法國化妝品登記法規問題集 -

法國化妝品登記法規問題集

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文章目錄 點擊收合

HLF-FR-10請問法國對於化妝品的歸類方式為何？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-FR-20外國公司要到法國銷售化妝品，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-FR-25假如需要辦理，請問法國有專業服務公司可以協助辦理化妝品公司營業許可證？

HLF-FR-30外國公司要到法國銷售化妝品，可以指派法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-FR-40外國公司銷售到法國化妝品本身，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？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

HLF-FR-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？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

HLF-FR-60經過核准登記的化妝品，進口到法國要檢附什麼文件？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-FR-70法國化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-FR-80外國子公司進口化妝品後，如果委託法國的經銷商銷售，經銷商需要化妝品營業許可證嗎？假如化妝品有品質瑕疵的話，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？

各國化妝品登記法規問答集

HLF-FR-10
請問法國對於化妝品的歸類方式為何？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 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：

在法國，化妝品市場的監管由法國國家藥品和健康產品安全局 (ANSM)和競爭政策、消費者事務和欺詐控制總局 (DGCCRF)負責。
化妝品是與人體表層(表皮、頭髮和毛細血管、指甲、嘴唇和外生殖器)，或牙齒和口腔黏膜接觸的任何物質或混合物。
以清潔、發出香味、改善外觀、改善身體氣味或保護身體使之保持良好狀態為主要目的的物質和製劑。
化妝品不能被展示為具有治療或預防人類疾病的特性，以及，旨在被攝入、吸入、注射或植入體內的產品不歸屬化妝品，即使它們聲稱對皮膚、牙齒、口腔黏膜和/或皮膚附件（頭髮、指甲）有特別的作用。
此外，化妝品由製造商、進口商或負責將其投放市場的人來監控其產品相關的聲明。

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.

【參考連結】

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

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

HLF-FR-20
外國公司要到法國銷售化妝品，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 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：

無須申請營業特許證。

No business license is required.

【參考連結】

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

HLF-FR-25
假如需要辦理，請問法國有專業服務公司可以協助辦理化妝品公司營業許可證？

Evershine RD：

無須申請營業特許證。
No business license is required.

HLF-FR-30
外國公司要到法國銷售化妝品，可以指派法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 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。在歐盟內被指定為責任人即能投放市場，責任人的主體需由歐盟境內的企業法人或自然人擔任，非歐盟商品進入歐盟與EFTA地區必須要指定歐盟當地法人或自然人擔任公司的責任人，才能將該化妝品投放歐盟市場。
一般默認化妝品的責任人為化妝品製造商，進口商，經銷商，如通過書面授權的形式，也可由第三方法人或自然人擔任。

1.責任人須符合其中一項資格：

·歐盟公民(不論居住地)。
·居住在歐盟或是歐洲經濟區會員國的自然人。
·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。
·在歐盟或歐洲經濟區內建立的組織。

2.完成化妝品備案通報流程

責任人必須在產品上市前經由歐盟統一線上平台進行通報（CPNP，網頁：https://reurl.cc/pM8R7x）方可進入歐盟市場。並且責任人須在產品上市前準備好產品信息檔案(PIF/DIP)文件，已備官方實地檢查，需檢具：

·產品類別
·產品名稱
·責任人姓名、地址
·上市地區(投放市場的成員國)
·標籤及包裝(合理清晰的照片)
·產品配方
·原產國
·聯繫人
·奈米材料(包括化學名稱、暴露條件)
·CMR類等特殊成分或生殖毒性物質的名稱、化學文摘或EC 編號
·遇到問題時的醫療處理

3. 產品信息檔案(PIF/DIP)內容包括：

·產品描述
·產品安全評估報告CPSR
·生產工藝描述和良好生產規範(GMP)聲明
·動物測試數據聲明
·產品功效證明

4.化妝品安全評估報告(CPSR)所需資料：

·產品名和內部編號
·詳細配方表
·原料質檢報告(CoA)和化學品安全技術書(MSDS)
·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA
·成品
·毒理和臨床研究報告
·微生物報告(包括挑戰試驗)
·穩定性報告
·包裝材料信息
·產品標籤
·案例報告
·產品的暴露數據

