韓國健康食品登記法規問題集 -

韓國健康食品登記法規問題集

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文章目錄 點擊收合

HLF-TW-10請問韓國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？

HLF-TW-20外國公司要到韓國銷售健康食品，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？

HLF-TW-30外國公司要到韓國銷售健康食品，可以指派韓國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？

HLF-TW-40外國公司銷售到韓國健康食品本身，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？可允許的語文除了韓文外，其他哪種語文也可以？網頁？

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？可允許的語文除了韓文外，其他哪種語文也可以？網頁？

HLF-TW-60經過核准登記的健康食品，進口到韓國要檢附什麼文件？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？

HLF-TW-70韓國健康食品審核機構，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 verification? Website?

HLF-TW-80外國子公司進口健康食品後，如果委託韓國的經銷商銷售，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？

各國健康食品登記法規問題集

HLF-TW-10
請問韓國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 Korea? 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：

健康食品在韓國稱為功能性保健食品，是指材料或成分對人體有益的功能性原料製造、加工食品。
功能性成分是指對健康有益的物質，屬下列各項之一：

(1)來源於動物、植物、微生物或水的加工原料。

(2) 1項中所述任何成分的提取物或純化物質。

(3) 2項所述任何成分的純化物質之合成複製品。

(4) 1、2 或3中描述任何成分的組合。

保健功能食品應生產以膠囊、片劑、粉劑、顆粒劑、液體、丸劑、薄片、糊劑、糖漿、凝膠、果凍、棒等形式加工，
每份易於攝入，以補充日常膳食中可能缺乏的營養物質或提供對人體有用的功能性成分。
常規食品或代餐食品須經食品藥品安全部《保健功能食品功能性成分批准條例》授權，但發酵乳、發酵乳粉不需要授權，

The term “functional health foods” means foods manufactured (including processing; hereinafter the same shall apply) with functional raw materials or ingredients beneficial to the human body.

The functional ingredient” is a substance providing health benefits and falls under any of the following subparagraphs.

(1) Processed raw material originated from animals, plants, microorganisms or water.

(2) Extract or purified substance of any ingredient described in subparagraph (1).

(3) Synthetic duplicate of the purified substance of any ingredient described in subparagraph (2).

(4) Combination of any ingredients described in subparagraph (1), (2), or (3)

The health functional food under this Code shall be manufactured or processed in order to supplement nutrients that may be deficient in daily meal or to provide functional ingredients useful for human body in a form of capsule, tablet, powder, granule, liquid, pill, flake, paste, syrup, gel, jelly, bar, film, etc. which is easy to intake per serving.
The conventional food or the food which substitutes for meal shall be authorized by the Ministry of Food and Drug Safety under the Regulation on Approval of Functional Ingredient for Health Functional Food.
But fermented milk (except fermented milk powder) in the Food Code do not need to be authorized

【參考連結】

https://www.mfds.go.kr/eng/brd/m_15/view.do?seq=70011

HLF-TW-20
外國公司要到韓國銷售健康食品，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 Korea, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an 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：

需要。欲申報保健功能食品進口或者銷售業務的人，應向地方食品藥品監督管理局提交申請表包含以下資料:
1.負責人姓名
2.居民登記號
3.地址
4.公司名稱
5.詳細業務類型

並檢附以下文件：

1.營業設施規畫。

2.教育結業證明書(應事先接受安全衛生教育)。

保健功能食品製造業務：8小時
保健功能食品進口業務：8小時
保健功能食品銷售業務：4小時

3.倉儲設施租賃合約(僅限有租賃倉儲設施情況需檢附) 。

4.生產企業的委託生產合同文件(僅限有委託生產情況需檢附)。

Any person, who intends to report the health functional food import business or the health functional food sales business, shall submit a business report application, which includes:
1. Name of person in charge
2. Resident registration number
3. Address
4. Product name
5. Detailed business types

Along with the following documents：

1. The arrangement plan of business facilities;

2. The education completion certificate under the Act (limited to the case where the education has been received in advance)

Health functional food manufacture business : Eight hours
Health functional food import business : Eight hours
Health functional food sales business : Four hours

3. The storage facility lease contract document (limited to the case where a storage facility is leased); and

4. The document of manufacturing entrustment contract with a health functional food manufacture-specializing business (limited to the health functional food distribution-specializing sales business).

