65.  The Law on National Standardization[47], the Law Amending and Supplementing the Law on National Standardization[48], the Law on Technical Requirements to Products[49], and the Law amending and supplementing the Law on Technical Requirements for Products[50], set forth the legal requirements for product standards, testing, and certification. The State Agency for Metrology and Technical Surveillance[51] is responsible for domestic implementation and administration of the WTO Agreement on Technical Barriers to Trade, while the Ministry of Economy is in charge of coordinating standards activities with the WTO. The Agency is also responsible for the designation of conformity assessment bodies, with the exception of those for construction products, which are designated by the Ministry of Regional Development and Public Works. The Executive Agency on Certification and Testing is the competent authority for the conformity assessment, certification, registration or testing of all products except pharmaceuticals, food products, and telecommunications equipment. The Agency requires a Bulgarian translation of the certificate(s) of approval from the corresponding national testing authority and the certificate identifying the testing protocol. The entire testing and certification process requires at least one month

66.  The competent authority for pharmaceuticals is the Bulgarian Drug Agency in the Ministry of Health. It establishes standards and performs testing and certification and is responsible for drug registration. Placement on the market of radio equipment using frequency bands outside the National Frequency Spectrum for Civil Uses is notified to the National Radio Frequency Spectrum Council and to the Communications Regulation Commission. This equipment is subject to registration at the Communications Regulation Commission

67.  Bulgaria is harmonizing its national standards with international or regional standards, in particular with EU standards. The Bulgarian Institute for Standardization manages, coordinates, and supervises the national standardization policy in compliance with international requirements. Bulgaria is a participant in the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). As of July 2003, a total of 17,571 standards were in force in Bulgaria, of which 9,995 were Bulgarian national standards, 6,469 European standards, and 1,107 ISO and/or IEC standards. Currently, 52% of EU standards have been implemented as Bulgarian standards. Bulgaria's goal is to meet 80% of EU standards by 2004 and to become a full member of the European Committee for Standardization (CEM)

68.  In line with international practice and the provisions of the TBT Agreement, Bulgarian standards are voluntary unless cited in technical regulations. Such regulations are applied to products for which safety is an issue such as food products, construction materials, medical devices, particular electrical equipment, etc. These products are subject to testing, certification or prior approval procedures. According to the Bulgarian authorities, an estimated 2% of norms are mandatory. Mandatory certification of products is carried out under the European Union's global approach modules.[52]

69.  Pursuant to the objective of separating accreditation functions from certification and standardization, the Bulgarian Accreditation Service (BAS) was established in 1999 as an independent national accreditation body.[53] According to the authorities, the BAS provides accreditation services in a transparent, independent, and non-discriminatory manner. The accreditations performed by the BAS are based on the EN 45000 series of standards[54], ISO/IEC 17000 series of standards, BDS EN ISO/IEC 17025, and ISO/IEC guides and guidelines

70.  Bulgaria is a member of the FAO/WHO Codex Alimentarius Commission (Codex), the Office International des Epizooties (OIE) and the FAO International Plant Protection Convention (IPPC). Bulgaria is a member of the European Plant Protection Organization (EPPO), which is a regional organization of FAO

71.  A series of sector-specific regulations and legislations have been adopted with the aim of harmonizing Bulgaria's sanitary and phytosanitary standards with those of the EU. The National Veterinary Medical Service is responsible for ensuring the optimum health environment for all live animals and the safety of all food products of animal origin. A veterinary certificate is required for the importation of certain animals, foodstuffs, and raw materials of animal origin. The Law on Veterinary Activities allows for the imposition of sanitary measures on imports. Bulgaria has notified the WTO of import bans on live bovines, sheep, and goats, and certain products from countries where BSE and foot and mouth diseases are known to occur.[55]

72.  All imports of live animals are subject to mandatory quarantine, except pets and sport horses with individual health passports issued pursuant to relevant internationally recognized norms. Otherwise, depending on the animal species and the animal health situation of the country of origin and other factors, the quarantine is effected under official veterinary control in specific farms, or special quarantine stations in the regions or at the border inspection post. In support of this inspection regime the National Veterinary Medical Service has developed detailed surveillance programmes for various animal diseases, including the development of an animal disease notification system. Bilateral agreements for cooperation addressing standards, technical regulations, and conformity assessment have been signed with: Russia, Ukraine, Moldova, Kazakhstan, Georgia, Lithuania, Armenia, Azerbaijan, Croatia, Macedonia, Slovak Republic, Czech Republic, and the former Federal Republic of Yugoslavia.[56]

73.  The Law on Plant Protection, amended in November 2001, provides the legal basis for phytosanitary measures affecting trade in plants. The ministries of agriculture, health, and economy are the responsible bodies. Amendments to the legislative structure continue to occur in this area. A new Seeds Law[57], adopted at the beginning of 2003, regulates the maintenance of the variety, production, processing, distribution, marketing, storage, and control of seeds and/or propagating material of agricultural plants and the keeping of the Official Variety List of the Republic of Bulgaria. The adoption of the new Seeds Law and the Ordinance for the Amendment and Supplement of Ordinance 1 on Phytosanitary Control[58] are a part of the ongoing harmonization of the national legislation with that of the European Commission directives and international rules. According to the Bulgarian authorities these measures are in accordance with international conventions and are based on the recommendations of the EPPO and FAO, and do not discriminate against imported products. Import bans could be applied to plants and plant products with listed quarantine pests, such as insects, bacteria, and parasites. In the area of food safety control, current priorities are being focused on equipment and their maintenance. Phytosanitary certificates are required for the importation of certain animal feeds. Bulgaria has concluded bilateral agreements for cooperation in the field of phytosanitary control of plants and plant products with 50 countries.[59]

74.  In accordance with the harmonization of its legal framework with that of the EU[60], Bulgaria has largely revised its marking, labelling, and packaging requirements. Bulgaria has begun negotiations for concluding a Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products. Under the proposed protocol, there would be mutual recognition between Bulgaria and the EU on each other's designated assessment bodies, thus eliminating the need for further product testing. The new protocol is intended to further facilitate trade between Bulgaria and the EU. Goods indicated as being covered by the protocol include low-voltage electrical machinery, gas appliances, and toys

75.  Traders are required to offer consumer goods that have labels in the Bulgarian language.[61] The label must feature information about the manufacturer, the importer, where the product is imported from, the type of product, its physical characteristics, the price, and if necessary instructions for its use; this information is expected to be comprehensible, accessible, and non-deceptive.[62]

76.  Under the current legal framework, ruminants are subject to compulsory marking by individual ear tags. Honey beehives must also be individually marked through poker-work labelling