SFDAFD CAC 193 - PDF document

SFDA.FD CAC 193 / 2018 ةيذغ�ا يف مومسلاو تاثولملل ةماع ةفصاوم General Standard for contaminants & toxins in food ICS: 67.040.00 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 sector has adopted the Codex Standard No.( CAC 193 ). This standard has been approved as national standard by SFDA board of directors in its meeting No (17 ) Held on ( 16 / 09 / 1439 AH) , ( 31 / 05 / 2018 G). * 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. G E NER A L S T AND A RD F O R C O N TA MINA N TS AND T O X INS IN FOODS 1 S COPE This Standard contains th e m ain principles and pro c edures which are used and rec o mmended by the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ) in dealing w i th conta m inants and to x i n s in foods, and lists the m axi m u m levels of cont a m inants and natural toxicants in foods which are r e c o mmended b y t h e (G S O ) t o be applied t o c o m m odities m oving in in t ernational trade. 2 DEFINITION OF TERMS 2.1 General The definitions for the purpose of the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ), as mentioned in t h e Procedural Manual, are applicable to the General Standard for Conta m inants and Toxins in Foods of (G S O ) a n d on l y the m o st i m portant o n es are repeated here. S o me new definitions are i

ntroduced, where this se e ms warranted to obtain optimal clarit y . When reference is made to f oods, this also applies to an i m al feed, in those cases where this is appropriate. 2.2 Contaminant St a nd ar d iz a ti on Or g a n iz a ti on (G S O ) defines a conta m inant as follows: "Any substance not intent i onal l y a dded to food, which is present in such food as a result of the product i on (including o p erations carried out in crop husband r y , ani m al husband r y and veterinary m edicine), manufacture, processing, preparation, trea t ment, packing, packaging, transport or hold i ng of such food or as a result of e n viron m ental c onta m ination. The te r m d o es not include insect f r agments, rodent hairs and other extraneous matter". This standard applies to any substance that m e ets the ter m s o f the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ) definition for a conta m inant, including co n ta m inants in feed for food - produci n g an i mals, excep t : 1 ) Conta m inants havi n g on l y fo o d quali t y significance, but n o publ i c health sig n ificance, in t h e food(s). 2 ) Pesticide residues, as def i ned b y the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ) definition that are within the terms of reference of the General St a nd ar d on Pesticide Residues. Pesticide residues arisi n g from pesticide uses not associated with food production m ay be considered for inclusion in the General Standard for Conta m inants and Toxins in Foods. 3 ) Residues of veterinary d r ugs, as defined by t h e (G S O ) definition, that are w i thin the terms of reference of the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ). 4 ) Microbial to x ins, such as botulin

um tox i n and staph y lococcus ente ro toxin, and microorganisms that are within the terms of reference of the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ). 5) Residues of processing aids that are within the terms of reference of the St a nd ar d iz a ti on Or g a n iz a ti on (G S O ) 1 . 6) Naturally occurring toxicants such as are produced as toxic metabolites of certain microfungi that are not intentionally added to food (mycotoxins). 2.3 Maximum level and related ter m s The G S O maximum level (ML) for a cont a m in ant in a food or feed c o m m odity is the m ax i m u m concentration of that substance rec o mmended by the G S O to be leg a lly per m itted in that c o m m odity. A G S O guideline level ( GL) is the maxi m u m level of a substance in a food or feed c o m m odity which is rec o mmended by the G S O to be acce p table for c o m m odities m o v ing in intern a tional trade. When the GL is exceeded, governments s h ould decide whether and under what circ u m stances th e food shou l d be distribu t ed within their t erritory or ju r isdiction 2 . 3. GENERAL PRINCIPLES REGARDING CONTAMINANTS IN FOODS 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. Conta m inant levels in foods shall be as low as reas o nab l y achievable. The following actio n s m ay serve to prevent or to reduce contamination of f oods and fee d s 3 : preventing food contamination at the source, e.g. by reducing environmental pollution. applying appropriate technology in food production, handling, storage, processing and packaging. applying measures aimed at decontamination of contaminated food or feed and

measures to prevent contaminated food or feed to be marketed for consumption. To ensure th a t adequate action is taken t o reduce con t a m ination of food and feed a Code of P r actice shall be elaborated co m p rising source related m easures and Good Manufacturing Practice as well as Good Agricultural Practice in re l ation to the s p ecific contamination proble m . The degree of conta m ination of f oods a nd feeds and the effect of actions to reduce conta m i n ation shall be ass e ssed by m onitoring, surv e y programs and m o re speciali z ed r e sea r ch programs, where n e ces s ar y . When there are indications that health hazards may be involved with cons u m ption of foods that are cont a m inate d , it is neces sa ry that a risk ass e s s ment is m ade. Wh e n health concerns can be s ubstantiated, a risk m anag e ment poli c y m u st be applied, based on a t horough evaluation of the situation. Depending on the ass e s s ment of the problems and the possible solutions, it m ay be neces s ary to establish m a x i m u m levels or other m e asu r es governing the conta m i n ation of foods. In special cases, it may also have to be considered t o give dietary r ec o mmendat i ons, when other m e asures are not suff i ciently adequate to exclu d e the possibility of hazards to health. National measures rega rd ing food c onta m ination s hou l d avo i d the creation of unnecessary barriers to international trade in food or feed c o m m odities. The purpose of t h e General Standard is to provide guidance about the possible approach of the conta m inat i on problem and to p r omote internat i onal har m onization thr ou gh rec o mmendations which may help to a v oid the creation of trade b a

rriers. For all contaminants, which m ay be present in m o re than one food or feed ite m , a broad approach shall be applied, taking into account all relev a nt infor m ation th at is availa b le, for the as s es s ment of risks and for the develop m ent of rec o mmendations and measures, including the setting of m axi m u m levels. 2 For the contaminants methylmercury, radionuclides, acrylonitrile and vinylchloride monomer a GSO guideline level (GL) has been established. A GSO guideline level (GL) is the maximum level of a substance in a food or feed commodity which is recommended by the GSO to be ac ceptable for commodities moving in i nternational 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 GSO has decided that the preferred format of a GSO standar d in fo od 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 General Standard, if appropriate. 3 In addition, reference is made to t he Code of Practice for source Directed measures to reduce contamination of food with chemicals and the Code of Practice on Good Animal Feeding . 3.2 Principles f o r establishi n g maximum levels in foods and feeds The maximum levels 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 GSO Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Food s or Food Groups (Section III of the Procedural Manual). The MLs 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 “Work ing principles for Risk Analysis for Food safety for Application by Government

s”. The principles of Good Manufacturing Practice and Good Agricultural Practice as defined by GSO shall be used. Maximum levels shall be based on sound scientific principles l eading 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. 3.3 Specific c rit e ria The following criteria should (not preventing the use of other relevant criteria) be considered when developing recommendations and making decisions in connection with the GSO General Standard for Contaminants and Toxins in Food and Feed: (Further details about these criteria are given in Annex I). Toxi cologic a l information identification of the toxic s ubstance(s); metabolism b y hu m ans and animals, as appropriate; toxicokineti c s and toxico d yna m i cs including information on possible carry - over of the toxic substance from feed to edible animal tissue/products; infor m ation about acute a n d lo n g term toxici t y and o t her relevant toxici t y ; integrated toxicological expert advice regarding the acceptability and safety of intake levels of conta m inants, includi n g in f o rmation on an y p opu l ati o n groups whi c h are especially vu l nerable. Analytical d a ta validated qualitative and quantitative data on representative sa m pl es; appropriate sa m p ling procedures. Intake data presence in foods of dietary significance for the contaminant intake; presence in foods that are widely consumed; food intake data for average and most exposed consumer groups; results from total diet studies; calculated contaminant intake data from food consumption models; data on intake by susceptible groups. Fair trade considerations existing or potential problems in international trade; commodities concerned moving in international trade; information about national regulations, in particular on the data and

considerations on which these regulations are based. Technological considerat ions information about contamination processes, technological possibilities, production and manufacturing practices and economic aspects related to contaminant level management and control. Risk asse s sment and risk management considerations ri sk assessment; risk management options and considerations; consideration of possible maximum levels in foods based on the criteria mentioned above; consideration of alternative solutions . 4 GSO PROCEDURE FOR ESTABLISH I NG STANDA R DS FOR CONTAMINAN T S AND TO X INS IN FOODS 4.1 General The Procedu r e for the ela b oration of GSO Standar d s, as contained in the P r ocedural Manual, is applicab l e. Further details are mentioned here regarding the p r ocedure to be followed and the criteria for decision making, in order to clarify and to facilitate the process of the elaboration of GSO Standards for Conta m inants and Tox i ns i n Fo o d s. 4.2 Procedure f o r prel i m ina r y discussion about contaminants and Toxins in Foods Suggestions for new contaminants or new cont a m i n a n t/c o m m odi t y co m b inations to be discussed in GSO Standards for Conta m inants and Tox i ns i n Fo o d s and to be included in the General Standard m ay be raised by d e legates or by the secre t a r iat. An initial discussion may be held based on oral contributions, but preferably on the basis of a note containing relevant and adequate infor m ation. For a satisfa c tory preli m inary review the following infor m ation is essential: 1) Identification of the cont a minant and concise information about th e background of the pr o b le m . 2) Indications about t h e availability of toxicolog i cal i n for m ation and ana l y tical and intake

