荷兰化妆品登记法规问题集

荷兰化妆品登记法规问题集

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文章目录 点击收合

各国化妆品登记法规问答集

HLF-NL-10
请问荷兰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 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.

【参考连结】

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

HLF-NL-20
外国公司要到荷兰销售化妆品,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 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:

无须申请营业特许证。

No business license is required.

【参考连结】

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

HLF-NL-25

假如需要办理,请问荷兰有专业服务公司可以协助办理化妆品公司营业许可证?

Evershine RD:

无须申请营业特许证。

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

1.责任人须符合其中一项资格:

·欧盟公民(不论居住地)。

·居住在欧盟或是欧洲经济区会员国的自然人。

·在欧盟或欧洲经济区内成立的公司(註册办事处,中央管理机构或主要机构)。

·在欧盟或欧洲经济区内建立的组织。

2.完成化妆品备案通报流程

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

·产品类别

·产品名称

·责任人姓名、地址

·上市地区(投放市场的成员国)

·标籤及包装(合理清晰的照片)

·产品配方

·原产国

·联繫人

·奈米材料(包括化学名称、暴露条件)

·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号

·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括:

·产品描述

·产品安全评估报告CPSR

·生产工艺描述和良好生产规范(GMP)声明

·动物测试数据声明

·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料:

·产品名和内部编号

·详细配方表

·原料质检报告(CoA)和化学品安全技术书(MSDS)

·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA

·成品

·毒理和临床研究报告

·微生物报告(包括挑战试验)

·稳定性报告

·包装材料信息

·产品标籤

·案例报告

·产品的暴露数据

5. 责任人的义务:

·承担产品安全和合规责任

·上市前完成CPNP通报

·责任人名称及地址需标註在产品标籤上

·责任人需准备完整PIF/DIP文件,应对主管当局的检查

·最后一批产品上市后,责任人须至少保存化妆品安全评估报告十年

·根据情况更新CPNP和PIF/DIP

·上市后及时上报严重不良反应( SUE)

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

产品责任

1. 製造商、授权代表、欧盟内的第一批进口商被视为生产商,主要任务是风险评估、进一步调查和纠正措施。

2.经销商必须收集、提供和传递信息。

3.零售商必须立即将有关不安全产品的信息(例如消费者投诉)传递给其供应商。

4. 如果产品不符合安全要求,生产商和分销商必须透由业务网路,在线向 NVWA报告所涉及的风险以及做了什麽来消除危险。

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.

【参考连结】

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
外国公司销售到荷兰化妆品本身,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 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,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信息档案(PIF/DIP)文件,已备官方实地检查,需检具:

·产品类别

·产品名称

·责任人姓名、地址

·上市地区(投放市场的成员国)

·标籤及包装(合理清晰的照片)

·产品配方

·原产国

·联繫人

·奈米材料(包括化学名称、暴露条件)

·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号

·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括:

·产品描述

·产品安全评估报告CPSR

·生产工艺描述和良好生产规范(GMP)声明

·动物测试数据声明

·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料:

·产品名和内部编号

·详细配方表

·原料质检报告(CoA)和化学品安全技术书(MSDS)

·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA

·成品

·毒理和临床研究报告

·微生物报告(包括挑战试验)

·稳定性报告

·包装材料信息

·产品标籤

·案例报告

·产品的暴露数据

5. 责任人的义务:

·承担产品安全和合规责任

·上市前完成CPNP通报

·责任人名称及地址需标註在产品标籤上

·责任人需准备完整PIF/DIP文件,应对主管当局的检查

·最后一批产品上市后,责任人须至少保存化妆品安全评估报告十年

·根据情况更新CPNP和PIF/DIP

·上市后及时上报严重不良反应( SUE)

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

标籤

1.製造商/进口商的名称、地址:负责将产品投放市场人员的名称和地址,标籤上通常有多个地址,产品信息文件所在的地址须加以强调。(如在地址下划线)

2.生产国:当产品在欧盟以外生产时,须在产品或包装上註明。

3.数量:包装时的含量,以重量或体积表示。

4.保质期:化妆品法规中包含了两种不同的系统来指示保质期。应使用哪种系统取决于生产后的保质期。

.如果未开封的产品保质期为三十个月或以上,则必须註明使用期限。(以打开罐子的符号标示)

