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

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

DG Enterprise and Industry – unit C3

• 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)

98/34 procedure – historical background

A system of notification

• f technical regulations

in draft form applying standstill periods during which the Commission and all Member States can react in a specific form

What is Directive 98/34/EC ?

Transparency Prevention 7 All participants in the notification procedure are informed Avoiding barriers to trade before they even appear Detecting those cases where EU intervention appears most appropriate Subsidiarity

Smooth functioning of the Internal Market + Better Regulation + Instrument for industrial policy

Objectives 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 be imputable to the State Measure must contain technical regulations

• r rules on Information Society services

Scope of Directive 98/34/EC

10

• A. Technical specifications

(products)

• B. Other requirements

(products)

• D. Rules on Information

Society services

• C. Laws/regulations/adm. provisions

prohibiting the manufacture, importation, marketing/use of a product or prohibiting the provision/use of a service (ECJ)

Technical regulations

Scope of Directive 98/34/EC

• Levels of quality,

performance, safety

• Dimensions
• Terminology, symbols,

labeling, …

• Testing, test methods
• Conformity assessment

procedures

Technical specifications

Scope of Directive 98/34/EC

• Affecting the life cycle after

placing on the market

• such as conditions of use,

recycling, reuse or disposal

Other requirements

Scope of Directive 98/34/EC

It goes well beyond a limitation to certain possible uses

• f 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) Other legislation prohibiting the manufacture, importation, marketing/use of a product or prohibiting the provision/use

• f a service (ECJ)

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 are… Voluntary agreements Laws/Regulations referring to some voluntary measures with presumption of conformity

De facto technical regulations

Scope of Directive 98/34/EC

Fiscal of financial measures affecting the consumption of products or services

Laws/Regulations referring to voluntary measures with presumption of conformity

• Laws/regulations referring to other measures laid down by bodies
• ther 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

Scope of Directive 98/34/EC

19

• Implementation of an ECJ judgement
• Amendment
• f

a technical regulation in accordance with a Commission request

• Complying with binding EU Acts
• Fulfilment of obligations under an international

agreement

• Making use of safeguard clauses (Article 114(10)
• f TFEU
• General Product Safety Directive

Exceptions under Article 10

• When the text is at a draft stage
• When substantial amendments can still be made

=> In any case, before its adoption! When should a text be notified?

Moment of 98/34 notification

• notification message
• text of the notified draft
• basic texts
• any other useful texts (impact studies etc.)

Documents to be submitted for notification:

Documents to be sent

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.

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

Notification message

24

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 respond Possible extension to 18 month

4 months for V.A. and IS services

Communication of the final text

Reactions from Commission and Member States

• 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)

Need for a new notification

Amendments necessitating re-notification

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

Article 9, paragraph 7, first indent of Directive 98/34/EC

Request for urgency

Request for urgency

Article 9, paragraph 7, second indent of Directive 98/34/EC

The original 3 months standstill period does not apply if a Member State invokes serious circumstances relating to: The protection of the security and integrity of the financial system, notably the protection of depositors, investors and ensured persons

CIA Security (C-194/94) Non-notified technical regulations Standstill period not respected Unilever (C-443/98)

Legal consequences of non-respect of the notification obligations

Principle of unenforceability ECJ confirmed this principle through its well established case-law

Total Detailed opinions Comments

2010 843 (817 MS) 48 (COM) + 5 blockings 56 (MS) 108 (COM) 171 (MS) 2011 698 (679 MS) 59 (COM) + 3 blockings 50 (MS) 147 (COM) 154 (MS) 2012 755 (734 MS) 64 (COM) + 4 blockings 85 (MS) 145 (COM) 209 (MS) 2013

(until 30/09/2013)

566 (542 MS) 68 (COM) + 3 blockings 58 (MS) 101 (COM) 92 (MS)

Results of the 98/34 procedure

Notifications per sectors in 2012

Notifications from Portugal

Statistics: 98/34 notifications received from Portugal:

• 2009 : 9
• 2010 : 7
• 2011 : 5
• 2012 : 5
• 09/2013 : 4

Participation of Portugal to the procedure:

Comments PT Detailed

• pinions PT

Comments EC Detailed opinions EC

2009 3 2010 3 5 1 2011 3 4 2012 4 2 2 1 2013

30.10.2013

1 1 2 1

Report on the functioning of Directive 98/34/EC

• Article 11 of Directive 98/34/EC
• Report of the Commission to the European Parliament, the

Council and the Economic and Social Committee every two years

• Last report – 2009 and 2010 – COM(2011) 853 final

Commission Internet site (TRIS): http://ec.europa.eu/enterprise/tris Commission email: dir83-189-central@ec.europa.eu

Useful links and contacts

Technical Regulations Information System

98/34 Online Database: TRIS (public)

A more competitive Europe

• Europe 2020 strategy: new approach of industrial policy based on an

analysis of European competitiveness proofing.

