台灣健康食品登記法規問題集
永輝提供公司註冊、薪酬、會計、稅務、盡職調查、法定審計等服務，服務對象爲臺灣外商企業（WFOE），其母公司來自世界各國。
我們與海外同仁使用雲端系統協同為客戶服務
聯絡人: 朱鍵彰 協理
電話 : +886-2-2717-0515 E103
手機 : +886-939-357-735
電郵：sales.taiwan@evershinecpa.com
HLF-TW-10
請問台灣對於健康食品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of health food in Taiwan? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
依「健康食品管理法」第 2 條定義，健康食品係指具有特定之「保 健功效」，並標示或廣告其具該功效，且須具有實質科學證據，非屬 治療、矯正人類疾病之醫療效能為目的之食品。
「健康食品」須經衛生福利部食品藥物管理署審查核可，通過後必須在產品包裝上標明 核准之保健功效敘述、健康食品標章(小綠人標章)及證號等。
健康食品安全性評估之分類依以下健康食品安全評估方法:
第一類:使用傳統食用且傳統加工之原料
第二類:傳統食用且非傳統加工
第三類: 非傳統食用之原料
第四類: 非傳統食用之原料並具有致癌物質者
而最終產品之安全性分類，仍須整體評估「各原料成分配方、學
名、部位、含量」、「製程(包含萃取所使用之溶劑及濃縮倍數之說
明)」、「人體每日建議攝食量」、「保健功效成分(原料)」、「產品原料規格書」、「食用目的、方式」、「最終產品型式」等相關資料來判定產品的安全性類別。
According to Health Food Control Act Article 2, the term “health food” shall denote food with health care effects, having been labeled or advertised with such effects.
The term “health care effects” shall mean an effect that has been scientifically proven to be capable of improving people’s health, and decreasing the harms and risks of diseases. However, it is not a medical treatment aimed at treating or remedying human diseases; such “health care effects” shall be announced by the central competent authority.
The classification of health food safety assessment is basically based on the classification stated in health food safety assessment methods. In short, the category 1 and category 2 are conventional raw materials, and the category 3 and category 4 are unconventional raw materials. Regarding the division between the category 1 and the category 2, generally, the conventional raw materials that are not extracted and concentrated by conventional methods should be put in category 2. The edible Chinese medicine materials that are not classified as “the medicine materials that can be used for food” are sorted into category 2.
【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=1507&r=2033735814
【參考連結】https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26597
【ENG】Health Food Control Act
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=550
HLF-TW-20
外國公司要到台灣銷售健康食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell health food in Taiwan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
健康食品銷售公司不需要申請營業特許證，它在經濟部營業項目中的代號尾碼為0不為1。
0代表不需辦理特許，1代表需要。
食品什貨批發業F102170 ；食品什貨、飲料零售業F203010
In the code table of the business of the Ministry of Economic Affairs, the last digit of the code is 0, which means no preliminary approval is required and 1 means that preliminary approval is required.
Food wholesale F102170；Food retail F203010
【參考連結】https://gcis.nat.gov.tw/cod/browseAction.do?method=browse&layer=1&code=F
HLF-TW-25
假如需要辦理，請問台灣有專業服務公司可以協助辦理健康食品公司營業許可證？
Evershine RD：
健康食品為食品類別，於經濟部工商登記中，須有販售食品等相關營業項目。無須另外登記其他許可證。
HLF-TW-30
外國公司要到台灣銷售健康食品，可以指派台灣公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell health food in Taiwan, can it assign a Taiwanese company to act as a business agent? What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
健康食品申請商須提出公司登記或商業登記，故個人無法申請健康食品查驗登記。
Those who import the health food should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to application.
依「健康食品管理法」第 3 條第 1 項規定，健康食品之核可 要件為：
- 第一款：經科學化之安全及保健功效評估試驗，證明無害人體健康，且成分具有明確保健功效。因此，申請者必須能夠提出科學評 估報告，而其內容必須符合中央主管機關所定之保健功效評估方法 和安全性(毒理學)評估方法。
- 第二款：成分符合中央 主管機關所定之健康食品規格標準者，亦得申請做為健康食品。(目前公布的規格標準者為: 魚油、紅麴)
A health food permit shall be issued only if one of the following requirements is met under the purpose of this Act.
