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wish平臺:如何遵守即將實施的歐盟產品合規法規(2021年7月生效)?-ESG跨境

wish平臺:如何遵守即將實施的歐盟產品合規法規(2021年7月生效)?

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wish觀察
2022-03-26
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wish平臺:如何遵守即將實施的歐盟產品合規法規(2021年7月生效)?

平臺:如何遵守即將實施的歐盟產品合規法規(2021年7月生效)?


本常見問題解答僅供參考,并非試圖提供、亦不構成對任何主題事項的法律建議。如果您需要幫助或對這些法規、您個人的義務/責任或本常見問題解答中的主題事項或信息有任何疑問,請向歐盟法律顧問咨詢。

自2021年7月16日起,歐盟將實施一項新的產品合規性法規,即《歐盟市場監管法規 (EU) 2019/1020》。這項新法規重點關注了可能危害人身安全和健康和/或違反歐盟及北愛爾蘭(統稱為“歐盟市場”)適用法律的產品,包括相關的預防、識別以及糾正措施。

該法規規定,銷往歐盟市場或在歐盟市場內銷售的特定種類的產品(包括玩具、電子產品、個人防護設備、化妝品、醫療設備和其他所有帶有 CE 標志的產品)必須滿足以下要求:

  • 產品在歐盟市場內有指定的責任人(個人或實體),其職責是在產品出現某些合規性問題時作為該產品的聯絡人。此外,若歐盟或北愛爾蘭監管機構發現產品存在特定問題,該責任人還需承擔若干項合規性法律責任,但加貼 CE 標志和遵守其他安全要求的責任通常仍由相關產品的制造商、品牌所有者、進口商和/或分銷商承擔。自2021年7月16日起,您必須根據法律規定為銷往歐盟市場或在歐盟市場內銷售的適用產品指定歐盟市場責任人。

  • 保留產品的相關技術文件,以備歐盟或北愛爾蘭監管機構審查,包括技術構造文件、符合性聲明、性能聲明等。

  • 符合相關標簽/包裝要求。在法律規定和適用的情況下,產品本身、包裝和/或隨附文件必須提供以下信息:(a) CE 標志;(b) 指定的歐盟市場責任人的聯系信息;(c) 說明書等。如果您對上述要求和法律責任/義務有任何疑問,請咨詢獨立的歐盟或北愛爾蘭產品或法律合規專家。

為了確保符合這些新規定,Wish 將要求向歐盟市場銷售適用產品的商戶在2021年7月9日之前向 Wish 提供指定責任人的詳細信息(具體操作請參閱此指南)。請注意,歐盟本土商戶目前不需要向 Wish 提供責任人詳細信息。有關這些新規定的更多詳情,請參閱下面的問題解答。

1. 什么是責任人?

責任人是指可在產品出現合規問題時作為聯絡人的個人或實體,當產品被發現存在特定問題時,責任人將需要承擔若干項合規性法律責任,但加貼 CE 標志和遵守其他安全要求的責任通常仍由適用產品的制造商、品牌所有者、進口商和/或分銷商承擔。根據即將實施的新法規,責任人必須位于歐盟市場內并保留所有必要文件。商戶必須確保指定的責任人滿足以下要求:

  • 保留產品的技術文件,包括技術構造文件、符合性聲明和性能聲明。在監管機構要求提供這些文件時,必須以監管機構要求的語言提供給監管機構。

  • 必須在每個產品的包裝上加貼責任人的姓名(名稱)/商標和聯系方式。

  • 責任人向歐盟或北愛爾蘭監管機構提供的所有信息(包括產品技術文件和歐盟符合性聲明/性能聲明)必須真實、采用書面形式并且妥善保管,且責任人了解提供虛假信息的后果。

  • 責任人如果有理由確信他們的產品存在安全問題或其他合規風險,應隨時通知監管機構,并在需要采取糾正措施(包括但不限于召回產品)時與歐盟或北愛爾蘭監管機構積極配合。

  • 責任人有能力處理與相應產品有關的任何法規咨詢。

  • 責任人應充分了解適用于相關產品的 CE 標志規定。

  • 如果可行,責任人應可以獲得(或擁有)在歐盟市場售賣的相關產品的樣品。

如果指定的責任人發生變更,商戶必須通知 Wish。此操作可通過商戶平臺/Merchant Plus 平臺的相關頁面和 API 來完成(詳細信息請參閱此指南)。

2. 如何知道我的產品是否需要指定責任人?

