UGANDA STANDARD
 
       US 738
Second Edition
2009-mm-dd
 
 Reference numbe r 
     US 738: 2009
 © UNBS 2009
  
General standard for contaminants and toxins in food and feed 
 US 738: 2009 
 
© UNBS  2009 – All rights reserved ii Compliance with this standard does not, of itself confer immunity from legal obligations 
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correct application  
© UNBS 2009 
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Uganda 
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       US 738: 2009  
© UNBS  2009 - All rights rese rved                iii National foreword 
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry  of Tourism, Trade and 
Industry established under Cap 327, of the Laws of U ganda. UNBS is mandated to co-ordinate the elaboration 
of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex A limentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT/SPS Agr eements of the World Trade Organisation (WTO). 
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a gi ven field or area and consists of representatives of 
consumers, traders, academician s, manufacturers, governme nt and other stakeholders. 
Draft Uganda Standards adopted by the Technical Committ ee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council. 
This Uganda Standard, US 738:2009, General standard for contaminants and toxins in food and feed , is 
identical with and has been reproduced from a Codex Standard, CODEX STAN 193:1995, Codex general 
standard for contaminants and toxins in food and feed , and adopted as a Uganda Standard. This standard 
cancels and replaces US 738: 2007 which has been tech nically revised. This standard was developed by the 
Food and Agriculture Standards Technical Committee (UNBS/TC 2). 
 CODEX STAN 193-1995 Page 1 of 44
 
Adopted 1995; Revised 1997, 2006, 2008, 2009; Amended 2009 CODEX GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FOOD AND FEED 
(CODEX STAN 193-1995) 
1. PREAMBLE 
1.1 S COPE  
This Standard contains the main principles which ar e recommended by the Codex Alimentarius in dealing 
with contaminants and toxins in food and feed, and lists the maximum levels and associated sampling plans 
of contaminants and natural toxicants in food and fe ed which are recommended by the CAC to be applied to 
commodities moving in international trade. 
This standard includes only maximum levels of contamin ants and natural toxicants in feed in cases where the 
contaminant in feed can be transferred to food of anim al origin and can be relevant for public health.  
1.2 D EFINITION OF TERMS  
1.2.1 General 
The definitions for the purpose of the Codex Alimen tarius, as mentioned in the Procedural Manual, are 
applicable to the General Standard for Contaminants and Toxins in Food and Feed (GSCTFF) and only the 
most important ones are repeated here. Some new defi nitions are introduced, where this seems warranted to 
obtain optimal clarity. When reference is made to foods , this also applies to an imal feed, in those cases 
where this is appropriate.  
1.2.2 Contaminant 
Codex Alimentarius defines a contaminant as follows: 
"Any substance not intentionally a dded to food, which is present in such food as a result of the production 
(including operations carried out in crop husbandr y, animal husbandry and veterinary medicine), 
manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as 
a result of environmental contamination.  The term do es not include insect fragments, rodent hairs and other 
extraneous matter".  
This standard applies to any substance that meets the terms of the Codex definition for a contaminant, 
including contaminants in feed for food-producing animals, except : 
1) Contaminants having only food and feed quality significance (e.g. copper), but no public health 
significance, in the food(s) given that the sta ndards elaborated within the Codex Committee on 
Contaminants in Foods (CCCF) has th e objective to protect public health. 
2) Pesticide residues, as defined by the Codex defin ition that are within the terms of reference of 
the Codex Committee on Pesticide Residues (CCPR).   
3) Residues of veterinary drugs, as defined by the C odex definition, that are within the terms of 
reference of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). 
4) Microbial toxins, such as botulinum toxin and staphylococcus enterotoxin, and microorganisms 
that are within the terms of reference of  the Codex Committee on Food Hygiene (CCFH). 
5) Residues of processing aids that are within the terms of reference of the Codex Committee on 
Food Additives (CCFA)1 . 
                                                           
1  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. 
 CODEX STAN 193-1995 Page 2 of 44
 
1.2.3 Natural toxins included in this standard 
The Codex definition of a contaminant implicitly in cludes naturally occurring toxicants including toxic 
metabolites of certain microfungi that are not inte ntionally added to food and feed (mycotoxins). 
Toxins that are produced by algae and that may be accu mulated in edible aquatic organisms such as shellfish 
(phycotoxins) are also included in this standard.  Mycotoxins and phycotox ins are both subclasses of 
contaminants.  
Endogenous natural toxicants, such as e.g. solanine in  potatoes, that are implicit constituents of food and 
feed resulting from a genus, species or strain ordinarily  producing hazardous levels of a toxic metabolite(s), 
i.e. phytotoxins are not generally consid ered within the scope of this standa rd.  They are, however, within the 
terms of reference of the CCCF and will be dealt with on a case by case basis. 1.2.4 Maximum level and related terms
2 
The Codex maximum level  (ML)  for a contaminant in a food or feed commodity is the maximum 
concentration of that substance recommended by th e Codex Alimentarius Commission (CAC) to be legally 
permitted in that commodity. 
1.3 P RINCIPLES REGARDING CONTAMINANTS IN FOOD AND FEED  
1.3.1  General 
Contamination of food and feed may pose a risk to hum an (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 Manufactur ing Practice (GMP) following an appropriate risk 
assessment.  The following actions may serve to prev ent or to reduce contamination of feed and food3: 
- preventing food and feed contamination at the source, e.g. by reducing environmental 
pollution. 
- applying appropriate technology control measure(s) in food and feed  production, 
manufacture, processing, preparation, treatment, packing, packaging, transport or holding.  
- applying measures aimed at decontamination of contaminated feed or food and measures to 
prevent contaminated feed or food to be marketed for consumption. 
To ensure that adequate action is taken to reduce contam ination of food and feed a Code of Practice shall be 
elaborated comprising source related measures and Good Manufacturing Practice as well as Good 
Agricultural Practice in relation to the specific contamination problem. 
The degree of contamination of food and feed and the effect of actions to reduce contamination shall be 
assessed by monitoring, survey programs and more  specialized research programs, where necessary. 
                                                           
2  For the contaminants methylmercury, radionuclides, acrylonitrile and vinylchloride monomer a Codex guideline 
level (GL)  has been established.  
A Codex guideline level  (GL) is the maximum level of a substance in a food or feed commodity which is 
recommended by the CAC to be accept able for commodities moving in intern ational trade.  When the GL is 
exceeded, governments should decide wh ether and under what circumstances  the food should be distributed 
within their territory or jurisdiction. 
 Because the CAC has decided that the preferred format of a Codex standard in food or feed is a maximum level, the 
present existing or proposed guideline levels shall be re viewed for their possible conversion to a maximum level 
after a risk assessment performed  by JECFA, if appropriate. 
3  In addition, reference is made to the Code of Practi ce for source Directed measures  to reduce contamination of 
food with chemicals (CAC/RCP 49-2001) and the Code  of Practice on Good Anim al Feeding (CAC/RCP 54-
2004)  CODEX STAN 193-1995 Page 3 of 44
 
When there are indications that health hazards ma y be involved with consum ption of food that is 
contaminated, it is necessary that a risk assessment shoul d be undertaken.  When health concerns can be 
substantiated, a risk management measure must be a pplied, based on a thorough evaluation of the situation 
and consideration of a range of risk management opt ions.  Depending on the assessment of the problems and 
the possible solutions, it may be necessary to establish MLs or other measures to control the contamination 
of food and feed.  In special ca ses, specific advice on dietary recommendations may also have to be 
considered to complement other regulatory measures, when the measures are not sufficiently adequate to 
protect public health and safety. 
National measures regarding food and feed contamina tion should avoid the creation of unnecessary barriers 
to international trade in food and feed commodities.   The purpose of the GSCTFF is to provide guidance 
about possible approaches to eliminate or reduce the contamination problem and to promote international 
harmonization through recommendations which in turn  may prevent trade barriers and disputes.   
For all contaminants, which may be present in more than  one feed or food item, a broad approach shall be 
applied, taking into account all relevant information that is available, for the assessing of risks and for 
developing recommendations and control measures,  including the setting of maximum levels.  
1.3.2 Principles for establishing maximum levels in food and feed  
MLs shall only be set for food in which the contaminant may be found in amounts that are significant for the 
total exposure of the consumer, taking into cons ideration the Policy of the Codex Committee on 
Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups 
(Section III of the Procedural Manual) 
The maximum levels shall be set in such a way that the consumer is adequately protected.  At the same time 
the other legitimate factors need to be considered. . This will be performed in  accordance with the "Working 
principles for Risk Analysis for Food saf ety for Application by Governments".  
The principles of Good Manufacturing Practice and Good Agricultural Practice as defined by Codex shall be 
used.  Maximum levels shall be based on sound scien tific principles leading to levels which are acceptable 
worldwide, so that there is no unjustified barrier to in ternational trade.  MLs shall be clearly defined with 
respect to status and intended use.  1.3.3 Specific criteria 
The following criteria should (not preventing the use of other relevant criteria) be considered when 
developing  MLs and/or other measures  in connection with the Codex General St andard for Contaminants 
and Toxins in Food and feed :  (Further deta ils about these criteria are given in Annex I). 
 Toxicological information 
- identification of the toxic substance(s); 
- metabolism by humans and animals, as appropriate; 
- toxicokinetics and toxicodynamics including in formation on possible carry-over of the toxic 
substance from feed to edible animal tissue/products; 
- information about acute and long term toxici ty and other relevant toxicity data; and  
- integrated toxicological expert advice regarding the acceptability and safety of intake levels of 
contaminants, including information on any popul ation groups which are specially vulnerable. 
 Analytical data 
- validated qualitative and quantitative da ta 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; CODEX STAN 193-1995 Page 4 of 44
 
- presence in feed  and feed components  
- food intake data for average and mo st exposed/high  consumer groups; 
- results from total diet studies; 
- calculated contaminant intake data  from food consumption models;  
- data on intake by susceptible groups; and 
- data on intake by food producing animals. 
 Technological considerations 
- information about contamination processes,  technological possibilities, production and 
manufacturing practices and economic aspects rela ted to contaminant level management and 
control. 
Risk assessment and risk management considerations (cf.  "Working Principles for Risk Analysis 
for Food Safety for Application by Governments”)  
- risk management options  and considerations; 
- consideration of possible maximum levels in fo od and feed based on the criteria mentioned 
above; and 
- consideration of alternative solutions.  
1.4 F ORMAT OF THE GENERAL STANDARD FOR CONTAMINANTS IN FOOD AND FEED  
The General Standard for Contaminants and Toxins in Food and feed contains one type of presentation for 
the Standards: Schedule I in which the standards are listed per contaminant in the various food and feed 
categories. In order to obtain maximum clarity, explanatory notes shall be added where appropriate. The format contains 
all elements necessary for full understanding of th e meaning, background, app lication and scope of the 
standards and contains references to the relevant doc uments and reports on which the standard is based.  
A full description of the format is provided in Annex II.    
 
 CODEX STAN 193-1995 
ANNEX I Page 5 of 44
 
ANNEX I  
CRITERIA FOR THE ESTABLISHMENT OF MAXIMUM LEVELS IN FOOD AND FEED 
Introduction 
In this Annex criteria are mentioned regarding info rmation which is considered necessary for evaluating 
contaminant problems in food and feed and for the establishment of maximum levels.  The criteria 
mentioned here are elaborated in more detail than in s ection 1.3.3. of the Preamble.  Only those aspects that 
need further clarification are detailed; however, criteria or aspects that are not specifically detailed here 
should not be ruled out in the evaluation process.  
Toxicological information 
Integrated toxicological expert advice regarding a safe/tolerable intake level  of a contaminant is essential 
when decisions about maximum levels in foods ar e considered.  A recommendation from JECFA regarding 
the maximum allowable or tolerable intake, based on a fu ll evaluation of an adequate toxicological data base, 
should be the main basis for decisions by Codex members.   In urgent cases, it may be possible to rely on less 
developed evaluations from JECFA or on toxicological  expert advice from other international or national 
bodies. 
When toxicological information is presented in relation to proposals for maximum levels for contaminants in 
food and feed, information about the following aspects is desirable: 
- identification of the toxic substance(s); 
- metabolism in humans and animals, as appropriate; 
- toxicokinetics and toxicodynamics including information on possible carry-over of the 
contaminant from feed to edible animal tissue/products; 
- information about acute and long term toxicity in animals and humans, including 
epidemiological data on humans a nd other relevant toxicity data; 
- conclusions and advice of toxicological expe rt(s) (groups), with references, including 
information on specially vulnerable population groups or animals. 
Analytical data 
Validated qualitative and quantitative an alytical data on representative samples  should be supplied. 
Information on the analytical and sampling methods used and on the validation of the results is desirable.  A 
statement on the representativeness of th e samples for the contamination of the product in general (e.g. on a 
national basis) should be added.  The portion of the commodity that was analyzed and to which the 
contaminant content is related should be clearly stated and preferably should be equivalent to the definition 
of the commodity for this purpose or to existing related contaminant regulation. 
Information on appropriate sampling procedures  should be supplied.  Special attention to this aspect is 
necessary in the case of contaminants that may not be homogeneously distributed in the product (e.g. 
mycotoxins in some commodities). 
Intake data 
It is desirable to have information about the contaminant concentrations in those foods or food groups that 
(together) are responsible for at least half and preferab ly 80% or more of the to tal dietary intake of the 
contaminant, both for consumers with average and high consumption patterns. 
Information about the  presence of the contaminant in foods that are widely consumed  (staple foods) is 
desirable in order to be able to make a satisfact ory assessment of the contaminant intake and of risks 
associated with food trade. CODEX STAN 193-1995 
ANNEX I Page 6 of 44
 