data, including references. 3) Indications about ( potenti a l) health pro b le m s. 4) Indications about existi n g and expected barriers to international trade. 5) Infor m ation about techno l ogical possibilities a nd ec o no m ic aspects related to the m anagement of the contaminant problem in food. 6) Preferably a proposal for a ction by the GSO Standards for Conta m inants and Tox i ns i n Fo o d s. The list of GSO conta m in ant standards for individual foods or food categories shall be presented accord in g to an agreed food categorization s y ste m . See Annex IV. 6 REVIEW AND REVISION OF THE GENERAL STANDARD The cont a m i n ant provisions for this Sta n dard shall be reviewed on a regular bas i s and revised as ne c es s ary in the light of r evisions of toxicological advice by General Standard or of changed risk management views, resid u e management possibilities, scientific knowledge or other i m portant rel e vant develop m ents. Specific atte n tion shall be given to the r eview of exi s ting Maxi m u m Levels and Gui d eline Levels and to their possible con v ersion to Ma x i m u m Levels. GSO STANDARD GSO CAC 193 / 2017 ANNEX I CRI T ERIA FOR T HE E STABLI SH MENT OF MAXIMUM LEVELS IN FOODS Introduction In this Ann e x criteria are mentioned regarding inf o r m ation whi c h is considered neces s ary for evaluating conta m inant proble m s in foods and for the establis h ment of maxi m u m levels. It is therefore i m portant that these criter i a are taken into account when infor m ation is supplied t o General Standard . The criteria mentioned here are elabor a ted in m o re detail than in s ection 1.3 . 3. o

f the Preamble. On l y t h ose aspects a r e mentioned that need further clarifi c ation, so criteria or aspects that a re not m entioned here should not be ruled out in the evaluation process. Toxicologic a l 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 General Standard regarding the m ax i m u m allowable or tolerable intake, based on a full evaluation of an adequate toxicological data base , shall be the main bas i s f o r decisions. In urgent cases, it m ay be possible to rely on less devel o ped evaluations from General Standard or on t o xicolog i cal expert a d vice fr o m other international or national bodies. When toxico l ogical information is presented in relation to p r opos a ls for m ax i mum leve l s for conta m inants in foods, i n dications are desirable about t h e following a spects: identification of the toxic s ubstance(s); metabolism in hu m ans and animals, as appropriate; toxicokineti c s and toxico d yna m i cs; infor m ation about acute and lo n g term toxicity in animals and hu mans, including epide m iological data on h u mans a nd other relevant toxicity data; conclusions and advice of toxicological exp e rt(s) (groups), with refere n ces, including infor m ation on especially vu lnerable pop u lation gr o ups or animals. Analytical da ta GSO STANDARD GSO CAC 193 / 2017 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 repre

sentat ively 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 b e equivalent to the definition of the com m o d i t y for t h is p u rpose or to e x isting 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. m y cotox i ns in some commodities). Intake data It is desirable to have inf o r m ation about the conta m inant concentrations in tho s e foods or f o od gr o ups t h at (together) are responsible for at least half and prefera b ly 80% or m o re of the total dietary intake of the cont a m inant, both for average cons u m e r s 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. For the contaminants which can be present in food of animal origin as a consequence of the carryover 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 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 inform ation 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 identi

fied. Detailed information about high consumption patterns is desirable, both regardin g 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 contaminan ts (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 cont aminant 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 GSO STANDARD GSO CAC 193 / 2017 Existing, expected or potential problems in international trade: In order to assess the urgency of a problem to be discussed by General Standard 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 det ails 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 assessmen

t and risk management policy which is used for making decisions regarding maximum levels in foods. Technological considerations Infor m ation about t he sou r ce of the co n ta m inant and the way i n which the f o od is contaminated, possib l y including in f o rmation, if i t is available, about cont a mination be i ng present in parts on l y of the product, is essential for assessing the possibilities to control the conta m inat i on process and to be able to guarantee a desired product quali t y . Where p o ssible Source - r elated measu r es s h ould be p r oposed. G o od Manufacturing Practice (GMP) and/ o r Good Agr i cultural Practice (GAP) should also b e for m ulated to control a cont a m ination proble m . Wh e n this is pos s ible, m ax i m u m leve l s may be based on GMP or GA P considerations and m ay thus be established at a level as low as reasonably achievable. Considerations regarding the technological possibilities to control a con t a m ination p r oble m , e.g. by cleaning, should also be taken into account when a primary risk assessment model (theoretical max i m u m daily i n take) shows possible intakes exceeding the tox i cological m a xi m u m intake rec o mmen d ation. In such a case the possibilities of lower contamination levels need further car e ful exa m ination. Then a detai l ed study about all the as p ects involved is necessar y , so t h at decisions about m ax i mum l i m i t s can be based on a thorough evaluation of both the public h e alth arguments and the pos s ibilities and problems to co m p ly with the proposed st a ndard. Risk asse s sment and risk management considerations Risk assessment and risk management are conducted in compliance with the Working Principles for Risk Analysis for food safety by g

overnments. Risk asses s ment is defined as the scientific evaluation of the p r ob a bili t y of occurrence of known or potent i al adverse health effects resulting from human exposure to foodbo r ne hazard s . The process consists of t h e following steps: hazard identification, hazard characteri za tion, expo s ure asse s sment and risk characteriza t ion . (The definition includes quantit a tive risk assessment, which e m phasizes reliance on nu m er i cal e x pressions of risk, and also qualitative e xpressions of risk, as well as an GSO STANDARD GSO CAC 193 / 2017 indication of the attendant uncertainties). The first st ep s are hazard identificat i o n and hazard characte r ization . Hazard identification is the identification of known or potential health effects in hu m ans, produced b y a conta m inant which may be present in a particular food or group of foods. Hazard characterization is the qualitative and, if possible, quantitative evaluation of t h e nature of t h e adverse effects associated with the food conta m inant, including a dose/response a s se ss ment and, when possible, the es t ablis h ment of a sa f ety standard (ADI, TDI or c o m p arable t oxicological rec o mmenda t ion) f o r the intake of the cont a m inant. The exposure asses s ment is the qualitative and, when possible, qu a ntitative evaluation of t h e likely intake of the contaminant via food, as well as exposure from other sources if relevant. In t h e risk characterization step, the hazard identification, hazard char a cteri z ation and exposure asses s ment are c o m b in e d into an est i m ation of the severity and occurrence o f known or p o tential health effects

likely t o occur in a given p o pulation, inc l uding attend a nt uncertainties. Potential public health risks can be con s idered to exi s t when there is evidence that the contaminant intake of (groups of) consu m e r s may exceed (on a long te r m b asis for long te r m r ec o mmendations) the toxicological rec o mmenda t ion about the max i m u m a cceptable or toler a ble intake level. More specific est i mation 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 cont a m inant. Risk management is defined as the process of weighing poli c y alternatives in the light of the risk asses s m e nt and, if requ i red, to select and i m plement appro p r i ate control options, including the establis h m ent and enforcement of m ax i m u m levels of con t a m inants in f ood s . It is based on ade q uate risk assessment and on infor m ation about p o li c y opti o ns and strategies to deal with conta m ination proble m s and i n volves risk commun i cation . Risk comm u nication is the interactive exchange of infor m ation and op i nions concerning r isk a m ong r i sk assessors, risk managers and other inte r ested parties. Responsible risk m anagement is based on consistent application o f an appropr i ate policy r e garding the p ro t ection of p ublic health, but also in vo lves taking i n to account other relevant criteria, such as the available anal y tical data, the technological possibilities to control the conta m ination of p r o d ucts, econo m ic factors and fair trade criteria.

