(At Step 8)
ANNEX I
CRITERIA FOR THE ESTABLISHMENT OF MAXIMUM LEVELS IN FOODS
INTRODUCTION
In this Annex criteria are mentioned regarding information which is considered necessary for evaluating contaminant problems in foods and for the establishment of maximum levels. It is therefore important that these criteria are taken into account when information is supplied to JECFA and/or to the CCFAC.
The criteria mentioned here are elaborated in more detail than in section I.3.3. of the Preamble. Only those aspects are mentioned that need further clarification, so criteria or aspects that are not mentioned here should not be ruled out in the evaluation process.
Toxicological information
Integrated toxicological expert advice regarding a safe/tolerable intake level of a contaminant is essential when decisions about maximum levels in foods are considered. A recommendation from JECFA regarding the maximum allowable or tolerable intake, based on a full evaluation of an adequate toxicological data base, shall be the main basis for decisions by CCFAC. In urgent cases, it may be possible to rely on less developed evaluations from JECFA or on toxicological expert advice from other international or national bodies.
When toxicological information is presented in relation to proposals for maximum levels for contaminants in foods, indications are desirable about the following aspects:
identification of the toxic substance(s)
metabolism in humans and animals, as appropriate
toxicokinetics and toxicodynamics
information about acute and long term toxicity in animals and humans, including epidemiological data on humans and other relevant toxicity data
conclusions and advice of toxicological expert(s) (groups), with references, including information on specially vulnerable population groups or animals.
Analytical data
Validated qualitative and quantitative analytical data on representative samples should be supplied. Information on the analytical and sampling methods used and on the validation of the results is desirable. A statement on the representativity of the samples for the contamination of the product in general (e.g. on a national basis) should be added. The portion of the commodity that was analyzed and to which the contaminant content is related should be clearly stated and preferably should be equivalent to the definition of the commodity for this purpose or to existing related residue regulation.
Appropriate sampling procedures should be applied. Special attention to this aspect is necessary in the case of contaminants that may be unequally distributed in the product (e.g. mycotoxins in some commodities).
Intake data
It is desirable to have information about the contaminant concentrations in those foods or food groups that (together) are responsible for at least half and preferably 80 % or more of the total dietary intake of the contaminant, both for average consumers and for high consumers.
Information about the presence of the contaminant in foods that are widely consumed (staple foods) is desirable in order to be able to make a satisfactory assessment of the contaminant intake and of risks associated with food trade.
Food consumption data for average, most exposed and susceptible consumer groups are desirable for evaluations of (potential) intake of contaminants. This problem, however, has to be addressed differently on a national and on an international scale. It is therefore important to have information about both average and high consumption patterns regarding a wide scale of foodstuffs, so that for every contaminant the most exposed consumer groups may be identified. Detailed information about high consumption patterns is desirable, both regarding group identification criteria (e.g. age or sex differences, vegetarian or regional dietary customs, etc.) and statistical aspects.
Dietary intake of contaminants: Reference is made to the Guidelines for the study of dietary intake of chemical contaminants (WHO). It is important to supply all relevant details, such as the type of study (duplicate diet, total diet or market basket study, selective study), and statistical details. Calculated contaminant intake data from food consumption models may also be useful. When results about food groups and about effects of preparation and cooking etc. are available, these should also be supplied.
Fair trade considerations
Existing, expected or potential problems in international trade: In order to assess the urgency of a problem to be discussed by CCFAC it is important to have information about the magnitude of existing or expected problems, both regarding the amount and the source of the food or feed that is at stake and the concerned parties and economic aspects involved. Potential problems should also be indicated.
Foods concerned moving in international trade: The main exporting and importing countries for commodities which are involved in the issue should be identified and it is essential that information is available about contaminant concentrations in the commodities originating from the main exporting countries.
Information about national regulations: It is desirable that details are made available by countries (especially the main exporting and importing countries) about their national regulations regarding the contaminant in question, in particular on the data and the considerations on which these regulations are based. For a good evaluation of the problem it is essential that not only the data base is clear, but also the risk assessment and risk management policy which is used for making decisions regarding maximum levels in foods.
