The notification procedures laid down by Directive 9834EC
The notification procedures laid down by Directive 98/34/EC European Commission Enterprise and Industry Prague, 20 May 2011 European Commission Enterprise and Industry Christos KYRIATZIS – DG ENTR Jana KRESTYNOVA – DG ENTR
Today’s Presentation – 11. 2010 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Directive 98/34/EC and the Internal Market (objectives and benefits) What needs to be notified (rules on products and on information society services, de facto technical reg. ) The notification procedure (moment of the notification, documents to be submitted, reactions) Need for a new notification and urgency procedure Exceptions under Article 10 of Directive 98/34/EC Legal consequences of the absence of notification Results of the procedure Brief presentation of the TRIS database Links between the Directive and Reg. (EC) 764/2008 Links between Directives 98/34/EC and 2006/123/EC Notifications under the TBT Agreement European Commission Enterprise and Industry 2
DG Enterprise and Industry – unit C 3 Role of Unit C/3 “Notifications” - - Responsible for Directive 98/34/EC Responsible for the TBT Agreement Coordination with the other services of the Commission Management of the database European Commission Enterprise and Industry 3
98/34 procedure – historical background - Cassis de Dijon judgment of the ECJ New policy for the Internal Market Adoption of Directive 83/189/EEC Now, Directive 98/34/EC (modified by Directive 98/48/EC) European Commission Enterprise and Industry 4
What is Directive 98/34/EC ? A system of notification of technical regulations in draft form applying standstill periods during which the Commission and all Member States can react in a specific form European Commission Enterprise and Industry 5
Objectives of Directive 98/34/EC Smooth functioning of the Internal Market • Transparency All participants in the notification procedure are informed • Prevention Avoiding barriers to trade before they even appear • Subsidiarity Detecting those cases where EU intervention appears most appropriate European Commission Enterprise and Industry + Better Regulation
Scope of Directive 98/34/EC • 27 EU Member States, EEA States, Switzerland, Turkey • The Directive applies to all industrial and agricultural products • Directive 98/48/CE extended the notification procedure to information society services European Commission Enterprise and Industry 7
Scope of Directive 98/34/EC • Factors triggering a notification: - Measure must contain technical regulations - Measure must be imputable to the State European Commission Enterprise and Industry 8
Scope of Directive 98/34/EC Technical regulations A. Technical specifications B. Other requirements (products) D. Rules on (information society) services European Commission Enterprise and Industry C. Laws, regulations or admin. provisions prohibiting the manufacture, importation, marketing/use of a product or prohibiting the provision/use of a service (ECJ)
Scope of Directive 98/34/EC Technical specifications • Levels of quality, performance, safety • Dimensions • Terminology, symbols, labelling, … • Testing, test methods • Conformity assessment procedures European Commission Enterprise and Industry 10
Scope of Directive 98/34/EC Other requirements • Affecting the life cycle after placing on the market • such as conditions of use, recycling, reuse or disposal European Commission Enterprise and Industry 11
Scope of Directive 98/34/EC Other legislation prohibiting the manufacture, importation, marketing/use of a product or prohibiting the provision/use of a service (ECJ) It goes well beyond a limitation to certain possible uses of the product in question and covers ‘national measures which leave no room for any use which can be made of the product concerned other than a purely marginal one’ (C-267/03 Lindberg) European Commission Enterprise and Industry 12
Scope of Directive 98/34/EC Rules on (information society) services Principle (98/34 notification required): • Service • At a distance • By electronic means • At the individual request of a recipient of services [+ specifically aimed at a service] European Commission Enterprise and Industry 13
Scope of Directive 98/34/EC Rules on (information society) services Exceptions (no 98/34 notification required): • Article 10 of Directive 98/34/EC (general exceptions) • Radio and TV services (covered by TVWF Directive) • Telecommunication services (if EU rules) • Financial services (if EU rules) and regulated markets European Commission Enterprise and Industry 14
Scope of Directive 98/34/EC De facto technical regulations De facto technical Regulations are… European Commission Enterprise and Industry Fiscal or financial measures affecting the consumption of products or services Voluntary agreements 15
