New Approach
New Approach
Single Market Regulatory Policy
 New Approach – General Principles
 New Approach Directives Structure
 Conformity Assessment
 Standardisation
 Examples of Procedures
 Conclusions
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New Approach
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Single market regulatory policy:
◦ Flexible regulatory framework providing access to the single market
◦ Contribution to the design, implementation and improvement of a
regulatory framework
◦ Protection of the essential public requirements
◦ Principle of mutual recognition of national legislations
◦ Usage of the New Approach legislative technique and recoursing to
the European Standardisation System
◦ Facilitating the operation and competitiveness of enterprises
◦ Prevention of new barriers to trade
◦ Commision is committed to monitor compliance to better
regulation principles in the Member States.
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Single market regulatory policy also aims to
facilitate access to third markets
New Approach
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The protection of the principle of free
movement of goods.
 The promotion of European standardisation.
 The promotion of better regulation principles
and the development of a simplification
programme of the existing regulations.
 The assessment of the transposition of the
acquis by candidate countries.
 The development of policy on implementation
of WTO/TBT agreement.
 the application of the New and Global
Approaches
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New Approach
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The protection of the principle of free
movement of goods
◦ National barriers to the free movement of goods within the EU be
removed.
◦ On-going harmonisation process in the Community
◦ In the absence of harmonised of legislation, EC Treaty forbids
Member States from maintaining or imposing intra-Community
trade barriers (except in special circumstances)
◦ Treaty prohibits quantitative restrictions on imports, exports or
goods in transit and all similar measures (it is not unconditional
provision)
◦ The Commission monitors effective application of the principle
◦ The Commission may and is obliged to bring an action only after
The European Court of Justice passes a sentence
New Approach
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The promotion of European standardisation
◦ Standardisation is a voluntary process
◦ It is carried out by independent standards bodies
◦ Stakeholders consensus (i.e. industry, SMEs, consumers, workers,
environmental NGOs, public authorities, etc.)
◦ CEN, CENELEC and ETSI - The EU Standards Organisations
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Standarisation supports innovations
◦ 'Towards an increased contribution from standardisation to
innovation in Europe’ Brussels, 11.03.2008 COM(2008) 133 final
– Commission Communication
◦ Standardisation has contributed to the support of the completion of
the Internal Market in the context of the New Approach legislation
◦ Standardisation supports EU policies related to competitiveness, ICT,
public procurement, interoperability, environment, transport, energy,
consumer protection, etc.
New Approach
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The promotion of better regulation principles:
 Process of updating existing rules to make them clear
 Withdrawing a number of pending legislative proposals
 Strategy for the simplification of the regulatory
environment /COM(2005) 535 final/ key issues:
 Usage of the stakeholders’ practical experience
 Modified regulatory approach - co-regulation
 From Directives to Regulations
 From Directives to Regulations
 Well defined aim - app. 300 legal acts /5000 pages/ in
the OJEU will be removed from the EC statute book.
New Approach
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The assessment of the transposition of the
acquis by candidate countries and the
contribution to the development of their quality
infrastructures.
◦ Negotiation and implementation of PECAs (Protocols to Europe
Agreements on Conformity Assessment and Acceptance of
Industrial Products)
◦ Management fo the Customs Union with Turkey
◦ Technical assistance
◦ Co-operation projects
New Approach
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The development of policy on implementation
of WTO/TBT agreement.
◦ Negotiations with WTO (World Trade Organisation)
◦ Implementation of the international agreements like WTO
Agreement on Technical Barriers to Trade
◦ Mutual Recognition Agreements (MRAs) promotes trade between
the EU and third countries
◦ Promotion of the regulatory convergence
◦ Administrative co-operation
◦ Solutions for market access problems
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Promotion of our own regulatory approach
New Approach
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New Approach to the Technical Harmonisation
and Standards
 3 Pillars of the New Approach
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◦ Council Resolution of 07.05.1985, where a 'New Approach to
technical harmonization and standards’.
◦ Council Resolution of 21.12.1989 on a Global Approach to
certification and testing, which states the guiding principles for
Community policy on conformity assessment.
◦ The Global Approach was completed by Council Decision
93/465/EEC by defining the modules for the various phases of the
conformity assessment procedures and the rules for the affixing and
use of the CE conformity marking
New Approach
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Basic principles:
◦ Legislative harmonisation is limited to essential requirements that products
placed on the Community market must meet, if they are to benefit from free
movement within the Community.
◦ Requirements are legal, not technical
◦ The technical specifications of products meeting the essential requirements set
out in the directives are laid down in harmonised standards.
◦ Limited to harmonisation of safety, health and environmental essential
requirements
◦ Harmonised standards remain voluntary and manufacturers can use other
methods. Other standards remains voluntary, and the manufacturer may always
apply other technical specifications to meet the requirements.
