EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 19.12.2017  
COM(2017) 795 final  
2017/0353 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
laying down rules and procedures for compliance with and enforcement of Union 
harmonisation legislation on products and amending Regulations (EU) No 305/2011, 
(EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of 
the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 
2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 
2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU 
and 2014/90/EU of the European Parliament and of the Council  
(Text with EEA relevance)  
{SWD(2017)  466 final} - {SWD(2017)  467 final} - {SWD(2017)  468 final} - 
{SWD(2017)  469 final} - {SWD(2017)  470 final}    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
1.1. Reasons for and objectives of the proposal  
Achieving a deeper and fairer single market, that  builds on its strengths and fully exploits its 
potential in all its dimensions, is one of the key political priorities of the European 
Commission's main political priorities.1 Following up and implementing the 2015 
Communication on Upgrading the Single Ma rket: more opportunities for people and business, 
is one of the main objectives of the 2017 Commission work programme.2 
Within the single market, free movement of goods is the most developed of all four 
fundamental freedoms. It generates around 25 % of EU GDP and 75 % of trade in goods 
between EU Member States. The EU accounts for around one sixth of the world’s trade in 
goods. Trade in goods between EU Member States was valued at EUR  3 063 billion in 2015.3 
However, there is still work to do to ensure a de ep and fair European single market.  
The increasing number of illegal and non -compliant products on the market distorts 
competition and puts consumers at risk. Many economic operators disregard the rules either 
through lack of knowledge or intentionally to  gain a competitive advantage. Greater deterrents 
are needed, yet market surveillance authorities are often underfunded and constrained by 
national boundaries. Businesses are often active both within the EU and worldwide, and 
modern supply chains are evolv ing rapidly. In e -commerce in particular, market surveillance 
authorities have great difficulty tracing non -compliant products imported into the Union and 
identifying the responsible entity within their jurisdiction.  
In its 2017 work programme4, the Commis sion announced an initiative to strengthen product 
compliance and enforcement Union harmonisation legislation on products, as part of the 
'Goods Package'. The initiative is to address the increasing amount of non -compliant products 
on the Union market whil e offering incentives to boost regulatory compliance and ensuring 
fair and equal treatment that will benefit of businesses and citizens.  
The initiative is mainly aimed at providing the right incentives to businesses, intensifying 
compliance checks and pro moting closer cross -border cooperation among enforcement 
authorities. It will:  
 consolidate the existing framework for market surveillance activities;  
 encourage joint actions by market surveillance authorities from several Member 
States;  
 improve the exchange of information and promote the coordination of market 
surveillance programmes;  
 create a strengthened framework for controls on products entering the Union market 
and for improved cooperation between market surveillance authorities and customs 
authorities.  
                                                 
1 Jean-Claude Juncker, ‘A New Start for Europe: My Agenda for Jobs, Growth, Fairness and Democratic Change’, Political 
Guidelines for the next European Commission, Opening Statement in the European Parliament Plenary Session, 15 July 2014: 
http://ec.europa.eu/about/juncker -commission/priorities/index_en.htm . 
2 COM(2016) 710 final: http://ec.europa.eu/atwork/key -documents/index_en.htm 
3 Source Eurostat.  
4 COM(2016) 710 final:  http://ec.europa.eu/atwork/key -documents/index_en.htm    
EN 2  EN 1.2. Consistency with existing policy provisions in the policy area  
(a) Regulation (EC) No 765/2008 of the European Parliament and of the Council5 and 
Decision No 768/2008/EC of the European Parliament and of the Council6  
Regulation (EC) No 765/2008 provides the current framework for the market surveillance of 
products and is complementary to Decision No 768/2008/EC. The Decision establishes 
reference provisions for Union legislation to harmonise marketing conditions for pr oducts, in 
particular the obligations for businesses in the supply chain.   
It is proposed that Articles 15 to 29 of the Regulation (EC) No 765/2008 will no longer apply 
to the legislation listed in the Annex to this legislative proposal.  
The reference pr ovisions established under Decision No 768/2008/EC will continue to 
provide the general framework for the obligations of manufacturers, authorised 
representatives, importers and distributors.  
(b) Proposal for a Regulation of the European Parliament and of the  Council on market 
surveillance of products and amending Council Directives 89/686/EEC and 
93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 
2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 
2007/23/EC, 2008/ 57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, 
Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) 
No 765/2008 of the European Parliament and of the Council7  
This proposal is consistent with the proposal for a Regulation  on market surveillance of 
products which was adopted by the Commission in February 2013 [COM(2013)75] as part of 
the 'Consumer Product Safety and Market Surveillance Package'. The overarching objective 
of COM(2013)75 was to simplify fundamentally the Unio n market surveillance framework in 
the field of non -food products through the reduction of the number of pieces of legislation 
containing market surveillance rules, and to produce a one -tier system in which all of those 
rules are brought together in a sing le instrument. In particular, COM(2013)75 was conceived 
to revise and streamline the rules on market surveillance of the General Product Safety 
Directive 2001/95/EC, Regulation (EC) 765/2008 and many sector -specific pieces of Union 
harmonisation legislatio n into a single legal instrument that would apply horizontally across 
all sectors.  
The European Parliament adopted its position at first reading on the proposal on 15 April 
2014. However, the legislative discussions stalled in 2015. If the legislative dis cussions on 
COM(2013)75 were to resume, an analysis of the Union harmonisation legislation that applies 
at that moment, taking into account the developments since 2013, and the present proposal, 
could feed into the progress made by the co -legislators on th e proposal, in accordance with 
the Interinstitutional Agreement between the European Parliament, the Council of the 
European Union and the European Commission on Better Law -Making.  
The present proposal contains 'lex generalis provisions' in order to avoid any possible risk of 
overlapping or contradictory provisions with the 'market surveillance proposal' 
COM(2013)75.  
(c) Union harmonisation legislation on products  
                                                 
5 Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and 
market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p.30).  
6 Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products 
and rep ealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).    
7 COM(2013) 75 final: http://eur -lex.europa.eu/legal -content/EN/TXT/?uri=COM:2013:0075:FIN   
EN 3  EN Union harmonisation legislation on products sets out common requirements on how a product 
has to b e manufactured, including rules on its product, size and composition. Its aim is not 
only to eliminate barriers to the free movement of goods in the single market, but also to 
ensure that only safe and compliant products are sold in the EU. In this way, ho nest traders 
will benefit from a level playing field, thus protecting consumers and professional users and 
promoting a competitive single market.  
Union harmonisation legislation on products as listed in the Annex to this proposed 
Regulation provides the s pecific framework for marketing each category of products it covers, 
and thus the obligations of each business in the supply chain.     
Smooth cooperation and good contacts between manufacturers and market surveillance 
authorities are key to ensuring that products comply with the Union harmonisation legislation. 
Under this initiative, a product can only be made available on the market if a person 
responsible for compliance information is established in the Union and can be a direct 
interlocutor for market s urveillance authorities. This person could be the manufacturer, the 
importer or any other economic operator mandated by the manufacturer.   
(d) Directive 2001/95/EC on General Product Safety8  
The Directive ensures that products placed on the Union market are safe, in particular by 
targeting products that pose a serious risk and where a Member State's authorities intend to 
deny or prohibit its marketing or use to mitigate the risk to consumer health and safety.  
(e) Regulation (EU) No 952/2013 of the European Parli ament and of the Council ( Union 
Customs Code)9 
Cooperation between market surveillance authorities and customs authorities is crucial to 
effectively enforce Union harmonisation legislation on products. This is because the most 
important filter for non -comp liant products is at the EU's external borders, where the 
authorities have a complete overview of trade flows . 
Furthermore, rules on safety and compliance controls need to be enforced in a more uniform 
manner. This can only be achieved through systematic c ooperation between market 
surveillance authorities and authorities in charge of checking products at the EU’s external 
borders.  
Effective and efficient cooperation is also important when more than one authority in the 
Member States is responsible for check ing that imported goods comply with product safety 
rules. Those authorities have to cooperate, in particular by sharing relevant information.  
1.3. Consistency with other Union policies  
The Commission recognised the essential role of enforcement networks an d set out to 
encourage and help Member States improve their capacity to enforce Union law and to make 
sure that administrative authorities and inspectorates are adequately equipped to perform their 
tasks10.  
In order to strengthen enforcement of Union harmo nisation legislation on products, the 
Commission took into account similar recent work to improve enforcement in other areas. 
One such area was food and feed, where Regulation (EU) 2017/625 on official controls and 
other official activities performed to en sure the application of food and feed law, rules on 
                                                 
8 Directive 2001/95/EC of the European Parliament and of the Council of 3  December 2001 on genera l product safety (OJ L 11, 
15.1.2002, p. 4).  
9 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).  
10 Commission Communication "EU Law: Better Results  through Better Application", 13.12.2016, Pages 5 -6.  
EN 4  EN animal health and welfare, plant health and plant protection products11 will improve Member 
States’ ability to prevent, eliminate or reduce health risks to humans, animals and plants. The 
Commission also p ut forward a proposal to reform the Consumer Protection Cooperation 
Regulation12 on the powers of enforcement authorities and the manner in which they can 
cooperate.  
The Commission also proposed new rules to further empower Member States’ competition 
autho rities and ensure they have all the tools they need to enforce EU antitrust rules more 
effectively13. Stronger enforcement powers are also a key issue in other recent legislative 
initiatives14 and data protection laws15 and recent legislation on fertilisers16. 
Increasing product imports yet declining resources for customs mean that the Customs 
Union’s governance needs to be better geared to current and future challenges. The provisions 
of this proposal take into account the advocated coordination and inter -agen cy cooperation 
mechanisms, and improved risk assessments, including at the level of the Customs Union, to 
make controls more efficient and effective17.  
Regarding global trade, the Commission reaffirmed its policy based on openness and 
cooperation. However,  to combat situations where rules exist but are not respected, the EU 
would need to have the instruments at its disposal to restore a level playing field and act 
decisively against countries or companies that engage in unfair practices. Strong enforcement 
of Union rules would also ensure that penalties are imposed on all companies present or active 
in Union which break the rules. This will be done in cooperation with Member State 
authorities and strengthened Union customs risk management in order to facilit ate and 
accelerate legitimate EU trade, while ensuring the safety and security of citizens by stopping 
fake or dangerous goods permeating EU borders18. 
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
2.1. Legal basis  
The proposal is based on Articles 33, 114 and 207 of the Treaty on the Functioning of the 
European Union.  
                                                 
11 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other offici al 
activities performed to ensure the application of food and feed law, rule s on animal health and welfare, plant health and plant 
protection products, amending Regulations (EC) No  999/2001, (EC) No  396/2005, (EC) No  1069/2009, (EC) No  1107/2009, 
(EU) No  1151/2012, (EU) No  652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European  Parliament and of the Council, 
Council Regulations (EC) No  1/2005 and (EC) No  1099/2009 and Council 
Directives  98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No  854/2004 
and (EC) No  882/2004 of the European P arliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 
90/425/EEC, 91/496/EEC, 96/23/EC,  96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation), 
OJ L 95, 7.4.2017, p. 1 -142. 
12 COM(2016)283 — Proposal for a Re gulation of the European Parliament and of the Council on cooperation between national 
authorities responsible for the enforcement of consumer protection laws.  
13 COM(2017)142 — Proposal for a Directive of the European Parliament and of the Council to empow er the competition 
authorities of the Member States to be more effective enforcers and to ensure the proper functioning of the internal market.  
14 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending 
Directive  2001/83/EC, Regulation  (EC)  No 178/2002 and Regulation  (EC)  No 1223/2009 and repealing Council 
Directives  90/38 5/EEC and 93/42/EEC  (Medical Devices); Regulation (EU); 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 -23); COM(2016)31 final - Proposal for a Regulation of the European Parliament and of the Council on the 
approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical unit s 
intended for such vehicles.  
15 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons 
with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/ EC (Gene ral 
Data Protection Regulation).  
16 COM(2016)157, SWD(2016)64 and 65.  
17 Developing the EU Customs Union and its governance, COM(2016)813 final, 21.12.2016.  
18 Point 3.3, Commission Reflection paper on harnessing globalisation, 10 May 2017: 
https://ec.europa.eu/commission/publications/reflection -paper -harnessing -globalisation_en    
EN 5  EN 2.2. Subsidiarity  
Market surveillance activities, and in particular enforcement of Union harmonisation 
legislation on products, fall within the competence of Member States’ national autho rities. 
This will not change. However, in order to be effective, the market surveillance effort must be 
uniform across the Union. If market surveillance is ‘softer’ in some parts of the EU, weak 
spots are created which threaten the public interest, create unfair trading conditions and 
encourage 'forum shopping'.  
The risk to the various public interests that Union harmonisation legislation tries to protect 
should be considered also as regards products imported into the Union. There must therefore 
be effecti ve market surveillance along the entire length of the Union’s external borders.  
It is therefore necessary to strengthen the enforcement of Union harmonisation legislation on 
products, preserve the public interests defended in this context, in particular he alth protection, 
and to ensure a level playing field for businesses established within and outside the EU. 
Market surveillance authorities should receive a set of powers allowing them to effectively 
enforce the Union harmonisation legislation on products. Their cooperation across borders 
and with customs authorities should be increased. Controls at the external borders of the 
Union should also be strengthened.  Consequently, market surveillance instruments and 
mechanisms must be established to make possible  and facilitate these endeavours, in 
particular by establishing an Union Product Compliance Network whose main task will be 
coordinating enforcement across the Union. Financing and reporting also all need to be 
addressed at Union level.  
2.3. Proportionalit y 
The proposal does not affect the Member States’ competences in enforcement. However, 
some Member States may need to adapt their national procedural laws to ensure that their 
market surveillance authorities can effectively use their enforcement powers in the cross -
border context, to cooperate and address product non -compliance within the EU.  
The measures set out in this proposal do not extent beyond what is necessary to solve the 
problems identified and to achieve its objectives. The proposal provides for a common set of 
powers for all competent authorities in the Member States which should help strengthen 
enforcement and compliance with Union harmonisation rules on products. The level of 
harmonisation chosen is necessary to ensure smooth cooperation and ex changes of evidence 
among competent authorities. Furthermore, it is necessary to remedy the current situation 
where certain product requirements laid down in Union harmonisation legislation are not 
enforced consistently and coherently in the single market because the market surveillance 
authorities in some Member States lack the powers needed to investigate and put an end to 
non-compliance.  
The proposal will improve enforcement cooperation without imposing a disproportionate or 
excessive burden on Member S tates' authorities. Therefore, the proposal does not exceed what 
is necessary to attain its objectives.  
2.4. Choice of the instrument  
The only suitable instrument to achieve the objective of improving enforcement of and 
compliance with Union harmonisation legislation on products is a Regulation. A Directive 
would not achieve the objectives as jurisdictional boundaries and potential jurisdictional 
conflicts would persist following its transposition.   
EN 6  EN 3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATION S AND  IMPACT  ASSESSMENTS  
3.1. Ex-post evaluations/fitness checks of existing legislation  
As part of the 2017 Commission work programme,  an evaluation of the current legal 
framework for market surveillance, notably of provisions of Article 15 to 29 of Regul ation 
(EC) No 765/2008 was undertaken.19 The evaluation covered the period from 2010 (date of 
application of the Regulation) to 2015.  
Effectiveness  
The evaluation of Regulation (EC) No 765/2008 indicated that it has been only partly 
effective in achieving its specific and strategic objectives. This is mainly because coordination 
and cooperation have still not reached a satisfactory level. Tools such as the Union Rapid 
Alert System for dangerous non -food products ( RAPEX) and the Information and 
Communication  System on Market Surveillance  (ICSMS) are in place to ensure cross -border 
market surveillance cooperation, but they are not sufficiently used by Member States. As a 
result, market surveillance authorities rarely restrict the marketing of a product if thei r 
counterpart in another Member State notifies them of measures related to the product. There 
seems to be limited scope for market surveillance and customs authorities to make use of 
findings (including test reports) made by peer authorities in another Mem ber State and, 
therefore, to avoid duplicating efforts. Furthermore, Regulation (EC) No 765/2008 is not yet 
uniformly applied, due to the significant differences in how Member States implement it. This 
concerns the organisation of market surveillance at na tional level, the availability of financial, 
human and technical resources, the strategies of market surveillance, the powers of inspection 
and of sanctions and the systems of monitoring and reporting. Last but not least, border 
controls on imported produc ts seem insufficient. The main difficulties caused by market 
surveillance authorities not having jurisdiction outside of their Member State, particularly in 
the context of online sales.  
Therefore, it is safe to assess that Regulation (EC) No 765/2008 doe s not fully meet its 
strategic objectives of strengthening the protection of public interests and of ensuring fair 
trading conditions for economic operators by reducing the number of non -compliant products 
on the single market. The data available suggest th at non -compliant products continue to be 
placed on the market, and are possibly increasing.  
Efficiency  
Most of the costs of the market surveillance are borne by Member States and their market 
surveillance authorities, and vary considerably from one Member  State to another. This is 
because different national organisational models require different levels of both human and 
financial resources, but also results from the different approaches of market surveillance 
authorities when reporting data on financial r esources used and the activities performed.  
Economic operators’ information costs due to Regulation (EC) No 765/2008 are perceived as 
insignificant. However, businesses point to the negative impact that across -the-board 
inconsistencies in Member States’ a pproach to market surveillance have on them, stressing 
that the current enforcement mechanism is not able to create equal conditions for businesses.  
                                                 
