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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that products are compliant with Union harmonisation legislation and therefore fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment, public security and protection of any other public interests protected by that legislation. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union market for goods can thrive. Rules are therefore necessary to ensure this enforcement, regardless of whether products are placed on the market via offline or online means and regardless of whether they are manufactured in the Union or not.

(2) Union harmonisation legislation covers a large share of manufactured products. Non-compliant and unsafe products put citizens at risk, and might distort competition with economic operators selling compliant products within the Union.

(3) Strengthening the single market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission of 28 October 2015 entitled ‘Upgrading the Single Market: more opportunities for people and business’. This should be achieved by strengthening market surveillance, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities.

(4) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Union harmonisation legislation relating to the ensuring of compliance of products and the framework for cooperation with organisations representing economic operators or end users, the market surveillance of products and controls on those products entering the Union market. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 (3), (EU) 2017/745 (4) and (EU) 2017/746 (5), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 (6) of the European Parliament and of the Council.

(5) Directive 2001/95/EC of the European Parliament and of the Council (7) lays down the general safety requirements for all consumer products and provides for specific obligations and powers of the Member States in relation to dangerous products as well as for the exchange of information to that effect through the Rapid Information Exchange System (RAPEX). Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. In order to achieve a higher level of safety for consumer products, the mechanisms for exchanges of information and rapid intervention situations provided for in Directive 2001/95/EC should be made more effective.

(6) The provisions on market surveillance of this Regulation should cover products that are subject to the Union harmonisation legislation listed in Annex I concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level and will help to increase the confidence of consumers and other end users in products placed on the Union market. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to specify whether this Regulation is also to apply to that legislation.

(7) Articles 15 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council (8) laying down the Community market surveillance framework and controls of products entering the Community market should be deleted and the respective provisions should be replaced by this Regulation. That framework includes the provisions on controls of products entering the Community market, in Articles 27, 28 and 29 of Regulation (EC) No 765/2008, which apply not only to products covered by the market surveillance framework, but to all products in so far as other Union law does not contain specific provisions relating to the organisation of controls on products entering the Union market. It is therefore necessary that the scope of the provisions of this Regulation with regard to products entering the Union market extend to all products.

(8) In order to rationalise and simplify the overall legislative framework, while simultaneously pursuing the objectives of Better Regulation, the rules applicable to controls on products entering the Union market should be revised and integrated into a single legislative framework for controls on products at the Union's external borders.

(9) Responsibility for enforcing Union harmonisation legislation should lie with the Member States, and their market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities. In this regard, the methodology and criteria for assessing risks should be further harmonised in all Member States in order to ensure a level playing field for all economic operators.

(10) In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate.

(11) Certain definitions currently set out in Regulation (EC) No 765/2008 should be aligned with definitions set out in other Union legal acts and, where appropriate, reflect the architecture of modern supply chains. The definition of ‘manufacturer’ in this Regulation should not relieve manufacturers of any obligations they might have under Union harmonisation legislation where specific definitions of manufacturer are applied, which might cover any natural or legal person who modifies a product already placed on the market in such a way that compliance with the applicable Union harmonisation legislation might be affected and places it on the market, or any other natural or legal person who places a product on the market under its name or trade mark.

(12) Economic operators throughout the entire supply chain should be expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market, so as to ensure compliance with the Union harmonisation legislation on products. This Regulation should be without prejudice to the obligations corresponding to the roles of each of the economic operators in the supply and distribution process pursuant to specific provisions in Union harmonisation legislation, and the manufacturer should retain ultimate responsibility for compliance of the product with requirements of the Union harmonisation legislation.

(13) The challenges of the global market and increasingly complex supply chains, as well as the increase of products that are offered for sale online to end users within the Union, call for the strengthening of enforcement measures, to ensure the safety of consumers. Furthermore, practical experience of market surveillance has shown that such supply chains sometimes involve economic operators whose novel form means that they do not fit easily into the traditional supply chains according to the existing legal framework. Such is the case, in particular, with fulfilment service providers, which perform many of the same functions as importers but which might not always correspond to the traditional definition of importer in Union law. In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is appropriate to include fulfilment service providers within the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures. By including fulfilment service providers within the scope of this Regulation, market surveillance authorities will be better able to deal with new forms of economic activity in order to ensure the safety of consumers and the smooth functioning of the internal market, including where the economic operator acts both as an importer as regards certain products and as a fulfilment service provider as regards other products.

(14) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective roles in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Union harmonisation legislation listed in Annex I to this Regulation, such as the producer of an article and the downstream user as defined in Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9) and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10), the installer as defined in Directive 2014/33/EU of the European Parliament and of the Council (11), the supplier as defined in Regulation (EC) No 1222/2009 of the European Parliament and of the Council (12) or the dealer as defined in Regulation (EU) 2017/1369 of the European Parliament and of the Council (13).