【參考連結】

https://www.mfds.go.kr/eng/brd/m_15/view.do?seq=70009

HLF-TW-25
假如需要辦理，請問韓國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：

HLF-TW-30
外國公司要到韓國銷售健康食品，可以指派韓國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 Korea, can it assign a Korean 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：

可以。欲申報保健功能食品進口或者銷售業務的人，應向地方食品藥品監督管理局提交申請表包含以下資料:
1.負責人姓名
2.居民登記號
3.地址
4.公司名稱
5.詳細業務類型

並檢附以下文件：

1.營業設施規畫。

2.教育結業證明書(應事先接受安全衛生教育)。

保健功能食品製造業務：8小時
保健功能食品進口業務：8小時
保健功能食品銷售業務：4小時

3.倉儲設施租賃合約(僅限有租賃倉儲設施情況需檢附) 。

4.生產企業的委託生產合同文件(僅限有委託生產情況需檢附)。

Along with the following documents：

1. The arrangement plan of business facilities;

2. The education completion certificate under the Act (limited to the case where the education has been received in advance)

Health functional food manufacture business : Eight hours
Health functional food import business : Eight hours
Health functional food sales business : Four hours

3. The storage facility lease contract document (limited to the case where a storage facility is leased); and

4. The document of manufacturing entrustment contract with a health functional food manufacture-specializing business (limited to the health functional food distribution-specializing sales business).

【參考連結】

https://www.mfds.go.kr/eng/brd/m_15/view.do?seq=70009

HLF-TW-35
假如需要辦理指派韓國公司擔任營業代理人，請問韓國有專業服務公司可以協助？

Evershine RD：

HLF-TW-40
外國公司銷售到韓國健康食品本身，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？
可允許的語文除了韓文外，其他哪種語文也可以？網頁？

Do foreign companies need to apply for an approval before importing health food sold to Korea?
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 Korean, which other languages are allowed? Website?

Evershine RD：

需要。欲進口保健功能食品到韓國的人或海外製造設施的進口商，應向食品藥品安全部登記海外製造機構相關資料:

1.國家名稱

2.公司名稱

3.負責人

4.地址

5.商品名稱

並檢附以下文件：

1.所用原材料及成分名稱相關文件，包含使用的組合比例、製造方法和食品添加劑的名稱及用量等。

2.保健功能食品的種類、名稱及製作方法。

3.帶有韓國標籤或標籤內容的包裝紙。

4.國內或國外官方認可的檢驗實驗室檢驗證明文件。

5.製造廠地址相關文件，包含建築物（機器和設施的佈置）及生產該保健功能食品的工作場所平面圖。

保健功能食品標示標準如下: (依食品標籤和廣告法-第4條規定)

產品名稱、含量及原料名稱
公司名稱和位置
有效期及儲存方法
攝入量、攝入方法及攝入注意事項，“保健功能食品”字樣或表明其為保健功能食品的設計
不是預防和治療疾病的藥物的表達方式
《保健功能食品法》第3條第2號規定的功能性信息以及原材料中顯示相應功能性的成分含量
法令規定的其他向消費者提供有關保健功能食品的信息
需翻譯成韓文

Persons who intend to import imported food into Korea or installers/operators of overseas manufacturing facilities (hereinafter referred to as “importers, etc.”) shall be decreed by the Prime Minister regarding the name, location, production items, etc. of overseas manufacturing facilities.
Matters specified in this Act must be registered with the Minister of Food and Drug Safety prior to import declaration.
Before importing, the import report and electronic file of health functional food should be submitted, which include:

1. Name of Country

2. Name of business establishment

3. Representative

4. Place

5. Name of product

Along with the following documents:

1. Documents relating to the name of raw materials used and the component combination ratio used, the manufacturing method, and the name of food additives used and its amount, etc.;

2. The type and name of health functional food and the manufacturing method document;

3. A packaging paper that has a Korean label or contents of label;

4. The original copy of the written result of examination or the certificate of examination by a domestic or foreign officially recognized examination laboratory, which confirms that the health functional food in question complies with the standards and specifications

5. Documents relating to the location of manufacturing factory, the arrangement plan of building (including the arrangements of machinery and facilities), the floor plan of workplace etc., that manufactures the health functional food in question

Food Labeling and Advertising Law – Article 4 (Labeling Standards) Health Functional Foods

Product name, content and raw material name
Business name and location
Expiration date and storage method
Intake amount, intake method, and precautions for intake mind. A letter indicating that it is a health functional food or a design indicating that it is a health functional food
Expressions that are not medicines for the prevention and treatment of diseases
Information on functionality under subparagraph 2 of Article 3 of the 「Health Functional Food Act」 and the content of ingredients showing the corresponding functionality in raw materials
Implementation Rules of the Food Labeling and Advertising Law, etc. – Article
Korean transcription of foreign languages

