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Contaminants and toxins in food and feed

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date_gregorian=2019-02-07 date_hijri=1440-06-02 document_type=regulation entity=format:application/pdf language=en taxonomy_l1=health taxonomy_l2=public_health taxonomy_l3=food_safety validity=valid validity_confidence=0.6

الهينه العامه للغذاء والدواء SAUDI FOOD & DRUG AUTHORITY (SFDA) مشروع مواصفه Draft Standard قطاع الغذاء Food Sector الملوثات والسموم في الاغذيه والاعلاف Contaminants and toxins in food and feed I.C.S: 67.040.00 This document is a draft Saudi Standard Circulated for comments. It is, therefore, subject to alteration and modification and may not be referred to as a Saudi Standard Until approved by SFDA. هذه الوثيقه مشروع لمواصفه قياسيه سعوديه تم توزيعها لابداء الراي والملحوظات بشانها، لذلك فانها عرضه للتغيير والتبديل، ولا يجوز الرجوع اليها كمواصفه قياسيه سعوديه الا بعد اعتمادها من الهينه. SFDA.FD ..... /2019 Foreword Saudi Food and Drug Authority (SFDA) is an independent organization with purpose of regulating and monitoring of foods, drugs and medical devices. One of SFDA functions is to issue national Standards /Technical Regulation in the fields of foods, drugs and medical devices, whether imported or manufactured locally. SFDA food sector has updated Standard No. SFDA.FD/ CAC 193 “GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FOODS”. This standard has been approved as national standard by SFDA board of directors in its meeting No ( ) Held on ( / /1440 AH), ( / /2019). * The limits of food contaminants in this regulation replaced all the food contaminants limits in the approved GSO food technical regulations and standards – if no limits or contaminants are listed for certain food products in this regulation, the food contaminants limits in food product regulation shall be applied. 1 SFDA.FD ..... /2019 Contaminants and toxins in food and feed 1. Scope This Standard contains maximum levels of contaminants and toxicants in food and feed, 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. 2. Definition of Terms When reference is made to foods, this also applies to animal feed, in those cases where this is appropriate. 2.1 Contaminant Any substance not intentionally added to food or feed for food producing animals, which is present in such food or feed 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 feed, 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 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. 2) Pesticide residues. 3) Residues of veterinary drugs, and residues of feed additives \( ^{1} \) . 4) Microbial toxins, such as botulinum toxin and staphylococcus enterotoxin. 5) Residues of processing aids \( ^{2} \) . 2.2 Natural toxins included in this Standard The 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. \( ^{1} \) Feed additives: “Any intentionally added ingredient not normally consumed as feed by itself, whether or not it has nutritional value, which affects the characteristics of feed or animal products. Residues of feed additives include the parent compounds and/or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the feed additive concerned. \( ^{2} \) 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 SFDA.FD ..... /2019 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 CCCF and will be dealt with on a case-by-case basis. 2.3 Maximum level and related terms \( ^{1} \) The maximum level (ML) for a contaminant in a food or feed commodity is the maximum concentration of that substance recommended by this standard to be legally permitted in that commodity. 3. Principles Regarding Contaminants in Food and Feed 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 food \( ^{2} \) : - 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. \( ^{1} \) 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 Codex Alimentarius Commission to be acceptable for commodities moving in international trade. \( ^{2} \) In addition, reference is made to the Code of Practice for source Directed measures to reduce contamination of food with chemicals (CXC 49-2001) and the Code of Practice on Good Animal Feeding (CXC 54-2004). 3 SFDA.FD ..... /2019 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. 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. 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 General Standard for Contaminants and Toxins in Food and Feed. Toxicological information - identification of the toxic substance(s); - metabolism by humans and animals, as appropriate; - 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 especially 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 4 SFDA.FD ..... /2019 - 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 - 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. 5 SFDA.FD ..... /2019 AFLATOXINS, TOTAL <table><tr><td>Reference to JECFA:</td><td>31 (1987), 46 (1996), 49 (1997), 68 (2007)</td></tr><tr><td>Toxicological guidance value:</td><td>Carcinogenic potency estimates for aflatoxins B, G, M (1997, Intake should be reduced to levels as low as reasonably possible)</td></tr><tr><td>Contaminant definition:</td><td>Aflatoxins total (B1 + B2 + G1 + G2)</td></tr><tr><td>Synonyms:</td><td>Abbreviations, AFB, AFG, with numbers, to designate specific compounds</td></tr><tr><td>Related code of practice:</td><td>Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts (CXC 55-2004)Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Tree Nuts (CXC 59-2005)Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and Supplemental Feedingstuffs for Milk Producing Animals (CXC 45-1997)Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Dried Figs (CXC 65-2008)</td></tr></table> <table><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Almonds</td><td>10</td><td>Whole commodity after removal of shell.</td><td>The ML applies to almonds “ready-to-eat” (**)For sampling plan, see Annex 2.</td></tr><tr><td>Almonds</td><td>15</td><td>Whole commodity after removal of shell.</td><td>The ML applies to almonds intended for further processing (*)For sampling plan, see Annex 2.</td></tr><tr><td>Brazil nuts</td><td>10</td><td>Whole commodity</td><td>The ML applies to shelled Brazil nuts ready-to-eat (**).For sampling plan, see Annex 2.</td></tr><tr><td>Brazil nuts</td><td>15</td><td>Whole commodity</td><td>The ML applies to shelled Brazil nuts intended for further processing (*)For sampling plan, see Annex 2.</td></tr><tr><td>Hazelnuts</td><td>10</td><td>Whole commodity after removal of shell.