(15) In the case of a product offered for sale online or through other means of distance sales, the product should be considered to have been made available on the market if the offer for sale is targeted at end users in the Union. In line with the applicable Union rules on private international law, a case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. An offer for sale should 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. For the case-by-case analyses, relevant factors, such as the geographical areas to which dispatch is possible, the languages available, used for the offer or for ordering, or means of payment, need to be taken into consideration. In the case of online sales, the mere fact that the economic operators' or the intermediaries' website is accessible in the Member State in which the end user is established or domiciled is insufficient.

(16) The development of e-commerce is also due, to a great extent, to the proliferation of information society service providers, usually through platforms and for remuneration, which offer intermediary services by storing third party content, without exercising control over that content, and therefore not acting on behalf of an economic operator. Removal of content regarding non-compliant products or, where this is not feasible, restricting access to non-compliant products offered through their services should be without prejudice to the rules laid down in Directive 2000/31/EC of the European Parliament and of the Council (14). In particular, no general obligation should be imposed on information society service providers to monitor the information which they transmit or store, nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity. Furthermore, hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal activity or information is apparent.

(17) While this Regulation does not deal with the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union harmonisation legislation, present risks to health and safety of end users, distort competition, endanger public interests and support other illegal activities. Therefore, Member States should continue taking effective measures to prevent counterfeit products from entering the Union market pursuant to Regulation (EU) No 608/2013 of the European Parliament and of the Council (15).

(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.

(20) The obligations of the economic operator with tasks regarding products subject to certain Union harmonisation legislation should be without prejudice to existing obligations and responsibilities of manufacturer, importer and authorised representative under the relevant Union harmonisation legislation.

(21) Obligations of this Regulation requiring an economic operator to be established in the Union in order to place products on the Union's market should only apply to areas where the need for an economic operator to act as a liaison point with the market surveillance authorities has been identified, taking into account a risk-based approach, having regard to the principle of proportionality, and taking into account high level of protection of end users in the Union.

(22) Moreover, those obligations should not apply where the specific requirements set out in certain legal acts on products achieve in effect the same result, namely Regulation (EC) No 648/2004 of the European Parliament and of the Council (16), Regulation (EC) No 1223/2009, Regulation (EU) No 167/2013 of the European Parliament and of the Council (17), Regulation (EU) No 168/2013 of the European Parliament and of the Council (18), Directive 2014/28/EU of the European Parliament and of the Council (19), Directive 2014/90/EU of the European Parliament and of the Council (20), Regulation (EU) 2016/1628 of the European Parliament and of the Council (21), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2017/1369 and Regulation (EU) 2018/858. Consideration should also be given to situations where potential risks or cases of non-compliance are low, or in which products are mainly traded through traditional supply chains, which is the case, for instance, for Directive 2014/33/EU, Regulation (EU) 2016/424 of the European Parliament and of the Council (22) and Directive 2010/35/EU of the European Parliament and of the Council (23).

(23) Contact information of economic operators with tasks regarding products subject to certain Union harmonisation legislation should be indicated with the product in order to facilitate checks throughout the supply chain.

(24) Economic operators should fully cooperate with market surveillance authorities and other competent authorities to ensure the smooth performance of market surveillance and to enable the authorities to perform their tasks. This includes, where requested by authorities, providing the contact information of the economic operators with tasks regarding products subject to certain Union harmonisation legislation where this information is available to them.

(25) Economic operators should have easy access to high quality, comprehensive information. Since the single digital gateway established under Regulation (EU) 2018/1724 of the European Parliament and of the Council (24) provides for a single point of online access to information, it can be used in respect to providing relevant information on Union harmonisation legislation to economic operators. Nevertheless, Member States should put in place procedures for ensuring access to the Product Contact Points established under Regulation (EU) 2019/515 of the European Parliament and of the Council (25) in order to assist the economic operators in addressing properly their requests for information. Guidance on issues relating to technical specifications or harmonised standards or design of a specific product should not be part of the obligations of Member States when providing such information.

(26) Market surveillance authorities might carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance on Union harmonisation legislation and with respect to specific categories of products, including those that are offered for sale online.

(27) Member States should designate their own market surveillance authorities. This Regulation should not prevent Member States from choosing the competent authorities to carry out the market surveillance tasks. In order to facilitate administrative assistance and cooperation, Member States should also appoint a single liaison office. Single liaison offices should at least represent the coordinated position of the market surveillance authorities and the authorities in charge of the control on products entering the Union market.

(28) E-commerce poses certain challenges for market surveillance authorities regarding the protection of the health and safety of end users from non-compliant products. Therefore, Member States should ensure their market surveillance is organised with the same effectiveness for products made available online as it is for products made available offline.

