Standardisation, regulation, worldwide strategies

Market access in the European Union

The R&TTE and EMC Directives
 EMC & R&TTE
Standardisation, regulation, worldwide strategies

 Introduction
 The EU policy on industrial products
 The EMC and R&TTE Directives
 Conclusion
 EMC & R&TTE
Standardisation, regulation, worldwide strategies

 Introduction
 The EU policy on industrial products
 The EMC and R&TTE Directives
 Conclusion
Standardisation, regulation, worldwide strategies

Introduction (1)

 Sector are rapidly globalising

 mobile communications: GSM, IMT-2000
 Short range radio devices: IEEE 802.11, Bluetooth
 Wired communication: xDSL, modem technologies
 Globalisation forces regulatory reform:
 Wealth of technical regulation around the world
hampers trade
• Diverging administrative provisions
• Diverging technical requirements
• Diverging conformity assessment procedures
 Regulators need to address non-tariff barriers
 Rethink the proportionality of existing regimes
Standardisation, regulation, worldwide strategies

Introduction (2)

 The EU has a lot of experience to share

 Single market forced the EU to resolve internal barriers
 Although still imperfect most of the barriers have been
removed
• Customs Union
• No import/export tariffs
• No need for local establishment
 Started in 1986 to address barriers caused by
conformity assessment in EMC and R&TTE sectors
• 1986: Exchange of test reports for TTE (86/361/EEC)
• 1989: EMC Directive (89/336/EEC)
• 1991: Mutual Recognition of approvals for TTE
(91/263/EEC)
• 1999: Deregulation: R&TTE Directive (1999/5/EC)
Standardisation, regulation, worldwide strategies

Introduction (3)

 The EU experience and conclusions:

 The market players are the prime responsible: build your legal
system on this
 Rely on horizontal liability and consumer protection
 A priori type approval regimes are an overkill to manage the
risks caused by electronic, electrical and R&TTE products
 Mutual Recognition Agreements are only 2nd best, cost/benefit
not always clear: Deregulate first
 It costs a lot of energy to reform legacy approval
infrastructures
 EMC & R&TTE
Standardisation, regulation, worldwide strategies

 Introduction
 The EU policy on industrial products
 New Approach: the policy
 Standardisation: development of technical standards
 Global Approach: conformity assessment principles
 The EMC and R&TTE Directives
 Conclusion
 EU policy products
Standardisation, regulation, worldwide strategies

New Approach (1)

 New Approach on technical regulation and

standardisation: Council resolution of 1985
 Applied since resolution except certain areas:
 Foodstuffs,
 Chemical products,
 Pharmaceutical products,
 Motor vehicles
 Tractors
 EU policy products
Standardisation, regulation, worldwide strategies

New Approach (2)

 New Approach Directives

 Low voltage equipment (73/23/EEC, amendment 93/68/EEC)
 Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC)
 Toys (88/378/EEC, amendment 93/68/EEC)
 Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC) (a further modification
under preparation)
 Machinery (98/37/EC, amendment 98/79/EC)
 Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC)
 Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC)
 Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/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)
 Lifts (95/16/EC)
 Refrigeration appliances (96/57/EC)
 Pressure equipment (97/23/EC)
 In vitro diagnostic medical devices (98/79/EC)
 Radio and telecommunications terminal equipment (1999/5/EC)
 EU policy products
Standardisation, regulation, worldwide strategies

New Approach (3)

 Principles:
 limited to harmonisation of safety, health and
environmental essential requirements
 requirements are legal, not technical
 technical solutions to meet these requirements laid
down in harmonised standards developed by European
Standardisation Organisations
 Harmonised standards remain voluntary and
manufacturers can use other methods
 When complying with harmonised standards presumed
to comply with the Directive and hence free circulation
within the EU
 EU policy products
Standardisation, regulation, worldwide strategies

Standardisation (1)

 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
 EU policy products
Standardisation, regulation, worldwide strategies

Standardisation (2)

International
Electrotechnical
ISO ITU IEC
Non electrotechnical Telecom

European

Non electrotechnical Telecom.

