The New Legislative Framework Miniseminar New Legal Framework Reykjavík, 10 December 2008 Doris Gradenegger Unit C1: Regulatory Approach for the Free Circulation of Goods

References NLF OJ L 218 P. 30 - Regulation 765/2008 on accreditation and market surveillance, P. 82 - Decision 768/2008 - common framework for the marketing of products Applicability: Regulation 1 January 2010, Decision to be used as from now on

Review of the New Approach New Approach – essential requirements rather than detailed technical specifications More than a NA review New Legal Framework

Complementary legislative tools REGULATION Accreditation Market surveillance - internal - imported products CE marking - general principles Applicable as from 01/01/2010 DECISION sui generis Definitions Obligations for economic operators Notified Bodies Conformity assessment procedures Safeguard mechanisms CE marking TOOLBOX

Why two instruments?  Legal reasons Regulation Addressed to MS Covers elements not already included in existing legislation Applicable as from 01/01/2010 Decision sui generis Addressed to legislator Not possible to change existing legislation via a single regulation (legal security) Covers elements already included in existing legislation (e.g. NBs, safeguard clause) TOOLBOX

The Technique Regulation applies as it stands from 1/1/2010 Decision = toolbox for new legislation and revision of existing legislation Art 2: “Legislation shall have recourse to the general principles and … reference provisions” Deviation possible if appropriate due to specificities of the sector; to be justified Alignment of sectoral Directives (currently toys Directive) to Decision

Regulation - the Scope Accreditation Market surveillance 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

Market surveillance - Exemptions Exemptions via product definition Art 15(4) Food and feed, human blood and tissues, living plants and animals Exemptions via lex specialis Art 15 (2) (“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) - Art 15(3)

Border Controls - Exemptions Specific provisions relating to the organisation of border controls of specific products prevail (e.g. endangered species)

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 - rapid information system (Art 22) Hear operator (10 days, except urgency) Measures: Proportionate well founded appeal 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 risk Inform market surveillance authorities Destruction of products

Decision – toolbox for future legislation General principles – NA approach technique, conformity assessment … Definitions Obligations of economic operators Requirements for notified bodies, notifying authorities 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

Obligations 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 I 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 Importer II If reason to believe that product not in conformity: not allowed to place it on the market inform manufacturer + authorities sample testing, investigate complaints and recalls + inform distributors If reason to believe that product already on market not in conformity: corrective action Provide information to authorities upon reasoned request

Obligations Distributor Distributor to act with due care Ensure presence of conformity marking and required documents If reason to believe that product is not compliant: not allowed to make product available on the market If product already on the market: ensure corrective action is taken, if risk: inform authorities Provide information to authorities upon reasoned request

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

Safeguard procedure 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

Notified Bodies Requirements for notifying authorities 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

CE marking Strengthening the CE 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

Study on a consumer safety mark No support from stakeholders rather enforce the existing system (NLF!) – market surveillance and border controls

By issue? Separate Directives? Groups of Directives? Omnibus? What’s next? Alignment of sectoral Directives By issue? Separate Directives? Groups of Directives? Omnibus?  to be decided soon

Thank you for your attention!