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

Web site: www.damtn.government.bg

E-mail: intldiv@sasm.orbitel.bg

Thank you!