ALICOM 99/22  |
| ALICOM 99/22 |
Conference on International Food Trade
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Harmonization, Mutual Recognition and Equivalence:
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by |
Dr Christine J. Lewis, Center for Food Safety and Applied Nutrition, Food and Drug Administration, USA |
1. This paper outlines the rationale for food labelling and considers food labelling within the context of how much is necessary for consumer protection. The endpoint of such discussions is not only to identify strategies whereby we can provide sufficient food labelling so that consumers are appropriately protected, but also to take into account the need to minimize the possibility that food labelling could result in unnecessary or undue restriction on trade and movement of food products across borders. The goal is not to strike a balance between these two interests, especially since they are not necessarily mutually exclusive, but to consider food labelling in a way that provides reasoned principles that can be used to draw lines between "necessary" and "unnecessary" labelling.
2. Food labels that are required to provide an excessive amount of information are clearly a concern as trade barriers and disincentives to food manufacturers, but more importantly such labels can also confuse and mislead consumers. In its simplest form, determining what is sufficient information for the food label is a function of agreement about what consumers need to know. But certainly the process is tempered by what consumers want to know, as well as what manufacturers want to tell them and what certain groups with special interests -- legitimate as well as self-serving -- want consumers to know.
3. The food label has been successful in large part because it has held to the basic tenet that ultimately it be framed by well-grounded, established, and accepted science. However, the food label is also an interface between food-control authorities, manufacturers, and consumers. This interface is a dynamic dialogue and the dialogue may change depending upon the demands of participating groups. Cultural differences bring to bear a variety of perspectives on what should be done for consumers, what consumers should be allowed to do for themselves, and how new and developing food technologies should be allowed to impact on the food supply. The dialogue can become very complicated and does not always operate exclusively in the realm of science-based decisions.
4. The first point to consider is the problem of defining "consumer protection." The meaning of consumer protection is not the same among all groups in all countries. The concept of consumer protection includes several basic tenets, but it is evolving at different rates, and sometimes in different ways, in different parts of the world. From the outset, we must agree that consumer protection as it relates to food labelling is largely an issue of consumer choice; that is, it allows the opportunity for informed choice based on truthful and accurate information. The premise is that there is certain information consumers need to have in order to make the best, or at least better, choices. And by allowing for better choices, the food label offers protection for consumers. Moreover, the protection is not possible without consumers' involvement. Consumers must use the information in order to be protected. This type of consumer protection is much more complicated than, and distinguished from, that which derives from "built-in" provisions that are implemented before consumers have the option to purchase and consume the food.
5. We must also agree that the food label appears on products produced under good manufacturing practices and that these products are basically considered to be safe. The food label should not be used to remedy fraudulent or unsafe products. In making the assumption of basic safety for products bearing food labels, we nonetheless recognize that the issue of food safety is, in certain emerging areas, subject to wide interpretation and, for this reason, enters into the debate about food labeling -- and thus, about consumer choice.
6. The consumer protection the food label offers generally requires some degree of development in a society's production and distribution of food. Also, literary and educational attainment must precede food labelling for it to be useful. Given that the food label is clearly most effective when consumers have and can make food choices, what is to be said about situations in which consumers have limited or no choices concerning the foods they eat?
7. As we consider food label harmonization, we should not lose sight of the fact that the first order of business in a developing country is to achieve the availability of enough food so that people do not starve or suffer the adverse health effects from poor nutrition. This is not to say food labelling does not play a role in developing countries, but rather that the concept of consumer protection is different than that of developed countries.
8. To the extent that a region or country lacks the apparently necessary level of food production development and/or lacks the sufficient level of literacy, food labelling may seem to only impact on trade concerns if the nation engages in food trade. Nonetheless, efforts for food labelling from a public health perspective should not be ignored solely on the grounds of limited food choice or literacy. In essence, nutritional needs are quite similar across a range of persons and cultures. However, food labelling can be useful at all points of the spectrum, with developing countries focusing on basic nutrient facts and more developed countries concerned about nutrient excesses and the interplay of various foodstuffs. The food label provides very important information in situations where the country is developing or is compromised economically, albeit the information that needs to be on a food label in a developing country may be quite different from the information that needs to be on the food label in a developed country. Basic nutrient information is often invaluable under such conditions, and includes for example not only ingredients and formulation but also calories, grams of protein, and protein quality.
