(CODEX) Contaminant Standard - 2018
(CODEX) Contaminant Standard - 2018
(CODEX) Contaminant Standard - 2018
CXS 193-1995
Adopted in 1995
Revised in 1997, 2006, 2008, 2009
Amended in 2010, 2012, 2013, 2014, 2015, 2016, 2017, 2018
CXS 193-1995 2
1.1 SCOPE
This Standard contains the main principles which are recommended by the Codex Alimentarius in
dealing with contaminants and toxins in food and feed, and lists the maximum levels and associated
sampling plans of contaminants and natural toxicants in food and feed which are recommended by the
Codex Alimentarius Commission (CAC) to be applied to commodities moving in international trade.
This Standard includes only maximum levels of contaminants and natural toxicants in feed in cases
where the contaminant in feed can be transferred to food of animal origin and can be relevant for public
health.
1.2 DEFINITION OF TERMS
1.2.1 General
The definitions for the purpose of the Codex Alimentarius, as mentioned in the Procedural Manual of
the Codex Alimentarius Commission, are applicable to the General Standard for Contaminants and
Toxins in Food and Feed (GSCTFF) and only the most important ones are repeated here. Some new
definitions are introduced, where this seems warranted to obtain optimal clarity. When reference is made
to foods, this also applies to animal feed, in those cases where this is appropriate.
1.2.2 Contaminant
Codex Alimentarius defines a contaminant as follows:
“Any substance not intentionally added to food or feed for food producing animals, which is present in
such food or feed as a result of the production (including operations carried out in crop husbandry,
animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing,
packaging, transport or holding of such food or feed, or as a result of environmental contamination. The
term does not include insect fragments, rodent hairs and other extraneous matter”.
This Standard applies to any substance that meets the terms of the Codex definition for a contaminant,
including contaminants in feed for food-producing animals, except:
1) Contaminants having only food and feed quality significance (e.g. copper), but no public
health significance, in the food(s) given that the standards elaborated within the Committee
on Contaminants in Foods (CCCF) has the objective to protect public health.
2) Pesticide residues, as defined by the Codex definition that are within the terms of reference
of the Committee on Pesticide Residues (CCPR).
3) Residues of veterinary drugs, as defined by the Codex definition, and residues of feed
additives (*), that are within the terms of reference of the 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 Committee on Food Hygiene
(CCFH).
5) Residues of processing aids that are within the terms of reference of the Committee on Food
Additives (CCFA) (**).
(*) Feed additives as defined in the Code of Practice on Good Animal Feeding (CXC 54-2004): “Any
intentionally added ingredient not normally consumed as feed by itself, whether or not it has nutritional
value, which affects the characteristics of feed or animal products.
Residues of feed additives include the parent compounds and/or their metabolites in any edible portion
of the animal product, and include residues of associated impurities of the feed additive concerned.
(**) 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.
1.2.3 Natural toxins included in this Standard
The Codex definition of a contaminant implicitly includes naturally occurring toxicants including toxic
metabolites of certain microfungi that are not intentionally added to food and feed (mycotoxins).
Toxins that are produced by algae and that may be accumulated in edible aquatic organisms such as
shellfish (phycotoxins) are also included in this Standard. Mycotoxins and phycotoxins are both
subclasses of contaminants.
CXS 193-1995 3
Endogenous natural toxicants, such as e.g. solanine in potatoes, that are implicit constituents of food
and feed resulting from a genus, species or strain ordinarily producing hazardous levels of a toxic
metabolite(s), i.e. phytotoxins are not generally considered within the scope of this Standard. They are,
however, within the terms of reference of CCCF and will be dealt with on a case-by-case basis.
1.2.4 Maximum level and related terms 1
The Codex maximum level (ML) for a contaminant in a food or feed commodity is the maximum
concentration of that substance recommended by the Codex Alimentarius Commission to be legally
permitted in that commodity.
1.3 PRINCIPLES REGARDING CONTAMINANTS IN FOOD AND FEED
1.3.1 General
Contamination of food and feed may pose a risk to human (and/or animal health). Moreover in some
cases they may also have a negative impact on the quality of the food or feed. Food and feed can
become contaminated by various causes and processes.
Contaminant levels in food and feed shall be as low as reasonably achievable through best practice
such as Good Agricultural Practice (GAP) and Good Manufacturing Practice (GMP) following an
appropriate risk assessment. The following actions may serve to prevent or to reduce contamination of
feed and food 2:
• Preventing food and feed contamination at the source, e.g. by reducing environmental
pollution.
• Applying appropriate technology control measure(s) in food and feed production,
manufacture, processing, preparation, treatment, packing, packaging, transport or holding.
• Applying measures aimed at decontamination of contaminated feed or food and measures
to prevent contaminated feed or food to be marketed for consumption.
To ensure that adequate action is taken to reduce contamination of food and feed a Code of Practice
shall be elaborated comprising source related measures and Good Manufacturing Practice as well as
Good Agricultural Practice in relation to the specific contamination problem.
The degree of contamination of food and feed and the effect of actions to reduce contamination shall be
assessed by monitoring, survey programs and more specialized research programs, where necessary.
When there are indications that health hazards may be involved with consumption of food that is
contaminated, it is necessary that a risk assessment should be undertaken. When health concerns can
be substantiated, a risk management measure must be applied, based on a thorough evaluation of the
situation and consideration of a range of risk management options. Depending on the assessment of
the problems and the possible solutions, it may be necessary to establish MLs or other measures to
control the contamination of food and feed. In special cases, specific advice on dietary recommendations
may also have to be considered to complement other regulatory measures, when the measures are not
sufficiently adequate to protect public health and safety.
National measures regarding food and feed contamination should avoid the creation of unnecessary
barriers to international trade in food and feed commodities. The purpose of the GSCTFF is to provide
guidance about possible approaches to eliminate or reduce the contamination problem and to promote
international harmonization through recommendations, which in turn may prevent trade barriers and
disputes.
For all contaminants, which may be present in more than one feed or food item, a broad approach shall
be applied, taking into account all relevant information that is available, for the assessing of risks and
for developing recommendations and control measures, including the setting of maximum levels.
1 For the contaminants methylmercury, radionuclides, acrylonitrile and vinylchloride monomer a Codex guideline
level (GL) has been established.
A Codex guideline level (GL) is the maximum level of a substance in a food or feed commodity which is
recommended by the Codex Alimentarius Commission to be acceptable for commodities moving in international
trade. When the GL is exceeded, governments should decide whether and under what circumstances the food
should be distributed within their territory or jurisdiction.
Because the Commission has decided that the preferred format of a Codex standard in food or feed is a maximum
level, the present existing or proposed guideline levels shall be reviewed for their possible conversion to a maximum
level after a risk assessment performed by JECFA, if appropriate.
2 In addition, reference is made to the Code of Practice for source Directed measures to reduce contamination of
food with chemicals (CXC 49-2001) and the Code of Practice on Good Animal Feeding (CXC 54-2004).
CXS 193-1995 4
1.3.2 Principles for establishing maximum levels in food and feed
MLs shall only be set for food in which the contaminant may be found in amounts that are significant for
the total exposure of the consumer, taking into consideration the Policy of the Committee on
Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups
(Section IV of the Procedural Manual).
