ALICOM 99/7





Conference on International Food Trade
Beyond 2000: Science-Based Decisions, Harmonization, Equivalence
and Mutual Recognition
Melbourne, Australia, 11-15 October 1999

Basic Approaches to Consumer Protection -
FAO/WHO Model Food Act - Control Procedures

by

Ezzeddine Boutrif and Catherine Bessy,
Food and Nutrition Division


Table of Contents


I. Introduction: Food Control - Objectives and Elements

1. National food control systems have a dual mission:

2. Food control operations amount to much more than repressive policing. By encouraging sound practices, they aim notably to reduce food losses during production, processing, storage, transport and sale, thereby increasing availability and promoting world food security.

3. A food control system is a composite of complementary elements, where the success of each determines the effectiveness of the system as a whole.

4. Having thus defined the framework of food control, this document now focuses on the different aspects of food legislation sensu lato and on control procedures.

II. Food Legislation

A. HISTORICAL BACKGROUND

5. Historically, the first legal provisions related to food date back to Antiquity. The process was then taken forward in the Middle Ages but with greater focus on protection against fraud. It was not until the 19th Century and the Industrial Revolution that more systematic regulation began to take shape, as a result of industrial development, which eclipsed artisanal and household production, and the emergence of very real problems of public health linked to food. The first general law of recent times, enacted in 1860 in Great Britain, dealt with the prevention of fraud in foodstuffs and beverages.

6. At the beginning of the 20th Century, in 1905, France passed its law on the repression of fraud which, although often modified since, still serves as a central prop of food control.

7. Legislation in the developing countries was in many cases imported with the colonial administration and very often inherited without changes to the provisions of the mother country. Initiatives taken at or after independence either left these provisions intact or modified them. However, the prevailing situation in these countries is very different and clearly calls for adaptation to the constitutional, administrative and indeed cultural systems and to the conditions and scale of production.

B. LAW AND REGULATIONS: DIFFERENCES AND COMPLEMENTARITY

8. Comprehensive and easily applied food legislation has two components that differ somewhat in substance but deal with the same topics. A distinction is generally made between the basic law and the implementation regulations (or texts).

9. The basic law on food consumption in countries that have opted for a separation of powers (in this case legislative and executive) generally falls within the competence of the legislative authority, as do all other basic laws. However, the subject matter (food) is subject to frequent change from technological advance in the production process and greater understanding of potential risks to consumer health. It is therefore important to make a distinction between a body of relatively stable principles on the one hand and precise regulations that can be quickly adjusted to developments on the other. This is the very purpose of the technical regulations which are generally formulated by the executive authority, as is prescribed in the law. Regulations can be modified much more easily and rapidly as they fall outside the remit of the legislative authority.

10. In this way, the law retains its relevance (being devoid of details that would soon become obsolete), is comprehensible (free off obscure specifications of little interest to the sector as a whole) and is therefore useable by all parties concerned, whether consumers, industrial operators or control officials, without these having to be legal experts.

11. Some countries have chosen to make a further distinction by separating the concept of standard from that of implementation regulation. But in all cases, the standards are part of the texts enabling the basic law to be implemented.

12. The basic law should therefore cover many areas and include a definition of underlying objectives, basic concepts and scope. It must determine responsibilities for implementation of the law, procedures and means of inspection and analysis, their enforcement, and sanctions. It should define the notion of standard and the principles for regulation of additives and authorization for their use, as well as for pesticides and contaminants, together with the notion of related tolerances, and the principles associated with packaging and labelling. Finally, it should set out the procedures for the elaboration and amendment of implementation regulations and for revocation of now obsolete laws.

13. Once the legal basis has been established, the regulations need to address the complementary aspects in detail, with all the technical requisites: rules and regulations (establishing standards and technical regulations), principles of food hygiene, food additives, pesticides, food packaging and labelling, advertising-style statements on foods and featured claims. In contrast to the law, regulations may be obligatory or optional, but whichever should be clearly stated.

