AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
Committee Events & Luncheons
The Committee looks forward to working with the Lai administration to further Taiwan’s progress in creating a healthy investment environment, promoting sustainable economic growth, and revitalizing the consumer market for the sake of securing future prosperity.
The following constructive suggestions aim to enhance regulatory harmonization and efficiency between Taiwan and its trade partners, positioning Taiwan as a significant global player. These recommendations are intended to benefit both Taiwan’s retail consumers and its exporters. The Committee hopes that by considering our recommendations, the government will show its commitment to good regulatory practices and dedication to innovation.
Suggestion 1: Enhance regulatory efficiency and harmonization.
1.1 Utilize digital technology to expedite engagement of direct selling distributors and customers. The U.S.-Taiwan Initiative on 21st Century Trade marks a significant collaborative milestone with specific relevance to the direct selling industry in Taiwan, in which more than one-sixth of the population is engaged. Key aspects of the Initiative, such as supporting small- and medium-sized enterprises in trade, harnessing the benefits of digital trade, and supporting environment and climate action, directly impact this sector.
Nevertheless, direct sellers face disproportionate regulatory burdens, especially due to the Fair Trade Commission (FTC) ban on their use of electronic online forms to legally launch their businesses. This ban, which is not imposed on industries such as life insurance or credit card services, places direct sellers at a disadvantage and contradicts modern digital practices that enhance transparency and accessibility, allowing stakeholders to understand their rights and duties effectively.
By embracing digitalization, Taiwan can align with international trade practices, facilitate international commerce, and support environmental goals by reducing paper waste. The Committee strongly urges the FTC to lift the prohibition on electronic sign-up agreements in the direct selling industry and promote the use of digital technology to foster a more equitable and progressive regulatory environment.
1.2 Remove requirements of overseas selling evidence or trial reports for infant and follow-on formula registrations. The Committee reiterates last year’s recommendation to remove the requirement making registration of infant and follow-on formula (excluding infant formula for special medical purposes) contingent on the provision of evidence of overseas sales or trial reports. Current registration regulations exempt nutritionally complete foods for special medical purposes (FSMPs) that meet compositional rules from this requirement.
Given that infant and follow-on formulas are similarly nutritionally complete and comply with national composition standards, it would be reasonable and consistent to extend this exemption to include these products. This change would simplify the registration process and align it with the treatment of comparable products, thereby removing unnecessary barriers to market entry.
1.3 Align food additive regulations with those of Taiwan’s major food trading partners. The Committee urges the government to engage in discussions with industry regarding the following recommendations concerning the Standards for Specification, Scope, Application and Limitation of Food Additives:
1.4 Limit restrictions on poultry and poultry products from state to the county level. In response to highly pathogenic avian influenza (HPAI) outbreaks in the United States, Taiwan has suspended imports of poultry and poultry products from entire states in which cases have occurred. Given the severe shortages of poultry meat and eggs during the 2023 avian influenza outbreak, however, it is time to consider strategic adjustments to current disease management policies. We highly recommend shifting the HPAI ban from state-wide to county-level enforcement. This approach would not only stabilize supply and pricing but also help the industry better meet domestic needs.
Adopting a county-specific ban aligns with international standards set by the World Organization for Animal Health and is consistent with practices in jurisdictions such as Canada, Hong Kong, New Zealand, and Singapore. The U.S. poultry industry, as the world’s largest producer and a major exporter, has historically been a key supplier for the Taiwan market. Import limitation from the state to county level would allow for more precise and effective disease control, minimizing disruptions to supply chains and reducing the economic impact of future outbreaks.
Suggestion 2: Streamline customs efficiency for imported food products.
2.1 Accelerate customs clearance for food products. Last year, businesses encountered operational delays due to slight discrepancies between the nutritional values displayed on the packaging and the Chinese labels. These discrepancies were caused by differing calculation methods or regulatory rounding rules. Despite these discrepancies falling within the permissible range set by the Regulations on Nutrition Labeling for Prepackaged Food Products, both foreign sellers and importers were required to provide detailed statements and explanations. The additional requirement typically extended the process by at least a week, creating unnecessary delays and inefficiencies.
