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The notification procedure under the Single Market Transparency Directive ( EU) 2 0 1 5 / 1 5 3 5 Lisbon, 2 4 June 2 0 1 9 Giuseppe Casella and Agnes Lecom te European Com m ission Directorate-General GROW Unit 'Prevention of technical


  1. The notification procedure under the Single Market Transparency Directive ( EU) 2 0 1 5 / 1 5 3 5 Lisbon, 2 4 June 2 0 1 9 Giuseppe Casella and Agnes Lecom te European Com m ission Directorate-General GROW Unit 'Prevention of technical barriers’

  2. Today’s Presentation 1 . Directive ( EU) 2 0 1 5 / 1 5 3 5 and the I nternal Market - objectives and scope 2 . Directive ( EU) 2 0 1 5 / 1 5 3 5 – the procedure and its legal consequences 3 . Participation of econom ic operators 4 . Presentation of the TRI S database

  3. Directorate-General for I nternal Market, I ndustry, Entrepreneurship and SMEs Unit GROW .B.2 The role of the GROW.B.2 'Prevention of technical barriers' unit: - management of the procedure under Directive (EU) 2015/ 1535; - management of the procedure provided for in the WTO Agreement on Technical Barriers to Trade (TBT Agreement); - internal coordination with other Commission services; - management of the TRIS and TBT databases.

  4. What is Directive (EU) 2015/1535? A system to notify technical regulations in draft form applying a standstill period during which the Com m ission and all Mem ber States can react in a specific form

  5. Objectives of Directive (EU) 2015/1535 Smooth functioning of the Internal Market Transparency All participants in the notification procedure are informed Prevention Avoiding barriers to EU trade before they even appear Subsidiarity Detecting those cases where EU intervention appears most appropriate + Better Regulation + Benchmarking + Instrument for industrial policy

  6. Scope of Directive (EU) 2015/1535 Technical regulations A. Technical specifications B. Other requirements (products) (products) C. Laws, regulations or admin. D. Rules on (information provisions prohibiting the society) services manufacture, importation, marketing/ use of a product or prohibiting the provision/ use of an (information society) service

  7. Reactions from Commission and Member States Comments Detailed opinion Blocking Total standstill Total standstill Total standstill period 3 months period 6 months period 12 months 4 months for V.A. and I S services Inform EC about Extension to follow up Taking into account 18 month possible EC reacts Communication of final text

  8. Legal consequences Principle of inapplicability CIA Security (C-194/ 94) Non-notified technical regulations Unilever (C-443/ 98) Standstill period not respected CJEU confirm ed this principle through its w ell-established case law

  9. Actors in the procedure Notifying Member State Commission and Member States: assessment of the notified draft and possible reaction Economic operators: sending their position to the Commission and/ or to Member States

  10. Effects of regulatory non-harm onisation • Hindering the expansion into new m arkets. • SMEs are m ore affected than larger com panies. • I nnovative SMEs are m ore affected. • Heterogeneous im pact from one sector to another ( the pharm aceuticals sector is the sector w here com panies report the highest regulatory costs) • The m ost com m on regulatory barriers relate to health, environm ent, safety, registration and certification requirem ents at the national level, and national differences in the transposition of EU directives.

  11. Opportunities offered by TRIS to the economic operators - To monitor draft technical regulations and final texts translated into the EU official languages - To send your comments directly (confidentiality option) - To consult the comments of other economic operators - To register yourself on the thematic mailing list - Search engine - List of contact points in the Member States

  12. Num ber of notifications per country in 2 0 1 8

  13. Num ber of notifications per country in 2 0 1 9

  14. Participation of Portugal Draft technical regulations notified by Portugal: 2016: 3 2017: 7 2018: 2 2019: 0 Reaction of Portugal to the notifications of another Mem ber States: Comments Detailed opinion 2016 1 3 2017 1 1 2018 0 2 2019 0 3

  15. 2015/1535 Online Database: TRIS http: / / ec.europa.eu/ growth/ tools-databases/ tris/ Potential for MS and stakeholders Information and contacts

  16. Links and contacts w w w http: / / ec.europa.eu/ growth/ tools-databases/ tris/ http: / / ec.europa.eu/ growth/ tools- databases/ tris/ en/ about-the-20151535/ @ GROW DIR2015-1535-CENTRAL@ec.europa.eu

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