西班牙化妝品登記法規問題集

西班牙主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。西班牙與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
China Time Zone:
聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
電話：+886-2-2717-0515 分機:100

各國化妝品登記法規問答集

時間：2023/10/28 drafted by Yvonne Chen

HLF-TW-10
請問西班牙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 Spain? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在西班牙，化妝品的監管機關是西班牙藥品和保健品局(AEMPS)，化妝品旨在與人體表面部分（表皮、毛髮和毛細血管系統、指甲、嘴唇和外生殖器官）或牙齒和口腔黏膜接觸的任何物質或混合物，專門或主要目的是用於清潔、添香、修飾外觀、保護、使它們處於良好狀態或糾正體味。
化妝品分類：
1.衛生用品
2.牙齒美白劑
3.牙膏
4.美容產品

In Spain, the regulatory authority for cosmetics is the Spanish Agency for Medicines and Health Products (AEMPS). Cosmetics are intended to come into contact with any surface part of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucosa. Substances or mixtures used exclusively or primarily for the purpose of cleaning, perfuming, beautifying, protecting, keeping in good condition or correcting body odor.
Cosmetics category:

1. Hygiene products
2. Teeth Whitening Agent
3. Toothpaste
4. Beauty products

【參考連結】
https://www.aemps.gob.es/
https://boe.gob.es/buscar/doc.php?id=BOE-A-2018-2693

HLF-TW-20
外國公司要到西班牙銷售化妝品，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 Spain, 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：
無營業特許證。
No business license.

【參考連結】
https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-25
假如需要辦理，請問西班牙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：
無營業特許證。
No business license.

HLF-TW-30
外國公司要到西班牙銷售化妝品，可以指派西班牙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 Spain, can it assign an Spain 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
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
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資訊檔案(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. 產品資訊檔案(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
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 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。

產品安全
1.責任人
．當化妝品對人類健康構成風險時，責任人應立即通報銷售相關產品的成員國以及提供該文件的成員國的國家主管當局，並應詳細說明不合格情況和採取的糾正措施。
．責任人要配合採取消除其投放市場的化妝品所帶來風險的行動，應根據國家主管機關的合理要求，以西班牙語證明產品符合性所需的所有資訊和文件。

2. 經銷商
   ．如果產品對人類健康構成風險，經銷商應立即通知責任人以及銷售相關產品的成員國的國家主管部門，並提供詳細資訊，特別是不合格的資料，以及採取的糾正措施。
   ．在對產品負責的同時，經銷商應確保儲存或運輸條件不會損害產品。
   ．經銷商應與主管機關合作，配合採取消除其投放市場的化妝品所帶來風險的行動，應根據國家主管機關的合理要求，以西班牙語證明產品符合性所需的所有資訊和文件。

Yes.
Only those designated as responsible persons in the EU can be put on the market. The responsible person must be a corporate legal person or natural person in the EU. Non-EU products entering the EU and EFTA areas must designate a local legal person or natural person in the EU as the responsible person of the company. Only then can the cosmetics be placed on the EU market. Generally, the default responsibility for cosmetics is the cosmetics manufacturer, importer, and distributor. If written authorization is provided, it can also be a third-party legal person or natural person.

1. The responsible person must meet one of the following qualifications:
   ·EU citizens (regardless of place of residence).
   ·Natural persons residing in the EU or a member state of the European Economic Area.
   · Companies established within the EU or EEA (registered office, central authority or principal establishment).
   ·Organizations established within the EU or European Economic Area.
2. Complete the cosmetics registration notification process
   The responsible person must notify the product through the EU unified online platform (CPNP, web page: https://reurl.cc/pM8R7x) before the product can enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product is put on the market, and prepare official on-site inspection. Inspection tools are required:
   ·Product Category
   ·Product name
   ·Responsible person’s name and address
   ·Region of listing (member state where it is placed on the market)
   ·Labels and packaging (reasonably clear photos)
   ·Product ingredients
   ·Country of origin
   ·Contact
   ·Nano materials (including chemical names, exposure conditions)
   ·The name, chemical abstract or EC number of special ingredients such as CMR or reproductive toxic substances
   ·Medical treatment when encountering problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment ReportCPSR
   ·Production process description and Good Manufacturing Practice (GMP) statement
   ·Animal Testing Data Statement
   ·Proof of product efficacy
4. Information required for Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed recipe table
   ·Raw material quality inspection report (CoA) and chemical safety data sheet (MSDS)
   ·Fragrances/Fragrances/Essential Oils: IFRA documents, allergens, MSDS, CoA
   ·Finished product
   ·Toxicological and clinical research reports
   ·Microbiological reporting (including challenge testing)
   ·Stability report
   ·Packaging material information
   ·product label
   ·Case report
   ·Product exposure data
5. Responsible person’s obligations:
   ·Assume responsibility for product safety and compliance
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person must be marked on the product label
   ·The responsible person needs to prepare complete PIF/DIP documents and respond to inspections by the competent authorities
   ·After the last batch of products are put on the market, the responsible person must keep the cosmetics safety assessment report for at least ten years
   ·Update CPNP and PIF/DIP as appropriate
   ·Promptly report serious adverse reactions (SUE) after marketing
   ·When there is reason to believe that a product put on the market does not meet regulatory requirements or has safety issues, take necessary corrective measures to withdraw or recall the product.

