Alan W. Randell, Ph.D.,
is the Secretary for the Codex Alimentarius Commission,
Joint FAO/WHO Food Standards Programme in Rome, Italy.
In 1995, the Codex Alimentarius Commission adopted four "Statements of principle concerning the role of science in the Codex decision-making process and the extent to which other factors are taken into account". The first two of these statements are worth quoting in full:
Like many other statements of principle, the four statements reflect the situ-ation at the time of their adoption, and they also set out challenges for their future interpretation. The primary and pre-eminent role of scientific analysis and evidence had not been questioned in the Codex decision-making process prior to 1995; the innovation was the introduction, formally, of the concept of "other legitimate factors" in the decision-making process. Here, too, it can be argued that non-scientific elements had always been part of the process, for example in decisions concerning food labelling.
It is no coincidence that 1995 was the critical year: the World Trade Organiz-ation (WTO) Agreement on the Appli-cation of Sanitary and Phytosanitary Measures (SPS Agreement) had entered into force on 1 January of that year, and the Codex Alimentarius Commission was scheduled to consider the adoption of maximum residue limits for certain growth-promoting hormones used in meat production. The subsequent dispute between the European Community, on one hand, and the United States of America and Canada on the other, led to increased scrutiny of the scientific bases and processes for decision-making when setting international standards for food safety and quality. The debate on these issues continues even today. It focuses on the role of scientific expert bodies and the means by which scientific advice is transformed into international standards. The key words are risk analysis - a relatively new paradigm for formal decision-making in the area of food safety.
Risk analysis was introduced into Codex in 1991 as a major recommen-dation of the International Conference on Food Standards, Chemicals in Food Trade and Food Standards held in March of that year. Prior to 1991, Codex standards in relation to chemicals in foods had been based on the principle that lifetime ex-posure on a daily basis to any of the chemicals approved for food use should result in no appreciable health risk. This concept, also known as acceptable daily intake, or ADI concept, is still utilized in relatively simple applications. These include approval of food additive uses or the establishment of maximum residue limits for agricultural and veterinary chemicals where there are no complicating factors such as acute dose effects, genotoxic or allergenic effects, or development of antibiotic resistance. The ADI concept requires considerable certainty in the scientific evidence and, in cases where the scientific evidence is uncertain, an ADI is not allocated for the chemical substance being evaluated.
Risk analysis is a broader concept that must take the notion of uncertainty into account and provide advice on the basis of a scientific risk assessment, which includes estimates of uncertainty where natural variability or paucity of data exist. This requires a structured and pre-cautionary approach at all stages of the risk assessment process and in the establishment of recommendations for risk management practices based on available scientific evidence.
Protecting the health of consumers from risks that may be present in their food is the primary objective of the Codex Alimentarius Commission. The Codex Alimentarius contains standards or other recommendations in the following areas:
Within the Codex Alimentarius Commission, specialized committees deal with these different aspects of food safety. These Committees receive advice from FAO/World Health Organization (WHO) expert bodies and transform the risk assessments and safety evaluations generated by these expert bodies into Codex standards and related texts. There are close linkages, therefore, between the relevant Codex bodies and their scientific expert counterparts.
The Codex Alimentarius Commission is in the process of establishing its working principles for risk analysis. The principles are based on the work of a series of FAO/WHO expert consultations dealing with risk assessment, risk management and risk communication held in the mid-1990s. The critical points of the Codex principles (which are still in draft) follow.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is the oldest scientific expert body of the United Nations system, having been established in 1955, some eight years before the Codex Alimentarius Commission itself. It is normally regarded as the model for other expert bodies, including those established at national and supranational levels.
FAO and WHO have complementary functions in selecting members for expert bodies. Normally FAO is responsible for selecting members to deal with the food science, chemistry and agricultural technologies of the issues at hand, while WHO is responsible for selecting members to specialize in the determination of health effects. Both FAO and WHO invite members who are responsible for assessing food intake, which is a critical step in the risk assessment process. The selection of members is made only after a careful consideration of the scientific credentials of the various candidates, and a balance between scientific expertise and other experience is considered essential.