9. Distribution of food with nutrition labelling in the language of the receiving country has been identified as a technique that can promote nutrition among the poor. Clearly, the needs are likely to be greatest for labelling information that provides the basic information of identity and composition, including basic nutritional composition. Therefore, multinational and national development assistance agencies that provide for the availability of food to needy people can promote nutritionally balanced diets through their use of labelling and a variety of other techniques as well including education and demonstration programs. Moreover, development assistance agencies could work with developing countries to determine what the governments and the people think are the needs for food information, including labelling information, and to assist with the development of responsive programs and laws. While it has been explored in arenas other than food labelling, the use of alternative approaches to the use of words for presenting information on the food label - use of pictograms, icons or symbols - is worthy of research and considerations. In the end, such activities emphasize that the food label is a critical public health tool and a consumer protection mainstay that has great versatility in its ability to be useful.
10. The relevance of recent trade agreements to concerns for food labelling can be divided into two topics, specifically issues related to either the Agreement on Technical Barriers to Trade (TBT) or to the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). Each agreement has a different impact on food labelling provisions.
11. The TBT is in essence a transparency code designed to open up the rulemaking processes of trading partners with respect to mandatory technical regulations and voluntary standards. It has recently been expanded to cover conformity assessment procedures and product-related process and production methods. An initial reaction would be that a national authority's decision to require provisions that specify the nature and content of a food label would be inconsistent with the TBT. However, the TBT Agreement language has been written to assure that its provisions do not prevent a national authority from taking measures necessary for the protection of human health at the levels it considers appropriate.
12. The TBT issue is perhaps most germane to food labelling when we consider the situation that resulted when the United States enacted wide-ranging provisions to require nutrition information on virtually all packaged foods sold in that country. While the issue has not been completely resolved, there is the strong argument that nutrition labelling measures such as those enacted by the United States during the last 10 years express the level of protection the United States considered appropriate and therefore are consistent with the TBT agreement. Other countries will presumably follow a similar path in providing for their consumers' interests and protection in the area of nutrition labelling in the future. The question for today is how to foster harmonization given these potentially diverse interests.
13. Some food labelling measures are subject to the SPS Agreement. These measures directly deal directly with food safety and those otherwise pertaining to protection of human life or health from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs. The SPS measures are relatively objective in nature in that they are expressed primarily in terms of scientific principles and the demonstration of equivalency through scientific means. The key consideration is that an SPS measure is applied only to the extent necessary to protect human health, and is not maintained without sufficient scientific evidence. While SPS provisions can play a role in labelling decisions, such as providing information about processing and treatment methods, they are commonly associated with food manufacturing and agricultural practices.
14. While it oversimplifies the varied nature of the components of the food label, for the purposes of our discussion, food label information can be grouped into three broad categories: Product Identification, Product Nutritional Value, and Product Processing/Treatment. Each category provides illustrations of the various factors that impact on the decision to provide for labelling. Moreover, as highlighted below, each category can be associated with activities that, if implemented, are likely to enhance international harmonization.
Harmonization Activities:
Enhanced search for technical agreement
15. The starting point for food labelling for consumer protection is its role in providing the essential information of identity and composition, information that can be considered to comprise the basic label. Clearly, manufacturers bear some responsibility in providing basic information to consumers about their product, and the food label serves this purpose. But, this information is also a regulatory tool because by requiring that it include information such as the identification of the product, listing of ingredients, quantity of contents, and manufacturer's address, food-control authorities can ensure that consumers are not misled and thereby are do not buy or consume fraudulent products or products which are not appropriately specified.
16. Consumers can also use the information to make choices about purchases or decisions to consume a food, most notably by using the list of ingredients. Conversely, the manufacturer can tell the consumer about the taste and convenience of the product, and even provide guidance such as preparation methods and recipes. Moreover, the basic label can identify preparation methods that serve certain cultural or religious concerns, a well-known example for which is kosher labelling.
