The New Approach and GPSD

1. The New Approach and GPSD

2. Objective Elimination of technical barriers to the free movement of goods by technical harmonisation Principles essential requirements reference to standards presumption of conformity mutual recognition New Approach Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards [OJ C136 of June 1985]

3. New Approach Directives Main elements • General clause for placing on the market • Essential safety requirements • Free movement clause • Means of proof of conformity (e.g. standards, third party attestation) • Means of attestation of conformity (e.g. certificates and marks of conformity issued by a third party, results of tests carried out by a third party, declaration of conformity issued by the manufacturer) • Safeguard clause • Standing committee

4. Council Decision 93/465/EEC(“Global Approach”, “Module Decision”, “Decision on CE-marking”…) Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives [Official Journal L 220 of 30.08.1993]. • procedures for assessing the conformity of products to the "essential requirements" laid down by the New Approach Directives • rules for the designation of notified bodies • rules for affixing the "CE" conformity marking provided for in the New Approach Directives

5. Council Decision 93/465/EEC 8 assessment procedures/modules (A-H): A: internal production control B: CE type-examination C: conformity to type D: production quality assurance E: product quality assurance F: product verification G: unit verification H: full quality assurance

6. A. (Internal control of production) B. (type examination) G. (unit verification) H. (full quality assurance) Manufacturer Notified body - Ascertains conformity with essential requirements - Carries out tests, if necessary - Issues EC type-examination certificate Notified body - Submits technical documentation DESIGN - Carries out surveillance of the QS - Verifies conformity of the design ( ) - Issues EC design examination certificate ( ) 1 EN 45004 (+observe requirements in EN 45001 for testing required), or EN 45011 (+observe requirements in EN 45001 for testing required) 1 Notified body Aa Notified body Notified body F. (product verification) E. (product quality assurance) D. (production quality assurance) C. (conformity to type) - Carries out surveillance of the QS - Verifies conformity with essential requirements - Issues certificate of conformity - Tests on specific aspects of the product ( ) - Product checks at random intervals ( ) Notified body Notified body Notified body Notified body 1 - Tests on specific aspects of the product ( ) - Product checks at random intervals (1) - Approves the QS - Carries out surveillance of the QS - Verifies conformity - Issues certificate of conformity - Approves the QS - Carries out surveillance of the QS P RODUCT ION 1 H EN 45012 (+product knowledge) Hbis EN 45012 (+product knowledge) and EN 45004, or EN 45011 1 1st and 2nd option: EN45001 (+ability to decide on conformity), or EN 45004 (+observe requirements in EN 45001 for testing required), or EN 45011 (+observe requirements in EN 45001 for testing required) 1st and 2nd option: EN45001 (+ability to decide on conformity), or EN 45004 (+observe requirements in EN 45001 for testing required), or EN 45011 (+observe requirements in EN 45001 for testing required) EN 45004 (+observe requirements in EN 45001 for testing required), or EN 45011 (+observe requirements in EN 45001 for testing required) EN 45012 (+product knowledge) EN 45012 (+product knowledge) EN 45001 (+ability to decide on conformity), or EN 45004 (+observe requirements in EN 45001 for testing required), or EN 45011 (+observe requirements in EN 45001 for testing required) ( ) Supplementary requirements which may be used in specific directives 1

7. General Product Safety Directive A horizontal regulatory framework for the safety of (non-food) consumer products Completes and complements vertical directives and other relevant Community legal instruments

8. General Product Safety Directive Main elements • General safety requirements • Conformity assessment criteria • Reference to standards • Provisions of market surveillance and enforcement • Provisions on administrative cooperation and exchange of information (esp. RAPEX) • Provisions for rapid measures by the Commission in case of serious risks

9. General Product Safety Directive Reinforces the obligations of producers and distributors:- traceability of products- information on dangerous products to surveillance authorities- actions to prevent risks posed by dangerous products- cooperation with enforcement authorities Reinforces the obligations of Member States:- establishment of authorities with necessary powers for surveillance and enforcement- establishment of internal cooperation arrangements between competent authorities- establishment of procedures for cooperation with producers and distributors

10. General Product Safety Directive Powers of the Enforcement Authorities • Require information, take samples, organise checks • Require warnings, to be marked in the language of the MS where the product is marketed • Order publication of warnings • Ban supply pending safety checks and assessment • Ban marketing, order or organise withdrawal from the market, order producer/distributor recalls

11. Revision of the New Approach Council Resolution Objective To increase coherence and efficiency of application of New Approach Directives through: • Clarification of horizontal definitions • Inclusion in a single legislative text • Provision of a more consistent range of modules • Devising means to pool technical expertise Key points: notified bodies and market surveillance

12. Revision of the New Approach • Communication from the Commission"Enhancing the implementation of the New Approach Directives“(COM(2003)240 final) • Council resolution on the Commission Communication(2003/C 282/02) • SOGS (Senior Officials Group on Standardization and Conformity Assessment)

13. Revision of the New Approach – Commission Communication Objective To strengthen and enhance the operational efficiency of the method by reviewing the following areas: • Notified bodies • Conformity assessment procedures • CE-marking • Market surveillance • Safeguard clause procedure

14. Revision of the New Approach – Commission Communication – notified bodies Objectives • Increase the efficiency and transparency of the notification procedure (on-line information system) • Increase the confidence for mutual recognition and acceptance of test reports and certificates issued • Develop policy for the use of accreditation procedures

15. Revision of the New Approach – Commission Communication – conformity assessment procedures • Overview of possible needs for adjustments of the balance between pre- and post market controls • Facilitate the conformity assessment of products covered by more than one directive in order to minimize the risk of overlaps

16. Revision of the New Approach – Commission Communication – CE-marking • Clarify and promote the meaning of CE marking • Clarify the relation to voluntary product marks • Strengthen the position of CE marking

17. Revision of the New Approach – Commission Communication – Market surveillance • Encourage reinforced administrative cooperation between MS and between MS and the Commission • Define common basic rules for market surveillance • Include all relevant aspects either in the directives or in a single horizontal legislative document

18. Revision of the New Approach Commission Communication – Safeguard clause procedure • Clarify the clause and improve the efficiency of community control • Consider means to pool scarce technical expertise

19. Revision of the New Approach Council Resolution – notified bodies • Consolidation of legal requirements • Establishment of information exchange procedures • Strengthening the role of accreditation

20. Revision of the New Approach Council Resolution – market surveillance Objective To achieve greater consistency in national approaches: • Definition of common objectives • Development of a legal framework for relevant administrative cooperation • Improvement of the safeguard clause procedure