# EUR-Lex - 52013PC0075 - EN

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# 52013PC0075

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council /* COM/2013/075 final - 2013/0048 (COD) */**

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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 four 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, supplemented by the mutual recognition principle, are sufficient
for the rest. But even a good legislative framework is only as effective as
those using it allow it to be. Alongside responsible 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 single
market against the type of trader we wish to encourage, damaging its
effectiveness and causing detriment to consumers and business, they also
threaten the public interests that our legislation 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
the coin, market surveillance is the other. It should enable unsafe or
otherwise harmful products to be identified and kept or taken off the market
and unscrupulous or even criminal 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 freely throughout 27 (and in some sectors up to 32)[2] national territories, market
surveillance 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 Directive" 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
market surveillance[4].
However, overlap of market surveillance rules and obligations of economic
operators laid down in various pieces of Union legislation (the GPSD, the
Regulation (EC) 765/2008 and sector-specific Union harmonisation legislation)
has led to confusion on the part of both economic operators and national
authorities and has seriously hampered the effectiveness of market surveillance
activity in the Union.

This proposal aims at clarifying the regulatory
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 legal
instrument that applies horizontally across all sectors.

Market surveillance action by national
authorities has important implications for small and medium-sized enterprises.
Consequently, their situation 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 Surveillance 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
boosting growth and creating jobs, the Commission added this proposal for a
single market surveillance regulation to the other two initiatives in response
to calls from the European Parliament and from stakeholders in industry and
public administrations. The Single Market Act II[6],
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 better coherence and enforcement of product
safety and 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 details
see the Proposal for a Consumer Product Safety Regulation). One of the main
substantive areas related to the improvement of market surveillance cooperation
and coordination, including the functioning of RAPEX.

One of the outcomes of the public consultation
process and the dialogue with interested parties was to transfer the market
surveillance rules from the current GPSD into a new standalone Market
Surveillance Regulation to be developed and adopted hand in hand with the
proposal 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 Board
delivered a favourable opinion in September 2012.

3.           LEGAL ELEMENTS OF THE PROPOSAL

Main elements

The overarching objective of this new
regulation is to simplify the Union market surveillance framework fundamentally
so that it works better for its main users: market surveillance authorities and
economic operators. At present, different product evaluation requirements and
procedures apply depending on the category of product involved. Market
surveillance authorities should be able to do their job of evaluating the risk
presented by products without being hindered by unnecessary complexities and to
share the results of their work efficiently.

The new Regulation will get rid of overlaps,
close gaps, reduce 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 application of market surveillance rules across the
Member States, providing better protection for consumers and other users, more
uniform trading conditions for economic operators, reduced administrative
burdens and enhanced 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 rather
cosmetic objective but the current set of market surveillance rules is spread
across the GPSD, Regulation 765/2008 and a range of sector-specific legislation
(which is increasingly based on the reference provisions of Decision 768/2008).
This ‘3-tier’ system causes problems for market surveillance authorities and economic
operators alike and was expressly targeted for criticism by the European
Parliament. The new Regulation would produce a one tier system in which all of
those rules are brought together in a single instrument. It may be complemented
by sector-specific rules laid down in the relevant Union harmonisation
legislation.

·
Eliminating overlaps in the current system

Regulation 765/2008 and sector-specific
legislation apply to all harmonised products regardless whether they are
intended (or likely) to be used by consumers or professionals. The GPSD applies
to all consumer products regardless whether they are non-harmonised or
harmonised. This obviously creates overlaps 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 would
dispense with the distinction between consumer and professional products for
market surveillance purposes. It would also avoid making a distinction between
harmonised products and non-harmonised products except where this is
unavoidable in applying certain specific provisions. To the greatest extent
possible the applicable rules are the same for all products.

·
Dovetailing the RAPEX and Union evaluation
procedures

At present, two separate procedures operate,
sometimes in parallel, which require the Member States to notify to the Commission
and the other Member States certain market surveillance action taken at
national level. This is an especially problematic aspect of the overlapping categories
of products mentioned above. Under the new Regulation the two procedures become
a single procedural flow with certain events triggering a single notification
to the other Member States and the Commission (made using either the proven RAPEX
rapid alert system or the Information and Communication System for Market
Surveillance in accordance with the distinction made in this Regulation).

In the case of products which are subject to sector-specific
Union harmonisation legislation, in the event of disagreement among Member
States about action taken by one of their number, the proposal would empower
the Commission to decide whether the measures taken by the original notifying
Member State are reasonable, necessary and proportionate and should be followed
by all 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 products not subject to sector-specific Union harmonisation
legislation as such a decision 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
empowered to adopt temporary or permanent measures requiring consistent action
across the EU against products presenting a serious risk where the risk cannot
be satisfactorily addressed by one or several individual Member States.

·
Making the legislation more accessible and
user-friendly

Apart from being spread across three tiers of
EU legislation (and in the case of directives, also in national implementing
measures), current market surveillance provisions are not based around a chronological
flow of events - from the identification by market surveillance authorities 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, evaluation and decision by the Commission at Union level. Instead, market
surveillance authorities and economic operators must hunt around in the
legislation for the provisions that affect them directly.

The new Regulation sets out the whole process
of a market surveillance exercise in a chronological, sequential manner. It
presents a chain of events, incorporating relevant provisions on natural
justice aspects, publication of information, notification etc. at each stage of
the procedure. This approach substantially improves the accessibility and
user-friendliness of the legislation, 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 surveillance is ‘softer’ in some parts
of the Union than others, weak spots are created which threaten the public
interest and create 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 entering 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 legislation
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
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. The modifications introduced by the Regulation
do not impose unnecessary burdens or costs on industry, having particular
regard to small 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 already envisaged
in existing or proposed programmes and respect the Commission proposal for the
new multiannual financial framework. This initiative will be financed through
redeployment of existing resources. The details are set out in the financial
statement attached to this proposal.

