# EUR-Lex - 52013PC0078 - EN

*|*

# 52013PC0078

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC /* COM/2013/078 final - 2013/0049 (COD) */**

			*

			*

EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

The free movement of safe consumer products is
one of the cornerstones of the European Union. It is an important pillar of the
single market and gives consumers confidence when purchasing products.

This proposal for a Regulation on consumer
product safety, which will replace Directive 2001/95/EC of the European
Parliament and of the Council on general product safety[1] (the "General Product
Safety Directive" or simply GPSD), concerns manufactured non-food consumer
products. Like the GPSD also the proposed Regulation requires that consumer
products must be "safe", sets certain obligations on economic
operators and contains provisions for the development of standards in support
of the general safety requirement.

However, the operation of the proposed
Regulation and its interface with other Union legislation will be significantly
streamlined and simplified whilst maintaining a high level of protection of the
health and safety of consumers.

Overlaps of market surveillance rules and
obligations of economic operators laid down in various pieces of Union
legislation (the GPSD, the Regulation (EC) No 765/2008 setting out the
requirements for accreditation and market surveillance relating to the
marketing of products[2]
and sector-specific Union harmonisation legislation that also covers consumer
products) 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 consumer products taking into account legislative developments in
recent years such as the New Legislative Framework on the Marketing of Products
adopted in 2008[3],
the alignment of sector-specific Union harmonisation legislation to that new
framework[4]
and the entry into application on 1 January 2013 of a new Regulation on
European standardisation[5].

The proposal is part of the "Product
Safety and Market Surveillance Package" which also includes a proposal for
a single market surveillance regulation and a multi-annual action plan for
market surveillance covering the period 2013-2015. The Single Market Act (2011)[6] identified the revision of the
GPSD and the drawing up of a market surveillance plan as initiatives that will
contribute to boosting growth and creating jobs. The Single Market Act II[7], 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 concerning the scope
of the impact assessment. Following the definition of the scope of the impact
assessment, the Commission proceeded to the second round of public consultation
which concentrated on four main substantive areas for improvement in the EU
product safety regime: (i) procedures for mandating standards under the GPSD
for non-harmonised products, (ii) harmonisation of safety evaluations, (iii)
market surveillance cooperation and coordination, including the functioning of
the EU Rapid Information System (RAPEX) and on-line distribution channels, and
(iv) alignment with the Free Movement of Goods Package.

The second round of public consultation on
problems identified and the solutions proposed by the Commission took place
between May and December 2010. Between 18 May and 20 August 2010, the
Commission held an internet public consultation focussing on those four areas.
The Commission sought feedback through four consultation papers and nine online questionnaires targeting various groups of
stakeholders. 55 national authorities responded, from all EU Member States
except one and from Norway, Iceland and Switzerland.
Various other stakeholders, including more than thirty business associations,
seventeen consumer organisations, and over fifty individual economic operators
(including several SMEs) contributed to the consultation. In total, 305 replies
were received to the nine online questionnaires. In addition, thirteen business
and consumer organisations provided separate position papers. A number of
presentations and direct exchanges with stakeholders (with both business and
consumer organisations) were also held during the consultation period.

The second round of public consultation ended
with an international stakeholder conference on the "Revision of the
General Product Safety Directive" on 1 December 2010 during which the
Commission received feedback from the stakeholders on key conclusions of the
public internet consultation.

The third round of public consultation took
place between January and March 2011. It took the form of targeted stakeholder
meetings with the participation of experts in the relevant areas. These
meetings covered structural topics, including the organisation of market
surveillance coordination, the impact of the new definitions of obligations of
economic operators (in particular traceability obligations), procedures for
establishing mandates leading to the establishment of European standards under
the GPSD and ways to establish a clear and understandable structure for
non-food product safety rules.

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 stand-alone Market
Surveillance Regulation to be developed and adopted hand in hand with the
present proposal for the revision of the GPSD.

The impact assessment prepared by the
Commission thus covers aspects related to both this proposal and the proposal
for a new Market Surveillance Regulation. The Commission's Impact Assessment
Board delivered a favourable opinion in September 2012.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

·
Scope and definitions

The proposed Regulation clearly delimits its
scope of application compared to sectoral Union harmonisation legislation.
Whilst the general principle that all non-food consumer products must be safe
applies across the board, the more detailed obligations on economic operators
only apply to those operators that are not subject to corresponding obligations
laid down in harmonising legislation covering a specific product sector. The
Commission envisages drawing up guidance which will help businesses, in
particular small and medium-size enterprises, to identify which legislation
applies to the consumer products they manufacture or distribute.

The definitions section has been updated and,
where applicable aligned with the New Legislative Framework for the Marketing
of Products[8].

·
General safety requirement and obligations of
economic operators

The requirement that all consumer products must
be safe when placed or made available on the Union market is a fundamental
pillar of EU legislation in the field of product safety. This general product
safety requirement, laid down already in the GPSD, has been kept. However, its
operation in practice will be significantly simplified due to the introduction
of a clear link with sector-specific legislation and a simplification of the
rules on standards.

Consumer products that comply with
sector-specific Union harmonisation legislation that aims at ensuring the
health and safety of persons shall be presumed to be safe also under this
proposed Regulation. If they do not comply with the applicable harmonisation
legislation, they would not benefit from the safety presumption but correction
of such situation would be governed by the sector-specific legislation in
conjunction with the future single market surveillance regulation.

Moreover, the proposal lays down the elementary
obligations of economic operators (manufacturers, importers, distributors)
involved in the supply chain of consumer products insofar as they are not
subject to corresponding requirements under sector-specific Union harmonisation
legislation. The obligations are based on the reference provisions set out 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[9]
and address, among others, issues related to labelling, product identification,
corrective actions to be taken in case of unsafe products and information of
the competent authorities. Proportionate to the potential risks of their
products, manufacturers will be obliged to establish a technical documentation
regarding their products which shall contain the necessary information to prove
that their product is safe.

Equally based on Decision No 768/2008/EC, the
proposal requires economic operators to be able to identify the operators who
supplied them with the product and to whom they supplied it. Where justified
due to the risks inherent to specific types of products, the Commission should
be empowered to adopt measures requiring economic operators to establish or
adhere to an electronic traceability system.

·
Use of European standards

Like the GPSD, also the proposal for the new
Regulation favours the use of standards in support of the implementation of the
general safety requirement. However, the process to identify existing European
standards or to ask for the development of European standards that would give
rise to presume that a product is safe has been significantly simplified and
aligned to Regulation (EU) No 1025/2012 that sets a new overarching framework
for European standardisation[10].
This underlines the importance the Commission gives to an approach of
co-regulation and will enhance the use of European standards in support of the
proposed Regulation.

·
Transfer of rules on market surveillance and
RAPEX to a new Market Surveillance Regulation

In line with the objective to strengthen and
streamline market surveillance for all products, whether harmonised or not and
whether intended for consumers or for professionals, the provisions regarding
market surveillance and RAPEX that are currently contained in the GPSD have
been transferred to the proposal for a new single
Market Surveillance Regulation. That new Regulation
would produce a one-tier system in which all market surveillance rules are
brought together in a single instrument and in which RAPEX will be the single
alert system regarding products presenting a risk. Further information is given
in the proposal for a Regulation on market surveillance of products.