17. Another aspect of the basic label is its intent to encompass certain targeted safety information. For example, in the case of allergic substances, their identification in the ingredient list may be sufficient to allow most consumers to make informed choices. For other allergens, specific statements on the packaging are necessary. Discussions continue about appropriate guidelines for how mixed ingredients are identified or declared on the label.
18. Overall, the basic label is characterized by information that is considered essential for consumer choice and is generally neutral in that it provides information on the most straightforward attributes of the food. Manufacturers acknowledge considerable responsibility at this level of labelling, and provide that information in several languages as dictated by trade interests. To date, the basic label has experienced considerable efforts to harmonize and is for this reason a well-accepted format used widely throughout the world. Its current general acceptance, however, is a function of directed and sometimes arduous work conducted by a variety of normative and regulatory authorities, most notably the Codex Alimentarius.
19. The components of the basic label may seem obvious at this point in time, but they began as controversial principles that were gradually agreed upon and backed by scientific investigations. Nonetheless, the "basic-ness" of this component of the food label is not meant to suggest that all issues have been resolved and we have a harmonious label. Rather, while many of the contentious principles have now been agreed upon, there are many technical differences that have yet to be fully addressed, ranging from how to express weights of packages to the rules for listing ingredients.
Harmonization Activities:
Elucidation and agreement on scientific principles for health promotion so as to allow for a uniform basis for impacting on a nation's decision to protect human health at levels appropriate; nutrition monitoring; consumer education.
20. The science of nutrition has developed rapidly in the later half of this century, sometimes at breathtaking speed. It was inevitable that at some point these scientific findings would have an impact on the food label because they impact on consumer choice. Over time, there has been increasing interest in the role nutrition can play in good health. This interest began initially with concern for nutrient deficiency diseases, and has progressed into areas that focus on promoting health and reducing the risk of chronic diseases due to over-consumption.
21. In some parts of the world, but certainly not all, the advances in nutrition science have expanded the concept of consumer protection. Assuming consumers are best protected if they can make informed choices, the rationale suggests that consumers need to know about the nutritional attributes of the food. This role can make the food label a tool for implementing nutrition education, but it does not make the label an educational vehicle in itself. Rather, there is the expectation that consumers have been informed about the role certain nutritional choices can play in their health and are motivated to make dietary changes. The label provides the necessary information to make healthy choices, but not the reasons to make those choices.
22. Moreover, the extent to which consumers are interested in such information dictates the degree to which manufacturers are interested in providing such information or perhaps in formulating products consistent with a healthy diet. It is not likely that manufacturers will incur the expense of providing nutrition information on their product if it is not used by consumers to select the product or demanded by consumers so that they can compare products. Nutrition labelling increases the productivity of the label when it leads to wiser food choices and assists government in advancing public health strategies.
23. The interest in this type of consumer protection via nutrition labelling is growing, but it is not universal. Because of its proximity during the purchase, preparation, and consumption, the food label can readily convey information about the nutritional quality of the food and its role in a healthful diet. However, the limited size of most food labels as well as the manufacturers' interest in product promotion, means that food labelling can be potentially confusing at best and misleading at worst. Therefore, controversy has swirled around how scientific findings about nutrition and health be translated for consumer use. And, in turn, what nutrition information do consumers truly need given the small space, and how can this type of information be provided so that it is not misleading.
24. Nutrition labelling is currently coalescing in a somewhat ordered fashion as the scientific controversies surrounding the role of nutrition in health are beginning to be resolved and consensus seems possible in at least several areas. Moreover, while it appears likely that nutrition labelling can move toward harmonization, it is also clear that harmonization will benefit if national authorities in conjunction with food manufacturers, scientists, and consumers make a concerted effort to conduct certain activities and develop databases. While food composition data are perhaps the most obvious information needed to support nutrition labelling, it is equally true that it cannot be supported without dietary guidance in the form of national nutrition policies and recommendations. Moreover, it is important to collect food intake data for a variety of reasons including characterizing the nature of diets for both excessive intakes and deficiencies, and potentially identifying average serving sizes. While food intake data provide a basis for monitoring nutritional adequacy, nutritional status assessment is the gold standard for determining actual status. Such clinical measures are often difficult and costly but are also essential to the establishment of dietary guidance.