Electrotechnical

National Standard
Organization(s) National
 EU policy products
Standardisation, regulation, worldwide strategies

Global Approach (1)

 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
 EU policy products
Standardisation, regulation, worldwide strategies

Global Approach (2)

Covers internal design and production control. This module does not require a notified body to
A Internal control of production take action.
Covers the design phase, and must be followed up by a module providing for assessment in the
B EC type-examination 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
C Conformity to type 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
D Production quality assurance 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
E Product quality assurance 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
F Product verification issues a certificate of conformity.
Covers the design and production phases. Each individual product is examined by a notified
G Unit verification 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
H Full quality assurance quality system for design, manufacture, final product inspection and testi
 EMC & R&TTE
Standardisation, regulation, worldwide strategies

 Introduction
 The EU policy on industrial products
 The R&TTE and EMC Directives
 Market in Europe
 Philosophy
 Details
 Implementation
 International aspects
 Conclusion
Standardisation, regulation, worldwide strategies

EU market

 Total sectors covered by EMC Directive: 250 b€

 R&TTE equipment: 58 b € /year in the EU in 1998
 Machinery market: >250 b € /year
 Telecommunication Services: 200 b € /year in 1999
 Diverse industry
 The Big Boys (Nokia, Ericsson, Motorola, Siemens, Philips, Alcatel,
Nortel)
 Many SMEs in e.g. Short Range Radio markets
 Before R&TTE Directive: highly fragmented
 > 1000 national regulations, around 30 harmonised EU regulations
 fragmentation of spectrum
 After R&TTE Directive: less fragmented
 fragmentation of spectrum
Standardisation, regulation, worldwide strategies

Philosophy (1)

 Scope R&TTE: terminal equipment + all radio equipment (harmonised

and non-harmonised frequency bands) with some minor exceptions
 Scope EMC: electrical equipment causing EMC disturbance
 No further national approval regulations
 but remember: the R&TTE Directive will NOT harmonise spectrum use!
 Community principles applied: free movement unless a MS has good
reasons to bar products (notably radio)
 New approach Directives:
 requirements are legal, not technical
 technical translation of requirements delegated to the market through ETSI
 voluntary standards giving presumption of conformity
 Safeguards for protecting spectrum
Standardisation, regulation, worldwide strategies

Philosophy (2)
 No ex ante market access controls on R&TTE and Electrical
products
 ex post market surveillance to deal with incompliant products
 market self regulation
 liberalisation of testing market: no accreditation of test houses
required!
 Redefinition of role of equipment regulation in addressing the
public interest
 Less protection for networks
 Leave technical details to the market players and voluntary
standardisation
 Obligation on operators to publish their interfaces
 Liability for products and consumer protection laws deterrent
 Relies on market surveillance
Standardisation, regulation, worldwide strategies

Details (overview)

 Which legislation applies to a product?

 Which requirements does a product need to meet?
 What standards are available?
 What conformity assessment procedure to follow
 What are the other administrative provisions to comply
with?
 Notification obligations
 User information
 Marking
 UKnational
UK national
Details (Applicable

regulations
regulations
etc.
legislation)

etc.
 Before: mixed structure of EU and national rules

(89/336/EEC)
compatibility (89/336/EEC)

IEnational
IE national
(73/23/EEC)
requirements (73/23/EEC)

regulations
regulations
What has changed with the R&TTE Directive?

FRnational
FR national
regulations
regulations
ESnational
ES national
regulations
regulations safety requirements
ELnational
EL national Electromagnetic compatibility
regulations
regulations
DEnational
DE national
regulations
regulations
DAnational
DA national
regulations

Electromagnetic
regulations

Electrical safety
SatelliteEarth
Satellite Earth
Stations
Stations
(93/97/EEC)
(93/97/EEC)

Electrical
Technically
Technically
harmonised
harmonised
TTE
TTE
(91/263/EEC)
(91/263/EEC)
Standardisation, regulation, worldwide strategies
 Details (Applicable
Standardisation, regulation, worldwide strategies

legislation 2)
 After: single market with national spectrums
R&TTE
R&TTE Directive
Directive (1999/5/EC)
(1999/5/EC)

National
Nationalinterface
interfaceregulations
regulations(radio
(radioonly)
only)

BE
BE DA
DA DE
DE EL
EL ES
ES
FR
FR IE
IE IT
IT LU
LU NL
NL
AA PT
PT SF
SF SV
SV UK
UK

NN IS
IS CH
CH

CZ
CZ HU
HU EE
EE SK
SK
(LVD+EMC
(LVD+EMCDirective
Directiveconformity
conformityassessment
assessmentprocedures
procedurescan
cancontinue
continueto
tobe
beused)
used)
 Details
Standardisation, regulation, worldwide strategies

