Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (Text with EEA relevance)
Date: 2008-07-09
Institutions: Council of the European Union, European Parliament
Subjects: EU law - national law, free movement of goods, market approval, single market, technical regulations

13.8.2008

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REGULATION (EC) No 764/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 July 2008

laying down procedures relating to the application of certain national technical rules to products
lawfully marketed in another Member State and repealing Decision No 3052/95/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(3)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Articles 37 and 95 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),

Whereas:

(1)

The internal market comprises an area without internal
frontiers, in which the free movement of goods is ensured
under the Treaty, which prohibits measures having effects
equivalent to quantitative restrictions on imports. That
prohibition covers any national measure which is capable
of hindering, directly or indirectly, actually or potentially,
intra-Community trade in goods.

(2) Obstacles to the free movement of goods between Member
States may be unlawfully created by the Member States'
competent authorities applying, in the absence of harmo-
nisation of legislation, to products lawfully marketed in
other Member States, technical rules laying down require-
ments to be met by those products, such as rules relating to
designation, form, size, weight, composition, presentation,
labelling and packaging. The application of such rules to
products lawfully marketed in another Member State can be
contrary to Articles 28 and 30 of the Treaty, even if they
apply without distinction to all products.

(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.

Justice of

the Court of

The principle of mutual recognition, which derives from
the case-law of
the European
Communities,
is one of the means of ensuring the free
movement of goods within the internal market. Mutual
recognition applies to products which are not subject to
Community harmonisation legislation, or to aspects of
products falling outside the scope of such legislation.
According to that principle, a Member State may not
prohibit the sale on its territory of products which are
lawfully marketed in another Member State, even where
those products were manufactured in accordance with
technical rules different from those to which domestic
products are subject. The only exceptions to that principle
are restrictions which are justified on the grounds set out in
Article 30 of the Treaty, or on the basis of other overriding
reasons of public interest and which are proportionate to
the aim pursued.

(4) Many problems still exist as regards the correct application
of the principle of mutual recognition by the Member
States. It is therefore necessary to establish procedures to
minimise the possibility of technical rules' creating unlawful
obstacles to the free movement of goods between Member
States. The absence of such procedures in the Member
States creates additional obstacles to the free movement of
goods, since it discourages enterprises from selling their
products, lawfully marketed in another Member State, on
the territory of the Member State applying technical rules.
Surveys have shown that many enterprises, in particular
small and medium-sized enterprises (SMEs), either adapt
their products in order to comply with the technical rules
of Member States, or refrain from marketing them in those
Member States.

(5) Competent authorities also lack appropriate procedures for
the application of their technical rules to specific products
lawfully marketed in another Member State. The lack of
such procedures compromises their ability to assess the
conformity of products in accordance with the Treaty.

(6)

The Council Resolution of 28 October 1999 on mutual
recognition (3) noted that economic operators and citizens
did not always make full and proper use of the principle of
mutual recognition because they were not sufficiently

(3) OJ C 141, 19.5.2000, p. 5.

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aware of the principle and its operational consequences. It
called upon the Member States to develop appropriate
measures in order to provide economic operators and
citizens with an effective framework for mutual recogni-
tion,
inter alia, by dealing effectively with requests from
economic operators and citizens and by replying rapidly to
those requests.

(7)

The European Council of 8 and 9 March 2007 underlined
the importance of giving fresh impetus to the internal
market
in goods by strengthening mutual recognition,
while guaranteeing a high level of safety and consumer
protection. The European Council of 21 and 22 June 2007
stressed that the further strengthening of the four freedoms
of
(the free movement of goods,
persons, services and capital) and improving its functioning
remain of paramount importance for growth, competitive-
ness and employment.

the internal market

necessary in order to achieve that aim. The compliance of
such a procedure with the principle of proportionality
should be assessed in the light of the considerations set out
in the case-law of the Court of Justice.

(12) A requirement that the placing of a product on the market
to prior authorisation should, as such, not
be subject
this
constitute a technical rule within the meaning of
Regulation, so that a decision to exclude or remove a
product from the market exclusively on the grounds that it
does not have valid prior authorisation should not
constitute a decision to which this Regulation applies.
When, however, an application for such mandatory prior
authorisation of a product is made, any intended decision
to reject the application on the basis of a technical rule
should be taken in accordance with this Regulation, so that
the applicant could benefit from the procedural protection
which this Regulation provides.