25. In order to place both current status and harmonization efforts in perspective, it is helpful to compare the international guidelines established by Codex Alimentarius to the nutrition labelling requirements of the United States which has developed detailed labelling provisions. On its face, the comparison suggests many differences, but these differences should not always be viewed as incongruities. Rather, most are outgrowths of varying needs for label specificity which, in turn, derive from the differences in the goals and purposes of an international guideline for nutrition labelling versus a national regulation. Beyond identified differences in specificity, there are true differences that stem from apparent scientific controversies and variations in interpretation available research.
Issues Related to Specificity: While the current Codex listing of nutrients focuses on four nutrient declarations (energy, protein, available carbohydrate and fat) and requires them only when a claim is made on the label, the United States system requires 14 nutrients as mandatory declarations with or without a claim. Yet there is a similarity between the two labelling systems that suggests a notable level of agreement for nutrition labelling. For example, virtually all systems specify quantitative listings for the amount of nutrients. Approaches generally limit declarations to those for which recommended intake levels have been established. Definitions of nutrients and identified analytical methods are similar in many cases, as are the calculation procedures when values are not directly measured. In short, there appears to be decreasing rather than increasing disparities, but at the same time both greater and lesser levels of required specificity for these declarations. This is undoubtedly due to the differing rate at which national authorities have reached agreement about the amount of nutrition information consumers need as well as to differences in consumers' interest in or awareness of such information within their country.
Issues Related to Controversies and Differences in Interpretation: There are 3 main issues that derive from more substantial controversies. First is the basis for making nutrient declarations. Many parts of the world support declarations based on 100 g portions or some other weight, while the United States system requires the use of established serving sizes. This issue identifies a clear lack of agreement concerning the relative utility of weight-based nutrient information as compared to values given on the basis of typical consumption (i.e., serving size). Resolution of the issue is important to harmonization and involves not only determining consumers's capacities and preferences worldwide but, if serving size were to be selected as the preferred approach, determining a serving size that would have international application and acceptance. Thus, an important consideration is that harmonization if possible may have to be preceded by consumer research.
26. A second issue is the use of reference value so that consumers have a standard by which to compare the amount in the food with a recommended daily intake of the nutrient. Reference values have the potential to be one of the most difficult aspects of harmonizing nutrition labelling. The problems in dealing with nutrient reference values on an international basis are daunting. Given their role in guiding most national nutrition policies, a number of countries have established such values. It is not unexpected that different countries emphasize different nutrients and specify different levels of intake. In many respects this difference is caused by the use of judgmental elements and cautionary factors which are applied to values which themselves have been based on a variety of criteria for setting recommended values. Moreover, values are established using diverse criteria, such as the avoidance of deficiency, achievement of biochemical parameters, and standards based on observed intakes. While a number of efforts to resolve such differences have been attempted, they usually involve representative groups meeting to revise already established values, yet invariably national authorities turn to national policies for final decisions. The key to harmonizing international reference values may lie in attempts to harmonize more basic factors than the values themselves, factors such as scientific concepts, terminology, and approaches for developing dietary standards. Such efforts require targeted and organized approaches.
27. A third issue is declarations for cholesterol, saturated fat, and sodium. These are food components that are mandatory declarations within the U.S. system. They have been considered by the developers of international guidelines and in some cases earmarked as voluntary declarations, but they are not required declarations. Their general absence from international guidelines is due to differences in their perceived utility and appropriateness as a nutrient listing as well as to lack of consensus concerning recommended intake levels. The resolution of this issue must await further consideration of the science as well as modifications as appropriate of national health policy recommendations consistent with the science.