2013/0048 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on market surveillance of products and
amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC,
94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC,
2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC,
2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation
(EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and
of the Council

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Articles 33, 114 and 207
thereof,

Having regard to the proposal from the
European Commission,

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

Having regard to the opinion of the
European Economic and Social Committee[7],

After consulting the European Data
Protection Supervisor,

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       In order to guarantee the
free movement of products within the Union, it is necessary to ensure that 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 the environment and public security.
Robust enforcement of these requirements is essential to the proper protection
of these interests and to create the conditions in which fair competition in
the Union goods market can thrive. Rules are therefore necessary on market
surveillance and on controls of products entering the Union from third
countries.

(2)       Market surveillance
activities covered by this Regulation should not be directed exclusively
towards the protection of health and safety but should also be applicable to 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 framework of rules and principles in relation to market
surveillance which should not affect the substantive rules of existing Union legislation
designed to protect public interests such as health and safety, consumer
protection and the protection of the environment, but should 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 accreditation and market surveillance relating to the
marketing of products[8]
was adopted to establish a framework for market surveillance to complement and
strengthen existing provisions in Union harmonisation legislation relating to
market surveillance and the enforcement of such provisions.

(5)       For the purpose of
ensuring the equivalent 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 framework for administrative
cooperation including the exchange of information among Member States.

(6)       Directive 2001/95/EC of
the European Parliament and of the Council of 3 December 2001 on general
product safety[9]
established rules to ensure the safety of products intended for or likely to be
used by consumers. Regulation (EC) No 765/2008 maintained the possibility for
market surveillance authorities to take the more specific measures available to
them under that Directive.

(7)       In its Resolution of 8
March 2011 on the revision of the General Product Safety Directive and market
surveillance[10]
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 the 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 integrate the provisions of Regulation 765/2008, Directive 2001/95/EC
and several sector-specific acts of Union harmonisation legislation relating to
market surveillance into a single regulation which covers products in both the
harmonised and non-harmonised 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 rules[11], establishes a comprehensive
framework for the performance of official controls and other official
activities to verify compliance with feed and food law, rules on animal health
and welfare, genetically modified organisms, plant health and plant
reproductive material, plant protection products, and pesticides. These areas
should therefore be excluded from the scope of this Regulation.

(10)     Union legislation
concerning medicinal products, medical devices, in vitro diagnostic medical
devices and substances of human origin contain special provisions to ensure
post-market safety based in particular on sector-specific vigilance and market
surveillance systems. Those products should therefore 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 the
European Parliament and of the Council of 16 June 2010 on transportable
pressure equipment[12]
applies not only to new transportable pressure equipment for the purpose of
making it available on the market but also to certain other transportable
pressure equipment for the purposes of its periodic inspections, intermediate
inspections, exceptional checks and use. It provides for the specific
Pi-marking and for a Union safeguard procedure and particular procedures for
dealing with transportable pressure equipment presenting a risk at national
level, with compliant transportable pressure equipment which 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 comprehensive 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 organise and carry out market surveillance,
require Member States to appoint market surveillance authorities 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 contains provisions on market surveillance and safeguard clauses. These
may be based on the reference provisions on market surveillance and safeguard
clauses contained 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 applicable to the products
falling within its scope. This Regulation should therefore include the reference
provisions on market surveillance and safeguard clauses contained in Decision
No 768/2008/EC. Provisions in existing Union harmonisation legislation that
relate to market surveillance and safeguard clauses, whether drafted before the
adoption of Decision No 768/2008/EC or based on its reference provisions,
should be removed from that harmonisation legislation unless there are specific
sectoral reasons for retaining them. Exemptions from the safeguard provisions should
be made in relation to products subject to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council of 18 December 2006 concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
certain fittings subject to Directive 2009/142/EC of the European Parliament
and of the Council of 30 November 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 subject 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 surveillance process transparent and easy to follow for both market
surveillance authorities and economic operators, the Regulation should clearly set
out the chronological steps of that process, from the moment when market
surveillance authorities identify a product which they believe may present a
risk, to the assessment of the risk presented, 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 account. A product that is subject to Union harmonisation
legislation which lays down essential requirements relating to protection of
certain public interests 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 legislation 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 and 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 interests protected by [Regulation
(EU) No xxxx (on consumer product safety)], sector-specific Union harmonisation
legislation and other Union legislation on products that are subject to this
Regulation. It should include, where available, data on risks that have
materialised previously with respect to the product in question. Account should
also be taken of any measures that may have been taken by the economic
operators concerned to alleviate the risks. The particular potential
vulnerability of consumers, as opposed to professional users, should be taken
into account as should the increased vulnerability of certain categories of
consumer such as children, the elderly or the disabled.

(19)     Both new and second hand
products originating outside the Union may be placed on the market only after
they have been released for free circulation. Effective controls are required
at the external borders of the Union to suspend 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 the effectiveness of such checks, cooperation
and exchange of information between those authorities and market surveillance
authorities concerning products presenting a risk should be enhanced.

(21)     Market surveillance
authorities should be given the power to destroy products, render inoperable or
order their destruction 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
circulation of products that are imported in the physical possession of persons
entering the Union for their personal, non-commercial
use should not be suspended or refused under this Regulation by the authorities
responsible for the control of products entering the Union market.

(23)     There should be effective,
speedy and accurate exchange of information among the Member States and between
the Member States and the Commission. It is therefore necessary to provide for
effective tools for such exchange. The Union rapid information system (RAPEX) has
proved its effectiveness and efficiency. RAPEX enables measures to be taken across
the Union 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 alert notifications required by this Regulation relating to products presenting a risk.

(24)     Coherent and cost-effective
market surveillance activity throughout the Union also requires well-structured,
comprehensive archiving and sharing among Member States of all pertinent
information on national activities 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 Market 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 authorities of the Member States are willing and able
to cooperate with each other effectively and to coordinate joint support and
action. Accordingly, mechanisms for mutual assistance should be established.

(26)     In order to facilitate
market surveillance of products entering the Union market from third countries,
this Regulation should provide a basis for cooperation between market
surveillance authorities of Member States and the authorities of those
countries.