(8)

The smooth functioning of the internal market in goods
requires adequate and transparent means of solving the
problems that result from applying technical rules of a
Member State to specific products lawfully marketed in
another Member State.

(13) Decisions of national courts or tribunals assessing the
legality of cases in which, on account of the application of a
technical rule, products lawfully marketed in one Member
State are not granted access to the market of another
Member State, or applying penalties, should be excluded
from the scope of this Regulation.

(9)

This Regulation should not prejudice further harmonisation
of
technical rules, where appropriate, with a view to
improving the functioning of the internal market.

(10) Trade barriers may also result from other types of measures
falling within the scope of Articles 28 and 30 of the Treaty.
include technical
Those measures may,
specifications drawn up for public procurement procedures
or obligations to use official
languages in the Member
States. However, such measures should not constitute
technical rules within the meaning of this Regulation and
should not therefore fall within its scope.

for example,

(11) Technical rules within the meaning of this Regulation are
sometimes applied during and by means of mandatory
prior authorisation procedures, established by the law of a
Member State and in accordance with which, before a
product or type of product may be placed on that Member
State's market or on a part thereof, the competent authority
of
that Member State should give its formal approval
following an application. The existence of such procedures
in itself restricts the free movement of goods. Therefore, in
to be justified with regard to the fundamental
order
principle of the free movement of goods within the internal
market, a mandatory prior authorisation procedure should
pursue a public-interest objective recognised by Commu-
nity law, and should be non-discriminatory and propor-
tionate; that is to say, it should be appropriate to ensure
achievement of the aim pursued but not go beyond what is

(14) Weapons are products that can constitute a serious risk to
the health and safety of persons and to the public security
of Member States. Several specific types of weapons
lawfully marketed in one Member State might, on grounds
of the protection of the health and safety of persons and the
prevention of crime, be subject to restrictive measures in
another Member State. Such measures might consist of
specific controls and authorisations before weapons law-
fully marketed in one Member State are placed on the
market of another Member State. Member States should
therefore be permitted to prevent weapons being placed on
their markets until their national procedural requirements
are fully met.

(15) Directive 2001/95/EC of the European Parliament and of
the Council of 3 December 2001 on general product
safety (1) specifies that only safe products may be placed on
the market and lays down the obligations of producers and
distributors with respect to the safety of products. It entitles
the authorities
to ban any dangerous product with
immediate effect or, for the period needed for the various
safety evaluations, checks and controls, to ban temporarily
a product that could be dangerous. It also entitles the
authorities to take the necessary action to apply with due
dispatch appropriate measures such as those referred to in
Article 8(1)(b) to (f) thereof, in the case of products posing a
serious risk. Therefore, measures taken by the competent
authorities of the Member States pursuant to national laws
adopted in implementation of Article 8(1)(d) to (f) and
Article 8(3) of that Directive should be excluded from the
scope of this Regulation.

(1) OJ L 11, 15.1.2002, p. 4.

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(16) Regulation (EC) No 178/2002 of the European Parliament
and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establish-
ing the European Food Safety Authority and laying down
procedures in matters of food safety (1) establishes, inter alia,
a rapid alert system for the notification of a direct or
indirect risk to human health deriving from food or feed. It
obliges the Member States to notify the Commission
immediately under the rapid alert system of any measure
they adopt which is aimed at restricting the placing on the
market of, withdrawing from the market or recalling food
or feed in order to protect human health, and which
requires rapid action. Measures taken by the compe-
tent authorities of the Member States pursuant to Arti-
that Regulation should
cle 50(3)(a) and Article 54 of
therefore be excluded from the scope of this Regulation.

(17) Regulation (EC) No 882/2004 of the European Parliament
and of the Council of 29 April 2004 on official controls
performed to ensure the verification of compliance with
feed and food law, animal health and animal welfare
rules (2) lays down general rules for the performance of
official controls to verify compliance with rules intended, in
particular, to prevent, eliminate or reduce to acceptable
levels risks to humans and animals, either directly or
through the environment, guaranteeing fair practices in
feed and food trade and protecting consumer interests,
including feed and food labelling and other forms of
consumer information. It lays down a specific procedure to
ensure that economic operators remedy a situation of non-
compliance with feed and food law, animal health and
animal welfare rules. Measures taken by the competent
authorities of the Member States pursuant to Article 54 of
that Regulation should therefore be excluded from the
scope of
this Regulation. However, measures taken or
intended to be taken by competent authorities on the basis
of national technical rules, insofar as they do not concern
the objectives of Regulation (EC) No 882/2004, should be
subject to this Regulation.