In short, the risk as s es s m e nt shall es t ablish how m a n y consu m ers possibly exceed the toxicological stand a rd, and for how l ong ti m e and how m u ch, and what this i m plies as real health risks. Risk m anagement involv e s, in a consiste n t wa y , 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 t o achieve sufficient public health protection and cont ro l of the contamination. Risk m a n agement dec i sions m ay lead to m ax i m u m leve l s for foods. In the process l eading to such a decision, the consequences, costs and b enefits should be presented and evaluated in relation to other pol i cy options. GSO STANDARD GSO CAC 193 / 2017 Establish m ent of m axi m um levels for conta m inants 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 cont a m in ants that present both a significant risk to public health and a known or expected problem in international trade. MLs shall be set on l y f o r t hose foods th at are significant for the to t al exposure o f the consumer to the c o ntaminant. When identi f ying the signif i ca n ce of certain foods i n t h e t o tal exposure to the conta m i n ant, the criteria contained in the GSO Policy for E xposure Assessment of Conta m inants and Toxins in Foods or Food Groups should be consulted. MLs shall be set as low as reasona b ly achiev a ble. Providing it

is acc e ptable from the toxicological point of view, MLs shall be set at a level which is (slight l y ) higher than the nor m al range of variation in lev e ls in foods t h at are produced with current adequate technological methods, in order to a v o i d u n due d isruptions of fo od p r oducti o n and trade. Where possible, MLs shall be based on GMP and/or GAP considerat i ons in which the health c o ncerns have b een incorporated as a guiding principle to achi e ve conta m inant levels as low as reas o nab l y achievable. Foods that are evidently c onta m ina t ed by local situations or pro c essing conditions that can be avoided b y reasonab l y achievable m e a n s shall be excl u d ed in this evaluation, unl e ss a higher ML can be shown to be accep t able from a public health point of view and appreciable econo m ic as p ects are at stake. Proposals for MLs in products shall be based on data from at least various countries and sources, enco m p assing the main produc t ion areas/p r ocesses of those products, as far as they a r e engaged in i n ternational trade. Wh e n the r e is e v idence that conta m inat i on patterns a r e sufficiently understood and will be co m p arable on a global scale, m o re l i m i t ed data m ay be enough. MLs m ay be set for product gr o ups when suff i cient information is available about the conta m ination pattern for t he whole gr o up, or when there are other arguments that extrapolation is appropriate. N u m eri c al v a lues for MLs shall prefer a bly be regul a r figures in a geo m etric scale ( 0.01, 0 . 02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5 etc.), unless this m ay pose problems in the acceptabili

ty of the MLs. MLs shall app l y to rep r esentative sa m pl es per l o t. If necessar y , appropr i ate methods of s a m p ling shall be specified. MLs should not be lower than a level which can be anal y zed wi t h m ethods of anal y sis t h at can be readily applied in no r mal product control l a bo r atories, unless public hea l th GSO STANDARD GSO CAC 193 / 2017 considerations necessi t ate a lower detect i on li m it whi c h can only be controlled by m e ans of a m o re elab o rate method of anal y sis. In all cases, however, a v a lidated m ethod of anal y sis should be available with which a ML can be controlled. The cont a m in ant as it s h ould be anal y zed and to which the ML applies s h ould be cle a rly defined. T h e definition may include i m portant metabolites when this is app r opriate from a n anal y tical or toxicological point of view. It m ay also be a i m ed at i ndicator sub s tances which are chosen from a group of related conta m inants. The pro d uct as it should b e anal y zed a n d to which t h e ML applies, should be clearly defined. In general, MLs are set on p ri m ary produ c ts. MLs sha l l in general p referably be expressed as a level of the conta m inant r elated to the product as it is, on a fresh weight basis. In some cases, however, there m ay be v a lid argu m ents to prefer expression on a dry weight basis. Prefe r ably the product s h all be defined as it m oves in t r ade, with provisions where necessary for t h e r e m oval of inedible parts that m ight disturb the preparation of the s a m p le and the anal y sis. The p

roduct definitions used by t h e GSO and contained in the Classification of foods and feeds may serve as guidance on this subject; other product definitions shou l d only be used f o r specified reasons. For c onta m inant purposes, ho w ever, anal y sis and consequently MLs will preferably be on the basis of the edible part of the product. For fat soluble conta m inants which m a y acc u m u l a te in ani m al products, prov i sions should be applied regarding t h e appl i cation of the ML to p r od u cts with various fat content (co m parable t o the provisions for fat soluble pesticides). Guidance is desirable regarding the possible app l ication of MLs established for pr i mary products to processed products and m u lti - ingredi e nt products. When products are concentra t ed, dried or di l u t ed, use of the concentration or di l u ti o n f actor is generally a p p r opr i ate in order to be able to obtain a pr i m ary judgment of th e conta m inant levels in t h ese processed products. The maxi m u m c o nta m inant concentration in a m u lti - ingredient food c a n likewise be calculated fr o m the c o m position of the fo o d . Information regarding the behaviour of the conta m inant during processing (e.g. washing, peeling, extraction, cook i ng, d r y i ng etc.) is however desirable to give m or e adequate guidance here. When conta m inant l e vels are consistently different in processed products related to the pr i mary pr o duc t s from whi c h they are deri v ed, and sufficient infor m ati o n is available about the c o nta m ination pattern, it may be a p pr o p riate to establish separate max i m u m le v els for these processed products. T h is a lso applies w h en conta m inat

ion m ay o c cur during processing. In general however, m ax i m u m le vels should preferably be set for pri m a r y agricultural products and may be appl i ed to p r ocessed, derived a nd m u lti - ing r edient foods by using appropriate factors. When these factors are s u fficiently known, th e y should be added to the data base about the c o nta m inant and mentioned in connection to the m axi m u m level in a product. MLs shall p r eferably not be set higher than is ac cep table in a pr i m ary (theoretical max i mum intake and risk est i m ation) approach of their acceptabili t y f r om a public health po i nt of view. When this poses probl e m s in relation to other c r iteria for establishing MLs, further evaluations are necessary regarding the possibilities to red u ce th e conta m inant levels, e.g. by i m proving GAP and/or GMP condit i ons. When t h is does not bring a satisfactory s o luti o n, fur t her refin e d risk assessment and cont am inant risk management e v aluations will have to be made in order to try to reach agreement about an acceptable ML. GSO STANDARD GSO CAC 193 / 2017 Procedure f o r risk ass e s s ment in rela t ion to (proposed) MLs for contaminants It is m o re difficult to control food conta m ination probl e ms than in the case of food additives and pesticide residues. Propos e d MLs will inevitably be influenced by t h is situation. In order to p r o m ote acceptance of GSO conta m in ant MLs, it is therefore i m portant th at assessments of the acceptability of t h ose MLs are done in a consistent and realistic wa y . The proce d ure involves assessment of the dietary intake in relation t

o the proposed or existing MLs and the toxicological reference value. In case a contaminant is transported from feed to food of animal origin, the intake of a contaminant by the different food producing animal species and the resulting levels in the food of animal origin must be evaluated. The best est i mate involves the national dietary pattern and corrections for residue losses during transport, storage, food preparation, for known residue level in foods as consu m ed, etc. It is rec o mmended to be cautious in using other than average fo o d consu m ption values, although it is con s idered appr o p riate to use relevant average food co n s u m ption da t a for identifiable subgroups of the populat i on. The p r ocedure is used to assess th e acce p tability of propo s ed MRLs and to pro m ote inte rn ational acc e ptance of GSO MRLs. For pesticide residues, Guidelines ( W HO, 19 8 9, rev i sed 19 9 5) have been pre p ared for pred i cting the die t ary intake, involving a two - tiered approach with increasingly realistic predictions of intake. In the crude est i mate pha s e, h y pothetical global and cultural diets a r e used to calculate the theoretical max i m u m d a ily intake (TMDI) (based on proposed or existing MRLs). For conta m inants and natural toxins in food, essenti a lly the same procedure is used. Food consu m ption patterns with a higher i n take of critical foods m ay be used in the i n take calculations when t h is is part of a n accepted national or i n ternational health protection and risk m a n age m ent polic y . A har m o n ized approa c h using an app r opriate intake esti m ation model that is as realistic as possible is recommended. Calculated d a ta should where possible alwa y s be co m p ared

with m easured intake data. Proposals for GSO MLs should be acc o m p anied by intake calculations and risk assessment conclusions regarding their acce p tability and use. The intake calculations should follow the methodo l ogy described in the GSO General Standard Policy for Exposure Ass e s s ment and, if appropriate, be acc o m p anied by the generation of distribution curves for th e concentration in specific f oods/food g r oups. State m ents fr o m Govern m en t s about the non - acceptance of (proposed) GSO M L s should refer to specified int a ke calculations and risk m a nage m ent conclusions which sup p ort this position. GSO STANDARD GSO CAC 193 / 2017 ANNEX IV FOOD CATEGORIZATION SYSTEM Introduction The food categorization s y s tem of the GSO is constructed to perf o rm the following f u nctions: It has a logical structure which enables a cl e ar and s y stematic presentation of the (proposed) MLs. It contains (references to) product definitions and defini t ions of the p a rt of the product which is anal y zed and t o which the ML refers. It c ontains codes for the food categories a n d the individual foods, so that data can be stored and retrieved in a convenient way. To achieve as m u ch ha r m onization as possible, an existing agreed categorization s y stem is u sed . The General Standard uses the s y st e m which is developed in t h e fr a mew o rk of the GSO as it is a l so suitable for conta m inants. It is adopted for characterizing t h e various food and feed groups and the indivi d u al c o m m odities. This s y stem i s espec i a l ly elaborated regarding pr i m ary agricultural

