EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, 13.2.2013  
COM(2013) 75 final 
2013/0048 (COD) 
  
PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on market surveillance of products and am ending Council Directiv es 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 Par liament and of the Council 
(Text with EEA relevance) 
{SWD(2013) 33 final} 
{SWD (2013 ) 34 final }   
EN 0   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
The European Union needs a Single Market that is operating at maximum efficiency 
to help get its economy back on track. The free movement of goods is the most developed and best established of the f our fundamental freedoms laid down in the 
Treaty on the Functioning of the European Union (TFEU) that make up the internal 
market. But it would be complacent to believe that the job is done. True, 
harmonisation rules
1 have now been put in place for most products and the free 
movement provisions of the TFEU, s upplemented by the mutual recognition 
principle, are sufficient for th e rest. But even a good legisl ative framework is only as 
effective as those using it allow it to be. Alongside re sponsible economic operators, 
prepared to adapt their methods  and incur the costs necessary  to comply with the law, 
there will always be those traders who cut corners or deliberately flout the rules to 
‘make a fast buck’ or gain a competitive edge. 
These sharp practices not only skew the singl e market against the type of trader we 
wish to encourage, damaging its effectiv eness and causing detr iment to consumers 
and business, they also threaten the public in terests that our legisl ation is designed to 
protect. In addition to financial burden, the European citizen is exposed to potentially 
dangerous products. The environment is put at risk. Public security may even be 
undermined. 
Market surveillance is the answer. If high quality legislation, based on a sound 
evaluation of market needs is one side of th e coin, market surveillance is the other. It 
should enable unsafe or otherwise harmful pr oducts to be identified and kept or taken 
off the market and unscrupulous or even crim inal operators punished. It should also 
act as a powerful deterrent. 
Market surveillance has not kept pace with  developments in the Union regulatory 
framework. In a single market in which products circulate freel y throughout 27 (and 
in some sectors up to 32)2 national territories, market su rveillance needs to be highly 
coordinated and capable of reacting rapidly over a huge area. Advances have been 
made over the last decade, in particular with the implementation of Directive 2001/95/EC of the European Parliament and of the Council on general product 
safety
3 (the "General Product Safety Directiv e" or simply GPSD) which had to be 
transposed by 2004 and with the coming into  application in 2010 of Regulation (EC) 
765/2008 setting out the requirements for accreditation and ma rket surveillance4. 
However, overlap of market surveillance ru les and obligations of  economic operators 
laid down in various pieces of Union legi slation (the GPSD, the Regulation (EC) 
765/2008 and sector-specific Union harmonisati on legislation) has led to confusion 
on the part of both economic operators a nd national authorities and has seriously 
hampered the effectiveness of market  surveillance activity in the Union. 
                                                 
1 Harmonisation rules seek to achieve free movement by protecting at a high level public interests that 
Member States might otherwise invoke to justify imposing restrictions on trade in products. 
2 In accordance with internationa l agreements of the EU with the EFTA countries and Turkey. 
3 OJ L 11, 15.1.2002, p. 4. 
4 OJ L 218, 13.8.2008, p. 30.  
EN 1   EN This proposal aims at clarifying the regulat ory framework for market surveillance in 
the field of non-food products. It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union 
harmonisation legislation into a single lega l instrument that applies horizontally 
across all sectors. 
Market surveillance action by national authorities has important implications for 
small and medium-sized enterprises. Cons equently, their situa tion should be taken 
into account particularly in relation to action that could impose additional administrative burdens. 
The proposal is part of the "Product Safety  and Market Surveill ance Package" which 
also includes a proposal for a regulation on consumer product safety (replacing the 
GPSD) and a multi-annual action plan for market surveillance covering the period 2013-2015. After the Single Market Act (2011)
5 had identified the revision of the 
GPSD and the drawing up of a multi-annual action plan for market surveillance as 
initiatives that will contribute to boosti ng growth and creating jobs, the Commission 
added this proposal for a single market surveillance regulati on to the other two 
initiatives in response to calls from the Eu ropean Parliament and from stakeholders 
in industry and public administra tions. The Single Market Act II6, adopted in 2012, 
confirms the "Product Safety and Market Surveillance Package" as a key action "to improve the safety of products circulating in the EU through be tter coherence and 
enforcement of product safety a nd market surveillance rules". 
2. RESULTS
 OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
From 2009 to 2011, the Commission held extensive public consultations on the 
revision of the GPSD (for more detail s see the Proposal for a Consumer Product 
Safety Regulation). One of the main substa ntive areas related to the improvement of 
market surveillance cooperation and coor dination, including the functioning of 
RAPEX.  
One of the outcomes of the public cons ultation process and the dialogue with 
interested parties was to transfer the ma rket surveillance rules from the current 
GPSD into a new standalone Market Surv eillance Regulation to be developed and 
adopted hand in hand with the propo sal for the revision of the GPSD.  
The impact assessment prepared by the Commission thus covers aspects related to 
both the GPSD revision and this proposal.  
The Commission's Impact Assessment Bo ard delivered a favourable opinion in 
September 2012. 
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
Main elements 
                                                 
5 COM(2011)206 final. 
6 COM(2012)573 final.  
EN 2   EN The overarching objective of this new regul ation is to simplify the Union market 
surveillance framework fundamentally so th at it works better for its main users: 
market surveillance authorities and economic operators. At present, different product 
evaluation requirements and procedures ap ply depending on the category of product 
involved. Market surveillance au thorities should be able to  do their job of evaluating 
the risk presented by products without be ing hindered by unnecessary complexities 
and to share the results of their work efficiently.  
The new Regulation will get rid of overlaps, close gaps, re duce the need to categorise 
products to a minimum and assimilate as far as possible the rules and procedures 
applicable to all products. This will result  in a more even a pplication of market 
surveillance rules across the Member St ates, providing better protection for 
consumers and other users, more uniform trading conditions for economic operators, reduced administrative burdens and enha nced information- and work-sharing 
between market surveillance authorities. This  is particularly important in the context 
of the economic crisis and responds to the need to make the internal market for goods more efficient and competitive. 
• Reducing the number of pieces of legislation containing market 
surveillance rules 
At first sight, this might seem to be a ra ther cosmetic objective but the current set of 
market surveillance rules is spread across the GPSD, Regulation 765/2008 and a 
range of sector-specific le gislation (which is increas ingly based on the reference 
provisions of Decision 768/2008) . This ‘3-tier’ system cau ses problems for market 
surveillance authorities and economic operato rs alike and was expr essly targeted for 
criticism by the European Parliament. Th e new Regulation would produce a one tier 
system in which all of those rules are brought  together in a singl e instrument. It may 
be complemented by sector-specific ru les laid down in the relevant Union 
harmonisation legislation.  
• Eliminating overlaps in the current system 
Regulation 765/2008 and sector-s pecific legislation apply to all harmonised products 
regardless whether they are intended (o r likely) to be used by consumers or 
professionals. The GPSD applies to all c onsumer products regardless whether they 
are non-harmonised or harmonised. This obvi ously creates overlap s in relation to 
harmonised products intended or likely to be  used by consumers. The current system 
tries to deal with this by means of complicated lex specialis provisions but this is 
universally regarded as unsatisfactory.  
The new market surveillance Regulation woul d dispense with the distinction between 
consumer and professional products for ma rket surveillance purposes. It would also 
avoid making a distinction between ha rmonised products and non-harmonised 
products except where this is unavoidable in  applying certain speci fic provisions. To 
the greatest extent possible the applicab le rules are the same for all products. 
• Dovetailing the RAPEX and Union evaluation procedures 
At present, two separate pr ocedures operate, sometimes in  parallel, which require the 
Member States to notify to the Commissi on and the other Member States certain  
EN 3   EN market surveillance action taken at national le vel. This is an especially problematic 
aspect of the overlapping categories of  products mentioned above. Under the new 
Regulation the two procedures become a singl e procedural flow with certain events 
triggering a single notification to the ot her Member States and the Commission 
(made using either the proven RAPEX rapi d alert system or the Information and 
Communication System for Market Surveilla nce in accordance with the distinction 
made in this Regulation).  
In the case of products which are subjec t to sector-specifi c Union harmonisation 
legislation, in the event of disagreement among Member St ates about action taken by 
one of their number, the proposal would em power the Commission to decide whether 
the measures taken by the original notifyi ng Member State are reasonable, necessary 
and proportionate and should be followed by a ll Member States in the interests of the 
single market. In this way, the market surveillance process may be brought to a 
definite close. This is not extended to pr oducts not subject to sector-specific Union 
harmonisation legislation as such a decisi on cannot be taken in the absence of the 
essential requirements for products that  are laid down in that legislation. 
In urgent situations the Commission is em powered to adopt temporary or permanent 
measures requiring consistent action acr oss the EU against products presenting a 
serious risk where the risk  cannot be satisfactorily ad dressed by one or several 
individual Member States.  
• Making the legislation more accessible and user-friendly 
Apart from being spread across three tier s of EU legislation (and in the case of 
directives, also in national implementi ng measures), current market surveillance 
provisions are not based around a chronol ogical flow of events - from the 
identification by market surveillance author ities of a product that may present a risk, 
through risk assessment, involvement of  the economic operators, action by the 
national authorities, notification to the other Member States, up to possible action 
across the Union by all Member States and,  where necessary, eval uation and decision 
by the Commission at Union level. Instead, market surveillance authorities and 
economic operators must hunt around in the le gislation for the prov isions that affect 
them directly.  
The new Regulation sets out th e whole process of a market surveillance exercise in a 
chronological, sequential manner. It pres ents a chain of ev ents, incorporating 
relevant provisions on natural justice aspect s, publication of in formation, notification 
etc. at each stage of the procedure. Th is approach substantially improves the 
accessibility and user-friendliness of the le gislation, and hence its effectiveness. 
Legal basis 
The proposal is based on Articles 33, 114 and 207 of the Treaty on the Functioning 
of the European Union. 
Subsidiarity 
Market surveillance is an activity which is carried out by the authorities of the 
Member States of the Union. This will not change. However, in order to be effective, the market surveillance effort must be uniform across the Union. If market  
EN 4   EN surveillance is ‘softer’ in some parts of the Union than others, weak spots are created 
which threaten the public interest and cr eate unfair trading conditions. Furthermore, 
much of the risk presented by products to the various public interests that Union legislation tries to protect  derives from products ente ring the Union from third 
countries. There must be effective market surveillance along the entire length of the 
Union’s external borders. 
There is therefore a need for Union legisl ation which creates uniform obligations in 
relation to the activities to be carried out, the resources to be attributed and the 
powers and duties of market surveillance authorities. Equally, there must be an 
obligation to cooperate and to coordinate  market surveillance and mechanisms and 
tools must be established to make possible and facilitate these endeavours. Penalties, 
financing and reporting also all need to be addressed at Union level. 
Proportionality 
In accordance with the principle of propor tionality, the proposed modifications do 
not go beyond what is necessa ry to achieve the objectives  set. The modifications 
introduced by the Regulation do not im pose unnecessary burdens or costs on 
industry, having particular regard to sm all and medium-sized enterprises, or 
administrations. Many modifications to the existing legislative framework relate to improving its clarity and workability without introducing significant new 
requirements with cost implication. Where a modification has an impact on burdens 
or costs, the impact analysis indicated that it represents the most proportionate 
response to the problem identified.  
4. BUDGETARY
 IMPLICATION   
The budgetary implications are alrea dy envisaged in ex isting or proposed 
programmes and respect the Commission pr oposal for the new multiannual financial 
framework. This initiative will be fi nanced through redeployment of existing 
resources. The details are set out in the fi nancial statement attach ed to this proposal.  
EN 5   EN  
2013/0048 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on market surveillance of products and amending Counc il 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 (E C) No 764/2008 and Regulation (EC) No 
765/2008 of the European Parliament and of the Council 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL 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 Eu ropean Economic and Social Committee
7, 
After consulting the European Data Protection Supervisor, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) In order to guarant ee the free movement of products within the Union, it is necessary 
to ensure that they fulfil requirements providing a high level of protection of public 
interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of th e 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 competiti on in the Union goods 
market can thrive. Rules are therefore necessary on market surveillance and on 
controls of products entering th e Union from third countries. 
(2) Market surveillance activities covered by this Regulation should not be directed 
exclusively towards the protection of health a nd safety but should also  be applicable to 
                                                
 
7 OJ C , , p. .  
EN 6   EN the enforcement of Union legislation which seeks to safeguard other public interests, 
for example, by means of regulating the accuracy of measurement, electromagnetic 
compatibility and energy efficiency.  
(3) It is necessary to establish an overall fr amework of rules and prin ciples in relation to 
market surveillance which should not affect  the substantive rules of existing Union 
legislation designed to protec t public interests such as he alth and safety, consumer 
protection and the protection of  the environment, but shou ld aim at enhancing their 
operation. 
(4) Regulation (EC) No 765/2008 of the European  Parliament and of the Council of 9 July 
2008 setting out the requirements for accredi tation and market surveillance relating to 
the marketing of products8 was adopted to establish a framework for market 
surveillance to complement and strengthen existing provisi ons in Union harmonisation 
legislation relating to market surveillance  and the enforcement of such provisions.  
(5) For the purpose of ensuring the equivale nt and consistent enforcement of Union 
harmonisation legislation, Regulation (EC)  No 765/2008 introduced a Union market 
surveillance framework, defining minimum requirements against the background of 
the objectives to be achieved by Member States and a framewor k for administrative 
cooperation including the exchange of  information among Member States. 
(6) Directive 2001/95/EC of the European Pa rliament and of the Council of 3 December 
2001 on general product safety9 established rules to ensu re the safety of products 
intended for or likely to be used by consumers. Regulation (EC) No 765/2008 
maintained the possibility for market survei llance authorities to take the more specific 
measures available to th em under that Directive. 
(7) In its Resolution of 8 March 2011 on th e revision of the General Product Safety 
Directive and market surveillance10 the European Parliament  states that having one 
single regulation is the only way to have one single market surveillance system for all 
products and therefore urges th e Commission to establish a single market surveillance 
system for all products, based on one act  covering both Directive 2001/95/EC and 
Regulation (EC) No 765/2008. 
(8) This Regulation should therefore inte grate the provisions of Regulation 765/2008, 
Directive 2001/95/EC and several sector-s pecific acts of Union harmonisation 
legislation relating to market surveillan ce into a single regul ation which covers 
products in both the harmonised and non-harm onised areas of the Union legislation, 
regardless whether they are intended for use, or are likely to be used, by consumers or 
professionals.  
(9) Union legislation applicable to products  and processes of the food chain, and in 
particular Regulation (EC) No 882/2004 of  the European Parliament and of the 
Council of 29 April 2004 on official controls performed to ensure the verification of 
compliance with feed and food law, animal health and animal welfare rules11, 
establishes a comprehensive framework for th e performance of official controls and 
                                                 