For the contaminants which can be pr esent in food of animal origin as a consequence of the carry over from 
feed, information about the presence of the contaminant in the feed and feed components should be given. 
Furthermore the intake of contaminants by the differe nt food producing animals a nd the resulting levels of 
the contaminant in the food of anim al origin should be estimated.   
Food consumption data for average, most exposed (h igh consumers) and susceptible consumer groups  are 
desirable for evaluations of (potential) intake of cont aminants.  This problem, however, has to be addressed 
differently on a national and on an international scale.  It is therefore important to have information about 
both average and high consumption patterns regarding a wide variety of foodstuffs, so that for every 
contaminant the most exposed consumer groups may be identified for every contaminant.  Detailed 
information about high consumption patterns is desira ble, both regarding group identification criteria (e.g. 
age or sex differences, vegetarian or regional dietary customs, etc.) and statistical aspects. 
Dietary intake of contaminants : Reference is made to the Guidelines for the study of dietary intake of 
chemical contaminants (WHO, 1985 - http://whq libdoc.who.int/offset/WHO_OFFSET_87.pdf).  It is 
important to supply all releva nt details, such as the type of study (duplicate diet, total diet or market basket 
study, selective study), and statistical details.  Calc ulated contaminant intake data from food consumption 
models may also be useful.  When results about fo od groups and about effects of preparation and cooking 
etc. are available, these should also be supplied. 
Technological considerations 
Information about the source of the contaminant and th e way in which the food and feed  is contaminated, 
possibly including information, if available, about cont amination being present in parts only of the product, 
is essential for assessing the possibilities to control the cont amination process and to be able to guarantee a 
desired product safety and quality.  Where possible Source-related measures  should be proposed. Good 
Manufacturing Practice (GMP)  and/or Good Agricultural Practice (GAP)  should also be adapted to control 
a contamination problem. When this is possible,  maximum levels may be based on GMP or GAP 
considerations to establish at a level as low as reasona bly achievable and necessary to protect the consumer. 
Considerations regarding the technological possibilities to control a contamination problem, e.g. by cleaning, 
should also be taken into account when a primary ri sk assessment model (theoretical maximum daily intake) 
shows possible intakes exceeding the toxicological refe rence value. In such a case the possibilities of lower 
contamination levels need further car eful examination. Then a detailed st udy about all the aspects involved is 
necessary, so that decisions about maximum levels can be based on a thorough evaluation of both the public 
health arguments and the potential problem w ith complying with the proposed standard.  
Risk assessment and risk management considerations 
Risk assessment and risk management are conducted in accordance with the Work ing Principles for Risk 
Analysis for Food Safety Application by Governments. 
Establishment of maximum levels  
In case it is decided that, on the basis of the outcome of  the risk assessment, ther e is no need to establish a 
maximum level to protect public health as the level of  hazard/risk does not pose a pub lic health problem, this 
should be communicated in a transparent and accessible manner (e.g. by using the full format as provided for 
Schedule I and to mention in the box of Maximum level "not necessary"). 
The establishment of maximum levels (MLs) of contaminants in food and feed  involves several principles, 
some of which have already been mentioned in this Pr eamble.  Briefly stated, the following criteria will help 
in maintaining a consistent policy in this matter: 
- MLs should be set only for those contaminants that present both a significant risk to public 
health and a known or expected problem in international trade.  CODEX STAN 193-1995 
ANNEX I Page 7 of 44
 
- MLs should be set only for food that is significant for the total exposure of the consumer to the 
contaminant. When identifying the significance of  certain foods in the total exposure to the 
contaminant, the criteria contained in para  11 of the Policy of the Codex Committee on 
contaminants in Foods for Exposure Assessment of  Contaminants and Toxins in Foods or Food 
Groups (section III of  the Codex Alimentari us Commission Procedural Manual) should be 
consulted.  
- MLs should be set as low as reasonably achievabl e and at levels necessary to protect the 
consumer. Providing it is acceptable from the toxi cological point of view, MLs should be set at 
a level which is (slightly) higher than the normal range of variation in le vels in food and feed 
that are produced with current adequate technological methods, in order to avoid undue 
disruptions of food and feed production and tr ade. Where possible, MLs should be based on 
GMP and/or GAP considerations in which the h ealth concerns have been incorporated as a 
guiding principle to achieve contaminant leve ls as low as reasonably achievable and necessary 
to protect the consumer. Foods that are evidentl y contaminated by local situations or processing 
conditions that can be avoided by reasonably achievable means shall be excluded in this 
evaluation, unless a higher ML can be shown to be acceptable from a public health point of 
view and significant economic aspects are at stake. 
- Proposals for MLs in products should be based  on data from various countries and sources, 
encompassing the main production areas/processes of  those products, as far as they are engaged 
in international trade. When there is eviden ce that contamination patterns are sufficiently 
understood and will be comparable on a global scale, more limited data may be enough. 
- MLs may be set for product groups when suffi cient information is available about the 
contamination pattern for the whole group, or wh en there are other arguments that extrapolation 
is appropriate. 
- Numerical values for MLs should preferably be re gular figures in a geometric scale (0.01, 0.02, 
0.05, 0.1, 0.2, 0.5, 1, 2, 5 etc.), unless this  may pose problems in the acceptability of the MLs. 
- MLs should apply to representative samples per lot. If necessary, appropriate methods of 
sampling should be specified. 
- MLs should not be lower than a level which can be analyzed with methods of analysis that can  readily be set up and applied in food and f eed control laboratories, unless public health 
considerations necessitate a lower ML which can only be controlled by means of a more 
elaborate and sensitive method of analysis with an  adequate lower detection limit. In all cases, a 
validated method of analysis should be availa ble with which a ML can be controlled.  
- The contaminant as it should be analyzed and to which the ML applies should be clearly 
defined. The definition may include important metabolites when this is appropriate from an 
analytical or toxicological point of view. It may also be aimed at indicator substances which are 
chosen from a group of related contaminants. 
- The product as it should be analyzed and to which the ML applies, should be clearly defined. In general, MLs are set on primary products. MLs s hould in general preferably be expressed as a 
level of the contaminant related to the product as it is, on a fresh weight basis. In some cases, 
however, there may be valid arguments to prefer expression on a dry weight basis (this might be 
in particular the case for contaminants in feed) or on a fat weight basis (this might be in particular the case for fat soluble contaminants). Preferably the product should be defined as it 
moves in trade, with provisions where necessary for the removal of inedible parts that might 
interfere with the preparation and the analysis of the sample. The product definitions used by 
the CCPR and contained in the Classification of food and feed may serve as guidance on this 
subject; other product definitions should only be  used for specified reasons. For contaminant 
purposes, however, analysis and consequently ML s should preferably be on the basis of the 
edible part of the product.  CODEX STAN 193-1995 
ANNEX I Page 8 of 44
 
For fat soluble contaminants which may accumula te in animal products, provisions should be 
applied regarding the application of the ML to products with various fat content (comparable to 
the provisions for fat soluble pesticides).  
- Guidance is desirable regarding the possible application of MLs established for primary 
products to processed products and multi-ingredie nt products. When products are concentrated, 
dried or diluted, use of the concentration or dilutio n factor is generally appr opriate in order to be 
able to obtain a primary judgement of the cont aminant levels in these processed products.  The 
maximum contaminant concentration in a multi- ingredient food and feed can likewise be 
calculated from the composition of the food and f eed. Information regarding the behaviour of 
the contaminant during processing (e.g. washing, pe eling, extraction, cooking, drying etc.) is 
however desirable to give more adequate guidance. When contam inant levels are consistently 
different in processed products related to the prim ary products from which they are derived, and 
sufficient information is available about the c ontamination pattern, it may be appropriate to 
establish separate maximum levels for these pr ocessed products. This also applies when 
contamination may occur during processing.  In general however, MLs should preferably be set 
for primary agricultural products and may be a pplied to processed, derived and multi-ingredient 
food and feed by using appropriate conversion factors. When these factors are sufficiently 
known, they should be mentioned in the suffix to the maximum level following the format of 
list of MLs as defined in Annex II. 
- MLs should preferably not be set higher than is acceptable in a primary (theoretical maximum 
intake and risk estimation) approach of their acceptability from a public health point of view. 
When this poses problems in relation to other cr iteria for establishing MLs, further evaluations 
are necessary regarding the possibilities to redu ce the contaminant levels, e.g. by improving 
GAP and/or GMP conditions. When this does not bring a satisfactory solution, further refined 
risk assessment and contaminant risk management ev aluations will have to be made in order to 
try to reach agreement about an acceptable ML. 
Procedure for risk assessment in relation to (proposed) MLs  
It is more difficult to control food and feed contam ination problems than in the case of food additives and 
pesticide residues.  Proposed MLs will inevitably be in fluenced by this situation. In order to promote 
acceptance of Codex contaminant MLs, it is therefore im portant that assessments of the impact of those MLs 
on dietary exposure are done in a c onsistent and realistic way.  The procedure involves assessment of the 
dietary intake in relation to the proposed or ex isting MLs and the toxicological reference value.  
In case a contaminant is carried over from feed to food of  animal origin, the intake of a contaminant by the 
different food producing animal spec ies and the resulting levels in the food of animal origin should be 
estimated.   CODEX STAN 193-1995 
ANNEX I Page 9 of 44
 
The best estimate of dietary intake  involves the national dietary pattern and corrections for concentration 
changes during transport, storage, food preparation, fo r known levels in foods as consumed, etc.  Caution is 
recommended when using other than average food consum ption values, although it is considered appropriate 
to use relevant average food consumption data fo r identifiable subgroups of the population.  Food 
consumption patterns with a higher intake of critical foods  may be used in the intake calculations when this 
is part of an accepted national or international health  protection and risk management policy.  A harmonized 
approach using an appropriate intake  estimation model that is as realis tic as possible is recommended. (cf. 
the "Policy of the Codex Committee on contaminants in Foods for Exposure Assessment of Contaminants 
and Toxins in Foods or Food Groups" -section III of the Codex Alimentarius Commission Procedural 
Manual). Calculated data should where possible always be compared with measured intake data.  Proposals 
for MLs should be accompanied by intake calculations  and risk assessment conclusions regarding their 
impact on dietary intake and use. The intake calcu lations should follow the methodology described in the 
CCCF Policy for Exposure Assessment and, if appropriat e, be accompanied by the generation of distribution 
curves for the concentration in specific foods/food gr oups (see paras 5-8 and 12-14 of the Policy of the 
Codex Committee on Contaminants in Foods for Expos ure Assessment of Contaminants and Toxins in 
Foods in the Codex Alimentarius  Commission Procedural Manual).   Statements from Governments about the 
non-acceptance of (proposed) Codex MLs should refer to sp ecified intake calculations and risk management 
conclusions which support this position. 
 CODEX STAN 193-1995 
ANNEX II Page 10 of 44
 
ANNEX II  
FORMAT OF THE GSCTF 
Introduction 
The format for Schedule shall co ntain the following elements: 
• Name of the contaminant:  symbols, synonyms, abbreviations, scientific descriptions shall be 
mentioned. 
• Reference to JECFA meetings  (in which the contaminant was discussed). 
• PMTDI, PTWI or similar toxicological reference value:  when the situation is complex a short 
statement and further references may be necessary here. 
• Contaminant definition:  definition of the contaminant as it shall be analyzed and to which the 
maximum level applies.  
• Reference to a source- directed measure or a code of practice for the contaminant, if appropriate. 
• List of Codex maximum levels  for that contaminant;  this list shall be composed of the following 
elements, in columns: 
- Classification number of feed/food commodity or feed/food category; 
- Name of feed/food commodity/category; 
- Numerical value of maximum level; 
- Suffix accompanying a ML to specify the application of the ML; 
- References to documents, or adoption year;  
- References to standard criteria for methods of analysis and sampling; 
- Notes/remarks. 
. CODEX STAN 193-1995 
Schedule I Page 11 of 44
 
SCHEDULE I - MAXIMUM AND GUIDELINE LEVELS FOR CONTAMINANTS 
AND TOXINS IN FOODS 
INDEX OF CONTAMINANTS  
 
 
 
