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Product Safety and Market Surveillance Package

Product Safety and Market Surveillance Package. Peter Bischoff-Everding. Product Safety and Market Surveillance Package 13 February 2013. Communication on More Product Safety and Better Market Surveillance in the Single Market of Products, COM(2013)74

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Product Safety and Market Surveillance Package

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  1. Product Safety and Market Surveillance Package Peter Bischoff-Everding

  2. Product Safety and Market Surveillance Package 13 February 2013 • Communication on More Product Safety and Better Market Surveillance in the Single Market of Products, COM(2013)74 • Proposal for a Regulation on Consumer Product Safety, COM(2013)78 • Proposal for a Regulation on Market Surveillance of Products, COM(2013)75 • Communication on 20 actions for safer and compliant products for Europe: multi-annual plan for surveillance, COM(2013)76 • Report on the Implementation of Regulation (EC) No 765/2008, COM(2013)77

  3. Proposal for a Consumer Product Safety Regulation

  4. CPSR proposal • From a Directive to a Regulation • Market surveillance provisions of the General Product Safety Directive (incl. RAPEX) moved to the proposed Regulation on Market Surveillance • Repeal of GPSD and of Directive 87/357/EEC on food-imitating products • All (non-food) consumer products, unless exempted

  5. Basic Principles • General safety requirement • Enhanced product identification and traceability • Obligations of economic operators • Co-regulation with European standardisation 5

  6. General safety requirement • Consumer products must be safe, Art. 4 • Presumption of safety, Art. 5 • Compliance with health and safety requirements of Union harmonisation legislation • Compliance with EN standards referenced in accordance with GPSD/CPSR • Compliance with national health and safety requirements • Safety assessment criteria, Art. 6 • In case of non-harmonised consumer products 6

  7. Product identification and traceability • Indication of origin, Art. 7 • Identification of the product, Art. 8/10 • Identification of the manufacturer and importer, Art. 8/10 • Verification by distributors, Art. 11 • Identification of economic operators in the supply chain (‘one up, one down’), Art. 14 • Possibility for specific traceability schemes, Art. 15

  8. Other obligations of economic operators • Technical documentation, Art 8/10 • Manufacturers’ risk analysis and risk management • Available to authorities for compliance checks and risk assessment • Information obligations, Art. 8-11 • Notification of unsafe products

  9. Co-regulation with European standardisation • EN standards in support of general safety requirement • Presumption of safety • Streamlined procedures • Aligned with Standardisation Regulation 1025/2012

  10. Proposal for a Regulation on Market Surveillance of Products

  11. MSR proposal • Merger of market surveillance rules of Reg. 765/2008, GPSD, sector-specific pieces of EU legislation • Simplification: 3  1 • Improving cross-border action and cooperation 11

  12. Scope of the MSR Proposal • Harmonised and non-harmonised products • Food & feed etc. excluded • Partially exclusion for medicinal products, medical devices etc. • Lex specialis rule 12

  13. Framework for market surveillance • Rights and obligations of market surveillance authorities • Appropriate powers and resources • ‘Tool-kit’ • Streamlined procedures • Basic principles • Control of products on the internal market • Control of imported products at the borders 13

  14. Union assessment of restrictive national measures • Possibility of objection by Member States or Commission • Assessment by the Commission 14

  15. Union action against unsafe products • Empowerment for Commission • In case of serious risk • Risk cannot be satisfactorily contained by Members States or other procedure under Union legislation • Bans or restrictions on products 15

  16. Exchange of information • RAPEX • moved from GPSD to new MSR • rapid information between Member States about products presenting a risk • brings together notifications under GPSD and Art. 22 Reg. 765/2008 • triggers Union assessment procedure regarding national restrictive measures 16

  17. Exchange of information • Information and Communication System for Market Surveillance (ICSMS) • sharing of information related to market surveillance activities • accessible to national market surveillance and customs authorities 17

  18. Cooperation and coordination • Mutual assistance • ad hoc in individual cases • European Market Surveillance Forum (EMSF) • Institutional framework 18

  19. State of play and next steps • Negotiations in Council and European Parliament • Council Working Parties • EP Committees • Envisaged adoption: spring 2014 19

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