法国化妆品登记法规问题集

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各国化妆品登记法规问答集

HLF-FR-10
请问法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？

What are the categories of cosmetics in France? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

在法国，化妆品市场的监管由法国国家药品和健康产品安全局 (ANSM)和竞争政策、消费者事务和欺诈控制总局 (DGCCRF)负责 。
化妆品是与人体表层(表皮、头发和毛细血管、指甲、嘴唇和外生殖器)，或牙齿和口腔黏膜接触的任何物质或混合物。
以清洁、发出香味、改善外观、改善身体气味或保护身体使之保持良好状态为主要目的的物质和製剂。
化妆品不能被展示为具有治疗或预防人类疾病的特性，以及，旨在被摄入、吸入、注射或植入体内的产品不归属化妆品，即使它们声称对皮肤、牙齿、口腔黏膜和/或皮肤附件（头发、指甲）有特别的作用。
此外，化妆品由製造商、进口商或负责将其投放市场的人来监控其产品相关的声明。

In France, the regulation of the cosmetic market is carried out by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Directorate-General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF).

Cosmetics are any substances or mixtures that come into contact with the surface layers of the human body (the epidermis, hair and capillaries, nails, lips, and external genitalia), or the teeth and the mucous membranes of the mouth. Substances and preparations whose main purpose is to cleanse, scent, improve appearance, improve body odor, or protect the body in good condition.

Cosmetics cannot be displayed as having properties for the treatment or prevention of human disease, and products intended to be ingested, inhaled, injected or implanted in the body are not classified as cosmetic, even if they claim to be harmful to the skin, teeth, oral mucosa and/or skin appendages (hair, nails) have a special effect. In addition, cosmetic products are monitored by the manufacturer, importer, or those responsible for placing them on the market for claims related to their products.

【参考连结】

file:///C:/Users/B109005/Downloads/20201214-faq-reglementation-cosmetiques.pdf

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-20
外国公司要到法国销售化妆品，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？

If a foreign company wants to sell cosmetics in France, 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：

无须申请营业特许证。

No business license is required.

【参考连结】

file:///C:/Users/B109005/Downloads/20201214-faq-reglementation-cosmetiques.pdf

HLF-FR-25
假如需要办理，请问法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：

无须申请营业特许证。
No business license is required.

HLF-FR-30
外国公司要到法国销售化妆品，可以指派法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 cosmetics in France, can it assign an France 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。在欧盟内被指定为责任人即能投放市场，责任人的主体需由欧盟境内的企业法人或自然人担任，非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。
一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。

1.责任人须符合其中一项资格：

·欧盟公民(不论居住地)。
·居住在欧盟或是欧洲经济区会员国的自然人。
·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。
·在欧盟或欧洲经济区内建立的组织。

2.完成化妆品备案通报流程

责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品信息档案(PIF/DIP)文件，已备官方实地检查，需检具：

·产品类别
·产品名称
·责任人姓名、地址
·上市地区(投放市场的成员国)
·标籤及包装(合理清晰的照片)
·产品配方
·原产国
·联繫人
·奈米材料(包括化学名称、暴露条件)
·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号
·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括：

·产品描述
·产品安全评估报告CPSR
·生产工艺描述和良好生产规范(GMP)声明
·动物测试数据声明
·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料：

·产品名和内部编号
·详细配方表
·原料质检报告(CoA)和化学品安全技术书(MSDS)
·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA
·成品
·毒理和临床研究报告
·微生物报告(包括挑战试验)
·稳定性报告
·包装材料信息
·产品标籤
·案例报告
·产品的暴露数据

5. 责任人的义务：

·承担产品安全和合规责任
·上市前完成CPNP通报
·责任人名称及地址需标註在产品标籤上
·责任人需准备完整PIF/DIP文件，应对主管当局的检查
·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年
·根据情况更新CPNP和PIF/DIP
·上市后及时上报严重不良反应（ SUE）

·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

化妆品在投放市场前无需经过营销授权，但指定负责人必须保证投放市场的产品在正常或可合理预见的使用条件下对人体健康是安全的，并且在化妆品上市后有义务通报，例如严重不良反应的声明或风险的通报，以及当产品不符合安全义务时须採取措施。
法国规定，当发生严重不良反应时，负责人须向法国的 ANSM 和 DGCCRF报告，履行报告风险和採取的措施的义务的通知，

Yes. Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.