(29) While performing market surveillance of products offered for sale online, market surveillance authorities are facing numerous difficulties, such as tracing products offered for sale online, identifying the responsible economic operators, or conducting risk-assessments or tests due to the lack of physical access to products. In addition to the requirements introduced by this Regulation, Member States are encouraged to use complementary guidance and best practices for market surveillance and for communication with businesses and consumers.

(30) Special attention should be given to emerging technologies, taking into account that consumers are increasingly using connected devices in their daily lives. The Union regulatory framework should therefore address the new risks to ensure the safety of the end users.

(31) In the age of constant development of digital technologies new solutions that could contribute to the effective market surveillance within the Union should be explored.

(32) Market surveillance should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities on a risk-based approach, taking the interests of those economic operators into account and limiting the said burden to what is necessary for the performance of efficient and effective controls. Furthermore, market surveillance should be performed with the same level of care by the competent authorities of the Member State irrespective of whether non-compliance of the given product is relevant on the territory of that Member State or is likely to have an impact on the market of another Member State. Uniform conditions for certain inspection activities carried out by the market surveillance authorities where products or categories of products present specific risks or seriously breach the applicable Union harmonisation legislation might be laid down by the Commission.

(33) Market surveillance authorities, when performing their duties, are confronted with different shortcomings in terms of resources, coordination mechanisms, as well as powers with regard to non-compliant products. Such differences lead to fragmented enforcement of Union harmonisation legislation and to market surveillance being more rigorous in some Member States than in others, potentially compromising the level playing field among businesses and creating also potential imbalances in the level of product safety throughout the Union.

(34) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States.

(35) This Regulation should be without prejudice to the freedom of Member States to choose the enforcement system that they consider to be appropriate. Member States should be free to choose whether their market surveillance authorities can exercise investigation and enforcement directly under their own authority, by recourse to other public authorities or upon application to the competent courts.

(36) Market surveillance authorities should be in a position to open investigations on their own initiative if they become aware of non-compliant products placed on the market.

(37) Market surveillance authorities should have access to all necessary evidence, data and information relating to the subject matter of an investigation in order to determine whether applicable Union harmonisation legislation has been infringed, and in particular to identify the economic operator responsible, irrespective of who possesses the evidence, data or information in question and regardless of where it is located and of the format in which it is held. Market surveillance authorities should be able to request economic operators, including those in the digital value chain, to provide all the evidence, data and information necessary.

(38) Market surveillance authorities should be able to carry out the necessary on-site inspections, and should have the power to enter any premises, land or means of transport, that the economic operator uses for purposes relating to its trade, business, craft or profession.

(39) Market surveillance authorities should be able to require a representative or a relevant member of staff of the economic operator concerned to give explanations or provide facts, information or documents relating to the subject matter of the on-site inspection, and to record the answers given by that representative or relevant member of staff.

(40) Market surveillance authorities should be able to check the compliance of products to be made available on the market with Union harmonisation legislation and to obtain evidence of non-compliance. They should, therefore, have the power to acquire products and, where the evidence cannot be obtained by other means, to purchase products under a cover identity.

(41) In the digital environment in particular, market surveillance authorities should be able to bring non-compliance to an end quickly and effectively, notably where the economic operator selling the product conceals its identity or relocates within the Union or to a third country in order to avoid enforcement. In cases where there is a risk of serious and irreparable harm to end users due to non-compliance, market surveillance authorities should be able to take measures, where duly justified and proportionate and where there are no other means available to prevent or mitigate such harm, including, where necessary, requiring the removal of content from the online interface or the display of a warning. When such a request is not observed, the relevant authority should have the power to require information society service providers to restrict access to the online interface. These measures should be taken in accordance with the principles laid down in Directive 2000/31/EC.

(42) The implementation of this Regulation and the exercise of powers in its application should also comply with other Union and national law, for example Directive 2000/31/EC, including with applicable procedural safeguards and principles of the fundamental rights. That implementation and that exercise of powers should also be proportionate and adequate in view of the nature and the overall actual or potential harm caused by the infringement. Competent authorities should take all facts and circumstances of the case into account and should choose the most appropriate measures, namely, those which are essential to address the infringement covered by this Regulation. Those measures should be proportionate, effective and dissuasive. Member States should remain free to set out conditions and limits for the exercise of the powers to fulfil duties in national law. Where, for example, in accordance with national law, prior authorisation to enter the premises of natural persons and legal persons is required from the judicial authority of the Member State concerned, the power to enter such premises should be used only after such prior authorisation has been obtained.

