Robin Croft organised in co-operation with TAIEX EUROPEAN LEGAL - PowerPoint PPT Presentation

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products Robin Croft organised in co-operation with TAIEX

EUROPEAN LEGAL FRAME WORK TO DELIVER PRODUCT SAFETY GENERAL PRODUCT SAFETY DIRECTIVE 2001/95/EC & EU REGULATION (EC) 765/2008 & EU DECISION (EC) 768/2008 & PRODUCT DIRECTIVES & REGULATIONS

GPSD & REGULATION 765/2008  Two horizontal Community laws  Both contain requirements for Market Surveillance regarding the safety of products  GPSD applies to all consumer products  Regulation allies to all “harmonised products”  Areas of clear overlap  Areas where both provisions apply 3

PRODUCT CATEGORIES General Product Safety New Approach Directives Other scenarios 4

General Product Safety Directive  Requirement on manufacturers & importers to place only safe products on the market  Post-sale duty to monitor their products  Update warnings and instructions  Withdraw an unsafe product  Recall from consumers 5 5

New Approach Directives  TECHNICAL REGULATIONS  Only products fulfilling the essential requirements may be placed on the market or put into service.  Harmonised standards are presumed to conform to the corresponding essential requirement = Presumption of conformity  CE mark = Mark of conformity  Technical files = Check on conformity  Declaration of Conformity = Included 6 6

CE MARK 7 LV/2006/IB/EC/01 7

Standard elements New Approach Directives  Application of harmonised standards is generally voluntary for consumer goods  Manufacturers are mainly free to choose any technical solution that provides compliance with the essential requirements  Self-certification can be allowed – if so - no need for any 3 rd party certification  Manufacturers may choose between the different conformity assessment procedures set out in the directives 8 8

Quality Framework  Conformity assessment and accreditation are important parts of the EU’s quality infrastructure.  By providing confidence in goods, services, management systems and people, they make a significant contribution to the economy, health and safety, and environment of all member states.  Accreditation is also conformity assessment but as it is used to evaluate third party conformity assessors, it functions better as part of the framework for the conformity assessment market rather than within it. In this paper therefore accreditation is considered separately from other forms of conformity assessment. 9

What is conformity assessment  Conformity assessment is the demonstration that what is supplied actually meets the requirements specified or claimed.  Conformity assessment can be applied to a product (including a service), a process, a system, a body or persons and includes activities such as testing, inspection and certification.  Conformity assessment can be by:-  any party that is interested in the outcome of the assessment; or  a third party conformity assessment by an independent body . 10

Conformity assessment in EU Acquis  A manufacturer can only place a product on the EU market when it meets all the applicable requirements.  Therefore some conformity assessment procedure has to be carried out before the product can be sold.  The regulations and directives set out the options for conformity assessment.  The European Commission’s main objective is to help ensure that unsafe or otherwise non-compliant products do not find their way to the EU market. 11

Objectives of the conformity assessment and accreditation procedures  To demonstrate to the manufacturer or importer that a product which they plan to place on the market complies with all legislative requirements.  To provide manufactures with a high degree of confidence in the results of the conformity assessment process  The procedure should also ensure confidence of consumers, public authorities regarding the conformity of products  A single IT product may need to meet the essential requirements of upto five separate directives – LVD/EMC/RoHS/R&TTE/WEEE 12

How does it work in practice?  Product legislation describes the conformity assessment procedures for each product.  Manufacturers may choose between different conformity assessment procedures, if applicable.  The assessment is carried out by or for the manufacturer.  If the applicable legislation requires it, a conformity assessment body is involved in the conformity assessment process – EU Notified bodies .  Conformity of a product is assessed before it is placed on the market. 13

What Conformity Assessment is NOT  Conformity assessment is not part of market surveillance  Market surveillance is concerned with conformity compliance  Conformity assessment is complementary to market surveillance.  Both procedures help ensure the smooth functioning of the internal market  Notified bodies are not allowed to engage in market surveillance 14

Declaration of Conformity As part of conformity assessment, the manufacturer or the authorised  representative must draw up an Declaration of conformity (DoC). The declaration should contain all information to identify:   the product  the legislation according to which it is issued  the manufacturer or the authorised representative  the notified body if applicable  a reference to harmonised standards or other normative documents, where appropriate . 15

EU REGULATION (EC) 765/2008  Important that conformity assessment bodies (CABs) operate to acceptable standards  Legal framework for the provision of accreditation services across Europe  Requires each Member State to appoint a single National Accreditation Body [NAB]  Accreditation process determines the technical competence and integrity of organisations such as those offering testing, calibration and certification services (conformity assessment)

Accreditation  Operates across all market sectors  Provides an impartial assessment against internationally recognised standards.  This has benefits for:  Government: supports the implementation of government policies and regulations that impact on health, welfare, security and the environment.  Industry: essential for decision-making and risk management  Consumers: enhances product safety and competition. 17

Regulation 756/2008 requirements  The Regulation promotes a uniformly rigorous approach to accreditation across Member States – so that one accreditation certificate will be enough to demonstrate the technical capacity of a CAB  The main principles of accreditation are:  One accreditation body per EU country  Possibility to use another country’s national accreditation body  Public authority/sector activity  Clear distinction from other national authorities  Not-for-profit operation  Must not compete with other national accreditation bodies  Cannot provide conformity assessment services provided by CABs

Requirements for NAB  Independent of conformity assessment bodies that it assesses  Free from commercial pressures and conflicts of interest  Decisions of attestation of competence taken by competent persons separate from the assessors  Adequate arrangements to safeguard confidentiality of information  Efficient management procedures and internal controls  Publish annual accounts prepared in accordance with accepted accounting principles 19

Duties of NAB  Evaluation of competency to ensure that CABs have the technical capacity to perform their duties adequately  Issue of accreditation certificates  Monitor the CABs that the have certified  Deal with complaints against CABs  Revoke certificates if CAB no longer can demonstrate competence  Accreditation aims to increase trust in conformity and mutual recognition

Requirements for NAB  Subject themselves to peer evaluation to determine if they meet the requirement of the Regulation  Conformity to relevant harmonised standard demonstrated through peer evaluation gives presumption of conformity to Regulation requirements  Publish the outcome of its peer evaluation  Inform other NABs of the areas of conformity assessment of which it operates accreditation  Allow participation of stakeholders in parts of the process 21

Notification  Member State “notifies” the EU of the bodies that it has designated to carry out conformity assessment of a directive.  Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State.  EEA members and other countries with which the EC has concluded Mutual Recognition Agreements (MRAs) and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) have designated Notified Bodies, established per directive. 22

Notified Bodies & Accreditation Directive / Regulation Specific requirements for products and to Conformity Assessment procedures Technical competence of ACCREDITATION the Conformity Assessment Body Specific competence of the DESIGNATION CAB with regard to (parts) of NOTIFICATION the Directive / Regulation 23 23 23 23