</td><td>The ML applies to hazelnuts, also known as filberts, “ready to eat” (**)For sampling plan, see Annex 2.</td></tr><tr><td>Hazelnuts</td><td>15</td><td>Whole commodity after removal of shell.</td><td>The ML applies to hazelnuts, also known as filberts, intended for further processing (*)For sampling plan, see Annex 2.</td></tr><tr><td>Peanuts</td><td>15</td><td>Unless specified, seed or kernels, after removal of shell or husk.</td><td>The ML applies for peanuts, also known as groundnuts, intended for further processing (*).For sampling plan, see Annex 1.</td></tr><tr><td>Pistachios</td><td>10</td><td>Whole commodity after removal of shell.</td><td>The ML applies to pistachios “ready to eat” (**).For sampling plan, see Annex 2.</td></tr><tr><td>Pistachios</td><td>15</td><td>Whole commodity after removal of shell.</td><td>The ML applies to pistachios intended for further processing (*)For sampling plan, see Annex 2.</td></tr><tr><td>Dried figs</td><td>10</td><td>Whole commodity</td><td>The ML applies to dried figs “ready-to-eat” (**)For sampling plan see Annex 3.</td></tr><tr><td colspan="4">(*) “destined for further processing” means intended to undergo an additional processing/treatment that has</td></tr></table> 6 SFDA.FD ..... / 2019 <table><tr><td colspan="4">proven to reduce levels of aflatoxins before being used as an ingredient in foodstuffs, otherwise processed or offered for human consumption. Processes that have proven to reduce levels of aflatoxins are shelling, blanching followed by colour sorting, and sorting by specific gravity and colour (damage). There is some evidence that roasting reduces aflatoxins in pistachios but for other nuts the evidence is still to be supplied.</td></tr><tr><td colspan="4">(**) “ready-to-eat” means “not intended to undergo an additional processing/treatment that has proven to reduce levels of aflatoxins before being used as ingredient in foodstuffs, otherwise processed or offered for human consumption.</td></tr><tr><td>Foods</td><td>20</td><td>Whole commodity</td><td>With the exception of foodstuffs listed in table.</td></tr><tr><td>Nuts with exception mentioned</td><td>10</td><td>Whole commodity</td><td>Nuts with exception mentioned, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs</td></tr><tr><td>Nuts with exception mentioned</td><td>4</td><td>Whole commodity</td><td>Nuts with exception mentioned, intended for direct human consumption or use as an ingredient in foodstuffs</td></tr><tr><td>Dried fruit and dried fruit products</td><td>10</td><td>Whole commodity</td><td>Dried fruit, other than dried figs, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs</td></tr><tr><td>Dried fruit and dried fruit products</td><td>4</td><td>Whole commodity</td><td>Dried fruit, other than dried figs, and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs</td></tr><tr><td>Cereals and all products derived from cereals</td><td>4</td><td>Whole commodity</td><td>All cereals and all products derived from cereals, including processed cereal products, with the exception of foodstuffs listed in table.</td></tr><tr><td>Maize and rice</td><td>10</td><td>Whole commodity</td><td>Maize and rice to be subjected to sorting or other physical treatment before human consumption or use as an ingredient in foodstuffs</td></tr></table> 7 SFDA.FD ..... / 2019 <table><tr><td>Spices</td><td>10</td><td>Whole commodity</td><td>Following species of spices: Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika) Piper spp. (fruits thereof, including white and black pepper) Myristica fragrans (nutmeg) Zingiber officinale (ginger) Curcuma longa (turmeric) Mixtures of spices containing one or more of the abovementioned spices</td></tr><tr><td>Animal Feeds – Corn and peanut products</td><td>300</td><td>Whole commodity</td><td>Corn and peanut products intended for finishing (i.e., feedlot) beef cattle</td></tr><tr><td>Animal Feeds – Cottonseed meal</td><td>300</td><td>Whole commodity</td><td>Cottonseed meal intended for beef, cattle, swine, or poultry (regardless of age or breeding status</td></tr><tr><td>Animal Feeds – Corn and peanut products</td><td>100</td><td>Whole commodity</td><td>Corn and peanut products intended for breeding beef cattle, or mature poultry</td></tr><tr><td>Animal Feeds – Corn, peanut products, and other animal feeds</td><td>20</td><td>Whole commodity</td><td>Corn, peanut products, and other animal feeds and feed ingredients but excluding cottonseed meal, intended for immature animals</td></tr><tr><td>Animal Feeds – Corn, peanut products, cottonseed meal, and other animal feed</td><td>20</td><td>Whole commodity</td><td>Corn, peanut products, cottonseed meal, and other animal feed ingredients intended for dairy animals, for animal species or uses not specified above, or when the intended use is not known</td></tr></table> 8 SFDA.FD ..... / 2019 AFLATOXIN M1 <table><tr><td colspan="4">Reference to JECFA: 56 (2001)</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">Cancer potency estimates at specified residue levels (2001, Using worst-case assumptions, the additional risks for liver cancer predicted with use of proposed maximum levels of aflatoxin M1 of 0.05 and 0.5 μg/kg are very small. The potency of aflatoxin M1 appears to be so low in HBsAg-individuals that a carcinogenic effect of M1 intake in those who consume large quantities of milk and milk products in comparison with non-consumers of these products would be impossible to demonstrate. Hepatitis B virus carriers might benefit from a reduction in the aflatoxin concentration in their diet, and the reduction might also offer some protection in hepatitis C virus carriers).</td></tr><tr><td>Contaminant definition:</td><td colspan="3">Aflatoxin M1</td></tr><tr><td>Synonyms:</td><td colspan="3">AFM1</td></tr><tr><td>Related code of practice:</td><td colspan="3">Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and Supplemental Feedingstuffs for Milk Producing Animals (CXC 45-1997)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Milks</td><td>0.5</td><td>Whole commodity.</td><td>Milk is the normal mammary secretion of milking animals obtained from one or more milkings without either addition to it or extraction from it, intended for consumption as liquid milk or for further processing.A concentration factor applies to partially or wholly dehydrated milks.