如果您的產品是在歐盟市場之外制造,但銷往歐盟市場或在歐盟市場內銷售,并且滿足以下任一條件,則需要指定歐盟市場責任人:

  • 產品帶有 CE 標志;或者

  • 屬于《歐盟市場監管法規 (EU) 2019/1020》規定的產品類別

請點擊此處,查看需貼 CE 標志(需要指定責任人)的產品類別列表。

商戶*還可以通過商戶平臺/Merchant Plus 平臺的相關頁面和 API 來查看需要指定責任人的歐盟市場路向產品。有關如何執行此操作以及如何為適用產品添加責任人的具體步驟,請參閱此指南。該頁面僅起到協助作用,可能無法列出所有適用的歐盟市場路向產品,因此商戶對確定適用的歐盟市場路向產品并為其指定責任人負有最終責任。

若要查看《歐盟市場監管法規 (EU) 2019/1020》的具體細則,請點擊此處。

*如上文所述,歐盟本土商戶目前不需要向 Wish 提供責任人詳細信息,也無法訪問商戶平臺或 Merchant Plus 的相關頁面。

3 . 如何找到并指定歐盟市場責任人?

如果您現在還沒有為適用產品指定歐盟市場責任人,您可以選擇我們推薦的下列產品合規合作伙伴之一,他們可以提供歐盟授權代表服務。歐盟授權代表是設立在歐盟市場內、由品牌方或制造商以書面形式任命并明確規定職責的任何自然人或法人實體。Wish 商戶若通過下面的鏈接完成注冊,可獲享受服務折扣:

  • Product IP:https://secure.productip.com/registration?code=wish2021 

  • Clever Representative: https://app.cleverrepresentative.eu/referral/wish 

商戶請注意,如果您不是適用產品的品牌所有者、進口商或實體產品制造商,您必須在任命歐盟授權代表之前取得制造商或供應商的書面授權。在聯系您的供應商之前,或者您對我們上面推薦的合作伙伴能否作為您產品類別的授權代表還有其他任何疑問,請向他們咨詢。

4. 我已經為我的產品指定了歐盟市場責任人,如何將責任人的詳細信息提供給 Wish?

有關如何通過商戶平臺/Merchant Plus 平臺或 API 向 Wish 提供責任人詳細信息的更多說明,請參閱此指南。

5. 如果我不為適用產品提供歐盟市場責任人會怎樣?

適用新規定的商戶若未在2021年7月9日之前向 Wish 提供歐盟市場責任人,將被處以商戶政策13 - 其他合規規定中規定的賠款,包括屏蔽適用產品在歐盟市場的曝光。正如前文所述,歐盟本土商戶目前不需要向 Wish 提供責任人詳細信息。此外,若商戶未為適用產品指定歐盟市場責任人,則自2021年7月16日起,可能還會面臨歐盟和北愛爾蘭監管機構的處罰。

6. 我是品牌所有者/制造商,我的產品需要指定歐盟境內責任人,我該怎么做?

如果您的產品需要加貼 CE 標志,請確保產品符合所有必要的法律要求,包括產品合規性和安全狀況。您需要起草、保留并向您指定的責任人提供所有相關的產品技術文檔(包括符合性聲明、官方認可的實驗室測試報告、說明書/用戶手冊、相關認證和要求的其他標志/標簽的副本、性能聲明等),以便于您的責任人在被要求時提供給歐盟或北愛爾蘭監管機構。

此外,我們還建議您將適用產品的樣品提供給您指定的歐盟市場責任人,以防歐盟或北愛爾蘭監管機構向他們索要樣品。

7. 什么樣的人可以成為歐盟市場責任人?

