1. Functioning of Directive 98/34/EC
European Commission
Enterprise and Industry Directorate General
Functioning of Directive 98/34/EC
Peter Bischoff-Everding - DG Enterprise and Industry
May 2006

2. Today’s Presentation Directive 98/34/EC & Internal Market
Objectives of Directive 98/34/EC
Scope of Directive 98/34/EC
Notification process
Reactions
Exceptions
Lack of Notification - Relevant ECJ Cases
Notification 2005/525/F: processing aids
Results of the Procedure
WTO/TBT Notification Procedure

3. 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)

4. A system of notification of technical regulations at a draft stage
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.

5. Objectives of Directive 98/34/EC
Transparency
All participants in the notification process are informed
Prevention
Avoiding barriers to trade before they appear
Subsidiarity
Detecting those areas where Community intervention appears most appropriate
Smooth functioning of the Internal Market
‘Better Regulation’ - greater competitiveness for enterprises

6. 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

7. Scope of Application of Directive 98/34/EC (2)
Factors triggering a notification:
a) must contain technical regulations
b) must fall outside the “harmonised” area
c) measures must be imputable to the state

8. Scope of Application of Directive 98/34/EC (3)
Technical regulations:
Other requirements
Technical specifications
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
Rules on I.S. services
at a distance
by electronic means
at the individual request of a recipient of services

9. Mandatory character of technical regulations
‘De iure’ mandatory: formal and binding act which is directly attributable to public authority
‘De facto’
technical
regulations
Voluntary agreements
Reference to tech. spec. (e.g. professional codes/codes of practice) conferring presumption of conformity
Fiscal or financial measures affecting the consumption of products or services

10. 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

11. Notification Process (1)
Member State notifies
Commission opens 3 month standstill period
Comments
Detailed opinion
Blocking
MS + COM
MS + COM
only COM

12. Notification Process (2)
Comments
Detailed opinion
Blocking
Total standstill
period 3 months
Total standstill
period 6 months
Total standstill
period 12 months
4 months for vol. agree.
and I.S. services
Taking into account
+ obligation to
answer
Taking into
account
Extension to
18 months poss.
Transmission of final text
Reference to notification procedure

13. 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

14. 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.

15. Absence of Notification (1)
ECJ judgments regarding the procedure
CIA Security (C-194/94)
Inapplicability of non-notified technical regulations
Unilever (C-443/98)
Inapplicability of technical regulations adopted during standstill period
Legal basis: Art. 8-9 Directive 98/34/EC are
precise and unconditional  direct effect

16. Absence of Notification (2)
Cases on the Directive’s scope of application
Unilever (C-443/98) and Canal Satélite Digital (C-390/99)
Narrow interpretation of « harmonised » area
Lemmens (C-226/97)
Rules falling under criminal law need to be notified if they contain technical regulations

17. Notification 2005/525/F: Processing aids
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 (standstill period: )
UK and DK: detailed opinions (extended standstill period: )
ELC and AAC: position papers
COM: treatment within pending infringement procedure (comments from industry and UK+DK detailed opinions taken into account)

18. Results of the Procedure (1)
Total
Detailed opinions
Comments
2003
486
80 (COM)
59 (MS)
165 (COM)
151 (MS)
2004
557
66 (COM)
60 (MS)
229 (COM)
178 (MS)
2005
739
77 (COM)
45 (MS)
263 (COM)
227 (MS)

19. 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)

20. 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

21. Useful links and contacts
Commission internet site:
Mailing list (see internet site)
Commission

22. The TBT Notification Procedure
Objectives of the TBT Procedure
Scope of Application
Procedure: three cases
Links with the 98/34 Procedure
Statistics
Internet Site

23. 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
Transparency
Dialogue
Harmonization

24. 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

25. Community texts Member States’ texts Third country texts Procedure
Commission prepares comments on 3rd country notifications; input from Member States and enterprises

26. Reactions of EC to 3rd country notifications
Statistics
Total
European Communities
Member States
Reactions of EC to 3rd country notifications
2003
794 21 55 37
2004
638 30 61 47
2005
673 22 75

27. Useful links and contacts
Commission Internet site (and mailing list):
Commission
WTO Internet site: