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European Commission
Functioning of Directive 98/34/EC
Peter Bischoff-Everding - DG Enterprise and Industry
May 2006
Enterprise and Industry Directorate General
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Today’s Presentation
1. Directive 98/34/EC & Internal Market2. Objectives of Directive 98/34/EC3. Scope of Directive 98/34/EC4. Notification process5. Reactions6. Exceptions7. Lack of Notification - Relevant ECJ Cases8. Notification 2005/525/F: processing aids9. Results of the Procedure10. WTO/TBT Notification Procedure
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Directive 98/34/EC & Internal Market
Free movement of goods = fundamental freedom
After „Cassis de Dijon“ judgment of the ECJ
• Mutual recognition (Article 28 EC Treaty)• Harmonisation in important sectors (protection
of health, safety and environment)• Preventive control mechanisms (e.g. Directive
83/189/EEC, replaced by 98/34/EC)
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What is Directive 98/34/EC?
A system of notification
of technical regulations
at a draft stage
applying standstill periods
during which the Commission
and all Member States
can react in a specific form.
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Objectives of Directive 98/34/EC
• Transparency
• Prevention
- All participants in the notification process are informed
- Avoiding barriers to trade before they appear
- Detecting those areas where Community intervention appears most appropriate
• Subsidiarity
Smooth functioning of the Internal Market
‘Better Regulation’ - greater competitiveness for enterprises
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Scope of Application of Directive 98/34/EC (1)
• The Directive applies to all industrial and agricultural products
• Directive 98/48/EC extended the notification procedure to Information Society services
• (Possible extension to other services)
• Geographical scope: 25 MS, EFTA, Turkey
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Scope of Application of Directive 98/34/EC (2)
• Factors triggering a notification:
b) must fall outside the “harmonised” area
c) measures must be imputable to the state
a) must contain technical regulations
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Scope of Application of Directive 98/34/EC (3)
Technical regulations:
• affecting the life cycle after placing on the market
• such as conditions of use, recycling, reuse or disposal
characteristics of a product:
• levels of quality, performance, safety• dimensions• terminology, symbols, labelling, packaging• testing, testing methods• conformity assessment procedures• production methods/processes
Technical specificationsOther requirements
Rules on I.S. services• at a distance• by electronic means• at the individual request of a recipient of services
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Mandatory character of technical regulations
‘De facto’ technical
regulations
Voluntary agreements
Fiscal or financial measures affecting the consumption of products or services
‘De iure’ mandatory: formal and binding act which is directly attributable to public authority
Reference to tech. spec. (e.g. professional codes/codes of practice) conferring presumption of conformity
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Moment of Notification
When to notify a text:
- when a text is still at a draft stage
- when substantial amendments can still be made
- in any case before its adoption
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Notification Process (1)
Member State notifies
Commission opens 3 month standstill period
Comments Detailed opinion BlockingMS + COM MS + COM only COM
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Notification Process (2)
Comments Detailed opinion Blocking
Total standstill period 12 months
Total standstill period 6 months
Total standstill period 3 months
Taking into account
Taking into account + obligation to
answer
Extension to 18 months poss.
4 months for vol. agree.and I.S. services
Transmission of final text Reference to notification procedure
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Request for Urgency
Article 9.7
No standstill period if a Member State invokes serious and unforeseeable circumstances relating to:• protection of public health or safety,
protection of animals and plants
• for rules on services, also to public policy, notably the protection of minors
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Exceptions
• Main exceptions to notification:
– complying with binding Community acts; – fulfilment of obligations under an international
agreement;– implementation of an ECJ judgment;– amendment of a technical regulation in accordance
with a Commission request; – making use of safeguard clauses; and– technical specifications linked to national social
security systems.
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Absence of Notification (1)
- CIA Security (C-194/94)
- Unilever (C-443/98)
ECJ judgments regarding the procedure
• Inapplicability of non-notified technical regulations
• Inapplicability of technical regulations adopted during standstill period
Legal basis: Art. 8-9 Directive 98/34/EC areprecise and unconditional direct effect
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Absence of Notification (2)
Cases on the Directive’s scope of application
- Unilever (C-443/98) and Canal Satélite Digital (C-390/99)
- Lemmens (C-226/97)
• Rules falling under criminal law need to be notified if they contain technical regulations
• Narrow interpretation of « harmonised » area
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Practical example
Notification 2005/525/F: Processing aids(Projet d’arrêté relatif à l’emploi d’auxiliaires technologiques dans la
fabrication de certaines denrées alimentaires)
• notified on 30.9.2005 (standstill period: 2.1.2006)• UK and DK: detailed opinions (extended
standstill period: 3.4.2006) • ELC and AAC: position papers• COM: treatment within pending infringement
procedure (comments from industry and UK+DK detailed opinions taken into account)
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Results of the Procedure (1)
TotalDetailedopinions
Comments
2003 48680 (COM)
59 (MS)
165 (COM)
151 (MS)
2004 55766 (COM)
60 (MS)
229 (COM)
178 (MS)
2005 73977 (COM)
45 (MS)
263 (COM)
227 (MS)
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Results of the Procedure (2)
Some statistics for 2005 : 739 notifications made by Member States 61 notifications made by EFTA & Turkey
Main sectors: Foodstuffs, agricultural products (130) Transport (102) Telecommunications (99) Building and construction (98)
Detailed opinions 77 (COM) 45 (MS)
Comments 263 (COM) 227 (MS)
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Results of the procedure (3)
Directive 98/34/EC is an instrument ensuring:• Transparency
– TRIS internet site
• Openness– alert system, brochure, etc.
• Participation– stakeholders’ comments are welcome
• Efficiency – prevention is better than cure
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Useful links and contacts
Commission internet site:
http://ec.europa.eu/enterprise/tris
Mailing list (see internet site)
Commission e-mail:
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The TBT Notification Procedure
1. Objectives of the TBT Procedure
2. Scope of Application
3. Procedure: three cases
4. Links with the 98/34 Procedure
5. Statistics
6. Internet Site
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Objectives of the TBT Procedure
• Transparency
– To inform WTO Members and stakeholders
• Dialogue
– To avoid obstacles to trade
• Harmonization
– To encourage compliance with international standards
Harmonization
Dialogue
Transparency
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Scope of Application
• Technical regulations
• Conformity assessment procedures
Conditions for the notification:
• Absence of relevant international standards /guides or non conformity with such standards/ guides
• Significant effect on trade
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Procedure
•Community texts
•Member States’ texts
•Third country textsCommission prepares comments on 3rd country notifications; input from Member States and enterprises
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Statistics
TotalEuropean
CommunitiesMember States
Reactions of EC to 3rd country
notifications
2003 794 21 55 37
2004 638 30 61 47
2005 673 22 75 61
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Useful links and contacts
Commission Internet site (and mailing list):
http://ec.europa.eu/enterprise/tbt/
Commission e-mail:[email protected]
WTO Internet site:www.wto.org