| activities |
added |
-
- date
- 2007-02-14
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-
- text
PURPOSE: i) to lay down the procedures for national
authorities in cases where they wish to deny the principle of
"mutual recognition" to a product and ii) to establish "Product
Contact Points" in the Member States.
PROPOSED ACT: Regulation of the European Parliament
and of the Council.
BACKGROUND: the internal market not only furthers
European integration it also enhances the overall competitiveness
of the European Union. Primary EU legislation forbids Member States
from refusing products which have been lawfully marketed in another
Member State and which are not subject to Community harmonisation -
unless they are forbidden on the ground of public health and
safety. The 1979 Cassis de Dijon judgement sets out, clarifies and
gives added authority to the principle of mutual
recognition.
However, in recent years, the principle of mutual
recognition is being undermined for the following
reasons:
-
both enterprises and national authorities lack
awareness of the mutual recognition principle;
-
the scope of the principle remains unclear. For
example, it is often unclear to which categories of product mutual
recognition applies;
-
enterprises still risk the possibility that
their products will not gain access to the Member State market
which they are targeting;
-
lack of regular dialogue between Member State
national authorities.
Although current policy has succeeded in eliminating
an overwhelming amount of technical barriers without the need for
harmonisation at an EU level, stakeholders are indicating that
current policy has reached its limits and that progress has come to
a standstill.
CONTENT: the purpose of this proposal, therefore, is
to define the rights and obligations of national authorities, on
the one hand, and the rights and obligations of enterprises wishing
to sell their products to another EU Member State, on the other. It
intends to do so:
-
firstly, by laying down procedures which the
national authorities will be obliged to follow in cases where they
choose to deny a product entry on to their market but which
has been lawfully marketed in another EU Member State;
and
-
secondly, by establishing Product Contact Points
which enterprises can contact for further information.
More specifically the Commission is
proposing:
-
the laying down of rules and procedures to be
followed by the national authorities if they intend to ban, refuse,
modify or withdraw a product which has been lawfully marketed in
another EU Member State;
-
the establishment, in each Member State, of
"Product Contact Points" in order to provide information on
national technical rules;
-
that the Regulation apply to any industrially
manufactured product or agricultural product (including fish
products) which have been lawfully marketed in another Member
State;
-
the establishment of a telematic network for the
exchange of information between the Product Contact
Points.
For further details of the financial
implications of this proposal, please refer to the financial
statement.
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The Committee on
the Internal Market and Consumer Protection adopted the report by
Mr. Alexander STUBB (EPP-ED, FI), amending, under first
reading of the co-decision procedure, the proposal for a regulation
laying down procedures relating to the application of certain
national technical rules to products lawfully marketed in another
Member State and repealing Decision 3052/95/EC.
The main amendments
adopted by the Committee are as follows:
Subject-matter: MEPs consider that the proposal should state
its principal aim more clearly, which is to strengthen the
functioning of the Internal Market, with free and undistorted
competition, by improving the free movement of products whilst
ensuring a high level of consumer protection and product
safety.
Scope: To
avoid legal uncertainty, MEPs consider that the reference to a
technical rule should be made in accordance with this Regulation
instead of with Directive 98/34/EC. Moreover, the Regulation shall
not apply to decisions of a judicial nature taken by national
courts or tribunals.
A further amendment
specifies that a technical rule means a law, regulation or
administrative provision of a Member State, which is not the
subject of harmonisation at Community level and:
a) prohibits the
marketing or use of a product or type of product in the territory
of that Member State ; or
b) with which
compliance is compulsory when a product or type of product is
marketed or used in the territory of that Member State;
c) and which lays
down either of the following: i) the characteristics required of
that product or type of product; ii) any other requirement which is
imposed on the product or type of product for the purposes of
protecting consumers or the environment, and which affects the life
cycle of the product after it has been placed on the market; iii)
testing and test methods or any test reports or certificates.
Procedure for
the application of a technical rule of the Member State of
destination: where the competent authority of the Member State
of destination submits a product or type of product to an
evaluation, it may request from the economic operator: a) relevant
information on the characteristics of the product or type of
product in question; or b) relevant and readily available
information on the lawful marketing of the product in another
Member State. MEPs also introduced an article on mutual recognition
of the level of competence of accredited conformity assessment
bodies.
Assessment of
the need to apply a technical rule of the Member State of
destination: MEPs consider that, when assessing the need to
take a decision, the Member State of destination needs to base the
analysis on the characteristics of the product or the type of
product in question. Such notice shall specify the time limit
within which to submit comments. If no reply is received from the
economic operator within that time, the competent authority may
take action.
