1. 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 EU Legislation relevant to the Engineering Industries

2. 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

3. 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

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. 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

7. 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

8. 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 directives implemented into national legislation

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

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 MLA signatory - 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 documentation for 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 competitive pressure 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: 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

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