5. 責任人的義務：

·承擔產品安全和合規責任
·上市前完成CPNP通報
·責任人名稱及地址需標註在產品標籤上
·責任人需準備完整PIF/DIP文件，應對主管當局的檢查
·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年
·根據情況更新CPNP和PIF/DIP
·上市後及時上報嚴重不良反應（ SUE）

·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

化妝品在投放市場前無需經過營銷授權，但指定負責人必須保證投放市場的產品在正常或可合理預見的使用條件下對人體健康是安全的，並且在化妝品上市後有義務通報，例如嚴重不良反應的聲明或風險的通報，以及當產品不符合安全義務時須採取措施。
法國規定，當發生嚴重不良反應時，負責人須向法國的 ANSM 和 DGCCRF報告，履行報告風險和採取的措施的義務的通知，

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,

【參考連結】

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
外國公司銷售到法國化妝品本身，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？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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，須以歐盟境內的企業法人或自然人名義申請。

非歐盟商品進入歐盟與EFTA地區必須要指定歐盟當地法人或自然人擔任公司的責任人，才能將該化妝品投放歐盟市場。
一般默認化妝品的責任人為化妝品製造商，進口商，經銷商，如通過書面授權的形式，也可由第三方法人或自然人擔任。

1.責任人須符合其中一項資格：
·歐盟公民(不論居住地)。
·居住在歐盟或是歐洲經濟區會員國的自然人。
·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。
·在歐盟或歐洲經濟區內建立的組織。

2.完成化妝品備案通報流程

3. 產品信息檔案(PIF/DIP)內容包括：

·產品描述

·產品安全評估報告CPSR

·生產工藝描述和良好生產規範(GMP)聲明

·動物測試數據聲明

·產品功效證明

4.化妝品安全評估報告(CPSR)所需資料：

·產品名和內部編號

·詳細配方表

·原料質檢報告(CoA)和化學品安全技術書(MSDS)

·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA

·成品

·毒理和臨床研究報告

·微生物報告(包括挑戰試驗)

·穩定性報告

·包裝材料信息

·產品標籤

·案例報告

·產品的暴露數據

5. 責任人的義務：

·承擔產品安全和合規責任

·上市前完成CPNP通報

·責任人名稱及地址需標註在產品標籤上

·責任人需準備完整PIF/DIP文件，應對主管當局的檢查

·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年

·根據情況更新CPNP和PIF/DIP

·上市後及時上報嚴重不良反應（ SUE）

·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

標籤

市場上提供的每件化妝品的容器和包裝，無論是免費還是付費，都必須以法語且清晰、易懂、不可磨滅的方式展示以下信息：

1. 負責人的姓名/公司名稱和地址：可以縮寫，前提是容易識別。

2. 原產國

3. 包裝時質量或體積含量，以下除外：

．少於 5 克或少於 5 毫升產品的包裝

．免費樣品

．以單劑量形式呈現的產品

．包含一組零件的預包裝產品，前提是預包裝上提到了零件的數量，或者該數量是否容易於從外部確定，或者該產品通常僅單獨銷售。

4. 最低保質期：必須明確提及日期，並按順序由月和年（例如：07/2013）或日、月和年（例如：06/07/2013）組成。如有必要，可以指出的耐久性的條件。

5. 開封後的使用期限：最短保質期大於 30 個月的產品強制要求標籤。由代表一罐奶油或綠色的符號表示，然後是使用期限（以月和/或年表示）。如果週期以月表示，則可以用數字後跟月一詞或縮寫M來表示。