We recommend that the government streamline this process by acknowledging and automatically accepting minor discrepancies that fall within the allowed ranges without requiring additional documentation. This adjustment would significantly reduce unnecessary delays and improve efficiency in the import and sales processes, aligning practice more closely with regulatory intentions and reducing burdens on businesses.
We recognize the critical importance of ensuring accurate nutritional information on food labels. To expedite the validation process, we propose implementing a system that automatically compares the original Certificate of Analysis (CoA), the nutritional panel from the packaging artwork, and the Chinese label using either a basic computer calculation or more advanced AI technologies. This system could be integrated into the TFDA’s existing e-food inspection framework.
Under this proposed system, no further action would be required if the discrepancies between documents fall within the tolerances specified by the regulations. This approach would allow inspectors to dedicate more time to addressing genuine food safety concerns rather than being encumbered by minor administrative discrepancies that do not pose a risk to public health.
2.2 Replace paper-based requirements with electronic procedures. This issue was brought up in the 2023 White Paper, but no substantial progress has been made. Despite Taiwan’s ambitious policy goals for digital governance and net-zero emissions – goals that emphasize reducing waste and enhancing operational efficiency – little progress has been made concerning the organic labeling permit application process. This process still necessitates the use of traditional postal money orders and requires applicants to submit printed documents in person to authorities. The Ministry of Agriculture (MOA) has indicated that it cannot change the application process since it is not included in the U.S.-Taiwan Organic Equivalence Arrangement. However, upon reviewing the relevant documents, it seems that no terms in the agreement explicitly prohibit Taiwan from adopting a digitalized application process for import permit documentation.
Improving this process is essential not only for aligning with Taiwan’s digital and environmental objectives but also for simplifying procedures to support the growth and efficiency of trade-related activities. We urge the MOA to modernize the application and review process for organic labeling approval by enabling electronic submissions and payments. Such improvements would significantly contribute to sustainability and operational efficiency, reflecting the government’s commitment to digital transformation and environmental responsibility.
Suggestion 3: Address impractical conditions in food safety regulations.
3.1 Establish FSMP clinical study pre-review and a standardized review timeline for food ingredient and additive applications. The Committee strongly recommends establishment of a pre-review and consultation process for FSMP clinical studies, similar to existing procedures for drugs and medical devices. This process would enable stakeholders to receive early feedback on study designs and the adequacy of referenced literature before the commencement of studies. Currently, the review process for non-traditional food ingredients and food additives often takes years and significantly lacks predictability and transparency. This delay hinders innovation and makes it challenging for the industry to plan effectively.
Implementing a clear, predictable review schedule would enhance transparency, allowing industry participants to better manage development timelines and accelerate innovation. Establishing these improvements is crucial for fostering a supportive regulatory environment that encourages advancements in food safety and nutrition.
3.2 Clarify Article 28 of the Act Governing Food Safety and Sanitation. Article 28 of the Act states that “the labeling, promotion or advertisement of foods, food additives, food cleansers and food utensils, food containers or packaging designated by the central competent authority in a public announcement shall not be false, exaggerated or misleading.”
As the global population and demand for food grows, genetic engineering has increasingly been utilized by farmers worldwide to produce genetically modified organism (GMO) crops. While the development of GMO crops continues to spark debate, governments globally strive to maintain transparency regarding their presence in the food supply. Addressing this issue, Article 22 of the Act mandates the labeling of genetically modified raw food materials, ensuring that consumers are aware of GMO content at the point of purchase.
However, it is equally vital to inform consumers about products that do not contain GMO materials. For instance, the Non-GMO Project Verified logo used in the United States accurately indicates that no GMO materials were used in the production of labeled food items. The U.S. government supports this practice as it provides truthful information without suggesting that all ingredients have GMO counterparts available globally.
