ALICOM 99/21  |
| ALICOM 99/21 |
Conference on International Food Trade Beyond 2000: Science-Based Decisions, Harmonization, Equivalence and Mutual cognition
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Harmonisation, Mutual Recognition and Equivalence
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by |
Digby Gascoine, Australian Quarantine and Inspection Service,
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A. Harmonisation: issues for the future
B. Harmonisation: recommendations
1. Around the world consumers seek safe, high quality and accurately described food at the lowest possible price. The demands of rising populations and increasing affluence have been met by greater production, and an even more rapid increase (more than ten-fold over the three decades to 1995) in international trade in food. Expansion in the volume and diversity of food supplies has been made possible particularly by the development of scientific knowledge and technological change in large scale food production and processing and in packaging, storage and transportation methods.
2. A major focus for scientific study and technical development has been the identification and control of food-borne hazards. The growth of scientific understanding of food-borne hazards has been parallelled by the development and implementation at the national level of food safety standards to protect consumers' health. The diversification of foods, of non-traditional production methods and of sources of supply have also given impetus to the application of food quality standard, which address attributes other than food safety and which are intended to facilitate commerce and protect consumers against deception and fraud. For more than 35 years the FAO/WHO Food Standards Programme and the Codex Alimentarius Commission have played the central role in establishing internationally accepted food standards to serve these purposes.
3. The concepts of harmonisation, mutual recognition and equivalence have a key role to play, in conjunction with Codex norms, in assisting the most efficient and effective application of food standards.
4. Harmonisation of standards means the adoption of the same standards by different countries. Typically, the reason countries seek to harmonise their standards with other countries is so that they may trade more freely with each other. Where harmonised standards are in place, goods produced in a country to meet its standards will be capable of being sold freely in another country which applies the same standards. The absence of harmonised standards will result in increased costs for food exporters and importers. Another incentive to international harmonisation is that if countries are able to rely upon a common authoritative source of food standards there will be less need at the national level to devote scarce technical resources to the formulation and validation of unique national standards.
5. Additional impetus towards harmonisation is given by the obligation which Members of the WTO have accepted under the SPS and TBT Agreements1 to harmonise their measures with relevant international standards, including Codex norms, wherever appropriate. Under the SPS Agreement WTO Members may be called upon to justify a decision to apply a measure which is more trade restrictive than would be consistent with a relevant Codex standard, guideline or recommendation. Under the TBT Agreement, Members proposing to make a technical regulation which is not in accordance with a relevant international standard and which may have a significant effect on trade are required to advise other Members, explain their intentions and take comments into account.
6. If standards are to be applied in common between different countries they must meet the requirements of each country in terms of protection of consumer health and protection against deceptive or fraudulent practices. Each country has the sovereign right to determine the level of health protection which food standards should provide for their populations, and this level can and does vary from one country to another. Moreover there is great diversity world-wide in dietary patterns and the circumstances in which food is handled and consumed. Despite this diversity it has been possible for Codex to develop international food standards which can and do provide the focal point for harmonisation.
7. Codex norms which address health risks are able to provide a basis for harmonisation because they reflect sound, contemporary, internationally-recognised science (for example, as to the toxicity to humans of a particular contaminant of food). They also reflect a broad international consensus on the methodology for developing standards on the basis of scientific data and other technical information (eg how to take into account differences in dietary patterns between countries). Furthermore, they are developed within an extremely thorough consensus-seeking process and in almost every case they are adopted by consensus.
8. There are no firm data as to the extent of use of Codex standards. The acceptance procedure by which Codex members are expected to voluntarily indicate their recognition of Codex norms at the national level is now rarely used. WTO Members when notifying new or revised technical requirements under the relevant procedure are expected to indicate whether their measure conforms with a relevant international (eg Codex) standard, guideline or recommendation, but such notifications can give only a very limited impression of whether Codex norms are meeting national needs and therefore providing a suitable basis for harmonisation. The SPS Agreement also provides, in Article 12.4 for the development of a procedure for monitoring the extent of harmonisation of Members' measures with international standards, guidelines and recommendations. At this time such a procedure is being initiated, but it will be some time before substantive information emerges from it.
9. Although comprehensive data are not available it is known that Codex norms have been very widely adopted by many countries as the basis for their food standards. An important issue for this conference to address is what more can be done to foster international harmonisation of food standards through the work of Codex.
10. Codex norms will achieve wider use as a basis for international harmonisation the more effectively they meet the needs of the 165 member countries of the Codex Alimentarius Commission. Member countries need standards which are technically sound and which fully address contemporary risks, whether these risks are to human health or are risks of deception or fraud. As well, countries need standards which have a high degree of credibility with both consumers and trading partners, and which are capable of being applied by both developing and developed countries. The following considerations are therefore particularly important in Codex's future work:
11. On the last of these points, the Codex Alimentarius Commission needs to consider to what extent and how it can assume a leadership role in the development of standards which address new and emerging issues. At present there is, for example, an increasing propensity for countries to develop and implement quantitative limits on microbiological contaminants. The application of standards in relation to genetically modified organisms is a matter of intense public controversy in a number of countries. Public confidence in the safety of the food supply is acutely sensitive to concerns about transmissible spongiform encephalopathies. Historically the members of Codex have elected to await the development of a degree of convergence between the separate national approaches of the major developed countries before deciding that an applicable Codex norm should be developed. Such will necessarily continue to be the case if the consensus basis of Codex norms is to be preserved. Thus the question is how the framework and mechanisms which the Codex system provides can be better used to facilitate the development of consensus on the basis of which appropriate new norms can be elaborated.