comm o dities, but needs further extension regarding processed products. W h ere necessa r y, new (sub ) group codes or com m odi t y codes are therefore introduced. These are described in Annex IV - A. Annex IV - A will also contain product descriptions as far as they are different from those co n t ained in the existing s y stem d escribed by the GSO. Where appropriate and possible, the d e scriptive tex t s acc o m pan y ing the food categories do or should also contain indi c ations about the concentration or dilut i on factor in t h e processed c o m m odities m entioned, in relation to the pri m ary product(s) inv o lved. In that w a y a first esti m ate can be made of the possible carr y - over of cont a minants fr o m pri m ary products to the various processed products. It has to be borne i n m i nd however that the specific distributi o n o f a conta m i n ant in the pr i mary pro d uct and the be h aviour dur i n g processing is a c o m p li c ating factor here. Further advice m ay be nec e ssary in those cas es . See also th e general indications in An n ex I and poss i ble specific infor m ation mentioned in r e lation to the c onta m inant. Description of the food categorization system of the GSO The first part contains the categorizati o n s y st e m as dev e loped a n d m aintained b y t h e GSO. It consis t s of 5 classes, c o vering pri m a r y f ood commodities of plant, resp. animal origin, pr i m ary feed commodities and processed c o mmodities of plant, resp. animal origin. The classes are subdivided in 19 t y pes and 93 g r oups, which are identified by code nu m bers and letters. Annex IV - A is the other part of the food categor i zation s y stem for th

e General Standard. It is developed and maintained by the GSO, and is comple m entary to the s y stem described in the first GSO STANDARD GSO CAC 193 / 2017 part. It is m ai n ly directed to processed, der i ved and m u l t i - ingredient f oods and en c o m p asses all those types and groups and c o m m odity descriptions that are nec e ssary to assign food categorization codes to existing or planned GSO MLs for cont a m inants. ANNEX IV - A COMPLEM E NTARY FOOD CATEGORI Z ATION SYSTEM FOR GSO Introduction The additions to the food categorizati o n s y s t em described in this Annex will serve the ne e d of assigning a food code nu m b er to c o m m odities that are not covered by this Annex. The commodities i n volved are mainly processed, derived and m ulti - ingredient f oods. The s y st e m has been d e signed as a c o m p rehens iv e list (on a general level), in order to be able to acc o mmodate possible future needs. In this phase no ind i vidual product def i nitions and codes are given. It seems sufficient to go no further t han a type or g r oup level in j udging the a cceptability of the s y ste m . The classi f ication can be developed in further detail as the need a r ises. The s y stem used in the GSO General Standard for Food Additives (GSFA) for food classification has b e en utilized as far as it is c o m p atible with the existing Codex classifi ca tion s y stem d escribed in this Annex. See the foll o wing list of proposed new food categories. So m e explanations (as shown in the list) and s o m e existing related food categories, for a better insight in the pro p osed s y ste m

. C o m m odity descriptions c a n often be d e rived from ex i sting GSO Standards. Infor m ation regarding co n centration and diluti o n facto r s, in relation to conta m in ant carr y - over fr o m pr i m ary products, will be added w h ere appropriate and available. Definitions for the part of the product that shall be anal y zed and to which the ML of a conta m inant will app l y , that a r e different from existing defi n itions in this Annex, will also be added. Class T y pe Gro u p Letter c o de Pro d uct g r o u p descri p tion D PR O CESS E D FO O DS OF PLANT O R I GIN GSO STANDARD GSO CAC 193 / 2017 (existing) D 01 Seco n da r y co mmod i ties o f pla n t ori g in ( 5 ex i s ti ng g ro u p s) D 01 06 TF Trea t ed f r u i t pr o d uc t s (pee le d , cu t , f r oz e n e tc .) ( New pro p os e d g r ou p ; c o m m o d ity c o des c an be derived from existi n g fr u it co d es) D 01 07 TV Treated v e getable pr o d u c ts ( c leaned, cut, frozen etc.) ( New pro p os e d g r ou p ; c o m m o d ity c o des c an be derived from existi n g vegetable cod e s) D 02 Der i ved p r o d ucts o f p l ant o r i g i n ( 7 ex i s ti ng g ro u p s) D 02 08 JV Vege ta b l e j u ic es a n d p u rees ( New pro p os e d g r ou p ; c o m m o d it y c o des can be der i v e d f r o m t h e existing v e getable codes) D 02 09 SH S u gar s , s yru ps and ho n ey (New proposed g r oup; co mmodity codes t o be develop e d ) D 03 M a n u fa c tur e d fo ods o f p l a nt origin ( m ulti - ingr e dien t ) ( 1 existing g ro up) D 03 01 C P M an u fac tu r ed m u l ti - i ngr e d i ent cereal p ro d u c t s (e . g .

b r ead and o t her cook e d c e real product s ) ( ex i s ti ng g ro u p ) GSO STANDARD GSO CAC 193 / 2017 Class T y pe Gro u p Letter c o de Pro d uct g r o u p descri p tion D 03 02 CB Bever a ges der i ved f r om cere a ls (e . g . be e r) (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) D 03 03 NF F r uit nectars ( New pro p os e d g r ou p ; c o m m o d it y c o des can be der i v e d f r o m t h e existi n g fr u it c od e s) D 03 04 FF Fer m ented f r u i t bev e r a ges (w i n e, c i de r ) ( New pro p os e d g r ou p ; c o m m o d it y c o des can be der i v e d f r o m t h e existing fruit c onc e rn e d) D 0 3 0 5 DA Distilled alc o h o lic b e v era g es (New propos e d g r oup; commodity codes to be deve l oped w h en the need arises) D 0 3 0 6 FJ Fr u it j a m s, j ellies, m a r m ala de s etc. ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g fr u it co d es) D 03 07 SF F r u i t c h u t ne y s and co m p ar a b l e p r ep a r a ti o n s ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g fr u it co d es) D 03 08 SV Veget a ble c h u t ne y s a n d co m p arable pr e p a r ations ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g vegetable cod e s) D 03 09 PS Pr e p arati o ns f r om nuts, oil s e eds an d other s eeds ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g p r o d uct c odes) D 03 l 0 PP O t h e r m anufa ct u r e d p l ant p ro duc t s (New propos e d g r oup; commodity codes to be deve l oped w h en t

he need arises) E P R O C E SS E D FO O D S OF A N I M A L OR IGIN (existing class) E 01 Seco n da r y co mmod i ties o f ani m al or i g in ( 2 existing g ro u p s) E 01 03 M S Sec o nd a ry m eat p ro ducts (e . g . c o ok e d m eat) ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g meat co des) E 0 1 0 4 ES Seco nd a ry e g g prod u cts ( e .g. e g g pow d e r) ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g egg codes) E 01 05 WS Sec o nd a ry fi sh ery p r od u cts ( e .g . , s m ok e d fi s h ) ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g fish c o des) E 02 Der i ved a n im al p r odu c ts o f an im al or i g i n ( 4 ex i s ti ng g ro u p s) E 02 05 M C Der i ved m eat p ro duc t s (e . g . m eat ex t rac t ) (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g meat co des) E 02 06 ED Der i ved e g g p r o d ucts (e . g . eg g white, y o l k ) (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g egg codes) GSO STANDARD GSO CAC 193 / 2017 Class T y pe Gro u p Letter c o de Pro d uct g r o u p descri p tion E 02 07 WD Der i ved fi s h e r y p ro ducts ( New pro p os e d gr ou p ; co m mo d it y codes t o b e der i ved fr om t h e ex i s ti n g fish c o des) E 03 M a n u fa c t ur e d fo od (si n gle ingredie n t), a nimal ori g in ( 1 existing g ro up) E 03 01 LI M an u fact u r ed m ilk p r o d ucts ( single i n g r edi e nt) ( ex i s ti ng g ro u p ) E 03 02 M T M an u fac tu red m eat pr od u cts (e . g . c u r e d m eat