下列幾項開封後的使用期限建議發佈在 ANSM 網站：

．最短期限少於30 個月

．沒有變質風險的產品（例如淡香精）

．使用這些產品不需要打開包裝（例如噴霧劑）

．僅打算使用一次（例如單次給藥）。

6. 使用的特殊注意事項、使用條件和警告，以及任何有關專業使用化妝品的特殊注意事項的說明。在沒有足夠空間的情況下，必須在產品上附有或附在產品上的傳單、標籤、帶子、卡片上進行報告。

7. 製造批號或允許識別製造。

8. 產品的功能（保濕霜、護髮素等）。

9. 產品按重量（數量）降序排列的成分清單：此列表可能僅出現在包裝上，或者出現在附在產品上的傳單、標籤或卡片上(可以通過縮寫詞或包裝上的符號來表示)。香水、芳香和芳香組合物及其原材料用香水或香氣一詞表示。此外，除了術語香水或香氣之外，在成分列表中還需指出物質，

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

·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,

【參考連結】

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？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？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 cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

須以歐盟境內的企業法人或自然人名義申請。

1.責任人須符合其中一項資格：

·歐盟公民(不論居住地)。

·居住在歐盟或是歐洲經濟區會員國的自然人。

·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。

·在歐盟或歐洲經濟區內建立的組織。

2.完成化妝品備案通報流程

·產品類別

·產品名稱

·責任人姓名、地址

·上市地區(投放市場的成員國)

·標籤及包裝(合理清晰的照片)

·產品配方

·原產國

·聯繫人

·奈米材料(包括化學名稱、暴露條件)

·CMR類等特殊成分或生殖毒性物質的名稱、化學文摘或EC 編號

·遇到問題時的醫療處理

3. 產品信息檔案(PIF/DIP)內容包括：

·產品描述

·產品安全評估報告CPSR

·生產工藝描述和良好生產規範(GMP)聲明

·動物測試數據聲明

·產品功效證明

4.化妝品安全評估報告(CPSR)所需資料：

·產品名和內部編號

·詳細配方表

·原料質檢報告(CoA)和化學品安全技術書(MSDS)

·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA

·成品

·毒理和臨床研究報告

·微生物報告(包括挑戰試驗)

·穩定性報告

·包裝材料信息

·產品標籤

·案例報告

·產品的暴露數據

5. 責任人的義務：

·承擔產品安全和合規責任

·上市前完成CPNP通報

·責任人名稱及地址需標註在產品標籤上

·責任人需準備完整PIF/DIP文件，應對主管當局的檢查

·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年

·根據情況更新CPNP和PIF/DIP

·上市後及時上報嚴重不良反應（ SUE）

·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

標籤

市場上提供的每件化妝品的容器和包裝，無論是免費還是付費，都必須以法語且清晰、易懂、不可磨滅的方式展示以下信息：

1. 負責人的姓名/公司名稱和地址：可以縮寫，前提是容易識別。

2. 原產國

3. 包裝時質量或體積含量，以下除外：

．少於 5 克或少於 5 毫升產品的包裝

．免費樣品

．以單劑量形式呈現的產品

．包含一組零件的預包裝產品，前提是預包裝上提到了零件的數量，或者該數量是否容易於從外部確定，或者該產品通常僅單獨銷售。

4. 最低保質期：必須明確提及日期，並按順序由月和年（例如：07/2013）或日、月和年（例如：06/07/2013）組成。如有必要，可以指出的耐久性的條件。

下列幾項開封後的使用期限建議發佈在 ANSM 網站：

．最短期限少於30 個月

．沒有變質風險的產品（例如淡香精）

．使用這些產品不需要打開包裝（例如噴霧劑）

．僅打算使用一次（例如單次給藥）。

7. 製造批號或允許識別製造。

8. 產品的功能（保濕霜、護髮素等）。

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

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

·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

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

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).

