3.58.  A significant amount of harmonization of SPS matters has been undertaken at the EAC level since the last Review (see main report). Tanzania has harmonized its SPS rules, based on a number of EAC instruments, including Articles 105 to 110 of the Treaty. The EAC SPS Protocol covers phytosanitary measures for fish and fishery products, food and feed safety measures, and sanitary measures for mammals, birds and bees. The process of ratification of the EAC Sanitary and Phytosanitary Protocol (2013) by the Tanzanian Parliament is still in progress. However, Tanzania has taken steps to implement it by establishing a technical working group and thoroughly reviewing the Protocol. As an SADC member, Tanzania subscribes to the SADC Protocol on Trade and its SPS Annex

3.59.  At the domestic level, the same laws and regulations remain in place. However, Tanzania has been taking many steps to move forward, especially to prepare for the EAC Phytosanitary Protocol. As such, it has been reviewing the Plant Protection Act, with a view to making amendments and taking steps to establish the necessary infrastructure

3.60.  The Ministry of Agriculture and the Ministry of Livestock and Fisheries of the Mainland are the main ministries involved in SPS measures, and oversee a number of acts and regulations concerning SPS matters, in particular the Plant Protection Act (1997) and the Plant Regulation Act, 1999, which provide the rules for the import and export of plants, and procedures and conditions to be met before importation. Conditions for biological control agents are outlined in the Plant Regulation Act. In addition, all pesticides to be imported and used in Tanzania must be registered by the Registrar of the Tropical Pesticides Research Institute

3.61.  The Plant Quarantine and Phytosanitary Services of the Ministry of Agriculture are responsible for SPS matters, including quarantine. For the period 2015/16, they inspected a total of 175,289.5 tonnes of imported crops and 714,372.4 tonnes of exported crops. Also, 5,516 phytosanitary certificates and 635 import permits were issued.[102]

3.62.  In the case of Zanzibar, SPS measures for exported agriculture products are pursuant to the Zanzibar Plant Protection Act No. 9 0f 1997. Under this Act, the products are inspected or tested by the Plant Protection Division of the Ministry of Agriculture, according to appropriate official procedures, before an export permit is granted, to ensure that the products are free from the quarantine pest specified by the importing country and that they conform with the current phytosanitary requirements of the importing country

3.63.  SPS measures on food safety are implemented under the Tanzania Food, Drugs and Cosmetics Act, and are guided by the National Health Policy under the ministry responsible for health, in collaboration with other ministries and stakeholders. The government policy stipulated the establishment of a law for food safety, and the Tanzanian Food, Drugs and Cosmetics Act, 2003 was enacted; subsequently, the Public Health Act was enacted in 2009 to regulate all issues related to environmental health. In line with food security, this is regulated by the Ministry of Agriculture. To ensure the effective enforcement of the law, food safety control in Tanzania is carried out on a number of levels

In 2013, Burundi adopted Decree No. 100/99 of 31 March 2013 on the creation, organization, role and operation of the National Committee for the Coordination and Monitoring of Sanitary and Phytosanitary Measures. The Committee reports to the national focal points for the CODEX (BBN), the OIE (Animal Health Department) and the IPPC (Plant Protection Department)[19], which are the main agencies in Burundi's SPS institutional framework

3.64.  At the national level, policies related to food safety are formulated by the national regulatory authority, the Tanzania Food and Drugs Authority (TFDA). It has overall responsibility for all matters related to food safety, i.e. regulating manufacturing, import and export control, distribution of food products, monitoring of food contaminants, and conducting analyses of food products. The government Chemist Laboratory Agency is also involved as a referral body in food safety analyses

According to the Decree, the Committee's objectives are to: coordinate activities related to sanitary and phytosanitary measures concerning animal health, food safety and plant protection at the national level; advise on policies relating to sanitary and phytosanitary measures and supervise their implementation at the national level; facilitate the dissemination of relevant information among all parties involved with sanitary and phytosanitary measures; coordinate prior consultations with all stakeholders in the preparation of country positions in respect of the international forums that address sanitary and phytosanitary matters; prepare and coordinate SPS training programmes at the national level; provide a forum for information exchange among focal points (CODEX, OIE and IPPC), and cooperation on SPS notifications; help raise awareness on issues relating to sanitary and phytosanitary measures among all public- and private-sector stakeholders throughout the country; and strengthen the partnership between the public and private sectors

3.65.  The local government authorities are responsible for routine enforcement of laws related to food safety control and environmental issues. The TFDA works with the TRA, health officers for plants and plant products, and zoo sanitary inspectors for livestock and fisheries, to control imports and exports of food and related products

In February 2014, under the SPS Agreement, Burundi notified the WTO of Decision No. 750/1103/2013 banning the importation, manufacture and marketing of liquor in plastic sachets and bottles.[20]

3.66.  During the review period, Tanzania has made one notification to the WTO SPS Committee. In 2017, it notified its Seeds (Amendment) Regulations, that impose certain rules on the trade of seeds. Importation or exportation of seeds requires a licence or other permit from the Ministry of Agriculture (Sections 3.1.5 and 3.2.3)

