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Product Safety and Market Surveillance Package
Peter Bischoff-Everding
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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
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Proposal for a Consumer Product Safety Regulation
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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
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Basic Principles General safety requirement
Enhanced product identification and traceability Obligations of economic operators Co-regulation with European standardisation 5
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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
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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
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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
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Co-regulation with European standardisation
EN standards in support of general safety requirement Presumption of safety Streamlined procedures Aligned with Standardisation Regulation 1025/2012
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Proposal for a Regulation on Market Surveillance of Products
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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
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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
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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
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Union assessment of restrictive national measures
Possibility of objection by Member States or Commission Assessment by the Commission 14
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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
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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
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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
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Cooperation and coordination
Mutual assistance ad hoc in individual cases European Market Surveillance Forum (EMSF) Institutional framework 18
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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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