Describes the country's standards landscape, identifies the national standards and accreditation bodies, and lists the main national testing organization(s) and conformity assessment bodies.
Last Published: 9/19/2019

Overview

Products tested and certified in the U.S. by U.S. standards entities are likely to be retested and re-certified to ensure they meet EU requirements as the EU approaches consumer and environmental protection differently.
 
While Bulgaria is trying to synchronize its national standards with EU and international standards it does have its own standardization, conformity assessment, accreditation and product certification bodies.  In certain areas, such as processed foods, beverages and pharmaceutical products, individual ministries or agencies issue sector-specific standards and certificates. 

  • Bulgaria is a member of the International Organization for Standardization (ISO), the International Electro Technical Commission (IEC) and International Technical Union (ITU)

  • Consult the Bulgarian Institute for Standardization: http://www.bds-bg.org/  or the Bulgarian Institute of Metrology at http://www.bim.government.bg

Requirements for product safety are regulated by ordinances issued by ministries and must comply with the respective EU directives. See http://www.bds-bg.org/pages/?button_id=38)
 
Standards organizations include:    

  • The Bulgarian State Agency for Metrological and Technical Surveillance (SAMTS); http://www.damtn.government.bg/ supervises, administers, executes technical supervision and carries out policies, laws and regulations on products

 

  • The Bulgarian Drug Agency (Ministry of Health) http://www.bda.bg is responsible for registration, product testing & certification, and establishing standards for pharmaceutical products and implants.  The Ministry of Healthcare http://www.mh.government.bg  handles certifications, registration, import licensing and establishing standards for some medical equipment, and medical and natural products.  In some cases, the Ministry of Healthcare performs these activities jointly with the Drug Agency

 

  • The Ministry of Agriculture and Food http://www.mzh.government.bg: tests and certifies agriculture and food products, registers technical documentation, product certification, the assessment of conformity, and establishing national policy with international standardization institutions, in-country and border control health and sanitary policy, etc. See http://www.nvms.government.bg/index.php.  

 

  • The Bulgarian Accreditation Service http://www.nab-bas.bg, has several laboratories for veterinary, food, and phytosanitary expertise to perform laboratory testing, inspection, certification, auditing and verification of food, phyto and veterinary products.

 

  • The Bulgarian Institute for Standardization (BIS) (www.bds-bg.org) performs activities related to standardization, verification, editing and registration of standards for industrial commodities, machinery and transport equipment, construction and materials, chemistry, textiles, foodstuffs, and electrical engineering commodities and, has agreements with:

  • DIN - Deutsches Institut für Normung

  • BSI - British Standards Institution

  • UNI - Ente Nazionale Italiano di Unificazione

  • ASTM International - American Society for Testing and Materials

  • BIS is a member of the International Electrotechnical Commission (IEC) and the International Standard Organization (ISO) and is an affiliate member of the EC for Electro Technical Standardization (CENELEC) and the EC for Standardization (CEN).

  • Bulgaria, a World Trade Organization (WTO) member, is required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries.

 

  • ‘Notify U.S.’ a U.S. government, National Institute for Standards (NIST) program provides a free, web-based e-mail subscription service to review and comment on proposed foreign technical regulations that can affect your access to international markets. Register online at http://www.nist.gov/notifyus/ 

 

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