1. The responsible person shall meet one of the qualifications:

·EU citizens (regardless of residence).
·A natural person resident in the European Union or a member state of the European Economic Area.
·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
·Organizations established in the European Union or the European Economic Area.

2. Complete the cosmetic filing notification process

The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.

·Product categories
·Product Name
·Name and address of the person responsible
·Listed area (the member country where the market is placed)
· Label and packaging (reasonable and clear photos)
·Product Formulation
·Country of origin
·Contact

Nanomaterials (including chemical name, exposure conditions)

The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
·Medical treatment in case of problems

3. Product information file (PIF/DIP) content includes:

·Product Description
·Product Safety Assessment Report CPSR
Production process description and Good Manufacturing Practice (GMP) statement
· Animal Testing Data Statement
·Product efficacy certificate

4. Information required for the Cosmetic Safety Assessment Report (CPSR):

·Product name and internal number
·Detailed formula table
·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
·Finished product
· Toxicology and clinical research reportsMicrobiological report (including challenge test)
·Stability report
·Packaging material information
·product label
·Case repor· Exposure data of products

5. Responsibilities of the Responsible Person:

·Assume product safety and compliance responsibilities
·Complete CPNP notification before listing
·The name and address of the responsible person should be marked on the product label
·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
· After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
· Update CPNP and PIF/DIP as appropriate
·Report serious adverse reactions (SUE) in a timely manner after listing
· When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.

Cosmetics do not need marketing authorization before they are put on the market, but the designated person in charge must ensure that the products put on the market are safe for human health under normal or reasonably foreseeable conditions of use, and are obliged to report after the cosmetics are put on the market, such as serious adverse reactions. statement or risk communication, and action to be taken when the product does not meet its safety obligations. France stipulates that when a serious adverse reaction occurs, the responsible person must report to the French ANSM and DGCCRF, a notification of fulfilling the obligation to report risks and take measures,

【参考连结】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/contact

https://www.economie.gouv.fr/dgccrf/securite/avis-rappels-produits

HLF-FR-35

HLF-FR-40
外国公司销售到法国化妆品本身，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？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing cosmetics sold to France? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD：

需要，须以欧盟境内的企业法人或自然人名义申请。

非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。
一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。

1.责任人须符合其中一项资格：
·欧盟公民(不论居住地)。
·居住在欧盟或是欧洲经济区会员国的自然人。
·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。
·在欧盟或欧洲经济区内建立的组织。

2.完成化妆品备案通报流程

责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品信息档案(PIF/DIP)文件，已备官方实地检查，需检具：

·产品类别
·产品名称
·责任人姓名、地址
·上市地区(投放市场的成员国)
·标籤及包装(合理清晰的照片)
·产品配方
·原产国
·联繫人
·奈米材料(包括化学名称、暴露条件)
·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号
·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括：

·产品描述

·产品安全评估报告CPSR

·生产工艺描述和良好生产规范(GMP)声明

·动物测试数据声明

·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料：

·产品名和内部编号

·详细配方表

·原料质检报告(CoA)和化学品安全技术书(MSDS)

·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA

·成品

·毒理和临床研究报告

·微生物报告(包括挑战试验)

·稳定性报告

·包装材料信息

·产品标籤

·案例报告

·产品的暴露数据

5. 责任人的义务：

·承担产品安全和合规责任

·上市前完成CPNP通报

·责任人名称及地址需标註在产品标籤上

·责任人需准备完整PIF/DIP文件，应对主管当局的检查

·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年

·根据情况更新CPNP和PIF/DIP

·上市后及时上报严重不良反应（ SUE）

·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

标籤

市场上提供的每件化妆品的容器和包装，无论是免费还是付费，都必须以法语且清晰、易懂、不可磨灭的方式展示以下信息：

1. 负责人的姓名/公司名称和地址：可以缩写，前提是容易识别。

2. 原产国

3. 包装时质量或体积含量，以下除外：

．少于 5 克或少于 5 毫升产品的包装

．免费样品

．以单剂量形式呈现的产品

．包含一组零件的预包装产品，前提是预包装上提到了零件的数量，或者该数量是否容易于从外部确定，或者该产品通常仅单独销售。

4. 最低保质期：必须明确提及日期，并按顺序由月和年（例如：07/2013）或日、月和年（例如：06/07/2013）组成。如有必要，可以指出的耐久性的条件。

5. 开封后的使用期限：最短保质期大于 30 个月的产品强制要求标籤。由代表一罐奶油或绿色的符号表示，然后是使用期限（以月和/或年表示）。如果週期以月表示，则可以用数字后跟月一词或缩写M来表示。