(27)     A European Market
Surveillance Forum composed of representatives from market surveillance
authorities should be established. The Forum should provide a means of
involving all stakeholders concerned, including
professional organisations and consumer organisations, in order to take
advantage of available information relevant for market surveillance when
establishing, implementing and updating market surveillance programmes.

(28)     The Commission should
provide 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 secretariat should organise the Forum's
meetings and provide other operational support for the accomplishment of its
tasks.

(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 information 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
documents[14].
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 data[15]
and Regulation (EC) No 45/2001 of the European Parliament and of the Council of
18 December 2000 on the protection of individuals with regard to the processing
of personal data by the Community institutions and bodies and on the free
movement of such data[16]
apply in the context of this Regulation.

(31)     Information exchanged
between competent authorities 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 competent courts and tribunals in respect of restrictive
measures taken by their authorities.

(33)     Member States should lay
down rules on penalties applicable to infringements of this Regulation and
ensure that they are implemented. Those penalties must be effective,
proportionate and dissuasive.

(34)     Market surveillance should
be financed at least in part by fees charged to economic operators where they are
required by market surveillance authorities 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 implement policies in the field of market surveillance
such as the drawing-up and updating of guidelines, preliminary or ancillary
activities in connection with the implementation of Union legislation and
programmes of technical assistance and cooperation with third countries as well
as the enhancement of policies at Union and international level.

(36)     Union financing should be
made available in accordance with Regulation (EU, Euratom) No 966/2012 of the
European Parliament and of the Council of 25 October 2012 on the financial
rules applicable to the general budget of the Union[17], depending on the nature of
the activity to be financed, in particular for support to the executive secretariat
of the EMSF.

(37)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission as regards national measures taken and
notified by a Member State in relation to products subject to Union
harmonisation legislation and the establishment of Union reference
laboratories.

(38)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission as regards uniform conditions for the
carrying out of checks by reference 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 should
also be conferred as regards the modalities for the provision of
information to market surveillance authorities by economic operators, as
regards establishing 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, where 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
specific procedure to address the risks in question. 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
concerning mechanisms for control by the Member States of the Commission's
exercise of its implementing powers[18].

(39)     The Commission should adopt
immediately applicable implementing acts where, in duly justified cases
relating to restrictive measures relating 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 the Member States relating to personal protective
equipment[19],
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
uses[20],
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 intended 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 craft[22],
European Parliament and Council Directive 95/16/EC of 29 June 1995 on the
approximation of the laws of the Member States relating to lifts[23], Directive 97/23/EC of the
European Parliament and of the Council of 29 May 1997 on the approximation of
the laws of the Member States concerning pressure equipment[24], 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
conformity[25],
Directive 2000/9/EC of the European Parliament and of the Council of 20 March
2000 relating to cableway installations designed to carry persons[26], Directive 2000/14/EC of the
European Parliament and of the Council of 8 May 2000 on the approximation of
the laws of the Member States relating to the noise emission in the environment
by equipment for use outdoors[27],
Directive 2001/95/EC, Directive 2004/108/EC of the European Parliament and 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 machinery[29], 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
within certain voltage limits[30],
Directive 2007/23/EC of the European Parliament and of the Council of 23 May
2007 on the placing on the market of pyrotechnic articles[31], Directive 2008/57/EC of the
European Parliament and of the Council of 17 June 2008 on the interoperability
of the rail system within the Community[32],
Directive 2009/48/EC of the European Parliament and of the Council of 18 June
2009 on the safety of toys[33],
Directive 2009/105/EC of the European Parliament and of the Council of 16
September 2009 relating to simple pressure vessels[34], Directive 2009/142/EC of the
European Parliament and of the Council of 30 November 2009 relating to
appliances burning gaseous fuels[35],
Directive 2011/65/EU of the European Parliament and of the Council of 8 June
2011 on the restriction of the use of certain hazardous substances in
electrical and electronic equipment[36],
Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9
March 2011 laying down harmonised conditions for the marketing of construction
products[37],
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 European Parliament and of the Council of 9 July 2008 laying down
procedures relating to the application of certain national technical rules to
products lawfully marketed in another Member State and repealing Decision No
3052/95/EC should be amended accordingly[38].

(41)     Since the objective of this
Regulation, namely 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 other public interests while guaranteeing the functioning
of the internal market by providing a framework for coherent market
surveillance in the Union, cannot be sufficiently achieved by the Member States
as the attainment of this objective requires a very high degree of cooperation,
interaction and uniformity of operation among all of the competent authorities
of all Member States, and can therefore, by reason of its scale and effects, be
better achieved at Union level, the Union may
adopt measures, in accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty on European Union. In accordance with the principle of
proportionality, as set out in that Article, this Regulation does not go beyond
what is necessary in order to achieve that objective.

(42)     This Regulation respects
the fundamental rights and observes the principles recognised in particular by
the Charter of Fundamental 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
verifying that products meet requirements which safeguard, at a high level, the
health and safety of persons 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 products assembled or manufactured for the manufacturer's own use,
and to the extent that Union harmonisation legislation does not contain a
specific provision with the same objective.

2.           Chapters I and IV and
Article 23 shall apply to all products covered by Union legislation to the
extent that other Union legislation does not contain specific provisions
relating to the organisation 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 human or veterinary use;

(b)
medical devices and in vitro diagnostic medical
devices;

(c)
blood, tissues, cells, organs and other
substances of human origin.

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 shall not apply to the following products:

(a)
products subject to Regulation (EC) No 1907/2006;

(b)
fittings as defined in Article 1(2)(b) of
Directive 2009/142/EC;

(c)
pressure equipment subject to the provisions 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
apply in the areas governed by Union legislation on official controls and other
official activities carried 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, including rules aimed
at guaranteeing 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 production, 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 minimising risks
to human and animal health arising from animal by-products 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 and labelling
of organic products;

(l)
rules on the use and labelling of protected
designations of origin, protected geographical indications and traditional
specialities guaranteed.

