the new legislative and market surveillance framework rita l’abbate welmec market surveillance...
TRANSCRIPT
The New Legislative and Market Surveillance
Framework
Rita L’Abbate
WELMECMarket Surveillance Conference
Malta, 24 October 2008
Overview
The New Legislative Framework (NLF)
The New Market Surveillance Framework
Implementation phase…
Why did we propose the review ?
Enhance and complete the existing NA system
More than a NA review Legal framework for the
marketing of goods
The Revision of the New Approach
• Some 700 Old Approach Directives
• 27 New Approach Directives
• Missing Chapters
• Incoherence / Confusion
• Mutual recognition not working as it should
The New Legislative Framework
New Approach concept
Conformity
AssessmentHarmonised
standards / Direct compliance
Essential Requirements
New Legislative Framework - Texts
OJEU L 218 - 13.08.08 : Regulation 764/2008 – procedures relating to
the application of certain national technical rules to products lawfully marketed in another MS (Mutual Recognition)
Regulation 765/2008 - requirements for accreditation and market surveillance relating to the marketing of products
Decision 768/2008/EC - a common framework for the marketing of products
Timeframe/Process
Adoption : 19 July 2008 Publication in OJEU – 13 August 2008Entry into force 20 days after publicationDate of application of Regulation
765/2008 is 1 Jan 2010Decision ‘sui generis’ = by issue/by sector
New Legislative Framework concept
Member
State
A
National
Authorities
Political trust ‘v’ Dispute
Member State
B
National
Authorities
Technical trust Technical trust
AccreditationMarking
Notified Bodies
Conformity Assessment Procedures
Manufacturers
Market – Product – Consumers
Market Surveillance
Interdependent relationships
Manufacturer
Market surveillance
Notified Bodies
Member States
Complementary legislative tools
REGULATION Accreditation Market Surveillance
• Internal• Imported products
General principles
Financing elements
Applicable 1 Jan 2010
DECISION Definitions / Obligations Notification (criteria /
process / accreditation) Conformity Assessment
Procedures Safeguard mechanisms
(& market surveillance) marking
Basis for future legislation
ACCREDITATION
Objective is to create confidence in accredited certificates thus establishing trust in the market place
Objective is to ensure ONE accreditation certificate for whole territory of EU
Need to introduce a horizontal framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application
Conformity Assessment
• Modules give flexibility of Approach
• Manufacturer chooses
• Remains responsible for products placed on the market
• All procedures lead to marking
• Choice product / QA certification
Notified Bodies
• Where the Directives delegate conformity assessment to third parties, these are undertaken by ‘Notified Bodies’
• Notified Bodies are officially ‘notified’ on the basis of set criteria (EN 45000..)
• National authorities justify conformity via accreditation or other evidence
Market Surveillance - An essential tool
Market surveillance guarantees:• Uniform application of Community law • Equal protection for all citizens • Maintenance of a level playing field for enterprises
Market surveillance:• Monitors products and checks conformity• Takes action, as necessary, to establish conformity
Why strengthen Market Surveillance?
Levels and rigour of market surveillance differ widely throught the EU
→ Stop unsafe products on the market
→ Stop fraud / counterfeit
→ Stop distortion of competion
Market Surveillance – Overall framework
REGULATION & DECISION Scope Organisation / Surveillance measures Restrictive measures Rapid information Communication and Co-ordination Control of products entering the Community
(ex Regulation 339/93) CE marking Definitions, economic operators obligations,
safeguards into the Decision, …
Market Surveillance – scope (1)
REGULATION
PART I (controls on the EU market)
General – applies to “industrial products” covered by Community harmonisation legislation
Market Surveillance – scope (2)
EXCLUSIONS :
1. via the product definition (Article 15): food - feed, living plants, animals, human tissues, …
2. Lex specialis :▪ Pharmaceuticals, aviation, drug precursors,
medical devices and motor vehicles - given as examples in recitals
Authorities may take more specific measures as provided for in GPSD (Consumer products)
Market Surveillance – Requirements (1)
Organisation Organise and carry out market surveillance
activities Inform on the responsible national authorities Establish adequate procedure to manage non-
compliances Have the necessary powers and resourcesEstablish programmes (general or sectoral) ….