</td></tr></table> 9 SFDA.FD ..... / 2019 DEOXYNIVALENOL (DON) <table><tr><td colspan="4">Reference to JECFA: 56 (2001), 72 (2010)</td></tr><tr><td colspan="4">Toxicological guidance value: Group PMTDI 0.001 mg/kg bw (2010, for DON and its acetylated derivatives)Group ARfD 0.008 mg/kg bw (2010, for DON and its acetylated derivatives)</td></tr><tr><td colspan="4">Contaminant definition: Deoxynivalenol</td></tr><tr><td colspan="4">Synonyms: Vomitoxin; Abbreviation, DON</td></tr><tr><td colspan="4">Related code of practice: Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CXC 51-2003)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Cereal-based foods for infants and young children</td><td>200</td><td>ML applies to the commodity on a dry matter basis.</td><td>All cereal-based foods intended for infants (up to 12 months) and young children (12 to 36 months)</td></tr><tr><td>Flour, meal, semolina and flakes derived from wheat, maize or barley</td><td>1000</td><td></td><td></td></tr><tr><td>Cereal grains (wheat, maize and barley) destined for further processing</td><td>2000</td><td></td><td>“Destined for further processing” means intended to undergo an additional processing/treatment that has proven to reduce levels of DON before being used as an ingredient in foodstuffs, otherwise processed or offered for human consumption. Codex members may define the processes that have been shown to reduce levels</td></tr><tr><td>Pasta (dry)</td><td>750</td><td></td><td></td></tr><tr><td>Bread, pastries, biscuits, cereal snacks and breakfast cereals</td><td>500</td><td></td><td>Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast cereals</td></tr></table> 10 SFDA.FD ..... / 2019 FUMONISINS (B\( _{1} \) + B\( _{2} \)) <table><tr><td colspan="4">Reference to JECFA: 56 (2001), 74 (2011)</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">PMTDI 0.002 mg/kg bw (2001, 2011)</td></tr><tr><td colspan="2">Contaminant definition:</td><td colspan="2">Fumonisins (B1+B2)</td></tr><tr><td colspan="2">Synonyms:</td><td colspan="2">Several related compounds have been described, notably fumonisin B1, B2 and B3 (abbreviation: FB1 etc.)</td></tr><tr><td colspan="2">Related code of practice:</td><td colspan="2">Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CXC 51-2003)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Raw maize grain</td><td>4000</td><td>Whole commodity</td><td></td></tr><tr><td>Maize flour and maize meal</td><td>2000</td><td>Whole commodity</td><td></td></tr><tr><td>Maize</td><td>1000</td><td></td><td>for direct human consumption</td></tr><tr><td>Maize-based breakfast cereals and maize-based snacks</td><td>800</td><td></td><td></td></tr><tr><td>Processed maize-based foods and baby foods for infants and young children</td><td>200</td><td></td><td></td></tr><tr><td>Maize-based foods for direct human consumption</td><td>1000</td><td></td><td>for direct human consumption</td></tr></table> 11 SFDA.FD ..... /2019 OCHRATOXIN A <table><tr><td colspan="4">Reference to JECFA: 37 (1990), 44 (1995), 56 (2001), 68 (2007)</td></tr><tr><td colspan="4">Toxicological guidance value: PTWI 0.0001 mg/kg bw (2001)</td></tr><tr><td colspan="4">Contaminant definition: Ochratoxin A</td></tr><tr><td colspan="4">Synonyms: (The term “ochratoxins” includes a number of related mycotoxins (A, B, C and their esters and metabolites), the most important one being ochratoxin A)</td></tr><tr><td colspan="4">Related code of practice: Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CXC 51-2003) Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Wine (CXC 63-2007) Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Coffee (CXC 69-2009) Code of Practice for the Prevention and Reduction of Ochratoxin A contamination in Cocoa (CXC 72-2013)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Wheat</td><td>5</td><td>Whole commodity</td><td>The ML applies to raw common wheat, raw durum wheat, raw spelt and raw emmer.</td></tr><tr><td>Barley</td><td>5</td><td>Whole commodity</td><td>The ML applies to raw barley.</td></tr><tr><td>Rye</td><td>5</td><td>Whole commodity</td><td>The ML applies to raw rye.</td></tr><tr><td>Unprocessed cereals</td><td>5</td><td></td><td>Unprocessed cereals</td></tr><tr><td>Products derived from unprocessed cereals, including processed cereal products and cereals</td><td>3</td><td></td><td>All products derived from unprocessed cereals, including processed cereal products and cereals intended for direct human consumption with the exception of foodstuffs listed in table.</td></tr><tr><td>Dried vine fruit</td><td>10</td><td></td><td>Dried vine fruit (currants, raisins and sultanas)</td></tr><tr><td>Roasted coffee beans and ground roasted coffee</td><td>5</td><td></td><td>excluding soluble coffee</td></tr><tr><td>Soluble coffee</td><td>10</td><td></td><td></td></tr><tr><td>Grape juice and concentrated grape juice</td><td>2</td><td></td><td>Grape juice, concentrated grape juice as reconstituted, grape nectar, grape must and concentrated grape must as reconstituted, intended for direct human consumption</td></tr><tr><td>Processed cereal-based foods and baby foods for infants and young children</td><td>0.5</td><td></td><td></td></tr><tr><td>Dietary foods for special medical purposes intended specifically for infants</td><td>0.5</td><td></td><td></td></tr><tr><td>Spices, including dried spices</td><td>15</td><td></td><td>Piper spp (fruits thereof, including white and black pepper)</td></tr></table> 12 SFDA.FD ..... /2019 <table><tr><td></td><td></td><td>Myristica fragrans (nutmeg)Zingiber officinale (ginger)Curcuma longa (turmeric)</td></tr><tr><td>Pepper</td><td>15</td><td>Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika)</td></tr><tr><td>Mixtures of spices</td><td>15</td><td>Mixtures of spices containing one of the abovementioned spices</td></tr><tr><td>Liquorice root</td><td>20</td><td>Liquorice root, ingredient for herbal infusion</td></tr><tr><td>Liquorice extract</td><td>80</td><td>For use in food in particular beverages and confectionary</td></tr><tr><td>Wheat gluten</td><td>8</td><td>not sold directly to the consumer</td></tr></table> 13 SFDA.FD ..... / 2019 PATULIN <table><tr><td colspan="4">Reference to JECFA: 35 (1989), 44 (1995)</td></tr><tr><td colspan="4">Toxicological guidance value: PMTDI 0.0004 mg/kg bw (1995)</td></tr><tr><td colspan="4">Contaminant definition: Patulin</td></tr><tr><td colspan="4">Related code of practice: Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages (CXC 50-2003)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) μg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Apple juice</td><td>50</td><td>Whole commodity (not concentrated) or commodity reconstituted to the original juice concentration.