The New Legislative and
Market Surveillance
Framework
Rita L’Abbate
WELMEC
Market 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
Conformit
y
Assessmen
Harmonised
t
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 2008
Entry into force 20 days after publication
Date of application of Regulation
765/2008 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
Interdependent relationships
Member States
Manufacturer
Notified
Bodies
Market
surveillance
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
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 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, 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)
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)
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:
Entr-reg-approach-for-free-circ@ec.europa.eu
Thank you
for your attention