The New EU Legislative Framework for Harmonisation Legislation for products Richard Lawson Deputy Director, Technical Regulations Sustainable Development & Regulation Directorate

What we do at BERR/ SDRD Responsible for the negotiation, transposition and “Competent Authority” administration of a range of about 17 Directives including:- - Machinery - Low Voltage Directive - Restriction of the use of certain Hazardous Substances - Batteries and Accumulators - Electromagnetic Compatibility & Radio & Telecommunications Terminal Equipment - Energy-using Products - ATEX - Waste Electrical & Electronic Equipment

What we do at BERR/ SDRD –Together with DIUS, we are/ have been responsible for the negotiation and implementation of the New Legislative Framework (NLF) for the marketing of products and for coordination of policy on NLF and the “New Approach” across Whitehall

Distribution of Ministerial responsibility Department of Business Enterprise & Regulatory Reform (BERR) is responsible for Overall New Legislative Framework (NLF) policy Policies on Market Surveillance and on CE Marking Policy on Obligations of “Economic Operators” General policies on Trade and Better Regulation

Distribution of Ministerial Responsibility Department for Innovation, Universities & Skills (DIUS) is responsible for: Standards policy Accreditation policy Conformity Assessment policy Notified Body policy

New Legislative Framework for the marketing of products including:- REGULATION No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) No 339/93 DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a common framework for the marketing of products, and repealing Decision 93/465/EEC

The Rationale The objective of the package is to facilitate the functioning of the Internal Market for goods and to strengthen and modernise the conditions for placing a wide range of products on the EU market. The package builds upon existing systems to introduce clear Community policies which will strengthen the application and enforcement of internal market legislation.

Timing The Regulation is directly applicable in all Member States from 1 January 2010 The Decision applies immediately and provides the model for all future Directives concerning the marketing of products as they are negotiated in Council.

Scope of the Regulation Accreditation Market Surveillance CE marking – general principles Financial provisions Operative provisions

The Regulation – in detail Accreditation Provisions: Definition of Accreditation to harmonised standards MS must appoint a single National Accreditation Body (NAB) Where Accreditation is not operated directly by the public authorities, the NAB must operate Accreditation as a public authority activity

The Regulation – in detail (cont.) Accreditation Provisions (cont) Non-competition between NABs Non-competition between NABs and Conformity Assessment Bodies Cross-border Accreditation under only limited circumstances Peer evaluation critical European Accreditation Infrastructure

The Regulation’s Market Surveillance (MS) provisions RAMS’ main internal MS requirements to: Have effective MS infrastructure & programmes and to review them periodically Tell EU & public who are the MS authorities Establish coordination between MSAs Establish appropriate MS procedures Protect the CE Marking

The Regulation’s Market Surveillance (MS) provisions The Regulation’s main external MS provisions: Fulfil RAPEX obligations Take part in information support system (ICSMS?) Cooperate with other Member States’ MSAs & Commission on MS With Customs authorities, to control Borders with 3rd countries (Chapter III, Section 3)

Regulation’s CE Marking provisions CE marking: Meaning and responsibility for CE marking defined Prevention of misleading marking Legal protection for CE marking

The Regulation’s other main provisions Community financing Monitoring and evaluation Technical guidelines Date of application

The Decision’s provisions Definitions e.g. making available/placing on the market (also in the regulation where used) Obligations of Economic Operators Provisions on Declarations of Conformity Notification of Notified Bodies (criteria, process, relationship with Accreditation) Safeguards mechanism CE marking – rules for affixing Conformity Assessment Procedures - the Modules

The Decision – Conformity Assessment (CA) Modules Systems with 8 basic modules plus 8 variants CA procedures used in sectoral legislation are to be chosen from listed modules Rationale  Provide simple & coherent choice for legislator  Serve as complete menu and sets maximum possible variants  Preserve choice for manufacturer (e.g. quality certification/ product certification)  Provide for simplest and least burdensome module

The Decision - Notified Bodies Notification will be based on assessment by a National Accreditation Body (NAB) to Conformity Assessment Body (CAB) standards or other equivalent process NAB will assess a CAB against minimum criteria in a directive In the UK, UKAS sends a report to the relevant Government Department. If the Department is satisfied, the applicant is appointed (or designated) The Department will notify the Commission Commission will assign a single ID number When the information appears on NANDO, the notification process is complete

Implementation of Regulation (RAMS) in UK Appointment of a NAB – DIUS consulting Co-ordination of Market Surveillance Authorities (MSA) via a new MS Co-ordination Committee designed to: - develop strategic MS programmes - address Border Controls issues - ensure EU info. exchange requirements

Implementation of RAMS in UK – Market Surveillance (MS) aspects (cont.) Encourage participation in EU MS activities Promote Best Practice, to improve UK’s MS models Advise on Better Regulation incl. legislative reform Promote dialogue with Business & other stakeholders Already subscribe to ICSMS National Guidance will be prepared Analysing stock of implementing legislation - Regulation has direct effect but may need legislative changes to MSA’s powers in areas like Recall and Withdrawal.

Implementation of RAMS’ MS provisions: at the EU level Information systems to be determined: - Article 22 (rapid information system)– RAPEX - Article 23 (general information system) – ICSMS (?) Guidance Market surveillance initiatives Consumer Safety Marking consultation

Thank you for listening. Any Questions?