韩国化妆品登记法规问题集

Email：sel4ww@evershinecpa.com
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联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
skype: rachelsu8
wechat: r0928486835
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各国化妆品登记法规问答集

HLF-TW-10
请问韩国对于化妆品的归类方式为何？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？

Evershine RD：

「化妆品」是指在通过涂抹、摩擦、喷洒等方式应用于人体以进行清洁，美化、提高吸引力或提亮容貌，或保持或改善皮肤和头发健康的任何物品，对人体有轻微影响。
其中「功能性化妆品」，是指以下任何一种：

(a) 有助于美白皮肤的产品；
(b) 有助于改善皮肤皱纹的产品；
(c) 有助于温和地晒黑皮肤或保护皮肤免受紫外线伤害的产品

对于功能性化妆品，责任卖方如有意通过製造或进口功能性化妆品製造或销售，根据化妆品法第 4 条，应向韩国食品药品安全部（Ministry of Food and Drug Safety, MFDS）提出申请。

The term “cosmetic” means any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human
The term “functional cosmetics” means cosmetics prescribed by Ordinance of the Prime Minister, falling under any of the following:

(a) Products aiding in the whitening of the skin;

(b) Products aiding in improving wrinkles in the skin;

(c) Products aiding in tanning skin gently or protecting skin from ultraviolet rays;

With regards to the functional cosmetics, a Responsible Seller who intends to manufacture or sell functional cosmetics by manufacturing or importing them shall undergo an evaluation by the Ministry of Food and Drug Safety (MFDS) or shall submit an application to the Minister of the MFDS for safety and effectiveness of each product pursuant to Article 4 of the Cosmetics Act (Examination, etc. of Functional Cosmetics).

【参考连结】Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=69983&srchFr=&srchTo=&srchWord=Cosmetics+Act&srchTp=7&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-20
外国公司要到韩国销售化妆品，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？

Evershine RD：

化妆品进口代理商须向MFDS註册登记为营销负责人。（製造设施所在地有管辖权的地区办事处）。
申请登记所需申请文件包括:

1、註册号和註册日期；

2. 製造商-销售商的姓名和出生日期；
3. 製造商-销售商的商号（法人名称）；
4. 生产销售机构所在地；
5. 生产销售经理姓名及出生日期；
6. 产销型。

化妆品代理商应聘用合格人员负责化妆品的安全和质量管理，其销售人员必须每年完成一次化妆品安全保障培训。
并且依规定准备和维护书面的製造管理标准，书面製造管理记录和书面质量控制记录。

Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

A Cosmetics Responsible Person shall hire a Qualified Person who is responsible for the safety and quality of cosmetic products a person who has a qualification as a responsible marketing officer, and the sales officer must complete a training on ensuring safety of cosmetics once a year.
It’s necessary to prepare and maintain written manufacture management standards, written manufacture management records and written quality control records

【参考连结】Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=69983&srchFr=&srchTo=&srchWord=Cosmetics+Act&srchTp=7&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

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化妆品公司营业许可证？

Evershine RD：

HLF-TW-30
外国公司要到韩国销售化妆品，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？

Evershine RD：

需指派韩国公司担任营业代理商。
依化妆品法第三条第一项规定登记为製造销售者（manufacturer-seller）如下：

1. 有意经销、销售自己生产的化妆品的人；
2. 拟经销、销售代销化妆品的人；
3. 拟经销、销售进口化妆品的人；
4. 以代理进口业务为目的的化妆品供应或奖励人（适用于电子商务）。

若符合以上规定的註册条件的製造销售者，由食品药品监督管理局地区办事处负责人将下列事项记入化妆品生产销售业务登记簿，颁发 “产销业务登记证明”<2014年9月24日修订>

1、註册号和註册日期；

2. 製造商-销售商的姓名和出生日期；
3. 製造商-销售商的商号（法人名称）；
4. 生产销售机构所在地；
5. 生产销售经理姓名及出生日期；
6. 产销型。

A person who is subject to registration as a manufacturer-seller (hereinafter referred to as the “manufacturer-seller”) pursuant to Article 3 (1) of the Act is as follows:

1. A person who intends to distribute and sell cosmetics produced by him or herself;
2. A person who intends to distribute and sell cosmetics produced by consignment;
3. A person who intends to distribute and sell imported cosmetics;
4. A person who intends to supply or award cosmetics, for the purpose of import agency business (applicable only to the electronic commerce).

