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8. Current risk management practices in the codex alimentarius commission, its subsidiary bodies, and advisory expert committees

The joint FAO/WHO Expert Committee on Food Additives and The Joint FAO/WHO Meeting on Pesticide Residues (JECFA and JMPR)
Codex Alimentarius Commission (CAC)
Codex Committee on Food Additives and Contaminants (CCFAC)
Codex Committee for Residues of Veterinary Drugs in Foods (CCRVDF)
Codex Committee on Pesticide Residues (CCPR)
Codex Committee on Food Hygiene (CCFH)
Codex Committee on General Principles (CCGP)
Codex Committee on Food Labelling (CCFL)
Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS)
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)
Codex Committee on Methods of Analysis and Sampling (CCMAS)
Codex Committee on Meat Hygiene (CCMH)

The joint FAO/WHO Expert Committee on Food Additives and The Joint FAO/WHO Meeting on Pesticide Residues (JECFA and JMPR)

FAO and WHO jointly convene sessions of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). Participants in sessions are eminent scientists selected by FAO and WHO to participate in these committees in their own personal capacity as scientific and technical experts. They have responsibility for providing FAO and WHO, after thorough evaluation of appropriate chemical, toxicological and other data necessary, with authoratative recommendations on the substances under review. These committees are completely independent of the Codex system and their advice is to FAO and WHO and to Members of FAO and WHO. In addition this meets the need of the Codex system for independent scientific advice in arriving at science based Codex recommendations.

JECFA and JMPR are scientific advisory bodies which were established in the 1950's, prior to the establishment of the CAC. Over the past forty years they have provided independent scientific advice to all FAO and WHO Member Countries. They have also provided science based evaluations of substances which have been requested by CCFAC and CCRVDF in the case of JECFA, and CCPR in the case of JMPR. The traditional and current activities of JECFA and JMPR are mainly in the area of risk assessment, not risk management. The WHO components of JECFA and JMPR provide a permanent formal mechanism for assessing the toxicity of food additives, contaminants, veterinary drugs, pesticides, feed additives, solvents and processing aids in food. Their primary role is to evaluate toxicological data to determine a safe level of human exposure - normally an Acceptable Daily Intake (ADI) for food additives, veterinary drugs and pesticides and a Provisional Tolerable Weekly (or Daily) Intake (PTWI) for contaminants.

The activities of the FAO component of JECFA are mainly in the area of preparing specifications of identity and purity for food additives, estimating intakes of food additives and contaminants, and proposing maximum limits for residues of veterinary drugs in foods of animal origin. The activities of the FAO components of JMPR are mainly in the area of technological efficacy and minimum effective levels of pesticides as they are used in agriculture to control crop pests and diseases, and on likely residues on various crops based on Good Agricultural Practice (GAP). JECFA and JMPR evaluate data on the use and presence of the chemicals they assess in primary agricultural produce, food of animal origin and processed food based on GAP, Good Practice in the Use of Veterinary Drugs (GPVD) and Good Manufacturing Practice (GMP), respectively. This includes consideration of other relevant data such as plant and animal metabolism and analytical methodology. These activities contribute to the overall objectives of food safety by assuring that food additives, veterinary drugs and pesticides are used properly and pose the minimum risk to consumers. The levels recommended (MRLs and Maximum Levels) by the FAO components of JECFA and JMPR are used as the initial basis for exposure calculations, which are an essential component of risk characterisation. FAO and WHO jointly estimate intakes of food additives and contaminants.

Risk Assessment Policy in JECFA and JMPR

JECFA and JMPR utilise certain significant risk assessment policies at specific decision points in their work. Such risk assessment policies are properly the responsibility of CCFAC, CCRVDF, CCPR and CAC. They are, however, used by JECFA and JMPR and are described in detail in relevant WHO Environmental Health Criteria documents. They include the following examples:

· Reliance on animal models to establish potential human effects.

· Using body weight scaling for interspecies comparison.

· Assuming that absorption in animals and humans is approximately the same.

· Using a 100-fold safety factor to account for likely inter- and intra-species differences in susceptibility, with guidelines for deviations that are permitted in specified situations.

· The decision not to assign ADIs to food additives, veterinary drugs and pesticides which are found to be genotoxic carcinogens. Quantitative risk assessment has not been employed for these substances. In effect, there is no recognized acceptable risk level for genotoxic food additives, residues of veterinary drugs or pesticides.