C. THE FAO/WHO BASIC FOOD LAW

14. In 1977, FAO and WHO devised a general food law model, with support from the UNEP. This model can be fully adapted to national contexts, but at the same time provides a structure that covers the essential factors needed for the system as whole to function properly. The model has been used on several occasions in the framework of FAO technical cooperation projects aimed at reinforcing national food control systems or one of their component parts (Kenya, Laos, Uganda, Zambia, etc.).

15. The text of the law covers the following aspects:

16. The food law must also protect consumers against fraud. It aims to ensure fair commercial practices and to foster consumer trust.

D. REGULATIONS

17. The essential purpose of the regulations is to put the basic law into effect. Regulations are published to provide all parties with precise indications as to how they should proceed; as such, they need to be accessible to all parties not versed in legal jargon. They should be intelligible, precise, up-to-date and easily amenable to advances in understanding or special circumstances requiring prompt action on the part of the authorities. All regulatory texts relating to food could be usefully grouped under one heading (such as "Code on Food") so that all administrations refer to the same body of texts when conducting their control activities, and so that all those operating in the sector can be sure that they have consulted all the regulatory texts covering their particular activity.

18. The regulatory texts are generally obligatory in scope. They can also serve to interpret current policy and thus facilitate the work of all those concerned, especially the enforcement officers.

19. In direct relation to the content of the law as mentioned above, the regulations specify the modalities of official intervention, the delegation of authority for inspection visits, the taking of samples, payment (if applicable), number and so forth.

20. The following aspects are also dealt with in detail:

21. One important component is of course the body of standards, which are useful to all parties (producers, traders, consumers and control authorities) as a common frame of reference defining the terms of trade. These should describe the food comprehensively and the context of its use: national, regional or international. They determine authorized composition and related limits and may also refer to a specific code of use. They include specifications for labelling, packaging and methods of analysis and sampling. The Codex Alimentarius has used this model to draft over 237 international food standards.

22. The elaboration of standards is a dynamic process that should collectively involve:

23. There are two types of standard: vertical standards that are product specific (e.g. pineapple juice) and horizontal standards that apply to all products (e.g. general provisions on food labelling).

24. These standards are supplemented by codes of hygiene which refer to one sector of activity and are formulated in the same manner as the standards, with the involvement of industrial operators, government officials, scientific experts and consumers. The codes provide recommendations on the raw materials to be used and their production, types of facilities and equipment in the production unit, conditions of hygiene to be respected during production, control measures to be adopted and health of personnel. The Codex Alimentarius Commission has drawn up 41 such codes at international level.

25. There are three areas of possibly prime interest to legislators that could be usefully examined in greater detail: food additives, pesticides and labelling.

(i) Food additives

26. Additives are currently widely used to preserve foods or to add to their value (preservation agents which slow down micro-organism activity; antioxidants which delay fat rancidity; texturizing, colouring, flavouring and other substances). Whatever their benefits, the application of additives has to be checked in terms of pre-evaluation (toxicity of molecule and permitted doses) and of quantities actually used by the food industry.

27. Lists of authorized and prohibited additives are drawn up. The fact that technology is changing constantly means that these lists cannot be rooted in legal texts but have to be included under the regulations where they can be amended as often as necessary.

28. A system of positive lists gives all the authorized additives, so those excluded are prohibited. Conversely, a system of negative lists features all forbidden additives, which implies that all others are authorized even when, in the case of new molecules, they have not undergone prior toxicological analysis. Related studies are conducted at international level under the responsibility of the Joint FAO/WHO Expert Committee on Food Additives. To date, 1005 food additives have been evaluated and the results made available in FAO and WHO serial publications.

29. This same committee also carries out studies on contaminants in foods (mycotoxins, heavy metals, etc.) and proposes maximum limits which need to be included in the regulations.

