I 
(Legislativ e acts) 
REGUL ATIONS 
REGUL ATION (EU) 2019/1020 OF THE EUR OPEAN PARLIAMENT AND OF THE COUNCIL 
of 20 June 2019 
on market surveillance and compliance of products and amending Directiv e 2004/42/EC and 
Regulations (EC) No 765/2008 and (EU) No 305/2011 
(Text with EEA relevance) 
THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, 
Having regar d to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 thereof, 
Having regar d to the proposal from the European Commission, 
After transmission of the draf t legislative act to the national parliaments, 
Having regar d to the opinion of the European Economic and Social Committ ee (1), 
Acting in accordance with the ordinar y legislative procedure (2), 
Whereas: 
(1)  In order to guarantee the free movement of products within the Union, it is necessar y to ensure that products are 
compl iant with Union harmonisation legislation and theref ore fulfil requirements provid ing a high level of 
prot ection of public interests, such as health and safety in general , health and safety in the workplace, prot ection 
of consumers, protection of the environment, public secur ity and prote ction of any other public interests 
prot ected by that legislation. Robust enforcement of these requirements is essential to the proper prote ction of 
these inter ests and to creat e the conditions in which fair competition in the Union mark et for goods can thrive. 
Rules are theref ore necessar y to ensure this enforcement, regar dless of whether products are placed on the 
mark et via offline or online means and regar dless of whether they are manuf actured in the Union or not. 
(2)  Union harmonisation legislation covers a large share of manufactured products. Non-compliant and unsaf e 
products put citizens at risk, and might distor t competition with economic operat ors selling compliant products 
within the Union. 
(3)  Strengthening the sing le mark et for goods through further enhancing efforts to keep non-com pliant products 
from being placed on the Union mark et was identified as a priority in the Communication from the Commission 
of 28 Octobe r 2015 entitled ‘Upgrading the Sing le Mark et: more oppor tunities for people and business’. This 
should be achi eved by strengthening mark et surveillance, provid ing economic operators with clear , transparent 
and compreh ensive rules, intensifying compliance controls and promoting closer cross-border cooperation 
among enforcement author ities, including through cooperation with custom s author ities. 25.6.2019 L 169/1 Official Jour nal of the European Union EN     
(1)OJ C 283, 10.8.2018, p. 19. 
(2)Position of the European Parliament of 17 Apr il 2019 (not yet published in the Offi cial Jour nal) and decision of the Council of 14 June 
2019. (4)  The framewor k for market surveillance established by this Regulation should compl ement and strengthen existing 
provis ions in Union harmonisation legislation relating to the ensur ing of compl iance of products and the 
framew ork for cooperation with organisati ons representing economic operators or end users, the mark et 
surveillance of products and controls on those products entering the Union market. Howe ver, in accordance with 
the principle of lex specialis, this Regulation should apply only in so far as there are no specifi c provisions with 
the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this 
Regulation should theref ore not apply in the areas covered by such specifi c provisions, for instance those set out 
in Regulations (EC) No 1223/2009 (3), (EU) 2017/745 (4) and (EU) 2017/746 (5), including as regar ds the use of 
the European database on medical devices (EUD AMED), 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 safet y 
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 Exchang e System (RAPEX). Marke t surveillance author ities should have the possibility of taking the 
more specifi c measures available to them under that Directive. In order to achi eve a higher level of safety for 
consumer products, the mec hanisms for exchange s of information and rapid intervention situations provid ed 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 har­
monisation legislation liste d in Annex I concer ning manuf actured products other than food, feed, medicinal 
products for human and veterinar y 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 unif orm framework for 
mark et 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 mark et. If new Union harmonisation legislation is adopt ed 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 framew ork and controls of products enter ing the Community mark et 
should be deleted and the respective provisions should be replaced by this Regulation. That framewor k includes 
the provisions on controls of products entering the Community market, in Articles 27, 28 and 29 of Regulation 
(EC) No 765/2008, whic h 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 specifi c provis ions relating to the organisation of controls 
on products entering the Union market. It is theref ore necessar y that the scope of the provi sions of this 
Regulation with regar d to products entering the Union mark et extend to all products. 
(8)  In order to rationalise and simplify the overall legislative framework, while simultaneously pursuing the 
objectives of Bett er Regulation, the rules applicable to controls on products enter ing the Union market should be 
revised and integrated into a sing le legislative framework for controls on products at the Union's extern al borders. 
(9)  Responsibility for enforcing Union harmonisation legislation should lie with the Member States, and their mark et 
surveillance author ities should be required to ensure that the legislation is fully compl ied with. The Member 
States should, theref ore, establish system atic approaches to ensure effectiveness of mark et 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. 25.6.2019 L 169/2 Official Jour nal of the European Union EN     
(3)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 
22.12.2009, p. 59). 
(4)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, amending Directive 
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC (OJ L 117, 5.5.2017, p. 1). 
(5)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and 
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 
(6)Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of 
motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending 
Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). 
(7)Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 
15.1.2002, p. 4). 
(8)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita ­
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, 
p. 30). (10)  In order to assist mark et surveillance author ities to strengthen consistency in their activities related to the 
application of this Regulation, an effective peer review syste m should be established for those mark et surveillance 
author ities wishing to participat e. 
(11)  Certain definitions currently set out in Regulation (EC) No 765/2008 should be aligned with definitions set out 
in other Union lega l acts and, where appropr iate, reflect the archit ecture of moder n supply chains. The definition 
of ‘manufa cturer ’ in this Regulation should not relieve manufacturers of any oblig ations they might have under 
Union harmonisation legislation where specific definitions of manuf acturer are applied, whic h might cover any 
natural or lega l person who modifies a product already placed on the market in such a way that compliance with 
the applicable Union harmonisation legislation might be affect ed and places it on the mark et, 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 expecte d to act responsibly and in full 
accordance with the legal requirements applicable when placing or making products available on the mark et, so 
as to ensure compl iance 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 operat ors in the supply 
and distr ibution process pursuant to specif ic provisions in Union harmonisation legislation, and the manufacturer 
should retain ultimate responsibility for compl iance of the product with requirements of the Union harmonisa ­
tion legislation. 
(13)  The challenges of the global mark et and increasing ly compl ex 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. Further more, practical exper ience of mark et 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 framew ork. Such is the case, in particular , with fulfilment 
service providers, whic h perform many of the same functions as impor ters but which might not alwa ys 
correspond to the traditional definition of impor ter in Union law. In order to ensure that market surveillance 
author ities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is 
appropr iate to include fulfilme nt service providers within the list of economic operat ors against whom it is 
possible for mark et surveillance author ities to take enforcement measures. By including fulfilment service 
provid ers within the scope of this Regulation, mark et surveillance author ities will be better able to deal with new 
forms of economic activity in order to ensure the safet y of consumers and the smooth functioning of the internal 
mark et, including where the economic operator acts both as an importer as regar ds certain products and as 
a fulfilment service provid er as regards other products. 
(14)  Moder n supply chains encompass a wide variety of economic operat ors 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 contr ibut e to the making available of products on the Union mark et. Theref ore, it is 
necessar y to apply this Regulation to economic operat ors that are directly concer ned by Union harmonisation 
legislation listed in Annex I to this Regulation, such as the producer of an article and the down stream 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). 25.6.2019 L 169/3 Official Jour nal of the European Union EN     
(9)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, 
Evaluation, Autho risation and Restr iction of Chemicals (REA CH), establishing a European Chemicals Agen cy, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as 
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006, p. 1). 
(10)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classific ation, labelling and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 
No 1907/2006 (OJ L 353, 31.12.2008, p. 1). 
(11)Directive 2014/33/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to lifts and safet y components for lifts (OJ L 96, 29.3.2014, p. 251). 
(12)Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with 
respect to fuel effic iency and other essential paramet ers (OJ L 342, 22.12.2009, p. 46). 
(13)Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and 
repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). (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 target ed at end users in the Union. 
In line with the applicable Union rules on private internatio nal law, a case-by-case analysis should be carried out 
in order to establish whether an offer is target ed at end users in the Union. An offer for sale should be considered 
to be target ed at end users in the Union if the relevant economic operat or directs, by any means, its activities to 
a Member State. For the case-by-case analyses, relevant factors, such as the geographical areas to whic h dispatch 
is possible, the languag es available, used for the offer or for order ing, 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 interm ediar ies' 
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 exte nt, to the prolife ration of information society service 
provid ers, usually through platf orms and for remuneration, whic h offer interm ediar y services by storing third 
party conte nt, without exer cising control over that conte nt, and theref ore not acting on behalf of an economic 
operat or. Removal of content regar ding non-com pliant products or, where this is not feasible, restr icting access to 
non-com pliant 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 oblig ation 
should be imposed on information society service provid ers 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 . Further more, hosting service provi ders should not be held liable as long as they do not have actual 
kno wledge of illegal activity or information and are not awar e 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 proper ty rights, it should never theless be 
borne in mind that often count erfeit products do not compl y with the requirements set out in the Union har­
monisation legislation, present risks to health and safety of end users, distor t competition, endanger public 
inter ests and suppor t other illegal activities. Theref ore, Member States should continue taking effective measures 
to prevent count erfeit products from entering the Union mark et pursuant to Regulation (EU) No 608/2013 of 
the European Parliament and of the Council (15). 
(18)  A faire r sing le mark et should ensure equal conditions for competiti on to all economic operators and protection 
against unfair compet ition. To this end, strengthened enforcement of Union harmonisation legislation on 
products is necessar y. Good cooperation between manufacturers and the mark et surveillance author ities is a key 
element, allowing immediate inter vention and corrective action in relation to the product. It is impor tant that, for 
certain products, there should be an economic operat or established in the Union so that mark et surveillance 
author ities have someone to whom requests can be addressed, including requests for information regarding 
a product's compl iance with Union harmonisation legislation, and who can cooperat e with mark et surveillance 
author ities in making sure that immediate corrective action is taken to remedy instances of non-com pliance. The 
economic operat ors who should perform those tasks are the manufacturer , or the importer when the 
manuf acturer is not established in the Union, or an author ised representative mandated by the manufacturer for 
this purpose, or a fulfilment service provid er 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 mark et surveillance author ities with regar d to the 
ensur ing of compl iance of products offered for sale online and the effective enforcement of Union harmonisation 
legislation. The number of economic operat ors offer ing products directly to consumers by electronic means is 
increasing. Theref ore, economic operators with tasks regarding products subject to certain Union harmonisation 
legislation perform an essential role by provi ding mark et surveillance author ities with an interlocutor established 
in the Union, and by performin g specifi c tasks in a timely manner to mak e sure that the products compl y with 
the requirements of Union harmonisation legislation, for the benefit of consumers, other end users and 
businesses within the Union. 25.6.2019 L 169/4 Official Jour nal of the European Union EN     
(14)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society 
services, in particular electronic commerce, in the Intern al Mark et (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). 
(15)Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concer ning customs enforcement of 
intel lectual proper ty rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (20)  The oblig ations of the economic operat or with tasks regarding products subject to certain Union harmonisation 
legislation should be without prejudice to existing obligations and responsibilities of manufa cturer , impor ter and 
author ised representative under the relevant Union harmonisation legislation. 
(21)  Obligati ons of this Regulation requir ing 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 operat or to act as 
a liaison point with the market surveillance author ities has been identif ied, taking into account a risk-based 
approac h, having regard to the principle of propor tionality , and taking into account high level of protection of 
end users in the Union. 
(22)  Moreover , those oblig ations should not apply where the specific requirements set out in certain legal acts on 
products achi eve 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 
whic h products are mainly traded through traditional supply chains, whic h 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 operat ors with tasks rega rding products subject to certain Union harmonisation 
legislation should be indicated with the product in order to facilitat e chec ks throughout the supply chain. 
(24)  Economic operat ors should fully cooperate with mark et surveillance author ities and other compet ent author ities 
to ensure the smooth performa nce of market surveillance and to enable the author ities to perform their 
tasks. This includes, where requeste d by author ities, provid ing the contact information of the economic operat ors 
with tasks rega rding products subject to certain Union harmonisation legislation where this information is 
available to them. 
(25)  Economic operat ors should have easy access to high quality , compre hensive information. Since the sing le digital 
gatewa y established under Regulation (EU) 2018/1724 of the European Parliament and of the Council (24) 
provid es for a sing le point of online access to information, it can be used in respect to provid ing relevant 
information on Union harmonisation legislation to economic operat ors. Never theless, Member States should put 25.6.2019 L 169/5 Official Jour nal of the European Union EN     
(16)Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on deterg ents (OJ L 104, 8.4.2004, 
p. 1). 
(17)Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 Febr uary 2013 on the approval and market 
surveillance of agricultural and forestr y vehicles (OJ L 60, 2.3.2013, p. 1). 
(18)Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 Januar y 2013 on the approval and market 
surveillance of two- or three-wheel vehicles and quadr icycles (OJ L 60, 2.3.2013, p. 52). 
(19)Directive 2014/28/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to the making avail able on the market and super vision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1). 
(20)Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on mar ine equipment and repealing Council 
Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146). 
(21)Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 Sept ember 2016 on requirements relating to gaseo us 
and particulate pollutant emission limits and type-approval for inter nal combustion engines for non-road mobile mac hiner y, amending 
Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53). 
(22)Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cablewa y installations and repealing 
Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1). 
(23)Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transpor table pressure equipment and 
repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1). 
(24)Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a sing le digital gatewa y to 
provi de access to information, to procedures and to assistance and problem-solving services and amending Regulation 
(EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1). in place procedures for ensur ing 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 operat ors in 
addressing properly their requests for information. Guidance on issues relating to technical specifi cations or 
harmonised standards or design of a specific product should not be part of the obligations of Member States 
when provi ding such information. 