Law No. 1/123 of 23 November 2017 on plant protection in Burundi (replacing Decree‑Law No. 1/033 of 30 June 1993) regulates border control of plant imports and exports and the issuance of phytosanitary certificates to exporters. The resulting controls and inspections are performed by the Plant Protection Department of the Ministry of Agriculture and Livestock. Fees are charged for these services: the phytosanitary certificate costs BIF 5,000 (less than USD 4), while phytosanitary inspection fees are not yet being collected pending the adoption of implementation instruments for the 2017 Law

3.67.  Ordinances No. 710/837 and No. 710/838 of 29 October 2001 set the status, respectively, of pesticides approved for agricultural use and pesticides prohibited for agricultural use in Burundi. Ordinance No. 770/406 of 24 March 2003 establishes a National Code of Conduct for Pesticide Management; and several ordinances authorize or prohibit the use of specific pesticides, based on information held by the National Committee responsible for the approval and control of pesticides (177 pesticides are approved, and 37 are banned from manufacture, marketing or importation in Burundi)

3.68.  Law No. 1/28 of 24 December 2009 on health policy in respect of domestic animals, wild animals, aquaculture and bees covers health control at the border, among other issues. It places special emphasis on export and import controls, the establishment of a fund to combat epizootic diseases and measures to prevent communicable diseases. In general, imports and exports of animals and animal products require a health certificate, and they are subject to inspection by the Burundi Animal Protection Service. Imports of animals listed in Article 85 of the Animal Health Law require a health certificate issued by the country of origin. This must state that the animals do not come from an area in which infection by one of the communicable diseases listed in Burundian legislation has been notified in the last 42 days or more

3.69.  In June 2017, Burundi ratified the EAC Protocol on SPS Measures, which was adopted by the Council of Ministers of the Member States and signed in July 2013. The protocol aims to harmonize sanitary and phytosanitary protection measures and to facilitate the circulation of plants, phytosanitary products, food and animals within the subregion

3.70.  On 1 August 2008, Burundi ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The country currently has a biosafety policy, a national biosafety committee, and a clearing house for information on the subject. A draft biotechnology safety law sets out basic rules to protect the population and the environment against the risks of genetically modified organisms (GMOs) and products derived therefrom through modern biotechnology. Once adopted, the law will apply to the import, export, transit, contained use, release or placing on the market of any GMO, whether intended for dissemination in the environment, or as a food, livestock feed, or processed product, or one derived from a GMO

3.72.  The EAC Treaty requires the countries to harmonize sanitary and phytosanitary (SPS) measures for pest and disease control. Under the Customs Union Protocol, the EAC countries are to cooperate in several areas, including SPS measures. In this context, an SPS Protocol was developed in 2013, based on the provisions of the WTO SPS Agreement. As of December 2017, harmonized measures and procedures have been developed for plants; mammals, birds and bees; fish and fishery products; and food safety (see Table 3.8)

3.73.  To date, the SPS Protocol has been ratified by Rwanda, Burundi, Kenya and Uganda. The Phytosanitary (Plant Health) Measures Act was adopted in 2016. It aims at minimizing phytosanitary risk, and facilitating the implementation of common and harmonized procedures in the areas of inspection and certification, movements of plants and plant products, and import and export requirements. The related SPS Bill was adopted by the Sectoral Council on Agriculture and Food Security in June 2017. Approval of the Bill by the Council of Ministers and its enactment into law by EALA are awaiting full ratification by all EAC member States

3.74.  A mutual recognition procedure for veterinary vaccines and pharmaceuticals was adopted in 2015, together with a harmonized registration system

3.75.  During the period under review, Uganda's framework for sanitary and phytosanitary (SPS) requirements appears largely unchanged. The main SPS-related legislation includes the Food and Drugs Act, 1964, the Public Health Act, 1964, the Plant Protection Act, 1964, the Drugs Act, 1993, the Seeds and Plant Act No. 3, 2007, and the Agricultural Chemicals (Control) Act No. 1, 2007. The authorities are revising or preparing laws and regulations in the SPS area, e.g. regulations for the Agricultural Chemicals (Control) Act, the draft Biosafety Act and Regulations, the Plant Protection and Health Act, and the Food and Nutrition Bill

3.76.  The MAAIF is the national enquiry point for all SPS-related issues (including for the issuance of permits and certificates), while the MITC is responsible for notifications to the WTO. During the period between 1 January 2012 and 31 July 2018, Uganda submitted 35 regular notifications to the WTO under the Agreement on the Application of Sanitary and Phytosanitary Measures, covering food safety, and animal health issues

3.77.  Various institutions share responsibility for the implementation of food safety controls. At the time of the previous Review, Uganda developed a National Food Safety Strategic Plan (2007-16), aiming at, inter alia, guiding the implementation of food safety laws, programmes, activities, and other food safety control systems.[42] The Ministry of Health is responsible for issues related to drugs and food safety. Imports of drugs require a valid import permit issued by the NDA.[43] The drugs are inspected by an NDA inspector at the port of entry, to ensure that they comply with the approved specifications and regulations. Each batch must be accompanied by a relevant certificate of analysis. The inspector may carry out sampling or pick samples for further investigation

