Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)
Date: 2008-07-09
Institutions: Council of the European Union, European Parliament
Subjects: EC conformity marking, EU financing, exchange of information, harmonisation of standards, market supervision, product safety

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REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 July 2008

setting out the requirements for accreditation and market surveillance relating to the marketing of
products and repealing Regulation (EEC) No 339/93

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(3)

This Regulation should be seen as complementary to
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 (3).

Having regard to the Treaty establishing the European Commu-
nity, and in particular Articles 95 and 133 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

(4)

(5)

Whereas:

(1)

(2)

It is necessary to ensure that products benefiting from the
free movement of goods within the Community fulfil
requirements providing a high level of protection of public
interests such as health and safety in general, health and
safety at the workplace, protection of consumers, protec-
tion of the environment and security, while ensuring that
the free movement of products is not restricted to any
extent greater than that which is allowed under Community
harmonisation legislation or any other relevant Community
rules. Provision should, therefore, be made for rules on
accreditation, market surveillance, controls of products
from third countries and the CE marking.

It is necessary to establish an overall framework of rules and
principles in relation to accreditation and market surveil-
lance. That framework should not affect the substantive
rules of existing legislation setting out the provisions to be
observed for the purpose of protecting public interests such
as health, safety and protection of consumers and of the
environment, but should aim at enhancing their operation.

(1) OJ C 120, 16.5.2008, p. 1.
(2) Opinion of the European Parliament of 21 February 2008 (not yet
published in the Official Journal) and Council Decision of 23 June
2008.

It is very difficult to adopt Community legislation for every
product which exists or which may be developed; there is a
need for a broad-based,
legislative framework of a
horizontal nature to deal with such products, to cover
lacunae, in particular pending revision of existing specific
legislation, and to complement provisions in existing or
in particular with a view to
future specific legislation,
ensuring a high level of protection of health, safety, the
environment and consumers, as required by Article 95 of
the Treaty.

The framework for market surveillance established by this
Regulation should complement and strengthen existing
provisions in Community harmonisation legislation relat-
ing to market surveillance and the enforcement of such
provisions. However, in accordance with the principle of lex
specialis, this Regulation should apply only in so far as there
are no specific provisions with the same objective, nature or
effect in other existing or future rules of Community
harmonisation legislation. Examples can be found in the
following sectors: drug precursors, medical devices, med-
icinal products for human and veterinary use, motor
vehicles and aviation. The corresponding provisions of this
Regulation should not therefore apply in the areas covered
by such specific provisions.

(6) Directive 2001/95/EC of the European Parliament and of
the Council of 3 December 2001 on general product
safety (4) established rules to ensure the safety of consumer
products. Market surveillance authorities should have the
possibility of taking the more specific measures available to
them under that Directive.

(7) However, in order to achieve a higher level of safety for
consumer products, the market surveillance mechanisms
provided for in Directive 2001/95/EC should be reinforced
as regards products presenting a serious risk, in accordance
with the principles established by this Regulation. Direc-
tive 2001/95/EC should therefore be amended accordingly.

(3) See page 82 of this Official Journal.
(4) OJ L 11, 15.1.2002, p. 4.

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(8) Accreditation is part of an overall system,

including
conformity assessment and market surveillance, designed
to assess and ensure conformity with the applicable
requirements.

(9)

The particular value of accreditation lies in the fact that it
provides an authoritative statement of
the technical
competence of bodies whose task is to ensure conformity
with the applicable requirements.

as an activity that is not intended to add any gain to the
resources of the body's owners or members. While national
accreditation bodies do not have the objective of maximis-
ing or distributing profits, they may provide services in
return for payment, or receive income. Any excess revenue
that results from such services may be used for investment
to develop their activities further, as long as it is in line with
their main activities. It should accordingly be emphasised
that the primary objective of national accreditation bodies
should be to support or engage actively in activities that are
not intended to produce any gain.

(10) Accreditation, though so far not regulated at Community
is carried out in all Member States. The lack of
level,
common rules for that activity has resulted in different
approaches and differing systems throughout the Commu-
nity, with the result that the degree of rigour applied in the
performance of accreditation has varied between Member
States. It is therefore necessary to develop a comprehensive
framework for accreditation and to lay down at Community
level the principles for its operation and organisation.

(11) The establishment of a uniform national accreditation body
should be without prejudice to the allocation of functions
within Member States.

(12) Where Community harmonisation legislation provides for
the selection of conformity assessment bodies for
its
implementation, transparent accreditation, as provided for
in this Regulation,
ensuring the necessary level of
confidence in conformity certificates, should be considered
by the national public authorities throughout the Commu-
nity the preferred means of demonstrating the technical
competence of those bodies. However, national authorities
may consider that they possess the appropriate means of
carrying out this evaluation themselves. In such cases, in
order to ensure the appropriate level of credibility of
evaluations carried out by other national authorities, they
should provide the Commission and the other Member
States with the necessary documentary evidence demon-
strating the compliance of
the conformity assessment
bodies evaluated with the relevant regulatory requirements.

(13) A system of accreditation which functions by reference to
binding rules helps
to strengthen mutual confidence
between Member States as regards the competence of
and consequently the
conformity assessment bodies
certificates and test reports issued by them.
It thereby
enhances the principle of mutual recognition and therefore
the provisions of this Regulation on accreditation should
apply in relation to bodies carrying out conformity
assessments in both the regulated and the non-regulated
areas. The issue at stake is the quality of certificates and test
reports irrespective of whether they fall within the regulated
the non-regulated area, and no distinction should
or
therefore be made between those areas.

(14) For the purposes of this Regulation, not-for-profit opera-
tion by a national accreditation body should be understood

(15) Since the purpose of accreditation is to provide an
authoritative statement of the competence of a body to
perform conformity assessment activities, Member States
should not maintain more than one national accreditation
body and should ensure that that body is organised in such
a way as to safeguard the objectivity and impartiality of its
activities. Such national accreditation bodies should operate
independently of commercial conformity assessment activ-
ities. It is therefore appropriate to provide that Member
States ensure that,
their tasks,
national accreditation bodies are deemed to exercise public
authority, irrespective of their legal status.

in the performance of

(16) For

the
the assessment and continued monitoring of
competence of a conformity assessment body, it is essential
to determine its technological knowledge and experience
and its ability to carry out assessment.
is therefore
necessary that the national accreditation body possess the
relevant knowledge, competence and means for the proper
performance of its tasks.

It

(17) Accreditation should in principle be operated as a self-
supporting activity. Member States should ensure that
financial support exists for the fulfilment of special tasks.

(18)

In those cases where it is not economically meaningful or
sustainable for a Member State to establish a national
accreditation body, that Member State should have recourse
to the national accreditation body of another Member State
and should be encouraged to have such recourse to the
fullest extent possible.

(19) Competition between national accreditation bodies could
lead to the commercialisation of their activity, which would
be incompatible with their role as the last level of control in
the conformity assessment chain. The objective of this
Regulation is to ensure that, within the European Union,
one accreditation certificate is sufficient for the whole
territory of the Union, and to avoid multiple accreditation,
which is added cost without added value. National
accreditation bodies may find themselves in competition
on the markets of third countries, but that must have no
effect on their activities inside the Community, or on the
cooperation and peer evaluation activities organised by the
body recognised under this Regulation.

