New Legislative Framework (NLF) for the EU Single Market for Products

Transcription

1 New Legislative Framework (NLF) for the EU Single Market for Products 15 September 2015 Danny Bunch, Deputy Head of Unit GROW/B1: Single Market Policy, Mutual Recognition and Surveillance

2 Free movement of goods is ensured through: EU Harmonisation (must add value & achieve high level of protection) or Mutual Recognition of national requirements

3 The EU internal market for industrial products Harmonised area (~80%) Old Approach & Others (e.g. motor vehicle sector) New Approach (e.g. electrical / electronic products, toys, machinery, radio and telecom) Non-harmonised area (~20%) (Principle of mutual recognition) (e.g. furniture, childcare articles )

4 Key Features of the New Approach 1) Legislation only sets essential requirements 2) Legislation supported by harmonised standards 3) Division of responsibilities among economic actors 4) Risk-based conformity assessment procedures 5) Uniform rules for notified bodies 6) Post-market surveillance

5 Why did the 2008 review take place? Experience showed that the Directives did not all function in the same way in all Member States. Lack of coherence in implementation and enforcement Distortion of competition Lack of trust in conformity marking Confusion for producers covered by several directives

6 Main elements covered by the Review of the New Approach Market surveillance Accreditation / Notified Bodies Role and significance of CE marking Common definitions & obligations

7 New Legislative Framework - Texts OJEU L : Regulation 765/ Requirements for accreditation and market surveillance relating to the marketing of products Decision 768/2008/EC - A common framework for the marketing of products Regulation 764/ Procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (Mutual Recognition)

8 The Regulation & the Decision REGULATION EU law Becomes law in all Member States at same time Directly Applicable Member States need to apply Immediately enforceable DECISION Also EU law Sui Generis Decision Applies to legislators themselves: European Parliament and Council Model Articles toolbox To be applied when sectoral legislation is created or revised

9 Why a Regulation and a Decision REGULATION Covers elements not already included in sectoral legislation e.g. accreditation / market surveillance, etc. Common elements to facilitate the internal market DECISION Covers elements already included in legislation e.g. notification / safeguard clause mechanisms, etc. BUT sectors can deviate according to specificities of the sector, if required

10 Complementary legislative tools REGULATION Accreditation Market Surveillance Internal Imported products General principles Financing elements Directly applicable from 1 Jan DECISION Definitions / Obligations Notification (criteria / process / accreditation) Conformity Assessment Procedures Safeguard mechanisms (& market surveillance) marking Basis for future legislation

11 Regulation Overall framework (1) Accreditation Single accreditation body per Member State Non-competition / public authority Requirements for accreditation bodies Peer evaluation Information obligation / transparency EA (European co-operation for Accreditation) No exclusions, regulated or voluntary

12 Regulation Overall framework (2) Strengthen Market Surveillance framework Scope, all products but Exclusions for : food, feed, human blood, cells, tissues and agricultural products via the product definition in Article 15 (4), and Lex specialis Art 15(2) : pharmaceuticals, aviation, medical devices and motor vehicles given as examples in recitals Organisation / Surveillance measures Restrictive measures Communication and co-ordination Control of products entering the EU

13 Regulation Overall framework (3) marking General principles Clarification on use Clarification on meaning Clarification of role as against other marks

14 Decision "Toolbox" for future legislation (1) Definitions / obligations for economic operators Manufacturers / distributor / importer, etc. Notification Requirements for notifying authorities Requirements for NBs / role of accreditation Subsidiaries and sub-contracting Accredited in-house bodies Electronic notification / de-notification Co-ordination GNBs

15 Decision "Toolbox" for future legislation (2) Conformity of the product Assessment procedures Market Surveillance Safeguard procedures Marking Rules and conditions for affixing form of the marking Scope of the Decision Recital 6 "Whenever legislation is drawn up, the legislator may depart, totally or partially, from the common principles and reference provisions laid down in this Decision on account of the specificities of the sector concerned. Any such departure should be justified.

16 Alignment of EU legislation to the NLF 1. Directive 2009/48/EC Toys Already applicable for some time: 2. Directive 2011/65/EU ROHS - restriction of hazardous substances in electrical and electronic equipment Implemented from 1 July Directive 2013/29/EU Pyrotechnic articles To be implemented from 18 January Directive 2013/53/EU Recreational crafts

17 Alignment of EU legislation to the NLF To be implemented from 20 April 2016: 1. Directive 2014/29/EU Simple pressure vessels 2. Directive 2014/30/EU Electromagnetic compatibility 3. Directive 2014/31/EU Non-automatic weighing instruments 4. Directive 2014/32/EU Measuring instruments 5. Directive 2014/33/EU Lifts 6. Directive 2014/34/EU Equipment for use in potentially explosive atmospheres 7. Directive 2014/35/EU Low voltage To be implemented from 13 June 2016: 8. Directive 2014/53/EU Radio equipment To be implemented from 18 July 2016: 9. Directive 2014/68/EU Pressure equipment

18 Alignment of EU legislation to the NLF To be implemented from 18 September 2016: 10. Directive 2014/90/EU Marine equipment Pending proposals: 11. Regulation on medical devices 12. Regulation on in vitro diagnostic medical devices 13. Regulation on gas appliances 14. Regulation on personal protective equipment 15. Regulation on cableway installations

19 Product legislation remaining to be aligned to the NLF: - Machinery - Other? Other sectors: Toys Evaluation of the Toy Safety Directive in 2015 Member States' reports and external study Pre-packaging? Construction

20 Future Challenges 1. Ensure the timely application of all relevant Directives in Address the high number of products placed on the market which still do not comply with the applicable requirements: Increase awareness and understanding single gateway? Facilitate demonstration of compliance digital compliance? Incentivise compliance/effectively sanction businesses selling non-compliant products?

21 Thank You! Much more information on the implementation of EU product rules is available in the "Blue Guide". Further details are at: cuments/11502?locale=da