The notification procedure laid down by Directive 98/34/EC Lisbon, - PowerPoint PPT Presentation

The notification procedure laid down by Directive 98/34/EC Lisbon, 30 October 2013 Giuseppe CASELLA– European Commission, DG Enterprise and Industry László KOJNOK – European Commission, DG Enterprise and Industry

Today’s Presentation – 30.10.2013 1. Directive 98/34/EC and the Internal Market (objectives and benefits) 2. What needs to be notified (rules on products and on Information Society services, de facto technical regulations) 3. Exceptions under Article 10 of Directive 98/34/EC 4. The notification procedure (moment of the notification, documents to be submitted) 5. Reactions from the Commission and Member States 6. Need for a new notification and urgency procedure 7. Legal consequences of the non-respect of the notification obligations 8. Results of the procedure 9. Presentation of the TRIS database 10. Notifications under the TBT Agreement

DG Enterprise and Industry – unit C3 Role of Unit C/3 “Prevention of Technical Barriers”  Responsible for Directive 98/34/EC  Responsible for the TBT Agreement  Coordination with the other services of the Commission  Management of the database

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)

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

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 + Better Regulation + Instrument for industrial policy 7

Scope of Directive 98/34/EC  28 EU Member States, Liechtenstein, Norway and Iceland (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

Scope of Directive 98/34/EC Factors triggering a notification: Measure must contain technical regulations or rules on Information Society services Measure must be imputable to the State

Scope of Directive 98/34/EC Technical regulations A. Technical specifications B. Other requirements (products) (products) C. Laws/regulations/adm. provisions D. Rules on Information prohibiting the manufacture, Society services importation, marketing/use of a product or prohibiting the provision/use of a service (ECJ) 10

Scope of Directive 98/34/EC Technical specifications  Levels of quality, performance, safety  Dimensions  Terminology, symbols, labeling, …  Testing, test methods  Conformity assessment procedures

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

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)

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]

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 the Audiovisual Directive)  Telecommunication services (if EU rules)  Financial services (if EU rules) and regulated markets

Scope of Directive 98/34/EC De facto technical regulations Laws/Regulations referring to some voluntary measures with De facto presumption of conformity technical Regulations Voluntary agreements are… Fiscal of financial measures affecting the consumption of products or services

Scope of Directive 98/34/EC Laws/Regulations referring to voluntary measures with presumption of conformity  Laws/regulations referring to other measures laid down by bodies other than the State (e.g. by a national standardisation body)  These measures are not compulsory as such (e.g. standards, codes of practice)  However the compliance is encouraged by a presumption of conformity with the provisions of the laws/regulations

Scope of Directive 98/34/EC Voluntary Agreements  To which a public authority is contracting party  And which provide for compliance with technical regulations Fiscal and financial measures  ‘Soft’ policy instrument to influence behaviour of businesses and consumers  No standstill period  Fiscal/financial measure itself not subject to scrutiny, but related to technical specifications  Not covered: State aid (Article 107 TFEU) and measures linked to national social security systems

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 (Article 114(10) of TFEU 19 - General Product Safety Directive

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!

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.)

Notification message 1. Special Code This is entered by the Commission. 2. Member State Sender of the message. 3A. Department Responsible Name and address (telephone N° , fax N° and e-mail address) of the Department in charge of circulating information ( Central Unit). 3B. Originating Department Department responsible for preparing the draft. 4. Notification Number and Product code This is generated by the system. This number should then be used in all messages or correspondence concerning the draft. 5. Title The notifying Member State must give the full formal title of the draft. 6. Products and/or Services Concerned The notifying Member State must indicate the products and/or services concerned by the draft regulation in plain language. 7. Notification Under Another Union Act The notifying Member State should specify at point 7 any other Union act under which it also wishes to notify the draft. 8. Main Content The notifying Member State must summarise the content of the draft technical regulation not more than 20 lines. The length of the summary should be in keeping with the importance of the draft.

Notification message 9. Brief Statement of Grounds The notifying Member State must set out in not more than 10 lines the reasons and the necessity for preparing the draft. (Member States are requested not to repeat information already given under other points of the notification message). 10. Reference Documents - Basic Texts 11. Invocation of the Emergency Procedure The notifying Member State must indicate whether Yes or NO it is having recourse to the emergency procedure. 12. Grounds for the Emergency If the Member State answers Yes it must give an exact and detailed justification of the grounds for the emergency. 13. Confidentiality a) The notifying Member State must indicate whether Yes or No it is requesting that the information supplied under Article 8 be treated as confidential as per Article 8.4. b) If the Member State answers Yes it must give reasons. 14. Fiscal Measures a) Yes (if yes the Commission will issue message 5) b) No 15. Impact assessment 16. TBT and SPS Aspects

Reactions from Commission and Member States Blocking Comments Detailed opinion Total standstill Total standstill Total standstill period 3 months period 6 months period 12 months 4 months for V.A. and IS services Taking into account Possible extension to + Obligation to Taking into account 18 month respond Communication of the final text 24

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)

Request for urgency Article 9, paragraph 7, first indent 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 or the preservation of plants  For rules on services, also to public policy, notably the protection of minors