(ii) Pesticides

30. Here too, groups of international experts, in the form of Joint FAO/WHO Meetings on Pesticide Residues (JMPR), evaluate pesticides and their use and toxicity, and propose maximum residue limits in food: 185 pesticides have so far been evaluated and 3274 limits suggested for various products. National rules and regulations should not only take these limits into account, but should also consider aspects associated with a correct employment of pesticides and make a distinction between coated seeds and grains for direct consumption, etc.

(iii) Labelling of food products

31. Comprehensive labelling is one of the best instruments of consumer protection and is often a good way of settling discussion on the authorization of a given production practice which, although not necessarily toxic, may occasion legitimate cultural resistance on the part of the consumer. It reverts freedom of choice to the end user while at the same time providing information on product characteristics.

III. Recent Developments in Approach to the Control of Food Quality and Safety

32. In the wake of the Second World War, the international community met to negotiate a new international trade order. The ensuing rounds of negotiations culminated in 1994, in Marrakech, in the foundation of the World Trade Organization (WTO) as the natural successor to the General Agreement on Tariffs and Trade (GATT). The final round of negotiations, the Uruguay Round, tackled the thorny issue of agriculture and its product - food. The first principle set by the Marrakech Agreements enshrines the free circulation of goods and in particular foodstuffs, so the public authorities are expected to do all they can to facilitate such trade; and any restriction resulting from control or regulatory provisions can only be for legitimate purposes. Two agreements, concerning foodstuffs in particular, were reached to give this new trade order a sharper framework: the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS for short) and the Agreement on Technical Barriers to Trade (TBT).

33. It should be noted that the legal commitments resulting from signature of the Marrakech Agreements supersede national legislations and the WTO has been given more effective means of sanctioning non-compliance.

34. The substance of these two Agreements - one referring specifically to food safety, the other to food quality - is to limit as far as possible obstacles to trade in the form of unjustifiable protectionist measures. The international community is therefore strongly urged to refer to all texts endorsed by international consensus. The terms are very clear in the case of the SPS Agreement: the Codex Alimentarius is specifically cited as the international reference for food safety, which of courses adds new status to the Codex standards. In this connection, it has been decided to attach more importance within Codex to the horizontal standards concerning food additives, contaminants, labelling, etc. In parallel, all the more generalized statements have been removed from standards for specific products. Such measures do not however preclude individual states from determining their own levels of consumer protection, although a level of protection higher than that negotiated internationally will have to be solidly backed by accepted scientific justification.

35. There is therefore every reason to review national legislation and compare it to existing international standards, notably the Codex standards, to determine disparities and their implications. By way of example, stricter standards applied to imports will need to be justified. As a rule, reference to Codex texts should included in the general law, specifying the relevant conditions.

36. It is strongly recommended that each process of justification should apply the principles of risk analysis and its constituent stages of risk assessment, management and communication. Risk assessment itself comprises several stages, one being an assessment of exposure to the perceived hazard. This implies that the country in question has a realistic idea of consumption figures and possible levels of contamination, and that its legislation provides for some form of consumption "watchdog" made up of scientific personages with recognized expertise in this field.

37. There are two overriding principles within these agreements that need to be reflected in national legislations: proportionality and reciprocity.

38. The principle of proportionality presupposes that the administrative or regulatory measure has a real protective or regulatory effect to satisfy the legitimate objective recognized by the WTO. This principle also implies that the measure is proportionate to the intended objective and is not unreasonable in terms of encroachment on the principle of freedom. This is why administrations are asked to adopt measures that have the least possible prejudicial impact on the economic rights of operators. It also implies that penalties should be proportionate to prejudice resulting from failure to comply with the regulatory measures. When applying this principle of proportionality, governments are also invited to implement procedures based on the principle of commercial trust in the economic operators and on their sense of professional responsibility. Finally, it is up to the each State to provide proof of proportionality and scientific justification for its control and regulatory measures.

39. With respect to reciprocity, the Marrakech Agreements establish the principle of mutual recognition of technical and trade legislations. On condition that measures are not inferior to recommended international standards and subject to reciprocity, goods manufactured in compliance with the regulations of the exporting country have freedom of circulation in the importing country. Furthermore, the control procedures and mechanisms of the exporting country are considered equivalent to those of the importing country.