12. The Codex Alimentarius system has a long history of producing technically credible food standards through a consensus approach. The challenge now is to enhance the utility of these standards as a basis for international harmonisation, within the new context created by the WTO Agreements on Sanitary and Phytosanitary Measures and Technical Barriers to Trade. One appropriate response to the challenge will be to reinforce and refine established principles and procedures; another will be to consider how within the Codex system the need for consensus-based standards addressing emerging issues can be met more rapidly and more effectively.
13. On the aspect of reinforcing and refining existing principles and procedures, the Conference may wish to consider the following proposals:
14. On the aspect of more effectively addressing emerging issues, the Conference could consider these additional proposals:
15. Mutual recognition is the outcome of a process of evaluation which leads two or more countries to agree that the standards and/or associated systems employed by each country are such as to allow goods marketed in one country to be freely marketed in each other country which is party to the agreement. The purpose of such agreements is to allow goods to flow more freely in international trade, unimpeded by differences in the national requirements of trading partners, provided that each participating country's appropriate level of protection is achieved. Typically a mutual recognition agreement would facilitate trade by reducing or eliminating the need for inspection control of goods at the point of entry to the importing country, relying instead on the effectiveness of control systems in the exporting country.
16. Mutual recognition may apply to all foods traded between countries which are party to an agreement or only to specified foods, and to all requirements applicable to specified foods (including food standards) or only some (such as conformity assessment procedures). Countries may elect to enter into an umbrella agreement consisting of general provisions and specific sectoral arrangements made under the umbrella agreement.
17. The feasibility of establishing mutual recognition will be greatest between countries which have broadly similar attitudes to the appropriate level of protection against health risks or deception of consumers, and between countries which have broadly similar capabilities in relation to the monitoring and enforcement of requirements. Mutual recognition is more likely to be established between countries which are in some kind of political or legal association with each other; often such countries will be neighbours with a long tradition of trading food.
18. One important consideration in relation to mutual recognition arrangements, at least for those countries which are Members of the World Trade Organisation, is that countries are obliged to conform with the principles of national treatment and non-discrimination. Accordingly the advantages of mutual recognition must be made available not merely to the partners to a mutual recognition arrangement but to all WTO Member countries who can demonstrate that their standards and/or systems can meet the appropriate level of protection of any of the parties to the arrangement.
19. Mutual recognition agreements embody the notion that different sets of requirements applied to food may have the same acceptable outcome in terms of achieving an appropriate level of protection. This is to say that mutual recognition involves a two-way (or many way) determination of equivalence. In that respect the development of mutual recognition arrangements will be assisted by Codex work on the concept of equivalence, as discussed below.
20. Beyond this there is no obvious role for the Codex Alimentarius Commission or the World Trade Organisation in the fostering or monitoring of mutual recognition arrangements.
21. The Conference could note that mutual recognition agreements can play a useful role in facilitating trade in food, but do not require contributory effort by the relevant multilateral organisations such as the Codex Alimentarius Commission and the WTO.
22. Any country must be satisfied that imported as well as domestically-sourced foods meet its legitimate requirements, so that public health is appropriately protected, quality standards are maintained, and fraudulent practices are prevented. An importing country must therefore judge the safety, wholesomeness and other attributes of imported food, but these attributes cannot necessarily be reliably and efficiently ascertained by inspecting products at the time of importation. It is common practice, therefore, for the regulatory authority of an importing country to rely upon the effectiveness of food inspection and/or certification measures undertaken in the exporting country.
23. However food inspection and certification systems operating in exporting countries often differ from those in the importing country, and such variation may be evident in any component of a food control system. The reasons for such differences are many and may include the absence, or very low prevalence, of particular hazards in the exporting country, and the greater efficiency and effectiveness of alternative means of achieving the same food safety outcomes.
24. International recognition of the legitimacy of diverse approaches has led to the principle of equivalence being included in trade agreements, specifically the SPS Agreement and the TBT Agreement. The SPS Agreement states
(Article 4)
"Members shall accept the sanitary and phytosanitary measures of other Members as equivalent, even if these measures differ from their own or those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection.
Members shall, upon request, enter into consultations with the aim of achieving bilateral or multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures."
25. The TBT Agreement states (Article 2.7:):
"Wherever appropriate, Members shall specify technical regulations based on product requirements in terms of performance rather than design or descriptive characteristics."
26. In relation to the application of the principle equivalence to food, the CAC has adopted Principles of Food Import and Export Inspection and Certification2 which state:
"Countries should recognise that different inspection/certification systems may be capable of meeting the same objective, and are therefore equivalent. The obligation to demonstrate equivalence rests with the exporting country."