(18) Directive 2004/49/EC of the European Parliament and of
the Council of 29 April 2004 on safety on the
Community's railways (Railway Safety Directive) (3) pro-
vides for a procedure for authorisation of the placing in
service of existing rolling stock,
leaving scope for the
application of certain national rules. Measures taken by the
competent authorities pursuant
that
Directive should therefore be excluded from the scope of
this Regulation.

to Article 14 of

(19) Council Directive 96/48/EC of 23 July 1996 on the
the trans-European high-speed rail
interoperability of
system (4) and Directive 2001/16/EC of
the European
Parliament and of the Council of 19 March 2001 on the
interoperability of
the trans-European conventional rail
system (5) provide for the gradual harmonisation of systems
and operations
through the progressive adoption of
Technical Specifications for Interoperability. Systems and
interoperability constituents that fall within the scope of
those Directives should therefore be excluded from the
scope of this Regulation.

the Council of 9 July 2008 setting out

(20) Regulation (EC) No 765/2008 of the European Parliament
and of
the
requirements for accreditation and market surveillance
relating to the marketing of products (6) establishes a
system of accreditation which ensures the mutual accep-
tance of the level of competence of conformity-assessment
bodies. The competent authorities of the Member States
should therefore no longer
reports and
certificates issued by an accredited conformity-assessment
body on grounds related to the competence of that body.
Furthermore, Member States may also accept test reports
and certificates issued by other conformity-assessment
bodies in accordance with Community law.

refuse test

(21) 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 standards
and regulations and of
rules on Information Society
services (7) obliges Member States to communicate to the
Commission and the other Member States any draft
including
technical regulation concerning any product,
agricultural and fish products, and a statement of
the
grounds which make the enactment of
that regulation
necessary. It is necessary, however, to ensure that, following
the adoption of such a technical regulation, the principle of
mutual recognition is correctly applied in individual cases
to specific products. This Regulation lays down a procedure
for the application of the principle of mutual recognition in
individual cases, by means of
the obligation on the
competent authority to indicate the technical or scientific
grounds on which the specific product in its current form

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).

(2) OJ L 165, 30.4.2004; corrected version in OJ L 191, 28.5.2004,
p. 1. Regulation as amended by Council Regulation (EC) No 1791/
2006 (OJ L 363, 20.12.2006, p. 1).

(3) OJ L 164, 30.4.2004, p. 44; corrected version in OJ L 220,

21.6.2004, p. 16.

(4) OJ L 235, 17.9.1996, p. 6. Directive as last amended by Commission

Directive 2007/32/EC (OJ L 141, 2.6.2007, p. 63).

(5) OJ L 110, 20.4.2001, p. 1. Directive as last amended by Commission

Directive 2007/32/EC.

(6) See page 30 of this Official Journal.
(7) 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).

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cannot be marketed in its Member State, in accordance with
Articles 28 and 30 of the Treaty. In the context of this
Regulation, evidence should not be understood as meaning
legal proof. The authorities of the Member States are not
obliged, in the context of this Regulation, to justify the
technical rule itself. However, they should justify, as laid
down in this Regulation, the possible application of the
technical rule to a product lawfully marketed in another
Member State.

(22)

In accordance with the principle of mutual recognition, the
procedure laid down in this Regulation should provide for
the competent authorities to communicate in each case to
the economic operator, on the basis of
the relevant
technical or scientific elements available, that there are
overriding reasons of public interest for imposing national
in
technical rules on the product or type of product
question and that less restrictive measures cannot be used.
The written notice should allow the economic operator to
comment on all relevant aspects of the intended decision
restricting access to the market. Nothing prevents the
competent authority from taking action after the deadline
for the receipt of those comments in the absence of a reply
from the economic operator.