</td><td>Relevant Codex commodity standard include CXS 247-2005 (apple products only). The ML applies also to apple juice used as an ingredient in other beverages.</td></tr><tr><td>Solid apple products and apple puree</td><td>25</td><td></td><td>Solid apple products, including apple compote, apple puree intended for direct consumption with exception mentioned</td></tr><tr><td>Apple juice and solid apple products</td><td>10</td><td></td><td>Apple juice and solid apple products, including apple compote and apple puree, for infants and young children and labelled and sold as such</td></tr><tr><td>Baby foods other than processed cereal-based foods for infants and young children</td><td>10</td><td></td><td></td></tr></table> 14 SFDA.FD ..... /2019 ARSENIC <table><tr><td colspan="4">Reference to JECFA: 5 (1960), 10 (1967), 27 (1983), 33 (1988), 72 (2010) SFDA Inorganic Arsenic in Rice and Rice Products Risk assessment</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">At the 72nd meeting of JECFA (2010), the inorganic arsenic lower limit on the benchmark dose for a 0.5% increased incidence of lung cancer (BMDL 0.5) was determined from epidemiological studies to be 3.0 μg/kg bw/day (2–7 μg/kg bw/day based on the range of estimated total dietary exposure) using a range of assumptions to estimate total dietary exposure to inorganic arsenic from drinking-water and food. The JECFA noted that the provisional tolerable weekly intake (PTWI) of 15 μg/kg bw (equivalent to 2.1 μg/kg bw/day) is in the region of the BMDL 0.5 and therefore was no longer appropriate. The JECFA withdrew the previous PTWI.</td></tr><tr><td colspan="2">Contaminant definition:</td><td colspan="2">Arsenic: total (As-tot) when not otherwise mentioned; inorganic arsenic (As-in); or other specification</td></tr><tr><td colspan="2">Synonyms:</td><td colspan="2">As</td></tr><tr><td colspan="2">Related code of practice:</td><td colspan="2">Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice (CXC 77-2017)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Edible fats and oils</td><td>0.1</td><td>Whole commodity</td><td>Relevant Codex commodity standards are CXS 19-1981, CXS 33-1981, CXS 210-1999, CXS 211-1999 and CXS 329-2017For fish oils covered by CXS 329-2017, the ML is for fish oils (As-in).Countries or importers may decide to use their own screening when applying the ML for As-in in fish oils by analysing total arsenic (As-tot) in fish oils. If the As-tot concentration is below the ML for As-in, no further testing is required and the sample is determined to be compliant with the ML. If the As-tot concentration is above the ML for As-in, follow-up testing shall be conducted to determine if the As-in concentration is above the ML.</td></tr><tr><td>Fat spreads and blended spreads</td><td>0.1</td><td></td><td>Relevant Codex commodity standard is CXS 256-2007.</td></tr><tr><td>Natural mineral waters</td><td>0.01</td><td></td><td>Relevant Codex commodity standard is CXS 108-1981.Calculated as total As in mg/l.</td></tr><tr><td>Rice, husked</td><td>0.25</td><td>Whole commodity</td><td>Determined as inorganic Arsenic</td></tr><tr><td>Rice, polished</td><td>0.08</td><td>Whole commodity</td><td>Determined as inorganic Arsenic</td></tr><tr><td>Salt, food grade</td><td>0.5</td><td></td><td>Relevant Codex commodity standard is CXS 150-1985.</td></tr><tr><td>Rice Products</td><td>0.2</td><td></td><td>Determined as inorganic Arsenic</td></tr></table> 15 SFDA.FD ..... /2019 <table><tr><td></td><td></td><td></td><td>Rice pies, rice flakes and rice cakes</td></tr><tr><td>Rice for baby and infant food</td><td>0.05</td><td></td><td>Determined as inorganic Arsenic Rice for baby and infant food</td></tr></table> 16 SFDA.FD ..... /2019 CADMIUM <table><tr><td colspan="4">Reference to JECFA: 16 (1972), 33 (1988), 41 (1993), 55 (2000), 61 (2003), 64 (2005), 73 (2010)</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">In view of the long half-life of cadmium, daily ingestion in food has a small or even a negligible effect on overall exposure. In order to assess long- or short-term risks to health due to cadmium exposure, dietary intake should be assessed over months, and tolerable intake should be assessed over a period of at least 1 month. To encourage this view, at the \(73^{\text{rd}}\) meeting (2010) the JECFA decided to express the tolerable intake as a monthly value in the form of a provisional tolerable monthly intake (PTMI) and established a PTMI of 25 μg/kg bw.</td></tr><tr><td>Contaminant definition:</td><td colspan="3">Cadmium, total</td></tr><tr><td>Synonyms:</td><td colspan="3">Cd</td></tr><tr><td>Related code of practice:</td><td colspan="3">Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Brassica vegetables</td><td>0.05</td><td>Head cabbages and kohlrabi: whole commodity as marketed, after removal of obviously decomposed or withered leaves. Cauliflower and broccoli: flower heads (immature inflorescence only). Brussels sprouts: “buttons” only.</td><td>The ML does not apply to Brassica leafy vegetables.</td></tr><tr><td>Bulb vegetables</td><td>0.05</td><td>Bulb/dry onions and garlic: whole commodity after removal of roots and adhering soil and whatever parchment skin is easily detached.</td><td></td></tr><tr><td>Fruiting vegetables</td><td>0.05</td><td>Whole commodity after removal of stems. Sweet corn and fresh corn: kernels plus cob without husk.</td><td>The ML does not apply to tomatoes and edible fungi.</td></tr><tr><td>Leafy vegetables</td><td>0.2</td><td>Whole commodity as usually marketed, after removal of obviously decomposed or withered leaves.</td><td>The ML also applies to Brassica leafy vegetables.</td></tr><tr><td>Legume vegetables</td><td>0.1</td><td>Whole commodity as consumed. The succulent forms may be consumed as whole</td><td></td></tr></table> 17 SFDA.FD ..... /2019 <table><tr><td></td><td></td><td>pods or as the shelled product.</td><td></td></tr><tr><td>Pulses</td><td>0.1</td><td>Whole commodity</td><td>The ML does not apply to soya bean (dry).</td></tr><tr><td>Root and tuber vegetables</td><td>0.1</td><td>Whole commodity after removing tops.Remove adhering soil (e.g. by rinsing in running water or by gentle brushing of the dry commodity).Potato: peeled potato.</td><td>The ML does not apply to celeriac.</td></tr><tr><td>Stalk and stem vegetables</td><td>0.1</td><td>Whole commodity as marketed after removal of obviously decomposed or withered leaves.Rhubarb: leaf stems only.Globe artichoke: flower head only.Celery and asparagus: remove adhering soil.