(26)  Mark et surveillance author ities might carry out joint activities with other author ities or organisations representing 
economic operators or end users, with a view to promoting compliance, identifying non-com pliance, raising 
awar eness and provi ding guidance on Union harmonisation legislation and with respect to specifi c categor ies of 
products, including those that are offered for sale online. 
(27)  Member States should designat e their own mark et surveillance author ities. This Regulation should not prevent 
Member State s from choosing the compet ent author ities to carry out the mark et surveillance tasks. In order to 
facilitate administrative assistance and cooperation, Member States should also appoint a sing le liaison office. 
Sing le liaison offices should at least represent the coordinated position of the market surveillance author ities and 
the author ities in charge of the control on products entering the Union mark et. 
(28)  E-commerce poses certain challenges for market surveillance author ities regarding the prot ection of the health 
and safety of end users from non-compliant products. Theref ore, Member States should ensure their mark et 
surveillance is organised with the same effectiveness for products made available online as it is for products made 
available offline. 
(29)  While performin g market surveillance of products offered for sale online, mark et surveillance author ities are 
facing numerous difficulties, such as tracing products offered for sale online, identifying the responsible economic 
operat ors, 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 encourage d to use compl ementar y guidance 
and best practices for mark et surveillance and for communication with businesses and consumers. 
(30)  Special attention should be given to emerging technologies, taking into account that consumers are increasing ly 
using connecte d devices in their daily lives. The Union regulatory framewor k should theref ore address the new 
risks to ensure the safet y of the end users. 
(31)  In the age of constant development of digital technologies new solutions that could contr ibut e to the effective 
mark et surveillance within the Union should be explored. 
(32)  Mark et 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, mark et surveillance 
author ities should organise and conduct inspection activities on a risk-based approach, taking the inter ests of 
those economic operat ors into account and limiting the said burden to what is necessar y for the performa nce of 
efficient and effective controls. Further more, mark et surveillance should be perf ormed with the same level of care 
by the compet ent author ities of the Member State irrespective of whether non-comp liance 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. Unif orm conditions for certain inspection activities carried out by the mark et surveillance author ities where 
products or catego ries of products present specific risks or seriously breach the applicable Union harmonisation 
legislation might be laid down by the Commission. 
(33)  Mark et surveillance author ities, when performi ng their duties, are confronted with differ ent shor tcomings in 
term s of resources, coordination mech anisms, as well as powers with regard to non-com pliant products. Such 
diffe rences lead to fragment ed enforcement of Union harmonisation legislation and to mark et surveillance being 
more rigorous in some Member State s than in others, poten tially compromising the level playing field among 
businesses and creating also poten tial imbalances in the level of product safety throughout the Union. 25.6.2019 L 169/6 Official Jour nal of the European Union EN     
(25)Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods 
lawfully market ed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1). (34)  In order to ensure that the Union harmonisation legislation on products is correctly enforced, mark et surveillance 
author ities should have a common set of investigat ive and enforcement powers, allowing for enhanced 
cooperation between mark et surveillance author ities and more effective deterrence for economic operat ors that 
willing ly infringe Union harmonisation legislation. Those powers should be suffic iently robust to tackle the 
enforcement challeng es of Union harmonisation legislation, along with the challenges of e-commerce and the 
digital environment and to prevent economic operat ors from exploiting gaps in the enforcement system by 
relocating to Member States whose mark et surveillance author ities are not equipped to tackle unlawful 
practices. In particular , the powers should ensure that information and evidence can be exchanged between 
compet ent author ities so that enforcement can be under take n equally in all Member States. 
(35)  This Regulation should be without prejudice to the freedom of Member State s to choose the enforcement system 
that they consider to be appropr iate. Member States should be free to choose whether their mark et surveillance 
author ities can exercise investigation and enforcement directly under their own author ity, by recourse to other 
public author ities or upon application to the compet ent cour ts. 
(36)  Mark et surveillance author ities should be in a position to open inve stigations on their own initiative if they 
become aware of non-comp liant products placed on the mark et. 
(37)  Mark et surveillance author ities should have access to all necessar y evidence, data and information relating to the 
subject matter of an inve stigation 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 rega rdless of where it is locat ed and of the format in which it is 
held. Mark et surveillance author ities should be able to request economic operat ors, including those in the digital 
value chain, to provid e all the evidence, data and information necessar y. 
(38)  Mark et surveillance author ities should be able to carry out the necessar y on-site inspections, and should have the 
power to enter any premises, land or means of transpor t, that the economic operat or uses for purposes relating 
to its trade, business, craft or profe ssion. 
(39)  Mark et surveillance author ities should be able to require a representative or a relevant member of staff of the 
economic operator concer ned to give explanations or provide facts, information or documents relating to the 
subject matt er of the on-site inspection, and to record the answers given by that representative or relevant 
member of staff. 
(40)  Mark et surveillance author ities should be able to check the compliance of products to be made available on the 
mark et with Union harmonisation legislation and to obtain evidence of non-com pliance. They should, theref ore, 
have the power to acquire products and, where the evidence cannot be obtained by other means, to purc hase 
products under a cover identity . 
(41)  In the digital environment in particular , mark et surveillance author ities should be able to bring non-com pliance 
to an end quickly and effectively , notably where the economic operat or selling the product conceals its identity or 
relocat es within the Union or to a third countr y in order to avoid enforcement. In cases where there is a risk of 
serious and irreparable harm to end users due to non-com pliance, market surveillance author ities should be able 
to take measures, where duly justified and propor tionate and where there are no other means available to prevent 
or mitig ate such harm, including, where necessar y, requir ing the removal of cont ent from the online interfa ce or 
the displa y of a warning. When such a request is not obser ved, the relevant author ity should have the power to 
require information society service providers to restr ict access to the online interface . These measures should be 
take n in accordance with the principles laid down in Directive 2000/31/EC. 
(42)  The implementation of this Regulation and the exer cise of powers in its application should also compl y with 
other Union and national law, for exam ple Directive 2000/31/EC, including with applicable procedural safeguards 
and principles of the fundamental rights. That imp lementation and that exercise of powers should also be propor ­
tionate and adequat e in view of the nature and the overall actual or poten tial harm caused by the infringemen t. 
Com petent author ities should take all facts and circumstances of the case into account and should choose the 25.6.2019 L 169/7 Official Jour nal of the European Union EN     most appropr iate measures, namely , those whic h are essential to address the infringement covered by this 
Regulation. Those measures should be propor tionate, 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 examp le, 
in accordance with national law, prior author isation to enter the premises of natural persons and legal persons is 
required from the judicial author ity of the Member State concer ned, the power to enter such premises should be 
used only after such prior author isation has been obtained. 
(43)  Mark et surveillance author ities act in the inter est of economic operat ors, of end users, and of the public, to 
ensure that public interests covered by relevant Union harmonisation legislation on products are consist ently 
preser ved and protect ed through appropr iate enforcement measures, and that compl iance with such legislation is 
ensured across the supply chain through appropr iate checks, taking into consideration the fact that administrative 
checks alone, in man y cases, cannot replace physical and laboratory checks in order to verify the compl iance of 
products with the relevant Union harmonisation legislation. Consequently , mark et surveillance author ities should 
ensure a high level of transparency while perf orming their activities and should make available to the public any 
information that they consider to be relevant in order to prot ect the inter ests 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 safeg uard clause procedure provid ed 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 ensur ing an equivalent level of prot ection throughout the Union, Member States are author ised to 
take measures in relation to products presenting a risk to health and safety , or other aspects of public inter est 
prot ection. 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 restr ict the free movement of 
products with a view to ensur ing the functioning of the internal mark et are justified. 
(46)  The exchange of information between mark et surveillance author ities, and the use of evidence and investigation 
findings should respect the principle of conf identiality . Information should be handled in accordance with 
applicable national law, in order to ensure that investigat ions are not comprom ised and that the reputation of the 
economic operator is not prejudiced. 
(47)  Where, for the purposes of this Regulation, it is necessar y to process personal data, this should be carried out in 
accordance with Union law on the prot ection 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 mark et surveillance framew ork 
with regard to specific products or a specifi c catego ry or group of products or for specifi c risks related to 
a catego ry or group of products, the Commission might designat e testing facilities of its own or public testin g 
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 conf licts of inter ests, 
Union testing facilities should only provid e services to market surveillance author ities, the Commission, the 
Union Product Com pliance Netw ork (the ‘Netw ork’) and other government or intergo vernmental entities. 
(49)  Member State s should ensure that adequate financial resources are alwa ys available for the appropr iate staffing 
and equipping of the market surveillance author ities. Efficient mark et surveillance is demanding in term s of 
resources, and stable resources should be provided at a level appropr iate to the enforcement needs at any given 
moment. Member States should have the possibility to supplement public financing by reclaiming from the 
relevant economic operat ors the costs incur red when performin g mark et surveillance in relation to products that 
were found to be non-com pliant. 
(50)  Mechani sms for mutual assistance should be established, since it is imperative for the Union mark et for goods 
that the mark et surveillance author ities of the Member State s cooperate with each other effectively . Authorities 
should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those 
concer ning access to EU declaration of conf ormity , declaration of perf ormance and technical documentation. 25.6.2019 L 169/8 Official Jour nal of the European Union EN     
(26)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 Apr il 2016 on the prot ection of natural persons with 
regar d to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data 
Prot ection Regulation) (OJ L 119, 4.5.2016, p. 1). 
(27)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons 
with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such 
data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (51)  It is appropr iate that Member State s designate the author ities responsible for applying the customs legislation and 
any other author ities in charg e under national law of control on products entering the Union mark et. 
(52)  An effective way to ensure that unsaf e or non-com pliant products are not placed on the Union market would be 
to detec t such products before they are released for free circulation. Author ities in charg e of the control on 
products entering the Union mark et have a compl ete overview of trade flows across the Union's extern al borders 
and should theref ore be required to carry out adequat e controls on a risk assessment basis to contr ibut e to a safer 
mark et place whic h ensures a high level of protection of public interests. It is for Member State s to designat e the 
specific author ities that are to be responsible for the appropr iate documentar y and, where necessar y, physical or 
laborat ory checks of products before those products are released for free circulation. A unif orm enforcement of 
Union harmonisation legislation on products can only be achi eved through systematic cooperation and exchang e 
of information between market surveillance and other author ities designat ed as author ities in charge of the 
control on products entering the Union market. These author ities should receive well in advance from the mark et 
surveillance author ities all the necessar y information concer ning non-com pliant products or information on 
economic operat ors where a higher risk of non-complian ce has been identif ied. In turn, author ities in charge of 
the control on products entering the customs territory of the Union should inform the mark et surveillance 
author ities 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. Further more, 
where the Commission becomes aware of a serious risk presented by an impor ted product, it should inform the 
Member States about that risk in order to ensure coordinated and more effective compl iance and enforcement 
controls at the first points of entr y 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) provid e that products entering the Union mark et that require further 
processing in order to be in compl iance with the applicable Union harmonisation legislation shall be placed 
under the appropr iate customs procedure allowing such processing by the importer. Generally , the release for free 
circulation should not be deemed to be proof of conf ormity with Union law, since such a release does not 
necessar ily include a complet e check of compliance. 
(54)  In order to use the EU Sing le Window envi ronment for customs and theref ore to optimise and unburden the data 
transfer between customs and mark et surveillance author ities, it is necessar y to set up electronic interfaces that 
allow automatic data transfe r. Cust oms and market surveillance author ities should contr ibut e to determi ne the 
data to be transmitted. Additional burden for customs author ities should be limited and the interfaces should be 
highly autom ated and easy-to-use. 
(55)  It is necessar y to establish the Network, hosted by the Commission, aimed at structured coordination and 
cooperation between enforcement author ities of the Member States and the Commission, and at streamlining the 
practices of mark et surveillance within the Union that facilitate the implementation of joint enforcement activities 
by Member States, such as joint investig ations. This administrative suppor t 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 infringe ­
ments. The involvement of administrative cooperation groups (ADC Os) in the Netw ork should not preclude the 
involvement of other , similar , groups involved in administrative cooperation. The Commission should provi de the 
necessar y administrative and financial suppor t to the Netw ork. 
(56)  There should be effective, speedy and accurate exchange of information among the Member State s and the 
Commission. A number of existing tools, such as the information and communication system for mark et 
surveillance (ICSMS) and RAPEX enable coordination among mark et surveillance author ities 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 poten tial and help to increase the level of cooperation and 
exchange of information between Member States and the Commission. 25.6.2019 L 169/9 Official Jour nal of the European Union EN     
(28)Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code 
(OJ L 269, 10.10.2013, p. 1). (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, sing le liaison offices, 
customs and market surveillance author ities. Further more, an electronic interface should be developed to allow 
effective exchang e of information between national syste ms of customs and mark et surveillance author ities. With 
regar d to the cases of mutual assistance requests, the sing le liaison office s should give any suppor t necessar y for 
cooperation between the relevant author ities. Theref ore, ICSMS should provid e the functions enabling an 
automat ed indication to the sing le liaison offices when deadlines are not met. When sectora l legislation already 
provid es for electronic syste ms for cooperation and data exchange, as is the case for example of EUD AMED for 
medical devices, those system s should be kept in use, when appropr iate. 
(58)  In general, ICSMS should be used to exchange information considered helpful for other market surveillance 
author ities. This might include checks under taken in the context of mark et surveillance projects, regardless of the 
outcome of the tests. The amount of data to be entered in ICSMS should strike a balance between imposin g too 
great a burden, when the efforts for entering the data would exceed the work involved in doing the actual checks, 
and being compr ehensive enough to suppor t greater efficiency and effectiveness on the side of the 
author ities. Thus, the data entered in ICSMS should also cover simpler checks than laborat ory tests only . 