The maximum levels shall be set in such a way that the consumer is adequately protected. At the same
time the other legitimate factors need to be considered. This will be performed in accordance with the
Working Principles for Risk Analysis for Food Safety for Application by Governments.
The principles of Good Manufacturing Practice and Good Agricultural Practice as defined by Codex shall
be used. Maximum levels shall be based on sound scientific principles leading to levels, which are
acceptable worldwide, so that there is no unjustified barrier to international trade. MLs shall be clearly
defined with respect to status and intended use.
1.3.3 Specific criteria
The following criteria should (not preventing the use of other relevant criteria) be considered when
developing MLs and/or other measures in connection with the General Standard for Contaminants and
Toxins in Food and Feed (Further details about these criteria are given in Annex I).
Toxicological information
• identification of the toxic substance(s);
• metabolism by humans and animals, as appropriate;
• toxicokinetics and toxicodynamics including information on possible carry-over of the toxic
substance from feed to edible animal tissue/products;
• information about acute and long term toxicity and other relevant toxicity data; and
• integrated toxicological expert advice regarding the acceptability and safety of intake levels
of contaminants, including information on any population groups which are especially
vulnerable.
Analytical data
• validated qualitative and quantitative data on representative samples; and
• appropriate sampling procedures.
Intake data
• presence in food of dietary significance for the contaminant;
• presence in food that are widely consumed;
• presence in feed and feed components;
• food intake data for average and most exposed/high consumer groups;
• results from total diet studies;
• calculated contaminant intake data from food consumption models;
• data on intake by susceptible groups; and
• data on intake by food producing animals.
Technological considerations
• Information about contamination processes, technological possibilities, production and
manufacturing practices and economic aspects related to contaminant level management
and control.
Risk assessment and risk management considerations (cf. Working Principles for Risk Analysis for
Food Safety for Application by Governments)
• risk management options and considerations;
• consideration of possible maximum levels in food and feed based on the criteria mentioned
above; and
• consideration of alternative solutions.
1.4 FORMAT OF THE GENERAL STANDARD FOR CONTAMINANTS IN FOOD AND FEED
A full description of the format is provided in Annex II.
CXS 193-1995 5
Annex I
CRITERIA FOR THE ESTABLISHMENT OF MAXIMUM LEVELS IN FOOD AND FEED
Introduction
In this Annex criteria are mentioned regarding information, which is considered necessary for evaluating
contaminant problems in food and feed and for the establishment of maximum levels. The criteria mentioned
here are elaborated in more detail than in Section 1.3.3 of the Preamble. Only those aspects that need further
clarification are detailed; however, criteria or aspects that are not specifically detailed here should not be ruled
out in the evaluation process.
Toxicological information
Integrated toxicological expert advice regarding a safe/tolerable intake level of a contaminant is essential
when decisions about maximum levels in foods are considered. A recommendation from the Joint FAO/WHO
Expert Committee on Food Additives (JECFA) regarding the maximum allowable or tolerable intake, based on
a full evaluation of an adequate toxicological database, should be the main basis for decisions by Codex
members. In urgent cases, it may be possible to rely on less developed evaluations from JECFA or on
toxicological expert advice from other international or national bodies.
When toxicological information is presented in relation to proposals for maximum levels for contaminants in
food and feed, information about the following aspects is desirable:
• identification of the toxic substance(s);
• metabolism in humans and animals, as appropriate;
• toxicokinetics and toxicodynamics including information on possible carry-over of the contaminant
from feed to edible animal tissue/products;
• information about acute and long term toxicity in animals and humans, including epidemiological
data on humans and other relevant toxicity data;
• conclusions and advice of toxicological expert(s) (groups), with references, including information
on especially vulnerable population groups or animals.
Analytical data
Validated qualitative and quantitative analytical data on representative samples should be supplied.
Information on the analytical and sampling methods used and on the validation of the results is desirable. A
statement on the representativeness of the samples for the contamination of the product in general (e.g. on a
national basis) should be added. The portion of the commodity that was analyzed and to which the contaminant
content is related should be clearly stated and preferably should be equivalent to the definition of the
commodity for this purpose or to existing related contaminant regulation.
Information on appropriate sampling procedures should be supplied. Special attention to this aspect is
necessary in the case of contaminants that may not be homogeneously distributed in the product
(e.g. mycotoxins in some commodities).
Intake data
It is desirable to have information about the contaminant concentrations in those foods or food groups that
(together) are responsible for at least half and preferably 80% or more of the total dietary intake of the
contaminant, both for consumers with average and high consumption patterns.
Information about the presence of the contaminant in foods that are widely consumed (staple foods) is
desirable in order to be able to make a satisfactory assessment of the contaminant intake and of risks
associated with food trade.
For the contaminants, which can be present in food of animal origin as a consequence of the carry over from
feed, information about the presence of the contaminant in the feed and feed components should be given.
Furthermore the intake of contaminants by the different food producing animals and the resulting levels of the
contaminant in the food of animal origin should be estimated.
Food consumption data for average, most exposed (high consumers) and susceptible consumer
groups are desirable for evaluations of (potential) intake of contaminants. This problem, however, has to be
addressed differently on a national and on an international scale. It is therefore important to have information
about both average and high consumption patterns regarding a wide variety of foodstuffs, so that for every
contaminant the most exposed consumer groups may be identified for every contaminant. Detailed information
about high consumption patterns is desirable, both regarding group identification criteria (e.g. age or sex
differences, vegetarian or regional dietary customs, etc.) and statistical aspects.
CXS 193-1995 6
Dietary intake of contaminants: Reference is made to the Guidelines for the Study of Dietary Intake of
Chemical Contaminants (WHO, 1985 - http://whqlibdoc.who.int/offset/WHO_OFFSET_87.pdf). It is important
to supply all relevant details, such as the type of study (duplicate diet, total diet or market basket study,
selective study), and statistical details. Calculated contaminant intake data from food consumption models
may also be useful. When results about food groups and about effects of preparation and cooking etc. are
available, these should also be supplied.
Technological considerations
Information about the source of the contaminant and the way in which the food and feed is contaminated,
possibly including information, if available, about contamination being present in parts only of the product, is
essential for assessing the possibilities to control the contamination process and to be able to guarantee a
desired product safety and quality. Where possible Source-related measures should be proposed. Good
Manufacturing Practice (GMP) and/or Good Agricultural Practice (GAP) should also be adapted to control
a contamination problem. When this is possible, maximum levels may be based on GMP or GAP
considerations to establish at a level as low as reasonably achievable and necessary to protect the consumer.
Considerations regarding the technological possibilities to control a contamination problem, e.g. by cleaning,
should also be taken into account when a primary risk assessment model (theoretical maximum daily intake)
shows possible intakes exceeding the toxicological reference value. In such a case the possibilities of lower
contamination levels need further careful examination. Then a detailed study about all the aspects involved is
necessary, so that decisions about maximum levels can be based on a thorough evaluation of both the public
health arguments and the potential problem with complying with the proposed standard.