下列几项开封后的使用期限建议发佈在 ANSM 网站：

． 最短期限少于30 个月

． 没有变质风险的产品（例如淡香精）

．使用这些产品不需要打开包装（例如喷雾剂）

．仅打算使用一次（例如单次给药）。

6. 使用的特殊注意事项、使用条件和警告，以及任何有关专业使用化妆品的特殊注意事项的说明。在没有足够空间的情况下，必须在产品上附有或附在产品上的传单、标籤、带子、卡片上进行报告。

7. 製造批号或允许识别製造。

8. 产品的功能（保湿霜、护发素等）。

9. 产品按重量（数量）降序排列的成分清单：此列表可能仅出现在包装上，或者出现在附在产品上的传单、标籤或卡片上(可以通过缩写词或包装上的符号来表示)。香水、芳香和芳香组合物及其原材料用香水或香气一词表示。此外，除了术语香水或香气之外，在成分列表中还需指出物质，

Yes. Applications must be made in the name of a corporate legal person or a natural person within the EU.

When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.

1. The responsible person shall meet one of the qualifications:

·EU citizens (regardless of residence).

·A natural person resident in the European Union or a member state of the European Economic Area.

·A company established in the European Union or European Economic Area (registered office, central authority or principal body).

·Organizations established in the European Union or the European Economic Area.

2. Complete the cosmetic filing notification process

The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.

·Product categories

·Product Name

·Name and address of the person responsible

·Listed area (the member country where the market is placed)

· Label and packaging (reasonable and clear photos)

·Product Formulation

·Country of origin

·Contact

Nanomaterials (including chemical name, exposure conditions)

The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs

·Medical treatment in case of problems

3. Product information file (PIF/DIP) content includes:

·Product Description

·Product Safety Assessment Report CPSR

Production process description and Good Manufacturing Practice (GMP) statement

· Animal Testing Data Statement

·Product efficacy certificate

4. Information required for the Cosmetic Safety Assessment Report (CPSR):

·Product name and internal number

·Detailed formula table

·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)

·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA

·Finished product

·Toxicology and clinical research reportsMicrobiological report (including challenge test)

·Stability report

·Packaging material information

·Product label

·Case report

·Exposure data of products

5. Responsibilities of the Responsible Person:

·Assume product safety and compliance responsibilities

·Complete CPNP notification before listing

·The name and address of the responsible person should be marked on the product label

·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority

·After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years

· Update CPNP and PIF/DIP as appropriate

·Report serious adverse reactions (SUE) in a timely manner after listing

·When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.

Label

The container and packaging of every cosmetic product offered on the market, whether free or paid, must present the following information in French and in a clear, understandable, indelible form:

1. Name/company name and address of the person in charge: It can be abbreviated, provided that it is easy to identify.

2. Country of Origin

3. Mass or volume content when packaged, except for:

·Packages of product less than 5 grams or less than 5 ml

·Free Sample

·Products in single-dose form

·A prepackaged product containing a set of parts, provided that the quantity of the parts is mentioned on the prepackage, or that the quantity is easily externally determinable, or that the product is usually only sold individually.

4. Minimum Shelf Life: Dates must be mentioned explicitly and consist of month and year (eg: 07/2013) or day, month and year (eg: 06/07/2013) in order. If necessary, conditions of durability can be indicated.

5. Shelf life after opening: Products with a minimum shelf life of more than 30 months are required to label. Indicated by the symbol representing a jar of cream or green, followed by the expiration date (in months and/or years). If the period is expressed in months, it can be expressed with a number followed by the word month or the abbreviation M.

The following shelf life recommendations are published on the ANSM website:

·Minimum period of less than 30 months

·Products without risk of spoilage (e.g. Eau de Parfum)

·Use of these products does not require opening the package (e.g. sprays)

·Intended for one-time use only (eg, a single dose).