· Permitting contaminants at levels "as low as reasonably achievable" (ALARA).

· Establishing temporary ADIs for additives and residues of veterinary drugs pending submission of requested data. It should be noted, however, that this policy is not used by JMPR in the establishment of ADIs for pesticide residues.

In carrying out their work the experts in JECFA and JMPR continually need to select and utilise various scientific assumptions. This is necessary because there are inevitable gaps in the science of risk assessment that need to be filled with default assumptions in order to be able to conduct a risk assessment. These assumptions also need to be constantly re-evaluated to keep them up-to-date with scientific developments. Each of these represent scientific value judgements ("risk assessment policy"), and the assumptions embodied in them can significantly influence the outcome of the risk assessment. Each also represents a choice among a number of plausible alternatives.

Codex Alimentarius Commission (CAC)

The primary purpose of the Joint FAO/WHO Food Standards Programme of CAC is to protect the health of consumers and ensure fair practice in the food trade. CAC formally adopts Codex standards, guidelines and other recommendations which have been developed by its subsidiary bodies. In addition, CAC provides guidance to these subsidiary bodies, including that related to risk management.

The development of standards, guidelines and recommendations has been delegated by CAC to its subsidiary bodies. Normally, the general subject ("horizontal") Codex committees are more routinely involved in risk management. These include the Codex Committees on Food Additives and Contaminants (CCFAC), Pesticide Residues (CCPR), Residues of Veterinary Drugs in Foods (CCRVDF), Food Hygiene (CCFH), General Principles (CCGP), Food Labelling (CCFL), Nutrition and Food for Special Dietary Uses (CCNFSDU), Import and Export Inspection and Certification Systems (CCFICS), and Methods of Analysis and Sampling (CCMAS). In addition, a range of commodity committees is also involved in risk management activities.

The work of these committees is supported by expert advisory groups, such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), as well as other expert bodies, such as ICMSF (International Commission on Microbiological Specifications for Food). In addition, FAO and WHO, usually jointly, convene consultations on specific matters of interest to Codex and member countries. However, the most important of these advisory groups for Codex are JECFA and JMPR. Recommendations of JECFA and JMPR are used by CCFAC, CCRVDF and CCPR as well as other Codex committees in the development of Codex standards, guidelines and other recommendations.

Standards may be for world-wide use, or for use by a given region or specific group of countries. All Members of CAC and interested international organisations are invited to comment on proposed standards, including possible implications for their economic interests. In considering such comments, CAC "should have due regard to the purposes of the Codex Alimentarius" (3). Members are encouraged to consult with interested and affected parties in their countries.

Provisions in Codex standards defining description, essential composition and quality factors should not be the subject of risk analysis within the context accepted by CCGP (4). However, the Procedural Manual of CAC notes that essential composition and quality factors can overlap with food safety i.e. "quality factors could include the quality of the raw material, with the object of protecting the health of the consumer" (3).

The production of genetically modified foods is expected to increase dramatically in the coming years. Biotechnology will be under consideration in several Codex committees and is expected to be addressed by CAC as a "horizontal" issue, taking into consideration the report of the Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety (30 September to 4 October 1996).

The CAC 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* state that standards, guidelines and other recommendations of Codex shall be based on the principle of sound scientific advice and evidence, and where appropriate. Codex will have regard to other legitimate factors relevant to the health protection of consumers and for the promotion of fair practices in food trade (5). Codex principles of risk management must be guided by these statements, as well as by the provisions of the SPS Agreement. To date, these "other legitimate factors" have not been defined or considered in the risk management context.

* The 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 include the following:

1. The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply.

2. When elaborating and deciding upon food standards Codex Alimentarius will have regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.

3. In this regard it is noted that food labelling plays an important role in furthering both of these objectives.

4. When the situation arises that members of Codex agree on the necessary level of protection of public health but hold differing views about other considerations, members may abstain from acceptance of the relevant standard without necessarily preventing the decision by Codex.

Codex Committee on Food Additives and Contaminants (CCFAC)

The primary role of CCFAC is to recommend appropriate standards for food additives and contaminants to CAC. In the case of additives, CCFAC specifically considers technological justification and need for proposed levels of use. CCFAC also assigns priorities to additives and contaminants for JECFA evaluation.