27. The CAC has also adopted Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems3 which states (Section 5):
"The recognition of equivalence of inspection and certification should be facilitated where it can be objectively demonstrated that there is an appropriate system for inspection and certification of food by the exporting country in accordance with these guidelines.
For the determination of equivalence, governments should recognise that:
Controls on imported food and domestically produced food should be designed to achieve the same level of protection."
28. Applying the concept of equivalence to different food control sanitary measures used in different countries according to the provisions of the WTO Agreements has a number of benefits such as:
29. While a considerable level of international recognition attaches to the principle of equivalence, it is evident that international guidelines are needed for systematic application. The Codex Alimentarius Commission (CAC) has identified judgement of equivalence as being an important result area in its 1998-2000 Term Plan4, and the 12th Session of Codex Committee on General Principles (1996) requested that principles be established in this area.5 The 22nd Session of the CAC (1997) also recognised that "judgement of equivalence of food control systems in different countries is a critical issue, and Codex principles and guidelines associated with determination of equivalence will facilitate this process"6 In this respect, the 22nd Session of the CAC endorsed the work plan for the Codex Committee on Food Import and Export Certification and Inspection Systems (CCFICS) which, inter alia, included the proposed consideration of a discussion paper on guidelines for the judgement of equivalence.7 At its 7th meeting (Melbourne, February 1999), CCFICS considered the discussion paper and recommended to the Commission that it initiate formal work on the elaboration of guidelines for the judgment of equivalence of sanitary measures. The Committee also requested the advice of the Executive Committee and the Commission as to how to proceed in relation to a proposal for the development of guidelines on the judgment of equivalence of technical regulations other than sanitary measures.
30. At its 23rd Session (Rome, June-July 1999) the Commission agreed that CCFICS should continue to study the proposed draft guidelines for the judgment of equivalence of sanitary measures associated with food inspection and certification systems as a discussion paper. However the Commission also agreed with the recommendation of the Executive Committee that CCFICS should proceed to develop guidance on the judgment of equivalence of systems for inspection and certification in relation to technical regulations other than sanitary measures in parallel with food safety issues. These matters will be progressed at the 8th CCFICS meeting (Adelaide, February 2000).
31. Meanwhile CCFICS has prepared draft guidelines for the development of equivalence agreements regarding food import and export inspection and certification systems, and the Codex Alimentarius Commission adopted these guidelines at its 23rd Session.
32. The application of the principle of equivalence is the focus of attention in a number of areas of food control. One of particular interest is in the area of meat inspection. Participants in the 6th World Congress on Meat and Poultry Inspection (Terrigal, Australia 28 February - 5 March 1999) concluded, inter alia:
To facilitate work of this kind it is desirable that the Codex Alimentarius Commission take the lead in the development of guidance for applying the concept of equivalence in relation to food standards.
33. The concept of equivalence is capable of broad application. It is already acknowledged within the Codex context that the work which until now has been carried on by CCFICS addresses a subject which is potentially of interest to a number of other committees particularly including the Codex Committee on Food Hygiene and the Codex Committee on Methods of Analysis and Sampling. The agreed strategy is for CCFICS to establish the basic elements of guidance on the application of the concept and for other subsidiary bodies of the Commission to take the matter up within their spheres of responsibility when appropriate. Draft guidelines on the judgment of equivalence were discussed by CCFICS at its 7th meeting earlier this year and will again be presented for discussion at the Committee's 8th meeting in February 2000.
34. To this time the concept of equivalence has not been widely applied in a formal way in respect of international trade in food. There are, of course, notable exceptions - for example, USA law provides that countries which are exporting meat to the United States must use control systems which are equivalent to those employed within the United States. However it is likely that there will be an increasing number of exporting countries which desire to use systems and methods of food control which are equivalent to those of importing countries. Exporting developing countries in particular may find such an option attractive.
35. As interest in applying the concept intensifies in exporting countries, so does the need of importing countries for methodology which will allow them to make judgments in an objective and coherent way about whether proposed standards and systems are equivalent to their own internal requirements. If there is not prior international agreement, developed through Codex mechanisms, on methodology for judging equivalence, specific bilateral issues between WTO Member countries are more likely to become the subject of formal consideration under the WTO dispute settlement procedure. Moreover the absence of guidance from Codex will be a severe disadvantage if a WTO dispute settlement panel or Appellate Body is called upon to rule whether a Member country has proceeded appropriately in judging (in relation to an SPS matter) whether equivalence has been objectively demonstrated by the exporting party.
36. In light of this discussion the Conference may wish to:
1. The WTO Agreement on the Application of Sanitary and Phytosanitary Measures ("the SPS Agreement") and the WTO Agreement on Technical Barriers to Trade ("the TBT Agreement").
2. CAC/GL 20-1995, paragraph 13
3. CAC/GL 26-1997
4. CAC/LIM 6 (ALINORM 97/6 - Add 1)
5. ALINORM 97/33, paragraphs 17-18
6. ALINORM 97/37, paragraph 164
7. ALINORM 97/21, Part II