We urge the TFDA to enable similar transparency in Taiwan by allowing clear labeling of non-GMO products to enhance consumer knowledge and choice, mirroring successful international practices. Such labeling would not only support consumers’ right to information but also contribute to an informed public capable of making choices aligned with their personal and dietary preferences.
Suggestion 4: Establish transparent scopes and clear classifications for raw materials with dual use in food and traditional Chinese medicine.
This issue has been raised by the Committee for three consecutive years without substantive progress. The issue stems from the simultaneous regulation by the TFDA and the Department of Chinese Medicine and Pharmacy (DCMP), both under the Ministry of Health and Welfare (MOHW).
The TFDA regulates all ingredients that may be used for food, including raw materials for dual-use food and medicinal ingredients, as authorized under Article 15-1 of the Act Governing Food Safety and Sanitation. In an effort to consolidate the regulation of all raw materials suitable for food use, the TFDA established a food ingredient platform that includes some Chinese herbs used as food raw materials in 2022. The instructions state that when the competent authority determines the attribute of the raw material to be medicinal, the material should meet the requirements specified in the Pharmaceutical Affairs Act.
In practice, before importing products, operators have confirmed that all the ingredients in the products comply with the food standards listed on the TFDA platform. However, they are still required to undergo additional assessments by the DCMP upon import without detailed regulations or standards to follow.
In addition, the DCMP has proposed the adoption of lists of Chinese medicinal ingredients suitable for use in food that would provide categorization and calculation methods to govern the scope, dosage, and safety assessment of use for such ingredients, with the proposal to be discussed at public hearings.
Article 15-1 has long authorized the TFDA to “restrict the methods or conditions of manufacture, processing, and preparation, or other matters of raw materials suitable for food use.” Therefore, provisions are already in place for the TFDA to regulate food and medicinal ingredients that are suitable for use both in food and as Chinese medicinal materials, and there is no need to separately formulate new laws or regulations.
The Committee has made this point repeatedly, but the response has been increasingly opaque administrative measures without any clear direction. We strongly recommend that the MOHW clarify the legal nature of substances that are fundamentally food and regulate them according to the Act.
Suggestion 5: Protect consumer health and trade facilitation by aligning Taiwan’s Tobacco and Alcohol Administration Act with international best practices.
We once again urge the Ministry of Finance (MOF) to implement regulations mandating the protection of manufacturer-applied lot codes on alcohol products, aligning Taiwan with international best practices. In the United States regulations strictly prohibit altering, removing, or destroying any marks, brands, or labels on beverage alcohol containers. Similarly, the European Union (including major alcohol markets like France and Italy), the United Kingdom, and Canada all require alcoholic products to bear manufacturer-applied lot codes. Notably, 31 out of the 34 OECD countries enforce regulations that mandate the use of these codes on the labels or containers of alcoholic beverages and prohibit their removal, tampering, or covering. Adopting such measures would ensure product traceability, enhance consumer safety, and maintain the integrity of the alcohol market in Taiwan.
Allowing importers to tamper with or remove original lot codes on alcoholic products violates three critical World Trade Organization agreements: the national treatment principle of the General Agreement on Tariffs and Trade, the national treatment provisions of the Agreement on Technical Barriers to Trade, and the provisions concerning trademark protection, geographical indications, and national treatment under the Agreement on Trade-Related Aspects of Intellectual Property Rights. Such practices unfairly disadvantage imported goods, leading to inequitable treatment in the marketplace.
Manufacturer-applied lot codes are essential for safeguarding consumer interests and safety. They ensure that alcoholic products can be traced and recalled if necessary. Importers who remove these codes and replace them with their own serial numbers compromise the traceability of the products. Such actions warrant strict administrative fines as they pose significant risks to consumer safety.
In light of these concerns, the Committee urges strict enforcement of Article 32, Paragraph 1, Section 6 of the Tobacco and Alcohol Administration Act. This legislation mandates that all alcoholic beverages must be labeled with the original lot code to preserve manufacturing information and maintain a trustworthy supply chain. No products should be imported or sold if the original lot code has been altered by a third party or is not clearly legible, as this disrupts product traceability and compromises the integrity of the supply chain. We sincerely hope that this year will bring significant breakthroughs in addressing this issue.