Scope of Directive 98/34/EC Fiscal and financial measures • ‘Soft’ policy instrument to influence behaviour of businesses and consumers (e. g. ecotaxes on certain packaging, financial incentives for purchase of certain environmentally friendly equipment, tax reduction for ‘clean cars’, etc. ) • No standstill period • Fiscal/financial measure itself not subject to scrutiny, but related to technical specifications • Not covered: State Aids (Article 107 TFEU) and measures linked to national social security systems European Commission Enterprise and Industry 16
Scope of Directive 98/34/EC Voluntary Agreements • To which a public authority is a contracting party • And which provide for compliance with technical regulations (excluding public procurement tender) European Commission Enterprise and Industry 17
Moment of 98/34 notification When should a text be notified? - When the text is at a draft stage - When substantial amendments can still be made => In any case, before its adoption! European Commission Enterprise and Industry 18
Documents to be sent Documents to be submitted for notification: - notification message text of the notified draft basic texts any other useful texts (impact studies etc. ) European Commission Enterprise and Industry 19
98/34 Notification process Comments Detailed opinion Blocking Total standstill period 3 months Total standstill period 6 months Total standstill period 12 months 4 months for V. A. and IS services Taking into account Extension to + Obligation to Taking into account 18 month poss. respond Communication of final text European Commission Enterprise and Industry 20
Need for a new notification Amendments necessitating re-notification: - significantly altering its scope - shortening the timetable for implementation - adding specifications or requirements - making specifications or requirements more restrictive => (no new notification required when amendments take account of a detailed opinion or comments) European Commission Enterprise and Industry 21
Request for urgency Article 9, paragraph 7, of Directive 98/34/EC The original 3 months standstill period does not apply 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 European Commission Enterprise and Industry 22
Request for urgency Requests Accepted Refused Closed 2008 13 4 7 2 2009 20 9 8 3 2010 33 20 12 1 European Commission Enterprise and Industry 23
Exceptions under Article 10 - Complying with binding EU Acts; - Fulfilment of obligations under an international agreement -Implementation of an ECJ judgement - Amendment of a technical regulation in accordance with a Commission request - Making use of safeguard clauses; -General product safety Directive European Commission Enterprise and Industry 24
Legal consequences Principle of unenforceability CIA Security (C-194/94) Non-notified technical regulations Unilever (C-443/98) Standstill period not respected ECJ confirmed this principle through its well established case-law European Commission Enterprise and Industry 25
Recent ECJ case-law • • C-65/05 Commission v Greece C-20/05 Schwibbert C-433/05 Sandström C-42/10, C-45/10, C-57/10 Vlaamse Dierenartsenvereniging and Janssens European Commission Enterprise and Industry 26
Results of the 98/34 procedure Total Detailed opinions Comments 2008 634 (601 MS) 52 (COM) + 8 blockings 51 (MS) 129 (COM) 135 (MS) 2009 736 (708 MS) 62 (COM) + 6 blockings 75 (MS) 136 (COM) 185 (MS) 2010 843 (817 MS) 48 (COM) + 5 blockings 56 (MS) 108 (COM) 171 (MS) European Commission Enterprise and Industry 27
Results of the 98/34 procedure Some statistics for 2010 : 843 notifications Ø 817 notifications made by Member States Ø 26 notifications made by EFTA (24) & Turkey (2) Main sectors: - Building and construction (222) - Food, agricultural products (115) - Telecommunications (86) - Transport (64) Detailed opinions 48 (COM) 75 (MS) Comments 108 (COM) 171 (MS) European Commission Enterprise and Industry 28
Notifications from the Czech Republic Some statistics Ø 98/34 notifications received from the Czech Republic: Ø 2007 : 24 Ø 2008 : 35 Ø 2009 : 26 Ø 2010 : 26 Ø Participation of Czech Republic to the procedure: Comments CZ Detailed opinions CZ Comments CE Detailed opinions CE 2007 8 - 17 4 + 2 blockings 2008 5 - 17 6 + 1 blocking 2009 8 3 12 2 + 1 blocking 2010 8 1 20 3 European Commission Enterprise and Industry 29
98/34 Online Database: TRIS (public) European Commission Enterprise and Industry
Useful links and contacts Commission Internet site (TRIS): T echnical R egulations I nformation S ystem http: //ec. europa. eu/enterprise/tris Commission email: dir 83 -189 -central@ec. europa. eu European Commission Enterprise and Industry 31
Directive 98/34/EC and Reg. N° 764/2008 • The Directive has the aim of preventing trade barriers which take the form of « technical regulations » before they are adopted, enabling the Commission and Member States to verify that the notified technical regulation is compatible with Community law. European Commission Enterprise and Industry 32