EXPLANATORY NOTES 
Reference to 
JECFA: References to JECFA meeting in which the contaminant was evaluated and the year 
of that meeting. 
Toxicological 
guidance value: Toxicological advice about the tolerable intake level of the contaminant for humans, expressed in milligrammes (mg) per kg body weight (bw). The year of 
recommendations and additional explanation are included.  
Residue definition:  Definition of the contaminant in the form of which the ML applies or which may or 
should be analyzed in commodities. 
Synonyms: Symbols, synonyms abbreviations, sci entific descriptions and identification codes 
used to define the contaminant. 
Commodity code: The code for food commodities is  according to the food and feed categorization 
system as contained in Annex IV-A of the GSCTF or the Codex Classification of foods and feeds. The food/feed categorization system also specifies the part of Commodity which should be analysed and to which the ML applies, unless a 
specific commodity definition is provided as an annex to the ML.  For those 
maximum levels contained in Codex commod ity standards, the relevant standard 
numbers are referred, if the code numbers are not readily available for these 
commodities. 
Suffix: A note accompanying an ML or GL, used  to specify the application or the future 
revision of the ML, e.g., specific residue definitions can be mentioned by 
abbreviations here.  See also “Qualification of MLs” below. 
Type: Indicates whether the value is Codex ma ximum level (ML) or Codex guideline level 
(GL).  See also the definitions of these terms in the preamble of the GSCTF. NAME PAGE 
Mycotoxins 13 
Aflatoxins, Total 13 
Aflatoxin M1 29 
Ochratoxin A 29 
Patulin 30 
Heavy Metals 31 
Arsenic 31 
Cadmium 32 
Lead 33 
Mercury 35 
Methylmercury 36 
Tin 36 
Radionuclides 38 
Others 43 
Acrylonitrile  43 
Chloropropanols 43 
Dioxins 44 
Vinylchloride monomer 44 CODEX STAN 193-1995 
Schedule I Page 12 of 44
 
Qualification of MLs 
C: In canned products only.  
Definitions of some toxicological terms PMTDI: (Provisional Maximum Tolerable Daily Intake)  
The endpoint used for contaminants with no cumulative properties. Its value represents 
permissible human exposure as a result of the na tural occurrence of the substance in food and 
in drinking-water. In the case of trace elem ents that are both essential nutrients and 
unavoidable constituents of food, a range is e xpressed, the lower value representing the level 
of essentiality and the upper value the PMTDI. 
PTWI: (Provisional Tolerable Weekly Intake)   
An endpoint used for food contaminants such as  heavy metals with cumulative properties. Its 
value represents permissible human weekly ex posure to those contaminants unavoidably 
associated with the consumption of otherwise wholesome and nutritious foods. 
PTMI: (Provisional Tolerable Monthly Intake)   
An endpoint used for a food contaminant with cu mulative properties that has a very long half-
life in the human body. Its value represents permissible human monthly exposure to a 
contaminant unavoidably associated with otherwise wholesome and nutritious foods. 
 
 CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 13 of 44 
   
AFLATOXINS , TOTAL  
Reference to JECFA: 31 (1987), 46 (1996), 49 (1997), 68 (2007) 
Toxicological guidance: Carcinogenic potency estimates for aflatoxins B, G, M (1997, Intake should be reduced to levels as low as reasonably possible.) 
Residue definition: Aflatoxins total (B1 +B2 + G1 + G2) 
Synonyms: Abbreviations, AFB, AFG, with numbers, to designate specific compounds 
Related Code of Practice: Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts (CAC/RCP 55-2 004) 
Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Tree Nuts (CAC/RCP 59-2005) 
Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and Supplemental Feedingstuffs for Milk Producing Animals 
(CAC/RCP 45-1997) 
Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Dried Figs (CAC/RCP 65-2008) 
Commodity/Product 
Code Name Level 
ug/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
SO 0697 Peanut 15  ML  The ML applies to peanuts intended for further processing. For sampling plan, see Annex 1 below. 
TN 0660 Almonds  15  ML  The ML applies to almonds intended for further processing For sampling plan, see Annex 2 below 
TN 0666 Hazelnuts 15  ML  The ML applies to hazelnuts intended for further processing For sampling plan, see Annex 2 below 
TN 0675 Pistachios 15  ML  The ML applies to pistachios intended for further processing For sampling plan, see Annex 2 below 
TN 0660 Almonds 10  ML  The ML applies to almonds “ready-to-eat”.  For sampling plan, see Annex 2 
TN 0666 Hazelnuts 10  ML  The ML applies tohazelnuts “ready-to-eat”.  For sampling plan, see Annex 2. 
TN 0675 Pistachios 10  ML  The ML applies to pistachios “ready-to- eat”.  For sampling plan, see Annex 2. 
Aflatoxins are a group of highly toxic mycotoxins produced by f ungi of the genus Aspergillus. The four main aflatoxins found in  contaminated plant products are B1, B2, G1 and 
G2 and are a group of structurally related difuranocoumarin deri vatives that usually occur together in varying ratios, AFB1 usu ally being the most important one. These compounds 
pose a substantial hazard to human and animal  health. IARC (1992) classified aflatoxin B1 in Group 1 (human  carcinogen) and AFM  in Group 2B (probable human carcinogen). 
The liver is the primary target organ.  CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 14 of 44 
   
Annex 1 
SAMPLING PLAN FOR TOTAL AFLATOXINS IN PEANUTS INTENDED FOR FURTHER PROCESSING 
INTRODUCTION 
1. The sampling plan calls for a single 20 kg laboratory sample of shelled peanuts (27 kg of unshelled peanuts)  to be taken from a peanut lot (sub-lot) and tested against a 
maximum level of 15 micrograms per kilogram ( μg/kg) total aflatoxins.   
2. This sampling plan has been designed for enforcement and controls concerning total aflatoxins in bulk consignments of peanuts t raded in the export market. To assist 
member countries in implementing the Codex sampling plan, sample selection methods, sample preparation methods and analytical m ethods required to quantify aflatoxin in bulk 
peanut lots are described in this document.   
A.  Definitions   
Lot:  an identifiable quantity of a food commodity delivered at one tim e and determined by the official to have common characteristic s, such as origin, variety, type 
of packing, packer, consignor or markings. 
Sublot: designated part of a large lot in order to apply the sampling method on that designated part. Each sublot must be physically se parate and identifiable. 
Sampling plan:  is defined by an aflatoxin test procedur e and an accept/reject limit. An aflatoxin te st procedure consists of three steps: sam ple selection, sample preparation and 
aflatoxin quantification. The accept/reject limit is a to lerance usually equal to the Codex   maximum limit. 
Incremental sample:  a quantity of material taken from a single random place in the lot or sublot. 
Aggregate sample:  the combined total of all the incremental samples taken from the lot or sublot. The aggregate sample has to be at least as lar ge as the 20 kg laboratory sample. 
Laboratory sample: smallest quantity of peanuts comminuted in a mill. The laborator y sample may be a portion of or the entire aggregate sample. If  the aggregate sample is larger 
than 20 kg, a 20 kg laboratory sample should be removed in a ra ndom manner from the aggregate sample. The sample should be fine ly ground and mixed 
thoroughly using a process that approaches as complete a homogenisation as possible. 
Test portion: portion of the comminuted laboratory sample. The entire 20 kg laboratory sample should be comminuted in a mill. A portion of th e comminuted 20 kg sample 
is randomly removed for the extraction of the aflatoxin for chemical analysis. Based upon grinder capacity, the 20 kg aggregate  sample can be divided into 
several equal sized samples, if  all results are averaged.   
B. Sampling 
Material to be Sampled  
3. Each lot which is to be examined must be sampled separately. La rge lots should be subdivided into sublots to be sampled separat ely. The subdivision can be done following 
provisions laid down in Table 1 below.  
4. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a 
maximum of 20 %.  CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 15 of 44 
   
Table 1: Subdivision of Large Lots into Sublots for Sampling 
Commodity Lot weight – tonne  (T) Weight or number of 
sublots Number of 
incremental 
samples Laboratory 
Sample Weight 
(kg) 
Peanuts ≥ 500 
>100 and <500 
≥ 25 and ≤ 100 
>15 and <= 25 100 tonnes 
5 sublots 
25 tonnes 
--1 sublot 100 
100 
100 
100 20 
20 
20 
20 
Number of Incremental Samples for Lots of Less than 15 Tonnes  
5. The number of incremental samples to be taken depends on the weight of the lot, with a minimum of 10 and a maximum of 100. The figures in the following Table 2 may be 
used to determine the number of incremental samples to be taken. It is necessary that the total sample weight of 20 kg is achie ved.   
Table 2: Number of Incremental Samples to be Taken Depending on the Weight of the Lot 
Lot weight tonnes – (T)  N° of incremental samples 
T≤ 1 10 
1 <T ≤ 5 40 
5< T   ≤ 10 60 
10<T < 15 80 
Incremental Sample Selection  
6. Procedures used to take incremental samples from a peanut lot are extremely important. Every individual peanut in the lot shoul d have an equal chance of being chosen. 
Biases will be introduced by the sample selection methods if equi pment and procedures used to select the incremental samples pr ohibit or reduce the chances of any item in the lot 
from being chosen.  
7. Since there is no way to know if the cont aminated peanut kernels are uniformly disper sed through out the lot, it is essential t hat the aggregate sample be the accumulation of 
many small portions or increments of the pr oduct selected from different locations throughout the lot. If the aggregate sample is larger than desired, it  should be blended and 
subdivided until the desired laboratory sample size is achieved. 
Static Lots  
8. A static lot can be defined as a large mass of peanuts contained either in a single large container such as a wagon, truck, or railcar or in many small containers such as sacks 
or boxes and the peanuts are stationary at the time a sample is  selected. Selecting a truly random sample from a static lot can  be difficult because the container may not allow access 
to all peanuts.  CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 16 of 44 
   
9. Taking a aggregate sample from a static lot usually requires the use of probing devices to select product from the lot. The pro bing devices used should be specially designed 
for the type of container. The probe should (1) be long enough to reach all product, (2) not restrict any item in the lot from being selected, and (3) not alter the items in the lot. As 
mentioned above, the aggregate sample should be a composite from many small increments of product taken from many different loc ations throughout the lot. 
10. For lots traded in individual packages, th e sampling frequency (SF), or number of packages that incremental samples are taken f rom, is a function of the lot weight (LT),  
incremental sample weight (IS), aggregate sample weight (A S) and the individual packin g weight (IP), as follows : 
Equation 1 : SF = (LT x IS)/(AS x IP).  The sampling frequency (SF) is the number of packages sampled. All weights should be in  the same mass units such as kg.   
Dynamic Lots  
11. True random sampling can be more nearly achieved when selecting an aggregate sample from a moving stream of peanuts as the lot is transferred, for example, by a 
conveyor belt from one location to another. When sampling from a moving stream, take small increments of product from the entir e length of the moving stream; composite the 
peanuts to obtain an aggregate sample; if the aggregate sample is larg er than the required laboratory sample, then blend and su bdivide the aggregate sample to obtain the desired 
size laboratory sample. 
12. Automatic sampling equipment such as cross-cut samplers are co mmercially available with timers that automatically pass a divert er cup through the moving stream at 
predetermined and uniform intervals. When automatic equipment is not available, a person can be assigned to manually pass a cup  though the stream at periodic intervals to collect 
incremental samples. Whether using automatic or manual methods, small increments of peanuts should be collected and composited at frequent and uniform intervals throughout 
the entire time peanuts flow past the sampling point.  
13. Cross-cut samplers should be installed in the following manner: (1) the plane of the opening of the diverter cup should be perp endicular to the direction of flow; (2) the 
diverter cup should pass through the entire cross sectional area of the stream; and (3) the opening of the diverter cup should be wide enough to accept all items of interest in the lot. 
As a general rule, the width of the diverter cup opening should be about three times the largest dimensions of the items in the  lot. 
14. The size of the aggregate sample (S) in kg, taken from a lot by a cross cut sampler is : 
Equation 2 : S = (D x LT) / (T x V).  D is the width of the diverter cup opening (in cm), LT is the lot size (in kg), T is inte rval or time between cup movement through the 
stream (in seconds), and V is cup velocity (in cm/sec).  
15. If the mass flow rate of the moving stream, MR (kg/sec), is known, then the sampling frequency (SF), or number of cuts made by the automatic sampler cup is : 
Equation 3 : SF = (S x V) / (D x MR). 
16. Equation 2 can also be used to compute other terms of interest such as the time between cuts (T). For example, the required tim e (T) between cuts of the diverter cup to 
obtain a 20 kg aggregate sample from a 30,000 kg lot where the diverter cup width is 5.08 cm (2 inches), and the cup velocity t hrough the stream 30 cm/sec. Solving for T in 
Equation 2, 
T = (5.08 cm x 30,000 kg)/(20 kg x 30 cm/sec) = 254 sec 
17. If the lot is moving at 500 kg per minute, the entire lot will pass through the sampler in 60 minutes and only 14 cuts (14 incr emental samples) will be made by the cup 
through the lot. This may be considered too infrequent, in th at too much product passes through the sampler between the time th e cup cuts through the stream.  CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 17 of 44 
   