</td><td></td></tr><tr><td>Cereal grains</td><td>0.1</td><td>Whole commodity</td><td>The ML does not apply to buckwheat, cañihua, quinoa, wheat and rice.</td></tr><tr><td>Rice, polished</td><td>0.4</td><td>Whole commodity</td><td></td></tr><tr><td>Wheat</td><td>0.2</td><td>Whole commodity</td><td>The ML applies to common wheat, durum wheat, spelt and emmer.</td></tr><tr><td>Marine bivalve molluscs</td><td>2</td><td>Whole commodity after removal of shell.</td><td>The ML applies to clams, cockles and mussels but not to oysters and scallops.</td></tr><tr><td>Cephalopods</td><td>2</td><td>Whole commodity after removal of shell.</td><td>The ML applies to cuttlefishes, octopuses and squids without viscera</td></tr><tr><td>Natural mineral waters</td><td>0.003</td><td></td><td>Relevant Codex commodity standard is CXS 108-1981.The ML is expressed in mg/l.</td></tr><tr><td>Salt, food grade</td><td>0.5</td><td></td><td>Relevant Codex commodity standard is CXS 150-1985.</td></tr><tr><td>Chocolate containing or declaring ≥ 50% to < 70% total cocoa solids on a dry matter basis</td><td>0.8</td><td>Whole commodity as prepared for wholesale or retail distribution</td><td>Including sweet chocolate, Gianduja chocolate, semi – bitter table chocolate, Vermicelli chocolate / chocolate flakes, and bitter table chocolate.</td></tr><tr><td>Chocolate containing or declaring ≥ 70% total cocoa solids on a dry matter basis</td><td>0.9</td><td>Whole commodity as prepared for wholesale or retail distribution</td><td>Including sweet chocolate, Gianduja chocolate, semi – bitter table chocolate, Vermicelli chocolate / Chocolate flakes, and bitter table chocolate.</td></tr><tr><td>Vegetables and fruit, with exception mentioned</td><td>0.05</td><td></td><td>with exception mentioned</td></tr><tr><td>Mushroom</td><td>0.2</td><td></td><td></td></tr><tr><td>Fungi with exception mentioned</td><td>1</td><td></td><td>with exception mentioned</td></tr><tr><td>Soy beans</td><td>0.2</td><td></td><td></td></tr><tr><td>Cocoa powder (drinking chocolate)</td><td>0.6</td><td></td><td>Cocoa powder sold to the final consumer or as an ingredient in sweetened cocoa powder sold to the final consumer (drinking chocolate)</td></tr><tr><td>Milk chocolate with < 30 % total dry cocoa solids</td><td>0.1</td><td></td><td></td></tr></table> 18 SFDA.FD ..... /2019 <table><tr><td>Chocolate with < 50 % total dry cocoa solids; milk chocolate with ≥ 30 % total dry cocoa solids</td><td>0.3</td><td></td><td></td></tr><tr><td>Meat of bovine animals, sheep and poultry</td><td>0.05</td><td></td><td>excluding offal</td></tr><tr><td>Horsemeat</td><td>0.2</td><td></td><td>excluding offal</td></tr><tr><td>Liver of bovine animals, sheep, poultry and horse</td><td>0.5</td><td></td><td></td></tr><tr><td>Kidney of bovine animals, sheep, poultry and horse</td><td>1</td><td></td><td></td></tr><tr><td>Muscle meat of fish: Mackerel, tuna and bichique</td><td>0.1</td><td>Muscle meat</td><td></td></tr><tr><td>Muscle meat of fish: bullet tuna</td><td>0.15</td><td>Muscle meat</td><td></td></tr><tr><td>Muscle meat of fish: Anchovy, swordfish and sardine</td><td>0.25</td><td>Muscle meat</td><td></td></tr><tr><td>Muscle meat of Fish with exception mentioned</td><td>0.05</td><td>Muscle meat</td><td></td></tr><tr><td>Crustaceans</td><td>0.5</td><td>Muscle meat</td><td></td></tr><tr><td>Powdered formulae manufac- tured from cows' milk proteins or protein hydrolysates</td><td>0.01</td><td></td><td></td></tr><tr><td>Liquid formulae manufactured from cows' milk proteins or protein hydrolysates</td><td>0.005</td><td></td><td></td></tr><tr><td>Powdered formulae manufac-tured from soya protein isolates, alone or in a mixture with cows' milk proteins</td><td>0.02</td><td></td><td></td></tr><tr><td>Liquid formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins</td><td>0.01</td><td></td><td></td></tr><tr><td>Processed cereal-based foods and baby foods for infants and young children</td><td>0.04</td><td></td><td></td></tr><tr><td>Food supplements consisting exclusively or mainly of dried seaweed, products derived from seaweed, or of dried bivalve molluscs</td><td>3</td><td></td><td></td></tr><tr><td>Food supplements with exception mentioned</td><td>1</td><td></td><td></td></tr></table> 19 SFDA.FD ..... /2019 LEAD <table><tr><td colspan="2">Reference to JECFA:</td><td colspan="2">10 (1966), 16 (1972), 22 (1978), 30 (1986), 41 (1993), 53 (1999), 73 (2010)</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">Based on the dose-response analyses, at the 73rd meeting (2010), JECFA estimated that the previously established PTWI of 25 μg/kg bw is associated with a decrease of at least 3 intelligence quotient (IQ) points in children and an increase in systolic blood pressure of approximately 3 mmHg (0.4 kPa) in adults. While such effects may be insignificant at the individual level, these changes are important when viewed as a shift in the distribution of IQ or blood pressure within a population. The JECFA therefore concluded that the PTWI could no longer be considered health protective and withdrew it.</td></tr><tr><td>Contaminant definition:</td><td colspan="3">Lead, total</td></tr><tr><td>Synonyms:</td><td colspan="3">Pb</td></tr><tr><td>Related code of practice:</td><td colspan="3">Code of Practice for the Prevention and Reduction of Lead Contamination in Foods (CXC 56-2004)Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Berries and other small fruits</td><td>0.1</td><td>Whole commodity after removal of caps and stems.</td><td>The ML does not apply to cranberry, currant and elderberry.</td></tr><tr><td>Cranberry</td><td>0.2</td><td>Whole commodity after removal of caps and stems.</td><td></td></tr><tr><td>Currants</td><td>0.2</td><td>Fruit with stem.</td><td></td></tr><tr><td>Elderberry</td><td>0.2</td><td>Whole commodity after removal of caps and stems.</td><td></td></tr><tr><td>Fruits</td><td>0.1</td><td>Whole commodity. Berries and other small fruits: whole commodity after removal of caps and stems.Pome fruits: whole commodity after removal of stems.Stone fruits, dates and olives: whole commodity after removal of stems and stones, but the level calculated and expressed on the whole commodity without stem.Pineapple: whole commodity after</td><td>The ML does not apply to cranberry, currant and elderberry.</td></tr></table> 20 SFDA.FD ..... / 2019 <table><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td></td><td></td><td>removal of crown. Avocado, mangos and similar fruit with hard seeds: whole commodity after removal of stone but calculated on whole fruit.