Probable daily exposures and their relationship to the ADI need to be taken into account when endorsing or establishing permitted maximum levels of additives in food. Different approaches are required for risk management of additives and contaminants. In the case of additives, both the range of foods in which the additive is allowed and the concentration of the additive in individual foods can be specifically controlled by choosing particular risk management options.

In the case of contaminants, however, these control options are often not available, and the normal mechanism is for CCFAC to set levels of contaminants which are as low as reasonably achievable (ALARA).

Previously, CCFAC incorporated food additive usage into individual Codex food standards. CCFAC is changing its risk management approach and is developing general risk analysis approaches that can be applied to all foods or classes of food through the development of the Draft General Standard for Food Additives (GSFA) and the Draft General Standard for Contaminants and Toxins in Foods (GSCTF) (6). The GSFA covers the use of additives in all foodstuffs. The approach recommended to be used in the GSFA provides the framework in which exposure assessments will be considered. Annex I of the GSCTF refers to the need for maximum limits to be based on an evaluation of both public health considerations and the possibilities and problems of complying with a proposed standard. Maximum levels may be based on Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) considerations and an ALARA approach. CCFAC is working on risk management criteria for assigning maximum levels for contaminants in traded foods, but they are not yet agreed. Annex II of GSCTF presents "Procedures for Risk Management Decisions" that categorise necessary information requirements and actions by CAC in the elaboration of maximum limits for contaminants, but no guidelines are provided on risk management decision-making per se.

The CCFAC preamble to the Codex General Standard for Contaminants and Toxins in Foods provides an initial framework for risk management decision-making for these classes of hazards (7). It is suggested that new consideration should be given to acute and long-term toxicity. Economic aspects related to contaminant level management and control are also listed as relevant criteria. "Acceptability" generally refers to notionally zero health risk, although other criteria are listed for possible consideration in risk management decisions.

Codex Committee for Residues of Veterinary Drugs in Foods (CCRVDF)

The primary role of CCRVDF is to recommend MRLs for residues of veterinary drugs in food. CCRVDF relies on its expert committee (JECFA) to derive initial recommendations for MRLs. In this regard, CCRVDF has accepted some risk management decision-making by JECFA. This includes the decision to use different safety factors based on the amount and quality of data available to JECFA and the formulation of new guidelines when necessary to address new or emerging issues such as the establishment of microbiological end-points as a safety criterion for antimicrobial drug residues. CCRVDF reviews the basis for JECFA recommendations prior to deciding whether to accept the proposed MRL.

CCRVDF may determine that an MRL should not be adopted because adequate methods of analysis are not available for detecting the residues in specific animal-derived foods, or because pertinent new information has been generated which was not available to JECFA when it undertook its evaluation. CCRVDF may request that JECFA reassess the recommendation for an MRL based on concerns raised by CCRVDF. On occasion CCRVDF has elected not to accept the recommendations of JECFA, by retaining indefinitely the MRL at Step 4 or Step 7 of the Codex process. To date, however, CCRVDF has not attempted to change the numerical value of an MRL without the concurrence of JECFA.

In principle, CCRVDF considers socio-economic and political issues as does CCFAC. Health-based end-points which are not related to toxicity, such as allergenic potential, pharmacological effects and antimicrobial effects of particular residues, are complex issues which often are addressed on a case-by-case basis.

When establishing an MRL, consideration is given to residues that occur in food of plant origin and/or in the environment. In the evaluation of substances that may have both veterinary drug and pesticide use, dialogue with CCPR is necessary and currently this is carried out on an ad hoc basis.

Codex Committee on Pesticide Residues (CCPR)

CCPR advises CAC on matters relating to pesticide residues affecting international trade, primarily by recommending draft Codex MRLs in food and animal feeds. Recommended ADIs and MRLs are provided to CCPR by JMPR after consideration of residue and other data.

Residue data are obtained primarily from supervised residue trials in accordance with nationally registered uses. Elaboration and acceptance of MRLs for particular pesticides rests on the premise of common agreement on what constitutes Good Agricultural Practices (GAP). There is a recognised need to accommodate those countries that have a legitimate need for GAP resulting in higher residues in food, as long as those residues do not present an "unacceptable" risk to human health.

There is no direct connection between the establishment of ADIs and MRLs. However, a comparison of dietary exposure estimates with the ADI should indicate that foods complying with MRLs are safe for human consumption.

