WORLD TRADE  
ORGANIZATION  G/TBT/2/Add.32/Rev.3 
15 December 2006 
 (06-6004) 
Committee on Technical Barriers to Trade Original:   English 
   
 
IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
ON TECHNICAL BARRIERS TO TRADE 
 
Communication from the Republic of Bulgaria
 
 
Revision  
  
 The following statement under Article 15.2 of the Agreement on Technical Barriers to Trade 
has been received from th e Republic of Bulgaria. 
 
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I. INTRODUCTION 
1. In accordance with Article 15.2 of the WTO Ag reement on Technical Barriers to Trade (TBT) 
and considering the decision of the TBT Committee of 14 July 1995 concerning the Statement on 
Implementation and Administration as contained in document G/TBT/1/Rev.8 of 23 May 2002, the 
following information regarding the measures taken by the Republic of Bulgaria to ensure the 
implementation and administration of the Agreem ent is submitted as a revision of the notified 
information in document G/TBT/2/Add.32/Rev.2. 
2. The Republic of Bulgaria, as a future EU member as of 1 January 2007, finalizes the adoption 
of the European regulatory measures with a view to establish a fully compatible legal system with the 
EC. 
II. IMPLEMENTATION OF THE TBT AGREEMENT  
3. The basic law in accordance with which the Re public of Bulgaria approved and formally 
undertook obligations under the Agreement on Technical Barriers to Trade, is the Law on ratification 
of the Protocol for the Accession of the Republ ic of Bulgaria to the Marrakech Agreement 
Establishing the World Trade Organization and of the Marrakech Agreement Establishing the 
World Trade Organization.  The Law was adopted  by the National Assembly on 24 October 1996 and 
published by Decree of the President No. 380 of  29 October 1996 in State Gazette No. 93 of 
1 November 1996.  The date of entry into force of the TBT Agreement for the Republic of Bulgaria is 
1 December 1996. 
III. REGULATORY MEASURES 
4. The Law on Technical Requirements for Products  (published in State Gazette No.86 of  
1 October 1999, amend. SG No.63/2002, SG No.93/2002, No.18/2003, No.107/2003, No.45/2005 , 
No.77/2005, No.88/2005, No.95/2005, No.105/2005, No.30/2006) is a horizontal framework law. Its priority objective is the implementation of the principles under the New Approach and the Global G/TBT/2/Add.32/Rev.3 
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  Approach.  This law establishes the provisions governing the procedure for setting out the essential 
Requirements for Products intended for placing on the market and/or putting into service; the 
obligations of persons placing products on the ma rket and/or putting them into service; the 
designation procedure for carrying out conformity assessment of products to the essential requirements; the surveillance of the placed on th e market and/or put into service products; the 
technical inspection of high-risk equipment.  
5.  A new Ordinance on Conformity Marking was adopted (Council of Ministers’ Decree 
No.191 of 16 August 2005, SG No. 69 of 23 August 2005).  The new Ordinance repeals the Ordinance on Conformity Marking with the Essen tial Technical Requirements for Products, adopted 
by Council of Ministers’ Decree No. 164 of 3 August 2000 (SG No.66 of 11 August 2000).  The 
Ordinance on Conformity Marking defines the rules for using and drawing of the conformity marking 
which certifies that the conformance has been  assessed against the essential Requirements for 
Products defined in the Ordinances, implementi ng the New Approach Directives, under the Law on 
Technical Requirements for Products.  The rules for its  affixing are equivalent to the rules for affixing 