Article 3

Definitions

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

(1)
‘product’ means a product obtained 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 making
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 manufactured and markets
that product under his name or trademark;

(5)
‘authorised representative’ means any natural or
legal person established within the Union who has received a written mandate
from a manufacturer to act on his behalf in relation to specified tasks;

(6)
‘importer’ means any natural or legal person
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 makes a product
available on the market;

(8)
‘economic operators’ means the manufacturer, the
authorised representative, the importer and the distributor;

(9)
‘conformity assessment’ means conformity
assessment 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 endanger health, safety or any other aspect of public interest protection
and, in the case of products falling within the scope of Union harmonisation
legislation, 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, health and safety in the workplace, consumer protection, the environment
and public security as well as other public interests to a degree which goes
beyond that considered reasonable and acceptable under the normal or reasonably
foreseeable conditions of use of the product concerned, including the duration
of use and, where applicable, its putting into service, installation and
maintenance requirements;

(14)
‘product presenting a serious risk’ means a product
presenting a risk requiring rapid intervention and follow-up, including cases
where the effects may not be immediate;

(15)
‘recall’ means any measure aimed at achieving
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
procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92[39];

(18)
‘Union harmonisation legislation’ means Union
legislation harmonising the conditions for the marketing of products;

(19)
‘European standard’ means a European standard as
defined in Article 2(1)(b) of Regulation (EU) No 1025/2012 of the European
Parliament and the Council[40];

(20)
‘harmonised standard’ means a harmonised
standard 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 surveillance 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 such 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.

4.           The results of the
monitoring and assessment of market surveillance activities carried out
pursuant to paragraph 3 shall be made available to the public, electronically
and, where appropriate, by other means.

Article 5

Market surveillance authorities

1.           Each Member State shall
establish or designate market surveillance authorities and define their duties,
powers and organisation.

2.           Market surveillance
authorities shall be given the powers and entrusted with the resources and
means necessary for the proper performance of their tasks.

3.           Each Member State shall
establish appropriate mechanisms to ensure that the market surveillance
authorities that it has established or designated exchange information,
cooperate and coordinate their activities both among themselves and with the
authorities in charge of controls 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 authorities and how those authorities may be contacted.

Article 6

General obligations of market surveillance
authorities

1.           Market surveillance
authorities shall 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 market 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 category 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 emerging 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 samples to be checked. These implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 32(2).

2.           Where appropriate, market
surveillance authorities shall alert users in their territories within an
adequate timeframe of products that those authorities have identified as
presenting a risk.

They shall cooperate with economic operators 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 adherence
to codes of good practice.

3.           Market surveillance
authorities shall carry out their duties independently, impartially and without
bias and shall fulfil their obligations under this Regulation; they shall
exercise their powers in relation to economic operators in accordance with the
principle of proportionality.

4.           Where it is necessary and
justified for carrying out their duties, market surveillance authorities may
enter the premises of economic operators and take any necessary samples of
products.

5.           Market surveillance
authorities shall:

(a)
provide consumers and other interested parties
with the opportunity to submit complaints on issues relating to product safety,
market surveillance activities and risks arising in connection with products
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 established and made known to the public to enable market surveillance
authorities to fulfil these obligations.

7.           Without prejudice to
national legislation 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 authorities and between them and the Commission on
condition of confidentiality shall remain confidential unless the originating
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 general market surveillance programme and shall review that
programme, and update it if necessary, at least every four years. The programme
shall cover market surveillance organisation and related activities and take
into account the specific needs of business 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 competence of the
authorities designated under Article 5(1);

(b)
the financial resources, staff, technical and
other means attributed to the authorities;

(c)
an indication of the priority areas of work of
the 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 authorities in sectoral
or project-oriented cooperation at Union level;

(g)
the means to fulfil the requirements of Article
6(5).

2.           Each Member State shall
draw up sector-specific 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 programmes and their updates shall be communicated to the other
Member States 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, where applicable, conformity assessment bodies, shall make
available to market surveillance authorities any documentation and information
that those authorities require for the purpose of carrying out their
activities, in a language which can be easily understood by them.

2.           Economic operators shall
provide all necessary information to market surveillance authorities including information
that enables the precise identification of the product and facilitates the
tracing of the product.

CHAPTER III

Control of
products within the Union

Article 9

Products presenting a risk

1.           Where, in the course of
carrying out the checks referred to in Article 6(1) or as a result of
information received, market surveillance authorities have sufficient reason to
believe that a product that is placed or made 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 taking 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 carried 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 shall give market surveillance authorities sufficient reason
to believe that the product may present a risk in any of the following cases:

(a)
the CE marking or other markings required by
Union harmonisation legislation have not been affixed or have been affixed
incorrectly;

(b)
the EU declaration of conformity, where
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
that the product in fact presents a risk, market surveillance authorities shall
require the economic operator 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 surveillance authorities find that a product does
present a risk they shall without delay specify the necessary corrective action
to be taken by the relevant economic operator to address the risk within a
specified period. Market surveillance authorities may recommend or agree with
the relevant economic operator the corrective action to be taken.

The economic operator shall ensure that all
necessary corrective 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
necessary information to market surveillance authorities pursuant to Article 8,
and in particular the following information:

(a)
a full description of the risk presented by the
product;

(b)
a description of any corrective action
undertaken to address the risk.

Where possible, market surveillance authorities
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 economic 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 the 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,
clearly worded, easily comprehensible warnings of the risks it may present, in
the official language or languages of the Member State in which the product is
made available on the market ;

(ii)      making the marketing of the product
subject to prior conditions;

(iii)     alerting the persons at risk to the risk,
in good time and in an appropriate form, including by publication of special
warnings;

(c)
in the case of a product that may present 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 otherwise
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 proper 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 economic operator cannot be ascertained by the market surveillance
authorities or where an economic operator has not taken the necessary
corrective action pursuant to Article 9(3) within the period specified, market
surveillance authorities shall take all necessary measures 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 authorities may destroy or
otherwise render inoperable a product presenting a risk where they deem it
necessary 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 paragraph 1 in relation to an economic operator who has failed to
take the necessary corrective action, market surveillance authorities shall
allow him at least 10 days within which to be heard.