·
Union competence, subsidiarity,
proportionality and legal form

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union (TFEU) which provides for the same
legal base for the establishment and functioning of the internal market on
which the current GPSD was adopted. In regulating product safety, the Union is
exercising its shared powers under Article 4(2) of the TFEU.

Within the internal market where products can
circulate freely, the rules on product safety can effectively be adopted only at
Union level. This is necessary in order to guarantee a high level of consumer
protection (in line with Article 169 TFEU) and also to prevent Member States
from adopting diverging product regulations which would result in fragmentation
of the single market. In accordance with the principles
of proportionality and subsidiarity, as set out in Article 5 of the Treaty on
European Union, this proposal does not go beyond what is necessary in order to
achieve those objectives.

The proposal takes the form of a Regulation.
This is the appropriate legal instrument as it imposes clear and detailed rules
which will become applicable in a uniform manner and at the same time throughout
the Union. It will avoid diverging transposition by Member States which is
liable to lead to different levels of health and safety protection and to create
obstacles to the internal market. Replacing the
national transposition measures also has a strong simplification effect since
it allows economic operators to conduct their business on the basis of a single
regulatory framework, rather than a 'patchwork' of Member States' national
laws.

·
Fundamental rights

In line with the Charter of Fundamental Rights
of the EU, this proposal seeks to ensure a high level of human health
protection (Article 35 of the Charter) and consumer protection (Article 38) by
assuring a high level of safety of consumer products made available on the
Union market. The proposal affects the freedom of economic operators to conduct
business (Article 16) but the obligations imposed on manufacturers, importers
and distributors of consumer products are necessary to guarantee a high level
of safety of those products.

4.           BUDGETARY IMPLICATION

The proposal does not have other budgetary
implications than those related to the proper management of the Regulation
which, in form of the GPSD, is already part of the Union law acquis. The budgetary implications are already foreseen in the existing or
proposed programmes and respect the Commission proposal for the new multiannual
financial framework. The details are set out in the financial statement
attached to this proposal.

5.           SIMPLIFICATION AND SMART
REGULATION

This proposal contributes to the simplification
of EU legislation and adheres to the principles of smart regulation. When
preparing this proposal the Commission has taken stock of the important
advancement of sector-specific legislation that aims at ensuring the safety of
products and which usually does not make a distinction whether the products
covered are intended for consumers or professional users. Contrary to the
situation 10 or 15 years ago, it is not necessary any more to apply a second
layer of obligations to economic operators who are already appropriately
regulated by sector-specific legislation. At the same time, the obligations for
those who produce, import or distribute consumer products that are not covered
by specific legislation are to a large extent aligned with those applicable to
harmonised products.

This approach will reduce administrative
burdens and compliance costs for businesses, in particular for small and
medium-sized enterprises. In the future, they can easily identify the set of
rules applicable to their commercial activity so that they will save on costs
caused by legal uncertainty.

Due to the subject-matter and objective of the
proposed Regulation, micro-enterprises as defined in
Commission Recommendation 2003/361/EC[11] cannot be exempted from its requirements because rules aiming at
protecting the health and safety of persons must apply regardless of the size
of the economic operator. But micro-enterprises are likely to benefit most from
the simplification that the new piece of legislation will bring about which is
fit for purpose and replaces two directives that have become out of date. The
Commission is committed to providing further guidance to businesses, in particular to small and medium-sized
enterprises, and consumers to help them to easily
identify their respective rights and obligations.

2013/0049 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on consumer product safety and repealing
Council Directive 87/357/EEC and Directive 2001/95/EC

(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 Article 114 thereof,

Having regard to the proposal from the
European Commission,

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

Having regard to the opinion of the
European Economic and Social Committee[12],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Directive 2001/95/EC of
the European Parliament and of the Council of 3 December 2001 on general
product safety[13]
lays down the requirement that consumer products must be safe and that Member
States' market surveillance authorities must take action against dangerous
products as well as exchange information to that effect through the Community rapid
information exchange system RAPEX. Directive 2001/95/EC needs to be
fundamentally revised to improve its functioning and to ensure consistency with
developments in Union legislation as regards market surveillance, obligations of
economic operators and standardisation. In the interest of clarity, Directive
2001/95/EC should be repealed and replaced by this Regulation.

(2)       A
Regulation is the appropriate legal instrument as it
imposes clear and detailed rules which do not give room for divergent
transposition by Member States. A Regulation ensures that legal requirements
are applicable at the same time throughout the Union.

(3)       This Regulation must contribute to the attainment of the objectives
referred to in Article 169 of the TFEU. In particular
it should aim at ensuring the
functioning of the internal market as regards products intended for consumers
by laying down uniform rules regarding a general safety requirement, assessment
criteria and obligations of economic operators. Given that rules on market surveillance, including rules on RAPEX, are
laid down in Regulation (EU) No [.../...] [on market
surveillance of products][14]
which applies also to products covered by this Regulation, no further
provisions on market surveillance or RAPEX are needed in this Regulation.

(4)       Union legislation on food,
feed and related areas sets up a specific regime ensuring the safety of the
products covered by it. This Regulation should therefore not apply to those
products with the exception of materials and articles intended to come into
contact with food insofar as risks are concerned that are not covered by
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of
27 October 2004 on materials and articles to come into contact with food[15] or by other food specific
legislation which only covers chemical and biological food related risks.

(5)       Medicinal products are
subject to a pre-market assessment that includes a specific risk-benefit
analysis. They should therefore be excluded from the scope of this Regulation.

(6)       This
Regulation should not cover services. However, in order to secure the
attainment of the protection of health and safety of consumers, it should apply
to products that are supplied or made available to consumers in the context of the
provision of services, including products to which
consumers are directly exposed during a service provision. Equipment on which consumers ride or travel which is operated by a
service provider should be excluded from the scope of this Regulation since it
has to be dealt with in conjunction with the safety of the service provided.

(7)       Despite
the development of sector-specific Union harmonisation legislation that
addresses safety aspects of specific products or categories of products, it is
practically impossible to adopt Union legislation for all consumer products
that exist or may be developed. There is therefore still a need for a
legislative framework of a horizontal nature to fill gaps and ensure consumer protection
not otherwise ensured, in particular with a view to achieving a high level of
protection of safety and health of consumers, as required by Article 114 and
Article 169 of the TFEU.

(8)       In
respect of the consumer products subject to this Regulation the scope of
application of the different parts of it should be clearly delimited from
sector-specific Union harmonisation legislation. Whilst the general product safety requirement and related provisions should be
applicable to all consumer products, the obligations of economic operators
should not apply where Union harmonisation legislation includes equivalent
obligations, such as Union legislation on cosmetics, toys, electrical
appliances or construction products.

(9)       In
order to ensure consistency between this Regulation and sector-specific Union
harmonisation legislation with regard to specific obligations of economic
operators, the provisions concerning manufacturers, authorised representatives,
importers and distributors should be based on the reference provisions included
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[16].

