Codex General Standard for Contaminants and Toxins in Food and Feed

1 Codex Standard 193-1995 Adopted 1995. Revised 1997, 2006, 2008, 2009. Amended 2010, 2012. CODEX GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FOOD AND FEED CODEX STAN 193-1995 1. PREAMBLE 1.1 SCOPE This Standard contains the main principles which are recommended by the Codex Alimentarius in dealing with contaminants and toxins in food and feed, and lists the maximum levels and associated sampling plans of contaminants and natural toxicants in food and feed which are recommended by the CAC to be applied to commodities moving in international trade. This Standard includes only maximum levels of contaminants and natural toxicants in feed in cases where the contaminant in feed can be transferred to food of animal origin and can be relevant for public health. 1.2 DEFINITION OF TERMS 1.2.1 General The definitions for the purpose of the Codex Alimentarius, as mentioned in the Procedural Manual, are applicable to the General Standard for Contaminants and Toxins in Food and Feed (GSCTFF) and only the most important ones are repeated here. Some new definitions are introduced, where this seems warranted to obtain optimal clarity. When reference is made to foods, this also applies to animal feed, in those cases where this is appropriate. 1.2.2 Contaminant Codex Alimentarius defines a contaminant as follows: “Any substance not intentionally added to food, which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter”. This standard applies to any substance that meets the terms of the Codex definition for a contaminant, including contaminants in feed for food-producing animals, except: 1) Contaminants having only food and feed quality significance (e.g. copper), but no public health significance, in the food(s) given that the standards elaborated within the Codex Committee on Contaminants in Foods (CCCF) has the objective to protect public health. 2) Pesticide residues, as defined by the Codex definition that are within the terms of reference of the Codex Committee on Pesticide Residues (CCPR). 3) Residues of veterinary drugs, as defined by the Codex definition, that are within the terms of reference of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). 4) Microbial toxins, such as botulinum toxin and staphylococcus enterotoxin, and microorganisms that are within the terms of reference of the Codex Committee on Food Hygiene (CCFH). 5) Residues of processing aids that are within the terms of reference of the Codex Committee on Food Additives (CCFA)1. 1.2.3 Natural toxins included in this standard The Codex definition of a contaminant implicitly includes naturally occurring toxicants including toxic metabolites of certain microfungi that are not intentionally added to food and feed (mycotoxins). Toxins that are produced by algae and that may be accumulated in edible aquatic organisms such as shellfish (phycotoxins) are also included in this standard. Mycotoxins and phycotoxins are both subclasses of contaminants. Endogenous natural toxicants, such as e.g. solanine in potatoes, that are implicit constituents of food and feed resulting from a genus, species or strain ordinarily producing hazardous levels of a toxic metabolite(s), i.e. phytotoxins are not generally considered within the scope of this standard. They are, however, within the terms of reference of the CCCF and will be dealt with on a case by case basis. 1 Processing aids are any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. 2 Codex Standard 193-1995 1.2.4 Maximum level and related terms2 The Codex maximum level (ML) for a contaminant in a food or feed commodity is the maximum concentration of that substance recommended by the Codex Alimentarius Commission (CAC) to be legally permitted in that commodity. 1.3 PRINCIPLES REGARDING CONTAMINANTS IN FOOD AND FEED 1.3.1 General Contamination of food and feed may pose a risk to human (and/or animal health). Moreover in some cases they may also have a negative impact on the quality of the food or feed. Food and feed can become contaminated by various causes and processes. Contaminant levels in food and feed shall be as low as reasonably achievable through best practice such as Good Agricultural Practice (GAP) and Good Manufacturing Practice (GMP) following an appropriate risk assessment. The following actions may serve to prevent or to reduce contamination of feed and food3: - preventing food and feed contamination at the source, e.g. by reducing environmental pollution. - applying appropriate technology control measure(s) in food and feed production, manufacture, processing, preparation, treatment, packing, packaging, transport or holding. - applying measures aimed at decontamination of contaminated feed or food and measures to prevent contaminated feed or food to be marketed for consumption. To ensure that adequate action is taken to reduce contamination of food and feed a Code of Practice shall be elaborated comprising source related measures and Good Manufacturing Practice as well as Good Agricultural Practice in relation to the specific contamination problem. The degree of contamination of food and feed and the effect of actions to reduce contamination shall be