3.78.  The MAAIF is responsible for initiating the formulation and review of laws, regulations, standards, strategies, and plans related to SPS measures and for the regulation of animal and animal products (including fish and fish products). A phytosanitary certificate is required from the exporting country for flowers, fruits, vegetables, and plants, and related products; and a health certificate is required for animals and animal products, certifying that they are free from infectious or contagious diseases. A permit from the relevant department under the MAAIF is required prior to the importation of these products

3.79.  The Department of Fisheries Resources is responsible for the certification of fish and fish products intended for export. It enforces fisheries regulations, including the inspection of factory premises, processing lines, landing sites, fish transport, and export points for adherence to safety and quality requirements, as well as maintaining a national fish inspection and quality control system

3.80.  There has been no major change to Kenya's sanitary and phytosanitary (SPS) legal and institutional framework since the last Review in 2012 (Table 3.8). National enquiry points under the WTO SPS Agreement are: the Kenya Plant Health Inspectorate Service, for plant health issues; the Department of Veterinary Services for animal health; and the Department of Public Health for food safety issues. Veterinary medicines and poisons are regulated by the Veterinary Medicine Directorate, established in 2016.[66]

The Crop Protection Department of the MAAIF is responsible for all matters related to plant health, including the control of SPS permits on imports, the issuance of export phytosanitary certificates for live plant material and horticultural crops, and the deployment of staff at all border posts to enforce agricultural import and export regulations and certification against crop pests and diseases. The Department is also responsible for enforcing regulations on the registration and use of pesticides and other agri-chemicals. Imports of flowers, fruits, vegetables, plants, and seeds require a phytosanitary certificate. Seed importers are subject to licensing requirements. Soil imports are prohibited

3.81.  During the review period, Kenya submitted five notifications to the WTO Committee on SPS Measures.[67] Kenya did not raise any specific trade concern (STC). However, it supported two concerns: European Union revised proposal for categorization of compounds as endocrine disruptors (STC N382); and India's fumigation requirements for cashew nuts (STC N427). Kenya is a member of Codex Alimentarius, the World Organization for Animal Health, and the International Plant Protection Convention. Kenya is party to the Cartagena Protocol on Biosafety, and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)

3.82.  Kenya ratified the EAC Protocol on SPS measures in July 2016

3.83.  Plant health is governed mainly by the Plant Protection Act. The importation of any plant product is subject to an import permit from the Kenya Plant Health Inspectorate Service (KEPHIS), and a phytosanitary certificate from the relevant authority in the exporting country.[68] Plants are inspected upon arrival at the port of entry, and laboratory tests may be carried out

3.84.  Live animals and other veterinary goods are subject to an import permit by the Directorate of Veterinary Services (DVS).[69] The permit is issued electronically through the single window system (Section 3.1.1). The Directorate also issues the international veterinary certificate for exports. In some cases, the application must be lodged with the relevant institutions such as: the Kenya Dairy Board, for milk and milk products; the Pharmacy and Poison Board for veterinary drugs and vaccines; the Fisheries Department for fish and other aquatic products; and the Kenya Wildlife Service, for game animals and their products. For genetically modified animals and feedstuffs, the importer must obtain the approval from the National Biosafety Council before applying for the import permit. Consignments are inspected at the port of entry by relevant institutions

3.85.  Between 2014 and 2017, KEPHIS received technical assistance under the Standards and Market Access Programme (SMAP) to enhance market access and the competitiveness of the country's animal and plant-based products

3.86.  Drugs and medical supplies are under the purview of the Kenya Medical Supplies Agency. It is responsible for procuring, warehousing and distributing drugs and medical supplies to health institutions.[70] It is also responsible for maintaining the national strategic reserve stock defined as equivalent to six months stocks of a list of prescribed medical supplies

3.42.  Standardization, testing and certification remain the responsibility of the Burundian Standardization and Quality Control Bureau (BBN), a government body with its own legal status and financial autonomy. Since 2006, Burundi has accepted the WTO Code of Good Practice for the Preparation, Adoption, and Application of Standards.[12]

3.43.  The BBN is a correspondent member of the International Organization for Standardization (ISO)[13], and has been notified as Burundi's enquiry point under the WTO Agreement on Technical Barriers to Trade (TBT). Burundi is neither a member of the International Electrotechnical Commission (IEC) nor part of the African Regional Organization for Standardization (ARSO)

3.44.  The BBN's main role in the process of developing standards is to prepare working papers, convene meetings of the technical committees, develop draft standards for public comment, and publish the standards and enforce them