(43) Market surveillance authorities act in the interest of economic operators, of end users, and of the public, to ensure that public interests covered by relevant Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement measures, and that compliance with such legislation is ensured across the supply chain through appropriate checks, taking into consideration the fact that administrative checks alone, in many cases, cannot replace physical and laboratory checks in order to verify the compliance of products with the relevant Union harmonisation legislation. Consequently, market surveillance authorities should ensure a high level of transparency while performing their activities and should make available to the public any information that they consider to be relevant in order to protect the interests of end users in the Union.

(44) This Regulation should be without prejudice to the functioning of RAPEX in accordance with Directive 2001/95/EC.

(45) This Regulation should be without prejudice to the safeguard clause procedure provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) of the Treaty on the Functioning of the European Union. With a view to ensuring an equivalent level of protection throughout the Union, Member States are authorised to take measures in relation to products presenting a risk to health and safety, or other aspects of public interest protection. They are also required to notify those measures to other Member States and the Commission, allowing the Commission to take a position on whether national measures that restrict the free movement of products with a view to ensuring the functioning of the internal market are justified.

(46) The exchange of information between market surveillance authorities, and the use of evidence and investigation findings should respect the principle of confidentiality. Information should be handled in accordance with applicable national law, in order to ensure that investigations are not compromised and that the reputation of the economic operator is not prejudiced.

(47) Where, for the purposes of this Regulation, it is necessary to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council (26) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (27), as applicable.

(48) To ensure the effectiveness and consistency of testing across the Union in the market surveillance framework with regard to specific products or a specific category or group of products or for specific risks related to a category or group of products, the Commission might designate testing facilities of its own or public testing facilities of a Member State as a Union testing facility. All Union testing facilities should be accredited in accordance with the requirements of Regulation (EC) No 765/2008. In order to avoid conflicts of interests, Union testing facilities should only provide services to market surveillance authorities, the Commission, the Union Product Compliance Network (the ‘Network’) and other government or intergovernmental entities.

(49) Member States should ensure that adequate financial resources are always available for the appropriate staffing and equipping of the market surveillance authorities. Efficient market surveillance is demanding in terms of resources, and stable resources should be provided at a level appropriate to the enforcement needs at any given moment. Member States should have the possibility to supplement public financing by reclaiming from the relevant economic operators the costs incurred when performing market surveillance in relation to products that were found to be non-compliant.

(50) Mechanisms for mutual assistance should be established, since it is imperative for the Union market for goods that the market surveillance authorities of the Member States cooperate with each other effectively. Authorities should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those concerning access to EU declaration of conformity, declaration of performance and technical documentation.

(51) It is appropriate that Member States designate the authorities responsible for applying the customs legislation and any other authorities in charge under national law of control on products entering the Union market.

(52) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Authorities in charge of the control on products entering the Union market have a complete overview of trade flows across the Union's external borders and should therefore be required to carry out adequate controls on a risk assessment basis to contribute to a safer market place which ensures a high level of protection of public interests. It is for Member States to designate the specific authorities that are to be responsible for the appropriate documentary and, where necessary, physical or laboratory checks of products before those products are released for free circulation. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and other authorities designated as authorities in charge of the control on products entering the Union market. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non-compliant products or information on economic operators where a higher risk of non-compliance has been identified. In turn, authorities in charge of the control on products entering the customs territory of the Union should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk presented by an imported product, it should inform the Member States about that risk in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union.

(53) Importers should be reminded that Articles 220, 254, 256, 257 and 258 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (28) provide that products entering the Union market that require further processing in order to be in compliance with the applicable Union harmonisation legislation shall be placed under the appropriate customs procedure allowing such processing by the importer. Generally, the release for free circulation should not be deemed to be proof of conformity with Union law, since such a release does not necessarily include a complete check of compliance.

(54) In order to use the EU Single Window environment for customs and therefore to optimise and unburden the data transfer between customs and market surveillance authorities, it is necessary to set up electronic interfaces that allow automatic data transfer. Customs and market surveillance authorities should contribute to determine the data to be transmitted. Additional burden for customs authorities should be limited and the interfaces should be highly automated and easy-to-use.

(55) It is necessary to establish the Network, hosted by the Commission, aimed at structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and at streamlining the practices of market surveillance within the Union that facilitate the implementation of joint enforcement activities by Member States, such as joint investigations. This administrative support structure should allow the pooling of resources and maintain a communication and information system between Member States and the Commission, thereby helping to strengthen enforcement of Union harmonisation legislation on products and to deter infringements. The involvement of administrative cooperation groups (ADCOs) in the Network should not preclude the involvement of other, similar, groups involved in administrative cooperation. The Commission should provide the necessary administrative and financial support to the Network.

(56) There should be effective, speedy and accurate exchange of information among the Member States and the Commission. A number of existing tools, such as the information and communication system for market surveillance (ICSMS) and RAPEX enable coordination among market surveillance authorities in the Union. These tools, together with the interface permitting data transfer from ICSMS into RAPEX should be maintained and further developed in order to exploit their full potential and help to increase the level of cooperation and exchange of information between Member States and the Commission.