【參考連結】

https://www.mfds.go.kr/eng/brd/m_15/view.do?seq=70009

https://www.law.go.kr/LSW//lsLinkProc.do?lsNm=%EC%8B%9D%ED%92%88+%EB%93%B1%EC%9D%98+%ED%91%9C%EC%8B%9C%E3%86%8D%EA%B4%91%EA%B3%A0%EC%97%90+%EA%B4%80%ED%95%9C+%EB%B2%95%EB%A5%A0&chrClsCd=010202&mode=20&ancYnChk=0#

HLF-TW-45

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？
可允許的語文除了韓文外，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 Korean, which other languages are allowed? Website?

Evershine RD：

可以。欲進口保健功能食品到韓國的人或海外製造設施的進口商，應向食品藥品安全部登記海外製造機構相關資料:

1.國家名稱

2.公司名稱

3.負責人

4.地址

5.商品名稱

並檢附以下文件：

1.所用原材料及成分名稱相關文件，包含使用的組合比例、製造方法和食品添加劑的名稱及用量等。

2.保健功能食品的種類、名稱及製作方法。

3.帶有韓國標籤或標籤內容的包裝紙。

4.國內或國外官方認可的檢驗實驗室檢驗證明文件。

5.製造廠地址相關文件，包含建築物（機器和設施的佈置）及生產該保健功能食品的工作場所平面圖。

保健功能食品標示標準如下: (依食品標籤和廣告法-第4條規定)

產品名稱、含量及原料名稱
公司名稱和位置
有效期及儲存方法
攝入量、攝入方法及攝入註意事項，“保健功能食品”字樣或表明其為保健功能食品的設計
不是預防和治療疾病的藥物的表達方式
《保健功能食品法》第3條第2號規定的功能性信息以及原材料中顯示相應功能性的成分含量
法令規定的其他向消費者提供有關保健功能食品的信息
需翻譯成韓文

Persons who intend to import imported food into Korea or installers/operators of overseas manufacturing facilities (hereinafter referred to as “importers, etc.”) shall be decreed by the Prime Minister regarding the name, location, production items, etc. of overseas manufacturing facilities. Matters specified in this Act must be registered with the Minister of Food and Drug Safety prior to import declaration.
Before importing, the import report and electronic file of health functional food should be submitted, which include:

1. Name of Country

2. Name of business establishment

3. Representative

4. Place

5. Name of product

Along with the following documents:

1. Documents relating to the name of raw materials used and the component

combination ratio used, the manufacturing method, and the name of food additives used and its amount, etc.;

2. The type and name of health functional food and the manufacturing method document;

3. A packaging paper that has a Korean label or contents of label;

Food Labeling and Advertising Law – Article 4 (Labeling Standards) Health Functional Foods

Product name, content and raw material name
Business name and location
Expiration date and storage method
Intake amount, intake method, and precautions for intake mind. A letter indicating that it is a health functional food or a design indicating that it is a health functional food
Expressions that are not medicines for the prevention and treatment of diseases
Information on functionality under subparagraph 2 of Article 3 of the 「Health Functional Food Act」 and the content of ingredients showing the corresponding functionality in raw materials
Implementation Rules of the Food Labeling and Advertising Law, etc. – Article
Korean transcription of foreign languages

【參考連結】

https://www.mfds.go.kr/eng/brd/m_15/view.do?seq=70009

HLF-TW-55

HLF-TW-60
經過核准登記的健康食品，進口到韓國要檢附什麼文件？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 documents are required when importing approved health food into Korea?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

如果功能性保健食品屬於以下任何一種，食品藥品安全部將不會要求進行檢驗：

經食品藥品安全部長官已公告可販售的功能性保健食品(須符合設施標準規定)。
功能性保健食品的進口商經由食品藥品安全部長官根據《食品藥品行業檢驗法》指定的食品檢驗機構或指定的外國檢驗機構進行檢驗，並提交檢驗記錄或證明書。

非以上範圍的功能性保健食品則必須進行以下檢驗；

食品藥品安全部長官可根據《韓國食品安全管理認證院設立及運營法》委託韓國食品安全管理認證院辦理現場檢查。
如果食品藥品安全部長官認為有必要有效地進行衛生評估（非面對面調查），可以委託境外指定的食品衛生評價機構進行。
根據第1、2項執行委託業務的機構進行現場檢查或衛生評估時，應向食品藥品安全部長官報告結果並提交相關文件。
現場檢查和衛生評價結果的報告時間和方法、提交的文件等細節由法令確定。

The Minister of Food and Drug Safety shall require relevant public officials or inspection institutions to conduct a necessary inspection of functional health foods reported , before completion of customs clearance procedures, when any of the grounds prescribed by Ordinance of the Prime Minister arises.