(10)     The
scope of this Regulation should not be limited to any selling technique of
consumer products, and thus also cover distance selling.

(11)     This
Regulation should apply to second hand products that re-enter the supply chain
in the course of a commercial activity, except for those second-hand products
for which the consumer cannot reasonably expect that they fulfil state-of-the
art safety standards, such as antiques.

(12)     This Regulation should also
apply to consumer products which, although not foodstuff, resemble
foodstuff and are likely to be confused with foodstuff in a way that consumers,
especially children, may place them in their mouths, suck or ingest them,
which might cause, for example, suffocation, poisoning, the perforation or
obstruction of the digestive tract. Those food-imitating products have so far
been regulated by Council Directive 87/357/EEC of 25
June 1987 on the approximation of the laws of the Member States concerning
products which, appearing to be other than they are, endanger the health or
safety of consumers[17]
which should be repealed.

(13)     The
safety of products should be assessed taking into account all the relevant
aspects, in particular their characteristics and presentation as well as the
categories of consumers who are likely to use the products taking into account
their vulnerability, in particular children, the elderly and the disabled.

(14)     To
avoid overlapping safety requirements and conflicts with other Union legislation,
a product which conforms to sector-specific Union harmonisation legislation that aims at the protection of
health and safety of persons should be presumed to be safe under this
Regulation.

(15)     Economic operators should
be responsible for the compliance of products, in relation to their respective
roles in the supply chain, so as to ensure a high level of protection of the
health and safety of consumers.

(16)     All
economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they only make available on the market products
which are safe and in conformity with this Regulation. It is necessary to provide
for a clear and proportionate distribution of obligations which correspond to the
role of each operator in the supply and distribution process.

(17)     Importers bear the
responsibility that products from third countries that they place on the Union
market comply with the requirements of this Regulation. The specific
obligations of importers should therefore be included in this Regulation.

(18)     Distributors make products
available on the market after they have been placed on the market by the
manufacturer or the importer and should act with due care to ensure that their
handling of the product does not adversely affect the compliance of the product
with this Regulation.

(19)     Any
economic operator that either places a product on the market under his own name
or trademark or modifies a product in such a way that compliance with the requirements
of this Regulation may be affected should be considered to be the manufacturer
and should assume the obligations of the manufacturer.

(20)     Ensuring
product identification and the traceability of products throughout the entire
supply chain helps to identify economic operators and to take effective
corrective measures against unsafe products, such as targeted recalls. Product
identification and traceability thus ensure that consumers and economic
operators obtain accurate information regarding unsafe products which enhances
confidence in the market and avoids unnecessary disruption of trade. Products
should therefore bear information allowing their identification and the
identification of the manufacturer and, if applicable, of the importer.
Manufacturers should also establish technical documentations regarding their
products for which they may choose the most appropriate
and cost-efficient way such as by electronic means.
Moreover, economic operators should be required to identify the operators who
supplied them and to whom they supplied a product. 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[18] is applicable to
the processing of personal data for the purposes of this Regulation.

(21)     The
indication of origin supplements the basic traceability requirements concerning
the name and address of the manufacturer. In particular, the indication of the
country of origin helps to identify the actual place of manufacture in all
those cases where the manufacturer cannot be contacted or its given address is
different from the actual place of manufacture. Such information can facilitate
the task of market surveillance authorities in tracing the product back to the
actual place of manufacture and enable contacts with the authorities of the
countries of origin in the framework of bilateral or multilateral cooperation
on consumer product safety for appropriate follow up actions.

(22)     In order to facilitate the
effective and consistent application of the general safety requirement set out
in this Regulation, it is important to make use of European standards covering
certain products and risks in such a way that a product which conforms to such
a European standard, the reference of which is published in the Official
Journal of the European Union, is to be presumed to be in compliance with
that requirement.

(23)     Where the Commission
identifies a need for a European standard ensuring compliance of certain products
with the general safety requirement under this Regulation, it should apply the
relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament
and of the Council of 25 October 2012 on European standardisation[19] to request one or several
European standardisation organisations to either draft or identify a standard
which is suitable to ensure that products which conform to it are presumed to
be safe. The references of such European standards should be published in the Official
Journal of the European Union.

(24)     The procedures to request European
standards in support of this Regulation, and on formal objections against them,
should be laid down in this Regulation and be aligned with Regulation (EU) No
1025/2012. To ensure overall consistency in European standardisation issues, requests for European standards, or objections to a European
standard, should therefore be brought before the committee set up by that Regulation,
after appropriate consultation of experts of the Member States in the field of
consumer product safety.

(25)     European standards, the
references of which have been published in accordance with Directive
2001/95/EC, should continue providing presumption of conformity with the
general safety requirement. Standardisation mandates issued by the Commission
in accordance with Directive 2001/95/EC should be deemed standardisation
requests issued in accordance with this Regulation.

(26)     Where no relevant European
standards or other recognised means to assess the safety of products exist, the
assessment of product safety should take into account Commission
recommendations adopted for this purpose pursuant to Article 292 TFEU.

(27)     In
order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission as regards the exemption
to the obligation to inform market surveillance authorities about products
presenting a risk, as regards the type of data carrier
and its placement on the product for the purposes of the traceability system,
as regards standardisation requests to European standardisation organisations
and as regards decisions on formal objections to European standards. Those powers should be exercised in accordance with Regulation
(EU) No 182/2011 of the European Parliament and of the Council of 16 February
2011 laying down the rules and general principles concerning mechanisms for
control by the Member States of the Commission's exercise of implementing
powers[20].

(28)     The advisory procedure
should be used for the adoption of implementing acts with respect to the
objections to European standards and where the references to the European
standard concerned have not yet been published in the Official Journal of
the European Union, given that the relevant standard has not yet led to the
presumption of conformity with the general safety requirement laid down in this
Regulation.

(29)     In order to maintain a high
level of health and safety of consumers, the power to adopt acts in accordance
with Article 290 TFEU should be delegated to the Commission in respect of products
for which the name and address of the manufacturer and of the importer does not
need to be indicated on the product itself due to the low level of risk related
to such products, and in respect of the identification
and traceability of products bearing a potential serious risk to health and safety. It is of particular
importance that the Commission carry out appropriate consultations during its
preparatory work, including at expert level. The Commission, when preparing and
drawing up delegated acts, should ensure a simultaneous, timely and appropriate
transmission of relevant documents to the European Parliament and to the
Council.

(30)     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.

(31)     To
allow economic operators, Member States and the Commission to adapt to the
changes introduced by this Regulation, it is appropriate to provide for a
sufficient transitional period until the requirements of this Regulation are
applicable.

(32)     Since the objective of this
Regulation, namely to ensure the functioning of the internal market as regards
products intended for consumers while guaranteeing a high level of health and
safety protection of consumers, cannot be sufficiently achieved by the Member
States and can therefore, by reason of the scale of the measure, 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.

(33)     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 the obligation to ensure a high
level of human health protection and consumer protection as well as the freedom
to conduct business.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

General
provisions

Article 1

Subject matter

This Regulation lays down rules on the
safety of consumer products placed or made available on the Union market.

