International Standards

Bulgaria does not have its own standardization, conformity assessment, accreditation and product certification bodies. There exist some individual ministries/agencies that issue sector-specific standards and certificates, in areas such as processed foods, beverages and pharmaceutical products. Generally, the country follows the EU and international standards. 

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

Standards organizations

The Bulgarian State Agency for Metrological and Technical Surveillance (SAMTS) supervises, administers and implements policies, laws and regulations on products. 

The Bulgarian Drug Agency (Ministry of Health) is responsible for registration, product testing, certification and establishing standards for pharmaceutical products and implants.  The Ministry of Healthcare is responsible for the certification, registration, import licensing and establishing standards for some medical equipment, and medical and natural products.

The Ministry of Agriculture and Food tests and certifies agriculture and food products, registers technical documentation, product certification, the assessment of conformity, and establishing national policy with international standardization institutions.

The Bulgarian Accreditation Service has several laboratories for veterinary, food, and phytosanitary expertise to perform laboratory testing, inspection, certification, auditing and verification of food, plants and veterinary products.

The Bulgarian Institute for Standardization (BIS) 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. BIS is a member of the International Electrotechnical Commission (IEC) and the International Standard Organization (ISO), as well as an affiliate member of the EC for Electro technical Standardization (CENELEC) and the EC for Standardization (CEN).

Conformity Assessment

The conformity assessment is a compulsory step to ensure compliance during all stages, from design to production, to facilitate acceptance of the final product. A manufacturer can choose not to use the harmonized EU standards, but then must demonstrate that the product meets essential safety and performance requirements. In this case, conformity assessment ranges from self-certification to a full quality assurance system.

Bulgaria is a member of the EC’s NANDO program and has Mutual Recognition Agreements (MRAs) with NANDO regarding harmonized standards and requirements for industrial products. 

Product Certification

To sell products on the European market exporters are required to apply CE marking on products covered by specific legislation. Products that have a CE mark will be allowed to circulate freely within the European Union. The CE marking addresses itself primarily to the national control authorities of the member states, and its use simplifies the task of essential market surveillance of regulated products.  

The CE marking is not intended to include detailed technical information on the product, but there must be enough information to enable the inspector to trace the product back to the manufacturer or the local contact established in the EU. This detailed information should not appear next to the CE marking, but rather on the declaration of conformity.

Product safety must comply with the respective EU guidelines. 

Accreditation

The Bulgarian Accreditation Service (BAS) is the only accreditation body of the country. BAS certifies laboratories, certification bodies, and inspection bodies and has seven technical accreditation and technical committees.

Contacts

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

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

Bulgarian Drug Agency: http://www.bda.bg 

Bulgarian Ministry of Health: http://www.mh.government.bg  

Bulgarian Accreditation Service: http://www.nab-bas.bg/index_en.php