Weight of the Incremental Sample  
18. The weight of the incremental sample should be approximately 200 grams or greater, depending on the total number of increments,  to obtain an aggregate sample of 20kg. 
Packaging and transmission of samples  
19. Each laboratory sample shall be placed in a clean, inert cont ainer offering adequate protection from contamination and against damage in transit. All necessary precautions shall be 
taken to avoid any change in composition of the laboratory sample which might arise during transportation or storage. 
Sealing and labelling of samples  
20. Each laboratory sample taken for official use shall be sealed at the place of sampling and identified. A record must be kept of  each sampling, permitting each lot to be identified 
unambiguously and giving the date and place of sampling together wi th any additional information likely to be of assistance to the analyst. 
C. Sample Preparation 
Precautions  
21. Daylight should be excluded as much as possible during the procedure, since aflatoxin gradually breaks down under the influence  of ultra-violet light.  
Homogenisation – Grinding  
22. As the distribution of aflatoxin is extremely non-homogeneous, samples should be prepared - and especially homogenised - with e xtreme care. All laboratory sample 
obtained from aggregate sample is to be used for the homogenisation/grinding of the sample.  
23. The sample should be finely ground and mixed thoroughly using a process that approaches as complete a homogenisation as possibl e. 
24. The use of a hammer mill with a #14 screen (3.1 mm diameter hole in the screen) has been proven to represent a compromise in te rms of cost and precision. A better 
homogenisation (finer grind – slurry) can be obtained by more soph isticated equipment, resulting in a lower sample preparation variance.  
Test portion  
25. A minimum test portion size of 100 g taken from the laboratory sample.  CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 18 of 44 
   
D. Analytical Methods 
Background  
26. A criteria-based approach, whereby a set of performance criteria is established with which the analytical method used should co mply, is appropriate. The criteria-based 
approach has the advantage that, by avoiding setting down specific details of the method used, developments in methodology can be exploited without having to reconsider or 
modify the specified method. The performance criteria established for methods should include all the parameters that need to be  addressed by each laboratory such as the detection 
limit, repeatability coefficient of variation, reproducibility coef ficient of variation, and the percent recovery necessary for  various statutory limits. Utilising this approach, 
laboratories would be free to use the anal ytical method most appropriate for their facilities. Analytical methods that are acce pted by chemists internationally (such as AOAC) may 
be used. These methods are regularly monitored and improved depending upon technology.  
Performance Criteria for Methods of Analysis  
Table 3: Specific Requirements with which Methods of Analysis Should Comply 
Criterion  Concentration Range  Recommended Value Maximum Permitted 
Value 
Blanks All Negligible - 
Recovery-Aflatoxins Total 1 - 15 μg/kg 70 to 110 %  
 > 15 μg/kg 80 to 110 %  
Precision RSD R All As derived from Horwitz 
Equation 2 x value derived from 
Horwitz Equation 
Precision RSD r may be calculated as 0.66 times Precision RSD R at the concentration of interest 
• The detection limits of the methods used ar e not stated as the precision values are given at the concentrations of interest; 
• The precision values are calculated from the Horwitz equation,  i.e.: 
 RSD
R = 2(1-0.5logC)
 
 where: 
∗ RSD R is the relative standard deviatio n calculated from results  generated under reprod ucibility conditions [(s R / x) x 100] 
∗ C   is the concentration ratio  (i.e. 1 = 100g/100g, 0.001 = 1,000 mg/kg) 
27. This is a generalised precision equation which has been found to be independent of analyte and matrix but solely dependent on c oncentration for most routine methods of 
analysis. CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 19 of 44
   
Annex 2 
 
SAMPLING PLANS FOR AFLATOXIN CONTAMINATION IN READY-TO-EAT TREENUTS AND 
TREENUTS DESTINED FOR FURTHER PROCESSING : ALMONDS, HAZELNUTS AND PISTACHIOS 
 
DEFINITION 
Lot - an identifiable quantity of a food commodity delivered at one time and determined by the official to have common 
characteristics, such as origin, variety, type of packing, packer, consignor, or markings. 
Sublot - designated part of a larger lot in order to apply the sampling method on that designated part. Each sublot must 
be physically separate and identifiable. 
Sampling plan - is defined by an aflatoxin test procedure and an accept/reject limit. An aflatoxin test procedure 
consists of three steps: sample selec tion, sample preparation and aflatoxin qu antification. The accept/ reject limit is a 
tolerance usually equal to the Codex maximum level. 
Incremental sample – the quantity of material taken from a si ngle random place in the lot or sublot. 
Aggregate sample - the combined total of all the incremental samples that is taken from the lot or sublot. The aggregate 
sample has to be at least as large as the laboratory sample or samples combined. 
Laboratory sample – the smallest quantity of tree nuts comminuted in a mill. The laboratory sample may be a portion 
of or the entire aggregate sample. If the aggregate sample is  larger than the laboratory sample(s), the laboratory 
sample(s) should be removed in a random manner from the aggregate sample. 
Test portion – a portion of the comminuted laboratory sample. The entir e laboratory sample should be comminuted in a 
mill. A portion of the comminuted laboratory sample is randomly removed for the extraction of the aflatoxin for 
chemical analysis.  
Ready-to-eat treenuts  – nuts, which are not intended to undergo an additional processing/treatment that has proven to 
reduce levels of aflatoxins.  
Treenuts destined for further processing  – nuts, which are intended to undergo an additional processing/treatment 
that has 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 color sorting, and sorting by specific gravity and color (damage).  There is  some evidence that roasting 
reduces aflatoxins in pistachios but for other nuts the evidence is still to be supplied. 
Operating Characteristic (OC) Curve  – a plot of the probability of a acceptin g a lot versus lot concentration when 
using a specific sampling plan design. The OC curve provides an estimat e of good lots rejected (exporter’s risk) and bad 
lots accepted (importer’s risk) by a speci fic aflatoxin sampling plan design.  
SAMPLING PLAN DESIGN CONSIDERATIONS 
1. Importers may commercially classify tr eenuts as either “ready-to-eat” (RTE) or “destined for further processing” 
(DFP). As a result, maximum levels and sampling plans are proposed for both commercial types of treenuts. 
Maximum levels need to be defined for treenuts destined for further processing and ready-to-eat treenuts before a 
final decision can be made about a sampling plan design. 
2. Treenuts can be marketed either as in shell or shelled nuts. For example, pi stachios are predomin ately marketed as 
inshell nuts while almonds are predominately marketed as shelled nuts.   
3. Sampling statistics, shown in Annex I, are based upon the uncertainty and aflatoxin distribution among laboratory samples of shelled nuts. Because the shelled nut count pe r kg is different for each of the three treenuts, the 
laboratory sample size is expressed in number of nuts fo r statistical purposes. However, the shelled nut count per 
kg for each treenut, shown in Annex I, can be used to convert laboratory sample size from number of nuts to mass 
and vice versa.   CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 20 of 44
   
4. Uncertainty estimates associated with  sampling, sample preparation, and analysis, shown in Annex I, and the 
negative binomial distribution4 are used to calculate operating characteristic (OC) curves that describe the 
performance of the proposed aflatoxin-sampling plans (Annex II).  
5. In Annex I, the analytical variance reflects a reproducibility  relative standard deviation of 22%, which is suggested 
by Thompson and is based upon Food Analysis Performance Assessment Scheme (FAPAS) data5. A relative 
standard deviation of 22% is considered by FAPAS as an  appropriate measure of the best agreement that can be 
reliably obtained between laboratories. An analytical uncertainty of 22% is larger than the within laboratory 
variation measured in the sampling studies for the three tr eenuts. The within laboratory analytical uncertainty for 
each treenut can be found at the website http://www5.bae.ncsu.edu/usda/www/ ResearchActDocs/treenutwg.html .  
6. The issue of correcting the analytical test result for recove ry is not addressed in this document. However, Table 2 
specifies several performance criteria for analytical me thods including suggestions for the range of acceptable 
recovery rates. 
AFLATOXIN TEST PROCEDUR E AND MAXIMUM LEVELS 
7. An aflatoxin-sampling plan is defined by an aflatoxin test procedure and a maximum level. A value for the 
proposed maximum level and the aflatoxin test procedure are given below in this section. 
8. The maximum levels for total aflatoxins in treenuts  (almonds, hazelnuts, and pistachios) “ready-to-eat” and 
“destined for further processing”   are 10 and 15 ng/g, respectively. 
9. Choice of the number and size of the laboratory sample is  a compromise between minimizing risks (false positives 
and false negatives) and costs related to sampling and rest ricting trade. For simplicity, it is recommended that the 
proposed aflatoxin sampling plans use a 20 kg aggregate sample for all three treenuts.   
10. The two sampling plans (RTE and DFP) have been design ed for enforcement and co ntrols concerning total 
aflatoxins in bulk consignments (lots) of treenuts traded in the export market.     
Treenuts destined for further processing  
Maximum level – 15 ng/g total aflatoxins 
Number of laboratory samples – 1 
Laboratory sample size - 20 kg 
 Almonds – shelled nuts 
 Hazelnuts – shelled nuts 
Pistachios – inshell nuts (equivalent to about 10kg shelled nuts that is calculated on the basis of the 
actual edible portion in the sample) 
Sample preparation – sample shall be finely ground and mixed thoroughly using a dry process, e.g., dry grind with 
a vertical cutter mixer type mill, that has been demonstrated to provide the lowest sample preparation variance. 
Analytical method – performance based (see Table 2) 
Decision rule – If the aflatoxin test result is less than or equal to 15 ng/g  total aflatoxins, then accept the lot. 
Otherwise, reject the lot. The operating characteristic curve descri bing the performance of the sampling plan for the three treenuts destined 
for further processing is shown in Annex II. 
Ready-to-eat treenuts
 
Maximum level – 10 ng/g total aflatoxins 
Number of laboratory samples – 2 
Laboratory sample size - 10 kg 
 Almonds – shelled nuts 
 Hazelnuts – shelled nuts 
Pistachios – inshell nuts (equivalent to about 5 kg shelled nuts per test sample that is calculated on the 
basis of the actual edible portion in the sample) 
                                                           
4  Whitaker, T., Dickens, J., Monroe, R., and Wiser, E. 1972. Comparison of the negative binomial distribution of 
aflatoxin in shelled peanuts to the negative binomial dist ribution. J. American Oil Chemists’ Society, 49:590-593. 
5  Thompson, M. 2000. Recent trends in  inter-laboratory precision at ppb and sub-ppb concentrations in relation to 
fitness for purpose criteria in proficiency testi ng. J. Royal Society of Chemistry, 125:385-386. CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 21 of 44
   
Sample preparation – sample shall be finely ground and mixed thoroughly using a dry process, e.g., dry grind with 
a vertical cutter mixer type mill, that has been demonstrated to provide the lowest sample preparation variance. 
Analytical method – performance based (see Table 2) 
Decision rule – If the aflatoxin test result is less than or equal to 10 ng/g total aflatoxin in both test samples, then 
accept the lot. Otherwise, reject the lot. The operating characteristic curve desc ribing the performance of the samplin g plan for the three ready-to-eat 
treenuts is shown in Annex II. 
11. To assist member countries implem ent these two Codex sampling plans, sample selection methods, sample 
preparation methods, and analytical methods required to quantify aflatoxin in laboratory samples taken from bulk 
treenut lots are described in the following sections. 
SAMPLE SELECTION 
Material to be sampled
 
12. Each lot, which is to be examined for aflatoxin, must be sampled separately. Lots larger than 25 tonnes should be 
subdivided into sublots to be sampled separately. If a lot is greater than 25 tonnes, the number of sublots is equal to 
the lot weight in tonnes divided by 25 tonnes. It is recommended that a lot or a sublot should not exceed 25 tonnes.  
The minimum lot weight should be 500 kg. 
13. Taking into account that the weight of the lot is not always an exact multiple of 25 tonne sublots, the weight of the 
sublot may exceed the mentioned weight by a maximum of 25%. 
14. Samples should be taken from the same lot, i.e. they should have the same batch code or at the very least the same 
best before date. Any changes which would affect the mycotoxin content, the analytical determination or make the 
aggregate samples collected unrepresentative should be avoided. For example do not open packaging in adverse 
weather conditions or expose samples to excessive moisture or sunlight. Avoid cross-contamination from other 
potentially contaminated consignments nearby.  
15. In most cases any truck or container will have to be unl oaded to allow representative sampling to be carried out. 
Incremental Sample Selection  
16. Procedures used to take incremental samples from a tree nut lot are extremely important. Every individual nut in the 
lot should have an equal chance of being chosen. Biases  will be introduced by sample selection methods if 
equipment and procedures used to sel ect the incremental samples prohibit or reduce the chances of  any item in the 
lot from being chosen. 
17. Since there is no way to know if the contaminated treenut kernels are uniformly dispersed throughout the lot, it is 
essential that the aggregate sample be the accumulation of  many small incremental samples of product selected 
from different locations throughout the lot. If the aggregate sample is larger than desired, it should be blended and 
subdivided until the desired laboratory sample size is achieved. 
Number of Incremental Samples for Lots of varying weight  
18. The number and size of the laboratory sample(s) will not va ry with lot (sublot) size. However, the number and size 
of the incremental samples will vary with lot (sublot) size.  
19. The number of incremental samples to be taken from a lot (sublot) depends on the weight of the lot. Table 1 shall 
be used to determine the number of incremental samples to be taken from lots or sublots of various sizes below 25 
tonnes. The number of incremental samples varies from a minimum of 10 and to a maximum of 100. 
 CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 22 of 44
   