In order to give
stronger certainty to the economic operator in the planning of its
activities, the rapporteur has introduced a deadline of 20 days
counting from the expiry of the deadline for receipt of comments
from the economic operator. Any decision may be challenged before
national courts or tribunals or other instances of appeal. If no
final decision is issued by the Member State, the product is deemed
to be legally on the market of that Member State.
Interim
measures: by default the product being observed within the
procedures of this regulation remains on the market of the Member
State of destination throughout the procedures until the final
decision is issued by the Member State. This new article states
that the Member State can temporarily withdraw from the market a
dangerous product or a product subject to a total ban on grounds of
public morality or security. The withdrawal is, however, to be
considered as an interim measure.
Product Contact
Points: MEPs introduced amendments specifying that Contact
Points must provide information to both the economic operators and
the competent authorities of the Member States. They shall respond
within ten working days of receipt of any request for information
or assistance. Where the request is unfounded, the Product Contact
Point shall inform the economic operator accordingly without delay.
Where a Product Contact Point assists the economic operator, it may
liaise with a Product Contact Point of the Member State of
destination. The assistance to the economic operator shall not
include the provision of legal advice in individual cases. Finally,
Product Contact Points shall not charge any fee for information or
assistance.
Reporting
obligations: MEPs introduced a yearly reporting obligation for
Member States. The Commission shall also analyse these reports and
act upon infringements. The Commission is also invited to publish
an indicative list of products falling under the scope of this
regulation. Within three years following the date of entry into
force, and every five years thereafter, the Commission shall carry
out a review and submit a report on the application of this
Regulation to the European Parliament and the Council. The
Commission shall, if appropriate, accompany the report with
relevant proposals with a view to improving the free movement of
goods.
MEPs consider that
the Member States need to be given a period of six months to set up
the Product Contact Points upon entry into force of the regulation.
However, the regulation itself should enter into force within 20
days of its publication.
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The European Parliament adopted a resolution based on
the report by Alexander STUBB (EPP-ED, FI), amending, under
first reading of the co-decision procedure, the proposal for a
regulation laying down procedures relating to the application of
certain national technical rules to products lawfully marketed in
another Member State and repealing Decision 3052/95/EC.
The main amendments are as follows:
Subject-matter: MEPs
consider that the regulation should state its principal aim more
clearly. The text now states that the aim of this Regulation is to
strengthen the functioning of the internal market by improving the
free movement of products.
Scope: this Regulation
applies to administrative decisions addressed to the economic
operator and taken or intended to be taken, on the basis of a
technical rule as defined in this regulation, 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) the prohibition
of the placing on the market of the product or type of product; b)
the modification or additional testing of the 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 definition of technical rule has been amended by
Parliament, and includes a rule which prohibits the marketing of a
product or type of product in the territory of that Member State.
Parliament specified that the Regulation will not apply to
decisions of a judicial nature taken by national courts or
tribunals; and to 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.
Parliament also clarified the relationship between the
regulation and other provisions of Community law and stated that
the former shall not apply to systems and interoperability
constituents falling within the scope of Directives 96/48/EC and
2001/16/EC.
Procedure for the application of a technical rule of
the Member State of destination:
where the competent authority of the Member State of destination
submits a product or type of product to an evaluation, it may
request from the economic operator with due regard to the principle
of proportionality: a) relevant information on the characteristics
of the product or type of product in question; or b) relevant and
readily available information on the lawful marketing of the
product in another Member State. MEPs also introduced an article on
mutual recognition of the level of competence of accredited
conformity assessment bodies.
Assessment of the need to apply a technical rule of
the Member State of destination:
Parliament specified that 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 a
notice, be allowed at least twenty working days in which to submit
comments. Such notice shall specify the time limit within which to
submit comments. Any decision shall be taken and notified to the
economic operator concerned and the Commission within twenty
working days following the expiry of the deadline for receipt of
comments from the economic operator. When duly justified by the
complexity of the issue, the competent authority may extend once
the time period referred to above by a maximum of twenty working
days. This extension shall be duly reasoned and shall be notified
to the economic operator before the initial period has
expired.
Any decision may be challenged before national courts
or tribunals or other instances of appeal. When, following the
procedure laid down, the competent authority fails to notify to the
economic operator a decision within the time period specified, the
product shall be deemed to be lawfully marketed in that Member
State in so far as the application of its technical rule is
concerned.
Temporary suspension of the marketing of a
product: Parliament introduced a new
Article on this and stated that during the application of the
procedure, the competent authority shall not temporarily suspend
the marketing of the product or type of product in question, except
where certain conditions are met, for example, that the product
poses a serious risk to the safety and health of the users. A
suspension of the marketing of a product adopted in accordance with
this Article may be challenged before the national courts or
tribunals or other instances of appeal.