Article 2

Scope

1.           This Regulation shall
apply to products obtained through a manufacturing process placed or made
available on the market, whether new, used or reconditioned, and which comply
with any of the following criteria:

(a)
which are intended for consumers;

(b)
which are likely, under reasonably foreseeable
conditions, to be used by consumers even if not intended for them;

(c)
to which consumers are exposed in the context of
a service provided to them.

2.           This Regulation shall not
apply to products to be repaired or reconditioned prior to being used where
those products are made available on the market as such.

3.           This Regulation shall not
apply to the following:

(a)
medicinal products for human or veterinary use;

(b)
food;

(c)
materials and articles intended to come into
contact with food insofar as risks related to those products are covered by
Regulation (EC) No 1935/2004 or other Union legislation applicable to food;

(d)
feed;

(e)
living plants and animals, genetically modified
organisms and genetically modified microorganisms in contained use, as well as
products of plants and animals relating directly to their future reproduction;

(f)
animal by-products and derived products;

(g)
plant protection products;

(h)
equipment on which consumers ride or travel
which is operated by a service provider within the context of a service
provided to consumers;

(i)
antiques.

4.           Chapters II to IV of this
Regulation shall not apply to products subject to requirements designed to
protect human health and safety laid down in Union harmonisation legislation or
pursuant to it.

Article 3

Definitions

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

(1)
‘safe product’ means any product which, under
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, does not present any risk or only
the minimum risks compatible with the product's use, considered acceptable and
consistent with a high level of protection of health and safety of persons;

(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 the manufacturer or the importer, who makes a
product available on the market;

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

(9)
‘European standard’ means a European standard as
defined in Article 2(1)(b) of Regulation (EU) No 1025/2012;

(10)
‘international standard’ means an international
standard as defined in Article 2(1)(a) of Regulation (EU) No 1025/2012;

(11)
‘national standard’ means a national standard as
defined in Article 2(1)(d) of Regulation (EU) No 1025/2012;

(12)
‘European standardisation organisation’ means a European
standardisation organisation as defined in Article 2(8) of Regulation (EU) No 1025/2012;

(13)
‘market surveillance authority’ means a market
surveillance authority as defined in Article [3(12] of Regulation (EU) No
[.../...] [on market surveillance of products];

(14)
‘recall’ means any measure aimed at achieving
the return of a product that has already been made available to the end user;

(15)
‘withdrawal’ means any measure aimed at
preventing a product in the supply chain from being further made available on
the market;

(16)
‘Union harmonisation legislation’ means any
Union legislation harmonising the conditions for the marketing of products;

(17)
‘serious risk’ means a risk requiring rapid
intervention and follow-up, including cases where the effects may not be
immediate.

Article 4

General safety requirement

Economic operators shall place or make
available on the Union market only safe products.

Article 5

Presumption of safety

For the purpose of this Regulation, a
product shall be presumed to be in compliance with the general safety
requirement laid down in Article 4 in the following cases:

(a)
as regards the risks covered by requirements designed
to protect human health and safety laid down in or pursuant to Union
harmonisation legislation, if it conforms to those requirements;

(b)
in the absence of requirements laid down in or
pursuant to Union harmonisation legislation referred to in point (a), as
regards the risks covered by European standards, if it conforms to relevant European
standards or parts thereof, the references of which have been published in the Official
Journal of the European Union in accordance with Articles 16 and 17;

(c)
in the absence of requirements laid down in or
pursuant to Union harmonisation legislation referred to in point (a) and
European standards referred to in point (b), as regards the risks covered by health
and safety requirements laid down in the law of the Member State where the
product is made available on the market, if it conforms to such national requirements.

Article 6

Aspects for assessing the safety of
products

1.           In the absence of Union
harmonisation legislation, European standards or health and safety requirements
laid down in the law of the Member State where the product is made available on
the market as referred to in points (a), (b) and (c) of Article 5, the
following aspects shall be taken into account when assessing whether a product
is safe, in particular:

(a)
the characteristics of the product, including
its composition, packaging, instructions for assembly and, where applicable,
for installation and maintenance;

(b)
the effect on other products, where it is
reasonably foreseeable that it will be used with other products;

(c)
the presentation of the product, the labelling,
any warnings and instructions for its use and disposal and any other indication
or information regarding the product;

(d)
the categories of consumers at risk when using
the product, in particular vulnerable consumers;

(e)
the appearance of the product and in particular
where a product, although not foodstuff, resembles foodstuff and is likely to be
confused with foodstuff due to its form, odour, colour,
appearance, packaging, labelling, volume, size or other characteristics.

The feasibility of obtaining higher levels of
safety or the availability of other products presenting a lesser degree of risk
shall not constitute grounds for considering a product not to be safe.

2.           For the purpose of
paragraph 1, when assessing whether a product is safe, the following aspects,
when available, shall be taken into account, in particular:

(a)
the state of the art and technology;

(b)
European standards other than those the
references of which have been published in the Official Journal of the European
Union in accordance with Articles 16 and 17;

(c)
international standards;

(d)
international agreements;

(e)
Commission recommendations or guidelines on
product safety assessment;

(f)
national standards drawn up in the Member State
in which the product is made available;

(g)
product safety codes of good practice in force
in the sector concerned;

(h)
reasonable consumer expectations concerning
safety.

Article 7

Indication of the origin

1.           Manufacturers and
importers shall ensure that products bear an indication of the country of
origin of the product or, where the size or nature of the product does not
allow it, that indication is to be provided on the packaging or in a document
accompanying the product.

2.           For the purpose of
determination of the country of origin within the meaning of paragraph 1, non-preferential
origin rules set out in Articles 23 to 25 of Council Regulation (EEC) No
2913/92 establishing a Community Customs Code[21] shall
apply.

3.           Where the country of
origin determined in accordance with paragraph 2 is a Member State of the
Union, manufacturers and importers may refer to the Union or to a particular
Member State.

CHAPTER II

Obligations
of economic operators

Article 8

Obligations of manufacturers

1.           When placing their
products on the market, manufacturers shall ensure that they have been designed
and manufactured in accordance with the general safety requirement laid down in
Article 4.

2.           Manufacturers shall ensure
that procedures are in place for series production to remain in conformity with
the general safety requirement laid down in Article 4.

3.           Proportionate to the
possible risks of a product, manufacturers shall, to protect the health and
safety of consumers, carry out sample testing of products made available on the
market, investigate complaints and keep a register of complaints,
non-conforming products and product recalls, and shall keep distributors
informed of any such monitoring.

4.           Proportionate to the
possible risks of a product, manufacturers shall draw up a technical
documentation.The technical documentation shall contain, as appropriate:

(a)
a general description of the product and its
essential properties relevant for assessing the product's safety;

(b)
an analysis of the possible risks related to the
product and the solutions adopted to eliminate or mitigate such risks,
including the outcome of any tests conducted by the manufacturer or by another
party on his behalf;

(c)
where applicable, a list of the European
standards referred to in point (b) of Article 5 or health and safety requirements
laid down in the law of the Member State where the product is made available on
the market referred to in point (c) of Article 5, or other aspects referred to
in Article 6(2), applied to meet the general safety requirement laid down in
Article 4.