19 SWD(2017)469 - Commission services staff working document on the evaluation of t he market surveillance provisions of 
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for 
accreditation and market surveillance relating to the marketing of products and repealing Regulat ion (EEC) No 339/93.   
EN 7  EN In terms of benefits, Regulation (EC) No 765/2008 did not improve safety for consumers and 
other end -users  as expected. The  persistence of and increase in non -compliant products  show 
that it did not create fair trading conditions for businesses either . 
Coherence  
The evaluation pointed to problems of consistency with the General Product Safety Directive 
2001/95/EC (GPSD), whose definitions are not always aligned with those of the Regulation. 
This proposal clarifies the boundaries between the GPSD and Regulation (EC) No 765/2008 . 
The coherence of Regulation (EC) No 765/2008 with sectoral directives is sufficiently 
safeguarded by the lex specialis  provision. Nonetheless, in certain cases, discrepancies and 
gaps in the definitions and terminology provided in the different pieces of legislation diminish 
the overall clarity of the framework for market surveillance, without hindering the 
implementation  of Regulation (EC) No 765/2008 .  
Relevance  
The evaluation highlighted some difficulties in understanding the scope of Regulation (EC) 
No 765/2008 . While its definitions are generally clear and appropriate, they are not complete 
and up -to-date, especially  as regards online sales. Regulation (EC) No 765/2008 is relevant 
when considering current stakeholders’ needs such as cooperation and exchange of 
information, and border controls, but it becomes less relevant when looking at needs related to 
current marke t dynamics (increasing online trade, budgetary constraints at national level), that 
requires a fast reaction.  
Only a revised framework for market surveillance could help reach the expected level of 
protection of public interests and of ensure fair trading conditions for market operators.  
EU added value  
Member States are responsible for enforcing Union harmonisation legislation and taking 
effective action against products that pose a risk. A single market without internal borders 
poses challenges for publi c authorities in enforcing this legislation since they are constrained 
by jurisdictional boundaries. Furthermore, weaknesses in the market surveillance organisation 
in a single Member State create weak links in the chain.  
To ensure consistent enforcement a nd to efficiently tackle non -compliance spanning over 
several Member States, it is necessary to coordinate activities across the Union. The 
evaluation indicated that the benefits of having a single piece of European legislation on 
harmonising market survei llance instead of several different pieces of national legislation are 
widely recognised.  
The EU added value of Regulation (EC) No  765/2008 mainly stems from provisions 
envisaging common information systems that will favour administrative cooperation and 
enhance cooperation between market surveillance authorities and authorities in charge of 
checking products at the EU’s external borders.  
Full EU added value is still hindered by the currently sub -optimal cross -border exchange of 
information and cooperation,  by inconsistent implementation of the market surveillance 
framework at national level, and by a lack of resources.  
3.2. Stakeholder consultations  
The market surveillance authorities  were consulted during several meetings of the Expert 
Group on the Interna l Market for Products held on 1 February 2016, 21 October 2016 and 31 
March 2017. The last meeting focused on the legislative proposal and its main objectives and 
especially on how to enhance cooperation between the Member States, create a uniform and  
EN 8  EN sufficient level of market surveillance and have stronger border controls on products imported 
into the Union market.  
A stakeholder conference open to industry, consumers, authorities, etc. was  organised by the 
Commission on 17 June 2016 . The aim was to identi fy the main issues related to the 
compliance of products in the single market, how to better enforce harmonisation legislation, 
and to identify possible ways forward.   
A public consultation in all EU official languages  was published on a consultation webs ite 
hosted on Europa. The consultation ran from 1 July to 31 October 2016. Its objective was to 
gather evidence and views on the actions to enhance enforcement and compliance in the 
single market for Goods. The European Enterprise Network  encouraged and su pported small 
and medium -sized enterprises  in the consultation . 239 replies were received from businesses 
(127), public authorities (80), and citizens (32).  
The consultation results show action is needed to increase product compliance in the single 
market because non -compliance negatively affects consumers and other end -users, but also 
sales and/or market shares of businesses that do comply with legal obligations. Furthermore, 
respondents suggested that the best way to reduce non -compliance is a mix of info rmation, 
support and enforcement by the public authorities . As regards non -compliant products traded 
by businesses located in a non -EU country, the results of the consultation point to the need for 
customs and market surveillance authorities to better coor dinate controls on products entering 
the Union market. It also noted the need to oblige businesses established in non -EU countries 
to designate a person located in the Union to be responsible for compliance information . 
3.3. Collection and use of expertise  
The Commission or external contractors carried out several surveys, consultations and studies 
between 2012 and 2016. Member States were also consulted on how effectively market 
surveillance functions across the Union.  
An external evaluation on the applica tion of Regulation (EC) No 765/2008 was carried out 
between July 2016 and May 2017.  
The results have been taken into account in this legislative proposal with the view to improve 
the enforcement of Union harmonisation legislation on products.      
3.4. Regulatory  fitness  and simplification   
The evaluation carried out on the current legal framework for market surveillance (see section 
3.1. above) concluded that most of the enforcement costs stemming from current market 
surveillance rules are borne by publ ic authorities, while costs on businesses only relate to 
information obligations (responding to requests from authorities, information on non -
compliances detected) and are therefore regarded as insignificant by them. The enhanced 
enforcement coordination a nd priority setting supported by the Union Product Compliance 
Network and peer reviewed enforcement strategies would results in a better level -playing 
field, reducing some of the negative impacts of across -the-board enforcement inconsistencies 
that busines ses face.  
The main potential for simplification and burden reduction lie nonetheless with authorities. 
The impact assessment underlying this proposal examined for each objective possible 
simplifications and/or administrative burden reduction, such as bett er use of IT tools used for 
simpler and quicker exchange information on planned controls, more effective mutual 
assistance requests, transferability of enforcement evidence and decisions to avoid duplication 
of work by authorities, a common set of investig ative and enforcement powers, and easier  
EN 9  EN access to compliance information for market surveillance authorities through the availability 
of a person responsible for compliance information.   
3.5. Impact assessment  
An impact assessment report prepared by the C ommission covers all aspects related to the 
legislative proposal20.   
The policy options envisaged range from maintaining the status quo, to more ambitious 
measures and EU coordination and action, as follows:  
(1) baseline;  
(2) improving existing tools and coopera tion mechanisms;  
(3) option (2) plus increased deterrence effect to enforcement tools and stepped up EU 
coordination; and  
(4) further added -on centralised EU level enforcement in certain cases.    
The preferred option is option (3), including in particular:  
(a) extending Product Contact Points’ advisory role to businesses and ad -hoc public -
private partnerships;  
(b) creating digital systems through which manufacturers or importers would make 
compliance information available to both consumers and market surveillance 
authorities, the obligation of manufacturers to designate a person responsible for 
compliance information established in the Union and setting up a common European 
portal for voluntary measures;  
(c) establishing rules on how to publicise decisions to restrict t he marketing of products, 
fine-tune authorities’ powers (notably in relation to online sales imports from non -
EU countries), recovering the costs of controls on products found to be non -
compliant; and  
(d) stricter obligations for mutual assistance and legal pr esumption that products found 
to be noncompliant in one Member State are non -compliant throughout the EU.  
Furthermore, Member States’ enforcement strategies setting out national control activities and 
capacity building requires an Union Product Compliance Network. This network would 
provide administrative support structure to peer review Member States’ performance and 
coordinate and help implement Member States’ joint enforcement activities.  
The impact assessment received an initial negative opinion, on 7 A pril 2017, and 
subsequently a positive opinion with reservations from the Regulatory Scrutiny Board on 8 
June 2017. The recommendations contained in the opinions have been incorporated into the 
report21. The amended report includes more extensive descriptio ns of the current market 
surveillance framework, the relation to the 2013 'Consumer Product Safety and Market 
Surveillance Package'  and the evaluation results. The presentation of the problems, objectives 
and options were reworked and supporting evidence a nd cost estimates added. In relation to 
the Union Product Compliance Network, the report sets out the expected outputs and cost in 
different scenarios and discusses the impacts and feasibility of governance options to host the 
Union Product Compliance Netw ork either in an existing agency or by the Commission. 
Considering the complexity of amending founding regulations of an existing agency, this 
                                                 
20 SWD (2017) 466, Commission services staff working document Impact assessment accompanying the proposal for a Regulation 
of the European Parliament and of the Council on Enforcement of Union harmonisation legislation  
21 The summary she et and the positive opinion of the Regulatory Scrutiny Board are available at [link to be inserted].   
EN 10  EN proposal tasks the Commission with the supporting secretariat of the Network. In relation to 
the obligation of ma nufacturers to designate a person responsible for compliance information 
established in the Union, the impact assessment report describes the main trade and business 
models affected, in particular distance sales from outside the EU. The report clarifies th e 
mandate of the person responsible for compliance information. It also estimates the cost 
related to compliance information facilitation and discusses the impacts on 3rd country traders 
and the fair market conditions for businesses operating in the Union.   
3.6. Fundamental rights  
The impact of various options examined took into account the impact on concerned 
fundamental rights. The legislative proposal respects fundamental rights and observes the 
principles recognised in particular by the Charter of Funda mental Rights of the European 
Union. It is to be interpreted and applied with respect to those rights and principles. Market 
surveillance authorities would exercise the powers set out in this Regulation, on the basis of 
proportionality and necessity, and s ubject to national procedural safeguards.   
This legislative proposal strikes a careful balance between the interests protected by 
fundamental rights health and safety, consumer protection, environmental protection the 
freedom to conduct business and freed om of information.   
4. BUDGETARY  IMPLICATIONS  
The proposal requires human and administrative resources, as well as operational 
appropriations, as highlighted in the financial statement.  
5. OTHER  ELEMENTS  
5.1. Implementation plans and monitoring, evaluation and reporting arrangements  
The Commission will review the implementation of this Regulation 5 years after the date on 
which it starts to apply, and will submit an evaluation report to the European Parliament and 
the Council. The report will asse ss whether the Regulation achieved its objectives, in 
particular with regard to reducing the number of non -compliant products, ensuring effective 
and efficient enforcement of Union harmonisation legislation, improving cooperation between 
competent authorit ies and strengthening the controls on products entering the Union market , 
taking into account its impact on business and in particular on small and medium -sized 
enterprises.  
5.2. Entry into application  
The proposal would delay the entry into application o f the Regulation until 1 January 2020 to 
allow Member States, market surveillance authorities, and the European Commission through 
the Union Product Compliance Network to make the necessary practical arrangements and 
legislative changes.  
5.3. Detailed exp lanation of the specific provisions of the proposal  
The proposal consists of 11 chapters comprising 64 articles and one Annex.  
Chapter I – General provisions  
This Chapter defines the scope and the main terms used in the Regulation. It updates the 
definit ions used in Regulation (EC) No 765/2008, in particular to take into account the 
diversity of actors in the supply chain and the need to make them all subject to enforcement of 
the Union harmonisation legislation on products. The proposed definition of ‘ec onomic 
operator’ encompasses all actors directly concerned by this legislation.    
EN 11  EN Chapter II – Compliance information  
This Chapter introduces the concept of a ‘person responsible for compliance information 
established within the Union’ as a necessary cond ition for making the products available on 
the market. The main objectives are to enforce of Union harmonisation legislation on products 
by ensuring good contacts between manufacturers or their designated representatives and the 
market surveillance authori ties, and to create fair trading conditions on the Union market.    
The person responsible for compliance information can be the manufacturer, the importer or 
any other economic operator designated by the manufacturer.  
The tasks of the person responsible for compliance information are essentially to provide 
information on the product to market surveillance authorities and to cooperate with the 
authorities.  
Chapter III – Assistance to and cooperation with economic operat ors 
This Chapter defines how to designate competent authorities and single liaison offices for this 
Regulation and clarifies the roles of the single liaison offices. It calls on the Member States to 
ensure smooth cooperation among the members of the enforc ement network in their territory. 
It requires Member States to ensure that other national authorities support the work of the 
competent authorities, in particular in cases where criminal measures are needed to stop the 
infringement.  
Chapter IV – Organisat ion and general principles of market surveillance  
The Regulation sets out the Member States’ obligations as regards organisation of market 
surveillance within their territory.  It also lays down the procedures they must establish to 
follow up complaints or  issues relating to risks; monitor accidents and harm to the health of 
end-users; verify corrective actions taken by economic operators; and follow up scientific and 
technical knowledge of safety issues.  
The Regulation defines how Member States should desi gnate market surveillance authorities 
and single liaison offices. It also lays down principles for the activities of market surveillance 
authorities, namely that surveillance must be effective, measures be proportional to 
compliance, that the authorities m ust take a risk -based approach against the background of 
defined factors, and act with transparency, independence and impartiality.  
The Regulation also requires Member States to issue regular national market surveillance 
strategies and lists what they must  include.  
Chapter V – Market surveillance powers and measures  
The Regulation provides for a set of powers for market surveillance authorities, defined with 
the view to ensure effective enforcement of Union harmonisation legislation on products is 
enforced  effectively across borders. These powers include the power to access data and 
documents related to an instance of non -compliance, to require economic operators and public 
entities to provide all information related to an instance of non -compliance; to car ry out on sit 
inspections; to make test purchases and carry out mystery shopping; to adopt temporary 
measures; to initiate investigations or procedures aimed at ceasing non -compliance; to 
prohibit the supply of products, or withdraw and recall and destroy them; to impose penalties 
and order the recovery of profits obtained as a result of non -compliance; and to publish 
decisions, including the identity of the concerned economic operator .  
When exercising these powers, Member States retain the possibility to decide whether the 
competent authorities will exercise the minimum powers directly under their own authority or  
EN 12  EN whether these powers will be exercised by application to courts, in accordance with national 
law.  
The Regulation also defines market surveillan ce measures and establishes the procedures and 
principles to be observed. As regards products which present a serious risk requiring rapid 
intervention, the Chapter links with Directive 2001/95/EC and the Union Rapid Alert System  
established under that Directive.  
The Regulation also introduces the possibility of designating Union testing facilities and 
specifies their tasks.  
In addition to the principle of financing market surveillance, this Chapter provides for market 
surveilla nce authorities to recover their costs by charging economic operators administrative 
fees for non -compliance.   
Chapter VI – Cooperation and procedure for mutual assistance  
Mutual assistance may take two forms:  
 requests for information, which enable marke t surveillance authorities in one 
Member State to obtain information and evidence from another; and  
 requests for enforcement measures which enable market surveillance authorities to 
request their counterparts in another Member State to take enforcement me asures.  
The Regulation sets out the procedure for mutual assistance requests. These requests must be 
sent to the single liaison offices in the Member States of both the requesting and the requested 
authorities, using standard forms by means of an informat ion and communication system. The 
Regulation also provides for that evidence obtained and investigation findings in one Member 
State may be used in another Member State.  
The underlying principle that is that products deemed to be non -compliant on the basis  of a 
decision taken by market surveillance authorities in one Member State are presumed to be 
non-compliant by market surveillance authorities in another Member State, unless the 
concerned economic operator can provide evidence to the contrary. The aim of  the 
instruments of mutual assistance is to address instances of non -compliance of a product in 
cross -border context, and to allow measures to end the non -compliance or the ban the product 
in all Member States. The Regulation will also help evidence and in vestigation findings 
obtained through the use of minimum powers of market surveillance authorities can be used 
across the borders.  
Under the Regulation, the requested authority must reply to a mutual assistance request within 
the time limit set the implem enting measures.  
The Regulation ensures the protection of professional and commercial secrets by providing 
that information communicated to market surveillance authorities will only be used to ensure 
compliance with Union harmonisation legislation.  
Chapt er VII – Products entering the Union market  
The Regulation provides for a strengthened framework for controls on products entering the 
Union market. It starts from the assumption that the most effective way to ensure that unsafe 
or non -compliant products a re not placed on the Union market is to carry out adequate checks 
before they are released for free circulation. Customs authorities execute controls based on 
risk analysis .  
It also strengthens the exchange of information between market surveillance autho rities and 
customs authorities, in particular through procedures for releasing products, suspending and  
EN 13  EN refusing of release for free circulation. Market surveillance authorities can be asked to provide 
information on products and economic operators where a  higher risk of non -compliance is 
detected. Customs authorities are required to inform the market surveillance authorities in 
timely manner on the placing of products under release for free circulation and the results of 
controls if that information is rel evant for enforcing of Union harmonisation legislation.  
The release for free circulation may be suspended if:  
 the product is not accompanied by the required documentation, is not marked or 
labelled as required, does not bear the CE marking or other marki ng required under 
the Union harmonisation legislation;  
 no person responsible for compliance information established within the Union can 
be identified; or  
 there is cause to believe that the product is not placed on the market in accordance 
with requirements set out by Union harmonisation legislation.  
The Regulation also provides for the favourable treatment of products declared for free 
circulation by autho rised economic operators with special status under Regulation (EU) No 
952/2013. It also lays down conditions for suspending this favourable treatment if non -
compliance is detected during the controls. Procedural rules for exchanging information on 
authoris ed economic operators, between market surveillance authorities and customs 
authorities , will be established in implementing measures.  
Chapter VIII – Coordinated enforcement and international cooperation  
The Regulation establishes a Union Product Complianc e Network ('Network'), within the 
Commission. The Network is composed of a board, administrative coordination groups and a 
secretariat; its tasks are detailed in the Regulation.  
The role of the Network will be to coordinate enforcement tasks, thereby boost ing market 
surveillance cooperation at EU level. Furthermore, the Network will be in charge of 
maintaining an information and communication system for collecting and storing information 
on the enforcement of Union harmonisation legislation on products. The  system is available to 
the Commission and market surveillance authorities in the Member States and will have a 
public interface in order to comply with the obligation to inform the general public and ensure 
transparency.  
The Regulation sets out the framew ork for international cooperation with third countries or 
international organisations to ensure Union harmonisation legislation on products is enforced. 
It also provides for a system for product related pre -export controls carried out by a third 
country on  products, before they are exported to the Union. The details of the implementation 
of this system will be established by implementing acts.  
Chapter IX – Financial provisions  
The Regulation provides for the financing by the Commission of activities in all  matters 
falling under the general market surveillance policy for the Union.  
The Regulation includes for general clauses on protecting the financial interests of the Union.  
Chapter X – Final provisions  
The Regulation provides that Union harmonisation leg islation listed its Annex will not be 
governed by Articles 15 to 29 of Regulation (EC) No 765/2008.   
EN 14  EN 23 legal instruments set out in the Annex to this Regulation have to be amended, by deleting 
references to Article 15 to 29 of Regulation (EC) No 765/2008. The Regulation also amends 
Directive 2004/42/EC of the European Parliament and of the Council22. 
Chapter XI – Penalties, evaluation, committee procedure and entry into force and 
application  
While recognising that establishing penalties is a national competence, this Regulation sets 
out guiding principle for penalties.  
The Regulation also lays down for standard provisions on evaluating of the application of this 
Regulation and on the committe e procedure for adopting of implementing acts.    
Annex  
The Annex lists the Union harmonisation legal instruments for products, thus determining the 
scope of the application of the Regulation.   
                                                 
22 Directive 2004/42/EC of the European Parliament and of the Council on the limitation of emissions of volatile organic 
compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products (OJ L 143, 30. 
4.2004, p. 87).  
  
EN 15  EN 2017/0353 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL  
laying down rules and procedures for compliance with and enforcement of Union 
harmonisation legislation on products and amending Regulations (EU) No 305/2011, 
(EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU ) 2017/1369 of 
the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 
2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 
2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU 
and 2014/90/EU of the European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Articles 33, 114 and 207 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee23,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) In order to guarantee the free movement of products within the Union, it is necessary 
to ensure that products fulfil requirements providing a high level of protection of 
public interests such as health and s afety in general, health and safety in the 
workplace, protection of consumers, protection of the environment and public 
security. Robust enforcement of these requirements is essential to the proper 
protection of these interests and to create the conditions  in which fair competition in 
the Union market for goods can thrive. Rules are therefore necessary to ensure this 
enforcement throughout the internal market, including on products entering the Union 
from third countries.  
(2) Strengthening the Single Market  for goods through further enhancing efforts to keep 
non-compliant products from being placed on the Union market was identified as a 
priority in the Communication from the Commission ‘Upgrading the Single Market: 
more opportunities for people and business es’24. This should be achieved by 
strengthening market surveillance, providing the right incentives to economic 
operators , intensifying compliance control s and promoting closer cross -border 
cooperation among enforcement authorities, including through cooper ation with 
customs authorities . 
                                                 
23 OJ C , , p. .  
24 COM(2015) 550 final of 28 October 2015.   
EN 16  EN (3) The framework for market surveillance should be strengthened, with a view to further 
improving compliance with and enforcement of Union harmonisation legislation on 
products.  
(4) Directive 2001/95/EC of the European Par liament and of the Council25 lays down the 
general safety requirements for all consumer products and provides for specific 
obligations and powers of the Member States in relation to dangerous products as well 
as for the exchange of information to that effec t through the Union Rapid Alert System 
for dangerous non -food products (RAPEX). Market surveillance authorities should 
have the possibility of taking the more specific measures available to them under that 
Directive. In order to achieve a higher level of s afety for consumer products, the 
mechanisms for exchanges of information and rapid intervention situations provided 
for in Directive 2001/95/EC and reinforced by Regulation (EC) No 765/2008 of the 
European Parliament and of the Council26 should be complemen ted to make them 
more effective.   
(5) This Regulation should cover products that are subject to the Union harmonisation 
legislation listed in the Annex. The legislation listed in the Annex should cover all 
Union harmonisation legislation concerning manufa ctured products other than food, 
feed, medicinal products for human and veterinary use, living plants and animals, 
products of human origin and products of plants and animals relating directly to their 
future reproduction. This will ensure a uniform framew ork for market surveillance of 
those products at Union level. Several instruments of Union harmonisation legislation 
on products need to be amended in consequence, in particular to remove references to 
certain provisions of Regulation (EC) No 765/2008. If new Union harmonisation 
legislation is adopted in the future, it will be for that legislation to provide whether this 
Regulation is also to apply to that legislation.  
(6) In order to rationalise and simplify the overall legislative framework, whilst 
simult aneously pursuing the objective of Better Regulation, the rules applicable to 
controls on products entering the Union market should be revisited and integrated into 
a single legislative framework for controls on products at the external borders.    
(7) Safety of consumers largely depends on the active enforcement of Union 
harmonisation legislation on products providing for safety requirements. It is therefore 
necessary to strengthen enforcement measures. These measures should be 
continuously improved and in creasingly effective with a view to meeting the current 
challenges of a global market and an increasingly complex supply chain.  
(8) The framework established by this Regulation should complement and strengthen 
existing provisions in Union harmonisation le gislation relating to the provision of 
compliance information about products and the framework for cooperation with 
economic operators, the market surveillance of products and controls on those 
products entering the Union. However, in accordance with the p rinciple of lex 
specialis , this Regulation should apply only in so far as there are no specific 
provisions with the same objective, nature or effect in other existing or future rules of 
Union harmonisation legislation. The corresponding provisions of this Regulation 
should not therefore apply in the areas covered by such specific provisions, for 
instance those set out in Regulation (EC) No 273/2004 of the European Parliament and 
                                                 