40. Finally, the notion of procedures of verification of conformity with the legislation of the importing country is closely tied to the preceding concepts. This is in fact a right of the importing country, but a right that can only be exercised to the extent that the verification process does not have a restrictive impact on imports. Systematic verification is considered excessive on account of the principle of proportionality. At the same time, verification processes carried out by industrial enterprises themselves are encouraged as these facilitate trade while retaining the objective of consumer protection.

41. In view of the above and of the two key SPS and TBT Agreements, two concepts come increasingly to the fore in the regulation context: the concept of safety and the concept of quality.

A. FOOD SAFETY

42. Although the concept of food safety would appear at first sight to be relatively straightforward - food needs to be safe at time of consumption - it becomes more difficult to manage if the whole production and market chain is taken into account. It is not reasonable to impose the safety obligation on one link of the chain, considering the multiplicity of intervening parties; yet the party first placing the food on the market is commonly held to be under an obligation to ensure that the item in question meets safety standards at that precise moment. This however presents problems of definition that the regulatory texts have to face: what is a first placing on the market in the context of so many processing sequences?

43. There are so many intervening parties that can only reasonably be held responsible for the part under their control, but surely the fact that they only constitute one link in the chain should not absolve them from overall responsibility.

44. Hence the concept of professional responsibility which means much more than compensation for damages that are difficult to quantify and repair where health is concerned. Professional responsibility operates more in terms of prevention of harm and immediately triggers the principle of self-regulation, which is becoming increasingly integral to national legislative and regulatory texts, with the State becoming more a controller of control, checking the control systems introduced by producers - a role that is also reflected in the texts.

B. THE NOTION OF QUALITY

45. The above provisions on food safety also of course contribute to food quality, but only in the sense of setting a minimum floor. The concept of quality is broader and has long been described in terms that are too generalized to be systematized in legislative texts. Yet, certain types of produce, such as wines, have long had specific attributes.

46. Economic rationale requires that quality characteristics be definable, measurable and verifiable, and thus become an integral and quantifiable feature of the product.

47. There are different marks of quality, such as:

48. In contrast to safety considerations, the quality factor is optional. It should however be identifiable from a clear consumer code and reliably established by an outside body appointed by the competent public authority.

IV. Food Safety and Administrative Action - Control Procedures

49. Having thus presented the principle of safety and referred to its immediate impact on professional obligations (notably self-regulation) and to the point of evaluation of the concept (first placement on the market, among others), we now need to examine the approach to be adopted by the control administration in its field actions. "Control administration" is understood to mean all public services involved in food control. What then should be the rationale (if not the detailed content) behind the powers allocated to the administrations charged with controlling food safety?

50. Firstly, such powers of intervention should be placed within a framework of administrative, not judicial, control. The basic aim is to prevent, not repress: to avoid an unsuitable, potentially dangerous or - all the more so - dangerous food reaching the market. Such powers must include the authority to remove a product from the market temporarily or permanently or to oblige the originator to withdraw the product and deal with it appropriately. Depending on the risk assessment, the administrative measure should be determined by the controlling officer, the administrative authority, or even, in the most extreme cases, by the Minister concerned.

51. Finally, such administrative control must clearly be compatible with the judicial authority that has long been held by food control officers. This necessary adjustment of course raises a far broader problem which will be dealt with later.

A. THE ADVISORY AUTHORITIES INTERVENING IN FOOD SAFETY AND RISK PREVENTION

52. The importance of food safety raises the issue of needing a competent independent authority that is able to assist the government bodies in evaluating the risks and making decisions affecting the right to food. Such a scientific body is all the more necessary in view of the WTO Agreements which specify that any sanitary or phytosanitary measure applied by a signatory state "is based on scientific principles and is not maintained without sufficient scientific evidence" (SPS Agreement Art.2.2). The same agreement also states that their measures "are based on an assessment ... of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations" (SPS Agreement Art.5.1). The organizations concerned (FAO, WHO, Codex Alimentarius Commission) have dwelt at length on the notion of risk and how to address the problem (cf. the definitions adopted by the Codex Alimentarius Commission at its session of June 1997). The scientific approach to risk served to highlight the importance of the World Trade Organization (WTO) as a future reference in the case of international trade disputes.