assessed by monitoring, survey programs and more specialized research programs, where necessary. When there are indications that health hazards may be involved with consumption of food that is contaminated, it is necessary that a risk assessment should be undertaken. When health concerns can be substantiated, a risk management measure must be applied, based on a thorough evaluation of the situation and consideration of a range of risk management options. Depending on the assessment of the problems and the possible solutions, it may be necessary to establish MLs or other measures to control the contamination of food and feed. In special cases, specific advice on dietary recommendations may also have to be considered to complement other regulatory measures, when the measures are not sufficiently adequate to protect public health and safety. National measures regarding food and feed contamination should avoid the creation of unnecessary barriers to international trade in food and feed commodities. The purpose of the GSCTFF is to provide guidance about possible approaches to eliminate or reduce the contamination problem and to promote international harmonization through recommendations which in turn may prevent trade barriers and disputes. For all contaminants, which may be present in more than one feed or food item, a broad approach shall be applied, taking into account all relevant information that is available, for the assessing of risks and for developing recommendations and control measures, including the setting of maximum levels. 1.3.2 Principles for establishing maximum levels in food and feed MLs shall only be set for food in which the contaminant may be found in amounts that are significant for the total exposure of the consumer, taking into consideration the Policy of the Codex Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups (Section III of the Procedural Manual). The maximum levels shall be set in such a way that the consumer is adequately protected. At the same time the other legitimate factors need to be considered. This will be performed in accordance with the “Working principles for Risk Analysis for Food safety for Application by Governments”. The principles of Good Manufacturing Practice and Good Agricultural Practice as defined by Codex shall be used. Maximum levels shall be based on sound scientific principles leading to levels which are acceptable worldwide, so that there is no unjustified barrier to international trade. MLs shall be clearly defined with respect to status and intended use. 1.3.3 Specific criteria The following criteria should (not preventing the use of other relevant criteria) be considered when developing MLs and/or other measures in connection with the Codex General Standard for Contaminants and Toxins in Food and Feed: (Further details about these criteria are given in Annex I). Toxicological information - identification of the toxic substance(s); - metabolism by humans and animals, as appropriate; 2 For the contaminants methylmercury, radionuclides, acrylonitrile and vinylchloride monomer a Codex guideline level (GL) has been established. A Codex guideline level (GL) is the maximum level of a substance in a food or feed commodity which is recommended by the CAC to be acceptable for commodities moving in international trade. When the GL is exceeded, governments should decide whether and under what circumstances the food should be distributed within their territory or jurisdiction. Because the CAC has decided that the preferred format of a Codex standard in food or feed is a maximum level, the present existing or proposed guideline levels shall be reviewed for their possible conversion to a maximum level after a risk assessment performed by JECFA, if appropriate. 3 In addition, reference is made to the Code of Practice for source Directed measures to reduce contamination of food with chemicals (CAC/RCP 49- 2001) and the Code of Practice on Good Animal Feeding (CAC/RCP 54-2004). 3 Codex Standard 193-1995 - toxicokinetics and toxicodynamics including information on possible carry-over of the toxic substance from feed to edible animal tissue/products; - information about acute and long term toxicity and other relevant toxicity data; and - integrated toxicological expert advice regarding the acceptability and safety of intake levels of contaminants, including information on any population groups which are specially vulnerable. Analytical data - validated qualitative and quantitative data on representative samples; and - appropriate sampling procedures. Intake data - presence in food of dietary significance for the contaminant; - presence in food that are widely consumed; - presence in feed and feed components; - food intake data for average and most exposed/high consumer groups; - results from total diet studies; - calculated contaminant intake data from food consumption models; - data on intake by susceptible groups; and - data on intake by food producing animals. Technological considerations - information about contamination processes, technological possibilities, production and manufacturing practices and economic aspects related to contaminant level management and control. Risk assessment and risk management considerations (cf. “Working Principles for Risk Analysis for Food Safety for Application by Governments”) - risk management options and considerations; - consideration of possible maximum levels in food and feed based on the criteria mentioned above; and - consideration of alternative solutions. 