25 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).  
26 Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditat ion and 
market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 
30).  
EN 17  EN of the Council on drug precursors27, Regulation (EC) No 1223/2009 of the Europea n 
Parliament and of the Council on cosmetic products28, Regulation (EU) 2017/745 of 
the European Parliament and of the Council on medical devices29 and Regulation (EU) 
2017/746 of the European Parliament and of the Council on in vitro diagnostic 
medical devi ces30.  
(9) Responsibility for enforcing Union harmonisation legislation should lie with the 
Member States, whose market surveillance authorities should be required to ensure 
that the legislation is fully complied with. The Member States should, therefore, 
establish systematic approaches to ensure effectiveness of market surveillance and 
other enforcement activities.  
(10) Certain definitions currently set out in Regulation (EC) No 765/2008 should be 
aligned with definitions set out in other Union acts and, w here appropriate, reflect the 
architecture of modern supply chains.  
(11) Economic operators throughout the entire supply chain should be expected to act 
responsibly and in full accordance with the legal requirements applicable when placing 
or making produc ts available on the market, so as to ensure compliance with the 
Union harmonisation legislation on products. This Regulation should be without 
prejudice to the obligations which correspond to the role of each economic operator in 
the supply and distributio n process pursuant to specific provisions in Union 
harmonisation legislation, with the manufacturer retaining ultimate responsibility for 
compliance of the product with requirements in the Union harmonisation legislation.  
(12) Modern supply chains encompas s a wide variety of economic operators who should all 
be subject to enforcement of Union harmonisation legislation, while taking due 
consideration of their respective role in the supply chain, and the extent to which they 
contribute to the making available  of products on the Union market. Therefore, it is 
necessary to apply this Regulation to economic operators that are directly concerned 
by Regulation (EC) No 273/2004 of the European Parliament and of the Council31, 
Regulation (EC) No 1907/2006 of the Europ ean Parliament and of the Council32, 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council33, 
Regulation (EC) No 1222/2009 of the European Parliament and of the Council34, 
Regulation (EC) No 1223/2009, Regulation (EU) 2016/424 of the Euro pean 
                                                 
27 Regulation (EU) No  1258/2013 of the European Parliament and of the Council of 20  November 2013 amending Regulation (E C) 
No 273/2004 on drug precursors ( OJ L 47, 18.2.2004, p. 1).  
28 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).  
29 Regulation (EU) 2017/745 of the European Pa rliament and of the Council of 5 April 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).  
30 Regulation ( EU) 2017/746 of the European Parliament and of the Council of 5 April 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).  
31 Regulation (EC) No 273/2004 of the Europe an Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 
18.2.2004, p. 1).  
32 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 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 Dire ctives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006, p. 1).  
33 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling 
and packaging of substances and mixtures, ame nding 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).  
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 parameters (OJ L 342, 22.12.2009, p. 46).   
EN 18  EN Parliament and of the Council35, Regulation (EU) 2016/425 of the European 
Parliament and of the Council36, Regulation (EU) 2016/426 of the European 
Parliament and of the Council37 and Regulation (EU) 2017/1369 of the European 
Parliament and of the Counci l38, Regulation (EU) 2017/745 and Regulation (EU) 
2017/746, and in Directive 2006/42/EC of the European Parliament and of the 
Council39,  Directive 2006/66/EC of the European Parliament and of the Council40, 
Directive 2009/48/EC of the European Parliament and  of the Council41, Directive 
2010/35/EU of the European Parliament and of the Council42, Directive 2013/29/EU 
of the European Parliament and of the Council43, Directive 2013/53/EU of the 
European Parliament and of the Council44, Directive 2014/28/EU of the Eur opean 
Parliament and of the Council45, Directive 2014/29/EU of the European Parliament 
and of the Council46, Directive 2014/30/EU of the European Parliament and of the 
Council47, Directive 2014/31/EU of the European Parliament and of the Council48, 
Directive 2 014/32/EU of the European Parliament and of the Council49, Directive 
2014/33/EU of the European Parliament and of the Council50, Directive 2014/34/EU 
of the European Parliament and of the Council51, Directive 2014/35/EU of the 
European Parliament and of the C ouncil52, Directive 2014/68/EU of the European 
                                                 
35 Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and 
repealing Directive 2000/9/EC (OJ L 81, 31.3.2 016, p. 1).  
36 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and 
repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).  
37 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).  
38 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).  
39 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 
95/16/EC (recast)  (OJ L 157, 9.6.2006, p. 24).  
40 Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and 
waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1).  
41 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. 1–37). 
42 Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and 
repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36 (  OJ L 165, 30.6.2010, p. 1 –18). 
43 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 av ailable on the market of pyrotechnic articles (recast) (OJ L 178, 28.6.2013, p. 27).  
44 Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal 
watercraft and repealing Directive 94/25/EC (OJ  L 354, 28.12.2013, p. 90).  
45 Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to the making available on the market and supervision of explosives for civi l uses (recast) (OJ L 96, 
29.3.2014, p. 1).  
46 Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to the making available on the market of simple pressure ves sels (OJ L 96, 29.3.2014, p. 45).  
47 Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p. 79).  
48 Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to the making available on the market of non -automatic weighing instruments (OJ L 96, 29.3.2014, p. 
107).  
49 Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to the making available on the market of measuring instruments (recast) (OJ L 96, 29.3.2014, p. 14 9). 
50 Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of th e 
Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).  
51 Directive 2014/34/EU of the  European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the 
Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJ  L 
96, 29.3.2014, p. 309).  
52 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the 
Member States relating to the making available on the market of electrical equipment designed for use within certain voltage 
limits  (OJ L 96, 29.3.2014, p. 357).   
EN 19  EN Parliament and of the Council53, and Directive 2014/90/EU of the European 
Parliament and of the Council54. 
(13) The development of e -commerce is also due to a great extent to the proliferation of 
information soci ety service providers, normally through platforms and for 
remuneration, which offer intermediary services by storing third party content, but 
without exercising any control over such content, thus not acting on behalf of an 
economic operator. Removal of co ntent regarding non -compliant products or where it 
is not feasible blocking access to non -compliant products offered through their 
services should be without prejudice to the rules laid down in Directive 2000/31/EC of 
the European Parliament and of the Cou ncil55. In particular, no general obligation 
should be imposed on service providers to monitor the information which they 
transmit or store, nor should a general obligation be imposed upon them to actively 
seek facts or circumstances indicating illegal acti vity. Furthermore, hosting service 
providers should not be held liable as long as they do not have actual knowledge of 
illegal activity or information and are not aware of the facts or circumstances from 
which the illegal activity or information is apparen t.  
(14) A fairer single market should ensure equal conditions for competition to all economic 
operators and protection against unfair competition. To this purpose, strengthened 
enforcement of Union harmonisation legislation on products is necessary. Good 
cooperation between manufacturers and the market surveillance authorities is a key 
element allowing immediate intervention and corrective action in relation to the 
product.  It is important that there should be a contact person established in the Union  
so that market surveillance authorities have someone to whom questions can be 
addressed regarding a product’s compliance with Union harmonisation legislation. The 
person responsible for providing such compliance information should be the 
manufacturer, or the  importer, or another person designated by the manufacturer for 
this purpose, for example another economic operator. The role of a person responsible 
for compliance information established in the Union is essential for providing market 
surveillance authori ties with an interlocutor established in the Union, and for 
performing specific tasks in a timely manner to ensure that the products comply with 
the requirements of Union harmonisation legislation, for the benefit of consumers, 
workers and businesses withi n the Union. The provisions in this Regulation requiring 
there to be a person established in the Union responsible for compliance information 
should not apply where specific requirements set out in certain legal instruments on 
products achieve the same res ult in effect, namely Article 4 of Regulation (EC) No 
1223/2009 , Article 15 of Regulation (EU) 2017/745 and Article 15 of Regulation 
2017/746.  
(15) Member States should provide assistance to economic operators either through 
information on the applicable Union harmonisation legislation by the Product Contact 
Points established under Regulation (EU) [ Reference to new Regulation on mutual 
recognition  to be ins erted ]56, or through guidance on the applicable Union 
harmonisation legislation by the market surveillance authority within the framework of 
compliance partnership arrangements. Market surveillance authorities should able to 
                                                 
53 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, 27.6.20 14, p. 164).  
54 Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council 
Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).  
55 Directive 2000/31/EC of the European Parliament and of the Counc il on certain legal aspects of information society services, in 
particular electronic commerce, in the Internal Market (Directive on electronic commerce) ( OJ L 178, 17.07.2000, p. 1).  
56 Regulation (EU) […] of the European Parliament and of the Council of …  (OJ L, , p. )   
EN 20  EN build on the existing cooperatio n with stakeholders and be permitted to conclude 
memoranda of understanding with stakeholders, with a view to promoting compliance 
or identifying non -compliance with regard to categories of product within a given 
geographical area.  
(16) Member States shou ld designate their own market surveillance authorities. In order to 
facilitate administrative assistance and cooperation, Member States should also 
designate a single liaison office. Liaison offices should ensure the coordination of 
enforcement and market surveillance activities, as well as communication with the 
market surveillance of other Member States and with the Commission.  
(17) It is necessary to establish a Union Product Compliance Network, hosted by the 
Commission, aimed at coordinating and facilit ating the implementation of joint 
enforcement activities by Member States, such as joint investigations. This 
administrative support structure should allow the pooling of resources and maintain a 
communication and information system between Member States a nd the Commission, 
thereby helping to strengthen enforcement of Union harmonisation legislation on 
products and deter infringements.  
(18) Market surveillance activities should be thorough and effective, to ensure that Union 
harmonisation legislation on pro ducts is applied correctly. Given that controls may 
represent a burden for economic operators, market surveillance authorities should 
organise and conduct inspection activities, taking their interests into account and 
limiting the said burden to what is ne cessary for the performance of efficient and 
effective controls. Furthermore, market surveillance activities should be performed 
with the same level of care by the competent authorities of the Member State 
irrespective of whether non -compliance of the give n product is relevant on the 
territory of that Member State or is likely to have an impact on the market of another 
Member State.  
(19) In order to ensure that the Union harmonisation legislation on products is correctly 
enforced, market surveillance author ities should have a common set of investigative 
and enforcement powers, allowing for enhanced cooperation between market 
surveillance authorities and more effective deterrence for economic operators that 
willingly infringe Union harmonisation legislation. Those powers should be 
sufficiently robust to tackle the enforcement challenges of Union harmonisation 
legislation, along with the challenges of e -commerce and the digital environment and 
to prevent economic operators from exploiting gaps in the enforcemen t system by 
relocating to Member States whose market surveillance authorities are not equipped to 
tackle unlawful practices. In particular, the powers should ensure that information and 
evidence can be exchanged between competent authorities so that enforc ement can be 
undertaken equally in all Member States.  
(20) This Regulation should be without prejudice to the freedom of Member States to 
choose the enforcement system that they deem appropriate. Member States should be 
free to choose whether their market surveillance authorities can exercise investigation 
and enforcement directly under their own authority or by application to the competent 
courts.  
(21) Market surveillance authorities should be in a position to open investigations on their 
own initiative if  they become aware of non -compliant products placed on the market.  
(22) Market surveillance authorities should have access to all necessary evidence, data and 
information relating to the subject matter of an investigation in order to determine  
EN 21  EN whether appl icable Union harmonisation legislation has been infringed, and in 
particular to identify the economic operator responsible, irrespective of who possesses 
the evidence, information or data in question and regardless of where it is located and 
of the format in which it is held. Market surveillance authorities should be able to 
request third parties in the digital value chain to provide all the evidence, data and 
information necessary.  
(23) Market surveillance authorities should be able to carry out the necess ary on -site 
inspections, and should have the power to enter any premises, land or means of 
transport, that the economic operator uses for purposes relating to his trade, business, 
craft or profession.  
(24) Market surveillance authorities should be able to require any representative or member 
of staff of the economic operator concerned to give explanations or provide facts, 
information or documents relating to the subject matter of the on -site inspection, and 
to record the answers given by that representativ e or staff member.  
(25) Market surveillance authorities should be able to check the compliance of products to 
be made available on the market with Union harmonisation legislation and to obtain 
evidence of non -compliance. They should, therefore, have the po wer to make test 
purchases and, where the evidence cannot be obtained by other means, to purchase 
products under a cover identity.  
(26) In the digital environment in particular, market surveillance authorities should be able 
to bring non -compliance to an end quickly and effectively, notably where the 
economic operator selling the product conceals his identity or relocates within the 
Union or to a third country in order to avoid enforcement. In cases where there is a 
risk of serious and irreparable harm to end-users due to non -compliance, market 
surveillance authorities should be able to take temporary measures, where there are no 
other means available to prevent or mitigate such harm, including, where necessary, 
the suspension of a website, service or accou nt, or putting a fully qualified domain 
name on hold for a specific period of time, in accordance with the principles laid down 
in Directive 2000/31/EC. Furthermore, market surveillance authorities should have the 
power to close down or require a third par ty service provider to close down a website, 
service or account or a part of it, or to delete a fully qualified domain name.  
(27) Market surveillance authorities act in the interest of economic operators, end -users, 
and of the general public, to ensure tha t public interests established by Union 
harmonisation legislation on products are consistently preserved and protected through 
appropriate enforcement action, and that compliance with such legislation is ensured 
across the supply chain through appropriate controls. Consequently, market 
surveillance authorities should account to economic operators, end -users and the 
general public for the efficiency and effectiveness of the activities they perform. They 
should provide access to information concerning the org anisation and performance of 
their activities, including controls, and regularly publish information on activities 
performed and the results of such activities. They should also, subject to certain 
conditions, be entitled to publish or to make available in formation about the 
compliance record of individual economic operators based on the outcome of market 
surveillance controls.  
(28) Economic operators should fully cooperate with market surveillance authorities and 
other competent authorities to ensure the s mooth performance of market surveillance 
activities and to enable the authorities to perform their tasks.   
EN 22  EN (29) This Regulation should be without prejudice to the functioning of RAPEX in 
accordance with Directive 2001/95/EC and Regulation (EC) No 765/2008.   
(30) This Regulation should be without prejudice to the safeguard clause procedure 
provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) 
of the Treaty. With a view to ensuring an equivalent level of protection throughout t he 
Union, Member States should be authorised to take restrictive measures in relation to 
products presenting a risk to health and safety, or other aspects of public interest 
protection. They should also be required to notify those measures to other Member 
States and the Commission, allowing the Commission to take a position on the 
national measures that restrict the free movement of products with a view to ensuring 
the functioning of the internal market.  
(31) Information exchanged between market surveillanc e authorities, and the use of 
evidence and investigation findings should be subject to the strictest guarantees of 
confidentiality and of professional and commercial secrecy. Information should be 
handled according to applicable national law, in order to e nsure that investigations are 
not compromised and that the reputation of the economic operator is not prejudiced.  
(32) Where for the purposes of this Regulation it is necessary to process personal data, this 
should be carried out in accordance with Union law on the protection of personal data. 
Any processing of personal data under this Regulation is subject to Regulation (EU) 
2016/679  of the European Parliament and of the Council57 and Regulation (EC) No 
45/2001  of the European Parliament and of the Council58, as the case may be.   
(33) To ensure the reliability and consistency of testing across the Union in the market 
surveillance framework, the Commission should designate Union testing facilities. 
Furthermore, a more comprehensive information system should b e developed for 
sharing test results within the Union in order to avoid unnecessary duplication and to 
ensure greater consistency at Union level.  
(34) Laboratories designated by the Commission as Union testing facilities should possess 
the expertise, equip ment, infrastructure and staff to carry out tasks to the highest 
standards. To ensure sound and reliable results, Union testing facilities should be 
accredited according to the relevant Union harmonised standards. The accreditation 
should be delivered by a  national accreditation body operating in accordance with 
Regulation (EC) No 765/2008.  
(35) Member States should be required to ensure that adequate financial resources are 
always available in order to staff and equip the market surveillance authorities 
appropriately. An efficient market surveillance activity is demanding in terms of 
resources, and stable resources should be provided, at a level appropriate to the 
enforcement needs at any given moment. Public financing should therefore be 
supplemented by th e collection of fees to cover the costs incurred when performing 
market surveillance activities in relation to products that were found to be non -
compliant, and taking due account of the economic operator's compliance record.   
(36) The financing of market  surveillance activities through fees collected from economic 
operators should take place in full transparency, so as to enable citizens and businesses 
                                                 
57 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons 
with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/4 6/EC (General 
Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).  
58 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of 
individuals with regard to the processing of personal data by the Comm unity institutions and bodies and on the free movement of 
such data (OJ L 8, 12.1.2001, p. 1).   
EN 23  EN to understand the method and data used to establish fees and to be informed on the use 
of revenue from f ees.  
(37) It is appropriate that Member States designate the authorities responsible for applying 
the customs legislation and any other authorities in charge under national law of 
control on products entering the Union market;  
(38) An effective way to en sure that unsafe or non -compliant products are not placed on the 
Union market would be to detect such products before they are released for free 
circulation. Customs authorities, as authorities in charge of the control on products 
entering the customs terr itory of the Union, enjoy a complete overview of trade flows 
across the external borders, and should therefore be required to carry out adequate 
controls on a risk assessment basis, to contribute to a safer market place. A uniform 
enforcement of Union harm onisation legislation on products can only be achieved 
through systematic cooperation and exchange of information between market 
surveillance and customs authorities. These authorities should receive well in advance 
from the market surveillance authorities  all the necessary information concerning non -
compliant products or information on economic operators where a higher risk of non -
compliance has been identified. In turn, customs authorities should inform the market 
surveillance authorities in a timely mann er of the release of products for free 
circulation, and the results of controls, where such information is relevant for the 
enforcement of Union harmonisation legislation on products. Furthermore, where the 
Commission becomes aware of a serious risk posed by an imported product, it should 
inform the Member States about those risks in order to ensure coordinated and more 
effective compliance and enforcement controls at the first points of entry to the Union.  
(39) In order to support customs and market survei llance authorities in carrying out tasks 
related to controls on products entering the customs territory of the Union, a more 
favourable treatment should be granted for products declared for free circulation by an 
authorised economic operator, as defined in  Article 38(2) of Regulation (EU) No 
952/2013, pending the establishment of the procedure for the exchange of information 
on the status of the authorised economic operators and their record of compliance 
related to product safety. Such an approach should a llow a more targeted control, on a 
risk basis, of products released for free circulation.   
(40) The Commission should be able to exchange market surveillance related information 
with regulatory authorities of third countries or international organisations , with a 
view to ensuring compliance prior to their export of products to the Union market.  
(41) In that context, it is necessary to maintain and further develop the existing Information 
and Communication System for Market Surveillance ( ICSMS). For the pu rpose of 
collecting information relating to the enforcement of Union harmonisation legislation 
on products, ICSMS should be upgraded and be accessible to the Commission, single 
liaison offices, and market surveillance authorities, as well as to the general  public 
through a public interface. Furthermore, an electronic interface should be developed to 
allow effective exchange of information between national customs systems and market 
surveillance authorities.  
(42) The Commission should carry out an evaluatio n of this Regulation against the 
objectives it pursues. Pursuant to point 22 of the Interinstitutional Agreement of 13 
April 2016 on Better Law Making59, the evaluation, based on efficiency, effectiveness, 
                                                 