8 OJ L 218, 13.8.2008, p.30. 
9 OJ L 11, 15.1.2002, p. 4. 
10 2010/2085(INI). 
11 OJ L 165, 30.4.2004, p. 1.  
EN 7   EN other official activities to verify complian ce with feed and food law, rules on animal 
health and welfare, genetically modifi ed organisms, plant health and plant 
reproductive material, plant protection produc ts, and pesticides. These areas should 
therefore be excluded from th e scope of this Regulation.  
(10) Union legislation concer ning medicinal products, medical devices, in vitro diagnostic 
medical devices and substances of human or igin contain special provisions to ensure 
post-market safety based in particular on sector-specific vigilance and market 
surveillance systems. Those products should th erefore also be excluded from the scope 
of this Regulation, with the exception of its provisions on control of products entering 
the Union market which should apply insofar as the relevant Union legislation does 
not contain specific rules relating to the organisation of border controls.  
(11) Directive 2010/35/EU of th e European Parliament and of  the Council of  16 June 2010 
on transportable pressure equipment12 applies not only to new transportable pressure 
equipment for the purpose of making it avai lable on the market but also to certain 
other transportable pressure equipment for the purposes of its pe riodic inspections, 
intermediate inspections, exceptional checks and use. It provides for the specific Pi-marking and for a Union safeguard procedur e and particular procedures for dealing 
with transportable pressure equipment presenting a risk at national level, with compliant transportable pressure equipment wh ich presents a risk to health and safety 
and with formal non-compliance. Therefore,  the procedures for the controls of 
products within the Union laid down in  this Regulation should not apply to 
transportable pressure equipment subject to Directive 2010/35/EU. 
(12) This Regulation should establish a compre hensive framework for market surveillance 
in the Union. It should define  the scope of the products covered and those excluded, 
impose an obligation on Member States to or ganise and carry out market surveillance, 
require Member States to a ppoint market surveillance aut horities and to specify their 
powers and duties, and make Member States  responsible for setting up general and 
sector-specific market surveillance programmes. 
(13) Some Union harmonisation legislation cont ains provisions on market surveillance and 
safeguard clauses. These may be base d on the reference provisions on market 
surveillance and safeguard clauses contai ned in Decision No 768/2008/EC of the 
European Parliament and of the Council of 9 July 2008 on a common framework for 
the marketing of products
13. This Regulation should contain all of the market 
surveillance provisions appli cable to the products falling within its scope. This 
Regulation should therefore include the re ference provisions on market surveillance 
and safeguard clauses contained in Deci sion No 768/2008/EC. Provisions in existing 
Union harmonisation legislatio n that relate to market surveillance and safeguard 
clauses, whether drafted before the adop tion of Decision No 768/2008/EC or based on 
its reference provisions, should be removed from that harm onisation legislation unless 
there are specific sectoral r easons for retaining them. Exem ptions from the safeguard 
provisions should be made in  relation to products subj ect to Regulation (EC) No 
1907/2006 of the European Parliament a nd of the Council of 18 December 2006 
concerning the Registration, Evaluation, Aut horisation and Restriction of Chemicals 
(REACH), certain fittings subject to Directive 2009/142/EC of the European 
                                                 
12 OJ L165, 30.6.2010, p.1. 
13 OJ L 218, 13.8.2008, p.82.  
EN 8   EN Parliament and of the Council of 30 N ovember 2009, certain pressure equipment 
subject to Directive 97/23/EC  of the European Parliament  and of the Council of 29 
May 1997 and certain pressure vessels su bject to Directive 2009/105/EC of the 
European Parliament and of the Council of 16 September 2009. 
(14) In order to make the entire market surv eillance process transparent and easy to follow 
for both market surveillanc e authorities and economic operators, th e Regulation 
should clearly set out the chr onological steps of that pro cess, from the moment when 
market surveillance authorities identify a product which they believe may present a 
risk, to the assessment of the risk presente d, the corrective action to be taken by the 
relevant economic operator within a specified  period and the measures to be taken by 
market surveillance authorities themselves if economic operators do not comply or in 
cases of urgency.  
(15) Market surveillance should be based on the assessment of the risk presented by a 
product taking all relevant data into acc ount. A product that is subject to Union 
harmonisation legislation which lays dow n essential requirements relating to 
protection of certain public in terests should be presumed not to present a risk to those 
public interests if it complies with those essential requirements.  
(16) Products subject to Union harmonisation le gislation that does not  lay down essential 
requirements but which is designed to ensure  the protection of certain public interests 
should be presumed not to present a risk to  those public interests provided that they 
comply with that legislation. 
(17) Similarly, a product that is not subject to Union harmonisation legislation but which 
complies with national rules on the health an d safety of persons or with European 
standards referenced in the Official Journal of the European Union  should be 
presumed not to present a risk to health and safety. 
(18) For the purposes of this Regulation risk assessment should be carried out to identify 
products which have the potential to affect adversely the public in terests protected by 
[Regulation (EU) No xxxx (on consumer product safety)], sector-specific Union 
harmonisation legislation and other Union legi slation on products that are subject to 
this Regulation. It should includ e, where available, data on ri sks that have materialised 
previously with respect to the product in question. Accoun t should also be taken of 
any measures that may have been take n by the economic operators concerned to 
alleviate the risks. The particular potentia l vulnerability of consumers, as opposed to 
professional users, should be taken into acc ount as should the increased vulnerability 
of certain categories of cons umer such as children, the elderly or the disabled. 
(19) Both new and second hand products origin ating outside the Uni on may be placed on 
the market only after they have been releas ed for free circulation. Effective controls 
are required at the exte rnal borders of the Union to susp end the release of  products that 
may present a risk if placed  on the market in the Union pending evaluation and a final 
decision by market surveillance authorities.  
(20) Obliging the authorities responsible for the control of  products entering the Union 
market to carry out checks on an adequate scale therefore contributes to a safer Union market for products. In order to increase th e effectiveness of such checks, cooperation  
EN 9   EN and exchange of information between thos e authorities and market surveillance 
authorities concerning products pres enting a risk should be enhanced. 
(21) Market surveillance author ities should be given the power to destroy products, render 
inoperable or order their dest ruction by the relevant economic  operator, if they deem it 
necessary and proportionate to ensure that such goods cannot  pose any further threats. 
(22) The release for free circul ation of products that are impor ted in the physical possession 
of persons entering the Union for their personal, non-commercial use should not be 
suspended or refused under this Regulati on by the authorities responsible for the 
control of products ente ring the Union market. 
(23) There should be effective, speedy a nd accurate exchange of information among the 
Member States and between the Member St ates and the Commission. It is therefore 
necessary to provide for effective tool s for such exchange. The Union rapid 
information system (RAPEX) has proved its  effectiveness and efficiency. RAPEX 
enables measures to be taken across the Un ion in relation to products that present a 
risk beyond the territory of a single Member  State. To avoid unnecessary duplication, 
this system should be used for all aler t notifications required by this Regulation 
relating to products presenting a risk.  
(24) Coherent and cost-effective market su rveillance activ ity throughout the Union also 
requires well-structured, comprehensive ar chiving and sharing among Member States 
of all pertinent information on national activi ties in this context, including a reference 
to notifications required by this Regulation, to form a complete database of market 
surveillance information. The Commission has established a database called 
‘Information and Communication System for Ma rket Surveillance’ which is suited for 
this purpose and should therefore be used.  
(25) Given the size of the Union market for goods  and as there are no internal borders, it is 
imperative that the market surveillance aut horities of the Member  States are willing 
and able to cooperate with each other eff ectively and to coordi nate joint support and 
action. Accordingly, mechanisms for mutual  assistance should be established. 
(26) In order to facilitate market surveillan ce of products entering the Union market from 
third countries, this Regulation should provi de a basis for cooperation between market 
surveillance authorities of Member States and the aut horities of those countries. 
(27) A European Market Surveillance Forum composed of representatives from market 
surveillance authorities should be establis hed. The Forum should provide a means of 
involving all stakeholders concerned, in cluding professional organisations and 
consumer organisations, in order to take a dvantage of available information relevant 
for market surveillance when establ ishing, implementing and updating market 
surveillance programmes. 
(28) The Commission should pr ovide support for cooperation between market surveillance 
authorities and participate in the Forum. The Regulation should set out a list of tasks to 
be performed by the Forum. An executive se cretariat should organise the Forum's 
meetings and provide other operational suppor t for the accomplishment of its tasks.   
EN 10   EN (29) Where appropriate, reference laboratories  should be established with a view to 
providing expert, impartial technical advice and conducting tests on products required 
in relation to market surveillance activities. 
(30) This Regulation should strike a balance between transparency through the release of 
the maximum possible amount of inform ation to the public and maintaining 
confidentiality, for example for reasons of personal data protection, commercial 
secrecy or the protection of investigations , in accordance with rules on confidentiality 
pursuant to applicable national law or, as  regards the Commission, Regulation (EC) 
No 1049/2001 of the European Parliament  and of the Council of 30 May 2001 
regarding public access to European  Parliament, Council and Commission 
documents14. Directive 95/46/EC of the European Parliament and of the Council of 24 
October 1995 on the protection of individuals  with regard to the processing of 
personal data and on the free movement of such data15 and Regulation (EC) No 
45/2001 of the European Parliament and of  the Council of 18 De cember 2000 on the 
protection of individuals w ith regard to the processing of personal data by the 
Community institutions and bodies a nd on the free movement of such data16 apply in 
the context of this Regulation. 
(31) Information exchanged between competent au thorities should be subject to the strictest 
guarantees of confidentiality and professional secrecy and be handled in a way that 
investigations are not compromised and that  the reputations of economic operators are 
not prejudiced.  
(32) Member States should provide means of redress in the competen t courts and tribunals 
in respect of restrictive meas ures taken by their authorities. 
(33) Member States should lay down rules on pena lties applicable to in fringements of this 
Regulation and ensure that they are implem ented. Those penalties must be effective, 
proportionate and dissuasive.  
(34) Market surveillance should be financed at least in part by fe es charged to economic 
operators where they are required by market surveillance authoritie s to take corrective 
action or where those authorities are obliged to take action themselves.  
(35) In order to achieve the objectives of this Regulation, the Union should contribute to 
the financing of activities required to im plement policies in the field of market 
surveillance such as the drawing-up and updating of guidelines, preliminary or 
ancillary activities in connection with th e implementation of Union legislation and 
programmes of technical assistance and coopera tion with third countries as well as the 
enhancement of policies at Union and international level.  
(36) Union financing should be made ava ilable in accordance with Regulation (EU, 
Euratom) No 966/2012 of the European Parlia ment and of the Council of 25 October 
2012 on the financial rules applicable to the general budget of the Union17, depending 
on the nature of the activity to be financed, in particular for support to the executive secretariat of the EMSF. 
                                                
 
14 OJ L 145, 31.5.2001, p. 43. 
15 OJ L 281, 23.11.1995, p. 31.  
16 OJ L 8, 12.1.2001, p. 1. 
17 OJ L 298, 26.10.2012, p. 1.  
EN 11   EN (37) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be  conferred on the Commis sion as regards national 
measures taken and notified by a Member St ate in relation to products subject to 
Union harmonisation legislation and the establishment of Un ion reference laboratories. 
(38) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be  conferred on the Commis sion as regards uniform 
conditions for the carrying out of checks by re ference to particular product categories 
or sectors, including the scale of checks to be carried out and the adequacy of samples to be checked. Implementing powers shoul d also be conferred as regards the 
modalities for the provision of informati on to market surveillance authorities by 
economic operators, as regards establishi ng uniform conditions for determining cases 
in which such information need not be provided. Implementing powers should also be conferred as regards the modalities and procedures for the exchange of information through RAPEX and as regards the adoption of temporary or permanent marketing 
restrictions on products  presenting a serious risk, wh ere appropriate, specifying the 
necessary control measures to be taken by the Member States for their effective 
implementation where other Union legislation does not provide a sp ecific procedure to 
address the risks in questi on. Those powers should be exercised in accordance with 
Regulation (EU) No 182/2011 of the European  Parliament and of the Council laying 
down the rules and general principles c oncerning mechanisms for control by the 
Member States of the Commission's ex ercise of its implementing powers
18.  
(39) The Commission should adopt immediately applicable implementing acts where, in 
duly justified cases relating to  restrictive measures relati ng to products that present a 
serious risk, imperative grounds of urgency so require.  
(40) The market surveillance provisions of Council Directive 89/686/EEC of 21 December 
1989 on the approximation of the laws of th e Member States relating to personal 
protective equipment19, Directive 93/15/EEC of 5 April 1993 on the harmonization of 
the provisions relating to the placing on the market and supervision of explosives for 
civil uses20, Directive 94/9/EC of the European  Parliament and the Council of 23 
March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intende d for use in potentially explosive 
atmospheres
21, Directive 94/25/EC of the European  Parliament and of the Council of 
16 June 1994 on the approximation of the laws, regulations and administrative 
provisions of the Member States  relating to recreational craft22, European Parliament 
and Council Directive 95/16/EC of 29 June  1995 on the approximati on of the laws of 
the Member States relating to lifts23, Directive 97/23/EC of the European Parliament 
and of the Council of 29 May 1997 on the appr oximation of the laws of the Member 
States concerning pressure equipment24, Directive 1999/5/EC of the European 
Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their 
                                                
