Directorate General for Enterprise and Industry European Commission The New Legislative Framework...

Directorate General for

Enterprise and IndustryEuropean Commission

The New Legislative Framework

Helsinki, 10 September 2008European Commission

Directorate General for Enterprise and Industry

Unit C1: Regulatory approach for the free circulation of goods

Doris Gradenegger


Enterprise and Industry

Timeframe / Process

Proposals were adopted by the Commission on 14 February 2007

COREPER adoption 13 February 2008

EP Plenary 21 February 2008

Adoption by the Council 23 June 2008

OJ L 218, p. 30 (Regulation 765/2008),

p. 82 (Decision 768/2008)

Entry into force 1 January 2010



Why did we propose the New Framework?

New Approach directives are not all functioning in the same way in all Member States Incoherent definitions/lack of definitions Unclear obligations for economic operators Abuse of CE marking Ad-hoc variants of modules Differing criteria for notified bodies Uneven level of market surveillance



Why did we propose the New Framework?

More than a NA review Legal framework for the marketing of

goods



Complementary legislative tools

REGULATION

Accreditation Market

surveillance - internal- imported products

CE marking

Applicable as from 01/01/2010

DECISION sui generis

Definitions Obligations for economic

operators Notified Bodies Conformity assessment

procedures Safeguard mechanisms CE marking

TOOLBOX



The technique

Split into two instruments for legal reasons:

Two different addressees: MS and legislator Regulation applies as it stands Alignment of sectoral Directives (currently

toys Directive) to Decision

Art 2: “Legislation shall have recourse to the general principles and … reference provisions”



Regulation - Scope

Accreditation Accreditation relating to conformity assessment

Market surveillance Products = Substances, preparations and goods produced

through a manufacturing process, except food, feed, human blood and tissues, living plants and animals

Border controls ALL products covered by Community harmonisation

legislation



Regulation - Scope

For the first time: Community rules on accreditation and market surveillance

Coherence throughout the EU



Market surveillance - Exemptions

Exemptions via product definition• Food and feed, human blood and tissues, living plants and animals

Exemptions via lex specialis (“Regulation applies insofar as there are no specific provisions …”)• Pharmaceuticals• Drug precursors• Civil aviation• Motor vehicles• Medical devices

Authorities may take more specific measures as provided for in GPSD (Consumer products)



Regulation - Exemptions

BORDER CONTROLS

Specific provisions relating to the organisation of border controls of specific

products prevail



Market surveillance - Main elements I

Common minimum requirements in all Member States

Organisational/operational requirements

- Infrastructures, resources and powers

- Adequate checks – internally and at borders



Market surveillance - Main elements II

- Ensure recall/withdrawal of products posing a serious risk, use RAPEX (Art 12 GPSD)

o Hear operator (10 days, except urgency)o Measures:

Proportionatewell foundedappeal possible

- Destruction of products- Ensure follow up of complaints and accidents



Market surveillance - Main elements III

Co-operation mechanism

- National level

- Community level Improvement of safeguard clause

mechanism & information procedure in Decision



Border controls - Main elements

Customs obliged to carry out checks at borders on an adequate scale

Suspension of release for free circulation if product

- is not properly marked or- presents a serious riskInform market surveillance authoritiesDestruction of products



Accreditation

Accreditation = a third-party attestation attesting the competence of a conformity assessment body to carry out specific conformity assessment tasks



Why introduce Accreditation?

Currently operates in all Member States, however due to lack of common rules:

Different approaches to accreditation

Differing systems with uneven rigour

Need to introduce a framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application



Accreditation - Requirements

Accreditation bodies should: Be completely independent from commercial

motivations; Be independent and impartial; NOT be involved in conformity assessment

activities for which they accredit other bodies; Demonstrate a high level of competence via

participation in the EA (European co-operation for accreditation) peer evaluation system.



Accreditation – Main principles

= Last level of control No competition between accreditors and between

accreditors and accredited CABs ONE national accreditation body per Member

State Public authority activity Peer evaluation Cooperation between national accreditation

bodies and EA



Decision – toolbox for future legislation

General principles – NA approach technique, conformity assessment …

Definitions

Obligations of economic operators

Notified bodies, notification

Safeguard procedure CE marking



Why harmonise definitions and obligations?

Different Directives use terms differently

Some Directives have no definitions at all

Obligations of economic operators are not consistent throughout sectoral legislation

-> Lack of clarity/legal security



Definitions

Economic operators Making available on the market Placing on the market ...



Obligations I

Economic operators are responsible for the compliance of the product in relation to their role in the supply and distribution chain

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



Obligations importer

Need to ensure compliance of third country products

-> IMPORTER to ensure that

- manufacturer has carried out conformity assessment

- manufacturer has drawn up the technical documentation

- product bears conformity mark

-> Indication of importer’s name and address



Obligations distributor

DISTRIBUTOR to act with due careEnsure presence of conformity marking and

required documents



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



Why strengthen requirements for Notified Bodies?

Notification is a Member State responsibility

Currently different requirements for notification in different Member States

NBs do not apply conformity assessment in an equal manner

=> Need to create a level playing field for both notified bodies and manufacturers



Notification

Ensure full technical competence Requirements for notifying authorities Requirements / obligations for NBs Subsidiaries and sub-contracting Accredited in-house bodies Procedure – electronic notification Challenge of competence – de-notification



Safeguard procedures

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 after consulting MS and operator, depending on the decision:- Measure to be withdrawn or- other MS have to ensure that product is withdrawn



CE marking in the New Legal Framework

Strengthening the marking

In Decision (rules on affixing) and Regulation (general principles incl. pictogram)

Clarify role and significance Manufacturer’s responsibility The ONLY conformity mark Rules and conditions for its affixing Community collective trade mark MS to ensure correct implementation



What’s next?

Alignment of sectoral Directives

By issue?

Separate Directives?

Groups of Directives?

Omnibus?

to be decided within the next months



European Consumer Safety Mark

Regulation on accreditation and market surveillance Co-decision procedure – discussed by EP in 2007 Summer 2007: Mattel recall case – “unsafe” toys bearing CE marking criticism of CE marking “CE is misleading the consumer as CE does not in all cases require 3rd party certification but only manufacturer’s declaration which is not reliable.” “CE marking does not mean safety.”



Safety of products

Safety requirements in legislationQuality of the manufacturerQuality of controls and testing Quality of surveillance by public authorities

If there is a weak link in the chain, the chain breaks down.



European Parliament

Regulation on accreditation and market surveillanceRecital introduced by EP:

COM to provide an in-depth analysis on the feasibility of a consumer safety mark, if necessary followed by a legislative proposal



Timeframe

Web-Questionnaire Consumers Enterprises Market surveillance authorities

Consultation closed 6 June Trends … Feedback to EP end of September



Issues to be clarified… additional mark, possibly involving third party certification BENEFIT for consumers? - safer products - need to understand the meaning ACCEPTANCE by consumers?- awareness/recognition- (higher) price BENEFIT or BURDEN for enterprises? - competitive advantage/disadvantage - procedures SMEs?



Issues to be clarified

Scope

- ALL consumer products?

- selected products? --> selection criteria? Relation to existing marks Voluntary or obligatory Enforcement, ownership



Thank you for your attention!

Directorate General for Enterprise and Industry European Commission The New Legislative Framework...

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