Never theless, there should be no need to include brief visual chec ks. As a guideline, checks which are individually 
documente d should also be entered in ICSMS. 
(59)  Member States are encourage d to use ICSMS for inter actions between customs and mark et surveillance 
author ities as an altern ative to the national systems. This should not replace the Community Risk Management 
System (CRMS) used by customs author ities. These two system s could work in parallel since they fulfil differ ent, 
compl ementar y roles, with ICSMS facilitating communication between customs and market surveillance 
author ities in order to allow for a smooth treatment of customs declarations in the scope of the product safety 
and compl iance framework while CRMS is for customs common risk manage ment and controls. 
(60)  Injur ies caused by non-com pliant products are important information for mark et surveillance author ities. ICSMS 
should theref ore provide for related data fields so that mark et surveillance author ities can enter readily available 
repor ts provided for in the course of their inve stigations, thus facilitating later statistical evaluations. 
(61)  The Commission should be able to exchange market surveillance related information with regulat ory author ities 
of third countr ies or international orga nisations within the framew ork of agreements concluded between the 
Union and third countr ies or intern ational orga nisations, with a view to ensur ing compl iance of products prior 
to their expor t to the Union mark et. 
(62)  In order to achi eve a high degree of compl iance with applicable Union harmonisation legislation on products 
while at the same time ensur ing an effective resource-allocation and a cost-efficient control of products entering 
the Union mark et, the Commission should be able to approve specifi c pre-expor t control systems . Products 
falling under such approved systems might, as part of the risk assessment perf ormed by author ities in charge of 
controls on products entering the Union market, benefit from a higher level of confidence than compar able 
products whic h have not been subject to a pre-expor t 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 Apr il 2016 on Bett er 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 
provis ions related to the tasks of economic operators placing products on the market, and the system of product- 
relat ed pre-expor t controls. 
(64)  The financial interests of the Union should be protect ed through propor tionat e measures throughout the 
expenditure cycle, including the prevention, detection and investigat ion of irregular ities, the reco very of funds 
lost, wrong ly paid or incor rectly used and, where appropr iate, administrative and financial penalties. 25.6.2019 L 169/10 Official Jour nal of the European Union EN     
(29)OJ L 123, 12.5.2016, p. 1. (65)  The diversity of sanctions across the Union is one of the main reasons for inadequate deter rence and uneven 
prot ection. Rules on establishing sanctions, including monetar y penalties, are a matt er of national jurisdiction 
and should, theref ore, be deter mined by national law. 
(66)  In order to ensure unif orm conditions for the imp lementation of this Regulation, implementing powers should 
be conferr ed on the Commission in relation to: deter mining the unif orm conditions for checks, criteria for deter ­
mination of the frequency of checks and amount of sam ples to be check ed in relation to certain products or 
catego ries of products, where specifi c risks or serious breac hes of Union harmonisation legislation have been 
continuously identif ied; specifying the procedures for the designation of Union testing facilities; laying down 
benc hmark s and techniques for checks on the basis of common risk analysis at the Union level; specifying the 
details of statistical data cover ing controls performe d by the designat ed author ities with respect to products 
subject to Union law; specifying the details of implementation arrangements for the information and communi ­
cation system and defining the data relating to the placing of products under the customs procedure ‘release for 
free circulation’ transmitted by customs author ities; and to the approval of specifi c syste ms of product-related 
pre-expor t controls and the withdrawal of such appro vals. 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 mark et by strengthening 
the mark et surveillance of products covered by Union harmonisation legislation, cannot be suffi ciently achi eved 
by the Member States given the need for a very high degree of cooperation, interaction and coherent action of all 
of the compet ent author ities in all Member State s, but can rather , by reason of its scale and effects, be better 
achi eved at Union level, the Union may adop t measures, in accordance with the principle of subsidiar ity as set 
out in Article 5 of the Treaty on European Union. In accordance with the principle of propor tionality as set out 
in that Article, this Regulation does not go beyond what is necessar y in order to achi eve that objective. 
(68)  This Regulation respects fundamental rights and obser ves the principles recognised in particular by the Char ter of 
Fundamental Rights of the European Union and present in the constitutional traditions of Member 
States. According ly, this Regulation should be interpreted and applied in accordance with those rights and 
principles, including those relat ed to the freedom and pluralism of the media. In particular , this Regulation seeks 
to ensure full respect for consumer prote ction, the freedom to conduct a business, the freedom of expression and 
information, the right to proper ty and the protection of personal data, 
HAVE ADOPTED THIS REGUL ATION: 
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 mark et 
surveillance of products covered by the Union harmonisation legislation refer red to in Article 2, with a view to ensur ing 
that only compl iant products that fulfil requirements providing a high level of protection of public inter ests, such as 
health and safety in general, health and safety in the workplace, the prot ection of consumers, the prot ection of the 
environment and public secur ity and any other public inter ests protect ed by that legislation, are made available on the 
Union mark et. 
2. This Regulation lays down rules and procedures for economic operat ors regarding products subject to certain 
Union harmonisation legislation and establishes a framewor k for cooperation with economic operat ors. 
3. This Regulation also provides a framew ork for controls on products enteri ng the Union market. 25.6.2019 L 169/11 Official Jour nal of the European Union EN     
(30)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general 
principles concer ning mec hanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 
28.2.2011, p. 13). Article 2 
Scope 
1. This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I 
(‘Un ion harmonisation legislation’), in so far as there are no specifi c provisions with the same objective in the Union har­
monisation legislation, which regulate in a more specifi c manner particular aspects of mark et 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 enteri ng the Union market in Union law. 
3. The application of this Regulation shall not prevent mark et surveillance author ities from taking more specifi c 
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 
Def initions 
For the purposes of this Regulation, the followi ng definitions shall apply:  
(1) ‘making available on the mark et’ means any supply of a product for distr ibution, consum ption or use on the Union 
mark et in the course of a commercial activity , whether in retur n for payment or free of charge;  
(2) ‘placing on the mark et’ means the first making available of a product on the Union mark et;  
(3) ‘mark et surveillance’ means the activities carried out and measures taken by market surveillance author ities to 
ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and 
to ensure prot ection of the public inter est covered by that legislation;  
(4) ‘mark et surveillance author ity’ means an author ity designat ed by a Member State under Article 10 as responsible 
for carrying out market surveillance in the territory of that Member State;  
(5) ‘applicant author ity’ means the mark et surveillance author ity that makes a request for mutual assistance;  
(6) ‘requeste d author ity’ means the mark et surveillance author ity that receives a request for mutual assistance;  
(7) ‘non-com pliance ’ means any failure to compl y with any requirement under the Union harmonisation legislation or 
under this Regulation;  
(8) ‘manufactur er’ means any natural or lega l person who manufactures a product or has a product designed or 
manuf actured, and markets that product under its name or trademark;  
(9) ‘impor ter’ means any natural or legal person established within the Union who places a product from a third 
countr y on the Union mark et;  
(10) ‘distr ibut or’ means any natural or lega l person in the supply chain, other than the manuf acturer or the impor ter, 
who makes a product available on the mark et;  
(11) ‘fulfilment service provider ’ means any natural or legal person offer ing, in the course of commercial activity , at 
least two of the followi ng 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 deliver y 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 transpor t services; 25.6.2019 L 169/12 Official Jour nal of the European Union EN     
(31)Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the 
internal market of Community postal services and the impro vement of quality of service (OJ L 15, 21.1.1998, p. 14). 
(32)Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 Apr il 2018 on cross-border parcel deliver y services 
(OJ L 112, 2.5.2018, p. 19). (12) ‘author ised representative ’ means any natural or legal person established within the Union who has received 
a written mandat e from a manufacturer to act on its behalf in relation to specified tasks with regard to the 
manuf acturer's oblig ations under the relevant Union harmonisation legislation or under the requirements of this 
Regulation;  
(13) ‘economic operat or’ means the manufacturer , the author ised representative, the importer, the distr ibut or, the 
fulfilment service provid er or any other natural or legal person who is subject to oblig ations in relation to the 
manuf acture of products, making them available on the mark et or putting them into service in accordance with 
the relevant Union harmonisation legislation;  
(14) ‘information society service provi der’ 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 operat ed by 
or on behalf of an economic operator , and whic h serves to give end users access to the economic operat or's 
products;  
(16) ‘corrective action’ means any action taken by an economic operator to bring any non-com pliance to an end where 
required by a mark et surveillance author ity or on the economic operator's own initiative;  
(17) ‘voluntar y measure ’ means a corrective action where not required by a mark et surveillance author ity;  
(18) ‘risk’ means the combination of the probability of an occur rence of a hazard causing harm and the degree of 
sever ity of that harm;  
(19) ‘product presenting a risk’ means a product having the poten tial to affect adversely health and safety of persons in 
general, health and safety in the workplace, protect ion of consumers, the environment, public secur ity and other 
public inter ests, prot ected by the applicable Union harmonisation legislation, to a degree which goes beyond that 
considered reasonable and acceptable in relation to its intende d purpose or under the normal or reasonably 
foreseeable conditions of use of the product concer ned, including the duration of use and, where applicable, its 
putting into service, installation and mainte nance requirements;  
(20) ‘product presenting a serious risk’ means a product presenting a risk, for whic h, based on a risk assessment and 
taking into account the normal and foreseeable use of the product, the combination of the probability of 
occur rence of a hazard causing harm and the degree of sever ity of the harm is considered to require rapid 
intervention by the mark et surveillance author ities, 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 industr ial or professional activities;  
(22) ‘recall’ means any measure aimed at achieving the retur n of a product that has already been made available to the 
end user;  
(23) ‘withdrawa l’ means any measure aimed at preventing a product in the supply chain from being made available on 
the mark et;  
(24) ‘cust oms author ities’ means customs author ities 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 enteri ng the Union market’ means products from third countr ies intended to be placed on the Union 
mark et or intende d for private use or consum ption within the customs territory of the Union and placed under the 
customs procedure ‘release for free circulation’ . 25.6.2019 L 169/13 Official Jour nal of the European Union EN     
(33)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 Sept ember 2015 laying down a procedure for the 
provi sion of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). CHA PTER II 
TASK S OF ECONOMIC OPERA TORS 
Article 4 
Tasks of economic operators regarding products subject to certain Union harmonisation legislation 
1. Notwithstanding any oblig ations set out in applicable Union harmonisation legislation, a product subject to 
legislation refer red 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 operat or refer red to in paragraph 1 means any of the follo wing: 
(a)  a manuf acturer established in the Union; 
(b)  an impor ter, where the manufacturer is not established in the Union; 
(c) an author ised representative who has a written mandat e from the manufacturer designating the author ised represen ­
tative to perform the tasks set out in paragraph 3 on the manuf acturer's behalf; 
(d)  a fulfilment service provid er established in the Union with respect to the products it handles, where no other 
economic operat or 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 operat or refer red to in paragraph 1 shall perf orm the followi ng tasks: 
(a)  if the Union harmonisation legislation applicable to the product provides for an EU declaration of conf ormity or 
declaration of performa nce and technical documentation, verifying that the EU declaration of conf ormity or 
declaration of performance and technical documentation have been drawn up, keeping the declaration of conf ormity 
or declaration of performa nce at the disposal of mark et surveillance author ities for the period required by that 
legislation and ensur ing that the technical documentation can be made available to those author ities upon request ; 
(b)  further to a reasoned request from a market surveillance author ity, provi ding that author ity with all information and 
documentation necessar y to demonstrate the conf ormity of the product in a language which can be easily 
underst ood by that author ity; 
(c)  when having reason to believe that a product in question presents a risk, informing the market surveillance 
author ities thereof; 
(d)  cooperating with the market surveillance author ities, including followi ng a reasoned request making sure that the 
immediate, necessar y, corrective action is take n to remedy any case of non-comp liance with the requirements set out 
in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitig ate the 
risks present ed by that product, when required to do so by the market surveillance author ities or on its own 
initiative, where the economic operat or 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 oblig ations of economic operat ors 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 operat or referred to in paragraph 1 shall be indicate d on the product or on its packag ing, the parcel or an 
accompan ying document. 25.6.2019 L 169/14 Official Jour nal of the European Union EN     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 
Author ised represent ativ e 
1. For the purposes of point (c) of Article 4(2), the author ised representative shall be mandate d by the manufacturer 
to perform the task s listed in Article 4(3), notwithstanding any other tasks mandat ed under the relevant Union harmon ­
isation legislation. 
2. The author ised representative shall perform the tasks specified in the mandate . It shall provide a copy of the 
mandate to the market surveillance author ities upon request, in a Union languag e determi ned by the mark et surveillance 
author ity. 
3. Author ised representatives shall have the appropr iate means to be able to fulfil their tasks. 
Article 6 
Dist ance sales 
Products offered for sale online or through other means of distance sales shall be deemed to be made available on the 
mark et if the offer is target ed at end users in the Union. An offer for sale shall be considered to be target ed at end users 
in the Union if the relevant economic operat or directs, by any means, its activities to a Member State. 25.6.2019 L 169/15 Official Jour nal of the European Union EN     
(34)Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for 
the marketing of constr uction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5). 
(35)Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal prot ective equipment and 
repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). 
(36)Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and 
repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). 
(37)Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the appro ximation of the laws of the Member 
States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). 
(38)Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on mac hiner y, and amending Directive 95/16/EC 
(OJ L 157, 9.6.2006, p. 24). 
(39)Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). 
(40)Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of 
ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). 
(41)Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restr iction of the use of certain hazardous 
substances in electr ical and electronic equipment (OJ L 174, 1.7.2011, p. 88). 
(42)Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member 
States relating to the making avail able on the market of pyrotec hnic articles (OJ L 178, 28.6.2013, p. 27). 
(43)Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal 
watercraf t and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90). 
(44)Directive 2014/29/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to the making avai lable on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). 
(45)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). 