4.           Where market surveillance
authorities consider that a product presents a serious risk, they shall take
all necessary measures and may do so without first requiring the economic
operator to take corrective 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 the economic
operator together with information about the remedies available 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 first
subparagraph, where the economic operator to whom the measure has been
communicated is not the economic operator concerned, the manufacturer located
within the Union or the importer shall be informed of the measure, provided
market surveillance authorities know his identity.

6.           Market surveillance
authorities shall publish information about product identification, the nature
of a risk and the 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 Union. 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 investigation activities.

7.           Any measure taken in
accordance with paragraphs 1 or 4 shall be subject to legal remedies, including
recourse to the competent national courts.

8.           Market surveillance
authorities may charge fees on economic operators 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 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 the 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 for objecting, indicate any difference in its
assessment of the risk presented by the product and mention any special
circumstances and any additional information relating to the product in
question.

2.           If no objection is raised
by a Member State pursuant to paragraph 1 and the Commission does not consider
that the national measures are contrary to Union legislation, the measures
taken by the original notifying Member State shall be deemed justified and each
Member State shall 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 delay enter into consultation with the relevant economic operator(s)
and shall evaluate the national measures, taking account of all available
scientific or technical evidence.

4.           On the basis of the
results of the evaluation conducted pursuant to paragraph 3, the Commission may
decide by implementing acts 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 national measures are justified, each Member State shall take the
necessary restrictive measures without delay. If it decides that the national
measure is not justified, the original 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 information exchange system pursuant to
Article 20.

6.           Where a national measure
is considered justified and the product is found not to be in compliance with
Union harmonisation legislation because of shortcomings in the relevant
harmonised standards, 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.

Article 12

Union action against products
presenting a serious risk

1.           Where it is evident that a
product, or a specific category or group 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 appropriate measures depending on the gravity of
the situation, including measures prohibiting, suspending or restricting 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 shall be adopted in accordance with the examination procedure
referred to in Article 32(2).

On duly justified imperative grounds of urgency
relating to the health and safety of persons in general, health and safety in
the workplace, consumer protection, the environment and public security and
other public interests, the Commission shall adopt immediately applicable
implementing acts in accordance with the procedure referred to in Article
32(3).

2.           For products and risks
subject to Regulation (EC) No 1907/2006, a decision taken by the Commission
pursuant to paragraph 1 of this 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 procedures provided in that Regulation.

3.           The exportation from the
Union of a product that has been prohibited to be placed or made available on
the Union market pursuant to a measure adopted in accordance with paragraph 1
shall be prohibited, unless the measure expressly so permits.

4.           Any Member State may submit
a substantiated 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 available 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, market surveillance authorities shall take into account the extent
to which the product complies with the following:

(a)
any requirements laid down in or pursuant to
Union harmonisation legislation that apply to the product and relate to the
potential risk under consideration, taking full account of test reports or
certificates attesting conformity and issued by a conformity assessment body;

(b)
in the absence of requirements laid down in or
pursuant to Union harmonisation legislation, specific rules laying down health
and safety requirements for such products in the national 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 adequately 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 compliance, the product presents a
risk.

4.           The feasibility of
obtaining higher levels of protection of the public interest concerned and the
availability of other products 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 Union shall have the powers and resources necessary for the proper
performance of their tasks. They shall carry out appropriate documentary and,
where necessary, physical and laboratory checks on products before those
products are released for free circulation.

2.           Where more than one
authority is responsible for market surveillance or external border controls in
a Member State, those authorities shall cooperate with each other, by sharing
information relevant to their functions.

3.           Subject to Article 17, the
authorities in charge of external border controls shall suspend release of a
product for free circulation 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 comply with
Union harmonisation legislation when it is released for free circulation,
formal non-compliance with that legislation shall give the authorities of
Member States sufficient reason to believe that the product may present a risk
in any of the following cases:

(a)
is not accompanied by the documentation required
by the legislation;

(b)
is not marked or labelled in accordance with
that legislation;

(c)
bears a CE marking or other marking 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 authorities 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 products or the parking of vehicles used for transport are
not incompatible with the preservation of those products.

6.           Where, in relation to
products that are 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 all 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 suspended by the authorities in charge of external border
controls pursuant to Article 14 shall be released if, within three working days
of the suspension of release, those authorities have not been requested by the
market surveillance authorities to continue the suspension or they have been
informed by the market surveillance authorities that the product does not
present a risk, and provided that all the other requirements and formalities
pertaining to such release have been fulfilled.

2.           If the market surveillance
authorities conclude that a product the release of which was suspended due to
formal non-compliance in accordance with the second sub-paragraph of paragraph
3 of Article 14 does not in fact present a risk, the economic operator shall
nevertheless rectify the formal non-compliance 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 reports 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 does 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 where there is
evidence that, despite such compliance, the product does in fact present a
risk.

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 circulation and to include the following
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 declared for a customs procedure other than release for free
circulation and provided that 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 documents 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 necessary and proportionate. The cost of such action
shall be borne by the person declaring the product for free circulation.

4.           Market surveillance
authorities shall provide the authorities in charge of external border controls
with information on product categories in which a risk has been identified
pursuant to paragraph 1.

5.           Any measure taken in
accordance with paragraphs 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 endanger 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.

Article 18

Union
assessment for products entering the Union and subject to harmonisation
legislation

1.           Within 60 days of
communication by the 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 Member State may object to that refusal where it
relates to a product subject to Union harmonisation legislation. The Member
State shall state its reasons for objecting, indicate any difference in its
assessment of the risk presented by the product and mention any special
circumstances and any additional information relating to the product in
question.

2.           If no objection is raised
by a Member State 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 State shall be deemed justified and each Member State
shall ensure that restrictive measures are taken without delay in respect of
the product concerned.

