1. 1 ACCREDITATION – BG situation 8 - 10 April 2014, Prague STATE AGENCY STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE TECHNICAL SURVEILLANCE 1

2. 2 Legal basis  REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;  Accreditation is carried out by one single national accreditation body appointed by its Member State (Art 4.1);  Accreditation is performed as a public authority activity (Art 4.5);  National accreditation body operates free from commercial motivations (Art 8.1) and on a not-for- profit basis (Art 4.7);  National accreditation bodies do not compete with conformity assessment bodies and among each other (Art 6.1 and Art 6.2). 2

3. 3 EU general principles  Principle of use of accreditation as a privilege tool for assessment of NBs competence, forming the last level of control :  Appointment of single National Accreditation Body.  National decision on use the accreditation as a precondition for notification, enforced by respective amendment of acting national legislation on notification if necessary.  Development of sectoral schemes for assessment of CABs for notification purposes. 3

4. 4 National Accreditation Body  Executive Agency Bulgarian Accreditation Service to the Minister of Economy – established in December 1999;  Law on accreditation – adopted in 2005;  Law on National Accreditation of Conformity Assessment Bodies - 2010  EA full member – 2001;  EA MLA signatory – 2005 - 2011: certification of quality systems - 2005 certification of personnel - 2005 product certification, inspection bodies, EMAS – 2010 calibration and testing labs – 2011

5. 5 Accredited Bodies - March 2014  Total number – 568 Testing labs – 214 Calibration labs – 16 Testing and calibration labs – 11 Inspection bodies – 290 MS certification bodies – 13 Product certification bodies – 8 Certification of persons – 4 Verifiers - 2

6. 6 Notifying Authorities  Ministry of Investment Planning – construction products  Executive Agency “Maritime Administration” – maritime equipment  Railway Administration Executive Agency - railways  State Agency for Metrological and Technical Surveillance – all NADs except above mentioned

7. 7 Legal basis for NA notifications by SAMTS  Law on Technical Requirements for Products – stipulates the notification procedure;  Horisontal Framework Law, defining; Scope, Objectives, general Obligations of Economic Operators; Preconditions for placing products on the Market – conformity assessment procedures, assessment procedure of CABs (notified bodies) competence; Market Surveillance provisions –responsible authorities, powers and obligations; Penalty provisions; Transitional and final provisions – definitions, entering into force.

8. 8 Legal basis for NA notifications by SAMTS  Ordinances on essential requirements and conformity assessment:  Secondary Legislation, defining; Scope, Specific Obligations of Economic Operators; Requirements for placing products on the Market – applicable conformity assessment procedures, additional specific requirements for CABs (notified bodies); Essential Requirements; Modules on conformity assessment; Transitional and final provisions – definitions, entering into force;

9. 99 Implementation practice - BG  Notification based on both – accreditation and without accreditation;  For accredited candidates – light procedure, that promotes the advantage of accreditation - technical competence acknowledged.  Legal transparent procedure for assessment of CABs competence established in the Law;  Right to appeal decision on designation and further notification.  Provision to restrict or withdraw the notification in case of non proper fulfillment of obligations related to conformity assessment.

10. 10 Implementation practice - BG  Requirement for Notified bodies according to Law on Technical Requirements to Products :  Full compliance in term of competence requirements.  Obligation to participate in European NBs working Groups – at least one representative by sector.  Obligation to follow European Standardization bodies work – to participate in TCs.  Obligation to report annually to the notifying authority – State Agency for Metrological and Technical Surveillance on their activities.  In case of incompliance - penalty provisions.

11. 11 Notified bodies (by SAMTS)

12. 12 Accreditation Status of NBs  Accredited NBs – 5; 17020 – 4 17024 – 1  Accredited in house labs – 11;  Non accredited in house labs – 6;  Accredited sub-contracted labs – 15;  Non-accredited sub-contracted labs -5.

13. 13 NBs informal structures in BG  Support to designated/notified bodies  establishment of National Board of designated bodies  establishment of national working groups by sector: Working Group 1: Gas appliances; Working Group 2: Pressure equipment and simple pressure vessels; Working Group 3: Equipment designed for use within certain voltage limits, electromagnetic compatibility and radio and telecommunications terminal equipment Working Group 4: Machinery; Working Group 5: Lifts; Working Group 6: Toys. 13

14. 14 Challenges for CABs/NBs  Need of training;  Need of testing equipment;  Support for participation in NB working groups at EU level;  Participation in standardization TCs work;  Participation in international projects;  Obligatory accreditation for all – acting and candidates.

15. 15 Web site: www.damtn.government.bg E-mail: damtn@damtn.government.bg Thank you!