Market surveillance cooperation at European level

Slides:



Advertisements
Similar presentations
THE EUROPEAN GENERAL PRODUCT SAFETY NETWORK Erik Hansson DG Health and Consumer Protection European Commission.
Advertisements

European Commission Jacques McMillan Enterprise Directorate-General Legal aspects linked to internal market EUROPEAN CONFERENCE ON MARKET SURVEILLANCE.
General introduction to the New Approach and CE marking Contribution to workshop in Sofia, Bulgaria on 19 and 20 april 2006 by Annette Dragsdahl, Senior.
Market surveillance. Internal market Enforcement of Community legislation is an obligation on Member States: Article 10 of the EC Treaty requires Member.
S4: Market Surveillance Physikalisch-Technische Bundesanstalt Session 4: Market surveillance Peter Ulbig, Harry Stolz Belgrade, 31 October.
Health and Consumers Health and Consumers 1 Commission’s expectations to MS’ structures of enforcement Enforcement of European Animal Welfare related legislation.
Market surveillance under the General Product Safety Directive (GPSD)
European Commission Enterprise and Industry Market surveillance and automotive type-approval legislation - 28/06/2012 | ‹#› WP.29 Enforcement Working Group.
Product Safety and Market Surveillance Package
Challenges and the benefits of interoperability for the railway industry and the rail transport Eric Fontanel UNIFE General Manager.
U D T Workshop on the Pressure Equipment Directive, Warsaw June 2004 INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC SYSTEM OF ENSURING.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
DG Enterprise and Industry Philippe JEAN Sustainable Mobility & Automotive Industry Unit WP.29 Enforcement Working Group meeting 27 June update.
Isdefe ISXXXX XX Your best ally Panel: Future scenarios for European critical infrastructures protection Carlos Martí Sempere. Essen.
Activities of MARS WP.6 UNECE. Activities of the UNECE „MARS“ Group by Mr. Arpád Gonda President of SOSMT, Bratislava Geneva, 24 – 26 October 2005.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
1 MARKET SURVEILLANCE IN THE EUROPEAN UNION A coordinate approach for metrology Lucia Palmegiani Policy Officer, DG ENTR I.5 WELMEC, WG 5, Malta, 23 October.
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission 1 PECAs David Eardley DG Enterprise and Industry European Commission Tel: 032 (2)
European Commission Enterprise and Industry New Legislative Framework Regulation 765/2008 ICSMS 8th MARS Group meeting Bratislava, 6-7 October 2010 European.
European Commission Rita L’ABBATE Legal aspects linked to internal market DG Enterprise and Industry MARKET SURVEILLANCE COMMUNITY FRAMEWORK UNECE “MARS”
1 REPUBLIC OF TURKEY PRIME MINISTRY UNDERSECRETARIAT OF FOREIGN TRADE General Directorate of Standardization for Foreign Trade Presented by Selin ÖZŞAHİN.
EMAS V ERIFICATION AND V ALIDATION Impressions from an Accreditation Body M ARC WOUTERS BELAC EMAS S TAKEHOLDERS D IALOGUE B RUSSELS The views.
S tefano S oro European Commission Health and Consumer Protection DG OBLIGATION OF PRODUCERS AND DISTRIBUTORS TO NOTIFY DANGEROUS PRODUCTS.
Warsaw, 5 th November 2012 Market Surveillance System of non-food products in Poland.
The New Approach and GPSD. Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards [OJ C136 of June 1985] New Approach.
1 MARKET SURVEILLANCE IN SWEDEN UN-ECE MARS GROUP, Bratislava October 2010 Amina Makboul
Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,
National Legislation on in- service inspections and the PED.
The New EU Legislative Framework for Harmonisation Legislation for products Richard Lawson Deputy Director, Technical Regulations Sustainable Development.
Proposal COM (2010) 395 final: Concrete recommendations from the health and safety perspective Stefano Boy, Engineer Paolo Derosas, Lawyer European Trade.
The New Legislative Framework
Milestones for Nuclear Power Infrastructure Development Establishment of A Regulatory Framework Gustavo Caruso, Section Head, Regulatory Activities Section.
The use and administration of ICSMS in Sweden UNECE MARS meeting in Bratislava, 12 September 2012 Amina Makboul.
Directorate General for Enterprise and Industry European Commission The New Legislative Framework Jacques McMillan Head of Unit Directorate General for.
Market surveillance Safeguard clause actions. Responsibilities of Member States Responsible for the safety of PE in the sense of market surveillance,
CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA.
European Commission The New Legislative Framework Jacques McMillan Head of Unit Directorate General for Enterprise and Industry Regulatory approach for.
Harmonised use of accreditation for assessing the competence of various Conformity Assessment Bodies Dr Andreas Steinhorst, EA ERA workshop 13 April 2016,
EU Certification Systems Dr. Friedrich Lüdeke, GLOBALG.A.P. Cairo, 12 June 2012.
Date: in 12 pts MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS Rita L'Abbate European Commission DG ENTERPRISE AND INDUSTRY.
Every employer must ensure, as far as is reasonable practicable, the health, safety and welfare of all his employees More specifically, employers must.
1 PHARMACOVIGILANCE & THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING SYSTEM Sarah Spiteri Post-Licensing Directorate Medicines Authority.
Jacques McMillan Has Accreditation fulfilled the expectations? Jacques McMillan Former European.
The New Legislative Framework Miniseminar New Legal Framework Reykjavík, 10 December 2008 Doris Gradenegger Unit C1: Regulatory Approach for the Free.
RAPEX Natalie CHEVALLIER
EET 422 EMC & COMPLIANCE ENGINEERING
Session 2 European Regulatory Environment (just a part!)
EU legislation on Personal Protective Equipment (PPE)
Training on standardisation
EU Reference Centres for Animal Welfare
PED AND PE SECTOR IN TURKEY
European Regulatory Environment (just a part!)
Regional Seminar for OIE National Focal Points on Animal Production Food Safety Importance of collaboration between the Veterinary Services and industry.
Consumer expectations on market surveillance
Pressure Equipment Workshop September 2007 – Day 2
The partnership principle in the implementation of the CSF funds ___ Elements for a European Code of Conduct.
Vehicle lifts activity
Group III Ways to Establish Good Communication in the Chain „Manufacturer, importer, Downstream User – Competent Authority“ Seminar on Chemical Substance.
2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.
“New Approach” legislation system
INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC
Legal Aspects of Finance
The Rapid Alert System: What’s in it for you?
PED Intentions and development
Market Surveillance – challenges and the way forward
Outline Background: development of the Commission’s position
The future of the PED BAYER Helmut.
National Legislation in the Pressure Sector and the PED
General principles of the New Approach legislation
EU Standardisation Policy
Presentation transcript:

Market surveillance cooperation at European level Helmut Bayer

Community legislation Market surveillance, responsibility of Member States Defined in horizontal Articles of Directives Revision of the New Approach, specific requirements to be fulfilled by MSt. Set up in horizontal regulation Ambitious objections

Scope Consumer products Products of professional use Priority for products with high potential risks Placing on the market and putting into service

Objective of market surveillance Products should satisfy community legislation Ensure a high level of safety Effective action against non compliant products Functioning information exchange

Need of market surveillance in the pressure equipment field Reduced third party involvement on conformity assessment procedures Competition of Notified Bodies Pressure Equipment as consumer products Increased imports from Third Contries

Role of Member States Responsible for the safety of PE in the sense of market surveillance, Art. 2 PED or Art. 2 SPVD Responsible for the notification of conformity assessment bodies Responsible for the installation and the operation of PE

Tasks of Member States Establish a market surveillance system Ensure adequate resources Empower their authorities to take necessary measures Draw up market surveillance programmes Establish information and cooperation systems

Tasks of Member States Authorities Perform appropriate checks on the safety of pressure equipment Take appropriate precautionary measures Take appropriate measures to inform parties involved Take part on European information and co-operation systems

Role of the Commission Performing the procedures of the safeguard clause Articles in SPVD and PED Monitoring MSt. in regard of free movement of PE Set up European co-operation and information on market surveillance Coordinate common market surveillance projects

Task of the Commission Set up ADCO groups and take part in their activities Establish and coordinate market surveillance projects Set up appropriate programme Ensure information exchange Develop electronic information systems

Role of the Notified bodies NB have an essential safety function in a global market If lower safety levels as the European accepted, their role becomes counterproductively The importance of the monitoring function of MSt authorities will increase

The Product safety Directive For PE used as consumer products like vessels for air compressors, pressure cookers, also the PSD applies For industrial PE only the relevant Articles of SPVD or PED apply

Specific problems in the pressure Equipment field Identification of defects New approach allows different technical solutions High potential risks Imports from outside Europe Consumer products as well as products for professional use High number of consumer products

Overview

Incomplete fusion

Formal problems Formal safeguard procedures take a long time MSt. will not trigger the safeguard clause if problem is solved internally Other MSt. will get information too late or no information at all

To deal with the problems on Community level Sharing of resources by cooperation between MSt. Authorities Exchange of information between MSt. Authorities Set up of electronic information system by the Commission Organisation and support of market surveillance programmes by the Commission Taking into account demands of market surveillance in the revision of Directives

Detection of non compliant pressure equipment Use of information tools like ICSMS, RAPEX, CIRCA Nat. Authorities provide the systems with information Appropriate information is offered timely Information on test results and possible distribution channels

Cooperation on European level ADCO Group Sectoral group of national Authorities and the Commission Exchange of expertise Development of best practices Information on detection of non compliant pressure equipment Set up and carry out common market surveillance programmes Cooperation on measures against dangerous products

Challenges for Member States Market surveillance is a new function Manpower shortage in many MSt. Safety does not enjoy political priority The authority has to assume liability, either for an accident because of inactivity or for an safeguard measure evaluated as unjustified

Perspective Common understanding of safety Economic aspects in the context with safety Awareness of safety aspects on side of Commission and MSt. Today technical safety is taken as obvious, but not seen as a task which needs resources. Also MS may be seen as a burden for industries. But European industries needs fair competition, otherwise products with a lower safety level will be successfully on the market. Safety is not only a matter of protection of health, but also necessary for economic operation of installations. The awareness of safety is rather low in politics today. Even in policy papers of relevant Commission units you will not find the word safety. But if safety is not seen as a priority you will not get necessary resources. Whether the ambiguous goals of the revision of the New Approach will be fulfilled or not depends also on the development of political awareness on safety.

Thank you for your attention