1. Duly supported by scientific assessment of the safety and health care effects of food that they are harmless and carry definite, certain health care effects; if current technology cannot identify ingredients contributing to such effects, the ingredients with the relevant health care effects and supporting literature shall be enumerated and provided to the central competent authority for evaluation and verification.
2. Ingredients conforming to the Health Food Specification Standards set by the central competent authority (fish oil and red yeast rice).
The methods by which health care effects and safety are assessed, and by which standards are determined in the preceding paragraph shall be determined by the central competent authority. If the central competent authority has not yet determined a method to assess the health care effects, a 2 method submitted by academics shall be reviewed and approved by the central competent authority.
另，依「食品安全衛生管理法」第21 條，輸入錠狀、膠囊狀食品應向衛生福利部食品藥物管理署辦理查驗登記，取得輸入許可書函，以利通關報驗之審查。擬自國外進口之錠狀、膠囊狀食品，於申請健康食品查驗登記前，應先取得輸入膠囊狀、錠狀食品查驗登記許可。
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants. (2022/02/10)
【參考連結】https://www.fda.gov.tw/TC/siteList.aspx?sid=1758&pn=1
【參考連結】「健康食品管理法」
https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=167
【ENG】 Act Governing Food Safety and Sanitation (2019)
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=1675
【ENG】Health Food Control Act
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=550
HLF-TW-35
假如需要辦理指派台灣公司擔任營業代理人，請問台灣有專業服務公司可以協助？
Evershine RD：
無此機制， 須以台灣當地公司名義代理。
HLF-TW-40
外國公司銷售到台灣健康食品本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
健康食品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了中文外，其他哪種語文也可以？網頁？
Do foreign companies need to apply for approval before importing health food sold to Taiwan?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Chinese, which other languages are allowed? Website?
Evershine RD：
依「食品安全衛生管理法」第21 條，輸入錠狀、膠囊狀食品應向衛生福利部食品藥物管理署辦理查驗登記，取得輸入許可書函，以利通關報驗之審查。擬自國外進口之錠狀、膠囊狀食品，於申請健康食品查驗登記前，應先取得輸入膠囊狀、錠狀食品查驗登記許可。
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
目前健康食品申請查驗登記為二階段審查及收費制度：初審8 萬元，複審 17 萬元，另領證費 1,500 元。
初審審查天數為 60 天，複審審查天 數為 180 天，不含業者補件時間。
第一軌查驗登記審查流程須經初審、複審，經健康食品審議小組 審查通過，並經產品送驗確認；第二軌查驗登記審查流程可免送交 健康食品審議小組複審，經初審通過及產品送驗確認後，即可領證。
The health food application inspection and registration is a two-stage review system: 80,000 NTD for the initial review, 170,000 NTD for the re-examination, and an additional certificate fee of 1,500 NTD.
The number of days for the initial review is 60 days, and the days for the review are 180 days, excluding the time for the supplier to make up the documents.