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(20)

to avoid multiple accreditation,

to enhance
In order
acceptance and recognition of accreditation certificates
and to carry out effective monitoring of accredited
conformity assessment bodies, conformity assessment
bodies
should request accreditation by the national
accreditation body of the Member State in which they are
established. Nevertheless, it is necessary to ensure that a
conformity assessment body is able to request accreditation
in another Member State in the event that there is no
national accreditation body in its own Member State or
where the national accreditation body is not competent to
provide the accreditation services requested. In such cases,
appropriate cooperation and exchange of
information
between national accreditation bodies should be estab-
lished.

the availability of accreditation activities operated by
national accreditation bodies should also be made public
and,
to conformity
assessment bodies.

therefore, accessible,

in particular

(25) Sectoral accreditation schemes should cover the fields of
activity where general requirements for the competence of
conformity assessment bodies are not sufficient to ensure
the necessary level of protection where specific detailed
technology or health and safety-related requirements are
imposed. Given the fact that the EA has at its disposal a
broad range of technical expertise, it should be requested to
develop such schemes, especially for areas covered by
Community legislation.

(21)

In order to ensure that national accreditation bodies fulfil
the requirements and obligations provided for in this
Regulation, it is important that Member States support the
proper functioning of the accreditation system, monitor
their national accreditation bodies regularly and take
appropriate corrective measures within a reasonable time-
frame where necessary.

(26) For the purpose of ensuring the equivalent and consistent
enforcement of Community harmonisation legislation, this
Regulation introduces a Community 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.

(22)

to ensure the equivalence of

the level of
In order
competence of conformity assessment bodies, to facilitate
mutual recognition and to promote the overall acceptance
of accreditation certificates and conformity assessment
it is necessary that
results issued by accredited bodies,
national accreditation bodies operate a rigorous and
transparent peer evaluation system and regularly undergo
such evaluation.

(27)

In the case of economic operators in possession of test
reports or certificates attesting conformity issued by an
accredited conformity assessment body, where the relevant
Community harmonisation legislation does not require
such reports or certificates, market surveillance authorities
should take due account of them when performing checks
on product characteristics.

the evaluation of

(23) This Regulation should provide for the recognition of a
single organisation at European level in respect of certain
functions in the field of accreditation. The European
cooperation for Accreditation (the EA), whose main
mission is to promote a transparent and quality-led system
for
the competence of conformity
assessment bodies throughout Europe, manages a peer
evaluation system among national accreditation bodies
from the Member States and other European countries.
That system has proved to be efficient and to provide
mutual confidence. The EA should, therefore, be the first
body recognised under this Regulation and Member States
should ensure that their national accreditation bodies seek
and maintain membership of the EA for as long as it is so
recognised. At the same time, the possibility of changing
the relevant body recognised under this Regulation should
be provided for, in case there is a need for it in the future.

for

the proper

(24) Effective cooperation among national accreditation bodies
implementation of peer
is essential
evaluation and with regard to cross-border accreditation.
In the interests of transparency, it is, therefore, necessary to
provide for an obligation on national accreditation bodies
to exchange information among themselves and to provide
the national authorities and the Commission with relevant
information. Updated and accurate information concerning

(28) Cooperation between competent authorities at national
level and across borders
in exchanging information,
investigating infringements and taking action to bring
about their cessation, even before the placing on the market
of dangerous products, by reinforcing measures to identify
them, mainly in seaports, is essential to the protection of
health and safety and to guaranteeing the
smooth
functioning of
the internal market. National consumer
protection authorities should cooperate, at national level,
with national market surveillance authorities and should
exchange information with them relating to products which
they suspect present a risk.

(29) Risk assessment should take all relevant data into account,
that have
including, where available, data on risks
materialised with respect
in question.
Account should also be taken of any measures that may
have been taken by the economic operators concerned to
alleviate the risks.

to the product

(30) Situations of serious risk posed by a product require rapid
the
intervention, which may entail
product,
its recall or the prohibition of its being made
available on the market. In those situations it is necessary to
have access to a system of rapid exchange of information
between Member States and the Commission. The system

the withdrawal of

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provided for in Article 12 of Directive 2001/95/EC has
proved its effectiveness and efficiency in the field of
consumer products. To avoid unnecessary duplication, that
system should be used for the purposes of this Regulation.
Moreover, coherent market surveillance throughout
the
Community requires a comprehensive exchange of infor-
mation on national activities in this context which goes
beyond this system.

in the case of products imported from third countries (4)
lays down rules regarding the suspension of the release of
products by customs authorities and provides for further
measures including the involvement of market surveillance
authorities. It is therefore appropriate that those provisions,
including the involvement of market surveillance author-
ities, be incorporated in this Regulation.

(31)

Information exchanged between competent authorities
should be subject to the strictest guarantees of confidenti-
ality and professional secrecy and be handled in accordance
with rules on confidentiality pursuant to the 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 docu-
ments (1),
in order to ensure that investigations are not
compromised and that
the reputations of economic
operators are not prejudiced. 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 (2) 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 (3) apply
in the context of this Regulation.

(35) Experience has shown that products which are not released
are often re-exported and subsequently enter the Commu-
nity market at other points of entry, thus undermining the
customs authorities' efforts. Market surveillance authorities
should therefore be given the means of proceeding with the
destruction of products if they deem it appropriate.

Journal of

(36) Within one year of the publication of this Regulation in the
Official
the Commission
the European Union,
should present an in-depth analysis in the realm of
consumer safety markings, followed by legislative proposals
where necessary.

(37) The CE marking, indicating the conformity of a product, is
the visible consequence of a whole process comprising
conformity assessment in a broad sense. General principles
governing the CE marking should be set out
in this
Regulation so as to make them immediately applicable and
to simplify future legislation.

(32) Community harmonisation legislation provides for specific
procedures establishing whether or not a national measure
restricting the free movement of a product is justified
(safeguard clause procedures). Those procedures apply
following a rapid exchange of information on products
presenting a serious risk.

(38) The CE marking should be the only marking of conformity
indicating that a product is in conformity with Community
harmonisation legislation. However, other markings may be
used as long as they contribute to the improvement of
consumer protection and are not covered by Community
harmonisation legislation.

(33) Points of entry at the external borders are well placed to
detect unsafe non-conforming products or products to
which the CE marking has been affixed falsely or in a
misleading manner even before they are placed on the
market. An obligation on authorities in charge of
the
control of products entering the Community market to
execute checks on an adequate scale can therefore
contribute to a safer market place. In order to increase
the effectiveness of such checks, those authorities should
receive all the necessary information concerning dangerous
non-conforming products from the market surveillance
authorities well in advance.

(39)

It is necessary for Member States to provide for appropriate
means of redress in the competent courts and tribunals in
respect of measures taken by the competent authorities
which restrict the placing on the market of a product or
which require its withdrawal or recall.

