Implementation of New Approach Directives in Bulgaria - C hallenges and O pportunities

1. 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

2. 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

3. 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.

4. 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

5. 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

6. 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 with essential requirements in New Approach directives of EU • Ordinances on essential requirements and conformity assessment • Ordinance on Market Surveillance • Ordinance on Conformity Marking

7. 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

8. New Approach directivesimplemented 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

9. Metrology Accreditation Standardisation Designating authorities Marketsurveillance Quality infrastructure Consumers Manufacturers Inspection bodies Laboratories Certification bodies

10. 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

11. Standardisation • Transposed harmonised standards to the New Approach Directives (by 1 January 2006) – approximately 90% • Translated in Bulgarian - 32 % of transposed harmonised standards

12. 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

13. Metrology - membership

14. 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 MLAsignatory - 2005 • certification of quality systems • certification of personnel

15. Designated bodies

16. 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

17. 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 documentationfor the required period.

18. PHARE Programmes:

19. 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 competitivepressure within the European Union ?

20. 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

21. 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

22. 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

23. Thank you! Web site: www.damtn.government.bg E-mail: intldiv@sasm.orbitel.bg