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This text provides an overview of Romania's implementation of the Pressure Equipment Directive (PED), including transposition of European legislation, monitoring of market surveillance activity, and the role of Romanian bodies involved in conformity assessment.
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EXPERIENCE OF ROMANIAIN IMPLEMENTINGPED Viorel Dumitrescu – counsellor Ministry of EconomyandCommerce General Division Industrial Policy
Ministry of EconomyandCommerce role / responsibilities • Transposition of European legislation • Implementation ofEuropean legislation • Monitoring of Market Surveillance activity • Organizationofworkshops/roundtables with producers, users, notified bodies, MS body • Attending working groups of the European Commission: WPG,WGP, ADCO BUCHAREST
Implementation measures (1) Romanian bodiesinvolvedin conformity assessment • ISCIR-CERT (NoBo) – SPV, GAD, NHWB, Lifts, PED. • ISIM CERT END (3rd part organization) – part of ISIM Timisoara ISIM representing Romania in IIW (International Institute of Welding) and member of European Welding Association BUCHAREST
Implementation measures (2) Certificationsissued by the Romanian CertificationBody • 875 certificates : • module B - 81 certificates; • module F - 392 certificates; • module G - 300 certificates; • module A1 - 39 certificates; • module B1 - 19 certificates; • module H1 - 25 certificates; • module E- 4 certificates; • module D - 8 certificates; • module C1 - 6 certificates; • module H - 1 certificate. BUCHAREST
Implementation measures (2) MarketSurveillance Bodies • Separate Unit - ISCIR – SPcreated in accordance with theprovisions of GDno.1340/2001 regarding organization andoperating of ISCIR – under MEC subordination - SPV, GAD, NHWB, Lifts, PED, TPED - programmed, ad-hoc and cross-border actions BUCHAREST
Implementation measures (4) Activityof market surveillance body - ISCIR SP Inspections;Conformities;Nonconformities; Sent Notifications;Sanctions BUCHAREST
Implementation measures (5) • MEC promotedand co-ordinatedthe romanian versionediting of“BLUE GUIDE” in 2004 • MEC elaboratedaleaflet with Romanian legislationwhich transposes the harmonised legislationin the field of manufacturing industry, including pressure equipment • MEC organisedperiodically seminariesandround tables withproducers, starting with 2001 • PSO technical assistance program “PED implementation in Romania” 2002 - 2004 BUCHAREST
Implementation measures (6) • MEC promotedand co-ordinated the elaboration of Romanian version of theGuideline prepared in Working Group Pressure in 2004, updated in 2006 • MEC promotedand co-ordinated the elaborationof a guidelineforthe implementation ofGD584/2004 which transposesPED • Periodical updatingof the web-sitewww.minind.rowith relevantinformation http://www.minind.ro/domenii_sectoare/index4.html BUCHAREST
Industry PED - important representationin industry • R&D institutes - over 20 • Producers – 30 large producersof equipmentand assemblies • Users – over 50 large companies (chemistry, petro – chemistry, pharmaceutical) BUCHAREST
HORIZONTAL LEGISLATION • Law no. 608/31 October 2001 concerning conformity assessment of products, republished • Government Decision no. 71/24 January 2002 –modules, republished • Government Decision no. 487/16 May 2002 for the approval of Methodological Norms concerning designation and notification ofbodies, republished • Government Decision no. 891/03 June 2004 concerning some measures of market surveillance, republished BUCHAREST
Legislation – pressure vessels BUCHAREST
Directive 97/23/CE PED • GD no. 752/2002establishing the conditions for placing on the market the pressure equipment, published in the Official Journal of Romania no. 622/22.08.2002. In forcefrom 1st ofJanuary 2004. Repealed by • GD no. 584/2004establishing the conditions for placing on the market the pressure equipment, publishedin the Official Journal of Romania no. 404/06.05.2004 • Amended byGD no. 1168/2005, publishedin the Official Journal of Romania no. 914/12.10.2005 BUCHAREST
PED implementation Standards (1) • Order no. 440/2004 approving the list of the Romanian standards adopting the European harmonised standards concerning pressure equipment Official Journal of Romania no. 705/04.08.2004 • Order no. 338/2005 replacing the Annex to Order no. 440/2004 approving the list of the Romanian standards adopting the European harmonised standards concerning pressure equipment Official Journal of Romania no. 563/30.06.2005 include all harmonized standards published till November 2006 80% are translated BUCHAREST
PED implementation Standards (2) - OJ of EU no. C 311/2006 New harmonized standards - ASRO, the national standardization bodyensures the transposition of them as SR EN – contract with MEC ASRO – CEN member from January 20006 - CENELEC member from February 2006 BUCHAREST
PED implementation Implementing legislation (1) • Order no. 542/2004regarding some measures for the approval of bodies which carry out the conformity assessment for the pressure equipment and of third party organizations which carry out the testing provided at points 3.1.2 and 3.1.3 of Annex 1 to GD no. 584/2004 establishing the conditions for placing on the market the pressure equipment Official Journal of Romaniano. 829/08.09.2004 BUCHAREST
PED implementation Implementing legislation(2) • Order no. 393/2005 regarding some measures for the recognition in order to be designated of the users inspectorates for the conformity assessment of pressure euquipment, according to art. 17 of the GD no. 584/2004 establishing the conditions for placing on the market the pressure equipment Official Journal of Romania no. 713/8.08.2005 BUCHAREST
PED implementation CONFORMITY ASSESSMENT BODIES NOTIFIED BY ROMANIA • NOTIFIED BODIES – ART.17 • ISCIR CERT • THIRD PART ORGANISATIONS – ART.18 Annex no. 2 point 3.1.2 and point 3.1.3. • ISIM CERT END • USERS INSPECTORATES – ART.19 • No applications received BUCHAREST
PED implementation List of bodies • Order no. 845/2006 for the approval of the List of bodies designatedto be notifiedand which perform the conformity assessment for pressure equipment - ISIM CERT END – 3P - ISCIR CERT – NoBo (1798) • notification- NANDO system BUCHAREST
Useful links • http://www.minind.ro/domenii_sectoare/index4.html - website MEC • http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html - link harmonized European standards • http://ec.europa.eu/enterprise/newapproach/nando/ - list of notified bodiesand of third part organisations • http://ec.europa.eu/enterprise/pressure_equipment/ped/index_en.html- site ofDirective pressure equipment • http://www.newapproach.org/- site newapproach BUCHAREST
ADMINISTRATORS of DIRECTIVE • Viorel DUMITRESCU, Dipl. Eng. Ministry of EconomyandCommerce GeneralDivision Industrial Policy, Phone: 305.52.20; Fax: 311.24.34 e-mail: viorel_dumitrescu@minind.ro • Roxana APREUTESEI, Legal issues Ministry of EconomyandCommerce, Internal Market Division Phone:202.52.44; Fax: 202.52.45 e-mail: roxana_apreutesei@minind.ro BUCHAREST
Thanks for your attention!Questions ? BUCHAREST