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III. Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS) and Agreement
on Technical Barriers to Trade (TBT)



Food Control: Fish as Food

C.A. Lima dos Santos
Fishery Industry Division


The objective of this module is to review the basic requirements and elements of a national fish inspection system. Common difficulties are identified and benefits are described. Up-to-date concepts, principles and methods are introduced. The importance of government, industry and consumer collaboration to achieve national goals for better consumer protection and economic advancement through trade in safe and quality fish and fishery products are emphasized.


14.1 Introduction

14.2 Safety of fish as food

14.3 Control of fish as food for consumer protection and its limitations

14.4 Factors promoting change in fish inspection systems

14.5 What is "equivalence"? CODEX approach

14.6 Conclusions and recommendations



The importance of trade in fish as food for developing countries

Developing countries are responsible for more than 50 percent of fish and fishery products involved in international trade. Almost all developing countries export some fishery products and for most of them the revenue from these exports is a major source of foreign currency. The European Community, Japan and the United States account for about 80 percent of world fish and fishery product imports. They dominate the market both in terms of prices and quality requirements.

Difficulties faced by developing countries

In the international market of fish and fishery products, one of the most serious difficulties faced by exporters from developing countries consists in the different standards and regimes being imposed by importing countries to ensure products meet their domestic requirements. The differences between the legislation, organization and function of inspection services and "modus operandi" of such services are among the most important practical difficulties faced by developing countries to comply with the requirements imposed by importing countries. Certificate requirements of different countries cause inconvenience to both exporter and responsible government regulatory agency. There are a number of different forms and languages, which often result in confusion.

Application of the Hazard Analysis Critical Control Point (HACCP) concept is an alternative choice to such traditional barriers, which is now embraced everywhere by public and private sectors. The worldwide application of HACCP principles, as recommended by the Codex Alimentarius Commission, is expected to become the vehicle which will stimulate international harmonization of the fish inspection system.

Nevertheless, even after the ratification of the Sanitary and Phytosanitary Agreement (SPS) under the World Trade Organization (WTO), differences are expected to continue between various national standards and inspection systems maintaining or creating new non-tariff trade barriers. Moving towards the "equivalence" approach to remove such a burden and liberalize the international seafood trade without sacrificing food quality or safety is essential. "Equivalence" is the capability of different inspection and certification systems to meet the same objectives, according to the Codex Alimentarius Commission.

This module offers an overview of the technical and practical particularities involved with fish as food and their control. An attempt is made to describe the major actions needed to be taken by developing countries to apply the "equivalence" approach in the field of inspection and quality control of internationally traded fish and fishery products. Problems and difficulties to pursue this kind of agreements are also identified.


Food safety risks of fish as food are well known and defined

Most fish and fishery products used as food are safe; however, like all foods, they carry some risk. The food safety issues for fish and fishery products are highly focused, well defined, and limited to a very few species. For fish and shellfish-borne illnesses reported to the US Centre for Disease Control and Prevention for which the cause was known, more than 90 percent of the outbreaks and 75 percent of the individual cases were associated with ciguatoxin (from a few reef fish species) and scombrotoxin (from tuna, mackerel, bluefish, and a few other species) and the consumption of bivalve molluscs (mostly raw).

Food safety risks of fish and fishery products (aquacultured and wild-caught) may be categorized by environment, process, distribution, and consumer-induced risk; the environmental risk category is further subdivided into natural hazards (e.g. biotoxins) and anthropogenic contaminants (e.g. polychlorinated biphenyls).

In broader terms, hazards associated with the consumption of fish and fishery products can be divided into three areas: product safety; commercial quality (freshness, hygiene, general appearance, size, colour, etc.) and mislabelling or economic fraud. Those hazards not related to food safety are considered as "defects" by the Codex Committee on Fish and Fishery Products.

Fish quality and quality changes

Problems associated with the rapid spoilage of fish are only too well known to fish technologists - how it occurs, why it occurs and the preventive action which should be taken. Spoilage occurs as a combined result of microbial activity, enzymatic and chemical breakdown. Action needed to prevent spoilage and preserve quality will include all steps necessary to handle fish with care and speed, and to keep the temperature of the fish low. Herein lies the first challenge for a quality control programme.


Fish inspection has a long tradition

Food inspection and quality control of fish and fishery products has a long tradition. In Europe it originates from medieval times when it covered a number of trade aspects related to the transport and sale of fish and fishery products. The type, weight and quality of products were severely controlled in the different harbours and markets. For instance, in France a barrel of salted pickled herring could be closed only after visual approval of an inspector who would then apply the official village seal on the barrel's tap.