(23) The concept of overriding reasons of public interest to
which reference is made in certain provisions of
this
Regulation is an evolving concept developed by the Court
of Justice in its case law in relation to Articles 28 and 30 of
the Treaty. This concept covers, inter alia, the effectiveness
of fiscal supervision, the fairness of commercial transac-
tions, the protection of consumers, the protection of the
environment, the maintenance of press diversity and the
risk of seriously undermining the financial balance of the
social security system. Such overriding reasons may justify
the application of
rules by the competent
authorities. However, no such application should constitute
a means of arbitrary discrimination or a disguised
restriction of trade between Member States. Furthermore,
the principle of proportionality should always be respected,
regard being had to whether the competent authority has in
fact made use of the least restrictive measure.

technical

(24) While applying the procedure laid down in this Regulation,
the competent authority of a Member State should not
withdraw or restrict the placing on its market of a product
or type of product lawfully marketed in another Member
State. However, it is appropriate that a competent authority
be able to adopt provisional measures where rapid
intervention is required to prevent harm to safety and
health of users. Such provisional measures may also be
adopted by a competent authority to prevent the placing on
its market of a product the marketing of which is generally
prohibited on grounds of public morality or public security,
including the prevention of crime. Therefore, Member
States should be allowed, at any stage of the procedure laid
down in this Regulation,
to suspend temporarily the
marketing on their territories of products or types of
product under those circumstances.

(25) Any decision to which this Regulation applies should
specify the remedies available so that an economic operator
can bring proceedings before the competent national court
or tribunal.

(26)

is appropriate that

It
the economic operator also be
informed of the availability of non-judicial problem-solving
mechanisms, such as the SOLVIT system,
in order to
prevent legal uncertainty and legal costs.

(27) Once a competent authority has taken a decision to exclude
a product on the basis of a technical rule in accordance with
the procedural requirements of this Regulation, no further
action taken in relation to that product which is based on
that decision and on the same technical rule should be
subject to the requirements of this Regulation.

(28)

It is important for the internal market in goods that the
accessibility of national technical rules be ensured, so that
enterprises, and in particular SMEs, can gather reliable and
precise information concerning the law in force.

(29)

is

It
therefore necessary to implement principles of
administrative simplification, inter alia, through the estab-
lishment of a system of Product Contact Points. This should
be designed to ensure that enterprises can gain access to
information in a transparent and correct manner, so that
the delays, costs and dissuasive effects which result from
national technical rules can be prevented.

(30)

In order to facilitate the free movement of goods, Product
Contact Points should provide, free of charge, information
concerning their national technical rules and the applica-
tion of
the principle of mutual recognition as regards
products. Product Contact Points should be adequately
equipped and resourced and encouraged also to make the
information available through a website and in other
Community languages. Product Contact Points could also
provide economic operators with additional information or
observations during the procedure laid down in this
Regulation. For additional
information, Product Contact
Points may charge fees that are proportionate to the costs of
this information.

(31) Since the creation of Product Contact Points should not
interfere with the allocation of functions among competent
authorities within the regulatory systems of the Member
States, it should be possible for Member States to set up
Product Contact Points according to regional or local

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competences. Member States should be able to entrust the
role of Product Contact Points to existing contact points
established in accordance with other Community instru-
ments, in order to prevent the unnecessary proliferation of
contact points and to simplify administrative procedures.
Member States should also be able to entrust the role of
Product Contact Points not only to existing services within
the public administration, but also to national SOLVIT
centres, chambers of commerce, professional organisations
and private bodies, in order not to increase administrative
costs for enterprises and competent authorities.

(32) Member States and the Commission should be encouraged
to work closely together to facilitate the training of staff
employed in Product Contact Points.

(33)

In view of the development and establishment of a pan-
European eGovernment service and the underlying inter-
operable telematic networks, the possibility of establishing
an electronic system for the exchange of
information
between Product Contact Points should be envisaged, in
accordance with Decision 2004/387/EC of the European
Parliament and of the Council of 21 April 2004 on the
interoperable delivery of pan-European eGovernment
services to public administrations, businesses and citizens
(IDABC) (1).

(34) Reliable and efficient monitoring and evaluation mechan-
isms should be established in order to provide information
on the application of this Regulation so as to enhance
the internal
knowledge concerning the functioning of
market in goods in sectors not subject to harmonisation
and to ensure that the principle of mutual recognition is
duly applied by the competent authorities of the Member
States. Such mechanisms should not go beyond what is
necessary to achieve those objectives.