Where any of the European standards, health and
safety requirements or other aspects referred to in point (c) of the first
subparagraph have been only partly applied, the parts which have been applied
shall be identified.

5.           Manufacturers shall keep,
for a period of ten years after the product has been placed on the market, the
technical documentation and make it available to the market surveillance authorities,
upon request.

6.           Manufacturers shall ensure
that their products bear a type, batch or serial number or other element allowing
the identification of the product which is easily visible and legible for
consumers, or, where the size or nature of the product does not allow it, that
the required information is provided on the packaging or in a document
accompanying the product.

7.           Manufacturers shall indicate
their name, registered trade name or registered trade mark and the address at
which they can be contacted on the product or, where that is not possible, on
its packaging or in a document accompanying the product. The address must
indicate a single point at which the manufacturer can be contacted.

8.           Manufacturers shall ensure
that their product is accompanied by instructions and safety information in a
language which can be easily understood by consumers, as determined by the Member
State in which the product is made available, except where the product can be
used safely and as intended by the manufacturer without such instructions and
safety information.

Member States shall inform the Commission about
any provisions adopted by them determining the required language(s).

9.           Manufacturers who consider
or have reason to believe that a product which they have placed on the market
is not safe or is otherwise not in conformity with this Regulation shall
immediately take the corrective action necessary to bring that product into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
product is not safe, manufacturers shall immediately inform the market
surveillance authorities of the Member States in which they made the product
available to that effect, giving details, in particular, of the risk to health
and safety and of any corrective action taken.

Article 9

Authorised representatives

1.           A manufacturer may, by a
written mandate, appoint an authorised representative.

The
obligations laid down in Article 8(1) and (4) shall not form part of the
authorised representative's mandate.

2.           An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:

(a)
further to a request from a market surveillance
authority, provide that authority with all the information and documentation
necessary to demonstrate the conformity of a product;

(b)
cooperate with the market surveillance authorities,
at their request, on any action taken to eliminate the risks posed by products
covered by their mandate.

Article 10

Obligations of importers

1.           Before placing a product
on the market importers shall ensure that the product is compliant with the
general safety requirement laid down in Article 4 and that the manufacturer has
complied with the requirements set out in Article 8(4), (6) and (7).

2.           Where an importer
considers or has reason to believe that a product is not in conformity with this
Regulation, he shall not place the product on the market until it has been
brought into conformity. Furthermore, where the product is not safe, the
importer shall inform the manufacturer and the market surveillance authorities of
the Member State in which he is established to that effect.

3.           Importers shall indicate
their name, registered trade name or registered trade mark and the address at
which they can be contacted on the product or, where that is not possible, on
its packaging or in a document accompanying the product. They shall ensure that
any additional label does not obscure any information on the label provided by
the manufacturer.

4.           Importers shall ensure
that the product is accompanied by instructions and safety information in a
language which can be easily understood by consumers, as determined by the
Member State in which the product is made available, except where the product
can be used safely and as intended by the manufacturer without such
instructions and safety information.

Member States shall inform the Commission about
any provisions adopted by them determining the required language(s).

5.           Importers shall ensure
that, while a product is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the general safety requirement
laid down in Article 4 and its conformity with Article 8(6).

6.           Proportionate to the
possible risks presented by a product, importers shall, to protect the health
and safety of persons, carry out sample testing of marketed products,
investigate complaints, and keep a register of complaints, of non-conforming
products and of product recalls, and shall keep the manufacturer and distributors
informed of such monitoring.

7.           Importers who consider or
have reason to believe that a product which they have placed on the market is
not safe or is otherwise not in conformity with this Regulation shall
immediately take the corrective action necessary to bring that product into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
product is not safe, importers shall immediately inform the market surveillance
authorities of the Member States in which they made the product available to
that effect, giving details, in particular, of the risk to health and safety and
of any corrective action taken.

8.           Importers shall keep, for a
period of ten years after the product has been placed on the market, the
technical documentation and make it available to the market surveillance authorities,
upon request.

Article 11

Obligations of distributors

1.           When making a product
available on the market, a distributor shall act with due care in
relation to the requirements of this Regulation.

2.           Before making a product
available on the market distributors shall verify that the manufacturer and the
importer have complied with the requirements set out in Article 8(6), (7) and (8)
and Article 10(3) and (4), as applicable.

3.           Where a distributor considers
or has a reason to believe that a product is not in conformity with this
Regulation, he shall not make the product available on the market until it has
been brought into conformity. Furthermore, where the product is not safe, the
distributor shall inform the manufacturer or the importer, as applicable, to
that effect as well as the market surveillance authority of the Member State in
which the distributor is established.

4.           Distributors shall ensure
that, while a product is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the general safety requirement
laid down in Article 4 and its conformity with Article 8(6), (7) and (8) and
Article 10(3) and (4), as applicable.

5.           Distributors who consider
or have reason to believe that a product which they have made available on the
market is not safe or is not in conformity with Article 8(6), (7) and (8) and
Article 10(3) and (4), as applicable, shall make sure that the corrective action
necessary to bring that product into conformity is taken, to withdraw it or
recall it, if appropriate. Furthermore, where the product is not safe,
distributors shall immediately inform the manufacturer or importer, as
applicable as well as market surveillance authorities of the Member States in
which they made the product available to that effect, giving details, in
particular, of the risk to health and safety and of any corrective action
taken.

Article 12

Cases in which obligations of
manufacturers apply to importers and distributors

An importer or distributor shall be
considered a manufacturer for the purposes of this Regulation and shall be
subject to the obligations of the manufacturer under Article 8, where he places
a product on the market under his name or trademark or modifies a product
already placed on the market in such a way that compliance with the
requirements of this Regulation may be affected.

Article 13

Exemption from certain obligations of
manufacturers, importers and distributors

1.           Obligation to inform the
market surveillance authorities in accordance with Article 8(9), Article 10(2)
and (7) and Article 11(3) and (5) shall not apply where the following
conditions are fulfilled:

(a)
only a limited number of well-identified
products are not safe;

(b)
the manufacturer, importer or distributor can
demonstrate that the risk has been fully controlled and cannot any more
endanger the health and safety of persons;

(c)
the cause of the risk of the product is such
that knowledge of it does not represent useful information for the authorities
or the public.

2.           The Commission may by
means of implementing acts determine the situations which meet the conditions
of paragraph 1. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 19(3).

3.           The Commission shall be
empowered to adopt delegated acts in accordance with Article
20 determining the products, categories or groups of products
for which, due to their low level of risk, the information referred to in
Article 8(7) and Article 10(3) does not need to be indicated on the product
itself.

Article 14

Identification of economic
operators

1.           Economic operators shall,
on request, identify the following to the market surveillance authorities:

(a)
any economic operator who has supplied them with
the product;

(b)
any economic operator to whom they have supplied
the product.

2.           Economic
operators shall be able to present the information referred to in the first
paragraph for a period of 10 years after they have been supplied with the
product and for a period of 10 years after they have supplied the product.

