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:(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 (bds-bg.org).

Standards organizations include:    

• The Bulgarian State Agency for Metrological and Technical Surveillance (SAMTS): https://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) https://www.bda.bg/bg/ is responsible for registration, product testing & certification, and establishing standards for pharmaceutical products and implants. 

• The Ministry of Healthcare https://www.mh.government.bg/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 https://www.mzh.government.bg/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 https://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) (https://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.

Use ePing to review proposed technical regulations and conformity assessment procedures 

The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by WTO Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present.  ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts.  Use it to browse notifications on past as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest.

Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for US stakeholders, has reached its end of life.  Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point.   National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat.  All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point. Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information.

Testing, Inspection, and Certification

Conformity Assessment

Bulgaria is a member of the EC’s NANDO program - ‘New Approach Notified and Designated Organizations’ Informational System and has Mutual Recognition Agreements (MRAs) with NANDO in reference to harmonized standards and requirements for industrial products which can then circulate freely within the EU. A manufacturer can choose not to use the harmonized EU standards, but then must demonstrate that the product meets essential safety and performance requirements.

A conformity assessment is a mandatory step for any manufacturer to ensure the consistency of compliance during all stages, from design to production, to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice regarding conformity assessment, depending on the level of risk involved in the use of their product. These range from self-certification, a production quality control system, to, a full quality assurance system.

To promote market acceptance of the final product, several voluntary conformity assessment programs exist.

Product Certification

To sell products in the EU market, U.S. exporters are required to apply CE marking whenever their product is covered by specific product legislation. A qualified distributor, agent or representative should be familiar with CE requirements and should know which safety/health concerns need to be addressed, which conformity assessment module is best suited to the manufacturing process, and whether to use EU-wide synchronized standards.

The CE marking is not intended to provide detailed technical information on the product, however enough information must be presented to enable the inspector to trace the product back to the manufacturer or EU authorized representative. Detailed information should not appear next to the CE mark, but rather in documents accompanying the product or on the declaration of conformity.

Accreditation

Bulgaria’s sole national accreditation body, the Bulgarian Accreditation Service (BAS) (https://www.nab-bas.bg/bg/)  reports directly to various ministers, consumer organizations, experts and others. BAS certifies laboratories, certification bodies, and inspection bodies and has seven technical accreditation and technical committees.

Publication of Technical Regulations

Each law, regulation, ordinance, Council of Ministers decree, decision, technical regulation, or agreement enters force after it appears in the official publication the State Gazette (only in Bulgarian), and the official journals of all issuing authorities.  Translated versions of the legislation can be found at: https://www.apis.bg/en/.

Contact Information

Bulgarian Institute for Standardization - http://www.bds-bg.org/pages/?button_id=39

Bulgarian Institute for Metrology - http://www.bim.government.bg

State Agency for Metrological & Technical Surveillance- https://www.damtn.government.bg/

Bulgarian Drug Agency - https://www.damtn.government.bg/

Bulgarian Ministry of Health - https://www.mh.government.bg/bg/ 

Bulgarian Accreditation Service - https://www.nab-bas.bg/bg/

EU Information Index

APIS

U.S. exporters may also contact the U.S. Dept. of Commerce Global Markets office in Sofia at: OfficeSofia@trade.gov.