REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011

欧洲议会和2019.6.20关于市场监督和产品合规性法规(EU) 2019/1020，2004/42/EC指令修订，(EC) No 765/2008和 (EU) No 305/2011法规修订

 

Subject matter主旨

1.The objective of this Regulation is to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation referred to in Article 2, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market.

本法规的目的是通过加强对第2条中提到的欧盟协调立法所涵盖产品的市场监督，来改善内部市场的功能, 为了确保只有符合要求的合规产品才能为公众利益提供高水平的保护，例如一般的健康和安全、工作场所的健康和安全、消费者的保护、环境和公共安全的保护以及受该立法保护的任何其他公共利益等，均可在联盟市场提供。

 

2.This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators.

本条例为经济经营者就受某些联盟协调立法管辖的产品制定了规则和程序，并建立了与经济经营者合作的框架。

 

3.This Regulation also provides a framework for controls on products entering the Union market.

本条例还为进入欧盟市场的产品提供了一个控制框架。

 

Scope范围

1. This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (‘Union harmonisation legislation’), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement.

本法规应适用于附件I(“联盟协调立法”)中所列的受联盟协调立法约束的产品，只要在联盟协调立法中没有具有相同目标的具体规定，哪一个以更具体的方式规范市场监督和执行的特定方面

2.Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law.

二十五条至第二十八条适用于联盟法所涵盖的产品，只要联盟法中没有关于对进入联盟市场的产品进行控制的组织的具体规定。

3.The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC.

本法规的适用不应阻止市场监督当局采取指令2001/95/EC规定的更具体措施。

4.This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.

本法规不损害2000/31/EC指令第12至15条。

 

Definitions定义

1. ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

“在市场上提供”指的是在商业活动过程中为分销、消费或使用在联盟市场上提供的任何产品，无论是作为报酬还是免费的;

2. ‘placing on the market’ means the first making available of a product on the Union market;

“投放市场”指产品首次投放联盟市场;

(12) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation;

“授权代表”是指任何自然或法人内建立工会曾收到制造商的书面授权代表其行事与指定任务对制造商的义务相关的工会协调立法或根据本条例的要求;

(13) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;

“经济经营者”指制造商、授权代表、进口商、分销商、履行服务提供商或任何其他与产品制造有关的义务的自然人或法人，使它们在市场上可用或使它们按照相关的联盟协调立法投入服务;

 

本法规18条、·19条明确了经济经营者的必要性

18) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this end, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers and the market surveillance authorities is a key element, allowing immediate intervention and corrective action in relation to the product. It is important that, for certain products, there should be an economic operator established in the Union so that market surveillance authorities have someone to whom requests can be addressed, including requests for information regarding a product's compliance with Union harmonisation legislation, and who can cooperate with market surveillance authorities in making sure that immediate corrective action is taken to remedy instances of non-compliance. The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union.

 

一个更公平的单一市场应确保所有经济经营者享有平等的竞争条件，并保护他们不受不公平竞争的影响。为此，有必要加强对产品统一立法的执行。制造商和市场监督当局之间的良好合作是一个关键因素，允许立即对产品进行干预和纠正行动。重要的是，对于某些产品，应该在欧盟设立一个经济经营者，这样市场监督当局就可以向其提出要求，包括要求提供有关产品是否符合欧盟协调立法的信息，谁能与市场监督当局合作，确保立即采取纠正措施，纠正不合规的情况。应执行这些任务的经济经营者是制造商，或制造商不在欧盟境内时的进口商，或制造商为此目的委托的授权代表，或在联盟内没有其他经济经营者时，为其处理的产品在联盟内设立的履行服务提供商。

 

(19) The development of e-commerce poses certain challenges for market surveillance authorities with regard to the ensuring of compliance of products offered for sale online and the effective enforcement of Union harmonisation legislation. The number of economic operators offering products directly to consumers by electronic means is increasing. Therefore, economic operators with tasks regarding products subject to certain Union harmonisation legislation perform an essential role by providing market surveillance authorities with an interlocutor established in the Union, and by performing specific tasks in a timely manner to make sure that the products comply with the requirements of Union harmonisation legislation, for the benefit of consumers, other end users and businesses within the Union.

电子商务的发展为市场监督当局在确保在线销售的产品符合规定和有效执行欧盟统一立法方面提出了某些挑战。经济经营者通过电子手段直接向消费者提供产品的数量不断增加。因此，对于受某些联盟协调立法约束的产品任务的经济经营者，通过向市场监督当局提供在联盟内建立的对话者，发挥了重要的作用，并通过及时执行特定任务，确保产品符合欧盟协调立法的要求，从而为消费者、其他终端用户和欧盟内部企业带来利益。

 

 

TASKS OF ECONOMIC OPERATORS经济经营者的职责

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.

尽管任何义务适用联盟协调立法出发,5款产品受制于立法指的可能是放置在市场上只有一个经济运营商建立工会负责的任务3款中规定的产品。

2.For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following: 本条第一款所称经济经营者，是指有下列情形之一者:

(a) a manufacturer established in the Union; 在联盟建立的制造商

(b) an importer, where the manufacturer is not established in the Union; 进口商，其制造商不在欧盟境内;

(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; 一名获得制造商书面授权的授权代表，该授权代表代表制造商执行第3段所述的任务;

(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. (a)、(b)和(c)点中所述的其他经济经营者在联盟中没有成立的，在联盟中就其处理的产品建立的履行服务供应商。

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: 在不影响经济经营者在适用的联盟协调立法下的任何义务的情况下，第1款所述的经济经营者应执行以下任务:

(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; 如果适用于产品的欧盟协调立法规定了欧盟符合性声明或性能声明和技术文件，则核实欧盟符合性声明或性能声明和技术文件已经拟定，在该法律规定的期间内，将符合规定的声明或履行规定的声明交由市场监督当局处理，并确保技术文件可在这些当局要求时提供;

(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;

针对市场监督当局提出的合理要求，以该当局易于理解的语言向该当局提供证明产品符合规定所需的所有信息和文件;

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

当有理由认为有问题的产品存在风险时，应通知市场监督当局;

(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. 与市场监督当局合作，包括遵循合理的要求，确保立即采取必要的纠正措施，以纠正任何不符合适用于问题产品的欧盟统一立法规定的要求的情况，或者，如果不可能，在第1款所述的经济经营者认为或有理由相信有关产品有风险的情况下，当市场监督当局要求或自行要求时，应减轻该产品所带来的风险。

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. 在不损害适用的欧盟统一立法下经济经营者的各自义务的情况下，第1款中提到的经济经营者的名称、注册商品名称或注册商标以及联系细节，包括邮政地址，应在产品或其包装上注明，包裹或随附的文件。

5.This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (34), (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council, and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council.

 

Authorised representative授权代表

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.

就第4(2)条(c)点而言，制造商应授权授权代表执行第4(3)条所列任务，尽管相关的欧盟协调法规规定了其他任务。

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.

获授权的代表应执行授权规定的任务。应市场监督当局要求，它应以市场监督当局确定的联盟语言向市场监督当局提供一份授权的副本。

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

获授权的代表应具有能够完成其任务的适当手段。

 

 

Entry into force and application 法规强制实施

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

本法规应在其在欧洲联盟官方公报上公布后的第20天生效

It shall apply from 16 July 2021. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021.

该法规将于2021年7月16日生效。但是，第二十九条、第三十条、第三十一条、第三十二条、第三十三条和第三十六条自2021年1月1日起适用。

 

以上信息源自欧盟官方OJ L 169, 25.6.2019