3.45.  The standardization and quality control system is regulated by Law No. 1/03 of 4 January 2011 on the national standardization system, metrology, quality assurance and testing; Decree No. 100/092 of 29 August 2001 on the statutes of the Burundian Standardization and Quality Control Bureau (BBN)[14]; Ordinance No. 750/1582 of 6 November 2013 on the status of and procedure for drafting national standards; Ordinance No. 750/1583 of 6 November 2013 determining the legal units of measurement system; and Ordinance No. 750/1584 of 6 November 2013 establishing requirements for the verification of instruments or measuring and weighing apparatus in legal metrology

3.46.  In principle, a standardization initiative can originate from the public authorities, or else from consumers' associations, producers or the BBN. Upon receipt of a request for the introduction of a standard, the BBN sends the application file to the relevant technical committee. In 2018, there were six technical committees, covering the areas of food, mechanical engineering, civil engineering, information and communication technology, electrotechnical engineering, chemistry and the environment. Technical committees are responsible for developing standards. Draft standards are subjected to a public inquiry to garner amendments from stakeholders. Following this phase, the technical committees adopt the draft standards. Lastly, an Ordinance issued by the Minister responsible for industry publishes the standard in the Official Journal

3.47.  The bulk of the BBN's standardization activities involve adopting ISO or EAC standards as national standards. When an EAC standard is adopted, any national standard having the same purpose is cancelled

3.48.  Once adopted, Burundian standards apply equally to any person, whether national or foreign, carrying on an economic activity in national territory. By August 2018, more than 1,000 EAC standards had been adopted as Burundian standards.[15]

3.49.  A Burundian standard may be made compulsory through an Ordinance issued by the Minister responsible for industry within his/her jurisdiction. On the recommendation of the BBN Board of Directors, the Minister may make a standard wholly or partly mandatory in Burundi (technical regulation). The mandatory application of a standard must pursue one or more of the following aims: to prevent misleading or fraudulent practices; to protect human safety and health; to protect the health and life of wild flora or fauna; or to protect the environment

Development of standards and technical regulations is a non-Union matter, thus there are different laws, standards organizations, and procedures for the Mainland and Zanzibar. There has been increased harmonization of standards at regional level during the review period. As an EAC member (partner State), Tanzania has implemented its standardization, quality assurance, metrology and testing (SQMT) pursuant to the EAC SQMT Act of 24 May 2006 (see main report). The conformity assessment marks for each partner State are now recognized, allowing for easier cross-border trade. Also, as a Member of the SADC, Tanzania adheres to the SADC Protocol on Trade and its TBT Annex. There have been a few developments in this area during the review period

3.50.  The Board of Directors must ensure that making the standard mandatory is the most effective way to solve a particular problem, and that national legislation and administrative and technical infrastructure allow for mandatory application of the standard. In principle, the WTO Secretariat must be notified pursuant to the Agreement on Technical Barriers to Trade (TBT), and the EAC Secretariat and member countries in accordance with current procedures

The Tanzania Bureau of Standards (TBS) is a key body in Mainland Tanzania's standards field. It issues certification of standards, mainly for manufactured products; it is a member of the International Organization for Standardization (ISO), and serves as the national enquiry point under the WTO TBT Agreement for Tanzania. The TBS is also responsible for managing information on technical regulations, proposing and adopting standards, conformity assessment procedures, and sanitary and phytosanitary measures

3.51.  Before making a standard mandatory, the Minister may publish his/her intention to do so in the Official Journal of Burundi and in at least one national newspaper. The information provided must include the reference and full title of the standard, state the reasons for which it is being made mandatory, specify the address at which the standard in question may be consulted or obtained, and invite any stakeholder to submit an objection in writing to the BBN Board of Directors within 90 days

Zanzibar is similar organized, and established the Zanzibar Bureau of Standards (ZBS) in 2012 as its main standards organization; it was established pursuant to the Zanzibar Standards Act, 2011.[96] The ZBS' main role is to develop, promote, and enforce standards on goods and services in Zanzibar. It operates three main product certification schemes the standards mark of quality certification scheme, the batch certification scheme, and the tested product certification scheme.[97] Zanzibar is particularly keen on ensuring that products, when they enter the Zanzibar market, comply with Zanzibar standards or other national or international standards. As such, a number of regulations have been issued pursuant to the Act, including the Certification, Compulsory Batch Certification of Imports, and Tested Products Regulations. The ZBS does not maintain a separate enquiry point; rather, all such work is conducted through the TBS enquiry point for Tanzania

3.52.  The main laws governing the sector on the Mainland include the Standards Act 2009 and the Food, Drugs, Cosmetics and Medical Devices Act. A number of new regulations were issued under the latter during the review period, including: the Tanzania Food, Drugs and Cosmetics (Marketing of Foods and Designated Products for Infants and Young Children) Regulations, 2013; the Scheduling of Medicines Regulations, 2015; the Control of Medical Devices Regulations, 2015; the Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials Regulations, 2015; and the Registration of Pharmaceutical Products Regulations, 2015

