1. BULGARIA 2003 1 STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE BULGARIA 2003

2. BULGARIA 2003 2 BULGARIAN EXPERIENCE IN TRANSPOSITION OF EU TECHNICAL LEGISLATION Violina Panayotova Director International Cooperation and European Integration SAMTS

3. BULGARIA 2003 3 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

4. BULGARIA 2003 4 Laws in Conformity 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)

5. BULGARIA 2003 5 Process of NAD transposition into Bulgarian 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

6. BULGARIA 2003 6 TRANSPOSITION-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

7. BULGARIA 2003 7 New Approach Directives implemented into the national legislation

8. BULGARIA 2003 8 New Approach Directives implemented into the national legislation

9. BULGARIA 2003 9 New Approach Directives implemented into the national legislation

10. BULGARIA 2003 10 New Approach Directives implemented into the national legislation

11. BULGARIA 2003 11 National 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.

12. BULGARIA 2003 12 Designating Authorities State Agency for Metrology and Technical Surveillance - for all New Approach Directives Ministry of Regional Development and Public Works - construction products

13. BULGARIA 2003 13 Designated Bodies

14. BULGARIA 2003 14 Applicants for designation

15. BULGARIA 2003 15 Support 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

16. BULGARIA 2003 16 ACCREDITATION 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

17. BULGARIA 2003 17 ACCREDITATION 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

18. BULGARIA 2003 18 ACCREDITATION

19. BULGARIA 2003 19 STANDARDISATION 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

20. BULGARIA 2003 20 STANDARDISATION - 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

21. BULGARIA 2003 21 STANDARDISATION

22. BULGARIA 2003 22 STANDARDISATION

23. BULGARIA 2003 23 METROLOGY State Agency for Metrology and Technical Surveillance is the responsible authority for Scientific Metrology Legal Metrology and Pre-packages Metrological Supervision

24. BULGARIA 2003 24 METROLOGY

25. BULGARIA 2003 25 METROLOGY - 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

26. BULGARIA 2003 26 MARKET 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

27. BULGARIA 2003 27 MARKET SURVEILLANCE

28. BULGARIA 2003 28 MARKET 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

29. BULGARIA 2003 29 MARKET 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

30. BULGARIA 2003 30 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% PECA negotiation

31. BULGARIA 2003 31 Thank you!