59 OJ L 123, 12.5.2016, p. 1.   
EN 24  EN relevance, coherence and value added, should provid e the basis for impact assessments 
of options for further action.   
(43) The financial interests of the Union should be protected through proportionate 
measures throughout the expenditure cycle, including the prevention, detection and 
investigation of irreg ularities, the recovery of funds lost, wrongly paid or incorrectly 
used and, where appropriate, administrative and financial penalties.  
(44) The diversity of sanctions across the Union is one of the main reasons for inadequate 
deterrence and uneven protection. Rules on establishing sanctions, including monetary 
penalties, are a matter of national jurisdiction and should, therefore, be determine d by 
national law. However, common criteria and guidance principles in determining the 
level of penalties should be established in order to achieve uniform and effective 
deterrence across the Union. Defining a set of criteria for determining effective, 
proportionate and dissuasive levels of penalty across the Union, in particular as 
regards the past behaviour of the economic operators, their cooperation during 
investigation by market surveillance authorities, and the level of harm, is essential to 
avoid wea k spots that could encourage forum -shopping.  
(45) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be conferred on the Commission in relation to the 
procedures for designating Union testing facili ties, to the procedure for requests for 
information and requests for enforcement measures, to statistical data covering 
controls performed by customs authorities with respect to products subject to Union 
harmonisation legislation, to the data to be exchang ed and the procedure to be 
followed for the exchange of information between customs authorities and market 
surveillance authorities on the status of authorised economic operators, to details of 
implementation arrangements for the information and communicat ion system and data 
relating to the placing of products under the customs procedure ‘release for free 
circulation’ transmitted by customs authorities, and to the implementation of the 
system of product -related pre -export controls, including a model for the  certificates of 
compliance or verification to be used. Those powers should be exercised in accordance 
with Regulation (EU) No 182/2011 of the European Parliament and of the Council60. 
(46) Since the objective of this Regulation, namely to ensure that produ cts placed on the 
Union market fulfil the requirements of Union harmonisation legislation cannot be 
sufficiently achieved by the Member States given the need for a very high degree of 
cooperation, interaction and coherent action of all of the competent aut horities in all 
Member States, but can rather, by reason of its scale and effects, be better achieved at 
Union level, the Union may adopt measures, in accordance with the principle of 
subsidiarity as set out in Article 5 of the Treaty on European Union. In  accordance 
with the principle of proportionality as set out in that Article, this Regulation does not 
go beyond what is necessary in order to achieve that objective.  
(47) This Regulation respects fundamental rights and observes the principles recognised i n 
particular by the Charter of Fundamental Rights of the European Union. Accordingly 
this Regulation must be interpreted and applied respecting those rights and principles. 
In particular, this Regulation seeks to ensure full respect for consumer protection , the 
freedom to conduct a business, the freedom of expression and information, the right to 
property and the protection of personal data,  
                                                 
60 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and 
general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing 
powers (OJ L 55, 28.2.2011, p. 13).   
EN 25  EN HAVE ADOPTED THIS REGULATION:  
Chapter I  
General provisions  
Article 1  
Subject matter  
This Regulation lays down rules and procedures for the provision of compliance information 
about certain products that are the subject of Union acts harmonising the conditions for the 
marketing of those products.  It establishes a framework for cooperation with economic 
operators in rela tion to such products.  
It also provides a framework for the market surveillance of such products to ensure that those 
products fulfil requirements providing a high level of protection of public interests such as 
health and safety in general, health and safety in the workplace, t he protection of consumers, 
protection of the environment and security.  
This Regulation also provides a framework for controls on such products entering the Union 
market.  
Article 2  
Scope  
1. This Regulation applies to all products that are subject to the U nion harmonisation 
legislation set out in the Annex to this Regulation (‘Union harmonisation 
legislation’).  
2. Each of the provisions of this Regulation shall apply in so far as there are no specific 
provisions with the same objective in the Union harmoni sation legislation, which 
regulate in a more specific manner particular aspects of market surveillance and 
enforcement.  
3.  The application of this Regulation shall not prevent market surveillance authorities 
from taking more specific measures as provided for in Directive 2001/95/EC.  
4. This Regulation is without prejudice to Articles 12, 13, 14 and 15 of Directive 
2000/31/EC.  
Article 3  
Definitions  
For the purposes of this Regulation, the following definitions shall apply:   
(1) ‘making available on the m arket’ means any supply of a product for distribution, 
consumption or use on the Union market in the course of a commercial activity, 
whether in return for payment or free of charge;  
(2) ‘placing on the market’ means the first making available of a produc t on the Union 
market;  
(3) ‘market surveillance’ means the activities carried out and measures taken by market 
surveillance authorities to ensure that products comply with the requirements under  
EN 26  EN Union harmonisation legislation and do not endanger health, s afety or any other 
aspect of public interest protection;  
(4) ‘market surveillance authority’ means an authority designated by a Member State 
under Article 11 as a market surveillance authority in the territory of that Member 
State;  
(5) ‘applicant authorit y’ means the market surveillance authority that makes a request for 
mutual assistance;  
(6) ‘requested authority’ means the market surveillance authority that receives a request 
for mutual assistance;  
(7) ‘non-compliance’ means any failure to comply with a ny of the requirements under 
the Union harmonisation legislation applicable to the product in question;  
(8)   ‘manufacturer’ means any natural or legal person who manufactures a product or has 
a product designed or manufactured, and markets that product u nder his name or 
trademark;  
(9) ‘importer’ means any natural or legal person established within the Union who 
places a product from a third country on the Union market;  
(10) ‘distributor’ means any natural or legal person in the supply chain, other than th e 
manufacturer or the importer, who makes a product available on the market;  
(11)  'authorised representative' means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in rel ation to specified tasks with regards to the manufacturer’s obligations under the 
relevant Union harmonisation legislation;  
(12) ‘economic operator’ means the manufacturer, the authorised representative, the 
importer or the distributor, and including:  
(a) any of the economic operators as referred to in Directives 2006/66/EC, 
2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 
2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 
2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU, 2014/90/EU, Regulati ons 
(EU) No 305/2011, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 
2017/745 and (EU) 2017/746;  
(b) the operators as defined in Regulation (EC) No 273/2004;  
(c) the producer of an article and the downstream user as defined in each case in 
Regulation (EC) No 19 07/2006 and Regulation (EC) No 1272/2008;  
(d) the private importer as defined in Directive 2013/53/EU;  
(e) the installer as defined in Directives 2006/42/EC and 2014/33/EU;  
(f) the supplier and the distributor as defined  in Regulation (EC) No 1222/2009;  
(g) the dealer as defined in Regulation (EU) 2017/1369 ; 
(h) any other natural or legal person established in the Union and other than a 
distributor, who warehouses, packages and ships products to or within the 
Union market ; 
(13) ‘corrective action’ means any actio n taken by an economic operator to bring  any 
non-compliance to an end, including action to restrict the making available of 
products on the market or to destroy a product on the market;   
EN 27  EN (14) ‘temporary measure’ means any temporary measure taken by a marke t surveillance 
authority aimed at suspending or restricting the making available of products on the 
market pending a final assessment on non -compliance, without prejudging any 
subsequent decisions;  
(15) ‘serious risk’ means any serious risk, including a se rious risk where the effects are 
not immediate, requiring rapid intervention by the market surveillance authorities;  
(16) ‘end-user’ means any natural or legal person, residing or established in the Union, to 
whom a product was made available either as a c onsumer, outside any trade, 
business, craft or profession, or as a professional end -user in the course of his 
industrial or professional activities;  
(17) ‘recall’ means any measure aimed at achieving the return of a product that has 
already been made avail able to the end -user;  
(18) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being made available on the market;  
(19) ‘customs authorities’ means customs authorities as defined in Article 5(1) of 
Regulation (EU) No 952/ 2013;  
(20) ‘release for free circulation ’ means the procedure laid down in Article 201 of 
Regulation (EU) No 952/2013 ; 
(21) ‘products entering the Union market’ means products from third countries intended 
to be placed on the Union market or intended for p rivate use or consumption within 
the customs territory of the Union and placed under the customs procedure ‘release 
for free circulation’;  
(22) ‘authorised economic operator’ means an economic operator enjoying the status 
granted pursuant to Article 38(1) of Regulation (EU) No 952/2013.  
 
Chapter II  
Compliance information  
Article 4  
Person responsible for compliance information  
1.          A product may be made available on the market only if the following conditions are 
met: 
(a) the manufacturer is established in the Union or there is at least one of the 
following in place with respect to the product:  
(i) an importer;  
(ii) a natural or legal person established in the Union who has a written 
mandate from the manufacturer designating him as a person responsible 
for performing the tasks listed in paragraph 3 and requiring him to 
perform those tasks on the manufacturer's behalf;   
EN 28  EN (b) the identity and contact details of the manufacturer, importer or other person 
meeting the requirements of point (a) are publicly available  in accordance with 
paragraph 4 and are indicated or identifiable in accordance with paragraph 5.  
2. For the purposes of this Article, ‘the person responsible for compliance information’ 
means the person, whether the manufacturer, importer or other person , meeting the 
requirements of paragraph 1(a) with respect to the product or, if there is more than 
one such person, any of them.  
3. The person responsible for compliance information shall perform the following 
tasks:  
(a) if the Union harmonisation legislation  applicable to the product provides for an 
EU declaration of conformity and technical documentation, keeping the 
declaration and technical documentation at the disposal of market surveillance 
authorities for the period required by that legislation;  
(b) further  to a reasoned request from a market surveillance authority, providing 
that authority with all the information and documentation necessary to 
demonstrate the conformity of the product in an official Union language 
determined by the Member State concerned;  
(c) cooperating with the market surveillance authorities, at their request, on any 
action taken to eliminate or, if that is not possible, mitigate the risks posed by 
the product.  
4.         Manufacturers shall make the identity and contacts details of the person responsible 
for compliance information with respect to the product publicly available either on 
their website or, in the absence of a website, by any other means that allows the 
infor mation to be readily accessed by the general public in the Union free of charge.  
5. The identity and contact details of the person responsible for compliance information 
with respect to the product shall be indicated on or identifiable from information 
indicated on the product, its packaging, the parcel or an accompanying document.   
6. For the purposes of paragraph 1:  
(a) manufacturers may designate a person under paragraph 1(a)(ii) whether or not 
they have a right or obligation to appoint an authorised repre sentative under the 
Union harmonisation legislation applicable to the product;  
(b) where the manufacturer has such a right or obligation under the Union 
harmonisation legislation, the appointment of an authorised representative 
under that legislation may count  as a designation for the purposes of paragraph 
1(a)(ii) provided the appointment meets the requirements of that paragraph.  
7. This Article shall not apply in relation to a product that is subject to Regulation (EC) 
No 1223/2009 , Regulation (EU) 2017/745, Regulation 2017/746 or Regulation 
2017/1369.  
Article 5  
Declaration of conformity  
Where Union harmonisation legislation provides for the drawing up of an EU  declaration of 
conformity, manufacturers shall make the declaration publicly available on their website or, in 
the absence of a website, by any other means that allows the declaration to be readily accessed 
by the general public in the Union free of charg e.   
EN 29  EN Chapter III  
 Assistance to and cooperation with economic operators  
Article 6  
Information to economic operators  
The Product Contact Points referred to in [ Regulation (EC) No 764/2008 of the European 
Parliament and the Council / Regulation (EU)…. of the European Parliament and the 
Council ] shall provide economic operators, at their request and free of charge, with 
information with respect to the Union harmonisation legislation applicable to a product.  
Article 7  
Compliance partnership arrangements  
1. A mar ket surveillance authority may enter into a partnership arrangement with an 
economic operator established in its territory under which the authority agrees to 
provide the economic operator with advice and guidance in relation to the Union 
harmonisation leg islation applicable to the products for which the economic operator 
is responsible.  
 The arrangement shall not cover the provision of conformity assessment activities 
that are entrusted to notified bodies under the Union harmonisation legislation.  
2. If a market surveillance authority enters into a partnership arrangement under 
paragraph 1, it shall enter that fact in the system referred to in Article 34, along with 
details of the scope of the arrangement and the names and addresses of itself and of 
the ec onomic operator.  
3. If a market surveillance authority enters into a partnership arrangement under 
paragraph 1, other market surveillance authorities shall inform that authority of any 
temporary measure taken by them against the economic operator, and any corrective 
action taken by the economic operator, in relation to compliance with the applicable 
Union harmonisation legislation.  
4. A market surveillance authority that enters into a partnership arrangement under 
paragraph 1 may charge the economic operato r fees representing the costs reasonably 
incurred by the authority in the exercise of its functions under paragraphs 1 and 2.  
Article 8  
Memoranda of understanding with stakeholders  
1.    Market surveillance authorities may enter into memoranda of understanding with 
businesses or organisations representing businesses or end -users for the carrying out, 
or financing, of joint activities aimed at identifying non -compliance or promoting 
complia nce in specific geographical areas or with respect to specific categories of 
product.  
The market surveillance authority in question shall make the memorandum available 
to the general public and shall enter it in the system referred to in Article 34.   
EN 30  EN 2. A market surveillance authority may use any information resulting from activities 
carried out or financed by other parties to a memorandum of understanding entered 
into by it under paragraph 1 as part of any investigation undertaken by it into non -
compliance , but only if the activity in question was carried out independently, 
impartially and without bias.  
3. Any exchange of information between market surveillance authorities and businesses 
or organisations referred to in paragraph 1 for the purposes of prepa ring or 
implementing a memorandum of understanding entered into by them under that 
paragraph shall be deemed not to infringe the requirements of professional secrecy.  
Article 9  
Publication of voluntary measures  
1.  The Commission shall develop and maintai n an on -line portal on which economic 
operators may publish information about measures voluntarily taken by them in 
relation to a product as defined in Directive 2001/95/EC or a product made available 
by them on the market, where the risks posed by the pro duct go beyond the territory 
of one Member State.  
The on -line portal shall be one to which end -users and market surveillance 
authorities are able to have access.  
2.  If an economic operator chooses to publish information on the portal referred to in 
parag raph 1, it shall ensure that the product can be precisely identified from the 
information published and that the risks are explained such that end -users can assess 
what action it might be appropriate for them to take in response to the risks. The 
informati on published shall be provided in all of the official languages of the 
Member States where the products are made available on the market and the 
economic operator shall be responsible for the provision and accuracy of the 
information.  
3. Publication referr ed to in paragraph 1 is without prejudice to any obligations of 
economic operators under the applicable Union harmonisation legislation or under 
Directive 2001/95/EC.  
Chapter IV  
Organisation and general principles of market surveillance  
Article 10  
Obligations of market surveillance authorities as regards organisation  
1.   Market surveillance authorities shall establish appropriate communication and 
coordination mechanisms with other market surveillance authorities.  
2.    Market surveillance authorit ies shall establish the following procedures in connection 
with products subject to the Union harmonisation legislation set out in the Annex:  
(a) procedures for following up of complaints or reports on issues relating to risks;  
(b) procedures for monitoring any a ccidents or any harm to the health or safety of 
end-users which are suspected of having been caused by such products;   
EN 31  EN (c) procedures for verifying that corrective action to be taken by economic 
operators has been taken;  
(d) procedures for collecting and explorin g scientific and technical knowledge 
concerning safety issues.  
Article  11 
Market surveillance authorities and single liaison offices  
1.  Each Member State shall designate one or more market surveillance authorities in its 
territory. It shall inform the Co mmission, through the Network established under 
Article 31, and the other Member States of the market surveillance authorities 
designated by it and the areas of competence of each of those authorities, using the 
information and communication system referre d to in Article 34.  
2. Each Member State shall designate one of its market surveillance authorities or any 
other competent authority as a single liaison office.  
3.  The single liaison office of a Member State shall be responsible for coordinating the 
enfor cement and market surveillance activities of the market surveillance authorities 
designated by that Member State.   
4.  Member States shall ensure that their market surveillance authorities and single 
liaison office have the necessary resources, including sufficient budgetary and other 
resources, expertise, procedures and other arrangements for the proper performance 
of the ir duties.   
5.  Where there is more than one market surveillance authority in their territory, 
Member States shall ensure that the respective duties of those authorities are clearly 
defined and that those authorities collaborate closely so that they can d ischarge their 
duties effectively.  
Article 12  
Activities of market surveillance authorities  
1. Market surveillance authorities shall conduct their activities in order to ensure the 
following:  
(a) the effective surveillance of the market within their territory  with respect to any 
products that are subject to the Union harmonisation legislation set out in the 
Annex;  
(b) the taking by them of appropriate and proportionate temporary measures and 
the taking by economic operators of appropriate and proportionate correct ive 
action in relation to compliance with that legislation and this Regulation.  
2. Market surveillance authorities shall perform controls as part of their activities set 
out in paragraph 1, on a risk -based approach, taking into account, as a minimum, the 
following factors:  
(a) the identified risks associated with:  
(i)  the product, such as the number of products on the market and any 
hazards associated with that product;   
EN 32  EN (ii)  the activities and operations under the control of the economic 
operator;  
(b) the econo mic operator's past record of non -compliance, including the risk 
profiling and the status of an authorised economic operator;  
(c) any further information that might indicate non -compliance in relation to a 
particular product . 
3. Market surveillance authoritie s shall ensure that a product is withdrawn or recalled 
from the market or that the making available of the product on the market is 
prohibited or restricted if, when it is being used either in accordance with its intended 
purpose or under conditions that c an be reasonably foreseen and it is properly 
installed and maintained, either of the following conditions would be met:  
(a) the product is liable to compromise the health or safety of end -users;  
(b) the product does not conform to applicable requirements under Uni on 
harmonisation legislation.  
Where the products are withdrawn, recalled, prohibited or restricted, the market 
surveillance authority shall ensure that the Commission through the Network 
established under Article 31, the other Member States and end -users are informed 
accordingly.  
4. Market surveillance authorities shall perform their activities with a high level of 
transparency and shall make available to the general public any information that they 
deem relevant for the general public. They shall also ens ure that the following 
information is entered in the system referred to in Article 34:  
(a) the type, number and outcome of the checks performed by them;  
(b) the type and the number of non -compliances detected by them;  
(c) the nature of the temporary measures taken by  them against economic 
operators and of the corrective action taken by economic operators ; 
(d) details of the cases of non -compliance where penalties were imposed by them.  
5.  Market surveillance authorities shall exercise their powers and carry out their duti es 
independently, impartially and without bias.  
Article 13  
National market surveillance strategies  
1.  Each Member State shall draw up a national market surveillance strategy, as a 
minimum, every 3 years. The strategy shall promote a consistent, comprehensive and 
integrated approach to market surveillance and enforcement of Union harmonisation 
legislation w ithin the territory of the Member State and shall include all sectors and 
stages of the product supply chain, including imports and digital supply chains.   
2.  The national market surveillance strategy shall include, as a minimum, the following 
elements:    
(a) an assessment of the occurrence of non -compliant products, in particular taking 
into account the risk -based controls referred to in Articles 12(2) and 26(3), and 
market trends that may affect non -compliance rates in the categories of 
product;    
EN 33  EN (b) the area s identified as a priority for the enforcement of Union harmonisation 
legislation;  
(c) the enforcement actions planned in order to reduce the occurrence of non -
compliance in those areas identified as a priority, including, where relevant, the 
minimum control l evels envisaged for categories of product which have 
significant levels of non -compliance;  
(d) an assessment of the effective performance and coordination of market 
surveillance activities pursuant to this Regulation, and, where applicable, the 
identification of capacity building needs and measures;  
(e) an assessment of the cooperation with market surveillance authorities in other 
Member States and of joint actions, where applicable;  
(f) a monitoring programme for the purposes of measuring progress in the 
implementati on of the strategy and verifying compliance with this Regulation.  
3.  Member States shall communicate their national market surveillance strategy through 
the system referred to under Article 34.  
 