14.3.1 Traditional control of fish as food and its limitations

Despite early beginnings, worldwide food control has been slow to develop in the area of fish and fishery products. In fact, many countries - developed and developing - still few years ago did not have any specific programmes for fish and fishery products. In most countries of the world, particularly in developing countries, national systems of food control have been developed over a period of time and generally more than one Ministry or Department are involved in the sector. As a result, in many countries several agencies still claim to have the right to carry on fish inspection and quality control activities.

Defects in current practices

A number of laws and regulations have been issued without appropriate coordination of the work of the different government agencies. This has sometimes led to overlapping and even contradictory provisions, and to difficulties in their meaningful enforcement. Often, outdated laws and regulations no longer answered the present needs of the country. Changes in the social structure, in food habits and in modern fisheries and food technology were inadequately reflected in these outdated regulations.

In most countries, the administration, operations and duties of the fish inspection agency were not clearly separated from those of other agencies within the parent department. Staff or facilities, particularly analytical services, were used from other divisions within the same umbrella-agency or from other agencies.

National institutions preparing standards for food products including those for fish and fishery products are present in practically all developing countries. Their organization and functions are very much alike and the volume of standards produced quite considerable. However, these standards generally have voluntary force and are applied only at national level. The standards with real practical significance, which are followed by the fish industry and enforced by government and agencies controlling exports, are those of the importing countries.

The general picture was that most of the existing fish inspection services lack sufficient qualified trained personnel and physical facilities, power and funds to carry on the work. Inspection for the purpose of quality control was relatively new and remained poorly understood. In the field, some countries only applied minimal inspection of fishery products or practically no inspection at all.

Existing fish inspection agencies mainly concentrated on licensing plants for the international market, carrying out laboratory analysis of end products, and issuing export certificates. Very little was done to improve the technology of handling and processing inside the plants; or the quality of fishery products sold at national level; or improve product diversification. Inspection agencies tended to neglect the local market. Few countries provided an equal coverage to both markets.

Low priority given to promoting and enforcing good manufacturing practices and effective quality control systems in processing plants was a weakness in most national quality assurance programmes. The inspection services devoted much of their effort and resources to the testing of products prior to export. As expected, the fundamental weakness of pre-shipment inspection schemes led to a long history of rejections and detentions of fish and fishery products from developing countries in their major importing markets.

As a direct consequence of the above situation, in most of the developing world the majority of the establishments in the fish-processing sector for the domestic market are small-scale and labour intensive. Sub-standard products with very short shelf life or very little appeal are being produced. The need for proper hygiene and quality control practices is often overlooked. Very little effort has been made to mechanize, improve the efficiency and modernize the operations. Fish markets are invariably located in the most inaccessible parts of town. They are often old, without adequate facilities for ensuring even basic standards of cleanliness and sanitation. Fish landing places generally offer the same poor picture. Transport, storage and distribution facilities follow the same pattern.

Very few industries detained a well-designed quality control system and, when such a programme existed, it generally was not understood or it was poorly executed. This does not apply only to the small-scale ("cottage") processing plants but also to factories involved in the international trade of fishery products. Large sectors of the industry failed to recognize their responsibility for the safety and quality of their products and for failures to meet acceptable standards. It was also a fact that in many processing plants understanding of quality control was limited to the work carried out in the laboratory rather than to a whole set of measures needed to retard spoilage, avoid contamination, and to manufacture a product according to the Good Manufacturing Practices (GMP) and specifications required.

As a result of such a wrong approach, the quality of raw materials was often a serious problem in many developing countries mainly due to poor practices of fish handling, preservation and storage on board of fishing vessels, as well as poor handling, unloading and transportation practices ashore. Pre-processing operations carried outside the plants under rather poor technical, hygienic and sanitary conditions were the main cause for contamination and decomposition: grading, heading and peeling shrimp; grading and cleaning cephalopods; picking crab meat; shucking shellfish, were carried out in sandy beaches, in the ground floor of fish landing places, sheds or family homes. The explanation was always the same: "We have no control of what happens outside the plant. It is not our business!".

Insufficient effort was made to educate workers in basic principles of personal hygiene. Education and training was almost impossible to achieve in countries where the labour force did not remain for a significant period of time in a single plant, for instance, the case of the utilization of daily-paid or piece-work personnel, a common approach in many developing countries.