Technological considerations
Information about the source of the contaminant and the way in which the food is contaminated, possibly including information, if it is available, about contamination being present n parts only of the product, is essential for assessing the possibilities to control the contamination process and to be able to guarantee a desired product quality. Where possible Source-related measures should be proposed. Good Manufacturing Practice (GMP) and/or Good Agricultural Practice (GAP) should also be formulated to control a contamination problem. When this is possible, maximum levels may be based on GMP or GAP considerations and may thus be established at a level as low as reasonably achievable. Considerations regarding the technological possibilities to control a contamination problem, e. g. by cleaning, should also be taken into account when a primary risk assessment model (theoretical maximum daily intake) shows possible intakes exceeding the toxicological maximum intake recommendation. In such a case the possibilities of lower contamination levels need further careful examination. Then a detailed study about all the aspects involved is necessary, so that decisions about maximum limits can be based on a thorough evaluation of both the public health arguments and the possibilities and problems to comply with the proposed standard.
Risk assessment and risk management considerations
A tiered approach, involving risk assessment and risk management procedures, is recommended for developing a consistent policy regarding public health risks related to contaminants in foods.
Risk assessment is defined as the scientific evaluation of the probability of occurrence of known or potential adverse health effects resulting from human exposure to foodborne hazards. The process consists of the following steps: hazard identification, hazard characterization, exposure assessment and risk characterization. (The definition includes quantitative risk assessment, which emphasizes reliance on numerical expressions of risk, and also qualitative expressions of risk, as well as an indication of the attendant uncertainties.
The first steps are hazard identification and hazard characterization. Hazard identification is the identification of known or potential health effects in humans, produced by a contaminant which may be present in a particular food or group of foods. Hazard characterization is the qualitative and, if possible, quantitative evaluation of the nature of the adverse effects associated with the food contaminant, including a dose/response assessment and, when possible, the establishment of a safety standard (ADI, TDI or comparable toxicological recommendation) for the intake of the contaminant. The exposure assessment is the qualitative and, when possible, quantitative evaluation of the likely intake of the contaminant via food, as well as exposure from other sources if relevant. In the risk characterization step, the hazard identification, hazard characterization and exposure assessment are combined into an estimation of the severity and occurrence of known or potential health effects likely to occur in a given population, including attendant uncertainties.
Potential public health risks can be considered to exist when there is evidence that the contaminant intake of (groups of) consumers may exceed (on a long term basis for long term recommendations) the toxicological recommendation about the maximum acceptable or tolerable intake level. More specific estimation and description of the risks will be necessary to deal adequately with cases when intakes exceeding the toxicological standard occur in practice and cannot easily be reduced. This also applies when it has not been possible to establish a safe dose level of the contaminant.
Risk management is defined as the process of weighing policy alternatives in the light of the risk assessment and, if required, to select and implement appropriate control options, including the establishment and enforcement of maximum levels of contaminants in foods. It is based on adequate risk assessment and on information about policy options and strategies to deal with contamination problems and involves risk communication.
Risk communication is the interactive exchange of information and opinions concerning risk among risk assessors, risk managers and other interested parties. Responsible risk management is based on consistent application of an appropriate policy regarding the protection of public health, but also involves taking into account other relevant criteria, such as the available analytical data, the technological possibilities to control the contamination of products, economic factors and fair trade criteria.
In short, the risk assessment shall establish how many consumers possibly exceed the toxicological standard, and for how long time and how much, and what this implies as real health risks. Risk management involves, in a consistent way, deciding what is acceptable in this respect and what is not, to what extent other factors can be taken into account, and decisions and actions to achieve sufficient public health protection and control of the contamination.
Risk management decisions may lead to maximum levels for foods. In the process leading to such a decision, the consequences, costs and benefits should be presented and evaluated in relation to other policy options.
Establishment of maximum levels for contaminants
The establishment of maximum levels of contaminants in foods involves several principles, some of which have already been mentioned. Briefly stated, the following criteria will help in maintaining a consistent policy in this matter:
MLs shall be set only for those contaminants that present both a significant risk to public health and a known or expected problem in international trade.
MLs shall be set only for those foods that are significant for the total exposure of the consumer to the contaminant
MLs shall be set as low as reasonably achievable. Providing it is acceptable from the toxicological point of view, MLs shall be set at a level which is (slightly) higher than the normal range of variation in levels in foods that are produced with current adequate technological methods, in order to avoid undue disruptions of food production and trade. Where possible, MLs shall be based on GMP and/or GAP considerations in which the health concerns have been incorporated as a guiding principle to achieve contaminant levels as low as reasonably achievable. Foods that are evidently contaminated by local situations or processing conditions that can be avoided by reasonably achievable means shall be excluded in this evaluation, unless a higher ML can be shown to be acceptable from a public health point of view and appreciable economic aspects are at stake.