◦ Products manufactured in compliance with harmonised standards benefit from a
presumption of conformity with the corresponding essential requirements
(when not compliant with h. standards). When complying with harmonised
standards presumed to comply with the Directive and hence free circulation
within the EU
◦ Technical solutions to meet these requirements laid down in harmonised
standards developed by European Standardisation Organisations
New Approach
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A consistent approach is developed in Community
legislation by devising modules for the various phases of
conformity assessment procedures, finally, for the use of
the CE marking.
The use of European standards (EN ISO 9000 series),
(EN 45000 series)
Setting up of accreditation systems and the use of intercomparison techniques are promoted in Member States.
Mutual recognition agreements concerning testing and
certification in the non regulatory sphere are promoted.
The differences of existing quality infrastructures
between MS are minimised by programmes.
International trade between the Community and third
countries is promoted by means of mutual recognition
agreements, cooperation and technical assistance
programmes.
New Approach
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The conformity assessment is based on:
◦ manufacturers’ internal design and production control activities;
◦ third party type examination combined with manufacturers’ internal
production control activities;
◦ third party type or design examination combined with third party
approval of product or production quality assurance
◦ systems, or third party product verification (5);
◦ third party unit verification of design and production; or
◦ third party approval of full quality assurance systems.
New Approach
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Basic common principles:
• Harmonisation is limited to essential requirements.
• Only products fulfilling the essential requirements may be placed on
the market and put into service.
• Harmonised standards, the reference numbers of which have been
published in the Official Journal and which have been transposed
into national standards, are presumed to conform to the
corresponding essential requirements.
• Application of harmonised standards or other technical
specifications remains voluntary, and manufacturers are free to
choose any technical solution that provides compliance with the
essential requirements.
• Manufacturers may choose between different conformity assessment
procedures provided for in the applicable directive.
New Approach
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Main issues:
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Scope
Placing on the market and putting into service
Responsibilities
Essential requirements
Free movement
Presumption of conformity
Safeguard clause
Conformity assessment
Notified bodies
CE marking
Coordination of implementation
Transposition and transitional provisions
New Approach
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New Approach
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New Approach directives apply to products which
are intended to be placed (or put into service) on
the Community market for the first time.
It is the responsibility of the manufacturer to verify
whether it is a matter of one or more directives.
Products that have been subject to important
changes may be considered as new products. This
has to be assessed on a case-by-case basis.
Products, which have been repaired without
changing the original performance, purpose or
type, are not subject to conformity assessment.
Products specially or exclusively intended for
military or police purposes are explicitly excluded
from the scope of certain New Approach directives.
New Approach
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Applied since resolution except certain areas:
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Foodstuffs,
Chemical products,
Pharmaceutical products,
Motor vehicles
Tractors
The R&TTE and EMC Directives
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Placing on the market is the initial action of making
a product available.
 Placing on the market is the initial action of making
a product available.
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◦ Physical presence on the territory of th EU does not mean that
products are placed.
A product must comply with the applicable New
Approach directives when it is placed on the
Community market for the first time and put into
service.
 Member States are obliged:
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not to prohibit, restrict or impede the placing on the
market and putting into service of products that
comply
to take measures to ensure that products not
endanger the safety and health of persons, or other
interests.
New Approach
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Manufacturer is responsible for:
◦ for designing and manufacturing the product in accordancewith essential requirements laid down
by the directive(s);
◦ for carrying out conformity assessment in accordancewith the procedure(s) laid down by the
directive(s).
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Authorised Representative
◦ Must be inside the Community – it tooks administrative responsibity
◦ Is not be responsible for the manufacturing process
◦ The manufacturer remains generally responsible for actions carried out by an authorised
representative on his behalf.
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Importer
◦ Person responsible for placing on the market products from third countries
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Distributor
Assembler or/and Istaller
User
◦ Directives do not lay down obligations for users, apart from those related to putting into service.
◦ Community legislation concerning the H&S of the workplace has an impact on the maintenance
and use of products covered by New Approach directives that are used at the workplace.
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Product liability issue
New Approach
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Essential requirements lay down the necessary
elements for protecting the public interest.
 Essential requirements are mandatory. Only
products complying with essential
requirements may be placed on the market
and put into service.
 Essential requirements must be applied as a
function of the hazards inherent to a given
product.
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New Approach
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Conformity with a national standard that
transposes a HS, confers a resumption of
conformity with the essential requirements of
the applicable directive that is covered by such
a standard.
 References (such as titles, identification
numbers) of HS are published in the OFEU.
 Member States must publish the reference of
the national standard that transposes a HS.
 The application of HS, which give a
presumption of conformity, remains voluntary
in the field of New Approach directives.
 The product may be manufactured directly on
the basis of the essential requirements.