A standard cannot be made mandatory until everyone that has submitted an objection has either been heard or has waived their objection. In 2014, there were some 227 technical regulations in force in Burundi, covering food products, chemicals, mechanical and electrical products, textiles and consumer goods, as well as construction and related products.[16] However, few of these measures have been notified to the WTO (Table 2.2)

3.53.  Regarding standards and conformity assessment procedures, the TBS performs standardization, conformity assessment (inspection, testing and certification), accreditation and metrology services based on ISO/International Electro Technical Commission (IEC) international best practices. The Mainland's standardization process involves technical committees, supervisory committees, and working groups that prepare preliminary draft standards. There are 8 supervisory committees and over 100 technical committees in place. Pursuant to the EAC SQMT Act, Tanzania issues national standards within six months that emanate from the harmonized EAC standards that are used by partner States for trade. These national standards are provided to the industry, traders and authorities for trade and for regulatory purposes

A legal metrology system operates in Burundi, based on three laboratories, specializing in the control of mass, volume and temperature, respectively. In 2013, the BBN metrology department was equipped by the German Institute of Metrology (PTB)

3.54.  The TBS maintains a database, or Standards Catalogue, that compiles the information on its standards. It has over 1,722 standards (voluntary) or technical regulations.[98] As of 2012, there were 136 national standards or technical regulations; this figure has grown significantly during the review period, and has more than doubled, to 396 standards as of 2016-17. The standards/technical regulations cover areas such as electrical engineering, mechanical engineering, civil engineering, environment, agriculture and food, packaging, labelling, textiles, building and construction, manufacturing, information and communication technologies (ICT), energy, quality management, conformity assessment, and services. Many are based on international or regional standards/technical regulations. According to the authorities, about one third are technical regulations (633 as of May 2018), often dealing with health and safety issues, and the remainder are voluntary standards.[99]

In 2014, a programme for checking compliance with preshipment standards was put in place to make sure imported products conform to standards that are mandatory in Burundi

3.55.  The TBS has nine testing laboratories covering sectors such as civil (building and construction), mechanical, and electrical, engineering; food and microbiology; textiles, leather and condoms; chemistry; metrology; cotton; and packaging. As of 2018, four have been accredited ISO 17025. The TBS also performs calibration and testing services; destination inspections; certification; and management of its TBS mark scheme. The TBS operates two types of control programmes, the Certificate of Conformity (CoC) for imports, and the Pre-Shipment Verification of Conformity (PVoC) for exports (Section 3.1.1), with the view to ensuring compliance with the relevant Tanzanian technical regulations. The CoC programme commenced in 2012, and the TBS has since issued 28,366 CoCs. The TBS contracted two private inspection companies to conduct the process. In 2018, Tanzania imposed a prohibition on the import and use of plastic bags of a certain thickness, except for emergency or medical reasons.[100]

The programme includes physical inspection, product testing in accredited laboratories, quality control of production processes (where applicable) and documentary review. The programme has not yet been notified to the WTO Committee on Technical Barriers to Trade

3.56.  According to the authorities, Tanzania, through the TBS, accepted and complies with the Code of Good Practice for the Preparation, Adoption and Application of Standards in Annex 3 to the TBT Agreement. During the review period, Tanzania submitted 184 new or revised technical regulations to the TBT Committee; many refer to East Africa standards. During the review period, two specific trade concerns were raised in the TBT committee with respect to alcoholic beverage products.[101]

The merchandise conformity verification programme is applicable to all products that may be imported into Burundi.[17] Any product subject to the verification programme must be accompanied by a certificate of conformity, which is compulsory for customs clearance in Burundi. If the goods do not meet the requirements, a non-conformity report is issued to the exporter, and the goods are not allowed to be imported into the country

3.57.  The TBS is a member of the Food and Agriculture Organization and the World Health Organization (FAO/WHO) Codex Alimentarius Commission; the East African Standards Committee (EASC); the SADC Committee of Experts for Standardization, Quality Assurance, Accreditation and Metrology (SQAMEG); the ISO; and the IEC

The certification procedure has three lanes, according to the profile of the trader; and the exporter must pay fees for the physical inspection and documentary review (Table 3.2). Sampling and testing fees are determined by agents conducting the pre-export verification of conformity process (PVoC) on a case-by-case basis. Any goods subject to PVoC arriving at the port of entry without a certificate of conformity are charged a destination inspection fee of 15% of their c.i.f. value

3.58.  To obtain the certificate of conformity, the goods must undergo a combination of the following processes: a physical inspection, testing by an accredited laboratory, an audit of manufacturing procedures, or a documentary verification

3.59.  BBN inspectors are tasked with checking the documents accompanying the goods, including the certificate of conformity for products subject to SGS inspection and the quality seal for products originating in another EAC country. This verification is followed by a physical inspection of the products.[18] The BBN assigns quality seals

3.60.  The BBN has signed a Memorandum of Understanding with the Kenya Bureau of Standards (KEBS)

3.61.  During the period under review, Uganda's framework for standards and technical requirements remained largely unchanged. The basic legislation is the Uganda National Bureau of Standards Act, Cap 327 (as amended). The UNBS is the sole statutory organization responsible for the formulation, promotion, and enforcement of standards and technical regulations. It is the national enquiry point for TBT issues in the context of the WTO[34]; the MTIC is responsible for notifications to the WTO