3.           Where an objection is
raised by a Member 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 available scientific or technical
evidence.

4.           On the basis of the
results of the evaluation 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 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 refusal is justified, each Member State shall take the necessary
restrictive measures without delay. If it decides that the refusal is not
justified, the original notifying Member State and any other Member State that
has taken a similar measure shall withdraw it and the notification made under
RAPEX pursuant to Article 20.

6.           Where a refusal is
considered justified and the product is found not to be in compliance with
Union harmonisation legislation because of shortcomings in the relevant
harmonised standards, 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

Article 19

Union Rapid Information Exchange
System - RAPEX

1.           The Commission shall
maintain the system for rapid exchange of information (RAPEX). Member States
shall use RAPEX for exchanging information about products presenting a risk in
accordance with this Regulation.

2.           Each Member State shall
designate a single contact point for RAPEX.

3.           The Commission may, by
means of implementing acts, prescribe the modalities and procedures for the
exchange of information 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 applicable in the Union.

Article 20

Notification through RAPEX of
products presenting a risk

1.           The RAPEX contact point
shall immediately 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 free
circulation pursuant to Article 16.

The first subparagraph shall not apply where the
RAPEX contact 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 shall 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, including a
summary of the results of the risk assessment;

(b)
the nature of any non-compliance with Union
harmonisation legislation;

(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 corrective
action was taken and its duration;

(f)
the nature of the measure or corrective 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
available 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 provided shall also indicate 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 referred
to in paragraph 1 relates to a product that has undergone conformity assessment
by a notified body, the market surveillance authorities shall ensure that the
relevant notified 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 results 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
system for market surveillance

1.           The Commission shall
maintain an information and communication system for market surveillance (ICSMS)
for the collection 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
surveillance activities;

(d)
complaints or reports about issues relating to
risks arising from products;

(e)
any non-compliance with Union harmonisation
legislation other than measures or corrective action notified under RAPEX in
accordance with Article 20;

(f)
any objection raised by a Member State 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, where
necessary or appropriate, for use by the authorities in charge of controls at
the external borders.

2.           For the purposes of
paragraph 1, Member States shall enter into ICSMS any information at their
disposal and not already 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 justification for action or inaction.

3.           Market surveillance
authorities shall recognise the validity and make 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
exchange confidential information, including information exchanged through RAPEX,
with regulatory 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 States, among the different authorities within each
Member State and between market surveillance authorities and the Commission and
the relevant Union agencies regarding market surveillance programmes and all
issues relating to products presenting a risk.

2.           Market surveillance
authorities shall, on receipt of a duly motivated request from a market
surveillance authority in another Member State, provide any relevant
information or documentation and carry out checks, inspections or
investigations and report on them and on any follow-up action 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
possible, by electronic means.

Article 24

Cooperation with the competent
authorities of third countries

1.           Market surveillance
authorities may cooperate with the competent authorities of third countries
with a view to exchanging information 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 activities 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 and, 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 third parties to attend meetings or provide written
contributions.

6.           The EMSF may establish
standing or temporary sub-groups which shall include the administrative
cooperation groups for market surveillance set up for the implementation of
Union harmonisation legislation. Organisations representing the interests of
industry, small and medium-sized enterprises, consumers, laboratories and
conformity assessment bodies at Union level may be invited to participate in
such sub-groups as observers.

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 Forum 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 cooperation 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 information on
products presenting a risk, risk assessment, test methods and results, recent
scientific developments and other aspects relevant to control activities;

(b)
to coordinate the preparation and implementation
of the general and sector-specific market surveillance programmes 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 and exchanges of
national officials;

(f)
to assist in monitoring activities as described
in Article 4(3);

(g)
to organise information campaigns and joint
visit programmes;

(h)
to improve cooperation at Union level with
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 authorities,
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 Regulation, taking due
account of the interests of business, in particular small and medium-sized
enterprises, and other stakeholders;

(k)
to provide advice and assist the Commission, at
its request, in its assessment of any issue relating to the implementation 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 laboratories that satisfy the criteria set out in paragraph 2.

2.           Each Union reference
laboratory shall satisfy the following criteria:

(a)
have suitably qualified staff with adequate
training in the analytical techniques used in their area of competence and an
adequate knowledge of standards and practices;

(b)
possess the equipment and reference material
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 confidential
nature of certain subjects, results or communications.

3.           Within the area of their
designation, Union reference laboratories 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 disputes
between the authorities of Member States, economic operators and conformity
assessment bodies;

(c)
providing independent technical 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

Article 29

Financing activities

1.           The Union may finance the
following activities in relation to the application of this Regulation:

(a)
the drawing up and updating of contributions to
guidelines on market surveillance;

(b)
the making available to the Commission of
technical or scientific expertise for the purpose of assisting the Commission
in its implementation of market surveillance administrative cooperation and the
Union assessment procedures referred to in Articles 11 and 18;

(c)
the performance of preliminary or ancillary work
in connection with the implementation of market surveillance activities linked
to the application of Union legislation such as studies, programmes,
evaluations, guidelines, comparative analyses, mutual joint visits, research
work, the development and maintenance of databases, training activities,
laboratory work, proficiency testing, inter-laboratory tests and conformity
assessment work, and European market surveillance campaigns and similar
activities;

(d)
activities carried out under programmes of
technical 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 market
surveillance authorities and the technical and logistic support by the
Executive 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 expenses pertaining to preparatory, monitoring,
control, audit and evaluation activities which are required for the management
of the activities pursuant to this Regulation and the achievement of their
objectives; in particular, studies, meetings of experts, information and
communication actions, including corporate communication 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 technical and administrative assistance expenses incurred by the
Commission for the management of the activities pursuant to this Regulation.

5.           The Commission shall
evaluate the relevance of the market surveillance activities that receive Union
financing in the light of the requirements of Union policies and legislation
and inform the European Parliament 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 implemented, the financial interests of the Union are protected by the
application of preventive measures against fraud, corruption and any other
illegal activities, by effective checks and, if irregularities are detected, by
the recovery of amounts wrongly paid and, where appropriate, by effective,
proportionate and dissuasive penalties.

