Implementation of New Approach Directives in Bulgaria - Challenges and Opportunities
Violina Panayotova - Director International Cooperation and European Integration
STATE STATE AAGENCY FOR METROLOGY AND GENCY FOR METROLOGY AND TECHNICAL SURVEILLANCETECHNICAL SURVEILLANCE
19-20 April 2006
EU Legislation relevant to the Engineering Industries
• 1993 - The Europe Agreement for Bulgaria was signed and became effective on 1 February 1995;
• February 2000 - The first Intergovernmental
Conference on Bulgaria’s accession launched the
negotiations for EU membership;• Presented national position on Chapter 1: FMG;
• May 2001 opened
• June 2002 provisionally closed
Milestones in the negotiation process
• 15 June 2004 - Completion of the negotiations –
all chapters provisionally closed;
• 25 April 2005 - the Accession Treaty was signed;
• 01 January 2007 - full membership expected.
Milestones in the negotiation process
Starting Point Situation
• Mandatory standards
• Total pre-market control
• Testing facilities owned by state authorities
• Lack of product certification practice
• On-going change of legislation
• New responsibilities of the all parties involved
Transposition issues
• Involvement of all stakeholders in transposition
process
• Establishment of administrative capacity for
implementation
• Strengthening coordination among institutions
• Raising awareness of parties concerned
• Need of training for economic operators
• Assuming new responsibilities by parties concerned
• Law on Technical Requirements for Products – adopted in 1999
• - amendment in 2005
• guarantee placing on the market and putting into service of safe products
• align essential requirements to products with essential requirements in New Approach directives of EU
• Ordinances on essential requirements and conformity assessment
• Ordinance on Market Surveillance
• Ordinance on Conformity Marking
Technical regulations
• indicates that product conforms to essential requirements
• the product has been subject to appropriate conformity assessment procedures.
• to be replaced by CE after signing of PECA
National conformity marking
•Transposed - LVD, EMC, R&TTE, ATEX, machinery, lifts, gas appliances,
simple pressure vessels, pressure equipment, PPE, toys, CIVEX,
recreational craft, construction products, NAWI, refrigeration appliances, hot
water boilers, noise emission, transportable pressure equipment and
cableways
• Transitional periods - non-automatic weighting instruments,
transportable pressure equipment and cableways
• Drafts - Directives 90/385/EEC, 93/42EEC and 98/79/EC on medical
devices
New Approach directivesimplemented into national legislation
Quality infrastructure
Manufacturers
Laboratories
Certification bodies
Inspection bodies
Co
nsu
mer
sMetrology
Accreditation
Standardisation
Market surveillance
Designating authorities
Standardisation
• Segregation of the Standardisation Directorate from
State Agency for Standardisation and Metrology • New Law on National Standardisation – adopted
in 2005• Establishment of Bulgarian Institute for
Standardisation (BIS) - public non-profit body
• Affiliate member of CEN/CENELEC
Standardisation
• Transposed harmonised standards to the New Approach
Directives (by 1 January 2006) – approximately 90%
• Translated in Bulgarian - 32 % of transposed harmonised
standards
Metrology
State Agency for Metrology and Technical Surveillance is the responsible authority for:
• Scientific Metrology• Legal Metrology and Pre-packages• Metrological Supervision
• Law on measurements – adopted in 2002 – amended in 2005 • Establishment of BIM – scientific and legal metrology
Metrology - membership
Organisation Membership status
Convention du Mètre Signatory 1910
OIML Full member 1956
WELMEC Associate member 2000
EUROMET Full member 2003
COOMET Member 1991
Accreditation
• Executive Agency Bulgarian Accreditation Service to the Minister of Economy – established in December 1999
• Law on accreditation – adopted in 2005 • EA full member - 2001• EA MLA signatory - 2005
• certification of quality systems
• certification of personnel
Designated bodies
3 34
4
1
18
2
1
3
45 3
Gas appliancesToysEMCSPVCIVEXCPDRTTEATEXLiftsMachineryPEDLVD
Enforcement authorities
• State Agency for Metrology and Technical Surveillance
•designation of conformity assessment bodies
•market surveillance
• Ministry for Regional Development and Public Works
•construction products
• Bulgarian Drug Agency and SAMTS
•medical devices
New responsibilities of the manufacturerNew responsibilities of the manufacturer
• to insure that the product intended to be placed on the Community market is designed and manufactured in accordance with the provisions of the applicable New Approach Directive;
• to develop technical documentation;
• to assess or have assessed the product conformity to the applicable essential requirements;
• to affix CE marking;
• to draw up a declaration of conformity;
• to keep the technical documentation for the required period.
PHARE Programmes:
Phare2005-2006
Phare2003
Phare2002
Phare2001
Phare2000
FundamentalmetrologyLegal metrology
MetrologysupervisionConformityassessmentMarketsurveillanceTechnicalinspectionAccreditation
Standardisation
Ministry of Economy and Energy – awareness campaigns
• National Communication Strategy
• Raising awareness of the business on EU integration
issues and respective obligations
• Dissemination of information materials and leaflets
• Establishment of a “Call center”
Are we ready to cope with competitive pressure within the European Union ?
SAMTS information activities - (1)
Awareness campaigns• Annual National Conference on Conformity Assessment
Joint seminars and workshops upon request from the business organisations, focused on:
• Conformity assessment of products. Practices and procedures• Responsibilities of manufacturers and importers for placing
products on the market according to the Law on Technical Requirements to Products and to the Law on Measurements
NEP• Providing information, materials and brochures
PECA: Protocol to the Europe Agreement on Conformity Assessment
• Establishes the mutual recognition of the results of conformity assessment and acceptance of industrial products - concluded between the European Communities and their Member States and CC (start of negotiations 2002)• Sectoral annexes – Machinery, toys, gas appliances, LVD, EMC, Lifts
PECA negotiations
What will change for producers?
• Producers in the PECA sectors will comply with EU legislation to access the domestic and EU market
• They affix CE marking to the product in the scope of PECA annexes
• This gives them immediate access to the EC market