(57) In that context, for the purpose of collecting information relating to the enforcement of Union harmonisation legislation on products, ICSMS should be upgraded and be accessible to the Commission, single liaison offices, customs and market surveillance authorities. Furthermore, an electronic interface should be developed to allow effective exchange of information between national systems of customs and market surveillance authorities. With regard to the cases of mutual assistance requests, the single liaison offices should give any support necessary for cooperation between the relevant authorities. Therefore, ICSMS should provide the functions enabling an automated indication to the single liaison offices when deadlines are not met. When sectoral legislation already provides for electronic systems for cooperation and data exchange, as is the case for example of EUDAMED for medical devices, those systems should be kept in use, when appropriate.

(58) In general, ICSMS should be used to exchange information considered helpful for other market surveillance authorities. This might include checks undertaken in the context of market surveillance projects, regardless of the outcome of the tests. The amount of data to be entered in ICSMS should strike a balance between imposing too great a burden, when the efforts for entering the data would exceed the work involved in doing the actual checks, and being comprehensive enough to support greater efficiency and effectiveness on the side of the authorities. Thus, the data entered in ICSMS should also cover simpler checks than laboratory tests only. Nevertheless, there should be no need to include brief visual checks. As a guideline, checks which are individually documented should also be entered in ICSMS.

(59) Member States are encouraged to use ICSMS for interactions between customs and market surveillance authorities as an alternative to the national systems. This should not replace the Community Risk Management System (CRMS) used by customs authorities. These two systems could work in parallel since they fulfil different, complementary roles, with ICSMS facilitating communication between customs and market surveillance authorities in order to allow for a smooth treatment of customs declarations in the scope of the product safety and compliance framework while CRMS is for customs common risk management and controls.

(60) Injuries caused by non-compliant products are important information for market surveillance authorities. ICSMS should therefore provide for related data fields so that market surveillance authorities can enter readily available reports provided for in the course of their investigations, thus facilitating later statistical evaluations.

(61) The Commission should be able to exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations, with a view to ensuring compliance of products prior to their export to the Union market.

(62) In order to achieve a high degree of compliance with applicable Union harmonisation legislation on products while at the same time ensuring an effective resource-allocation and a cost-efficient control of products entering the Union market, the Commission should be able to approve specific pre-export control systems. Products falling under such approved systems might, as part of the risk assessment performed by authorities in charge of controls on products entering the Union market, benefit from a higher level of confidence than comparable products which have not been subject to a pre-export control.

(63) The Commission should carry out an evaluation of this Regulation in light of the objective it pursues, and taking into consideration new technological, economic, commercial and legal developments. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better L aw Making (29), the evaluation, based on efficiency, effectiveness, relevance, coherence and value added, should provide the basis for impact assessments of options for further action, particularly as regards the scope of this Regulation, the application and enforcement of the provisions related to the tasks of economic operators placing products on the market, and the system of product-related pre-export controls.

(64) The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties.

(65) The diversity of sanctions across the Union is one of the main reasons for inadequate deterrence and uneven protection. Rules on establishing sanctions, including monetary penalties, are a matter of national jurisdiction and should, therefore, be determined by national law.

(66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to: determining the uniform conditions for checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of Union harmonisation legislation have been continuously identified; specifying the procedures for the designation of Union testing facilities; laying down benchmarks and techniques for checks on the basis of common risk analysis at the Union level; specifying the details of statistical data covering controls performed by the designated authorities with respect to products subject to Union law; specifying the details of implementation arrangements for the information and communication system and defining the data relating to the placing of products under the customs procedure ‘release for free circulation’ transmitted by customs authorities; and to the approval of specific systems of product-related pre-export controls and the withdrawal of such approvals. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (30).

(67) Since the objective of this Regulation, namely to improve the functioning of the internal market by strengthening the market surveillance of products covered by Union harmonisation legislation, cannot be sufficiently achieved by the Member States given the need for a very high degree of cooperation, interaction and coherent action of all of the competent authorities in all Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(68) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and present in the constitutional traditions of Member States. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles, including those related to the freedom and pluralism of the media. In particular, this Regulation seeks to ensure full respect for consumer protection, the freedom to conduct a business, the freedom of expression and information, the right to property and the protection of personal data,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1 Subject matter 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.

Article 2 Scope 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.

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 (31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (32), 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 (33); (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 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. 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.

Article 5 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.

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 1. Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators. 2. Information society service providers shall cooperate with the market surveillance authorities, at the request of the market surveillance authorities and in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services.

