Transcript EU Legislation

Chamber of Commerce and Industry, Ljubljana
Implementation
of Technical Regulations on Company Level
The System of The New
Approach
Expert: Frans Dooms
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Chamber of Commerce and Industry, Ljubljana
Implementation
of Technical Regulations on Company Level
The System of the
New Approach
Expert: Christèle Hubert
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The System of The New Approach
EU Legislation
Member States and the legal
structures to accomplish the
"Unified Europe"
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EU Legislation
15 Member States
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Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
The Netherlands
Portugal
Spain
Sweden
United Kingdom
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States of the EEA
-- Iceland
-- Norway
-- Liechtenstein
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EU Legislation
EU Institutions
European Parliament
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626 Members, directly elected by the
citizens of the Member States
helps to draft, amend and adopt European
laws
approves the budget
approves the appointment of the
Commission
has the power to censure the Commission
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EU Legislation
EU Institutions
The Commission
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20 Commissioners
independant from the national governments
acts as a college
makes proposals for the European Legislation
oversees the implementation of common
policies
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EU Legislation
EU Institutions
The Council of the European Union
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one minister of each Member State
different Councils for different subjects
adopt together with the Parliament
Community legislation initially proposed by
the Commission
The European Council
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Heads of States or Governments of the
Member States and the President of the
Commission
meets twice a year
decides on policy lines for the Community
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EU Legislation
Legal documents
Regulations
 general application, directly applicable in the Member
States
Directives
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binding the Member States, freedom for the form of
implementation
Decisions
 binding entirely upon those to whomthey are
addressed
Recommandations
Opinions
 have both no binding force
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EU Legislation
Directive
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Proposal by the Commission
submitted to the Council and the Parliament
having obtained the opinion of the Parliament the Council
adopts a common position by a qualified majority
information of the Parliament of the common position
information of the Parliament by the Commission
when the Parliament accepts
the Council shall adopt the proposed directive
when the Parliament does not accept
counciliation is necessary
only under certain provisions the Council may adopt the
directive but then by unanimity only
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EU Legislation
Implementation of directives
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transposition in to national law within
the dates mentioned in the directive
but direct application possible for the
citizens, when the Member State fails to
implement the directive in time
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EU Legislation
EC Directives
According Art. 94, 95 (former Art. 100, 100a)
 Realisation of the internal market
 Transposition in national law without
changes
According Art. 138 (former Art. 118a)
 Approximation of laws and regulations
 Minimum requirements
 National laws can be more stringent
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EU Legislation
Article 95
Article 138
 High security
 Progressive
level
 No technical
barriers
raising of health
and safety levels
at work
 All persons
Workers
 Design of
Use of products
products
at work
 Essential
«Social» direc-
requirements,
harmonized EN
tives, minimum
requirements
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The System of The New Approach
New Approach
Council Resolution of 7 May 1985
on a new approach to technical
harmonization and standards
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The System of The New Approach
Purpose of directives
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approximation of laws, regulations and
administrative provisions in the Member States
reduce barriers to trade
avoid repercussions on the operation of the
internal market
Old Style directives
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detailed technical specifications in the directive
difficult to change when technical innovations are
developed
lack of experts in the Commission to fullfill this
task in time
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The System of The New Approach
New Approach Directives
 contain requirements defining the technical
characteristics of products
 encompass a large number of similar products which
present the same type of hazards and can therefore be
defined by similar requirements
 do not define technical details but state "essential
requirements" valid in the whole EU
 when the essential requirements are fullfilled, the
legal objectives of the directive are fullfilled too.
 in the legal sense only on the basis of these essential
requirement alone a product will be assessed for its
ability to be put on the market
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The System of The New Approach
NEW APPROACH
No technical requirements
Only essential requirements
references to standards
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The System of The New Approach
Harmonized Standards
 define the technical limits for fullfilling the essential
requirements of the directive
 mandated by the Commission
 drafted by a European Standardization
Organization(CEN, CENELEC or ETSI)
 voted and ratified properly according the rules of
these organizations
 conveyed to the Commission for publication in the
Official Journal under the directive in question
 transposed by all Member States into national law
presumption of conformity
 products made according to Harmonized Standards
are expected to fulfil the essential requirements
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The System of The New Approach
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Low Voltage
Medical Devices
Radio and
Telecom Terminal
Equipment
Machinery
Explosive
Atmosphere
EMC
Construction
Products
Some
important
Directives
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
Automotive
 Active
Implantable
 Tractors and
agricultural
vehicles
 Pressure
equipment
 ...
 over 47 directives
(20 are New
Approach)
The System of The New Approach
STANDARDIZATION
activity (process) of establishing provisions
(appointments/specifications) for common
and repeated use, aimed at the achievement
of the optimum degree of order in a given
context.