Chapter V  
Market surveillance powers and measures  
Article  14 
Powers and duties of market surveillance authorities  
1.  Member States shall confer on their market surveillance authorities the powers of 
market surveillance, investigation and enforcement necessary for the application of 
this Regulation and for the application of the Union harmonisation legislation set out 
in the Annex to this Regulation.  
2. When conferring powers under paragraph 1, including a power required by 
paragraph 3, Member States may provide for the power to be exercisable in one of 
the fol lowing ways as appropriate:  
(a) directly by the market surveillance authorities under their own authority;  
(b) by recourse to other public authorities;  
(c) by application to courts competent to grant the necessary decision to approve 
the exercise of that power.  
3. The powers conferred on market surveillance authorities under paragraph 1 shall 
include the following powers as a minimum:  
(a) the power to require economic operators to provide information necessary to 
determine the frequency of checks under Article 15, inclu ding information 
about the number of products on the market and the activities of those 
operators;  
(b) the power to perform system audits of economic operators’ organisations, 
including audits of any procedures that they have in place to ensure compliance 
with this Regulation and with applicable Union harmonisation legislation;   
EN 34  EN (c) the power to have access to any relevant document, data or information related 
to an instance of non -compliance, in any form or format and irrespective of its 
storage medium or the place  where it is stored;  
(d) the power to require any public authority, body or agency within the market 
surveillance authority's Member State, or any natural or legal person, to 
provide any information, data or document, in any form or format and 
irrespective of its storage medium or  the place where it is stored, for the 
purposes of enabling the market surveillance authority to investigate whether 
any non -compliance has occurred or is occurring and to establish the details of 
that non -compliance, including in particular information, d ata or documents 
required for the purposes of identifying and tracing financial and data flows, 
ascertaining the identity and contact details of persons involved in financial 
and data flows and ascertaining bank account information and the ownership of 
websites;   
(e) the power to do any of the following, or to request another public authority to 
do any of the following, for the purposes of an investigation by the market 
surveillance authority or at the request of an applicant authority:  
(1) to carry out on -site in spections, including power to enter any premises, 
land or means of transport that the economic operator in question uses for 
purposes related to his trade, business, craft or profession, in order to 
examine, seize, take or obtain copies of information, dat a or documents, 
irrespective of their storage medium;  
(2) to seal any premises or seize any information, data or documents of an 
economic operator during the inspection for a necessary period and to the 
extent necessary for the purposes of the investigation;  
(3)  to request any representative or member of staff of the economic 
operator to give explanations of facts, information or documents relating 
to the subject -matter of the inspection and to record their answers;  
(f) the power to take samples of products free of c harge in order to detect non -
compliance and obtain evidence;  
(g) the power to purchase products as test purchases, including under a cover 
identity, in order to detect non -compliance and obtain evidence;  
(h) the power to take temporary measures, where there are n o other effective 
means available to prevent a serious risk, including in particular temporary 
measures requiring hosting service providers to remove, disable or restrict 
access to content or to suspend or restrict access to a website, service or 
account o r requiring domain registries or registrars to put a fully qualified 
domain name on hold for a specific period of time;   
(i) the power to start investigations or proceedings on their own initiative in order 
to bring an instance of non -compliance within the te rritory of the Member State 
concerned to an end and, where appropriate, to publish information about the 
investigation through the system referred to in Article 34;  
(j) the power to seek to obtain a commitment from an economic operator to bring 
an instance of non-compliance to an end;  
(k) the power to prohibit the making available of products on the market or to 
withdraw, recall or destroy products, where economic operators fail to provide  
EN 35  EN the information requested by the market surveillance authority to verify th e 
compliance of those products and while the failure persists;  
(l) the power to impose penalties on an economic operator, including fines or 
periodic penalty payments, for non -compliance or for failure to comply with 
any decision, order, temporary measure or o ther measure taken by the market 
surveillance authority;  
(m) the power to order the restitution of profits obtained as a result of an instance 
of non -compliance;  
(n) the power to publish any final decisions, final measures, commitments given 
by the economic opera tor or decisions taken or made pursuant to this 
Regulation, including the publication of the identity of the economic operator 
who was responsible for the non -compliance.  
4. Market surveillance authorities  shall publish any commitments given to them by 
economic operators, details of any corrective action taken by economic operators in 
their territory, and details of any temporary measures taken by the relevant market 
surveillance authority pursuant to this Regulation.  
5. Market surveillance authorities s hall exercise their powers in accordance with the 
principle of proportionality.  
Article 15  
Market surveillance measures  
1.    Market surveillance authorities shall perform appropriate checks on the 
characteristics of products on an adequate scale, by means  of documentary checks 
and, where appropriate, physical and laboratory controls on the basis of a 
representative sample.  
In deciding what checks to perform and on what scale, market surveillance 
authorities shall take into account, in particular, establis hed principles of risk 
assessment and complaints.  
Where economic operators present test reports or certificates attesting conformity of 
their products with Union harmonisation legislation issued by an accredited 
conformity assessment body, market surveilla nce authorities shall take due account 
of such reports or certificates.  
2.    Market surveillance authorities shall take appropriate measures, without delay, to 
alert end -users within their territories to hazards that they have identified relating to 
any p roduct so as to reduce the risk of injury or other damage.  
The authorities shall cooperate with economic operators regarding actions which 
could prevent or reduce risks that are caused by products made available by those 
operators.  
3.    Where the market s urveillance authorities of one Member State decide to withdraw a 
product manufactured in another Member State, they shall inform the economic 
operator concerned without delay.  
Article 16  
Use of information, professional and commercial secrecy   
EN 36  EN Market surveillance authorities shall observe the principle of confidentiality where necessary 
in order to protect professional and commercial secrets or to preserve personal data pursuant 
to national legislation, subject to the requirement that information be ma de public to the 
fullest extent possible in order to protect the interests of end -users in the Union.  
Article  17 
Restrictive measures  
1.    Any measure, decision or order taken or made by market surveillance authorities 
pursuant to Union harmonisation legi slation or this Regulation to prohibit or restrict 
the making available of products on the market or to withdraw, recall or destroy 
products on the market shall be proportionate and shall state the exact grounds on 
which it is based.  
2.    Any such measure s, decisions or order shall be communicated without delay to the 
relevant economic operator, who shall at the same time be informed of the remedies 
available to him under the law of the Member State concerned and of the time limits 
to which those remedies are subject.  
3.    Before a measure, decision or order referred to in paragraph  1 is taken or made, the 
economic operator concerned shall be given the opportunity to be heard within an 
appropriate period of not less than 10 days, unless it is not possible to give him that 
opportunity because of the urgency of the measure, decision or order, based on health 
or safety requirements or other grounds relating to the public interests covered by the 
relevant Union harmonisation legislation.  
If the measure, decisi on or order is taken or made without the economic operator 
being given the opportunity to be heard, he shall be given that opportunity as soon as 
possible thereafter and the measure, decision or order shall be reviewed promptly by 
the authority.  
4.    The market surveillance authority shall promptly withdraw or amend any measure, 
decision or order referred to in paragraph  1 where the economic operator can 
demonstrate that he has taken effective corrective action.  
Article 18  
Products presenting a serious ris k 
1.  Market surveillance authorities shall take measures to recall or withdraw products 
which present a serious risk or to prohibit the making available of them on the 
market. They shall inform the Commission of such measures without delay, in 
accordance with Article 19.  
2.  The decision whether or not a product presents a serious risk shall be based on an 
appropriate risk assessment which takes account of the nature of the hazard and the 
likelihood of its occurrence. The feasibility of obtaining higher le vels of safety or the 
availability of other products presenting a lesser degree of risk shall not constitute 
grounds for considering that a product presents a serious risk.  
Article 19  
Exchange of information — Union Rapid Alert System    
EN 37  EN 1.  Where a market s urveillance authority takes or intends to take a measure in 
accordance with Article 18 and considers that the reasons which prompted the 
measure or the effects of the measure go beyond the territory of its Member State, it 
shall immediately notify the Comm ission of that measure, in accordance with 
paragraph 4 of this Article. It shall also inform the Commission without delay of the 
modification or withdrawal of any such measure.  
2.  If a product presenting a serious risk has been made available on the marke t, market 
surveillance authorities shall notify the Commission of any voluntary measures taken 
and communicated by an economic operator.  
3.  The information provided in accordance with paragraphs 1 and 2 shall include all 
available details, in particular t he data necessary for the identification of the product, 
the origin and the supply chain of the product, the related risk, the nature and the 
duration of the national measure taken and any voluntary measures taken by 
economic operators.  
4.  For the purpose s of paragraphs 1, 2 and 3, the market surveillance and information 
exchange system provided for in Article 12 of Directive 2001/95/EC shall be used. 
Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis . 
Article 20  
Union testi ng facilities  
1. The Commission may designate Union testing facilities for specific products or a 
specific category or group of products or for specific risks related to a category or 
group of products which are made available on the market.  
2. The Union testing facilities referred to in paragraph 1 shall satisfy the following 
criteria:  
(a) they must have suitably qualified staff with adequate training in the analytical 
techniques used in their area of competence and an adequate knowledge of 
standards and prac tices;  
(b) they  must be equipped to carry out the tasks assigned to them under paragraph 
4; 
(c) they must act in the public interest in an impartial and independent manner;  
(d) they must ensure, where appropriate, the confidential nature of topics, results 
or communications;  
(e) they must be accredited in accordance with Chapter II of Regulation (EC) No 
765/2008.  
3. A notified body or any other conformity assessment body designated pursuant to 
Union harmonisation legislation may not be designated as a Union testing  facility.  
4. Union testing facilities shall, within the area of their competence, perform the 
following tasks as a minimum:  
(a) carry out product -testing in relation to market surveillance activities and 
investigations;  
(b) contribute to the resolution of disput es between the market surveillance 
authorities of Member States, economic operators and conformity assessment 
bodies;   
EN 38  EN (c) provide independent technical or scientific advice to the Commission 
including, the Network established under Article 31, and to the Membe r States;  
(d) develop new techniques and methods of analysis;  
(e) disseminate information to testing facilities in the Member States and provide 
training for such testing facilities.  
5.  The Commission shall adopt implementing acts specifying the procedures for 
designating Union testing facilities. Those implementing acts shall be adopted in 
accordance with the examination procedure referred to in Article 63.  
Article 21  
Financing and recovery of costs by market surveillance authorities  
1. Member States shall ensur e that market surveillance authorities within their territory 
are provided with the necessary financial resources for the proper performance of 
their tasks.  
2. Market surveillance authorities may charge economic operators administrative fees 
in relation to  instances of non -compliance by that economic operator in order to 
enable the authorities to recover the costs of their activities with respect to these 
instances of non -compliance . Those costs may include the costs of carrying out 
testing for the purposes  of a risk assessment, the costs of taking measures in 
accordance with Article 30(1) and (2) and the costs of their activities relating to 
products that are found to be non -compliant and subject to corrective action prior to 
their release for free circulat ion. 
Chapter VI  
Cooperation and procedure for mutual assistance  
Article 22  
Requests for information  
1.  At the request of an applicant authority, the requested authority shall supply any 
information that the requested authority deems relevant to establish  whether a 
product is non -compliant and to ensure that the non -compliance can be brought to an 
end.  
2.  The requested authority shall undertake appropriate investigations or take any other 
measures that are appropriate in order to gather the required info rmation. Where 
necessary, those investigations shall be carried out with the assistance of other 
market surveillance authorities.  
3.  At the request of the applicant authority, the requested authority may allow officials 
of the applicant authority to acco mpany their counterparts in the requested authority 
during the course of their investigations.  
4.  The requested authority shall reply to the request under paragraph 1 using the 
procedure and within the time limits specified by the Commission under paragra ph 5.  
5.  The Commission shall adopt implementing acts specifying the time limits, standard 
forms and further details of the procedure to be used for making and responding to  
EN 39  EN requests for information under paragraph 1. Those implementing acts shall be 
adopted in accordance with the examination procedure referred to in Article 63.  
Article 23  
Requests for enforcement measures  
1.  At the request of an applicant authority, the requested authority shall without delay 
take all necessary enforcement measures usi ng the powers conferred on it under this 
Regulation in order to bring an instance of non -compliance  to an end.  
2. The requested authority shall determine the appropriate enforcement measures 
required to bring an instance of non -compliance  to an end . Where necessary, 
enforcement measures shall be determined and implemented with the assistance of 
other public authorities.  
3.  The requested authority shall regularly and without undue delay inform and consult 
the applicant authority about the measures referred to in paragraph 2 that have been 
taken or which are intended to be taken.  
The requested authority shall without delay notify the applicant authority, the market 
surveillance authorities of other Member States, and the Commission of the measures 
taken by it and of their effect on the non -compliance in question. The notification 
shall be made using the system referred to in Article 34 and shall include the 
following information as a minimum:  
(a) whether temporary measures have been imposed;  
(b) whether the non-compliance has ceased;  
(c) whether penalties have been imposed and, if so, what;  
(d) whether other measures taken by the requested authority or the economic 
operator have been implemented.  
4.  The requested authority shall reply to the request under paragraph 1 using the 
procedure and within the time limits specified by the Commission under paragraph 5.  
5.  The Commission shall adopt implementing acts specifying the time limits, standard 
forms and further details of the procedures to be used for making and res ponding to 
requests for enforcement measures under paragraph 1. Those implementing acts shall 
be adopted in accordance with the examination procedure referred to in Article 63.  
Article 24  
Procedure for mutual assistance requests  
1.  The applicant authorit y shall provide sufficient information, in the case of requests 
for mutual assistance under Article 22 or 23, to enable the requested authority to 
fulfill the request, including any necessary evidence obtainable only in the Member 
State of the applicant au thority.  
2.  Requests for mutual assistance under Article 22 or 23 shall be sent by the applicant 
authority to the single liaison office of the Member State of the requested authority 
and also to the single liaison office of the Member State of the applica nt authority for 
information purposes. The single liaison office of the Member State of the requested 
authority shall pass the requests on to the appropriate competent authority, without 
undue delay.   
EN 40  EN 3.  Requests for mutual assistance under Article 22 or 23 and all communication linked 
to them shall be made using electronic standard forms by means of the the system 
referred to in Article 34.  
4.  The languages to be used for requests for mutual assistance under Article 22 or 23 
and for all communication li nked to them shall be agreed upon by the competent 
authorities concerned.  
5.  Where no agreement about the languages to be can be reached between the 
competent authorities concerned, the requests for mutual assistance under Article 22 
or 23 shall be sent in the official language of the Member State of the applicant 
authority and the replies to such requests in the official language of the Member 
State of the requested authority. In that instance, the applicant authority and the 
requested authority shall ar range for the translation of the requests, replies or other 
documents that it receives from the other.  
6.  The requested authority shall reply directly to the applicant authority and also to the 
single liaison offices of the Member States of both the appl icant authority and the 
requested authority.  
Article 25  
Use of evidence and investigation findings  
1.  Market surveillance authorities may use any information, document or a certified 
true copy of a document, finding, statement, or any intelligence as evid ence for the 
purpose of their investigations, irrespective of the format in which and medium on 
which they are stored.  
2.  The evidence referred to in paragraph 1 that is used by a market surveillance 
authority in one Member State may be used as part of i nvestigations to verify product 
compliance carried out by market surveillance authorities in another Member State 
without any further formal requirements.  
3. Products deemed to be non -compliant on the basis of a decision of a market 
surveillance authority in one Member State, shall be presumed to be non -compliant 
by market surveillance authorities in another Member State, unless economic 
operators can provide evidence to the contrary.  
4. The decisions of a market surveillance authority referred to in paragr aph 3 shall be 
published in the information and communication system referred to in Article 34.  
Chapter VII  
Products entering the Union market  
Article 26  
Controls on products entering the Union market  
1.        Member States shall designate customs authorities, one or more market surveillance 
authorities or any other authority in their territory as the authorities in charge of the 
control on products entering the Union market.   
EN 41  EN  Each Member State shall inform the  Commission and the other Member States of the 
authorities designated under the first subparagraph and of their areas of competence 
through the system referred to in Article 34.  
2. The authorities designated under paragraph 1 shall have the necessary power s and 
resources for the proper performance of their tasks as referred to in that paragraph.  
3. Products subject to Union harmonisation legislation that are to be placed under the 
customs procedure ‘release for free circulation’ shall be subject to control s 
performed by the authorities designated under paragraph 1. They shall perform those 
controls on the basis of risk analysis in accordance with Articles 46 and 47 of 
Regulation (EU) No 952/2013.  
4. Products entering the Union market that require further pr ocessing in order to be in 
compliance with the Union harmonisation legislation applicable to them shall be 
placed under the appropriate customs procedure allowing such processing.  
5.        Risk-related information shall be exchanged between:  
(a) the authoriti es designated under paragraph 1 in accordance with Article 47(2) 
of Regulation (EU) No 952/2013;  
(b) customs authorities in accordance with Article 46(5) of Regulation (EU) No 
952/2013.  
 Where, in relation to products subject to Union harmonisation legislatio n that are 
either in temporary storage or placed under a customs procedure other than release 
for free circulation, customs authorities at the first point of entry have reason to 
believe that those products present a risk, they shall transmit all relevant information 
to the competent customs office of destination.  
6.  Market surveillance authorities shall provide authorities designated under paragraph 
1 with information on categories of product or the identity of economic operators 
where a higher risk of n on-compliance has been identified.  
7. By 31 March each year, Member States shall submit to the Commission statistical 
data covering controls performed by the authorities designated under paragraph 1 
with respect to products subject to Union harmonisation legislation during the 
previous calendar year, including data covering:  
(a) the number of interventions in the field of controls on such products, including 
product safety and compliance;  
(b) the number of cases communicated to the market surveillance authorities;  
(c) the results of controls on such products;  
(d) the characteristics of any product found to be non -compliant.  
The Commission shall draw up a report each year by 30 June, containing the 
information submitted by the Member States for the previous calendar year. T he 
report shall be published in the system referred to in Article 34.  
8.  Where the Commission becomes aware of a serious risk posed in a Member State by 
products subject to Union harmonisation legislation that are imported from a third 
country, it shall recommend to the Member State concerned that it takes appropriate 
market surveillance measures.  
9. The Commission shall specify further by means of implementing acts the details of 
the data to be submitted by Member States under paragraph 7. Those implemen ting  
EN 42  EN acts shall be adopted in accordance with the examination procedure referred to in 
Article 63.  
Article 27  
Suspension of release for free circulation  
1. Authorities designated under Article 26(1) shall suspend the release of a product for 
free circulati on if, in the course of controls referred to in Article 26, it is established 
that:  
(a) the product is not accompanied by the documentation required by the Union 
harmonisation legislation applicable to it;  
(b) the product is not marked or labelled in accordance w ith that Union 
harmonisation legislation;  
(c) the product bears a CE marking or other marking required by that Union 
harmonisation legislation which has been affixed in a false or misleading 
manner;  
(d) the identity and contact details of a person responsible for  compliance 
information with respect to the product is not indicated or identifiable in 
accordance with Article 4(5);  
(e) for any other reason, there is cause to believe that the product will not comply 
with the requirements set out in the Union harmonisation legislation applicable 
to it when it is placed on the market or that it will pose a serious risk.  
2. Authorities designated under Article 26(1) shall immediately notify the market 
surveillance authorities of any suspension of release referred to in paragraph 1.  
3. Where the market surveillance authorities have reason to believe that a product will 
not comply with the Union harmonisation legislation applicable to it or will pose a 
serious risk, they shall require the authorities designated under Artic le 26(1) to 
suspend the process for its release for free circulation.  
4.     During any suspension of the process for release of a product for free circulation, 
Articles 197, 198 and 199 of Regulation (EU) No 952/2013 shall apply accordingly.  
Article 28  
Release of products  
Where the release of a product for free circulation of a product has been suspended in 
accordance with Article 27, that product shall be released for free circulation where all the 
other requirements and formalities relating to such a rel ease have been fulfilled and if any of 
the following conditions is satisfied:  
(a) within five working days of the suspension, the authorities designated under Article 
26(1) have not been requested by the market surveillance authorities to maintain the 
suspensi on; 
(b) the authorities designated under Article 26(1) have been informed by the market 
surveillance authorities that there is cause to believe that the product, when it is 
placed on the market, will comply with the Union harmonisation legislation 
applicable t o it.  
EN 43  EN A product released for free circulation in accordance with point (a) shall not be deemed to be 
in compliance with Union harmonisation legislation merely by reason of having been released 
for free circulation.  
Article 29  
Cooperation with authorised ec onomic operators  
1.  Market surveillance authorities shall treat as a matter of priority products declared 
free for circulation by an authorised economic operator as set out in Article 38(2) of 
Regulation (EU) No 952/2013, the release of which is suspende d in accordance with 
Article 28(1) of this Regulation.  
2.  Market surveillance authorities may notify the customs authorities to release such 
products for free circulation at the request of the authorised economic operator, 
provided that all the other requ irements and formalities pertaining to their release 
have been fulfilled.  
Without prejudice to Article 47 of Regulation (EU) No 952/2013, on the basis of a 
request by an authorised economic operator market surveillance authorities may 
carry out controls o n such products at a place other than the place where products 
have been presented to customs.  
3.  Market surveillance authorities and the customs authorities shall exchange 
information on the status of the authorised economic operators and their record of  
compliance related to product safety.  
4. Where any non -compliance is identified in the course of controls described in the 
second subparagraph of paragraph 2, the market surveillance authorities shall 
suspend the favourable treatment provided for in para graph 1 and the first 
subparagraph of paragraph 2 and shall enter details of the non -compliance in the 
system referred to in Article 34.  
5.  The Commission shall specify by means of implementing acts the data to be 
exchanged and the procedure to be follow ed for the exchange of information 
between customs authorities and market surveillance authorities on the status of 
authorised economic operators and their compliance related to product safety. Those 
implementing acts shall be adopted in accordance with th e examination procedure 
referred to in Article 63.  
Article 30  
Refusal to release  
1. Where the market surveillance authorities conclude that a product presents a serious 
risk, they shall take measures to prohibit the placing of the product on the market and  
shall require the authorities designated under Article 26(1) not to release it for free 
circulation. They shall also require these authorities to include the following notice 
on the commercial invoice accompanying the product and on any other relevant 
accompanying document, including in the customs data -processing system:  
 ‘Dangerous product – release for free circulation not authorised – Regulation 
[Reference to this Regulation to be added]’;  
 Market surveillance authorities shall immediately enter that information into the 
system referred to in Article 34.   
EN 44  EN 2. Where market surveillance authorities conclude that a product may not be placed on 
the market as it does not comply with the Union harmonisation legislation applicable 
to it, they shall take measure s to prohibit the placing of the product on the market and 
shall require the authorities designated under Article 26(1) not to release it for free 
circulation. They shall also require these authorities to include the following notice 
on the commercial invo ice accompanying the product and on any other relevant 
accompanying document, including in the customs data -processing system:  
 ‘Product not in conformity – release for free circulation not authorised – Regulation 
[Reference to this Regulation to be added ].’ 
 Market surveillance authorities shall immediately enter that information into the 
system referred to in Article 34.  
3. Where the product referred to in paragraph 1 or 2 is subsequently declared for a 
customs procedure other than release for free circu lation and provided that the 
market surveillance authorities do not object, the notices required by paragraph 1 or 
2 shall also be included, under the same conditions as required by that paragraph, on 
the documents used in connection with that procedure.  
4.  Authorities designated under Article 26(1) may destroy or otherwise render 
inoperable a product which presents a risk to the health and safety of end -users 
where it is deemed, by the authority in question, necessary and proportionate to do 
so. The cost of such action shall be borne by the person declaring the product for free 
circulation.  
Articles 197, 198 and 199 of Regulation (EU) No 952/2013 shall apply accordingly.  
Chapter VIII  
Coordinated enforcement and international cooperation  
Article 31  
Union Product Compliance Network  
An Union Product Compliance Network (‘the Network’) is hereby established.  
Article 32  
Composition of the Union Product Compliance Network  
1. The Network shall be composed of a Union Product Compliance Board (‘EUPC 
Board’),  administrative coordination groups and a secretariat.  
2. The EUPC Board shall consist of one representative from each of the single liaison 
offices referred to in Article 11, and two representatives from the Commission, and 
their respective alternates.  
3.   The Commission shall establish separate or joint administrative coordination groups 
for all the instruments of Union harmonisation legislation listed in the Annex to this 
Regulation. Each administrative coordination group shall be composed of 
representa tives of the competent national market surveillance authorities and, if 
appropriate, representatives of the single liaison offices, and representatives of the 
relevant business associations and of consumer associations.   
EN 45  EN 4.    The secretariat shall be compo sed of Commission staff.  
5.  The Commission may attend the meetings of the administrative coordination groups.  
Article 33  
Coordinated enforcement tasks  
1.  The Commission shall have the following tasks:  
(a) to adopt and monitor the implementation of the work programme of the 
Network  on the basis of a proposal from the Secretariat;  
(b) to support the functioning of the Product Contact Points referred to in Article 
6; 
(c) to coordinate the activities of the single liaison offices referred to in Article 11;  
(d) to support th e establishment and functioning of Union testing facilities referred 
to in Article 20;  
(e) to apply the instruments of international cooperation referred to in Article 35;  
(f) to organise cooperation and the effective exchange of information and best 
practices bet ween market surveillance authorities;  
(g) to develop and maintain the system referred to in Article 34, including the 
interface with the EU Single Window referred to in paragraph 4 of that Article, 
and provide information to the general public by means of tha t system;  
(h) to organise the meetings of the EUPC Board and administrative coordination 
groups referred to in Articles 32;  
(i) to assist the Network to perform preliminary or ancillary work in connection 
with the implementation of market surveillance activities linked to the 
application of Union harmonisation legislation such as studies, programmes, 
evaluations, guidelines, comparative analyses, mutual joint visits, research 
work, the development and maintenance of databases, training activities, 
laboratory work,  proficiency testing, inter -laboratory tests and conformity 
assessment work, and to prepare and assist in the implementation of Union 
market surveillance campaigns and similar activities;  
(j) to organise peer reviews, common training programmes and facilitate 
exchanges of personnel between market surveillance authorities and, where 
appropriate, with the market surveillance authorities of third countries or with 
international organisations;  
(k) to carry out activities under programmes of technical assistance, cooperation 
with third countries and the promotion and enhancement of Union market 
surveillance policies and systems among interested parties at Union and 
international levels;  
(l) to facilitate technical or scientific expertise for the purpose of implementing  
market surveillance administrative cooperation;  
(m) to examine, on its own initiative or at the request of the EUPC Board, any 
question covering the application of this Regulation and issue guidelines, 
recommendations and best practices in order to encourage consistent  
EN 46  EN application of this Regulation, including by setting standards for minimum 
penalties.  
2. The EUPC Board shall have the following tasks:  
(a) to define the priorities for common market surveillance actions;  
(b) to ensure the coordination and monitoring of  the administrative coordination 
groups and their activities;  
(c) to assist in the drawing up and implementation of the memoranda of 
understanding referred to in Article 8;  
(d) to adopt rules of procedure for itself and for the functioning of the 
administrative co ordination groups.   
3. The administrative coordination groups shall have the following tasks:  
(a) to coordinate the enforcement of Union harmonisation legislation within their 
area of competence;  
(b) to ensure that the enforcement action taken by national market surveillance 
authorities is followed up across the Union;  
(c) to increase the efficiency of market surveillance throughout the single market 
bearing in mind the existence of different systems of market surveillance in the 
Member States;  
(d) to establish appropriat e communication channels between national market 
surveillance authorities and the Network;  
(e) to establish and coordinate common actions such as cross -border market 
surveillance activities;  
(f) to develop common practices and methodologies for effective market 
surveillance;  
(g) to inform each other of national market surveillance methods and activities and 
to develop and promote best practices;  
(h) to identify issues of shared interest relating to market surveillance and suggest 
common approaches to be adopted.  
Article  34 
Information and communication system  
1. The Commission shall develop and maintain an information and communication 
system for the collection and storage of information, in a structured form, on issues 
relating to the enforcement of Union harmonisation legislation. The Commission, 
single liaison offices, and authorities designated in accordance with Article 26(1)  
shall have access to that system.  
2. Single liaison offices shall enter the following information in the system:  
(a) the identity of the market su rveillance authorities in their Member State and 
areas of competence of those authorities pursuant to Article 11(1);  
(b) the identity of the authorities designated by their Member States as authorities 
in charge of controls on products at the external borders of the Union.  
3. Market surveillance authorities shall enter the following information into the system:   
EN 47  EN (a) details of the national market surveillance strategies strategy drawn up by their 
Member State under Article 13;  
(b) any partnership arrangements entered in to by them under Article 7;  
(c) the results from the monitoring, review and assessment of the market 
surveillance strategy drawn up by their Member State;  
(d) all complaints received by them and reports made by them about issues relating 
to non -compliant products;  
(e) in relation to products made available on the market in their territory, without 
prejudice to Article 12 of Directive 2001/95/EC and Article 19 of th is 
Regulation, the following information:  
(i) any non -compliance;  
(ii) the identification of hazards and the economic operator concerned;  
(iii) any possible risks not restricted to their territory;  
(iv) the results of testing carried out by them or the concerned economic 
operator;  
(v) details of voluntary measures taken by economic operators;  
(vi) details of restrictive measures taken by that market surveillance 
authority, where applicable, the penalties imposed;  
(vii) the outcome of contacts with an eco nomic operator and the follow up by 
that economic operator;  
(viii)  failures by a person responsible for compliance information to comply 
with Article 4 (3);  
(ix)  failures by manufacturers to comply with Article 4(4).   
(f) in relation to products entering the  Union market for which the process for the 
release for free circulation has been suspended in accordance with Article 27, 
in their territory, the following information:  
(i) any non -compliance;  
(ii) the identification of any hazards and the economic operat or concerned;  
(iii) the results of testing carried out by them or the concerned economic 
operator;  
(iv) details of restrictive measures taken by that market surveillance authority 
and, where applicable, the penalties imposed;  
(v) the outcome of contacts wi th an economic operator and the follow up by 
that economic operator;  
(vi) any other control or test reports carried out by or at the request of the 
market surveillance authority;  
(vii) any objection raised by a Member State in accordance with the applicabl e 
safeguard procedure in the Union harmonisation legislation applicable to 
the product and any subsequent follow -up. 
4. Where relevant for the enforcement of Union harmonisation legislation and for the 
purposes of minimising risk and combating fraud, custo ms authorities shall extract  
EN 48  EN from national customs systems and transmit to the information and communication 
system data relating to the placing of products under the customs procedure ‘release 
for free circulation’ and the results of controls related to p roduct safety.  
The Commission, in the context of the EU Single Window environment for customs, 
shall develop an electronic interface to enable the transmission of such data. This 
interface shall be in place [four years] from the date of adoption of the im plementing 
acts.  
5. Market surveillance authorities shall recognise the validity of and shall make use of 
test reports prepared by or for their counterparts in other Member States and which 
have been entered into the information and communication system.  
6. The Commission shall adopt implementing acts specifying the details of 
implementation arrangements for paragraphs 1 to 4 and defining the data to be 
transmitted in accordance with paragraph 4. Those implementing acts shall be 
adopted in accordance with the examination procedure referred to in Article 63.  
Article 35  
International cooperation  
1. The Commission may exchange confidential market surveillance related information 
with regulatory authorities of third countries or international organisations where it 
has concluded confidentiality arrangements based on reciprocity with those 
authorities or organisations.  
2. The Commission may set up a framework for cooperation and exchange of selected 
information contained in the information exchange system pro vided for in Article 12 
of Directive 2001/95/EC, with applicant countries, third countries or international 
organisations. The cooperation or exchange of information may relate, inter alia, to 
the following:  
(a) risk assessment methods used and the results of product -testing;  
(b) coordinated product recalls or other similar actions;  
(c) the measures taken by market surveillance authorities under Article 15.  
3. The Commission may approve a specific system of product -related pre -export 
control carried out by a third cou ntry on products immediately prior to their export 
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 granted in 
respect of one or more products, in respect of one or more categories of product or in 
respect of products or categories of product manufactured by certain manufacturers.  
4. Where such an approval has been granted, the number and frequency of import 
controls for those products or categories of product entering the Union market, 
referred to in paragraph 3, may be reduced.  
Customs authorities may however carry out controls those products or categories of 
product entering the Union market, in order to ensure that the pre -export controls 
carried  out by the third country are effective to determine compliance with Union 
harmonisation legislation.  
5.    Approval may only be granted to a third country under paragraph 3 following an 
audit within the Union demonstrating that the following conditions ar e satisfied:   
EN 49  EN (a) products exported to the Union from that third country satisfy the requirements 
set out in Union harmonisation legislation;  
(b) the controls carried out in that third country are sufficiently effective and 
efficient to replace or reduce the documentary and physical controls laid down 
in such legislation.  
6.    The approval referred to in paragraph 3 shall specify the competent authority of the 
third country under whose responsibility the pre -export controls are to be performed 
and that compet ent authority shall be the counterpart for all contacts with the Union.  
7. The competent authority, referred to in paragraph 6, shall ensure the official 
verification of the products prior to their entry into the Union.  
8. Where controls on products enter ing the Union market referred to in paragraph 3 
reveal significant non -compliance, the market surveillance authorities shall notify 
immediately the Commission through the system referred to in Article 34 and 
increase the number of controls on such products . 
9.    The Commission shall withdraw an approval granted under paragraph 3 where it is 
revealed that the products entering the Union market do not comply with Union 
harmonisation legislation in a significant number of instances.  
10.  The Commission shall adopt implementing acts for the implementation of the system 
of product -related pre -export controls, referred to in paragraph 3, for specifying a 
model for the certificates of compliance or verification to be used. Those 
implementing acts shall be adopted in accordance with the examination procedure 
referred to in Article 63.  
Chapter IX  
Financial provisions  
Article 36  
Financing activities  
1. The Union shall finance performance of the tasks of the Network referred to in 
Article 34.  
2. The Union may finance  the following activities in relation to the application of this 
Regulation:  
(a) the functioning of the Product Contact Points referred to in Article 6;  
(b) the establishment and functioning of Union testing facilities referred to in 
Article 20;  
(c) the development of  instruments of international cooperation referred to in 
Article 35;  
(d) the drawing up and updating of contributions to guidelines on market 
surveillance;  
(e) the making available to the Commission of technical or scientific expertise for 
the purpose of assisting the Commission in its implementation of market 
surveillance administrative cooperation;   
EN 50  EN (f) the implementation of national market surveillance strategies referred to in 
Article 13 and Member States' and Union market surveillance campaigns;  
(g) activities carried out under programmes providing technical assistance, 
cooperation with third countries and the promotion and enhancement of Union 
market surveillance po licies and systems amongst interested parties at Union 
and international levels.  
3. The financing of the electronic interface referred to in Article 34(4) shall be shared 
between the Union and the Member States. The Union shall be responsible for 
financing  the central module and link to the Network. Member States shall be 
responsible for financing the adaptation of their national systems.  
4. The Union's financial assistance to the activities under this Regulation shall be 
implemented in accordance with Regu lation (EU, Euratom) No 966/2012  of the 
European Parliament and of the Council61, either directly, or by delegating budget 
implementation tasks to the entities listed in Article 58(1)(c) of that Regulation.  
5. The appropriations allocated to activities refe rred to in this Regulation shall be 
determined each year by the budgetary authority within the limits of the financial 
framework in force.  
6. The appropriations determined by the budgetary authority for the financing of market 
surveillance activities may a lso cover expenses relating to preparatory work, 
monitoring, control, audit and evaluation activities which are required for the 
management of the activities set out in this Regulation and for the achievement of 
their objectives. These expenses shall inclu de the costs of conducting studies, 
arranging meetings of experts, information and communication actions, including 
corporate communication of the political priorities of the Union insofar as far as they 
are related to the general objectives of market surv eillance activities, expenses linked 
to information technology networks focusing on information processing and 
exchange together with all other related technical and administrative assistance 
expenses incurred by the Commission.  
Article 37  
Protection of th e Union's financial interests of the Union  
1. The Commission shall take appropriate measures to ensure that, when actions 
financed under this Regulation are implemented, the financial interests of the Union 
are protected by the application of preventive me asures against fraud, corruption and 
any other illegal activities, by effective controls and, if irregularities are detected, by 
the recovery of the amounts wrongly paid and, where appropriate, by effective, 
proportionate and dissuasive administrative and financial penalties.  
2. The Commission or its representatives and the Court of Auditors shall have the 
power of audit, on the basis of documents and of on -the-spot inspections, over all 
grant beneficiaries, contractors and subcontractors who have received  Union funds 
under this Regulation.  
3. The European Anti -fraud Office (OLAF) may carry out investigations, including on -
the-spot controls and inspections, in accordance with the procedures laid down in 
                                                 
