Upload
alexis-haynes
View
213
Download
0
Tags:
Embed Size (px)
Citation preview
Anca SANDRU –Head office for Quality Infrastructure and Competitivity
Ministry of Economy and Commercewww.minind.ro
UNECE ROUND TABLE ON REGULATORY COOPERATION IN
SOUTH EAST EUROPE
GENEVA
22 November 2004
ROMANIA is engaged to take the appropriate legally and organization measures, for its alignment to the European requirements, exigencies and practice.
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
The target:The obtaining of the European Union member state statute
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
The main activities:
the transposition and the implementation at the national level of the European technical regulations
the deregulating, when was necessary
the development of an institutional and procedural harmonized frame in the field of the standardization and conformity assessment.
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
THE SITUATION OF THE IMPLEMENTATION OF THE NEW APPROACH DIRECTIVES
No.No. Short Title Of DirectiveShort Title Of Directive No. of DirectiveNo. of Directive Full implementationFull implementation
datedate
11 Low VoltageLow Voltage 73/23/EEC 73/23/EEC 2002 2002
22 Simple Pressure VesselsSimple Pressure Vessels 87/404/EEC87/404/EEC 20022002
33 Safety of toysSafety of toys 88/378/EEC88/378/EEC 20022002
44 Construction productsConstruction products 89/106/EEC89/106/EEC 20052005
55 Electromagnetic compatibility (EMC)Electromagnetic compatibility (EMC) 89/336/EEC89/336/EEC 20022002
66 MachineryMachinery 98/37/EC98/37/EC 20042004
77 Personal protective equipment (PPE)Personal protective equipment (PPE) 89/686/EEC89/686/EEC 20042004
88 Non-automatic weighing instrumentsNon-automatic weighing instruments 90/384/EEC90/384/EEC 20022002
99 Active implantable medical devicesActive implantable medical devices 90/385/EEC90/385/EEC 20042004
1010 Gas appliances Gas appliances 90/396/EEC90/396/EEC 20022002
1111 Efficiency Requirements For New Hot-Efficiency Requirements For New Hot-Water Boilers Fired With Liquid Or Water Boilers Fired With Liquid Or Gaseous FuelsGaseous Fuels
92/42/EEC92/42/EEC 20032003
1212 Medical devicesMedical devices 93/42/EEC93/42/EEC 20032003
1313 Equipment explosive atmospheres Equipment explosive atmospheres (ATEX)(ATEX)
94/9/EC94/9/EC 20042004
1414 Recreational craftRecreational craft 94/25/EC94/25/EC 20042004
1515 Packaging and packaging wastePackaging and packaging waste 94/62/EC94/62/EC 20022002
1616 Lifts Lifts 95/16/EC95/16/EC 20032003
MINISTRY OF ECONOMY AND COMMERCE
THE SITUATION OF THE IMPLEMENTATION OF THE NEW APPROACH DIRECTIVES
1717 Pressure equipmentPressure equipment 97/23/EC97/23/EC 20042004
1818 In vitro diagnostic medical devicesIn vitro diagnostic medical devices 98/79/EC98/79/EC 20032003
1919 Radio Equipment and Radio Equipment and Telecommunications Terminal Telecommunications Terminal Equipment Equipment
99/5/EC99/5/EC 20032003
2020 Cableway installations designed to Cableway installations designed to carry personscarry persons
00/9/EC00/9/EC 20042004
2121 Energy efficiency requirements for Energy efficiency requirements for household electric refrigerators, household electric refrigerators, freezes and combinations thereforefreezes and combinations therefore
96/57/EC96/57/EC 20022002
2222 Marine equipmentMarine equipment 96/98/EC96/98/EC 20002000
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
HIGHEST PRIORITY (2004-2005)
No.No. Short Title Of Short Title Of DirectiveDirective
No. of DirectiveNo. of Directive FullFull
implementatioimplementationn
datedate
ComentsComents
1.1. Transportable Transportable pressure equipmentpressure equipment
99/36/EC99/36/EC 20052005 The Directive The Directive was transposed was transposed in the national in the national legislation in legislation in 2004. 2004.
2.2. Explosives for civil useExplosives for civil use 93/15/EEC93/15/EEC 20052005 Will be Will be transposed transposed until the end of until the end of this year this year
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
StandardizationStandardization
European and international European and international ASRO activityASRO activity
Affiliate member ofAffiliate member of CENELEC CENELEC (European Committee (European Committee for Electrotechnical Standardization)for Electrotechnical Standardization)
Affiliate member ofAffiliate member of CEN CEN (European Committee for (European Committee for Standardization)Standardization)
Affiliate member ofAffiliate member of ETSI ETSI (European (European Telecommunications Standards Institute)Telecommunications Standards Institute)
Full member ofFull member of ISO ISO (International Standardization (International Standardization Organization)Organization)
Member of Member of CEI CEI (International Electrotechnical (International Electrotechnical Commission)Commission)
GENEVA
22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
Standardization
The objective for a short time:The obtaining, in 2005, of the CEN and CENELEC full member statute.