The Head of the Regional Office of the MFDS in receipt of the application pursuant to the paragraph (2) shall verify the certificate of registered contents for corporations (applicable only to a corporation) through the administrative information that is to be shared among administrative agencies pursuant to Article 36 (1) of the Electronic Government Act.

If the application for registration meets the requirements for registration prescribed in the paragraph 2, the Head of Regional Office of the MFDS shall record the following matters in the registry for cosmetics manufacture-sales business and issue the “certificate of registration for manufacture-sales business” of registration for cosmetics manufacture-sales business.

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller;
3. Trade name of the manufacturer-seller;
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-40
外国公司销售到韩国化妆品本身，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？化妆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？

Evershine RD：

化妆品进口代理商须向MFDS註册登记为营销负责人。
（製造设施所在地有管辖权的地区办事处）。
申请登记所需申请文件包括:
1.註册号和註册日期；
2. 製造商-销售商的姓名和出生日期；
3. 製造商-销售商的商号（法人名称）；
4.生产销售机构所在地；
5.生产销售经理姓名及出生日期；
6.产销型。

化妆品标籤须包含以下讯息：
– 化妆品名称
– 製造商的名称和地址以及
– 批号
– 开封后的有效期或使用期限
– 价格
– 用于製造化妆品的所有成分
– 体积或重量
– 必须显示“功能性化妆品”以防万一
– 使用注意事项
-其他

Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller;
3. Trade name of the manufacturer-seller;
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

Claims of Cosmetic Labeling
– Name of a cosmetic product
– Name and address of the manufacturer and
– Batch number
– Expiration date or use-by dates after opening
– Price
– All ingredients used to manufacture cosmetics
– Volume or weight
– “Functional Cosmetics” has to be displayed in case
– Precautions for use
– Others required by the Enforcement Rule

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-45
请问在韩国有哪些专业服务机构，可以协助办理化妆品产品许可证？

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？
化妆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？

Evershine RD：

需以韩国代理商名义申请。
化妆品进口代理商须向MFDS註册登记为营销负责人。（製造设施所在地有管辖权的地区办事处）。
申请登记所需申请文件包括:

1、註册号和註册日期；

2. 製造商-销售商的姓名和出生日期；
3. 製造商-销售商的商号（法人名称）；
4. 生产销售机构所在地；
5. 生产销售经理姓名及出生日期；
6. 产销型。

化妆品标籤须包含以下讯息：
– 化妆品名称
– 製造商的名称和地址以及
– 批号
– 开封后的有效期或使用期限
– 价格
– 用于製造化妆品的所有成分
– 体积或重量
– 必须显示“功能性化妆品”以防万一
– 使用注意事项
-其他

The application is supposed to be submitted by the Korean agent.
Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

Claims of Cosmetic Labeling
– Name of a cosmetic product
– Name and address of the manufacturer and
– Batch number
– Expiration date or use-by dates after opening
– Price
– All ingredients used to manufacture cosmetics
– Volume or weight
– “Functional Cosmetics” has to be displayed in case
– Precautions for use
– Others required by the Enforcement Rule

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-55
请问在韩国有哪些专业服务机构，可以协助以外国公司名义办理化妆品产品许可证？

HLF-TW-60
经过核准登记的化妆品，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？

Evershine RD：

审查核准后，进口化妆品之营销负责人在清关之前需提交“进口产品入境通知书”
若是进口功能性化妆品必须获得MFDS 审查核准。审查期约60天。
需检附以下资料:

1. 验证安全性、有效性或功能的数据

• 关于R&D的起源和细节的数据
• 有关安全的数据
• 验证有效性或功能的数据
• 防晒係数 (SPF)、防水防晒係数 (SPF)、和 UV-A (PA) 数据的保护係数

2. 有关标准和测试方法的数据（包括样品）

The marketing responsible person shall submit an “Entry Notice of Imported Products Report” before customs clearance
Those who intend to manufacture or import functional cosmetics are required to have them approved by the MFDS through evaluation.
Data requirement:

1. Data that verify safety, effectiveness, or function

• Data concerning the origin and the details of R&D
• Data concerning the safety
• Data that verify effectiveness, or function
• Sun Protection Factor (SPF), waterproof Sun Protection Factor (SPF), and Protection Factor of UV-A (PA) data

2. Data concerning the standards and test methods (Including samples)

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-70
韩国化妆品审核构，需要附上的实验室检验资料有哪些? 网页？

Evershine RD：
进口功能性化妆品销售者，须经MFDS 审查核准通过，须附资料如下：.