本委員會期待持續與政府合作,進一步健全台灣的投資環境、促進永續的經濟成長及振興台灣消費市場活力,以確保台灣未來榮景。
下列各項建言旨在加強台灣與貿易夥伴的法規調和及監管效能,成為全球貿易夥伴一員,並使台灣消費者與零售業出口產業受益。本委員會冀望藉由我們的建議,台灣將體現致力於良好法制作業與創新的決心。
建議一:提升監管效能與法規協調性
1.1 利用數位科技加速直銷商與客戶間的互動。
「台美21世紀貿易倡議」是一個顯著的里程碑,其中特別提及在台灣超過六分之一就業人口的直銷產業。上述貿易倡議主要的幾個面向也直接影響此產業,包含支持中小企業貿易、運用數位貿易之益處以及支持環境和氣候行動。
然而,直銷產業面臨著不符比例的法遵負擔,尤其因為台灣公平交易委員會禁止直銷產業使用電子線上表格合法開展業務,而壽險或信用卡服務等行業則不受限制。上開作法除不利直銷產業發展,亦與現今以數位化來提升透明度、易達性,使利害關係人了解其權利義務之目標相矛盾。
通過數位轉型,台灣可以與國際貿易慣例保持一致、促進國際商業往來,並通過減少紙張浪費來支持環境目標。委員會強烈敦促公平交易委員會取消對直銷產業線上簽約的禁令,並提升數位科技的使用,以促進監管環境更加公平及革新。
1.2 針對嬰兒配方奶粉及較大嬰兒配方奶粉,取消其註冊所需的海外銷售證明或試用報告。
本委員會重申去年之議題,即針對嬰兒配方奶粉和較大嬰兒配方奶粉(不包括特殊醫療用途的嬰兒配方奶粉)取消註冊需提供海外銷售證明或試用報告的要求。對符合成分標準且營養均衡完整的特殊醫學用途配方食品(FSMPs),現行的註冊法規對其免除前述要求。鑑於嬰兒配方奶粉和較大嬰兒配方奶粉同為營養均衡完整,並符合國家成分標準,將這些產品納入豁免範圍是合理且一致的。此變更將簡化註冊流程,並使其與類似產品的處理方式保持一致,從而消除不必要的市場准入障礙。
1.3 使食品添加物法規與台灣主要食品貿易夥伴的法規保持一致。
委員會敦促政府與業界就「食品添加劑規格、範圍、應用和限量標準」的以下問題進行討論:
1.4 將家禽及家禽產品的限制單位由州改為郡。
因應美國爆發高病原性禽流感(HPAI),台灣停止進口來自美國所有發生案例州的家禽及家禽產品。然而,在2023年禽流感爆發期間,家禽肉和蛋類出現了嚴重短缺,因此對當前疾病管理政策進行策略性的調整有其必要。我們強烈建議將針對高致病性禽流感的禁令,將限制單位由州改為郡。這種做法不僅可以穩定供給和價格,也能滿足國內需求。
採取特定區域的禁令符合世界動物衛生組織(WOAH)設定的國際標準,並與加拿大、紐西蘭、新加坡和香港等國家的做法一致。作為世界上最大的家禽生產商和主要出口國,美國一直是臺灣市場的主要供應商。將進口限制之單位由州改為郡將能更精確和有效地管理,也最大程度地減少對供應鏈的干擾,同時減輕未來相關疫情爆發對經濟之影響。
建議二:提升在進口食品的海關作業效率
2.1 加速食品海關通關。
去年,有許多委員會成員由於輸入食品時,其原文外包裝上顯示的營養標示與中文標籤上有細微差異,而導致了通關的延誤。這些差異係因不同的計算方法或監管四捨五入規則所造成,儘管這些差異在「包裝食品營養標示應遵行事項」規定的允許範圍內,委員會成員仍被要求需由進口商或是外國供應商提供詳細的聲明和解釋。這項額外要求通常會使通關報驗流程至少延長一周或以上的時間,造成不必要的延誤和效率低下。