Predictions of dietary exposure are used for deciding on the acceptability of proposed draft Codex MRLs. If the ADI is exceeded by the estimate of exposure after all relevant factors are applied, dietary exposure concerns become a risk management issue.

JMPR and CCPR use the 1989 Guidelines on the Prediction of Dietary Intake of Pesticide Residues on a routine basis in establishing MRLs. Each year JMPR publishes a summary of the dietary exposure estimates of the pesticides evaluated in that year in their report and makes detailed calculations available to CCPR. Whenever Members of CCPR express reservations against MRLs because their exposure estimates exceed the ADI, they are invited to submit their exposure calculations. In the case of pesticides the only risk management option is to amend GAP in order to ensure that the MRLs no longer give rise to exposure concerns.

Exposure calculations performed at the international and national level may give very different results. JMPR uses the GEMS/Food regional diets to calculate the exposure. These diets reflect average regional consumption patterns, however, national governments may use national diets, when available. Some Governments routinely calculate the exposure for higher percentiles of their population or may consider the exposure of sensitive sub-groups (e.g. young children).

Because of these different approaches in dietary exposure estimates, Members of CCPR may arrive at different conclusions about the acceptability of certain MRLs. Moreover, there are different policy views about the point at which concern for exposure becomes a risk management issue. The Guidelines explicitly state that a worst-case estimate is a gross overestimate of true exposure and that more refined calculations should be performed using other relevant data. However, some Members of CCPR reject MRLs when this additional data is not available. Others rely, for instance, on monitoring data, which may demonstrate that no exposure problems are to be expected.

Since 1992 CCPR has begun to deal with these issues in a more systematic way. As a consequence CCPR decided not to advance a number of MRLs through the Codex step procedure. It is recognised that harmonisation of exposure models at the international level is not feasible at present. The currently developed Revised Guidelines for Predicting Dietary Intake of Pesticide Residues, based upon the recommendations of a joint FAO/WHO consultation held 2-6 May 1995 in York, United Kingdom, has important risk assessment and risk management implications. The use of these revised guidelines should significantly reduce the number of cases where exposure assessments cause unnecessary concern. Nevertheless there is still a need for CCPR to reach consensus on these matters. The York Consultation identified acute food intake and sensitive consumer groups as new issues for dietary exposure.

Recent meetings of JMPR have established acute reference doses (acute RfD) for several pesticides which have the potential for causing acute effects after consumption of one meal or over the course of meals eaten during one day. The York consultation has recommended a general screening method for estimating exposure for acute hazards and details of implementing this method will be discussed at the Joint FAO/WHO Consultation on Food Consumption and Exposure Assessment of Chemicals, 10-14 February 1997 at WHO Headquarters, Geneva. Consequently CCPR will face risk management decisions in these new areas.

It should be realised that, while amending GAP is the only management option for CCPR, CCPR cannot enforce changes in GAP and can only request Governments and manufacturers to do so. However, if this proves unsuccessful, CCPR may have no other option than to recommend deletion of MRLs from the Codex system.

The work of CCPR in elaborating guidelines for interpretation of residue findings in food consignments is an example of a risk management approach of a qualitative type.

Codex Committee on Food Hygiene (CCFH)

CCFH is a general purpose Committee that has the overall responsibility for all provisions on food hygiene prepared by Codex commodity committees, which are contained in commodity standards, codes of practice and guidelines. CCFH also develops general principles, codes of practice and guidelines for food hygiene as well as microbiological criteria for food, to be applied horizontally across Codex Committees. Food hygiene is defined as "all conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain" (13, Appendix II).

According to deliberations at the 29th session of CCFH (8), the microbiological safety of foods is principally assured by control at the source, product design and process control and the application of good hygienic practices during production, processing (including labelling), handling, distribution, storage, sale, preparation and use, preferably in conjunction with the application of the Hazard Analysis and Critical Control Point (HACCP) system. This "preventive" system offers more control than end-product testing, because the effectiveness of microbiological examination in assessing the safety of food is limited.

When objectives for food safety have been established by Codex or national risk managers, these can be taken up by the industry, and by the application of HACCP (or an equivalent food safety management system) the industry can assure that these objectives are met. This is a use of HACCP as a "corrective" risk management option - a risk is identified and a management option selected and implemented. HACCP is also used as a "preventive" risk management tool. In this case, a hazard analysis (the first analytical step in the application of HACCP) identifies potential hazards in raw materials, production line and line-environment that need to be controlled to prevent potential harm to the consumer. "Hazard analysis" is defined as "The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan". (8, Appendix II) Input concerning the potential hazards and their control could come from risk analysis, but often such information is not available and industries need to apply best judgement.