28. Guidelines for the use of claims, including nutritional claims, emerged within the international community as early as 1979 in the form of Codex Alimentarius guidelines. The underlying principle has been that no food should be described or presented in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character. Nutritional claims require additional considerations such as definitions specified to ensure consistency and utility to consumers. The claims that have been considered by most national authorities to date have focused on drawing attention to the fact that a food is particularly high in an important nutrient (e.g., good source of calcium), or perhaps especially low in a nutrient that in some of the developed countries are over-consumed (e.g., fat). Agreement is needed on the criteria for what constitutes, for example, a rich source of a particular nutrient, which nutrients can be highlighted on labels using claims, what the reference standard should be, etc. While nutrition claims require this set of scientific agreements, the basis for such claims is often tied to the nutrition content of the food, thereby making the basis for claims highly dependent upon the nutrition label. So, many of the same issues that are raised for nutrient content information reappear when nutrient claims are considered.
29. To date, a Codex committee has been actively working to identify conditions under which nutrient content claims for "source" and "high" can be used to describe levels of nutrients for which there is a reference standard. This work has progressed with remarkable speed considering the inherent difficulty in harmonizing. However, the work has also revealed an important need to foster work on nutrient reference value. Reference values are often used to determine whether a food contains a significant amount of a nutrient. That is if, for a designated unit, a food contains xx% of reference value for that nutrient, that food may be considered eligible to make a particular nutrient content claim.
30. Nutrient content claims for foods are an important emerging area in terms of consumer protection. If they are considered useful in alerting consumers to important attributes of food -- and from the United States experience there is evidence that this is true -- they build upon the existing interest in coordinating label information with health recommendations and relevant consumer education. Equally, there are other types of nutritional claims waiting to be explored for use on an international scale. Specifically, there is emerging interest in the possibility of providing for claims that focus on either reducing disease risk or on enhanced function. Such claims are still largely at the early definitional stages within the international arena, but with such work it is important to remember it is a wise practice to harmonize early.
Harmonization Activities:
Science, consumer education, discussion, patience
31. The underlying principle for providing labelling information about product processing or treatments has rested on two sequential determinations: first, whether the processing/treatment is readily identifiable to consumers without labelling information; and if not, whether the processing/treatment has resulted in an important change or difference in the food. The latter component of this determination focuses on the principle of "substantial equivalence," or perhaps the newly preferred term "equivalence." However, in any event, the process/treatment must first be considered safe.
32. All aspects of the food label have, at one time or another, been controversial. They have forced regulators and government authorities to consider the role of the food label and the nature of consumer choice, as well as the science about safety and the role of nutrition in good health. These questions always have been coupled with questions about free trade and the burden placed on food manufacturers. Today, labelling focused on product processing and treatment is at the forefront of controversy. Many current issues arise out of concern about emerging science and developing technologies with a changing view of consumer protection. There are debates about the potential use of the food label to inform consumers about modes of production or methods of processing that are controversial for a variety of reasons or may not be universally accepted from a scientific perspective. The issues of right to know and want to know continue to be raised.
33. It may be a sanguine outlook, but it is likely that many debates will be resolved using scientific data in conjunction with consumer education and changes in consumers' acceptance over time. This has been the case, at least in part, with the basic label identification and nutritional labelling. But it also appears that consumers today are more likely to demand that they be the referee for the kinds of choices they are allowed to make, rather than government or other regulatory authorities. Also, some consumers prefer to make food choices consistent with certain philosophical beliefs, lifestyles or personal values. This interest in making their own choices occurs even when the issue is a highly complicated scientific debate.
34. Part of the reason for this consumer change -- and why it has important long-term ramifications for harmonizing the food label -- is that for some consumers today's world is characterized by a concern that scientists are "fiddling with nature." There may be an unease in accepting scientific principles as adequate. In other cases, consumers have general concerns about the unknown or developments that by their nature do not have a long history of use. Further, there may be distrust of, or disaffiliation with, authoritative bodies as well as food manufacturers.