(46)Directive 2014/31/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to the making avai lable on the market of non-auto matic weighing instr uments (OJ L 96, 29.3.2014, p. 107). 
(47)Directive 2014/32/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to the making avai lable on the market of measur ing instr uments (OJ L 96, 29.3.2014, p. 149). 
(48)Directive 2014/34/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, 
p. 309). 
(49)Directive 2014/35/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the 
Member States relating to the making available on the market of electr ical equipment designed for use within certain voltage limits 
(OJ L 96, 29.3.2014, p. 357). 
(50)Directive 2014/53/EU of the European Parliament and of the Council of 16 Apr il 2014 on the harmonisation of the laws of the Member 
States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, 
p. 62). 
(51)Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member 
States relating to the making avail able on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164). Article 7 
Obligation of cooperation 
1. Economic operat ors shall cooperat e with mark et surveillance author ities regar ding actions whic h could eliminate 
or mitig ate risks that are presented by products made available on the mark et by those operat ors. 
2. Information society service provid ers shall cooperate with the market surveillance author ities, at the request of the 
mark et surveillance author ities and in specifi c cases, to facilitate any action take n to eliminate or, if that is not possible, 
to mitig ate the risks presented by a product that is or was offered for sale online through their services. 
CHAPTER III 
ASSIST ANCE TO AND COOPERA TION WITH ECONOMIC OPERA TORS 
Article 8 
Information to economic operators 
1. The Commission, in accordance with Regulation (EU) 2018/1724, shall ensure that the Your Europe portal 
provid es users with easy online access to information about the product requirements and rights, oblig ations and rules 
derived from the Union harmonisation legislation. 
2. Member States shall put in place procedures for providin g economic operat ors, at their request and free of charg e, 
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. Mark et surveillance author ities may agree with other relevant author ities 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-com pliance, raising awareness and providing guidance in relation to the Union harmonisation legislation 
with respect to specifi c catego ries of products, in particular categor ies of products that are often found to present 
a serious risk, including products offered for sale online. 
2. The mark et surveillance author ity in question and the parties refer red to in paragraph 1 shall ensure that the 
agreement on joint activities does not lead to unfai r competiti on between economic operat ors and does not affect the 
objectivity , independence and impartiality of the parties. 
3. A market surveillance author ity may use any information resulting from joint activities carried out as part of any 
investigation regarding non-com pliance that it under takes. 
4. The mark et surveillance author ity 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 refer red 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 
ORGANIS ATION , ACTIVITIES AND OBLIGA TIONS OF MARKET SUR VEILL ANCE AUTHORITIES AND THE 
SINGLE LIAISON OFFICE 
Article 10 
Designation of mark et surveillance author ities and the single liaison office 
1. Member States shall organise and carry out mark et surveillance as provided for in this Regulation. 
2. For the purposes of paragraph 1 of this Article, each Member State shall designat e one or more mark et 
surveillance author ities in its territory. Each Member State shall inform the Commission and the other Member State s of 
its mark et surveillance author ities and the areas of compe tence of each of those author ities, using the information and 
communication system referred to in Article 34. 
3. Each Member State shall appoint a sing le liaison office. 25.6.2019 L 169/16 Official Jour nal of the European Union EN     4. The sing le liaison office shall at least be responsible for representing the coordinat ed position of the market 
surveillance author ities and the author ities designat ed under Article 25(1) and for communicating the national strategies 
as set out in Article 13. The sing le liaison office shall also assist in the cooperation between mark et surveillance 
author ities in different Member State s, as set out in Chapt er VI. 
5. In order to carry out mark et surveillance of products made available online and offline with the same effectiveness 
for all distr ibution channels, Member State s shall ensure that their mark et surveillance author ities and sing le liaison 
office have the necessar y resources, including sufficient budgetary and other resources, such as a suffi cient number of 
compet ent personnel, exper tise, procedures and other arrang ements for the proper performa nce of their duties. 
6. Where there is more than one mark et surveillance author ity in their territory , Member State s shall ensure that the 
respective duties of those author ities are clearly defined and that appropr iate communication and coordination 
mech anisms are established to enable those author ities to collaborate closely and exer cise their duties effectively . 
Article 11 
Activities of marke t surveillance author ities 
1. Mark et surveillance author ities shall conduct their activities in order to ensure the followi ng: 
(a)  effective mark et 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 appropr iate and propor tionate corrective action in relation to compl iance with 
that legislation and this Regulation; 
(c)  the taking of appropr iate and propor tionate measures where the economic operat or fails to take corrective action. 
2. Mark et surveillance author ities shall exercise their powers and carry out their duties independently , impar tially and 
without bias. 
3. Mark et surveillance author ities, as part of their activities set out in paragraph 1 of this Article, shall perform 
appropr iate checks on the charact eristics of products on an adequate scale, by means of documentar y checks and, where 
appropr iate, physical and laboratory chec ks based on adequat e samples, prioritising their resources and actions to ensure 
effective market surveillance and taking into account the national market surveillance strateg y refer red to in Article 13. 
In deciding on whic h chec ks to perform, on which types of products and on what scale, market surveillance author ities 
shall follow a risk-based approac h taking into account the following factors: 
(a)  possible hazards and non-com pliance associated with the products and, where available, their occur rence on the 
mark et; 
(b)  activities and operations under the control of the economic operator; 
(c)  the economic operat or's past record of non-com pliance; 
(d)  if relevant, the risk prof iling performe d by the author ities designat ed under Article 25(1); 
(e)  consumer compl aints and other information received from other author ities, economic operators, media and other 
sources that might indicate non-com pliance. 
4. The Commission, after consulting the Netw ork, may adopt implementing acts determining the unif orm conditions 
of checks, criteria for deter mination of the frequency of chec ks and amount of samp les to be check ed in relation to 
certain products or categor ies of products, where specific risks or serious breaches of applicable Union harmonisation 
legislation have been continuously identified, in order to ensure high level of prot ection of health and safety or other 
public interests protect ed by that legislation. Those implementing acts shall be adopt ed in accordance with the 
examination procedure refer red to in Article 43(2). 
5. Where economic operators present test repor ts or certificates attes ting the conf ormity of their products with 
Union harmonisation legislation issued by a conf ormity assessment body accredited in accordance with Regulation (EC) 
No 765/2008, mark et surveillance author ities shall take due account of those repor ts or certificates. 25.6.2019 L 169/17 Official Jour nal of the European Union EN     6. Evidence that is used by a mark et surveillance author ity in one Member State may be used as part of investig ations 
to verify product compl iance carried out by market surveillance author ities in another Member State , without any 
further formal requirements. 
7. Mark et surveillance author ities shall establish the following procedures in connection with products subject to the 
Union harmonisation legislation: 
(a)  procedures for followi ng up on compl aints or repor ts on issues relating to risks or non-com pliance; 
(b)  procedures for verifying that the corrective action that was to be take n by economic operat ors has been taken. 
8. With a view to ensur ing communication and coordination with their count erparts in other Member States, mark et 
surveillance author ities shall actively participate in administrative cooperation groups (ADC Os) as refer red 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-com pliant on the basis of a decision of a mark et surveillance author ity in 
one Member State shall be presumed to be non-compliant by market surveillance author ities in other Member State s, 
unless a relevant mark et surveillance author ity in another Member State concluded the contrar y on the basis of its own 
investigation, taking into account the input, if any, provid ed by an economic operator . 
Article 12 
Peer reviews 
1. Peer reviews shall be organised for mark et surveillance author ities 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 mark et 
surveillance author ities. When establishing the methodology and the rolling plan, the Networ k shall take into considera ­
tion, at least, the number and the size of mark et surveillance author ities in the Member States, the number of personnel 
available and other resources for perf orming the peer review , and other relevant criteria. 
3. Peer reviews shall cover best practices developed by some mark et surveillance author ities which may be of benefit 
for other market surveillance author ities, and other relevant aspects related to the effectiveness of market surveillance 
activities. 
4. The outcome of the peer reviews shall be repor ted to the Network. 
Article 13 
National marke t surveillance strategies 
1. Each Member State shall draw up an overarching national mark et surveillance strateg y, at least ever y four 
years. Each Member State shall draw up the first such strateg y by 16 July 2022. The national strategy shall promot e 
a consiste nt, comprehensive and integrat ed approach to market surveillance and to the enforcement of Union harmon ­
isation legislation within the territory of the Member State. When drawing up the national mark et 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 strateg y shall include at least the follo wing elements, when this does not 
compromise market surveillance activities: 
(a)  the available information on the occur rence of non-com pliant products, in particular taking into account the checks 
and controls refer red to in Articles 11(3) and 25(3), respectively , and, where applicable, mark et trends that may 
affect non-compliance rates for the categor ies of products, and possible threats and risks related to emerging 
technologies; 
(b)  the areas identif ied by the Member State s as priorities for the enforcement of Union harmonisation legislation; 25.6.2019 L 169/18 Official Jour nal of the European Union EN     (c)  the enforcement activities planned in order to reduce non-com pliance in those areas identif ied as priorities, 
including, where relevant, the minimum control levels envisag ed for cate gories of products which have significant 
levels of non-com pliance; 
(d)  an assessment of the cooperation with market surveillance author ities in other Member State s, as referred to in 
Article 11(8) and Chapt er VI. 
3. Member States shall communicate their national mark et surveillance strateg y to the Commission and other 
Member State s through the information and communication system referred to in Article 34. Each Member State shall 
publish a summar y of its strategy . 
CHAPTER V 
MARKET SUR VEILL ANCE POWERS AND MEASURES 
Article 14 
Powers of market surveillance author ities 
1. Member State s shall confer on their mark et surveillance author ities the powers of mark et surveillance, investig ation 
and enforcement necessar y for the application of this Regulation and for the application of Union harmonisation 
legislation. 
2. Mark et surveillance author ities shall exer cise the powers set out in this Article efficiently and effectively , in 
accordance with the principle of propor tionality , to the extent that such exercise relat es to the subject matter and the 
purpose of the measures and the nature and the overall actual or poten tial harm resulting from the instance of non- 
compl iance. Powers shall be conferr ed and exercised in accordance with Union and national law, including the principles 
of the Char ter 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 safeg uards and with the 
Union rules on data prot ection, in particular Regulation (EU) 2016/679. 
3. When confe rring powers under paragraph 1, Member States may provid e for the power to be exercisable in one of 
the follo wing ways, as appropr iate: 
(a)  directly by the mark et surveillance author ities under their own author ity; 
(b) by recourse to other public author ities in accordance with the division of powers and the institutional and adminis ­
trative organisation of the Member State in question; 
(c)  upon application to cour ts compet ent to grant the necessar y decision to appro ve the exercise of that power , 
including, where appropr iate, on appeal, if the application to grant the necessar y decision was not successful. 
4. The powers confe rred on mark et surveillance author ities under paragraph 1 shall include at least the followi ng: 
(a)  the power to require economic operat ors to provi de relevant documents, technical specifications, data or 
information on compl iance and technical aspects of the product, including access to embedded software in so far as 
such access is necessar y for the purpose of assessing the product's compl iance with applicable Union harmonisation 
legislation, in any form or format and irrespective of the medium of stora ge 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 operat ors to provide relevant information on the supply chain, on the details of the 
distr ibution network, on quantities of products on the mark et and on other product models that have the same 
technical character istics as the product in question, where relevant for compliance with the applicable requirements 
under Union harmonisation legislation; 
(c)  the power to require economic operat ors to provid e relevant information required for the purpose of ascer taining 
the ownership of websites, where the information in question is relat ed to the subject matte r of the investig ation; 
(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 transpor t 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-com pliance 
and to obtain evidence; 
(f)  the power to start investigations on market surveillance author ities' own initiative in order to identify non- 
compl iances and bring them to an end; 25.6.2019 L 169/19 Official Jour nal of the European Union EN     (g)  the power to require economic operators to take appropr iate action to bring an instance of non-compliance to an 
end or to eliminate the risk; 
(h)  the power to take appropr iate measures where an economic operat or fails to take appropr iate corrective action or 
where the non-com pliance or the risk persists, including the power to prohibit or restr ict 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 samp les and to reverse- 
engineer them in order to identify non-com pliance 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 displa y of a warning to end users when they access an online interfa ce; or 
(ii)  where a request according to point (i) has not been compl ied with, to require information society service 
providers to restr ict access to the online interface, including by requesting a relevant third party to implement 
such measures. 
5. Mark et surveillance author ities may use any information, document, finding, statement, or any intelligence as 
evidence for the purpose of their investigat ions, irrespective of the format in whic h and medium on which they are 
stored. 
Article 15 
Reco very of costs by market surveillance author ities 
1. Member States may author ise their mark et surveillance author ities to reclaim from the relevant economic operat or 
the totalit y of the costs of their activities with respect to instances of non-com pliance. 
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 stora ge and the costs of activities relating to 
products that are found to be non-com pliant and are subject to corrective action prior to their release for free 
circulation or their placing on the mark et. 
Article 16 
Mark et surveillance measures 
1. Mark et surveillance author ities shall take appropr iate 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 conf orm to applicable Union harmonisation legislation. 
2. Where mark et surveillance author ities make findings refer red to in point (a) or (b) of paragraph 1, they shall 
without dela y require the relevant economic operator to take appropr iate and propor tionate corrective action to bring 
the non-com pliance 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 operat or may include, 
inter alia: 
(a)  bringing the product into compliance, including by rectifying formal non-com pliance as defined by the applicable 
Union harmonisation legislation, or by ensur ing that the product no long er presents a risk; 
(b)  preventing the product from being made available on the mark et; 
(c)  withdrawin g or recalling the product immediat ely and alerting the public to the risk presented; 
(d)  destro ying the product or other wise render ing it inoperable; 25.6.2019 L 169/20 Official Jour nal of the European Union EN     (e)  affixing to the product suitable, clearly worded, easily compreh ensible warnings of the risks that it might present, in 
the language or languag es determined by the Member State in whic h the product is made available on the mark et; 
(f)  setting prior conditions for making the product concer ned available on the market ; 
(g)  alerting the end users at risk immediately and in an appropr iate form, including by publication of special warnings 
in the languag e or languages deter mined by the Member State in which the product is made available on the market. 
