 100 items. Japan clearly distinguishes substances that may be used for food based on their properties, while South Korea maintains a comprehensive database of permitted and restricted plant-derived ingredients. Singapore has also published a list of commonly used TCM substances that are approved for food use.
   Taiwan’s current list of ingredients permitted for dual use has been reduced from 215 to just 37 items, raising concerns within the industry. Given the cultural significance and historical use of many of these substances in Chinese dietary practice, the Committee recommends expanding the list and aligning the regulatory framework with that of other advanced regulatory systems.
3. Strengthen government-industry collaboration. The Committee recommends that the government further strengthen collaboration with industry stakeholders to improve regulatory predictability and facilitate the lawful use of dual-use ingredients in both food and TCM applications.
   First, the list of permitted dual-use ingredients should be updated on a regular basis, at least once every two years. A regular update mechanism would ensure alignment with scientific developments, international standards, and evolving market needs.
   Second, the Committee suggests optimizing import-related procedures by integrating the functions of the TFDA, DCMP, and TFDA border inspection authorities into a streamlined, one-stop digital platform. Such integration reduces inconsistencies across agencies and mitigates delays at the border caused by overlapping jurisdiction or duplicative review.
   Finally, public hearings and stakeholder consultations should be institutionalized as part of the Ministry of Health and Welfare’s regulatory development process. These engagements would ensure that practical industry knowledge informs policy decisions and would help support the growth of Taiwan’s TCM-related industries.

Suggestion 5: Strengthen consumer protection and trade facilitation by aligning the Tobacco and Alcohol Administration Act with international best practices.

The Committee urges the MOF to bring the TAAA and its related interpretative orders into closer alignment with international practices governing alcoholic beverages. In particular, enforcement of Article 32 of the TAAA, which requires all packaged alcoholic products sold in Taiwan to bear a manufacturing lot code, remains inconsistent. This provision is central to protecting public health, as lot codes serve as essential tools for product traceability and recall in the event of safety concerns.

Under the Consumer Protection Act, the government bears a legal obligation to enforce labeling laws that protect consumer rights. However, according to industry reports, certain local parallel importers have been removing original lot codes and replacing them with unrelated serial numbers. This practice undermines product traceability, weakens consumer protection, and violates the intent of the TAAA.

Global best practice supports maintaining manufacturer-applied lot codes. For example, U.S. regulations prohibit the alteration, removal, and/or destruction of any mark, brand, or label on alcoholic beverage containers that are sold on the market, regardless of whether that information is mandatory or voluntary. The European Union, United Kingdom, and Canada all require original lot codes to be preserved on alcoholic products. The EU Directive 2011/91/EU mandates that all packaged food and beverage products, including alcoholic beverages, display a lot code identifying the production batch. A review of OECD member states shows that 31 out of 34 countries prohibit the removal, tampering, or covering of such codes on alcoholic beverages.

The MOF has acknowledged that in 2024, approximately 0.3% of imported whisky products, representing an estimated 100,000 bottles, entered Taiwan without proper lot codes. This situation raises serious concerns about the government’s ability to effectively trace or recall affected products in the event of a food safety incident.

The Committee recommends that the MOF amend relevant laws and regulations to explicitly prohibit the removal or alteration of original manufacturer lot codes on alcoholic products. Further, we urge the authorities to strengthen enforcement through systematic inspections at the border and throughout the supply chain. This policy adjustment would not only enhance consumer protection but also improve regulatory consistency, support fair competition, and ensure Taiwan’s continued compliance with international trade norms.