荷蘭化妝品登記法規問題集 -

荷蘭化妝品登記法規問題集

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文章目錄 點擊收合

HLF-NL-10請問荷蘭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-NL-20外國公司要到荷蘭銷售化妝品，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-NL-30外國公司要到荷蘭銷售化妝品，可以指派荷蘭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-NL-40外國公司銷售到荷蘭化妝品本身，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-NL-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-NL-60經過核准登記的化妝品，進口到荷蘭要檢附什麼文件？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-NL-70荷蘭化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-NL-80外國子公司進口化妝品後，如果委託荷蘭的經銷商銷售，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-NL-10
請問荷蘭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 the Netherlands? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

In the Netherlands, the regulation of cosmetic products is the responsibility of the Netherlands Food and Consumer Product Safety Authority (NVWA). 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 are personal care products. For example: cosmetics, deodorants, perfumes, face creams, soaps, shampoos, body washes, toothpaste, shaving cream and sunscreen.

【參考連結】

https://www.nvwa.nl/onderwerpen/cosmetica

HLF-NL-20
外國公司要到荷蘭銷售化妝品，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 Kingdom of the Netherlands, 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】

https://www.nvwa.nl/onderwerpen/cosmetica

HLF-NL-25

假如需要辦理，請問荷蘭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。

HLF-NL-30
外國公司要到荷蘭銷售化妝品，可以指派荷蘭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 Kingdom of the Netherlands, can it assign a Kingdom of the Netherlands 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。

產品責任

1. 製造商、授權代表、歐盟內的第一批進口商被視為生產商，主要任務是風險評估、進一步調查和糾正措施。

2.經銷商必須收集、提供和傳遞信息。

3.零售商必須立即將有關不安全產品的信息（例如消費者投訴）傳遞給其供應商。

4. 如果產品不符合安全要求，生產商和分銷商必須透由業務網路，在線向 NVWA報告所涉及的風險以及做了什麼來消除危險。

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 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.

Product Liability

1. Manufacturers, authorized representatives, first importers within the EU are considered as producers and the main tasks are risk assessment, further investigation and corrective action.

2. Distributors must collect, provide and transmit information.

3. Retailers must immediately pass on information about unsafe products, such as consumer complaints, to their suppliers.

4. If the product does not meet the safety requirements, the manufacturer and distributor must report the risk involved and what has been done to eliminate the hazard by reporting to the NVWA online through the business gateway.

【參考連結】

https://formulieren.nvwa.nl/formulier/nl-NL/Extern/sc1133_KlachtenformulierKeuze.aspx/f1133_Hoofdgroep

https://www.nvwa.nl/onderwerpen/melden-onveilige-producten-non-food/melden-onveilige-producten-rol-van-producent-distributeur-detaillist

HLF-NL-35

HLF-NL-40
外國公司銷售到荷蘭化妝品本身，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 Kingdom of the Netherlands? 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。

只有在歐盟內被指定為責任人才能投放市場，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

·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

1.製造商/進口商的名稱、地址：負責將產品投放市場人員的名稱和地址，標籤上通常有多個地址，產品信息文件所在的地址須加以強調。(如在地址下劃線)

2.生產國：當產品在歐盟以外生產時，須在產品或包裝上註明。

3.數量：包裝時的含量，以重量或體積表示。

4.保質期：化妝品法規中包含了兩種不同的系統來指示保質期。應使用哪種系統取決於生產後的保質期。

．如果未開封的產品保質期為三十個月或以上，則必須註明使用期限。(以打開罐子的符號標示)

．如果產品自生產後的保質期少於三十個月，則必須在保質期之前加上最好在結束前使用或沙漏符號。

．在某些情況下，如果開封後的保質期概念不影響，則不需要說明保質期。

5.使用特別注意事項：關於如何最好地使用該產品的使用說明。至少必須說明化妝品的警告和特殊注意事項。

6.批號或代碼：這是產品的唯一編號，如果對產品的品質有任何疑問，可以檢查這是否適用於整個批次。

7.產品功能：產品說明，例如沐浴露、潤唇膏、曬後或剃鬚泡沫。化妝品的功能必須在包裝上註明，除非從包裝或產品名稱中可以清楚地看出這一點。

8.成分聲明：生產中使用的所有成分必須在包裝上註明。(以INCI國際命名化妝品成分表示)

