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Product Safety and Market Surveillance Update by the European Commission. Peter Bischoff-Everding. Product Safety and Market Surveillance Package 13 February 2013. Proposal for a Regulation on Consumer Product Safety, COM(2013)78
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Product Safety and Market SurveillanceUpdate by the European Commission Peter Bischoff-Everding
Product Safety and Market Surveillance Package 13 February 2013 • 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
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 Dir. 2001/95/EC (GPSD) and of Dir. 87/357/EEC on food-imitating products • Scope: all (non-food) consumer products, unless exempted
Basic Principles • General safety requirement • Enhanced product identification and traceability • Obligations of economic operators • Co-regulation with European standardisation 5
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
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
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
Co-regulation with European standardisation • EN standards in support of general safety requirement • Presumption of safety • Streamlined procedures • Aligned with Standardisation Regulation 1025/2012
Proposal for a Regulation on Market Surveillance of Products
MSR proposal • Brings together market surveillance rules from • Regulation 765/2008 • GPSD • sector-specific pieces of EU legislation • Improving cross-border action and cooperation 11
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
Framework for market surveillance • Rights and obligations of market surveillance authorities • Appropriate powers and resources • ‘Tool-kit’ • Basic principles • Streamlined procedures • Control of products on the internal market • Control of imported products at the EU's external borders 13
Union assessment of restrictive national measures • Possibility of objection by Member States or Commission • Assessment by the Commission 14
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
Exchange of information • RAPEX • moved from GPSD to new MSR • brings together notifications under GPSD and Art. 22 Reg. 765/2008 • rapid information between Member States about products presenting a risk 16
Cooperation and coordination • Better information exchange • Information and Communication System for Market Surveillance (ICSMS) • Mutual assistance • ad hoc in individual cases • European Market Surveillance Forum (EMSF) • Institutional framework 17
State of play and next steps • Negotiations in Council and European Parliament • Council Working Parties • EP Committees • Envisaged adoption: 2015 18
Multi-annual plan for market surveillance • 20 actions for safer and compliant products, e.g. • Improvement of cross-border cooperation • Joint actions • Exchange of officials • Support for Admin. Coop. groups • Safety of products sold online • Traceability of products • Methodology for risk assessment 19
Standardisation • Means to provide presumption of compliance with general safety requirement of the GPSD • Product-specific safety requirements laid down in Commission Decision (not directly applicable) • Framework for CEN/Cenelec to draw up standards • Publication of standards' reference in Official Journal = presumption of safety 20
Standardisation • Safety requirements for childcare products • Children seats (Dec. 2013/121/EU) • Cot mattresses, cot bumpers, suspended baby beds, duvets, sleep bags (Dec. 2010/376/EU) • Bath rings, bathing aids, bath tubs and stands (Dec. 2010/9/EU) • Childcare articles in general (Mandate 294/1997) 21
Standardisation • Standards referenced • Soothers and soother holders; EN 1400-1,2,3:2002; EN 12586:1999 (revised versions not yet referenced because of problems with EN 1400:2013+A1) • Carry cots and stands; EN 1466:2004 • Cribs and cradles; EN 1130-1,2:1996 • Drinking equipment; EN 14350-1:2004 • Baby carriers; EN 13209-1:2004 • Child seats for cycles; EN 14344:2004 • Baby walking frames; EN 1273:2005 22
International cooperation • Regulatory dialogue with main trading partners such as US, Canada, China • Participation in multilateral organisations such as OECD Consumer Product Safety Working Party 23
More information • http://ec.europa.eu/consumers/consumers_safety/index_en.htm • Thank you! 24