3.105.  Several ministries and agencies (e.g. the Ministry of Agriculture, the Ministry of Health and Family Welfare, the Ministry of Fisheries, the Bangladesh Food Safety Authority/Ministry of Food (see below), and the BSTI/Ministry of Industries) remain responsible for SPS measures, depending on their area of expertise (Sections 3.3.2 and 3.3.3.2).[160] Food safety standards continue to be set by the BSTI, which generally seeks to base them on the international Codex Alimentarius standards.[161] The BSTI focuses on the implementation of the mandatory food BDSs for which it is responsible (Sections 3.3.2.1 and 3.3.3.2); as of July 2018, there were 598 food BDSs, of which 82 were mandatory (about 14%), and 140 had been adopted from Codex Alimentarius standards.[162] All established maximum residue limits (MRLs), and are implemented across the board for both imported and locally produced products. To improve the country's seemingly complicated food inspection framework, following the passing of relevant legislation (see above), as from 2 February 2015, the Bangladesh Food Safety Authority (BFSA), a statutory body under the Ministry of Food, was established to ensure the overall coordination.[163] The BFSA is the main body for ensuring food safety, and for establishing rules and regulations for setting MRLs (see below) and applicable limits for chemicals and other contaminants according to Codex standards. The BFSA's multidisciplinary National Food Safety Management Advisory Council is tasked with providing advice and direction/guidance to the BFSA and all others concerned with food safety management.[164] International cooperation

3.106.  Bangladesh is a member of the World Organization for Animal Health (OIE). In partnership with the BSTI, the United Nations Food and Agriculture Organization (FAO) Food Safety Programme has continued to support capacity development activities to strengthen the country's participation in the Codex standard-setting process.[165] Bangladesh signed SPS-related MoUs with Sri Lanka, Viet Nam, India, and the Russian Federation. Regulatory developments

3.107.  Since its previous TPR, Bangladesh's main laws and regulations governing food standards and sanitary and phytosanitary (SPS) standards were added to with food safety legislation, including: the Food Safety Act, 2013; the Food Safety (Food processing and administration system) Rules, 2014; the Formalin Control Act, 2015; the Formalin (Import, Production, Transportation, Storage, Sales and Usage) Control Rules, 2015; the Food Safety (Contaminants, Toxins and Harmful Residues) Regulations, 2017; the Food Safety (Labelling) Regulations, 2017; the Use of Food Additives Regulations, 2017; the Food Sample Collection, Testing and Analysis Regulations, 2017; the Food Safety (Technical Committee) Rules, 2017; and the Safe Food (Food Hygiene) Regulation, 2018.[166] This legislation was passed to ensure the establishment of an efficient and effective authority (see below), and to regulate, through coordination, the activities relating to food production, import, processing, stock, supply, marketing and sales, to ensure access to safe food through the appropriate application of scientific process

3.108.  As at July 2018, the BSTI's BDSs covered 27 pesticides (including one insecticide) (Section 3.3.3.1). MRLs are checked by the Plant Protection Wing of the Department of Agricultural Extension under the Ministry of Agriculture. This Wing ensures the prevention of the introduction of quarantine pests through imported plants and plants products, beneficial organisms and packaging materials. The BFSA is responsible for setting and promulgating MRLs for food; its Food Safety (Contaminants, Toxins and Harmful Residues) Regulations contain a set of MRLs for most foods for human consumption. Food additives

3.109.  The BFSA is responsible for setting limits on food additives. Its Use of Food Additive Regulations set these limits for different food products and ingredients. The BSTI ensures that a product standard is in line with the requirements set in the Regulation. As at July 2018, the BSTI's BDSs covered 19 food colourings, artificial sweeteners, and additives (Section 3.3.2.2). Genetically modified raw materials

3.110.  The Biosafety Rules, 2012 govern the approval process for the introduction of genetically engineered (GE) products developed domestically or by a third country. According to these Rules, all GE products must be approved before they can be imported or sold domestically.[167] Under the Plant Quarantine Rules, 2018, genetically modified raw materials may be imported for scientific purposes only (Section 3.3.3.2)

3.111.  Customs, in close collaboration with port authorities, remains responsible for border food inspection, as prescribed by the IPO in place as well as a number of subsidiary acts and standards (see below, and Sections 3.3.2.1 and 3.3.3.1).[168] The authorities indicated that, since 2012, the International Standards for Phytosanitary Measures (ISPMs) guidelines (including ISPM No. 31, methodologies for sampling of consignments) have been followed for carrying out food import inspections.[169] Shipping documents must include radioactivity test reports and certificates declaring the food "fit for human consumption", and "not mixed with harmful substances", and indicating the country of origin; the implementation of this requirement appears to have raised some concern.[170] Customs carries out physical tests, including organoleptic tests, at the port of entry. According to a 2010 FAO report, imported food samples may be analysed by laboratories at the BSTI (products subject to mandatory BDSs only (Section 3.3.3.1)), the Bangladesh Atomic Energy Commission, the Plant Protection Wing, the Department of Agricultural Extension, the Fish Inspection and Quality Control Wing of the Department of Fisheries, the Bangladesh Council of Scientific and Industrial Research, and the Customs Department Laboratory in Chittagong.[171] Products not complying with the rules may be re-labelled correctly, downgraded to purposes other than for human consumption, or destroyed, depending on the issue. Customs keeps information on the compliance history of importers, for risk management administration purposes. Phytosanitary measures

