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
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.
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.
3.This Regulation also provides a framework for controls on products entering the Union market.
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.
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.
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.
4.This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.
- ‘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;
- ‘placing on the market’ means the first making available of a product on the Union market;
(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;
(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;
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.
(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.
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.
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;
(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. 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.
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.
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.
It shall apply from 16 July 2021. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021.
以上信息源自欧盟官方OJ L 169, 25.6.2019