Table 1. Number and size of incremental samples co mposited for an aggregate sample of 20 kga as a function of lot (or 
sublot) weight.  
a/ Minimum aggregate sample size = laboratory sample size of 20 kg 
b/ 1 Tonne = 1000 kg 
c/  Minimum incremental sample size = laboratory sample  size (20 kg)/minimum  number of incremental samples, 
i.e. for 0.5<T< 1 tonne, 2000 g = 20000/10 
 
Weight of the Incremental Sample  
20. The suggested minimum weight of the incremental sample should be approximately 200 grams for lots of 25 metric 
tonnes (25,000 kg). The number and/or size of incremental samples will have to be larger than that suggested in 
Table 1 for lots sizes below 25,000 kg in order to obtain an aggregate sample greater than or equal to the 20 kg 
laboratory sample.  
Static Lots  
21. A static lot can be defined as a large mass of treenuts contained either in a large single container such as a wagon, 
truck or railcar or in many small containers such as sacks or boxes and the nuts are stationary at the time a sample 
is selected. Selecting a truly random sample from a static lot can be difficult because all containers in the lot or 
sublot may not be accessible.  
22. Taking incremental samples from a static lot usually requires the use of probing devices to select product from the lot. The probing devices should be specifically designed for the commodity and type of container. The probe 
should (1) be long enough to reach all products, (2) not rest rict any item in the lot from being selected, and (3) not 
alter the items in the lot. As mentioned above, the aggregate sample should be a composite from many small incremental samples of product taken from ma ny different locations throughout the lot.   
23. For lots traded in individual packages, the sampling frequency (SF), or number of packages that incremental samples are taken from, is a function of the lot weight (LT), incremental sample weight (IS), aggregate sample 
weight (AS) and the individual packing weight (IP), as follows: 
Equation 1:  SF=(LT x IS)/(AS x IP).  
24. The sampling frequency (SF) is the number of packages sampled. All weights should be in the same mass units such as kg. 
Dynamic Lots
 
25. Representative aggregate samples can be more easily pr oduced when selecting increm ental samples from a moving 
stream of treenuts as the lot is transferred from one location to another. When sampling from a moving stream, take 
small incremental samples of product from the entire length of the moving stream; composite the incremental 
samples to obtain an aggregate sample; if the aggregate samp le is larger than the requ ired laboratory sample(s), 
then blend and subdivide the aggregate sample to obtain the desired size laboratory sample(s). Lot or Sublot 
Weightb
 (T in Tonnes)Minimum Number 
of Incremental 
SamplesMinimum 
Incremental Sample 
Sizec
 (g)Minimum Aggregate 
Sample Size
(kg)
            T<1 10 2000 20
        1≤T<5 25 800 20
        5≤T<10 50 400 20
      10≤T<15 75 267 20
      15≤T 100 200 20CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 23 of 44
   
26. Automatic sampling equipment such as a cross-cut sa mpler is commercially available with timers that 
automatically pass a diverter cup through the moving stream at predetermined and uniform intervals. When 
automatic sampling equipment is not available, a person can be assigned to manually pass a cup through the stream 
at periodic intervals to collect incremental samples. Whether using automatic or manual methods, incremental 
samples should be collected and composited at frequent and uniform intervals throughout the entire time the nuts 
flow past the sampling point. 
27. Cross-cut samplers should be installed in the following manner: (1) the plane of the opening of the diverter cup 
should be perpendicular to the direction of the flow; (2) the diverter cup should pass through the entire cross 
sectional area of the stream; and (3) the opening of the diverter cup should be  wide enough to accept all items of 
interest in the lot. As a general rule, the width of the diverter cup opening should be about two to three times the 
largest dimensions of items in the lot. 
28. The size of the aggregate sample (S) in kg, taken from a lot by a cross cut sampler is: 
Equation 2: S=(D x LT) / (T x V),  
where D is the width of the diverter cup opening (cm), LT is the lot size (kg), T is interval or time between cup movement through the stream (seconds), and V is cup velocity (cm/sec). 
29. If the mass flow rate of the moving stream, MR (kg/sec), is known, then the sampling frequency (SF), or number of cuts made by the automatic sampler cup can be computed from Equation 3 as a function of S, V, D, and MR.  
Equation 3: SF = (S x V) / ( D x MR). 
30. Equations 2 and 3 can also be used to compute other terms of interest such as the time between cuts (T). For 
example, the time (T) required between cuts of the diverter cup to obtain a 20 kg aggregate sample from a 20,000 
kg lot where the diverter cup width is 5.0 cm and the cup velocity through the stream 30 cm/sec. Solving for T in 
Equation 2,  
T = (5.0 cm x 20,000 kg)/(20 kg x 20 cm/sec) = 250 sec.      
31. If the lot is moving at 500 kg per minute, the entire lot will pass through the sampler in 40 minutes (2400 sec) and 
only 9.6 cuts (9 incremental samples) will be made by the cup through the lot (Equation 3). This may be considered 
too infrequent, in that too much product (2,083.3 kg) passes through the sampler between the time the cup cuts 
through the stream.  
Packaging and Transportation of Samples 
 
32. Each laboratory sample shall be placed in a clean, inert container offering adequate protection from contamination, 
sunlight, and against damage in tran sit. All necessary precautions shall be taken to avoid any change in 
composition of the laboratory sample, which might arise during transportation or storage. Samples should be stored 
in a cool dark place. 
Sealing and Labelling of Samples  
33. Each laboratory sample taken for official use shall be s ealed at the place of sampling and identified. A record must 
be kept of each sampling, permitting each lot to be id entified unambiguously and gi ving the date and place of 
sampling together with any additional information likely to be of assistance to the analyst. 
SAMPLE PREPARATION 
Precautions  
34. Sunlight should be excluded as much as possible during sample preparation,  since aflatoxin gradually breaks down 
under the influence of ultra-violet light. Also, envi ronmental temperature and relative humidity should be 
controlled and not favor mold growth and aflatoxin formation. 
Homogenization - Grinding  
35. As the distribution of aflatoxin is extremely non-homogeneous, laboratory samples should be homogenized by 
grinding the entire laboratory sample received by the la boratory.  Homogenization is  a procedure that reduces 
particle size and disperses the contaminated particles evenly throughout the comminuted laboratory sample. 
36. The laboratory sample should be finely ground and mixed thoroughly using a process that approaches as complete 
homogenization as possible. Complete homogenization implies that particle size is extremely small and the 
variability associated with sample preparation (Annex I) ap proaches zero.  After grinding, the grinder should be 
cleaned to prevent aflato xin cross-contamination. CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 24 of 44
   
37. The use of vertical cutter mixer type grinders that mix and comminute the laboratory sample into a paste represent 
a compromise in terms of cost and fineness of grind or particle size reduction6. A better homogenization (finer 
grind), such as a liquid slurry, can be obtained by more sophisticated equipment and should provide the lowest 
sample preparation variance7.  
Test portion  
38. The suggested weight of the test portion taken from the comminuted laboratory sample should be approximately 50 
grams. If the laboratory sample is prepared using a liquid slurry, the slurry should contain 50 g of nut mass. 
39. Procedures for selecting the 50 g test portion from the comminuted laboratory sample should be a random process. 
If mixing occurred during or after the comminution process, the 50 g test portion can be selected from any location 
throughout the co mminuted laboratory sample. Otherwise, the 50  g test portion should be the accumulation of 
several small portions selected throughout the laboratory sample.  
40. It is suggested that three test portions be selected from  each comminuted laboratory sample. The three test portions 
will be used for enforcement, a ppeal, and confirmation if needed. 
ANALYTICAL METHODS 
Background  
41. A criteria-based approach, whereby a set of performance cr iteria is established with which the analytical method 
used should comply, is appropriate. The criteria-based approach has the a dvantage that, by avoiding setting down 
specific details of the method used, developments in methodology can be exploited without having to reconsider or 
modify the specific method. The performance criteria established for methods should include all the parameters that 
need to be addressed by each laboratory such as the dete ction limit, repeatability coefficient of variation (within 
lab), reproducibility coefficient of vari ation (among lab), and the percent reco very necessary for various statutory 
limits. Analytical methods that are accepted by chemis ts internationally (such as AOAC) may be used. These 
methods are regularly monitored and improved depending upon technology. 
Performance Criteria for Methods of Analysis  
42. A list of criteria and performance levels are shown in Table 2. Utilizing this approach, laboratories would be free to 
use the analytical method most appropriate for their facilities.  
Table 2: Specific Requirements with which Methods of Analysis  Should Comply 
 
CriterionConcentration 
Range
(ng/g)Recommended ValueMaximum Permitted 
Value
Blanks All Negligible n/a
1 to 15 70 to 110% n/a
>15 80 to 110% n/a
1 to 120 Equation 4 by Thompson2 x value derived 
from Equation 4
>120 Equation 5 by Horwitz2 x value derived 
from Equation 5
1 to 120Calculated as 0.66 times 
Precision RSD R n/a
>120Calculated as 0.66 times 
Precision RSD r n/aPrecision or Relative Standard Deviation 
RSD R (Reproducibility)
Precision or Relative Standard Deviation RSD
r (Repeatability)Recovery
 
n/a = not applicable 
                                                           
6  Ozay, G., Seyhan, F., Yilmaz, A., Whitaker, T., Slat e, A., and Giesbrecht, F. 2006. Sampling hazelnuts for 
aflatoxin: Uncertainty associated w ith sampling, sample preparation, and analysis. J. Association Official 
Analytical Chemists, Int., 89:1004-1011. 
7  Spanjer, M., Scholten, J., Kastrup, S., Jorissen, U., Schatzki, T., Toyofuku, N. 2006. Sample comminution for 
mycotoxin analysis: Dry milling or slurry mixing?, Food Additives and Contaminants, 23:73-83. CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 25 of 44
   
43. The detection limits of the methods used are not stated. Only the precision values are given at the concentrations of 
interest. The precision values are calculated from equations 4 and 5 developed by Thompson2 and Horwitz and 
Albert8, respectively. 
 
Equation 4:   RSD R = 22.0    (for C ≤ 120 ng/g or c ≤ 120x10-9) 
 
Equation 5:   RSD R  = 2(1-0.5logc)   (for C >120 ng/g or c > 120x10-9)  
where: 
• RSD R = the relative standard deviatio n calculated from results generate d under reproducibility conditions  
• RSD r = the relative standard deviation calculated from  results generated under repeatability conditions = 
0.66RSD R 
• c = the aflatoxin concentration ratio (i.e. 1 = 100g/100g, 0.001 = 1,000 mg/kg) 
• C = aflatoxin concentration or mass of aflatoxin to mass of treenuts (i.e. ng/g) 
44. Equations 4 and 5 are generalized precision equations, which have been found to be independent of analyte and 
matrix but solely dependent on concentration for most routine methods of analysis. 
45. Results should be reported on the edible portion of the sample. 
 
                                                           
8  Horwitz, W. and Albert, R. 2006. The Horwitz ratio (HorRat): A useful index of method performance with 
respect to precision. J. Associ ation of Official An alytical Chemists, Int., 89:1095-1109. CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 26 of 44
   
 Annex I   
Uncertainty, as measured by the varian ce, associated with sampling, sample preparation, and analytical steps of 
the aflatoxin test procedure used to estimate af latoxin in almonds, hazel nuts, and pistachios.  
Sampling data for almonds, hazelnuts, and pistachios were supplied by the United States, Turkey, and Iran, 
respectively.  
Variance estimates and the negative binomial distribution1 were used to compute operating characteristic curves for 
each treenut in Annex II. Sampling, sample preparation, an d analytical variances associ ated with testing almonds, 
hazelnuts, and pistachios are shown in Table 1 below. 
Because of the computational complex ities associated with use of the nega tive binomial distribution to compute 
operational characteristic (OC) curves for various sampling plan designs, the effect of various laboratory sample sizes, 
various numbers of laboratory samples, and various maximum levels on the performance (OC curves) of sampling plan 
designs is provided at the website address http://www5.bae.ncsu.edu/usda/www /ResearchActDocs/treenutwg.html . 
  