 
18 OJ L 55, 28.2.2011, p. 11. 
19 OJ L 399, 30.12.1989, p. 18.  
20 OJ L 121, 15.5.1993, p. 20. 
21 OJ L 100, 19.4.1994, p. 1. 
22 OJ L 164, 30.6.1994, p. 15. 
23 OJ L 213, 7.9.1995, p. 1. 
24 OJ L 181, 9.7.1997, p. 1.  
EN 12   EN conformity25, Directive 2000/9/EC of the European  Parliament and of the Council of 
20 March 2000 relating to cableway inst allations designed to carry persons26, 
Directive 2000/14/EC of the European Parl iament and of the Council of 8 May 2000 
on the approximation of the laws of the Memb er States relating to the noise emission 
in the environment by equipment for use outdoors27, Directive 2001/95/EC, Directive 
2004/108/EC of the European Parliament a nd of the Council of 15 December 2004 on 
the approximation of the laws of the Member States relating to electromagnetic compatibility
28, Directive 2006/42/EC of the European  Parliament and of the Council 
of 17 May 2006 on machinery29, Directive 2006/95/EC of th e European Parliament 
and of the Council of 12 December 2006 on th e harmonisation of th e laws of Member 
States relating to electrical equipment designed for use within certain voltage limits30, 
Directive 2007/23/EC of the European Parlia ment and of the Council of 23 May 2007 
on the placing on the market  of pyrotechnic articles31, Directive 2008/57/EC of the 
European Parliament and of the Council of 17 June 2008 on the inter operability of the 
rail system within the Community32, Directive 2009/48/EC of the European 
Parliament and of the Council of 18 June 2009 on the safety of toys33, Directive 
2009/105/EC of the European Parliament a nd of the Council of 16 September 2009 
relating to simple pressure vessels34, Directive 2009/142/EC of the European 
Parliament and of the Council of 30 Nove mber 2009 relating to appliances burning 
gaseous fuels35, Directive 2011/65/EU of the European  Parliament and of the Council 
of 8 June 2011 on the restriction of the us e of certain hazardous substances in 
electrical and electronic equipment36, Regulation (EU) No 30 5/2011 of the European 
Parliament and of the Council of 9 Ma rch 2011 laying down harmonised conditions 
for the marketing of construction products37, and Regulation (EC) No 765/2008 
overlap with the provisions of this Regulation. Therefore,  these provisions should be 
deleted. Regulation (EC) No 764/2008 of the Eu ropean Parliament and of the Council 
of 9 July 2008 laying down procedures relating to the application of certain national 
technical rules to products lawfully market ed in another Member  State and repealing 
Decision No 3052/95/EC should be amended accordingly38.  
(41) Since the objective of this Regulation, na mely to ensure that products on the market 
covered by Union legislation fulfil the requirements providing a high level of 
protection of health and safety and othe r public interests while guaranteeing the 
functioning of the internal market by provi ding a framework for coherent market 
surveillance in the Union, cannot be sufficien tly achieved by the Member States as the 
attainment of this objective requires a very high  degree of coopera tion, interaction and 
uniformity of operation among all of the comp etent authorities of all Member States, 
and can therefore, by reason of its scale and e ffects, be better achieved at Union level, 
                                                 
25 OJ L 91, 7.4.1999, p. 10. 
26 OJ L 106, 3.5.2000, p. 21. 
27 OJ L 162, 3.7.2000, p. 1. 
28 OJ L 390, 31.12.2004, p. 24. 
29 OJ L 157, 9.6.2006, p. 24. 
30 OJ L 374, 27.12.2006, p. 10. 
31 OJ L 154, 14.6.2007, p. 1. 
32 OJ L 191, 18.7.2008, p. 1. 
33 OJ L 170, 30.6.2009, p. 1. 
34 OJ L 264, 8.10.2009, p. 12. 
35 OJ L 330, 16.12.2009, p. 10. 
36 OJ L 174, 1.7.2011, p. 88. 
37 OJ L 88, 4.4.2011, p. 5. 
38 OJ L 218, 13.8.2008, p. 21.  
EN 13   EN 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. 
(42) This Regulation respects the fundamental rights and observes the pr inciples recognised 
in particular by the Charter of Fundament al Rights of the European Union. in 
particular this Regulation seeks to ensure full respect for obligation to ensure a high level of human health protection and consumer  protection as well as full respect of the 
freedom to conduct a business and the right to property,  
HAVE ADOPTED THIS REGULATION: 
CHAPTER I 
General provisions 
Article 1 
Subject matter 
This Regulation lays down a framework for veri fying that products meet requirements which 
safeguard, at a high level, the hea lth and safety of pers ons in general, health  and safety in the 
workplace, consumer protection, the environment, public security and other public interests.  
Article 2 
Scope  
1. Chapters I, II, III, V and VI of this Regulation shall apply to all products that are 
subject to Regulation (EU) No [… on Consumer Product Safety] or Union 
harmonisation legislation, including to pr oducts assembled or manufactured for the 
manufacturer's own use, and to the extent that Union ha rmonisation legislation does 
not contain a specific provisi on with the same objective. 
2. Chapters I and IV and Article 23 sha ll apply to all products covered by Union 
legislation to the extent that other Uni on legislation does not contain specific 
provisions relating to the orga nisation of external border controls or to cooperation 
between authorities in charge of  external border controls.  
3. Chapters II, III, V and VI shall not apply to the following products:  
(a) medicinal products for huma n or veterinary use;  
(b) medical devices and in vitr o diagnostic medical devices; 
(c) blood, tissues, cells, organs and othe r substances of human origin.  
EN 14   EN 4. Chapter III of this Regulation shall not apply to transportable pressure equipment 
subject to Directive 2010/35/EU. 
5. Articles 11 and 18 of this Regulation sh all not apply to the following products: 
(a) products subject to Regul ation (EC) No 1907/2006; 
(b) fittings as defined in Article 1(2)(b) of Directive 2009/142/EC; 
(c) pressure equipment subject to the provi sions of Article 3(3) of Directive 
97/23/EC;  
(d) simple pressure vessels subject to the provisions of Article 3(2) of Directive 
2009/105/EC.  
6. This Regulation shall not a pply in the areas governed by Un ion legislation on official 
controls and other official activities carri ed out for the verification of compliance 
with the following rules:  
(a) rules governing food and food safety, at  any stage of production, processing 
and distribution of food, in cluding rules aimed at guara nteeing fair practices in 
trade and protecting consumer interests and information;  
(b) rules governing the manufacture and use of  materials and articles intended to 
come into contact with food; 
(c) rules governing the deliberate release into the environment of genetically 
modified organisms; 
(d) rules governing feed and feed safety, at  all stages of pr oduction, processing and 
distribution of feed and the use of feed, including rules aimed at guaranteeing 
fair practices in trade and protecting consumer interests and information; 
(e) rules laying down animal health requirements; 
(f) rules aiming at preventing and minimisi ng risks to human and animal health 
arising from animal by-produc ts and derived products; 
(g) rules laying down welfare requirements for animals; 
(h) rules on protective measures against pests of plants; 
(i) rules on the production, with a view to  placing on the market, and placing on 
the market of plant reproductive material; 
(j) rules laying down the requirements for placing on the market and the use of 
plant protection products and the sustainable use of pesticides; 
(k) rules governing organic production a nd labelling of organic products; 
(l) rules on the use and labell ing of protected designati ons of origin, protected 
geographical indications and trad itional specialities guaranteed.  
EN 15   EN Article 3 
Definitions 
For the purposes of this Regulation th e following definitions shall apply: 
(1) ‘product’ means a product obtaine d through a manufacturing process; 
(2) ‘making available on the market’ means any supply of a product for distribution, 
consumption or use on the Union market in  the course of a commercial activity, 
whether in return for payment or free of charge; 
(3) ‘placing on the market’ means the first ma king available of a product on the Union 
market; 
(4) ‘manufacturer’ means any natural or legal person who manufactures a product or has 
a product designed or manuf actured and markets that product under his name or 
trademark; 
(5) ‘authorised representa tive’ means any natural or lega l person established within the 
Union who has received a written mandate fr om a manufacturer to act on his behalf 
in relation to specified tasks; 
(6) ‘importer’ means any natural or legal pe rson established within the Union who 
places a product from a third country on the Union market; 
(7) ‘distributor’ means any natural or legal person in the supply chain, other than a 
manufacturer or importer, who make s a product available on the market; 
(8) ‘economic operators’ means the manufactur er, the authorised representative, the 
importer and the distributor;  
(9) ‘conformity assessment’ means conformity a ssessment as defined in Regulation (EC) 
No 765/2008; 
(10) ‘conformity assessment body’ means conformity assessment body as defined in 
Regulation (EC) No 765/2008; 
(11) ‘market surveillance’ means the activities carried out and measures taken by public 
authorities to ensure that products do not e ndanger health, safety or any other aspect 
of public interest protection and, in the cas e of products falling within the scope of 
Union harmonisation legislati on, that they comply with the requirements set out in 
that legislation; 
(12) ‘market surveillance authority’ means an authority of a Member State responsible for 
carrying out market surveillance on its territory; 
(13) ‘product presenting a risk’ means a product having the potential to affect adversely 
health and safety of persons in general, he alth and safety in the workplace, consumer 
protection, the environment an d public security as well as  other public interests to a 
degree which goes beyond that consider ed reasonable and acceptable under the 
normal or reasonably foreseeable conditio ns of use of the product concerned,  
EN 16   EN including the duration of use and, where applicable, its putting into service, 
installation and maintenance requirements;  
(14) ‘product presenting a serious risk’ means a product presenting a risk requiring rapid 
intervention and follow-up, including cases wh ere the effects may not be immediate; 
(15) ‘recall’ means any measure aimed at achi eving the return of  a product that has 
already been made available to the end user; 
(16) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being made available on the market;  
(17) ‘release for free circulation’ means the pro cedure laid down in Article 79 of Council 
Regulation (EEC) No 2913/9239; 
(18) ‘Union harmonisation legislation’ mean s Union legislation harmonising the 
conditions for the marketing of products;  
(19) ‘European standard’ means a European sta ndard as defined in Article 2(1)(b) of 
Regulation (EU) No 1025/2012 of the Eu ropean Parliament and the Council40; 
(20) ‘harmonised standard’ means a harmonised sta ndard as defined in Article 2(1)(c) of 
Regulation (EU) No 1025/2012.  
CHAPTER II 
Union market surveillance framework 
Article 4 
Market surveillance obligation 
1. Member States shall carry out market su rveillance in respect of products covered by 
this Regulation. 
2. Market surveillance shall be organised and carried out in accordance with this 
Regulation with a view to ensuring that  products presenting a risk are not made 
available on the Union market and, where su ch products have been made available, 
effective measures are taken to remove the risk presented by the product. 
3. The implementation of market surveillance activities and external border controls 
shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include 
statistics regarding the number of controls  carried out and shall be communicated to 
all Member States. Member States may make  a summary of the results accessible to 
the public. 
                                                