Product Safety

1. Responsible person
   ．When a cosmetic product poses a risk to human health, the responsible person shall immediately notify the competent national authorities of the Member State in which the relevant product is marketed and of the Member State providing the document, and shall detail the nonconformity and the corrective measures taken.
   ．To cooperate with the actions taken to eliminate the risks posed by the cosmetic products it places on the market, the responsible person shall provide in Spanish all information and documentation necessary to demonstrate the conformity of the product, as reasonably requested by the national competent authority.
2. Distributor
   ．If a product poses a risk to human health, the distributor shall immediately notify the responsible person and the national competent authority of the Member State where the relevant product is sold, and provide detailed information, in particular non-conformities, and the corrective measures taken.
   ．While being responsible for the products, dealers should ensure that storage or transportation conditions do not damage the products.
   ．Distributors shall cooperate with the competent authorities in taking actions to eliminate the risks posed by the cosmetics they place on the market and shall provide in Spanish all information and documentation necessary to demonstrate the conformity of the products, as reasonably requested by the national competent authorities.

【參考連結】
https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-35
假如需要辦理指派西班牙公司擔任營業代理人，請問西班牙有專業服務公司可以協助？

HLF-TW-40
外國公司銷售到西班牙化妝品本身，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 Spain? 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：
需要辦理產品許可證
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
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資訊檔案(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. 產品資訊檔案(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
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 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
化妝品只有在容器和包裝上以不可磨滅、易於辨認和可見的字符顯示以下資訊才能上市：
1.責任人的姓名或公司名稱和地址
2.原產國
3.包裝時的標稱含量(以重量或體積表示)，但容器容量小於 5 克或 5 毫升、免費樣品和單劑量除外，對於成套銷售且重量或體積標註不重要的預包裝產品，只要在包裝上標明單位數量，則無需標明內容物。當從外部很容易確定單位數量或產品通常僅以單一單位出售時，則無需標識
4.最短保存期限，由月和年或按日、月和年的順序組成，最短保存期限超過三十個月的化妝品，則不強制標示最短保存期限日期。
5.使用時的特殊注意事項，以及與專業使用化妝品必須遵守的特殊注意事項
6.生產批號或可識別化妝品的參考號碼
7.化妝品的功能
8.成分清單
9.標籤以西班牙語標識。

Product license required
Only those designated as responsible persons in the EU can be put on the market. The responsible person must be a corporate legal person or natural person in the EU. Non-EU products entering the EU and EFTA areas must designate a local legal person or natural person in the EU as the responsible person of the company. Only then can the cosmetics be placed on the EU market. Generally, the default responsibility for cosmetics is the cosmetics manufacturer, importer, and distributor. If written authorization is provided, it can also be a third-party legal person or natural person.

1. The responsible person must meet one of the following qualifications:
   ·EU citizens (regardless of place of residence).
   ·Natural persons residing in the EU or a member state of the European Economic Area.
   · Companies established within the EU or EEA (registered office, central authority or principal establishment).
   ·Organizations established within the EU or European Economic Area.
2. Complete the cosmetics registration notification process
   The responsible person must notify the product through the EU unified online platform (CPNP, web page: https://reurl.cc/pM8R7x) before the product can enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product is put on the market, and prepare official on-site inspection. Inspection tools are required:
   ·Product Category
   ·Product name
   ·Responsible person’s name and address
   ·Region of listing (member state where it is placed on the market)
   ·Labels and packaging (reasonably clear photos)
   ·Product ingredients
   ·Country of origin
   ·Contact
   ·Nano materials (including chemical names, exposure conditions)
   ·The name, chemical abstract or EC number of special ingredients such as CMR or reproductive toxic substances
   ·Medical treatment when encountering problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment ReportCPSR
   ·Production process description and Good Manufacturing Practice (GMP) statement
   ·Animal Testing Data Statement
   ·Proof of product efficacy
4. Information required for Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed recipe table
   ·Raw material quality inspection report (CoA) and chemical safety data sheet (MSDS)
   ·Fragrances/Fragrances/Essential Oils: IFRA documents, allergens, MSDS, CoA
   ·Finished product
   ·Toxicological and clinical research reports
   ·Microbiological reporting (including challenge testing)
   ·Stability report
   ·Packaging material information
   ·product label
   ·Case report
   ·Product exposure data
5. Responsible person’s obligations:
   ·Assume responsibility for product safety and compliance
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person must be marked on the product label
   ·The responsible person needs to prepare complete PIF/DIP documents and respond to inspections by the competent authorities
   ·After the last batch of products are put on the market, the responsible person must keep the cosmetics safety assessment report for at least ten years
   ·Update CPNP and PIF/DIP as appropriate
   ·Promptly report serious adverse reactions (SUE) after marketing
   ·When there is reason to believe that a product put on the market does not meet regulatory requirements or has safety issues, take necessary corrective measures to withdraw or recall the product.

