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STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE. BULGARIA 2003 . BULGARIAN EXPERIENCE IN TRANSPOSITION OF EU TECHNICAL LEGISLATION. Violina Panayotova Director International Cooperation and European Integration SAMTS. Responsibilities:.

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bulgarian experience in transposition of eu technical legislation
BULGARIAN EXPERIENCE IN TRANSPOSITION OF EU TECHNICAL LEGISLATION

Violina Panayotova

Director International Cooperation and

European Integration

SAMTS

BULGARIA 2003

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 2003

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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)

BULGARIA 2003

process of nad transposition into bulgarian legislation
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 correspondencewith EU Directives
  • inter-ministerial co-ordination
  • adoptionof the Ordinances by the Council of Ministers
  • publishing the adopted Ordinances in the State Gazette

BULGARIA 2003

transposition related issues
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

BULGARIA 2003

national conformity marking
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.

BULGARIA 2003

designating authorities
Designating Authorities
  • State Agency for Metrology and Technical Surveillance - for all New Approach Directives
  • Ministry of Regional Development and Public Works - construction products

BULGARIA 2003

designated bodies
Designated Bodies

BULGARIA 2003

support to designated bodies
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

BULGARIA 2003

accreditation
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

BULGARIA 2003

accreditation17
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

BULGARIA 2003

accreditation18
ACCREDITATION

BULGARIA 2003

standardisation
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

BULGARIA 2003

standardisation related issues
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

BULGARIA 2003

standardisation21
STANDARDISATION

BULGARIA 2003

standardisation22
STANDARDISATION

BULGARIA 2003

metrology
METROLOGY

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

  • Scientific Metrology
  • Legal Metrology and Pre-packages
  • Metrological Supervision

BULGARIA 2003

metrology24
METROLOGY

BULGARIA 2003

metrology related issues
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

BULGARIA 2003

market surveillance
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

BULGARIA 2003

market surveillance27
MARKET SURVEILLANCE

BULGARIA 2003

market surveillance28
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

BULGARIA 2003

market surveillance related issues
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

BULGARIA 2003

peca negotiation
PECAnegotiation
  • 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%

BULGARIA 2003

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Thank you!

BULGARIA 2003

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