3.112.  Plant protection activities remain under the Director of the Plant Protection Wing. During the review period, some changes were made to the main laws and regulations on phytosanitary requirements and procedures. Phytosanitary measures continue to be governed by the Destructive Insects and Pest Rules, 1966 and the Plant Quarantine Act, 2011 (last amended in 2018).[172] Since 2012, the Plant Quarantine Rules, 2018 and the Pesticide Act, 2018 have been introduced. As at 2018, the list of plants and plant products permitted for importation, which is currently operated by the Department of Agricultural Extension of the Ministry of Agriculture and is to be issued by the National Plant Quarantine Authority upon its establishment, covered 125 items (including cereals, fruits, vegetables, spices, oil seeds, pulses, flowers and flower bulbs/seeds, herbaceous/ornamental plants, timber logs and forest products, coffee, tea, tobacco, cotton and some industrial (non-food) crops) and indicated their use, country of origin, the requirement of additional declarations, and special conditions of import; it also contained a list of 38 weed species subject to quarantine. Any imported plants or plant products must be accompanied by a phytosanitary certification, issued by the authorities of the exporting country, and are subject to quarantine and inspection. If the requirements are not met, the Quarantine Officer may send the commodity back to the shipper/reject entry/destroy it, or may allow entry, subject to treatment. As at November 2018, Bangladesh had 32 (26 in 2012) plant quarantine stations/entry points, of which 3 (3 in 2012) are located in international airports, 3 (2 in 2012) in seaports, 3 (1 in 2012) in river ports, 1 (1 in 2012) in an Inland Container Depot (ICD), and 22 (19 in 2012) in border land ports. The authorities indicated that the legislation provides for a transaction time of 24 hours for perishable items for the issuance of a phytosanitary certificate; for other items, the 24-hour requirement may be extended to meet relevant fumigation, inspection or any other treatment or test needs. According to the Plant Protection Wing, transaction times were low, one to two hours if documents were satisfactory and no inspection problems were found.[173] If testing was needed, up to three days could be required to finalize the transaction; in the case of seeds, the transaction time could exceed three days. Sanitary measures

3.113.  During the review period, the main laws and regulations on sanitary quarantine requirements remained unchanged (see below). They include: the Bangladesh Diseases of Animal Act, 2005; the Bangladesh Diseases of Animal Rules, 2008; the Bangladesh Animal and Animal Product Quarantine Act, 2005; the Bangladesh Fish and Animal Feed Act, 2010; the Bangladesh Animal Slaughter and Meat Quality Control Act, 2011; and the Animal Feed Rules, 2013.[174] The Ministry of Health and Family Welfare (MOHFW) and the Ministry of Fisheries and Livestock continue to cooperate for the prevention and control of human and animal exotic diseases that are transmissible through international trade and commerce (e.g. human cases of avian influenza). Animals and animal products remain subject to inspection and quarantine. Meat from EU countries must be certified as free from bovine spongiform encephalopathy (BSE).[175]

3.114.  Fisheries measures remain governed by: the Fish and Fish Products (Inspection and Quality Control) Ordinance, 1983; the Fish and Fish Products (Inspection and Quality Control) Rules, 1997 (amended in 2008, 2014 and 2017); the Fish Feed and Animal Feed Act, 2010; the Fish and Fish Production (Inspection and Quality Control) Rules, 1997 (last amended in 2008); the Fish Feed Rules, 2011; the Fish Hatchery Act, 2010; the Fish Hatchery Rules, 2011; and the Fish Quarantine Act, 2018. In 2015, the Quality Control (QC) laboratories were separated from the Fish Inspection and Quality Control (FIQC) section of the Department of Fisheries, under the administrative control of the Ministry of Fisheries and Livestock, now run by a Quality Assurance Officer. QC laboratories are involved in the testing of pre-export samples of fish and fish products and samples under the residue monitoring programme (RMP), such as the National Residue Monitoring Program (NRCP), as well of fish feed and feed ingredients. Exportable fish and fish products are harvested, collected, transported, preserved, processed and packed as per FIQC rules and regulations and the importing country's standards. As at 2018, pre-export tests of fish, shrimp and fishery products were conducted in three QC laboratories in Dhaka, Khulna and Chittagong. Bangladesh has faced, and continues to face, ongoing challenges in meeting standards for its fish exports, in particular to the EU market, which is the largest importer of Bangladesh shrimp; frozen shrimp accounted for 42% of total agricultural exports (HS 1-24) in 2016/17, and 10% of the total EU imports of this item in 2017.[176]

