BUSINESS GUIDE ON SANITARY AND PHYTOSANITARY MEASURES AND STANDARDS IN EAC REGION

Transcription

1 EAST AFRICAN BUSINESS COUNCIL BUSINESS GUIDE ON SANITARY AND PHYTOSANITARY MEASURES AND STANDARDS IN EAC REGION EAST AFRICAN BUSINESS COUNCIL Plot 1 Olorien, Kijenge. P O Box 2617, Arusha, Tanzania Tel: +255 (27) Fax: info@eabc-online.com website:

2

3 Foreword from EABC On July 1, 2010, the East African Community (EAC) began implementing a Common Market which is expected to enhance free movement of goods, capital, labour, and services. Although it is envisaged that the deepened EAC integration will increase free movement of goods across the EAC, traders still face challenges in complying with various legal requirements aimed at facilitating trade due to absence of ready-to-use information. Traders in agricultural products still find it quite challenging to comply with EAC Sanitary and Phyto Sanitary Measures (SPS) which are rules and procedures that governments use to ensure that foods and beverages are safe to consume and to protect animals and plants from pests and diseases. While many SPS measures are fully justified and are in line with World Trade Organisation requirements, oftentimes governments hide behind discriminatory and protectionist trade measures in the guise of ensuring plant, animal and human safety. These SPS barriers not only hinder trade, they also deprive consumers in the region of access to high quality agricultural goods. The East African Business Council together with the East African Community Secretariat with support from UNIDO and PTB, therefore, developed this business guide partly to respond to the concerns of traders in agricultural products who are running into SPS trade barriers as they seek to export quality agricultural products within EAC. One of the other challenge facing EAC is the variation in certification, testing, inspection practices, and standards used by Partner States. The guide contains information on EAC Standardisation, Quality Assurance, Metrology Testing (SQMT) Act which provides a legal framework for the development of regional standards. It seeks to harmonise standards and conformity assessment procedures and for Partner States to recognize each other s certification results, to avoid discriminatory, non-transparent, and unnecessary obstacles to trade. The first section of the guide documents some of the cases where SPS measures have become barriers to trade and seeks to inform traders of their rights and obligations. The second section of the guide contains information on the EAC SQMT Act. EABC and EAC Secretariats are committed to raising awareness on the current SPS measures and SQMT Act with the ultimate goal of increasing trade in the region. The guide is an easy to use information tool for traders in the region and we hope the business community will use the wealth of information contained in this guide to improve their compliance and further increase trade in EAC. EABC will continue to work with traders, relevant government agencies, and other stakeholders to ensure that the business community is fully aware and conform to EAC SPS measures and provisions within the SQMT Act. At EABC, we are committed to playing our rightful role in contributing towards a better business environment in the EAC and we hope this guide will prove a useful information tool for anyone seeking to do businesses in the region. Agatha Nderitu, Executive Director, East African Business Council

4

5 Foreword from EAC In preparation of this Business Guide on Sanitary and Phytosanitary (SPS) measures and standards, the East African Community Secretariat has collaborated with the East African Business Council to enhance dissemination of information in SPS Area. In advent of implementation of the East African Community Common Market (CM) that was commenced from July 2010, the value and volumes of products traded across borders in EAC region and outside of the region are expected to increase. The increase in trade will only be achieved if the requirements and trade conditions that affect most of the products produced and traded by the region are harmonised among Partner States. Harmonization of requirements will also ensure that products meet the requirements of other global markets abroad. All the EAC Partner States are members of World Trade Organisation (WTO) and are bound to meet the obligations of the WTO agreement on SPS measures and Technical Bariers to Trade. More importantly, majority of the population in the region are engaged in agriculture, and therefore any increase in agro-trade will need preparing the business operators in the region to meet the provisions of the WTO agreement concerning SPS and food related standards. These issues have always been considered whenever EAC is harmonizing standards or SPS measures in order to ensure that the business community in the region access regional as well as international markets. This Guide will be handy in ensuring that agro-food procedures and business operators are properly guided to produce and transact products that meet requirements for regional and international trade. The Guide explains the legal frameworks being put in place by the EAC to facilitate the business community to access the available markets in the region and aboard. The development of the Guide was based on the current state of agro-production, industry and trade in the region, the requirements of the WTO agreement on SPS and TBT and other international obligations in regard to trade in agro-food products. It is therefore largely targeted to the Business Community in the region; and it is hoped that the relavant business operators will access and read it to understand the SPS and standards infrastructure being laid out in the EAC. Many concerns by the business community regarding complying with SPS measures and standards, and the facilitation expected from relevant public agencies to the business community are explained in the guide as an information dissemination mechanism. EAC therefore encourages the business community to use this Guide for their own benefit. Mr. Peter N Kiguta, MBS Director General (Trade and Customs) East African Community

6

7 Table of Contents Glossary of Acronyms... ii Glossary of Technical Terms in Plain Language... iii Preface... iv Acknowledgements... v Introduction... 1 Background and Progress of Economic and Trade Integration among EAC Partner State...1 Definition of Saitary and Phytosanitary Measures...3 Definition of Technical Regulations and Standards...5 Difference Between a Standard and Technical Regulation...5 When does a Technical Regulation become an unnnecessary barrier to trade...6 Difference between Technical Regulations and SPS Measures...7 Business Implications EAC Legal Regime on Sanitary and Phytosanitary Measures...13 EAC Protocol on Sanitary and Phytosanitary Standards...13 EAC Harmonized SPS Measures...16 Harmonized Phytosanitary Measures and Procedures for Plants Vol. I...16 Harmonized Sanitary Measures and Procedures for Mammals, Birds and Bees Vol. II...18 Harmonized Sanitary Measures and Procedures for Fish and Fishery Products Vol. III...19 Harmonized Measures for Food Safety...20 Standardization and Technical Regulations Issues...26 Types of Standards...26 International Rules Governing Standardization...26 Code of Good Practice for voluntary Standardization...29 Conformity Assessment Procedures...30 EAC Invites on Standardization...34 EAC Protocol on Standardization, Quality Assurance, Metrology and Testing...34 The EAC Standardization, Quality Assurance, Metrology and Testing Act...35 Summary of EAC SQMT Structures...37 EAC Harmonized Standards Frequently Asked Questions (FAQ)...44 i

8 Glossary of Acronyms ARSO CODEX COMESA EAC EABC EASC EC FAO FTA GATT IPPC ISO NSB OIE SPS SQAM SQF SQMT TBT UNIDO UNBS WHO WTO African Regional Standardization Organization Codex Alimentarius Commission Common Market for East and Southern Africa East African Community East Africa Business Council East African Standards Committee European Community Food and Agriculture Organization Free Trade Area General Agreement on Tariffs and Trade International Plant Protection Convention International Standards Organization National Standards Body International Office of Epizootics (World Animal Health Organization) Sanitary and Phytosanitary Standardization, Quality Assurance, Accreditation & Metrology Safe Quality Food Standardization, Quality Assurance, Metrology and Testing Technical Barriers to Trade United Nations Industrial Development Organisation Uganda National Bureau of Standards World Health Organization World Trade Organization ii

9 Glossary of Technical Terms in Plain Language Accreditation Calibration Certification Conformity Inspection Metrology Mutual Recognition Arrangement Product certification Pest Risk Analysis Accreditation is the internationally accepted procedure that recognizes the competence of testing and calibration laboratories, product certification bodies, quality system certification bodies and inspection bodies. Accreditation schemes minimize the duplication or re-testing and re-certification, reduces cost and eliminates nontariff barriers to trade and market access delays. Calibration means set of operations that establish under specified conditions, the relationship between values of quantities indicated by a measuring instrument and corresponding values realized by standards. Means the issue of a written statement by a third-party, based on a decision following review, that products, processes, systems or persons have fulfilled specified requirements. Conformity assessment procedures are technical activities such as testing, Assessment verification, inspection, and certification which confirm that products or processes fulfill the requirements laid down in regulations and standards. Inspection means examination of a product design, process or installation and determination of its conformity with specific requirements or on the basis of professional judgment, with specific requirements. Inspection of a process may include inspection of persons, facilities, technology and methodology. Metrology is the science of measurement; No testing would be possible unless the characteristics of the product or service in question can be measured in a way, which compares them against physical or chemical reference of known values. Therefore, adequate methods for measuring the properties of products and services are fundamental to the quality assessment process. Mutual Recognition Arrangements are formal agreements between parties whereby they agree to recognize the results of each other s testing, inspection, certification, or accreditation MRAs are an important step towards reducing the multiple conformity assessment that products, services, systems, processes and materials may need to undergo, especially when they are traded across borders. Product certification may consist of initial testing of a product combined with assessment of its supplier s quality management system and testing of samples from the factory and/or the open market. Other product certification schemes comprise initial testing and surveillance testing, while still others rely on the testing of a sample product this is known as type testing. Pest Risk Analysis is the process of evaluating biological or other scientific and economic evidence to determine whether an organism is a pest, whether it should be regulated, and the strength of any phytosanitary measures to be taken against it. iii