.如果产品自生产后的保质期少于三十个月,则必须在保质期之前加上最好在结束前使用或沙漏符号。

.在某些情况下,如果开封后的保质期概念不影响,则不需要说明保质期。

5.使用特别注意事项:关于如何最好地使用该产品的使用说明。至少必须说明化妆品的警告和特殊注意事项。 

6.批号或代码:这是产品的唯一编号,如果对产品的品质有任何疑问,可以检查这是否适用于整个批次。

7.产品功能:产品说明,例如沐浴露、润唇膏、晒后或剃鬚泡沫。化妆品的功能必须在包装上註明,除非从包装或产品名称中可以清楚地看出这一点。

8.成分声明:生产中使用的所有成分必须在包装上註明。(以INCI国际命名化妆品成分表示)

.成分按重量递减的顺序列出。

.产品中含量低于 1% 的成分可以在成分列表末尾以任何顺序列出。

.有些产品由一系列颜色组成,为了不必为每种新色调製作单独的标籤,所有颜色都可以列在一份成分说明中。

.在适用的情况下,应使用 CI 命名法(颜色指数)来列出染料。

9.有些产品的包装太小,以至于没有空间放置成分说明、使用说明和警告。在这种情况下,手打开书符号或文本可以参考该信息。然后可以将成分、使用说明和警告信息与产品一起打印在单独的卡片或传单上。

10.产品标籤需以荷兰语标示,有使用说明或警告的产品必须提供荷兰语翻译。

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

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 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.

【参考连结】

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信息档案(PIF/DIP)文件,已备官方实地检查,需检具:

·产品类别

·产品名称

·责任人姓名、地址

·上市地区(投放市场的成员国)

·标籤及包装(合理清晰的照片)

·产品配方

·原产国

·联繫人

·奈米材料(包括化学名称、暴露条件)

·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号

·遇到问题时的医疗处理

3. 产品信息档案(PIF/DIP)内容包括:

·产品描述

·产品安全评估报告CPSR

·生产工艺描述和良好生产规范(GMP)声明

·动物测试数据声明

·产品功效证明

4.化妆品安全评估报告(CPSR)所需资料:

·产品名和内部编号

·详细配方表

·原料质检报告(CoA)和化学品安全技术书(MSDS)

·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA

·成品

·毒理和临床研究报告

·微生物报告(包括挑战试验)

·稳定性报告

·包装材料信息

·产品标籤

·案例报告

·产品的暴露数据

5. 责任人的义务:

·承担产品安全和合规责任

·上市前完成CPNP通报

·责任人名称及地址需标註在产品标籤上

·责任人需准备完整PIF/DIP文件,应对主管当局的检查

·最后一批产品上市后,责任人须至少保存化妆品安全评估报告十年

·根据情况更新CPNP和PIF/DIP

·上市后及时上报严重不良反应( SUE)

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

标籤

1.製造商/进口商的名称、地址:负责将产品投放市场人员的名称和地址,标籤上通常有多个地址,产品信息文件所在的地址须加以强调。(如在地址下划线)

2.生产国:当产品在欧盟以外生产时,须在产品或包装上註明。

3.数量:包装时的含量,以重量或体积表示。

4.保质期:化妆品法规中包含了两种不同的系统来指示保质期。应使用哪种系统取决于生产后的保质期。

.如果未开封的产品保质期为三十个月或以上,则必须註明使用期限。(以打开罐子的符号标示)

.如果产品自生产后的保质期少于三十个月,则必须在保质期之前加上最好在结束前使用或沙漏符号。

.在某些情况下,如果开封后的保质期概念不影响,则不需要说明保质期。

5.使用特别注意事项:关于如何最好地使用该产品的使用说明。至少必须说明化妆品的警告和特殊注意事项。 

6.批号或代码:这是产品的唯一编号,如果对产品的品质有任何疑问,可以检查这是否适用于整个批次。

7.产品功能:产品说明,例如沐浴露、润唇膏、晒后或剃鬚泡沫。化妆品的功能必须在包装上註明,除非从包装或产品名称中可以清楚地看出这一点。

8.成分声明:生产中使用的所有成分必须在包装上註明。(以INCI国际命名化妆品成分表示)

.成分按重量递减的顺序列出。

.产品中含量低于 1% 的成分可以在成分列表末尾以任何顺序列出。

.有些产品由一系列颜色组成,为了不必为每种新色调製作单独的标籤,所有颜色都可以列在一份成分说明中。

.在适用的情况下,应使用 CI 命名法(颜色指数)来列出染料。

9.有些产品的包装太小,以至于没有空间放置成分说明、使用说明和警告。在这种情况下,手打开书符号或文本可以参考该信息。然后可以将成分、使用说明和警告信息与产品一起打印在单独的卡片或传单上。

10.产品标籤需以荷兰语标示,有使用说明或警告的产品必须提供荷兰语翻译。

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

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 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.