Risk assessment and risk management considerations
Risk assessment and risk management are conducted in accordance with the Working Principles for Risk
Analysis for Food Safety for Application by Governments (CAC/GL 62-2007).
Establishment of maximum levels
In case it is decided that, on the basis of the outcome of the risk assessment, there is no need to establish a
maximum level to protect public health as the level of hazard/risk does not pose a public health problem, this
should be communicated in a transparent and accessible manner (e.g. by using the full format as provided for
Schedule I and to mention in the box of Maximum level “not necessary”).
The establishment of maximum levels (MLs) of contaminants in food and feed involves several principles,
some of which have already been mentioned in this Preamble. Briefly stated, the following criteria will help in
maintaining a consistent policy in this matter:
• MLs should be set only for those contaminants that present both a significant risk to public health
and a known or expected problem in international trade.
• 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 Section 3 of the Policy of the Committee on Contaminants
in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups (Section
IV of the Procedural Manual) should be consulted.
• MLs should be set as low as reasonably achievable and at levels necessary to protect the
consumer. Providing it is acceptable from the toxicological point of view, MLs should be set at a
level which is (slightly) higher than the normal range of variation in levels in food and feed that are
produced with current adequate technological methods, in order to avoid undue disruptions of food
and feed production and trade. Where possible, MLs should be based on GMP and/or GAP
considerations in which the health concerns have been incorporated as a guiding principle to
achieve contaminant levels as low as reasonably achievable and necessary to protect the
consumer. Foods that are evidently 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 evidence 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 sufficient information is available about the contamination
pattern for the whole group, or when there are other arguments that extrapolation is appropriate.
CXS 193-1995 7
• Numerical values for MLs should preferably be regular 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 feed 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 available 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 should 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 (CAC/MISC 4) may serve as guidance on this
subject; other product definitions should only be used for specified reasons. For contaminant
purposes, however, analysis and consequently MLs should preferably be on the basis of the edible
part of the product.
For fat-soluble contaminants, which may accumulate 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-ingredient products. When products are concentrated, dried or
diluted, use of the concentration or dilution factor is generally appropriate in order to be able to
obtain a primary judgement of the contaminant 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 feed. Information regarding the behaviour of the contaminant during
processing (e.g. washing, peeling, extraction, cooking, drying etc.) is however desirable to give
more adequate guidance. When contaminant levels are consistently different in processed
products related to the primary products from which they are derived, and sufficient information is
available about the contamination pattern, it may be appropriate to establish separate maximum
levels for these processed 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 applied 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 criteria for establishing MLs, further evaluations are
necessary regarding the possibilities to reduce 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 evaluations 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 contamination problems than in the case of food additives and
pesticide residues. Proposed MLs will inevitably be influenced by this situation. In order to promote acceptance
of Codex MLs, it is therefore important that assessments of the impact of those MLs on dietary exposure are
done in a consistent and realistic way. The procedure involves assessment of the dietary intake in relation to
the proposed or existing MLs and the toxicological reference value.
CXS 193-1995 8
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 species and the resulting levels in the food of animal origin should be
estimated.
The best estimate of dietary intake involves the national dietary pattern and corrections for concentration
changes during transport, storage, food preparation, for known levels in foods as consumed, etc. Caution is
recommended when using other than average food consumption values, although it is considered appropriate
to use relevant average food consumption data for 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 realistic as possible is recommended. (cf. the Policy of the
Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food
Groups - Section IV of the 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 calculations should follow
the methodology described in the Policy for Exposure Assessment and, if appropriate, be accompanied by the
generation of distribution curves for the concentration in specific foods/food groups (see Sections 2 and 4 of
the Policy of the Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins
in Foods or Food Groups – Section IV of the Procedural Manual). Statements from Governments about the
non-acceptance of (proposed) Codex MLs should refer to specified intake calculations and risk management
conclusions, which support this position.
CXS 193-1995 9
Annex II
FORMAT OF THE GSCTFF
Introduction
The format for the Schedule shall contain the following elements:
• Name of the contaminant
• Synonyms: symbols, synonyms, abbreviations, scientific descriptions shall be mentioned.
• Reference to JECFA meetings (in which the contaminant was discussed).
• PMTDI, PTWI or similar toxicological guidance 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 or guideline level applies.
• Reference to a source-directed measure or a related code of practice for the contaminant, if
appropriate.
• List of Codex maximum levels or guideline levels for that contaminant; this list shall be
composed of the following elements, in columns:
- feed/food commodity/product name;
- Numerical value of maximum level or guideline level and units in which it is expressed;
- Portion of the Commodity/Product to which the maximum level or guideline level applies;
- Notes/Remarks, including reference to relevant Codex commodity standards and where
necessary, definition of the commodity product
CXS 193-1995 10
SCHEDULE
MAXIMUM AND GUIDELINE LEVELS FOR CONTAMINANTS AND TOXINS IN FOODS
INDEX OF CONTAMINANTS
NAME PAGE
Mycotoxins
Aflatoxins, Total 13
Aflatoxin M1 32
Deoxynivalenol (DON) 33
Fumonisins 38
Ochratoxin A 43
Patulin 44
Metals
Arsenic 45
Cadmium 47
Lead 49
Mercury 53
Methylmercury 54
Tin 55
Radionuclides 56
Others
Acrylonitrile 61
Chloropropanols 62
Hydrocyanic acid 63
Melamine 64
Vinylchloride monomer 65
CXS 193-1995 11
EXPLANATORY NOTES
Reference to JECFA References to the JECFA meeting in which the contaminant was evaluated and
the year of that meeting.
Toxicological Toxicological advice about the tolerable intake level of the contaminant for
guidance value humans, expressed per kg body weight (bw). The year of recommendations and
additional explanation are included.
Contaminant Definition of the contaminant in the form of which the ML or GL applies or which
definition may or should be analyzed in commodities/products.
Commodity / The commodities or products, to which the ML or GL applies, other than the terms
product name feed or food, are those that are intended for human consumption, unless
otherwise specified.
The ML or GL contained in Codex commodity standards apply to the commodities
within the scope of the Codex commodity standard. Reference to the Codex
Standard is provided and the definition of the commodity/product is the definition
as provided in the Codex commodity standard.
When the ML or GL applies only to the commodity within the scope of the Codex
commodity standard then the reference is mentioned as “Relevant Codex
commodity standard(s) is (are) …”. In case the reference to Codex commodity
standards is provided as example for commodities to which the ML or GL applies
then the reference is mentioned as “Relevant Codex Commodity standards
include …”
For the other commodities or products not contained in Codex commodity
standards the definition of the commodity or product is provided in the
Classification of Food and Feed (CAC/MISC 4), unless otherwise specified.
In case a ML or GL applies to a product group (e.g. legume vegetables), the ML or
GL applies to all individual products belonging to the group as defined in
CAC/MISC 4
For any other commodities or products other than those described above, where
necessary, the definition of the commodity/product is provided in “Notes/Remarks”.