10 Preface The purpose of this guide is to provide the business operator with a simplified source of information regarding SPS requirements and standards to be complied with in order to participate in regional and international trade. The guide is also aimed at providing an update to the business operators and other stakeholders of the initiatives being undertaken by the region to harmonize SPS and quality infrastructure to ease crossborder trade amongst the EAC partners and with their neighbors as well as accessing international trade The guide is expected to be useful to exporters, importers and the business community in general who intend to access the EAC market. It is designed to inform the business community in the EAC region about legal and regulatory frameworks governing standardization and SPS issues. Awareness and understanding of these SPS and standardization rules is becoming increasingly necessary in the region and will go a long way in helping the business community make more informed investments and trade-related decisions. This guide is not legislation or regulation. For the actual legal provisions on SPS and Standardization issues in the EAC region, reference should be made to/from the EAC Treaty, the EAC SPS Protocol and its Annexes the SPS harmonized measures, the EAC Protocol on SQMT and the EAC SQMT Act. The guide is divided into four sections: The introductory section addresses sanitary and phytosanitary measures, standards and technical regulations with a focus on background information and the distinctions and similarities between the different types of measures; the second section examines the proposed and existing legal and regulatory framework governing sanitary and phytosanitary standards in East Africa with specific emphasis on EAC SPS Protocol and the EAC harmonized SPS measures that form the Annexes to the protocol. The section guides the importers and/or exporters on the various stages they have to go through in accessing markets, including securing the necessary export/import permits, licenses and SPS certificates. The third section looks at the standards and technical regulations, the international rules governing standardization and conformity assessment and then explores EAC initiatives on standardization (standards, quality assurance, metrology and testing) with particular emphasis on the SQMT Act and the nature of Partner States obligations there under. The last section addresses a number of frequently asked questions and provides the relevant answers. 1 As of today, the Protocol is still in draft form and is only awaiting approval from EAC Sectoral Council on Legal and Judicial Affairs. iv

11 Acknowledgements This guide has been developed with technical and financial support from United Nations Industrial Development Organization (UNIDO) Programme on Trade Capacity Building in Agro- Industry Products for the Establishment and Proof of Compliance with International Markets Requirements. The author wishes to recognize the technical reviews of the business guide done by Dr. Ananias Bagumire, the UNIDO Trade Capacity Building Regional Programme Coordinator and Mr. Martin G. Kellerman, the Quality Infrastructure expert on the PTB (Germany) funded project on Improvement of Quality infrastructure in the EAC. The author also acknowledges the inputs provided by Mr. Moses Marwa, the Principal Agriculture Economist who doubled as the focal officer for SPS in the EAC and Mr. Willy Musinguzi, the Principal Standards Officer. The comments obtained from the regional workshop on SPS/SQMT private-public sector dialogue organized on August 2010 by the EABC and EAC provided vital information in shaping and finalizing the guide. The contribution of UNIDO and PTB Germany in organizing the workshop and the participants in the workshop especially those that represented the private sector are hereby acknowledged. The Author acknowledges the support provided by Ms. Agatha Anderitu the Executive Director of EABC and Mr. Charles Mdeme Yegella (RIP) the Trade Fellow at EABC for the good points and guidance they provided which guided layout of sections in the guide. v

12

13 Introduction Background and Progress of Economic and Trade Integration among EAC Partner States

14 Introduction Background and Progress of Economic and Trade Integration among EAC Partner States The East Africa cooperation commenced in 1993 with the signing of a declaration on closer East African cooperation, with intent to cooperate in virtually all economic, social and political sectors. The EAC derives her mandate and agenda from the Treaty for the Establishment of the East African Community (herein after referred to as EAC Treaty) which was signed on 30th November 1999 and entered into force on 7th July The broad goal of the EAC is to widen and deepen cooperation among the Partner States in economic, social, and political fields. Chapter 18 of the EAC Treaty specifically deals with cooperation in agriculture and food security. The overall objective of cooperation in this area is to achieve food security and rational agricultural production within the Community. Among the areas envisaged under the Treaty for Co-operation is in the area of plant and disease control. The Partner States pledged to; harmonize policies, legislation and regulations for enforcement of pests and disease control; harmonize and strengthen zoo-sanitary and phytosanitary services inspection and certification; and to adopt common mechanisms to ensure safety, efficacy and potency of agricultural inputs including chemicals drugs and vaccines. Under the provisions of Article 81 of the EAC Treaty, Partner States also recognize the significance of standardization in the enhancement of standards of living, reduction of unnecessary variety of products, consumer protection, promotion of health as well as protection of life property, and the environment. The Partner States expressed their commitment to evolve a common policy on standardization, quality assurance, metrology and testing of goods and services produced and traded within the community. The Partner States also agreed to conclude a common protocol on SQMT for goods and services produced and traded within the community. The EAC treaty sets the Customs Union as the first stage of the new co-operation. However, it provides a clear trajectory towards deeper co-operation as indicated by Article 5 (2) which states that the Partner States undertake to establish among themselves and in accordance with the provisions of this Treaty, a Customs Union, a Common Market, subsequently a Monetary Union and ultimately a Political Federation Figure 1.1 EAC Integration Stages and Timelines Customs Union Common Market Monetary Union Political Federation July Date 1

15 The Movement from one phase to another has been through negotiated protocols, starting with that on the establishment of an EAC Customs Union (CU). A Protocol establishing the EAC Customs Union was signed in December 2004 and the implementation of the CU commenced on 1st January 2005 and has since made steady progress in the implementation of its programmes. Article 38 of the Customs Union Protocol requires Partner States to co-operate in several areas including sanitary and phytosanitary measures and standardization, quality assurance, metrology and testing. The Partner states are required to conclude protocols which spell out the objectives, scope of cooperation and institutional mechanisms for co-operation in these areas. Following the attainment of the Customs Union, the Common Market is the next intended level of integration in East Africa. As stipulated in the EAC Treaty (Article 104) the Partner States are required to adopt measures to achieve the free movement of persons, labour and services. The overall development objective for the Common Market it to allow free movement of people within the region. This was planned to be achieved through the harmonization of policies, legislation, standards and procedures. Under Article 6 of the East African Common Market Protocol, the free movement of goods between Partner States is to be governed by several laws including; the EAC Protocol of Standardization, Quality Assurance, Metrology and Testing (herein after referred to as the SQMT Protocol); the EAC Standardization, Quality Assurance, Metrology and Testing ACT (hereinafter referred to as the SQMT ACT); and other protocols that may be concluded in the areas of Sanitary and Phytosanitary Measures and Technical Barriers to Trade. Under Article 45 of the same protocol, the Partner States set out to establish an effective regime on sanitary and phytosanitary measures, standards and technical regulations. The above legal provisions of the EAC Treaty, the Customs Union Protocol and the Common Market Protocol provide the foundation for the EAC s legal regime on SPS and standardization issues. The next section will focus on understanding the two types of measures (SPS and technical regulations), the distinctions between the two types of measure and their implications for business. 2

