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:Entr-reg-approach-for-free-circ@ec.europa.eu

Thank you

for your attention