(40) Member States may find it useful to establish cooperation
with the stakeholders concerned, including sectoral profes-
sional organisations and consumer organisations, in order
to take advantage of available market intelligence when
implementing and updating market surveil-
establishing,
lance programmes.

(34) Council Regulation (EEC) No 339/93 of 8 February 1993
on checks for conformity with the rules on product safety

(1) OJ L 145, 31.5.2001, p. 43.
(2) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(3) OJ L 8, 12.1.2001, p. 1.

(41) The Member States should lay down rules on penalties
applicable to infringements of
this
Regulation and ensure that they are implemented. Those

the provisions of

(4) OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation

(EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

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penalties should be effective, proportionate and dissuasive
and could be increased if the relevant economic operator
has previously committed a similar infringement of the
provisions of this Regulation.

(42)

In order to achieve the objectives of this Regulation, it is
necessary for the Community to contribute to the financing
of activities required to implement policies in the field of
accreditation and market surveillance. Financing should be
provided in the form of grants to the body recognised
under this Regulation without a call for proposals, in the
form of grants after a call for proposals, or by the award of
contracts to that or to other bodies, depending on the
nature of the activity to be financed and in accordance with
Council Regulation (EC, Euratom) No 1605/2002 of
25 June 2002 on the Financial Regulation applicable to
the general budget of the European Communities (1) (the
Financial Regulation).

(43) For some specialised tasks, such as the production and
revision of sectoral accreditation schemes, and for other
tasks related to the verification of the technical competence
and the facilities of
laboratories and certification or
inspection bodies, the EA should initially be eligible for
Community financing, since it is well adapted to providing
the necessary technical expertise in this respect.

(44) Given the role of the body recognised under this Regulation
in the peer evaluation of accreditation bodies and its ability
to assist the Member States with the management of that
peer evaluation, the Commission should be in a position to
provide grants for the functioning of the secretariat of the
this Regulation, which should
body recognised under
provide ongoing support
for accreditation activities at
Community level.

(45) A partnership agreement should be signed, in accordance
with the provisions of the Financial Regulation, between the
Commission and the body recognised under this Regula-
tion in order to fix the administrative and financial rules on
the financing of accreditation activities.

(46)

In addition, financing should also be available to bodies
other than the body recognised under this Regulation for
other activities in the field of conformity assessment,
metrology, accreditation and market surveillance, such as
the drawing-up and updating of guidelines, inter-compar-
ison activities linked to the operation of safeguard clauses,
preliminary or ancillary activities in connection with the
implementation of Community legislation in those areas
and programmes of technical assistance and cooperation
with third countries as well as the enhancement of policies
in those areas at Community and international level.

(1) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation

(EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9).

(47) This Regulation respects
the principles

observes
Fundamental Rights of the European Union.

rights and
the fundamental
reflected in the Charter of

(48) Since the objective of this Regulation, namely to ensure that
products on the market covered by Community legislation
fulfil 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 accreditation and market
surveillance, cannot be sufficiently achieved by the Member
States and can therefore, by reason of its scale and effects,
be better achieved at Community level, the Community
may adopt measures, in accordance with the principle of
subsidiarity as set out
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,

in Article 5 of

the Treaty.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

1. This Regulation lays down rules on the organisation and
operation of accreditation of conformity assessment bodies
performing conformity assessment activities.

2. This Regulation provides a framework for
the market
surveillance of products to ensure that those products fulfil
requirements providing a high level of protection of public
interests, such as health and safety in general, health and safety at
the workplace, the protection of consumers, protection of the
environment and security.

3. This Regulation provides a framework for controls on
products from third countries.

4. This Regulation lays down the general principles of the CE
marking.

Article 2

Definitions

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

1.

‘making available on the market’ shall mean any supply of a
product
for distribution, consumption or use on the
Community market in the course of a commercial activity,
whether in return for payment or free of charge;

2.

3.

4.

5.

6.

7.

8.

9.

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‘placing on the market’ shall mean the first making available
of a product on the Community market;

13.

‘conformity assessment body’ shall mean a body that
performs conformity assessment activities including cali-
bration, testing, certification and inspection;

‘manufacturer’ shall mean 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;

14.

‘recall’ shall mean any measure aimed at achieving the
return of a product that has already been made available to
the end user;

‘authorised representative’ shall mean any natural or legal
person established within the Community who has received
a written mandate from a manufacturer to act on his behalf
in relation to specified tasks with regard to the latter's
obligations under the relevant Community legislation;

shall mean any natural or

‘importer’
legal person
established within the Community who places a product
from a third country on the Community market;

‘distributor’ shall mean any natural or legal person in the
supply chain, other than the manufacturer or the importer,
who makes a product available on the market;

‘economic operators’ shall mean the manufacturer,
the
authorised representative, the importer and the distributor;

specification’

‘technical
that
prescribes technical requirements to be fulfilled by a
product, process or service;

shall mean a document

‘harmonised standard’ shall mean a standard adopted by
the European standardisation bodies listed in
one of
Annex I to Directive 98/34/EC of the European Parliament
and of
the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of
technical
rules on
standards and regulations and of
Information Society services (1) on the basis of a request
made by the Commission in accordance with Article 6 of
that Directive;

10.

‘accreditation’ shall mean an attestation by a national
accreditation body that a conformity assessment body
meets the requirements set by harmonised standards and,
where applicable, any additional requirements including
those set out in relevant sectoral schemes, to carry out a
specific conformity assessment activity;

11.

‘national accreditation body’ shall mean the sole body in a
Member State that performs accreditation with authority
derived from the State;

15.

‘withdrawal’ shall mean any measure aimed at preventing a
product in the supply chain from being made available on
the market;

16.

17.

‘peer evaluation’ shall mean a process for the assessment of
a national accreditation body by other national accredita-
tion bodies, carried out in accordance with the require-
ments of this Regulation, and, where applicable, additional
sectoral technical specifications;

‘market surveillance’ shall mean the activities carried out
and measures taken by public authorities to ensure that
products comply with the requirements set out in the
relevant Community harmonisation legislation and do not
endanger health, safety or any other aspect of public interest
protection;

18.

‘market surveillance authority’ shall mean an authority of a
Member State
carrying out market
responsible
surveillance on its territory;

for

19.

20.

‘release for free circulation’ shall mean the procedure laid
down in Article 79 of Council Regulation (EEC) No 2913/
92 of 12 October 1992 establishing the Community
Customs Code (2);

‘CE marking’
shall mean a marking by which the
manufacturer indicates that the product is in conformity
with the applicable requirements set out in Community
harmonisation legislation providing for its affixing;

21.

‘Community harmonisation legislation’ shall mean any
Community legislation harmonising the conditions for the
marketing of products.

CHAPTER II

ACCREDITATION

Article 3

Scope

12.

‘conformity assessment’ shall mean the process demon-
strating whether
relating to a
product, process, service, system, person or body have
been fulfilled;

specified requirements

This Chapter shall apply to accreditation, used on a compulsory
or voluntary basis, relating to conformity assessment, whether
that assessment is compulsory or not, and irrespective of the
legal status of the body performing the accreditation.

(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council

Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

(2) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by
Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

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Article 4

General principles

Article 5

Operation of accreditation

Each Member State shall appoint a single national accred-

1.
itation body.