6. Special precautions for use, conditions of use and warnings, and instructions for any special precautions for professional use of cosmetic products. In cases where there is insufficient space, the report must be made on flyers, labels, tapes, cards attached to or attached to the product.

7. Manufacture Lot Number or allow to identify manufacture.

8. Function of product (moisturizer, conditioner, etc.).

9. Product ingredient list in descending order by weight (quantity): This list may appear only on the packaging, or on a leaflet, label, or card affixed to the product (may be indicated by an abbreviation or a symbol on the packaging) . Perfume, fragrances and fragrance compositions and their raw materials are denoted by the term perfume or aroma. In addition, in addition to the term perfume or aroma, the substance should be indicated in the ingredient list,

【参考连结】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-45

HLF-FR-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？可允许的语文有哪些？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 cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD：

须以欧盟境内的企业法人或自然人名义申请。

非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。
一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。

1.责任人须符合其中一项资格：

·欧盟公民(不论居住地)。

·居住在欧盟或是欧洲经济区会员国的自然人。

·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。

·在欧盟或欧洲经济区内建立的组织。

2.完成化妆品备案通报流程

责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品信息档案(PIF/DIP)文件，已备官方实地检查，需检具：

·产品类别

·产品名称

·责任人姓名、地址

·上市地区(投放市场的成员国)

·标籤及包装(合理清晰的照片)

·产品配方

·原产国

·联繫人

·奈米材料(包括化学名称、暴露条件)

·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号

·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括：

·产品描述

·产品安全评估报告CPSR

·生产工艺描述和良好生产规范(GMP)声明

·动物测试数据声明

·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料：

·产品名和内部编号

·详细配方表

·原料质检报告(CoA)和化学品安全技术书(MSDS)

·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA

·成品

·毒理和临床研究报告

·微生物报告(包括挑战试验)

·稳定性报告

·包装材料信息

·产品标籤

·案例报告

·产品的暴露数据

5. 责任人的义务：

·承担产品安全和合规责任

·上市前完成CPNP通报

·责任人名称及地址需标註在产品标籤上

·责任人需准备完整PIF/DIP文件，应对主管当局的检查

·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年

·根据情况更新CPNP和PIF/DIP

·上市后及时上报严重不良反应（ SUE）

·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

标籤

市场上提供的每件化妆品的容器和包装，无论是免费还是付费，都必须以法语且清晰、易懂、不可磨灭的方式展示以下信息：

1. 负责人的姓名/公司名称和地址：可以缩写，前提是容易识别。

2. 原产国

3. 包装时质量或体积含量，以下除外：

．少于 5 克或少于 5 毫升产品的包装

．免费样品

．以单剂量形式呈现的产品

．包含一组零件的预包装产品，前提是预包装上提到了零件的数量，或者该数量是否容易于从外部确定，或者该产品通常仅单独销售。

4. 最低保质期：必须明确提及日期，并按顺序由月和年（例如：07/2013）或日、月和年（例如：06/07/2013）组成。如有必要，可以指出的耐久性的条件。

5. 开封后的使用期限：最短保质期大于 30 个月的产品强制要求标籤。由代表一罐奶油或绿色的符号表示，然后是使用期限（以月和/或年表示）。如果週期以月表示，则可以用数字后跟月一词或缩写M来表示。

下列几项开封后的使用期限建议发佈在 ANSM 网站：

． 最短期限少于30 个月

． 没有变质风险的产品（例如淡香精）

．使用这些产品不需要打开包装（例如喷雾剂）

．仅打算使用一次（例如单次给药）。

6. 使用的特殊注意事项、使用条件和警告，以及任何有关专业使用化妆品的特殊注意事项的说明。在没有足够空间的情况下，必须在产品上附有或附在产品上的传单、标籤、带子、卡片上进行报告。

7. 製造批号或允许识别製造。

8. 产品的功能（保湿霜、护发素等）。

9. 产品按重量（数量）降序排列的成分清单：此列表可能仅出现在包装上，或者出现在附在产品上的传单、标籤或卡片上(可以通过缩写词或包装上的符号来表示)。香水、芳香和芳香组合物及其原材料用香水或香气一词表示。此外，除了术语香水或香气之外，在成分列表中还需指出物质，

Applications must be made in the name of a corporate legal person or a natural person within the EU.

When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.

1. The responsible person shall meet one of the qualifications:

·EU citizens (regardless of residence).