the “CE” marking in the European Union.  Th e new Ordinance introduces the “CE” marking which 
will be applicable by the date of accession to the EU and will replace the “CO” marking for all 
products covered by the New Approach Directives. 
6. At this time twenty two of the twenty five New and Global Approach Directives falling 
within the scope of Chapter “Free Movement of  Goods” have been adopted as ordinances under the 
Law on Technical Requirements for Products and entered into force.  
7. Transposition of New Approach legislation creat es the legal basis for the development of the 
relevant conformity assessment system offering services to manufactures.   
A. C
ONFORMITY ASSESSMENT BODIES  
8. According to the Law on Technical Require ments for Products the State Agency for 
Metrological and Technical Surveillance (SAMTS ) is the body responsible for designation of 
conformity assessment bodies under all ordinances,  transposing the relevant New Approach 
Directives with the exception of the Ordina nce on the essential requirements and conformity 
assessment of construction products for which the Ministry of Regional Development and Public 
Works (MRDPW) is the designating authority. Dir ectorate "Designation of Conformity Assessment 
Bodies" within SAMTS is responsible for ascertain ing the technical competency and capability of 
bodies, applying for designation, to perform the procedures for conformity assessment of products 
with the essential requirements of New Approach  Directives. The Directorate contributes to the 
establishment of a national conformity assessment system by assisting and coordinating designated 
bodies' participation in international projects and programmes.  
9. By October 2006 fifty nine (59) designations have  been granted in the scope of eighteen (18) 
ordinances implementing the New Approach Direc tives (one designation means one designated body 
under a particular ordinance). 
10. With respect of preparation for signing PECA (Protocols to the Europe Agreements on 
Conformity Assessment and Acceptance of Industr ial Products) in the six sectors under negotiations 
(gas appliances, EMC (electromagnetic compatibility), LVD (low voltage directive), machinery, toys 
and lifts) nine designated bodies proposed by SAMTS for notification were assessed by EU experts 
contracted by the European Commission.  G/TBT/2/Add.32/Rev.3 
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  B.  MARKET SURVEILLANCE  
11. The Law on Technical Requirements for Products  as a horizontal framework law regulates the 
carrying out of market surveillance activities as requi red by the respective New Approach Directives. 
According to the provisions of this law SAMTS carries out market surveillance activities through its 
specialized administrative units.  
12. An Ordinance on the conditions and procedure fo r carrying out market surveillance has been 
adopted and brought into force. The latter provides possibilities for effectively carrying out the market 
surveillance activities. 
C. INTERACTION OF MARKET SURVEILLANCE WITH OTHER BODIES : 
13. SAMTS, through Directorate General “Market Su rveillance”, respects the provisions of the 
following agreements and instruction: 
• Agreement for cooperation and joint activities with the Commission on Trade and Consumer 
Protection; 
• Agreement for cooperation and joint activities in the field of construction products with the 
National Construction Control Directorate; 
• Agreement for cooperation and joint activities in the field of machinery and personal 
protective equipment with the Labor Inspection; 
• Common Instruction covering the regulations and procedures of interaction between the 
Customs authorities and State Agency for Metrology and Technical Surveillance. 
 
D. METROLOGY  
14. The Law on Measurements (State Gazette No.46 of 7 May 2002, as last amended by State 
Gazette No.88/2005) has been in force since 7 November 2002 and established the basis for ensuring 
traceability, accuracy and reliability of measurements and created the legal basis for transposition of 
the legislation in the field of legal metrology and pre-packages. 
15. In accordance with the last amendments of the Law on Measurements SAMTS has been 
reorganized into State Agency for Metrological and Technical Surveillance after the Directorate 
General for National Center of Metrology (DG NC M) and the Directorate General for Measures and 
Measuring Instruments (DG MMI) have been segreg ated from the SAMTS. On the basis of the 
directorates segregated the Bulgarian Institute for Metrology (BIM) has been established to serve as 
the governmental authority with responsibilities in th e field of fundamental and legal metrology. By 
the establishment of these new institutions a potentia l conflict of interests between the different 
activities related to conformity assessment, desi gnation of conformity assessment bodies and market 
surveillance is avoided.  
16. The Bulgarian Institute for Metrology has been assigned with the following functions: 
• to develop, keep and improve national measurement standards; 
• to ensure the traceability of the national measurement standards to international 
measurement standards or to measurement standards of Member States of the Meter Convention; 
• to ensure the traceability of measurements; 
• to disseminate the units of the national me asurement standards to the subsequent in 
accuracy measurement standards in the country by means of calibration. G/TBT/2/Add.32/Rev.3 
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  E. P
ROTOCOLS TO THE EUROPE AGREEMENTS ON CONFORMITY ASSESSMENT AND ACCEPTANCE 
OF INDUSTRIAL PRODUCTS (PECA)    
17. Signing of PECA is one of the important intern ational agreements contributing to removal of 
technical barriers to trade at regional level. 
18. Sectors under negotiations for signing of the PECAs  are machinery, lifts, gas appliances, toys, 
EMC, LVD. 
F. STANDARDIZATION  
19. The new Law on National Standardisation was adopted by the Parliament on 20 October 2005 
and published in State Gazette No. 88 of 4 Nove mber 2005. The law entered into force on 5 May 
2006 and this has changed the statute of the Bulgar ian Institute for Standardisation (BIS) into an 
independent non-governmental, non-profit organizati on. BIS is responsible for the notifications 
foreseen in Annex 3 of the Agreement on Techni cal Barriers to Trade an d presents them in the 
Information Center of ISO/IEC in Geneva, Switz erland. BIS responds to enquiries of interested 
parties and submits information th rough its National Enquiry points for standards. Work proceeding 
on draft standards, as well as their references after approval, is announced in the Official Bulletin of 
BIS.  
G. ACCREDITATION  
20. The Law on the Accreditation performed by the Bulgarian Accreditation Service was adopted 
by the Parliament on 29 November 2005 (published in State Gazette No.100 of 13 December 2005) 
and entered into force on 14 January 2006. The law aims to ensure sustainable regulation of 
accreditation activities, which were regulated by  secondary legislation before its adoption. 
21. The Executive Agency Bulgarian Accreditation Service (BAS) is the national accreditation 
body in the Republic of Bulgaria. All accreditation procedures are developed in compliance with the 
requirements of BDS EN 45000 and ISO 17000 series of standards and EA Guides. In relation to the 
entry into force of the new standard ISO/IE C 17011:2004 the management system of BAS was 
modified in 2005. 
22. At present BAS operates the following accreditation schemes: 
• accreditation of testing and/or calibration laboratories; 
• accreditation of product certification bodies; 
• accreditation of quality management systems certification bodies; 
• accreditation of personnel certification bodies; 
• accreditation of environmental management systems certification bodies; 
• accreditation of inspection bodies; 
• accreditation of verifiers; 
• attestation of conformity of laboratories w ith the principles of good laboratory practice. 
 23. In March 2001, as a result of its application s ubmitted in October 2000, BAS was accepted as 
a full EA member. In June 2001 BAS signed the EA  Memorandum of Unders tanding and received the 
right to apply for a signatory to the EA Multila teral Agreements. In December 2002 BAS submitted 
an application for becoming a signatory to the EA Multilateral Agreements in the field of the quality 
systems for certification and personnel certificati on. BAS has successfully completed the evaluation 
procedures for signing EA MLA (European Accredita tion Multilateral Agreement) for certification of 
quality systems and for certification of personnel. At its meeting in March 2005 EA MAC has voted  G/TBT/2/Add.32/Rev.3 
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  the accession of BAS to the EA MLA in these two areas, and on 8 June 2005 at the General Assembly 
meeting the Protocol on BAS accession to the EA MLA was signed. The evaluation procedure for the 
remaining areas has started in October and November 2006. 
H. TRANSPARENCY  
24. Council of Ministers’ Decree No.165 of 14 July 2004 on the organization and coordination of 
the exchange of information in the field of tec hnical regulations and rules on information society 
services transposes in the Bulgarian legislation the requirements of Directive 98/34/EC and its amendment 98/48/EC. 
25. This Decree regulates the order for coordinatio n and exchange of in formation related to 
technical regulations, which lay down technical sp ecifications and other requirements for products, 
the rules on services. It assigns the president of the State Agency for Metrological and Technical 
Surveillance, through the Interna tional Cooperation and European Inte gration Directorate, to fulfill 
the obligations of a National Information Center fo r the exchange of information on draft technical 
regulations with the European Commission. 
26. After the ratification by the National Assembly  of the Convention on Information and legal 
co-operation concerning “Information Society Serv ices” with an Act (published in State Gazette 
No.38/2005), the Council of Ministers’ Decree No. 165 of 14 July 2004 has been amended with the 
aim to ensure the implementation of the provisions  of the Convention on Information and legal co-
operation concerning Information Society Services. 
IV. ADMINISTRATION OF THE TBT AGREEMENT 
27. 
The obligations under the TBT Ag reement of relevant nationa l authorities to meet the 
requirements on notification procedures is se t out in Decree of th e Council of Ministers 
No.307/1996 on the coordination and implementati on of the obligations arising from the 
membership of Republic of Bulgaria in the WTO as last amended by the Decree of the 
Council of Ministers No.67/ 2003. According to Decree No.165 of the Council of Ministers from 
14 July 2004 on the organization and coordination of  the exchange of information in the field of 
technical regulations and rules on information soci ety services (State Gazette No.64 of 23 July 2004, 
amend. SG No.91 of 15 November 2005) the pr esident of SAMTS, through the Directorate for 
International Cooperation and Europ ean Integration, is assigned to fulfill the obligations as National 
Information Center for the exchange of informati on on draft technical regulations with the European 
Commission and with the Secretary General of the Council of Europe.  
28. In line with these two Decrees  and with the Rules of the organizational structure of 
the State Agency for Metrological and T echnical Surveillance (State Gazette No. 20/2003; 
amend. SG No.48/2005, SG No.78/2005; SG No .96/2005; SG No.15/2006; SG No.28/2006; SG 
No.40/2006) the State Agency for Metrological and Technical Surveillance performs the functions of 
a National Enquiry Point for the following draft doc uments: (1) technical regulations under Article 10 
of the Agreement on the Technical Barriers to Tr ade under Annex 1A to the Marrakech Agreement 
establishing the World Trade Organization; (2) techni cal regulations and rules on information society 
services. 
29. The Enquiry point on technical regulations and conformity assessment procedures is fully 
operational and performs information exchange as fo reseen in Article 10 of the TBT Agreement. It 
has been established at the State Agency for Metr ological and Technical Surveillance and as required 
by the relevant international agreements, replies to  enquiries and information on notifications of draft 
technical regulations, Bulgarian standards impl ementing the European harmonized standards and G/TBT/2/Add.32/Rev.3 
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  conformity assessment procedures. The Enquiry Poin t ensures the dissemination of notifications and 
information provided by the Secretariat of the Co mmittee for Technical Barriers to Trade, to the 
relevant government authorities and NGOs, translated  in Bulgarian. Information about the received 
notifications is published in the Official Bulletin of the State Agency for Metrological and Technical 
Surveillance. The texts of the adopted new technical  regulations are published in the State Gazette.  
30. Address, telephone, fax numbers and E-mail a ddress of the National Enquiry Point for 
technical regulations and conformity assessment procedures: 
State Agency for Metrological and Technical Surveillance 
21, 6
th September St 
1000 Sofia, Bulgaria 
Tel.: +359 2 981 44 51 
Fax: +359 2 986 17 07 E-mail:   intldiv@sasm.orbitel.bg 
    nep@mail.orbitel.bg 
Contact person: Ms. Violetta Veleva 
 
31. Address, telephone, fax numbers and E-mail a ddress of the National Enquiry Point for 
standards  
  Bulgarian Institute for Standardization 
  3A, 165 Street, Izgrev 
1797 Sofia, Bulgaria 
Tel.: +359 2 817 45 52 
Fax: +359 2 873 55 97 E-mail:   Violeta.Yordanova@bds-bg.org Website:  www.bds-bg.org Contact person: Ms. Violetta Yordanova 
 
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