(35) This Regulation applies only to products or particular
features of products which are not subject to Community
harmonisation measures intended to eliminate obstacles to
trade between Member States resulting from the existence
of divergent national technical rules. The provisions of such
harmonisation measures are often exhaustive, in which case
Member States may not prohibit, restrict or impede the
placing on the market
in their territories of products
complying with those measures. Some Community har-
monisation measures, however, permit Member States to
impose additional technical conditions on the placing of a
product on their market. Such additional conditions should
be subject to Articles 28 and 30 of the Treaty and to the
provisions of this Regulation. It is therefore appropriate,
with a view to the efficient application of this Regulation,
that the Commission should establish an indicative and
non-exhaustive list of products which are not subject to
harmonisation at Community level.

(36) The monitoring

scheme

by Decision
No 3052/95/EC of the European Parliament and of the
Council of 13 December 1995 establishing a procedure for
information on national measures
the

exchange of

established

derogating from the principle of the free movement of
goods within the Community (2) has proved largely
unsuccessful in that its implementation has not provided
the Commission with sufficient information to identify
sectors where harmonisation might be appropriate. Nor has
it brought about a rapid resolution of certain free-
movement problems. Decision No 3052/95/EC should
therefore be repealed.

(37)

It is appropriate to introduce a transitional period for the
application of
in order to enable the
competent authorities to adapt to the requirements laid
down herein.

this Regulation,

(38) Since

the objective of

this Regulation, namely the
elimination of technical obstacles to the free movement
of goods between Member States, 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 Article 5 of
the Treaty. In accordance with the principle of proportion-
ality, as set out in that Article, this Regulation does not go
beyond what is necessary in order to achieve that objective.

(39) The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
implementing powers
the exercise of
procedures
conferred on the Commission (3),

for

HAVE ADOPTED THIS REGULATION:

CHAPTER 1

SUBJECT MATTER AND SCOPE

Article 1

Subject matter

1. The aim of this Regulation is to strengthen the functioning
of the internal market by improving the free movement of goods.

2. This Regulation lays down the rules and procedures to be
followed by the competent authorities of a Member State when
taking or intending to take a decision, as referred to in Arti-
cle 2(1), which would hinder the free movement of a product
lawfully marketed in another Member State and subject
to
Article 28 of the Treaty.

(1) OJ L 144, 30.4.2004; corrected version in OJ L 181, 18.5.2004,

p. 25.

(2) OJ L 321, 30.12.1995, p. 1.
(3) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

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It also provides for the establishment of Product Contact
3.
Points in the Member States to contribute to the achievement of
the aim of this Regulation, as set out in paragraph 1.

Article 2

Scope

1. This Regulation shall apply to administrative decisions
addressed to economic operators, whether taken or intended, on
the basis of a technical rule as defined in paragraph 2, in respect
of any product, including agricultural and fish products, lawfully
marketed in another Member State, where the direct or indirect
effect of that decision is any of the following:

(a)

(b)

the prohibition of
product or type of product;

the placing on the market of

that

the modification or additional testing of that product or
type of product before it can be placed or kept on the
market;

(c)

the withdrawal of that product or type of product from the
market.

the purposes of point

the first subparagraph,
For
modification of the product or type of product shall mean any
modification of one or more of the characteristics of a product
or a type of product as listed in point (b)(i) of paragraph 2.

(b) of

affects the life-cycle of the product after it has been
placed on the market, such as conditions of use,
recycling, reuse or disposal, where such conditions can
significantly influence the composition, nature or
marketing of the product or type of product.

3. This Regulation shall not apply to:

(a)

decisions of a judicial nature taken by national courts or
tribunals;

(b)

decisions of a judicial nature taken by law enforcement
authorities in the course of the investigation or prosecution
of a criminal offence as regards the terminology, symbols or
any material reference to unconstitutional or criminal
organisations or offences of a racist or xenophobic nature.

Article 3

Relationship with other provisions of Community law

1. This Regulation shall not apply to systems or interoper-
ability constituents falling within the scope of Directives 96/48/
EC and 2001/16/EC.

2. This Regulation shall not apply in the case of measures taken
by the authorities of the Member States pursuant to:

(a) Article 8(1)(d) to (f) and Article 8(3) of Directive 2001/95/

EC;

2.
For the purposes of this Regulation, a technical rule is any
provision of a law, regulation or other administrative provision
of a Member State:

(b) Article 50(3)(a) and Article 54 of Regulation (EC) No 178/

2002;

(a) which is not the subject of harmonisation at Community

level; and

(d) Article 14 of Directive 2004/49/EC.

