Post on 14-Jan-2016
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
BULGARIA 20034
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
BULGARIA 20037
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
BULGARIA 20038
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
BULGARIA 20039
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.
BULGARIA 200312
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
BULGARIA 200315
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
BULGARIA 200321
STANDARDISATIONSTANDARDISATION
0
2000
4000
6000
8000
10000
12000
14000
1998 1999 2000 2001 2002 2003
BDS
BDS ISO
BDS IEC
BDS EN
BULGARIA 200322
STANDARDISATIONSTANDARDISATION
0
1000
2000
3000
4000
5000
6000
7000
8000
1998 1999 2000 2001 2002 2003
BDS EN
BULGARIA 200323
METROLOGYMETROLOGY
State Agency for Metrology and Technical Surveillance is the responsible authority for
Scientific Metrology Legal Metrology and Pre-packages Metrological Supervision
BULGARIA 200324
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
BULGARIA 200326
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
BULGARIA 200328
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!