Proposals for MLs in products shall be based on data from at least various countries and sources, encompassing the main production areas/processes of those products, as far as they are engaged in international trade. When there is evidence that contamination patterns are sufficiently understood and will be comparable on a global scale, more limited data may be enough.
MLs may be set for product groups when sufficient information is available about the contamination pattern for the whole group, or when there are other arguments that extrapolation is appropriate.
Numerical values for MLs shall preferably be regular figures in a geometric scale (0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5 etc.), unless this may pose problems in the acceptability of the MLs.
MLs shall apply to representative samples per lot. If necessary, appropriate methods of sampling shall be specified.
MLs should not be lower than a level which can be analyzed with methods of analysis that can be readily applied in normal product control laboratories, unless public health considerations necessitate a lower detection limit which can only be controlled by means of a more elaborate method of analysis. In all cases, however, a validated method of analysis should be available with which a ML can be controlled.
The contaminant as it should be analyzed and to which the ML applies should be clearly defined. The definition may include important metabolites when this is appropriate from an analytical or toxicological point of view. It may also be aimed at indicator substances which are chosen from a group of related contaminants.
The product as it should be analyzed and to which the ML applies, should be clearly defined. In general, MLs are set on primary products. MLs shall in general preferably be expressed as a level of the contaminant related to the product as it is, on a fresh weight basis. In some cases, however, there may be valid arguments to prefer expression on a dry weight basis. Preferably the product shall be defined as it moves in trade, with provisions where necessary for the removal of inedible parts that might disturb the preparation of the sample and the analysis. The product definitions used by the CCPR and contained in the Classification of foods and feeds may serve as guidance on this subject; other product definitions should only be used for specified reasons. For contaminant purposes, however, analysis and consequently MLs will preferably be on the basis of the edible part of the product.
For fat soluble contaminants which may accumulate in animal products, provisions should be applied regarding the application of the ML to products with various fat content (comparable to the provisions for fat soluble pesticides).
Guidance is desirable regarding the possible application of MLs established for primary products to processed products and multi-ingredient products. When products are concentrated, dried or diluted, use of the concentration or dilution factor is generally appropriate in order to be able to obtain a primary judgment of the contaminant levels in these processed products. The maximum contaminant concentration in a multi-ingredient food can likewise be calculated from the composition of the food. Information regarding the behaviour of the contaminant during processing (e.g. washing, peeling, extraction, cooking, drying etc.) is however desirable to give more adequate guidance here. When contaminant levels are consistently different in processed products related to the primary products from which they are derived, and sufficient information is available about the contamination pattern, it may be appropriate to establish separate maximum levels for these processed products. This also applies when contamination may occur during processing. In general however, maximum levels should preferably be set for primary agricultural products and may be applied to processed, derived and multi-ingredient foods by using appropriate factors. When these factors are sufficiently known, they should be added to the data base about the contaminant and mentioned in connection to the maximum level in a product.
MLs shall preferably not be set higher than is acceptable in a primary (theoretical maximum intake and risk estimation) approach of their acceptability from a public health point of view. When this poses problems in relation to other criteria for establishing MLs, further evaluations are necessary regarding the possibilities to reduce the contaminant levels, e.g. by improving GAP and/or GMP conditions. When this does not bring a satisfactory solution, further refined risk assessment and contaminant risk management evaluations will have to be made in order to try to reach agreement about an acceptable ML.
Procedure for risk assessment in relation to (proposed) MLs for contaminants
It will be evident that in the case of contaminants, it is more difficult to control food contamination problems than in the case of food additives and pesticide residues. Proposed MLs will inevitably be influenced by this situation. In order to promote acceptance of Codex contaminant MLs, it is therefore important that assessments of the acceptability of those MLs are done in a consistent and realistic way. The procedure involves assessment of the dietary intake in relation to the proposed or existing MLs and the maximally acceptable intake from the toxicological point of view.