16 Definition of Sanitary and Phytosanitary Measures (SPS) What are sanitary and phytosanitary measures? SPS measures refer to regulations concerning the safe handling and production of food and plant and animal products. Sanitary refers to regulations whose basic objective is to ensure food safety and to prevent animal borne diseases from entering a country. Phytosanitary on the other hand refers to regulations on plant health. SPS measures are therefore those measures whose primary objective is to protect health of humans, animals and plants. Annex A1 of the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (herein after referred to as the WTO SPS Agreement) contains the full definition of an SPSmeasure. 2 All countries maintain SPS measures to ensure that food is safe for consumers, and to prevent the spread of pests or diseases among animals and plants. These may take many forms, such as setting of allowable maximum levels of pesticide residues or permitted use of only certain additives in food. However as a WTO fact sheet acknowledges, countries can use SPS measures as barriers to trade in agriculture, food, and other products: Summary SPS measures typically deal with: Additives in food or drink Contaminants in food or drink Poisonous substances in food or drink Residues of veterinary drugs or pesticides in food and drink Certification: food safety, animal or plant health Processing methods with implications for food safety Labeling requirements directly related to food safety Plant/animal quarantine Declaring areas free from pests and disease Preventing diseases or pests spreading to a county 2 Annex A1 of the SPS Agreement states that: Sanitary or phytosanitary measure is any measure applied: (a) to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms; (b) to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; (c) to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or (d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests. Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety. 3

17 Sanitary and phytosanitary measures, by their very nature, may result in restrictions on trade. All governments accept the fact that some trade restrictions may be necessary to ensure food safety and animal and plant health protection. However, governments are sometimes pressured to go beyond what is needed for health protection and to use sanitary and phytosanitary restrictions to shield domestic producers from economic competition. Such pressure is likely to increase as other trade barriers are reduced as a result of the Uruguay Round agreements. 3 A sanitary or phytosanitary restriction which is not actually required for health reasons can be a very effective barrier to trade and can be misused by some countries to shield domestic producers from competition. It therefore becomes very important for the EAC countries to adopt rules and regulations on SPS measures to prevent states from abusing them or using SPS measures for trade protectionism. The basic aim of these rules and regulations is to streamline the SPS requirements across the region and also to ensure that the Partner States do not use SPS measures for protectionist purposes. Box Kenya-Uganda Standoff in Livestock Trade In 2008, there was a standoff between Kenya and Uganda on chicks, beef and bull semen trade. Kenya maintained that Ugandan firms were to be allowed to export day-old chicks and chicken products to Kenya only on condition that they were sold through agents in the latter country, who would conduct risk assessment on the imports. Uganda on the other hand maintained that their Kenyan counterparts must first submit a risk assessment report before an 11 year old ban on importation of beef, bull semen, and other associated products from Kenya can be lifted. The positions taken by both countries, contradicted an earlier stand taken by both counties on the sidelines of a World Organization for Animal Health general session, where they agreed in principle to lift the ban unconditionally. The industry players in both countries blamed each other for politicizing the issue against the spirit of EAC trade integration. The stalemate affected the livestock industry in both countries, especially their leading firms, Ugachick in Uganda and Kenchick in Kenya. It is estimated that Ugachick was losing up to USD 200,000 per month as a result of the stalemate. The above stalemate could have been averted if both countries adopted harmonized standards on trading of livestock and livestock products, vaccination, and traceability so that neither side perceives being disadvantaged due the arbitrary nature of national decisions 3 Excerpted from WTO (1998) World Trade Organisation Series: Sanitary and Phytosanitary Measures 4th Edition Geneva: WTO Publications at 6 4

18 Definition of Technical Regulations and Standards What are Technical Regulations? Technical Regulations are documents which set out rules and guidelines on characteristics of products, related process and production methods and procedures of testing conformity with set standards. The term therefore covers: Product characteristics including those relating to quality; Process and production methods (PPMs) that have an effect on product characteristics; Terminology and symbols; and Packaging and labeling requirements as they apply to the product. What are Standards? Standards on the other hand are formulations approved by recognized body such as Codex or the International Standards Organisation (ISO) providing for rules and guidelines on characteristics of products and related process and production methods. Difference between a standard and a technical regulation The difference between standards and technical regulations lies in compliance. While compliance with standards is voluntary, technical regulations are by nature mandatory. They have different implications for international and regional trade. If an imported product does not fulfill the requirements of a technical regulation, it will not be allowed to be put on sale. In case of standards, non complying imported products will be allowed on the market, but then their market share may be affected if consumers prefer products that comply with standards. Countries often have an interest in making sure that imported products meet certain standards. In order to ensure that such standards are met, countries enact technical regulations. For example, some countries have a regulation that toys for children may not contain certain toxic chemicals. National regulations may also require that motor vehicles be equipped with seat belts to minimize injury in the event of road accidents, or that sockets be manufactured in a way to protect users from electric shocks. Such regulations all fall under the category of technical regulations. These regulations should apply equally to imported and domestic products. The largest number of technical regulations and standards are adopted with the aim of protecting human safety or health. Widely accepted standards also make it possible to have uniform designs, machinery, tools, and inputs. They also help the consumers, who have more confidence in buying a product if standards for the product have been laid down and the producer is known to adhere to the standards. However, as with SPS measures, countries sometimes use technical regulations improperly in order to protect domestic industries from foreign competition. 5

19 Example: Country A adopts a technical regulation that requires imported cigarettes to have a warning label on each pack, indicating that they are harmful. But a Country A does not require its own domestic producers of cigarettes to put warning labels on their packaging. This is a technical barrier to trade that is discriminatory because it does not apply to both foreign and domestic producers. When does a Technical Regulation become an unnecessary barrier to trade? While technical regulations facilitate trade transactions by enabling foreign buyers to assess the specifications and the quality of products offered for sale, they can become barriers to trade in two ways: a) When they differ widely from country to country. Manufacturers wishing to carry out manufacturing operations in other countries may have to adjust their production processes to those countries specifications. This increases tooling costs and prevents producers from taking advantage of economies of scale. b) When they are more restrictive than necessary to achieve a given policy objective, or when it does not fulfill a legitimate objective. All technical regulations are aimed at achieving a certain policy objective. Such objectives include national security requirements, prevention of deceptive practices, protection of human health or safety, protection of animal and plant life or health, or the environment. However countries can sometimes take measures that go beyond what is necessary to achieve a stated policy objective in order to protect their own domestic producers. Summary Technical Regulations typically deal with: Regulations for electrical appliances Regulations for cordless phones, radio equipment e.t.c Textiles and garments labeling Testing vehicles and accessories Regulations for ships and ship equipment Safety regulations for toys Labeling of food, drink and drugs Quality requirements for fresh food Packaging requirements for fresh food Packaging and labeling for dangerous chemicals and toxic substances 6

20 Box The Diary war: Kenya versus Uganda and Tanzania Milk processed by Musoma Dairy Limited, Tanzania was denied entry into Kenya in mid-2008 by the Kenya Revenue Authority. The Kenyan authorities required milk exporters from Tanzania and Uganda to have certificates proving that these products had been processed under constant supervision by veterinary authorities in the region. Tanzania and Uganda argued that the restrictions and multiplicity of controls were contrary to what the EAC member states had agreed on milk exports. Secondly, it was argued that the veterinary standards imposed by the Kenyan authorities were neither made public nor was the information shared with veterinary authorities in the region. The main trade barrier restricting milk trade in this case were the national legislations and the outdated/cumbersome import authorization systems that in effect were not really intended for enforcing technical standards or sanitary and food safety standards. In order to avert disputes like the one above and to ensure that technical regulations and standards do not create unnecessary trade barriers, the EAC countries have evolved clear rules and regulations aimed at applying uniform rules and procedures for the formulation of national standards; adopting and implementing East African standards as national standards; and harmonizing procedures for sampling and testing of products for conformity with quality standards. What is the difference between Technical Regulations and SPS Measures? The basic difference between Technical Regulations and SPS measures arises from the objective for which they are adopted. In the case of SPS measures, their aim is limited and specific i.e. to protect human, animal and plant life or health by ensuring food safety and preventing animal and plantborne diseases from entering a country. Technical regulations, on the other hand, are imposed for a variety of policy objectives. They include as noted earlier, national security requirements, prevention of deceptive practices and protection of the environment. They may however be adopted to protect human health safety, or animal or plant life for objectives other than those for which health and SPS measures are implemented. How do they differ? The SPS applies only to measures directly affecting health of humans, animals and plants. Technical Regulations and standards on other hand apply to every kind of measure for whatever purpose including protection of health. Technical Regulations and SPS: Summary Both Technical Regulations and SPS measures aim at preventing unfair trade barriers. A measure that limits trade can be seen as a Technical Regulation (with a general goal) or an SPS measure with the specific goal of protecting health. If the goal is general, then the measure is evaluated under rules of SQMT. Only measures specifically addressing a limited range of health problems will be evaluated under the SPS rules. 7