Portion of the The portion of the feed or food to which the ML or GL applies, is the portion
Commodity/Product defined in the Codex commodity standard or CAC/MISC 4 or defined at the
to which the establishment of the ML or GL, unless otherwise specified.
maximum level (ML)
or guideline level
(GL) applies
CXS 193-1995 12
DEFINITIONS OF SOME TOXICOLOGICAL TERMS
Maximum Level
Commodity/Product Portion of the Commodity/Product to
(ML) Notes/Remarks
Name which the ML applies
µg/kg
The ML applies to pistachios intended for further processing (*)
Pistachios 15 Whole commodity after removal of shell.
For sampling plan, see Annex 2.
The ML applies to dried figs “ready-to-eat” (**)
Dried figs 10 Whole commodity
For sampling plan see Annex 3.
(*) “destined for further processing” means 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 colour sorting, and sorting by specific gravity and colour (damage). There is some evidence that roasting reduces aflatoxins
in pistachios but for other nuts the evidence is still to be supplied.
(**) “ready-to-eat” means “not intended to undergo an additional processing/treatment that has proven to reduce levels of aflatoxins before being used as
ingredient in foodstuffs, otherwise processed or offered for human consumption.
CXS 193-1995 15
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 µg/kg total
aflatoxins.
2. This sampling plan has been designed for enforcement and controls concerning total aflatoxins in bulk
consignments of peanuts traded in the export market. To assist member countries in implementing the
sampling plan, sample selection methods, sample preparation methods and analytical methods
required, to quantify aflatoxin in bulk peanut lots are described in this document.
A. DEFINITIONS
Designated part of a large lot in order to apply the sampling method on that designated
Sublot
part. Each sublot must be physically separate and identifiable.
Incremental
A quantity of material taken from a single random place in the lot or sublot.
sample
The combined total of all the incremental samples taken from the lot or sublot. The
Aggregate sample
aggregate sample has to be at least as large as the 20 kg laboratory sample.
The smallest quantity of peanuts comminuted in a mill. The laboratory sample may be
a portion of or the entire aggregate sample. If the aggregate sample is larger than
Laboratory sample 20 kg, a 20 kg laboratory sample should be removed in a random manner from the
aggregate sample. The sample should be finely ground and mixed thoroughly using a
process that approaches as complete a homogenisation as possible.
B. SAMPLING
Material to be sampled
3. Each lot, which is to be examined, must be sampled separately. Large lots should be subdivided into sublots
to be sampled separately. 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%.
Table 1. Subdivision of large lots into sublots for sampling
Number of Laboratory
Lot weight – Weight or
Commodity incremental sample
tonne (T) number of sublots
samples weight (kg)
≥ 500 100 tonnes 100 20
> 100 and < 500 5 sublots 100 20
Peanuts
≥ 25 and ≤ 100 25 tonnes 100 20
> 15 and <= 25 --1 sublot 100 20
CXS 193-1995 16
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 achieved.
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 should have an equal chance of being chosen. Biases will be introduced by
the sample selection methods if equipment and procedures used to select the incremental samples
prohibit or reduce the chances of any item in the lot from being chosen.
7. Since there is no way to know if the contaminated peanut kernels are uniformly dispersed throughout
the lot, it is essential that the aggregate sample be the accumulation of many small portions or
increments of the 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.
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.
9. Taking a aggregate sample from a static lot usually requires the use of probing devices to select product
from the lot. The probing 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 locations throughout the lot.
10. 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)
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 entire length of the
moving stream; composite the peanuts to obtain an aggregate sample; if the aggregate sample is larger
than the required laboratory sample, then blend and subdivide the aggregate sample to obtain the
desired size laboratory sample.
12. Automatic sampling equipment such as cross-cut samplers are commercially available with timers that
automatically pass a diverter 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.
CXS 193-1995 17
13. 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 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 interval 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 time (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 through 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 incremental samples) will be made by the cup through the lot. This may be considered
too infrequent in that too much product passes through the sampler between the time the cup cuts
through the stream.
Weight of the incremental sample
18. The weight of the incremental sample should be approximately 200 g or greater, depending on the total
number of increments, to obtain an aggregate sample of 20 kg.
Packaging and transmission of samples
19. Each laboratory sample shall be placed in a clean, inert container 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 with 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 extreme 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 possible.
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 terms of cost and precision. A better homogenisation (finer grind – slurry)
can be obtained by more sophisticated equipment, resulting in a lower sample preparation variance.
Test portion
25. A minimum test portion size of 100 g taken from the laboratory sample.
CXS 193-1995 18
D. ANALYTICAL METHODS
Background
26. A criteria-based approach, whereby a set of performance criteria is established with which the analytical
method used should comply, 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 coefficient of variation,
and the percent recovery necessary for various statutory limits. Utilising this approach, laboratories
would be free to use the analytical method most appropriate for their facilities. Analytical methods that
are accepted 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
Maximum Permitted
Criterion Concentration Range Recommended Value
Value
Blanks All Negligible -
Recovery-Aflatoxins Total 1 – 15 µg/kg 70 to 110%
> 15 µg/kg 80 to 110%
Precision RSDR All As derived from 2 x value derived from
Horwitz Equation Horwitz Equation
Precision RSDr may be calculated as 0.66 times Precision RSDR at the concentration of interest
• The detection limits of the methods used are not stated as the precision values are given at the
concentrations of interest;
• The precision values are calculated from the Horwitz equation, i.e.:
(1-0.5logC)
RSD =2
R
where:
∗ RSDR is the relative standard deviation calculated from results generated under reproducibility
conditions [(Sr / x ) x 100]
∗ C is the concentration ratio (i.e. 1 = 100 g/100 g, 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 concentration for most routine methods of analysis.
CXS 193-1995 19
Annex 2
SAMPLING PLANS FOR AFLATOXIN CONTAMINATION IN
READY-TO-EAT TREENUTS AND TREENUTS
DESTINED FOR FURTHER PROCESSING: ALMONDS, HAZELNUTS, PISTACHIOS
AND SHELLED BRAZIL NUTS
DEFINITIONS
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.
Incremental sample The quantity of material taken from a single 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 entire 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 before being used as an
ingredient in foodstuffs, otherwise processed or offered for human
consumption.
Treenuts destined for Nuts, which are intended to undergo an additional processing/treatment that
further processing 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 colour sorting, and sorting by specific gravity and
colour (damage). There is some evidence that roasting reduces aflatoxins in
pistachios but for other nuts the evidence is still to be supplied.
Operating A plot of the probability of a accepting a lot versus lot concentration when
characteristic using a specific sampling plan design. The OC curve provides an estimate
(OC) curve of good lots rejected (exporter’s risk) and bad lots accepted (importer’s risk)
by a specific aflatoxin sampling plan design.