35. For a food label based on sound science, suggestions that science is not the answer is a conundrum. There is no easy solution when food labelling takes on these controversies. The accepted process seems to be to continue to work at establishing scientifically-based rationales and to rely on good science as the final arbiter. But the evolution is by necessity slow and there are many views. Examples of labelling related to food processing and treatment that can be used to illustrate our discussions include the use of irradiation, use of the term organic, and the presence or use of genetically-modified organisms (GMOs). They identify several paths that the evolution of labelling may follow and emphasize the importance of established principles and criteria for making decisions about food labelling.
36. Irradiation has, even with all of its controversies, followed a classic path to a labelling endpoint. As with all components of the food label, the safety of process/treatment begins by a consideration of the supporting science for safety; this aspect occurs before issues of labelling are considered. While, for some, the safety of irradiation continues to be questionable, many have accepted that the process results in safe food products. It is, however, important to correct a common misunderstanding. Irradiation is mistakenly understood by some to be a food additive. Irradiation is in fact a process, not a food additive.1 It therefore is a candidate for labelling if the process has resulted in important changes to the product, i.e., the irradiated product is no longer equivalent to the non-irradiated product.
37. Once safety is demonstrated, the question is whether consumers can readily identify a product that had been treated -- such as the difference between canned vegetables and frozen vegetables -- and, in turn, whether the processing has made a difference to the food. Should such differences occur, that information may be a "material fact" that consumers must have, and therefore it needs to be provided by the food label. When irradiation is used it is not likely that consumers could determine by using the standard labelling that the food had been treated with irradiation. This finding, however, is a necessary but not sufficient condition for the decision to label. The food-control evaluation must go on to determine if the process/treatment has resulted in an important change to the food. If there is no longer equivalence, then consumers need to know.
38. In the case of irradiation, there is evidence that there are changes in organoleptic properties of products treated with irradiation. Thus, labelling for irradiation is consistent with existing principles for labelling under the processing/treatment rubric. But, as might be expected, once one set of issues seems to be heading toward resolution, others emerge. Today's debate about irradiation labelling focuses on the differences between the finished product and the ingredients
39. A second example, the organic nature of foods, is a process/treatment issue that was resolved from a safety perspective. In turn, equivalence was demonstrated and so use of the term organic was not a candidate for mandatory labelling. But, it returned to the labelling arena in another form.
40. Specifically, as the science has accumulated over time, many food-control authorities seemed to agree that, from a safety perspective, the difference between organic foods and other foods were not meaningful. Conventional foods could not be determined to be less safe than organic foods and equivalence seemed to be evident. Thus, the use of organic processes did not appear to warrant special information on the label as there was no need for consumer protection, the use of apparently organic approaches to producing food did not change the product. However, despite the prevailing science, consumer interest in organic products continued. This interest may be due to personal lifestyle choices, unease with newer methods of food processing, or interest in back-to-nature strategies for our society.
41. Therefore, in the absence of clear guidelines for the use of the term organic coupled with continued consumer attention and continued reference to it by some food manufacturers, the matter shifted from a food safety concern to an economic deception concern. Guidelines were needed so that the use of a label statement about organic could have an appropriate and measurable standard. Certainly, guidelines for organic still relate to process/treatment, but not in terms of equivalence, but as a concern related to fraud. For this purpose, efforts have begun at the international level to harmonize the meaning of the term organic. This experience might suggest that a scientific solution to an issue may not end it, and consumer protection of some type may still be needed.
42. Third, GMOs reflect an example of a process/treatment issue that on its face could be a candidate for a resolution path similar to that for irradiation. That is, the surrounding issues would move from safety to discussions of equivalence. However, in today's world the discussions about GMOs have the added dimension of occurring at a time when consumer concern and unease about the adequacy of science seem to be on the rise. In an ideal world, the debate would move sequentially from the basic safety of GMOs to questions that surround equivalence. However, the issue of GMOs has entered the labelling evaluation for equivalence with some groups not entirely assured about the science.