4. Corrective actions refer red 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 operat or fails to take corrective action refer red to in paragraph 3 or where the non-com pliance or 
the risk referred to in paragraph 1 persists, market surveillance author ities shall ensure that the product is withdrawn or 
recalled, or that its being made available on the mark et is prohibit ed or restr icted, and that the public, the Commission 
and the other Member State s are informed according ly. 
6. The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be 
communicate d through the information and communication system refer red to in Article 34. That communication of 
information shall also be deemed to fulfil notifi cation requirements for the applicable safeg uard procedures of Union 
harmonisation legislation. 
7. Where a national measure is considered to be justified in accordance with the applicable safegua rd procedure, or 
where no market surveillance author ity of another Member State concluded the contrar y as refer red to in Article 11(9), 
the compe tent mark et surveillance author ities in the other Member States shall take the necessar y measures in respect of 
the non-com pliant product and shall enter the relevant information in the information and communication system 
referred to in Article 34. 
Article 17 
Use of information, prof essional and commercial secrecy 
Mark et surveillance author ities shall perform their activities with a high level of transparency and shall mak e available to 
the public any information that they consider to be relevant in order to prote ct the inter ests of end users. Mark et 
surveillance author ities 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 mark et surveillance author ities 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 dela y to the relevant economic operat or, who 
shall at the same time be informed of the remedies available to it under the law of the Member State concer ned and of 
the time limits to which those remedies are subject. 
3. Before a measure, decision or order refer red to in paragraph 1 is taken or made, the economic operator concer ned 
shall be given the oppor tunity to be heard within an appropr iate period of not less than 10 working days, unless it is 
not possible to give the economic operator that oppor tunity because of the urgency of the measure, decision or order , 
based on health or safety requirements or other grounds relating to the public inter ests covered by the relevant Union 
harmonisation legislation. 
If the measure, decision or order is take n or made without the economic operat or being given the oppor tunity to be 
heard, the economic operat or shall be given that oppor tunity as soon as possible thereaf ter and that measure, decision 
or order shall be reviewed promp tly by the market surveillance author ity. 25.6.2019 L 169/21 Official Jour nal of the European Union EN     Article 19 
Products presenting a serious risk 
1. Mark et surveillance author ities shall ensure that products presenting a serious risk are withdra wn or recalled, 
where there is no other effective means available to eliminate the serious risk, or that their being made available on the 
mark et is prohibit ed. Mark et surveillance author ities shall notify the Commission thereof immediate ly, in accordance 
with Article 20. 
2. A decision whether or not a product presents a serious risk shall be based on an appropr iate risk assessment that 
take s account of the nature of the hazard and the likelihood of its occur rence. The feasibility of obtaining higher levels 
of safety and the availability of other products presenting a lesser degree of risk shall not constitut e grounds for 
consider ing that a product presents a serious risk. 
Article 20 
Rapid Information Exc hange System 
1. Where a market surveillance author ity takes or intends to take a measure pursuant to Article 19 and considers 
that the reasons whic h prom pted the measure or the effects of the measure go beyond the territory of its Member State, 
it shall immediate ly notify the Commission of that measure in accordance with paragraph 4 of this Article. The mark et 
surveillance author ity shall also inform the Commission without dela y of the modification or withdrawal of any such 
measure. 
2. If a product presenting a serious risk has been made available on the mark et, market surveillance author ities shall 
immediately notify the Commission of any volun tary measures taken and communicate d to the market surveillance 
author ity by an economic operat or. 
3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular 
the data necessar y for the identif ication 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 volun tary measures taken by 
economic operators. 
4. For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) 
provid ed 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 provid e and maintain a data interface between RAPEX and the information and communi ­
cation system referred to in Article 34 so as to avoid double data entr y. 
Article 21 
Union testing facilities 
1. The objective of the Union testing facilities is to contr ibut e to enhancing laborat ory capacity , as well as to ensur ing 
the reliability and consist ency of testing, for the purposes of market surveillance within the Union. 
2. For the purposes of paragraph 1, the Commission may designat e a public testing facility of a Member State as 
a Union testing facility for specific catego ries of products or for specific risks relat ed to a catego ry of products. 
The Commission may also designate one of its own testing facilities as a Union testing facility for specifi c categor ies of 
products or for specific risks relat ed to a categor y of products, or for products for which testing capacity is missing or is 
not suffi cient. 
3. Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008. 
4. The designation of Union testin g facilities shall not affect the freedom of market surveillance author ities, the 
Networ k and the Commission to choose testing facilities for the purpose of their activities. 
5. Designat ed Union testing facilities shall provid e their services solely to market surveillance author ities, the 
Networ k, the Commission and other govern ment or intergo vernmental entities. 25.6.2019 L 169/22 Official Jour nal of the European Union EN     6. Union testing facilities shall, within the area of their compet ence, perform the followi ng activities: 
(a)  carry out testing of products at the request of market surveillance author ities, the Network or the Commission; 
(b)  provid e 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 cate gories of products or for specifi c risks relat ed to 
a cate gory 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 adopt ed in accordance with the examination procedure referred to in 
Article 43(2). 
CHAPTER VI 
CROSS-BORDER MUTU AL ASSIST ANCE 
Article 22 
Mutual Assist ance 
1. There shall be efficient cooperation and exchange of information among the mark et surveillance author ities of the 
Member States, and between mark et surveillance author ities and the Commission and the relevant Union agencies. 
2. When a mark et surveillance author ity is unable to conclude its investig ation because of its inability to access 
certain information, despite having made all appropr iate efforts to obtain that information, it may submit a reasoned 
request to the market surveillance author ity of another Member State where access to this information can be enforced. 
In this case the request ed author ity shall supply to the applicant author ity without dela y, and in any event within 
30 days, any information that the requested author ity considers to be relevant in order to establish whether a product is 
non-com pliant. 
3. The request ed author ity shall under take appropr iate investiga tions or take any other measures that are appropr iate 
in order to gather the request ed information. Where necessar y, those investigations shall be carried out with the 
assistance of other market surveillance author ities. 
4. The applicant author ity shall remain responsible for any investig ation that it has initiat ed, unless the request ed 
author ity agrees to take over responsibility . 
5. In duly justif ied cases, a request ed author ity may refuse to compl y with a request for information under 
paragraph 2 where: 
(a)  the applicant author ity has not suffi ciently substantiated that the request ed information is necessar y in order to 
establish non-complian ce; 
(b) the requeste d author ity demonstrate s reasonable grounds showi ng that compl ying with the request would substan ­
tially impair the execution of its own activities. 
Article 23 
Requests for enforcement measures 
1. Where bringing non-com pliance with regar d 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 
author ity may submit a duly reasoned request for enforcement measures to a request ed author ity in that other Member 
State. 
2. The requeste d author ity shall without dela y take all appropr iate and necessar y enforcement measures using the 
powers conferred on it under this Regulation in order to bring the instance of non-complian ce to an end by exer cising 
the powers laid down in Article 14 and any additional powers grant ed to it under national law. 25.6.2019 L 169/23 Official Jour nal of the European Union EN     3. The request ed author ity shall inform the applicant author ity about the measures refer red to in paragraph 2 that 
have been taken or whic h are intende d to be taken. 
A requeste d author ity may refuse to compl y with a request for enforcement measures in any of the followi ng situations: 
(a)  the requeste d author ity concludes that the applicant author ity has not provi ded suffi cient information; 
(b)  the requeste d author ity considers that the request is contrar y to Union harmonisation legislation; 
(c) the requeste d author ity demonstrate s reasonable grounds showi ng that compl ying with the request would substan ­
tially impair the execution of its own activities. 
Article 24 
Procedure for mutual assis tance requests 
1. Before submitting a request under Article 22 or 23, the applicant author ity shall endeav our to carry out all 
reasonable possible investigat ions. 
2. When submitting a request under Article 22 or 23, the applicant author ity shall provid e all available information 
in order to enable the request ed author ity to fulfil the request, including any necessar y evidence obtainable only in the 
Member State of the applicant author ity. 
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 refer red to in Article 34. 
4. Communication shall take place directly between the involved mark et surveillance author ities or through the sing le 
liaison office s of the Member States concer ned. 
5. The language s 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 author ities concer ned. 
6. Where no agreement about the languag es to be used can be reached between the market surveillance author ities 
concer ned, the requests under Articles 22 and 23 shall be sent in the official language of the Member State of the 
applicant author ity, and the replies to such requests shall be sent in the official languag e of the Member State of the 
request ed author ity. In such case, the applicant author ity and the requeste d author ity shall arrange for the translation of 
the requests, replies or other documents that it receives from the other author ity. 
7. The information and communication syste m refer red to in Article 34 shall provide structured information on 
mutual assistance cases to the sing le liaison office s involved. Using this information, sing le liaison offices shall provide 
any suppor t that is necessar y to facilitate assistance. 
CHA PTER VII 
PRODUCTS ENTERING THE UNION MARKET 
Article 25 
Controls on products enter ing the Union market 
1. Member State s shall designate customs author ities, one or more mark et surveillance author ities or any other 
author ity in their territory as the author ities in charge of the control on products entering the Union mark et. 
Each Member State shall inform the Commission and the other Member States of the author ities designate d under the 
first subparagraph and of their areas of compet ence through the information and communication system refer red to in 
Article 34. 
2. The author ities designate d under paragraph 1 shall have the necessar y powers and resources for the proper 
performa nce of their tasks as refer red 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 perf ormed by the author ities designate d 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 refer red to in the second subparagraph of Article 11(3) of this 
Regulation. 25.6.2019 L 169/24 Official Jour nal of the European Union EN     4. Risk -relat ed information shall be exchanged between: 
(a)  the author ities designat ed under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) 
No 952/2013; and 
(b)  customs author ities 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 temporar y storage or placed under a customs 
procedure other than ‘release for free circulation’, customs author ities at the first point of entr y have reason to believe 
that those products are not compl iant with applicable Union law or present a risk, they shall transmit all relevant 
information to the compet ent customs office of destination. 
5. Mark et surveillance author ities shall provide author ities designat ed under paragraph 1 with information on 
catego ries of products or the identity of economic operat ors where a higher risk of non-com pliance has been identified. 
6. By 31 March of each year , Member State s shall submit to the Commission detailed statistical data cover ing controls 
performed by the author ities designat ed under paragraph 1 with respect to products subject to Union law during the 
previous calendar year. The statistical data shall cover the number of inter ventions in the field of controls on such 
products with rega rd to product safety and compl iance. 
The Commission shall draw up a repor t by 30 June of each year , containing the information provid ed by the Member 
States for the previous calendar year and an analysis of the data submitte d. The repor t shall be published in the 
information and communication system referred to in Article 34. 
7. Where the Commission becomes aware of a serious risk present ed by products subject to Union law that are 
imported from a third countr y, it shall recommend to the Member State concer ned to take appropr iate mark et 
surveillance measures. 
8. The Commission, after consulting the Network, may adop t implementing acts laying down benc hmark s and 
techniques for chec ks on the basis of common risk analysis on the Union level, in order to ensure a consiste nt 
enforcement of Union law, to strengthen the controls on products enter ing the Union mark et and to ensure an effective 
and unif orm level of such controls. Those implementing acts shall be adop ted in accordance with the examination 
procedure refer red 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 adopt ed in accordance with the examination procedure 
referred to in Article 43(2). 
Article 26 
Suspension of release for free circulation 
1. Author ities 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 accompan ied by the documentation required by the Union law applicable to it or there is 
a reasonable doubt as to the authenticity , accuracy or compl eteness 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 whic h has been affixed 
in a false or misleading manner ; 
(d)  the name, registere d trade name or registere d trade mark and the contact details, including the postal address, of an 
economic operator with tasks regar ding the product subject to certain Union harmonisation legislation is not 
indicated or identif iable 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, safet y, the environment or any other public inter est refer red to in 
Article 1. 
2. Author ities designat ed under Article 25(1) shall immediate ly notify the mark et surveillance author ities of any 
suspension of release refer red to in paragraph 1 of this Article. 25.6.2019 L 169/25 Official Jour nal of the European Union EN     3. Where the mark et surveillance author ities have reasonable grounds to believe that a product does not compl y with 
the Union law applicable to it or presents a serious risk, they shall request the author ities designate d 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 system s used by customs author ities, 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 followi ng conditions is satisfi ed: 
(a)  within four working days of the suspension, the author ities designated under Article 25(1) have not been requeste d 
by the market surveillance author ities to maintain the suspension; 
(b)  the author ities designat ed under Article 25(1) have been informed by the market surveillance author ities of its 
approval for release for free circulation. 
The release for free circulation shall not be deemed to be proof of conf ormity with Union law. 
Article 28 
Refusal to release for free circulation 
1. Where the market surveillance author ities 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 author ities designated under Article 25(1) not 
to release it for free circulation. They shall also require these author ities to include the followi ng notice in the customs 
data-processing system , and, where appropr iate, on the commercial invoice accompan ying the product and on any other 
relevant accompan ying document: 
‘Dange rous product — release for free circulation not author ised — Regulation (EU) 2019/1020’. 
Mark et surveillance author ities shall immediately enter that information in the information and communication system 
referred to in Article 34. 