我們建議邊境查驗主管機關接受營養標示資訊中屬於法規允許範圍內的些微數據差異可無需提供額外的文件。我們相信此一調整將可顯著減少不必要的延誤,並在維持監管目的之同時提高進口和銷售流程的效率也減輕企業的負擔。
在此同時,我們也理解確保食品標籤上準確的營養資訊有其重要性。為加速通關報驗流程,我們建議食品藥物管理署逐漸採用能透過電腦計算或更先進的人工智慧技術自動比較成分分析報告(CoA)、外包裝營養成分標籤和中文標籤。前述系統也可以整合到食品藥物管理署現有的食品查核及檢驗資訊平台中。
在此系統下,如果文件之間的差異在「包裝食品營養標示應遵行事項」規定的容許誤差範圍內,則無需採取進一步的行動。此方法可使檢驗人員能夠投入更多時間來解決真正的食品安全問題,而無需因不對公共衛生構成風險的行政差異而導致耽誤。
2.2 以電子化流程取代紙本要求。
這個議題在2023年的白皮書中已被提出,但目前尚未有實質進展。儘管台灣在數位治理和淨零排放方面訂定了雄心勃勃的政策目標—前述目標強調廢棄物減量和提高營運效率,但在進口有機農產品同意文件的申請流程方面卻進展甚微。目前,相關申請作業仍需要使用紙本郵局匯票繳費,並要求申請人送交紙本申請表至主管機關。儘管農業部表示,美台現有協議並未涵蓋申請程序,然而,在審查相關文件後,協議當中並未明確提及禁止台灣採取電子化的進口文件申請許可。
改善此流程不僅對台灣的數位和環境目標至關重要,更能簡化程序以支持貿易相關活動的效率與成長。我們敦促農業部透過電子支付及電子化申請作業以達成進口有機農產品同意文件之申請和審查流程的現代化,這些改進將深遠地促進永續發展和營運效率,並反映台灣對於數位轉型和環境責任的承諾。
建議三:解決食品安全規定中不符現況之條件
3.1 建立特殊醫學用途配方食品(FSMP)臨床研究預審機制,以及標準化食品成分和添加物申請的審查時間表。
本委員會建議食品藥物管理署參考藥品及醫療器材臨床試驗之預審及諮詢機制,亦建立特殊醫學用途配方食品臨床人體食用研究之預審及諮詢機制,使產業中的利害關係人得透過預審或諮詢機制調整並執行合適的臨床人體食用研究。
現今,對非傳統食品原料及食品添加物查驗流程時間冗長且處理期限未明,嚴重阻礙創新並使得相關產業難以產出有效的規劃。
實施明確且可預測的審查時程將增強透明度,使產業參與者能夠更好地管理發展時程並加速創新。建立這些改善對於促進支持性的監管環境、鼓勵食品安全和營養方面的進步至關重要。
3.2 闡明《食品安全衛生管理法》第28條。
《食品安全衛生管理法》第28條規定:「食品、食品添加物、食品用洗潔劑及經中央主管機關公告之食品器具、食品容器或包裝,其標示、宣傳或廣告,不得有不實、誇張或易生誤解之情形。」
隨著全球人口和對食品的需求增加,農民們利用越來越多的基因工程技術生產基因改造作物。儘管發展基因改造作物仍然引發許多爭議,但各國政府努力保持食品供應中基因改造作物的透明度。為解決這個問題,《食品安全衛生管理法》第22條規定了基因改造原料的標示要求,確保消費者在購買時了解基因改造的含量。
然而,同等重要的是要讓消費者辨別哪些是不含基因改造原料的產品訊息。例如,美國的「非基因改造計畫標章」明確地標示食品中未使用基因改造原料,因為標章在不暗示全球所有成分皆含有基因改造原料的前題下亦提供了可信任的資訊,而受到美國政府支持。
我們敦促台灣的食品藥物管理署借鏡國際上成功的案例,透過非基因改造產品的明確標示,以提升消費者的了解和選擇權。這樣的標示不僅能確保消費者獲取資訊的權利,還將有助於大眾能根據個人和飲食偏好做出選擇。
