西班牙化妆品登记法规问题集

西班牙主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支援的会计薪资服务。西班牙与臺湾同事携手协同爲您服务。为地球暖化尽一份心力，减少空中旅行。
Email：bcn4ww@evershinecpa.com
或
西班牙永辉BPO有限公司
Barcelona time zone:
Anna Wang, 说西班牙文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
电话：+886-2-2717-0515 分机:110

各国化妆品登记法规问答集

时间：2023/10/28 drafted by Yvonne Chen

HLF-TW-10
请问西班牙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 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，化妆品的监管机关是西班牙药品和保健品局(AEMPS)，化妆品旨在与人体表面部分（表皮、毛发和毛细血管系统、指甲、嘴唇和外生殖器官）或牙齿和口腔黏膜接触的任何物质或混合物，专门或主要目的是用于清洁、添香、修饰外观、保护、使它们处于良好状态或纠正体味。
化妆品分类：
1.卫生用品
2.牙齿美白剂
3.牙膏
4.美容产品

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

【参考连结】
https://www.aemps.gob.es/
https://boe.gob.es/buscar/doc.php?id=BOE-A-2018-2693

HLF-TW-20
外国公司要到西班牙销售化妆品，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 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：
无营业特许证。
No business license.

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

HLF-TW-25
假如需要办理，请问西班牙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：
无营业特许证。
No business license.

HLF-TW-30
外国公司要到西班牙销售化妆品，可以指派西班牙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 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
只有在欧盟内被指定为责任人才能投放市场，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资讯档案(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. 产品资讯档案(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
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 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。

产品安全
1.责任人
．当化妆品对人类健康构成风险时，责任人应立即通报销售相关产品的成员国以及提供该文件的成员国的国家主管当局，并应详细说明不合格情况和採取的纠正措施。
．责任人要配合採取消除其投放市场的化妆品所带来风险的行动，应根据国家主管机关的合理要求，以西班牙语证明产品符合性所需的所有资讯和文件。

2. 经销商
   ．如果产品对人类健康构成风险，经销商应立即通知责任人以及销售相关产品的成员国的国家主管部门，并提供详细资讯，特别是不合格的资料，以及採取的纠正措施。
   ．在对产品负责的同时，经销商应确保储存或运输条件不会损害产品。
   ．经销商应与主管机关合作，配合採取消除其投放市场的化妆品所带来风险的行动，应根据国家主管机关的合理要求，以西班牙语证明产品符合性所需的所有资讯和文件。

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.

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

HLF-TW-35
假如需要办理指派西班牙公司担任营业代理人，请问西班牙有专业服务公司可以协助？

HLF-TW-40
外国公司销售到西班牙化妆品本身，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 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：
需要办理产品许可证
只有在欧盟内被指定为责任人才能投放市场，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资讯档案(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. 产品资讯档案(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
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 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
化妆品只有在容器和包装上以不可磨灭、易于辨认和可见的字符显示以下资讯才能上市：
1.责任人的姓名或公司名称和地址
2.原产国
3.包装时的标称含量(以重量或体积表示)，但容器容量小于 5 克或 5 毫升、免费样品和单剂量除外，对于成套销售且重量或体积标註不重要的预包装产品，只要在包装上标明单位数量，则无需标明内容物。当从外部很容易确定单位数量或产品通常仅以单一单位出售时，则无需标识
4.最短保存期限，由月和年或按日、月和年的顺序组成，最短保存期限超过三十个月的化妆品，则不强制标示最短保存期限日期。
5.使用时的特殊注意事项，以及与专业使用化妆品必须遵守的特殊注意事项
6.生产批号或可识别化妆品的参考号码
7.化妆品的功能
8.成分清单
9.标籤以西班牙语标识。

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.

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

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

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？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。
只有在欧盟内被指定为责任人才能投放市场，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资讯档案(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. 产品资讯档案(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
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 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
化妆品只有在容器和包装上以不可磨灭、易于辨认和可见的字符显示以下资讯才能上市：
1.责任人的姓名或公司名称和地址
2.原产国
3.包装时的标称含量(以重量或体积表示)，但容器容量小于 5 克或 5 毫升、免费样品和单剂量除外，对于成套销售且重量或体积标註不重要的预包装产品，只要在包装上标明单位数量，则无需标明内容物。当从外部很容易确定单位数量或产品通常仅以单一单位出售时，则无需标识
4.最短保存期限，由月和年或按日、月和年的顺序组成，最短保存期限超过三十个月的化妆品，则不强制标示最短保存期限日期。
5.使用时的特殊注意事项，以及与专业使用化妆品必须遵守的特殊注意事项
6.生产批号或可识别化妆品的参考号码
7.化妆品的功能
8.成分清单
9.标籤以西班牙语标识。

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.

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

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

HLF-TW-60
经过核准登记的化妆品，进口到西班牙要检附什麽文件？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 Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海关

1. 经济经营者註册和识别(EORI)
   向西班牙海关( OEA )申请取得 EORI 号码
   网页：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申请书内容

．自然人：护照或其他有效身分证件；公司名称/责任人姓名
．西班牙的纳税住所。
．创建日期/生日
．人员类型：自然人/法人/团体
．地址、电话、电子邮件
．联络资讯、联络人姓名、地址、电话号码、传真号码、电子邮件
．商业登记证明
．如果申请人不是自然人，也不是被授予EORI代码的法人或团体的法定代表人则必须缴交：经公证的授权书正本、授权书原件
．经济活动部门4位代码：商业登记处註明的欧盟经济活动统计分类(NACE)主要经济活动的4位数代码

2. 报关
   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
   ．商业发票副本 (西班牙语)
   ．计量(单位必须是公制)
   ．原产地声明

销售前通知
在化妆品投放市场之前，责任人应透过电子传输方式向委员会缴交以下资讯：
1.化妆品的类别及其可特定辨识的名称
2.可提供产品资讯文件的责任人的姓名、地址
3.原产国
4.化妆品投放市场的成员国
5.需要时联络的自然人的联络方式
6.奈米材料形式存在的物质以及标籤(包括化学名称IUPAC)
7.合理可预见的暴露条件
8.法规ECEC编号
9.在出现安全问题时能够提供快速且充分医疗的流程
10.原始标籤以及相应包装的照片

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

【参考连结】

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

HLF-TW-70
西班牙化妆品审核机构，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：

责任人需在欧盟的化妆品通知门户（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)的产品资讯文件 (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-TW-75
西班牙化妆品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

HLF-TW-77

HLF-TW-80
外国子公司进口化妆品后，如果委託西班牙的经销商销售，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 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：

无营业特许证。

产品安全

1.责任人

．当化妆品对人类健康构成风险时，责任人应立即通报销售相关产品的成员国以及提供该文件的成员国的国家主管当局，并应详细说明不合格情况和採取的纠正措施。

．责任人要配合採取消除其投放市场的化妆品所带来风险的行动，应根据国家主管机关的合理要求，以西班牙语证明产品符合性所需的所有资讯和文件。

2. 经销商

．如果产品对人类健康构成风险，经销商应立即通知责任人以及销售相关产品的成员国的国家主管部门，并提供详细资讯，特别是不合格的资料，以及採取的纠正措施。

．在对产品负责的同时，经销商应确保储存或运输条件不会损害产品。

．经销商应与主管机关合作，配合採取消除其投放市场的化妆品所带来风险的行动，应根据国家主管机关的合理要求，以西班牙语证明产品符合性所需的所有资讯和文件。

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.

【参考连结】

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

HLF-TW-85

各国化妆品登记法规问答集

联系我们：
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或
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Anna Wang, 说西班牙文中文和英文
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