Samplingb,c S2s = (7 730/ns) 5.759C1.561 S2s = (10 000/ns) 4.291C1.609 S2s = 8 000/ns) 7.913C1.475 ss2 = (1 850/ns) 4.8616C1.889
Sample Prepd S2sp = (100/nss) 0.170C1.646 S2sp = (50/nss) 0.021C1.545 S2sp = (25/nss) 2.334C1.522 sss2 = (50/nss) 0.0306C0.632
experimental
sa2 = (1/n) 0.0164C1.117
Analyticale S2a = (1/na) 0.0484C2.0 S2a = (1/na) 0.0484C2.0 S2a = (1/na) 0.0484C2.0 or
FAPAS
sa2 = (1/n) 0.0484C2.0
Total variance S2s + S2sp + S2a S2s + S2sp + S2a S2s + S2sp + S2a S2s + S2sp + S2a
a/ Variance = S2 (s, sp, and a denote sampling, sample preparation, and analytical steps, respectively, 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 concentration in µg/kg total aflatoxin.
c/ Shelled nut count/kg for almonds, hazelnuts, pistachios and Brazil nuts is 773, 1 000, 1 600 and 185,
respectively.
d/ Sample preparation for almonds, hazelnuts, and pistachios reflect Hobart, Robot Coupe, Marjaan Khatman
and Turrax type mills, respectively. Laboratory samples were dry ground into a paste for each treenut except
for Brazil nut that were prepared as a slurry Brazil nut/water 1/1 w/w.
e/ Analytical variances reflect FAPAS recommendation for upper limit of analytical reproducibility uncertainty.
A relative standard deviation of 22%, which is based upon FAPAS data, is considered, 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 sampling studies for the four treenuts.
CXS 193-1995 26
Annex 3
SAMPLING PLAN FOR AFLATOXIN CONTAMINATION IN DRIED FIGS
DEFINITIONS
Designated part of a larger lot in order to apply the sampling method on that
Sublot
designated part. Each sublot must be physically separate and identifiable.
Incremental sample The quantity of material taken from a single random place in the lot or sublot.
The combined total of all the incremental samples that is taken from the lot or
Aggregate sample sublot. The aggregate sample has to be at least as large as the laboratory
sample or samples combined.
A plot of the probability of accepting a lot versus lot concentration when using
Operating
a specific sampling plan design. The OC curve also provides an estimate of
characteristic
good lots rejected (exporter’s risk) and bad lots accepted (importer’s risk) by
(OC) curve
a specific aflatoxin sampling plan design.
Incremental sample The quantity of material taken from a single 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 shelled cereal 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 in such a way to
ensure that the laboratory sample is still representative of the sublot sampled.
Test portion A portion of the comminuted laboratory sample. The entire laboratory sample
should be comminuted in a mill. A portion of the comminuted laboratory sample is
randomly removed for the extraction of the DON for chemical analysis.
SAMPLING PLAN DESIGN CONSIDERATIONS
M ATERIAL TO BE SAMPLED
1. Each lot of cereal, which is to be examined for DON, must be sampled separately. Lots larger than 50
tonnes should be subdivided into sublots to be sampled separately. If a lot is greater than 50 tonnes,
the lot should be subdivided into sublots according to Table 1.
Table 1. Subdivision of cereal sublots according to lot weight
Lot weight Maximum Weight or minimum Number of Minimum laboratory
(t) number of sub lots incremental sample Sample Weight (kg)
≥ 1500 500 tonnes 100 1
> 300 and
3 sublots 100 1
< 1500
≥ 100 and
100 tonnes 100 1
≤ 300
≥ 50 and
2 sublots 100 1
< 100
< 50 - 3-100* 1
* see table 2
2. Taking into account that the weight of the lot is not always an exact multiple of the weight of sublots, the
weight of the sublot may exceed the mentioned weight by a maximum of 20%.
INCREMENTAL SAMPLE
3. The suggested minimum weight of the incremental sample should be 100 grams for lots ≥ 0.5 tonnes.
4. For lots less than 50 tonnes, the sampling plan must be used with 3 to 100 incremental samples,
depending on the lot weight. For very small lots (≤ 0.5 tonnes) a lower number of incremental samples
may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at
least 1 kg. Table 2 may be used to determine the number of incremental samples to be taken.
Table 2. Number of incremental samples to be taken depending on the weight of the lot of
Minimum Laboratory Sample
Lot weight (t) Number of incremental sample
Weight (kg)
≤ 0.05 3 1
> 0.05 - ≤ 0.5 5 1
> 0.5 - ≤ 1 10 1
>1-≤3 20 1
> 3 - ≤ 10 40 1
> 10 - ≤ 20 60 1
> 20 - < 50 100 1
CXS 193-1995 36
STATIC LOTS
5. A static lot can be defined as a large mass of shelled cereal 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 cereal is
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.
6. 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 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 incremental samples of product taken from many different
locations throughout the lot.
7. 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:
SF = (LT x IS)/(AS x IP).
8. The sampling frequency (SF) is the number of packages sampled. All weights should be in the same
mass units such as kg.
DYNAMIC LOTS
9. Representative aggregate samples can be more easily produced when selecting incremental samples
from a moving stream of shelled cereal 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
sample is larger than the required laboratory sample(s), then blend and subdivide the aggregate sample
to obtain the desired size laboratory sample(s).
10. Automatic sampling equipment such as a cross-cut sampler 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 cereal flow past the sampling point.
11. 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.
12. The size of the aggregate sample (S) in kg, taken from a lot by a cross cut sampler is:
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).
13. 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 as a function of S, V, D, and MR.
SF = (S x V) / (D x MR).
PACKAGING AND TRANSPORTATION OF SAMPLES
14. Each laboratory sample shall be placed in a clean, inert container offering adequate protection from
contamination, sunlight, 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.
Samples should be stored in a cool dark place.
15. 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 with any additional information likely to be of assistance to the
analyst.
SAMPLE PREPARATION
16. Sunlight should be excluded as much as possible during sample preparation, since DON may gradually
break down under the influence of ultra-violet light. Also, environmental temperature and relative
humidity should be controlled and not favour mould growth and DON formation.
CXS 193-1995 37
17. As the distribution of DON is extremely non-homogeneous, laboratory samples should be homogenised
by grinding the entire laboratory sample received by the laboratory. Homogenisation is a procedure that
reduces particle size and disperses the contaminated particles evenly throughout the comminuted
laboratory sample.
18. The laboratory sample should be finely ground and mixed thoroughly using a process that approaches
as complete homogenisation as possible. Complete homogenisation implies that particle size is
extremely small and the variability associated with sample preparation approaches zero. After grinding,
the grinder should be cleaned to prevent DON cross-contamination.
TEST PORTION
19. The suggested weight of the test portion taken from the comminuted laboratory sample should be
approximately 25 g
20. Procedures for selecting the test portion from the comminuted laboratory sample should be a random
process. If mixing occurred during or after the comminuting process, the test portion can be selected
from any location throughout the comminuted laboratory sample. Otherwise, the test portion should be
the accumulation of several small portions selected throughout the laboratory sample.
21. It is suggested that three test portions be selected from each comminuted laboratory sample. The three
test portions will be used for enforcement, appeal, and confirmation if needed.
ANALYTICAL METHODS
22. A criteria-based approach, whereby a set of performance criteria is established with which the analytical
method used should comply, 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 specific method. A list of possible criteria and
performance levels are shown in Table 3). Utilising this approach, laboratories would be free to use the
analytical method most appropriate for their facilities.
Table 3. Proposed method criteria for DON in cereals.