(c) Article 54 of Regulation (EC) No 882/2004;

(b) which prohibits the marketing of a product or type of
product in the territory of that Member State or compliance
with which is compulsory when a product or type of
product is marketed in the territory of that Member State,
and which lays down either:

(i)

the characteristics required of that product or type of
product, such as levels of quality, performance or
safety, or dimensions,
including the requirements
applicable to the product or product type as regards
the name under which it
terminology,
symbols, testing and test methods, packaging, mark-
ing or labelling; or

sold,

is

CHAPTER 2

PROCEDURE FOR THE APPLICATION OF A TECHNICAL RULE

Article 4

Information on the product

Where a competent authority submits a product or type of
product to an evaluation to determine whether or not to adopt a
decision as referred to in Article 2(1), it may request from the
economic operator identified in accordance with Article 8, with
due regard to the principle of proportionality, any of
the
following in particular:

(ii)

any other requirement which is imposed on the
for the purposes of
product or type of product
protecting consumers or the environment, and which

(a)

relevant information concerning the characteristics of the
product or type of product in question;

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(b)

relevant and readily available information on the lawful
marketing of the product in another Member State.

Article 5

Mutual recognition of the level of competence of accredited
conformity-assessment bodies

Member States shall not refuse certificates or test reports issued
by a conformity-assessment body accredited for the appropriate
field of conformity-assessment activity in accordance with
Regulation (EC) No 765/2008 on grounds related to the
competence of that body.

Article 6

Assessment of the need to apply a technical rule

1. Where a competent authority intends to adopt a decision as
referred to in Article 2(1), it shall send the economic operator
identified in accordance with Article 8 written notice of that
intention, specifying the technical rule on which the decision is
to be based and setting out technical or scientific evidence to the
effect that:

(a)

(b)

the intended decision is justified on one of the grounds of
public interest set out in Article 30 of the Treaty or by
reference to other overriding reasons of public interest; and

the intended decision is appropriate for the purpose of
achieving the objective pursued and does not go beyond
what is necessary in order to attain that objective.

Any intended decision shall be based on the characteristics of the
product or type of product in question.

The economic operator concerned shall, following receipt of
such notice, be allowed at least 20 working days in which to
submit comments. The notice shall specify the time limit within
which comments may be submitted.

2. Any decision as referred to in Article 2(1) shall be taken and
notified to the economic operator concerned and to the
Commission within a period of 20 working days from the
expiry of the time limit for the receipt of comments from the
economic operator referred to in paragraph 1 of this Article. It
shall take due account of those comments and shall state the
grounds on which it is based, including the reasons for rejecting
the arguments,
if any, put forward by the operator, and the
technical or scientific evidence as referred to in paragraph 1 of
this Article.

Any decision as referred to in Article 2(1) shall also specify the
remedies available under the law in force in the Member State
concerned and the time limits applying to such remedies. Such a
decision may be challenged before national courts or tribunals or
other instances of appeal.

3. Where, after giving written notice in accordance with
paragraph 1, the competent authority decides not to adopt a
decision as referred to in Article 2(1), it shall immediately inform
the economic operator concerned accordingly.

4. When the competent authority fails to notify the economic
operator of a decision as referred to in Article 2(1) within the
period specified in paragraph 2 of this Article, the product shall
be deemed to be lawfully marketed in that Member State insofar
as the application of
rule as referred to in
its technical
paragraph 1 of this Article is concerned.

Article 7

Temporary suspension of the marketing of a product

1. The competent authority shall not temporarily suspend the
marketing of the product or type of product in question, during
the procedure laid down in this Chapter, except where either:

(a)

(b)

under normal or reasonably foreseeable conditions of use,
the product or type of product in question poses a serious
risk to the safety and health of the users; or

the marketing of the product or type of product in question
is generally prohibited in a Member State on grounds of
public morality or public security.

2. The competent authority shall
immediately notify the
economic operator identified in accordance with Article 8 and
the Commission of any suspension as referred to in paragraph 1
of this Article. In the cases referred to in paragraph 1(a) of this
Article, that notification shall be accompanied by a technical or
scientific justification.

3. Any suspension of the marketing of a product pursuant to
this Article may be challenged before national courts or tribunals
or other instances of appeal.