Table 1. Variances
a associated with the aflatoxin test procedure for each treenut. 
------------------------------------------------------------------------------------------------------------------------------- ----------------- 
Test Procedure            Almonds    Hazelnuts   Pistachios 
------------------------------------------------------------------------------------------------------------------------------- ----------------- 
Samplingb,c      S2
s = (7,730/ns)5.759C1.561 S2
s = (10,000/ns)4.291C1.609 S2
s = 8,000/ns)7.913C1.475 
 
Sample Prepd     S2
sp = (100/nss)0.170C1.646 S2
sp = (50/nss)0.021C1.545  S2
sp = (25/nss)2.334C1.522  
Analyticale     S2
a = (1/na)0.0484C2.0  S2
a = (1/na)0.0484C2.0  S2
a = (1/na)0.0484C2.0 
 
Total variance      S2
s + S2
sp + S2
a   S2
s + S2
sp + S2
a   S2
s + S2
sp + S2
a  
------------------------------------------------------------------------------------------------------------------------------- ----------------- 
a/ Variance = S2 (s, sp, and a denote sampling, sample preparation, an d analytical steps, respec tively, of aflatoxin test 
procedure) 
b/ ns = laboratory sample size in number of shelled nuts, nss =test portion size in grams, na = number of aliquots 
quantified by HPLC, and C = aflatoxin con centration in ng/g total aflatoxin.  
c/ Shelled nut count/kg for almonds, hazelnuts, and pistachios is 773, 1000, and 1600, respectively. 
d/ Sample preparation for almonds, hazelnuts, and pistachi os reflect Hobart, Robot Coupe , and Marjaan Khatman type 
mills, respectively. Laboratory samples were dry ground into a paste for each treenut. 
e/ Analytical variances reflect FAPAS recommendation for upper limit of analytical reproducibility uncertainty. A 
relative standard deviation of 22% is considered by Thompson2 (based upon FAPAS data) as  an appropriate measure of 
the best agreement that can be obtained between laboratories. An analytical uncertainty of 22 % is larger than the within 
laboratory uncertainty measured in the sa mpling studies for the three treenuts.   
 CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 27 of 44
 
Annex II   
Operating Characteristic Curves describing the perf ormance of draft aflatoxin sampling plans for almonds, 
hazelnuts, and pistachios. 
Treenuts Destined for Further Processing  
Operating Characteristic curve describing  the performance of the aflatoxin samp ling plan for almonds, hazelnuts, and 
pistachios destined for further processing using a single laboratory sample of 20 kg and a maximum level of 15 ng/g for 
total aflatoxins. The operating characteristic curve reflects uncertainty associ ated with a 20 kg laboratory sample of 
shelled nuts for almonds and hazelnuts a nd a 20 kg laboratory sample of inshe ll nuts (about 10kg shelled nuts) for 
pistachios, dry grind with a vertical cutter mixer type mill, 50 g test portion, and quantification of aflatoxin in the test 
portion by HPLC.  
 
0102030405060708090100
0 1 02 03 04 05 06 07 08 0
Lot Aflatoxin Concentration (Total ng/g)Accept Probability (%)  OC Curves for Almonds, Hazelnuts and Pistachios
  Laboratory Sample Size 20 kg
  Dry Grind, 50 g Test Portion
  Analysis, 1 Aliquot, 22% Reproducibility RSD  Maximum Level = 15 ng/g Total AflatoxinMaximum LevelShelled Hazelnuts
Inshell Pistachios (10 kg Shelled)Shelled Almonds
 
 CODEX STAN 193-1995 
Schedule I - Mycotoxins Page 28 of 44
 
Ready-to-Eats Treenuts  
Operating Characteristic curve describing the performance of  the aflatoxin sampling plan for ready-to-eat almonds, 
hazelnuts, and pistachios using two laboratory samples of  10 kg each and a maximum level of 10 ng/g for total 
aflatoxins, dry grind with a vertical cutter mixer type mill, 50  g test portion, and quantifica tion of aflatoxin in the test 
portion by HPLC. 
 
 
 
0102030405060708090100
0 1 02 03 04 05 06 0
Lot Aflatoxin Concentration (Total ng/g)Accept Probability (%)  OC Curves for Almonds, Hazelnuts and Pistachios
  Laboratory Sample Size 2x10 kg
  Dry Grind, 50 g Test Portion
  Analysis, 1 Aliquot, 22% Reproducibility RSD
  Maximum Level = 10 ng/g Total Aflatoxin
Shelled Hazelnuts
Inshell Pistachios (2x5 kg Shelled)Shelled AlmondsMaximum Level
 
 
 
 CODEX STAN 193-1995 
Schedule I – Mycotoxins Page 29 of 44 
 
 
AFLATOXIN M1 
Reference to JECFA: 56 (2001) 
Toxicological guidance: Cancer potency esti mates at specified residue levels (2001, Using worst-case assumptions, the additiona l 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 mil k 
and milk products in comparison with non-consumers of these pr oducts 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.) 
Residue definition: Aflatoxin M1 
Synonyms: AFM1 
Commodity/Product 
Code Name Level ug/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
ML 0106 Milk 0.5  ML   
 
OCHRATOXIN A  
Reference to JECFA: 37 (1990), 44 (1995), 56 (2001), 68 (2007) 
Toxicological guidance: PTWI 0.0001 mg/kg bw (2001) 
Residue definition: Ochratoxin A 
Synonyms: (The term ‘ochratoxins’includes a number of related mycotoxins (A, B, C and their esters and metabolites), the most i mportant one 
being ochratoxin A) 
Related Code of Practice: Code of Practi ce for the Prevention and Reduc tion of Mycotoxin Contamination in Cereals, including An nexes on Ochratoxin A, 
Zearalenone, Fumonisins and Tricothecenes  (CAC/RCP 51-2003) 
Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Wine (CAC/RCP 63-2007) 
 
Commodity/Product 
Code Name Level ug/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
GC 0654 Raw Wheat 5  ML   
GC 0640 Barley 5  ML   
GC 0650 Rye 5  ML   
 CODEX STAN 193-1995 
Schedule I – Mycotoxins Page 30 of 44 
 
PATULIN  
Reference to JECFA: 35 (1989), 44 (1995) 
Toxicological guidance: PMTDI 0.0004 mg/kg bw (1995) 
Residue definition: patulin 
Related Code of Practice: Code of Practi ce for the Prevention and Reduc tion of Patulin Contamination in Apple Juice and Apple J uice Ingredients in Other 
Beverages (CAC/RCP 50-2003) 
Commodity/Product 
Code Name Level ug/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
JF 0226 Apple juice 50  ML  The ML also covers apple juice as  ingredient in other beverages. 
Patulin is a low molecular weight hemiacetal lactone mycotoxin produced by species of the genera Aspergillus, Penicillium and B yssochlamys.  CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 31 of 44 
 
 
ARSENIC  
Reference to JECFA: 5 (1960), 10 (1967), 27 (1983), 33 (1988) 
Toxicological guidance: PTWI 0.015 mg/kg bw (1988, For inorganic arsenic) 
Residue definition: Arsenic: total (As-tot) when not otherwise mentioned; inorganic arsenic (As-in); or other specification 
Synonyms: As 
Related Code of Practice: Code of Practice for Source Directed Measures to Reduce Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
 Edible fats and oils 0.1  ML CS 19-1981 Edible fats and oils not covered by individual standards 
 Margarine 0.1  ML CS 32-1981  
 Minarine 0.1  ML CS 135-1981  
 Named animal fats 0.1  ML CS 211-1999 Lard, rendered pork fat, premier jus and edible tallow. 
OR 0305 Olive oil, refined 0.1  ML CS 33-1981  
OC 0305 Olive oil, virgin 0.1  ML CS 33-1981  
OR 5330 Olive, residue oil 0.1  ML CS 33-1981 Olive pomace oil 
OC 0172 Vegetable oils, Crude 0.1  ML CS 210-1999 Named vegeable oils from arachis, babassu, coconut, cottonseed, grapeseed, 
maize, mustardseed, palm kernel, palm, rapeseed, safflowerseed, 
sesameseed, soya bean, and sunflowerseed, and palm olein, stearin and 
superolein. 
OR 0172 Vegetable oils, Edible 0.1  ML CS 210-1999 Named vegeable oils from arachis, babassu, coconut, cottonseed, grapeseed, 
maize, mustardseed, palm kernel, palm, rapeseed, safflowerseed, 
sesameseed, soya bean, and sunflowerseed, and palm olein, stearin and 
superolein. 
 Natural mineral waters 0.01  ML CS 108-1981 Expressed in total As mg/l 
 Salt, food grade 0.5  ML CS 150-1985  
Arsenic is a metalloid element which is normally occurring in mineral bound form in the earth's crust and which can become more  easily available by natural sources such as 
volcanic activity and weathering of minerals, and by anthropogenic  activity causing emissions in the environment, such as ore s melting, burning of coal and specific uses, such as 
arsenic-based wood preservatives, pesticides or veterinary or human medicinal drugs.  As a result of naturally occurring metabo lic processes in the biosphere arsenic occurs as a 
large number of organic or inorganic chemical forms in food (speci es).  Especially in the marine environment arsenic is often f ound in high concentrations of organic forms, up to 
50 mg/kg of arsenic on a wet weight basis in some seafood including s eaweed, fish, shellfish and crustaceans.  In fresh water a nd in the terrestrial environments arsenic is normally 
found in much lower levels (typically 0-20 ug/kg) in crop plants and in livestock.  Higher levels may be found in rice, mushroo ms and sometimes in poultry which is fed fish meal 
containing arsenic. The most toxic forms of arsenic are the inorganic arsenic (III) and (V) compounds; the inorganic arsenic tr ioxide is well known as a rat poison, which was also 
sometimes used for homicide. Methylated forms of arsenic have a low acute toxicity; arsenobetaine  which is the principal arseni c form in fish and crustaceans is considered non-
toxic. In shellfish, molluscs and seaweed dimethylarsinylriboside derivatives occur ("arsenosugars"), the possible toxicity of which is not known in detail. Only a few percent of the 
total arsenic in fish is present in inorganic form, which is the only form about which a PTWI has been developed by JECFA. The human epidemiological data used for this risk CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 32 of 44 
 
assessment is based on exposure to inorganic arsenic in drinking water. IARC has classified inorganic arsenic as a human carcin ogen, and the estimated lifetime risk for arsenic-
induced skin cancer which may be caused by drinking water at or in excess of the WHO guideline for arsenic in drinking water is  estimated at 6x 10-4.  
 
CADMIUM  
Reference to JECFA: 16 (1972), 33 (1988), 41 (1993), 55 (2000), 61 (2003), 64 (2005) 
Toxicological guidance: PTWI 0.007 mg/kg bw (1988 (maintained in 2000 & 2003), The 64th JECFA concluded that the effect of diff erent MLs on overall 
intake of cadmium would be very small.  At the proposed Codex MLs, mean intake of cadmium would be reduced by 
approximately 1% of the PTWI.  The imposition of MLs one level lower would result in potential reductions in intake of cadmium 
of no more than 6% (wheat grain, potatoes) of the PTWI.  At the proposed Codex MLs, no more than 9% of a commodity would be violative (oysters).  MLs one level below those proposed would result in approximately 25% of molluscs, potatoes, and other 
vegetables being violative.) 
Residue definition: Cadmium, total 
Synonyms: Cd 
Related Code of Practice: Code of Practice for Source Directed Measures to Reduce Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
VB 0040 Brassica vegetables 0.05  ML   
VA 0035 Bulb vegetables 0.05  ML   
VC 0045 Fruiting vegetables, cucurbits 0.05  ML   
VO 0050 Fruiting vegetables, other than cucurbits  0.05  ML  Excluding tomatoes and edible fungi. 
VL 0053 Leafy vegetables 0.2  ML   
VP 0060 Legume vegetables 0.1  ML   
VR 0589 Potato 0.1  ML  Peeled 
VD 0070 Pulses 0.1  ML  Excluding soya bean (dry)  
VR 0075 Root and tuber vegetables 0.1  ML  Excluding potato and celeriac 
VS 0078 Stalk and stem vegetables 0.1  ML   
GC 0081 Cereal grains, except buckwheat, cañihua 
and quinoa 0.1  ML  Excluding wheat and rice; and bran and germ 
CM 0649 Rice, polished 0.4  ML   
GC 0654 Wheat 0.2  ML   
IM 0151 Marine bivalve molluscs 2  ML  Excluding oysters and scallops 
IM 0152 Cephalopods 2  ML  Without viscera 
 Natural mineral waters 0.003  ML CS 108-1981 Expressed in mg/l 
 Salt, food grade 0.5  ML CS 150-1985  CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 33 of 44 
 
Cadmium is a relatively rare element, released to the air, land , and water by human activities. In general, the two major sourc es of contamination are the production and utilization of 
cadmium and the disposal of wastes containing cadmium. Increases  in soil cadmium content will result in an increase in the upta ke of cadmium by plants; the pathway of human 
exposure from agricultural crops is thus susceptible to increases in soil cadmium. The cadmium uptake by plants from soil is gr eater at low soil pH. Edible free-living food organisms 
such as shellfish, crustaceans, and fungi are natural accumulators of ca dmium. Similar to humans, there are increased levels of  cadmium in the liver and kidney of horses and some 
feral terrestrial animals. Regular consumption of these items can  result in increased exposure. To bacco is an important source of cadmium uptake in smokers. (Environmental health 
criteria for cadmium; International Programme on Chemical Safety (IPCS); 1992) 
 