3.115.  Under a livestock diseases prevention and control project, Bangladesh constructed 24 quarantine stations in different sea, land and airport entry points, to enhance the level of border controls and inspections, to ensuring the protection of human, animal and plant life or health in its territory, in line with relevant OIE obligations (Section 3.3.3.1)

3.116.  Under the EU's Rapid Alert System for Food and Feed (RASFF), between January 2012 and June 2018, there have been 143 notification cases, including border rejections and information for attention/follow-up, for food items (e.g. shrimp, fruit and vegetables, cereals and bakery products, confectionery, and herbs and spices) from Bangladesh, involving, inter alia, the presence of salmonella enterica or unauthorized substances, a drop compared to 235 cases between 2005 and 2011.[177]

3.117.  So far, Bangladesh has not submitted any notification (in the sense of Paragraph 5 of Annex B of the Agreement on the Application of Sanitary and Phytosanitary Measures) to the WTO Committee on Sanitary and Phytosanitary Measures, and neither has it been subject to SPS-related specific trade concerns

3.118.  The Food Safety (Labeling) Regulation, 2017, which was introduced in 2017 and replaced the Pure Food Rules, 1967, determines all the major aspects of food packaging and labeling. Marketing, labeling and packaging materials of genetically modified organism (GMO) food requirements are based on the Biosafety Rules

3.100.  During the review period, the legal framework governing HACCPs was updated. For fisheries, it consists of Rule 5(1) and 19 and Schedule 9 of the Fish and Fish Product (Inspection and Quality Control) Rules, 1997 (amended in 2008 and 2014) and, for livestock, the Framing of Animal Slaughter and Meat Control Rules, 2018 are under preparation; a quality control laboratory will be established at Savar, Dhaka

3.101.  The BAB remains empowered to accredit Testing and Calibration Laboratories, Medical Laboratories, Inspection Bodies, Personnel Certification, and Product Certification. It already accredited different types of testing and calibration laboratory system certification to national and multinational organizations/companies. As at November 2018, the BAB had accredited 66 Conformity Assessment Bodies (CABs), of which 50 were testing laboratories, 9, calibration laboratories, 2, medical laboratories, 2, system certifications bodies, and 3, inspection bodies; some applications for accreditation are being processed. International accreditation bodies seemingly operate in Bangladesh and, in the future, may compete with the BAB; they appear to primarily service the garment industry and similar export-oriented light manufacturing industries.[154] The BAB is responsible for framing policies and approving rules and regulations for accreditation, and establishing multilateral recognition arrangements (MRAs) with regional and international accreditation bodies. Since 2015, it has been the signatory to, and full member of, the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the International Laboratory Accreditation Cooperation (ILAC).[155] It is an affiliated member of the Pacific Accreditation Cooperation (PAC), and applied for membership of the International Accreditation Forum (IAF). It also works closely with the Standards and Metrology Institute for Islamic Countries (SMIIC), the SAARC Expert Group on Accreditation (SEGA), and the HALAL scheme

3.102.  Transparency in the area of standards appears to remain a concern. According to a 2010 United Nations Industrial Development Organization (UNIDO) baseline study report, as the legislation is focused on technical regulations, many BDSs have remained unpublished for years; as at November 2018, there were about 1,500 (out of 3,768) unpublished BDSs.[156] Bangladesh has not submitted any notification on draft measures (technical regulations) or conformity assessment procedures to the WTO Committee on Technical Barriers to Trade so far.[157] Until now, it has not been subject to TBT-related specific trade concerns

3.103.  In 2016/17, 654 mobile courts had been established (Section 3.3.7.3.3), and 1,219 surveillance actions were undertaken, leading to 1,323 cases being filed against standards' offenders by the BSTI, and requiring them to cease the sale and/or distribution of illegal and/or sub‑standard products.[158] At the same time; 505 mobile courts had been established and 367 surveillance actions were conducted against users of illegal weights and measures, resulting in 1,280 filed cases. Offenders were fined a total of BDT 5.43 crore

3.104.  During the review period, the main regulatory framework in this area remained virtually unchanged, except for jute packaging. Marking, labelling and packaging requirements are contained in relevant BDSs. Labelling requirements are also found in the Bangladesh Standards of Weights and Measures (Packaged Commodities) Rules, 2007, under the Weights and Measures Ordinance, 1982. Each package should contain: the name and address of the manufacturer and packer; the common or generic name of the product, with all ingredients; the net weight; the dates of manufacture and expiry; and the retail price of the package. Upon the enactment of the Compulsory Use of Jute Fiber Packaging Act, 2010 and the Rules for Compulsory Use of Jute Fiber Packaging, 2013, another measure to support the jute sector, jute fibre packaging has become compulsory for 17 items.[159]

