wish平台:如何遵守即将实施的欧盟产品合规法规(2021年7月生效)?
本常见问题解答仅供参考,并非试图提供、亦不构成对任何主题事项的法律建议。如果您需要帮助或对这些法规、您个人的义务/责任或本常见问题解答中的主题事项或信息有任何疑问,请向欧盟法律顾问咨询。
自2021年7月16日起,欧盟将实施一项新的产品合规性法规,即《欧盟市场监管法规 (EU) 2019/1020》。这项新法规重点关注了可能危害人身安全和健康和/或违反欧盟及北爱尔兰(统称为“欧盟市场”)适用法律的产品,包括相关的预防、识别以及纠正措施。
该法规规定,销往欧盟市场或在欧盟市场内销售的特定种类的产品(包括玩具、电子产品、个人防护设备、化妆品、医疗设备和其他所有带有 CE 标志的产品)必须满足以下要求:
产品在欧盟市场内有指定的责任人(个人或实体),其职责是在产品出现某些合规性问题时作为该产品的联络人。此外,若欧盟或北爱尔兰监管机构发现产品存在特定问题,该责任人还需承担若干项合规性法律责任,但加贴 CE 标志和遵守其他安全要求的责任通常仍由相关产品的制造商、品牌所有者、进口商和/或分销商承担。自2021年7月16日起,您必须根据法律规定为销往欧盟市场或在欧盟市场内销售的适用产品指定欧盟市场责任人。
保留产品的相关技术文件,以备欧盟或北爱尔兰监管机构审查,包括技术构造文件、符合性声明、性能声明等。
符合相关标签/包装要求。在法律规定和适用的情况下,产品本身、包装和/或随附文件必须提供以下信息:(a) CE 标志;(b) 指定的欧盟市场责任人的联系信息;(c) 说明书等。如果您对上述要求和法律责任/义务有任何疑问,请咨询独立的欧盟或北爱尔兰产品或法律合规专家。
为了确保符合这些新规定,Wish 将要求向欧盟市场销售适用产品的商户在2021年7月9日之前向 Wish 提供指定责任人的详细信息(具体操作请参阅此指南)。请注意,欧盟本土商户目前不需要向 Wish 提供责任人详细信息。有关这些新规定的更多详情,请参阅下面的问题解答。
1. 什么是责任人?
责任人是指可在产品出现合规问题时作为联络人的个人或实体,当产品被发现存在特定问题时,责任人将需要承担若干项合规性法律责任,但加贴 CE 标志和遵守其他安全要求的责任通常仍由适用产品的制造商、品牌所有者、进口商和/或分销商承担。根据即将实施的新法规,责任人必须位于欧盟市场内并保留所有必要文件。商户必须确保指定的责任人满足以下要求:
保留产品的技术文件,包括技术构造文件、符合性声明和性能声明。在监管机构要求提供这些文件时,必须以监管机构要求的语言提供给监管机构。
必须在每个产品的包装上加贴责任人的姓名(名称)/商标和联系方式。
责任人向欧盟或北爱尔兰监管机构提供的所有信息(包括产品技术文件和欧盟符合性声明/性能声明)必须真实、采用书面形式并且妥善保管,且责任人了解提供虚假信息的后果。
责任人如果有理由确信他们的产品存在安全问题或其他合规风险,应随时通知监管机构,并在需要采取纠正措施(包括但不限于召回产品)时与欧盟或北爱尔兰监管机构积极配合。
责任人有能力处理与相应产品有关的任何法规咨询。
责任人应充分了解适用于相关产品的 CE 标志规定。
如果可行,责任人应可以获得(或拥有)在欧盟市场售卖的相关产品的样品。
如果指定的责任人发生变更,商户必须通知 Wish。此操作可通过商户平台/Merchant Plus 平台的相关页面和 API 来完成(详细信息请参阅此指南)。
2. 如何知道我的产品是否需要指定责任人?
如果您的产品是在欧盟市场之外制造,但销往欧盟市场或在欧盟市场内销售,并且满足以下任一条件,则需要指定欧盟市场责任人:
产品带有 CE 标志;或者
属于《欧盟市场监管法规 (EU) 2019/1020》规定的产品类别
请点击此处,查看需贴 CE 标志(需要指定责任人)的产品类别列表。
商户*还可以通过商户平台/Merchant Plus 平台的相关页面和 API 来查看需要指定责任人的欧盟市场路向产品。有关如何执行此操作以及如何为适用产品添加责任人的具体步骤,请参阅此指南。该页面仅起到协助作用,可能无法列出所有适用的欧盟市场路向产品,因此商户对确定适用的欧盟市场路向产品并为其指定责任人负有最终责任。
若要查看《欧盟市场监管法规 (EU) 2019/1020》的具体细则,请点击此处。
*如上文所述,欧盟本土商户目前不需要向 Wish 提供责任人详细信息,也无法访问商户平台或 Merchant Plus 的相关页面。
3 . 如何找到并指定欧盟市场责任人?