歐盟市場責任人必須是以下其中的一個或多個:

  • 設立在歐盟境內、由品牌方或制造商書面任命為責任人(并書面明確規定制造商義務和授權代表 (AR) 職責)的授權代表

  • 設立在歐盟市場內的品牌所有者或制造商

  • 設立在歐盟市場內的登記進口商或子公司

  • 設立在歐盟市場內的訂單履行服務提供商 (FSP)

  • 在歐盟市場分銷產品的分銷商

  • 您的產品使用的測試實驗室或認證機構(如果他們提供“責任人”服務)

  • 第三方產品合規顧問(必須有書面授權)

8. 如果我銷售多種類別的產品,是否需要指定多個責任人?

如果您銷售多種類別的產品,則可能需要指定多個責任人。例如,如果您銷售的產品分為“玩具”類別和“電子產品”類別,則可能需要為每個類別分別指定一個責任人。通常,一個責任人可能只擁有某一個產品類別(例如電子產品)方面的專業知識,因此只能作為該特定類別的責任人。

我們將于近期在商戶平臺/Merchant Plus 平臺上增加新的頁面和 API,便于您指定和添加多個責任人,并將他們與您的適用產品關聯起來(有關如何操作的具體信息,我們將于2021年6月初公布)。

9. 什么是 CE 標志?

根據歐盟協調法規定,許多產品須加貼 CE 標志方可進入歐洲經濟區 (EEA) 并在 EEA 內自由交易。產品加貼 CE 標志,則表明該產品符合 EEA 的健康、安全和環境保護標準。常見的需要加貼 CE 標志的產品包括醫療器械、玩具、個人防護裝備等。根據即將實施的新法規規定,任何歐盟路向帶有 CE 標志的產品必須按法律規定指定歐盟責任人。

我們在此提醒您,請自查售往 EEA 的產品,并在需要 CE 標志的產品上加貼 CE 標志。如因未加貼 CE 標志導致包裹派送延誤、無法投遞、被銷毀或遭歐盟海關罰款,所有相關責任、稅務和費用均由您自行承擔。

如需了解有關 CE 標志的更多信息,請點擊此處。

如需查看歐盟路向需要加貼 CE 標志的產品類別的完整列表,請點擊此處。



How can I comply with the upcoming EU product compliance regulation (effective July 2021)?


This FAQ was created for informational purposes only, and does not, nor is intended to, constitute or be construed as legal advice on any subject matter. Should you require assistance or have any questions concerning these regulations, your independent obligations/duties, or related to the subject matter or information in this FAQ, please reach out to EU legal counsel.

Starting July 16, 2021, a new European Union (EU) product compliance regulation called Market Surveillance Regulation (EU) 2019/1020 will take effect. This new regulation is focused on preventing, identifying, and remediating products that are likely to compromise the health or safety of users, and/or do not conform to applicable European Union and Northern Ireland (EU Market) laws.

Per this regulation, certain categories of products (including Toys, Electronics, Personal Protective Equipment, Cosmetics, Medical Devices, and generally all other CE marked products) shipped to or within the EU Market will need to meet the following requirements:

  • Have an appointed EU Market-based Responsible Person for the product(s), who is a person or entity acting as a point of contact for product compliance purposes. This Responsible Person is also legally responsible for several compliance obligations when products are reported to have a particular concern by the EU or Northern Ireland regulatory authorities, though CE marking and other safety requirements typically remain the responsibility of the manufacturer, brand owner, importer, and/or distributor of the products in question. You will be legally required to have an EU Market-based Responsible Person for applicable products being sold to or within the EU Market starting July 16, 2021. 

  • Have prepared technical product documentation ready to provide upon request by the EU or Northern Ireland regulatory authorities, including technical construction files, Declaration of Conformity, Declaration of Performance, and more.

  • Meet a variety of labeling/packaging requirements. As legally required and applicable, the following will need to be affixed on or included within the packaging, the product, and/or accompanying documents: (a) the CE marking; (b) the appointed EU Market-based Responsible Person’s contact information; (c) instruction manuals; and so forth. Please consult an independent EU or Northern Ireland product or legal compliance professional if you have any questions regarding these preceding requirements and legal responsibilities/obligations.