For foods derived from biotechnology, safety assessment is designed to identify information on the nature and severity of hazards that may be present, allowing appropriate management methods to be defined
FAO/WHO expert bodies meet in closed sessions, with participation limited to the experts themselves and the secretariat (which may include temporary scientific advisers and consultants). Representatives of governments or of other interested parties are excluded. FAO and WHO meet the costs of the experts' attendance. The opinions of FAO/WHO expert bodies are normally consensus opinions; in rare cases individual experts submit dissenting opinions that are published together with the main findings of the expert body. Summaries of the expert bodies' findings are published on the Internet as soon as possible after each meeting.
The scientific evaluation of food additives deals primarily with an assessment of potential toxicity. However, in order to ensure that the toxicity evaluations are valid, it is first necessary to specify the nature of the additive and its chemical purity. The outcomes of an evaluation are therefore:
The Codex Committee on Food Additives and Contaminants assesses the technological uses of each additive in the full range of foods and estimates the potential intake to the high-end consumer of these foods. The so-called Danish Budget Method is used for a first screening.
If the additive poses no toxicological problem (i.e. its ADI is not specified), it may be used in most foods according to good manufacturing practice (GMP). GMP in this case means that the additive is used only where required and in amounts sufficient to achieve the desired purpose, but no more. The use of an additive is not considered to be GMP in the case of some foods (e.g. milk). The Codex Committee has established a list of these foods.
If there are toxicological limitations on the use of a particular additive, the Codex Committee seeks to restrict the number of foods in which it can be used to those where there is no alternative to the use of the additive.
The scientific evaluation of contaminants deals with both an assessment of the potential toxicity and an assessment of exposure to the contaminant. The outcome of the toxicological evaluation is usually presented in the form of a maximum tolerable daily (or weekly) intake, and it is the task of the Codex Committee on Food Additives and Contaminants to determine what maximum or guideline levels should be applied to ensure that the high-end consumer of foods is not exposed to levels close to this maximum intake. In some cases, special guidelines and advice might be given to protect the most sensitive consumers (e.g. mercury as regards pregnant and nursing women); in other cases, codes of practice aimed at reducing contamination are prepared.
In many cases, contamination cannot be totally avoided. In the case of aflatoxins in groundnuts, JECFA carried out a comparative risk assessment of two levels being proposed by the Codex Committee and determined that although both levels presented a theoretical risk of liver cancer, the lower level was not much more effective than the higher in protecting the general population.
The Joint FAO/WHO Meetings on Pesticide Residues (JMPR) began work in 1962. These meetings convene two independent expert panels: one deals with the toxicological effects of pesticides (WHO) and the other with the effects of pesticides in agriculture and the environment (FAO).
In considering the safety of residues, the scientific evaluation is based on the potential toxicity of the chemical concerned or its metabolites when present as a residue, together with an evaluation of the levels that occur in the food product following the use of the chemical in accordance with good agricultural practice (pesticides) or good veterinary practice (veterinary drugs). Good practice here means the most limited use of the chemical under consideration, provided that the intended effect (crop protection or animal health) can be achieved.
An assessment is also made of the potential intake of the chemicals concerned, and on this basis a maximum residue limit (MRL) is fixed by the appropriate Codex Committee.
Safety assessment of whole foods and of many complex food ingredients requires an approach that differs from the strategy used to assess the safety of single, well-defined chemicals, such as food additives, pesticides and contaminants. Here, the approach is case by case, based on an evaluation of multidisciplinary data and information derived from, but not limited to, agronomic, genetic, molecular biologi-cal, nutritional, toxicological and chemical properties, as appropriate. Toxicology testing in animals is not routinely employed, but when necessary (based on an assessment of available data and information) tests should be designed to address specific issues.
Genetically modified foods and conventional foods have many characteristics in common and, in many cases, the new food or food ingredient will be nutritionally equivalent to its conventional counterpart. Analytical methods traditionally applied in the evaluation of food constituents (such as total protein, fat, ash, fibre and micronutrients) may need to be augmented with additional analyses using profiling methods to identify unexpected effects and modified nutrient profiles that may have an impact on dietary intake and health. Because of the potential for broad changes in nutrient levels and interactions with other nutrients as well as of other unexpected effects, it may be necessary in certain instances to undertake feeding tests in animals to determine outcomes that result from changes in nutrient profiles and nutrient bioavailability. Nutritional modifications that are within normal ranges of nutrient variation might require a less extensive evaluation than those outside normal ranges.