依健康食品申請許可辦法，申請查驗登記之健康食品，符合健康食品管理法第三條第一項第一款規定者(經科學化之安全及保健功效評估試驗，證明無害人體健康，且成分具有明確保健功效；其保健功效成分依現有技術無法確定者，得依申請人所列舉具該保健功效之各項原料及佐證文獻，再交由食品藥物管理署評估認定之)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之安全評估報告。
四、產品之保健功效評估報告。
五、產品之保健功效成分鑑定報告及其檢驗方法。
六、產品之安定性試驗報告。
七、產品製程概要。
八、良好作業規範之證明資料。
九、產品衛生檢驗規格及其檢驗報告。
十、一般營養成分分析報告。
十一、相關研究報告文獻資料。
十二、產品包裝、標籤及說明書。
十三、申請者公司登記或商業登記之證明文件。
申請查驗登記之健康食品，符合健康食品管理法第三條第一項第二款規定者(成分符合中央主管機關所定之健康食品規格標準)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之保健功效成分鑑定報告及其檢驗方法。
四、產品之安定性試驗報告。
五、產品製程概要。
六、良好作業規範之證明資料。
七、產品衛生檢驗規格及其檢驗報告。
八、一般營養成分分析報告。
九、產品包裝、標籤及說明書。
十、申請者公司登記或商業登記之證明文件。
依據康食品管理法第十三條，健康食品應以中文及通用符號顯著標示下列事項於容器、包裝或說明書上：
一、品名。
二、內容物名稱；其為二種以上混合物時，應依其含量多寡由高至低分別標示之。
三、淨重、容量或數量。
四、食品添加物名稱；混合二種以上食品添加物，以功能性命名者，應分別標明添加物名稱。
五、有效日期、保存方法及條件。
六、廠商名稱、地址。輸入者應註明國內負責廠商名稱、地址。
七、核准之功效。
八、許可證字號、「健康食品」字樣及標準圖樣。
九、攝取量、食用時應注意事項、可能造成健康傷害以及其他必要之警語。
十、營養成分及含量。
十一、其他經中央主管機關公告指定之標示事項。
此外，標示亦不得違反第十四條「標示或廣告不得有虛偽不實、誇張，及超過許可範圍之內容。」另，原文標示可保留。
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
The following material facts shall be conspicuously displayed on the containers, packaging or written instruction of health food in Chinese and in commonly used symbols:
1. product name;
2. name of the ingredients; those that contain two or more ingredients shall
indicate the respective ingredients in descending order of proportion;
3. net weight, volume or quantity;
4. name of food additives; in the case of a mixture of two or more food
additives which are named according to its function shall indicate the name of each additive separately;
5. expiry date, method and conditions of preservation;
6. name and address of the responsible business operator; the name and address of the importer shall be specified if the health food is imported;
7. the approved health care effects;
8. reference number of the permit, the legend of “health food” and standard logo;
9. amount of intake and important message for consumption of the health food, possible side effect and other necessary warnings;
10. nutrient and its content; and
11. other material facts designated by the central competent authority.
The format and contents of the labeling described in subparagraph 10 above
shall be prescribed by the central competent authority.
【參考連結】https://www.fda.gov.tw/TC/siteList.aspx?sid=1758&pn=1
【參考連結】「健康食品申請許可辦法」https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=160
【參考連結】「健康食品管理法」
https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=167
【ENG】Health Food Control Act
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=550
HLF-TW-45
請問在台灣有哪些專業服務機構，可以協助辦理健康食品產品許可證？
Evershine RD：
台美檢驗https://www.superlab.com.tw/registration/
HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？
申請程序為何？健康食品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了中文外，其他哪種語文也可以？網頁？
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Chinese, which other languages are allowed? Website?
Evershine RD：
健康食品申請商須具備本國公司登記或商業登記，也要有食品業者登錄字號，且申請商於經濟部工商登記中，須有販售食品等相關營業項目。故國外公司無法直接申請健康食品查驗登記。
依「食品安全衛生管理法」第21 條，輸入錠狀、膠囊狀食品應向衛生福利部食品藥物管理署辦理查驗登記，取得輸入許可書函，以利通關報驗之審查。擬自國外進口之錠狀、膠囊狀食品，於申請健康食品查驗登記前，應先取得輸入膠囊狀、錠狀食品查驗登記許可。
目前健康食品申請查驗登記為二階段審查及收費制度：初審8 萬元，複審 17 萬元，另領證費 1,500 元。初審審查天數為 60 天，複審審查天 數為 180 天，不含業者補件時間。第一軌查驗登記審查流程須經初審、複審，經健康食品審議小組 審查通過，並經產品送驗確認；第二軌查驗登記審查流程可免送交 健康食品審議小組複審，經初審通過及產品送驗確認後，即可領證。
Those who import the health food should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to apply.
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
The health food application inspection and registration is a two-stage review system: 80,000 NTD for the initial review, 170,000 NTD for the re-examination, and an additional certificate fee of 1,500 NTD. The number of days for the initial review is 60 days, and the days for the review are 180 days, excluding the time for the supplier to make up the documents.