For pesticide residues, Guidelines (WHO, 1989, revised 1995) have been prepared for predicting the dietary intake, involving a two-tiered approach with increasingly realistic predictions of intake. In the crude estimate phase, hypothetical global and cultural diets are used to calculate the theoretical maximum daily intake (TMDI) (based on proposed or existing MRLs). The best estimate involves the national dietary pattern and corrections for residue losses during transport, storage, food preparation, for known residue level in foods as consumed, etc. It is recommended to be cautious in using other than average food consumption values, although it is considered appropriate to use relevant average food consumption data for identifiable subgroups of the population. The procedure is used to assess the acceptability of proposed MRLs and to promote international acceptance of Codex MRLs.
For contaminants and natural toxins in food, essentially the same procedure is used. Food consumption patterns with a higher intake of critical foods may be used in the intake calculations when this is part of an accepted national or international health protection and risk management policy. A harmonized approach using an appropriate intake estimation model that is as realistic as possible is recommended. Calculated data should where possible always be compared with measured intake data. Proposals for Codex MLs should be accompanied by intake calculations and risk assessment conclusions regarding their acceptability and use. Statements from Governments about the (non-acceptance of (proposed) Codex MLs should refer to specified intake calculations and risk management conclusions which support this position.
ANNEX II
PROCEDURE FOR RISK MANAGEMENT DECISIONS
INTRODUCTION
The recommended procedure for risk management decisions in the CCFAC is presented here as a simple decision scheme based on the main criteria, mentioned in the Preamble, I.4.2.. Criterion (1), basic information about the contaminant (problem) is not further mentioned, because it is considered a prerequisite, without which no sensible discussion can take place, hazard identification and characterization. Criterion (5), technological and economic aspects, is an essential tool for making recommendations about the risk management of the contaminant problem and for developing MLs, and when this information is not adequate, further data shall be requested. Bearing this in mind, it need not be further mentioned in the decision scheme, which is shown below. Decisions can be based on the availability of information (- or + or ?) on the following criteria:
| (2a) | Tox | toxicological information, |
| (3) | PHP | potential health problems, |
| (2b) | A/In | analytical and intake data, |
| (4) | TP | international trade problems. |
The question mark ? is used in the column PHP, to indicate that only toxicological information is sufficiently available, or only intake data, so that there is no sufficient basis to decide whether there are potential health problems. Obviously, in practice there will be many situations which are not so clear cut as it is presented in the scheme. Information may be considered sufficient by some, and inadequate by others. Decisions will have to be taken on a case by case basis, considering the criteria mentioned in Annex I. Further quantification of the criteria for the necessary data base for making decisions may become inevitable when serious problems are encountered in practice regarding this aspect.
Risk management decision scheme for CCFAC
| Criterion | |||||
|---|---|---|---|---|---|
| Case | (2a) Tox | (2b) A/In | (3) PHP | (4) TP | CCFAC Action |
| 1. | - | + | ? | - | Request Tox data/evaluation by JECFA |
| 2. | - | + | ? | + | Request Tox data/evaluation by JECFA, national risk assessment. In urgent cases, CCFAC statement |
| 3. | + | - | ? | - | Request analytical/intake data |
| 4. | + | + | - | - | No further action |
| 5. | + | + | - | + | Request national risk assessment. After evaluation (in urgent cases, after a preliminary assessment) a CCFAC statement |
| 6. | + | + | + | - | Development of MLs by CCFAC |
| 7. | + | + | + | + | Development of MLs by CCFAC, with priority (in urgent cases, if necessary, temporary MLs) |
ANNEX III
FORMAT OF THE STANDARD
INTRODUCTION
The format for Schedule I shall contain the following elements:
Name of the contaminant: Symbols, synonyms, abbreviations, scientific descriptions and identification codes that are commonly used shall be mentioned, too.
Codex number of the contaminant: Number according to the list described in Annex IV.
Reference to JECFA meetings (in which the contaminant was discussed).
ADI, TDI, PTWI or similar toxicological intake recommendation: When the situation is complex a short statement and further references may be necessary here.
Residue definition: Definition of the contaminant as it shall be analyzed and to which the maximum level applies.
List of Codex standards for the contaminant in foods: This list shall be composed by the following elements, in columns:
When appropriate, instead of a maximum level a (note referring to a) statement regarding the contaminant in the mentioned food (category) may be inserted.
The format of Schedule II shall contain the following elements:
Name of food commodity/category
Classification number of food commodity or food category
List of Codex standards for contaminants in that food commodity/category
This list shall be composed by the following elements, in columns:
References to a Code of practice for the food, if appropriate