21 Box SPS OR Technical Regulation Where does a measure fall? Is it food drink or feed, and is its objective to protect one of these? Human life: Risks from Additives Contaminants Toxins Plant or animal- carried disease Animal life: risks from Additives Toxins Pests Diseases Disease causing organisms Plant life: risks from Pests Diseases Disease-causing organisms A country: risks from. Pests entering, establishing or spreading YES SPS NO Is it a Technical regulation, standard? Or procedure for assessing whether a Product conforms to a standard? YES SPS NO OTHER 8

22

23 Business Implication

24

25 Business Implication Since the coming into force of the Treaty for the Establishment of the East African Community tariffs for a large number of industrial and agricultural goods have declined significantly. The Partner States have initiated the conversion of all non-tariff import restrictions to tariffs paving way for their gradual decline. This ordinarily would mean an increase in market access for both agricultural and industrial products. However the success of EAC in reducing tariffs has been countered by the emergence of new non tariff barriers through SPS measures and technical regulations hindering exports of agriculture and food products. SPS regulations occupy a particularly relevant place in the regulators agenda because their primary aim is to protect citizens from everyday food hazards. Compliance with SPS guidelines therefore constitutes a basic requirement for any exporter seeking increased market access for agricultural products in the regional and international trading system. Several exports from East African countries also often suffer rejections in foreign countries, due to non-compliance with importing country SPS regulations. Failures of food safety and quality systems often have devastating impacts on a country s exports. There are numerous examples of products such as fish, milk, day old chicks, and maize flour from East African countries that have been banned in some countries due to failure to meet food safety requirements. These bans cost millions of dollars in lost income for the exporters. Regional standards harmonization and collaborative capacity building offers considerable opportunities for East African countries in efforts to build modern and sustainable systems of standards and SPS infrastructure. Regional cooperation is one way to reduce the disparities in control, capacities and resources among East African countries. This may be achieved through enforcing regional quarantines and the control of smuggling of potentially harmful products at boarder points. More importantly, through regional co-operation, countries have the opportunity to reduce costs of implementing the SPS measures by operating regional testing and laboratory facilities. This would reduce on the number of inspections for export, costs and the time cargo spends in bonds going through numerous checks and time scheduled shipments. Furthermore, through regional cooperation, there is an opportunity to improve the individual standardization and SPS regulatory systems, coordinate their operations, and even harmonize the procedures and policies among the different countries in the region. Lastly, by EAC countries adopting harmonized rules and procedures on SPS and standardization issues, exporters of products in the different Partner States benefit from the elimination of unjustified barriers to their products. This reduces uncertainty about the conditions for selling to a specific market. Efforts to produce safe products for another market should not be thwarted by regulations imposed for purely protectionist purposes under the guise of health or other unjustified policy measures. 12

26 EAC Legal Regime on Sanitary and Phytosanitary Measures EAC Protocol on Sanitary and Phytosanitary Standards The EAC SPS Protocol was developed in line with Article 108 of the EAC Treaty which requires the Partner States to harmonize sanitary and phytosanitary measures for pest and disease control. Taking cognizance of the above provisions of Article 108 of the EAC Treaty, Article 38 of the Protocol on the Establishment of the East African Customs Union requires Partner States to co-operate in several areas including sanitary and phytosanitary measures. The Partner states are required under paragraph 1 of Article 151 of the Treaty; to conclude such Protocols as may be necessary in each area of co-operation, which shall spell out the objectives and scope of, and institutional mechanisms for, co-operation and integration. It is in line with the above requirements of the EAC treaty and the Customs Union Protocol that the SPS Protocol was developed. The primary objective of the EAC SPS Protocol is to adopt and enforce SPS measures in order to minimize their negative effects on trade. The Protocol elaborates rules for application, which relate to the use of SPS measures, and recognizes the rights of importing countries to implement these measures. Key Features The Protocol was developed basing on the WTO SPS guiding principles which include: a) Measures must be based on Science For an SPS measure to be valid under the EAC SPS Protocol, it must respect the necessity requirement. Necessity is defined by reference to science. As such, measures must applied only to the extent necessary to protect human, animal, and plant life or health and must be based on scientific principles and not maintained without sufficient scientific evidence. Under the EAC SPS protocol, only measures that ensure food safety and protect the health of animals and plants are to be enforced in the EAC, the decision as to which measure passes the criteria is to be reached based as far as possible on the analysis and assessment of objective and accurate scientific data. This is necessary to businesses to avoid disguised trade obstacles as one illustrated in example 1 and safeguard safety and health as illustrated in example 2. Example1: Country A adopts an SPS measure on maize, requiring that maize imports only come from farms that practice a certain type of crop rotation. There is no scientific evidence that crop rotation affects the safety of corn consumers, so this measure is not permitted under the rules. Example 2: County A adopts an SPS measure on eggs, requiring that imported eggs be stored below a certain temperature. There is scientific evidence that storage practices affect the safety of eggs, so this regulation is permitted under the SPS rules b) Harmonization Article 6 of the Protocol requires Partner States to establish SPS measures consistent with international standards, guidelines and recommendations, where they exist. This process is often referred to as harmonization. Harmonization between 13

27 states is to be promoted by following the standards set by international scientific organizations. Such standards are developed by leading scientists in the field and government experts on health protection and are subject to international scrutiny and review. The advantage to be enjoyed by the business community in EAC as a result of harmonizing local standards with international ones is illustrated in the example below: Example: Country A, Country B, and Country C adopt SPS measures on coffee imports that are in harmony with international standards. This allows coffee growers in Country D to export coffee to each of these countries without worrying about safety. Common standards make trade easier between countries. In addition, the Protocol requires Partner States to adopt and implement the Community Harmonized SPS Measures including other relevant harmonized documents to be developed from time to time. c) Equivalence Under Article 7 of the protocol, the Partner States agree to comply with the equivalence provisions of the WTO SPS Agreement. The concept of Equivalence recognizes that different methods may be used to achieve the same level of health protection. If an exporting country s measures can achieve the importing member s appropriate level of SPS protection, then those measures may be acceptable, even if they differ from those used by the importing country. In other words, the important factor is meeting the importing countries SPS protection requirements rather than the means by which it is achieved. This concept also serves as a basis for bilateral and multilateral agreements among trading partners on the basis of equivalence referred to as Mutual Recognition Agreements. The example below illustrates the benefits that come with implementing the equivalency provisions of the protocol. Example: Country A imports frozen chicken from Country B. Country B s SPS measures are different from Country A s SPS measures, but they achieve the same level of SPS protection. The rule of equivalence requires that country A accept Country B s frozen chicken exports without demanding that County B undertake additional safety requirements. d) Assessment of Risk The protocol requires Partner States to establish SPS measures basing on an appropriate assessment of the actual risks involved, and, if requested, make known what factors they took into consideration, the assessment procedures they used and the level of risk they determined to be acceptable. The level of protection or risk relates to the likelihood or probability of an adverse health effect resulting from a particular activity. For example, a level of protection or risk might be expressed as a risk of 1 in 1 million, meaning that out of every 1 million humans in the relevant population, one person could be expected to suffer the adverse health effect from consuming a product that is contaminated with a food hazard or coming in contact with an animal infected with disease causing organisms. A proper risk assessment must therefore evaluate the likelihood, i.e., the probability, of entry, establishment or spread of diseases and associated biological and economic consequences as well as the likelihood, i.e., probability, of entry, establishment or spread of diseases according to the SPS measures which might be applied. 14