LEAD 
Reference to JECFA: 10 (1966), 16 (1972), 22 (1978), 30 (1986), 41 (1993), 53 (1999) 
Toxicological guidance: PTWI 0.025 mg/kg bw (1987 for infants and young children, extended to all age groups in 1993,  maintain ed 1999) 
Residue definition: Lead, total 
Synonyms: Pb 
Related Code of Practice: Code of Practice for the Prevention and Reduction of Lead Contamination in Foods (CAC/RCP 56-2004) 
Code of Practice for Source Directed M easures to Reduce Contamination of Fo ods with Chemicals (CAC/RCP 49-2001) 
Commodity/Product 
Code Name Level 
mg/kgSuffix Type Reference Notes/Remarks  
for Codex Alimentarius 
FT 0026 Assorted (sub)tropical fruits, edible 
peel 0.1   ML   
FI 0030 Assorted (sub)tropical fruits, inedible 
peel 0.1   ML   
FB 0018 Berries and other small fruits 0.2   ML   
FC 0001 Citrus fruits 0.1   ML   
FP 0009 Pome fruits 0.1   ML   
FS 0012 Stone fruits 0.1   ML   
VB 0040 Brassica vegetables 0.3   ML  Excluding kale 
VA 0035 Bulb vegetables 0.1   ML   
VC 0045 Fruiting vegetables, Cucurbits 0.1   ML   
VO 0050 Fruiting vegetables, other than 
Cucurbits 0.1   ML  Excluding mushrooms 
VL 0053 Leafy vegetables 0.3   ML  Including Brassica leafy veget ables but excluding spinach. 
VP 0060 Legume vegetables 0.2   ML   
VD 0070 Pulses 0.2   ML   
VR 0075 Root and tuber vegetables 0.1   ML  Including peeled potatoes 
 Canned fruit cocktail 1   ML CS 78-1981  
 Canned grapefruit 1   ML CS 15-1981  
 Canned mandarin oranges 1   ML CS 68-1981  
 Canned mangoes 1   ML CS 159-1987  CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 34 of 44 
 
Commodity/Product 
Code Name Level 
mg/kgSuffix Type Reference Notes/Remarks  
for Codex Alimentarius 
 Canned pineapple 1   ML CS 42-1981  
 Canned raspberries 1   ML CS 60-1981  
 Canned strawberries 1   ML CS 62-1981  
 Canned tropical fruit salad 1   ML CS 99-1981  
 Jams (fruit preserves) and jellies 1   ML CS 79-1981  
 Mango chutney 1   ML CS 160-1987  
 Table olives 1   ML CS 66-1981  
 Canned asparagus 1   ML CS 56-1981  
 Canned carrots 1   ML CS 116-1981  
 Canned green beans and canned wax 
beans 1   ML CS 16-1981  
 Canned green peas 1   ML CS 58-1981  
 Canned mature processed peas 1   ML CS 81-1981  
 Canned mushrooms 1   ML CS 55-1981  
 Canned palmito 1   ML CS 144-
1985  
 Canned sweet corn 1   ML CS 18-1981  
 Canned tomatoes 1   ML CS 13-1981  
 Pickled cucumbers (cucumber pickles) 1   ML CS 115-
1981  
 Processed tomato concentrates 1.5   ML CS 57-1981  
JF 0175 Fruit juices 0.05   ML  Including nectars; Ready to drink 
GC 0081 Cereal grains, except buckwheat, 
cañihua and quinoa 0.2   ML   
 Canned chestnuts and canned 
chestnuts puree 1   ML CS 145-
1985  
MM 0097 Meat of cattle, pigs and sheep 0.1   ML  Also applies to the fat from meat 
PM 0110 Poultry meat 0.1   ML   
MO 0812 Cattle, Edible offal of 0.5   ML   
MO 0818 Pig, Edible offal of 0.5   ML   
PO 0111 Poultry, Edible offal of 0.5   ML   
 Edible fats and oils 0.1   ML CS 19-1981 Edible fats and oils not covered by individual standards 
 Fish 0.3  ML   
 Margarine 0.1   ML CS 32-1981  
 Minarine 0.1   ML CS 135-
1981  
 Named animal fats 0.1   ML CS 211-
1999 Lard, rendered pork fat, premier jus and edible tallow. CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 35 of 44 
 
Commodity/Product 
Code Name Level 
mg/kgSuffix Type Reference Notes/Remarks  
for Codex Alimentarius 
OR 0305 Olive oil, refined 0.1   ML CS 33-1981  
OC 0305 Olive oil, virgin 0.1   ML CS 33-1981  
OR 5330 Olive, residue oil 0.1   ML CS 33-1981 Olive pomace oil 
PF 0111 Poultry fats 0.1   ML   
OC 0172 Vegetable oils, Crude 0.1   ML CS 210-
1999 Oils of arachis, babasu, coconut, cottonseed, grapeseed, maize, mustardseed, palm kernel, 
palm, rapeseed, saflowerseed, sesameseed, soya bean, and sunflowerseed, and palm olein, 
stearin and superolein and other oils but excluding cocoa butter. 
OR 0172 Vegetable oils, Edible 0.1   ML CS 210-
1999 Oils of arachis, babasu, coconut, cottonseed, grapeseed, maize, mustardseed, palm kernel, 
palm, rapeseed, saflowerseed, sesameseed, soya bean, and sunflowerseed, and palm olein, 
stearin and superolein and other oils but excluding cocoa butter. 
ML 0106 Milks 0.02   ML  A concentration factor applies to partially or wholly dehydrated milks. 
LS Secondary milk products 0.02   ML  As consumed 
 Natural mineral waters 0.01   ML CS 108-
1981 Expressed in mg/l 
 Infant formula 0.02   ML  Ready to use 
 Salt, food grade 2   ML CS 150-
1985  
 Wine 0.2   ML   
 
MERCURY  
Reference to JECFA: 10 (1966), 14 (1970), 16 (1972), 22 (1978) 
Toxicological guidance: PTWI 0.005 mg/kg bw (1978) 
Residue definition: Mercury, Total 
Synonyms: Hg 
Related Code of Practice: Code of Practice for Source Directed Measures to Reduce Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
 Natural mineral waters 0.001  ML CS 108-1981 Expressed in mg/l 
 Salt, food grade 0.1  ML CS 150-1985  
Mercury is a naturally occurring metallic element which can be pres ent in foodstuffs by natural causes; elevated levels can als o occur due to e.g. environmental contamination by 
industrial or other uses of mercury.  Methylmercury and also total mercury levels in terrestrial animals and plants are usually  very low; the use of fish  meal as animal feed can 
however also lead to higher methyl mercury levels in other animal products. 
 CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 36 of 44 
 
METHYLMERCURY  
Reference to JECFA: 22 (1978), 33 (1988), 53 (1999), 61 (2003) 
Toxicological guidance: PTWI 0.0016 mg/kg bw (2003) 
Residue definition: Methylmercury 
Related Code of Practice: Code of Practice for Source Directed Measures to Reduce Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
 Fish 0.5  GL  Except predatory fish The Guideline levels are intended for meth ylmercury in fresh or processed fish 
and fish products moving in international trade.  
 Predatory fish 1  GL  Predatory fish such as shark (WS 0131) , swordfish, tuna (WS 0132), pike (WF 
0865) and others. The Guideline level for methylmercury in fresh or processed fish and fish 
products moving in international trade.  
Lots should be considered as being in compliance with the guide line levels if the level of methylmercury in the analytical samp le, derived from the composite bulk sample, does not 
exceed the above levels.  Where these Guide line levels are exceeded, governments should  decide whether and under what circumsta nces, the food should be distributed within their 
territory or jurisdiction and what recommendations, if any, should be given as regards restrictions on consumption, especially by vulnerable groups such as pregnant women. 
Methylmercury is the most toxic form of mercury and is formed in aquatic environments. Methylme rcury therefore is found mainly in aquatic organisms. It can accumulate in the 
food chain; the levels in large predatory fish species are therefore higher than in ot her species and fish is the predominant s ource of human exposure to methylmercury. 
Methylmercury and also total mercury levels in terrestrial animals and plants are usually very low;  the use of fish meal as ani mal feed can however also lead to higher methyl 
mercury levels in other animal products.  
 
TIN 
Reference to JECFA: 10 (1966), 14 (1970), 15 (1971), 19 (1 975), 22 (1978), 26(1982), 33(1988), 55 (2000), 64 (2005) 
Toxicological guidance: PTWI 14 mg/kg bw (1988, Expressed as Sn ; includes tin from food additive uses; maintained in 2000.) 
Residue definition: Tin, total (Sn-tot) when not otherwise mentioned; inorganic tin (Sn-in); or other specification 
Synonyms: Sn 
Related Code of Practice: Code of Practice for the Prevention and Reduction of Inorganic Tin Contamination in Canned Foods (CAC /RCP 60-2005) 
Code of Practice for Source Directed M easures to Reduce Contamination of Fo ods with Chemicals (CAC/RCP 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
 Canned foods (other than beverages) 250 C ML   
 Canned beverages 150 C ML   
 Canned fruit cocktail 250 C ML CS 78-1981  CODEX STAN 193-1995 
Schedule I –Heavy Metals Page 37 of 44 
 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
 Canned grapefruit 250 C ML CS 15-1981  
 Canned mandarin oranges 250 C ML CS 68-1981  
 Canned mangoes 250 C ML CS 159-1987  
 Canned pineapple 250 C ML CS 42-1981  
 Canned raspberries 250 C ML CS 60-1981  
 Canned strawberries 200 C ML CS 62-1981  
 Canned tropical fruit salad 250 C ML CS 99-1981  
 Jams (fruit preserves) and jellies 250 C ML CS 79-1981  
 Mango chutney 250 C ML CS 160-1987  
 Table olives 250 C ML CS 66-1981  
 Canned asparagus 250 C ML CS 56-1981  
 Canned carrots 250 C ML CS 116-1981  
 Canned green and wax beans 250 C ML CS 16-1981  
 Canned green peas 250 C ML CS 58-1981  
 Canned mature processed peas 250 C ML CS 81-1981  
 Canned mushrooms 250 C ML CS 55-1981  
 Canned palmito 250 C ML CS 144-1985  
 Canned sweet corn 250 C ML CS 18-1981  
 Canned tomatoes 250 C ML CS 13-1981  
 Pickled cucumber 250 C ML CS 115-1981  
 Processed tomato concentrates 250 C ML CS 57-1981  
 Canned chestnuts and chestnut purée 250 C ML CS 145-1985  
 Cooked cured chopped meat 200 C ML CS 98-1981 For products in tinplate containers 
 Cooked cured chopped meat 50  ML CS 98-1981 For products in other containers 
 Cooked cured ham 50  ML CS 96-1981 For products in other containers 
 Cooked cured ham 200 C ML CS 96-1981 For products in tinplate containers 
 Cooked cured pork shoulder 50  ML CS 97-1981 For products in other containers 
 Cooked cured pork shoulder 200 C ML CS 97-1981 For products in tinplate containers 
 Corned beef 50  ML CS 88-1981 For products in other containers 
 Corned beef 200 C ML CS 88-1981 For products in tinplate containers 
 Luncheon meat 200 C ML CS 89-1981 For products in tinplate containers 
 Luncheon meat 50  ML CS 89-1981 For products in other containers 
Tin is mainly used in tinplated containers, but it is also extensively used in solders, in alloys including dental amalgams. In organic tin compounds, in which the element may be 
present in the oxidation states of +2 or +4, are used in a variet y of industrial processes for the strengthening of glass, as a  base for colours, as catalysts, as stabilizers in perfumes and 
soaps, and as dental anticariogenic agents. On the whole, contamination of the environment by tin is only slight. Food is the m ain source of tin for man. Small amounts are found in 
fresh meat, cereals, and vegetables. Larger amounts of tin may be found in foods stored in plain cans and, occasionally, in foo ds stored in lacquered cans. Some foods such as 
asparagus, tomatoes, fruits, and their juices tend to contain high  concentrations of tin if stored in unlaquered cans (Environm ental health criteria for tin; International Programme on CODEX STAN 193-1995 
Schedule I – Radionuclides Page 38 of 44 
 
Chemical Safety (IPCS); 1980). Inorganic tin is found in food in the +2 and +4 oxidation states; it may occur in a cationic for m (stannous and stannic compounds) or as inorganic 
anions (stannites or stannates).  
R
ADIONUCLIDES  
 
Commodity 
Code Product Name Representative radionuclides Dose per unit intake factor in 
Sv/Bq Level in 
Bq/kg Type Reference Notes/Remarks for Codex Alimentarius 
        
 Infant foods* 238Pu, 239Pu, 240Pu, 241Am  1 GL   
 Infant foods * 90Sr, 106Ru, 129I, 131I, 235U  100 GL   
 Infant foods * 35S**, 60Co, 89Sr, 103Ru, 134Cs, 
137Cs, 144Ce, 192Ir  1000 GL   
 Infant foods * 3H***, 14C, 99Tc  1000 GL   
 Foods other than infant foods  238Pu, 239Pu, 240Pu, 241Am  10 GL   
 Foods other than infant foods 90Sr, 106Ru, 129I, 131I, 235U  100 GL   
 Foods other than infant foods 35S**, 60Co, 89Sr, 103Ru, 134Cs, 
137Cs, 144Ce, 192Ir  1000 GL   
 Foods other than infant foods 3H***, 14C, 99Tc  10000 GL   
* When intended for use as such. 
** 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, whi ch have been contam inated following a 
nuclear or radiological emergency1. 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 c orresponding Guideline Levels, the food 
should be considered as safe for human consumption. When the Guideline Levels are exceeded, nati onal governments shall decide w hether and under what circumstances the food 
should be distributed within their territory or jurisdiction. Na tional governments may wish to adopt different values for inter nal 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, that represent a sm all percentage of total diet and hence a small addition to the  total dose, the Guideline Levels may be increased by a 
factor of 10. 
                                                           
1  For the purposes of this document, the term “eme rgency” includes both accide nts and malevolent actions. CODEX STAN 193-1995 
Schedule I – Radionuclides Page 39 of 44 
 
Radionuclides:  The Guideline Levels do not include all radionuclides. Radionuclides included are those important for uptake into the food cha in; are usually contained in nuclear 
installations or used as a radiation source in large enough qu antities to be significant potential contributors to levels in fo ods, 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 f rom consideration in this document. 
In the Table, the radionuclides are grouped according to the guid eline levels rounded logarithmically by orders of magnitude. G uideline 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 probl em.  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 tak en from the "International Basic Safety Standards" 
(IAEA, 1996)2. 
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 sho uld be added together3.  
 