61 Regulation (EU, Euratom) No 966/2012  of the European Parliament and of the Council  of 25  October 2012 on th e financial rules 
applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No  1605/2002  (OJ L 298, 
26.10.2012, p. 1).   
EN 51  EN Regulation (EU, Euratom) No 883/2013 of the European P arliament and of the 
Council62 and Council Regulation (Euratom, EC) No 2185/9663 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 agre ement or 
grant decision or a contract funded under this Regulation.  
4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third 
countries and with international organisations, contracts, grant agreements and grant 
decisions resulting f rom the implementation of this Regulation shall contain 
provisions expressly empowering the Commission, the Court of Auditors and OLAF 
to conduct such audits and investigations, in accordance with their respective 
competences..  
Chapter X  
Final provisions  
Article 38  
Applicability of Regulation (EC) 765/2008 and amendments to Union harmonisation 
legislation  
Articles 15 to 29 of Regulation (EC) 765/2008 shall not apply to Union harmonisation 
legislation set out in the Annex.  
Article 39  
Amendments to Directive 2004/42/EC  
 Articles 6 and 7 of Directive 2004/42/EC are deleted.  
Article 40  
Amendments to Directive 2009/48/EC  
Directive  2009/48/EC is amended as follows:  
(1)  Article 40 is deleted;  
(2) In Article 42, paragraph 1 is deleted;  
(3)  Article 44 is deleted.  
 Article 41  
Amendments to Directive 2010/35/EU  
Directive  2010/35/EU is amended as follows:  
(1) Article 16 is deleted;  
(2) In Article 30, paragraph 1 is deleted.  
                                                 