28 Having assessed the likelihood or probability of entry or spread of disease and the associated consequences, a Partner State must then determine the level of risk that its society can live with and in so doing, it defines the level of protection it deems appropriate. The level of protection is therefore the goal the Member seeks to achieve in terms of health protection. SPS measures on the other hand are the means to achieve that goal. e) Adaptation to Regional Conditions Due to differences in climate, existing pests or diseases, or food safety conditions, it is not always appropriate to impose the same sanitary and phytosanitary requirements on food, animal and plant products coming from different countries. Therefore, SPS measures sometimes vary depending on the country of origin of the food, animal or plant product concerned. This is taken into account in the EAC SPS Protocol. Partner States commit themselves to recognize disease free areas which may not correspond to political boundaries, and appropriately adapt their requirements to products from these areas. In addition, the Protocol requires partner states to adopt, maintain or apply different risk assessment procedures for a pest free or disease free areas other than for an area of low pest or disease prevalence. f) Transparency Partner States are required to notify each other of any new or changed SPS requirements which affect trade. They also must open to scrutiny how they apply their food safety and animal and plant regulations. In addition, Article 8 (2) of the Protocol requires a Partner States proposing to adopt or modify an SPS measure of general application at the community level to publish a notice and inform other partner states of the proposed measure and identify in the notification the commodities to which the measure would apply, together with a brief description of the objective and reason for the measure. The partner State is also required to identify any provision in the measure that deviates in substance from relevant international standards, guidelines or recommendations. Such increased transparency protects the interests of consumers, as well of the Partner States, from hidden protectionism through unnecessary technical requirements. g) Consultation and Dispute settlement The protocol has provisions on settlement of disputes among Partner States. Where a dispute arises between the Partner States, the first course of action is consultations with a view of finding an amicable resolution. The Partner States shall use the dispute settlement mechanism provided by the WTO SPS Agreement where amicable solution has not been found through consultations. h) Institutional framework The Protocol lays out an elaborate institutional framework to manage SPS issues in the Community. It establishes a Committee known as the East African Community Sanitary and Phytosanitary Committee whose function is to oversee the implementation of this Protocol, and coordinate activities related to the management of sanitary and phytosanitary measures within the Community. The Protocol also requires Partner States to form National Sanitary and Phytosanitary Measures Committees or their equivalent to be made up of National Sanitary and Phytosanitary experts. The basic function of these committees is to oversee the implementation of the Protocol at the national level. 15

29 EAC Harmonized SPS Measures Pursuant to the provisions of Article 108 of the EAC treaty which requires the Partner States to harmonize SPS measures for pest and disease control, the EAC states intend to effectively implement the SPS protocol. The protocol under Article 6 requires Partner States shall adopt and implement the Community Harmonized SPS Measures for, plant health, animal health and fish and fishery products as its annexes which lay the specific procedures for implementing its provisions. The same Article 6 of the Protocol empowers the EAC to develop other harmonized measures and documents necessary to protect health and promote regional trade. Under this provision, the EAC is developing food safety measures to harmonize the way food is produced and traded to safeguard safety of consumers and reduce of trade obstacles related to varying conformity assessment procedures by EAC member states. Harmonization of SPS is an essential requirement towards greater economic integration since it encourages a free flow of goods and services within the community. Harmonization of SPS measures also protects health and safety of consumers, animals, plants and the environment in general. The measures that have so far been harmonized are: 1. Harmonized Phytosanitary measures and Procedures for plants Vol.1 2. Harmonized sanitary measures and procedures for Mammals, Birds and Bees. Vol. II 3. Harmonized Sanitary measures and procedures for Fish and Fishery Products Vol. III 4. Harmonized measures on food safety Vol. IV (by the time this guide was developed was being developed). Below, the content and procedures set by each of the three volumes are separately outlined Harmonized Phytosanitary Measures and Procedures for Plants Vol.1 These measures were prepared to prevent the spread, establishment and introduction of pests within the Community. These measures provide for common and harmonized: Inspection and certification procedures for plants and/or plant products Plant quarantine measures Regulation of importation, research, development and use of Living Modified Organisms and products of modern biotechnology. Safe movement of plants and plant products Systems for pest surveillance, pest listing, pest risk analysis, pest reporting, and designation of pest free areas and areas of low pest prevalence Requirements for importation and exportation of plants and plant products Import Regulations Under the aforesaid measures, before importation of a plant or plant product, a trader must first obtain a Plant Import Permit from the National Plant Protection Organization (NPPO) of the importing Partner State. A Pest risk analysis is then carried out as required under the International Standards for Phytosanitary Measures (ISPMs). Imported materials must be accompanied by a Phytosanitary Certificate from the country of origin certifying that the conditions 16

30 stipulated in the Plant Import Permit have been met, which will be verified by the Plant Health Inspectors at the port of entry. If the imported materials are found to have a low risk, the importer will be advised by the Plant Health Inspectors to pay a fee charged at an on-going rate. All plant imports into community must meet the EAC quality standards. These standards are enforced through inspections of plant imports by the respective Bureau of Standards at the ports of entry. Export Requirements Under the measures, before exporting a plant or plant product, an exporter must first obtain plant import permit from the NPPO of the country of import and provide same permit to the NPPO of the exporting country; Inspection of the plants and / or products shall them be carried out as prescribed in the import permit; The Exporter must then obtain a phytosanitary certificate. This should be done not more than 14 days prior to shipment. The phytosanitary certificate essentially stipulates the quality and health standards required by the country of import and is obtained by the exporter for use during the importation of the plant material. Further details on import and export requirements for plant and plant products can be obtained from the offices listed below: Kenya: Kenya Plant Health Inspectorate Service (KEPHIS) P. O. Box 49592, NAIROBI KENYA Tel /2 Fax: director@kephis.org United Republic of Tanzania: (a) Ministry of Agriculture Food Security and Cooperatives Plant Health Services P.O. Box 9192, DAR ES SALAAM TANZANIA Tel Fax: pps@kilimo.go.tz (b) Ministry of Agriculture, Livestock and Environment Plant Protection Division, P. O. Box 1062, ZANZIBAR Tel/fax: ppdznz@zanlink.com Rwanda: Ministry of Agriculture and Animal Resources Rwanda Agricultural Development Authority Plant Protection Unit PO BOX 538, KIGALI, RWANDA Tel : (+250) info@rada.gov.rw Uganda: Ministry of Agriculture, Animal industry and Fisheries (MAAIF) Department of Plant Protection P.O Box 102, Entebbe Tel: (+256) / Burundi: Ministry of Agriculture and Livestock Department of Plant Protection P.O. Box 114, Gitega BURUNDI Tel: dpvbdi@yahoo.fr 17

31 Harmonized Sanitary Measures and Procedures for Mammals, Birds and Bees. Vol. II This particular volume contains sanitary standards for breeding cattle and poultry, artificial insemination centers, multiplication units and hatcheries, and measures for importation of ducks, slaughter cattle, sheep, goats, pigs, camel, donkeys, horses, dogs and cats. The document sets out the minimum conditions to be followed by importers and exporters of animals and animal products wishing to trade with/within EAC Partner States. Import requirements An importer must apply and collect an import permit from the veterinary administration of the respective Partner State. An importer is then required to fill out an application for the import permit in the format set out in the prescribed forms which have to be signed and attested to by an authorized veterinary officer of exporting country. The application for import permit must provide the following information; a) Name and address of importer b) Name and address of exporter c) Name and address of the semen/embryo collection centre. The centre must be licensed to operate by the Veterinary authority of the exporting Country. d) Country of origin, port of entry, means of transport, packaging and quantity e) The species and type of animal. An import permit is issued for a single consignment only and for a given timeframe. The permit will specify all the tests and conditions that must be fulfilled by the exporter and Veterinary authorities of the exporting country. In order to facilitate importations of animal and animal products in EAC region, models of harmonized import permits have been developed to be adopted by member States. Annex 2(a): Model permit for importation of bovine semen, embryos/ova Annex 2(b): Model permit for importation of poultry, day old chicks and hatching eggs Annex 2(c): Model permit for importation of ducks, day old ducklings and hatching eggs Annex 2(d) Model permit for importation of trade cattle for slaughter Annex 2(e) Model permit for importation of breeding cattle Annex 2(f) Model permit for importation of breeding sheep and goats Annex 2(g) Model permit for importation of trade goats and sheep for slaughter Annex 2(h) Model permit for importation of breeding pigs Annex 2(i) Annex 2(j) Model permit for importation of trade pigs slaughter Model permit for importation of camels Annex 2(k) Model permit for importation of equines Annex 2(m) Model permit for importation of dogs and cats 18