依健康食品申請許可辦法，申請查驗登記之健康食品，符合健康食品管理法第三條第一項第一款規定者(經科學化之安全及保健功效評估試驗，證明無害人體健康，且成分具有明確保健功效；其保健功效成分依現有技術無法確定者，得依申請人所列舉具該保健功效之各項原料及佐證文獻，再交由食品藥物管理署評估認定之)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之安全評估報告。
四、產品之保健功效評估報告。
五、產品之保健功效成分鑑定報告及其檢驗方法。
六、產品之安定性試驗報告。
七、產品製程概要。
八、良好作業規範之證明資料。
九、產品衛生檢驗規格及其檢驗報告。
十、一般營養成分分析報告。
十一、相關研究報告文獻資料。
十二、產品包裝、標籤及說明書。
十三、申請者公司登記或商業登記之證明文件。
申請查驗登記之健康食品，符合健康食品管理法第三條第一項第二款規定者(成分符合中央主管機關所定之健康食品規格標準)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之保健功效成分鑑定報告及其檢驗方法。
四、產品之安定性試驗報告。
五、產品製程概要。
六、良好作業規範之證明資料。
七、產品衛生檢驗規格及其檢驗報告。
八、一般營養成分分析報告。
九、產品包裝、標籤及說明書。
十、申請者公司登記或商業登記之證明文件。
依據康食品管理法第十三條，健康食品應以中文及通用符號顯著標示下列事項於容器、包裝或說明書上：
一、品名。
二、內容物名稱；其為二種以上混合物時，應依其含量多寡由高至低分別標示之。
三、淨重、容量或數量。
四、食品添加物名稱；混合二種以上食品添加物，以功能性命名者，應分別標明添加物名稱。
五、有效日期、保存方法及條件。
六、廠商名稱、地址。輸入者應註明國內負責廠商名稱、地址。
七、核准之功效。
八、許可證字號、「健康食品」字樣及標準圖樣。
九、攝取量、食用時應注意事項、可能造成健康傷害以及其他必要之警語。
十、營養成分及含量。
十一、其他經中央主管機關公告指定之標示事項。
此外，標示亦不得違反第十四條「標示或廣告不得有虛偽不實、誇張，及超過許可範圍之內容。」另，原文標示可保留。
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
The following material facts shall be conspicuously displayed on the containers, packaging or written instruction of health food in Chinese and in commonly used symbols:
1. product name;
2. name of the ingredients; those that contain two or more ingredients shall
indicate the respective ingredients in descending order of proportion;
3. net weight, volume or quantity;
4. name of food additives; in the case of a mixture of two or more food
additives which are named according to its function shall indicate the name of each additive separately;
5. expiry date, method and conditions of preservation;
6. name and address of the responsible business operator; the name and address of the importer shall be specified if the health food is imported;
7. the approved health care effects;
8. reference number of the permit, the legend of “health food” and standard logo;
9. amount of intake and important message for consumption of the health food, possible side effect and other necessary warnings;
10. nutrient and its content; and
11. other material facts designated by the central competent authority.
The format and contents of the labeling described in subparagraph 10 above
shall be prescribed by the central competent authority.
【參考連結】https://www.fda.gov.tw/TC/siteList.aspx?sid=1758&pn=1
【參考連結】「健康食品申請許可辦法」https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=160
【參考連結】「健康食品管理法」
https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=167
【ENG】Health Food Control Act
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=550
HLF-TW-55
請問在台灣有哪些專業服務機構，可以協助以外國公司名義辦理健康食品產品許可證？
Evershine RD：
台美檢驗https://www.superlab.com.tw/registration/
HLF-TW-60
經過核准登記的健康食品，進口到台灣要檢附什麼文件？
經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What are the required documents for the application of importing health food registration?
What is the application process? Website?
Evershine RD：
依「食品安全衛生管理法」第21 條，輸入錠狀、膠囊狀食品應向衛生福利部食品藥物管理署辦理查驗登記，取得輸入許可書函，以利通關報驗之審查。
擬自國外進口之錠狀、膠囊狀食品，於申請健康食品查驗登記前，應先取得輸入膠囊狀、錠狀食品查驗登記許可。
Import of edible oil, special dietary foods, food in tablet or capsule form and products which are approved by the central competent authority should be accompanied with designated documents by obligatory inspection applicants.