3.94.  During the review period, the institutional setting in this area remained virtually unchanged. The Ministry of Industries continues to be responsible for leading and facilitating the legal and technical institutional framework for national standards (except pharmaceutical products), quality, and conformity assessment.[145] Its main institutions are the Bangladesh Standards and Testing Institution (BSTI), the sole national standardization, enforcement and quality certification body, that also provides metrology and calibration services; and the Bangladesh Accreditation Board (BAB) (Sections 3.3.2.2 and 3.3.3.1). According to the authorities, the Department of Fisheries, under the administrative control of the Ministry of Fisheries and Livestock, is in charge of Hazard Analysis and Critical Control Points (HACCP) certification (Section 3.3.2.2). The BSTI Council, the highest decision-making organ of the institution, consists of representatives from different ministries, business chambers, scientific organizations, and universities. It remains the WTO enquiry point and had not subscribed to ePing as at November 2018 (http://www.epingalert.org/en#/enquiry-points/tbt). It coordinates and heads a system of technical committees, consisting of a mixture of government, academia, and private sector representatives, that draft voluntary standards; it also influences the adoption and formulation of mandatory standards, while simultaneously benefitting from the incomes derived from testing, inspection, and certification against these mandatory standards.[146] Although no regulatory impact analysis (RIA) appears to be in place, Bangladesh gathers stakeholders' opinions prior to the adoption of a standard or technical regulation

3.95.  During the review period, MoUs or bilateral cooperation agreements (BCAs) signed between national standards bodies (NSBs) and the BSTI increased from 2 in 2012 to 9 in 2018 (September); the new arrangements involved the NSBs of India, Saudi Arabia, Nepal, Bhutan, Sri Lanka, Turkey, and China. Policy developments

3.96.  The main policy objectives in this area remain unchanged, and involve the harmonization of national standards with international ones, and the adoption of international standards. During the review period, steps were taken, inter alia, to expand the activities of the BSTI throughout the country under the 2015 Expansion and Strengthening of Bangladesh Standards and Testing Institutions Project (in five districts). A modern energy-efficient testing laboratory was established in the BSTI Head Office, under the technical and financial assistance of the Deutsche Gesellschaft fr Internationale Zusammenarbeit GmbH (GIZ) (Germany) (Section 4.2.2.3).[147] Regulatory framework

3.97.  During the review period, the main legislative framework in the area of standards remained largely unchanged, except for new BSTI (Amendment) Act, 2018 (passed on 28 October 2018), and the Weights and Measures Standards Act, 2018; in both cases, the amendments, inter alia, increased fines and prison offence durations.[148] A number of standards' "special rules" are contained the IPO issued by the MOC. For example, the 2015-18 Order includes applicable conditions for the import of food for human consumption, secondary quality imports of certain sheets and plates (e.g. stainless steel, tin plate, and silicon), and the testing of standards for electric kW meters.[149]

3.98.  Standards continue to be implemented on a voluntary basis, unless they are designated as technical regulations (compulsory). As at June 2018, the BSTI had formulated and adopted 3,768 (3,300 in 2012) BDSs. Alignment with international standards reduces the trade restrictiveness of technical regulations; according to the authorities, as at June 2018, about 52% (42% in 2012) of BDSs were aligned with international standards, and 4.5% (1.5% in 2012) with regional standards (i.e. 171 European Standards (ENs) and 3 South Asian Regional Standards Organization standards).[150] In 2018, international standards adopted by the BSTI included 1,535 (1,368 in 2012) International Organization for Standardization (ISO) standards, 198 (163 in 2012) International Electrotechnical Commission (IEC) standards, 86 ISO/IEC standards, and 140 Codex Alimentarius Commission (CAC) standards. As at May 2018, 166 (4.4% of all BDSs) were mandatory (i.e. under the Mandatory Certification Marks Scheme); and 55 (43 in 2012) imported products required mandatory certification (i.e. inspection and testing) before customs clearance. The BSTI provides Clearance Certificates of Imported Commodities through ASYCUDA World.[151] According to the BSTI, all consignments are inspected, and no risk profiling is used to prioritize the burden of conformity assessment.[152] At the time of the previous TPR, the authorities indicated that testing and certification procedures for technical regulations were the same for domestic and imported products

3.99.  Since 2010, Management System Certification (MSC) has been an important addition to the BSTI; as at July 2018, it had issued 48 different system certificates under the quality, environment and food safety management systems.[153]