2. Where a Member State considers that it is not economically
meaningful or sustainable to have a national accreditation body
or to provide certain accreditation services, it shall, as far as
possible, have recourse to the national accreditation body of
another Member State.

3. A Member State shall inform the Commission and the other
Member States where, in accordance with paragraph 2, recourse
is had to the national accreditation body of another Member
State.

4. On the basis of the information referred to in paragraph 3
and Article 12, the Commission shall draw up and update a list
of national accreditation bodies which it shall make publicly
available.

5. Where accreditation is not operated directly by the public
authorities themselves, a Member State shall entrust its national
accreditation body with the operation of accreditation as a public
authority activity and grant it formal recognition.

6. The responsibilities and tasks of the national accreditation
body shall be clearly distinguished from those of other national
authorities.

7. The national accreditation body shall operate on a not-for-
profit basis.

8. The national accreditation body shall not offer or provide
any activities or services that conformity assessment bodies
provide, nor shall it provide consultancy services, own shares in
in a
or otherwise have a financial or managerial
conformity assessment body.

interest

Each Member State shall ensure that its national accredita-
9.
tion body has the appropriate financial and personnel resources
for the proper performance of its tasks, including the fulfilment
of special tasks, such as activities for European and international
accreditation cooperation and activities that are required to
support public policy and which are not self-financing.

10. The national accreditation body shall be a member of the
body recognised under Article 14.

1. A national accreditation body shall, when requested by a
conformity assessment body, evaluate whether that conformity
assessment body is competent to carry out a specific conformity
assessment activity. Where it is found to be competent, the
national accreditation body shall issue an accreditation certificate
to that effect.

2. When a Member State decides not to use accreditation, it
shall provide the Commission and the other Member States with
all the documentary evidence necessary for the verification of the
competence of the conformity assessment bodies it selects for
the implementation of the Community harmonisation legislation
in question.

3. National accreditation bodies shall monitor the conformity
assessment bodies to which they have issued an accreditation
certificate.

4. Where a national accreditation body ascertains that a
conformity assessment body which has received an accreditation
certificate is no longer competent
to carry out a specific
conformity assessment activity or has committed a serious
breach of its obligations, that accreditation body shall take all
appropriate measures within a reasonable timeframe to restrict,
suspend or withdraw the accreditation certificate.

5. Member States shall establish procedures for the resolution
of appeals, including, where appropriate, legal remedies against
accreditation decisions or the absence thereof.

Article 6

Principle of non-competition

1. National accreditation bodies
conformity assessment bodies.

shall not compete with

2. National accreditation bodies shall not compete with other
national accreditation bodies.

3. National accreditation bodies shall be permitted to operate
across national borders, within the territory of another Member
State, either at the request of a conformity assessment body in
the circumstances set out in Article 7(1), or, if they are asked to
do so by a national accreditation body in accordance with
Article 7(3), in cooperation with the national accreditation body
of that Member State.

Article 7

Cross-border accreditation

11. National accreditation bodies shall establish and maintain
appropriate structures to ensure the effective and balanced
involvement of all interested parties within both their organisa-
tions and the body recognised under Article 14.

1. Where a conformity assessment body requests accreditation
it shall do so with the national accreditation body of the Member
State in which it is established or with the national accreditation
body to which that Member State has had recourse in accordance
with Article 4(2).

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However, a conformity assessment body may request accredita-
tion by a national accreditation body other than those referred to
in the first subparagraph in any one of the following situations:

(a) where the Member State in which it is established has
decided not to establish a national accreditation body and
has not had recourse to the national accreditation body of
another Member State in accordance with Article 4(2);

(b) where the national accreditation bodies referred to in the
first subparagraph do not perform accreditation in respect
of
the conformity assessment activities for which ac-
creditation is sought;

(c) where the national accreditation bodies referred to in the
first subparagraph have not successfully undergone peer
evaluation under Article 10 in respect of the conformity
assessment activities for which accreditation is sought.

2. Where a national accreditation body receives a request
pursuant to paragraph 1(b) or (c), it shall inform the national
accreditation body of the Member State in which the requesting
conformity assessment body is established. In such cases, the
national accreditation body of the Member State in which the
requesting conformity assessment body is established may
participate as an observer.

3. A national accreditation body may request another national
accreditation body to carry out part of the assessment activity. In
such a case, the accreditation certificate shall be issued by the
requesting body.

Article 8

Requirements for national accreditation bodies

A national accreditation body shall fulfil the following require-
ments:

1.

2.

3.

4.

5.

it shall be organised in such a manner as to make it
independent of
it
assesses and of commercial pressures, and to ensure that
no conflicts of interest with conformity assessment bodies
occur;

the conformity assessment bodies

it shall be organised and operated so as to safeguard the
objectivity and impartiality of its activities;

it shall ensure that each decision relating to the attestation
of competence is taken by competent persons different
from those who carried out the assessment;

it shall have adequate arrangements to safeguard the
confidentiality of the information obtained;

it shall
identify the conformity assessment activities for
which it is competent to perform accreditation, referring,
where appropriate,
to relevant Community or national
legislation and standards;

7.

8.

9.

10.

it shall have a number of competent personnel at its
disposal sufficient for the proper performance of its tasks;

it shall document the duties, responsibilities and authorities
of personnel who could affect the quality of the assessment
and of the attestation of competence;

it shall establish, implement and maintain procedures for
the
monitoring the performance and competence of
personnel involved;

it shall verify that conformity assessments are carried out in
an appropriate manner, meaning that unnecessary burdens
are not imposed on undertakings and that due account is
taken of the size of an undertaking, the sector in which it
operates,
its structure, the degree of complexity of the
product technology in question and the mass or serial
nature of the production process;

11.

it shall publish audited annual accounts prepared in
accordance with generally accepted accounting principles.

Article 9

Compliance with requirements

1. Where a national accreditation body does not meet the
requirements of this Regulation or fails to fulfil its obligations
hereunder, the Member State concerned shall take appropriate
corrective action or shall ensure that such corrective action is
taken, and shall inform the Commission thereof.

2. Member States shall monitor their national accreditation
bodies at regular intervals in order to ensure that they fulfil the
requirements laid down in Article 8 on a continuing basis.

3. Member States shall take the utmost account of the results of
the
peer evaluation under Article 10 when carrying out
monitoring referred to in paragraph 2 of this Article.

4. National accreditation bodies
necessary procedures
conformity assessment bodies they have accredited.

shall have in place the
the

to deal with complaints against

Article 10

Peer evaluation

1. National accreditation bodies shall subject themselves to
peer evaluation organised by the body recognised under
Article 14.

2.
Stakeholders shall have the right to participate in the system
set up for the supervision of peer evaluation activities, but not in
individual peer evaluation procedures.

6.

it shall set up the procedures necessary to ensure efficient
management and appropriate internal controls;

3. Member States shall ensure that their national accreditation
required by
bodies
paragraph 1.

regularly undergo peer evaluation as

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Peer evaluation shall be operated on the basis of sound and
4.
transparent evaluation criteria and procedures,
in particular
concerning structural, human resource and process require-
ments, confidentiality and complaints. Appropriate appeal
procedures against decisions taken as a result of such evaluation
shall be provided for.

