2021年7月16日起出口欧盟带CE标志商品必须提供一位欧洲负责人

时间：2021-09-01

作者：深圳市华商检测技术有限公司

根据新的欧盟商品安全法规《市场监管法规（EU）2019/1020》要求，自2021年7月16日起，大部分带有CE标志的商品在欧盟境内销售，需要欧盟负责人作为其商品合规的联系人。

这意味着，如果您出口欧盟的产品带有CE标志，那么必须确保产品在2021年7月16日前：

1.有CE标志的商品具有在欧盟负责人；

2.带有CE标志的商品需体现欧盟负责人的联系信息（包括欧盟境内负责人的名称、注册商标名称、通信地址、邮箱、电话等）应体现在商品、商品包装、包裹或随附文件中；

3.要区分制造商信息与欧盟代表信息，可在相应联系信息前分别加上“制造商”和”欧盟代表”。

欧盟负责人要求：

A、欧盟境内成立的制造商；

B、欧盟本地进口商（当制造商不在欧盟境内）；

C、欧盟境内成立的授权代表（由制造商以书面形式授权欧盟境内负

责人，代制造商履行责任，在市场监管机构要求时向其提供授权书）；

D、欧盟境内成立的配送服务商；

根据法规要求，如果在2021年7月16日之后，产品带有CE标志，但不能提供欧盟授权代表信息的商家，将被认定构成违法行为。

可能造成的后果包括：

1.2021年7月16日起进入欧盟的带有CE标志的大部分产品，产品包装若无贴有欧盟负责人的相关信息，可能会被海关扣留或退运；

2.已经进入欧盟海关的货物，会因无欧盟负责人信息而被扣留、销毁；

3.已经在市场流通的商品，有被投诉的风险。

若出口企业的产品无欧盟内成立的制造商、进口商时，建议出口企业在市场上寻找合适的授权代表。

TASKS OF ECONOMIC OPERATORS

Tasks of economic operators regarding products subject to certain Union harmonisation legislation

1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.

2. For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:

(a)a manufacturer established in the Union;

(b)an importer, where the manufacturer is not established in the Union;

(c)an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf;

(d)a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.

3. Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:

(a)if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request;

(b)further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority;

(c)when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof;

(d)cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.

4. Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

Authorised representative

1. For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonisation legislation.

2. The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority.

3. Authorised representatives shall have the appropriate means to be able to fulfil their tasks.

Distance sales

Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.

欧盟发布了25条技术指令（每个指令针对特定的产品类别），除医疗器械、民用爆炸物以及某些升降机和索道装置外，所有欧盟内带有CE标志的产品均受此法规约束。如玩具、电子产品、个人防护装备、机械、建筑商品、燃气设备、休闲和私人船艇、压力容器以及测量设备等。制造商在产品上加贴CE标志的步骤如下：

1.确定适用的指令和协调标准；

2.验证产品特定要求；

3.确定是否需要（由公告机构）进行独立的合格评定；

4.测试产品并检查其符合性；

5.起草并保留所需的技术文件；

6.贴上 CE 标志并起草欧盟符合性声明。

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