Article 15

Traceability of products

1.           For certain products,
categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible
to bear a serious risk to health and safety of persons,
the Commission may require economic operators who place and make available
those products on the market to establish or adhere to a system of traceability.

2.           The
system of traceability shall consist of the collection
and storage of data by electronic means enabling the identification of the
product and of the economic operators involved in its supply chain as well as
of the placement of a data carrier on the product, its packaging or
accompanying documents enabling access to that data.

3.           The
Commission shall be empowered to adopt delegated acts in accordance with Article
20:

(a)
determining the products, categories or groups
of products susceptible to bear a serious risk to health and safety of persons
as referred to in paragraph 1;

(b)
specifying the data which economic operators shall
collect and store by means of the traceability system referred to in paragraph
2.

4.           The Commission may by
means of implementing acts determine the type of data carrier and its placement
as referred to in paragraph 2. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 19(3).

5.           When adopting the measures
referred to in paragraphs 3 and 4, the Commission shall take into account the
following:

(a)
the cost-effectiveness of the measures,
including their impact on businesses in particular small
and medium-sized enterprises;

(b)
the compatibility with traceability systems
available at international level.

CHAPTER III

European
standards providing presumption of conformity

Article 16

Standardisation requests to European
standardisation organisations

1.           The
Commission may request one or several European standardisation organisations to
draft or identify a European standard, which aims at ensuring that products
that conform to such standard or parts thereof comply with the general safety
requirement laid down in Article 4. The Commission shall determine the
requirements as to the content to be met by the requested European standard and
a deadline for its adoption.

The Commission shall adopt the request referred to
in the first subparagraph by an implementing decision. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in Article
19(3).

2.           The
relevant European standardisation organisation shall indicate, within one month
following receipt of the request referred to in paragraph 1, if it accepts it.

3.           Where
a request for funding is made, the Commission shall inform the relevant
European standardisation organisations, within two months following the receipt
of the acceptance referred to in paragraph 2, about the award of a grant for
drafting a European standard.

4.           The
European standardisation organisations shall inform the Commission about the
activities undertaken for the development of the European standard referred to
in paragraph 1. The Commission together with the European standardisation
organisations shall assess the compliance of the European standards drafted or
identified by the European standardisation organisations with its initial
request.

5.           Where the European
standard satisfies the requirements it aims to cover and the general safety requirement
laid down in Article 4, the Commission shall publish a reference to such
European standard without delay in the Official Journal of the European
Union.

Article 17

Formal objections to European
standards

1.           When a Member State or the
European Parliament considers that a European standard referred to in Article 16
does not entirely satisfy the requirements it aims to cover and the general
safety requirement laid down in Article 4, it shall inform the Commission
thereof with a detailed explanation and the Commission shall decide:

(a)
to publish, not to publish or to publish with
restriction the references to the European standard concerned in the Official
Journal of the European Union;

(b)
to maintain, to maintain with restriction or to
withdraw the references to the European standard concerned in or from the Official
Journal of the European Union.

2.           The Commission shall
publish information on its website on the European standards that have been
subject to a decision referred to in paragraph 1.

3.           The Commission shall
inform the European standardisation organisation concerned of the decision
referred to in paragraph 1 and, if necessary, request the revision of the
European standard concerned.

4.           The decision referred to
in point (a) of paragraph 1 of this Article shall be adopted in accordance with
the advisory procedure referred to in Article 19(2).

5.           The decision referred to
in point (b) of paragraph 1 of this Article shall be adopted in accordance with
the examination procedure referred to in Article 19(3).

CHAPTER IV

Final
provisions

Article 18

Penalties

1.           The Member States shall
lay down the rules on penalties applicable to infringements of the provisions
of this Regulation 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.

2.           The penalties referred to
in paragraph 1 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 19

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.

However, for the purposes of Articles 16 and 17
of this Regulation the Commission shall be assisted by the Committee
established by Regulation (EU) No 1025/2012. That Committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.

2.           Where reference is made to
this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.           Where reference is made to
this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4.           Where the opinion of the
Committee referred to in the second subparagraph of paragraph 1 is to be
obtained by written procedure, that procedure shall be terminated without
result when, within the time-limit for delivery of the opinion, the chair of
the committee so decides or a simple majority of committee members so request.

Article 20

Exercise of the delegation

1.           The
power to adopt the delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2.           The
power to adopt delegated acts referred to in Articles 13(3) and 15(3) shall be
conferred on the Commission for an indeterminate period of time from [insert date - the date of entry into
force of this Regulation].

3.           The
delegation of power referred to in Articles 13(3) and 15(3) may be revoked at
any time by the European Parliament or by the Council. A decision of revocation
shall put an end to the delegation of the power specified in that decision. It
shall take effect the day following its publication in the Official Journal
of the European Union or at a later date specified therein. It shall not
affect the validity of any delegated acts already in force.

4.           As
soon as it adopts a delegated act, the Commission shall notify it
simultaneously to the European Parliament and to the Council.

5.           A
delegated act adopted pursuant to Articles 13(3) and 15(3) shall enter into
force only if no objection has been expressed either by the European Parliament
or by the Council within a period of two months of notification of that act to
the European Parliament and the Council or if, before the expiry of that
period, the European Parliament and the Council have both informed the
Commission that they will not object. That period may be extended by two months
at the initiative of the European Parliament or of the Council.

Article 21

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. This report shall assess if this
Regulation achieved its objectives, in particular with regard to enhancing the protection of consumers against unsafe products,
taking into account its impact on business and in particular on small and
medium-sized enterprises.

Article 22

Repeal

1.           Directive 2001/95/EC is
repealed with effect from [insert date - day of application of this
Regulation].

2.           Directive 87/357/EEC is
repealed with effect from [insert date - day of application of this
Regulation].

3.           References to Directive 2001/95/EC
and Directive 87/357/EEC shall be construed as references to this Regulation
and shall be read in accordance with the correlation table in the Annex.

Article 23

Transitional provisions

1.           Member States shall not
impede the making available on the market of products covered by Directive
2001/95/EC which are in conformity with that Directive and which were placed on
the market before [insert date - day of application of this Regulation].

2.           European standards the
reference of which is published in the Official Journal of the European Union in
accordance with Directive 2001/95/EC shall be deemed to be European standards
referred to in point (b) of Article 5 of this Regulation.

3.           Mandates given by the
Commission to a European standardisation organisation in accordance with
Directive 2001/95/EC shall be deemed standardisation requests referred to in
Article 15(1) of this Regulation.

Article 24

1.           This Regulation shall
enter into force on [insert date - the same day as entry into force of Regulation
(EU) No [.../...][on market surveillance of products].

2.           It shall apply from [insert
date - the same day as date of application of Regulation (EU) No [.../...][on
market surveillance of products].