There is no accreditation body in Burundi

3.62.  In the period between 1 January 2012 and 31 July 2018, Uganda submitted about 700 regular notifications to the WTO under the TBT Agreement. The notifications cover, inter alia, food and beverages, cosmetic products, construction materials, fertilizers, fuel products, medical instruments, clothing and textiles, mechanical devices, and measuring devices. Most of these notifications specified a comment period of at least 60 days and a proposed date of adoption. During the same period, Uganda also submitted a large number of addenda, providing additional information on the adoption, entry into force, and content of the final text of previously notified TBT measures. Some WTO Members in the TBT Committee expressed their concerns about EAC-harmonized technical regulations on alcoholic beverages

The legal framework for marking and labelling appears to be unchanged since the last review. Burundi does not have national provisions on marking, labelling or packaging; and it uses the Codex Alimentarius standard as the main reference for food labelling. According to the Commercial Code, however, the Ministry responsible for trade may, inter alia, lay down requirements on the composition, quality, and denomination of goods intended for sale and the affixing of indications specifying their origin, composition, weight, volume, quantity or measurements

3.63.  Any interested party (i.e. public sector, private sector, academia, or members of the public) may submit proposals for national standards/technical regulations to the UNBS. The technical committees prepare the draft standards, and publish them for comments.[35] A 60-day period is usually given for public comments from a wider range of stakeholders. The authorities noted that the UNBS responds to all comments in writing. Final texts of standards must be approved by the National Standards Council, prior to being declared as national standards by the Minister for Trade

3.64.  Upon the recommendation from the National Standards Council, the Minister may declare a standard a technical regulation (i.e. mandatory standards). The Council recommends a standard to be declared compulsory depending on the objectives it intends to achieve. These objectives include quality requirements, the protection of human health or safety, the protection of the environment, the protection of animal or plant life or health, the prevention of deceptive trade practices and consumer protection, and consumer information or labelling. A 60-day period is accorded to the public for the submission of any objection. If no objection is registered, the standards become technical regulations when the Minister of Trade declares them as such.[36]

3.65.  The UNBS publishes a bi-annual catalogue of standards. A list of technical regulations is also maintained on the UNBS website. As of end-2017, a total of 3,125 standards were in force, of which 1,317 were compulsory (i.e. technical regulations). According to the authorities, Uganda considers relevant international standards as the basis for preparing national standards and technical regulations, unless the international standards are ineffective (due to climate or geographic conditions, for instance) or inappropriate to achieve the intended, legitimate objectives. The authorities noted that 747 technical regulations were directly adopted or derived from international standards, while 270 were EAC regional standards

3.66.  Under the EAC Treaty, member countries are to adopt a common policy on standardization, quality assurance, metrology, and testing of goods and services produced and traded within the Community. The CM Protocol further calls on members to "harmonize and mutually recognize standards and implement a common trade policy for the Community".[57]

Products (domestically-produced or imported) subject to technical regulations must be tested for conformity before they are placed on the market.[37] In principle, the tests are carried out by the appropriate UNBS laboratories in the fields of chemistry, microbiology, mechanics, building materials, and electrical equipment. The UNBS operates a product certification scheme, under which manufacturers apply for and are granted permits to use the Uganda Standards Distinctive Mark on their products. The Mark is mandatory for products subject to technical regulations. As of end-July 2018, 1,200 products had been certified and 400 companies had benefited from this scheme

3.67.  The Standards, Quality, Metrology and Testing (SQMT) Act, 2006 and the SQMT Protocol of 2001 constitute the main framework for the Community's evolution towards a common policy. During the review period, a number of regulations have been adopted to operationalize the SQMT Act. These relate, inter alia, to product certification, designation of laboratories, and enforcement of technical regulations. The implementation of the SQMT Act is hindered by a number of challenges, including limited awareness about the issue, and the lack of financial resources in some countries. According to the EAC Secretariat, the Act was reviewed in 2010, which resulted in the adoption of a Metrology Bill and a Standardization, Accreditation and Conformity Assessment (SACA) Bill

For locally-produced goods, the UNBS carries out scheduled and surprise site visits to industrial plants to ensure safety and conformity with technical regulations. The UNBS has established an Import Inspection and Clearance Scheme that requires all imported products subject to technical regulations to be inspected for conformity. The inspection may follow one of two methods: pre-export verification of conformity (PVoC), or destination inspection.[38]