The Draft Revised Principles for the Establishment and Application of Microbiological Criteria for Foods states: "Microbiological criteria should be established according to these principles, and be based on scientific analysis and advice, and where sufficient data are available, on a risk analysis appropriate to the foodstuff and its use." (8, Appendix III) These criteria may be relevant to the examination of foods, including raw materials and ingredients of unknown or uncertain origin, or when no other means of verifying the efficacy of HACCP based systems and good hygienic practices are available. Microbiological criteria may also be used to determine that processes are consistent with the General Principles of Food Hygiene. Microbiological criteria are not normally suitable for monitoring Critical Limits as defined in the HACCP system.

Establishing microbiological criteria, and food safety objectives in general, is difficult because of the considerable knowledge gap relating to biological hazards and their relationship to adverse human health outcomes. This has led to many evaluations by CCFH which are based on subjective or qualitative assessments being used as the basis for recommendations. While aware of these limitations, CCFH is now developing a framework of principles and guidelines for the application of microbiological risk assessment. This was in response to the recommendation of the 1995 Joint FAO/WHO Expert Consultation on the Application of Risk Assessment to Food Standards, relating to application of risk assessment within the Joint FAO/WHO Food Standards Programme. ICMSF and CCFH delegations are also in the process of developing background papers on a number of foodborne pathogens, to better enable quantitative risk assessments and subsequent food safety objectives to be set. Notwithstanding the development of risk analysis approaches by these groups, it is apparent that the work of CCFH and all Codex committees would benefit from advice from an expert body on foodborne biological hazards for purposes of risk management. The committee could be modelled on JECFA and JMPR, allowing for the unique consideration of pathogens causing human illness, including epidemiological and clinical data and the dynamics of microbial populations in food throughout the food chain.

Control of Listeria monocytogenes in foods provides an example of the need to consider a structured risk management approach. Listeria are frequently consumed in small amounts by the general population without apparent ill effects. It is believed by many that only higher levels of Listeria have caused severe disease problems. It is also believed that Listeria is a bacterium which will always be present in the environment. Therefore, the critical issue may not be how to prevent Listeria in foods, but how to control its survival and growth in order to minimise the potential risk. Complete absence of Listeria is unrealistic and unattainable in many foods, and trying to achieve this goal can limit trade without having any appreciable benefit to public health. A relevant risk management option, therefore, is to focus on foods which have historically been associated with human disease, and foods that support growth of Listeria to high levels, rather than those that do not. Thus, establishment of tolerable low levels of Listeria in specific foods may be one food safety objective established by risk managers after a rigorous and transparent risk analysis. Such an approach is now being considered by CCFH based on an initial risk assessment by the ICMSF and certain CCFH delegations.

Although Listeria presents unique challenges in terms of its widespread occurrence and the particular susceptibility of vulnerable groups, CCFH is also addressing pathogens such as E. coli 0157:H7, Salmonella and Campylobacter. These microbial pathogens produce acute foodborne illnesses and can also cause severe chronic sequela, creating a significant public health burden and food safety concern.

Codex Committee on General Principles (CCGP)

CCGP deals with procedural and general matters, including establishment of principles which define the purpose and scope of the Codex Alimentarius and the nature of Codex standards. Development of mechanisms to address any economic impact statements is also a responsibility of CCGP. However, at present, there is no guidance on how this should be done.

CCGP will have an increasing role in the evolution of a risk analysis approach and this is formally recognised in the report of the Twelfth Session (4). At this Session, CCGP proposed that CAC annex The 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 into its Procedural Manual. CCGP also proposed that the Statements of Principle Relating to The Role of Food Safety Risk Assessment and Risk Analysis Definitions be annexed to the Manual.

CCGP has recommended that the "Elaboration Procedures" section of the Procedural Manual should contain a new chapter on integrating risk management principles into the Codex decision-making process, outlining the responsibilities of the committees concerned (9).