</td><td></td></tr><tr><td>Brassica vegetables</td><td>0.1</td><td>Bulb/dry onions and garlic: whole commodity after removal of roots and adhering soil and whatever parchment skin is easily detached.</td><td>The ML does not apply to kale and leafy Brassica vegetables.</td></tr><tr><td>Bulb vegetables</td><td>0.1</td><td>Bulb/dry onions and garlic: whole commodity after removal of roots and adhering soil and whatever parchment skin is easily detached.</td><td rowspan="2">The ML does not apply to fungi and mushrooms.</td></tr><tr><td>Fruiting vegetables</td><td>0.05</td><td>Whole commodity after removal of stems Sweet corn and fresh corn: kernels plus cob without husk.</td></tr><tr><td>Leafy vegetables</td><td>0.3</td><td>Whole commodity as usually marketed, after removal of obviously decomposed or withered leaves.</td><td>The ML applies to leafy Brassica vegetables but does not apply to spinach.</td></tr><tr><td>Legume vegetables</td><td>0.1</td><td>Whole commodity as consumed. The succulent forms may be consumed as whole pods or as the shelled product.</td><td></td></tr><tr><td>Fresh farmed mushrooms (common mushrooms (Agaricus bisporous), shiitake mushrooms (Lentinula edodes), and oyster mushrooms (Pleurotus ostreatus))</td><td>0.3</td><td>Whole commodity</td><td>Relevant Codex commodity standard is CXS 38-1981</td></tr><tr><td>Pulses</td><td>0.1</td><td>Whole commodity</td><td></td></tr><tr><td>Root and tuber vegetables</td><td>0.1</td><td>Whole commodity after removing tops. Remove adhering soil (e.g. by rinsing in running water or by gentle brushing of the dry commodity). Potato: peeled potato.</td><td></td></tr></table> 21 SFDA.FD ..... /2019 <table><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Canned fruits</td><td>0.1</td><td>The ML applies to the product as consumed.</td><td>Relevant Codex commodity standards are CXS 242-2003, CXS 254-2007, CXS 78-1981, CXS 159-1987, CXS 42-1981, CXS 99-1981, CXS 60-1981, CXS 62-1981</td></tr><tr><td>Jams, jellies and marmalades</td><td>0.4</td><td></td><td>Relevant Codex commodity standard is CXS 296-2009 (for jams and jellies only).</td></tr><tr><td>Mango chutney</td><td>0.4</td><td></td><td>Relevant Codex commodity standard is CXS 160-1987.</td></tr><tr><td>Canned vegetables</td><td>0.1</td><td>The ML applies to the product as consumed.</td><td>Relevant Codex commodity standard is CXS 297-2009.</td></tr><tr><td>Preserved tomatoes</td><td>0.05</td><td></td><td>Relevant Codex commodity standard is CXS 13-1981.In order to consider the concentration of the product, the determination of the maximum levels for contaminants shall take into account the natural total soluble solids, the reference value being 4.5 for fresh fruit.</td></tr><tr><td>Table olives</td><td>0.4</td><td></td><td>Relevant Codex commodity standard is CXS 66-1981.</td></tr><tr><td>Pickled cucumbers (cucumber pickles)</td><td>0.1</td><td></td><td>Relevant Codex commodity standard is CXS 115-1981.</td></tr><tr><td>Canned chestnuts and canned chestnuts puree</td><td>0.05</td><td></td><td>Relevant Codex commodity standard is CXS 145-1985.</td></tr><tr><td>Fruit juices</td><td>0.03</td><td>Whole commodity (not concentrated) or commodity reconstituted to the original juice concentration, ready to drink.The ML applies also to nectars, ready to drink.</td><td>The ML does not apply to juices exclusively from berries and other small fruit.Relevant Codex commodity standard is CXS 247-2005.</td></tr><tr><td>Fruit juices obtained exclusively from berries and other small fruits</td><td>0.05</td><td>Whole commodity (not concentrated) or commodity reconstituted to the original juice concentration, ready to drink. The ML applies also to nectars, ready to drink.</td><td>The ML does not apply to grape juice.Relevant Codex commodity standard is CXS 247-2005.</td></tr><tr><td>Grape juice</td><td>0.04</td><td>Whole commodity (not concentrated) or commodity reconstituted to the original juice concentration, ready to drink. The ML applies also to nectars, ready to drink</td><td>Relevant Codex commodity standard is CXS 247-2005.</td></tr><tr><td>Cereal grains</td><td>0.2</td><td>Whole commodity</td><td>The ML does not apply to buckwheat</td></tr></table> 22 SFDA.FD ..... / 2019 <table><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td></td><td></td><td></td><td>cañihua and quinoa.</td></tr><tr><td>Infant formula, formula for special medical purposes intended for infants and follow-up formula</td><td>0.01</td><td>Whole commodity</td><td>Relevant Codex commodity standards are CXS 72-1981 and CXS 156-1987. The ML applies to formula as consumed.</td></tr><tr><td>Fish</td><td>0.3</td><td>Whole commodity (in general after removing the digestive tract)</td><td></td></tr><tr><td>Meat of cattle and sheep</td><td>0.1</td><td>Whole commodity (without bones)</td><td>The ML also applies to fat from the meat.</td></tr><tr><td>Meat and fat of poultry</td><td>0.1</td><td>Whole commodity (without bones)</td><td></td></tr><tr><td>Cattle, edible offal of</td><td>0.5</td><td>Whole commodity</td><td></td></tr><tr><td>Poultry, edible offal of</td><td>0.5</td><td>Whole commodity</td><td></td></tr><tr><td>Edible fats and oils</td><td>0.08</td><td>Whole commodity as prepared for wholesale or retail distribution.</td><td>Relevant Codex commodity standards are CXS 19-1981, CXS 33-1981, CXS 210-1999, CXS 211-1999 and CXS 329-2017</td></tr><tr><td>Fat spreads and blended spreads</td><td>0.04</td><td>Whole commodity as prepared for wholesale or retail distribution.</td><td>Relevant Codex commodity standard is CXS 256-2007.</td></tr><tr><td>Milk</td><td>0.02</td><td>Whole commodity</td><td>Milk is the normal mammary secretion of milking animals obtained from one or more milkings without either addition to it or extraction from it, intended for consumption as liquid milk or for further processing.A concentration factor applies to partially or wholly dehydrated milks</td></tr><tr><td>Secondary milk products</td><td>0.02</td><td>Whole commodity</td><td>The ML applies to the food as consumed.</td></tr><tr><td>Natural mineral waters</td><td>0.01</td><td></td><td>Relevant Codex commodity standard is CXS 108-1981.The ML is expressed in mg/l.