3.68.  The SQMT Act provides for the adoption and harmonization of standards by member states, the enforcement of technical regulations, the declaration and acceptance of certification marks, and the alignment of national laws and regulations. At the regional level, the institutional setting comprises: the East African Standards Committee (EASC), in charge of coordinating activities related to standardization, metrology and conformity assessment, and monitoring their implementation at national and community levels; the Liaison Office, tasked with providing administrative support to the EASC; and the East African Accreditation Board (EAAB). The EASC is responsible for developing new standards and harmonizing existing ones. It has four technical subcommittees on: standards, quality assurance, metrology, and testing. Efforts are underway to establish a "TBT-SPS Forum" to address issues including technical regulations. At national level, the institutional setting is supplemented by national standard bodies (NSBs) and bodies in charge of metrology, and accreditation

PVoC is usually applied to imports valued above USD 2,000 (f.o.b.). Under it, importers must present a Certificate of Conformity (COC)[39] at the point of entry; in the absence of a COC, the arrival cargoes are subject to destination inspection, instead. In most cases, COCs are required before the goods are loaded in the exporting countries (i.e. pre-export). COCs may be issued by inspection agents, who are pre-qualified and commissioned by the UNBS; the UNBS also accepts test reports issued by accredited foreign laboratories.[40] In general, the inspection fees are charged at ad valorem rates on the f.o.b. value of the shipment[41]: 0.5% for unregistered products, 0.45% for registered products, and 0.25% for licensed products. The authorities stated that the inspection fees have remained unchanged since 2013

There has been no major change to the legal and institutional framework governing standards and technical regulations in Kenya. The Standards Act, Cap 496, is the main legislation governing standardization activities in Kenya. The institutional framework comprises the Kenya Bureau of Standards (KEBS) as the agency responsible for standardization and certification activities; the National Standards Council as the oversight body; and, the Standards Tribunal to hear appeals to decisions by the other institutions. KEBS is the national enquiry point under the TBT Agreement. The MITC is the national notification Authority.[58]

3.69.  Proposals for standards and technical regulations are received by NSBs. The proposal must be endorsed by at least two NSBs before being considered as accepted at the regional level and developed by the relevant committee or subcommittee. The "Draft EAC Standard" goes through a 60-day public comments stage.[58] The Draft is then revised accordingly and sent to the NSBs. If accepted by all the NSBs, the Draft Standard is adopted and declared an "EAC standard" by the Council of Ministers. Countries have six months to adopt the EAC standard as a national one. The maximum duration allowed for the completion of a standard project is 24 months, from the proposal stage to the time of approval. As at 30 September 2018, the EAC catalogue included 1,526 standards, of which 1,007 are international

The UNBS provides facilitation procedures for products subject to PVoC requirements. Products that have been registered with the UNBS, or frequent importers of homogeneous products, may enjoy self-declaration of compliance supported by substantiated evidence of conformity and consistency (test reports, certificates, Quality Management Certificates, etc); product registration is valid for one year, renewable. Exporters to Uganda may also apply for a UNBS Product Compliance Licence, under which COCs will be issued if the licence review is satisfactory; this Licence is renewable annually. Imports bearing the Uganda Standards Distinctive Mark are exempted from the PVoC requirement. Under the principle of intra-EAC transfer, imports originating in other EAC members are not subject to PVoC, if they bear notified certification marks of other EAC partner States

Kenya is a member of the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the African Regional Organization for Standardization (ARSO)

3.70.  The Council of Ministers may declare a standard to be a technical regulation, upon recommendation by the EASC. The related notice must be published in the Gazette and in at least one newspaper of national circulation in each country before the enforcement of the regulation

For goods valued at less than USD 2,000, destination inspection is applied on their arrival at the point of entry. No inspection fees are charged for this inspection. However, if goods subject to PVoC fail to produce COCs at the point of entry, a surcharge for the inspection is imposed, at a rate of 15% of the c.i.f. value of the shipment

In Kenya, any interested party can launch the initiative for setting a standard, and revising or amending an existing one. The relevant technical committee evaluates the request in consultation with stakeholders and may decide to launch the standardization process. When the process is launched, KEBS is required to publish a notice in the Gazette informing the public of the standard development process. The draft standard prepared by the technical committee is then published in the KEBS Standards Work Programme Bulletin. Interested parties, including from any WTO Member, have 60 days to make written comments.[59] The draft standard becomes a national standard once declared as such through a legal notice by the MITC

3.71.  EAC countries experience some challenges in the harmonization of their regimes on standards and technical regulations, particularly with regards to the mutual recognition of inspection certificates. This forces traders to undergo repeated certification tests within the region. The priority in the harmonization process is based on goods traded in the region

In order to accelerate customs clearance, in February 2017, the UNBS introduced a new procedure to release imported goods under seal to a bond house or to the importers' own premises while the actual release is pending laboratory testing results. Importers now apply for release under seal, upon all relevant payments being made and cash worth 15% of the c.i.f. value of the goods being deposited as a bond. The bond is returned to the importer when the Import Clearance Certificate is issued; the bond is used for the destruction or re-export of the goods if the test result is not in favour of the importer