43. This is not surprising since agreement of any type is generally a gradual process and not all interested parties reach the same conclusion at the same time even when faced with the same evidence. However, the discussions about GMOs have included a wide audience of interested parties and have placed the food label in a controversial position. Unease or discomfort with the science and rationale for GMOs have led some interested parties to suggest that regardless of whether there is equivalence or not, there is still a need for labelling. While the discussion is at times cast by interested parties as the consumers' right to know, there are others who suggest that the demand for labelling over-reaches current established principles concerning process/treatment labelling. The key question is how are "other legitimate factors" -- usually considered to be factors other than scientific outcomes and sometimes identified as including precautionary principles -- addressed relative to food labelling. These factors may be viewed as imported from environmental and sustainable development discussions and which are now making their way into discussions concerning agricultural practice. It must be acknowledged that the time is right for a debate about "other legitimate factors" relative to the role of food-control systems and, in turn, to food labelling. It will be a difficult debate because there are some that suggest that food-control systems are poor candidates for environmental/lifestyle/philosophical debates and others who believe it is essential. In any case, this debate must be fully aired before specific application of "other legitimate factors" to GMOs labelling or any other food labelling can occur.
44. It may be that the discussions underway on labelling for GMOs seem highly controversial only because they are so current. Perhaps with time sufficient discussions will have taken place so that compromise can occur and acceptable principles applied or developed. Or, it may be that we have entered a new era when the number of considerations that must be taken into account when deciding to provide for labelling will have expanded greatly. We must watch these events closely. Overall, we should keep in mind that the food label is small and if forced to carry too much may collapse under its own weight.
45. Experience suggests that the rationale for food labelling is best served if decisions are science-based and principles are applied systematically. It is the relentless pursuit of science and an adherence to principles that will take us to the maximal level of harmonization. Moreover, science-based decisions are most likely to stand the test of time and thus serve harmonization best. Other legitimate factors have not clearly emerged.
46. Discussions about the current status of food labelling also suggest some pragmatic observations. One observation is that more consumer involvement in food labelling is likely, and this must be accompanied by consumer education. Another observation is that while the food label can serve diverse needs, it is nonetheless tiny and can carry only a limited informational burden. Perhaps most obvious but least understood is the fact that harmonization must be considered early in the process. Certainly, in the end, food labelling decisions must be respectful of provisions that are intended to give individual nations the right to protect public health at levels their authorities find to be appropriate. But this apparent inconsistency with the goal of harmonization can often be resolved by identifying as a principle the likelihood that increased understanding and scientific data are the key to harmonizing such national decisions. When all nations face the same, sound scientific conclusions, they may not take the same public health actions but the chances that they will do so are much greater with the availability of the scientific evidence than without it. Finally, as controversies arise, an important consideration is that the potential conflict between the consumers' need to know and their interest in knowing, as well as the interplay of manufacturing and trade interests, must not be short-circuited. Harmonization cannot be superimposed, it must evolve and will entail adjustment of laws, regulations, policies, standards, and practices between different jurisdictions so as to minimize dissonance and facilitate commercial activity.
47. The following are general recommendations for FAO/WHO/WTO and member governments that are intended to provide for an adequate and acceptable science base for the food label and to provide some guidance when the science itself is at issue or lacking:
The following references provided valuable background information:
Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme (1999). Report of the Twenty-First Session of the Codex Committee on Food Labelling (draft), ALINORM 99/22A, FAO/WHO, Rome.
Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme (1999). Report of the Twenty-First Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses, ALINORM 99/26, FAO/WHO, Rome.
Gourlie, Katharine. (1995) Food Labelling: A Canadian and International Perspective. Nutrition Reviews, 53: 103-105.
Horton, Linda R. (1995) International Harmonization and Compliance, in Nutrition Labeling Handbook, Marcel Dekker, New York.
Lewis, Christine J., Randell, Alan, and Scarborough, F. Edward. (1996) Nutrition Labelling of Foods: Comparisons between U.S. Regulations and Codex Guidelines. Food Control, 7: 285-293.
1. Part of the confusion may be due to the fact that in the United States the equipment used to irradiate food is regulated as a food additive. This provision was originally established as a legal construct to ensure that the process was conducted safely, but it has no other practical application. The process itself -- irradiation -- is not a food additive within the U.S. system.