) (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g meat co des) E 03 03 EM M an u fac tu red egg pr o d uc t s ( e.g. e g g w h it e p ow d e r ) (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g egg codes) E 0 3 0 4 WP Ma n u factured fis h ery prod u cts (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g fish c o des E 04 M a n u fa c t ur e d fo od (mult i - ingredie n t) o f ani m al or i g in ( 1 existing g ro up) E 04 01 LM M an u fact u red m ilk p r o d ucts ( m ulti - ingr e d ient) ( ex i s ti ng g ro u p ) E 0 4 0 2 MP Ma n u factured meat p rod u cts ( m u lti - i ng re d ie n t) (e. g . sa u sage) (New proposed g r oup; co mmodity co des t o be develop e d i n re l a tion to co mm odity de s cription) E 04 03 EP M an u fact u red egg pr o d ucts ( m ulti - ingr e d ient) (New propos e d g r oup s ; commodity codes t o be deve l op e d i n relation to co mm odity de s cription) E 0 4 0 4 WI Ma n u factured fis h ery prod u cts ( m u lti - i ng redie n t ) (N ew pr op o s e d g ro u p ; com m o d it y c od e s t o be d e r i ved f r o m ex i s tin g fish c o des) F MULT I - I N G REDI E NT M A N U FA CT U RED FO O DS (New proposed class) F 01 Bever a ges ( m ulti - ingr e die n t) (New p ro p osed ty p e) F 01 01 BS Bever a ges ( s o f t dr i nks e n d co m p arable pr ep aration s ) (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 01 02 BA Alc o holic m u l t i - i n g redi e nt b e ver a ges (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 0 2 S

a uces, s a lad dressings, s o ups, bouill o ns etc. (New p ro p osed ty p e) F 02 01 SP Seas o n in gs an d c o n d i m en t s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 0 2 0 2 PV Vi n e g ars ( m u lti - i n gre d ie n t) (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) GSO STANDARD GSO CAC 193 / 2017 Class T y pe Gro u p Letter c o de Pro d uct g r o u p descri p tion F 02 03 PM M u s t a r ds (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 02 04 BS S o u p s a n d b ro t hs (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 02 05 M E Sauces a n d co m p arab l e p rod u c t s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 02 06 BC Salads an d s an d wi c h s p re a d s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 03 Choco l ate & other c o nfect i o nery (New p ro p osed ty p e) F 03 01 C C C ho c o l a t e p r od u c t s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 03 02 CS S u gar c o nfect i on e r y , i n cl u d i n g nut bas e d an d c o m p arable m ul ti - i ng re d ie n t confecti on e ry (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 03 03 CG C h ew i n g g u m (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 04 Ma rg ar i nes & o ther m u l t i - i ngred i e n t f a t t y f o ods (New

p ro p osed ty p e) F 04 01 HF M arg a ri n es � 8 0 % fat (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 04 02 LF M arg a r i n es 8 0 % fat (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 04 03 OF Oth e r p r o d ucts bas e d o n fat e m ulsions (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 05 Multi - ingred i ent bakery wares (New p ro p osed ty p e) F 05 01 BF Fine bak e ry w ares (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 05 02 BS Sa v o r y s n ac k s ( po t a to , c e re a l or s t ar c h bas e ) (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 05 03 NS Sa v o r y c o ated nut s , other n u t s n ack s , nut m ixtures (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 Mu l t i - in gred i ent f o o d s f o r s pec i al d i e t a r y uses (New p ro p osed ty p e) GSO STANDARD GSO CAC 193 / 2017 Class T y pe Gro u p Letter c o de Pro d uct g r o u p descri p tion F 06 01 ID I n fant an d fo l l o w - o n f o r m u l ae (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 02 C D Wean i n g fo ods (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 03 HD Dietetic f o ods i n tend e d f o r s p ecial m edical pu rp o ses (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 04 TD Dieteti

c for m ulae f o r sli mm ing p ur pos e s a n d wei g ht re d u ction (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 05 SD S u pp l e m en t ary f o o d s f o r d i e t e ti c uses (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) F 06 06 AD F o od s u p p l e m e n t s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) G OTHER E DIBLE PRODUCTS (New proposed class) G 01 Water, mine r a ls and o r gan i c co m pounds (New p ro p osed ty p e) G 01 01 D W Dr i nk i ng wate r , m ineral wate r , table waters (New propos e d g r oup, co mmodity c o des to be deve l oped w h e n t h e n ecessity arises) G 0 1 0 2 SW Salt, salt su b stit u tes, m i n eral pr e p aratio n s (New propos e d g r oup; commodity codes to be deve l oped w h en the n ecessity arises) GSO STANDARD GSO CAC 193 / 2017 Table I - MA X IMUM AND GUID E LI N E LEVELS F O R C O N TA MINA N TS AND T O X INS IN FOODS INDEX OF CON T A M IN A NTS NAME 1 Heavy Metals : Arsenic Ca d m i u m Lead Mercury Meth y l m erc u ry Tin 2 Radionuclides : 3 Others : Chloropropanols Acrylonitrile Melamine Vin y lch l oride m on o m e r Hydrocyanic acid GSO STANDARD GSO CAC 193 /2017 Table 1.2 Maximum levels of Heavy Metals in foodstuff Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Edible fats and oils 0.1 0.1 0.001 Whole commodity Fat spreads and blended

spreads 0.1 0.1 Natural mineral waters 0.01 0.003 0.01 Rice, husked 0.35 Whole commodity Rice, polished 0.2 0.4 Whole commodity Calculated as total As in mg/l. Salt, food grade 0.5 0.5 2 0.1 Cereals excluding bran, germ, wheat and rice Brassica vegetables 0.05 0.1 Head cabbages and kohlrabi: whole commodity as marketed, after removal of obviously decomposed or withered leaves. Cauliflower and broccoli: flower heads The ML does not apply to Brassica lea fy vegetables GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) (immature inflorescence only). Brussels sprouts: “buttons” only. Bulb vegetables 0.05 0.1 Bulb/dry onions and garlic: whole commodity after removal of roots and adhering soil and whatever parchment skin is easily detached Fruiting vegetables 0.05 0.05 Whole commodity after removal of stems. Sweet corn and fresh corn: kernels plus cob without husk The ML does not apply to tomatoes and edible fungi Leafy vegetables 0.2 0.3 Whole commodity as usually marketed, after removal of obviously decomposed or withered leaves The ML also applies to Brassica leafy vegetables. Legume vegetables 0.1 0.1 Whole commodity as consumed. The succulent forms may be consumed as whole pods or as the shelled product. GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Pulses 0.1 0.2 Whole commodity The ML does not apply to soya bean (dry). Root and tuber vegetables 0.1 0.1

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. The ML does not apply to celeriac. Stalk and stem vegetables 0.1 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. Cereal grains 0.1 0.2 Whole commodity The ML does not apply to buckwheat, GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) cañihua, quinoa, wheat and rice Wheat 0.2 Whole commodity The ML applies to common wheat, durum wheat, spelt and emmer. Marine bivalve molluscs 2 Whole commodity after removal of shell. The ML applies to clams, cockles and mussels but not to oysters and scallops. Cephalopods 2 Whole commodity after removal of shell. The ML applies to cuttlefishes, octopuses and squids without viscera. Berries and other small fruits 0.1 Whole commodity after removal of caps and stems. The ML does not apply to cranberry, currant and elderberry. Cranberry 0.2 Whole commodity after removal of caps and stems. Currants 0.2 Fruit with stem GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Elderberry 0.2 Whole commodity after removal of caps and stems. Fruits 0.1 Whole commodity. Berries and other small fruits: whole commodity after removal of caps and stems. Pome fruit

s: 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 removal of crown. Avocado, mangos and similar fruit with hard seeds: whole commodity after removal of stone but calculated on whole fruit. The ML does not apply to cranberry, currant and elderberry. GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Canned fruits 0.1 250 The ML applies to the product as consumed. Jams (fruit preserves) and jellies 1 Mango chutney 1 250 Canned vegetables 0.1 250 The ML applies to the product as consumed. The ML does not apply to canned brassica vegetables. Preserved tomatoes 1 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. Table olives 0.4 GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Pickled cucumbers (cucumber pickles) 0.1 Processed tomato concentrates 1.5 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. Canned chestnuts and canned chestnuts puree 1 250 Fruit juices 0.03 Who

le commodity (not concentrated) or commodity reconstituted to the original juice concentration, ready to The ML does not apply to juices exclusively from berries and other small fruit. GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) drink. The ML applies also to nectars, ready to drink Canned chestnuts and canned chestnuts puree 1 Meat of cattle and sheep 0.1 Whole commodity (without bones) Also applies to the fat from meat Meat and fat of poultry 0.1 Whole commodity (without bones) Cattle, Edible offal of 0.5 Whole commodity. Poultry, Edible offal of 0.5 Whole commodity. Milk 0.02 Whole commodity. 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 GSO STANDARD GSO CAC 193 /2017 Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) consumption as liquid milk or for further processing. A concentration factor applies to partially or wholly dehydrated milks Infant formula, formula for special medical purposes intended for infants and follow - up formula 0.01 Whole commodity. Fish 0.3 0.5 Whole commodity (in general after removing the digestive tract) The GL does not apply to predatory fish. The guideline levels are intended for methylmercury in fresh or processed fish and fish products moving in international trade. GSO STANDARD GSO CAC 193 /2017