Minimum
ML LOD LOQ Precision on
Commodity applicable Recovery
(mg/kg) (mg/kg) (mg/kg) HorRat
range (mg/kg)
Cereal grains (wheat,
maize and barley)
2.0 ≤ 0.2 ≤ 0.4 ≤2 1-3 80 - 110%
destined for further
processing
Cereal-based foods
for infants and young 0.2 ≤ 0.02 ≤ 0.04 ≤2 0.1 – 0.3 80 – 110%
children
Flour, semolina,
meal and flakes
derived from wheat, 1.0 ≤ 0.1 ≤ 0.2 ≤2 0.5 – 1.5 80 – 110%
maize
or barley
CXS 193-1995 38
8. The sampling frequency (SF) is the number of packages sampled. All weights should be in the same
mass units such as kg.
DYNAMIC LOTS
9. Representative aggregate samples can be more easily produced when selecting incremental samples
from a moving stream of shelled maize 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
sample is larger than the required laboratory sample(s), then blend and subdivide the aggregate sample
to obtain the desired size laboratory sample(s).
10. Automatic sampling equipment such as a cross-cut sampler 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 maize flow past the sampling point.
11. 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.
12. The size of the aggregate sample (S) in kg, taken from a lot by a cross cut sampler is:
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).
13. 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 as a function of S, V, D, and MR.
SF = (S x V) / (D x MR).
PACKAGING AND TRANSPORTATION OF SAMPLES
14. Each laboratory sample shall be placed in a clean, inert container offering adequate protection from
contamination, sunlight, 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.
Samples should be stored in a cool dark place.
15. 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 with any additional information likely to be of assistance to the
analyst.
SAMPLE PREPARATION
16. Sunlight should be excluded as much as possible during sample preparation, since fumonisin may
gradually break down under the influence of ultra-violet light. Also, environmental temperature and
relative humidity should be controlled and not favor mold growth and fumonisin formation.
17. As the distribution of fumonisin is extremely non-homogeneous, laboratory samples should be
homogenised by grinding the entire laboratory sample received by the laboratory. Homogenisation is a
procedure that reduces particle size and disperses the contaminated particles evenly throughout the
comminuted laboratory sample.
18. The laboratory sample should be finely ground and mixed thoroughly using a process that approaches
as complete homogenisation as possible. Complete homogenisation implies that particle size is
extremely small and the variability associated with sample preparation approaches zero. After grinding,
the grinder should be cleaned to prevent fumonisin cross-contamination.
TEST PORTION
19. The suggested weight of the test portion taken from the comminuted laboratory sample should be
approximately 25 g
20. Procedures for selecting the test portion from the comminuted laboratory sample should be a random
process. If mixing occurred during or after the comminuting process, the test portion can be selected
from any location throughout the comminuted laboratory sample. Otherwise, the test portion should be
the accumulation of several small portions selected throughout the laboratory sample.
CXS 193-1995 42
21. It is suggested that three test portions be selected from each comminuted laboratory sample. The three
test portions will be used for enforcement, appeal, and confirmation if needed.
ANALYTICAL METHODS
22. A criteria-based approach, whereby a set of performance criteria is established with which the analytical
method used should comply, 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 specific method. A list of possible criteria and
performance levels are shown in Table 3). Utilising this approach, laboratories would be free to use the
analytical method most appropriate for their facilities.
Table 3. Performance criteria for Fumonisin B1+ B2.
Maize Grain
* - The LOD and LOQ were derived based upon typical B1:B2 ratio of 5:2 in naturally-contaminated samples
Maize Flour/Meal
* - The LOD and LOQ were derived based upon typical B1:B2 ratio of 5:2 in naturally-contaminated samples
CXS 193-1995 43
OCHRATOXIN A
Reference to JECFA: 37 (1990), 44 (1995), 56 (2001), 68 (2007)
Toxicological guidance value: PTWI 0.0001 mg/kg bw (2001)
Contaminant definition: Ochratoxin A
Synonyms: (The term “ochratoxins” includes a number of related mycotoxins (A, B, C and their esters and metabolites), the
most important one being ochratoxin A)
Related code of practice: Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CXC 51-2003)
Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Wine (CXC 63-2007)
Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Coffee (CXC 69-2009)
Code of Practice for the Prevention and Reduction of Ochratoxin A contamination in Cocoa (CXC 72-2013)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name µg/kg to which the ML applies
The ML applies to raw common wheat, raw durum wheat, raw spelt and
Wheat 5 Whole commodity
raw emmer.
Barley 5 Whole commodity The ML applies to raw barley.
Rye 5 Whole commodity The ML applies to raw rye.
CXS 193-1995 44
PATULIN
Reference to JECFA: 35 (1989), 44 (1995)
Toxicological guidance value: PMTDI 0.0004 mg/kg bw (1995)
Contaminant definition: Patulin
Related code of practice: Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice
Ingredients in Other Beverages (CXC 50-2003)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name µg/kg to which the ML applies
Relevant Codex commodity standard include CXS 247-2005 (apple
Whole commodity (not concentrated) products only).
Apple juice 50 or commodity reconstituted to the
original juice concentration. The ML applies also to apple juice used as an ingredient in other
beverages.
CXS 193-1995 45
ARSENIC
Reference to JECFA: 5 (1960), 10 (1967), 27 (1983), 33 (1988), 72 (2010)
Toxicological guidance value: At the 72nd meeting of JECFA (2010), the inorganic arsenic lower limit on the benchmark dose for a 0.5% increased
incidence of lung cancer (BMDL 0.5) was determined from epidemiological studies to be 3.0 μg/kg bw/day (2–
7 μg/kg bw/day based on the range of estimated total dietary exposure) using a range of assumptions to estimate
total dietary exposure to inorganic arsenic from drinking-water and food. The JECFA noted that the provisional
tolerable weekly intake (PTWI) of 15 μg/kg bw (equivalent to 2.1 μg/kg bw/day) is in the region of the BMDL 0.5
and therefore was no longer appropriate. The JECFA withdrew the previous PTWI.
Contaminant 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 Contamination of Foods with Chemicals (CXC 49-2001)
Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice (CXC 77-2017)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
Relevant Codex commodity standards are CXS 19-1981, CXS 33-1981,
CXS 210-1999,
CXS 211-1999 and CXS 329-2017
For fish oils covered by CXS 329-2017, the ML is for fish oils (As-in).
Countries or importers may decide to use their own screening when
Edible fats and oils 0.1 Whole commodity applying the ML for As-in in fish oils by analysing total arsenic (As-tot) in
fish oils. If the As-tot concentration is below the ML for As-in, no further
testing is required and the sample is determined to be compliant with
the ML. If the As-tot concentration is above the ML for As-in, follow-up
testing shall be conducted to determine if the As-in concentration is
above the ML.
Fat spreads and
0.1 Relevant Codex commodity standard is CXS 256-2007.
blended spreads
Natural mineral Relevant Codex commodity standard is CXS 108-1981.
0.01
waters Calculated as total As in mg/l.
The ML is for inorganic arsenic (As-in).
Countries or importers may decide to use their own screening when
applying the ML for As-in in rice by analysing total arsenic (As-tot) in
Rice, husked 0.35 Whole commodity rice. If the As-tot concentration is below or equal to the ML for As-in, no
further testing is required and the sample is determined to be compliant
with the ML. If the As-tot concentration is above the ML for As-in, follow-
up testing shall be conducted to determine if the As-in concentration is
above the ML.