62 Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2 013 concerning 
investigations conducted by the European Anti -Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the 
European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).  
63 OJ L292, 14.11.1996, p.2.   
EN 52  EN Article 42  
Amendments to Regulation (EU) No 305/2011  
In Article 56 of Regulation (EU) No 305 /2011, paragraph 1 is deleted.  
Article 43  
Amendments to Regulation (EU)  No 528/2012  
In Article 65 of Regulation (EU) No 528/212 of the European Parliament and of the Council, 
the second sentence of paragraph 1 is replaced by the following:  
‘Regulation (EU ) 2018 /[XX Please insert number of this Regulation]  of the European 
Parliament and of the Council* shall apply accordingly. ’  
* Regulation (EU) 2018/[ XX Please insert number of this Regulation ] of the European 
Parliament and of the Council of [Please insert date and full title of this Regulation 
and the OJ reference in brackets] . 
Article 44  
Amendments to Directive  2013/29/EU  
Directive  2013/29/EU  is amended as follows:  
(1) In Article 38, paragraph 2 is deleted;  
(2) In Article 39(1), the fourth subpara graph is deleted.  
Article 45  
Amendments to Directive  2013/53/EU  
Directive  2013/53/EU  is amended as follows:  
(1) Article 43 is deleted;  
(2) In Article 44(1), the fifth subparagraph is deleted.  
Article 46  
Amendments to Directive  2014/28/EU  
Directive 2014/28/EU  is amended as follows:  
(1) In Article 41, the first paragraph is deleted;  
(2) In Article 42(1), the fourth subparagraph is deleted.  
Article 47  
Amendments to Directive 2014/29/EU  
Directive 2014/29/EU  is amended as follows:  
(1) Article 34 is deleted;  
(2) In Article 35(1), the fourth subparagraph is deleted.   
EN 53  EN Article 48  
Amendments to Directive 2014/30/EU  
Directive 2014/30/EU  is amended as follows:  
(1) Article 37 is deleted;  
(2) In Article 38(1), the fourth subparagraph is deleted.  
Article 49  
Amendments to Directive 2014/31/EU  
Directive 2014/31/EU  is amended as follows:  
(1) Article 36 is deleted;  
(2) In Article 37(1), the fourth subparagraph is deleted.  
Article 50  
Amendments to Directive  2014/32/EU  
Directive 2014/32/EU  is amended a s follows:  
(1) Article 41 is deleted;  
(2) In Article 42(1), the fourth subparagraph is deleted.  
Article 51  
Amendments to Directive 2014/33/EU  
Directive 2014/33/EU is amended as follows:  
(1) Article 37 is deleted;  
(2) In Article 38(1), the fifth subparagraph is deleted.  
Article 52  
Amendments to Directive 2014/34/EU  
Directive 2014/34/EU is amended as follows:  
(1) Article 34 is deleted;  
(2) In Article 35(1), the fourth subparagraph is deleted.  
Article 53  
Amendments to Directive 2014/35/EU  
Directive 2014/35/EU is amended as follows:  
(1) Article 18 is deleted;  
(2) In Article 19(1), the third subparagraph is deleted.   
EN 54  EN Article 54  
Amendments to Directive 2014/53/EU  
Directive  2014/53/EU is amended as follows:  
(1) Article 39 is deleted;  
(2) In Article 40(1), the fourth subparagraph is deleted.  
Article 55  
Amendments to Directive 2014/68/EU  
Directive 2014/68/EU is amended as follows:  
(1) Article 39 is deleted;  
(2) In Article 40(1), the third subparagraph is deleted.  
Article 56  
Amendments to Directive 2014 /90/EU  
Directive 2014/90/EU is amended as follows:  
(1) In Article 12, paragraph 10 is deleted;  
(2) In Article 25, paragraph 1 is replaced by the following:  
'As regards marine equipment, the Member States shall undertake market surveillance 
in accordance with the EU market surveillance framework laid down in Regulation 
[number of the new Enforcement Regulation], subject to paragraph 2 and 3 of this 
Article.'  
 (3)     In Article 25, paragraph 4 is deleted;  
(4) In Article 26(1), the fourth subparagraph is de leted.  
Article 57  
Amendments to Regulation (EU)  2016/424  
Regulation (EU) 2016/424 is amended as follows:  
(1) Article 39 is deleted;  
(2) In Article 40(1), the fourth subparagraph is deleted.  
Article 58  
Amendments to Regulation (EU)  2016/425  
Regulation (EU ) 2016/425 is amended as follows:  
(1)  Article 37 is deleted;  
(2) In Article 38(1), the fourth subparagraph is deleted.  
Article 59  
Amendments to Regulation (EU)  2016/426   
EN 55  EN Regulation (EU) 2016/426  is amended as follows:  
(1) Article 36 is deleted;  
(2) In Article 37(1), the fourth subparagraph is deleted.  
Article 60  
Amendments to Regulation (EU) 2017/1369  
Regulation (EU) 2017/1369 is amended as follows:  
(1) In Article 8, paragraphs 1 and 3 are deleted;  
(2) In Article 9(2), the second subparagraph is deleted.  
Chapter XI  
Penalties, evaluation, committee procedure and entry into force 
and application  
Article 61  
Penalties  
1. The Member States shall lay down the rules on penalties applicable to infringements 
of the provisions of this Regulation that impose  obligations on economic operators 
and to infringements of provisions of any Union harmonisation legislation on 
products covered by this Regulation that impose obligations on economic operators 
where that legislation does not provide for penalties, and sha ll take all measures 
necessary to ensure that they are implemented. The penalties provided for shall be 
effective, proportionate and dissuasive.  
The Member States shall notify those provisions to Commission, by [31 March 
2020], notify the Commission of th ose rules and of those measures and shall notify it 
without delay of any subsequent amendment affecting them.  
2. When a decision is being made whether to impose a penalty in each individual case, 
due regard shall be given to the following:  
(a) the financial si tuation of small and medium -sized enterprises;  
(b) the nature, gravity and duration of the non -compliance taking into account the 
harm caused to end -users;  
(c) the intentional or negligent character of the infringement;  
(d) the level of cooperation shown by the econom ic operator during the period of 
the investigation carried out by the market surveillance authorities;  
(e) any relevant similar infringements previously committed by the economic 
operator.  
3. The penalties  may be increased where the economic operator  has previ ously 
committed a similar infringement and may include criminal penalties for serious 
infringements of Union harmonisation legislation.   
EN 56  EN 4. The Member States shall ensure that financial penalties for intentional infringements 
of Union harmonisation legisla tion shall as a minimum offset the economic 
advantage arising from the infringement.  
5. Member States shall ensure, in particular, that penalties can be imposed where the 
economic operator fails or refuses to cooperate during market surveillance controls 
and activities.  
Article 62  
Evaluation  
By [31 December 2024] and every five years thereafter, the Commission shall shall carry out 
an evaluation of this Regulation against the objectives it pursues and present a report on the 
main findings to the European Parliament, to the Council  and to the European Economic and 
Social Committee. .  
The report shall assess whether this Regulation achieved its objectives, in particular with 
regard to reducing the number of non -compliant products on the Union market, ensurin g 
effective and efficient enforcement of Union harmonisation legislation within the Union, 
improving cooperation between competent authorities and strengthening the controls on 
products entering the Union market , whilst taking into account the impact on bu siness and in 
particular on small and medium -sized enterprises. In addtion, the evaluation should also 
assess the effectiveness of the market surveillance activities that receive Union financing in 
the light of the requirements of Union policies and legisl ation.  
Article 63  
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.  
Article 64  
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply from [ 1 January 2020 ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President   
EN 57  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
 1.1. Title of the proposal/initiative  
 1.2. Policy area(s) concerned in the ABM/ABB structure  
 1.3. Nature of the proposal/initiative  
 1.4. Objective(s)  
 1.5. Grounds for the proposal/initiat ive  
 1.6. Duration and financial impact  
 1.7. Management mode(s) planned  
2. MANAGEMENT  MEASURES   
 2.1. Monitoring and reporting rules  
 2.2. Management and control system  
 2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
 3.1. Heading(s) of the multiannual financial framework and expenditure budget 
line(s) affected  
 3.2. Estimated impact on expenditure   
 3.2.1.  Summary of estimated impact on expenditure  
 3.2.2.  Estimated impact on operational  appropriations  
 3.2.3.  Estimated impact on appropriations of an administrative nature  
 3.2.4.  Compatibility with the current multiannual financial framework  
 3.2.5.  Third -party contributions  
 3.3. Estimated impact on revenue   
EN 58  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of the European Parliament and the Council laying down 
rules and procedures for compliance with and enforcement of Uni on harmonisation 
legislation on products  
1.2. Policy area(s) concerned in the ABM/ABB structure64  
02 03 Internal Market for goods and services  
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to a new action   
 The proposal/initiative relates to a new action following a pilot 
project/preparatory action65  
 The proposal/initiative relates to the extension of an existing action   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objective(s)  
1.4.1.  The Commission's multiannual strategic objective(s) targeted by the 
proposal/initiative  
In the Single Market Strategy, Upgrading the Single Market: more opportunities for 
people and business (COM(2015)555/2) the Commission announced an initiative to 
strengthen market surveillance of products to combat the increasing number of illegal 
and non -compliant products on the market which distort competition and put 
consumers at risk. This proposal aims to strengthen product compliance by providi ng 
the right incentives to economic operators, intensifying compliance checks and 
promoting closer cross -border cooperation among enforcement authorities, including 
through cooperation with customs authorities.  
This proposal is part of the "Goods Package" and should be set in the context of the 
fourth priority policy area to be tackled under President Juncker’s Agenda for Jobs, 
Growth, Fairness and Democratic Change, i.e. a deeper and fairer internal market 
with a strengthened industrial base.  
1.4.2.  Specif ic objective(s) and ABM/ABB activity(ies) concerned  
Specific objective No  
1. Reinforcing market surveillance cooperation procedures among enforcement 
authorities, reducing fragmentation and inefficiencies;  
2. Increasing operational capacity, improving eff iciency and availability of 
resources for cross -border controls and coordination of enforcement;  
3. Strengthening the enforcement toolbox, allowing market surveillance 
authorities to use more deterrent, effective and future -proof tools;  
                                                 
64 ABM: activity -based management; ABB: activity -based budgeting.  
65 As referred to in Article 54(2)(a) or (b) of the Financial Regulation.   
EN 59  EN 4. Promoting compli ance with EU legislation on non -food products, improving 
accessibility of compliance information and assistance to businesses.  
The objectives cover market surveillance within the EU and at the external borders 
and encompass digital as well as traditional supply chains  
1.4.3.  Expected result(s) and impact  
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.  
The proposal is expected to strengthen the market surveillance framework, leading to 
reduced numbers of n on-compliant products in the Single Market.  
Member State market surveillance authorities will be able to more frequently re -use 
evidence and replicate restrictive measures from other member states allowing cost -
savings and efficiency gains.  
The Union Prod uct Compliance Network will assist market surveillance authorities 
to conduct more coordinated cross -border control campaigns, based on better 
prioritised joint actions and improved intelligence. This will allow a better 
integration of EU Single Market Dim ension in national controls and more visible EU 
wide action.  
The consistency of enforcement on products traded in the Union and on imports will 
improve due to the coordination of enforcement by the Network. In turn businesses 
that trade cross -border will b enefit from a more level -playing field, legal certainty 
and predictability.   
Consumers and businesses will have easier access to information and businesses will 
benefit from assistance to help them comply with Union product legislation.  
1.4.4.  Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative.  
• Compliance rates by Member State/sectors and for e -commerce and imports 
(improvements in availability and quality of information in Member State 
enforcement strategies, progress in reduction of compliance gaps)    
• Number of coordination controls campaign s and results (detected infringements 
corrective measures)  
• Usage of mutual assistance mechanisms by market surveillance authorities  
(number, types, timelines, outcomes) and number of measures taken by other 
authorities 'replicated' in each Member State    
• Awareness/understanding of product rules by businesses  
• Number of voluntary measures registered in the common web -portal on 
voluntary measures  
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term  
The as sessment of the market surveillance framework identified important 
shortcomings that are driven by four main factors, namely (1) fragmentation and 
limited coordination of market surveillance in the EU, (2) resources constraints for 
market surveillance auth orities, (3) low deterrence of the current enforcement tools, 
notably with respect to imports from third countries and e -commerce and (4)  
EN 60  EN important information gaps (i.e. lack of awareness of rules by businesses and little 
transparency as regards product c ompliance). To address these problems, the 
proposal foresees  
- a mechanism for effective mutual assistance requests between market surveillance 
authorities of different Member States and transferability of enforcement evidence 
and decisions;  
- an administ rative support structure to coordinate and implement joint enforcement 
activities (Union Product Compliance Network), Member State enforcement 
strategies, performance indicators and peer reviews;  
- common investigative and enforcement powers for market sur veillance authorities 
and the obligation of manufacturers to designate a person responsible for compliance 
information in the EU;  
- more systematic publication of restrictive measures taken by market surveillance 
authorities and recovery of control costs in case of non -compliant products;   
- an extension of the advice role to businesses of Product Contact Points, a web -
portal on voluntary measures taken by businesses on dangerous products, and digital 
publication of compliance information by manufacturers  and importers.  
1.5.2.  Added value of EU involvement  
The enforcement of Union harmonisation legislation within the single market creates 
major challenges for public authorities whose action is constrained by their 
jurisdictional boundaries, while many unde rtakings implement their business models 
in several Member States or at the EU level. To increase the level of compliance on 
the market, every Member State depends on the market surveillance of its 
neighbours. Consequently, weaknesses in the organisation o f market surveillance in 
one single Member State can seriously undermine the efforts taken by other Member 
States to keep non -compliant products from the market; this creates a weak link in 
the chain.  
Therefore to ensure consistent enforcement of Union ha rmonisation legislation 
across the EU and to tackle efficiently non -compliance spanning over several 
Member States, it is necessary to coordinate public enforcement activities. The issue 
being addressed has therefore cross -border aspects which cannot be su fficiently 
achieved by the Member States’ individual actions because they cannot ensure 
cooperation and coordination by acting alone and need to be achieved at the Union 
level.  
1.5.3.  Lessons learned from similar experiences in the past  
The assessment of t he existing market surveillance framework and in particular 
Regulation (EC) n° 765/2008 concluded that it is not fully effective in relation to its 
strategic objectives of strengthening the protection of public interests and of ensuring 
a level playing fie ld among economic operators through the reduction of the number 
of non -compliant products on the Internal Market. Data available actually points to 
the persistence and possibly to the increase of non -compliant products. As a 
consequence the existing market  surveillance framework does not realise the 
expected improved safety for consumers/ users and level playing field for businesses. 
The main weaknesses identified were insufficient coordination and cooperation 
among market surveillance authorities and Membe r States, insufficient uniformity 
and rigorousness of market surveillance and border controls on imported products.  
EN 61  EN Limited resources are available for market surveillance and vary significantly among 
Member States with a direct impact on the controls mark et surveillance can 
undertake. Across -the-board inconsistencies in the approach taken on market 
surveillance by different Member States on businesses may reduce businesses' 
willingness to comply with the rules and discriminate businesses that abide by the 
rules against those who do not.    
The definitions in Regulation (EC) n° 765/2008 are generally clear and appropriate, 
however they are not complete and up -to-date, especially when considering the need 
to cover also online sales.  
Overall the evaluation found that the benefits of having a single piece of European 
legislation on harmonising market surveillance instead of having several different 
pieces of national legislation were widely recognised. However the potential for the 
Regulation to achieve a ful l EU added value is still hindered by the sub -optimal level 
of cross -border exchange of information and cooperation, and by the lack of a 
uniform implementation of the market surveillance framework at the national level.  
1.5.4.  Compatibility and possible s ynergy with other appropriate instruments  
The proposal is one of the initiatives under the European Commission's Single 
Market Strategy.  
The proposal ensures a better alignment with the provisions of the EU Customs Code 
which entered into force in 2013. T he proposal takes into account the new concepts 
advocated in the Code as regards coordination and inter -agency cooperation 
mechanisms, facilitations for trusted traders with good track -record and enhanced 
risk assessments including at the level of the Cust oms Union to make controls more 
efficient and effective.  
The proposal is fully consistent and compatible with the existing EU policies and 
recent proposals to strengthen enforcement in other policy areas, such as Food and 
Feed controls, Consumer Protectio n Cooperation and Competition.   
EN 62  EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
 Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  
 Financial impact from YYYY to YYYY  
 Proposal/initiative of unlimited duratio n 
Implementation with a start -up period from 2020 to 2022, followed by full -scale operation.  
1.7. Management mode(s) planned66  
 Direct management  by the Commission  
 by its departments, including by its staff in the Union delegations;  
 by the executive agencies  
 Shared management  with the Member States  
 Indirect management  by entrusting budget implementation tasks to:  
 third countries or the bodies they have designated;  
 international organisations and their agencies (to be specif ied); 
the EIB and the European Investment Fund;  
 bodies referred to in Articles 208 and 209 of the Financial Regulation;  
 public law bodies;  
 bodies governed by private law with a public service mission to the extent that they 
provide adequate financia l guarantees;  
 bodies governed by the private law of a Member State that are entrusted with the 
implementation of a public -private partnership and that provide adequate financial guarantees;  
 persons entrusted with the implementation of specific actions in the CFSP pursuant to Title 
V of the TEU, and identified in the relevant basic act.  
If more than one management mode is indicated, please provide details in the ‘Comments’ section.  
Comments  
 
                                                 
66 Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html   
EN 63  EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
The IT -tool that connects market surveillance authorities and the Commission will be 
strengthened by this proposal (Article 34, Information and Communication System).  
By using the IT -tool the monitoring of operational activity could take place on an 
ongoing basis in an efficient manner. The monitoring through the IT -tool will be 
completed by the work of the Union Product Compliance Network se t up by this 
Regulation and the provision by Member States of more reliable and more 
comprehensive information on compliance rates and enforcement activity as part of 
their national enforcement strategies. The Union Product Compliance Network will 
set up a nd monitor overall performance indicators and perform peer reviews.  
2.2. Management and control system  
2.2.1.  Risk(s) identified  
Operational risks regards the IT -tool: risk that the IT -system fail to effectively 
support the cooperation of market surveill ance authorities and the Union Product 
Compliance Network.  
2.2.2.  Information concerning the internal control system set up  
Effective IT -governance processes, which actively involve the systems’ users.  
2.2.3.  Estimate of the costs and benefits of the controls and assessment of the expected level 
of risk of error  
The costs of controls are negligible compared to the appropriations for the 
development of the IT tool itself  
2.3. Measures to prevent fraud and irreg ularities  
Specify existing or envisaged prevention and protection measures.  
The measures implemented by the Commission will be subject to the ex -ante and ex -
post controls in accordance with the Financial Regulation. Contracts and agreements 
financing the implementation of this Regulation will expressly entitle the 
Commission, incl uding OLAF and the Court of Auditors to conduct audits, on the 
spot checks and inspections.    
EN 64  EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financial framework and expenditure budget 
line(s ) affected  
 Existing budget lines  
In order  of multiannual financial framework headings and budget lines.  
Heading of 
multiannual 
financial 
framework  Budget line  Type of  
expenditure  Contribution  
Chapter 02.03  
Internal market of goods and services  Diff./Non -
diff.67 from 
EFTA 
countries
68 
 from 
candidate 
countries69 
 from third 
countries  within the 
meaning of 
Article  21(2)(b) of 
the Financial 
Regulation  
1a 02.03.01 Internal market of goods and 
services  Diff.  YES  NO NO NO 
                                                 
67 Diff. = Differentiated appropriations / Non -diff. = Non -differentiated appropriations.  
68 EFTA: European Free Trade Associa tion.  
69 Candidate countries and, where applicable, potential candidates from the Western Balkans.   
EN 65  EN 3.2. Estimated impact on expenditure  
3.2.1.  Summary of estimated impact on expenditure  
The expenditure in this financial statement is limited to the current multi -annual financial framework, up to 2020 included. Given the budgetary 
constraints in the current Multiannual Financial Framework, allocations would have to be covered at least partially by redeployments during the 
annual budgetary procedure. Indicative estimates of the longer term financial impacts of the measures in this proposal are se t out in the i mpact 
assessment.  
EUR million (to three decimal places)  
Heading of multiannual financial  
framework  Number  1A Competitiveness for Growth and Jobs  
 
DG GROW    Year 
202070 Year 
- Year 
-   
 Operational appropriations       
02.03.01 Internal market of goods  and 
services - Union Product Compliance 
Network  Commitments  (1) 4.450      
Payments  (2) 2.910      
02.03.01 Internal market of goods and 
services  - Other measures 
Compliance and Enforcement 
initiative (pilot strategies, benchmark 
study)  Commitments  (1a) 4.000      
Payments  (2a) 1.700      
Appropriations of an administrative nature financed from the 
envelope of specific programmes71       
                                                 
70 Year N is the year in which implementation of the proposal/initiative starts.   
EN 66  EN  
Number of budget line   (3)      
TOTAL appropriations  
for DG GROW  Commitments  =1+1a 
+3 8.450      
Payments  =2+2a  
+3 4.610      
 
TOTAL    Year 
202072 Year 
- Year 
-   
 TOTAL operational appropriations  Commitments  (4) 8.450      
Payments  (5) 4.610      
 TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)      
TOTAL appropriations  
under HEADING 1A  
of the multiannual financial framework  Commitments  =4+ 6  8.450      
 
Heading of multiannual financial  
framework  5 ‘Administrative expenditure’  
EUR million (to three decimal places)  
   Year 
2020  Year 
- Year 
-   
                                                                                                                                                                                                                                           
71 Technical and/or administrative assistance and expenditure in support of th e implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.  
72 Year N is the year in which implementation of the proposal/initiative starts.   
EN 67  EN DG: GROW  
Human resources  0.787      
Secretariat Union Product Compliance Network  3.246      
 Human resources (total)  4.033      
 Other administrative expenditure  0.093      
TOTAL DG GROW  4.126  6.752      
 
TOTAL appropriations  
under HEADING  5 
of the multiannual financial framework   (Total commitments = 
Total payments)  4.126      
EUR million (to three decimal places)  
   Year 
202073 Year 
- Year 
-   
TOTAL appropriations  
under HEADINGS 1 to 5  
of the multiannual financial framework   Commitments  12.576      
Payments  8.736      
                                                 
73 Year N is the year in which implementation of the proposal/initiativ e starts.   
EN 68  EN 3.2.2.  Estimated impact on operational appropriations  
 The proposal/initiative does not require the use of operational appropriations   
 The proposal/initiative requires the use of operational appropriations:  
Commitment appropriations in EUR million (to three decimal places)  
Indicate 
objectives and 
outputs  
 
   Year 
2020  Year 
- Year 
-    
OUTPUTS  
Type
74 
 Avera
ge 
cost 
No 
Cost 
No 
Cost 
No 
Cost 
  
    
SPECIFIC OBJECTIVE No 175 . Reinforcing market surveillance cooperation procedure s among enforcement authorities, reducing fragmentation and inefficiencies  
             
SPECIFIC OBJECTIVE No 276 . Increasing operational capacity, improving efficiency and availability of resources for cross -border controls and coordination of 
enforcement  
Pilot national enforcement strategies  
(n°co -funded pilot strategies/year)  3 3.000            
Peer review/performance indicators 
(baseline study)  
 1 1.000            
Union Product Compliance Network  
(headline indicator: n° of joint 
control campaigns)*  15 4.450            
SPECIFIC OBJECTIVE No 377 . Strengthening the enforcement toolbox, allowing market surveillance authorities to use more deterrent, effective and future -proof tools  
                                                 