(Requirements 1)

 Protection requirements of the EMC Directive:

 Limited your emissions
 Be immune to those emissions
 How to meet those requirements?
 Comply with harmonised standards
 Obtain a competent body report
 Details
Standardisation, regulation, worldwide strategies

(Requirements 2)

 Essential requirements of the R&TTE Directive:

 Electrical Safety and health (as in Low Voltage Directive,
73/23/EEC),
 ElectroMagnetic Compatibility (as in EMC Directive, 89/336/EEC)
 Spectrum use (effective use so as to avoid harmful interference)
 possibility to define some additional public interest
requirements: Decisions
Decisionson
onapplication
applicationfor:
for:
• End-to-end interworking maritime
maritimeequipment
equipment
• No network harm inland
inlandwaterways
waterways
• privacy protection avalanche
avalanche beacons
beacons
• avoidance fraud
• access emergency services
• Features for the disabled
 Needs to operate properly in nationally defined radio spectrum
(access via R&TTE website)
 Details
Standardisation, regulation, worldwide strategies

(Requirements 3)

 How to meet radio requirements?

 Member States have to publish the rules for accessing the
spectrum (Art.4.1). High level description of intended
transmissions:
• frequency band, transmission power, channel spacing etc.
 R&TTE Essential requirements to ensure that other users of the
spectrum are not disturbed (non-intended transmissions):
• spurious emissions, out of band transmission etc.
 Where Harmonised Standard is available it provides the easiest
route to market
 Usability in a Member State can only be declared if equipment
abides by the national frequency plan
 Details
Standardisation, regulation, worldwide strategies

(Requirements 4)
 How to meet the requirements for wired
telecommunication equipment?
 Level of regulation will be reduced but this doesn’t guarantee
interworking:
• no physical harm to the network or disturbances
• no further telecommunication specific requirements
 Similar depth of regulation as e.g. US FCC Part 68
 To ensure interworking, operators have to publish the
characteristics of their interfaces (Article 4.2), in their own interest
to be complete, so that products don’t cause problems
 Details (Harmonised
Standardisation, regulation, worldwide strategies

standards 1)

 Technical interpretation of the essential requirements delegated to

standardisation
 The European Commission, after consultation of the Member States,
formally asks the development of standards interpreting the essential
requirements of the Directive
 3 recognised European Standardisation Organisations:
 CEN (not active in R&TTE area, a few EMC standards)
 CENELEC (Safety standards, including RF hazards, EMC standards)
 ETSI (Radio standards, EMC standards for R&TTE)
 Details (Harmonised
Standardisation, regulation, worldwide strategies

standards 2)

 Harmonised standards are (to the extent possible) technology

neutral
 Delegation to private bodies of such standards requires full
transparent procedures:
 A Decision on a work item is taken (in ETSI 4 Members is
sufficient)
 Technical Committee drafts standard
 Draft standard goes for public enquiry
 Standard is formally voted upon (weighted national vote)
 The Directive provides for safeguards against faulty standards
 Details (Harmonised
Standardisation, regulation, worldwide strategies

standards 3)

 Article 3.1.a R&TTE: Most important Safety standards

(published both under the R&TTE and the LV Directive):
 EN 41003 Particular safety requirements for equipment to be connected to telecommunications networks
 EN 50083-1 Cabled distribution systems for television and sound signals. Part 1: Safety
requirements
 EN 60065 Audio, video and similar electronic apparatus: Safety requirements
 EN 60215 Safety requirements for radio transmitting equipment
 EN 60825 Safety of laser products: Part 1: Equipment classification, requirements and user's guide and
Part 2: Safety of optical fibre communications systems
 EN 60950 Safety of information technology equipment, including electrical business equipment

 Harmonised Standards for Electromagnetic Fields

 EN50360 & EN50361 for handsets
 Details (Conformity
Standardisation, regulation, worldwide strategies

assessment 1)

 Main principle:
 Manufacturer takes full responsibility and should test to reinsure himself
 Technical file to be kept at the disposal of surveillance authorities for 10
years after last product has been marketed!
 Exception (R&TTE): for radio transmitters, there are obligations
to contact a notified body:
 When harmonised standards don’t prescribe essential radio tests a
NB prescribes (Annex III)
 Where a product doesn’t follow harmonised standards: NB to give an
opinion on these aspects in the technical file (Annex IV)
 Exception (EMC): obligation to contact a competent body
 When product doesn’t comply with a harmonised standard
 Details (Conformity
Standardisation, regulation, worldwide strategies

assessment 2)

