SLIDE 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’
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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
SLIDE 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.
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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
What is Directive (EU) 2015/1535?
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Transparency Prevention All participants in the notification procedure are informed Avoiding barriers to EU trade before they even appear Detecting those cases where EU intervention appears most appropriate Subsidiarity
Smooth functioning of the Internal Market
+ Better Regulation + Benchmarking + Instrument for industrial policy
Objectives of Directive (EU) 2015/1535
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- A. Technical specifications
(products)
(products)
society) services
- C. Laws, regulations or admin.
provisions prohibiting the manufacture, importation, marketing/ use of a product or prohibiting the provision/ use of an (information society) service Technical regulations
Scope of Directive (EU) 2015/1535
SLIDE 7 Comments Detailed opinion Blocking Total standstill period 12 months Total standstill period 6 months Total standstill period 3 months Taking into account Inform EC about follow up EC reacts Extension to 18 month possible
4 months for V.A. and I S services
Communication of final text
Reactions from Commission and Member States
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CIA Security (C-194/ 94) Non-notified technical regulations Standstill period not respected Unilever (C-443/ 98)
Legal consequences
Principle of inapplicability CJEU confirm ed this principle through its w ell-established case law
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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
SLIDE 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
sector to another ( the pharm aceuticals sector is the sector w here com panies report the highest regulatory costs)
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.
SLIDE 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
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Num ber of notifications per country in 2 0 1 8
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Num ber of notifications per country in 2 0 1 9
SLIDE 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 2 2019 3
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2015/1535 Online Database: TRIS
http: / / ec.europa.eu/ growth/ tools-databases/ tris/ Potential for MS and stakeholders Information and contacts
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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
Links and contacts