依健康食品申請許可辦法，申請查驗登記之健康食品，符合健康食品管理法第三條第一項第一款規定者(經科學化之安全及保健功效評估試驗，證明無害人體健康，且成分具有明確保健功效；其保健功效成分依現有技術無法確定者，得依申請人所列舉具該保健功效之各項原料及佐證文獻，再交由食品藥物管理署評估認定之)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之安全評估報告。
四、產品之保健功效評估報告。
五、產品之保健功效成分鑑定報告及其檢驗方法。
六、產品之安定性試驗報告。
七、產品製程概要。
八、良好作業規範之證明資料。
九、產品衛生檢驗規格及其檢驗報告。
十、一般營養成分分析報告。
十一、相關研究報告文獻資料。
十二、產品包裝、標籤及說明書。
十三、申請者公司登記或商業登記之證明文件。
申請查驗登記之健康食品，符合健康食品管理法第三條第一項第二款規定者(成分符合中央主管機關所定之健康食品規格標準)，應繳納初審審查費，並檢具完整樣品及下列文件：
一、申請書表。
二、產品原料成分規格含量表。
三、產品之保健功效成分鑑定報告及其檢驗方法。
四、產品之安定性試驗報告。
五、產品製程概要。
六、良好作業規範之證明資料。
七、產品衛生檢驗規格及其檢驗報告。
八、一般營養成分分析報告。
九、產品包裝、標籤及說明書。
十、申請者公司登記或商業登記之證明文件。
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 1, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report of the ingredients with health care effect of a product and its test method
(6) Product stability test report
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Package, label and product information sheet
(13) Registration certificate of corporation or business
Applicants applying for product registration under paragraph 1 of Article 7 of the Act and meeting the requirements of subparagraph 2, paragraph 1 of Article 3 of the Act shall pay the preliminary review fee and provide intact product samples, as well as the following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Identification report of the ingredients with health care effect of a product and its test method 2
(4) Product stability test report
(5) Summary of manufacturing process
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product information sheet
(10) Registration certificate of corporation or business
【參考連結】https://www.fda.gov.tw/TC/siteList.aspx?sid=1758&pn=1
【參考連結】「健康食品申請許可辦法」https://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=160
【ENG】Health Food Control Act
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=550
HLF-TW-70
台灣健康食品審核構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for TFDA verification?
Evershine RD：
健康食品之試驗單位並未限制由特定單位進行，惟試驗單位需有相當之專業研究能力及公正性。另如有通過相關認證/查核之機構執行者，可提供證明文件供 佐證試驗品質。
財 團 法 人 醫 藥 品 查 驗 中 心 承 辦 健 康 食 品 查 驗 登 記 查 業 務，該中心並無協助業者執行相關試驗，且為公平性及利益迴避，該中心亦無代辦申請業務。
對於國外執行之試驗內容仍須符合我國健康食品法規，方可引用作 為評估報告文件，故須請業者確認報告之試驗內容是否符合我國規 定。
健康食品查驗登記送驗查核表 (中文)須附上資料如下：
- 文件
1. 送驗通知正本
2. 健康食品查驗登記樣品檢驗遞送表
3. 健康食品查驗登記送驗查檢表
4. 檢驗方法標準作業程序：須符合健康食品查驗登記食品化學檢驗方法審核查檢表/健康食品查驗登記功效微生物檢驗方法審核查檢表中檢驗方法標準作業程序應載內容
5. 檢驗報告書(須包含以下內容)
(1) 規格：功效/指標/特定成分之含量合格範圍
(2) 性狀：應註明產品外觀顏色及形狀等
(3) 檢驗方法依據
(4) 檢驗結果：依據上述檢驗方法所得之檢驗結果(含層析圖譜/電泳圖/鏡檢圖/序列圖等)
- 送驗檢體
1. 完整最小販售包裝樣品至少5份(如為益生菌產品，則檢體(內容物)總量至少大於100公克或100毫升)
2. 樣品外包裝需有批號及有效期限
3. 樣品未逾有效期限(宜距有效日期三個月以上)
4. 樣品應為同批號
- 試藥器材
1. 對照用標準品/測試菌株(檢附純度證明/來源證明)
2. 層析管柱
3. 特殊試藥、試劑、培養基等
- 其他
The health care effect assessment report shall be derived from the actual trial of the products. The safety assessment report shall be derived from the final products under the following principles.