The data and information should be of sufficient quality and quantity to withstand scientific peer review. Safety assessment is designed to identify information on the nature and the severity of any hazards that may be present, allowing appropriate management methods to be defined.
Food hygiene is ensured primarily through the application of codes of good food-hygiene practices. The basic Codex text is the "Recommended international code of practice - General principles of food hygiene",3 which includes an extensive annex containing guidelines for the application of the Hazard Analysis and Critical Control Point (HACCP) System for ensuring food safety. These codes, which provide guidance for controlling contamination levels, are basically empirical texts that presume that the presence of microbiological contamination in foods poses a risk to human health. The Codex Committee on Food Hygiene is exploring the possibility of using quantitative risk assessments as the basis of more specific rules governing the microbiological safety of foods. FAO and WHO have organized a series of expert consultations to establish the scientific basis for this work.
Codex standards, guidelines and recommendations are "soft law". Governments are invited to accept these standards by ensuring that the product to which the standard applies may be freely distributed within the territory of the country concerned, and that products not complying with the standard will not be distributed under the name and description laid down in the standard. There is no obligation in the rules or procedures of the Codex Alimentarius Commission, however, for governments to accept or apply Codex standards.
The value that may be attributed to Codex standards therefore comes from external sources. In part, the value of Codex standards is a reflection of the commitment of governments to enter into negotiations on the content of each and every standard and to base these negotiations on the scientific finding of the appropriate expert panel. The other significant contributor to the value of Codex standards is the reference made to them in the SPS Agreement, which adds a legal value to them (Article 3.1 of the SPS Agreement) as well as to the risk assessment techniques used by the FAO/WHO expert bodies (Article 5.1 of the SPS Agreement).4
Codex food safety standards, guidelines and recommendations - based on risk assessment - stand alongside other international instruments that use the same risk-based approach. These are:
The use of scientific risk assessments as the basis for decision-making under these international legal instruments strengthens their use as the basis for decision-making within the soft law of Codex.
The decision of the Codex Alimentarius Commission in 1995 to recognize other legitimate factors in its decision-making process led to a long debate as to the nature of these factors. It has now been admitted that establishing a list (whether open or closed) of such factors would be counterproductive, and the Commission has instead adopted criteria for identifying what constitutes a legitimate factor at its 24th session in 2001, the key elements5 of which are listed below.
The distinction between the scientific risk assessment and the development of risk management or other consumer protection measures is therefore maintained. This distinction will be critical to the ongoing debate in the Codex as regards the extent to which traceability is a risk management measure and to what extent it is used to meet other legitimate objectives such as consumer information.
Scientific analysis of potential hazards has proved to be a firm basis for decision-making in the management of food safety risks. Since 1955, the use of scientific expert bodies by FAO and WHO to evaluate food safety risks has provided sound advice to the Member Governments and the Codex Alimentarius Commission on how to manage such risks. The pro-cedures have also served as models for similar expert bodies serving in member countries.
Scientific evidence is not sufficient in itself for the establishment of risk management measures. Other legitimate factors need to be taken into account, but they need to be well documented and should not affect the scientific process. They should never be presented as an alternative to the scientific process.
1 This article was one of the papers presented at the Legal Platform for Consumer Concerns and International Trade in Food and Agriculture, The Hague, 15-16 February 2002.
2 Codex Alimentarius Commission, Appendix to the Procedural Manual, General Decisions (adopted at the 21st Session of the Commission, 1995), 12th ed., FAO/WHO, Rome, 2001 (also available at http://www.fao.org/docrep/005/y2200e/y2200e00.htm).
3 This text is Section 2 of FAO, Food quality and safety systems - A training manual on food hygiene and the hazard analysis and critical control point (HACCP)
system, Rome, 1998 (http://www.fao.org/docrep/ W8088E/W8088E00.htm).
4 The EC-United States-Canada dispute on hormones in meat production provided an opportunity to closely examine the risk assessment process used by JECFA and the subsequent establishment of standards by the Codex Alimentarius Commission. In the final analysis, however, the Codex standards were not critical determinants in the resolution of the dispute.
5 The full list of criteria for the identification of other legitimate factors may be found in Codex Alimentarius Commission, op. cit., Appendix, "Criteria for the consideration of the other factors referred to in the second statement of principle", Decision of the 24th Session of the Commission, 2001.