To ensure compliance with these upcoming new regulations, Wish will require merchants selling applicable EU Market-bound products to provide the details of their appointed Responsible Person(s) to Wish by July 9, 2021 (see this guide for more information on how to do this). Please note that EU domiciled merchants are currently NOT required to provide details of their Responsible Person(s) to Wish. See below for more details related to these upcoming new regulations.

1. What is a Responsible Person?

A Responsible Person is a person or entity acting as a point of contact for product compliance purposes, who will be legally responsible for several compliance obligations when products are reported to have a specific concern, though CE marking and other safety requirements typically remain the responsibility of the manufacturer, brand owner, importer, and/or distributor of the products in question. To comply with the upcoming new regulations, the Responsible Person(s) must be located in the EU Market and have all required documentation. Merchants must ensure the following for each Responsible Person they appoint:

  • Technical product documentation (including technical construction files, Declaration of Conformity, and Declaration of Performance) is available upon request in the requesting authority’s language.

  • The Responsible Person's name/trademark and contact details will be affixed to the packaging of each product.

  • Any information provided by the Responsible Person to EU or Northern Ireland regulatory authorities (including technical product documentation and EU Declarations of Conformity/Performance) is verified, drawn up, and adequately maintained and the Responsible Person is aware of the consequences of providing false information.

  • The Responsible Person is ready to inform regulators if they have reason to believe their products present a safety or other compliance risk, and also cooperates with EU or Northern Ireland regulatory authorities during any corrective action required, including (but not limited to) product recalls.

  • The Responsible Person is able to handle any regulatory inquiries necessary regarding the products in question.

  • The Responsible Person should have sufficient knowledge of the CE marking regulations applicable to the products they represent.

  • If feasible, the Responsible Person has access to (or possesses) a sample of the relevant product(s) being sold into the EU Market.

Merchants will be required to notify Wish if an appointed Responsible Person changes, which is possible via our informational Merchant Dashboard/Merchant Plus page and API (see this guide for details).

2. How do I know if my products will require a Responsible Person?

You will need to appoint an EU Market-based Responsible Person for your products if these products have been manufactured outside of the EU Market and are shipping to or within the EU Market, and meet either of the following criteria:

  • CE marked products; or

  • Any product type covered under the Market Surveillance Regulation (EU) 2019/1020 regulation

For a full list of CE marked product categories (that will require a Responsible Person), please click here. 

Merchants* can also view various EU Market-bound products that may require a Responsible Person via our informational Merchant Dashboard/Merchant Plus page and API. Please see this guide for a walkthrough of how to do this and add Responsible Persons to applicable products. Though this page may provide some assistance, it may not list every applicable EU Market-bound product and merchants will ultimately be responsible for identifying applicable EU Market-bound products and appointing a Responsible Person as required to comply with the upcoming new regulations.

To review the Market Surveillance Regulation (EU) 2019/1020 regulation, please click here.

*As noted above EU domiciled merchants are currently NOT required to provide details of their Responsible Person(s) to Wish, and currently do not have access to our informational Merchant Dashboard/Merchant Plus page.

3. How can I find an EU Market-based Responsible Person to appoint for my products?

If you do not already have an EU Market-based Responsible Person for your applicable products, you may utilize one of our preferred product compliance partners providing EU Authorized Representative services, listed below. An EU Authorized Representative is any natural or legal entity that is established in the EU Market who is appointed (in writing, with responsibilities written out) as the Responsible Person by the brand or manufacturer. Wish merchants will receive a discount on services from our preferred partners by signing up through the below provided links:

  • Product IP: https://secure.productip.com/registration?code=wish2021 

  • Clever Representative: https://app.cleverrepresentative.eu/referral/wish 

Merchants should be aware that if they are not the brand owner, importer, or physical product manufacturer of their applicable EU Market-bound products, they may require written authorization from the manufacturer, or the merchants’ own suppliers, before proceeding with appointing an EU Authorized Representative. Please check with either of our preferred partners above before reaching out to your suppliers, as well as for any other questions regarding the status of the preferred partners acting as an Authorized Representative for your product categories.