Peer

the national
5.
evaluation shall
accreditation bodies meet
laid down in
Article 8, taking into account the relevant harmonised standards
referred to in Article 11.

ascertain whether
the requirements

evaluation, the conformity assessment activities in respect of
which it operates accreditation and any changes thereto.

Article 13

Requests to the body recognised under Article 14

1. The Commission may, after consulting the Committee set up
by Article 5 of Directive 98/34/EC, request the body recognised
under Article 14 to contribute to the development, maintenance
and implementation of accreditation in the Community.

6. The outcome of peer evaluation shall be published and
communicated by the body recognised under Article 14 to all
Member States and the Commission.

2. The Commission may also, following the procedure laid
down in paragraph 1:

in cooperation with the Member
7. The Commission shall,
States, oversee the rules and the proper functioning of the peer
evaluation system.

(a)

request the body recognised under Article 14 to lay down
evaluation criteria and procedures for peer evaluation and
to develop sectoral accreditation schemes;

Article 11

(b)

accept any existing scheme that already lays down
evaluation criteria and procedures for peer evaluation.

Presumption of conformity for national accreditation
bodies

1. National accreditation bodies that demonstrate conformity
with the criteria laid down in the relevant harmonised standard,
the reference of which has been published in the Official Journal of
the European Union, by having successfully undergone peer
evaluation under Article 10 shall be presumed to fulfil the
requirements laid down in Article 8.

2. National authorities shall recognise the equivalence of the
services delivered by those accreditation bodies which have
successfully undergone peer evaluation under Article 10, and
thereby accept, on the basis of the presumption referred to in
paragraph 1 of this Article, the accreditation certificates of those
bodies and the attestations issued by the conformity assessment
bodies accredited by them.

Article 12

Information obligation

Each national accreditation body shall

inform the other
1.
national accreditation bodies of
the conformity assessment
activities in respect of which it operates accreditation and of any
changes thereto.

2.
Each Member State shall inform the Commission and the
body recognised under Article 14 of the identity of its national
accreditation body and of all conformity assessment activities in
respect of which that body operates accreditation in support of
Community harmonisation legislation, and of any changes
thereto.

3. The Commission shall ensure that sectoral schemes identify
the technical specifications necessary to meet
the level of
competence required by Community harmonisation legislation
in fields with specific requirements relating to technology, health
and safety or environment related requirements or any other
aspect of public interest protection.

Article 14

European accreditation infrastructure

1. The Commission shall, after consulting the Member States,
recognise a body which satisfies the requirements set out in
Annex I to this Regulation.

2. A body which is to be recognised pursuant to paragraph 1
shall conclude an agreement with the Commission. That
agreement shall specify, inter alia, the detailed tasks of the body,
funding provisions and provisions for its supervision. Both the
Commission and the body shall be able to terminate the
agreement without cause at the expiry of a reasonable period of
notice to be defined therein.

3. The Commission and the body shall make the agreement
public.

4. The Commission shall communicate the recognition of a
body pursuant to paragraph 1 to the Member States and to
national accreditation bodies.

5. The Commission may not recognise more than one body at
a time.

Each national accreditation body shall

regularly make
3.
publicly available information concerning the results of its peer

6. The first body recognised under this Regulation shall be the
European cooperation for accreditation, provided that it has
concluded an agreement as specified in paragraph 2.

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CHAPTER III

harmonisation legislation provides that its provisions shall apply
to such products.

COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND
CONTROLS OF PRODUCTS ENTERING THE COMMUNITY
MARKET

SECTION 1

General provisions

Article 15

Scope

1. Articles 16 to 26 shall apply to products covered by
Community harmonisation legislation.

SECTION 2

Community market surveillance framework

Article 17

Information obligations

1. Member States shall inform the Commission of their market
surveillance authorities and their areas of competence. The
information to the other
that
Commission shall
Member States.

transmit

Each of the provisions of Articles 16 to 26 shall apply in so
2.
far as there are no specific provisions with the same objective in
Community harmonisation legislation.

2. Member States shall ensure that the public is aware of the
existence,
responsibilities and identity of national market
surveillance authorities, and of how those authorities may be
contacted.

3. The application of this Regulation shall not prevent market
surveillance authorities from taking more specific measures as
provided for in Directive 2001/95/EC.

For the purposes of Articles 16 to 26, a ‘product’ shall mean
4.
a substance, preparation or good produced through a manu-
facturing process other than food, feed, living plants and animals,
products of human origin and products of plants and animals
relating directly to their future reproduction.

5. Articles 27, 28 and 29 shall apply to all products covered by
Community legislation in so far as other Community legislation
does not contain specific provisions relating to the organisation
of border controls.

Article 16

General requirements

Article 18

Obligations of the Member States as regards organisation

1. Member States shall establish appropriate communication
and coordination mechanisms between their market surveillance
authorities.

2. Member States shall establish adequate procedures in order
to:

(a)

follow up complaints or reports on issues relating to risks
arising in connection with products subject to Community
harmonisation legislation;

(b) monitor accidents and harm to health which are suspected

to have been caused by those products;

1. Member States
surveillance as provided for in this Chapter.

shall organise and carry out market

(c)

verify that corrective action has been taken; and

2. Market surveillance shall ensure that products covered by
Community harmonisation legislation which, when used in
accordance with their intended purpose or under conditions
which can be reasonably foreseen and when properly installed
and maintained, are liable to compromise the health or safety of
users, or which otherwise do not conform to applicable
requirements set out in Community harmonisation legislation
are withdrawn or their being made available on the market is
prohibited or restricted and that the public, the Commission and
the other Member States are informed accordingly.

surveillance

3. National market
and pro-
grammes shall ensure that effective measures can be taken in
relation to any product category subject
to Community
harmonisation legislation.

infrastructures

4. Market surveillance shall cover products assembled or
manufactured for the manufacturer's own use where Community

(d)

follow up scientific and technical knowledge concerning
safety issues.

3. Member States shall entrust market surveillance authorities
with the powers, resources and knowledge necessary for the
proper performance of their tasks.

4. Member States
surveillance
ensure
authorities exercise their powers in accordance with the principle
of proportionality.

that market

shall

5. Member States shall establish, implement and periodically
update their market surveillance programmes. Member States
shall draw up either a general market surveillance programme or
sector specific programmes, covering the sectors in which they
conduct market surveillance, communicate those programmes to
the other Member States and the Commission and make them

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available to the public, by way of electronic communication and,
where appropriate, by other means. The first such communica-
tion shall be effected by 1 January 2010. Subsequent updates of
the programmes shall be made public in the same manner.
Member States may cooperate with all relevant stakeholders to
those ends.

5. Market surveillance authorities shall observe confidentiality
where necessary in order to protect commercial secrets or to
preserve personal data pursuant to national legislation, subject to
the requirement that information be made public under this
Regulation to the fullest extent necessary in order to protect the
interests of users in the Community.