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

Directive 2001/95/EC || Directive 87/357/EEC || This Regulation

Article 1(1) || || Article 1

Article 1(2), 1st subparagraph || || Article 2(1)

Article 1(2), 2nd subparagraph || || Article 2(4)

Article 2 || || Article 3

Article 2(b)(i)-(iv) || || Article 6(1)

Article 3(1) || || Article 4

Article 3(2) || || Article 5

Article 3(3) || || Article 6(2)

Article 3(4) || || -

Article 4 || || Articles 16 and 17

Article 5(1), 1st subparagraph || || Article 8(8)

Article 5(1), 2nd subparagraph || || -

Article 5(1), 3rd subparagraph || || Article 8(9)

Article 5(1), 4th subparagraph || || Article 8(3), (6) and (7)

Article 5(1), 5th subparagraph || || -

Article 5(2) || || Article 11

Article 5(3), 1st subparagraph || || Article 8(9) and Article 11(5)

Article 5(3), 2nd subparagraph || || -

Article 5(4) || || -

Article 6(1) || || -

Article 6(2) and (3) || || -

Article 7 || || Article 18

Article 8(1)(a) || || -

Article 8(1)(b) – (f) || || -

Article 8(2), 1st subparagraph || || -

Article 8(2), 2nd subparagraph || || -

Article 8(2), 3rd subparagraph || || -

Article 8(3) || || -

Article 8(4) || || -

Article 9(1) || || -

Article 9(2) || || -

Article 10 || || -

Article 11 || || -

Article 12 || || -

Article 13 || || -

Article 14 || || -

Article 15 || || Article 19

Article 16 || || -

Article 17 || || -

Article 18(1) || || -

Article 18(2) || || -

Article 18(3) || || -

Article 19(1) || || -

Article 19(2) || || Article 21

Article 20 || || -

Article 21 || || -

Article 22 || || Article 22

Article 23 || || Article 24

Annex I, section 1 || || Article 8(9) and Article 11(5)

Annex I, section 2, first sentence || || -

Annex I, section 2, second sentence || || Article 13(1) and (2)

Annex I, section 3 || || -

Annex II || || -

Annex III || || -

Annex IV || || Annex

|| Article 1 || Article 6(1)(e)

|| Articles 2 to 7 || -

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 consumer product safety

1.2.        Policy area(s) concerned
in the ABM/ABB structure[22]

Title 17 – Health and consumer protection – Chapter 17 02: Consumer
policy

1.3.        Nature of the
proposal/initiative

 ̈ The
proposal/initiative relates to a new action

 ̈ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[23]

X The proposal/initiative relates to the
extension of an existing action

 ̈ The
proposal/initiative relates to an action redirected towards a new action

1.4.        Objectives

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

The proposal contributes to the European Union’s ten-year
growth strategy "Europe 2020" by enhancing consumer confidence in the
safety of products and improving the functioning of the single market.

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

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.

On consumers: Reinforced confidence that consumer products made
available on the single market are safe.

On economic operators: Clearer rules as regards the respective
obligation incumbent on manufacturers, importers and distributors.

On authorities: Clear legal framework to enforce general safety
requirement and obligations on economic operators and better identification of
(dangerous) consumer products.

1.4.4.     Indicators of results and
impact

Specify the
indicators for monitoring implementation of the proposal/initiative.

Ratio of traceable/non-traceable consumer products covered by this
Regulation notified under RAPEX.

Number of mandates to European standardisation organisations and
number of European standards referenced in the OJ pursuant to the new
Regulation.

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The objective is to build a consistent regulatory framework for safe
products in the single market. This shall overcome the fragmentation of market
surveillance rules and obligations of economic operators among various pieces
of Union legislation (Directive 2001/95/EC, Regulation (EC) No 765/2008 and
sector-specific Union harmonisation legislation) which 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.

Along with a series of other actions, the Single Market Act I and II
identified the revision of the General Product Safety Directive as part of the
Product Safety Market Surveillance Package as important initiatives to contribute
to boosting growth and creating jobs.

1.5.2.     Added value of EU involvement

The proposed revision of Directive 2001/95/EC, which will integrate
the modifications of the Lisbon Treaty, can only be achieved at Union level.
The proposal is based on Article 114 Treaty on the Functioning of the European
Union (TFEU), to which also Article 169 TFEU refers, in order to ensure a high
level of protection of health and safety of all European consumers and
establish an internal market for consumer goods.

In accordance with the principles of proportionality and
subsidiarity, as set out in Article 5 of the Treaty on European Union, this
proposal does not go beyond what is necessary to achieve those objectives.

1.5.3.     Lessons learned from
similar experiences in the past

The use of European standards in support of Directive 2001/95/EC is
cumbersome and resource-intensive. The proposal aims at simplifying the
procedures.

The application of Directive 2001/95/EC in terms of market
surveillance measures to consumer products covered also by sector-specific
legislation was not always clear which will be clarified.

1.5.4.     Coherence and possible
synergy with other relevant instruments

This proposal is part of the Product Safety and Market Surveillance
Package and thus fully coherent with the proposal for a Regulation of the
European parliament and of the Council on market surveillance of products.

This proposal aligns definitions and economic operators' obligations
with the New Legislative Framework adopted in 2008. It is therefore coherent
with the "Alignment Package" of sectoral Union harmonisation
legislation currently negotiated in the European Parliament and in the Council.

The provisions on European standards are coherent with the recently
adopted Regulation (EU) No 1025/2012 on European standardisation.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

–
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

–
 ̈  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration

–
Implementation with a start-up period from YYYY
to YYYY,

–
followed by full-scale operation.

1.7.        Management mode(s) envisaged[24]

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[25]

–
 ̈  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.

Comments:

Implementation of the proposed Regulation should be ensured through
centralised direct management by the Commission.

The management of the proposed Regulation may be complemented by
actions with the involvement of the Executive Agency on Health and Consumers
(EAHC) that, in accordance with Council Regulation (EC) No 58/2003 of 19
December 2002[26],
can be entrusted with certain tasks in the management of Community programmes.
The Commission has entrusted[27] 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 Executive Agency for Health and Consumers (EAHC).

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

The GPSD committee (which the proposed
Regulation will transform into a committee within the meaning of Regulation
(EU) No 182/2011) and existing expert groups and/or the European Market
Surveillance Forum foreseen in the proposal for a single market surveillance
regulation will provide a regular platform to discuss
issues related to the implementation of the new Regulation.

The proposal suggests that the Commission should
review its implementation and submit a report theron to the European parliamnet
and to the Council.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

The two proposals (on general product safety and on market
surveillance) forming part of the Package are separated from each other during
the legislative negotiations and do not progress in parallel.