 
39 OJ L 302, 19.10.1992, p. 1 
40 OJ L 316, 14.11.2012, p. 12.  
EN 17   EN 4. The results of the monitoring and assessment of market surveillan ce activities carried 
out pursuant to paragraph 3 shall be made av ailable to the public , electronically and, 
where appropriate, by other means. 
Article 5 
Market surveillance authorities 
1. Each Member State shall establish or desi gnate market surveillance authorities and 
define their duties, powers and organisation. 
2. Market surveillance author ities shall be given the pow ers and entrusted with the 
resources and means necessary for th e proper performance of their tasks. 
3. Each Member State shall establish appropria te mechanisms to ensure that the market 
surveillance authorities that it has establ ished or designated exchange information, 
cooperate and coordinate their activities both among themselves and with the 
authorities in charge of c ontrols of products at the external borders of the Union. 
4. Each Member State shall inform the Commission about its market surveillance 
authorities and their areas of competence, providing the necessary  contact details, 
and the Commission shall transmit this information to the other Member States and publish a list of market surveillance authorities. 
5. Member States shall inform the public of the existence, responsibilities and identity 
of national market surveillance authori ties and how those authorities may be 
contacted. 
Article 6 
General obligations of market surveillance authorities 
1. Market surveillance authorities sh all perform appropriate checks on the 
characteristics of products on an adequate  scale and with adequate frequency, by 
means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the 
information and communication system for ma rket surveillance referred to in Article 
21. 
In cases of known or emerging risk related to the objectives set out in Article 1 of 
this Regulation and concerning a particular  product or a cate gory of products, the 
Commission may adopt implementing acts to  establish uniform conditions for the 
carrying out of the checks performed by one or several market surveillance 
authorities in relation to that particular  product or category of products and the 
characteristics of that known or emer ging risk. These conditions may include 
requirements for a temporary increase of the scale and frequency of checks to be 
carried out and the adequacy of sample s to be checked. These implementing acts 
shall be adopted in accordan ce with the examination proced ure referred to in Article 
32(2).  
EN 18   EN 2. Where appropriate, market surveillance author ities shall alert users in their territories 
within an adequate timeframe  of products that those auth orities have identified as 
presenting a risk.  
They shall cooperate with economic operato rs to prevent or reduce risks caused by 
products made available by those operators. For this purpose, they shall encourage and promote voluntary action by economic operators including, where applicable, 
through the development of and adhe rence to codes of good practice. 
3. Market surveillance authorities shall carry  out their duties inde pendently, impartially 
and without bias and shall fu lfil their obligations under th is Regulation; they shall 
exercise their powers in relation to ec onomic operators in accordance with the 
principle of proportionality. 
4. Where it is necessary and justified for ca rrying out their duties, market surveillance 
authorities may enter the pr emises of economic operators  and take any necessary 
samples of products.  
5. Market surveillance authorities shall:  
(a) provide consumers and other interested pa rties with the opportunity to submit 
complaints on issues relating to product safety, market surveillance activities 
and risks arising in connection with pr oducts and follow up those complaints as 
appropriate; 
(b) verify that corrective action has been taken; 
(c) follow and keep up to date with developments in scientific and technical 
knowledge concerning the safety of products. 
6. Adequate procedures shall be establishe d and made known to the public to enable 
market surveillance authorities to fulfil these obligations. 
7. Without prejudice to national legislatio n in the area of confidentiality, the 
safeguarding of confidentiality with regard to information received and collated by 
market surveillance authorities shall be  ensured. Information exchanged between 
national market surveillance authoritie s and between them and the Commission on 
condition of confidentiality sh all remain confiden tial unless the orig inating authority 
has agreed to its disclosure.  
8. The protection of confidentiality shall not prevent the dissemination to market 
surveillance authorities of information necessary to ensure effective market 
surveillance. 
Article 7 
Market surveillance programmes 
1. Each Member State shall draw up a genera l market surveillance programme and shall 
review that programme, and update it if n ecessary, at least every four years. The 
programme shall cover market surveillance  organisation and related activities and  
EN 19   EN take into account the specific needs of bus iness generally, and SMEs in particular, 
when implementing Union harmonisation legislation and Regulation (EU) No 
[…/…] [on consumer product safety], and provide for guidance and assistance. It 
shall include the following: 
(a) the sectoral and geographical competen ce of the authorities designated under 
Article 5(1); 
(b) the financial resources, staff, techni cal and other means attributed to the 
authorities; 
(c) an indication of the prior ity areas of work of th e different authorities; 
(d) the mechanisms of coordination among the different authorities and with 
customs authorities; 
(e) the participation of  the authorities in  the exchange of information under 
Chapter V; 
(f) the participation of the aut horities in sectoral or proj ect-oriented cooperation at 
Union level;  
(g) the means to fulfil the requirements of Article 6(5).  
2. Each Member State shall draw up sector-s pecific programmes and shall review these 
programmes, and update them if necessary, every year. These programmes shall cover all sectors in which authorities conduct market surveillance activities. 
3. The general and sector-specific pr ogrammes and their updates shall be 
communicated to the other Member Stat es and the Commission and, subject to 
Article 6(6), shall be made accessible to  the public electronically and, where 
appropriate, by other means.  
Article 8 
General obligations of economic operators 
1. On request, economic operators and, wh ere applicable, conformity assessment 
bodies, shall make available to market surveillance authorities any documentation 
and information that those authorities requ ire for the purpose of carrying out their 
activities, in a language which can be easily understood by them. 
2. Economic operators shall pr ovide all necessary information to market surveillance 
authorities including information that enable s the precise identific ation of the product 
and facilitates the tr acing of the product. 
CHAPTER III 
Control of products within the Union  
EN 20   EN Article 9 
Products presenting a risk 
1. Where, in the course of carrying out the ch ecks referred to in Article 6(1) or as a 
result of information received, market surv eillance authorities have sufficient reason 
to believe that a product that is placed or ma de available on the market or is used in 
the course of the provision of a service may present a risk, they shall carry out a risk 
assessment in relation to that product ta king account of the considerations and 
criteria set out in Article 13. 
Market surveillance authorities shall take due consideration of any readily available 
test result and risk assessment that has already been ca rried out or issued in relation 
to the product by an economic operator or any other person or authority including the 
authorities of other Member States. 
2. In relation to a product that is subject to Union harmonisation legislation, formal 
non-compliance with that legislation sha ll give market surveillance authorities 
sufficient reason to believe that the product may presen t a risk in any of the 
following cases: 
(a) the CE marking or other markings requi red by Union harmonisation legislation 
have not been affixed or have been affixed incorrectly; 
(b) the EU declaration of conformity, wh ere required, has not been drawn up or 
has been drawn up incorrectly; 
(c) the technical documentation is incomplete or unavailable;  
(d) the required labelling or instructions  for use are incomplete or missing.  
Regardless whether the risk assessment shows th at the product in fact presents a risk, 
market surveillance authorities shall requi re the economic opera tor to rectify the 
formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled. 
3. Without prejudice to Article 10(4), where market surveill ance authorities find that a 
product does present a risk th ey shall without delay spec ify the necessary corrective 
action to be taken by the relevant economic operator to address the risk within a 
specified period. Market surveillance aut horities may recommend or agree with the 
relevant economic operator the corrective action to be taken. 
The economic operator shall en sure that all necessary co rrective action is taken in 
respect of all the products  concerned that it has made  available on the market 
throughout the Union.  
The economic operator shall provide all nece ssary information to market surveillance 
authorities pursuant to Article 8, and in  particular the following information: 
(a) a full description of the ri sk presented by the product; 
(b) a description of any corrective actio n undertaken to address the risk.  
EN 21   EN Where possible, market surveillance auth orities shall identify the manufacturer or 
importer of the product and take action in  relation to that economic operator in 
addition to the distributor. 
4. Corrective action to be taken by econo mic operators in relation to a product 
presenting a risk may include: 
(a) in the case of a product subject to the requirements laid down in or pursuant to 
Union harmonisation legislation, taking th e measures necessary to bring the 
product into compliance with those requirements;  
(b) in the case of a product that is liable to  present a risk only in certain conditions 
or only to certain persons and where such  risk is not addressed by requirements 
of Union harmonisation legislation: 
(i) affixing to the product suitable, cl early worded, easily comprehensible 
warnings of the risks it may present,  in the official language or languages 
of the Member State in which th e product is made available on the 
market ; 
(ii) making the marketing of the pr oduct subject to prior conditions; 
(iii) alerting the persons at risk to th e risk, in good time and in an appropriate 
form, including by publication of special warnings; 
(c) in the case of a product that may presen t a serious risk, temporarily preventing 
the product from being placed or made available on the market pending a risk 
assessment; 
(d) in the case of a product that  presents a serious risk: 
(i) preventing the product from being placed or made available on the 
market; 
(ii) withdrawing or recalling the product and alerting the public to the risk 
presented; 
(iii) destroying the product or ot herwise rendering it inoperable. 
5. The Commission may adopt implementing acts establishing the modalities for the 
provision of information in accordance with  the third subparagraph of paragraph 3, 
while ensuring the effectiveness and pr oper functioning of the system. These 
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2). 
Article 10 
Measures taken by market surveillance authorities 
1. Where the identity of the relevant econom ic operator cannot be  ascertained by the 
market surveillance authorities or wher e an economic operator has not taken the 
necessary corrective action pursuant to Article 9(3) within the period specified,  
EN 22   EN market surveillance authorities shall take all necessary measur es to deal with the risk 
presented by the product. 
2. For the purpose of paragraph 1, market surveillance authorities may oblige the 
relevant economic operators to  take, inter alia, any of the corrective action referred to 
in Article 9(4) or take such measures themselves, as appropriate.  
Market surveillance au thorities may destroy or otherw ise render inoperable a product 
presenting a risk where they deem it nece ssary and proportionate. They may require 
the relevant economic operator to bear the cost of such action. 
The first subparagraph shall not prevent Member States from enabling market 
surveillance authorities to take other, supplementary measures. 
3. Prior to taking any measure under paragra ph 1 in relation to an economic operator 
who has failed to take the necessary correc tive action, market surveillance authorities 
shall allow him at least 10 days within which to be heard. 
4. Where market surveillance au thorities consider that a pr oduct presents a serious risk, 
they shall take all necessary measures and may do so without first requiring the 
economic operator to take co rrective action pursuant to  Article 9(3) and without 
giving the operator the opportunity to be  heard beforehand. In such cases the 
economic operator shall be heard as soon as practicable.  
5. Any measure taken pursuant to  paragraphs 1 or 4 shall: 
(a) be communicated without delay to th e economic operato r together with 
information about the remedies availabl e under the law of the Member State 
concerned; 
(b) state the exact grounds on which it is based; 
(c) be lifted without delay where the economic  operator has demonstrated that he 
has taken the required action. 
For the purposes of point (a) of the firs t subparagraph, where the economic operator 
to whom the measure has been comm unicated is not the economic operator 
concerned, the manufacturer located with in the Union or the importer shall be 
informed of the measure, provided market surveillance authorities  know his identity.  
6. Market surveillance aut horities shall publish in formation about product 
identification, the nature of a risk and th e measures taken to prevent, reduce or 
eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Uni on. This information shall not be published 
where it is imperative to observe confidentiality in order to protect commercial secrets, preserve personal data pursuant to national and Union legislation or avoid 
undermining monitoring and i nvestigation activities.  
7. Any measure taken in accordance with para graphs 1 or 4 shall be subject to legal 
remedies, including recourse to the competent national courts.  
EN 23   EN 8. Market surveillance authorities may ch arge fees on economic operators which 
wholly or partly cover the co sts of their activities, including testing carried out for 
the risk assessment, where they take measur es in accordance with paragraphs 1 or 4. 
Article 11 
Union assessment for products controlled within the Union and subject to 
harmonisation legislation  
1. Within 60 days of communication by th e Commission to the Member States, 
pursuant to Article 20(4), of measures taken pursuant to paragraphs 1 or 4 of Article 
10 by the original notifying Member State,  a Member State may object to those 
measures where they relate to a product subject to Union harmonisation legislation. 
The Member State shall state its reasons fo r objecting, indicate any difference in its 
assessment of the risk presented by the product and mention any special 
circumstances and any additional informa tion relating to the product in question.  
2. If no objection is raised  by a Member State pursuan t to paragraph 1 and the 
Commission does not consider that the national measures are contrary to Union legislation, the measures taken by the or iginal notifying Member State shall be 
deemed justified and each Member State sh all ensure that restrictive measures are 
taken without delay in respect of the product concerned. 
3. Where an objection is raised by a Member State pursuant to paragraph 1 or the 
Commission considers that the national measures may be contrary to Union 
legislation, the Commission shall without de lay enter into consultation with the 
relevant economic operator(s) and shall evaluate the national measures, taking 
account of all available scientif ic or technical evidence.  
4. On the basis of the results of the eval uation conducted pursuant to paragraph 3, the 
Commission may decide by implementing act s whether the national measures are 
justified and similar measures should be taken by all Member States that have not 
already done so. In this case, it shall address the decision to the Member States 
concerned and immediately communicate it to all Member States and the relevant 
economic operator or operators.  
5. If the Commission decides that the nati onal measures are just ified, each Member 
State shall take the necessary restrictive m easures without delay. If it decides that the 
national measure is not justified, the orig inal notifying Member State and any other 
Member State that has taken a similar measure shall withdraw the measure and the notification made under the rapid informati on exchange system pursuant to Article 
20. 
6. Where a national measure is considered just ified and the product is  found not to be in 
compliance with Union harmonisation legisl ation because of shortcomings in the 
relevant harmonised standard s, the Commission shall inform the relevant European 
standardisation organisation and may make an  appropriate request pursuant to Article 
11 of Regulation (EU) No 1025/2012.   
EN 24   EN Article 12 
Union action against products presenting a serious risk 
1. Where it is evident that a product, or a sp ecific category or gr oup of products, when 
used in accordance with the product's intended purpose or under conditions which can be reasonably foreseeable, presents  a serious risk the Commission may, by 
means of implementing acts, take any appr opriate measures depending on the gravity 
of the situation, including measures prohibi ting, suspending or rest ricting the placing 
or making available on the market of such products or laying down special 
conditions for their marketing, in order to ensure a high level of  protection of the 
public interest, provided that the risk cannot be contained satisfactorily by means of 
measures taken by the Member State(s) concerned or by any other procedure under 
Union legislation. By those implementing acts, the Commission may lay down the appropriate control measures to be taken by Member States to ensure their effective 
implementation. 
The implementing acts referred to in the first subparagraph sh all be adopted in 
accordance with the examination proce dure referred to in Article 32(2). 
On duly justified imperative grounds of urgenc y relating to the hea lth and safety of 
persons in general, health and safety in  the workplace, consumer protection, the 
environment and public security and othe r public interests, the Commission shall 
adopt immediately applicable implementi ng acts in accordance with the procedure 
referred to in Article 32(3).  
2. For products and risks subject to Regulat ion (EC) No 1907/2006, a decision taken by 
the Commission pursuant to paragraph 1 of th is Article shall be valid for up to two 
years and may be extended for additional periods of up to two years. Such a decision shall be without prejudice to proced ures provided in that Regulation. 
3. The exportation from the Union of a product th at has been prohibited to be placed or 
made available on the Union market pursu ant to a measure adopted in accordance 
with paragraph 1 shall be prohibited, unl ess the measure expr essly so permits. 
4. Any Member State may submit a substa ntiated request to the Commission to 
examine the need for the adoption of a measure referred to in paragraph 1. 
Article 13 
Risk assessment 
1. Risk assessment shall be based on ava ilable scientific or technical evidence. 
For products subject to Regulation (EC)  No 1907/2006, risk assessment shall be 
carried out as appropriate in accordance with  the relevant parts of Annex I to that 
Regulation. 
2. In the context of the risk assessment, mark et surveillance authorities shall take into 
account the extent to which the prod uct complies with the following:  
EN 25   EN (a) any requirements laid down in or purs uant to Union harmonisation legislation 
that apply to the product and relate to the potential risk u nder consideration, 
taking full account of test reports or certificates attes ting conformity and issued 
by a conformity assessment body; 
(b) in the absence of requirements laid  down in or pursuant to Union 
harmonisation legislation, specific ru les laying down health and safety 
requirements for such products in the na tional law of the Member State where 
it is made available on the market, provided that such rules are in accordance with Union law;  
(c) any European standards the references of which have been published in the 
Official Journal of the European Union . 
3. Compliance with the criteria referred to in points (a), (b) and (c) of paragraph 2 shall 
raise a presumption that the product ade quately safeguards the public interests to 
which those criteria relate. However, this shall not prevent market surveillance authorities from taking action under this Regulation where there is new evidence 
that, despite such conformity or co mpliance, the product presents a risk. 
4. The feasibility of obtaining higher leve ls of protection of the public interest 
concerned and the availability of other produc ts presenting a lesser risk shall not be a 
reason to consider that a product presents a risk. 
CHAPTER IV 
Control of products entering the Union 
Article 14 
Checks and suspension of release 
1. The authorities of the Member States in charge of the control of products at the 
external borders of the Uni on shall have the powers and resources necessary for the 
proper performance of their tasks. They sh all carry out appropria te documentary and, 
where necessary, physical and laboratory checks on products before those products are released for free circulation. 
2. Where more than one author ity is responsible for market  surveillance or external 
border controls in a Member State, those au thorities shall cooperate with each other, 
by sharing information rele vant to their functions. 
3. Subject to Article 17, the authorities in charge of external border controls shall 
suspend release of a product for free circ ulation on the Union market when, in the 
course of the checks referred to in paragraph 1, they have  reason to believe that the 
product may present a risk. 
In relation to a product which must comp ly with Union harmonisation legislation 
when it is released for free circulation, formal non-compliance with that legislation  
EN 26   EN shall give the authorities of Member Stat es sufficient reason to believe that the 
product may present a risk in any of the following cases:  
(a) is not accompanied by the documenta tion required by the legislation; 
(b) is not marked or labelled in acco rdance with that legislation;  
(c) bears a CE marking or other mark ing required by Union harmonisation 
legislation which has been affixed in a false or misleading manner.  
4. The authorities in charge of external border controls shall immediately notify the 
market surveillance authorities of  any suspension under paragraph 3. 
5. In the case of perishable products, the au thorities in charge of external border 
controls shall, as far as possible, seek to ensure that any requirements they may 
impose with regard to the storage of produc ts or the parking of vehicles used for 
transport are not incompatible with  the preservation of those products. 
6. Where, in relation to products that ar e not declared for free circulation, the 
authorities in charge of external border controls have reason to believe that those products present a risk, they shall transmit a ll relevant information to the authorities 
in charge of external border controls in  the Member State of final destination. 
Article 15 
Release 
1. A product the release of which has been su spended by the authorities in charge of 
external border controls pursuant to Article  14 shall be releas ed if, within three 
working days of the suspension of release, those authorities have not been requested 