4. I have an EU Market-based Responsible Person for my products. How can I provide the details of this Responsible Person to Wish?

Please see this guide for more information on providing your Responsible Person(s) to Wish via Merchant Dashboard/Merchant Plus or API.

5. What happens if I don’t provide an EU Market-based Responsible Person for applicable products?

Applicable merchants who fail to provide an EU Market-based Responsible Person to Wish by July 9, 2021 will be subject to penalties outlined in Merchant Policy 13 - Other Regulatory Compliance, including applicable products being impression blocked in the EU Market. As noted above, EU domiciled merchants are currently NOT required to provide details of their Responsible Person(s) to . Additionally, you may face penalties imposed by the EU and Northern Ireland regulatory authorities if you do not have an EU Market-based Responsible Persons for applicable EU-bound products starting July 16, 2021.

6. I am a brand owner/manufacturer of applicable products requiring an EU-based Responsible Person. What should I do?

If your products require CE markings, ensure that they meet all necessary legal requirements, including product compliance and safety conditions. Any applicable technical product documentation (including Declarations of Conformity, accredited lab test reports, instruction sheets/user manuals, copies of relevant certification and other required markings/labels, Declarations of Performance, etc.) should be drafted, available, and shared with your selected Responsible Person(s) for them to provide to EU or Northern Ireland regulatory authorities as needed. 

Additionally, we recommend you provide samples of applicable products to your appointed Responsible Person(s) in the EU, in case of request from the EU or Northern Ireland regulatory authorities. 

7. What qualifies someone as an EU Market-based Responsible Person?

An EU Market-based Responsible Person will need to be one or more of the following:

  • Any Authorized Representative (AR) that is established in the EU who is appointed (in writing, with manufacturer obligations and AR tasks expressly specified) as the Responsible Person on behalf of the brand or manufacturer

  • A brand or manufacturer that is established in the EU Market

  • An importer-of-record or corporate subsidiary that is already established in the EU Market

  • A fulfillment service provider (FSP) that is established in the EU Market

  • A distributor that makes the product available on the EU Market marketplace

  • If they offer Responsible Person services, the testing lab or certification agency that you use for your products 

  • A 3rd party product compliance consultant (that must be authorized in writing

8. Do I need to appoint more than one Responsible Person if I sell multiple categories of products?

If you sell multiple categories of products, you may need to appoint more than one Responsible Person. For example, if you are selling products under the Toys category and the Electronics category, you may need to appoint two Responsible Persons, one for each product category. Typically, a Responsible Person may have expertise in a single product category (such as Electronics) and can be appointed to cover products specifically under this category. 

You will be able to conveniently assign and add multiple applicable Responsible Persons and link them to your applicable products via our upcoming new Merchant Dashboard/Merchant Plus page and API (details of this functionality will be announced towards the beginning of June 2021).

9. What is the CE mark?

As part of the European Union’s harmonisation legislation, the CE mark is required for many products so that they can be imported into and traded throughout the European Economic Area (EEA) without restrictions. The CE mark represents that a product meets the health, safety, and environmental protection standards for the EEA. Common examples of products that are required to be CE marked include Medical Devices, Toys, Personal Protective Equipment, etc. Per upcoming new regulations, any EU-bound CE marked products will legally require an appointed EU-based Responsible Person.

As a reminder, please check your products sold to the EEA and affix CE marks on products that are required to be CE marked. If packages are delayed or fail to deliver, are disposed of, or are penalized by the EU Customs authorities due to a lack of CE marks, merchants shall be responsible for all relevant duties, levies, and fees. 

To learn more about CE markings, please see here.

For a full list of product categories that require a CE marking shipping to the EU, please see here.



特別聲明:以上文章內容僅代表作者本人觀點,不代表ESG跨境電商觀點或立場。如有關于作品內容、版權或其它問題請于作品發表后的30日內與ESG跨境電商聯系。

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