2. Where mark et surveillance author ities conclude that a product may not be placed on the market since it does not 
compl y with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the 
mark et and shall require the author ities designated under Article 25(1) not to release it for free circulation. They shall 
also require those author ities to include the follo wing notice in the customs data-processing system, and, where 
appropr iate, on the commercial invoice accompan ying the product and on any other relevant accompan ying document: 
‘Product not in conf ormity — release for free circulation not author ised — Regulation (EU) 2019/1020’. 
Mark et surveillance author ities shall immediately enter that information in the information and communication system 
referred to in Article 34. 
3. Where the product refer red to in paragraph 1 or 2 is subsequently declared for a custom s procedure other than 
release for free circulation and provided that the market surveillance author ities 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. Author ities designat ed under Article 25(1) may destro y or other wise render inoperable a product which presents 
a risk to the health and safet y of end users where the author ity in question considers that it is necessar y and propor ­
tionate to do so. The cost of such measure shall be borne by the natural or legal person declar ing the product for free 
circulation. 
Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply according ly. 25.6.2019 L 169/26 Official Jour nal of the European Union EN     CHAPTER VIII 
COORDINA TED ENF ORCEMENT AND INTERNA TIONAL COOPERA TION 
Article 29 
Union Product Compliance Netw ork 
1. A Union Product Compliance Network (‘the Network’) is hereby established. 
2. The purpose of the Network is to serve as a platf orm for structured coordination and cooperation between 
enforcement author ities of the Member States and the Commission, and to streamline the practices of mark et 
surveillance within the Union, thereby making market surveillance more effective. 
Article 30 
Composition and functioning of the Netw ork 
1. The Network shall be compo sed of representatives from each Member State , including a representative of each 
sing le liaison office refer red to in Article 10 and an optional national exper t, the chairs of ADC Os, and representatives 
from the Commission. 
2. Separate or joint ADCOs shall be established for the unif orm application of Union harmonisation legislation. 
ADC Os shall be composed of representatives of the national mark et surveillance author ities and, if appropr iate, 
representatives of the sing le liaison offices. 
ADC Os meetings are intended only for representatives of mark et surveillance author ities and the Commission. 
Relevant stake holders, such as organisations representing the inter ests of industr y, small and medium-sized enterprises 
(SMEs), consumers, testing laboratories, standardisation and conf ormity assessment bodies at Union level, may be invit ed 
to attend the ADCOs meetings depending on the subject matt er of discussion. 
3. The Commission shall suppor t and encourage cooperation between market surveillance author ities through the 
Networ k and participat e in the meetings of the Netw ork, its sub-groups and the ADC Os. 
4. The Network shall meet at regular inter vals and, where necessar y, at the reasoned request of the Commission or 
a Member State . 
5. The Network may establish standing or temporar y sub-groups dealing with specif ic questions and tasks. 
6. The Network may invite exper ts and other third parties, including the orga nisations representing the interests of 
industr y, SMEs, consumers, testing laborat ories, standardisation and conf ormity assessment bodies at Union level, to 
attend meetings as obser vers or to provide written contr ibutions. 
7. The Network shall use its best endeav ours to reach consensus. Decisions take n by the Network shall be legally 
non-binding recommendations. 
8. The Network shall establish its own rules of procedure. 
Article 31 
Role and task s of the Netw ork 
1. In carrying out the tasks set out in paragraph 2, the Network shall address general, horizontal issues of mark et 
surveillance with a view to facilitating the cooperation among sing le liaison office s, as well as the Commission. 
2. The Network shall have the following task s: 
(a)  to prepare, adopt and monitor the implementation of its work programme; 
(b)  to facilita te the identification of common priorities for mark et surveillance activities and the exchange of 
information across sectors on evaluations of products, including risk assessment, test methods and results, recent 
scientific developments and new technologies, emerging risks and other aspects relevant to control activities and on 
the imple mentation of national mark et surveillance strategies and activities; 25.6.2019 L 169/27 Official Jour nal of the European Union EN     (c)  to coordinat e ADC Os and their activities; 
(d)  to organise cross-sector joint mark et surveillance and testing projects and define their priorities; 
(e)  to exchang e exper tise and best practices, in particular regar ding the imp lementation of national mark et surveillance 
strateg ies; 
(f)  to facilitate the organisation of training programmes and exchanges of personnel; 
(g)  in collaboration with the Commission, to organise information camp aigns and voluntar y mutual visit programmes 
between mark et surveillance author ities; 
(h)  to discuss questions arising from cross-border mutual assistance mec hanisms; 
(i)  to contr ibute to the development of guidance to ensure the effective and unif orm application of this Regulation; 
(j)  to propose the financing of activities referred to in Article 36; 
(k)  to contr ibute to unif orm administrative practices with regard to mark et surveillance in the Member States; 
(l)  to provi de advice and assist the Commission with issues related to the further development of RAPEX and the 
information and communication system referred to in Article 34; 
(m)  to promot e the cooperation and exchange of exper tise and best practices between mark et surveillance author ities 
and author ities in charg e of controls at the Union's exte rnal borders; 
(n)  to promote and facilitat e collaboration with other relevant netw orks and groups, with a view to explore possibilities 
for using new technologies for the purposes of mark et surveillance and traceability of products; 
(o)  to evaluate regularly the national market surveillance strateg ies, the first such evaluation taking place by 16 July 
2024; 
(p)  to take up any other issues in activities within the remit of the Network, with the aim of contr ibuting to the 
effective functioning of market surveillance within the Union. 
Article 32 
Role and task s of administ rativ e cooperation groups 
1. In carrying out the tasks set out in paragraph 2, ADC Os shall address specifi c matt ers related to mark et 
surveillance and sector specif ic issues. 
2. ADC Os shall have the followi ng tasks: 
(a)  to facilitate the unif orm application of Union harmonisation legislation within their area of compet ence with a view 
to increasing the efficiency of market surveillance throughout the internal market ; 
(b)  to promote communication between mark et surveillance author ities and the Networ k and develop mutual 
conf idence between mark et surveillance author ities; 
(c)  to establish and coordinat e common projects, such as cross-border joint mark et surveillance activities; 
(d)  to develop common practices and methodologies for effective mark et surveillance; 
(e)  to inform each other of national mark et surveillance methods and activities and to develop and promote best 
practices; 
(f)  to identify issues of shared inter est relating to mark et surveillance and sugges t common approach es to be adopt ed; 
(g)  to facilitate sector-specific evaluations of products, including risk assessments, test methods and results, recent 
scientific developments and other aspects relevant to control activities. 
Article 33 
Role and tasks of the Commission 
The Commission shall have the follo wing tasks: 
(a)  to assist the Networ k, its sub-groups, and the ADCOs by means of an executi ve secretar iat that provides technical 
and logistic suppor t; 
(b)  to keep and make available to the sing le liaison offices and ADC O chairs an updated list of ADC O chairs, including 
their contact information; 25.6.2019 L 169/28 Official Jour nal of the European Union EN     (c)  to assist the Netw ork in prepar ing and monitori ng its work programme; 
(d)  to suppor t the functioning of the Product Contact Points having duties assigned by Member State s in relation to 
Union harmonisation legislation; 
(e)  to determi ne, in consultation with the Network, the need for additional testin g capacity and to propose solutions 
for that purpose, in accordance with Article 21; 
(f)  to apply the instr uments of internati onal cooperation refer red to in Article 35; 
(g)  to provid e suppor t for the establishment of separate or joint ADC Os; 
(h)  to develop and maintain the information and communication system refer red to in Article 34, including the 
interfa ce refer red to in Article 34(7), as well as the interface with national market surveillance databases, and 
provid e information to the public by means of that system; 
(i)  to assist the Network to perform preliminar y or ancillar y work in connection with the implementation of mark et 
surveillance activities linked to the application of Union harmonisation legislation, such as studies, programmes, 
evaluations, comparat ive analyses, mutual joint visits and visit programmes, exchange of personnel, research work, 
laboratory work, prof iciency testin g, inter -laboratory tests and conf ormity assessment work; 
(j)  to prepare and assist in the implementation of Union mark et surveillance campai gns and similar activities; 
(k)  to organise joint mark et surveillance and testing projects, and common training programmes, to facilitat e exchanges 
of personnel between mark et surveillance author ities and, where appropr iate, with the market surveillance 
author ities of third countr ies or with international organisations, and to organise information campaigns and 
volun tary mutual visit programmes between market surveillance author ities; 
(l)  to carry out activities under programmes of technical assistance, cooperation with third countr ies and the 
promotion and enhancement of Union market surveillance policies and systems among inter ested parties at Union 
and international level; 
(m)  to facilitat e technical or scientifi c exper tise for the purpose of implementing market surveillance administrative 
cooperation; 
(n)  to examine, at the request of the Networ k or on its own initiative, any question cover ing the application of this 
Regulation and issue guidelines, recommendations and best practices in order to encourage consist ent application of 
this Regulation. 
Article 34 
Informa tion and communication system 
1. The Commission shall further develop and maintain an information and communication system for the collection, 
processing and stora ge of information, in a structured form, on issues relating to the enforcement of Union harmonisa ­
tion legislation, with the aim of improving the shar ing of data among Member State s, including for the purpose of 
requests for information, provid ing a comprehensive overview of mark et surveillance activities, results and trends. The 
Commission, mark et surveillance author ities, sing le liaison offices, and author ities designate d under Article 25(1) shall 
have access to that system. The Commission shall develop and maintain the public user interface of this system , where 
key information for end-users about mark et surveillance activities shall be provid ed. 
2. The Commission shall further develop and maintain electronic interf aces between the syste m referred to in 
paragraph 1 and national market surveillance system s. 
3. Sing le liaison office s shall enter the follo wing information in the information and communication system : 
(a)  the identity of the mark et surveillance author ities in their Member State and areas of compet ence of those 
author ities pursuant to Article 10(2); 
(b)  the identity of the author ities designat ed under Article 25(1); 
(c)  the national market surveillance strateg y drawn up by their Member State under Article 13 and the results from the 
review and assessment of the mark et surveillance strategy . 25.6.2019 L 169/29 Official Jour nal of the European Union EN     4. Mark et surveillance author ities shall enter into the information and communication system in relation to products 
made available on the mark et for which an in-dep th chec k of compl iance has been carried out, without prejudice to 
Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products 
entering the Union market for whic h the process for the release for free circulation has been suspended in accordance 
with Article 26 of this Regulation, in their territory, the following information concer ning: 
(a)  measures according to Article 16(5) taken by that market surveillance author ity; 
(b)  repor ts of testing carried out by them; 
(c)  corrective action taken by economic operators concer ned; 
(d)  readily available repor ts on injur ies caused by the product in question; 
(e) any objection raised by a Member State in accordance with the applicable safeg uard procedure in the Union harmon ­
isation legislation applicable to the product and any subsequent follow-up; 
(f)  where available, failures by author ised representatives to compl y with Article 5(2); 
(g)  where available, failures by manufacturers to compl y with Article 5(1). 
5. Where market surveillance author ities consider it useful, they may enter into the information and communication 
system any additional information relat ed to the checks they perform and results of testing carried out by them or at 
their request. 
6. Where relevant for the enforcement of Union harmonisation legislation and for the purpose of minimising risk, 
customs author ities shall extract from national customs syste ms information on products placed under the customs 
procedure ‘release for free circulation’ relat ed to the enforcement of Union harmonisation legislation and transmit it to 
the information and communication system. 
7. The Commission shall develop an electronic interface to enable the transmission of data between national customs 
system s and the information and communication system. This interface shall be in place within four years from the date 
of adoptio n of the relevant imp lementing act refer red to in paragraph 8. 
8. The Commission shall adopt implementing acts specifying the details of implementation arrange ments for 
paragraphs 1 to 7 of this Article, and in particular the data processing to be applied on data collect ed in accordance 
with paragraph 1 of this Article, and defining the data to be transmitted in accordance with paragraphs 6 and 7 of this 
Article. Those implementing acts shall be adop ted in accordance with the examination procedure refer red to in 
Article 43(2). 
Article 35 
Inter national cooperation 
1. In order to improve the efficiency of mark et surveillance in the Union, the Commission may cooperat e with and 
exchange mark et surveillance relat ed information with regulatory author ities of third countr ies or international organ­
isations within the framewor k of agreements concluded between the Union and third countr ies or intern ational organ­
isations. Any such agreements shall be based on reciprocity , include provisions on confidentiality corresponding to those 
applicable in the Union, and ensure that any exchange of information is in accordance with applicable Union law. 
2. The cooperation or exchange of information may relat e, inter alia, to the follo wing: 
(a)  risk assessment methods used and the results of product-t esting; 
(b)  coordinat ed product recalls or other similar actions; 
(c)  the measures taken by market surveillance author ities under Article 16. 
3. The Commission may approve a specifi c syste m of product-related pre-expor t control carried out by a third 
countr y on products immediately prior to their expor t into the Union in order to verify that those products satisfy the 
requirements of the Union harmonisation legislation applicable to them. The approval may be grant ed in respect of one 
or more products, in respect of one or more categor ies of products or in respect of products or categor ies of products 
manufa ctured by certain manufact urers. 
4. The Commission shall produce and maintain a list of those products or categor ies of products with regar d to 
whic h approval has been grant ed as referred to in paragraph 3 and shall make this list available to the public. 25.6.2019 L 169/30 Official Jour nal of the European Union EN     5. Approv al may only be granted to a third countr y under paragraph 3 if followi ng conditions are satisfied: 
(a)  the third countr y possesses an efficient verification system of the compliance of products expor ted to the Union, 
and the controls carried out in that third countr y are sufficiently effective and efficient to replace or reduce impor t 
controls; 
(b)  audits within the Union and, if relevant, in the third countr y demonstrate that products expor ted from that third 
countr y to the Union satisfy the requirements set out in Union harmonisation legislation. 
