外國食品進口到台灣，需要辦理哪些程序？

Send an email to tpe4ww.food@evershinecpa.com
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735  
Tel No.: +886-2-2717-0515 ext. 103  

What are procedures when importing a foreign food into Taiwan?

Step 1. Composition Review

English:
Check whether any ingredient is listed as prohibited or restricted by the Taiwan Food and Drug Administration (TFDA).
If prohibited, the product cannot be imported.

Chinese:
確認產品成分是否包含在 衛福部食品藥物管理署 (TFDA) 公告之 禁止或限制成分。
若屬禁止成分，則不得輸入。

📄 Required Documents:

• Full ingredient list (with percentage)
• Certificate of Analysis (COA)
• Product specification sheet

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Step 2. Special Forms (Tablet / Capsule) – Pre-Market Approval

English:
If the product is in tablet or capsule form (often considered close to dietary supplements), you must apply for TFDA pre-market approval before import.

Chinese:
若產品為 錠劑或膠囊劑型（常視同保健食品），需先向 TFDA 申請輸入前審查核可，經核准後才能進口。

📄 Required Documents:

• Application form to TFDA
• Ingredient safety data
• Free Sale Certificate from country of origin
• Manufacturing license of factory

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Step 3. Food Labeling & Marking

English:
Prepare a Chinese food label compliant with Taiwan’s Food Labeling Act. Labels must include:

• Product name
• Ingredient list
• Net weight/volume
• Expiry date / shelf life
• Importer’s name, address, and phone number (must be Taiwan registered entity)
• Country of origin
• Nutrition facts (if required)

Chinese:
依據 食品標示法規 製作 中文標籤，必須包含：

• 品名
• 成分表
• 淨重 / 容量
• 有效日期 / 保存期限
• 進口商名稱、地址、電話（需台灣登記公司）
• 原產地
• 營養標示（若需）

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Step 4. Import Declaration & Border Inspection

English:
File an import declaration with Taiwan Customs, and submit the product to TFDA border inspection. If passed, TFDA issues a release notice, and goods can enter the Taiwan market.

Chinese:
向台灣海關辦理 進口報關，並接受 TFDA 輸入查驗。查驗合格後，TFDA 出具放行通知，貨品方可流入台灣市場。

📄 Required Documents:

• Import declaration form
• Invoice, packing list, bill of lading
• TFDA pre-approval (if applicable)
• Chinese label sample

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✅ Summary Table

Step	English	中文	Key Notes
1	Composition Review	成分審查	Check TFDA prohibited list
2	TFDA Approval (if capsule/tablet)	膠囊/錠劑需申請 TFDA 核准	Applies only for supplements-type forms
3	Food Labeling	食品中文標示	Must comply with TFDA labeling rules
4	Import & Border Inspection	進口報關與邊境查驗	Customs + TFDA clearance

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🔗 Official References

TFDA – Food Safety and Inspection: Food Import Regulations (中文)

Taiwan Food and Drug Administration (TFDA): https://www.fda.gov.tw/ENG/

What composition are prohibited or restricted ?

Check whether any ingredient is listed as prohibited or restricted by the Taiwan Food and Drug Administration (TFDA).
If prohibited or restricted, the product cannot be imported.

1) Food additives｜食品添加物

Rule (English)
Only additives listed in TFDA’s “Standards for Specification, Scope of Application and Limitation of Food Additives” may be used, and only in the specified foods and at/under the stated limits. If an additive is not listed, it is prohibited. 食品藥物管理署

中文規則
只能使用列在 「食品添加物規格暨使用範圍及限量標準」 的添加物，且必須依規定之食品類別與使用劑量。未列名者一律不得使用（視同禁止）。 食品藥物管理署

Where to check｜查核位置
TFDA English law page & Appendix tables（英/中）：食品藥物管理署+1

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2) Pesticide residues (MRLs)｜農藥殘留容許量

Rule (English)
Foods must meet TFDA “Standards for Pesticide Residue Limits in Foods.” Taiwan uses a positive list; if a pesticide/commodity MRL is not listed, it is not allowed (zero-tolerance by default). 食品藥物管理署+1

中文規則
食品須符合 「食品中農藥殘留容許量標準」。採 正面表列；未列入之農藥/品項視為不允許（實務上等同零容許）。 食品藥物管理署+1

Where to check｜查核位置
TFDA English law page（英）：食品藥物管理署

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3) Veterinary drug residues｜動物用藥殘留