32 Annex 2(n) Model permit for importation of veterinary vaccines Annex 2(p) Sanitary standards for importation of meat, meat products and meat by-products All imports of animal and animal products in EAC region must meet the harmonized EAC sanitary standards prescribed in the regulations. The standards prescribed in these regulations apply uniformly throughout the East African Community Partner States. Non compliance with these standards amounts to a violation of the laws and regulations controlling animal diseases of the country where the offence/violation occurs. The standards set out in this volume conform to the international standards spelt out by the OIE or World Animal Health Organization and the Codex Alimentarius to which all the EAC partner States are signatories. Further details can be obtained from the listed offices below: KENYA -COMPETENT AUTHORITIES 1. Department of Veterinary Services in the Ministry of Livestock Development; 2. Codex Contact Point in the Kenya Bureau of Standards; TANZANIA - COMPETENT AUTHORITIES Director of Veterinary Services Ministry Of Livestock Development & Fisheries P.O. Box 9152, Dar, Tanzania Tel: dvs@mifugo.go.tz ZANZIBAR - COMPETENT AUTHORITIES Director-Department of Livestock Ministry of Agriculture, Livestock & Environment P.O. Box 159-Zanibar TEL: kilimo@zanlink.co RWANDA SANITARY EXPERT COMPETENT AUTHORITIES Veterinary Services Unit RARDA (Animal health & Fisheries infection) Ministry of Agriculture and Animal Resources P.O. Box 602, Kigali, Rwanda BURUNDI COMPETENT AUTHORITIES Ministry Of Agriculture and Livestock Department Of Animal Health P.O. Box 227, Bunjumbura, Burundi Phone: Fax: UGANDA CONTACT POINT Ministry of Agriculture, Animal Industry and Fisheries Department of Livestock Health and Entomology P.O Box 102, Entebbe Asst. Commissioner for Entomology Tel: (+256) It should however be noted that these measures were being updated by the time this guide was developed. It is therefore important to contact the addresses mentioned above or cross-check with the updated measures to determine the currently required conditions or procedures when planning to import or export animals within and out of the region. Harmonized Sanitary Measures and Procedures for Fish and Fishery Products Vol. III These measures were prepared to protect aquatic animal or human health or life within the Community and to enhance trade in fish and fishery products within the EAC and beyond. This is to be achieved through common and harmonized: Inspection and certification procedures for fish and fishery products Policies, legislation and regulations for management of fish and fishery products; 19

33 Safe movements of fish and fishery products; Systems for surveillance of aquatic animal disease. Requirements for importation and exportation of fish and fishery products Section of the regulations requires Partner States to immediately notify each other of fish disease outbreaks and other fish and fishery products hazards in their territories. Each Partner State is required to designate a Competent Government Authority to be responsible for the supervision and implementation of fish health and welfare measures, international veterinary certification and other standards and recommendations in the Aquatic code in the whole territory. The respective competent authorities in each Partner State are: KENYA -COMPETENT AUTHORITIES Department of Fisheries in the Ministry of Fisheries Development; TANZANIA - COMPETENT AUTHORITIES Department of Fisheries, Ministry of Livestock Development & Fisheries P.O. Box 9152, Dar, Tanzania Tel: Dvs@Mifugo. Go.Tz RWANDA COMPETENT AUTHORITIES RARDA (Animal health & Fisheries infection Ministry of Agriculture and Animal Resources P.O. Box 602, Kigali, Rwanda BURUNDI COMPETENT AUTHORITIES Department of Fisheries and Fish Farming Ministry Of Agriculture and Livestock P.O. Box 161, Gitega, Burundi Phone: / Fax: UGANDA CONTACT POINT Department of Fisheries Resources, Ministry of Agriculture, Animal Industry and Fisheries P. O Box 4, Entebbe, Uganda Tel: (256) /04 Under the harmonized measures Partner States are also required to have harmonized and transparent procedures for carrying out risk analysis with the objective of assessing disease risks associated with importation of fish and fishery products. Partner States are also required to base their import requirements for fish and fishery products on the OIE standards to maximize harmonization of the aquatic animal health aspects of regional and international trade. OIE standards are developed by the World Animal Health Organization. Harmonized Measures for Food Safety These measures are being developed with the objective of establishing a regionally harmonized, coordinated and integrated approach to achieve food safety s dual mandate of ensuring consumer protection and facilitating intra-region and international trade. They aim at facilitating intra-eac region cross-border trade envisaged in the East African Common Market Protocol and in accordance with draft EAC SPS protocol. The proposed measures recognize the linkage between food safety and Animal and plant health. Therefore where necessary, they are expected to cross-reference with the existing harmonized measures for animal and plant health and fish sanitary measures, and the draft protocol establishing EAC Commission on Medicines and Food Safety. The proposed are measures are expected to lay out strategies for food operators to gradually achieve requirements of ISO standard by encouraging adoption of a HACCP approach. The measures are 20

34 to be consistent with WTO/SPS agreement and other requirements for trade with the region s international trade partners such as the EU, US, among others. They seek to adopt international guiding principles of Farm-to-Fork approach, Precautionary approach, Risk Analysis, Transparency and Traceability among others by addressing major issues hindering trade among EAC states. Such issues being addressed by the measures include: inadequate coordination in enforcement of laws covering entire food chain; development of science-based food control systems while recognizing the state of economies of member countries; instituting proper verification and validation systems such as inspection, testing, and certification for compliance with recommended food safety practices in entire food chain; Traceability of products including the institution of appropriate crisis management systems such as product recall; establishing a food safety alert system and response mechanisms and information exchanges within agencies, the chain players and trade partners at regional, national and enterprise level. 21

35

36

37 Standardization and Technical Regulation Issues

38

39 Standardization and Technical Regulation Issues Standards and technical regulations are documents that list the commonly accepted guidelines, rules and criteria that help determine if a product, process or service is suitable for its intended purpose. If they are clearly defined and easily accessible, standards and technical regulations enable companies to communicate quality requirements with their suppliers and customers precisely, consistently and efficiently. Whereas most standards are voluntary, technical regulations are typically mandatory. Types of Standards There are two types of standards: (i) product related standards that define the physical characteristics of the final product and (ii) process and production method (PPM) standards which specify the norms relating to how goods should be produced. PPM standards apply before and during the production stage, i.e. before the product is placed on the market. International Rules Governing Standardization International rules on the application of mandatory standards are contained in the Agreement on Technical Barriers to Trade (TBT). The Agreement uses the term technical regulations to cover standards with which compliance is mandatory and the term standard is used to cover standards used on a voluntary basis. Both terms cover: Product characteristics including those relating to quality Process and production methods (PPMs) that have an effect on the product characteristics; Terminology and symbols; and Packaging and labeling requirements as they apply to the product. The TBT Agreement provides that mandatory standards (read technical regulations) should not be applied by countries as to cause unnecessary obstacles to international trade. The agreement assumes that this aim can be attained if countries use, wherever appropriate and possible, international standards in formulating their technical regulations or in developing voluntary national standards. Likewise, it calls on member countries to use guidelines and recommendations developed by international standardization organizations as a basis for testing of products for conformity with quality standards. To provide an incentive to countries to use international standards, the Agreement provides that where international standards or guidelines have been used as a basis for a technical regulation, it shall be presumed that they do not create unnecessary obstacles to trade. It further urges member countries to participate in the work of international standardization organizations. The main organizations developing international standards applicable to industrial products are the following: International Organization for Standardization (ISO); International Electro technical Commission (IEC); 26