·A natural person resident in the European Union or a member state of the European Economic Area.

·A company established in the European Union or European Economic Area (registered office, central authority or principal body).

·Organizations established in the European Union or the European Economic Area.

2. Complete the cosmetic filing notification process

The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.

·Product categories

·Product Name

·Name and address of the person responsible

·Listed area (the member country where the market is placed)

· Label and packaging (reasonable and clear photos)

·Product Formulation

·Country of origin

·Contact

Nanomaterials (including chemical name, exposure conditions)

The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs

·Medical treatment in case of problems

3. Product information file (PIF/DIP) content includes:

·Product Description

·Product Safety Assessment Report CPSR

Production process description and Good Manufacturing Practice (GMP) statement

· Animal Testing Data Statement

·Product efficacy certificate

4. Information required for the Cosmetic Safety Assessment Report (CPSR):

·Product name and internal number

·Detailed formula table

·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)

·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA

·Finished product

·Toxicology and clinical research reportsMicrobiological report (including challenge test)

·Stability report

·Packaging material information

·Product label

·Case report

·Exposure data of products

5. Responsibilities of the Responsible Person:

·Assume product safety and compliance responsibilities

·Complete CPNP notification before listing

·The name and address of the responsible person should be marked on the product label

·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority

·After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years

· Update CPNP and PIF/DIP as appropriate

·Report serious adverse reactions (SUE) in a timely manner after listing

·When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.

Label

The container and packaging of every cosmetic product offered on the market, whether free or paid, must present the following information in French and in a clear, understandable, indelible form:

1. Name/company name and address of the person in charge: It can be abbreviated, provided that it is easy to identify.

2. Country of Origin

3. Mass or volume content when packaged, except for:

·Packages of product less than 5 grams or less than 5 ml

·Free Sample

·Products in single-dose form

·A prepackaged product containing a set of parts, provided that the quantity of the parts is mentioned on the prepackage, or that the quantity is easily externally determinable, or that the product is usually only sold individually.

4. Minimum Shelf Life: Dates must be mentioned explicitly and consist of month and year (eg: 07/2013) or day, month and year (eg: 06/07/2013) in order. If necessary, conditions of durability can be indicated.

5. Shelf life after opening: Products with a minimum shelf life of more than 30 months are required to label. Indicated by the symbol representing a jar of cream or green, followed by the expiration date (in months and/or years). If the period is expressed in months, it can be expressed with a number followed by the word month or the abbreviation M.

The following shelf life recommendations are published on the ANSM website:

·Minimum period of less than 30 months

·Products without risk of spoilage (e.g. Eau de Parfum)

·Use of these products does not require opening the package (e.g. sprays)

·Intended for one-time use only (eg, a single dose).

6. Special precautions for use, conditions of use and warnings, and instructions for any special precautions for professional use of cosmetic products. In cases where there is insufficient space, the report must be made on flyers, labels, tapes, cards attached to or attached to the product.

7. Manufacture Lot Number or allow to identify manufacture.

8. Function of product (moisturizer, conditioner, etc.).

9. Product ingredient list in descending order by weight (quantity): This list may appear only on the packaging, or on a leaflet, label, or card affixed to the product (may be indicated by an abbreviation or a symbol on the packaging) . Perfume, fragrances and fragrance compositions and their raw materials are denoted by the term perfume or aroma. In addition, in addition to the term perfume or aroma, the substance should be indicated in the ingredient list,

【参考连结】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-55

HLF-FR-60
经过核准登记的化妆品，进口到法国要检附什麽文件？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 cosmetics into France? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。

海关

1. 经济经营者註册和识别

于法国海关註册取得EORI 编号

申请书内容：

．公司名称/姓名(自然人)

．创建日期/生日

．地址、电话、电子邮件

．联络人

．SIRET号码

．增值税号码

2. 于Delta网站完成电子报关，包含申报单（空运或海运舱单）、单一行政文件 (SAD)，网页：https://reurl.cc/eOQ2pQ。

申报单内容

．运营商的名称和EORI

．清关办事处代码

．报关处代码

．包裹数量

．发件人的姓名和地址、收件人的姓名和地址

．商品的商业描述

．以千克为单位的总质量

．原产国代码

．发票价值和货币

．进口声明等

单一行政文件 (SAD)