Rule (English)
Foods must comply with “Standards for Veterinary Drug Residue Limits in Foods.” Drugs not listed shall not be detected; listed drugs must not exceed the given limits. 食品藥物管理署+1

中文規則
須符合 「食品中動物用藥殘留量標準」。未列名之動物用藥不得檢出；列名者不得超過限量。 食品藥物管理署+1

Where to check｜查核位置
TFDA English law page（英）與PDF（中）：食品藥物管理署+1

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4) Heavy metals, mycotoxins & other contaminants｜重金屬、黴菌毒素與其他污染物

Rule (English)
Foods must meet TFDA “Sanitation Standard for Contaminants and Toxins in Food.” Anything above the maximum levels is prohibited; limits have been recently tightened for some categories (e.g., infant/young child foods, offal, nuts/oils). 全國法規資料庫+2USDA Apps+2

中文規則
食品須符合 「食品中污染物質及毒素衛生標準」。超過 最高容許量 即屬 不符合（禁止）；近年對嬰幼兒食品、家畜副產品、堅果/油脂等有修訂更嚴。 全國法規資料庫+2USDA Apps+2

Where to check｜查核位置
TFDA English index（英）與合併標準解讀：食品藥物管理署+1

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5) Form-factor & import inspection triggers｜劑型與輸入查驗

Rule (English)
All imported food, food additives, utensils/packaging, cleansers are subject to border inspection under TFDA’s import inspection regulations. Tablet/capsule “food” often faces pre-market scrutiny and must still comply with the above substance standards. 食品藥物管理署

中文規則
所有輸入之 食品、食品添加物、器具/包材、洗潔劑 均適用 輸入查驗。錠劑/膠囊等「食品」實務上常受 事前審查/高強度檢驗，且須同時符合前述各項物質標準。 食品藥物管理署

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Practical “Prohibited/Restricted” examples｜實務常見之禁止/限制範例

• Additives not listed in TFDA additive standard → prohibited. 食品藥物管理署
• Pesticide residues beyond TFDA MRLs or not listed at all → not allowed. 食品藥物管理署+1
• Veterinary drugs not listed (detectable) or exceeding limits → not allowed. 食品藥物管理署+1
• Contaminants (e.g., lead, cadmium, aflatoxins) exceeding TFDA maximum levels → not allowed (note: several heavy-metal limits were tightened effective 2024/7/1). USDA Apps+1
• Melamine and veterinary drug residues in milk specifically flagged as prohibited in dairy standards (illustrative historical rule). USDA Apps

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How to use this in compliance reviews｜合規審查操作建議

English:

1. List every ingredient/additive with CAS No. and inclusion rate.
2. Verify each additive against TFDA’s additive Appendix (if not listed → prohibited).
3. For agricultural/animal ingredients, verify pesticide/veterinary-drug limits and test reports.
4. Check contaminant limits relevant to the food category.
5. Keep records for TFDA border inspection.

中文：

1. 逐一列出成分/添加物（含 CAS 號與含量）。
2. 逐項對照「添加物標準附表」（未列名＝禁止）。
3. 農畜來源成分檢核 農藥/動物用藥 限量與檢測報告。
4. 依食品類別查核 污染物/毒素 最高限量。
5. 完整保存文件以備 輸入邊境查驗。

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Official references｜官方參考連結

• Additives 標準（英）：TFDA “Standards for Specification, Scope, Application and Limitation of Food Additives” （未列名不得用）食品藥物管理署
• Pesticide MRLs（英）：TFDA “Standards for Pesticide Residue Limits in Foods”（採正面表列）食品藥物管理署+1
• Veterinary drugs（英/中）：TFDA “Standards for Veterinary Drug Residue Limits in Foods”（未列名不得檢出）食品藥物管理署+1
• Contaminants/Toxins（英/解讀）：TFDA index + WTO/USDA通報（2024/7/1修正）食品藥物管理署+1
• Import inspection（英）：TFDA “Regulations of Inspection of Imported Foods and Related Products” 食品藥物管理署

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My take｜我的專業意見

• Taiwan is strictly positive-list for additives and residues. If your ingredient/additive isn’t explicitly listed with a permitted use, assume “no.” This is the safest default for client advice. 食品藥物管理署+2USDA Apps+2
• For risk control, build a pre-screen matrix (ingredient ↔ TFDA table entry ↔ allowable food type ↔ max level ↔ COA/test report). I can draft this matrix (bilingual) if you want.