40 International Telecommunication Union (ITU); and Codex Alimentarius Commission Where international standards or guidelines are considered ineffective or inappropriate for the achievement of national objectives (for instance, because of fundamental climatic or geographical factors, or fundamental technological problems) or where international standards do not exist, countries are free to develop their own national standards. However, in all cases where such proposed measures are expected to have a significant effect, the Agreement imposes an obligation on countries to; Publish in draft form the proposed technical regulations, standards and the conformity assessment systems; Give reasonable opportunity to other international parties to comment on these drafts; and Take into account these comments in finalizing the drafts. Specific Rules In order to ensure that technical regulations as well as voluntary standards do not create unnecessary barriers to trade, the Agreement further lays down certain principles and rules. These call on regulatory agencies to ensure that technical regulations and standards: Are applied so as not to discriminate among imported products by origin (MFN principle) Do not treat imported product less favorably than domestically produced products (national treatment principle); Are, where relevant, based on scientific and technical information and Are not formulated or applied in a manner as to cause unnecessary obstacles to international trade. The Agreement lays down specific guidelines for regulatory authorities in formulating technical regulations, in order to ensure that these regulations do not create unnecessary obstacles to trade (see box

41 Box Guidelines for determining whether technical regulations have an effect of creating unnecessary obstacles to trade The Agreement on TBT provides that technical regulations which lay down product standards as well as packaging, marking and labeling requirements should not ordinarily be considered as causing unnecessary obstacles to trade if: They are adopted to achieve legitimate objectives; They are based on international standards; and Where international standards are considered inappropriate or do not exist, the technical regulations are applied so that they - are not more restrictive than necessary to fulfill the above legitimate objectives and - take into account the risks non-fulfillment (of these objectives) would create. The legitimate objectives for which countries can adopt technical regulations include: National security requirements The prevention of deceptive practices Protection of human, animal or plant life or health, or the environment In light of these provisions, whether a technical regulation that is not based on international standards can be considered an unnecessary obstacle to trade would depend firstly on the objectives for which it has been adopted. If it has been adopted to attain one of the abovementioned legitimate objectives, the next question to be examined is whether the regulation is more restrictive than is necessary for the achievement of the objective, and whether, if a less trade restrictive measure were adopted, there were risks of non-fulfillment of the objective. In assessing the risks of non-fulfillment, the elements to be considered are: Available scientific and technical regulations Related processing technology; or The intended end use of a product. 28

42 Code of Good Practice for voluntary standardization Many of the standards used by industries are voluntary standards. These are often formulated by national standardizing bodies in various partner states. Voluntary standards can create problems in international trade if they vary widely from country to country. The Code of Good Practice for the Preparation, Adoption and Application of Standards, an integral part of the Agreement on TBT, therefore urges countries to use their best endeavors to require national standardizing bodies to use the same principles and rules in applying voluntary standards as are laid down for mandatory standards. Conformity Assessment Procedures Conformity assessment procedures are procedures used, to determine that relevant requirements in technical regulations or standards have been fulfilled. Access to conformity assessment services enables firms to demonstrate that they comply with relevant market requirements. Depending on the sort of standard or technical regulations, conformity assessment services may be provided by laboratories and testing facilities with specialized metrology equipment. In developing countries, conformity assessment services are largely provided by state-sponsored firms/institutions. The assessment of conformity to set standards by using a neutral third party may take the following forms: Testing of products; Certification of products after inspection; Assessment of quality management systems; and Accreditation procedures. Testing of products The first form of conformity assessment is product testing, generally carried out by independent testing laboratories. The International Organization for Standardization (ISO) defines a test, in the context of conformity assessment, as a technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure. Testing services thus includes a broad spectrum of technical activities. Materials, parts and completed products may be tested for their physical properties, such as strength and durability. Certification of products after inspection The second form of conformity assessment is certification. Again ISO defines certification as a procedure by which a third party gives written assurance that a product, process or services conforms to specified requirements. Certification always measures a product or service against one or more specific standards. Certification results in a formal statement of conformity- a certificate- that can be used by the manufacturer to show compliance with regulations. Certification gives confidence to the customer on account of the systematic intervention of a competent body. In EAC most certification bodies are public institutions, such as NSBs. In addition to providing testing services, many of these laboratories take the additional step of certifying the product as meeting a particular standard. Quality management systems The third form of conformity assurance is assessment by a third party of the producer s quality management system. While 29

43 testing and certification aim at evaluating the quality of the products themselves, the assessment of the quality assurance system by a third party aims at assuring the consumer that the manufacturer has in place a viable and effective system that is capable of producing products of consistent quality. The best known quality assurance system is the ISO 9000 series of standards. Developed by ISO, the system lays down the documentation procedures and records that a company should maintain in order to demonstrate to, and assure, its clients and purchasers that adequate attention is being paid to the maintenance of the quality system. Accreditation procedures Accreditation is a process or procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific task repetitively and consistently. Supplying industries as well as clients are likely to have confidence in conformity assurance systems if the competence of the testing laboratory or product certifier is accredited by an independent technical body. Accreditation is an essential process guaranteeing that particular standards are being met with regard to certification activities. This is particularly important in countries where there are a large number of certification bodies and testing laboratories. 30

44

45 EAC Initiatives on Standardisation

46

47 EAC Initiatives on Standardisation EAC Protocol on Standardization Quality Assurance, Metrology and Testing Under the provisions of Article 81 of the EAC Treaty Partner States recognize the significance of standards and technical regulations in the enhancement of standards of living, reduction of unnecessary trade obstacles related to variety of products, consumer protection, promotion of health as well as protection of life, property, and the environment. The Partner States expressed their commitment to evolve a common policy on standardization, quality assurance, metrology and testing (SQMT) of goods and services produced and traded within the community. The Partner States also agreed to conclude a common protocol on SQMT for goods and services produced and traded within the community. Article 38 of the Customs Union Protocol takes cognizance of the above provisions of the treaty on areas of co-operation including; standardization, quality assurance, metrology and testing. It also requires partner states to conclude protocols which spell out the objectives, scope of co-operation and institutional mechanisms for co-operation in the area of SQMT among others areas. It is in line with the above requirements of the EAC treaty and the Protocol, the SQMT Protocol was developed. The protocol was signed in 2001, as part of a broader trade agreement signed by the original three EAC countries of Uganda, Kenya and Tanzania two years earlier. 4 Under this protocol, the countries agreed to apply a common policy on standardization; metrology and conformity assessment of goods produced and traded within the Community. 5 The protocol lays down the principles for cooperation among the three member states and defines their obligations in various spheres. 6 Under the protocol, the Partner States countries committed to, among other things; applying uniform rules and procedures for the formulation of national standards; adopting and implementing East African standards as national standards 7 (East African standards would be drawn from those adopted by the African Regional Organization for Standardization and, where these are not available, suitable international standards); harmonizing procedures for sampling and testing of products for conformity with quality standards 8 ; and adopting a harmonized system for legal, scientific, and industrial metrology. 9 The protocol also provides the institutional framework to give effect to the provisions of the treaty. This institutional framework is well elaborated in the SQMT Act discussed below. Note: This Protocol applies to all products whether manufactured, produced, or packaged within the community or in a third country and traded within the community. It also applies to services offered in the manufacture, production, handling, packaging or delivery of products traded within the community and the natural environment in the community. The Protocol however does not apply to goods in transit through the community from the country of origin to a third country. 4 EAC East Africa Community Protocol on Standardization, Quality Assurance, Metrology, and Testing See Preamble to the Protocol. 6 Art 3 of the Protocol. 7 Art 4.1 of the Protocol. 8 Art 4.2(a) of the Protocol. 9 Art 4.5 of the Protocol. 34