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
StandardizationStandardization
Number of CEN/CENELEC standards Number of CEN/CENELEC standards adoptedadopted--September 2004-September 2004-
CEN standards : 8285 (90,93%)CEN standards : 8285 (90,93%) CENELEC standards : 4181 (91,39%)CENELEC standards : 4181 (91,39%)
The method used for adoption:The method used for adoption: Translation: 4797 standardsTranslation: 4797 standards Cover sheet: 7669 standardsCover sheet: 7669 standards
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
AccreditationAccreditation
The national accreditation body-RENARThe national accreditation body-RENAR founding member of International Laboratory founding member of International Laboratory
Accreditation Cooperation, Accreditation Cooperation, ILACILAC, since 1996, since 1996 full member of International Accreditation full member of International Accreditation
Forum, Forum, IAFIAF, since 2002, since 2002 full member of the European Cooperation for full member of the European Cooperation for
Accreditation, Accreditation, EA,EA, since 1998 since 1998
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
AccreditationAccreditation
Results of the accreditation activityResults of the accreditation activity- 304 test laboratories- 304 test laboratories -1 calibration laboratory-1 calibration laboratory -19 certification bodies for the quality management systems-19 certification bodies for the quality management systems -7 certification bodies for the environment management -7 certification bodies for the environment management
systemssystems -21 product certification bodies-21 product certification bodies -2 personnel certification bodies-2 personnel certification bodies -6 inspection bodies-6 inspection bodies
Only the accredited laboratories/bodies can be Only the accredited laboratories/bodies can be designated/notified by the Romanin competent authoritiesdesignated/notified by the Romanin competent authorities
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
Market surveillance
This activity was regulated in Romania by taking into account the recommendations and considerations formulated in connection with this subject, in the Guide for the implementations of the New Approach and Global Approach directives, elaborated by European Commission.
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
EQUIPMENTS APPRECIATED HAVING A HIGH LEVEL OF RISK
-Medical Devices-Equipments and installations for amusement parks and playground -Cranes -Forklift - trucks -Electric and hydraulic lifts for persons and for materials -Cable way installations for persons -Steam hot and warm water-Transportable pressure equipments -Gas, liquids and solid fuel consuming equipments -Pressure equipments
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
THE AREAS/SECTORS WHERE NATIONAL REGULATORS SEE A NEED FOR ADDITIONAL TECHNICAL
REGULATIONS (BASED ON NATIONAL SPECIFIC REQUIREMENTS AND WHICH ARE NOT COVERED BY
EXISTING EU LEGISLATION/DIRECTIVES)
HIGHEST PRIORITY (2004-2006)
Sector/area/product Sector/area/product grupgrup
The scope of a The scope of a proposed proposed
regulation/problem to regulation/problem to be addressed be addressed
Year when a new Year when a new national regulation is national regulation is
foreseen to be foreseen to be prepared/Comments (if prepared/Comments (if
any) any)
Non-harmonized Non-harmonized measure meansmeasure means
Mutual recognitionMutual recognition 20052005
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
No.No. Short Title Of DirectiveShort Title Of Directive No. of DirectiveNo. of Directive Full implementationFull implementation
datedate
11 Low VoltageLow Voltage 73/23/EEC 73/23/EEC 2002 2002
22 Simple Pressure VesselsSimple Pressure Vessels 87/404/EEC87/404/EEC 20022002
33 Safety of toysSafety of toys 88/378/EEC88/378/EEC 20022002
44 Electromagnetic compatibility (EMC)Electromagnetic compatibility (EMC) 89/336/EEC89/336/EEC 20022002
55 MachineryMachinery 98/37/EC98/37/EC 20042004
66 Non-automatic weighing instrumentsNon-automatic weighing instruments 90/384/EEC90/384/EEC 20022002
77 Gas appliances Gas appliances 90/396/EEC90/396/EEC 20022002
88 Lifts Lifts 95/16/EC95/16/EC 20032003
99 Radio Equipment and Radio Equipment and Telecommunications Terminal Telecommunications Terminal EquipmentEquipment
99/5/EC99/5/EC 20032003
THE FIELDS PROPOSED FOR PECA
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
Future plans
the conclusion of PECA
the reducing of the barriers to trade through:
•technical harmonization
•mutual recognition.
GENEVA 22 November 2004
MINISTRY OF ECONOMY AND COMMERCE
GENEVA 22 November 2004
GENEVA 22 November 2004