BULGARIA 20031

STATE AGENCY FOR METROLOGY AND

TECHNICAL SURVEILLANCE

BULGARIA

2003

BULGARIA 20032

BULGARIAN EXPERIENCE IN BULGARIAN EXPERIENCE IN TRANSPOSITION OFTRANSPOSITION OF

EU TECHNICAL LEGISLATION EU TECHNICAL LEGISLATION

Violina Panayotova

Director International Cooperation and

European Integration

SAMTS

BULGARIA 20033

Responsibilities:Responsibilities:

The State Agency for Metrology and Technical Surveillance is responsible for implementation of the government policy in the field of:

Metrology Market surveillance in the scope of New Approach Directives Technical inspection of high-risk equipment Designation of Conformity Assessment Bodies

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LawsLaws in in ConformityConformity Assessment Area Assessment Area

Law on National Standardisation (State Gazette 55/18.06.1999, last amendment State Gazette 13/05.02.2002)

Law on Technical Requirements to Products (State Gazette 86/01.10.1999, last amendment State Gazette 18/25.02.2003)

Law on Measurements (State Gazette 46/07.05.2002)

BULGARIA 20035

Process of NAD transposition into Bulgarian Process of NAD transposition into Bulgarian legislation:legislation:

working groups within the responsible Ministry/Agency - draft Ordinances

working group 1.14 “New Approach Directives” - assessment of level of correspondence with EU Directives

inter-ministerial co-ordination adoption of the Ordinances by the Council of Ministers publishing the adopted Ordinances in the State Gazette

BULGARIA 20036

TRANSPOSITION-RELATED ISSUESTRANSPOSITION-RELATED ISSUES

Involvement of all stakeholders in transposition process Strengthening of administrative capacity for

implementation Strengthening coordination between institutions Rising awareness of parties concerned Taking over new responsibilities by parties concerned Need of training for economic operators

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New Approach DirectivesNew Approach Directivesimplemented into the national legislationimplemented into the national legislation

EU Directive Enters into force Organization in charge

Low voltage equipment73/23/EEC

14.01.2003 Ministry of Economy

Simple pressure vessels87/404/EEC

03.10. 2002 State Agency for Metrology andTechnical SurveillanceMinistry of Economy

Safety of toys88/378/EEC

14.07.2002 Ministry of Health

Electromagnetic compatibility89/336/EEC

12.09.2002 Ministry of Transport andTelecommunicationsMinistry of Economy

Construction products89/106/EEC

14.11.2001 Ministry of Regional Developmentand Public Works

Safety of machinery98/37/EC

27.04.2003 Ministry of EconomyMinistry of Labour and Social Policy

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New Approach DirectivesNew Approach Directivesimplemented into the national legislationimplemented into the national legislation

EU Directive Enters into force Organization in charge

Lifts95/16/EC

03.05.2003 Ministry of EconomyState Agency for Metrology andTechnical Surveillance

Personal protective equipment89/686/EEC

16.11.2003 Ministry of HealthMinistry of Labor and SocialPolicy

Non-automatic weighinginstruments90/384/EEC

01.01.2005 State Agency for Metrology andTechnical Surveillance

Medical devices: General93/42/EEC

draft Ministry of HealthMinistry of Economy

Medical devices: activeimplantable90/385/EEC

draft Ministry of HealthMinistry of Economy

Medical devices: In VitroDiagnostic98/79/EC

draft Ministry of HealthMinistry of Economy

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New Approach DirectivesNew Approach Directivesimplemented into the national legislationimplemented into the national legislation

EU Directive Enters into force Organization in charge

Gas appliances90/396/EEC

13.06.2001 State Agency for Metrology andTechnical Surveillance

New hot-water boilers fired withliquid or gaseous fuels92/42/EEC

draft Ministry of Energy and EnergyResourcesState Agency for Metrology andTechnical SurveillanceMinistry of Economy

Explosives for civil uses93/15/EEC

31.12.2002 Ministry of EconomyMinistry of Interior

Equipment and protectivesystems in potentially explosiveatmospheres94/9/EC

01.07.2003 Ministry of EconomyMinistry of Energy and EnergyResources

Recreational craft94/25/EC

10.05.2003 Ministry of EconomyMinistry of Transport andTelecommunications

BULGARIA 200310

New Approach DirectivesNew Approach Directivesimplemented into the national legislationimplemented into the national legislation

EU Directive Enters into force Organization in charge

Radio equipment andtelecommunications terminalequipment and mutualrecognition of conformity99/5/EC

12.09.2002 Ministry of Transport andTelecommunications

Pressure equipment97/23/EC

13.03.2004 Ministry of EconomyState Agency for Metrology andTechnical Surveillance

Energy efficiency requirementsfor household electricrefrigerators, freezers andcombinations thereof96/57/EC

05.03.2004 Ministry of Energy and EnergyResourcesMinistry of Economy

Cableway installations2000/9/EC

draft State Agency for Metrology andTechnical Surveillance

BULGARIA 200311

National Conformity MarkingNational Conformity Marking

The conformity marking indicates that the products conform to the essential requirements that apply to them, as laid down in the Ordinance, transposing respective New Approach Directive, and that they have been subject to the appropriate conformity assessment procedures.

