Transcript The New EU Market Surveillance Framework Rita L’Abbate 6th MARS Group meeting Bratislava, 2 October 2008

The New EU Market
Surveillance Framework
Rita L’Abbate
6th MARS Group meeting
Bratislava, 2 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
Conformit
y
Assessmen
Harmonised
t
standards / Direct
compliance
Essential Requirements
New Legislative Framework - Texts
OJEU L 218 - 13.08.08 :
 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
 Regulation 764/2008 – procedures relating to
the application of certain national technical rules
to products lawfully marketed in another
Member State
Timeframe/Process
Adoption : 19 July 2008
Publication in OJEU – 13 August 2008
Entry into force 20 days after publication
Date of application of Regulation on
accreditation and market surveillance is
1 Jan 2010
Decision ‘sui generis’ = by issue/by sector
New Legislative Framework concept
Political trust ‘v’ Dispute
Member
State
A
National
Authorities
Technical trust
Technical trust
Accreditation
Marking
Notified Bodies
Conformity Assessment Procedures
Manufacturers
Market – Product – Consumers
Market Surveillance
Member
State
B
National
Authorities
The Regulation & the Decision
REGULATION
 EU “law”
 Becomes law in all
Member States at
same time
 Directly Applicable
 Member States need
to be ready to apply
Immediately
enforceable
DECISION
 Also EU “law”
 Sui Generis Decision
 Applies to legislators
themselves
 Model Articles “toolbox”
Applies ONLY when
sectoral legislation is
revised or to new
legislation
Complementary legislative tools
REGULATION
 Accreditation
 Market Surveillance
• Internal
• Imported products

General
principles
 Financing elements
DECISION
 Definitions / Obligations
 Notification (criteria /
process / accreditation)
 Conformity Assessment
Procedures
 Safeguard mechanisms
(& market surveillance)

marking
Applicable 1 Jan 2010
Basis for future legislation
Why 2 ? a Regulation & a Decision
REGULATION
 Covers elements not
already included in
sectoral legislation
e.g. accreditation /
market surveillance
etc
 Common elements to
facilitate the internal
market
DECISION
 Covers elements already
included in legislation
e.g. notification /
safeguard clause
mechanisms etc
 BUT sectors will be able
to deviate according to
specificities of the sector
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
 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 - Definition
« market surveillance » means the
activities carried out and measures taken by
public authorities to ensure that products
comply with the requirements set out in the
relevant Community harmonisation legislation
and do not endanger health, safety or any
other aspect of public interest protection
Market Surveillance – scope (1)
PART I (controls on the EU market)
General – applies to “industrial
products” covered by Community
harmonisation legislation
Market Surveillance – scope (2)
 EXCLUSIONS (Article 15) :
1. via the product definition: 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 noncompliances
 Have the necessary powers and resources
 Establish 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:
Proportionate
well founded
appeal possible
Market Surveillance – Requirements (4)
Rapid information
Rapid intervention in case of serious
risks also if the effects are not immediate
Inform 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 Coordination
Ensure efficient co-operation at EU and
national levels
Provide assistance and information to other
Member States
Share expertise and best practices, improve the
overall system, develop and organise trainings,
exchange of officials, 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)
Requirements
Perform 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)
Requirements
Restore the release if no action
Prohibit 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 use
 Clarification on meaning
 Clarification of role ‘v’ other marks
 The ONLY conformity mark
 Rules and conditions for its affixing
 Community collective trade mark
 MS to ensure correct implementation
Market Surveillance – Decision (1)
…
 Definitions (for ex. manufacturer,..)
 Obligations of economic operators
 Safeguard procedures
 CE marking
Market surveillance – Decision (2)
OBLIGATIONS
Economic 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 care
Ensure 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)
DECISION
Alignment of sectoral Directives
 By issue?
 Separate Directives?
 Groups of Directives?
 Omnibus?
 to be decided within the next months
Implementation phase … (3)
In other words create a
comprehensive environment
to strengthen market
surveillance and reinforce
safety
Web site addresses
• New internal market package:
http://ec.europa.eu/enterprise/regulation/in
ternal_market_package/index_en.htm
• Questions:
[email protected]
NLF & Market Surveillance Framework
Thank you
for your attention