Information to the economic operator: Parliament inserted this Article specifying to whom
the request for information, the written notice and the decision
should be sent. The economic operator is in the first instance the
manufacturer of the product, when he is established in the
Community, or the person who has placed the product on the market
or is requesting to the competent authority that the product be
placed on the market. The Article specifies the persons to contact
when the manufacturer cannot be identified.
Product Contact Points:
MEPs introduced amendments specifying that Contact Points must
provide information to both the economic operators and the
competent authorities of the Member States. They shall respond
within fifteen working days of receipt of any request for
information or assistance. The information provided will include
the technical rules applicable to a specific type of product in the
territory where those Product Contact Points are established and
information as to whether that type of product is subject to a
requirement for prior authorisation under the laws of their Member
State, together with information about the principle of mutual
recognition and the application of the Regulation in the territory
of that Member State. Product Contact Points shall not charge any
fee for information or assistance.
Reporting obligations and review: MEPs introduced a yearly reporting obligation for
Member States. In light of the information provided by Member
States, the Commission shall analyse the decisions taken and make
an assessment of their justification. The Commission shall, within
three years following entry into force of the Regulation, and every
five years thereafter, carry out a review and submit a report on
the application of the Regulation to the European Parliament and
the Council. It shall, if relevant, accompany the report with
appropriate proposals with a view to improving the free movement of
goods. It shall also publish and regularly update a non-exhaustive
list of products which are not subject to harmonisation at
Community level. It shall make this list accessible through a
website.
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- Enterprise and Industry
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- VERHEUGEN Günter
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PURPOSE: to lay down the procedures for national
authorities which would hinder the free movement of a product
lawfully marketed in another Member State, and to establish Product
Contact Points in Member States.
LEGISLATIVE ACT: Regulation (EC) No 764/2008 of the
European Parliament and of the Council 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
CONTENT: the aim of this Regulation is to strengthen
the functioning of the internal market by improving the free
movement of goods. Obstacles to the free movement of goods between
Member States may be unlawfully created by the Member States'
applying to products lawfully marketed in other Member States,
technical rules laying down requirements to be met by those
products. These might include 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 the Treaty, even if they
apply without distinction to all products.
This Regulation lays down the rules and procedures to
be followed by the competent authorities of a Member State when
taking a decision which would hinder the free movement of a product
lawfully marketed in another Member State and subject to Article 28
of the Treaty. It also provides for the establishment of Product
Contact Points in the Member States to contribute to the
achievement of the aim of the Regulation.
Scope: the Regulation
applies to administrative decisions addressed to economic
operators, on the basis of a technical rule, 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)
the prohibition of the placing on the market of
that product or type of product;
b)
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.
Procedure for the application of a technical rule of
the Member State of destination:
where the competent authority of the Member State of destination
submits a product or type of product to an evaluation, it may
request from the economic operator with due regard to the principle
of proportionality:
a)
relevant information on the characteristics of
the product or type of product in question; or
b)
relevant and readily available information on
the lawful marketing of the product in another Member
State.
Assessment of the need to apply a technical
rule: where a competent authority
intends to adopt a decision, it shall send the economic operator
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)
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
b)
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. The economic
operator concerned shall be allowed at least 20 working days in
which to submit comments.
Product Contact Points:
Member States shall designate Product Contact Points, which shall,
at the request of, inter alia, an economic operator or a competent
authority of another Member State, provide the following
information:
a)
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 under
the laws of their Member State, together with information
concerning the principle of mutual recognition and the application
of the Regulation in the territory of that Member State;
b)
the contact details of the competent authorities
within that Member State by means of which they may be contacted
directly, including the particulars of the authorities responsible
for supervising the implementation of the technical rules in
question in the territory of that Member State;
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 must not charge any fee for the
provision of this information. They shall respond within 15 working
days of receiving any request for information.
Telematic network: the
Commission may establish a telematic network for the implementation
of the provisions of the Regulation concerning the exchange of
information between Product Contact Points and/or the competent
authorities of the Member States.
Reporting obligations:
each Member State shall send the Commission on a yearly basis a
report on the application of this Regulation. In the light of this
information, the Commission shall analyse the decisions taken and
assess the grounds on which they were based. 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, accompany the report with proposals with a view
to improving the free movement of goods.
APPLICATION: from 13/05/2009.
ENTRY INTO FORCE: 02/09/2008.
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-
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- OJ L 218 13.08.2008, p. 0021
|
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|
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- 2.10 Free movement of goods
- 4.60.08 Safety of products and services, product liability
|