Annex 1 
SCIENTIFIC JUSTIFICATION FOR PROPOSED DRAFT REVISED GUIDELINE LEVELS FOR RADIONUCLIDES IN FOODS CONTAMINATED FOLLOWING 
A NUCLEAR OR RADIOLOGICAL EMERGENCY 
The proposed draft revised Guideline Levels for Radionuclides in Foods and specifically the values presented in Table 1 above a re based on the following general radiological 
considerations and experience of application of the existing in ternational and national standard s for control of radionuclides in food.  
Significant improvements in the assessment of radiation doses resu lting from the human intake of radioactive substances have be come available since the Guideline Levels were 
issued by the Codex Alimentarius Commission in 19894 (CAC/GL 5-1989). 
Infants and adults:  The levels of human exposure resulting from consumption of foods containing radionuclides listed in Table 1 at the suggested g uideline levels have been 
assessed both for infants and adults and checked fo r compliance with the appr opriate dose criterion.   
                                                           
2  Food and Agriculture Organization of the United Nations, International Atomic Energy Agency, International Labour Office, OEC D Nuclear Energy Agency, Pan American Health Organization, 
World Health Organization (1996) Internatio nal Basic Safety Standards for Protection against Ionizing Radiation and for the Saf ety of Radiation S ources, IAEA, Vienna. 
3  For example, if 134Cs and 137Cs are contaminants in food, the guideline level of 1000 Bq/ kg refers to the summed activit y of both these radionuclides. 
4  The Codex Alimentarius Commission at its 18th Session (Geneva 1989) adopted Guideline Levels for Radionuclides in Foods Follo wing Accidental Nuclear Contamination for Use in 
International Trade (CAC/GL 5-1989) applicable for six radionuclides (90Sr, 131I, 137Cs, 134Cs, 239Pu and 241Am) during one year afte r the nuclear accident. CODEX STAN 193-1995 
Schedule I – Radionuclides Page 40 of 44 
 
In order to assess public exposure and the associated health risks from intake of radionuclides in food, estimates of food cons umption rates and ingestion dose coefficients are 
needed. According to Ref. (WHO, 1988) 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 (F. Luykx, 19905; US DoH, 19986; NRPB, 20037). 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 fro m the gastro-intestinal tract 
and retained in body tissues, are taken from the (IAEA, 1996). 
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 Co mmission on Radiological Protection as safe for 
members of the public (ICRP, 1999)8. 
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 f rom these radionuclides when naturally present in the 
diet are unamenable to control; the resources that would be requ ired to affect exposures would be out of proportion to the bene fits 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 nuclea r or radiological 
emergency it might be difficult to readily replace foods imported from contaminated re gions with foods imported from unaffected  areas. According to FAO statistical data the mean 
fraction of major foodstuff quantities imported by all the countries worldwide is 0.1. The values in Table 1 as regards foods c onsumed by infants and the general population have 
been derived to ensure that if a country continues to import major foods from areas contaminated with radionuclides, the mean a nnual internal dose of its inhabitants will not exceed 
around 1 mSv (see Annex 2). This conclusion might not apply for some radionuclides if the fraction of contaminated food is foun d to be higher than 0.1, as might be the case for 
infants who have a diet essentially based on milk with little variety.  
Long-term exposure assessment: Beyond one year after the emergency the fraction of contaminated food placed on the market will generally decrease as a result of national 
restrictions (withdrawal from the ma rket), changes to other produce, agricultural co untermeasures and decay. 
Experience has shown that in the long term the fraction of importe d contaminated food will decrease  by a factor of a hundred or  more. Specific food categories, e.g. wild forest 
products, may show persistent or even increasing levels of contamination. Other categories of food may gradually be exempted fr om controls. Nevertheless, it must be anticipated 
that it may take many years before levels of individual exposure  as a result of contaminated food could be qualified as negligi ble.  
                                                           
5  F. Luykx (1990) Response of the European Communities to environm ental contamination following the Chernobyl accident. In: Envir onmental Contamination Following a Major Nuclear 
Accident, IAEA, Vienna, v.2, 269-287. 
6  US DoHHS (1998) Accidental Radioactiv e Contamination of Human Food and Animal F eeds: Recommendations for State and Local Agen cies. Food and Drug Administration, Rockville. 
7  K. Smith and A. Jones (2003) Generalised Habit Da ta for Radiological Assessments. NRPB Report W41. 
8  International Commission on Ra diological Protection (1999). Principles for the Pr otection of the Public in Situations of Prol onged Exposure. ICRP Publicati on 82, Annals of the ICRP.  CODEX STAN 193-1995 
Schedule I – Radionuclides Page 41 of 44 
 
Annex 2 
ASSESSMENT OF HUMAN INTERNAL EXPOSURE WHEN THE GUIDELINE LEVELS ARE APPLIED 
For the purpose of assessment of the mean public exposure level in a country caused by the import of food products from foreign  areas with residual radioactivity, in implementing 
the present guideline levels the following data should be used: annual food consumption rates for infants and adults, radionucl ide- and age-dependent ingestion dose coefficients and 
the import/production factors. When assessing the mean internal do se in infants and adults it is suggested that due to monitori ng 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 f oodstuffs imported from foreign areas with residual 
radioactivity are contaminated with radionuclides 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 b e 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)  
eing(A) is the age-dependent ingestion dose coefficient (mSv/Bq) 
IPF is the import/production factor9 (dimensionless). 
Assessment results presented in Table 2 both for infants and adu lts demonstrate that for all the twenty radionuclides doses fro m consumption of imported foods during the 1st year 
after major radioactive contamination do no t exceed 1 mSv. It should be noted that the doses were calculated on the basis 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 esti mate 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 wh ereas this is valid mainly during sucklin g period recently estimated by ICRP to be as average first 
six months of life (ICRP, 200510). For the subsequent six months of the first year of life the gut  absorption factors are much lower. This is not the case for 3H, 14C, 35S, iodine and 
caesium isotopes. 
As an example, dose assessment for 137Cs in foods is presented below for the first year  after the area contamination with this nuclide. 
For adults: E = 1000 Bq /kg ·550 kg ·1.3·10-5 mSv/Bq ·0.1 = 0.7 mSv;  
For infants: E = 1000 Bq/kg ·200 kg ·2.1·10-5 mSv/Bq ·0.1 = 0.4 mSv  
                                                           
9  The import/production factor ( IPF) is defined as the ratio of the amount of foodstuffs imported per year from areas contaminated with radionuclides to the total  amount 
produced and imported annually in the region or country under consideration. 
10  International Commission on Radiological Protection (2005) Doses to Infants from Radionuclides Ingested in Mothers Milk. To b e published. CODEX STAN 193-1995 
Schedule I – Radionuclides Page 42 of 44 
 
TABLE 2 
ASSESSMENT OF EFFECTIVE DOSE FOR INFANTS AND ADU LTS FROM INGESTION OF IMPORTED FOODS IN A YEAR 
Guideline Level (Bq/kg) Effective dose (mSv) 
1st year after major 
contamination  
 
Radionuclide 
  Infant foods  Other foods 
Infants Adults 
238Pu 0.08 0.1 
239Pu 0.08 0.1 
240Pu 0.08 0.1 
241Am  
1  
10 
0.07 0.1 
90Sr 0.5 0.2 
106Ru 0.2 0.04 
129I 0.4 0.6 
131I 0.4 0.1 
235U   
100   
100 
 
 0.7 0.3 
35S* 0.2 0.04 
60Co 1 0.2 
89Sr 0.7 0.1 
103Ru 0.1 0.04 
134Cs 0.5 1 
137Cs 0.4 0.7 
144Ce 1 0.3 
192Ir   
 
1000  
 
 
1000 
0.3 0.08 
3H** 0.002 0.02 
14C 0.03 0.3 
99Tc  
1000  
10000 
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 “Assessment of human internal exposure when the G uideline Levels are applied” (Annex 2).CODEX STAN 193-1995 
Schedule I - Others Page 43 of 44 
 
ACRYLONITRILE  
Reference to JECFA: 28 (1984) 
Toxicological guidance: 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.) 
Residue 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 Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
 Food 0.02  GL   
Acrylonitrile monomer is the starting substance for the manufacture of polymers which are used as fibres, resins, rubbers and a lso as packaging material for o.a. foods.  Acrylonitrile 
is not known to occur as a natural product. Acrylonitrile is cl assified by IARC as possibly carci nogenic to humans (Group 2B). Polymers derived from acrylonitrile may still contain 
small amounts of free monomer.  
 
CHLOROPROPANOLS  
Reference to JECFA: 41 (1993; for 1,3-dichloro-2-propanol only), 57 (2001), 67 (2006) 
Toxicological guidance: PMTDI 0.002 mg/kg bw (2001, for 3-chloro-1,2-propanediol); maintained in 2006.  Establishment of tolera ble 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 (for 1,3-dichloro-2-propanol); MOE, 65000 (general population), 2400 (high level intake, 
including young children) 
Residue definition: 3-MCPD 
Synonyms: Two substances are the most important members of this group: 3-monochloropropane-1,2-diol (3-MCPD, also referred to a s 3-
monochloro-1,2-propanediol) and 1,3-dichloro-2-propanol (1,3-DCP) 
Related Code of Practice: Code of Practice for the Reduction of 3-Monochloropropane-1,2-diol (3-MCPD) during the production of Acid-Hydrolyzed 
Vegetable Proteins (Acid-HVPs) and Products that Contain Acid-HVPs (CAC/RCP 64 – 2008) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
 Liquid condiments containing acid-
hydrolyzed vegetable proteins (excluding 
naturally fermented soy sauce) 0.4  ML   
 CODEX STAN 193-1995 
Schedule I - Others Page 44 of 44 
 
DIOXINS  
Reference to JECFA: 57 (2001) 
Toxicological guidance: PTMI 70 pg TEQ/kg bw (2001, Including coplanar PCBs) 
Synonyms: Polychlorinated dibenzo-dioxins and -furans  
Related Code of Practice: Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-like PCB Contamination in Food  and Feeds (CAC/RCP 
62-2006); Code of Practice for Source Dir ected Measures to Reduce Contamination of  Foods with Chemicals (CAC/RCP 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
NO ML       
 
VINYL CHLORIDE MONOMER  
Reference to JECFA: 28 (1984) 
Toxicological guidance: Provisional Acceptance (1984, the use of food-contact materials from which vinyl chloride may migrate i s provisionally accepted, 
on condition that the amount of the substance migrating into food is reduced to the lowest level technologically  
Residue definition: Vinylchloride monomer 
Synonyms: Monochloroethene, chloroethylene; abbreviation VC or VCM 
Related Code of Practice: Code of Practice for Source Directed Measures to Reduce Cont amination of Foods with Chemicals (CAC/RC P 49-2001) 
Commodity/Product 
Code Name Level 
mg/kg Suffix Type Reference Notes/Remarks  
for Codex Alimentarius 
       
 Food 0.01  GL  The GL in food packaging material is 1.0 mg/kg. 
Vinylchloride monomer is the main starting substance for the manufacture of polymers which are used as resins, as packaging mat erial for foods.  Vinyl chloride is not known to 
occur as a natural product. Residues of VCM may be still present in the polymer. Vinyl chloride is considered by IARC to be a h uman carcinogen (as has been shown in occupational 
exposure situations).