CHAPTER III

ASSISTANCE TO AND COOPERATION WITH ECONOMIC OPERATORS

Article 8 Information to economic operators 1. The Commission, in accordance with Regulation (EU) 2018/1724, shall ensure that the Your Europe portal provides users with easy online access to information about the product requirements and rights, obligations and rules derived from the Union harmonisation legislation. 2. Member States shall put in place procedures for providing economic operators, at their request and free of charge, with information with respect to the national transposition and implementation of Union harmonisation legislation applicable to products. For this purpose, Article 9(1), (4) and (5) of Regulation (EU) 2019/515 shall apply.

Article 9 Joint activities to promote compliance 1. Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online. 2. The market surveillance authority in question and the parties referred to in paragraph 1 shall ensure that the agreement on joint activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties. 3. A market surveillance authority may use any information resulting from joint activities carried out as part of any investigation regarding non-compliance that it undertakes. 4. The market surveillance authority in question shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34. At the request of a Member State, the Network established under Article 29 shall assist in the drawing up of the agreement on joint activities.

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 1. Member States shall organise and carry out market surveillance as provided for in this Regulation. 2. For the purposes of paragraph 1 of this Article, each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34. 3. Each Member State shall appoint a single liaison office. 4. The single liaison office shall at least be responsible for representing the coordinated position of the market surveillance authorities and the authorities designated under Article 25(1) and for communicating the national strategies as set out in Article 13. The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI. 5. In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties. 6. Where there is more than one market surveillance authority in their territory, Member States shall ensure that the respective duties of those authorities are clearly defined and that appropriate communication and coordination mechanisms are established to enable those authorities to collaborate closely and exercise their duties effectively.

Article 11 Activities of market surveillance authorities 1. 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. 2. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias. 3. Market surveillance authorities, as part of their activities set out in paragraph 1 of this Article, shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples, prioritising their resources and actions to ensure effective market surveillance and taking into account the national market surveillance strategy referred to in Article 13. 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. 4. The Commission, after consulting the Network, may adopt implementing acts determining the uniform conditions of checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of applicable Union harmonisation legislation have been continuously identified, in order to ensure high level of protection of health and safety or other public interests protected by that legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 5. Where economic operators present test reports or certificates attesting the conformity of their products with Union harmonisation legislation issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, market surveillance authorities shall take due account of those reports or certificates. 6. Evidence that is used by a market surveillance authority in one Member State may be used as part of investigations to verify product compliance carried out by market surveillance authorities in another Member State, without any further formal requirements. 7. 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. 8. With a view to ensuring communication and coordination with their counterparts in other Member States, market surveillance authorities shall actively participate in administrative cooperation groups (ADCOs) as referred to in Article 30(2). 9. Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator.

Article 12 Peer reviews 1. Peer reviews shall be organised for market surveillance authorities wishing to participate in such reviews, in order to strengthen consistency in market surveillance activities in relation to the application of this Regulation. 2. The Network shall develop the methodology and the rolling plan for peer reviews among participating market surveillance authorities. When establishing the methodology and the rolling plan, the Network shall take into consideration, at least, the number and the size of market surveillance authorities in the Member States, the number of personnel available and other resources for performing the peer review, and other relevant criteria. 3. Peer reviews shall cover best practices developed by some market surveillance authorities which may be of benefit for other market surveillance authorities, and other relevant aspects related to the effectiveness of market surveillance activities. 4. The outcome of the peer reviews shall be reported to the Network.

Article 13 National market surveillance strategies 1. Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by 16 July 2022. The national strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and to the enforcement of Union harmonisation legislation within the territory of the Member State. When drawing up the national market surveillance strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, shall be considered. The priorities set out within the work programme of the Network may also be considered. 2. 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. 3. Member States shall communicate their national market surveillance strategy to the Commission and other Member States through the information and communication system referred to in Article 34. Each Member State shall publish a summary of its strategy.

CHAPTER V

MARKET SURVEILLANCE POWERS AND MEASURES

Article 14 Powers of market surveillance authorities 1. Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of Union harmonisation legislation. 2. Market surveillance authorities shall exercise the powers set out in this Article efficiently and effectively, in accordance with the principle of proportionality, to the extent that such exercise relates to the subject matter and the purpose of the measures and the nature and the overall actual or potential harm resulting from the instance of non-compliance. Powers shall be conferred and exercised in accordance with Union and national law, including the principles of the Charter of Fundamental Rights of the European Union, as well as with principles of national law relating to freedom of expression and the freedom and pluralism of the media, with applicable procedural safeguards and with the Union rules on data protection, in particular Regulation (EU) 2016/679. 3. 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. 4. 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. 5. Market surveillance authorities may use any information, document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored.

Article 15 Recovery of costs by market surveillance authorities 1. Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance. 2. The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market.