6. Member States shall periodically review and assess the
functioning of their surveillance activities. Such reviews and
assessments shall be carried out at least every fourth year and the
results thereof shall be communicated to the other Member
States and the Commission and be made available to the public,
by way of electronic communication and, where appropriate, by
other means.

Article 19

Market surveillance measures

Article 20

Products presenting a serious risk

1. Member States shall ensure that products which present a
serious risk requiring rapid intervention, including a serious risk
the effects of which are not immediate, are recalled, withdrawn
or that their being made available on their market is prohibited,
and that the Commission is informed without delay thereof, in
accordance with Article 22.

1. Market surveillance authorities shall perform appropriate
checks on the characteristics of products on an adequate scale, by
means of documentary checks and, where appropriate, physical
and laboratory checks on the basis of adequate samples. When
doing so they shall take account of established principles of risk
assessment, complaints and other information.

2. The decision whether or not a product represents a serious
risk shall be based on an appropriate risk assessment which takes
account of the nature of the hazard and the likelihood of its
occurrence. The feasibility of obtaining higher levels of safety or
the availability of other products presenting a lesser degree of
risk shall not constitute grounds for considering that a product
presents a serious risk.

Market surveillance authorities may require economic operators
to make such documentation and information available as
appear to them to be necessary for the purpose of carrying out
their activities, and, where it is necessary and justified, enter the
premises of economic operators and take the necessary samples
of products. They may destroy or otherwise render inoperable
products presenting a serious risk where they deem it necessary.

Where economic operators present test reports or certificates
attesting conformity issued by an accredited conformity
assessment body, market surveillance authorities shall take due
account of such reports or certificates.

surveillance

take appropriate
authorities
2. Market
measures to alert users within their territories within an adequate
timeframe of hazards they have identified relating to any product
so as to reduce the risk of injury or other damage.

shall

They shall cooperate with economic operators regarding actions
which could prevent or reduce risks caused by products made
available by those operators.

3. Where the market surveillance authorities of one Member
State decide to withdraw a product manufactured in another
Member State,
inform the economic operator
concerned at the address indicated on the product in question
or in the documentation accompanying that product.

they shall

Article 21

Restrictive measures

1. Member States
shall ensure that any measure taken,
pursuant to the relevant Community harmonisation legislation,
to prohibit or restrict the product's being made available on the
market, to withdraw it from the market or to recall
is
proportionate and states the exact grounds on which it is based.

it,

2.
Such measures shall be communicated without delay to the
relevant economic operator, which shall at the same time be
informed of the remedies available under the law of the Member
State concerned and of the time limits to which such remedies
are subject.

Prior to the adoption of a measure referred to in paragraph 1,
3.
the economic operator concerned shall be given the opportunity
to be heard within an appropriate period of not less than
10 days, unless such consultation is not possible because of the
urgency of the measure to be taken, as justified by health or
safety requirements or other grounds relating to the public
interests covered by the relevant Community harmonisation
legislation. If action has been taken without the operator's being
heard, the operator shall be given the opportunity to be heard as
soon as possible and the action taken shall be reviewed promptly
thereafter.

4. Market surveillance authorities shall carry out their duties
independently, impartially and without bias.

4. Any measure referred to in paragraph 1 shall be promptly
withdrawn or amended upon the economic operator's demon-
strating that he has taken effective action.

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Article 22

Exchange of information — Community Rapid Information
System

1. Where a Member State takes or intends to take a measure in
accordance with Article 20 and considers that the reasons which
prompted the measure or the effects of the measure go beyond
its territory, it shall immediately notify the Commission of that
measure, in accordance with paragraph 4 of this Article. It shall
also inform the Commission without delay of the modification
or withdrawal of any such measure.

2.
If a product presenting a serious risk has been made
shall notify the
available on the market, Member States
Commission of any voluntary measures taken and commu-
nicated by an economic operator.

3. The information provided in accordance with paragraphs 1
and 2 shall include all available details, in particular the data
necessary for the identification of the product, the origin and the
supply chain of the product, the related risk, the nature and the
duration of
the national measure taken and any voluntary
measures taken by economic operators.

4.
For the purposes of paragraphs 1, 2 and 3, the market
surveillance and information exchange system provided for in
Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2,
3 and 4 of Article 12 of that Directive shall apply mutatis
mutandis.

Article 23

General information support system

1. The Commission shall develop and maintain a general
archiving and exchange of information system, using electronic
means, on issues relating to market surveillance activities,
programmes and related information on non-compliance with
Community harmonisation legislation. The system shall appro-
priately reflect notifications and information provided under
Article 22.

2.
For the purposes of paragraph 1, Member States shall
provide the Commission with information at their disposal and
not already provided under Article 22 on products presenting a
identification of risks, results of
risk regarding,
testing carried out, provisional
taken,
restrictive measures
contacts with the economic operators concerned and justifica-
tion for action or inaction.

in particular,

3. Without prejudice to Article 19(5) or to national legislation
in the area of confidentiality, the safeguarding of confidentiality
with regard to the information content shall be ensured. The
protection of confidentiality shall not prevent the dissemination
to market surveillance authorities of information relevant to
ensuring the effectiveness of market surveillance activities.

Article 24

Principles of cooperation between the Member States and
the Commission

1. Member States
exchange of

shall ensure efficient cooperation and
information between their market surveillance

authorities and those of the other Member States and between
their own authorities and the Commission and the relevant
Community agencies regarding their market surveillance pro-
grammes and all issues relating to products presenting risks.

2.
For the purposes of paragraph 1, the market surveillance
authorities of one Member State shall give the market
surveillance authorities of other Member States assistance on
an adequate scale by supplying information or documentation,
by carrying out appropriate investigations or any other
appropriate measure and by participating in investigations
initiated in other Member States.

3. The Commission shall collect and organise such data on
national market surveillance measures as will enable it to fulfil its
obligations.

4. Any information provided by an economic operator under
Article 21(3) or otherwise shall be included when the reporting
Member State notifies other Member States and the Commission
of its findings and actions. Any subsequent information shall be
clearly identified as relating to the information already provided.

Article 25

Sharing of resources

1. Market surveillance initiatives designed to share resources
and expertise between the competent authorities of the Member
States may be set up by the Commission or the Member States
concerned. Such initiatives
coordinated by the
Commission.

shall be

For the purposes of paragraph 1, the Commission shall, in

2.
cooperation with the Member States:

(a)

(b)

develop and organise training programmes and exchanges
of national officials;

develop, organise and set up programmes for the exchange
of experience, information and best practice, programmes
and actions for common projects, information campaigns,
joint visit programmes and the consequent sharing of
resources.

3. Member States shall ensure that their competent authorities
participate fully in the activities referred to in paragraph 2, where
appropriate.

Article 26

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 European systems and promoting activities
relating to conformity assessment, market surveillance and
accreditation.

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The Commission shall,
develop appropriate programmes for that purpose.

in cooperation with Member States,

2. Cooperation with the competent authorities of
third
countries shall take the form of, inter alia, the activities referred
to in Article 25(2). Member States shall ensure that
their
competent authorities participate fully in those activities.