74 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, et c.). 
75 As described in point 1.4.2. ‘Specific objective(s)…’  
76 As described in point 1.4.2. ‘Specific objective(s)…’   
EN 69  EN              
SPECIFIC OBJECTIVE No 478 . Promoting compliance with EU legislation on non -food products, improving accessibility of compliance information and assistance to 
businesses  
European Portal on voluntary 
measures (n° notifications)              
TOTAL COST   8.450            
 
                                                                                                                                                                                                                                           
77 As described in point 1.4.2. ‘Specific objective(s)…’  
78 As described in point 1.4.2. ‘Specific objective(s)…’   
EN 70  EN 3.2.3.  Estimated impact on appropriations of an administrative nature  
3.2.3.1.  Summary  
 The proposal/initiative does not require the use of appropriations of an administrative 
nature  
 The proposal/initiative requires the use of appropriations of an administrative nature, 
as explained below:  
EUR million (to three decimal places)  
 Year 
2020 79 Year 
- Year 
- Year 
- Enter as many years as necessary to show the 
duration of the impact (see point 1.6)  TOTAL  
 
HEADING 5  
of the multiannual 
financial framework          
Human resources  4.033         
Other administrative 
expenditure  0.093         
Subtotal HEADING 5  
of the multiannual 
financial framework  4.126         
 
Outside HEADING 580 
of the multiannual 
financial framework  
         
Human resources          
Other expenditure  
of an administrative 
nature          
Subtotal  
outside HEADING 5  
of the multiannual 
financial framework          
 
TOTAL  4.126      
The appropriations required for human resources and other expenditure of an administrative nature will be met by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the 
DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints.  
                                                 
79 Year N is the year in which implementation of the proposal/initiative starts.  
80 Technical and/or administrative assistance and expenditure i n support of the implementation of EU  programmes and/or actions 
(former ‘BA’ lines), indirect research, direct research.   
EN 71  EN 3.2.3.2.  Estimated requirements of human resources  
 The proposal/initiative does not require the use of human resources.  
 The proposal/initiative requires the use of human resources, as explained below:  
Estimate to be expressed in full time equivalent units  
 
Year 
2020  Year 
- Year  
- Year  
- Enter as 
many 
years as 
necessary 
to show 
the 
duration 
of the 
impact 
(see 
point 
1.6) 
 Establishment plan posts (officials and temporary staff)    
02 01 01 01 (Headquarters and 
Commission’s Representation Offices - 
GROW)  5.7       
02 01 01 01 (Headquarters and 
Commission’s Representation Offices – 
GROW – Secretariat Union Product 
Compliance Network)  22       
XX 01 01 02 (Delegations)         
XX 01 05  01 (Indirect research)         
 External staff (in Full Time Equivalent unit: FTE)81 
 
XX 01 02 01 (AC, END, INT from the 
‘global envelope’)  3       
XX 01 02 02 (AC, AL, END, INT and 
JED in the delegations)         
XX 01 04 
yy 82 
 - at 
Headquarters  
        
- in 
Delegations         
XX 01 05 02 (AC, END, INT - Indirect 
research)         
10 01 05 02 (AC, END, INT - Direct 
research)         
Other budget lines (specify)         
TOTAL  30.7       
XX is the policy area or budget title concerned.  
The human resources required will be met by staff from the DG who are already assigned to management of the 
action and/or have been redeployed within the DG, together if necessary with any additional allocation which 
may be granted to the managing DG under the annua l allocation procedure and in the light of budgetary 
constraints.  
                                                 
81 AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JED=  Junior Experts in 
Delegations.  
82 Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).   
EN 72  EN Description of tasks to be carried out:  
Officials and temporary staff 
(Commission)  In the set -up phase (2020 -2022) preparation of implementing/delegated acts, set -up of 
the Union Product Compliance Network, pilot national enforcement strategies, study 
to set the baseline for perfomance indicators and monitoring of the Regulation.  
AD staff for the Head of the Union Product Compliance Network Secretariat, market 
surveillance technical and le gal analysis, IT and data -systems supervision and design.  
AST staff for support to meeting organisation, administrative and financial 
management tasks.  
External staff  Contract agents - routine IT maintenance and specific development projects  
Seconded national experts (SNE) – joint actions management, specific market 
surveillance expertise. The possibility to recruit SNE to the Network is kept open as an 
option as national expertise. Market surveillance authorities currenlty critically lack 
resources so  that it is highly uncertain that they could second staff to the Network, 
especially in the initial phases of the Network.  
Estimated phasing in of staff in the set -up phase of the Union Product Compliance Network (Secretariat hosted 
by the Commission) within the time -span of the current multi -annual framework upto 2020 included.  
Function group and grade  Year 2020  Year - Year -   
AD 9 -15 1     
AD 5 -12 17     
AD Total  18     
AST 1 -11 / AST/SC 1 -6 4     
AST/SC Total  4     
GRAND TOTAL  22     
 
Estimated  phasing in of staff in the set -up phase and total staff of the Union Product Compliance Network – 
external personnel  
Contract agents  Year 2020  Year – Year -   
Function group III/IV  3     
Total  3     
 
Seconded National Experts  Year 2020  Year - Year -   
Total  pm     
  
EN 73  EN 3.2.4.  Compatibility with the current multiannual financial framework  
 The proposal/initiative is compatible the current multiannual financial 
framework.  
 The proposal/initiative will entail reprogramming of the relevant heading in the 
multiannual financial framework.  
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts.  
[…] 
 The proposal/initiative requires application of the flexibility instrument or 
revision of the multiannual financial framework.  
Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts.  
[…] 
3.2.5.  Third -party contributions  
 The proposal/initiative does not provide for co -financing by third parties.  
 The prop osal/initiative provides for the co -financing estimated below:  
Appropriations in EUR million (to three decimal places)  
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6)  Total  
Specify the  co-financing 
body           
TOTAL appropriations 
co-financed          
 
  
EN 74  EN 3.3. Estimated impact on revenue  
 The proposal/initiative has no financial impact on revenue.  
 The proposal/initiative has the following financial impact:  
  on own resources  
  on miscellaneous revenue  
EUR million (to three decimal places)  
Budget revenue line:  Appropriation
s available for 
the current 
financial year  Impact of the proposal/initiative83 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary to show 
the duration of the impact (see point 1.6)  
Article ………….          
For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected.  
[…] 
Specify the method for calculating the impact on revenue.  
[…] 
 
                                                 
83 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross 
amounts after deduction of 25  % for collection  costs.   
EN 75  EN ANNEX to the LEGISLATIVE FINANCIAL STATEMENT  
Name of the proposal/initiative:  
Proposal for a European Parliament and Council Regulation  
on Compliance and Enforcement of Union Harmonisation Legislation on Products  
(1) NUMBER and COST of HUMAN RESOURCES CONSIDERED NECESSARY  
(2) COST of OTHER ADMINISTRATIVE EXPENDITURE  
(3) METHODS of CALCULATION USED for ESTIMATING COSTS  
(a) Human resources  
(b) Other administrative expenditures  
(4) SUMMARY of all COSTS (human resources, other administrative expenditure and 
operational budget)  
 
 
This annex must accompany the legislative financial statement when the inter -services consultation is 
launched.  
The data tables are used as a source for the tables contained in the legislative financial statement. 
They are strictly for internal use within the Commission.  
 
  
EN 76  EN (1) Cost of human resources considered necessary   
 The proposal/initiative does not require the use of human resources  
 The proposal/initiative requires the use of human resources, as explained below:  
 
EUR million (to three decimal places)  
HEADING 5  
of the multiannual financial framework  Year 2020  Year 2021  Year  2022 Year 2023 and 
onwards  ... enter as many years as 
necessary to show the 
duration of the impact 
(see point 1.6)  TOTAL  
FTE Appropriations  FTE Appropriations  FTE Appropriations  FTE Appropriations  FTE Appropriations  FTE Appropriations  
 Establishment plan posts (officials and temporary staff)  
02 01 01 01 (Headquarters and 
Commission’s Representation Offices) 
GROW  AD 5 0,690  5 0,690  4,5 0,621  4 0,552      
AST 0,7 0,097  0,7 0,097  0,5 0,069  0,5 0,069      
02 01 01 01 (Headquarters and 
Commission’s Representation Offices) 
GROW – secretariat Union Product 
Compliance Network  AD 18 2,484  33 4,554  42 5,796  42 5,796      
AST  
4 0,552   
7 0,966   
10 1,380   
10 1,380   
  
 
33 01 01 01 (Headquarters and 
Commission’s Representation Offices) 
JUST – portal for publication of voluntary 
measures economic operators  AD   0,5 0,069  0,5 0,069  0,5 0,069      
AST  
  
  
  
  
  
 
XX 01 01 02 (in Union Delegations)  AD             
AST             
 External staff 84 
XX 01 02 01 (‘global envelope’) 
secretariat Union Product Compliance 
Network  AC 3 0,210  5 0,350  7 0,490  7 0,490      
END pm pm pm pm pm pm pm pm     
INT             
XX 01 02 02 (in Union Delegations)  AC             
AL             
END              
                                                 
84 AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT= agency staff; JED = junior experts in delegations .  
EN 77  EN INT             
JED             
Other budget lines ( specify )              
Subtotal – HEADING 5  
of the multiannual financial framework   30,7 4,033  51,2 6,726  64,5 8,425  64 8,356      
XX is the policy area or budget title concerned.  
The human resources required will be met by staff from the DG who are already assigned to management of the action and/or hav e been redeployed within the DG, together if necessary with any additional 
allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraint s.  
EN 78  EN (2) Cost of other administrative expenditure  
 The proposal/initiative does not require the use of administrative appropriations  
 The proposal/initiative requires the use of administrative appropriations, as explained below:  
EUR million (to three decimal places)  
 Year  
2020  Year 
2021  Year 
2022  Year 
2023 and 
onwards  ... enter  as many years as necessary to show 
the duration of the impact  
 (see point 1.6)  TOTAL  
HEADING 5  
of the multiannual financial framework          
 At headquarters:          
02 01 02 11 01 - Mission and representation expenses  0,003  0,005  0,008  0,008      
XX 01 02 11 02 - Conference and meeting costs          
02 01 02 11 03 - Committees85  0,090  0,090  0,030  pm     
XX 01 02 11 04 - Studies and consultations          
XX 01 02 11 05 – Information and management systems          
XX 01 03 01 – ICT equipment and services86         
Other budget lines ( specify where necessary )         
 In Union delegations          
XX 01 02 12 01 - Missions, conferences and representation expenses          
XX 01 02 12 02 - Further training of staff          
XX 01 03 02 01 - Acquisition, renting and related expenditure          
XX 01 03 02 02 Equipment, furniture, supplies and services          
Subtotal HEADING 5  
of the multiannual financial framework  0,093  0,095  0,038  0,008      
XX is the policy area or budget title concerned.   
                                                 
85 Specify the type of committee and the group to which it belongs.  
86 ICT: Information and Communication Technologies: D IGIT must be consulted.   
EN 79  EN  
TOTAL  
HEADING 5 and Outside HEADING 5  
of the multiannual financial framework  4,126  6,821  8,463  8,364      
 
The administrative appropriations required will be met by the appropriations which are already assigned to management of the action and/or which have been redeployed, together if 
necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in  the light of existing budgetary constraints.  
  
EN 80  EN (3) Methods of calculation used to estimate costs  
(a) Human resources  
This part sets out the method of calculation used to estimate the human resources considered necessary 
(workload assumptions, including specific jobs (Sysper 2 work profiles), staff categories and the corresponding 
average costs)  
 
HEADING 5  of the multiannual financial framework  
NB: The average costs for each category of staff at Headquarters are available on BudgWeb:  
https://myintracomm.ec.europa.eu/budgweb/EN/pre/legalbasis/Pages/pre -040-020_preparation.aspx  
 Officials and temporary staff  
 
Committee management, Implementing/delegated acts:  1 AD, 0.2 AST in 2020, 1 AD, 0.2 AST in  2021, 0.5 AD in 2022  
 
Pilot national enforcement strategies, performance indicators, reference levels study:   
first pilots in 2020: 1 AD  2020 and 2021  
Continued support to new strategies from 2021 onward (1AD)    
 
Market surveillance policy  
Market surveillance policy development, enlargement and international aspects, monitoring of the Regulation's 
implementation; COM representation in Union product comp liance board and liasion to the network; Handling of mutual 
assistance request/safeguard cases, follow -up of peer review findings: 3 AD/year, 0,5 AST from 2020 onwards  
 
Secretariat Union Product Compliance Network : 
 
AD staff: 18 in 2020, +15 (33 total) in 2021, +9 (42 total) in 2022. From 2023 onwards: 42  
AST staff:  4 in 2020, + 3 (7 total), in 2021 +3 (10 total) in 2022. From 2023 onwards: 10  
 
DGJUST  Voluntary portal RAPEX  monitoring/verification content: 0,5 AD/year from 2021 onwards  
 
 External staff  
 
Union Product Compliance network  
Contract agents : 2020: 3, 2021: +2 (5 total),  2022: +2 (7 total). 2023 onwards: 7/year total.  
 
Seconded national experts: pm.  Seconded National Experts (SNE) could be valuable to the Union Product Compliance 
Network, but is more difficult to factor in specifically for the start -up of the Network. The number of staff that authorities could 
second to form a structural part of the Network is uncertain. A key problem which the Network should overcome is the very 
limited re sources that authorities can make available for cross -border cooperation (i.e. limited candidates for ADCO chairs, 
project coordinators, and limited skills for EU project coordination). The possibility for secondments should nonetheless be 
kept open (pm).  
 
Note: no external staff counted for heading 5 for IT 'intra -muros' staff - charged to operational budget  lines  
(part of IT costs Union product compliance network; DGJUST maintenance voluntary portal RAPEX:  0.2 AC/year from 
2021 onwards (Consumer Programm e 33 04 in current Multiannual Financial Framework))  
 
Outside HEADING 5  of the multiannual financial framework  
 Only posts financed from the research budget   
 
EN 81  EN  
 External staff  
 
 
 
 
(b) Other administrative expenditure  
 
Give details of the method of calculation used for each budget line  
and in particular the underlying assumptions (e.g. number of meetings per year, average costs, etc.)  
HEADING 5  of the multiannual financial framework  
 
Committee meetings: for discussion,  adoptiof on implementing/delegated acts  
30.000 €/meeting  
2020: 3 meetings; 2021 3 meetings; 2022: 1 meeting.  
 
Mission costs  
COM Secretariat Union Product Compliance Network – missions to meetings held in Member States, international meetings 
enforcement  cooperation: Mission costs: 4/year 2020 @ 750€ = 3 000€, 6/year 2021 @750€ = 4 500€ , 10/year from 
2022 @750 = 7 500 €  
 
 
 
Outside HEADING 5  of the multiannual financial framework  
 
 
 
 
 
 
 
(4) SUMMARY of all COSTS (human resources, other administrative expenditure and 
operational budget  
This section gives a summary of all estimated impacts on human resources, other 
administrative costs and operational budget expenditure related to the set -up phase (up to 
2020 included in the current multi -annual financia l framework) and the estimated yearly costs 
once the full implementation stage is reached of the proposal, from 2023 onwards:   
 
 
 
 
 
  
EN 82  EN  
(a) Indicative operational appropriations(up to 2025):  
 
  Year 
202087 Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  
Union Product Compliance 
Network  Commitments  
4.450  6.950  9.450  9.950  9,950  9,950  
Other measures Compliance 
and Enforcement initiative 
(pilot strategies, benchmark 
study)  Commitments  
4.000  3.000  3.000   
3,000   
3,000   
3,000  
Supporting the functioning 
and modernisation of the 
customs union – set-up costs 
interface MSA -customs 
systems (incl. Single 
Window)  Commitments  
 0,550  0,660   
 
0,560   
 
0,710   
 
0,710  
Portal for publication of 
volutary measures by 
economic operators  Commitments  
 0,059  0,029   
0,029   
0,029   
0,029  
 
TOTAL operational 
appropriations  
 Commitments  8.450  10.559  13.139  13,539   
 
13,689  13.689  
  
 
Commitment appropriations in EUR million (to three decimal places)  
Measures and 
outputs  
 
   Year 
2020  Year 
2021  Year 
2022  Each year from  
2023 and onwards  
Type
88 
 Avera
ge 
cost 
No 
Cost 
No 
Cost 
No 
Cost 
No Cost 
 
SPECIFIC MEASURES  
National strategies  
(n° co -funded pilot strategies/yr)  3 3,000  3 3,000  3 3,0000  3 3,000  
                                                 
87 Year N is the year in which implementation of the proposal/initiative starts.  
88 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, et c.).  
EN 83  EN Peer review/performance indicators 
(baseline study)  
 1 1.000        
Union Product Compliance Network  
(headline indicator: n° of joint 
control campaigns)*  15 4.450  20 6.950  30 9.450  30 -
40 9.950  
Set-up costs interface customs – 
market surveillance systems  
(2021 -2025)    1 0.550  1 0.660  1 0.660  
(average/year 
2023 -2025)  
European Portal on voluntary 
measures (n° notifications)    250 0.059  500 0.029  800 0.029  
TOTAL COST   8.450   10.559   13.139   13.639  
 
* Key tasks and outputs of the Union Product Compliance Network  
Strategy & workprogramme  (organisation Union Product Compliance Board meetings, 
priorities for joint actions, market studies, performance indicators, peer reviews of national 
enforcement strategies): 2 to 3 meetings/year; 2 to 3 market studies/year; 5 in -depth 
reviews/year.  
Coor dination of enforcement and support to joint actions  (support to administrative 
coordination groups, financing of joint control campaigns, joint procurement, monitoring 
mutual assistance requests): 30 to 40 coordinated control campaigns/year, 2 to 3 joint 
procurement/partnership projects (5 year period).  
International cooperation  (development of enforcement cooperation protocols, exchange of 
information/best -practice): 3 cooperation protocols (5 year period).  
Training  (mapping of training needs market surve illance, training events, e -learning 
materials).   
Dissemination and development and management of communication and IT tools , 
including exhange of information and linking of market surveillance and customs systems. 
(Set-up costs to interface MSA and custo ms sustems (e.g. Single Windows) amount to around 
on average 640K€/year and would be spread over 5 years, indicatively 2021 -2025).  
 
(b) Human resources and other administrative costs:  
   Year 
2020  Year 
2021  Year 
2022  Each year from  
2023 and 
onwards  
DG: GROW  
Human resources  0.787  0.787  0.690  0.621  
Secretariat Union Product Compliance Network  3.246  5.870  7.666  7.666  
 Human resources (total)  4.033  6.657  8.356  8.287  
 Other administrative expenditure  0.093  0.095  0.038  0.008  
TOTAL DG GROW   4.126  6.752  8.394  8.295  
DG: JUST   
EN 84  EN  Human resources   0.069  0.069  0.069  
 Other administrative expenditure      
TOTAL DG JUST  Appropriations   0.069  0.069  0.069  
 
TOTAL appropriations  
 (Total 
commitments = 
Total payments)  4.126  6.821  8.463  8.364  
 
Estimated phasing in of staff in the set -up phase and cumulative total staff of the Union Product Compliance 
Network (Secretariat hosted by the Commission)  
Function group and grade  Year 2020  Year 2021  Year 2022  Cumulative  
total 
AD 9 -15 1 0 0 1 
AD 5 -12 17 15 9 41 
AD Total  18 15 9 42 
AST 1 -11 / AST/SC 1 -6 4 3 3 10 
AST/SC Total  4 3 3 10 
GRAND TOTAL  22 18 12 52 
 
Estimated phasing in of staff in the set -up phase and total staff of the Union Product Compliance Network – 
external personnel  
Contract agents  Year 2020  Year 2021  Year 2022  Cumulative  
total 
Function group III/IV  3 2 2 7 
Total  3 2 2 7 
 
Seconded National Experts  Year 2020  Year 2021  Year 2022  Cumulative  
total 
Total  pm pm pm pm 
 
(c) Total costs (operational budget, human resources and other administrative costs (4(c)  = 
4(a) + 4(b))  
EUR million (to three decimal places)   
EN 85  EN    Year 
202089 Year 
2021  Year 
2022  Each year from  
2023 and onwards  
TOTAL appropriations  
Total costs  Commitments  12.576  17.380  21.602  22.003  
Payments  8.736  15.130  20.012  21.383  
 
                                                 
89 Year N is the year  in which implementation of the proposal/initiative starts.