6. Where such an approval has been grant ed, the risk assessment applied to impor t controls for those products or 
catego ries of products entering the Union market, referred to in paragraph 3, shall include the grant ed approvals. 
Author ities designated under Article 25(1) may however carry out controls on those products or catego ries of products 
entering the Union mark et, including in order to ensure that the pre-expor t controls carried out by the third countr y are 
effective to deter mine compl iance with Union harmonisation legislation. 
7. The appro val refer red to in paragraph 3 shall specify the compet ent author ity of the third countr y under whose 
responsibility the pre-expor t controls are to be performe d and that compet ent author ity shall be the counter part for all 
contacts with the Union. 
8. The compet ent author ity, refer red to in paragraph 7, shall ensure the official verification of the products prior to 
their entr y into the Union. 
9. Where controls on products entering the Union market refer red to in paragraph 3 of this Article reveal significant 
non-com pliance, the mark et surveillance author ities shall notify immediately the Commission through the information 
and communication system refer red to in Article 34 and adap t the level of controls on such products. 
10. The Commission shall adopt implementing acts appro ving each specific system of product-relate d pre-expor t 
controls, referred to in paragraph 3 of this Article. Those implementing acts shall be adopt ed in accordance with the 
examination procedure refer red to in Article 43(2). 
11. The Commission shall regularly monitor the correct functioning of the appro val granted under paragraph 3 of 
this Article. The Commission shall adopt implementing acts withdrawing that appro val where it is revealed that the 
products entering the Union mark et do not compl y with Union harmonisation legislation in a signif icant number of 
instances. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red to in 
Article 43(2). The Commission shall immediately inform the third countr y concer ned thereof. 
12. The syste m of product-related pre-expor t control shall be evaluated in accordance with Article 42(4). 
CHAPTER IX 
FINANCIAL PROVISIONS 
Article 36 
Financing activities 
1. The Union shall finance perf ormance of the task s of the Network refer red to in Article 31 and the peer reviews 
referred to in Article 12. 
2. The Union may finance the followi ng activities in relation to the application of this Regulation: 
(a)  the functioning of the Product Contact Points; 
(b)  the establishment and functioning of Union testing facilities refer red to in Article 21; 
(c)  the development of instr uments of international cooperation referred to in Article 35; 
(d)  the drawing up and updating of contr ibutions to guidelines on mark et surveillance; 
(e)  the making available to the Commission of technical or scientifi c exper tise for the purpose of assisting the 
Commission in its implementation of market surveillance administrative cooperation; 
(f)  the imple mentation of national mark et surveillance strategies refer red to in Article 13; 
(g)  Member States' and Union market surveillance campaigns and associated activities, including resources and 
equipment, IT tools and training; 25.6.2019 L 169/31 Official Jour nal of the European Union EN     (h)  the performance of preliminar y or ancillar y work in connection with mark et surveillance activities related to the 
application of Union harmonisation legislation, such as studies, programmes, evaluations, guidelines, comparative 
analyses, mutual joint visits and visit programmes, exchange of personnel, research work, training activities, 
laboratory work, prof iciency testin g, inter -laboratory tests and conf ormity assessment work; 
(i)  activities carried out under programmes provid ing technical assistance, cooperation with third countr ies and the 
promotion and enhancement of Union mark et surveillance policies and systems amongst interested parties at Union 
and international level. 
3. The Union shall finance the electronic interfa ce referred to in Article 34(7), including the development of the 
information and communication system refer red to in Article 34 to enable it to receive automatic flows of electronic 
data from the national custom s systems. 
4. The Union shall finance the electronic interfaces referred to in Article 34(2) enabling the exchange of data between 
the information and communication system referred to in Article 34 and the national market surveillance syste ms. 
5. The Union's financial assistance with respect to the activities in suppor t of this Regulation shall be implemented in 
accordance with Regulation (EU, Euratom ) 2018/1046 of the European Parliament and of the Council (52), either 
directly , or by entr usting budget implementation task s to the entities listed in point (c) of Article 62(1) of that 
Regulation. 
6. The appropr iations allocated to activities referred to in this Regulation shall be determined each year by the 
budgetary author ity within the limits of the financial framew ork in force. 
7. The appropr iations determined by the budgetary author ity for the financing of market surveillance activities may 
also cover expenses relating to preparatory work, monitoring, control, audit and evaluation activities whic h are required 
for the manage ment of the activities set out in this Regulation and for the achi evement of their objectives. These 
expenses shall include the costs of conducting studies, arranging meetings of exper ts, information and communication 
activities, including corporat e communication of the political priorities of the Union in so far as they are relat ed to the 
general objectives of mark et surveillance activities, expenses linke d to information technology netw orks focusing on 
information processing and exchang e together with all other related technical and administrative assistance expenses 
incur red by the Commission. 
Article 37 
Protection of the financial interes ts of the Union 
1. The Commission shall take appropr iate measures to ensure that, when activities financed under this Regulation are 
implemented, the financia l inter ests of the Union are prot ected by the application of preventive measures against fraud, 
corruption and any other illegal activities, by effective controls and, if irregular ities are detected, by the recovery of the 
amounts wrong ly paid and, where appropr iate, by effective, propor tionate and dissuasive administrative and financial 
penalties. 
2. The Commission or its representatives and the Cour t of Aud itors shall have the power of audit, on the basis of 
documents and of on-the-spot inspections, over all grant benefi ciaries, contractors and subcontractor s who have 
received Union funds under this Regulation. 
3. The European Anti-Fraud Office (OLAF) may carry out inve stigations, including on-the-spot controls and 
inspections, in accordance with the provi sions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of 
the European Parliament and of the Council (53) and Council Regulation (Euratom, EC) No 2185/96 (54) with a view to 
establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the 
Union in connection with a grant agreement or grant decision or a contract funded under this Regulation. 25.6.2019 L 169/32 Official Jour nal of the European Union EN     
(52)Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to 
the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, 
(EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU 
and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). 
(53)Regulation (EU, Eurato m) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concer ning investi ­
gatio ns conducted by the European Anti-Fraud Offi ce (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament 
and of the Council and Council Regulation (Eurat om) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). 
(54)Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concer ning on‑the‑spot checks and inspections carried out by the 
Commission in order to protect the European Communities' financial interests again st fraud and other irregular ities (OJ L 292, 
15.11.1996, p. 2). 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countr ies and with international 
organisations, contracts, grant agreements and grant decisions resulting from the imp lementation of this Regulation shall 
contain provisions expressly empo wering the Commission, the Cour t of Aud itors and OLAF to conduct such audits and 
investigations, in accordance with their respective compet ences. 
CHA PTER X 
AMENDMENTS 
Article 38 
Amendments to Directiv e 2004/42/EC 
Articles 6 and 7 of Directive 2004/42/EC of the European Parliament and of the Council (55) are delet ed. 
Article 39 
Amendments to Regulation (EC) No 765/2008 
1. Regulation (EC) No 765/2008 is amended as follows:  
(1) the title is replaced by the followi ng: 
‘Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the 
requirements for accreditation and repealing Regulation (EEC) No 339/93’;  
(2) in Article 1, paragraphs 2 and 3 are delet ed;  
(3) in Article 2, points 1, 2, 14, 15, 17, 18 and 19 are deleted;  
(4) Chapt er III, containing Articles 15 to 29, is deleted;  
(5) paragraph 1 of Article 32 is amended as follows: 
(a)  point (c) is replaced by the followi ng: 
‘(c)  the drawing up and updating of contr ibutions to guidelines in the fields of accreditation, notifi cation to the 
Commission of conf ormity assessment bodies and conf ormity assessment ;’; 
(b)  points (d) and (e) are delet ed; 
(c)  points (f) and (g) are replaced by the follo wing: 
‘(f)  the perf ormance of preliminar y or ancillar y work in connection with the implementation of the conf ormity 
assessment, metrology and accreditation activities linked to the implementation of Community legislation, 
such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research 
work, the development and maintenanc e of databases, training activities, laborat ory work, prof iciency 
testing, inter -laboratory tests and conf ormity assessment work; 
(g)  activities carried out under programmes of technical assistance, cooperation with third countr ies and the 
promotion and enhancement of European conf ormity assessment and accreditation policies and systems 
among interest ed parties in the Community and at international level.’ 
2. References to the deleted provisions of Regulation (EC) No 765/2008 shall be constr ued as references to the 
provis ions of this Regulation and shall be read in accordance with the correlation table in Annex III to this Regulation. 
Article 40 
Amendments to Regulation (EU) No 305/2011 
In Article 56(1) of Regulation (EU) No 305/2011, the first subparagraph is replaced by the followi ng: 
‘1. Where the mark et surveillance author ities of one Member State have sufficient reason to believe that 
a constr uction product covered by a harmonised standard or for which a European Technical Assessment has been 
issued does not achi eve the declared performance and presents a risk for the fulfilment of the basic requirements for 
constr uction works covered by this Regulation, they shall carry out an evaluation in relation to the product 
concer ned cover ing the respective requirements laid down by this Regulation. The relevant economic operat ors shall 
cooperat e as necessar y with the mark et surveillance author ities.’ 25.6.2019 L 169/33 Official Jour nal of the European Union EN     
(55)Directive 2004/42/EC of the European Parliament and of the Council of 21 Apr il 2004 on the limitation of emissions of volatile organic 
compo unds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending 
Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87). CHAPTER XI 
FINAL PROVISIONS 
Article 41 
Penalties 
1. The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and of 
Union harmonisation legislation listed in Annex II that imp ose oblig ations on economic operat ors and shall take all 
measures necessar y to ensure that they are implemented in accordance with national law. 
2. The penalties provid ed for shall be effective, propor tionate and dissuasive. 
3. The Member States shall, by 16 October 2021, notify those provisions to the Commission, where they have not 
previously been notified , and shall notify it, without dela y, of any subsequent amendment affecting them. 
Article 42 
Evaluation, review and guidelines 
1. By 31 December 2026 and ever y five years thereaf ter, the Commission shall carry out an evaluation of this 
Regulation in light of the objectives that it pursues and shall present a repor t thereon to the European Parliament, to the 
Council and to the European Economic and Social Committee. 
2. The repor t shall assess whether this Regulation achi eved its objective, in particular with rega rd to reducing the 
number of non-com pliant products on the Union mark et, ensur ing effective and efficient enforcement of Union harmon ­
isation legislation within the Union, improving cooperation between compet ent author ities and strengthening the 
controls on products entering the Union mark et, while taking into account the imp act on business and in particular on 
SMEs. In addition, the evaluation shall also assess the scope of this Regulation, the effectiveness of the peer review 
system and of the mark et surveillance activities that receive Union financing in the light of the requirements of Union 
policies and law and the possibilities to further impro ve the cooperation between the mark et surveillance author ities and 
customs author ities. 
3. By 16 July 2023, the Commission shall prepare an evaluation repor t on the implementation of Article 4. The 
repor t shall in particular evaluate the scope of that Article, its effects and its costs and benefits. The repor t shall be 
accompan ied, where appropr iate, by a legislative proposal. 
4. Within four years after the first appro val of a specifi c system of product-relat ed pre-expor t control referred to in 
Article 35(3), the Commission shall carry out an evaluation of its effects and cost efficiency . 
5. In order to facilitate the implementation of this Regulation, the Commission shall draw up guidelines for the 
practical implementation of Article 4 for the purposes of mark et surveillance author ities and economic operators. 
Article 43 
Committee procedure 
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of 
Regulation (EU) No 182/2011. 
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply . 
Where the committee delivers no opinion, the Commission shall not adopt the draf t imple menting act in respect of the 
implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this 
Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply . 
Article 44 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 16 July 2021. Howe ver, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 Januar y 2021. 25.6.2019 L 169/34 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 20 June 2019. 