Label
Cosmetics may be placed on the market only if the following information appears on the container and packaging in indelible, easily legible and visible characters:

1. Name or company name and address of the responsible person
   2.Country of origin
2. Nominal content (expressed by weight or volume) at the time of packaging, except for container capacity less than 5 grams or 5 ml, free samples and single doses. For pre-packaged products sold in sets and the weight or volume labeling is not important, as long as the If the unit quantity is indicated on the packaging, there is no need to indicate the contents. Labeling is not required when the unit quantity is easily determined externally or the product is typically sold in single units only
3. The minimum shelf life consists of month and year or in the order of day, month and year. For cosmetics with a minimum shelf life of more than thirty months, it is not mandatory to indicate the minimum shelf life date.
4. Special precautions when using, and special precautions that must be observed with professional use of cosmetics
5. Production batch number or reference number that identifies the cosmetic product
6. Functions of cosmetics
7. Ingredients list
8. Labels are in Spanish.

【參考連結】
https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-45
請問在西班牙有哪些專業服務機構，可以協助辦理化妝品產品許可證？

HLF-TW-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。
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
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資訊檔案(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. 產品資訊檔案(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
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 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
化妝品只有在容器和包裝上以不可磨滅、易於辨認和可見的字符顯示以下資訊才能上市：
1.責任人的姓名或公司名稱和地址
2.原產國
3.包裝時的標稱含量(以重量或體積表示)，但容器容量小於 5 克或 5 毫升、免費樣品和單劑量除外，對於成套銷售且重量或體積標註不重要的預包裝產品，只要在包裝上標明單位數量，則無需標明內容物。當從外部很容易確定單位數量或產品通常僅以單一單位出售時，則無需標識
4.最短保存期限，由月和年或按日、月和年的順序組成，最短保存期限超過三十個月的化妝品，則不強制標示最短保存期限日期。
5.使用時的特殊注意事項，以及與專業使用化妝品必須遵守的特殊注意事項
6.生產批號或可識別化妝品的參考號碼
7.化妝品的功能
8.成分清單
9.標籤以西班牙語標識。

Application must be made in the name of a corporate legal person or natural person within the EU.
Only those designated as responsible persons in the EU can be put on the market. The responsible person must be a corporate legal person or natural person in the EU. Non-EU products entering the EU and EFTA areas must designate a local legal person or natural person in the EU as the responsible person of the company. Only then can the cosmetics be placed on the EU market. Generally, the default responsibility for cosmetics is the cosmetics manufacturer, importer, and distributor. If written authorization is provided, it can also be a third-party legal person or natural person.