建議四:針對食藥兩用原料釐清規範並建立明確分類
委員會連續三年提出此項議題,但皆無實質進展,可歸因於原料同時由衛生福利部之食品藥物管理署及中醫藥司兩個不同行政單位管理。
食品藥物管理署訂定了法律、法規和指導方針,如「可供食品使用原料彙整一覽表」係根據《食品安全衛生管理法》第15-1條的授權,規範所有可用於食品的成分,也包括食藥兩用的原料。為了統一規範所有可供食品使用的原料,食品藥物管理署於2022年建立了食品原料整合查詢平台,其中包含一些用於食品的中草藥原料。另於說明事項中說明,當主管機關確定原料屬於藥用時,該原料則應符合《藥事法》中指定的要求。
實際執行上,業者於產品進口前原料皆確認已符合食藥署平台所列之食品規範,產品歸類於食品,但進口時在無詳細法規和標準可供遵循下,仍需接受中醫藥司額外的屬性判斷,另中醫藥司訂定「可同時提供食品使用之中藥材」列表,及研擬「得供食品原料使用之中藥材分類及品項」等計畫在公開聽證會上討論草案,涵蓋食藥兩用原料在使用範圍、劑量及安全評估的相關分類和計算方法。
《食品安全衛生管理法》第15-1條長期授權主管機關「得限制其製造、加工、調配之方式或條件、食用部位、使用量、可製成之產品型態或其他事項。」
因此,衛生福利部已有相應規定,規範適用食藥兩用的原料,並無需額外制定新的法規。
雖然委員會已多次提出此項建議,但觀察不到更透明的行政措施,故委員會強烈建議衛生福利部根據《食品藥物管理法》明確就係屬於食品的法律性質的原料進行相關規範。
建議五:將台灣的《菸酒管理法》與國際最佳實務協調一致,以保護消費者健康並強化貿易便捷化
本委員會再次呼籲財政部實踐法規,強制保護酒類產品製造商的原廠產製批號,使台灣與國際最佳實踐保持一致 。在美國,法規嚴格禁止更改、移除或銷毀酒精飲料容器上的任何標記、品牌或標籤。同樣地,歐盟(包括法國和義大利等主要酒類市場)、英國和加拿大都要求酒類產品保有製造商的原廠產製批號。值得注意的是,在34個經濟合作暨發展組織國家中的 31 個國家均執行相關法規,強制要求在酒精飲料的標籤或容器上使用產製批號,並禁止移除、篡改或覆蓋。採取這些措施將確保產品的可追溯性、增強消費者的安全並維護台灣酒類市場的誠信。
允許進口商篡改或刪除酒類產品的原廠產製批號違反了三項關鍵世界貿易組織的協議:《關稅及貿易總協定》(GATT)的國民待遇原則、《技術性貿易壁壘協定》(TBT)的國民待遇條款以及《與貿易有關的智慧財產權協議》(TRIPs)中有關商標保護、地理標示和國民待遇的規定。這種不公平做法使進口產品處於不利地位,導致市場上的不平等待遇。
製造商的原廠產製批號對於保護消費者的利益和安全至關重要,他們確保酒精產品一旦產生問題時可以溯源並被追蹤和召回。進口商移除這些產製批號並替換自身的編碼必定會損害產品的可追溯性。此類行為需要接收嚴厲的行政裁處,基於此行為對消費者的安全構成重大風險。
有鑑於以上擔憂,本委員會敦促政府嚴格執行《菸酒管理法》第32條第一項第六款之法規。該法條強制規範所有酒精飲料皆必須貼上原廠產製批號的標籤,以保存製造資訊並維持可信賴的供應鏈。如果原始產製批號已被第三方更改或導致無法提供完整資訊,則不應允許進口或銷售,因為這將破壞產品的可追溯性並損害供應鏈的完整性。委員會衷心期待此議題在今年能有突破性的進展。