Commodity / Product ARSENIC CADMIUM LEAD MERCURY METHYLMERCURY TIN Portion of the Commodity /Product to which the ML applies Notes/Remarks Level mg/kg (ppm) Predatory fish 1 Whole commodity (in general after removing the digestive tract) Predatory fish such as shark, swordfish, tuna, pike and others. The guideline levels are intended for methylmercury in fresh or processed fish and fish products moving in internati onal trade. Canned beverages 150 Canned foods (other than beverages) 250 Cooked cured chopped meat 50 Corned beef 50 Luncheon meat 50 GSO STANDARD GSO CAC 193 /2017 Table 1 . 3 Guidelins for Radionuclides in food RADIONUCLIDES Commodity / Product Name Guideline Level (GL) (Bq/kg) Rep r e s entat i v e Portion of the Commodity/Product to which the GL applies T y pe Notes/Re m a rk s Infant foods* 1 23 8 Pu , 2 3 9 Pu , 24 0 Pu , 2 4 1 Am GL The GL applies to foods intended for consumption by infants. Infant foods * 100 90 Sr, 1 0 6 Ru, 1 2 9 I, 13 1 I, 2 3 5 U GL The GL applies to foods intended for consumption by infants. Infant foods * 1,0 0 0 3 5 S**, 6 0 Co, 8 9 S r, 1 0 3 Ru, 1 3 4 Cs, 13 7 Cs , 1 4 4 Ce, 1 9 2 Ir GL The GL applies to foods intended for consumption by infants. Infant foods * 1,0 0 0 3 H***, 1 4 C, 99 Tc GL The GL applies to foods intended for consumption by infants. Foods other t h an inf a nt foods 10 23 8 Pu , 2 3 9 Pu , 24 0 Pu , 2 4 1 Am GL Foods other t h an inf a nt foods 100 90 Sr, 1 0 6 Ru, 1 2 9 I, 13 1 I, 2 3 5 U GL Foods other t h an inf a nt foods 1,0 0 0 3 5 S**, 6 0 Co, 8 9 S r, 1 0 3 Ru, 1 3 4 Cs, 13 7 Cs , 1 4 4 Ce, 1 9 2 Ir GL Foods other t h an inf a nt foods 10 ,0 00 3 H***, 1 4 C, 99 Tc GL (*) This represents the value for or

ganically bound sulphur. (* *) This represents the value for organically bound tritium. GSO STANDARD GSO CAC 193 /2017 Scope : T h e Gui d eli n e Le v els a pp ly to ra d ion u cli d es co n tained in fo od s d e sti n ed for hu m an c o ns u m p ti o n and tra d ed i n t er n atio n ally, w h i ch h a ve been conta m i n ated f o llowing a nuc l e a r or r a d i o lo g i cal e m ergenc y 1 . T h ese g u i d eli n e le v els a pp l y to fo o d after rec o nstit u ti o n or as pre p ared for c o ns u m p ti o n, i.e., no t t o d ried o r co n c e n trated f o o d s , a n d a re based on an i n ter v e n tion e x e m p ti o n level o f 1 m Sv in a year. Application: As far a s gen er ic radio l ogical p r otection o f f o o d co nsu m ers is c o nce r n e d, wh e n rad i o n u c li d e levels in f o o d d o not e x c eed t h e c orresp o n d i ng G u i d eli n e Le v els, t h e fo o d shou l d be co n s ider e d as safe for hu m an consu m ption. W h en t h e Gu i d eline L e vels a r e exceed e d , national govern m en ts s h all dec i de w he t h e r an d u n d e r what c ir cu m s t ances t h e f o o d sh ou l d b e d i stri bu t ed wit h in t h eir territ o ry or j u ris d icti o n. N a tional g o v er n m ents m ay wish to ad opt di ff erent val u es f o r i n te r n al u se wit h in t h e i r own territories where t h e ass u m p ti on s conc er n in g f o od d i s t r i b u ti o n t h at have be e n m ade t o d eri ve t h e G u i d e l i n e L e ve l s m a y not a p p ly , e . g., i n t h e c a se o f w i d e - s p re a d rad i oactive conta m ination. For foods th a t are c o ns u m ed in small qu a n tities, s u ch as s p ices, t h at represent a s m all p erce n ta g e o f t o tal diet a n d h e n ce a s m a ll a dd iti o n to t h e t o

tal d o se, t h e G u i d eli n e Le v els m ay b e i n creased by a f act o r of 1 0 . Radio n uclide s : T h e Gu i d e lin e Leve l s d o no t i n c l ude a l l r a d io nuc li d e s. R ad io nuc li d e s i n c lu d ed are t h ose i m por t ant f o r up ta k e i n t o t h e fo od cha i n ; are u s ually contain e d i n nuclear i n stallati on s o r use d a s a ra d iati o n so u r c e i n l a r g e e n ou g h q ua n tities to b e si gn ifica n t po t e n tial co n trib u t o rs to le v els i n f o ods, and; could be acc i den t ally released into the en vironment f r om ty p i cal i n s t a ll a ti ons o r mi ght be e m p l o y ed i n m a l evo l ent ac tio ns. R ad io nuc li d es of na t u ral or i g i n a re gen e ra ll y exc lu d e d f r o m co n si d erati o n in t h is d o c u m e n t. 1 For the purpo s es of t h is docume n t, the term “eme r genc y ” includes both acci d e nts and malevolent actions. 2 Food and Agriculture Organization of the United Nations, International Atomic Energy Agency, International Labour Office, OECD Nuclear Energy Agency, Pan American HealthOrganization, World Health Organiz ation (1996) International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources , IAEA,Vienna 3 For example, if 134Cs and 137Cs are contaminants in food, the guideline level of 1 000 Bq/kg refers to the summed activity of both these radionuclides GSO STANDARD GSO CAC 193 /2017 33 In t h e T a ble, t h e r a di o nucli d es are g ro up e d a c co r d i n g t o t h e gu i deli n e leve l s r o un d ed l o g a rit h m ically by o r de r s of m ag n itude. G u i de lin e l eve l s are d efi ned f o r t wo s e para t e ca te g o r i es “i n fa n t f o o d s” a n d “ o t h er f o o d s”. T h is is b e ca u se, f o r a n u m

b er o f ra d ion u cli d es, t h e sensiti v ity o f infa n ts c ou l d po se a pro b l e m . The g u i d eli n e levels h a ve been c h eck e d a g ainst ag e - dep en d ent i ng e stion d o se c o e f ficients d e fin e d as co m m itted effecti v e d o s e s p e r unit i n t ak e f o r ea c h r a dio n ucli d e, w h i c h a r e ta k e n f ro m t h e " I n t erna t i onal B as i c S af e t y S t and a rds" ( I A E A, 1 9 9 6 ) 2 . Multiple r a d i o nuclides in f o ods : T h e gu i d e li n e l eve l s h a ve been d e ve lo ped w it h t h e u nd e rs t a n d in g t h at t h e r e i s no need t o ad d co n t r ib u tio ns f ro m rad i o n uc li d e s i n d if f e r e n t g r ou p s. Each g ro u p sh ou l d be t rea te d i nd e p e nd e n tly . Ho wev e r, t h e ac ti v it y conce nt ra ti ons o f ea c h rad i o n uc li d e w it h i n t h e sa m e g r ou p s h o u l d be ad ded to ge t h e r 3 . ----------------------------------------------------------------------- 2 Food and Agric u lture Orga n izati o n of the United Nations, International Atomic E n er g y Agenc y , Internatio n al Labo u r Office, OECD Nuclear Ener g y Agen c y , P a n A m erican He a lth Organiz a tio n , World Health O r ganization (199 6 ) Inter n atio n al B asic Sa f ety Sta n dards for Protection a g ainst Io n izing Radiation a n d for t h e Sa f ety of Radiation S ources, IAEA, Vienna. 3 F or exa m ple, if 1 34 Cs and 137 Cs a r e co n taminants in food, the guideline le v el of 10 0 0 Bq / kg r e fers to the summed activi t y of both the s e ra d ionuclides. GSO STANDARD GSO CAC 193 /2017 34 Annex 1 SCI E NTIF I C J U STIF I CA T ION F O R PR OPOS E D D R AFT REV I S E D G U I D ELI N E LEVELS F OR R A D I ON UCL I D ES IN FO O D S C ONT AM IN ATED F OLLOW I NG A N