by the market surveillance aut horities to continue the suspension or they have been 
informed by the market surveillance author ities that the product does not present a 
risk, and provided that all th e other requirements and form alities pertaining to such 
release have been fulfilled. 
2. If the market surveillance authorities conc lude that a product the release of which 
was suspended due to formal non-complia nce in accordance w ith the second sub-
paragraph of paragraph 3 of Article 14 does not in fact present a risk, the economic 
operator shall nevert heless rectify the formal non-co mpliance before the product is 
released. 
3. Compliance with the requirements of any Union harmonisation legislation that apply 
to the product upon its release which relate to the potential  risk under consideration, 
taking full account of test re ports or certificates attesting conformity and issued by a 
conformity assessment body, shall raise a presumption on the part of market 
surveillance authorities that the product doe s not present a risk. However, this shall 
not prevent those authorities from instructing the authorities in charge of external 
border controls not to release the product wh ere there is evidence that, despite such 
compliance, the product does in fact present a risk.  
EN 27   EN Article 16 
Refusal to release 
1. Where the market surveillance authorities conclude that a product does present a risk, 
they shall instruct the authorities in charge  of external border controls not to release 
the product for free circula tion and to include the fo llowing endorsement on the 
commercial invoice accompanying the product and on any other relevant 
accompanying document: 
“Product presents a risk — release for free circulation not authorised — Regulation 
(EU) No XXX/XXXX”. 
2. Where that product is subsequently decl ared for a customs procedure other than 
release for free circulation and provided th at the market surveillance authorities do 
not object, the endorsement set out in paragraph 1 shall also be included, under the conditions set out in paragraph 1, on the doc uments used in connection with that 
procedure. 
3. Market surveillance authorities or the authorities in charge of external border 
controls, as the case may be, may destroy or otherwise render inoperable a product 
presenting a risk where they deem it nece ssary and proportionate. The cost of such 
action shall be borne by the person decl aring the product for free circulation. 
4. Market surveillance authorit ies shall provide the authori ties in charge of external 
border controls with information on produc t categories in which a risk has been 
identified pursuant to paragraph 1.  
5. Any measure taken in accordance with para graphs 1 or 3 shall be subject to legal 
remedies, including recourse to the competent national courts. 
6. Market surveillance authorities may charge  fees which wholly or partly cover the 
costs of their activities, including testing carried out for the risk assessment, where 
they take measures in accordance with paragraph 1. 
Article 17 
Personal imports 
1. Where a product enters the Union accompanied by, and in the physical possession of, 
a natural person and reasonably appears to be  destined for the personal use of that 
person, its release shall not be suspended pursuant to Article 14(3) except where the 
use of the product can endange r the health and life of persons, animals or plants. 
2. A product shall be deemed to be destined for the personal use of a natural person 
bringing it into the Union if it is of an  occasional nature and exclusively intended for 
use by that person or his family and does not  by its nature or quantity indicate any 
commercial intent.   
EN 28   EN Article 18 
Union assessment for products entering the Union and subject to harmonisation 
legislation 
1. Within 60 days of communication by th e Commission to the Member States, 
pursuant to Article 20 (4), of any refusal to release a product for free circulation by 
the original notifying Member State, a Me mber State may object to that refusal 
where it relates to a produc t subject to Union harmonisa tion legislation. The Member 
State shall state its reasons for objecting, i ndicate any difference in its assessment of 
the risk presented by the product and men tion any special circumstances and any 
additional information relating to the product in question.  
2. If no objection is raised by a Member St ate under paragraph 1 and the Commission 
does not consider that the national measures  are contrary to Union legislation, the 
refusal by the original notifying Member St ate shall be deemed justified and each 
Member State shall ensure that restrict ive measures are taken without delay in 
respect of the product concerned. 
3. Where an objection is raised by a Me mber State under paragraph 1 or the 
Commission considers that the refusal may be contrary to Union legislation, the 
Commission shall without delay enter into consultation with the relevant economic 
operator(s) and shall evaluate the refusal, taking account  of all availabl e scientific or 
technical evidence.  
4. On the basis of the results of the eval uation conducted pursuant to paragraph 3, the 
Commission may decide by implementing acts  whether the refusal is justified and 
similar action should be taken by all Member States that ha ve not already done so. In 
this case, it shall address the decision to the Member States concerned and immediately communicate it to all Member  States and the relevant economic 
operator or operators.  
5. If the Commission decides that the refusal is justified, each Member State shall take 
the necessary restrictive measures without de lay. If it decides that  the refusal is not 
justified, the original notifying Member St ate and any other Member State that has 
taken a similar measure shall withdraw it and the notificatio n made under RAPEX 
pursuant to Article 20. 
6. Where a refusal is considered justifie d and the product is found not to be in 
compliance with Union harmonisation legisl ation because of shortcomings in the 
relevant harmonised standard s, the Commission shall inform the relevant European 
standardisation organisation and may make an  appropriate request pursuant to Article 
11 of Regulation (EU) No. 1025/2012. 
CHAPTER V 
Exchange of information  
EN 29   EN Article 19 
Union Rapid Information Exchange System - RAPEX 
1. The Commission shall maintain the syst em for rapid exchange of information 
(RAPEX). Member States shall use RA PEX for exchanging information about 
products presenting a risk in accordance with this Regulation. 
2. Each Member State shall designate a single contact poi nt for RAPEX.  
3. The Commission may, by means of implemen ting acts, prescribe the modalities and 
procedures for the exchange of inform ation through RAPEX. Those implementing 
acts shall be adopted in accordance with the examination procedure referred to in Article 32(2). 
4. Participation in RAPEX shall be open to  applicant countries,  third countries or 
international organisations within the framework of and in accordance with 
agreements between the Union and those countries or organisations. Any such 
agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those a pplicable in the Union. 
Article 20 
Notification through RAPEX of products presenting a risk 
1. The RAPEX contact point shall immediat ely notify to the Commission information 
on any of the following: 
(a) any corrective action taken by economic operators pursuant to Article 9(3); 
(b) any measure taken by market surveillance authorities pursuant to Article 10(1) 
or (4), unless it concerns  a product subject to a notification pursuant to point 
(a);  
(c) any refusal to release a product for fr ee circulation pursuan t to Article 16. 
The first subparagraph shall not apply where the RAPEX c ontact point has reason to 
believe that the effects of the risk presented by a product do not go beyond the 
territory of its Member State.  
The RAPEX contact point sh all inform the Commission without delay of any 
relevant update, modification or withdrawal  of the corrective action or measures 
referred to in the first subparagraph. 
2. The information provided in accordance with  paragraph 1 shall include all available 
details relating to the risk and at least the following information: 
(a) the nature and level of the risk, includi ng a summary of the results of the risk 
assessment; 
(b) the nature of any non-compliance with  Union harmonisation legislation;  
EN 30   EN (c) the data necessary to identify the product; 
(d) the origin and the supply chain of the product;  
(e) the date on which the measure or correc tive action was taken and its duration; 
(f) the nature of the measure or correc tive action taken and whether voluntary, 
approved, required;  
(g) whether the economic operator has been  given the opportunity to be heard. 
The information referred to in the first subparagraph shall be transmitted using the 
standard notification form made availabl e by the Commission in the RAPEX system. 
3. Where a notification relates to a product found not to comply with Union 
harmonisation legislation, the information pr ovided shall also i ndicate whether the 
non-compliance is due to any of the following: 
(a) the failure of the product to satisfy the requirements of the applicable 
legislation; 
(b) shortcomings in the harmonised standards referred to in that legislation which 
confer a presumption of conformity with those requirements. 
Where a measure or corrective action referre d to in paragraph 1 relates to a product 
that has undergone conformity a ssessment by a notified body, the market 
surveillance authorities shall ensure that the relevant no tified body is informed of the 
corrective action or measures taken. 
4. On receiving a notification, the Commission shall communicate it to the other 
Member States. If the notification does not satisfy the requirements set out in 
paragraphs 1, 2 and 3, the Commission may suspend it. 
5. The Member States shall immediately inform the Commission of the action or 
measures taken following receipt of a notification and shall provide any 
supplementary information, including the resu lts of any tests or analyses carried out 
or possible differences in views. The Commission shall immediately transmit this 
information to other Member States. 
Article 21 
Information and communication sy stem for market surveillance 
1. The Commission shall maintain an in formation and communication system for 
market surveillance (ICSMS) for the collecti on and structured storage of information 
on issues relating to market surveillance, in particular the following information: 
(a) market surveillance authorities and their areas of competence; 
(b) market surveillance programmes; 
(c) the monitoring, review and assessment of market survei llance activities;  
EN 31   EN (d) complaints or reports about issues re lating to risks arising from products;  
(e) any non-compliance with Union harmonisati on legislation other than measures 
or corrective action notified under RAPE X in accordance with Article 20; 
(f) any objection raised by a Member Stat e in accordance with Articles 11(1) or 
18(1) and the follow-up. 
ICSMS shall contain a record of references  to the notifications of measures or 
corrective action made under RAPEX in accordance with Article 20.  
ICSMS may also be made available, wher e necessary or appropriate, for use by the 
authorities in charge of cont rols at the external borders. 
2. For the purposes of paragraph 1, Member  States shall enter into ICSMS any 
information at their disposal and not al ready notified under Article 20 about products 
presenting a risk regarding, in particular, the identification of risks, results of testing 
carried out, restrictive measures taken, contacts with the economic operators 
concerned and justificati on for action or inaction. 
3. Market surveillance author ities shall recognise  the validity and ma ke use of test 
reports prepared by or for their counterparts  in other Member States and entered into 
ICSMS. 
Article 22 
International exchange of confidential information 
The Commission and Member States may exch ange confidential information, including 
information exchanged through RAPEX, with re gulatory authorities of third countries or 
international organisations with which the Commission and the Member State or group of 
Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity. 
CHAPTER VI 
Cooperation  
Article 23 
Mutual assistance 
1. There shall be efficient cooperation and exchange of information among the market 
surveillance authorities of the Member Stat es, among the different authorities within 
each Member State and between market su rveillance authorities and the Commission 
and the relevant Union agencies regardi ng market surveillance programmes and all 
issues relating to produc ts presenting a risk.  
EN 32   EN 2. Market surveillance authorit ies shall, on receipt of a dul y motivated request from a 
market surveillance authority in anothe r Member State, provide any relevant 
information or documentation and carry out ch ecks, inspections or investigations and 
report on them and on any follow-up acti on taken to the requesting authority. 
The information, documentation and reporting referred to in the first subparagraph 
shall be used only in respect of the matter for which it was requested and shall be processed as quickly as possi ble, by electronic means.  
Article 24 
Cooperation with the competent authorities of third countries 
1. Market surveillance authorit ies may cooperate with the co mpetent authorities of third 
countries with a view to exchanging in formation and technical support, promoting 
and facilitating access to Union information exchange systems including the RAPEX system in accordance with Article 19(4) , and promoting activities relating to 
conformity assessment and market surveillance. 
2. Cooperation with the competent authorities of  third countries shall take the form of, 
inter alia, the types of activiti es referred to in Article 27. Member States shall ensure 
that their competent authorities participate in those activities. 
Article 25 
European Market Surveillance Forum 
1. A European Market Surveillance Forum (EMSF) is established.  
2. Each Member State shall be represented in meetings of the EMSF by a person or 
persons selected by the Member State having the particular knowledge and experience required in accordance with the subject matter of the meeting in question. 
3. The EMSF shall meet at regular intervals a nd, where necessary, at  the request of the 
Commission or a Member State. 
4. The EMSF shall use its best endeavours to reach consensus. If consensus cannot be 
reached, the EMSF shall adopt its position by a simple majority of its members. 
Members may request that their positions and the grounds on which they are based 
are officially recorded. 
5. The EMSF may invite experts and other thir d parties to attend meetings or provide 
written contributions. 
6. The EMSF may establish standing or tem porary sub-groups which shall include the 
administrative cooperation groups for market surveillance set up for the 
implementation of Union harmonisation legi slation. Organisations representing the 
interests of industry, small and medium-si zed enterprises, consumers, laboratories 
and conformity assessment bodies at Union level may be invited to participate in 
such sub-groups as observers.   
EN 33   EN 7. The EMSF shall establish its rules of procedure which shall enter into force after 
receiving a favourable opinion from the Commission. 
8. The EMSF shall cooperate with the Fo rum for Exchange of Information on 
Enforcement established by Regulation (EC) No 1907/2006.  
Article 26 
Commission support and executive secretariat 
1. The Commission shall support co operation between market surveillance authorities. 
It shall participate in  the meetings of the EMSF and its sub-groups. 
2. To perform the tasks set out in Article  27, the EMSF shall be assisted by an 
executive secretariat that provides technical and logistic support to the EMSF and its 
sub-groups.  
Article 27 
Tasks of the EMSF 
The EMSF shall have the following tasks: 
(a) to facilitate the exchange of informa tion on products presenting a risk, risk 
assessment, test methods and results, r ecent scientific developments and other 
aspects relevant to control activities; 
(b) to coordinate the preparation and imple mentation of the general and sector-
specific market surveillance program mes referred to in Article 7; 
(c) to organise joint market surveillance and joint testing projects; 
(d) to exchange expertise and best practices; 
(e) to organise training programmes a nd exchanges of national officials; 
(f) to assist in monitoring activitie s as described in Article 4(3); 
(g) to organise information campai gns and joint visit programmes; 
(h) to improve cooperation at Union level w ith regard to the tracing, withdrawal 
and recall of products presenting a risk;  
(i) to ensure the easy access, retrieval and sharing of product safety information 
collected by market surveillance au thorities, including information on 
complaints, accidents, injury reports and investigation and test results; 
(j) to contribute to the development of guidance to ensure the effective and 
uniform implementation of this Regulati on, taking due account of the interests 
of business, in particular small and medium-sized enterprises, and other 
stakeholders;  
EN 34   EN (k) to provide advice and assist the Commission, at its reques t, in its assessment of 
any issue relating to the impleme ntation of this Regulation; 
(l) to contribute to uniform administrative  practices with regard to market 
surveillance in the Member States. 
Article 28 
European Union reference laboratories 
1. For specific products or a category or group of products or for specific risks related 
to a category or group of products, the Commission may by means of implementing acts designate Union reference laboratorie s that satisfy the criteria set out in 
paragraph 2.  
2. Each Union reference laboratory sh all satisfy the following criteria: 
(a) have suitably qualified staff with adequa te training in the an alytical techniques 
used in their area of competence and an  adequate knowledge of standards and 
practices; 
(b) possess the equipment and reference mate rial needed to carry out the tasks 
assigned to them; 
(c) act in the public interest in an  impartial and independent manner; 
(d) ensure that the staff respect the confiden tial nature of certain subjects, results 
or communications. 
3. Within the area of their designation, Un ion reference laborat ories shall where 
appropriate have the following tasks: 
(a) carrying out product testing in relation to market surveillance activities and 
investigations; 
(b) contributing to the resolution of disput es between the authorities of Member 
States, economic operators and conformity assessment bodies; 
(c) providing independent tec hnical or scientific advice to the Commission and the 
Member States; 
(d) developing new techniques and methods of analysis; 
(e) disseminating information and providing training. 
CHAPTER VII 
Financing  
EN 35   EN Article 29 
Financing activities 
1. The Union may finance the following activitie s in relation to the application of this 
Regulation: 
(a) the drawing up and updating of contri butions to guidelines on market 
surveillance; 
(b) the making available to the Commission of technical or scientific expertise for 
the purpose of assisting the Commissi on in its implementation of market 
surveillance administrative cooperation and the Union assessment procedures 
referred to in Articles 11 and 18; 
(c) the performance of preliminary or an cillary work in connection with the 
implementation of market surveillance act ivities linked to the application of 
Union legislation such as studies, programmes, evaluations, guidelines, 
comparative analyses, mutual joint visi ts, research work, the development and 
maintenance of databases, training ac tivities, laboratory work, proficiency 
testing, inter-laboratory tests and conf ormity assessment work, and European 
market surveillance campaigns and similar activities; 
(d) activities carried  out under programmes of tec hnical assistance, cooperation 
with third countries and the promotion and enhancement of European market 
surveillance policies and systems among interested parties at European and international levels; 
(e) the functioning of cooperation among mark et surveillance au thorities and the 
technical and logistic support by the Execu tive Secretariat to the EMSF and its 
sub-groups. 
2. The Union's financial assistance to the activities under this Regulation shall be 
implemented in accordance with Regulation (EU, Euratom) No 966/2012, either 
directly, or indirectly by delegating budget implementation tasks to the entities listed 
in Article 58(1)(c) of Regulation (EU, Euratom) No 966/2012. 
3. The appropriations allocated to activities referred to in this Regulation shall be 
determined each year by the budgetary authority within the limits of the financial framework in force. 
4. The appropriations determined by the budgetary  authority for the financing of market 
surveillance activities may also cover expens es pertaining to preparatory, monitoring, 
control, audit and evaluation activities whic h are required for the management of the 
activities pursuant to this Regulation a nd the achievement of their objectives; in 
particular, studies, meetings of expert s, information and communication actions, 
including corporate communicati on of the political priorities  of the Union as far as 
they are related to the general objectives of  market surveillance activities, expenses 
linked to information technology networks focusing on information processing and exchange, together with all other techni cal and administrative assistance expenses 
incurred by the Commission for the management of the activities pursuant to this Regulation.  
EN 36   EN 5. The Commission shall evaluate the releva nce of the market su rveillance activities 
that receive Union financing in the light of the require ments of Union policies and 
legislation and inform the European Parl iament and the Council of the outcome of 
that evaluation by [ five years following the date of application ] and every five years 
thereafter. 
Article 30 
Protection of the Union's financial interests 
1. The Commission shall take appropriate measures ensuring that, when actions 
financed under this Regulation are implement ed, the financial interests of the Union 
are protected by the application of preventi ve measures against fraud, corruption and 
any other illegal activities, by effective check s and, if irregulariti es are detected, by 
the recovery of amounts wrongly paid and, where appropriate, by effective, 
proportionate and dissuasive penalties.  
2. The Commission or its representatives a nd the Court of Audito rs shall have the 
power of audit, on the basis of document s and on-the-spot checks, over all grant 
beneficiaries, contractors and subcontra ctors and other thir d parties who have 
received Union funds under this Regulation. 
3. The European Anti-fraud Office (OLAF)  may carry out on-the-spot checks and 
inspections on economic operators concerned directly or indirec tly by such funding 
in accordance with the procedures laid down in Council Regulation (Euratom, EC) 
No 2185/9641 with a view to establishing whethe r there has been fraud, corruption or 
any other illegal activity aff ecting the financial interests of the Union in connection 
with a grant agreement or grant decision or a contr act concerning Union funding. 
4. Without prejudice to paragraphs 1 and 2, c ooperation agreements wi th third countries 
and international organisations and gran t agreements and grant decisions and 
contracts resulting from the implementati on of this Regulation shall expressly 
empower the Commission, the Court of A uditors and OLAF to conduct audits, on-
the-spot checks and inspections. 
CHAPTER VIII 
Final provisions 
Article 31 
Penalties 
The Member States shall lay down the rules on pe nalties applicable to infringements of the 
provisions of this Regul ation that impose obliga tions on economic operators  and to 
infringements of provisions of any Union harm onisation legislation on  products covered by 
this Regulation that impose obligations on econo mic operators where that legislation does not 
                                                 