</td></tr><tr><td>Salt, food grade</td><td>1</td><td>Whole commodity as prepared for wholesale or retail distribution</td><td>Relevant Codex commodity standard is CXS 150-1985.Excluding salt from marshes</td></tr><tr><td>Concentrated fruit juices and fruit nectars</td><td>0.05</td><td></td><td></td></tr><tr><td>Infant formulae and follow-on formulae</td><td>0.02</td><td></td><td></td></tr><tr><td>Crustaceans</td><td>0.5</td><td>Muscle meat</td><td></td></tr><tr><td>Bivalve molluscs</td><td>1.5</td><td></td><td></td></tr><tr><td>Cephalopods</td><td>1</td><td></td><td>Without viscera</td></tr><tr><td>Food supplements</td><td>3</td><td></td><td></td></tr></table> 23 SFDA.FD ..... /2019 MERCURY <table><tr><td colspan="4">Reference to JECFA: 10 (1966), 14 (1970), 16 (1972), 22 (1978), 72 (2010)</td></tr><tr><td colspan="2">Toxicological guidance value:</td><td colspan="2">At the \( 72^{rd} \) meeting (2010), JECFA established a PTWI for inorganic mercury of 4 μg/kg bw. The previous PTWI of 5 μg/kg bw for total mercury, established at the sixteenth meeting, was withdrawn. The new PTWI for inorganic mercury was considered applicable to dietary exposure to total mercury from foods other than fish and shellfish. For dietary exposure to mercury from these foods the previously established PTWI for methyl mercury should be applied.</td></tr><tr><td colspan="2">Contaminant definition:</td><td colspan="2">Mercury, Total</td></tr><tr><td colspan="2">Synonyms:</td><td colspan="2">Hg</td></tr><tr><td colspan="2">Related code of practice:</td><td colspan="2">Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Natural mineral waters</td><td>0.001</td><td></td><td>Relevant Codex commodity standard is CXS 108-1981. The ML is expressed in mg/l.</td></tr><tr><td>Salt food grade</td><td>0.1</td><td></td><td>Relevant Codex commodity standard is CXS 150-1985.</td></tr><tr><td>Tuna</td><td>1.2</td><td>Whole commodity after removing the digestive tract</td><td></td></tr><tr><td>Alfonsino</td><td>1.5</td><td>Whole commodity after removing the digestive tract</td><td></td></tr><tr><td>Marlin</td><td>1.7</td><td>Whole commodity after removing the digestive tract</td><td></td></tr><tr><td>Shark</td><td>1.6</td><td>Whole commodity after removing the digestive tract</td><td></td></tr><tr><td>Fishery products and muscle meat of fish with exception mentioned, Crustaceans and crabs</td><td>1</td><td></td><td></td></tr><tr><td>Food supplements</td><td>0.1</td><td></td><td></td></tr><tr><td>Wheat pink kernels</td><td>1</td><td></td><td>Pink kernels only</td></tr></table> 24 SFDA.FD ..... / 2019 METHYL MERCURY IN CERTAIN FISH SPECIES AND CRUSTACEANS <table><tr><td colspan="4">Reference to JECFA: 22 (1978), 33 (1988), 53 (1999), 61 (2003), 67 (2006)</td></tr><tr><td colspan="4">Toxicological guidance value: PTWI 0.0016 mg/kg bw (2003, confirmed in 2006)</td></tr><tr><td colspan="4">Contaminant definition: Methylmercury</td></tr><tr><td colspan="4">Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)</td></tr><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Tuna</td><td>1.2</td><td rowspan="4">Whole commodity fresh or frozen (in general after removing the digestive tract)</td><td rowspan="4">The ML also applies to fresh or frozen fish intended for further processing.</td></tr><tr><td>Alfonsino</td><td>1.5</td></tr><tr><td>Marlin</td><td>1.7</td></tr><tr><td>Shark</td><td>1.6</td></tr><tr><td>Crustaceans and crabs</td><td>1</td><td></td><td></td></tr></table> 25 SFDA.FD ..... /2019 TIN <table><tr><td>Reference to JECFA:</td><td>10 (1966), 14 (1970), 15 (1971), 19 (1975), 22 (1978), 26 (1982), 33 (1988), 55 (2000), 64 (2005)</td></tr><tr><td>Toxicological guidance value:</td><td>PTWI 14 mg/kg bw (1988, expressed as Sn; includes tin from food additive uses; maintained in 2000)</td></tr><tr><td>Contaminant definition:</td><td>Tin, total (Sn-tot) when not otherwise mentioned; inorganic tin (Sn-in); or other specification</td></tr></table> <table><tr><td>Synonyms:</td><td>Sn</td></tr><tr><td>Related code of practice:</td><td>Code of Practice for the Prevention and Reduction of Inorganic Tin Contamination in Canned Foods (CXC 60-2005)</td></tr></table> Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001) <table><tr><td>Commodity/Product Name</td><td>Maximum Level (ML) mg/kg</td><td>Portion of the Commodity/Product to which the ML applies</td><td>Notes/Remarks</td></tr><tr><td>Canned foods (other than beverages)</td><td>250</td><td></td><td>The ML does not apply to non-tinplate canned cooked cured chopped meat, cooked cured ham, cooked cured pork shoulder, corned beef and luncheon meat.Relevant Codex commodity standards include CXS 62-1981, CXS 254-2007, CXS 296-2009, CXS 242-2003, CXS 297-2009, CXS 78-1981, CXS 159-1987, CXS 42-1981, CXS 60-1981, CXS 99-1981, CXS 160-1987, CXS 66-1981, CXS 13-1981, CXS 115-1981, CXS 57-1981, CXS 145-1981, CXS 98-1981, CXS 96-1981, CXS 97-1981, CXS 88-1981, CXS 89-1981.</td></tr><tr><td>Canned beverages</td><td>150</td><td></td><td>Relevant Codex commodity standards include CXS 247-2005.</td></tr><tr><td>Cooked cured chopped meat</td><td>50</td><td></td><td>The ML applies to products in containers other than tinplate containers.Relevant Codex commodity standard is CXS 98-1981.</td></tr><tr><td>Corned beef</td><td>50</td><td></td><td>The ML applies to products in containers other than tinplate containers.Relevant Codex commodity standard is CXS 88-1981.</td></tr><tr><td>Luncheon meat</td><td>50</td><td></td><td>The ML applies to products in containers other than tinplate containers.Relevant Codex commodity standard is CXS 89-1981.</td></tr><tr><td>Canned baby foods and processed cereal-based foods for infants</td><td>50</td><td></td><td></td></tr></table> 26 SFDA.FD ..... /2019 <table><tr><td>and young children, excluding dried and powdered products</td><td></td><td></td><td></td></tr><tr><td>Canned infant formulae and follow-on formulae, excluding dried and powdered products</td><td>50</td><td></td><td></td></tr><tr><td>Canned dietary foods for special medical purposes intended specifically for infants, excluding dried and powdered products</td><td>50</td><td></td><td></td></tr></table> 27 SFDA.FD ..... /2019 RADIONUCLIDES <table><tr><td>Commodity/Product Name</td><td>Guideline Level (GL) (Bq/kg)</td><td>Representative radionuclides</td><td>Portion of the Commodity/Product to which the GL applies</td><td>Notes/Remarks</td></tr><tr><td>Infant foods</td><td>1</td><td>Pu-238, Pu-239, Pu-240, Am-241</td><td></td><td>The GL applies to foods intended for consumption by infants.</td></tr><tr><td>Infant foods</td><td>100</td><td>Sr-90, Ru-106, I-129, I-131, U-235</td><td></td><td>The GL applies to foods intended for consumption by infants.</td></tr><tr><td>Infant foods</td><td>1000</td><td>S-35 (*), Co-60, Sr-89, Ru-103, Cs-134, Cs-137, Ce-144, Ir-192</td><td></td><td>The GL applies to foods intended for consumption by infants.