The Rapid Alert System: What’s in it for you?

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.
RISK ASSESSMENT How to perform the risk assessment
S4: Market Surveillance Physikalisch-Technische Bundesanstalt Session 4: Market surveillance Peter Ulbig, Harry Stolz Belgrade, 31 October.
Hogan Lovells EU Product Safety and Market Surveillance Reforms How will this impact businesses – Lawyers' view BIICL seminar, 2 October.
Rapid Alert System for Food and Feed
Market surveillance under the General Product Safety Directive (GPSD)
Exchange of information about dangerous products via the RAPEX system
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
DANGEROUSPRODUCTSHAVE TOBENOTIFIED ! BUSINESS APPLICATION DANGEROUS PRODUCTS HAVE TO BE NOTIFIED! adam romanowski European Commission Health & Consumer.
Erik Hansson DG Health and Consumer Protection (DG SANCO) European Commission Developments on product safety in the EU.
Making the Services Directive Work Dublin 6 March 2014 Services Directive and why it matters.
Elizabeth McNulty Head of Incident Response Food Standards Agency.
ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.
Market Surveillance: The implementation of Regulation 765/2008 in the EU Bratislava, 13 September 2011 Rita L’Abbate Unit C1: Regulatory approach for the.
European Rapid Alert System for Dangerous Consumer Products
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.
Directive Patient mobility Brigitte van der Zanden Taskforce Health AEBR 12 November 2009 Brussels - AER.
A project implemented by the HTSPE consortium This project is funded by the European Union SECURITY AND CITIZENS SECURITY AND CITIZENSHIP CONSUMER
Greek experience on the enforcement of Product Safety legislation Community safety legislation and current situation in Greece.
European Commission Enterprise and Industry New Legislative Framework Regulation 765/2008 ICSMS 8th MARS Group meeting Bratislava, 6-7 October 2010 European.
General safety requirements EU Overview Product safety training for buyers and sourcing professionals Shanghai, Guangzhou and Shunde August-September.
European Commission Rita L’ABBATE Legal aspects linked to internal market DG Enterprise and Industry MARKET SURVEILLANCE COMMUNITY FRAMEWORK UNECE “MARS”
The New Legislative Framework Jacques McMillanJacques McMillan Head Of UnitHead Of Unit DG Enterprise and IndustryDG Enterprise and Industry Regulatory.
S tefano S oro European Commission Health and Consumer Protection DG OBLIGATION OF PRODUCERS AND DISTRIBUTORS TO NOTIFY DANGEROUS PRODUCTS.
ICPHSO Meeting “Building the future” Josep Tous Orlando, February 2011
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.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Business seminar on export to Europe Support to the Modernisation.
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,
Federal Motor Transport Authority KBA - We score with road safety - Vehicle Technology- Product Safety and Recalls Informal document EFWG (1 st meeting.
The New EU Legislative Framework for Harmonisation Legislation for products Richard Lawson Deputy Director, Technical Regulations Sustainable Development.
The EU Directive on "Services in the internal market", COM(2004) 2 final/3 Agnese Knabe Project coordinator European Public Health Alliance Civic Alliance.
The New Legislative Framework
Co-operation between market surveillance authorities, case Finland European Market Surveillance Programming Conference Brussels, 11th March 2005 Director.
Florence Forum, November 2008 Regulation (EC) 1228/ ERGEG Compliance Monitoring.
The use and administration of ICSMS in Sweden UNECE MARS meeting in Bratislava, 12 September 2012 Amina Makboul.
TAIEX GPSD Free Movement and Safety Vitomir Fister Beograd,
European Commission The New Legislative Framework Jacques McMillan Head of Unit Directorate General for Enterprise and Industry Regulatory approach for.
1. Consumers, Health, Agriculture and Food Executive Agency RAPID ALERT SYSTEM for FOOD and FEED An overview of the functioning of the RASFF system as.
1. Consumers, Health, Agriculture and Food Executive Agency General presentation on the Regulation (EC) No 882/2004 Providing an overview of the main.
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.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 28 – Consumer and Health Protection.
1 PHARMACOVIGILANCE & THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING SYSTEM Sarah Spiteri Post-Licensing Directorate Medicines Authority.
© 2009 Michigan State University licensed under CC-BY-SA, original at Incident Management.
TAIEX WORKSHOP Introduction of EU Legislation on Cosmetic Products (INT MARKT 61190) Belgrade, February 2016 CHALLENGES AND BEST PRACTICE IN TRANSITION.
Jacques McMillan Has Accreditation fulfilled the expectations? Jacques McMillan Former European.
The Citizen in the centre in EU, Bratislava November,2005
66 items – 70% of circulated products
EU tobacco and nicotine regulations - general aspects
The New Legislative Framework Miniseminar New Legal Framework Reykjavík, 10 December 2008 Doris Gradenegger Unit C1: Regulatory Approach for the Free.
STRESS TESTS and TAIWAN PEER REVIEW PROCESS
RAPEX Natalie CHEVALLIER
About the NIS directive
26/08/2018 EU PPE Regulation 2016/425 Henk Vanhoutte secretary general European Safety Federation European Safety Federation ivzw.
TRACEABILITY REQUIREMENTS UNDER EU GENERAL FOOD LAW
Vytenis Andriukaitis European Commissioner for Health and Food Safety
The Mutual Recognition Regulation
FOOD AND VETERINARY OFFICE
Regional Seminar for OIE National Focal Points on Animal Production Food Safety Importance of collaboration between the Veterinary Services and industry.
Pressure Equipment Workshop September 2007 – Day 2
Vehicle lifts activity
TRACES Version 5.31and BIP BTSF ATHENS June 2012 Didier CARTON
Market surveillance cooperation at European level
2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.
Working Party on Regulatory Cooperation and Standardization Policies
EU Standardisation Policy
Presentation transcript:

The Rapid Alert System: What’s in it for you? Alicia GONZÁLEZ CHAVES European Commission Directorate-General Justice and Consumer Product Safety and Rapid Alert System

European Rapid Alert System for dangerous non-food products – what is it? System for rapid exchange of information between MS and EFTA/EEA countries (28+3) and the European Commission about measures and actions taken in relation to products posing a serious risk to consumers RAPEX general

RAPEX networks a) RAPEX Contact Points network at European level: 31 RAPEX National Contact Points, 1 per MS/EEA b) National RAPEX networks in Member States RAPEX Contact Points Customs authorities Market surveillance authorities Etc.

Notification criteria for Member States Consumer/professional product Consumer harmonised & non-harmonised / Non-consumer harmonised Excluding food/feed, pharmaceutical, medical devices 2) Posing a serious risk to the health and safety of consumers and to environment Serious risk only National authorities = risk assessors 3) Subject to measures which prevent, restrict or impose specific conditions on the marketing and use Mandatory and voluntary measures All kinds of preventive or restrictive measures (sales ban, withdrawal, recall, etc.) 4) The serious risk has a cross-border effect go beyond the territory of one Member State RAPEX general & legal

RAPEX notifications… …contain information necessary to: Identify the product Identify the marketing and distribution channels Trace origin of the product Determine the related risks Identify the measures taken to prevent risks Composition of risk assessment in GRAS

RAPEX Worflow Notification created at MS level Notification validated at MS level (by the RAPEX contact point) Notification checked by the Commission Notification validated by the Commission and distributed to all countries Publication of an extract of the notification on the RAPEX public website Follow up of the notification by other countries: possible submission of a reaction Helmuth asked us to present our service/where we are working I'm one of several persons checking the notifications in terms of accurateness, coherence, information/photos, legislation, info for the web…sending follow-up questions to the MS if necessary or liaising with other services of the EC - Working on IT changes

Follow-up to RAPEX notifications After receiving the notification all Member States must examine the notification and: Find out if the product was marketed on their territory Perform risk assessment (if needed) Evaluate whether national measures should be adopted Collect any relevant information Submit a « reaction » to the Commission via RAPEX if relevant

Interesting for economic operators… 1. Publication (search, weekly reports, etc.) 2. Statistical tool All info at https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm

1. Notifications are published online

Example - a notification from Malta

2. Statistical tool

Economic operators: Tools to comply with their obligations 3. Business gateway 4. RAG tool (Risk Assessment Guidelines) All info at https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm

3. « Old » Business Application…

…to be replaced by Business Gateway (mid-March 2018)

Submission form New features: Panel view Direct creation and submission of notifications in the application, no need to generate and send pdfs No need to confirm the submission Possibility for Economic Operators to save drafts

Draft list for economic operators Generate PDFs Edit/Delete/ Submission buttons Status

4. RAG tool for risk assessment (mid-March 2018)

Visits to RAPEX networks to improve the impact and efficiency of the Rapid Alert System Reality shows that there are difficulties with regard to timeliness, quality and follow-up of notifications Differences in practices and approaches that hinder efficiency of the system The European Commission is visiting all Member States/EEA to Grasp realities on the ground (resources, structure, sampling & testing, communication, etc.) Identify areas where authorities face problems and where Commission can help Why am I here? Main tasks of the national contact point – but difficulties remain (internal organisation, legislation, cooperation, resources, political priorities, etc.) Resulting in difficulties respecting timeliness, quality and follow up of notifications, There are important differences in approaches and activities across countries that jeopardize the optimal operation of the RAPEX network and by extension, the functioning of the single market

Thank you for your attention Thank you for your attention ! For more information visit our website: http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm Or send us an e-mail : just-rapex@ec.europa.eu