SECTION 3

Controls of products entering the Community market

Article 27

Controls of products entering the Community market

the Member States in charge of

the
1. The authorities of
control of products entering the Community market shall have
the powers and resources necessary for the proper performance
of their tasks. They shall carry out appropriate checks on the
characteristics of products on an adequate scale, in accordance
with the principles set out in Article 19(1), before those products
are released for free circulation.

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

to their

3. The authorities in charge of external border controls shall
suspend release of a product
free circulation on the
Community market when any of the following findings are
made in the course of the checks referred to in paragraph 1:

for

(a)

(b)

the product displays characteristics which give cause to
believe that the product, when properly installed, main-
tained and used, presents a serious risk to health, safety, the
environment or any other public interest referred to in
Article 1;

the product is not accompanied by the written or electronic
documentation required by the
relevant Community
harmonisation legislation or is not marked in accordance
with that legislation;

(c)

the CE marking has been affixed to the product in a false or
misleading manner.

The authorities in charge of external border controls shall
immediately notify the market surveillance authorities of any
such suspension.

4.
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.

For the purposes of this Section, Article 24 shall apply in
5.
respect of authorities in charge of external border controls,
without prejudice to the application of Community law
providing for more specific systems of cooperation between
those authorities.

Article 28

Release of products

1. A product the release of which has been suspended by the
authorities in charge of external border controls pursuant to
Article 27 shall be released if, within three working days of the
suspension of release, those authorities have not been notified of
any action taken by the market surveillance authorities, and
provided that all
requirements and formalities
pertaining to such release have been fulfilled.

the other

2. Where the market surveillance authorities find that the
product in question does not present a serious risk to health and
safety or cannot be regarded as being in breach of Community
harmonisation legislation,
shall be released,
provided that all
requirements and formalities
pertaining to such release have been fulfilled.

that product

the other

Article 29

National measures

1. Where the market surveillance authorities find that a
product presents a serious risk, they shall take measures to
prohibit that product from being placed on the market and shall
require the authorities in charge of external border controls to
include the following endorsement on the commercial invoice
accompanying the product and on any other relevant accom-
panying document or, where data processing is carried out
electronically, in the data-processing system itself:

‘Dangerous product — release for free circulation not authorised
— Regulation (EC) No 765/2008’.

2. Where the market surveillance authorities find that a
product does not comply with Community harmonisation
legislation, they shall take appropriate action, which may,
if
necessary, include prohibiting the product's being placed on the
market.

Where placing on the market is prohibited pursuant to the first
subparagraph, the market surveillance authorities shall require
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 accompany-
ing the product and on any other relevant accompanying
document or, where data processing is carried out electronically,
in the data-processing system itself:

‘Product not in conformity — release for free circulation not
authorised — Regulation (EC) No 765/2008’.

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3. Where that product is subsequently declared for a customs
procedure other than release for free circulation and provided
that
the
the market surveillance authorities do not object,
endorsements set out in paragraphs 1 and 2 shall also be
included, under the same conditions, on the documents used in
connection with that procedure.

4. Member States' authorities may destroy or otherwise render
inoperable products presenting a serious risk where they deem it
necessary and proportionate.

5. Market surveillance authorities shall provide authorities in
charge of external border controls with information on product
categories in which a serious risk or non-compliance within the
meaning of paragraphs 1 and 2 has been identified.

CHAPTER IV

CE MARKING

Article 30

General principles of the CE marking

1. The CE marking shall be affixed only by the manufacturer or
his authorised representative.

2. The CE marking as presented in Annex II shall be affixed
only to products to which its affixing is provided for by specific
Community harmonisation legislation, and shall not be affixed
to any other product.

the
3. By affixing or having affixed the CE marking,
manufacturer
the
indicates that he takes responsibility for
conformity of the product with all applicable requirements set
out
in the relevant Community harmonisation legislation
providing for its affixing.

4. The CE marking shall be the only marking which attests the
conformity of the product with the applicable requirements of
the relevant Community harmonisation legislation providing for
its affixing.

5. The affixing to a product of markings, signs or inscriptions
which are likely to mislead third parties regarding the meaning or
form of the CE marking shall be prohibited. Any other marking
the visibility,
may be affixed to the product provided that
legibility and meaning of
thereby
impaired.

the CE marking is not

6. Without prejudice to Article 41, Member States shall ensure
the correct implementation of the regime governing the CE
marking and take appropriate action in the event of improper
the marking. Member States shall also provide for
use of
penalties
criminal
sanctions for serious infringements. Those penalties shall be
proportionate to the seriousness of the offence and constitute an
effective deterrent against improper use.

infringements, which may include

for

CHAPTER V

COMMUNITY FINANCING

Article 31

Body pursuing an aim of general European interest

The body recognised under Article 14 shall be considered a body
pursuing an aim of general European interest within the meaning
of Article 162 of Commission Regulation (EC, Euratom)
No 2342/2002 of 23 December 2002 laying down detailed
rules for
the implementation of Regulation (EC, Euratom)
No 1605/2002 (1).

Article 32

Activities eligible for Community financing

1. The Community may finance the following activities in
connection with the application of this Regulation:

(a)

(b)

(c)

(d)

(e)

(f)

the production and revision of
schemes referred to in Article 13(3);

sectoral accreditation

the activities of the secretariat of the body recognised under
Article 14, such as the coordination of accreditation
activities, the processing of technical work linked to the
operation of the peer evaluation system, the provision of
interested parties with information and the participation of
the body in the activities of international organisations in
the field of accreditation;

the drawing up and updating of contributions to guidelines
in the fields of accreditation, notification to the Commis-
sion of conformity assessment bodies, conformity assess-
ment and market surveillance;

inter-comparison activities linked to the operation of
safeguard clauses;

the making available to the Commission of
technical
expertise for the purpose of assisting the Commission in its
administrative
surveillance
implementation of market
cooperation,
including the financing of administrative
cooperation groups, market surveillance decisions and
safeguard clause cases;

the performance of preliminary or ancillary work in
connection with the implementation of the conformity
assessment, metrology, accreditation and market surveil-
lance activities linked to the implementation of Community
studies, programmes, evaluations,
legislation,
guidelines,
joint visits,
research work,
the development and maintenance of
databases, training activities, laboratory work, proficiency
inter-laboratory tests and conformity assessment
testing,
work, as well as European market surveillance campaigns
and similar activities;

such as
comparative

analyses, mutual

(1) OJ L 357, 31.12.2002, p. 1. Regulation as last amended by
Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007,
p. 13).

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(g)

technical
activities carried out under programmes of
assistance, cooperation with third countries and the
promotion and enhancement of European conformity
assessment, market surveillance and accreditation policies
and systems among interested parties in the Community
and at international level.

2. The activities referred to in paragraph 1(a) shall be eligible
for Community financing only if the Committee set up by
Article 5 of Directive 98/34/EC has been consulted on the
requests to be submitted to the body recognised under Article 14
of this Regulation.

Article 33

Bodies eligible for Community financing

Community financing may be granted to the body recognised
under Article 14 for the implementation of the activities set out
in Article 32.

However, Community financing may also be granted to other
bodies for the carrying out of the activities set out in Article 32,
except those set out in paragraph 1(a) and (b) of that Article.