The Minister of Food and Drug Safety may fully or partially omit an inspection, notwithstanding paragraph (2), if functional health foods reported under paragraph (1) fall under any of the following:

1. Functional health food that has been announced for sale by the Minister of Food and Drug Safety (subject to facility standards)

2. When the importers of the functional health foods have undergone an

inspection conducted by a testing and inspection institution of foods, etc. designated by the Minister of Food and Drug Safety or a foreign testing and inspection institution designated by the Minister of Food and Drug Safety.

Otherwise, should follow:

The Minister of Food and Drug Safety can entrust the Korea Food Safety Management Certification Institute to conduct on-site inspections in accordance with the “Korea Food Safety Management Certification Institute Establishment and Operation Act”.
If the Minister of Food and Drug Safety deems it necessary to conduct an effective sanitation assessment (non-face-to-face survey), he may entrust an overseas designated food sanitation assessment agency to conduct it.
In the case of on-site inspection or sanitation assessment conducted by the agency performing the entrusted work in accordance with Paragraph 1 and Paragraph 2, the result shall be reported to the Minister of Food and Drug Safety and relevant documents shall be submitted.
Details such as the reporting time and method of on-site inspection and sanitation evaluation results, and the documents to be submitted shall be determined by the Prime Minister’s Decree.

【參考連結】

https://www.foodsafetykorea.go.kr/portal/board/boardDetail.do

HLF-TW-70
韓國健康食品審核機構，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 verification? Website?

Evershine RD：

尚未公佈的功能性原料被用作保健功能性食品的製造/進口業者，須向食品藥品安全部提交有關其安全性和功能性的數據。

保健功能食品功能性成分認證申請資料：

1. 材料2份（含原件1份）

2. 1張包含提交材料的CD

3.產品或原型和功能成分（或指示成分）標準產品

4.國內某保健功能食品檢驗機構出具的檢測報告

其他應檢附文件：

1.所有提交材料的概述

2.來源、發展歷程、國內外認可及使用狀況等資料。

3.製造方法及相關數據

4.原材料特性數據

5.功能性成分（或指示性成分）的規格和測試數據

6.有害物質標準及檢測方法數據

7.安全數據

8.功能內容及相關數據

9.攝取量、攝取注意事項及設定數據

10.與藥品不同或不相似的資料

Unpublished functional raw materials are used as health functional food manufacturers/importers, have submitted data on their safety and functionality to the Minister of Food and Drug Safety.

Application for functional ingredient certification of health functional food (including application in electronic form)

1. 2 copies of submitted materials (including 1 original)

2. 1 CD containing the submitted materials

3. Product or prototype and functional ingredient (or indicated ingredient) standard product

4. Test report issued by a domestic health functional food inspection agency

HLF-TW-80
外國子公司進口健康食品後，如果委託韓國的經銷商銷售，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 Korea to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

食品醫藥品安全部收到不良事件報告時，應向保健功能食品的相關安全性及與不良事件的因果關係進行調查分析。
在這種情況下，食品藥品安全部認為必要時，可以要求經營者（包括根據藥事法登記的藥店和進口特別法登記進口食品的進口商和銷售商等）或相關利害關係人作出聲明或要求提交調查所需的材料、物品等。

When the Minister of Food and Drug Safety receives an adverse event report, he shall investigate and analyze the safety of the relevant health functional food and the causal relationship with the adverse event.
In such a case, the Minister of Food and Drug Safety may request the operators (including pharmacies registered under the Pharmaceutical Affairs Act and importers and sellers of imported food registered under the Special Import Act, etc.) or relevant interested parties, if deemed necessary by the Minister of Food and Drug Safety Make a statement or request the submission of materials, items, etc. required for the investigation.

【參考連結】

https://www.law.go.kr/LSW//lsLinkProc.do?lsNm=%EA%B1%B4%EA%B0%95%EA%B8%B0%EB%8A%A5%EC%8B%9D%ED%92%88%EC%97%90+%EA%B4%80%ED%95%9C+%EB%B2%95%EB%A5%A0&chrClsCd=010202&mode=20&ancYnChk=0#J10:2

HLF-TW-85

各國健康食品登記法規問題集

**請注意下列事項：
以上內容為永輝研發及教育中心 (簡稱:永輝RD)於2021年10月摘要。
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