• Member States must act as the "guardians of competitiveness" by

adopting and implementing the legislation needed for economic growth.

• Industrial Policy Communication of October 2012 and Internal Market

Committee of the European Parliament.

• The Internal Market Committee of the European Parliament (IMCO),

January 2013.

Role of the notifications in the framework of Directive 98/34/EC

• Objective:

To transpose at national level a strategy already put in place at EU level

• Directive 98/34/EC: a legal instrument to prevent technical barriers to

trade which may also serve the industrial policy and economic operators.

• Recommendation that Member States use competitiveness proofing of

their draft technical regulations in the context of national impact assessment.

Message 037 Communication from the Commission - TRIS/ (xxxx)xxxxx Directive 98/ 34/ EC Notification: xxxx/ xxx/ xx Competitiveness analysis (MSG: xxxxxxxxx.xx) In compliance with the latest update of the Communication on Industrial Policy of 10 October 2012(1) , according to which: "…. The preventive nature of this procedure (established by Directive 98/ 34) has prevented infractions of the rules on the free m ovem ent of goods . This notification procedure can also be used, however, to improve national legislation in line with "Better Regulation" principles and through benchmarking. Its potential can be further exploited by recom m ending that Member States use competitiveness proofing in the context of national impact assessm ents", with the opinion of the European Parliament Domestic Market Com mittee of 21 January 2013(2) , according to which: "The Commission will continue to exploit the potential of the procedure envisaged by Directive 98/ 34/ EC, insomuch as it is an industrial policy instrum ent and with the aim of helping determine the future legislative priorities of the EU, in particular to encourage Member States to introduce impact assessm ents and competitiveness proofing in their national legislative processes, right from the draft stage", as well as that announced to the Member States during the last Committee 98/ 34, held on 22 April 2013; the commission asks the Member States to prepare a competitiveness analysis of the national legislation notified under the scope

• f the procedure established by Directive 98/ 34/ EC.

By way of example, the link below will give you access to the "Operational guidance for assessing impacts on sectoral competitiveness within the commission impact assessment": <link>

(1) Communication of the Commission to the European Parliament, to the Council, to the European Social and Economic Committee and to the Committee

• f the Regions - A stronger European industry at the service of economic growth and re-launch - Update to the communication on industrial policy - COM

(2012)582 final. (2) Opinion of the I nternal Market and Consumer Protection Commission for the Commission of I ndustry, Research and Energy on "Re-industrialising Europe to promote competitiveness and sustainability" (2013/ 2006(I NI)).

New Message 037 that will be sent

The TBT Agreement

• Agreement on Technical Barriers to Trade
• one of the 13 Multilateral Agreements on Trade in

Goods listed in Annex 1A to the WTO Agreement

• f 1994
• all WTO Members (currently 159) are parties to the

TBT Agreement

The TBT notification procedure

• Transparency

Inform WTO members

• Dialogue

Avoid discrimination and unnecessary obstacles to trade

• Harmonisation

Encourage conformity with international standards

Scope of the TBT Agreement

The 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)

Technical regulation

“Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

(TBT Agreement, Annex 1, paragraph 1)

Conformity assessment procedure

“Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled” (TBT Agreement, Annex 1, paragraph 3)

Procedure

Conditions for a notification :

• No relevant international standards/guides
• r
• Draft measure not in line with such standards/guides

+

• Significant impact on trade

= The measure is to be notified

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

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 the draft text at the time of the notification
• Enter into discussions on written comments

Procedure

Adoption of the draft text:

• Obligation of publication of the notified text, once adopted
• Grant reasonable time between date of publication and date of

entering into force (6 months recommended)

Procedure

Risk of non-notification:

• No sanctions under the TBT Agreement (but general WTO DSU)
• Trading partners may raise concerns (bilaterally or within TBT Committee)
• Trade dispute
• Importers not aware of new requirements

Procedure

Managing the procedure:

• European Commission

EU TBT Notification and Enquiry Point

• Each Member State (MS)

Service responsible for the WTO/TBT notification procedure

Links between the TBT and the 98/34 notification

procedure

Directive 98/34/EC technical regulations =TBT+SPS TBT Agreement

• technical regulations
• conformity assessment

procedures

• no SPS

Directive 98/34/EC  notification to the Commission  indication in the notification form if SPS/TBT notification is intended to be carried out (point 16) TBT Agreement  MS notify on their own directly to the WTO  After or during 98/34 procedure

Links between the TBT and the 98/34 notification

procedure

EC TBT public website

Conclusions End of the Seminar Thank you for your attention!

Closure of the seminar