Article 34

Financing

The appropriations allocated to the activities referred to in this
Regulation shall be determined each year by the budgetary
authority within the limits of the financial framework in force.

Article 35

Financing arrangements

1. Community financing shall be provided:

(a) without a call for proposals, to the body recognised under
those activities referred to in
Article 14 to carry out
Article 32(1)(a) to (g) for which grants can be awarded in
accordance with the Financial Regulation;

(b)

in the form of grants after a call for proposals, or by public
procurement procedures, to other bodies to carry out the
activities referred to in Article 32(1)(c) to (g).

2. The activities of the secretariat of the body recognised under
Article 14 referred to in Article 32(1)(b) may be financed on the
basis of operating grants. In the event of renewal, the operating
grants shall not be decreased automatically.

3. Grant agreements may authorise flat-rate cover of
the
beneficiary's overheads up to a maximum of 10 % of total
eligible direct costs for actions, except where the beneficiary's
indirect costs are covered through an operating grant financed
from the Community budget.

4. The common cooperation objectives and the administrative
and financial conditions relating to the grants awarded to the
body recognised under Article 14 may be defined in a framework
partnership agreement signed by the Commission and that body,
in accordance with the Financial Regulation and Regulation (EC,
Euratom) No 2342/2002. The European Parliament and the
Council shall be informed of
the conclusion of any such
agreement.

Article 36

Management and monitoring

1. The appropriations determined by the budgetary authority
for the financing of conformity assessment, accreditation and
market surveillance activities may also cover administrative
expenses relating to preparation, monitoring, inspection, audit-
ing and evaluation which are directly necessary for
the
this Regulation, and in
achievement of
particular
information and publication
activities, expenses relating to informatics networks for the
information and any other expenditure on
exchange of
administrative and technical assistance which the Commission
may use for conformity assessment and accreditation activities.

studies, meetings,

the objectives of

the
2. The Commission shall evaluate the relevance of
conformity assessment, accreditation and market surveillance
activities that receive Community financing in the light of the
requirements of Community policies and legislation, and inform
the European Parliament and the Council of the outcome of that
evaluation by 1 January 2013 and every five years thereafter.

Article 37

Protection of the Community's financial interests

1. The Commission shall ensure that, when the activities
financed under this Regulation are implemented, the Commu-
nity's financial
interests are protected by the application of
preventive measures against fraud, corruption and other illegal
activities, by effective checks and by the recovery of amounts
irregularities are detected, by effective,
if
unduly paid and,
proportionate and dissuasive penalties,
in accordance with
Council Regulation (EC, Euratom) No 2988/95 of 18 December
1995 on the protection of the European Communities financial
interests (1), Council Regulation (Euratom, EC) No 2185/96 of
11 November 1996 concerning on-the-spot
and
inspections carried out by the Commission in order to protect
the European Communities' financial interests against fraud and
other irregularities (2) and Regulation (EC) No 1073/1999 of the
the Council of 25 May 1999
European Parliament and of
concerning investigations conducted by the European Anti-Fraud
Office (OLAF) (3).

checks

For the purposes of

2.
the Community activities financed
under this Regulation, the notion of irregularity referred to in

(1) OJ L 312, 23.12.1995, p. 1.
(2) OJ L 292, 15.11.1996, p. 2.
(3) OJ L 136, 31.5.1999, p. 1.

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Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean
any infringement of a provision of Community law or any
breach of a contractual obligation resulting from an act or
omission by an economic operator which has, or would have,
the effect of prejudicing the general budget of the European
Union or budgets managed by it by an unjustified item of
expenditure.

3. Any agreements and contracts resulting from this Regula-
tion shall provide for monitoring and financial control by the
Commission or any representative which it authorises and for
audits by the Court of Auditors, which may be conducted on the
spot if necessary.

CHAPTER VI

FINAL PROVISIONS

Article 38

Technical guidelines

In order to facilitate the implementation of this Regulation, the
Commission shall draw up non-binding guidelines in consul-
tation with stakeholders.

Article 39

Transitional provision

Accreditation certificates issued before 1 January 2010 may
remain valid until the date of their expiry, but no later than
31 December 2014. This Regulation shall, however, apply in the
case of their extension or renewal.

Article 40

Review and reporting

report

By 2 September 2013, the Commission shall submit to the
European Parliament and to the Council a report on the
application of this Regulation, of Directive 2001/95/EC and of
any other relevant Community instrument addressing market
in particular, analyse the
surveillance. That
shall,
consistency of Community rules
in the field of market
surveillance. If appropriate, it shall be accompanied by proposals
to amend and/or consolidate the instruments concerned, in the
interests of better regulation and simplification. It shall include
an evaluation of the extension of the scope of Chapter III of this
Regulation to all products.
By 1 January 2013, and every five years
Commission,

the
in cooperation with the Member States, shall

thereafter,

produce and submit to the European Parliament and to the
Council a report on the implementation of this Regulation.

Article 41

Penalties

this Regulation and shall

infringements, applicable to infringements of

The Member States shall
lay down rules on penalties for
economic operators, which may include criminal sanctions for
serious
the
take all measures
provisions of
necessary to ensure that they are implemented. The penalties
provided for shall be effective, proportionate and dissuasive and
may be increased if
the relevant economic operator has
previously committed a similar infringement of the provisions
shall notify the
of
Commission of those provisions by 1 January 2010 and shall
notify it without delay of any subsequent amendment affecting
them.

this Regulation. The Member States

Article 42

Amendment to Directive 2001/95/EC

Article 8(3) of Directive 2001/95/EC shall be replaced by the
following:

‘3.
In the case of products posing a serious risk, the competent
authorities shall with due dispatch take the appropriate measures
referred to in paragraph 1(b) to (f). The existence of a serious risk
shall be determined by the Member States, assessing each
individual case on its merits and taking into account
the
guidelines referred to in point 8 of Annex II.’.

Article 43

Repeal

Regulation (EEC) No 339/93 is hereby repealed with effect from
1 January 2010.

References to the repealed Regulation shall be construed as
references to this Regulation.

Article 44

Entry into force

This Regulation shall enter into force on the 20th day after its
publication in the Official Journal of the European Union.

It shall apply from 1 January 2010.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 9 July 2008.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

J.-P. JOUYET

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ANNEX I

Requirements applicable to the body to be recognised under Article 14

1.

2.

3.

4.

5.

The body recognised under Article 14 of the Regulation (the body), shall be established within the Community.

Under the body's constitution, national accreditation bodies from within the Community shall be entitled to be
members of it, provided that they comply with the rules and objectives of the body and with the other conditions set
out herein and as agreed with the Commission in the framework agreement.

The body shall consult all relevant stakeholders.

The body shall provide its members with peer evaluation services satisfying the requirements of Articles 10 and 11.

The body shall cooperate with the Commission in accordance with this Regulation.

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ANNEX II

CE marking

1.

The CE marking shall consist of the initials ‘CE’ taking the following form:

2.

If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be
respected.

3. Where specific legislation does not impose specific dimensions, the CE marking shall be at least 5 mm high.