Article 8

Information to the economic operator

References to the economic operators in Articles 4, 6 and 7 shall
be considered references:

Where duly justified by the complexity of
the
competent authority may, once only, extend the period specified
in the first subparagraph by a maximum of 20 working days.
That extension shall be duly reasoned and shall be notified to the
economic operator before the expiry of the initial period.

the issue,

(a)

to the manufacturer of the product, if established in the
Community, or the person who has placed the product on
the market or requests to the competent authority that the
product be placed on the market;

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(b) where the competent authority cannot establish the identity
and contact details of any of
the economic operators
referred to in point (a), to the manufacturer's representative,
when the manufacturer is not established in the Commu-
nity or,
if there is no representative established in the
Community, to the importer of the product;

(c)

the remedies generally available in the territory of that
Member State in the event of a dispute between the
competent authorities and an economic operator.

Product Contact Points shall respond within 15 working

2.
days of receiving any request as referred to in paragraph 1.

(c) where the competent authority cannot establish the identity
and contact details of any of
the economic operators
referred to in points (a) and (b), to any professional in the
supply chain whose activity may affect any property of the
product regulated by the technical rule which is being
applied to it;

3.
Product Contact Points in the Member State in which the
economic operator concerned has lawfully marketed the product
in question may provide the economic operator or
the
competent authority as referred to in Article 6 with any relevant
information or observations.

(d) where the competent authority cannot establish the identity
and contact details of any of
the economic operators
referred to in points (a), (b) and (c), to any professional in
the supply chain whose activity does not affect any
property of the product regulated by the technical rule
which is being applied to it.

Product Contact Points shall not charge any fee for the

4.
provision of the information referred to in paragraph 1.

Article 11

Telematic network

CHAPTER 3

PRODUCT CONTACT POINTS

Article 9

Establishment of Product Contact Points

1. Member States shall designate Product Contact Points in
their territories and shall communicate their contact details to
the other Member States and to the Commission.

2. The Commission shall draw up and regularly update a list of
Product Contact Points and publish it in the Official Journal of the
European Union. The Commission shall
that
information available through a website.

also make

Article 10

Tasks

Product Contact Points shall, at the request of, inter alia, an
1.
economic operator or a competent authority of another Member
State, provide the following information:

The Commission may,
in accordance with the advisory
procedure referred to in Article 13(2), establish a telematic
network for
this
Regulation concerning the exchange of information between
Product Contact Points and/or the competent authorities of the
Member States.

the implementation of

the provisions of

CHAPTER 4

FINAL PROVISIONS

Article 12

Reporting obligations

1.
Each Member State shall send the Commission on a yearly
basis a report on the application of this Regulation. That report
shall include the following information at least:

(a)

(b)

the number of written notices sent pursuant to Article 6(1)
and the type of products concerned;

information concerning any decisions taken
sufficient
pursuant to Article 6(2), including the grounds on which
those decisions were based and the type of products
concerned;

(a)

(b)

the technical rules applicable to a specific type of product in
the territory in which those Product Contact Points are
established and information as to whether that type of
product is subject to a requirement for prior authorisation
together with
under the laws of
information concerning the principle of mutual recognition
and the application of this Regulation in the territory of
that Member State;

their Member State,

(c)

the number of decisions taken pursuant to Article 6(3) and
the type of products concerned.

In the light of the information provided by Member States
2.
pursuant to paragraph 1, the Commission shall analyse the
decisions taken pursuant to Article 6(2) and assess the grounds
on which they were based.

the contact details of the competent authorities within that
Member State by means of which they may be contacted
authorities
directly,
responsible for supervising the implementation of
the
technical rules in question in the territory of that Member
State;

including the particulars of

the

3. By 13 May 2012, and every five years thereafter,
the
Commission shall review the application of this Regulation and
shall submit a report thereon to the European Parliament and to
the Council. The Commission may, where appropriate, accom-
pany the report with proposals with a view to improving the free
movement of goods.

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4. The Commission shall draw up, publish and regularly update
a non-exhaustive list of products which are not subject to
Community harmonisation legislation. It shall make that list
accessible through a website.

Article 14

Repeal

Article 13

Committee procedure

1. The Commission shall be assisted by a committee composed
the Member States and chaired by a
of representatives of
representative of the Commission.

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC shall
apply, in accordance with Article 7(3) and Article 8 thereof.

Decision No 3052/95/EC is hereby repealed with effect from
13 May 2009.

Article 15

Entry into force and application

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

It shall apply from 13 May 2009.

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