Transcript No Slide Title

EU Legislation relevant to the
Engineering Industries
Implementation of New Approach Directives in Bulgaria Challenges and Opportunities
Violina Panayotova - Director International Cooperation and
European Integration
STATE AGENCY FOR METROLOGY AND
TECHNICAL SURVEILLANCE
19-20 April 2006
Milestones in the negotiation process
• 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.
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
Technical regulations
•
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
requirements in New Approach directives of EU
with
essential
•
Ordinances on essential requirements and conformity assessment
•
Ordinance on Market Surveillance
•
Ordinance on Conformity Marking
National conformity marking
•
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
New Approach directives
implemented into national legislation
•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
Quality infrastructure
Metrology
Standardisation
Manufacturers
Accreditation
Laboratories
Designating
authorities
Inspection
bodies
Certification
bodies
Consumers
Market surveillance
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
5
3
3
4
3
4
4
3
1
1
2
18
Gas appliances
Toys
EMC
SPV
CIVEX
CPD
RTTE
ATEX
Lifts
Machinery
PED
LVD
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 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:

Phare
2005-2006
Fundamental
metrology
Legal metrology
Metrology
supervision
Conformity
assessment
Market
surveillance
Technical
inspection
Accreditation
Standardisation
Phare
2003
Phare
2002
Phare
2001
Phare
2000
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 negotiations
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
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
Thank you!
Web site:
www.damtn.government.bg
E-mail: [email protected]