41 OJ L292, 14.11.1996, p.2.  
EN 37   EN provide for penalties, and shall take all m easures necessary to ensure that they are 
implemented. The penalties provided for must be effective, proportionate and dissuasive. 
Member States shall notify those provisions to the Commission by [ insert date - 3 months 
prior to the date of applic ation of this Regulation ] and shall notify it without delay of any 
subsequent amendment affecting them. 
The penalties referred to in the first subpara graph shall have regard to the size of the 
undertakings and in particular to the situati on of small and medium-sized enterprises. The 
penalties may be increased if the relevant  economic operator has previously committed a 
similar infringement and may include crim inal sanctions for serious infringements. 
Article 32 
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 para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
3. Where reference is made to this para graph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 5 thereof, shall apply. 
Article 33 
Evaluation 
No later than [five] years after the date of  application, the Commission shall assess the 
application of this Regulation and transmit an evaluation report to the European Parliament 
and the Council. That report shall assess if this Regulation achieved its objectives, in particular with regard to ensu ring more effective and efficient enforcement of product safety 
rules and Union harmonisation legislatio n, improving cooperation between market 
surveillance authorities , strengthening the controls of  products entering the Union  and better 
protecting the health and safety of persons in general, health and safety in the workplace, 
consumer protection, the environment, publ ic security and other public interests,  taking into 
account its impact on business and in particular on small and medium-sized enterprises.  
Article 34 
Amendments 
1. The following provisions are deleted: 
(a)  Article 18 of Dir ective 2011/65/EU;  
(b) Article 7 of Council Di rective 89/686/EEC;  
(c)  Paragraphs 2 and 3 of Article 7 a nd Article 8 of Di rective 93/15/EEC;
.  
EN 38   EN (d) Article 7 of Directive 94/9/EC;  
(e) Article 7, paragraph 4 of Article 10 a nd Article 11 of Directive 94/25/EC;  
(f) Articles 7 and 11 of Directive 95/16/EC; 
(g)  Articles 8, 16 and 18 of Directive 97/23/EC;  
(h)  Article 9 of Directive 1999/5/EC;  
(i) Articles 14, 15 and 19 of Directive 2000/9/EC;  
(j) Article 5 of Directive 2000/14/EC; 
(k) Paragraphs 2 and 3 of Article 6 a nd Articles 8, 9, 10, 11, 12 and 13 of, and 
Annex II to, Directive 2001/95/EC; 
(l)  Articles 10 and 11 of  Directive 2004/108/EC;  
(m) Paragraphs 3 and 4 of Article 4 and Articles 11, 17 and 20 of Directive 
2006/42/EC;  
(n)  Article 9 of Directive 2006/95/EC;  
(o)  Paragraphs 5 and 6 of Article 14 and Articles 15, 16 and 17 of Directive 
2007/23/EC;  
(p) Paragraph 5 of Article 13 and Article 14 of Directive 2008/57/EC;  
(q)  Articles 39, 40, 42 to 45 of Directive 2009/48/EC;  
(r) Articles 7, 15 and 17 of Directive 2009/105/EC;  
(s) Articles 7, 11 and 12 of Directive 2009/142/EC;  
(t) Articles 56 to 59 of Regulation (EU) No 305/2011.  
2. Point (a) of Article 3(2) of Regulation (EC) No 764/2008 is replaced by the 
following:  
'(a) Article 10 of Regulation (EU) No [… ] [on market surveill ance of products];' 
3. Regulation (EC) No 765/2008 is amended as follows: 
(a)  Paragraphs 2 and 3 of Article 1, po ints 14, 15, 17, 18 and 19 of Article 2, 
Chapter III and Article 32(1)(e) of Re gulation (EC) No 765/2008 are deleted; 
(b) The title of Regulation (EC) No 765/2008 is replaced by the following: 
'Regulation (EC) No 765/2008 of the Eur opean Parliament and of the Council 
of 9 July 2008 laying down the requireme nts for accreditation of conformity 
assessment bodies and general principl es of CE marking and repealing 
Regulation (EEC) No 339/93'  
EN 39   EN References to the provisions of Articles 15 to  29 of Regulation (EC) No 765/2008 shall be 
construed as references to this Regulation and shall be read in accordance with the correlation 
table in the Annex. 
Article 35 
Transitional provisions 
Procedures initiated at national or Union level pu rsuant to any of the pr ovisions referred to in 
Article 34 of this Regulation or to Articles 6 to  9 of Directive 2001/95/EC shall continue to be 
governed by those provisions. 
Article 36 
Entry into force 
This Regulation shall enter into force on [ insert date - the same day as Regulation (EU) No 
[…/…] [on Consumer Product Safety ] 
It shall apply from 1 January 2015. 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 40   EN ANNEX  
Correlation table 
Regulation EC No. 765/2008 This Regulation 
Article 15(1), (2) and (5) Article 2 
Article 15(3) - 
Article 15(4) Article 3(1) 
Article 16(1) Article 4(1) 
Article 16(2) Article 4(2) read in conjunction with Article 
3(12); Article 17(1) and Article 26 (5) 
Article 16(3) - 
Article 16(4) -  
Article 17(1) Article 5(4) 
Article 17(2) Article 26(1) 
Article 18(1) Article 5(3) 
Article 18(2) Article 6(6) 
Article 18(3) Article 5(2) 
Article 18(4) Article 6(4) 
Article 18(5) and (6) Article 4( 3), Article 6(7)(8) and (9) and 
Article 26(2) 
Article 19(1) first subparagraph Article 6(1) 
Article 19(1) second subparagra ph Article 6(5) and Article 7 
Article 19(1) third subparagraph Article 8(1) second subparagraph 
Article 19(2) Article 6(2) 
Article 19(3) Article 9(5)(a) 
Article 19(4) Article 6(3) 
Article 19(5) Article 26(5) and Article 27 
Article 20(1) Articles 9(4) and 18(1)(b)  
EN 41   EN Article 20(2)  Article 12 
Article 21 Article 6(4) and Article 9 
Article 22(1), (2) and (3) Article 18(1) and (2) 
Article 22(4) Article 17 
Article 23(1) and (2) Article 19 
Article 23(3) Article 27 
Article 24(1) and (2) Article 20 
Article 24(3) Article 19(1) 
Article 24(4) Article 18( 2) and Article 19(2) 
Article 25 Articles 22 to 24 
Article 26 Article 21 
Article 27 Article 13 
Article 28 Article 14 
Article 29 Article 15  
EN 42   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/initiative  1.6. Duration and financial impact  1.7. Management method(s) envisaged  
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 financ ial 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 opera tional 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 participation in financing  
3.3. Estimated impact on revenue  
EN 43   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 of the Council on market 
surveillance of products 
1.2. Policy area(s) concerned in the ABM/ABB structure42  
Title 2 – Enterprise - Chapter 02 03: Intern al market for goods and sectoral policies 
Title 17 – Health and consumer protection – Chapter 17 02: Consumer policy 
1.3. Nature of the proposal/initiative  
The proposal/initiative relates to the extension of an existing action   
1.4. Objectives 
1.4.1. The Commission's multiannual strategi c objective(s) targeted by the 
proposal/initiative  
Internal market for goods and sectoral pol icies: to improve the functioning of the 
single market and to achieve a high level of  protection of consumers, other users and 
other public interests; 
Security and citizenship – consumer policy.  
1.4.2. Specific objective(s) and ABM /ABB activity(ies) concerned  
ENTR specific objective: To continually review existing internal market acquis and 
propose new legislative or non-legisl ative action whenever appropriate. 
SANCO specific objective : To consolidate and enhance product safety through 
effective market surveill ance throughout the Union 
                                                 