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Designating AuthoritiesDesignating Authorities

State Agency for Metrology and Technical Surveillance - for all New Approach Directives

Ministry of Regional Development and Public

Works - construction products

BULGARIA 200313

Designated BodiesDesignated Bodies

Number of designated bodies

2

2

2

11

6

2Gas appliances

Toys

EMC

SPV

CIVEX

CPD

RTTE

BULGARIA 200314

Applicants for designationApplicants for designation

Applicants for designation

3

2

1

4

23

1

3

1 1 1

Gas appliances

EMC

Toys

SPV

Pressure equipment

Lif ts

Machinery

LVD

ATEX

RTTE

PPE

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Support to designated bodiesSupport to designated bodies

need of training need of testing equipment participation in EU NB working groups participation in TC standardisation work establishment of National Board of designated

bodies

BULGARIA 200316

ACCREDITATIONACCREDITATION

Executive Agency “Bulgarian Accreditation Service” - national body for accreditation of :

testing and/or calibration laboratories product certification bodies quality management system certification bodies environmental management system certification bodies personnel certification bodies inspection bodies

BULGARIA 200317

ACCREDITATIONACCREDITATION

EA full member – March 2001 EA Memorandum of Understanding for MLA

signatory application right – June 2001 Strategy for signing EA MLA in different fields Application for signing EA MLA in the field of quality

system certification and personnel certification - December 2002

Initial evaluation with respect of BAS preparedness for signing EA MLA - May 2003

BULGARIA 200318

ACCREDITATIONACCREDITATION

Number of accredited labs and bodies

44

139

4 3 2BDS EN ISO/IEC 17025

BDS EN 45004

BDS EN 45011

BDS EN 45012

BDS EN 45013

BULGARIA 200319

STANDARDISATIONSTANDARDISATION

Segregation of the Standardisation Directorate from State Agency for Standardisation and Metrology

Establishment of Bulgarian Institute for Standardisation (BIS) to the Council of Ministers (Decree 152/19.07.2002 of the Council of Ministers, State Gazette 73/26.07.2002)

Voluntary standards Transposition of EN standards - 62 % Application for CEN/CENELEC full membership -

second half of 2004

BULGARIA 200320

STANDARDISATION - RELATED ISSUESSTANDARDISATION - RELATED ISSUES

Transposition of harmonised standards - 100% Transposition of harmonised standards by

translation into Bulgarian language Transposition by endorsement - English,

translation of the standard’s cover page - problems for users

IT facilities

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STANDARDISATIONSTANDARDISATION

0

2000

4000

6000

8000

10000

12000

14000

1998 1999 2000 2001 2002 2003

BDS

BDS ISO

BDS IEC

BDS EN

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STANDARDISATIONSTANDARDISATION

0

1000

2000

3000

4000

5000

6000

7000

8000

1998 1999 2000 2001 2002 2003

BDS EN

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METROLOGYMETROLOGY

State Agency for Metrology and Technical Surveillance is the responsible authority for

Scientific Metrology Legal Metrology and Pre-packages Metrological Supervision

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METROLOGYMETROLOGY

Organisation Membership status

Convention du Mètre Signatory 1910

OIML Full member 1956

WELMEC Associate member 2000

EUROMET Full member 2003

COOMET Member 1991

BULGARIA 200325

METROLOGY - RELATED ISSUESMETROLOGY - RELATED ISSUES

New metrology complex

State-of-the-art measurement standards (scientific metrology)

Reorganisation with respect of MID implementation

State-of-the-art testing equipment (legal metrology)

Respond to industry demands

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MARKET SURVEILLANCEMARKET SURVEILLANCE

NEW APPROACH

State Agency for Metrology and Technical Surveillance - in charge of market surveillance in the scope of New Approach Directives

State Agency for Metrology and Technical Surveillance and Ministry of Regional Development and Public Works - in charge of market surveillance in the scope of construction products

Market surveillance in the scope of medical devices will be regulated by a separate Law

BULGARIA 200327

MARKET SURVEILLANCEMARKET SURVEILLANCE

Number of inspected products(July-September 2003)

58418223

12141

28353

1490 Gas appliances

Construction products

Toys

LVD&EMC

Machinery

Products bearing conformity marking (July-September 2003)

47%

20%20%

20%

47% Gas appliances

Construction products

Toys

LVD&EMC

Machinery

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MARKET SURVEILLANCEMARKET SURVEILLANCE

OTHER FIELDS

Law on Foodstuffs Hygiene-Epidemiological Inspectorates, National

Veterinary Service and National Service on Plant Protection Law on Medicines and Pharmacies in Human Medicine Executive Agency on Medicines and the Hygiene-

Epidemiological Inspectorates Law on Consumer Protection and Trade Rules

Commission for Trade and Consumer Protection

BULGARIA 200329

MARKET SURVEILLANCE - RELATED ISSUESMARKET SURVEILLANCE - RELATED ISSUES

Need of continuous training for inspectors IT facilities Budgetary resources available for sampling

and testing activities Establishing effective cooperation with customs

authorities and other governmental and non-governmental institutions

BULGARIA 200330

Start of negotiations for signing PECA (Fact Finding Mission - 19.09.2002)

Sectors covered: Safety of Machinery Lifts Gas Appliances Safety of Toys EMC LVD

Adopted harmonised standards - over 80%

PECAPECA negotiationnegotiation

BULGARIA 200331

Thank you!