A standard becomes a technical regulation upon declaration through a legal notice by the Cabinet Secretary responsible for Standards and Technical Regulations. The authorities may exempt some importers and manufacturers from complying with a technical regulation; the decision is taken on a case-by-case basis.[60] Standards are in principle reviewed after three years for the first time, and every five years thereafter. As at October 2018, Kenya has 9 150 standards, of which 65.2% derive from international standards. These are: ISO standards (45.3% of national standards), IEC (7.7%), East African Standards (6.5%), and Codex (4.6%)

3.72.  The UNBS conducts market surveillance. Where necessary, it draws samples of the product for laboratory testing. Testing charges are imposed if samples are drawn for laboratory analysis. If the product does not meet the critical minimum requirements for health, safety, and performance, as set out in the relevant Ugandan Standard, the product is prohibited from entry on those grounds and seized for destruction or re-exportation at the importer's expense

Kenya operates a pre-shipment inspection programme on the conformity of imported goods with applicable standards, specifications or regulations. For products not subject to Kenyan standards, the verification is carried out against the relevant international standards or those applicable in the country of origin. Five companies are operating the verification programme on behalf of KEBS: Socit Gnrale de Surveillance SA; Intertek International Ltd.; China Certification and Inspection (Group) Co. Ltd.; Bureau Veritas; and Cotecna Inspection SA.[61] Each company is appointed for 36 months and has monopoly over inspection activities in countries assigned to it by the authorities

3.73.  Uganda concluded a mutual recognition agreement (MRA) with other EAC partner States within the framework of EAC SQMT Act. It has not concluded any MRAs with other countries, nor is it a member of any accreditation forums. According to the authorities, a bill on accreditation has been submitted to the legislature

The verification may include: physical inspection of goods; sampling, testing and analysis; audit of the production process; documentary check; and conformity assessment to Kenyan standards. The requirement was notified to the WTO in November 2015.[62] Since December 2015, the verification programme has covered virtually all finished goods imported into Kenya. The list of exempted goods includes: products regulated by other government agencies; raw materials, machinery and spare parts imported by registered manufacturers; Completely-knocked-down (CKD) motor vehicles and motor bikes imported for local assembly; courier parcels; printed and copyrighted digital materials; and goods certified by KEBS under the Diamond Mark of Quality scheme.[63] Goods manufactured in another EAC country are accepted based on the certification issued by the respective national standards bodies

3.74.  The following information must be clearly marked on imports and exports: importer/exporter name, consignee, flight/vehicle details, place of discharge, number of packages, container identity, description of goods, airway bill number/bill of lading, and country of origin/destination. Additional labelling requirements have been adopted for used clothing. Uganda's standards on labelling and packaging apply to, inter alia, food, textile products, and cosmetics

There are four possible routes for obtaining the certification (Table 3.7). Owing to their risks of fraud, the following products can only be certified through route A, which requires testing and physical inspection: sugar, cereals and pulses, fertilizer, animal and fishery products, fresh dairy products, fresh horticultural produce, used and second-hand goods. A registration and/or licensing is required for route B, C and D. Registration and licensing fees are calculated on a case-by-case basis by each inspection company and apply to its area of operation. Depending on the outcome of the assessment, the company may issue a Certificate of conformity, a Non- conformity report, or an Uncompleted process report. The Certificate of conformity is required for customs clearance

3.75.  Goods imported without a certificate of conformity are subject to a destination inspection by KEBS at a fee of 15% of their c.i.f. values. The importer is required to post a bond of a similar value pending the verification. Depending on the certification route, the inspection fee may range from 0.35% to 0.75% of the f.o.b. value of the consignment, with a minimum perception of USD 265 and a maximum of USD 2,700. Due to their ad valorem nature, the fees charged may not be commensurate with the cost of the inspection service. Furthermore, the application of a minimum perception may result in higher charges for small traders.[64]

3.76.  The Kenya Accreditation Services (KENAS) is the body mandated by the government to provide accreditation services. KENAS is a member of the International Laboratory Accreditation Cooperation, the International Accreditation Forum, and the African Accreditation Cooperation. It provides accreditation services to certification and inspection bodies; calibration, testing and medical laboratories; and proficiency tests providers. Accredited bodies are subject to an initial assessment fee of KES 250,000, and an annual fee of KES 192,500

3.77.  Kenya maintains labelling requirements for foodstuffs and excisable goods. All foodstuffs must be labelled in English and/or Swahili. Packaged goods must be marked with a batch number, the dates of expiration and/or production. For products with limited shelf live, 50% (for non-food items) to 75% (for food items) of the shelf live must be valid from the date of expected arrival in Kenya

3.78.  Since November 2017, operators have been required to affix an excise stamp on all excisable goods manufactured or imported into Kenya (Section 3.1.5). Depending on their end use, excisable goods must be labelled with one of the following mentions: "For use in Kenya", "Duty free", "Kenya Defence Forces", or "National Police Service"

3.79.  Food and feed containing at least 1% (by weight) of genetically modified organisms are subject to labelling and traceability requirements.[65] Operators are required to ensure that the words "genetically modified 'name of ingredient or food' " appear on the label. They are also required to inform any subsequent operator in the production or distribution chain that the product contains or consists of genetically modified organisms