</td></tr><tr><td>Infant foods</td><td>1000</td><td>H-3(**) , C-14, Tc-99</td><td></td><td>The GL applies to foods intended for consumption by infants.</td></tr><tr><td>Foods other than infant foods</td><td>10</td><td>Pu-238, Pu-239, Pu-240, Am-241</td><td></td><td></td></tr><tr><td>Foods other than infant foods</td><td>100</td><td>Sr-90, Ru-106, I-129, I-131, U-235</td><td></td><td></td></tr><tr><td>Foods other than infant foods</td><td>1000</td><td>S-35 (*), Co-60, Sr-89, Ru-103, Cs-134, Cs-137, Ce-144, Ir-192</td><td></td><td></td></tr><tr><td>Foods other than infant foods</td><td>10000</td><td>H-3(**) , C-14, Tc-99</td><td></td><td></td></tr></table> (*)This represents the value for organically bound sulphur (**)This represents the value for organically bound tritium Scope: The Guideline Levels apply to radionuclides contained in foods destined for human consumption and traded internationally, which have been contaminated following a nuclear or radiological emergency \( ^{1} \) . These guideline levels apply to food after reconstitution or as prepared for consumption, i.e., not to dried or concentrated foods, and are based on an intervention exemption level of 1 mSv in a year. Application: As far as generic radiological protection of food consumers is concerned, when radionuclide levels in food do not exceed the corresponding Guideline Levels, the food should be considered as safe for human consumption. When the Guideline Levels are exceeded, national governments shall decide whether and under what circumstances the food should be distributed within their territory or jurisdiction. National governments may wish to adopt different values for internal use within their own territories where the assumptions concerning food distribution that have been made to derive the Guideline Levels may not apply, e.g., in the case of wide-spread radioactive contamination. For foods that are consumed in small quantities, such as spices, \( ^{1} \) For the purposes of this document, the term “emergency” includes both accidents and malevolent actions. 28 SFDA.FD ..... /2019 that represent a small percentage of total diet and hence a small addition to the total dose, the Guideline Levels may be increased by a factor of 10. Radionuclides: The Guideline Levels do not include all radionuclides. Radionuclides included are those important for uptake into the food chain; are usually contained in nuclear installations or used as a radiation source in large enough quantities to be significant potential contributors to levels in foods, and; could be accidentally released into the environment from typical installations or might be employed in malevolent actions. Radionuclides of natural origin are generally excluded from consideration in this document. In the Table, the radionuclides are grouped according to the guideline levels rounded logarithmically by orders of magnitude. Guideline levels are defined for two separate categories “infant foods” and “other foods”. This is because, for a number of radionuclides, the sensitivity of infants could pose a problem. The guideline levels have been checked against age-dependent ingestion dose coefficients defined as committed effective doses per unit intake for each radionuclide, which are taken from the “International Basic Safety Standards” (IAEA, 1996) \( ^{1} \) . Multiple radionuclides in foods: The guideline levels have been developed with the understanding that there is no need to add contributions from radionuclides in different groups. Each group should be treated independently. However, the activity concentrations of each radionuclide within the same group should be added together \( ^{2} \) . \( ^{1} \) Food and Agriculture Organization of the United Nations, International Atomic Energy Agency, International Labour Office, OECD Nuclear Energy Agency, Pan American Health Organization, World Health Organization (1996) International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA, Vienna. \( ^{2} \) For example, if \( {}^{134} \) Cs and \( {}^{137} \) Cs are contaminants in food, the guideline level of 1 000 Bq/kg refers to the summed activity of both these radionuclides. 29 SFDA.FD ..... / 2019 Annex A SCIENTIFIC JUSTIFICATION FOR THE GUIDELINE LEVELS FOR RADIONUCLIDES IN FOODS CONTAMINATED FOLLOWING A NUCLEAR OR RADIOLOGICAL EMERGENCY Infants and adults: The levels of human exposure resulting from consumption of foods containing radionuclides listed in Table 1 at the suggested guideline levels have been assessed both for infants and adults and checked for compliance with the appropriate dose criterion. In order to assess public exposure and the associated health risks from intake of radionuclides in food, estimates of food consumption rates and ingestion dose coefficients are needed. It is assumed that 550 kg of food is consumed by an adult in a year. The value of infant food and milk consumption during first year of life used for infant dose calculation equal to 200 kg is based on contemporary human habit assessments. The most conservative values of the radionuclide-specific and age-specific ingestion dose coefficients, i.e. relevant to the chemical forms of radionuclides which are most absorbed from the gastro-intestinal tract and retained in body tissues, are taken from the IAEA. Radiological criterion: The appropriate radiological criterion, which has been used for comparison with the dose assessment data below, is a generic intervention exemption level of around 1 mSv for individual annual dose from radionuclides in major commodities, e.g. food, recommended by the International Commission on Radiological Protection as safe for members of the public. Naturally occurring radionuclides: Radionuclides of natural origin are ubiquitous and as a consequence are present in all foodstuffs to varying degrees. Radiation doses from the consumption of foodstuffs typically range from a few tens to a few hundreds of microsieverts in a year. In essence, the doses from these radionuclides when naturally present in the diet are unamenable to control; the resources that would be required to affect exposures would be out of proportion to the benefits achieved for health. These radionuclides are excluded from consideration in this document as they are not associated with emergencies. One-year exposure assessment: It is conservatively assumed that during the first year after major environmental radioactive contamination caused by a nuclear or radiological emergency it might be difficult to re …(104,003 more chars)