U C LEA R O R RA D IOLOGI CAL EME R GENCY T h e p r o p osed d raft re v i sed G u i d eli n e Le v els f o r Ra d i on u cli d es i n Foods a n d s p ecifically the va l u es pr es ented i n T a ble 1 a b ove a re b a sed o n t h e f o ll o w i ng g e n e ral rad i ol o g ical c o nsi d eratio n s a n d ex p e rie n ce of a pp licati o n o f t h e e x isti n g in ter n atio n al a n d n a tio n al sta nd ar d s f o r c on t rol of r a di on u c lides in foo d . Si gn i fica n t im p r o v e m e n ts in t h e assess m e n t of ra d i ati o n doses res u lti n g fr o m t h e hu m an i n ta k e o f ra d i oacti v e su b sta n c es h a v e be c o me available s i nce the Gu i d eline Levels w e re issued by t h e C od e x Ali m ent a rius C o mm ission in 1 9 8 9 4 ( C A C / G L 5 - 19 8 9 ) . Infa n ts and adult s : T h e levels o f h u m an e x p o s u re res u lti n g fr o m c o nsu m pt i o n o f f o ods co n tai n ing ra d io nu cli d es listed in Ta b le 1 at t h e s u g g ested g u i de li n e le v el s h a ve been assessed b o t h f o r i n f a n t s an d adu lt s an d c h e cked f o r co m p liance with the appropriate dose criterion. In o rd e r t o ass e ss pu b li c e x p os u re a n d t h e as s o c i a t ed hea lt h r i sks f rom i n t ake of r a d io nuc l i des i n f o o d , e st i m a t es of f o o d c o n s u m p ti on r a t es a n d in ges t i on d o se c o e f f i c i en t s are need e d . Ac cor d in g t o R ef. ( W H O, 19 8 8 ) i t i s as s u m ed t h at 5 5 0 k g of f o o d i s co nsu m ed by an a d u l t i n a y ear. T h e va l u e of i n f a nt f o od a n d m ilk c o n s u m ption d u r i ng fi r st y ear of life us e d fo r in fant d o se ca l cu l a tio n e qual t o 2 0 0 kg i s based o n con t e m por a r y hu m an h a b i t a s sess m en t s (F. Lu yk x , 19 9 0 5 ; U S D o H , 1 99 8 6 ; N R PB, 2 0 0 3 7 ). T h e m o st conservative va l u e

s of the rad i onu c lide - spec i fic and a g e - s p ecific i ng e sti o n d o se c o efficie n ts, i.e. rele v a n t t o the che m ical for m s of r a dionu c lides w h ich are m o st a b sor b ed fr o m t h e g astr o - i n testi n al tract a n d retai n ed i n b od y tiss u es, are ta k e n fr o m th e (IAEA, 1 9 9 6 ). R a diol o g ical c ri t erio n : T h e a p pr o p riate r a diol o g ical criter i o n , whi c h has been u sed f o r c o m p arison with t h e dose ass e ss m ent data b e l o w, is a g e ner i c i n ter v e n tion e x e m p ti o n level o f arou n d 1 m Sv for in d i v id u al a n n u al d o se fr o m ra d i o n u clides in m a jo r comm od ities, e.g. f o o d , rec o mme nd ed b y t h e I n ter n atio n al C o mmi ss i on o n R ad i o lo g i cal P r o t ec ti on as safe f o r m e m b ers of the p ub lic (ICRP, 19 9 9 ) 8 . N a t u r a ll y o c c urr i ng r a d i o n uc li des: Ra d io nuc li d e s of na t u ral or i g i n a re ub i qu ito us a n d as a co nse q u e nce a re pres e n t i n a l l fo ods t u f fs t o v a r yin g d egree s . Ra d i a ti o n d o ses fr o m t h e co n su m p ti on o f fo o d s t u f fs t y p i ca ll y ra n g e fr o m a few te ns t o a f e w h un d r e ds of m i cros i ever t s i n a y e a r. In ess e nce, t h e d o ses f r o m t h es e ra d io nu c li d e s w h e n n a t u ral l y p r ese n t i n t h e diet are una m en able t o c on t rol; the re s o urces that would be req u i r ed to affect e x p o s ur e s w o u ld b e o u t of p r o po r ti o n to t h e b e n e fits ac h ie v e d for h ealt h . T h ese ra d io nu cli d es are excluded from consideration i n t h is d o c u m e n t as t h ey are not associated w i th e m ergencie s . GSO STANDARD GSO CAC 193 /2017 35 One - y e ar e x p o sure assess m ent: It is con s ervatively assumed

that during t h e first year after m a jo r e nv i ro n m e n tal rad i oac ti v e c o nt a m i n a ti on ca u sed by a nuc le a r o r r a diol o g i cal e m ergency it might be diffi c u lt to re a d ily replace foods im ported from conta m inated r e gions with foods i m ported from un a ffect e d area s . Ac c o rding to FAO sta t istical data the mean fraction o f m a jo r f o o d stuff qua n tities i m por ted b y all t h e c o u n tries w o rldwi d e is 0 . 1 . T h e v al u es i n Ta b l e 1 as re g ar d s foo d s c on sum ed by i n fants a n d t h e g e ne r al p op u lation h a v e been der i ved t o e n s u re t h at i f a co un t ry c o n t i nues t o i m port m ajor f o o d s fr o m areas c on tami n a t ed w it h r ad io nuc li d e s, t h e m ean a n n u a l i n ter n al d o se o f its in h a b itants will n o t e x ceed ar ou n d 1 m Sv (see A nn e x 2 ) . This c onc l u sion m ight n o t a pply f o r so m e rad i o n ucli d es if t h e fracti o n o f c onta m i n ated f o o d is f ou n d to be higher than 0.1, as m i g h t be t h e case f o r i n fa n ts who h a v e a d iet esse n tially b ased o n milk with little v a riety. Long - term ex po s ure asses s ment: Beyo n d on e year after t h e e m er g e n cy t h e fraction o f c on ta m i n ated fo o d p laced o n the m ar k et will ge n erally d ecrease as a res u lt o f na ti onal restrictions (w i t hdrawal from the m a rket), ch ang e s to o t her produc e , a g ri c u ltural co untermeasures an d decay. Ex p erie n ce h a s sh o w n t h at in t h e long term t h e fracti o n o f i m por t e d co n tami n ated food will d ecrease b y a fact o r of a h u ndred o r m o re. Specif i c food cat e g ories, e.g. wild forest p ro duc t s, m ay s h ow p e rs i s t e n t or e v en

i n c r e as i ng l eve l s o f c o n t a m i n a ti on. O t her ca t e gori es o f f oo d m ay gr ad ua ll y be exe m p t ed f r om c on tr o ls. Ne v er t h eless, it m u st b e a n tici p ated t h at i t m ay t ake m any y ears b ef o re l eve l s o f i nd i v i dual exp o s u re a s a re s u l t of c o n t a m i n ated f oo d c ou l d be qua li f ie d as neg li g i ble. 1 The Co de x Alimentarius Commission at its 1 8th Session (Geneva 1989) ad o pted Gui d eli n e Levels for Ra dionuclides in F o ods Foll o wing Accide n tal Nuc l ear Co n ta m ina ti on for U s e in International T r ade (CAC/GL 5 - 1 989) applica b le f or six ra d ionuclides (90 Sr, 131I , 137 Cs, 134 Cs, 239 Pu and 241 Am) during one ye ar a f t e r the nuclear accident. 2 F. L uy kx (199 0 ) Response of t he European C omm unities to environ m ental co n ta m ination f o ll o wing the Cher n o by l accide n t. I n: Envi r on m en ta l Conta m in a ti o n Following a Major Nucl ea r Accide n t, IAEA, Vienna, v. 2, 2 6 9 - 287. 3 US DoHHS (1 9 98) Acci de ntal Radioacti v e Co n tamination of H uman Food and Animal F eeds: R ecommendations for State and L o cal Age n cies. Food and Drug Administration, R o ckville. 4 K. Smith and A. Jones (2003) Generali s ed Habit Data for Ra d iol o gical Assessme n ts. NRPB Report W41. 5 International Commission on Radiological Protection (1999). Principles for the Protection of the Public in Situations of Prolonged Exposure. ICRP Publication 82, Annals of the ICRP. GSO STANDARD GSO CAC 193 /2017 36 Annex 2 A SSESS M EN T O F HU M A N I N TERNA L E X POSUR E WHE N TH E G U I D ELIN E LE V EL S A RE A PPLIED For the purpose of assessment of the mean public exposure level in a country caused by the imp