42 ABM: Activity-Based Management – ABB: Activity-Based Budgeting.  
EN 44   EN 1.4.3. Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
The expected result of this initiative is to improve the framework of the market 
surveillance which is still fragmented in the Union. This proposal amalgamates the provisions of the Regulation 765/2008/EC  and of the General Product Safety 
Directive regarding the market surveillance into one single piece of legislation covering products in both the harmonise d and non-harmonised acquis, regardless 
whether they are destined for use, or are likely to be used, by consumers or 
professionals. 
 
This proposal will have an impact on ec onomic operators and national authorities 
who will be better informed on their ob ligations regarding market surveillance 
actions.   The proposal will also enhance the prot ection of consumers and other users of 
products through more effective enforcem ent of product-related requirements. 
1.4.4. Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative. 
- Number of notifications regardi ng unsafe products in the GRAS-RAPEX 
information system;  
- % of RAPEX notifications en tailing at least one reacti on (by other Member States 
- Ratio number of reactions / number of  notifications (serious risks)-  
- Volume and quality of data exchange d the general inform ation support system 
ICSMS, 
- Number and results of joint market surveillance actions,  
- Work- and resource-sharing. 
- Product safety enforcement indicators ( budgets, inspections, laboratory tests, 
measures taken etc.) 
1.5. Grounds for the proposal  
1.5.1. Requirement(s) to be met in the short or long term  
The general objective of this initiative is  to improve the functioning of the single 
market and to achieve a high level of prot ection of consumers, other users and other 
public interests through th e reduction of number of unsafe or non-compliant 
products.  
EN 45   EN 1.5.2. Added value of EU involvement 
Despite the existence of the single Eur opean market, the enforcement of product 
safety requirements is the Member States' competence. Due to the existing 
differences in the national organisation of market surveillance in the Member States 
and to the interdependence of  the national market surveillance authorities, problems 
still appears. The EU has the right to act  on the basis of Article 114 TFEU, in order 
to ensure the proper functioning of the si ngle market for consumer products and to 
increase the efficiency of cross-border ma rket surveillance. Ar ticle 169(1) of TFEU 
complements this right to act. It stipulates that in order to promote the interests of 
consumers and to ensure a high level of  consumer protection,  the Union shall, 
amongst others, contribute to protecting the health, safety and economic interests of 
consumers. However, in order to comply with the subsidiari ty principle, this proposal 
does not affect the competence of the Memb er States to carry out procedures and 
actions against concrete products posing risks.  
1.5.3. Lessons learned from sim ilar experiences in the past 
Although the EU has achieved the Single Market and the free movement of goods is 
the most developed and best established of  the four freedoms making up the internal 
market, there are still things to be done. Public health and safety in the workplace, 
protection of consumers, protection of th e environment and other public interests 
may be undermined due to some traders w ho do not comply with the law and place 
on the market dangerous products. Market surv eillance is meant to be an answer to 
all these issues. Nevertheless, market  surveillance has not kept pace with 
developments in the Union re gulatory framework. It need s to be highly coordinated 
and capable of reacting rapidl y throughout EU. It is true that progress has been made 
with the implementation of the General Product Safety Directive and with the 
Regulation 765/2008/EC, but the fragmentati on of market surveillance rules among 
different pieces of EU legislation (the General Product Safety Directive, the 
Regulation 765/2008/EC and many sectorial di rectives) has led to  confusion of both 
economic operators and national authorities a nd to a reduced effec tiveness of market 
surveillance activity in the Union. Therefore,  this proposal for a single, self-standing 
market surveillance regulation would be essential to tackle these problems. 
1.5.4. Coherence and possible synergy wi th other relevant instruments 
This initiative is entirely coherent with the acquis on the free movement of goods, in 
particular Directive 2009/48/EC  of the European Parliament  and of the Council of 18 
June 2009 on the safety of toys, Directiv e 2011/65/EU of the European Parliament 
and of the Council of 8 June 2011 on the rest riction of the use of certain hazardous 
substances in electrical and electronic equipment, Directive 2002/96/EC of the 
European Parliament and of the Council of  27 January 2003 on wa ste electrical and 
electronic equipment (WEEE), Directive 2012/19/EU of the European Parliament 
and of the Council of 4 July 2012 on wa ste electrical and electronic equipment 
(WEEE), Directive 2006/95/EC of the European  Parliament and of the Council of 12 
December 2006 on the harmonisation of the laws of Member States relating to 
electrical equipment designed for use w ithin certain voltage limits, Directive  
EN 46   EN 2009/142/EC of the European Parliament and of the Council of 30 November 2009 
relating to appliances burning gaseous fuels.43 
This proposal is also coherent with th e accompanying proposal for a Regulation on 
Consumer Product Safety which will replace Directive 2001/95/EC on General 
Product Safety. 
The proposal creates synergies with regard to the notification of  unsafe products and 
of safeguard measures under sectoral legislat ion which in the future will need to be 
notified only once under the revised RAPEX system. 
                                                 
43 The whole list of the sectoral legislation can be found in the annex of this regulation.  
EN 47   EN 1.6. Duration and financial impact  
Proposal/initiative of unlimited duration 
1.7. Management mode(s) envisaged  
X Centralised direct management  by the Commission  
X Centralised indirect management  with the delegation of implementation tasks 
to: 
• X executive agencies  
•  bodies set up by the Communities44  
•  national public-sector bodies/bodies with public-service mission  
 persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and identifi ed in the relevant basic act within the 
meaning of Article 49 of the Financial Regulation  
 Shared management with the Member States  
 Decentralised management  with third countries  
 Joint management  with international organisations (to be specified) 
If more than one management mode is indicated, pl ease provide details in the "Comments" section. 
Comment: 
This initiative does not require new budgetary  resources but will be financed through 
redeployment of existing resources. Some actions will be managed by the Executive 
Agency for Health and Consumers (EAHC):  In accordance with Council Regulation 
(EC) No 58/2003 of 19 December 2002 la ying down the statute for Executive 
Agencies to be entrusted with certain tasks in the management of Community 
programmes45, the Commission has entrusted46 the Executive Agency for Health and 
Consumers with implementation tasks for the management of the Programme of 
Community Action in the field of Cons umer policy for 2007- 2013. The Commission 
may therefore decide to entrust the Executiv e Agency for Health and Consumers also 
with implementation tasks for the mana gement of the Consumers Programme 2014-
2020, which, once adopted, should be the legal basis for procurement and grants in 
the field of product safety. The envisa ged programme delegation will be the 
extension of tasks already ex ternalised to the EAHC.  
Furthermore, this initiative  does not require additional budget resources for the costs 
related to the management, maintenance an d adaptations for both IT systems, i.e. 
                                                 
44 As referred to in Article 185 of the Financial Regulation. 
45 OJ L 11, 16.1.2003, p. 1. 
46 Commission Decision C(2008)4943 of 9 September 2008.  
EN 48   EN GRAS-RAPEX and ICSMS, compared to t hose already included in the operational 
budgets of DG SANCO and DG ENTR proposed for the MFF 2014-2020.   
EN 49   EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions. 
The future market Surveillance Forum (EMSF) will be the platform for discussions 
regarding the proper implementa tion of the future regulation. 
A final provision also proposes that the Commission makes an evaluation and drafts 
a report regarding the implemen tation five years after its entry into force. This should 
identify possible problems and shortcomi ngs of the Regulation and could be the 
starting point for further actions, including a possible proposal to amend it, in view 
of further improvement of ma rket surveillance framework. 
2.2. Management and control system  
2.2.1. Risk(s) identified  
Risks relating to the proper functioning of RAPEX (e.g. increase of number of 
notifications diverting atte ntion from really dangerous  products or reducing its 
credibility; IT-related probems such as breakdown of the system, confidentiality 
issues). 
The risks related to the func tioning of ICSMS relate mainly to IT-related probems 
such as a possible breakdown of the system and confidentiality issues. 
2.2.2. Control method(s) envisaged  
The control methods envisaged are laid dow n in the Financial Regulation and Rules 
of Application. 
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures. 
The Commission must ensure that the financ ial interests of the Union are protected 
by the application of preventive measures against fraud, corruption and other illegal 
activities, by effective checks and by the recovery of amounts unduly paid and, if 
irregularities are de tected, by effective, proportionate  and dissuasive penalties, in 
accordance with Regulations (EC, Eurato m) No 2988/95, (Euratom, EC) No 2185/96 
and (EC) No 1073/1999. In addition to the application of all regulatory control 
mechanisms, the competent Commission servic es will devise an anti-fraud strategy 
in line with the Commission's new anti-f raud strategy (CAFS; adopted on 24 June 
2011) in order to ensure inter alia  that its internal anti-fraud related controls are fully 
aligned with the CASF and th at its fraud risk management  approach is geared to 
identify fraud risk areas and adequate responses. Where necessary, networking 
groups and adequate IT tools dedicated to  analysing fraud cases related to the 
Consumer Programme will be set up. In particular a series of measures will be put in 
place such as:  
EN 50   EN • decisions, agreements and contracts resulting from the implementation of the 
Consumer Programme will expressly en title the Commission, including OLAF, 
and the Court of Auditors to c onduct audits, on-the-spot checks and 
inspections; 
• during the evaluation phase of a call for proposals/ tender, the proposers and 
tenderers are checked against the published exclusion criteria based on 
declarations and the Earl y Warning System (EWS); 
• the rules governing the eligibility of cost s will be simplified in accordance with 
the provisions of th e Financial Regulation. 
• regular training on issues rela ted to fraud and irregularit ies is given to all staff 
involved in contract management as we ll as to auditors and controllers who 
verify the beneficiaries' declarations on the spot.  
EN 51   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected  
Existing expenditure budget lines 
In order  of multiannual financial framewor k headings and budget lines. 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework Number  
[Description………………………...……….]  Diff./non-
diff. 
(47) from 
EFTA48 
countries from 
candidate 
countries49 from third 
countries within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  
N° 1: 
Internal 
Market for 
goods and 
sectoral 
policies 02.03.01. 
 Diff YES NO NO NO 
N° 3: 
Security and 
citizenship 17.01.04.01 
Administrative expenditure in support of the 
Consumer Programme 2014 - 2020  Non-
diff. YES NO NO NO 
New budget lines requested 
In order  of multiannual financial framework headings and budget lines. 
Budget line  Type of 
expenditureContribution  
Heading of 
multiannual 
financial 
framewor k Number  
[Heading……………………………………..]  Diff./non-
diff. from 
EFTA 
countries from 
candidate 
countries from third 
countries within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  
N° 3: 
Security and 
citizenship 17 02 01 
Consumer Programme 2014 - 2020  Diff. YES YES  NO  NO 
                                                 
