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codex general standard for contaminants and toxins in food and feed

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2 Codex St<strong>and</strong>ard 193-19951.2.4 Maximum level <strong>and</strong> related terms 2The Codex maximum level (ML) <strong>for</strong> a contam<strong>in</strong>ant <strong>in</strong> a <strong>food</strong> or <strong>feed</strong> commodity is the maximum concentration of thatsubstance recommended by the Codex Alimentarius Commission (CAC) to be legally permitted <strong>in</strong> that commodity.1.3 PRINCIPLES REGARDING CONTAMINANTS IN FOOD AND FEED1.3.1 GeneralContam<strong>in</strong>ation of <strong>food</strong> <strong>and</strong> <strong>feed</strong> may pose a risk to human (<strong>and</strong>/or animal health). Moreover <strong>in</strong> some cases they mayalso have a negative impact on the quality of the <strong>food</strong> or <strong>feed</strong>. Food <strong>and</strong> <strong>feed</strong> can become contam<strong>in</strong>ated by variouscauses <strong>and</strong> processes.Contam<strong>in</strong>ant levels <strong>in</strong> <strong>food</strong> <strong>and</strong> <strong>feed</strong> shall be as low as reasonably achievable through best practice such as GoodAgricultural Practice (GAP) <strong>and</strong> Good Manufactur<strong>in</strong>g Practice (GMP) follow<strong>in</strong>g an appropriate risk assessment. Thefollow<strong>in</strong>g actions may serve to prevent or to reduce contam<strong>in</strong>ation of <strong>feed</strong> <strong>and</strong> <strong>food</strong> 3 :- prevent<strong>in</strong>g <strong>food</strong> <strong>and</strong> <strong>feed</strong> contam<strong>in</strong>ation at the source, e.g. by reduc<strong>in</strong>g environmental pollution.- apply<strong>in</strong>g appropriate technology control measure(s) <strong>in</strong> <strong>food</strong> <strong>and</strong> <strong>feed</strong> production, manufacture,process<strong>in</strong>g, preparation, treatment, pack<strong>in</strong>g, packag<strong>in</strong>g, transport or hold<strong>in</strong>g.- apply<strong>in</strong>g measures aimed at decontam<strong>in</strong>ation of contam<strong>in</strong>ated <strong>feed</strong> or <strong>food</strong> <strong>and</strong> measures to preventcontam<strong>in</strong>ated <strong>feed</strong> or <strong>food</strong> to be marketed <strong>for</strong> consumption.To ensure that adequate action is taken to reduce contam<strong>in</strong>ation of <strong>food</strong> <strong>and</strong> <strong>feed</strong> a Code of Practice shall be elaboratedcompris<strong>in</strong>g source related measures <strong>and</strong> Good Manufactur<strong>in</strong>g Practice as well as Good Agricultural Practice <strong>in</strong> relationto the specific contam<strong>in</strong>ation problem.The degree of contam<strong>in</strong>ation of <strong>food</strong> <strong>and</strong> <strong>feed</strong> <strong>and</strong> the effect of actions to reduce contam<strong>in</strong>ation shall be assessed bymonitor<strong>in</strong>g, survey programs <strong>and</strong> more specialized research programs, where necessary.When there are <strong>in</strong>dications that health hazards may be <strong>in</strong>volved with consumption of <strong>food</strong> that is contam<strong>in</strong>ated, it isnecessary that a risk assessment should be undertaken. When health concerns can be substantiated, a riskmanagement measure must be applied, based on a thorough evaluation of the situation <strong>and</strong> consideration of a range ofrisk management options. Depend<strong>in</strong>g on the assessment of the problems <strong>and</strong> the possible solutions, it may benecessary to establish MLs or other measures to control the contam<strong>in</strong>ation of <strong>food</strong> <strong>and</strong> <strong>feed</strong>. In special cases, specificadvice on dietary recommendations may also have to be considered to complement other regulatory measures, whenthe measures are not sufficiently adequate to protect public health <strong>and</strong> safety.National measures regard<strong>in</strong>g <strong>food</strong> <strong>and</strong> <strong>feed</strong> contam<strong>in</strong>ation should avoid the creation of unnecessary barriers to<strong>in</strong>ternational trade <strong>in</strong> <strong>food</strong> <strong>and</strong> <strong>feed</strong> commodities. The purpose of the GSCTFF is to provide guidance about possibleapproaches to elim<strong>in</strong>ate or reduce the contam<strong>in</strong>ation problem <strong>and</strong> to promote <strong>in</strong>ternational