ort of food products from foreign areas with residual radioactivity, in implementing the present guideline levels the following data should be used: annua l food consumption rates for infants and adults, radionuclide - and agedependent ingestion dose coefficients and the import/production factors. When assessing the mean internal dose in infants and adults it is suggested that due to monitoring and inspection the radionuclide concentration in imported foods does not exceed the present guideline levels. Using cautious assessment approach it is considered that all the foodstuffs imported from foreign areas with residual radioactivity are contaminated with radion uclides at the present guideline levels. Then, the mean internal dose of the public, E (mSv), due to annual consumption of imported foods containing radionuclides can be estimated using the following formula: E = GL(A) M(A) e ing (A) IPF where: GL(A) is the Guideline Level (Bq/kg) M(A) is the age - dependent mass of food consumed per year (kg) e ing (A) is the age - dependent ingestion dose coefficient (mSv/Bq) IPF is the import/production factor1 (dimensionless) Assessment results presented in Table 2 both for infants and adults demonstrate that for all the twenty radionuclides doses from consumption of imported foods during the 1st year after major radioactive contamination do not exceed 1 mSv. It should be noted that the doses were calculated on the b asis of a value for the IPF equal to 0.1 and that this assumption may not always apply, in particular to infants who have a diet essentially based on milk with little variety It should be noted that for 239Pu as well as for a number of other radionuclides the dose estimate is conservative. This is because elevated gastro - intestinal tract absorption factors and associated ingestion dose coefficients are applied for the whole first year of life whereas this is valid mainly during suckling period recently esti mated by ICRP to be as average first six months of life. For the subsequent six months of the first year of life the gut absorption facto

rs are much lower. This is not the case for 3H, 14C, 35S, iodine and caesium isotopes . As an example, dose assessment f or 137Cs in foods is presented below for the first year after the area GSO STANDARD GSO CAC 193 /2017 37 contamination with this nuclide . For adults: E = 1 000 Bq/kg 550 kg 1.3 10 - 5 mSv/Bq 0.1 = 0.7 mSv; For infants: E = 1 000 Bq/kg 200 kg 2.1 10 - 5 mSv/Bq 0.1 = 0.4 mSv 9 T h e i m por t/pr o d u ction factor ( IPF ) i s d e f i ned as t h e ra ti o of t h e a m o u nt o f f oo d s tu f f s i m por t ed per year from areas conta m inat e d with ra d i o nucli d es to t h e t o tal a m ount p ro duc e d an d im ported a n n u a lly in t h e r e gi o n or c ou n t r y un d er c o nsi d e r ati o n . 10 In t e r n a tio nal C o mmi ss i on o n R ad i o lo g i cal P r o t ec tio n (2 0 05 ) Dos e s t o I n f a n t s fr o m R ad i onuc li d e s In ges t ed i n M o t h ers Mil k . To b e pu b lis h e d. GSO STANDARD GSO CAC 193 /2017 38 ASSESSMENT OF EFFECTIVE DOSE FOR INFANTS AND ADULTS FROM INGESTION OF IMPORTED FOODS IN A YEAR Radionuclide Guideline Level (Bq/kg) Effective dose (mSv) Infant foods Other foods 1 st year after major contamination Infants Adults 238 Pu 1 10 0.08 0.1 239 Pu 0.08 0.1 240 Pu 0.08 0.1 241 Am 0.07 0.1 90 Sr 100 100 0.5 0.2 106 Ru 0.2 0.04 129 I 0.4 0.6 131 I 0.4 0.1 235 U 0.7 0.3 35 S* 1000 1000 0.2 0.04 60 Co 1 0.2 89 Sr 0.7 0.1 103 Ru 0.1 0.04 134 Cs 0.5 1 137 Cs 0.4 0.7 144 Ce 1 0.3 192 Ir 0.3 0.08 3 H** 1000 10000 0.002 0.02 14 C 0.03 0.3 99 Tc 0.2 0.4 * This represents the value for organically bound Sulphur ** This represents the value for organically bound tritium See for “Scientific Justification for the Guideline Levels” (Annex 1) and the “Asse

ssment of Human Internal Exposure when the Guideline Levels are Applied” (Annex 2) GSO STANDARD GSO CAC 193 /2017 39 ACRYLONITRILE Reference to JECFA: 28 (1984) Toxicological guidance value: Provisional Acceptance (1984, the use of food - contact materials from which acrylonitrile may migrate is provisionally accepted on condition that the amount of the substance migrating into food is reduced to the lowest level technologically attainable) Contaminant definition: acrylonitrile (monomer) Synonyms: 2 - Propenenitrile; vinyl cyanide (VCN); cyanoethylene; abbreviations, AN, CAN. Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CAC/RCP 49 - 2001 ) Commodity/Product Name Maximum Level (ML) mg/kg Portion of the Commodity/Product to which the ML applies Notes/Rema rks Food 0.02 GSO STANDARD GSO CAC 193 /2017 40 CHLOROPROPANOLS Reference to JECFA: 41 (1993; for 1,3 - dichloro - 2 - propanol only), 57 (2001), 67 (2006) Toxicological guidance value: PMTDI 0.002 mg/kg bw (2001, for 3 - chloro - 1,2 - propanediol); maintained in 2006. Establishment of tolerable intake was considered to be inappropriate for 1,3 - dichloro - 2 - propanol because of the nature of the toxicity (tumorogenic in various organs in rats and the contaminant can interact with chromosomes and/or DNA). BMDL 10 cancer, 3.3 mg/kg bw/day (fo r 1,3 - dichloro - 2 - propanol); MOE, 65 000 (general population), 2 400 (high level intake, including young children). Contaminant definition: 3 - MCPD Synonyms: Two substances are the most important members of this group: 3 - monochloropropane - 1,2 - diol (3 - MCPD , also referred to as 3 - monochloro - 1,2 - propanediol) and 1,3 - dichloro - 2 - propanol (1,3 - DCP). Related code of pr

actice: Code of Practice for the Reduction of 3 - Monochloropropa ne - 1,2 - diol (3 - MCPD) during the production of AcidHydrolyzed Vegetable Proteins (A cid - HVPs) and Products that Contain Acid - HVPs (CAC/RCP 64 – 2008). Commodity/Product Name Maximum Level (ML) mg/kg Portion of the Commodity/Product to which the ML applies Notes/Remarks Liquid condiments containing acid hydrolyzed vegetable proteins 0.4 The ML does not apply to naturally fermented soy sauce. GSO STANDARD GSO CAC 193 /2017 41 HYDROCYANIC ACID Reference to JECFA: 39 (1992), 74 (2011) Toxicological guidance value: ARfD 0.09 mg/kg bw as cyanide (2011, this cyanide - equivalent ARfD applies only to foods containing cyanogenic glycosides as the main source of cyanide) PMTDI 0.02 mg/kg bw as cyanide (2011) Contaminant definition: See explanatory notes in the column “Notes/Remarks. Synonyms: HCN Related code of practice: Code of Practice for the Reduction of Hydroc yanic Acid (HCN) in Cassava and Cassava products (CAC/RCP 73 - 2013) Commodity/Product Name Maximum Level (ML) mg/kg Portion of the Commodity/Product to which the ML applies Notes/Remarks Gari 2 Whole commodity The ML is expressed as free hydrocyanic acid. Relevant standards include GSO 2351 Cassava flour 10 The ML is expressed as free hydrocyanic acid. Relevant standards include GSO CODEX STAN 176 GSO STANDARD GSO CAC 193 /2017 42 MELAMINE Reference to JECFA: FAO/WHO Expert Meeting (2008) Toxicological guidance value: TDI 0.2 mg/kg bw (2008)) Contaminant definition: Melamine Synonyms: Monochloroethene, chloroethylene; abbreviation VC or VCM Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CAC/RCP 49 - 2001)

Commodity/Product Name Maximum Level (ML) mg/kg Portion of the Commodity/Product to which the ML applies Notes/Remarks Food (other than infant formulae) and feed 2.5 Whole commodity The ML applies to food other than infant formula. The ML applies to levels of melamine resulting from its non - intentional and unavoidable presence in feed and food. The ML does not apply to feed and food for which it can be proven that the level of melamine higher than 2.5 mg/kg is the consequence of: Authorised use of cyromazine as insecticide. The melamine level shall not exceed the level of cyromazine. Migration from food contact materials taking account of any nationally authorised migration limit. The ML does not apply to melamine that could be present in the follo wing feed ingredients / additives: guanidine acetic acid (GAA), urea and biuret, as a result of normal production processes. Powdered infant formula 1 Liquid infant formula 0.15 The ML applies to liquid infant formula as consumed. GSO STANDARD GSO CAC 193 /2017 43 VINYL CHLORIDE MONOMER Reference to JECFA: 28 (1984) Toxicological guidance value: Provisional Acceptance (1984, the use of food - contact materials from which vinyl chloride may migrate is provisionally accepted, on condition that the amount of the substance migrating into food is reduced to the lowest level technologically achievable. Contaminant definition: Vinylchloride monomer Synonyms: Monochloroethene, chloroethylene; abbreviation VC or VCM Related code of practice: Code of Practice for Source Directed Measur es to Reduce Contamination of Foods with Chemicals (CAC/RCP 49 - 2001) Commodity/Product Name Maximum Level (ML) mg/kg Portion of the Commodity/Product to which the GL applies Notes/Remarks Food 0.01 Whole commodity The GL in food packaging material is 1.0 mg/kg. Reference - GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FO