7. Manufacture Lot Number or allow to identify manufacture.

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

【參考連結】

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
經過核准登記的化妝品，進口到法國要檢附什麼文件？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 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：

責任人必須在產品上市前經由歐盟統一線上平台進行通報（CPNP，網頁：https://reurl.cc/pM8R7x）方可進入歐盟市場。

海關

1. 經濟經營者註冊和識別

於法國海關註冊取得EORI 編號

申請書內容：

．公司名稱/姓名(自然人)

．創建日期/生日

．地址、電話、電子郵件

．聯絡人

．SIRET號碼

．增值稅號碼

2. 於Delta網站完成電子報關，包含申報單（空運或海運艙單）、單一行政文件 (SAD)，網頁：https://reurl.cc/eOQ2pQ。

申報單內容

．運營商的名稱和EORI

．清關辦事處代碼

．報關處代碼

．包裹數量

．發件人的姓名和地址、收件人的姓名和地址

．商品的商業描述

．以千克為單位的總質量

．原產國代碼

．發票價值和貨幣

．進口聲明等

單一行政文件 (SAD)

．託運人

．收件人

．申報人

．出發時運輸工具、國家

．過境運輸工具、國家

．運輸方式

．商業編號

．付款方式

．目的地代碼

．交貨條款

．交易性質

．貨櫃編號、密封貼及編號

．商品代碼、重量

．稅務計算

．抵港日期

．辦事處

．聲明人等

3. 清關所需文件

．發票，應以法語書寫(或附有翻譯)

．計量(單位必須是公制)

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

．根據 CETA 協議的原產地聲明

．證明符合 EC 或法國標準的文件

無銷售許可證，但在化妝品投放市場前，負責人需確保以下幾點：

1. 化妝品的成分：化妝品所含成分的選擇必須符合化妝品法規，包含

．禁用物質

．受限制物質

．授權為的物質

．著色劑

．防腐劑

．紫外線過濾器

2. 製造：化妝品的生產是按照良好生產規範(GMP)進行的。

3. 編制化妝品信息文件 (DIP)：必須為投放市場的每種化妝品製定產品信息文件，包括香皂、免費樣品或促銷化妝品等。
DIP 必須在產品標籤上出現的負責人的地址處，供主管當局使用，且由負責人保存 10 年(自最後一批化妝品投放市場之日起)其格式可以是電子格式或紙質格式，可以使用法語或英語。

包括以下信息：

．化妝品的描述：

包括產品的定性、定量配方、產品的確切名稱、代碼、標識或配方名稱，以便明確識別。

．產品安全報告

．符合良好生產規範 (GMP) 的聲明(GMP 符合性聲明可由負責人或第三方作出。)

．與製造商、其代理商或供應商進行的動物實驗有關的數據，以及與化妝品或其安全性的開發或評估有關的數據

4. 編制化妝品信息文件 (DIP)：必須為投放市場的每種化妝品製定產

5. 容器和包裝標籤符合規則

6. 完成化妝品備案通報流程(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)

【參考連結】

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

HLF-FR-70
法國化妝品審核機構，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：

負責人需在歐盟的妝品通知門戶（CPNP）申請，包含以下內容：

1. 化妝品的生產應符合良好生產規範(GMP)

亦可採用與該標準同等級之其他標準或體系。在歐盟地區是由業者自我管理，企業不需要提供任何 GMP 證書或要求歐盟主管機關核發 GMP 認證。

2. 化妝品安全報告 (CPSR)的產品信息文件 (PIF)

．產品成分之定性及定量組成

．化粧品物理性、化學性及安定性

．微生物含量

．不純物、殘留量及包裝材料資訊

．產品標示及警示

．化粧品的使用

．成分、成分的毒理資料

．不良反應和嚴重不良反應

．(其他相關)化粧品的資訊等

3. 動物試驗及驗證結果

4. 奈米材料

．如有必要，將委託消費者安全科學委員會 (SCCS) 評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.

【參考連結】

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

HLF-FR-75

HLF-FR-77

HLF-FR-80
外國子公司進口化妝品後，如果委託法國的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，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 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：

無須申請營業特許證。

No business license is required.

【參考連結】

https://ansm.sante.fr/contact

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

HLF-FR-85

各國化妝品登記法規問答集

連繫人:
Email：par4ww@evershinecpa.com
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