Directive 98/34/EC and Reg. N° 764/2008 • Member States are still invited to insert into their draft national technical regulations mutual recognition clauses for products lawfully manufactured and/or marketed in other EU Member States or in Turkey, or lawfully manufactured in an EFTA/EEA State. European Commission Enterprise and Industry 33
Directive 98/34/EC and Reg. N° 764/2008 • The Regulation applies after the adoption of a « technical rule » and aims to ensure that competent authorities taking decisions based on such rules apply correctly the principle of mutual recognition in individual cases. European Commission Enterprise and Industry 34
Directive 98/34/EC and Reg. N° 764/2008 • The standard mutual recognition clause may be completed with an additional reference to the applicability of the Regulation. • Ex: « The application of this law is subject to Regulation (EC) No 764/2008 » . European Commission Enterprise and Industry 35
Dir 98/34 and Dir 2006/123 (Article 15(7)) Technical regulations which fall under the Services Directive notification procedure and under Directive 98/34/EC, i. e. : • concern information society services and include some of the requirements of Art. 15 (2) of Services Directive or • combination of technical regulations on products and on services (if requirements covered by Art. 15(2) of the SD) → One stop shop facility European Commission Enterprise and Industry 36
Dir 98/34 and Dir 2006/123 (Article 15(7)) • Member State : Indication of the Services Directive in the notification message (point 7), indication which articles of the notified law are concerned, indication which requirements set out in Article 15 (2) are concerned and indication of the reasons justifying these requirements • Commission : Analysis of the draft European Commission Enterprise and Industry 37
The TBT notification procedure (Agreement on Technical Barriers to Trade) • Transparency § Inform WTO members • Dialogue § Avoid discrimination and (unnecessary) obstacles to trade • Harmonisation § Encourage conformity to international standards European Commission Enterprise and Industry 38
Scope TBT procedure applies to : • All products (industrial & agricultural) • Technical regulations • Conformity assessment procedures Two exceptions: • Technical regulations related to purchasing (governmental organisations) • Sanitary & Phytosanitary measures (SPS Agreement) European Commission Enterprise and Industry 39
Procedure Conditions for a notification (check list!): • No relevant international standards/guides or • Draft measure not in line with such standards/guides + • Significant impact on trade = Measure is to be notified European Commission Enterprise and Industry 40
Procedure Timing of the notification: • At a draft stage • At an early appropriate stage • When amendments can still be introduced in the draft and comments taken into account European Commission Enterprise and Industry 41
Procedure Reactions: • A reasonable time shall be granted for written comments • Minimum of 60 days, if possible 90 days (recommendation of WTO/TBT Committee) • transmission of draft/text at the time of the notification • Enter into discussions on written comments European Commission Enterprise and Industry 42
Procedure Adoption of draft/text: • Obligation of publication of texts, once adopted • Grant reasonable time between date of publication and date of entering into force (6 months recommended) European Commission Enterprise and Industry 43
Procedure Risk of non-notification: • No sanctions under TBT Agreement (but general WTO DSU) • Trading partners may raise concerns (bilaterally or within TBT Committee) • Trade dispute • Importers not aware of new requirements European Commission Enterprise and Industry 44
Procedure Managing the procedure: • European Commission - EC TBT Notification and Enquiry Point • Each Member State (MS) - Service responsible for the WTO/TBT notification procedure European Commission Enterprise and Industry 45
Procedure EC TBT Notification and Enquiry point Tasks depend on type of notification: • EC notifications • Member States’ notifications • Third country notifications European Commission Enterprise and Industry 46
EC TBT public website European Commission Enterprise and Industry 47
Useful links and contacts Commission website: http: //ec. europa. eu/enterprise/tbt/ E-mail of the Commission: ec-tbt@ec. europa. eu WTO website: http: //www. wto. org European Commission Enterprise and Industry 48 48
Case studies waste packaging legislation European Commission Enterprise and Industry red shiny shoes regulations incentive to stimulate sales of cars and light commercial vehicles on-line gambling 49 49
Closure of the seminar Conclusions End of the Seminar Thank you for your attention! European Commission Enterprise and Industry
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