For the Europ ean Parliament 
The President 
A. TAJANI  For the Council 
The Presid ent 
G. CIAMBA   25.6.2019 L 169/35 Official Jour nal of the European Union EN     ANNEX I 
List of Union harmonisation legislation  
1. Council Directive 69/493/EEC of 15 December 1969 on the appro ximation of the laws of the Member States 
relating to crystal glass (OJ L 326, 29.12.1969, p. 36);  
2. Council Directive 70/157/EEC of 6 Febr uary 1970 on the appro ximation of the laws of the Member State s relating 
to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);  
3. Council Directive 75/107/EEC of 19 December 1974 on the appro ximation of the laws of the Member States 
relating to bottles used as measur ing containers (OJ L 42, 15.2.1975, p. 14);  
4. Council Directive 75/324/EEC of 20 May 1975 on the appro ximation of the laws of the Member States relating to 
aerosol dispensers (OJ L 147, 9.6.1975, p. 40);  
5. Council Directive 76/211/EEC of 20 Januar y 1976 on the appro ximation of the laws of the Member States relating 
to the making-up by weight or by volume of certain pre-pac kaged products (OJ L 46, 21.2.1976, p. 1);  
6. Council Directive 80/181/EEC of 20 December 1979 on the appro ximation of the laws of the Member States 
relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40);  
7. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-wate r boilers fired with liquid 
or gaseous fuels (OJ L 167, 22.6.1992, p. 17);  
8. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the appro ximation of the 
laws, regulations and administrative provisions of the Member States relating to labelling of the mater ials used in 
the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);  
9. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste 
(OJ L 365, 31.12.1994, p. 10);  
10. Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of 
petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58);  
11. Directive 98/79/EC of the European Parliament and of the Council of 27 Octobe r 1998 on in vitro diagnostic 
medical devices (OJ L 331, 7.12.1998, p. 1);  
12. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the appro ximation of the 
laws of the Member State s relating to the noise emission in the environment by equipment for use outdoors 
(OJ L 162, 3.7.2000, p. 1);  
13. Directive 2000/53/EC of the European Parliament and of the Council of 18 Sept ember 2000 on end-of-lif e vehicles 
(OJ L 269, 21.10.2000, p. 34);  
14. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to 
fertilisers (OJ L 304, 21.11.2003, p. 1);  
15. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents 
(OJ L 104, 8.4.2004, p. 1);  
16. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 Apr il 2004 on persiste nt 
organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7);  
17. Directive 2004/42/EC of the European Parliament and of the Council of 21 Apr il 2004 on the limitation of 
emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and 
vehicle refinis hing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87);  
18. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of 
motor vehicles with regard to their reusability , recy clability and recoverab ility and amending Council Directive 
70/156/EEC (OJ L 310, 25.11.2005, p. 10); 25.6.2019 L 169/36 Official Jour nal of the European Union EN     19. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machiner y, and 
amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);  
20. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from 
air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, 
p. 12);  
21. Directive 2006/66/EC of the European Parliament and of the Council of 6 Sept ember 2006 on batter ies and 
accumulators and waste batter ies and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, 
p. 1);  
22. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning 
the Registration, Evaluation, Author isation and Restr iction of Chemicals (REA CH), establishing a European 
Chemicals Agen cy, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and 
Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1);  
23. Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of 
motor vehicles with respect to emissions from light passeng er and commercial vehicles (Euro 5 and Euro 6) and on 
access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1);  
24. Directive 2007/45/EC of the European Parliament and of the Council of 5 Sept ember 2007 laying down rules on 
nominal quantities for pre-pack ed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and 
amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17); 
25. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classifi ­
cation, labelling and packag ing of substances and mixtures, amending and repealing Directives 67/548/EEC and 
1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1);  
26. Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 Januar y 2009 on the type- 
approval of motor vehicles with regar d to the protection of pedestr ians and other vulnerable road users, amending 
Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1);  
27. Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 Januar y 2009 on type-approval 
of hydrogen-po wered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32);  
28. Directive 2009/34/EC of the European Parliament and of the Council of 23 Apr il 2009 relating to common 
provis ions for both measur ing instr uments and methods of metrological control (OJ L 106, 28.4.2009, p. 7);  
29. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys 
(OJ L 170, 30.6.2009, p. 1);  
30. Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of 
motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle 
repair and maintenanc e information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and 
repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1);  
31. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concer ning type- 
approval requirements for the general safety of motor vehicles, their trailers and systems, compo nents and separate 
technical units intended theref or (OJ L 200, 31.7.2009, p. 1);  
32. Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing 
a framew ork for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10);  
33. Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 Sept ember 2009 on 
substances that deplet e the ozone layer (OJ L 286, 31.10.2009, p. 1);  
34. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the 
labelling of tyres with respect to fuel efficiency and other essential parameter s (OJ L 342, 22.12.2009, p. 46); 25.6.2019 L 169/37 Official Jour nal of the European Union EN     35. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 Novem ber 2009 on cosmetic 
products (OJ L 342, 22.12.2009, p. 59);  
36. Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU 
Ecolabel (OJ L 27, 30.1.2010, p. 1);  
37. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transpor table pressure 
equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC 
(OJ L 165, 30.6.2010, p. 1);  
38. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 Marc h 2011 laying down 
harmonised conditions for the mark eting of constr uction products and repealing Council Directive 89/106/EEC 
(OJ L 88, 4.4.2011, p. 5);  
39. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restr iction of the use 
of certain hazardous substances in electr ical and electronic equipment (OJ L 174, 1.7.2011, p. 88);  
40. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile 
fibre names and relat ed labelling and marking of the fibre compo sition of textile products and repealing Council 
Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council 
(OJ L 272, 18.10.2011, p. 1);  
41. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concer ning the 
making available on the mark et and use of biocidal products (OJ L 167, 27.6.2012, p. 1);  
42. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electr ical and 
electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38);  
43. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 Febr uary 2013 on the approval 
and mark et surveillance of agricultural and forestr y vehicles (OJ L 60, 2.3.2013, p. 1);  
44. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 Januar y 2013 on the approval 
and mark et surveillance of two- or three-wheel vehicles and quadr icycles (OJ L 60, 2.3.2013, p. 52);  
45. Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the 
laws of the Member States relating to the making available on the mark et of pyrote chnic articles (OJ L 178, 
28.6.2013, p. 27);  
46. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft 
and personal water craft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);  
47. Directive 2014/28/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member States relating to the making available on the market and super vision of explosives for 
civil uses (OJ L 96, 29.3.2014, p. 1);  
48. Directive 2014/29/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 
29.3.2014, p. 45);  
49. Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member State s relating to electromagnetic compati bility (OJ L 96, 29.3.2014, p. 79);  
50. Directive 2014/31/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member States relating to the making available on the mark et of non-automati c weighing 
instr uments (OJ L 96, 29.3.2014, p. 107);  
51. Directive 2014/32/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member States relating to the making available on the market of measur ing instr uments (OJ L 96, 
29.3.2014, p. 149);  
52. Directive 2014/33/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member State s relating to lifts and safety compo nents for lifts (OJ L 96, 29.3.2014, p. 251); 25.6.2019 L 169/38 Official Jour nal of the European Union EN     53. Directive 2014/34/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member State s relating to equipment and protective systems intende d for use in potentially 
explosive atmospheres (OJ L 96, 29.3.2014, p. 309);  
54. Directive 2014/35/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation 
of the laws of the Member State s relating to the making available on the market of electr ical equipment designed 
for use within certain voltag e limits (OJ L 96, 29.3.2014, p. 357);  
55. Directive 2014/40/EU of the European Parliament and of the Council of 3 Apr il 2014 on the appro ximation of the 
laws, regulations and administrative provis ions of the Member States concer ning the manuf acture, presentation and 
sale of tobacco and relat ed products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1);  
56. Directive 2014/53/EU of the European Parliament and of the Council of 16 Apr il 2014 on the harmonisation of 
the laws of the Member State s relating to the making available on the market of radio equipment and repealing 
Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62);  
57. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the 
laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 
27.6.2014, p. 164);  
58. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on mar ine equipment and 
repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);  
59. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 Apr il 2014 on fluor inated 
greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195);  
60. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 Apr il 2014 on the sound level 
of motor vehicles and of replacement silencing syste ms, and amending Directive 2007/46/EC and repealing 
Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131); 
61. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cablewa y instal ­
lations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);  
62. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal prote ctive 
equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);  
63. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning 
gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);  
64. Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements 
relating to gaseous and particulat e pollutant emission limits and type-appro val for intern al combustion engines for 
non-road mobile machi nery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and 
repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53);  
65. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, 
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing 
Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);  
66. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic 
medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, 
p. 176);  
67. Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercur y, and 
repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1);  
68. Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framewor k for 
energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1);  
69. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and 
mark et surveillance of motor vehicles and their trailers, and of systems, compo nents and separate technical units 
intende d for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 
2007/46/EC (OJ L 151, 14.6.2018, p. 1); 25.6.2019 L 169/39 Official Jour nal of the European Union EN     70. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the 
field of civil aviation and establishing a European Union Aviation Safety Agen cy, and amending Regulations (EC) 
No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 
2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) 
No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 
22.8.2018, p. 1), in so far as the design, production and placing on the mark et of aircraf ts refer red to in points (a) 
and (b) of Article 2(1) thereof, where it concer ns unmanned aircraf t and their engines, propellers, parts and 
equipment to control them remot ely, are concer ned.  25.6.2019 L 169/40 Official Jour nal of the European Union EN     ANNEX II 
List of Union harmonisation legislation without provisions on penalties  
1. Council Directive 69/493/EEC of 15 December 1969 on the appro ximation of the laws of the Member States 
relating to crystal glass (OJ L 326, 29.12.1969, p. 36);  
2. Council Directive 70/157/EEC of 6 Febr uary 1970 on the appro ximation of the laws of the Member State s relating 
to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);  
3. Council Directive 75/107/EEC of 19 December 1974 on the appro ximation of the laws of the Member States 
relating to bottles used as measur ing containers (OJ L 42, 15.2.1975, p. 14);  
4. Council Directive 75/324/EEC of 20 May 1975 on the appro ximation of the laws of the Member States relating to 
aerosol dispensers (OJ L 147, 9.6.1975, p. 40);  
5. Council Directive 76/211/EEC of 20 Januar y 1976 on the appro ximation of the laws of the Member States relating 
to the making-up by weight or by volume of certain pre-pac kaged products (OJ L 46, 21.2.1976, p. 1);  
6. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-wate r boilers fired with liquid 
or gaseous fuels (OJ L 167, 22.6.1992, p. 17);  
7. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the appro ximation of the 
laws, regulations and administrative provisions of the Member States relating to labelling of the mater ials used in 
the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);  
8. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste 
(OJ L 365, 31.12.1994, p. 10);  
9. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the appro ximation of the 
laws of the Member State s relating to the noise emission in the environment by equipment for use outdoors 
(OJ L 162, 3.7.2000, p. 1);  
10. Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles 
(OJ L 269, 21.10.2000, p. 34);  
11. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of 
motor vehicles with regard to their reusability , recy clability and recoverab ility and amending Council Directive 
70/156/EEC (OJ L 310, 25.11.2005, p. 10);  
12. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from 
air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, 
p. 12);  
13. Directive 2007/45/EC of the European Parliament and of the Council of 5 Sept ember 2007 laying down rules on 
nominal quantities for pre-pack ed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and 
amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17);  
14. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the 
labelling of tyres with respect to fuel efficiency and other essential parameter s (OJ L 342, 22.12.2009, p. 46);  
15. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transpor table pressure 
equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC 
(OJ L 165, 30.6.2010, p. 1);  
16. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 Marc h 2011 laying down 
harmonised conditions for the mark eting of constr uction products and repealing Council Directive 89/106/EEC 
(OJ L 88, 4.4.2011, p. 5); 25.6.2019 L 169/41 Official Jour nal of the European Union EN     17. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile 
fibre names and relat ed labelling and marking of the fibre compo sition of textile products and repealing Council 
Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council 
(OJ L 272, 18.10.2011, p. 1);  
18. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on mar ine equipment and 
repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);  
19. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 Apr il 2014 on the sound level 
of motor vehicles and of replacement silencing syste ms, and amending Directive 2007/46/EC and repealing 
Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131).  25.6.2019 L 169/42 Official Jour nal of the European Union EN     ANNEX III 
Cor relation table 
Regulation (EC) No 765/2008 This Regulation 
Article 1(2) Article 1(1) 
Article 1(3) Article 1(3) 
Article 2, point 1 Article 3, point 1 
Article 2, point 2 Article 3, point 2 
Article 2, point 14 Article 3, point 22 
Article 2, point 15 Article 3, point 23 
Article 2, point 17 Article 3, point 3 
Article 2, point 18 Article 3, point 4 
Article 2, point 19 Article 3, point 25 
Article 15(1) and (2) Article 2(1) 
Article 15(3) Article 2(3) 
Article 15(4) — 
Article 15(5) Article 2(2) 
Article 16(1) Article 10(1) 
Article 16(2) Article 16(5) 
Article 16(3) — 
Article 16(4) — 
Article 17(1) Article 10(2) 
Article 17(2) Article 34(1), last senten ce and Article 34(3), point (a) 
Article 18(1) Article 10(6) 
Article 18(2), point (a) Article 11(7), point (a) 
Article 18(2), point (b) — 
Article 18(2), point (c) Article 11(7), point (b) 
Article 18(2), point (d) — 
Article 18(3) Articles 10(5) and 14(1) 
Article 18(4) Article 14(2) 
Article 18(5) Article 13 
Article 18(6) Article 31(2), point (o) 
Article 19(1), first subparagraph Article 11(3) 
Article 19(1), second subparagraph Article 14(4), points (a), (b), (e) and (j) 
Article 19(1), third subparagraph Article 11(5) 
Article 19(2) Article 16(3), point (g) 
Article 19(3) Article 18(2) 
Article 19(4) Article 11(2) 
Article 19(5) Article 17 25.6.2019 L 169/43 Official Jour nal of the European Union EN     Regulation (EC) No 765/2008 This Regulation 
Article 20(1) Article 19(1) 
Article 20(2) Article 19(2) 
Article 21(1) Article 18(1) 
Article 21(2) Article 18(2) 
Article 21(3) Article 18(3) 
Article 21(4) — 
Article 22(1) Article 20(1) 
Article 22(2) Article 20(2) 
Article 22(3) Article 20(3) 
Article 22(4) Article 20(4) 
Article 23(1) and (3) Article 34(1) 
Article 23(2) Article 34(4) 
Article 24(1) Article 22(1) 
Article 24(2) Article 22(2) to (5) 
Article 24(3) — 
Article 24(4) — 
Article 25(1) — 
Article 25(2), point (a) Article 31(2), point (f) and Article 33(1), points (i) and (k) 
Article 25(2), point (b) Article 31(2), points (g) and (m) and Article 33(1), points 
(i) and (k) 
Article 25(3) — 
Article 26 — 
Article 27(1), first sentence Article 25(2) 
Article 27(1), second sentence Article 25(3) 
Article 27(2) Article 25(4) 
Article 27(3), first subparagraph Article 26(1) 
Article 27(3), second subparagraph Article 26(2) 
Article 27(4) — 
Article 27(5) — 
Article 28(1) Article 27, first paragraph, point (a) 
Article 28(2) Article 27, first paragraph, point (b) 
Article 29(1) Article 28(1) 
Article 29(2) Article 28(2) 
Article 29(3) Article 28(3) 
Article 29(4) Article 28(4) 
Article 29(5) Article 25(5) 
Article 32(1), point (d) — 
Article 32(1), point (e) Article 36(2), point (e)   25.6.2019 L 169/44 Official Jour nal of the European Union EN