Article 16 Market surveillance measures 1. 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. 2. Where market surveillance authorities make findings referred to in point (a) or (b) of paragraph 1, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period they specify. 3. 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. 4. Corrective actions referred to in points (e), (f) and (g) of paragraph 3 may only be required in cases where the product is liable to present a risk only in certain conditions or only to certain end users. 5. If the economic operator fails to take corrective action referred to in paragraph 3 or where the non-compliance or the risk referred to in paragraph 1 persists, market surveillance authorities shall ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly. 6. The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34. That communication of information shall also be deemed to fulfil notification requirements for the applicable safeguard procedures of Union harmonisation legislation. 7. Where a national measure is considered to be justified in accordance with the applicable safeguard procedure, or where no market surveillance authority of another Member State concluded the contrary as referred to in Article 11(9), the competent market surveillance authorities in the other Member States shall take the necessary measures in respect of the non-compliant product and shall enter the relevant information in the information and communication system referred to in Article 34.

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 1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation shall state the exact grounds on which it is based. 2. Any such measure, decision or order shall be communicated without delay to the relevant economic operator, who shall at the same time be informed of the remedies available to it under the law of the Member State concerned and of the time limits to which those remedies are subject. 3. Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give the economic operator that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation. 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 1. Market surveillance authorities shall ensure that products presenting a serious risk are withdrawn or recalled, where there is no other effective means available to eliminate the serious risk, or that their being made available on the market is prohibited. Market surveillance authorities shall notify the Commission thereof immediately, in accordance with Article 20. 2. A decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety and the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.

Article 20 Rapid Information Exchange System 1. Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it shall immediately notify the Commission of that measure in accordance with paragraph 4 of this Article. The market surveillance authority shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, market surveillance authorities shall immediately notify the Commission of any voluntary measures taken and communicated to the market surveillance authority by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the risk related to the product, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis. 5. The Commission shall provide and maintain a data interface between RAPEX and the information and communication system referred to in Article 34 so as to avoid double data entry.

Article 21 Union testing facilities 1. The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union. 2. For the purposes of paragraph 1, the Commission may designate a public testing facility of a Member State as a Union testing facility for specific categories of products or for specific risks related to a category of products. The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient. 3. Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008. 4. The designation of Union testing facilities shall not affect the freedom of market surveillance authorities, the Network and the Commission to choose testing facilities for the purpose of their activities. 5. Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities. 6. Union testing facilities shall, within the area of their competence, perform the following activities: (a) carry out testing of products at the request of market surveillance authorities, the Network or the Commission; (b) provide independent technical or scientific advice at the request of the Network; (c) develop new techniques and methods of analysis. 7. The activities referred to in paragraph 6 of this Article shall be remunerated and may be financed by the Union in accordance with Article 36(2). 8. Union testing facilities may receive financing by the Union in accordance with Article 36(2) in order to increase their testing capacity or to create new testing capacity for specific categories of products or for specific risks related to a category of products for which the testing capacity is missing or is insufficient. 9. The Commission shall adopt implementing acts specifying the procedures for the designation of Union testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

CHAPTER VI

CROSS-BORDER MUTUAL ASSISTANCE

Article 22 Mutual Assistance 1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, and between market surveillance authorities and the Commission and the relevant Union agencies. 2. When a market surveillance authority is unable to conclude its investigation because of its inability to access certain information, despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the market surveillance authority of another Member State where access to this information can be enforced. In this case the requested authority shall supply to the applicant authority without delay, and in any event within 30 days, any information that the requested authority considers to be relevant in order to establish whether a product is non-compliant. 3. The requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the requested information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance authorities. 4. The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility. 5. In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where: (a) the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance; (b) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.

Article 23 Requests for enforcement measures 1. Where bringing non-compliance with regard to a product to an end requires measures within the jurisdiction of another Member State and where such measures do not result from the requirements of Article 16(7), an applicant authority may submit a duly reasoned request for enforcement measures to a requested authority in that other Member State. 2. The requested authority shall without delay take all appropriate and necessary enforcement measures using the powers conferred on it under this Regulation in order to bring the instance of non-compliance to an end by exercising the powers laid down in Article 14 and any additional powers granted to it under national law. 3. The requested authority shall inform the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken. A requested authority may refuse to comply with a request for enforcement measures in any of the following situations: (a) the requested authority concludes that the applicant authority has not provided sufficient information; (b) the requested authority considers that the request is contrary to Union harmonisation legislation; (c) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.