53. There is therefore every reason to put in place a national scientific body able to assess risk and advise on regulations intended either to eliminate the risk or to keep it to an acceptable level, in the context of the national food and nutrition situation.

B. REGULATORY REFERENCES RECOGNIZED BY INTERNATIONAL AGREEMENT

54. A number of underlying principles need to be recognized in connection with the commitments.

55. As regards regulatory sources and bases applicable to products:

C. VERIFICATION PROCEDURES RECOGNIZED BY INTERNATIONAL AGREEMENT

56. As regards the procedures of verification of conformity to the legislation of the importing country or to legislation considered as being equivalent:

D. GENERAL OBJECTIVES AND CHARACTERISTICS OF CONTROL

57. The public authorities should determine a verification strategy to prevent the market release of food products that do not conform to the principles of the law or to the recommendations of the international bodies: they must be organizationally structured to this end. A posteriori crackdown and inspection of finished products alone cannot meet the objectives of prevention. Similarly, and with this same objective of prevention and enhanced quality in mind, the control actions of the different services need to be coordinated. The method of verification should be such that foodstuffs are effectively controlled, which calls for a broad vision of the scope of control given the complexity of the food production and marketing process.

E. AUTHORITIES RESPONSIBLE FOR ADMINISTRATIVE VERIFICATIONS

58. The law must determine the intervention and injunction competence of the administrative authorities empowered to carry out verifications and organize controls. This competence should be exercised at central level and entrusted to a specially designated minister so that there can be prompt action. A similar definition of competence needs to be made for the decentralized authorities with powers delegated by the central administration. The powers of special administrative control include a list of preventive measures as well as individual measures that can be contested at a higher level or that are open to recourse on the grounds of excess of functions. Here too there is a need to make a radical distinction between powers of intervention and powers of regulation.

F. VERIFICATION POWERS OF THE ADMINISTRATIVE OFFICERS

59. As this is a matter of control on company premises, the officers' powers need to be expressly codified as powers of administrative control. The law should therefore be carefully looked at and refined to deal with such powers. The ability to enter company premises for checks and to seize or temporarily detain documents, objects and products constitutes an encroachment on personal liberty and property: only the legislator has the authority to act in this domain.

60. Also, this being a question of prevention, inspectors should be able to make recommendations and offer advice to economic operators on matters of conformity. This is particularly important in the case of small food-sector concerns that are often poorly informed and badly organized.

G. PROTECTION OF PERSONAL RIGHTS

61. Particular care should be taken over the rights of individuals responsible for the foods that are inspected. Modalities ensuring transparency, recourse and individual guarantees need to be expressly underscored, even if this is just formalizing the normal process of public law. Thus, under the principle of proportionality and on pain of nullifying proceedings, the following actions should be integral to verification:

V. Conclusion:

62. Food legislation and its constituent parts (basic law, implementation texts, decrees, decisions, etc.) serve as the basis for food control and effective action to protect the consumer and ensure the fair trade of food products at national and international level. Recent developments in the form of the WTO Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT) have required adjustments to the principles and rules governing the trade of food products between WTO countries. These adjustments, and in particular those relating to risk analysis, proportionality and reciprocity of sanitary and phytosanitary measures, transfer of responsibility to the economic operators, equivalence and the mutual recognition of control systems between trade partners, place food control laws and regulations under a new perspective. Greater emphasis is now given to prevention over repression, while at the same time providing consumers with the necessary assurances of quality and safety. The FAO/WHO basic food law provides a useful model that can be adapted to these developments and tailored to the specific conditions of individual countries.