Made (drawn up) with consensus by all
relevant parties concerned.
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The System of The New Approach
STANDARDIZATION AIMS AT
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fitness for purpose
compatibility/interchangeability
variety reduction and efficiency
(self)regulation of the market
elimination of (technical) barriers to trade
safety and health
protection of the environment
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The System of The New Approach
DIRECTIVES AIM AT
• free movement
• harmonization of laws
• safety
• health
• environment
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The System of The New Approach
STANDARDIZATION BENEFITS
• reduction of enterprise risks
• serves the competitiveness
• means market opportunities
• market oriented application of Know-how
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The System of The New Approach
Standardisation procedure
under the New Approach
1.
Mandate drawn up after consultation of Member States
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Mandate transmitted to European Standards Organisations
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E.S.O accept the mandate and elaborate a work programme
4.
Technical Committee elaborates a draft standard
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E.S.O and National Standards Bodies organise public enquiry
6.
Technical Committee considers comments
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The System of The New Approach
Standardisation procedure
under the New Approach
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National Standards Bodies vote and E.S.O ratify
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E.S.O transmit references to the Commission
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Commission publishes the references
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N.S.B transpose the European standard
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National authorities publish references of national
standards
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The System of The New Approach
THE STANDARDS WORLD
Telecom
Electro
Other
Global
ITU
IEC
ISO
European
ETSI
CENELEC CEN
Slovenia
SMIS
SMIS
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SMIS
The System of The New Approach
NEW APPROACH
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since 1985
directive per group of products
only essential requirements
technical requirements by
CEN/CENELEC
• permanent committee (judge standards)
• publication in the official journal
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The System of The New Approach
Conformity Assessment
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Dependant of the safety problems the
procedures are defined in the directive
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a general common system is given in the
"Global Approach" communication
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even in the case of third party testing the
manufacturer or his representative have to
deliver a EC Declaration of conformity
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The products shall bear the CE Marking to show
the conformity with all directives applicable to
the product
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The System of The New Approach
CONFORMITY ASSESSMENT
A. Internal control of production.
B. Type examination
C. Conformity to type
D. Production quality assurance
E. Product quality assurance
F. Product verification
G. Unit verification
H. Full quality assurance
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The System of The New Approach
DECLARATION OF CONFORMITY
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name and address of manufacturer
identification of the product
conformity to directives
(if applicable) notified body
(if applicable) conformity to technical file
(if applicable) reference to standards
responsibility of the manufacturer
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The System of The New Approach
TECHNICAL FILES
• Information to demonstrate conformity
In the European Community
• To keep 10 years after last manufacture
• To cover design, manufacturing and
operation
• Risk analysis
• Official language of member state
• Available for authorities
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The System of The New Approach
INSTRUCTIONS FOR USE
Must be in the official
languages of the country of
destination
e.g. Belgium
= Dutch
+ French
+ German
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The System of The New Approach
NOTIFIED BODIES
Nominated by the member states
Notification to the Commission
number of 4 digits
Can subcontract
under the responsability of the notified body
Obligation of co-ordination
(obligation of assisting standardisation)
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The System of The New Approach
CE-marking
• Compliance with all applicable
directives
• internal quality control system
• procedure on how conformity is
achieved
• applying the CE-mark
• retain documentation for 10 years
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The System of The New Approach
CE- marking
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The System of The New Approach
Fundamental explanations
Placing on the market
 Initial action of making availble on the Community market, against
payment or free of charge, a product covered by the directive for the
view to distribution and/or use in the Community
 Putting a product into service
 first use on the Community territory of a product refers to in the
directive by its final user
Manufacturer
 person responsible for designing and manufacturing a product
covered by the Directive, with a view to placing it on the Community
market on his own behalf
 Authorized representative
 person appointed by the manufacturer to act on his behalf in carrying
out certain tasks required by the directive
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The System of The New Approach
Safeguard clause (normally Article 9)
Nonconform Products
 by market surveillance or information from the
competitors the authorities identify unsafe products
Member State calls for an "Article 9" - case
 notifies the measures taken to the Commission
 withdrawing from the market
 prohibiting the further placement on the market
 restricting the free movement of the product
 consultation with the parties concerned by the
Commission
 when measures are justified information of the Member
States
 when not, dropping the case
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The System of The New Approach
Safeguard clause
challenging a Standard
 if the non compliant product has been made
according to a Harmonized Standard published in
the Official Journal
 the European Standardization Institute responsible
for is addressed by the Commission to change the
standard
 if the standard is not amended in time it is
withdrawn from the list in the Official Journal and
looses its quality of providing presumption of
conformity
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