Article 24 Procedure for mutual assistance requests 1. Before submitting a request under Article 22 or 23, the applicant authority shall endeavour to carry out all reasonable possible investigations. 2. When submitting a request under Article 22 or 23, the applicant authority shall provide all available information in order to enable the requested authority to fulfil the request, including any necessary evidence obtainable only in the Member State of the applicant authority. 3. Requests under Articles 22 and 23 and all communication related to them shall be made using electronic standard forms by means of the information and communication system referred to in Article 34. 4. Communication shall take place directly between the involved market surveillance authorities or through the single liaison offices of the Member States concerned. 5. The languages to be used for requests under Articles 22 and 23 and for all communication linked to them shall be agreed upon by the market surveillance authorities concerned. 6. Where no agreement about the languages to be used can be reached between the market surveillance authorities concerned, the requests under Articles 22 and 23 shall be sent in the official language of the Member State of the applicant authority, and the replies to such requests shall be sent in the official language of the Member State of the requested authority. In such case, the applicant authority and the requested authority shall arrange for the translation of the requests, replies or other documents that it receives from the other authority. 7. The information and communication system referred to in Article 34 shall provide structured information on mutual assistance cases to the single liaison offices involved. Using this information, single liaison offices shall provide any support that is necessary to facilitate assistance.

CHAPTER VII

PRODUCTS ENTERING THE UNION MARKET

Article 25 Controls on products entering the Union market 1. Member States shall designate customs authorities, one or more market surveillance authorities or any other authority in their territory as the authorities in charge of the control on products entering the Union market. Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34. 2. The authorities designated under paragraph 1 shall have the necessary powers and resources for the proper performance of their tasks as referred to in that paragraph. 3. Products subject to Union law that are to be placed under the customs procedure ‘release for free circulation’ shall be subject to controls performed by the authorities designated under paragraph 1 of this Article. They shall perform those controls on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 and, where relevant, on the basis of risk-based approach as referred to in the second subparagraph of Article 11(3) of this Regulation. 4. Risk-related information shall be exchanged between: (a) the authorities designated under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) No 952/2013; and (b) customs authorities in accordance with Article 46(5) of Regulation (EU) No 952/2013. Where, in relation to products subject to Union law that are either in temporary storage or placed under a customs procedure other than ‘release for free circulation’, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination. 5. Market surveillance authorities shall provide authorities designated under paragraph 1 with information on categories of products or the identity of economic operators where a higher risk of non-compliance has been identified. 6. By 31 March of each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union law during the previous calendar year. The statistical data shall cover the number of interventions in the field of controls on such products with regard to product safety and compliance. The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34. 7. Where the Commission becomes aware of a serious risk presented by products subject to Union law that are imported from a third country, it shall recommend to the Member State concerned to take appropriate market surveillance measures. 8. The Commission, after consulting the Network, may adopt implementing acts laying down benchmarks and techniques for checks on the basis of common risk analysis on the Union level, in order to ensure a consistent enforcement of Union law, to strengthen the controls on products entering the Union market and to ensure an effective and uniform level of such controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 9. The Commission shall adopt implementing acts further specifying the details of the data to be submitted under paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

Article 26 Suspension of release for free circulation 1. Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that: (a) the product is not accompanied by the documentation required by the Union law applicable to it or there is a reasonable doubt as to the authenticity, accuracy or completeness of such documentation; (b) the product is not marked or labelled in accordance with the Union law applicable to it; (c) the product bears a CE marking or other marking required by the Union law applicable to it which has been affixed in a false or misleading manner; (d) the name, registered trade name or registered trade mark and the contact details, including the postal address, of an economic operator with tasks regarding the product subject to certain Union harmonisation legislation is not indicated or identifiable in accordance with Article 4(4); or (e) for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it or that it presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1. 2. Authorities designated under Article 25(1) shall immediately notify the market surveillance authorities of any suspension of release referred to in paragraph 1 of this Article. 3. Where the market surveillance authorities have reasonable grounds to believe that a product does not comply with the Union law applicable to it or presents a serious risk, they shall request the authorities designated under Article 25(1) to suspend the process for its release for free circulation. 4. Notifications under paragraph 2 and requests under paragraph 3 of this Article may take place by means of the information and communication system referred to in Article 34, including through the use of electronic interfaces between this system and systems used by customs authorities, when they are available.

Article 27 Release for free circulation Where the release of a product for free circulation has been suspended in accordance with Article 26, that product shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied: (a) within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension; (b) the authorities designated under Article 25(1) have been informed by the market surveillance authorities of its approval for release for free circulation. The release for free circulation shall not be deemed to be proof of conformity with Union law.

Article 28 Refusal to release for free circulation 1. Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: ‘Dangerous product — release for free circulation not authorised — Regulation (EU) 2019/1020’. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 2. Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: ‘Product not in conformity — release for free circulation not authorised — Regulation (EU) 2019/1020’. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 3. Where the product referred to in paragraph 1 or 2 is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the notice required by paragraph 1 or 2 shall also be included, under the same conditions as required by paragraph 1 or 2, in the documents used in connection with that procedure. 4. Authorities designated under Article 25(1) may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users where the authority in question co