Transcript Product Safety and Market Surveillance Package 13 February 2013

Product Safety and
Market Surveillance
Package
Health and
Consumers
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
• 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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Consumers
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
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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
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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
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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
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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
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Union assessment of restrictive
national measures
• Possibility of objection by Member States or
Commission
• Assessment by the Commission
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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
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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
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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
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Cooperation and coordination
• Mutual assistance
• ad hoc in individual cases
• European Market Surveillance Forum
(EMSF)
• Institutional framework
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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
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