2.2.2.     Control method(s) envisaged

The provisions on entry into force are interlinked in both
proposals.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

In addition to the application of all regulatory control mechanisms,
DG SANCO 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. ([28]) || from EFTA[29] countries || from candidate countries[30] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

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[31]

EUR million in current prices (to 3 decimal places)

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) || 1,107 || 1,189 || 1,272 || 1,356 || 1,443 || 1,530 || 7,897

Payments || (2) || 0,554 || 1,148 || 1,230 || 1,314 || 1,400 || 2,251 || 7,897

Appropriations of an administrative nature financed  from the envelope for specific programmes[32] || || || || || || ||

Number of budget line: 17.01.04.01 || Commitments || (1a) || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,564

Payments || (2a) || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,564

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

TOTAL appropriations for DG SANCO || Commitments || =1+1a || 1,201 || 1,283 || 1,366 || 1,450 || 1,537 || 1,624 || 8,461

Payments || =2+2a || 0,648 || 1,242 || 1,324 || 1,408 || 1,494 || 2,345 || 8,461

Ÿ TOTAL operational appropriations || Commitments || (3) || 1,107 || 1,189 || 1,272 || 1,356 || 1,443 || 1,530 || 7,897

Payments || (4) || 0,554 || 1,148 || 1,230 || 1,314 || 1,400 || 2,251 || 7,897

ŸTOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (5) || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,564

TOTAL appropriations under HEADING 3 of the multiannual financial framework || Commitments || =3+ 5 || 1,201 || 1,283 || 1,366 || 1,450 || 1,537 || 1,624 || 8,461

Payments || =4+ 5 || 0,648 || 1,242 || 1,324 || 1,408 || 1,494 || 2,345 || 8,461

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million in current prices (to 3 decimal places)

|| || || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

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

Ÿ Human resources || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 3,144

Ÿ Other administrative expenditure (missions, meetings) || 0,069 || 0,069 || 0,069 || 0,069 || 0,069 || 0,069 || 0,414

TOTAL || Appropriations || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 3,558

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 3,558

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 || 1,794 || 1,876 || 1,959 || 2,043 || 2,130 || 2,217 || 12,019

Payments || 1,241 || 1,835 || 1,917 || 2,001 || 2,087 || 2,938 || 12,019

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[33] || 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: To consolidate and enhance product safety through effective market surveillance throughout the Union || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || ||

Product safety: scientific advice, international cooperation, monitoring and assessing of the safety of products, knowledge base || || 1,316 || 4 || 1,107 || 4 || 1,189 || 4 || 1,272 || 4 || 1,356 || 4 || 1,443 || 4 || 1,530 || 24 || 7,897 ||

Sub-total for specific objective: To consolidate and enhance product safety through effective market surveillance throughout the Union || 4 || 1,107 || 4 || 1,189 || 4 || 1,272 || 4 || 1,356 || 4 || 1,443 || 4 || 1,530 || 24 || 7,897 ||

TOTAL COST || 4 || 1,107 || 4 || 1,189 || 4 || 1,272 || 4 || 1,356 || 4 || 1,443 || 4 || 1,530 || 24 || 7,897 ||

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 || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 3,144

Other administrative expenditure || 0,069 || 0,069 || 0,069 || 0,069 || 0,069 || 0,069 || 0,414

Subtotal HEADING 5 of the multiannual financial framework || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 0,593 || 3,558

Outside HEADING 5[34] of the multiannual financial framework || || || || || || ||

Human resources || 0 || 0 || 0 || 0 || 0 || || 0

Other expenditure of an administrative nature || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,564

Subtotal outside HEADING 5 of the multiannual financial framework || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,094 || 0,564

TOTAL || 0,687 || 0,687 || 0,687 || 0,687 || 0,687 || 0,687 || 4,122

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 || TOTAL

17 01 01 01 (Headquarters and Commission’s Representation Offices) || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 3,144

XX 01 01 02 (Delegations) || 0 || 0 || 0 || 0 || 0 || ||

XX 01 05 01 (Indirect research) || 0 || 0 || 0 || 0 || 0 || ||

10 01 05 01 (Direct research) || 0 || 0 || 0 || 0 || 0 || ||

XX 01 02 01 (CA, INT, SNE from the "global envelope") || 0 || 0 || 0 || 0 || 0 || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || 0 || 0 || 0 || 0 || 0 || ||

XX 01 04 yy [35] || - at Headquarters[36] || 0 || 0 || 0 || 0 || 0 || ||

- in delegations || 0 || 0 || 0 || 0 || 0 || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || 0 || 0 || 0 || 0 || 0 || ||

10 01 05 02 (CA, INT, SNE - Direct research) || 0 || 0 || 0 || 0 || 0 || ||

Other budget lines (specify) || 0 || 0 || 0 || 0 || 0 || ||

TOTAL || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 0,524 || 3,144

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 account of 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 product safety. Follow policy developments in the area of product safety and information exchange between Member States. Participate and represent the Commission in comitology meetings and expert groups linked to product safety. Identify and prepare initiatives within the framework of the Consumer Product Safety Regulation to ensure a consistent and high level of consumer product safety, in particular standardisation mandates and assessment of standards and specifications to support the application of the Regulation. Assistants: Ensure the administrative support with the operation of the comitology committee and expert groups. Carry out various tasks related to the interface with internal and external correspondents and stakeholders in the area of product safety. Assist in launching, managing and monitoring calls for tenders and the implementation of contracts.

3.2.4.     Compatibility with the
current multiannual financial framework

–
X  Proposal/initiative is compatible with the new
multiannual financial framework 2014-2020 as proposed by the Commission.

–
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts. NA

–
 ̈  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[37].

Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts. NA

3.2.5.     Third-party contributions

–
The proposal does not provide for co-financing
by third parties

3.3.        Estimated impact on
revenue

–
X  The proposal has no financial impact on
revenue.

[1]               OJ L 11, 15.1.2002, p. 4.

[2]               OJ L 218, 13.8.2008, p. 30.

[3]               Consisting of Regulation (EC) No 765/2008 and
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, OJ L 218, 13.8.2008, p. 82.

[4]               Adopted by the Commission on 21 November 2011, http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-legislative-framework/index_en.htm.

[5]               Regulation (EU) No 1025/2012 of the European
Parliament and of the Council of 25 October 2012, OJ L 316, 14.11.2012, p. 12.

[6]               COM(2011)206 final.

[7]               COM(2012)573 final.

[8]               See footnote 3.

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

[10]             See footnote 5.

[11]             OJ L 124, 20.5.2003, p. 36.

[12]             OJ C , , p. .

[13]             OL L 11, 15.1.2002, p. 4.

[14]             OJ L , , p. .

[15]             OJ L 338, 13.11.2004, p. 4.

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

[17]             OJ L 192, 11.7.1987, p. 42.

[18]             OJ L 281, 23.11.1995, p. 31.

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

[20]             OJ L 55, 28.2.2011, p. 13.

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

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

[23]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[24]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[25]             As referred to in Article 185 of the Financial
Regulation.

[26]             OJ L 11, 16.1.2003, p. 1.

[27]             Commission Decision C(2008)4943 of 9 September 2008.

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

[29]             EFTA: European Free Trade Association.

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

[31]             Amounts subject to the outcome of the legislative
process based on the Commission proposal for the new Multiannual Financial
Framework 2014-2020.

[32]             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.

[33]             The output consists in ensuring a high level of
consumer product safety. It would be difficult to further break it down in
quantitative outputs because, due to lack of reliable data, it is not possible
to indicate in absolute or relative terms a target number for fewer unsafe products
on the market. The number of RAPEX notifications does not necessarily reflect
the number of unsafe products on the market. An increased number of RAPEX
notifications can mean more effective market surveillance but less unsafe products
and vice versa.

[34]             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.

[35]             Under the ceiling for external personnel from
operational appropriations (former "BA" lines).

[36]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[37]             See points 19 and 24 of the Interinstitutional
Agreement.