2.           The Commission or its
representatives and the Court of Auditors shall have the power of audit, on the
basis of documents and on-the-spot checks, over all grant beneficiaries,
contractors and subcontractors and other third 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 indirectly by such funding in accordance with
the procedures laid down in Council Regulation (Euratom, EC) No 2185/96[41] with a view to establishing
whether there has been fraud, corruption or any other illegal activity
affecting the financial interests of the Union in connection with a grant
agreement or grant decision or a contract concerning Union funding.

4.           Without prejudice to
paragraphs 1 and 2, cooperation agreements with third countries and
international organisations and grant agreements and grant decisions and
contracts resulting from the implementation of this Regulation shall expressly
empower the Commission, the Court of Auditors 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
penalties applicable to infringements of the provisions of this Regulation that
impose obligations on economic operators and to infringements
of provisions of any Union harmonisation legislation on products covered by
this Regulation that impose obligations on economic operators where that
legislation does not provide for penalties, and shall take all measures
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
application of this Regulation] and shall notify it without delay of any
subsequent amendment affecting them.

The penalties referred to in the first
subparagraph shall have regard to the size of the
undertakings and in particular to the situation 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 criminal 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 paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3.           Where reference is made to
this paragraph, 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 ensuring more
effective and efficient enforcement of product safety rules and Union
harmonisation legislation, 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, public 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 Directive 2011/65/EU;

(b)
Article 7 of Council Directive 89/686/EEC;

(c)
 Paragraphs 2 and 3 of Article 7 and Article 8
of Directive 93/15/EEC;.

(d)
Article 7 of Directive 94/9/EC;

(e)
Article 7, paragraph 4 of Article 10 and 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 and 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 surveillance of products];'

3.           Regulation (EC) No
765/2008 is amended as follows:

(a)
 Paragraphs 2 and 3 of Article 1, points 14, 15,
17, 18 and 19 of Article 2, Chapter III and Article 32(1)(e) of Regulation (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 European
Parliament and of the Council of 9 July 2008 laying down the requirements for
accreditation of conformity assessment bodies and general principles of CE
marking and repealing Regulation (EEC) No 339/93'

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 pursuant to any of the provisions 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

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 subparagraph || 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)

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

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 financial framework and expenditure budget line(s) affected

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

3.2.2.     Estimated impact on
operational appropriations

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.4.     Compatibility with the
current multiannual financial framework

3.2.5.     Third-party participation
in financing

3.3.        Estimated impact on
revenue

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 structure[42]

Title 2 – Enterprise - Chapter 02 03: Internal
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 strategic objective(s) targeted by the proposal/initiative

Internal market for goods and sectoral
policies: 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-legislative action whenever appropriate.

SANCO specific objective: To consolidate and enhance product safety through effective market
surveillance throughout the Union

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 harmonised 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 economic operators and national authorities who will be better informed on their obligations regarding market surveillance actions. The proposal will also enhance the protection of consumers and other users of products through more effective enforcement 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 regarding unsafe products in the
GRAS-RAPEX information system;

- % of RAPEX notifications entailing at least one reaction (by other
Member States

- Ratio number of reactions / number of notifications (serious
risks)-

- Volume and quality of data exchanged the general information
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 protection of
consumers, other users and other public interests through the reduction of
number of unsafe or non-compliant products.

1.5.2.     Added value of EU
involvement

Despite the existence of the single European 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 single
market for consumer products and to increase the efficiency of cross-border market
surveillance. Article 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 subsidiarity principle, this proposal does not
affect the competence of the Member States to carry out procedures and actions
against concrete products posing risks.

1.5.3.     Lessons learned from
similar 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 the environment
and other public interests may be undermined due to some traders who do not
comply with the law and place on the market dangerous products. Market surveillance
is meant to be an answer to all these issues. Nevertheless, market surveillance
has not kept pace with developments in the Union regulatory framework. It needs
to be highly coordinated and capable of reacting rapidly 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 fragmentation of
market surveillance rules among different pieces of EU legislation (the General
Product Safety Directive, the Regulation 765/2008/EC and many sectorial
directives) has led to confusion of both economic operators and national
authorities and to a reduced effectiveness 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 with 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, Directive 2011/65/EU of the European Parliament and of the Council of
8 June 2011 on the restriction 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 waste electrical and electronic equipment (WEEE),
Directive 2012/19/EU of the
European Parliament and of the Council of 4 July 2012 on waste 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 within certain
voltage limits, Directive 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 the 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 legislation which in
the future will need to be notified only once under the revised RAPEX system.

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 Communities[44]

·
 ̈         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 identified 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, please 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 laying down the
statute for Executive Agencies to be entrusted with certain tasks in the
management of Community programmes[45],
the Commission has entrusted[46]
the Executive Agency for Health and Consumers with implementation tasks for the
management of the Programme of Community Action in the field of Consumer policy
for 2007-2013. The Commission may therefore decide to entrust the Executive
Agency for Health and Consumers also with implementation tasks for the
management 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
envisaged programme delegation will be the extension of tasks already
externalised to the EAHC.

Furthermore, this initiative does not require additional budget
resources for the costs related to the management, maintenance and adaptations
for both IT systems, i.e. GRAS-RAPEX and ICSMS, compared to those already
included in the operational budgets of DG SANCO and DG ENTR proposed for the
MFF 2014-2020.

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 implementation of the future regulation.

A final provision also proposes that the Commission makes an
evaluation and drafts a report regarding the implementation five years after
its entry into force. This should identify possible problems and shortcomings
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
market 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 attention from really dangerous products or
reducing its credibility; IT-related probems such as breakdown of the system,
confidentiality issues).