1. 初始和发展的资料。
2. 安全数据：
3. 单剂量毒性试验数据；
4. 原发性皮肤刺激研究数据；
5. 眼和其他膜刺激研究的数据；
6. 皮肤致敏试验数据；

e.光毒性和光敏试验数据；

1. 人体贴片试验数据
2. 功效与效用数据：
3. 功效试验数据；
4. 应用于人体的数据
5. 确定防晒係数（SPF）和UV-A（PA）保护係数的证据资料（仅适用于通过阻挡或散射紫外线来帮助保护皮肤免受紫外线伤害的化妆品）。
6. 标准和检验方法资料（包括临床标本）。

若MFDS已公开公佈表明产品功效和效果的成分和含量，可以省略提交第1至4项的数据；对标准和试验方法公开的产品，可以省略第五项数据的提交。

The manufacturer-seller who intends to sell functional cosmetics by manufacturing or importing them pursuant shall attach the following documents and receive an examination by the Ministry of Food and Drug:

1. Data on the details about the origin and development.
2. Data on safety:
3. Data on toxicity test with single dose;
4. Data on primary dermal irritation study;
5. Data on ocular and other membranes irritation studies;
6. Data on skin sensitization test;
7. Data on phototoxicity and photo sensitization test;
8. Data on patch test on a human body.
9. Data on efficacy and functions:
10. Data on efficacy test;
11. Data on application to a human body.
12. Evidentiary data about establishing the sun protection factor (SPF) and the protection factor of UV-A (PA) (applicable only to cosmetics aiding in protecting skin from ultraviolet rays by blocking or scattering the ultraviolet rays).
13. Data on the standards and test methods (including the clinical specimen).

However, where the Minister of the MFDS has publicly announced the ingredient and content that indicate the efficacy and effects of a product, submission of the data in subparagraphs 1 through 4 may be omitted.
And for products of which standards and test methods are publicly announced, submission of the data in subparagraph 5 may be omitted.

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-75
韩国化妆品审核构，能够接受海外检验机构的检验资料吗？
假如是的话，有哪些被认可的机构？网页？

Evershine RD：

无特别规定。UL  SGS 等国际检测机构皆可。

HLF-TW-77
请问在韩国有哪些化妆品检验机构可以提供化妆品检验服务？网页？

HLF-TW-80
外国子公司进口化妆品后，如果委託韩国的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，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？

Evershine RD：

拟经销、销售代销化妆品的人，依化妆品法第三条第一项规定须向食品药品监督管理局地区办事处註册登记：

1、註册号和註册日期；

2. 製造商-销售商的姓名和出生日期；
3. 製造商-销售商的商号（法人名称）；
4. 生产销售机构所在地；
5. 生产销售经理姓名及出生日期；
6. 产销型。

化妆品责任人必须每半年向 MFDS 报告化妆品的安全信息。
化妆品营销负责人必须在发现严重不良事件后 15 日内及时向 MFDS 报告。
有品质瑕疵的化妆品将可能遭受MFDS禁止销售、召回、丢弃，增加使用主义事项等处分。

Cosmetics sell agent shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

A Cosmetics Responsible Person must report the safety information of cosmetics to the MFDS every half year; A cosmetic marketing responsible person must promptly report to the MFDS within 15 days of discovery of a serious adverse event.
If the cosmetic products have quality defects, MFDS has right to issue a restraining order of Prohibition of sales, recall, disposal, adding precautions for use, etc.

【参考连结】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-85
请问在韩国有哪些专精于化妆品销售与消费权益相关法律服务的业者？

各国化妆品登记法规问答集

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Email：sel4ww@evershinecpa.com
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联络人：苏 玉 燕  副总经理
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我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
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