1. The responsible person must meet one of the following qualifications:
   ·EU citizens (regardless of place of residence).
   ·Natural persons residing in the EU or a member state of the European Economic Area.
   · Companies established within the EU or EEA (registered office, central authority or principal establishment).
   ·Organizations established within the EU or European Economic Area.
2. Complete the cosmetics registration notification process
   The responsible person must notify the product through the EU unified online platform (CPNP, web page: https://reurl.cc/pM8R7x) before the product can enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product is put on the market, and prepare official on-site inspection. Inspection tools are required:
   ·Product Category
   ·Product name
   ·Responsible person’s name and address
   ·Region of listing (member state where it is placed on the market)
   ·Labels and packaging (reasonably clear photos)
   ·Product ingredients
   ·Country of origin
   ·Contact
   ·Nano materials (including chemical names, exposure conditions)
   ·The name, chemical abstract or EC number of special ingredients such as CMR or reproductive toxic substances
   ·Medical treatment when encountering problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment ReportCPSR
   ·Production process description and Good Manufacturing Practice (GMP) statement
   ·Animal Testing Data Statement
   ·Proof of product efficacy
4. Information required for Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed recipe table
   ·Raw material quality inspection report (CoA) and chemical safety data sheet (MSDS)
   ·Fragrances/Fragrances/Essential Oils: IFRA documents, allergens, MSDS, CoA
   ·Finished product
   ·Toxicological and clinical research reports
   ·Microbiological reporting (including challenge testing)
   ·Stability report
   ·Packaging material information
   ·product label
   ·Case report
   ·Product exposure data
5. Responsible person’s obligations:
   ·Assume responsibility for product safety and compliance
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person must be marked on the product label
   ·The responsible person needs to prepare complete PIF/DIP documents and respond to inspections by the competent authorities
   ·After the last batch of products are put on the market, the responsible person must keep the cosmetics safety assessment report for at least ten years
   ·Update CPNP and PIF/DIP as appropriate
   ·Promptly report serious adverse reactions (SUE) after marketing
   ·When there is reason to believe that a product put on the market does not meet regulatory requirements or has safety issues, take necessary corrective measures to withdraw or recall the product.

Label
Cosmetics may be placed on the market only if the following information appears on the container and packaging in indelible, easily legible and visible characters:

1. Name or company name and address of the responsible person
   2.Country of origin
2. Nominal content (expressed by weight or volume) at the time of packaging, except for container capacity less than 5 grams or 5 ml, free samples and single doses. For pre-packaged products sold in sets and the weight or volume labeling is not important, as long as the If the unit quantity is indicated on the packaging, there is no need to indicate the contents. Labeling is not required when the unit quantity is easily determined externally or the product is typically sold in single units only
3. The minimum shelf life consists of month and year or in the order of day, month and year. For cosmetics with a minimum shelf life of more than thirty months, it is not mandatory to indicate the minimum shelf life date.
4. Special precautions when using, and special precautions that must be observed with professional use of cosmetics
5. Production batch number or reference number that identifies the cosmetic product
6. Functions of cosmetics
7. Ingredients list
8. Labels are in Spanish.

【參考連結】
https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-55
請問在西班牙有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？

HLF-TW-60
經過核准登記的化妝品，進口到西班牙要檢附什麼文件？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 Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關

1. 經濟經營者註冊和識別(EORI)
   向西班牙海關( OEA )申請取得 EORI 號碼
   網頁：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申請書內容

．自然人：護照或其他有效身分證件；公司名稱/責任人姓名
．西班牙的納稅住所。
．創建日期/生日
．人員類型：自然人/法人/團體
．地址、電話、電子郵件
．聯絡資訊、聯絡人姓名、地址、電話號碼、傳真號碼、電子郵件
．商業登記證明
．如果申請人不是自然人，也不是被授予EORI代碼的法人或團體的法定代表人則必須繳交：經公證的授權書正本、授權書原件
．經濟活動部門4位代碼：商業登記處註明的歐盟經濟活動統計分類(NACE)主要經濟活動的4位數代碼

2. 報關
   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
   ．商業發票副本 (西班牙語)
   ．計量(單位必須是公制)
   ．原產地聲明

銷售前通知
在化妝品投放市場之前，責任人應透過電子傳輸方式向委員會繳交以下資訊：
1.化妝品的類別及其可特定辨識的名稱
2.可提供產品資訊文件的責任人的姓名、地址
3.原產國
4.化妝品投放市場的成員國
5.需要時聯絡的自然人的聯絡方式
6.奈米材料形式存在的物質以及標籤(包括化學名稱IUPAC)
7.合理可預見的暴露條件
8.法規ECEC編號
9.在出現安全問題時能夠提供快速且充分醫療的流程
10.原始標籤以及相應包裝的照片

Customs

1. Economic Operator Registration and Identification (EORI)

Apply to Spanish Customs (OEA) to obtain an EORI number

Website: https://sede.agenciatributaria.gob.es/Sede/inicio.html

Application content

． Natural person: passport or other valid identity document; company name/name of responsible person

． Spanish tax residence.

． Creation date/birthday

． Personnel type: natural person/legal person/group

． Address, phone number, email

． Contact information, contact name, address, telephone number, fax number, email

． Business registration certificate

． If the applicant is not a natural person, nor is he the legal representative of a legal person or group that has been granted an EORI code, he must submit: the original notarized power of attorney, and the original power of attorney.