【参考连结】

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

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

HLF-NL-55

HLF-NL-60
经过核准登记的化妆品,进口到荷兰要检附什麽文件?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 Kingdom of the Netherlands? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD:

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

海关

1. 经济经营者註册和识别:于荷兰海关註册取得EORI 编号

申请书内容:

.公司名称、地址、邮政编码、城镇/城市、RSIN/BSN

.增值税识别号

.签名

2. 荷兰海关系统註册

网页:https://nh.douane.nl/

.申请人姓名或公司名称、地址、邮政编码和城镇、商会编号、EORI 编号或 RSIN、联繫人姓名、角色、电话号码、文件声明。

.许可证、软体和通信连接

.14 天内的预期船舶数量

.14 天内到期的总关税

.额外授权

.签署(姓名、角色、地方、日期、签名)

3.报关

.公司详细信息:姓名、地址、邮政编码、城市、电话号码、传真号码、EORI 编号/RSIN

.通知详情:到达/进入、离开/结果、异常情况

.註册号或集装箱号

.数据声明或书面证据

.商品的简要说明、酒精百分比

.商品代码、数量、重量、出发地、目的地、货币、价值

.签署(姓名、角色、地方、日期、签名)

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: obtain EORI number from Dutch customs registration

Contents of application form:

.Company name, address, zip code, town/city, RSIN/BSN

.VAT ID

.Sign

2. Register with the Dutch customs system

URL:https://nh.douane.nl/

.Applicant’s name or company name, address, zip code and town, chamber of commerce number, EORI number or RSIN, contact name, role, phone number, statement of documents.

.Licenses, software and communication connections

.Expected number of vessels within 14 days

.Total tariffs due within 14 days

.Additional authorization

.Sign (name, role, place, date, signature)

3. Customs declaration

.Company Details: Name, Address, Zip Code, City, Phone Number, Fax Number, EORI Number/RSIN

.Notification details: arrival/entry, departure/result, exceptions

.Registration or container number

.Data claims or documentary evidence

.A brief description of the product, alcohol percentage

.Commodity Code, Quantity, Weight, Origin, Destination, Currency, Value

.Sign (name, role, place, date, signature)

【参考连结】

https://www.belastingdienst.nl/wps/wcm/connect/en/customs/customs

https://www.belastingdienst.nl/wps/wcm/connect/bldcontenten/belastingdienst/customs/customs-processes/import/forms-explanations-brochures/

HLF-NL-70
荷兰化妆品审核机构,需要附上的实验室检验资料有哪些? 网页?

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD:

负责人需在欧盟的妆品通知门户(CPNP)申请,包含以下内容:

1. 化妆品的生产应符合良好生产规范(GMP)

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

2. 化妆品安全报告 (CPSR)的产品信息文件 (PIF)

.产品成分之定性及定量组成

.化粧品物理性、化学性及安定性

.微生物含量

.不纯物、残留量及包装材料资讯

.产品标示及警示

.化妆品的使用

.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。

荷兰食品和消费品安全局(NVWA)有可能向负责人要求提供具体的产品信息,製造商或供应商必须在 3 个工作日内提供(荷兰语)。

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.

The Netherlands Food and Consumer Product Safety Authority (NVWA) may request specific product information from the person in charge, which the manufacturer or supplier must provide within 3 working days (in Dutch).

【参考连结】

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

https://www.rvo.nl/onderwerpen/eu-wetgeving/specifieke-producteisen/cosmetica

HLF-NL-75

HLF-NL-77

HLF-NL-80
外国子公司进口化妆品后,如果委託荷兰的经销商销售,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 Kingdom of the Netherlands 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:

产品责任

1. 製造商、授权代表、欧盟内的第一批进口商被视为生产商,主要任务是风险评估、进一步调查和纠正措施。

2.经销商必须收集、提供和传递信息。

3.零售商必须立即将有关不安全产品的信息(例如消费者投诉)传递给其供应商。

4. 如果产品不符合安全要求,生产商和分销商必须透由业务网关在线向 NVWA报告所涉及的风险以及做了什麽来消除危险。

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.

【参考连结】

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

HLF-NL-85

各国化妆品登记法规问答集

联系我们:
Email:ams4ww@evershinecpa.com

荷兰永辉BPO有限公司
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捷运文湖线南京復兴站,兄弟大饭店附近
所长 Principal Partner:
陈中成 Dale C.C. Chen;
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