如果您现在还没有为适用产品指定欧盟市场责任人,您可以选择我们推荐的下列产品合规合作伙伴之一,他们可以提供欧盟授权代表服务。欧盟授权代表是设立在欧盟市场内、由品牌方或制造商以书面形式任命并明确规定职责的任何自然人或法人实体。Wish 商户若通过下面的链接完成注册,可获享受服务折扣:
Product IP:https://secure.productip.com/registration?code=wish2021
Clever Representative: https://app.cleverrepresentative.eu/referral/wish
商户请注意,如果您不是适用产品的品牌所有者、进口商或实体产品制造商,您必须在任命欧盟授权代表之前取得制造商或供应商的书面授权。在联系您的供应商之前,或者您对我们上面推荐的合作伙伴能否作为您产品类别的授权代表还有其他任何疑问,请向他们咨询。
4. 我已经为我的产品指定了欧盟市场责任人,如何将责任人的详细信息提供给 Wish?
有关如何通过商户平台/Merchant Plus 平台或 API 向 Wish 提供责任人详细信息的更多说明,请参阅此指南。
5. 如果我不为适用产品提供欧盟市场责任人会怎样?
适用新规定的商户若未在2021年7月9日之前向 Wish 提供欧盟市场责任人,将被处以商户政策13 - 其他合规规定中规定的赔款,包括屏蔽适用产品在欧盟市场的曝光。正如前文所述,欧盟本土商户目前不需要向 Wish 提供责任人详细信息。此外,若商户未为适用产品指定欧盟市场责任人,则自2021年7月16日起,可能还会面临欧盟和北爱尔兰监管机构的处罚。
6. 我是品牌所有者/制造商,我的产品需要指定欧盟境内责任人,我该怎么做?
如果您的产品需要加贴 CE 标志,请确保产品符合所有必要的法律要求,包括产品合规性和安全状况。您需要起草、保留并向您指定的责任人提供所有相关的产品技术文档(包括符合性声明、官方认可的实验室测试报告、说明书/用户手册、相关认证和要求的其他标志/标签的副本、性能声明等),以便于您的责任人在被要求时提供给欧盟或北爱尔兰监管机构。
此外,我们还建议您将适用产品的样品提供给您指定的欧盟市场责任人,以防欧盟或北爱尔兰监管机构向他们索要样品。
7. 什么样的人可以成为欧盟市场责任人?
欧盟市场责任人必须是以下其中的一个或多个:
设立在欧盟境内、由品牌方或制造商书面任命为责任人(并书面明确规定制造商义务和授权代表 (AR) 职责)的授权代表
设立在欧盟市场内的品牌所有者或制造商
设立在欧盟市场内的登记进口商或子公司
设立在欧盟市场内的订单履行服务提供商 (FSP)
在欧盟市场分销产品的分销商
您的产品使用的测试实验室或认证机构(如果他们提供“责任人”服务)
第三方产品合规顾问(必须有书面授权)
8. 如果我销售多种类别的产品,是否需要指定多个责任人?
如果您销售多种类别的产品,则可能需要指定多个责任人。例如,如果您销售的产品分为“玩具”类别和“电子产品”类别,则可能需要为每个类别分别指定一个责任人。通常,一个责任人可能只拥有某一个产品类别(例如电子产品)方面的专业知识,因此只能作为该特定类别的责任人。
我们将于近期在商户平台/Merchant Plus 平台上增加新的页面和 API,便于您指定和添加多个责任人,并将他们与您的适用产品关联起来(有关如何操作的具体信息,我们将于2021年6月初公布)。
9. 什么是 CE 标志?
根据欧盟协调法规定,许多产品须加贴 CE 标志方可进入欧洲经济区 (EEA) 并在 EEA 内自由交易。产品加贴 CE 标志,则表明该产品符合 EEA 的健康、安全和环境保护标准。常见的需要加贴 CE 标志的产品包括医疗器械、玩具、个人防护装备等。根据即将实施的新法规规定,任何欧盟路向带有 CE 标志的产品必须按法律规定指定欧盟责任人。
我们在此提醒您,请自查售往 EEA 的产品,并在需要 CE 标志的产品上加贴 CE 标志。如因未加贴 CE 标志导致包裹派送延误、无法投递、被销毁或遭欧盟海关罚款,所有相关责任、税务和费用均由您自行承担。
如需了解有关 CE 标志的更多信息,请点击此处。
如需查看欧盟路向需要加贴 CE 标志的产品类别的完整列表,请点击此处。
wish商户官网原文详情:
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 Wish. 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.
文章内容来源:wish商户官方网站