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 (Text with EEA relevance.)

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

Article 2

Scope

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(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;

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

(3) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;

(4) ‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State;

(5) ‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance;

(6) ‘requested authority’ means the market surveillance authority that receives a request for mutual assistance;

(7) ‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation;

(8) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark;

(9) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(10) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(11) ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council (¹), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (²), and any other postal services or freight transport services;

(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;

(14) ‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (³);

(15) ‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products;

(16) ‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative;

(17) ‘voluntary measure’ means a corrective action where not required by a market surveillance authority;

(18) ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;

(19) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

(20) ‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate;

(21) ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;

(22) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(23) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(24) ‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013;

(25) ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;

(26) ‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’.

CHAPTER II

TASKS OF ECONOMIC OPERATORS

Article 4

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

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.

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.

Article 5

Authorised representative

Article 6

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.

Article 7

Obligation of cooperation

CHAPTER III

ASSISTANCE TO AND COOPERATION WITH ECONOMIC OPERATORS

Article 8

Information to economic operators

Article 9

Joint activities to promote compliance

CHAPTER IV

ORGANISATION, ACTIVITIES AND OBLIGATIONS OF MARKET SURVEILLANCE AUTHORITIES AND THE SINGLE LIAISON OFFICE

Article 10

Designation of market surveillance authorities and the single liaison office

Article 11

Activities of market surveillance authorities

Market surveillance authorities shall conduct their activities in order to ensure the following:

(a) effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation;

(b) the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation;

(c) the taking of appropriate and proportionate measures where the economic operator fails to take corrective action.

In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors:

(a) possible hazards and non-compliance associated with the products and, where available, their occurrence on the market;

(b) activities and operations under the control of the economic operator;

(c) the economic operator's past record of non-compliance;

(d) if relevant, the risk profiling performed by the authorities designated under Article 25(1);

(e) consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance.

Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation:

(a) procedures for following up on complaints or reports on issues relating to risks or non-compliance;

(b) procedures for verifying that the corrective action that was to be taken by economic operators has been taken.

Article 12

Peer reviews

Article 13

National market surveillance strategies

The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:

(a) the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, and possible threats and risks related to emerging technologies;

(b) the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation;

(c) the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance;

(d) an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI.

CHAPTER V

MARKET SURVEILLANCE POWERS AND MEASURES

Article 14

Powers of market surveillance authorities

When conferring powers under paragraph 1, Member States may provide for the power to be exercisable in one of the following ways, as appropriate:

(a) directly by the market surveillance authorities under their own authority;

(b) by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question;

(c) upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful.

The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following:

(a) the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product's compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof;

(b) the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation;

(c) the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation;

(d) the power to carry out unannounced on-site inspections and physical checks of products;

(e) the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence;

(f) the power to start investigations on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end;

(g) the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk;

(h) the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled;

(i) the power to impose penalties in accordance with Article 41;

(j) the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence;

(k) the power, where no other effective means are available to eliminate a serious risk: (i) to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or (ii) where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures.

Article 15

Recovery of costs by market surveillance authorities

Article 16

Market surveillance measures

Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained:

(a) is liable to compromise the health or safety of users; or

(b) does not conform to applicable Union harmonisation legislation.

For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:

(a) bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk;

(b) preventing the product from being made available on the market;

(c) withdrawing or recalling the product immediately and alerting the public to the risk presented;

(d) destroying the product or otherwise rendering it inoperable;

(e) affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market;

(f) setting prior conditions for making the product concerned available on the market;

(g) alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market.

Article 17

Use of information, professional and commercial secrecy

Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law.

Article 18

Procedural rights of economic operators

If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority.

Article 19

Products presenting a serious risk

Article 20

Rapid Information Exchange System

Article 21

Union testing facilities