1.4 FORMAT OF THE GENERAL STANDARD FOR CONTAMINANTS IN FOOD AND FEED The General Standard for Contaminants and Toxins in Food and Feed contains one type of presentation for the Standards: Schedule I in which the standards are listed per contaminant in the various food and feed categories. In order to obtain maximum clarity, explanatory notes shall be added where appropriate. The format contains all elements necessary for full understanding of the meaning, background, application and scope of the standards and contains references to the relevant documents and reports on which the standard is based. A full description of the format is provided in Annex II. 4 Codex Standard 193-1995 ANNEX I CRITERIA FOR THE ESTABLISHMENT OF MAXIMUM LEVELS IN FOOD AND FEED Introduction In this Annex criteria are mentioned regarding information which is considered necessary for evaluating contaminant problems in food and feed and for the establishment of maximum levels. The criteria mentioned here are elaborated in more detail than in section 1.3.3 of the Preamble. Only those aspects that need further clarification are detailed; however, criteria or aspects that are not specifically detailed 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, should be the main basis for decisions by Codex members. 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 food and feed, information about the following aspects is desirable: - identification of the toxic substance(s); - metabolism in humans and animals, as appropriate; - toxicokinetics and toxicodynamics including information on possible carry-over of the contaminant from feed to edible animal tissue/products; - 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 representativeness 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 contaminant regulation. Information on appropriate sampling procedures should be supplied. Special attention to this aspect is necessary in the case of contaminants that may not be homogeneously 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 consumers with average and high consumption patterns. 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. For the contaminants which can be present in food of animal origin as a consequence of the carry over from feed, information about the presence of the contaminant in the feed and feed components should be given. Furthermore the intake of contaminants by the different food producing animals and the resulting levels of the contaminant in the food of animal origin should be estimated. Food consumption data for average, most exposed (high consumers) 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 variety of foodstuffs, so that for every contaminant the most exposed consumer groups may be identified for every contaminant. 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, 1985 - http://whqlibdoc.who.int/offset/WHO_OFFSET_87.pdf). 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. 5 Codex Standard 193-1995 Technological considerations Information about the source of the contaminant and the way in which the food and feed is contaminated, possibly including information, if available, about contamination being present in 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 safety and quality. Where possible Source-related measures should be proposed. Good Manufacturing Practice (GMP) and/or Good Agricultural Practice (GAP) should also be adapted to control a contamination problem. When this is possible, maximum levels may be based on GMP or GAP considerations to establish at a level as low as reasonably achievable and necessary to protect the consumer. 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 reference value. 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 levels can be based on a thorough evaluation of both the public health arguments and the potential problem with complying with the proposed standard. Risk assessment and risk management considerations Risk assessment and risk management are conducted in accordance with the Working Principles for Risk Analysis for Food Safety Application by Governments. Establishment of maximum levels In case it is decided that, on the basis of the outcome of the risk assessment, there is no need to establish a maximum level to protect public health as the level of hazard/risk does not pose a public health problem, this should be communicated in a transparent and accessible manner (e.g. by using the full format as provided for Schedule I and to mention in the box of Maximum level “not necessary”). The establishment of maximum levels (MLs) of contaminants in food and feed involves several principles, some of which have already been mentioned in this Preamble. Briefly stated, the following criteria will help in maintaining a consistent policy in this matter: - MLs should be set only for those contaminants that present both a significant risk to public health and a known or expected pro