The risks related to the functioning 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 down 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 financial 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 detected, by effective,
proportionate and dissuasive penalties, in accordance with Regulations (EC,
Euratom) 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 services will devise an anti-fraud strategy in line with the
Commission's new anti-fraud 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 that 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:

·
decisions, agreements and contracts resulting
from the implementation of the Consumer Programme will expressly entitle the
Commission, including OLAF, and the Court of Auditors to conduct 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 Early Warning System (EWS);

·
the rules governing the eligibility of costs
will be simplified in accordance with the provisions of the Financial
Regulation.

·
regular training on issues related to fraud and
irregularities is given to all staff involved in contract management as well as
to auditors and controllers who verify the beneficiaries' declarations on the
spot.

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

Existing expenditure budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff. ([47]) || from EFTA[48] countries || from candidate countries[49] || 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.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

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

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure[50]

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

Ÿ Operational appropriations || || || || || || ||

Number of budget line 02.03.01 || Commitments || (1) || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

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 programmes[51] || 0 || 0 || 0 || 0 || 0 || 0 || 0

Number of budget line: || Commitments || (1a) || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || (2a) || 0 || 0 || 0 || 0 || 0 || 0 || 0

|| || || || || || ||

TOTAL appropriations for DG ENTR || Commitments || =1+1a || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

Payments || =2+2a || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

Ÿ TOTAL operational appropriations || Commitments || (3) || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

Payments || (4) || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (5) || 0 || 0 || 0 || 0 || 0 || 0 || 0

TOTAL appropriations under HEADING 02 of the multiannual financial framework || Commitments || =3+ 5 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 1,300 || 7,800

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

Ÿ Operational appropriations || || || || || || ||

Number of budget line 17.02.01 || Commitments || (1) || 3,000 || 3,060 || 3,121 || 3,184 || 3,247 || 3,312 || 18,924

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 programmes[52] || || || || || || ||

Number of budget line: 17.01.04.01 || Commitments || (1a) || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,600

Payments || (2a) || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,600

|| || || || || || || || ||

TOTAL appropriations for DG SANCO || Commitments || =1+1a || 3,100 || 3,160 || 3,221 || 3,284 || 3,347 || 3,412 || 19,524

Payments || =2+2a || 1,600 || 3,130 || 3,191 || 3,252 || 3,315 || 5,036 || 19,524

Ÿ TOTAL operational appropriations || Commitments || (3) || 3,000 || 3,060 || 3,121 || 3,184 || 3,247 || 3,312 || 18,924

Payments || (4) || 1,500 || 3,030 || 3,091 || 3,152 || 3,215 || 4,936 || 18,924

ŸTOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (5) || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,100 || 0,600

TOTAL appropriations under HEADING 3 of the multiannual financial framework || Commitments || =3+ 5 || 3,100 || 3,160 || 3,221 || 3,284 || 3,347 || 3,412 || 19,524

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:

Ÿ TOTAL operational appropriations || Commitments || (6) || 4,300 || 4,360 || 4,421 || 4,484 || 4,547 || 4,612 || 26,724

Payments || (7) || 2,800 || 4,330 || 4,391 || 4,452 || 4,515 || 6,236 || 26,724

Ÿ 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

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =6+ 8 || 4,400 || 4,460 || 4,521 || 4,584 || 4,647 || 4,712 || 27,324

Payments || =7+ 8 || 2,900 || 4,430 || 4,491 || 4,552 || 4,615 || 6,336 || 27,324

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 || || ||

Ÿ Human resources || 0,786 || 0,786 || 0,786 || 0,786 || 0,786 || 0,786 || 4,716

Ÿ Other administrative expenditure || 0,079 || 0,079 || 0,079 || 0,079 || 0,079 || 0,079 || 0,474

DG SANCO || || || || || || ||

Ÿ Human resources || 1,048 || 1,048 || 1,048 || 1,048 || 1,048 || 1,048 || 6,288

Ÿ 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

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 6,392 || 6,452 || 6,513 || 6,576 || 6,639 || 6,704 || 39,276

Payments || 4,892 || 6,422 || 6,483 || 6,544 || 6,607 || 8,328 || 39,276

3.2.2.     Estimated impact on
operational appropriations

The proposal/initiative requires the use of
operational appropriations, as explained below:

Commitment appropriations in EUR million in current
prices (to 3 decimal places)

Indicate objectives and outputs ò || || || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

||

Type of output[53] || Average 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 OBJECTIVE[54]: 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

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

|| || || || || || || || || || || || || || || ||

Sub-total for specific objective SANCO || 4 || 3,000 || 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

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 5[55] 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

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

XX 01 04 yy [56] || - at Headquarters[57] || 0 || 0 || 0 || 0 || 0 || 0

- 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 met by
staff from the DG who are already assigned to management of the action and/or
have been redeployed within the DG, together if necessary with any additional
allocation which may be granted to the managing DG under the annual allocation
procedure 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
already 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 the area of market surveillance. Participate in developing tools and carrying out benchmarking of Member States' enforcement of the Market surveillance Regulation. Participate in the operation of the RAPEX system, including 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, adoption 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 document management in relation to validation of notifications and reactions in RAPEX. Elaborate and manage statistics and reports related to RAPEX. Elaborate internal procedures relating to GRAS RAPEX management and contribute to corresponding manuals.

External personnel ||

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.

[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 international 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.

[5]               COM(2011)206 final.

[6]               COM(2012)573 final.

[7]               OJ C , , p. .

[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.

[12]             OJ L165, 30.6.2010, p.1.

[13]             OJ L 218, 13.8.2008, p.82.

[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.

[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.

[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.

[39]             OJ L 302, 19.10.1992, p. 1

[40]             OJ L 316, 14.11.2012, p. 12.

[41]             OJ L292, 14.11.1996, p.2.

[42]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[43]             The whole list of the sectoral legislation can be found
in the annex of this regulation.

[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.

[47]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations

[48]             EFTA: European Free Trade Association.

[49]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[50]             Amounts subject to the outcome of the Commission
proposal for the new Multi-annual Financial Framework 2014-2020.

[51]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[52]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[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)..."

[55]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[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).