．託运人

．收件人

．申报人

．出发时运输工具、国家

．过境运输工具、国家

．运输方式

．商业编号

．付款方式

．目的地代码

．交货条款

．交易性质

．货柜编号、密封贴及编号

．商品代码、重量

．税务计算

．抵港日期

．办事处

．声明人等

3. 清关所需文件

．发票，应以法语书写(或附有翻译)

．计量(单位必须是公制)

．运输文件（LTA/AWB、Maritim Connaissement/Bill of Lading、LTM、CMR 或 LVI）

．根据 CETA 协议的原产地声明

．证明符合 EC 或法国标准的文件

无销售许可证，但在化妆品投放市场前，负责人需确保以下几点：

1. 化妆品的成分：化妆品所含成分的选择必须符合化妆品法规，包含

．禁用物质

．受限制物质

． 授权为的物质

．着色剂

．防腐剂

．紫外线过滤器

2. 製造：化妆品的生产是按照良好生产规范(GMP)进行的。

3. 编制化妆品信息文件 (DIP)：必须为投放市场的每种化妆品製定产品信息文件，包括香皂、免费样品或促销化妆品等。
DIP 必须在产品标籤上出现的负责人的地址处，供主管当局使用，且由负责人保存 10 年(自最后一批化妆品投放市场之日起)其格式可以是电子格式或纸质格式， 可以使用法语或英语。

包括以下信息：

．化妆品的描述：

包括产品的定性、定量配方、产品的确切名称、代码、标识或配方名称，以便明确识别。

．产品安全报告

．符合良好生产规范 (GMP) 的声明(GMP 符合性声明可由负责人或第三方作出。)

．与製造商、其代理商或供应商进行的动物实验有关的数据，以及与化妆品或其安全性的开发或评估有关的数据

4. 编制化妆品信息文件 (DIP)：必须为投放市场的每种化妆品製定产

5. 容器和包装标籤符合规则

6. 完成化妆品备案通报流程(CPNP)

The responsible person must notify through the EU unified online platform (CPNP, URL: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market.

Customs

1. Registration and identification of economic operators

Registered with French customs to obtain EORI number

Contents of application form:

． Company Name/Name (Natural Person)

． Creation Date/Birthday

． Address, phone, email

． Contact person

． SIRET number

． VAT number

2. Complete the electronic customs declaration on the Delta website, including the declaration form (air or sea manifest), single administrative document (SAD), website: https://reurl.cc/eOQ2pQ.

Contents of declaration form

． Operator’s name and EORI

． Customs Clearance Office Code

． Customs code

． Number of packages

． Sender’s name and address, recipient’s name and address

． Commercial description of the item

． Total mass in kilograms

． Country of origin code

． Invoice value and currency

． Import declaration, etc.

Single Administrative Document (SAD)

． Shipper

． Recipient

． Declarer

． Means of transport, country on departure

． Transit conveyance, country

． Shipping method

． Commercial number

． Payment method

． Destination code

． Terms of Delivery

． Transaction nature

． Container Numbers, Seals and Numbers

． Product code, weight

． Tax calculations

． Arrival date

． Office

． Declarant, etc.

3. Required documents for customs clearance

．Invoice, which should be written in French (or accompanied by a translation)

．Measurement (units must be in metric)

．Shipping Documentation (LTA/AWB, Maritim Connaissement/Bill of Lading, LTM, CMR or LVI)

．Declaration of Origin under CETA Agreement

．Documents proving conformity to EC or French standards

There is no sales license, but before the cosmetics are put on the market, the responsible person needs to ensure the following:

1. Composition of cosmetics: The selection of ingredients contained in cosmetics must comply with cosmetic regulations, including

． Banned Substances

． Restricted Substances

． Substances authorized as

． Colorant

． Preservatives

． UV filter

2. Manufacture: The manufacture of cosmetic products is carried out in accordance with Good Manufacturing Practice (GMP).

3. Preparation of Cosmetic Information File (DIP): A product information file must be prepared for each cosmetic product placed on the market, including soaps, free samples or promotional cosmetic products, etc. The DIP must be at the address of the person in charge that appears on the product label, be available to the competent authority, and be kept by the person in charge for 10 years (from the date of the last batch of cosmetic products placed on the market) in either electronic or paper format, available French or English.