48 The EAC Standardization, Quality Assurance, Metrology and Testing Act. This Act was developed in line with the EAC protocol on SQMT which provides for regional cooperation in the areas of standards, metrology, conformity assessment, accreditation and technical regulations. The Act is meant to facilitate industrial development and trade and to ensure the protection of health and safety of society and the environment within the community. The Act establishes three administrative structures at the community level. These are: a) The East African Standards Committee (EASC). This committee coordinates all activities related to standardization, metrology and conformity assessment and monitors their implementation at national and community levels. The committee is comprised of two chief executives from the national quality system institutions, from each partner state, one representative of the private sector testing laboratory and certification organizations from each partner states and two representatives of national manufacturing associations, trading associations and consumer organizations from each partner state. b) A liaison office. This office provides administrative and logistical support to the EASC particularly in the design and management of community projects for implementation of regional standards and procedures. c) The East African Accreditation Board. This board facilitates cooperation and coordinates accreditation activities to avoid duplication of functions of national accreditation bodies and national focal points. It is important to note that the SQMT Act also provides for the development of East African standards. The standards are to be developed jointly by the national standards bodies of the partner states in accordance with the procedures approved and maintained by the EASC. The EASC, may however for purposes of urgency develop and approve a normative document to serve as an East African Standard. A normative document means a document developed and approved by the Committee, that resembles an East African Standard, but which for reasons of urgency, cost, or expediency, has not achieved the same degree of consensus as an East African Standard. Such a document is developed for purposes of urgency in place of an East African Standard. It is ad-hoc and only valid for 2 years. In as much as possible, all national technical regulations should be modeled on East African standards. Section 19 of SQMT Act gives the Council of Ministers powers to declare an East African Standard or a provision of that standard to be a compulsory throughout the Community. A compulsory standard is one whose compliance with is obligatory. In other words, no person is allowed to manufacture, sell, trade or distribute any product that does not conform to the requirements of such standard. This is often done to prevent deceptive practices, protect human, animal or plant health. 35

49 Under the Act, suppliers of products or processes over which a compulsory standard is applicable must procure conformity assessment services to demonstrate compliance with the compulsory standard, from the registered national conformity assessment service providers. As earlier explained, conformity assessment services are technical services, such as testing, inspection and certification which confirm that the products fulfill the requirement laid down in the standard. Generally, suppliers of the product bear the cost of this service. Under Section 21 of the Act each partner state is required to register technically competent national conformity assessment service providers including inspection agencies, test laboratories and certification organizations to provide services in support of the implementation of compulsory standards in its territory. The Act also contains important provisions on product certification marks. A certification mark is a mark given by a third party affirming that a product, process or services conforms to specified requirements The Act requires Partner States to recognize as equal to their own product certification marks awarded by national quality systems institutions of other Partners States. There are however a set of stringent requirements that have to be fulfilled for this to happen. These include: a) The product certification mark has to be established and appropriately registered to confer protection similar to trade marks b) The product certification mark must not be identical to or so nearly resembling any trade mark registered under the trade law of any partner state. c) The product to which the certification mark is attached must comply with the relevant standard. Mutual recognition of product certification marks by partner states will go a long way in reducing the costs of redundant re-testing and re-certification of products since a product that is tested in one of the Partner States will be accepted in the markets of the other trading partners. 36

50 Summary of EAC SQMT - Structures Treaty for the Establishment of the East African Community (2000) Article 81 Standardization, Quality Assurance, Metrology, Testing Protocol on Standardization, Quality Assurance, Metrology and Testing (2001) The East African Community Standardization, Quality Assurance, Metrology and Testing Act 2006 East African Standards Committee (EASC) (sectoral committee consisting of Heads of NSBs and others reporting to Council of Ministers through the Coordinating Committee of Permanent Secretaries) EAC Standards Technical Sub-Committee (1996) EAC Metrology Technical Sub-Committee (2002) EAC Quality Assurance & Accreditation Technical Sub-Committee (2004) EAC Testing Technical Sub-committee (2004) Existing or envisaged regional activities Guidelines and Procedures for Developing EAC Standards The East African Standards Committee has well laid out guidelines and procedures for the development of East African Standards. These procedures lay down the basic principles and mechanisms by which the Committee and the Partner States are to develop and publish EAC Standards. How are EAC standards developed? EAC standards are developed according to the following basic principles: Consensus, the view of all stakeholders are taken into account. Wherever possible, source documents to establish EAC standards shall be international standards. It is only in absence of suitable international standards, that a national standard of one of the Partner States may be used. The procedures also lay out the different stages in the preparation and harmonization of standards and the roles and responsibilities of the different bodies and institutions involved in the standardization process both at the Community level and the national level. It is important to note that the private sector is actively involved in the process of formulating and shaping standards which ultimately form the basis of much of the technical regulations. The East African Standards Committee which is primarily responsible for developing EAC standards has got representatives from private sector testing laboratories and certification organizations from each partner states and two representatives of national manufacturing associations, trading associations and consumer organizations from each partner state. 37

51 Stages in the preparation and harmonization process A complete list of project stages, together with the designations of associated documents is given in the table below: Proposal Stage The NSB receives a proposition for a new work item or a harmonized standard and decides either to prepare a formal New Work Item proposal for submission to the EASC or not. A proposal for a work item may be initiated by anybody (institutions, associations, organizations industry e.t.c). New Work Item Proposals should be informed (guided) by Trade data e.g. needs of the industry; National Government priorities; EA Council of Ministers priorities; Security and safety considerations e.g. technical regulations; and Export promotion legislation. A New Work Item Proposal can also be generated at the level of the Council of Ministers in which case the EASC allocates the development of the formal proposal to a specific NSB. Preparatory Stage A working document or draft is developed by the Project Secretariat should no international or regional standard be readily available. Committee Stage At this stage, comments on committee draft from NSBs are received and consensus built for progression of the draft to the enquiry stage. Approval Stage At this stage, the Final Draft Harmonized Standard is reviewed and approved by the EASC and subsequently endorsed by the Council of Ministers and gazette as an EAC standard. 38

52 EAC Harmonized Standards In line with the above policies and procedures, the EASC has developed a large number of harmonized standards for the Partner States. 10 These standards have been developed through consensus by industry, government agencies, research organizations, universities, private organizations, e.t.c. Most of the standards relate to product specifications, that is defining food product in technical or other terms. A number of these food-related standards cover sampling and testing methods, labeling and other matters that might truly affect trade. Agro-food Standards Harmonized under the EAC Product Covered by Standards Number of Type of Standards Standards Processes in the food industry 2 Code of practice, HACCP General methods of tests and 9 Specifying methods for different analysis for food microbiological testing Cereals, pulses and derived 25 Specifications/methods of products testing Fruits, vegetables 27 Specifications, sampling and method of testing Milk and milk products 24 Specifications, methods of microbiological testing and analysis Meat, meat products and other 4 Specifications/methods for animal produce nitrogen analysis Beverages 18 Specifications/methods of testing Tea, Coffee, Cocoa 5 Specifications Sugar, Sugar products, starch 18 Specifications/methods of chemical analysis Edible oils and fats, oil seeds 28 Specifications, sampling methods, determination of level of certain metals Code of hygiene for transportation of edible fats and oils Prepackaged and prepared foods 2 Specifications, labeling Animal feeding stuffs 23 Specifications, methods of testing 10 Kibriti O (2005) Towards Harmonized Standards, Quality Assurance, Metrology, and Testing, and Sanitary and Phytosanitary Measures for Enhanced Trade. A Paper Prepared for the East African Community and the Common Market for East and Southern Africa, Nairobi, Kenya, April

53 The Liaison office is responsible for maintaining a catalogue of all East African Standards and normative documents. These are maintained in hard and electronic copies and the same are to be made available to the public. Already there are over 1080 standards in the EAS Catalogue with over 700 standards regarding food, animal and plants or their products. The catalogue is obtainable free of any charge from the respective National Bureaus of Standards in each of the EAC Partner States. The texts of the standards can also be obtained from the said National Bureaus of Standards at a fee. Further details and information can be obtained from the listed offices below: Burundi Bureau of Standards (BBN) P.O.Box 3535, Bunjumbura, Burundi Phone: Fax: Bbmzime@Yahoo.Fr Rwanda Bureau of Standards P.O.Box 7099, Kigali Kenya Bureau of Standards Head Office Kapiti Road, Off Mombassa Road, Nairobi Tel: ; /1. Tanzania Bureau of Standards Headquaters Morongo Road, Dar Es Salaam, Ubungo Area Tel: Or Uganda National Bureau of Standards Plot No. 217 Nakawa, Industrial Area Kampala, Uganda Tel:

54

55 Frequently Asked Questions (FAQ)

56