．4-digit code of the economic activity sector: the 4-digit code of the main economic activity in the Statistical Classification of Economic Activity in the European Union (NACE) indicated in the commercial register

2. Customs declaration

Declaration form content

． Operator’s name and EORI

． Customs clearance office code

． Customs declaration office code

． Package quantity

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

． Commercial description of the product

． Total mass in kilograms

． Country of origin code

． Invoice value and currency

． Import declaration, etc.

Single Administrative Document (SAD)

． Shipper

． Recipient

． Notifier

． Means of transportation and country at departure

． Transit transport, country

． Transportation method

． Business number

． Payment method

． Destination code

． Terms of Delivery

． Nature of transaction

． Container number, sealing sticker and serial number

． Product code, weight

． Tax calculation

． Arrival date

． Office

． Declarant etc.

3. Documents required for customs clearance

． Copy of commercial invoice (Spanish)

． Measurement (units must be metric)

． Declaration of origin

Pre-sale notice

Before placing a cosmetic product on the market, the responsible person should submit the following information to the Commission via electronic transmission:

1. Categories of cosmetics and their specifically identifiable names

2. The name and address of the person responsible for providing product information documents

3. Country of origin

4. Member States where cosmetics are placed on the market

5. Contact information of the natural person to be contacted when necessary

6. Substances in the form of nanomaterials and labels (including chemical name IUPAC)

7. Reasonably foreseeable exposure conditions

8. Regulation ECEC number

9. Ability to provide quick and adequate medical procedures when safety issues arise

10. Photos of original labels and corresponding packaging

【參考連結】

https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-70
西班牙化妝品審核機構，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：

責任人需在歐盟的化妝品通知門戶（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)的產品資訊文件 (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-TW-75
西班牙化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

HLF-TW-77

HLF-TW-80
外國子公司進口化妝品後，如果委託西班牙的經銷商銷售，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 Spain 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：

無營業特許證。

產品安全

1.責任人

．當化妝品對人類健康構成風險時，責任人應立即通報銷售相關產品的成員國以及提供該文件的成員國的國家主管當局，並應詳細說明不合格情況和採取的糾正措施。

．責任人要配合採取消除其投放市場的化妝品所帶來風險的行動，應根據國家主管機關的合理要求，以西班牙語證明產品符合性所需的所有資訊和文件。

2. 經銷商

．如果產品對人類健康構成風險，經銷商應立即通知責任人以及銷售相關產品的成員國的國家主管部門，並提供詳細資訊，特別是不合格的資料，以及採取的糾正措施。

．在對產品負責的同時，經銷商應確保儲存或運輸條件不會損害產品。

．經銷商應與主管機關合作，配合採取消除其投放市場的化妝品所帶來風險的行動，應根據國家主管機關的合理要求，以西班牙語證明產品符合性所需的所有資訊和文件。

No business license.

Product Safety

1. Responsible person

． When a cosmetic product poses a risk to human health, the responsible person shall immediately notify the competent national authorities of the Member State in which the relevant product is marketed and of the Member State providing the document, and shall detail the nonconformity and the corrective measures taken.

．To cooperate with the actions taken to eliminate the risks posed by the cosmetic products it places on the market, the responsible person shall provide in Spanish all information and documentation necessary to demonstrate the conformity of the product, as reasonably requested by the national competent authority.

2. Distributor

．If a product poses a risk to human health, the distributor shall immediately notify the responsible person and the national competent authority of the Member State where the relevant product is sold, and provide detailed information, in particular non-conformities, and the corrective measures taken.

．While being responsible for the products, dealers should ensure that storage or transportation conditions do not damage the products.

．Distributors shall cooperate with the competent authorities in taking actions to eliminate the risks posed by the cosmetics they place on the market and shall provide in Spanish all information and documentation necessary to demonstrate the conformity of the products, as reasonably requested by the national competent authorities.

【參考連結】

https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:02009R1223-20230816#tocId10

HLF-TW-85

各國化妝品登記法規問答集

联系我们：
Email：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
China Time Zone:
聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
電話：+886-2-2717-0515 分機:100

附加資訊:
台北永輝協同網路服務股份有限公司
永輝啟佳聯合會計師事務所
地址:104臺北市中山區長春路378號6樓
捷運文湖線南京復興站,兄弟大飯店附近
所長 Principal Partner:
陳中成 Dale C.C. Chen;
會計師 in 台灣+中國+英國/企管碩士+企管博士/台灣專利師;
CPA in Taiwan+China+UK/ MBA+DBA/ Patent Attorney in Taiwan;
Mobile: +86-139-1048-6278 in China ;
Mobile:+886-933920199 in Taipei;
Wechat ID: evershiinecpa ;
Line ID:evershinecpa;
Skype:daleccchen ;
Linkedin Address:  Dale Chen Linkedin

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永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

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