geneva 22 november 2004

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



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.



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


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



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



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


Standardization

The objective for a short time:The obtaining, in 2005, of the CEN and CENELEC full member statute.



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



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



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



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.



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



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



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



Future plans

the conclusion of PECA

the reducing of the barriers to trade through:

•technical harmonization

•mutual recognition.



geneva 22 november 2004

Documents

european requirements

radio equipment

marine equipment

commerce17pressure equipment

member statute

european technical regulations

implementation date

commercethe situation