47 Diff. = Differentiated appropriations / Non- diff. = Non-Differentiated Appropriations 
48 EFTA: European Free Trade Association.  
49 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 52   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure50  
EUR million in current prices (to 3 decimal places)  
Heading of multiannual financial 
framework:  1 Internal market for goods and sectoral policies 
 
DG: ENTR   2015 2016 2017 2018 2019 2020 TOTAL 
y Operational appropriations         
Commitments (1) 1,300 1,300 1,300 1,300 1,300 1,300 7,800 Number of budget line 02.03.01  Payments (2) 1,300 1,300 1,300 1,300 1,300 1,300 7,800 
Appropriations of an administrative nature financed 
 from the envelope for specific programmes51  0 0 0 0 0 0 0 
Commitments (1a) 0 0 0 0 0 0  0 Number of budget line:  Payments (2a) 0 0 0 0 0 0  0 
        
Commitments =1+1a 1,300 1,300 1,300 1,300 1,300  1,300  7,800 TOTAL appropriations 
for DG ENTR  Payments =2+2a 1,300 1,300 1,300 1,300 1,300  1,300  7,800 
 
Commitments (3) 1,300 1,300 1,300 1,300 1,300 1,300 7,800 y TOTAL operational appropriations  Payments (4) 1,300 1,300 1,300 1,300 1,300 1,300 7,800 
                                                 
50 Amounts subject to the outcome of the Commission proposal  for the new Multi-annual Fi nancial Framework 2014-2020. 
51 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, 
direct research.  
EN 53   EN y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (5) 0 0 0 0 0 0 0 
Commitments =3+ 5 1,300 1, 300 1,300 1,300 1,300 1,300 7,800 TOTAL appropriations  
under HEADING 02 
of the multiannual financial framework Payments =4+ 5 1,300 1,300 1,300 1,300 1,300 1,300 7,800 
 
Heading of multiannual financial 
framework:  3 Security and citizenship 
 
DG: SANCO   2015 2016 2017 2018 2019 2020 TOTAL 
y Operational appropriations         
Commitments (1) 3,000 3,060 3,121 3,184 3,247 3,312 18,924 
Number of budget line 17.02.01  
Payments (2) 1,500 3,030 3,091 3,152 3,215 4,936 18,924 
Appropriations of an administrative nature financed 
 from the envelope for specific programmes52              
Commitments (1a) 0,100 0,100 0,100 0,100 0,100 0,100 0,600 
Number of budget line: 17.01.04.01  
Payments (2a) 0,100 0,100 0,100 0,100 0,100 0,100 0,600 
          
Commitments =1+1a 3,100 3,160 3,221 3,284 3,347 3,412 19,524 TOTAL appropriations 
for DG SANCO  Payments =2+2a 1,600 3,130 3,191 3,252 3,315 5,036 19,524 
                                                 
52 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, 
direct research.  
EN 54   EN  
Commitments (3) 3,000 3,060 3,121 3,184 3,247 3,312 18,924 
y TOTAL operational appropriations  
Payments (4) 1,500 3,030 3,091 3,152 3,215 4,936 18,924 
yTOTAL appropriations of an administrative nature financed 
from the envelope fo r specific programmes  (5) 0,100 0,100 0,100 0,100 0,100 0,100 0,600 
Commitments =3+ 5 3,100 3,160 3,221 3,284 3,347 3,412 19,524 TOTAL appropriations  
under HEADING 3 
of the multiannual financial framework  Payments =4+ 5 1,600 3,130 3,191 3,252 3,315 5,036 19,524 
 
If more than one heading is affected by the proposal / initiative:  
Commitments (6) 4,300 4,360 4,421 4,484 4,547 4,612 26,724 
y TOTAL operational appropriations  
Payments (7) 2,800 4,330 4,391 4,452 4,515 6,236 26,724 
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (8) 0,100 0,100 0,100 0,100 0,100 0,100 0,600 
Commitments =6+ 8 4,400 4,460 4,521 4,584 4,647 4,712 27,324 TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount)  Payments =7+ 8 
2,900 4,430 4,491 4,552 4,615 6,336 27,324 
  
EN 55   EN  
Heading of multiannual financial 
framework:  5 " Administrative expenditure "  
EUR million in current prices (to 3 decimal places) 
   2015 2016 2017 2018 2019 2020 TOTAL 
DG: ENTR   
y Human resources  0,786 0,786  0,786  0,786  0,786  0,786  4,716 
y Other administrative expenditure  0,079 0,079 0,079 0,079 0,079 0,079  0,474 
DG SANCO        
y Human resources  1,048 1,048 1,048 1,048 1,048 1,048 6,288 
y Other administrative expenditure (missions, meetings)  0,079 0,079 0,079 0,079 0,079 0,079 0,474 
TOTAL  Appropriations  1,992  1,992  1,992  1,992  1,992  1,992  11,952 
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework   (Total commitments 
= Total payments) 1,992  1,992  1,992  1,992  1,992  1,992  11,952  
EUR million in current prices (to 3 decimal places) 
   2015 2016 2017 2018 2019 2020 TOTAL 
Commitments  6,392  6,452  6,513  6,576  6,639  6,704  39,276  TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework Payments  4,892  6,422  6,483  6,544  6,607  8,328  39,276   
EN 56   EN 3.2.2. Estimated impact on opera tional appropriations  
The proposal/initiative requires the use of opera tional appropriations, as explained below: 
Commitment appropriations in EUR million in current prices (to 3 decimal places) 
  2015 2016 2017 2018 2019 2020 TOTAL 
 Indicate objectives 
and outputs  
 
Ø  Type 
of 
output
53 Avera
ge 
cost  
of the 
output 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost Total 
number 
of 
outputs Total  
cost 
SPECIFIC OBJECTIVE54: To 
continually review existing internal market 
acquis and propose new legislative or non-
legislative action whenever appropriate                
Guidelines and 
inter-comparison 
activities  0.050 1 0.050 1 0.050 1 0.050 1 0.050 1 0.050 1 0,050 6 0.300 
Technical expertise 
and assistance  0.600 1 0.600 1 0.600 1 0.600 1 0.600 1 0.600 1 0,600 6 3.600 
 
Promotion of 
European market 
surveillance 
policies  0.050 1 0.050 1 0.050 1 0.050 1 0.050 1 0.050 1 0.050 6 0.300 
                                                 
53 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc .). 
54 As described in Section 1.4.2. "Specific objective(s)…"  
EN 57   EN Cooperation with 
third countries  0.100 1 0.100 1 0.100 1 0.100 1 0.100 1 0.100 1 0.100 6 0.600 
Support to market 
surveillance 
authorities 
(including ICSMS)  0.500 2 0.500 2 0.500 2 0.500 2 0.500 2 0.500 2 0.500 12 3.000 
Sub-total for specific objective ENTR 6 1.300 6 1.300 6 1.300 6 1. 300 6 1.300 6 1.300 36 7.800 
SPECIFIC OBJECTIVE: 
SANCO               
- Output                 
Market surveillance 
and enforcement 
actions (joint 
actions, exchange 
of officials, funding 
of the Market 
Surveillance Forum 
Secretariat)  2,357 3 2,242 3 2,287 3 2,333 3 2,380 3 2,427 3 2,425 18 14,144 
Further 
development and 
management of 
RAPEX (especially 
IT applications)  0,797 1 0,758 1 0,773 1 0,788 1 0,804 1 0,820 1 0,837 6 4,780  
EN 58   EN         
Sub-total for specific objective 
SANCO  43,000 4 3,060 4 3,121 4 3,184 4 3,247 4 3,312 24 18,924 
TOTAL COST   4,300  4,360  4,421  4,484  4,547  4,612  26,724  
EN 59   EN 3.2.3. Estimated impact on appropriations  of an administrative nature 
3.2.3.1. Summary  
The proposal/initiative requires the use of administrative appropriations, as 
explained below: 
EUR million in current prices (to 3 decimal places) 
 2015 2016 2017 2018 2019 2020 TOTAL 
 
HEADING 5 
of the multiannual financial 
framework       
 
Human resources ENTR  0,786 0,786 0,786 0,786 0,786 0,786 4.716 
Human resources SANCO 
(Average cost FTE: 131.000 €) 1,048 1,048 1,048 1,048 1,048 1,048 6,288 
Other administrative 
expenditure ENTR 0,079 0,079 0,079 0,079 0,079 0,079 0,474 
Other administrative 
expenditure SANCO 0,079 0,079 0,079 0,079 0,079 0,079 0,474 
Subtotal HEADING 5 
of the multiannual financial 
framework  1,992 1,992 1,992 1,992 1,992 1,992 11,952 
 
Outside HEADING 555 
of the multiannual financial 
framework         
Human resources  0 0 0 0 0 0  
Other expenditure  
of an administrative nature 
SANCO 0,100 0,100 0,100 0,100 0,100 0,100 0,600 
Subtotal  
outside HEADING 5 
of the multiannual financial 
framework  0,100 0,100 0,100 0,100 0,100 0,100 0,600 
 
TOTAL  2,092 2,092 2,092 2,092 2,092 2,092 12,552 
                                                 
55 Technical and/or administrative assistance and expenditure in support of the implementation of EU 
programmes and/or actions (former "BA" li nes), indirect research, direct research.  
EN 60   EN 3.2.3.2. Estimated requirements of human resources  
The proposal/initiative requires the use of human resources, as explained below: 
EUR million in current prices (to 3 decimal places) 
 2015 2016 2017 2018 2019 2020 
02 01 01 01 (Headquarters and Commission’s 
Representation Offices) – ENTR   0,786 0,786 0,786 0,786 0,786 0,786 
17 01 01 01 (Headquarters and Commission’s 
Representation Offices) – SANCO  (Average 
cost FTE: 131.000 €)  1,048 1,048 1,048 1,048 1,048 1,048 
XX 01 01 02 (Delegations) 0 0 0 0 0 0 
XX 01 05 01 (Indirect research) 0 0 0 0 0 0 
10 01 05 01 (Direct research) 0 0 0 0 0 0 
XX 01 02 01 (CA, INT, SNE from the "global 
envelope")  0 0 0 0 0 0 
XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 0 0 0 0 0 0 
- at Headquarters57 0 0 0 0 0 0 
XX 01 04 yy 56 
- in delegations  0 0 0 0 0 0 
XX 01 05 02 (CA, INT, SNE - Indirect 
research) 0 0 0 0 0 0 
10 01 05 02 (CA, INT, SNE - Direct research) 0 0 0 0 0 0 
Other budget lines (specify) 0 0 0 0 0 0 
TOTAL (ENTR, SANCO) 1,834 1,834 1,834 1,834 1,834 1,834 
XX is the policy area or budget title concerned. 
The human resources required will be me t 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 wh ich may be granted to the 
managing DG under the annual allocation pr ocedure and in the light of budgetary 
constraints. The resources required are indicated without taking into account the 
tasks which will be implemented by an executive agency. The proposal does not lead to an increase of the resources alre ady involved in the executive agency. 
Description of tasks to be carried out:  
Officials and temporary agents 
 Administrators: 
• Ensure, monitor and report on the proper implementation and 
application of EU policies in th e area of market surveillance. 
• Participate in developing tools and carrying out benchmarking of 
Member States' enforcement of th e Market surveillance Regulation. 
• Participate in the operation of the RAPEX system, including 
                                                 
56 Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
57 Essentially for Structural Funds , European Agricultural Fund for Rural Development (EAFRD) and 
European Fisheries Fund (EFF).  
EN 61   EN assessment of notifications and reactions; 
• Management and development of the ICSMS platform and the 
corresponding guidelines; 
• Follow policy developments in the area of market surveillance and 
information exchange between Member States. 
• Participate and represent the Commission in expert groups linked to 
market surveillance. 
• Conceive new activities or extensions of existing activities and 
perform conceptual reflections.  
• Develop and ensure Member States ' market surveillance coordination 
and joint actions. 
• Participate in the development, a doption and then implementation of 
revised RAPEX guidelines and revised risk-assessment guidelines. 
Assistants: 
• Provide administrative assistance in relation to the operation of the 
RAPEX system as a member of the internal RAPEX team. 
• Signal possible inconsistencies or  overlaps in notifications and 
contribute to and provide assistance in RAPEX Contact Points 
meetings. 
• Contribute to follow up of RAPEX notifications, under the supervision 
of the responsible Administrator, in case of a formal noncompliance of 
notification. 
• Contribute towards the preparation of the weekly report regarding 
validated notifications. 
• Co-ordinate and authorize translation requests through Poetry. 
• Contribute to the implementation and the carrying out of the internal 
control standards in particular by  ensuring business continuity in 
RAPEX alerting team coordinator and management in cases of issues 
arising requiring their attention 
• Coordinate information and docum ent management in relation to 
validation of notifications  and reactions in RAPEX. 
• Elaborate and manage statistics and reports related to RAPEX. 
• Elaborate internal procedures rela ting to GRAS RAPEX management 
and contribute to corresponding manuals. 
 
External personnel   
EN 62   EN 3.2.4. Compatibility with the current multiannual financial framework  
The proposal is compatible with the new Multi-annual Financial Framework 2014-
2020 as proposed by the Commission. 
3.2.5. Third-party contributions  
The proposal does not provide for co-financing by third parties  
3.3. Estimated impact on revenue  
The Proposal has no financial impact on revenue.