．成分按重量遞減的順序列出。

．產品中含量低於 1% 的成分可以在成分列表末尾以任何順序列出。

．有些產品由一系列顏色組成，為了不必為每種新色調製作單獨的標籤，所有顏色都可以列在一份成分說明中。

．在適用的情況下，應使用 CI 命名法（顏色指數）來列出染料。

9.有些產品的包裝太小，以至於沒有空間放置成分說明、使用說明和警告。在這種情況下，手打開書符號或文本可以參考該信息。然後可以將成分、使用說明和警告信息與產品一起打印在單獨的卡片或傳單上。

10.產品標籤需以荷蘭語標示，有使用說明或警告的產品必須提供荷蘭語翻譯。

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

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

·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 reports Microbiological 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

1. Manufacturer/Importer’s Name, Address: Name and address of the person responsible for placing the product on the market. There are often multiple addresses on the label, and the address where the product information file is located must be highlighted. (such as underscore the address)

2. Country of Origin: When the product is produced outside the EU, it must be indicated on the product or packaging.

3. Quantity: The content in packaging, expressed by weight or volume.

4. Shelf life: There are two different systems included in cosmetic regulations to indicate shelf life. Which system should be used depends on the shelf life after production.

．If the unopened product has a shelf life of thirty months or more, the expiry date must be indicated. (indicated by an open jar symbol)

．If the product has a shelf life of less than thirty months from production, it must be preceded by a best before end or hourglass symbol before the expiration date.

．In some cases, the expiration date does not need to be stated if the concept of shelf life after opening is not affected.

5. Special Precautions for Use: Instructions for use on how to best use this product. At a minimum, the warnings and special precautions for the cosmetic product must be stated.

6. Lot number or code: This is the unique number of the product, if you have any doubts about the quality of the product, you can check if this applies to the whole lot.

7. Product function: Product description, such as body wash, lip balm, after-sun or shaving foam. The function of the cosmetic must be stated on the packaging unless this is clearly evident from the packaging or product name.

8. Ingredient Declaration: All ingredients used in the production must be declared on the packaging. (represented by the INCI international name cosmetic ingredients)

．Ingredients are listed in order of decreasing weight.

．Ingredients that are less than 1% in a product can be listed at the end of the ingredient list in any order.

．Some products consist of a range of colors, and in order to avoid having to make a separate label for each new shade, all of the colors can be listed in one ingredient statement.

．Dyes should be listed using CI nomenclature (color index) where applicable.

9. Some products come in packages that are so small that there is no room for ingredient descriptions, directions for use and warnings. In this case, hand open book symbol or text can refer to this information. The ingredients, directions for use and warnings can then be printed on a separate card or leaflet with the product.

10. Product labels must be marked in Dutch, and products with instructions for use or warnings must be translated into Dutch.

【參考連結】

https://wetten.overheid.nl/BWBR0029746/2014-03-01#Opschrift

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

https://www.nvwa.nl/onderwerpen/cosmetica/checklist-etiketteringsverplichtingen-cosmetica

HLF-NL-45

HLF-NL-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

2.生產國：當產品在歐盟以外生產時，須在產品或包裝上註明。

3.數量：包裝時的含量，以重量或體積表示。

4.保質期：化妝品法規中包含了兩種不同的系統來指示保質期。應使用哪種系統取決於生產後的保質期。

．如果未開封的產品保質期為三十個月或以上，則必須註明使用期限。(以打開罐子的符號標示)

．如果產品自生產後的保質期少於三十個月，則必須在保質期之前加上最好在結束前使用或沙漏符號。

．在某些情況下，如果開封後的保質期概念不影響，則不需要說明保質期。

5.使用特別注意事項：關於如何最好地使用該產品的使用說明。至少必須說明化妝品的警告和特殊注意事項。

6.批號或代碼：這是產品的唯一編號，如果對產品的品質有任何疑問，可以檢查這是否適用於整個批次。

7.產品功能：產品說明，例如沐浴露、潤唇膏、曬後或剃鬚泡沫。化妝品的功能必須在包裝上註明，除非從包裝或產品名稱中可以清楚地看出這一點。

8.成分聲明：生產中使用的所有成分必須在包裝上註明。(以INCI國際命名化妝品成分表示)

．成分按重量遞減的順序列出。

．產品中含量低於 1% 的成分可以在成分列表末尾以任何順序列出。

．有些產品由一系列顏色組成，為了不必為每種新色調製作單獨的標籤，所有顏色都可以列在一份成分說明中。

．在適用的情況下，應使用 CI 命名法（顏色指數）來列出染料。

10.產品標籤需以荷蘭語標示，有使用說明或警告的產品必須提供荷蘭語翻譯。

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

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

·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