Market Surveillance – Requirements (2)
Surveillance measures Perform appropriate checks on an adequate scale Enter the premises of economic operators, and
destroy unsafe products, if necessary co-operation with economic operators (require
documentation, reduce the risks, etc.)Alert the users, where appropriate Observe independence, confidentiality, professional
secrecy
Market Surveillance – Requirements (3)
Restrictive measures
Ensure recall/withdrawal of products posing a serious risk
Inform the economic operators of remedies taken→Hear operator (10 days, except urgency)→Measures:
Proportionatewell foundedappeal possible
Market Surveillance – Requirements (4)
Rapid information Rapid intervention in case of serious
risks also if the effects are not immediateInform rapidly on products presenting a
serious risk by using a rapid exchange information system like RAPEX
Develop a general IT tool for the exchange of information
Market Surveillance – Requirements (5)
Communication and Co- ordination Ensure efficient co-operation at EU and national
levelsProvide assistance and information to other
Member StatesShare expertise and best practices, improve the
overall system, develop and organise trainings, exchange of officials, common projects, joint visit programmes, etc.
Market surveillance – Border Controls (1)
PART II Controls by customs authorities (ex Regulation 339/93)
Scope:General – applies to “all products” covered by
Community legislation
Exclusions: Lex specialis - Specific provisions relating to the organisation of border controls prevail
Market Surveillance – Border Controls (2)
RequirementsPerform checks on adequate scale Suspend the release for free circulation if
there are grounds to believe that the product presents a serious risk
Destroy the products, if necessary
Market Surveillance – Border Controls (3)
RequirementsRestore the release if no actionProhibit the placing on the market by
stamping on the official document : dangerous product or non- conforming product
Market Surveillance – CE marking
marking – General principles
Clarification on useClarification on meaningClarification of role ‘v’ other marksThe ONLY conformity markRules and conditions for its affixingCommunity collective trade markMS to ensure correct implementation
Market Surveillance – Decision (1)
… Definitions (for ex. manufacturer,..) Obligations of economic operators Safeguard procedures CE marking
Market surveillance – Decision (2)
OBLIGATIONSEconomic operators are responsible for the compliance of the product in relation to their role in the supply and distribution chain
OBLIGATIONS of MANUFACTURER Only manufacturer has detailed knowledge of design and
production process -> Distinguish between manufacturer and operators further
down the chain: conformity assessment is responsibility of manufacturer alone
Market Surveillance – Decision (3)
OBLIGATIONS of IMPORTER Need to ensure compliance of third country
products
-> IMPORTER shall ensure that - manufacturer has carried out conformity assessment- manufacturer has drawn up the technical documentation- product bears conformity mark(s)
-> Indication of importer’s name and address
Market Surveillance – Decision (4)
OBLIGATIONS of DISTRIBUTOR
Act with due careEnsure presence of conformity
marking and required documents
Market Surveillance – Decision (5)
TRACEABILITY
Each operator shall be able to identify to market surveillance authorities :
→Any operator who has supplied them with a product
→Any operator to whom they have supplied a product
Market Surveillance – Decision (6)
SAFEGUARD MECHANISMS
Two phases:MS informs MS and COM about specific measure
taken ▪If all MS agree: all MS to take measure; measure is
deemed to be justified ▪If objections are raised: COM to decide whether measure is justified; depending on the decision:
- measure to be withdrawn or- other MS have to ensure that product is withdrawn
Implementation phase…(1)
REGULATION
• Work plan to ensure consistent application
• Wider consultation with MS and Stakeholders Internal to the Commission
Implementation phase …(2)
REGULATION• Agreement on scope (Art. 15 – sectoral
legislation and GPSD)• Extension of RAPEX• General IT tool, possible use of ICSMS• Co-ordination infrastructure• Customs co-operation (e.g. RIF review)• Budget, etc….
Implementation phase … (3)
REGULATION – CE Marking• In-depth study on the feasibility of a
consumer safety mark – Commission information to EP and Council
• Finalise registration of marking as a collective mark
• Feed into National legislation concerning sanction of misuse and abuse
Implementation phase …(4)
DECISION:• By issue / by sector• Practical issues• - NANDO• - Validity of existing
notifications – “clean-up”• - Information mechanisms –
safeguard mechanism application
Implementation phase … (5)
In other words create a comprehensive environment to strengthen the market surveillance and reinforce safety
Web site addresses
• New internal market package:http://ec.europa.eu/enterprise/regulation/internal_market_package/index_en.htm
• Questions:[email protected]
Thank you
for your attention