(1) The no-observed-adverse-effect level (NOAEL) shown on the safety assessment report can be used to calculate the safety of recommended intake.
a. Products of safety category 3 or above shall have no adverse effect at a dose greater than or equal to 100 times of the recommended human intake.
b. In principle, the products of safety category 2 in the solid forms of capsule, tablet, powder, or liquid products with a recommended daily intake of 100 mL (or less), their no-observed-adverse-effect level shall be greater than 60 times no adverse effect dose should be greater than or equal to the recommended intake of 60 times of the recommended human intake. If the daily recommended intake of the product is higher than the aforesaid, the no-observed-adverse effect level shall be greater than or equal to 30 times of the recommended intake. c. The health food review committee of the central competent health authority may comprehensively evaluate the animal feeding limit and the formula (such as consumption limit and quantity of each ingredients), process (such as manufacture methods of raw materials and products, whether the concentration and purification of specific ingredients are involved), characteristics and consumption method of the product. If necessary, no-observed-adverse effect level may be required to be greater than or equal to 100 times of the recommended intake.
(2) The safety assessment report shall be derived from the final products. If the feeding limit (including concentration) exceeds the prescribed limit but still fails to meet the requirements mentioned in the preceding paragraph, additional testing may be required on raw materials or ingredients of the product.
(3) If the product used in the safety assessment is not the final product, there shall be sufficient evidence to prove the relevance of the tested product and final products. Description regarding necessity and rationality shall be attached.
If the assessment method used in the test report is slightly different from the method announced by the FDA (such as the measurement method), the scientific basis of the method shall be attached for the assessment. If the assessment method used in the test report is not designated by the FDA (such as health care effect items or assessment mode), the applicant can first follow “Guide on proposal of health care effect assessment methods of health food” and provide related information. After passing the evaluation, the applicant may be notified to accept the examination of the investigation and registration cases.
Health care effect assessment report that is published in academic journals are preferred. If the assessment report has not been published, it shall be completed by institutions with public credibility, or by the company itself if the research ability and impartiality of the company can be supported.
【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=1507
【參考連結】https://www.fda.gov.tw/TC/siteList.aspx?sid=1833
【ENG】Regulations for Application of Health Food Permit
https://www.fda.gov.tw/ENG/siteList.aspx?sid=10534
HLF-TW-75
台灣健康食品審核構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：健康食品之試驗單位並未限制由特定單位進行，惟國外執行之試驗內容須符合我國健康食品法規規定。
HLF-TW-77
請問在台灣有哪些健康食品檢驗機構可以提供健康食品檢驗服務？網頁？
Evershine RD：
台美檢驗https://www.superlab.com.tw/registration/
HLF-TW-80
外國子公司進口健康食品後，如果委託台灣的經銷商銷售，經銷商需要健康食品營業許可證嗎？
假如健康食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports health food and entrusts a distributor in Taiwan to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if health food products have quality defects? Is it joint liability?
Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
若因產品瑕疵而造成的消費者損害，台灣之輸入業者(經銷商/代理商/進口商)有責任對於消費者之損害做出賠償。然，台灣輸入業者與國外原廠公司之合約中可明確規範相關條例；再者，亦可針對產品投保產品責任險。
衛生福利部於110年9月28日公告修正「食品業者投保產品責任保險」，從111年1月1日起，應針對所輸入或製造的食品及食品添加物投保產品責任保險。
In case of consumer damage caused by product defects, Taiwanese importers (distributors/agents) are responsible for making compensation for consumer damages. The relevant regulations can be clearly specified in the contracts between Taiwanese importers and foreign original companies; moreover, product liability insurance can also be purchased for products.
The Ministry of Health and Welfare announced on September 28, 110 to amend the “food industry insured product liability insurance”. From January 1, 111, product liability insurance should be insured for imported or manufactured food and food additives
【參考連結】https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=27328
HLF-TW-85
請問在台灣有哪些專精於健康食品銷售與消費權益相關法律服務的業者？
Evershine RD：
**請注意下列事項：
以上內容為永輝研發及教育中心於2021年10月摘要。
隨著時間的推移，法規可能會發生變化，不同情況下會採用不同的選擇。
所以在選擇選項之前，請與我們聯系或諮詢該領域您信任的專業人士。
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