Fish inspection activities were dramatically affected during the last five to ten years by factors that are introducing radical changes in traditional working procedures and methods of carrying on these activities. The advent of the HACCP concept, the harmonization of the European Community fish inspection regulations and the implementation of the United States mandatory seafood regulations are the main driving forces for changes in the way government and industry apply fish inspection everywhere. The pace of change will accelerate in the near future, since many players are still unable to understand the need for such changes and/or to put them into practice.

14.4.1 The impact of HACCP on fish inspection activities

Among existing systems, HACCP (Hazard Analysis and Critical Control Point) is considered to be the best strategy to offer greater security to the fish consumer. Production and inspection of fish and fishery products with respect to food safety and quality is shifting from inspection and testing to this new control approach where critical problems are prevented before they occur.

The great advantage of the HACCP system is that it constitutes a systematic, structured, rational, multi-disciplined, adaptable and cost-effective approach of preventive quality assurance. Properly applied, there is no other system or method which can provide the same degree of safety and assurance of quality, and the daily running cost of a HACCP-based system is small compared with a large sampling programme.

The widespread adoption of the HACCP concept by the fish industry and its enforcement by national regulatory agencies is a major step towards assuring the safety and better quality of fish as food at a global level. The benefits of HACCP are:

Benefits of HACCP

Overall better communication

Concerning the trade aspects, the introduction of the HACCP concept forces a better communication and understanding between the private sector (producer, exporter, importer), the regulatory agencies, the scientific community and the general public, and will bring benefits to all of them.

The case of developing countries

Most countries, but particularly developing countries, are responding positively to the challenge of implementing HACCP in their fish industry. The general principle of the HACCP concept is to direct energy and resources toward areas where they are necessary and most useful. This makes HACCP an ideal tool where resources are scarce, as is the case in many developing countries. It may appear an immense and impossible target to upgrade an underdeveloped industry. However, by using the HACCP concept it is possible to identify where the necessary changes and improvements must be introduced.

Closer collaboration between Government and Industry

Government and private industry have strengthened existing collaborative links and/or established improved means to upgrade national fish inspection and quality control structures at all levels.

Overall commitment "to improve safety and quality"

A very strong commitment "to improve safety and quality" has developed in an increasing number of countries. Everyone wishes to participate: first by learning what is HACCP, the European Community Directive, the International Standards Organization (ISO) series, the Canadian Quality Management Program (QMP), Total Quality Management and then how to develop and apply these quality assurance techniques.

Education and training activities at all levels

Education and training initiatives in fish technology, inspection and quality assurance at all levels of the government and private sectors are flourishing in many countries - again in close collaboration with industry, fish inspection and quality control services, training institutions and private quality control companies. Many of these training activities were carried out with and/or without international assistance. The main objective is to teach the development and application of the HACCP concept and the new import requirements of the European Community, the United States and Canada.

Optimistic approach: "we must, we can do it"

The majority of the above initiatives are being carried out with an optimistic approach: "we must do it", "we can do it". The understanding of the technical details of the HACCP concept gives the assurance to all that the new sanitary measures will considerably facilitate the trade of fishery products. However, there is a general feeling that more should be done to change and improve, through hard work and studying, collaboration among all interested sectors and financial investment where necessary.

The prize: maintain and increase markets and better prices

The prize is the maintaining of the international markets, the possibility of achieving better prices and different markets through better quality and safer products.

14.4.2 European Community: harmonization reached!

The harmonization of national legislation of European Community countries into a single Directive (91/493/EEU of 22 July 1991) is a unique step in the field of upgrading inspection and quality control of fishery products at the international level. The main practical objective of the European Community Directive is to assure the safety of these products and to avoid systematic detention, heavy sampling and laboratory checks at the point of entry in the Community. A shift to the preventive systematic approach provided by the HACCP concept is the main technical characteristic of the new inspection and quality control procedures included in the Directive.

The adoption of the HACCP concept and its enforcement in the European Community Member Countries and in those countries that wish to export to the Community is a major step towards assuring the safety and better quality of fish as food at a global level

14.4.3 USA: finally mandatory fish inspection!

The United States Food and Drug Administration (FDA) mandatory HACCP system became effective on 18 December 1997. It is designed only for safety - processors are free to apply HACCP to quality and economic fraud, but are not required to do so. The new regulations apply to all domestic seafood processors and to all overseas processors that export seafood to the United States. Processors include manufacturers, packers, warehouses, factory trawlers, but not fishing vessels, common carriers, or retail establishments. Importers are required to take an active role in verifying that the products they import were processed under HACCP.