harmonization throughrecommendations which <strong>in</strong> turn may prevent trade barriers <strong>and</strong> disputes.For all <strong>contam<strong>in</strong>ants</strong>, which may be present <strong>in</strong> more than one <strong>feed</strong> or <strong>food</strong> item, a broad approach shall be applied,tak<strong>in</strong>g <strong>in</strong>to account all relevant <strong>in</strong><strong>for</strong>mation that is available, <strong>for</strong> the assess<strong>in</strong>g of risks <strong>and</strong> <strong>for</strong> develop<strong>in</strong>grecommendations <strong>and</strong> control measures, <strong>in</strong>clud<strong>in</strong>g the sett<strong>in</strong>g of maximum levels.1.3.2 Pr<strong>in</strong>ciples <strong>for</strong> establish<strong>in</strong>g maximum levels <strong>in</strong> <strong>food</strong> <strong>and</strong> <strong>feed</strong>MLs shall only be set <strong>for</strong> <strong>food</strong> <strong>in</strong> which the contam<strong>in</strong>ant may be found <strong>in</strong> amounts that are significant <strong>for</strong> the totalexposure of the consumer, tak<strong>in</strong>g <strong>in</strong>to consideration the Policy of the Codex Committee on Contam<strong>in</strong>ants <strong>in</strong> Foods <strong>for</strong>Exposure Assessment of Contam<strong>in</strong>ants <strong>and</strong> Tox<strong>in</strong>s <strong>in</strong> Foods or Food Groups (Section III of the Procedural Manual).The maximum levels shall be set <strong>in</strong> such a way that the consumer is adequately protected. At the same time the otherlegitimate factors need to be considered. This will be per<strong>for</strong>med <strong>in</strong> accordance with the “Work<strong>in</strong>g pr<strong>in</strong>ciples <strong>for</strong> RiskAnalysis <strong>for</strong> Food safety <strong>for</strong> Application by Governments”.The pr<strong>in</strong>ciples of Good Manufactur<strong>in</strong>g Practice <strong>and</strong> Good Agricultural Practice as def<strong>in</strong>ed by Codex shall be used.Maximum levels shall be based on sound scientific pr<strong>in</strong>ciples lead<strong>in</strong>g to levels which are acceptable worldwide, so thatthere is no unjustified barrier to <strong>in</strong>ternational trade. MLs shall be clearly def<strong>in</strong>ed with respect to status <strong>and</strong> <strong>in</strong>tended use.1.3.3 Specific criteriaThe follow<strong>in</strong>g criteria should (not prevent<strong>in</strong>g the use of other relevant criteria) be considered when develop<strong>in</strong>g MLs<strong>and</strong>/or other measures <strong>in</strong> connection with the Codex General St<strong>and</strong>ard <strong>for</strong> Contam<strong>in</strong>ants <strong>and</strong> Tox<strong>in</strong>s <strong>in</strong> Food <strong>and</strong> Feed:(Further details about these criteria are given <strong>in</strong> Annex I).Toxicological <strong>in</strong><strong>for</strong>mation- identification of the toxic substance(s);- metabolism by humans <strong>and</strong> animals, as appropriate;23For the <strong>contam<strong>in</strong>ants</strong> methylmercury, radionuclides, acrylonitrile <strong>and</strong> v<strong>in</strong>ylchloride monomer a Codex guidel<strong>in</strong>e level (GL) has been established.A Codex guidel<strong>in</strong>e level (GL) is the maximum level of a substance <strong>in</strong> a <strong>food</strong> or <strong>feed</strong> commodity which is recommended by the CAC to beacceptable <strong>for</strong> commodities mov<strong>in</strong>g <strong>in</strong> <strong>in</strong>ternational trade. When the GL is exceeded, governments should decide whether <strong>and</strong> under whatcircumstances the <strong>food</strong> should be distributed with<strong>in</strong> their territory or jurisdiction.Because the CAC has decided that the preferred <strong>for</strong>mat of a Codex <strong>st<strong>and</strong>ard</strong> <strong>in</strong> <strong>food</strong> or <strong>feed</strong> is a maximum level, the present exist<strong>in</strong>g or proposedguidel<strong>in</strong>e levels shall be reviewed <strong>for</strong> their possible conversion to a maximum level after a risk assessment per<strong>for</strong>med by JECFA, if appropriate.In addition, reference is made to the Code of Practice <strong>for</strong> source Directed measures to reduce contam<strong>in</strong>ation of <strong>food</strong> with chemicals (CAC/RCP 49-2001) <strong>and</strong> the Code of Practice on Good Animal Feed<strong>in</strong>g (CAC/RCP 54-2004).

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