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New Approach
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Low voltage equipment (73/23/EEC, amendment 93/68/EEC)
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Toys (88/378/EEC, amendment 93/68/EEC)
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Electromagnetic compatibility (89/336/EEC, amendments
92/31/EEC, 93/68/EEC, 2004/108/EC)
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General product safety (92/59/EEC)
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Personal protective equipment (89/686/EEC, amendments
93/68/EEC, 93/95/EEC and 96/58/EC)
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Non-automatic weighing instruments (90/384/EEC, amendment
93/68/EEC)
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Active implantable medical devices (90/385/EEC, amendments
93/42/EEC and 93/68/EEC)
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Medical devices (93/42/EEC, amendment 98/79/EC)
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Radio and telecommunications terminal equipment (1999/5/EC)
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Cableway installations designed to carry persons (2000/9/EC)
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Measuring instruments 2004/22/EEC
The R&TTE and EMC Directives
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Simple pressure vessels (87/404/EEC, amendments
90/488/EEC and 93/68/EEC)
Construction products (89/106/EEC)
Gas appliances (90/396/EEC, amendment 93/68/EEC)
Hot water boilers (92/42/EEC, amendment 93/68/EEC)
Civil explosives (93/15/EEC)
Medical devices (93/42/EEC, amendment 98/79/EC)
Potentially explosive atmospheres (94/9/EC)
Recreational craft (94/25/EC)
Packaging and packaging waste (94/62/EC)
Lifts (95/16/EC)
Refrigeration appliances (96/57/EC)
Pressure equipment (97/23/EC)
Machinery safety (98/37/EC, amendment 98/79/EC)
In vitro diagnostic medical devices (98/79/EC)
The R&TTE and EMC Directives
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Harmonised Standards:
◦ Commission mandates harmonised standards from the European
Standardisation Organisations (CEN, CENELEC and ETSI)
◦ Standardisation process open and transparent
◦ Before vote, public enquiry
◦ Adoption based on a national weighted vote
◦ After adoption, publication in the Official Journal. Only after publication
they give presumption!
◦ Directives provide for safeguard procedures against faulty standards
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Harmonised Standards Revision
◦ The presumption of conformity to the essential requirements apply also
to the revised version of harmonised standards.
◦ During the transitional period, both the old and the revised standards
give presumption of conformity, provided that the conditions for this are
met by both standards.
The R&TTE and EMC Directives
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International
Electrotechnical
ISO
ITU
Non electrotechnical
IEC
Telecom
European
Non electrotechnical
Telecom.
National Standard
Organization(s)
Electrotechnical
National
The R&TTE and EMC Directives
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1. A mandate is drawn up, following consultation with the Member
States.
2. The mandate is transmitted to European standards organisations.
3. European standards organisations accept the mandate (80).
4. European standards organisations elaborate a (joint) programme.
5. The technical committee elaborates a draft standard.
6. European standards organisations and national standards bodies
organise a public enquiry.
7. The technical committee considers comments.
8. National standards bodies vote/European standards organisations
ratify.
9. European standards organisations transmit references to the
Commission.
10. The Commission publishes the references.
11. National standards bodies transpose the European standard.
12. National authorities publish references of national standards.
New Approach
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Global Approach on conformity assessment: Council
Decision 93/465/EC concerning the modules for the
various phases of the conformity assessment
procedures and the rules for the affixing and the
use of EC conformity marking which are intended to
be used in the technical harmonisation directives
 Defines standard conformity assessment procedures
to be used in new approach Directives
 Hierarchy from Module A (Manufacturers
Declaration) to Module H (Full Quality Assurance)
 Choice linked to the risk which is regulated
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The R&TTE and EMC Directives
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A
Internal control of production
B
EC type-examination
C
Conformity to type
D
Production quality assurance
E
Product quality assurance
F
Product verification
G Unit verification
H Full quality assurance
Covers internal design and production control. This module does not require a notified body to
take action.
Covers the design phase, and must be followed up by a module providing for assessment in the
production phase. The EC type-examination certificate is issued by a notified body.
Covers the production phase and follows module B. Provides for conformity with the type as
described in the EC type-examination certificate issued according to module B. This module
does not require a notified body to take action.
Covers the production phase and follows module B. Derives from quality assurance standard EN
ISO 9002, with the intervention of a notified body responsible for approving and controlling the
quality system for production, final product inspection and testi
Covers the production phase and follows module B. Derives from quality assurance standard EN
ISO 9003, with the intervention of a notified body responsible for approving and controlling the
quality system for final product inspection and testing set up by
Covers the production phase and follows module B. A notified body controls conformity to the
type as described in the EC type-examination certificate issued according to module B, and
issues a certificate of conformity.
Covers the design and production phases. Each individual product is examined by a notified
body, which issues a certificate of conformity.
Covers the design and production phases. Derives from quality assurance standard EN ISO
9001, with the intervention of a notified body responsible for approving and controlling the quality
system for design, manufacture, final product inspection and testi
The R&TTE and EMC Directives
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New Approach
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Flow chart for the conformity assessment procedures
provided for in Directive 73/23/EEC on electrical
equipment designed for use within certain voltage limits
New Approach
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New Approach
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New Approach
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Single Market policy benefits consumers and
entrepreneurs.
 New Approach to the legislation proved its
value.
 Standardisation processes are streamlined.
 Simplified access to the market of wide range
of products – the main aim of the whole policy
– is in great part achieved.
 The success story of the New Approach opens
door to new programmes for simplification of
legislation.
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New Approach
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