韩国健康食品登记法规问题集

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各国健康食品登记法规问题集

HLF-TW-10
请问韩国对于健康食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：

健康食品在韩国称为功能性保健食品，是指材料或成分对人体有益的功能性原料製造、加工食品。
功能性成分是指对健康有益的物质，属下列各项之一：

(1)来源于动物、植物、微生物或水的加工原料。

(2) 1项中所述任何成分的提取物或纯化物质。

(3) 2项所述任何成分的纯化物质之合成複製品。

(4) 1、2 或3中描述任何成分的组合。

保健功能食品应生产以胶囊、片剂、粉剂、颗粒剂、液体、丸剂、薄片、糊剂、糖浆、凝胶、果冻、棒等形式加工，
每份易于摄入，以补充日常膳食中可能缺乏的营养物质或提供对人体有用的功能性成分。
常规食品或代餐食品须经食品药品安全部《保健功能食品功能性成分批准条例》授权，但发酵乳、发酵乳粉不需要授权，

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

【参考连结】

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

HLF-TW-20
外国公司要到韩国销售健康食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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。欲申报保健功能食品进口或者销售业务的人，应向地方食品药品监督管理局提交申请表包含以下资料:
1.负责人姓名
2.居民登记号
3.地址
4.公司名称
5.详细业务类型

并检附以下文件：

1.营业设施规画。

2.教育结业证明书(应事先接受安全卫生教育)。

• 保健功能食品製造业务：8小时
• 保健功能食品进口业务：8小时
• 保健功能食品销售业务：4小时

3.仓储设施租赁合约(仅限有租赁仓储设施情况需检附) 。

4.生产企业的委託生产合同文件(仅限有委託生产情况需检附)。

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).

【参考连结】

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

HLF-TW-25
假如需要办理，请问韩国有专业服务公司可以协助办理健康食品公司营业许可证？

Evershine RD：

HLF-TW-30
外国公司要到韩国销售健康食品，可以指派韩国公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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。欲申报保健功能食品进口或者销售业务的人，应向地方食品药品监督管理局提交申请表包含以下资料:
1.负责人姓名
2.居民登记号
3.地址
4.公司名称
5.详细业务类型

并检附以下文件：

1.营业设施规画。

2.教育结业证明书(应事先接受安全卫生教育)。

• 保健功能食品製造业务：8小时
• 保健功能食品进口业务：8小时
• 保健功能食品销售业务：4小时

3.仓储设施租赁合约(仅限有租赁仓储设施情况需检附) 。

4.生产企业的委託生产合同文件(仅限有委託生产情况需检附)。

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).

【参考连结】

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

HLF-TW-35
假如需要办理指派韩国公司担任营业代理人，请问韩国有专业服务公司可以协助？

Evershine RD：

HLF-TW-40
外国公司销售到韩国健康食品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？健康食品包装内容及各种标示，需要事先核准吗？
可允许的语文除了韩文外，其他哪种语文也可以？网页？

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。欲进口保健功能食品到韩国的人或海外製造设施的进口商，应向食品药品安全部登记海外製造机构相关资料:

1.国家名称

2.公司名称

 3.负责人

 4.地址

 5.商品名称

并检附以下文件：

1.所用原材料及成分名称相关文件，包含使用的组合比例、製造方法和食品添加剂的名称及用量等。

2.保健功能食品的种类、名称及製作方法。

3.带有韩国标籤或标籤内容的包装纸。

4.国内或国外官方认可的检验实验室检验证明文件。

5.製造厂地址相关文件，包含建筑物（机器和设施的佈置）及生产该保健功能食品的工作场所平面图。

保健功能食品标示标准如下: (依食品标籤和广告法-第4条规定)

• 产品名称、含量及原料名称
• 公司名称和位置
• 有效期及储存方法
• 摄入量、摄入方法及摄入注意事项，“保健功能食品”字样或表明其为保健功能食品的设计
• 不是预防和治疗疾病的药物的表达方式
• 《保健功能食品法》第3条第2号规定的功能性信息以及原材料中显示相应功能性的成分含量
• 法令规定的其他向消费者提供有关保健功能食品的信息
• 需翻译成韩文

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

【参考连结】

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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？健康食品包装内容及各种标示，需要事先核准吗？
可允许的语文除了韩文外，其他哪种语文也可以？网页？

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。欲进口保健功能食品到韩国的人或海外製造设施的进口商，应向食品药品安全部登记海外製造机构相关资料:

1.国家名称

2.公司名称

3.负责人

4.地址

5.商品名称

并检附以下文件：

1.所用原材料及成分名称相关文件，包含使用的组合比例、製造方法和食品添加剂的名称及用量等。

2.保健功能食品的种类、名称及製作方法。

3.带有韩国标籤或标籤内容的包装纸。

4.国内或国外官方认可的检验实验室检验证明文件。

5.製造厂地址相关文件，包含建筑物（机器和设施的佈置）及生产该保健功能食品的工作场所平面图。

保健功能食品标示标准如下: (依食品标籤和广告法-第4条规定)

• 产品名称、含量及原料名称
• 公司名称和位置
• 有效期及储存方法
• 摄入量、摄入方法及摄入註意事项，“保健功能食品”字样或表明其为保健功能食品的设计
• 不是预防和治疗疾病的药物的表达方式
• 《保健功能食品法》第3条第2号规定的功能性信息以及原材料中显示相应功能性的成分含量
• 法令规定的其他向消费者提供有关保健功能食品的信息
• 需翻译成韩文

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

【参考连结】

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-55

HLF-TW-60
经过核准登记的健康食品，进口到韩国要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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属于以下任何一种，食品药品安全部将不会要求进行检验：

1. 经食品药品安全部长官已公告可贩售的功能性保健食品(须符合设施标准规定)。
2. 功能性保健食品的进口商经由食品药品安全部长官根据《食品药品行业检验法》指定的食品检验机构或指定的外国检验机构进行检验，并提交检验记录或证明书。

非以上范围的功能性保健食品则必须进行以下检验；

1. 食品药品安全部长官可根据《韩国食品安全管理认证院设立及运营法》委託韩国食品安全管理认证院办理现场检查。
2. 如果食品药品安全部长官认为有必要有效地进行卫生评估（非面对面调查），可以委託境外指定的食品卫生评价机构进行。
3. 根据第1、2项执行委託业务的机构进行现场检查或卫生评估时，应向食品药品安全部长官报告结果并提交相关文件。
4. 现场检查和卫生评价结果的报告时间和方法、提交的文件等细节由法令确定。

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:

1. 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”.
2. 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.
3. 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.
4. 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.

【参考连结】

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

HLF-TW-70
韩国健康食品审核机构，需要附上的实验室检验资料有哪些? 网页？
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/进口业者，须向食品药品安全部提交有关其安全性和功能性的数据。

保健功能食品功能性成分认证申请资料：

1. 材料2份（含原件1份）

2. 1张包含提交材料的CD

3.产品或原型和功能成分（或指示成分）标准产品

4.国内某保健功能食品检验机构出具的检测报告

其他应检附文件：

1.所有提交材料的概述

2.来源、发展历程、国内外认可及使用状况等资料。

3.製造方法及相关数据

4.原材料特性数据

5.功能性成分（或指示性成分）的规格和测试数据

6.有害物质标准及检测方法数据

7.安全数据

8.功能内容及相关数据

9.摄取量、摄取注意事项及设定数据

10.与药品不同或不相似的资料

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

Other documents to be submitted：

1. Overview of all submissions

2. Information on sources, development history, domestic and foreign recognition and usage status.

3. Manufacturing method and related data

4. Raw material characteristic data

5. Specification and test method data for functional ingredients (or indicative ingredients)

6. Data on Hazardous Substance Standards and Testing Methods

7. Security Data

8. Function content and related data

9. Intake amount, precautions for intake and setting data

10. Information that is different or dissimilar to the drug

【参考连结】

https://www.foodsafetykorea.go.kr/

HLF-TW-75
韩国健康食品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

Evershine RD：

依规定仅接受韩国境内保健功能食品检验机构出具的检测报告。

HLF-TW-77

HLF-TW-80
外国子公司进口健康食品后，如果委託韩国的经销商销售，经销商需要健康食品营业许可证吗？
假如健康食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？

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：

食品医药品安全部收到不良事件报告时，应向保健功能食品的相关安全性及与不良事件的因果关係进行调查分析。
在这种情况下，食品药品安全部认为必要时，可以要求经营者（包括根据药事法登记的药店和进口特别法登记进口食品的进口商和销售商等）或相关利害关係人作出声明或要求提交调查所需的材料、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.

【参考连结】

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

各国健康食品登记法规问题集

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