Include the following information:

． Description of the cosmetic:

Include the qualitative, quantitative formula of the product, the exact name of the product, code, logo or formula name for clear identification.

．Product Safety Report

．Declaration of conformity with Good Manufacturing Practice (GMP) (The GMP declaration of conformity can be made by the responsible person or by a third party.)

． Data related to animal testing conducted by the manufacturer, its agents or suppliers, as well as data related to the development or evaluation of cosmetic products or their safety

4. Preparation of the Cosmetic Information File (DIP): A product must be prepared for each cosmetic product placed on the market.

5. Container and packaging labels comply with the rules

6. Complete the Cosmetic Filing Notification Process (CPNP)

【参考连结】

https://www.douane.gouv.fr/professionnels

HLF-FR-70
法国化妆品审核机构，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：

负责人需在欧盟的妆品通知门户（CPNP）申请，包含以下内容：

1. 化妆品的生产应符合良好生产规范(GMP)

亦可採用与该标准同等级之其他标准或体系。在欧盟地区是由业者自我管理，企业不需要提供任何 GMP 证书或要求欧盟主管机关核发 GMP 认证。

2. 化妆品安全报告 (CPSR)的产品信息文件 (PIF)

．产品成分之定性及定量组成

．化粧品物理性、化学性及安定性

．微生物含量

．不纯物、残留量及包装材料资讯

．产品标示及警示

．化粧品的使用

．成分、成分的毒理资料

．不良反应和严重不良反应

．(其他相关)化粧品的资讯等

3. 动物试验及验证结果

4. 奈米材料

．如有必要，将委託消费者安全科学委员会 (SCCS) 评估奈米材料的安全性。

The responsible person needs to apply in the EU’s Cosmetic Notification Portal (CPNP), including the following:

1.Compliance with Good Manufacturing Practices (GMP)

Other standards or systems of the same level as this standard may also be used. In the EU region, it is self-managed by the industry, and the company does not need to provide any GMP certificate or require the EU competent authority to issue GMP certification.

2.Product Information File (PIF) for Cosmetic Safety Report (CPSR)

． Qualitative and quantitative composition of product ingredients

． Cosmetics physical, chemical and stability

． Microbial content

． Information on Impurities, Residues and Packaging Materials

． Product Labeling and Warnings

． Use of cosmetics

． Toxicological information on ingredients, ingredients

． Adverse Reactions and Serious Adverse Reactions

． (Other related) information on cosmetics, etc.

3.Animal experiments and verification results

4. Nanomaterials

．If necessary, the Scientific Committee on Consumer Safety (SCCS) will be commissioned to assess the safety of nanomaterials.

【参考连结】

https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

HLF-FR-75

HLF-FR-77

HLF-FR-80
外国子公司进口化妆品后，如果委託法国的经销商销售，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？

After a foreign subsidiary imports cosmetics and entrusts a distributor in France to sell it, does the distributor need a cosmetics 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：

无须申请营业特许证。

化妆品在投放市场前无需经过营销授权，但指定负责人必须保证投放市场的产品在正常或可合理预见的使用条件下对人体健康是安全的，并且在化妆品上市后有义务通报，例如严重不良反应的声明或风险的通报，以及当产品不符合安全义务时须採取措施。
法国规定，当发生严重不良反应时，负责人须向法国的 ANSM 和 DGCCRF报告，履行报告风险和採取的措施的义务的通知，

No business license is required.

Cosmetics do not need marketing authorization before they are put on the market, but the designated person in charge must ensure that the products put on the market are safe for human health under normal or reasonably foreseeable conditions of use, and are obliged to report after the cosmetics are put on the market, such as serious adverse reactions. statement or risk communication, and action to be taken when the product does not meet its safety obligations. France stipulates that when a serious adverse reaction occurs, the responsible person must report to the French ANSM and DGCCRF, a notification of fulfilling the obligation to report risks and take measures,

【参考连结】

https://ansm.sante.fr/contact

https://www.economie.gouv.fr/dgccrf/securite/avis-rappels-produits

HLF-FR-85

各国化妆品登记法规问答集

连繫人:
Email：par4ww@evershinecpa.com
或
法国永辉BPO有限公司
Paris time zone:
Manager Zhu, 法国永居卡居民 说法文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

永辉100%关係企业
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其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
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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