CXS 193-1995 46
CADMIUM
Reference to JECFA: 16 (1972), 33 (1988), 41 (1993), 55 (2000), 61 (2003), 64 (2005), 73 (2010)
Toxicological guidance value: In view of the long half-life of cadmium, daily ingestion in food has a small or even a negligible effect on overall
exposure. In order to assess long- or short-term risks to health due to cadmium exposure, dietary intake should be
assessed over months, and tolerable intake should be assessed over a period of at least 1 month. To encourage
this view, at the 73rd meeting (2010) the JECFA decided to express the tolerable intake as a monthly value in the
form of a provisional tolerable monthly intake (PTMI) and established a PTMI of 25 μg/kg bw.
Contaminant definition: Cadmium, total
Synonyms: Cd
Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)
Cereal grains 0.1 Whole commodity The ML does not apply to buckwheat, cañihua, quinoa, wheat and rice.
Marine bivalve Whole commodity after removal of The ML applies to clams, cockles and mussels but not to oysters and
2
molluscs shell. scallops.
LEAD
Reference to JECFA: 10 (1966), 16 (1972), 22 (1978), 30 (1986), 41 (1993), 53 (1999), 73 (2010)
Toxicological guidance value: Based on the dose–response analyses, at the 73rd meeting (2010), JECFA estimated that the previously
established PTWI of 25 μg/kg bw is associated with a decrease of at least 3 intelligence quotient (IQ) points in
children and an increase in systolic blood pressure of approximately 3 mmHg (0.4 kPa) in adults. While such effects
may be insignificant at the individual level, these changes are important when viewed as a shift in the distribution
of IQ or blood pressure within a population. The JECFA therefore concluded that the PTWI could no longer be
considered health protective and withdrew it.
Contaminant definition: Lead, total
Synonyms: Pb
Related code of practice: Code of Practice for the Prevention and Reduction of Lead Contamination in Foods (CXC 56-2004)
Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
Berries and other Whole commodity after removal of
0.1 The ML does not apply to cranberry, currant and elderberry.
small fruits caps and stems.
Whole commodity after removal of
Cranberry 0.2
caps and stems.
Currants 0.2 Fruit with stem.
Whole commodity after removal of
Elderberry 0.2
caps and stems.
Whole commodity.
Berries and other small fruits: whole
commodity after removal of caps and
stems.
Pome fruits: whole commodity
after removal of stems.
Stone fruits, dates and olives:
whole commodity after removal of
Fruits 0.1 stems and stones, but the level The ML does not apply to cranberry, currant and elderberry.
calculated and expressed on the
whole commodity without stem.
Pineapple: whole commodity
after removal of crown.
Avocado, mangos and similar fruit
with hard seeds: whole commodity
after removal of stone but calculated
on whole fruit.
CXS 193-1995 50
Whole commodity as prepared for Relevant Codex commodity standards are CXS 19-1981, CXS 33-1981,
Edible fats and oils 0.08
wholesale or retail distribution. CXS 210-1999, CXS 211-1999 and CXS 329-2017
MERCURY
Reference to JECFA: 10 (1966), 14 (1970), 16 (1972), 22 (1978), 72 (2010)
Toxicological guidance value: At the 72rd meeting (2010), JECFA established a PTWI for inorganic mercury of 4 μg/kg bw. The previous PTWI of
5 μg/kg bw for total mercury, established at the sixteenth meeting, was withdrawn. The new PTWI for inorganic
mercury was considered applicable to dietary exposure to total mercury from foods other than fish and shellfish.
For dietary exposure to mercury from these foods the previously established PTWI for methyl mercury should be
applied.
Contaminant definition: Mercury, Total
Synonyms: Hg
Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
Natural mineral Relevant Codex commodity standard is CXS 108-1981.
0.001
waters The ML is expressed in mg/l.
Salt food grade 0.1 Relevant Codex commodity standard is CXS 150-1985.
CXS 193-1995 54
TIN
Reference to JECFA: 10 (1966), 14 (1970), 15 (1971), 19 (1975), 22 (1978), 26 (1982), 33 (1988), 55 (2000), 64 (2005)
Toxicological guidance value: PTWI 14 mg/kg bw (1988, expressed as Sn; includes tin from food additive uses; maintained in 2000)
Contaminant 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 (CXC 60-
2005)
Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
The ML does not apply to non-tinplate canned cooked cured chopped
meat, cooked cured ham, cooked cured pork shoulder, corned beef and
luncheon meat.
Canned foods (other Relevant Codex commodity standards include CXS 62-1981, CXS 254-
250 2007, CXS 296-2009, CXS 242-2003, CXS 297-2009, CXS 78-1981,
than beverages)
CXS 159-1987, CXS 42-1981, CXS 60-1981, CXS 99-1981, CXS 160-
1987, CXS 66-1981, CXS 13-1981, CXS 115-1981, CXS 57-1981,
CXS 145-1981, CXS 98-1981, CXS 96-1981, CXS 97-1981, CXS 88-
1981,CXS 89-1981.
Canned beverages 150 Relevant Codex commodity standards include CXS 247-2005.
Cooked cured The ML applies to products in containers other than tinplate containers.
50
chopped meat Relevant Codex commodity standard is CXS 98-1981.
The ML applies to products in containers other than tinplate containers.
Cooked cured ham 50
Relevant Codex commodity standard is CXS 96-1981.
Cooked cured pork The ML applies to products in containers other than tinplate containers.
50
shoulder Relevant Codex commodity standard is CXS 97-1981.
The ML applies to products in containers other than tinplate containers.
Corned beef 50
Relevant Codex commodity standard is CXS 88-1981.
The ML applies to products in containers other than tinplate containers.
Luncheon meat 50
Relevant Codex commodity standard is CXS 89-1981.
CXS 193-1995 56
RADIONUCLIDES
TABLE 1
1 For the purposes of this document, the term “emergency” includes both accidents and malevolent actions.
CXS 193-1995 57
Radionuclides: The Guideline Levels do not include all radionuclides. Radionuclides included are those important for uptake into the food chain; are usually contained
in nuclear installations or used as a radiation source in large enough quantities to be significant potential contributors to levels in foods, and; could be accidentally
released into the environment from typical installations or might be employed in malevolent actions. Radionuclides of natural origin are generally excluded from
consideration in this document.
In the Table, the radionuclides are grouped according to the guideline levels rounded logarithmically by orders of magnitude. Guideline levels are defined for two
separate categories “infant foods” and “other foods”. This is because, for a number of radionuclides, the sensitivity of infants could pose a problem. The guideline
levels have been checked against age-dependent ingestion dose coefficients defined as committed effective doses per unit intake for each radionuclide, which are
taken from the “International Basic Safety Standards” (IAEA, 1996) 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 should be added
together 3.
2 Food and Agriculture Organization of the United Nations, International Atomic Energy Agency, International Labour Office, OECD Nuclear Energy Agency, Pan American Health
Organization, World Health Organization (1996) International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA,
Vienna.