Codex Committee on Food Labelling (CCFL)

Risk analysis concepts are being applied with greater rigour in the consideration of public health related matters. This was apparent in the way CCFL responded to the recommendations of the FAO Technical Consultation on Food Allergies, 13-14 November 1995, Rome. CCFL will be discussing the labelling of biotechnology products and the subject could serve as a model for the application of the risk management framework as elaborated in this report. Labelling is one important risk management option. For example, risk is reduced and/or avoided through the identification of allergenic substances and the display of preparation and storage instructions.

Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS)

Codex is increasingly recognising the need for application of the broad mandate of a risk analysis approach to all aspects of food safety. One aspect of this is reflected in the recent work of CCFICS. This Committee has stated that its programme of work is to be fully based on risk analysis principles and the draft Proposed guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems states that "the frequency and intensity of controls by inspections systems should be designed so as to take account of risk and reliability of controls already carried out by those handling the products including producers, manufacturers, importers, exporters, and distributors." (10). This suggests that Codex texts incorporating "horizontal" risk management issues should not be overly prescriptive, and should be focused on agreed food safety outcomes rather than processes.

CCFICS recognises that differences in food safety programmes between countries inevitably exist, and are often the result of a different spectrum and prevalence of foodborne hazards or different food production systems. However, a food safety programme in an exporting country may achieve an importing country's appropriate level of sanitary protection and the concept of "equivalence" describes the justification for trade in such circumstances. CCFICS has defined equivalence as "the capability of different inspection systems to meet the same objectives" (11, Appendix 3).

CCFICS work in elaborating general principles and guidelines for the design and operation of food inspection systems has as a core component the application of risk analysis approaches. In assessing different food inspection systems it is recognised that different risk management approaches may produce the same food safety outcomes with the result that the different systems may be regarded as equivalent. These Codex "norms" therefore provide practical guidance for the broad application of risk management to the design and operation of food inspection programmes and are consistent with the provisions of the SPS Agreement relating to the use of scientifically based risk assessment procedures.

The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)

The CCNFSDU is responsible for developing guidelines, general principles and standards for food for special dietary uses, alone or in cooperation with other Codex committees, and for studying nutritional issues referred to it by the CAC, including endorsement of provisions covering the nutritional aspects of all draft standards or Codex texts. In considering the risk management option, the CCNFSDU must often contend with nutritional hazards posed by both under- and over-consumption of nutrients. Hazards posed by food intolerances are also difficult to assess, particularly in defining the population at risk. Moreover, great uncertainties surround nutritional risk assessment, especially with respect to appropriate levels of dietary intake for micronutrients.

The CCNFSDU has successfully addressed a number of potentially controversial topics which require skillful risk management and communication to achieve consensus. For example, a broad spectrum of views on foods for infants and children, including infant formula, is reflected in corresponding divergent views on their control. Another example is the standard for labelling of and claims for foods for special medical purposes which is an area that is replete with risk management concerns. This Committee is currently drafting "Guidelines on use of nutritional claims" and considering proposed draft "Guidelines on dietary supplements", both of which involve substantial risk management judgement. In the future, the CCNFSDU will be asked to evaluate the nutritional aspects of foods derived by biotechnology which will present a significant risk management and communication challenge.

Codex Committee on Methods of Analysis and Sampling (CCMAS)

CCMAS considers, amends if necessary, and endorses methods of analysis and sampling proposed by specific committees. Performance criteria are selected as appropriate and guidelines for sampling systems must be practical in their application and have a sound statistical basis. Committees submitting sampling plans to CCMAS need to supply details that include decision rules, and "levels of risk to be accepted" (3).

Codex Committee on Meat Hygiene (CCMH)

CCMH provides one example of a commodity committee which will be increasingly concerned with risk management. The function of CCMH is to elaborate standards and/or codes of practice for meat hygiene. In CCMH's recent review of its codes of practice, risk analysis principles were addressed. These principles recognise the fact that it is inconsistent to recommend subjective and generally non-quantified guidelines for controlling contamination, yet have very detailed but unproven lists of procedures for post mortem inspection of broad classes of livestock for application on an international basis. HACCP is advocated as the risk management tool of choice to limit contamination and multiplication of pathogens during the production of meat.

Systematic application of risk analysis methodology is required to make an overall assessment of risks and benefits in a meat hygiene programme and allocate inspection resources accordingly. This places important risk management responsibilities on national controlling authorities. Unseen contamination of meat with enteric pathogens has emerged as the dominant cause of meat-borne diseases, and reallocation of resources within meat hygiene programmes is required to combat this source of hazards.

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