Over 50 percent of seafood consumed in the United States is imported. Traditionally, FDA's primary strategy for checking imports has been through examination at ports of entry. FDA traditionally has conducted a limited number of inspections of overseas processors. Checking at ports of entry will continue. How FDA targets its checking will change, however, based on which countries the United States has entered into equivalence-type agreements with or not. The development of these agreements will be a priority.


According to the Codex Alimentarius Commission (CAC), "Equivalence is the capability of different inspection and certification systems to meet the same objectives" (Codex Alimentarius Commission, 1997). Accordingly, emphasis is given on the capability of different inspection and certification systems to achieve the same objectives, regardless of details related to the methods applied by both systems.

The "Proposed Draft Guidelines for the Design, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems" recently prepared by the Codex Alimentarius Commission (1997) recommend necessary steps to be taken in determining equivalence between two or more interested trading countries. The matters of consideration should include the national legislative framework, effectiveness and adequacy of enforcement and control programmes and availability of facilities, equipment, transportation and communications. The document also encourages the use of the HACCP approach and emphasizes the importance of government and industry staff training on the subject. As indicated before, the general assumption is that HACCP principles will play a fundamental role in every equivalence agreement. Prerequisite requirements for sanitation, end product sampling and testing by exporting countries would play a minor but necessary part to fulfil the objective of the agreement. Importing countries are expected to avoid systematic physical checks on imports, which will lead us back to the traditional way of inspection.

The role of risk assessment principles

A key point reiterated by the Codex Alimentarius Commission in their proposed draft guidelines is the need to abide by risk assessment principles. Risk assessment is the scientific evaluation of the likelihood and severity of known or potential adverse health effects resulting from human exposure to foodborne hazards (FAO/WHO, 1995). For the determination of equivalence between inspection systems, different countries may present different hazards and risk assessment. Control methods can be different but should achieve equivalent results. Inspection services should draw up control programmes based on precise objectives and appropriate risk analysis. In the absence of detailed scientific research, control programmes should be based on requirements developed from current knowledge and practice. Every effort should be made to apply risk analysis based on internationally accepted methodology.

With the world moving towards HACCP principles and equivalence agreements, where control from harvesting to consumption is emphasized, end-product analysis for certification purposes should be kept to a minimum. Time, cost and effort should instead be shifted to prevent the occurrence of possible health hazards in the production chain.

Facing the reality

Whilst equivalence may not be an immediate goal for several countries, to remain competitive on the global market first priority should be given to improving or establishing an effective fish inspection and quality control as well as regulatory systems. Compliance with basic requirements, such as implementation of HACCP or national importing requirements such as the European Community Directives, in order to acquire import permission is a more realistic goal to achieve for the time being.


The introduction and mandatory implementation of the preventive approach or HACCP concept has obviously made a considerable impact on national fish inspection and quality control services worldwide. It is reflected in the number of developing countries that are in the process of promulgating new legislation to mandate HACCP in fish processing establishments and throughout the production chain. While exporting countries are struggling to implement HACCP under intense scrutiny by the buyers, the latter should also ensure that a proper HACCP based system is effectively applied within their own fish industry. It should be noted that, despite strong efforts made by international organizations such as WTO and CODEX to oppose non-tariff trade barriers, the problem still exists and is far from elimination.

In achieving global free trade and providing maximum health protection, equivalence agreements based on recommended Codex guidelines should be actively pursued. The ultimate goal cannot be accomplished if communication, understanding and mutual confidence between inspection services of both trading partners is not improved. Importing countries should exercise more positive attitudes towards fish inspection and quality control efforts made by exporting countries.

Importing countries, which are well advanced in fish inspection systems, should contribute to less developed trading partners in terms of technical assistance and financial supports. This would lead to mutual benefits to all parties concerned.

Problems of shortage of qualified staff, adequate training and auxiliary facilities to achieve better performance in the field of inspection and verification should be addressed and tackled by international aid organizations as well as industrialized countries. Exporting and importing countries should organize and implement joint training programmes for their inspectors so as to promote better understanding and communication between inspection agencies.

The traditional fish inspection approach of end product testing should be reduced to a minimum to avoid unnecessary economic losses in carrying out laboratory tests and misleading consumers in the level of health protection. Certificate requirements should no longer be considered major criteria for accepting a shipment. The process only yields additional work and may create false expectations of the quality of the certified lot. Importing countries should apply more realistic and achievable standards and regulations based on scientific justification and risk assessment recommended by the Codex Alimentarius Commission.



FAO/WHO. 1995. Report of the Joint Expert Consultation on the application of risk analysis to food standards issues.

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