3 For example, if 134Cs and 137Cs are contaminants in food, the guideline level of 1 000 Bq/kg refers to the summed activity of both these radionuclides.
CXS 193-1995 58
Annex 1
SCIENTIFIC JUSTIFICATION FOR THE GUIDELINE LEVELS FOR RADIONUCLIDES IN FOODS
CONTAMINATED FOLLOWING A NUCLEAR OR RADIOLOGICAL EMERGENCY
The Guideline Levels for Radionuclides in Foods and specifically the values presented in Table 1 above are
based on the following general radiological considerations and experience of application of the existing
international and national standards for control of radionuclides in food.
Significant improvements in the assessment of radiation doses resulting from the human intake of radioactive
substances have become available since the Guideline Levels were issued by the Codex Alimentarius
Commission in 1989 1 (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 guideline levels have been assessed both for infants and adults
and checked for compliance with the appropriate dose criterion.
In order to assess public exposure and the associated health risks from intake of radionuclides in food,
estimates of food consumption rates and ingestion dose coefficients are needed. It is assumed that 550 kg of
food is consumed by an adult in a year. The value of infant food and milk consumption during first year of life
used for infant dose calculation equal to 200 kg is based on contemporary human habit assessments. The
most conservative values of the radionuclide-specific and age-specific ingestion dose coefficients, i.e. relevant
to the chemical forms of radionuclides which are most absorbed from the gastro-intestinal tract and retained
in body tissues, are taken from the IAEA.
Radiological criterion: The appropriate radiological criterion, which has been used for comparison with the
dose assessment data below, is a generic intervention exemption level of around 1 mSv for individual annual
dose from radionuclides in major commodities, e.g. food, recommended by the International Commission on
Radiological Protection as safe for members of the public.
Naturally occurring radionuclides: Radionuclides of natural origin are ubiquitous and as a consequence are
present in all foodstuffs to varying degrees. Radiation doses from the consumption of foodstuffs typically range
from a few tens to a few hundreds of microsieverts in a year. In essence, the doses from these radionuclides
when naturally present in the diet are unamenable to control; the resources that would be required to affect
exposures would be out of proportion to the benefits achieved for health. These radionuclides are excluded
from consideration in this document as they are not associated with emergencies.
One-year exposure assessment: It is conservatively assumed that during the first year after major
environmental radioactive contamination caused by a nuclear or radiological emergency it might be difficult to
readily replace foods imported from contaminated regions 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 consumed 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 annual 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 found 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 market),
changes to other produce, agricultural countermeasures and decay.
Experience has shown that in the long term the fraction of imported 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 from 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 negligible.
1 The Codex Alimentarius Commission at its 18th Session (Geneva 1989) adopted Guideline Levels for
Radionuclides in Foods Following 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 after the nuclear
accident.
CXS 193-1995 59
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, radionuclide- and age-
dependent ingestion dose coefficients and the import/production factors. When assessing the mean internal
dose in infants and adults it is suggested that due to monitoring and inspection the radionuclide concentration
in imported foods does not exceed the present guideline levels. Using cautious assessment approach it is
considered that all the foodstuffs imported from foreign areas with residual radioactivity are contaminated with
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 be estimated using the following formula:
1 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.
CXS 193-1995 60
TABLE 2
ASSESSMENT OF EFFECTIVE DOSE FOR INFANTS AND ADULTS FROM INGESTION
OF IMPORTED FOODS IN A YEAR
ACRYLONITRILE
Reference to JECFA: 28 (1984)
Toxicological guidance value: Provisional Acceptance (1984, the use of food-contact materials from which acrylonitrile may migrate is
provisionally accepted on condition that the amount of the substance migrating into food is reduced to the lowest
level technologically attainable)
Contaminant definition: acrylonitrile (monomer)
Synonyms: 2-Propenenitrile; vinyl cyanide (VCN); cyanoethylene; abbreviations, AN, CAN.
Related code of practice: Code of Practice for Source Directed Measures to Reduce Contamination of Foods with Chemicals (CXC 49-2001)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
Food 0.02
CXS 193-1995 62
CHLOROPROPANOLS
Reference to JECFA: 41 (1993; for 1,3-dichloro-2-propanol only), 57 (2001), 67 (2006)
Toxicological guidance value: PMTDI 0.002 mg/kg bw (2001, for 3-chloro-1,2-propanediol); maintained in 2006. Establishment of tolerable intake
was considered to be inappropriate for 1,3-dichloro-2-propanol because of the nature of the toxicity (tumorogenic
in various organs in rats and the contaminant can interact with chromosomes and/or DNA).
BMDL 10 cancer, 3.3 mg/kg bw/day (for 1,3-dichloro-2-propanol); MOE, 65 000 (general population), 2 400 (high
level intake, including young children).
Contaminant definition: 3-MCPD
Synonyms: Two substances are the most important members of this group: 3-monochloropropane-1,2-diol (3-MCPD, also
referred to as 3-monochloro-1,2-propanediol) and 1,3-dichloro-2-propanol (1,3-DCP).
Related code of 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 (CXC 64–2008).
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
Liquid condiments
containing acid
0.4 The ML does not apply to naturally fermented soy sauce.
hydrolyzed vegetable
proteins
CXS 193-1995 63
HYDROCYANIC ACID
Reference to JECFA: 39 (1992), 74 (2011)
Toxicological guidance value: ARfD 0.09 mg/kg bw as cyanide (2011, this cyanide-equivalent ARfD applies only to foods containing cyanogenic
glycosides as the main source of cyanide)
PMTDI 0.02 mg/kg bw as cyanide (2011)
Contaminant definition: See explanatory notes in the column “Notes/Remarks”
Synonyms: HCN
Related code of practice: Code of Practice for the Reduction of Hydrocyanic Acid (HCN) in Cassava and Cassava products
(CXC 73-2013)
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
The ML is expressed as free hydrocyanic acid.
Gari 2 Whole commodity
Relevant Codex commodity standards include CXS 151-1989.
The ML is expressed as total hydrocyanic acid
Cassava flour 10
Relevant Codex commodity standards include CXS 176-1989.
CXS 193-1995 64
MELAMINE
Reference to JECFA: FAO/WHO Expert Meeting (2008)
Toxicological guidance value: TDI 0.2 mg/kg bw (2008)
Contaminant definition: Melamine
Commodity/Product Maximum Level (ML) Portion of the Commodity/Product
Notes/Remarks
Name mg/kg to which the ML applies
The ML applies to food other than infant formula.
The ML applies to levels of melamine resulting from its non-intentional
and unavoidable presence in feed and food.
The ML does not apply to feed and food for which it can be proven that
the level of melamine higher than 2.5 mg/kg is the consequence of:
Food (other than
• Authorised use of cyromazine as insecticide. The melamine
infant formulae) and 2.5
feed level shall not exceed the level of cyromazine.
• Migration from food contact materials taking account of any
nationally authorised migration limit.
The ML does not apply to melamine that could be present in the
following feed ingredients / additives: guanidine acetic acid (GAA), urea
and biuret, as a result of normal production processes.
Powdered infant
1
formula
Liquid infant formula 0.15 The ML applies to liquid infant formula as consumed.
CXS 193-1995 65