 Alternative to obligations to consult a Notified Body: Full

Quality Assurance (Annex V)
 Possibility to use LVD and EMC procedures
 Manufacturers may VOLUNTARILY seek the opinion of a
Notified Body on any aspect of their technical file
 Details (Administrative
Standardisation, regulation, worldwide strategies

1)
 Only for R&TTE:
 No administrative approval by the authorities is necessary
anymore but certain radio products need to be notified to
national spectrum authorities before being marketed (article
6.4) at least 4 weeks before marketing
 Difference of opinion between MS on which products need
to be notified

 MS may go and test product in 4 week period as part of

market surveillance
 Details (Administrative
Standardisation, regulation, worldwide strategies

2)
 How should a product be marked?
 Article 4.1: Equivalence between interfaces and definition of equipment classes.
Current application: 2 main classes subdivided in subclasses.
• Class 1: equipment, which can freely move and be switched on in the Community (wired
equipment, GSM, Receive-only equipment, etc.)
• Class 2: equipment, for which this is not the case (transmitters, which are to be licensed)
 Marking: simple marking scheme agreed between Member States:
• CE mark only for class 1 equipment (+ NB Numbers)
• CE mark + for class 2 equipment (+ NB Numbers)

 Most radio products are class 2 (unfortunately)!

 For EMC: CE mark only
Standardisation, regulation, worldwide strategies

Details (Administrative 3)

 User information (R&TTE only)

 Marking should go on the packaging
 Marking should go in the user manual
 Copy of the Declaration of Conformity to go in the manual
• Too strict interpretation of article 6.3 would have led to unworkable
situation: original DoC in 11 languages and signed
• Compromise: Original DoC on web or otherwise available and generic
statement on compliance in the manual
 Manufacturer obliged to extensively inform the user of:
• the intended use of equipment (notably to which network types it can
be connected)
• the geographic limitations (in which spectrum can it function)
 The international agenda
Standardisation, regulation, worldwide strategies

(1)

 3 Developments to address the globalisation of the R&TTE market:

 Mutual Recognition Agreements (MRAs) on conformity assessment.
• No harmonisation of the requirements but (part of) certification can be done
abroad
• EU with US, CDN, AUS, NZ, JPN
• Framework agreements in the Americas (CITEL) and Asia-Pacific (APEC)
 Deregulation: rather then overcoming barriers to trade, avoid them
• R&TTE Directive (EU)
• Revision Part 68 (US)
• Regulatory reforms in AUS and NZ
• Deregulation of conformity assessment not the complete story: administrative,
customs and local establishment requirements are problematic, notably for
smaller companies
 The international agenda
Standardisation, regulation, worldwide strategies

(2)
 Regulatory convergence: regional agreements to harmonise product
requirements
• All EU Directives
• EU Directives extended to 3rd countries (EEA, CH, HU,CZ,EE,SK,SL,Algeria?)
• Non-reciprocal acceptance of products regulated in dominant markets (EU
compliant, FCC compliant)
 EU follows a policy to have MRAs with its main trading
partners, whereas in parallel pushing deregulation and
regulatory convergence:
 With South-East Asia: Discussions on deregulation in ASEM context
 With US: MRA implementation cumbersome, starting discussions on
regulatory convergence in context of the Transatlantic Economic Partnership
 With candidate Member States: regulatory convergence through PECAs
 In ITA: discussions on deregulation as a tool for removing non-tariffs
 EMC & R&TTE
Standardisation, regulation, worldwide strategies

 Introduction
 The EU policy on industrial products
 The EMC and R&TTE Directives
 Conclusion
Standardisation, regulation, worldwide strategies

Conclusions

 Europe has a lighter market access regime than its main

trading partners and hence CABs are not involved in
main stream standard products;
 A main problem in Europe remains the lack of spectrum
harmonisation. Manufacturers should carefully inform
themselves about that;
 Less ex ante more ex post: We are setting up an efficient
surveillance infrastructure;
 Public authorities will leave more to the market: markets
should not fail to take their responsibility
 We need to address the global picture however as well,
notably in the interest of smaller companies