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

European Commission

Functioning of Directive 98/34/EC

Peter Bischoff-Everding - DG Enterprise and Industry

May 2006

Enterprise and Industry Directorate General

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

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)

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.

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

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

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

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

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

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

Notification Process (1)

Member State notifies

Commission opens 3 month standstill period

Comments Detailed opinion BlockingMS + COM MS + COM only COM

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

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

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.

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

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

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)

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)

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)

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

Useful links and contacts

Commission internet site:

http://ec.europa.eu/enterprise/tris

Mailing list (see internet site)

Commission e-mail:

[email protected]

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

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

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

Procedure

•Community texts

•Member States’ texts

•Third country textsCommission prepares comments on 3rd country notifications; input from Member States and enterprises

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

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