Includes conformity assessment, certification and accreditation requirements.
Last Published: 9/19/2019

Conformity Assessment

Bulgaria is a member of the EC’s NANDO program - ‘New Approach Notified and Designated Organizations’ Informational System see http://ec.europa.eu/enterprise/newapproach/nando/ 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) (http://www.nab-bas.bg/index_en.php), 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 http://www.apis.bg/en/.

Contact Information

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

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

State Agency for Metrological & Technical Surveillance- http://www.damtn.government.bg/ 
Bulgarian Drug Agency - http://www.bda.bg
Bulgarian Ministry of Health - http://www.mh.government.bg 
http://www.nvms.government.bg/index.php.  
Bulgarian Accreditation Service - http://www.nab-bas.bg/index_en.php
http://ec.europa.eu/enterprise/newapproach/nando/
http://exact.e-gov.bg. 
http://www.apis.bg/en/
 
U.S. exporters may also contact the U.S. Department of Commerce Global Markets office in Sofia at OfficeSofia@trade.gov.

Prepared by the International Trade Administration. With its network of more than 100 offices across the United States and in more than 75 markets, the International Trade Administration of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.


More Information

Bulgaria Market Access