GCC Standardization Organization (Gso)

‫هيئة التقييس لدول مجلس التعاون لدول الخليج العربية‬
GCC STANDARDIZATION ORGANIZATION (GSO)
‫مشروع مواصفة أولي‬

Draft of Standard DS
TC05 ‫اعداد اللجنة الخليجية رقم‬
Prepared by GSO Technical Committee No. TC05
GSO /2019
‫الملوثات والسموم في األغذية واألعالف‬

Contaminants and toxins in food and feed
This document is a draft GSO Standard ‫هذه الوثيقة مشروع لمواصفة قياسية خليجية تم‬
circulated for comments. It is, therefore,
‫ لذلك‬،‫توزيعها إلبداء الرأي والملحوظات بشأنها‬
subject to alteration and modification and
may not be referred to as a GSO Standard ‫ وال يجوز الرجوع‬،‫فإنها عرضة للتغيير والتبديل‬
until approved by GSO. ‫إليها كمواصفة قياسية خليجية إال بعد اعتمادها من‬
.‫الهيئة‬
ICS: 67.040
GSO STANDARD GSO /2019
Foreword
GCC Standardization Organization (GSO) is a regional Organization which consists of the

National Standards Bodies of GCC member States. One of GSO main functions is to issue
Gulf Standards /Technical regulations through specialized technical committees (TCs).
GSO through the technical program of committee TC No.(5) " Technical committee for
standards of food and agriculture products " has prepared the GSO Technical regulation .
The Draft Technical regulation has been prepared by Kingdom of Saudi Arabia.
This Technical regulation has been approved by GSO Board of Directors in its meeting No.
( ), held on ( ) .
* The limits of food contaminants in this regulation replaced all the food contaminants limits
in the approved GSO food technical regulations and standards - if no limits or contaminants
are listed for certain food products in this regulation, the food contaminants limits in food
product regulation shall be applied.
This regulation shall hereby cancel and replace the following regulations:
- GSO 1807:2007 “Maximum level for cadmium in food”.

- GSO 988:1998 “Limits of radioactivity levels permitted in foodstuffs - Part 1”.
- GSO 2042:2010 “Maximum levels of Melamine in Foods and Feeds”.
- GSO 841:1997 “Maximum limits of mycotoxins permitted in foods and animal feeds
- Aflatoxins”.
2
Contaminants and toxins in food and feed
1. Scope
This Standard contains maximum levels of contaminants and toxicants in food
and feed, This Standard includes only maximum levels of contaminants and
natural toxicants in feed in cases where the contaminant in feed can be
transferred to food of animal origin and can be relevant for public health.
2. Complementary References
GSO CAC/GL 41 “Analysis of pesticide residues – Portion of commodities to
which Codex MRLS apply and which is analyzed”
2. Definition of Terms
When reference is made to foods, this also applies to animal feed, in those cases
where this is appropriate.
2.1 Contaminant
Any substance not intentionally added to food or feed for food producing
animals, which is present in such food or feed as a result of the production
(including operations carried out in crop husbandry, animal husbandry and
veterinary medicine), manufacture, processing, preparation, treatment, packing,
packaging, transport or holding of such food or feed, or as a result of
environmental contamination. The term does not include insect fragments,
rodent hairs and other extraneous matter.
This Standard applies to any substance that meets the terms for a contaminant,
including contaminants in feed for food-producing animals, except:
1) Contaminants having only food and feed quality significance (e.g. copper),
but no public health significance.
2) Pesticide residues.
3) Residues of veterinary drugs, and residues of feed additives1.
4) Microbial toxins, such as botulinum toxin and staphylococcus enterotoxin.
5) Residues of processing aids2.
2.2 Natural toxins included in this Standard
The definition of a contaminant implicitly includes naturally occurring toxicants
including toxic metabolites of certain microfungi that are not intentionally added
to food and feed (mycotoxins).
1
Feed additives: “Any intentionally added ingredient not normally consumed as feed by itself, whether or not
it has nutritional value, which affects the characteristics of feed or animal products.
Residues of feed additives include the parent compounds and/or their metabolites in any edible portion of the
animal product, and include residues of associated impurities of the feed additive concerned.
2
Processing aids are any substance or material, not including apparatus or utensils, and not consumed as a
food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to
fulfil a certain technological purpose during treatment or processing and which may result in the non-
intentional but unavoidable presence of residues or derivatives in the final product.
3
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.
Endogenous natural toxicants, such as e.g. Solanine in potatoes, that are implicit
constituents of food and feed resulting from a genus, species or strain ordinarily
producing hazardous levels of a toxic metabolite(s), i.e. phytotoxins are not
generally considered within the scope of this Standard. They are, however,
within the terms of reference of CCCF and will be dealt with on a case-by-case
basis.
2.3 Maximum level and related terms1
The maximum level (ML) for a contaminant in a food or feed commodity is the
maximum concentration of that substance recommended by this standard to be
legally permitted in that commodity.
3. Principles Regarding Contaminants in Food and Feed

3.1 General
Contamination of food and feed may pose a risk to human (and/or animal health).
Moreover in some cases they may also have a negative impact on the quality of
the food or feed. Food and feed can become contaminated by various causes and
processes.
Contaminant levels in food and feed shall be as low as reasonably achievable
through best practice such as Good Agricultural Practice (GAP) and Good
Manufacturing Practice (GMP) following an appropriate risk assessment. The
following actions may serve to prevent or to reduce contamination of feed and
food2:
• 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
1
For the contaminants methylmercury, radionuclides, acrylonitrile and vinylchloride monomer a Codex
guideline level (GL) has been established.
A Codex guideline level (GL) is the maximum level of a substance in a food or feed commodity which is
recommended by the Codex Alimentarius Commission to be acceptable for commodities moving in
international trade.
2
In addition, reference is made to the Code of Practice for source Directed measures to reduce
contamination of food with chemicals (CXC 49-2001) and the Code of Practice on Good Animal Feeding
(CXC 54-2004).
4
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.
3.2 Principles for establishing maximum levels in food and feed
MLs shall only be set for food in which the contaminant may be found in
amounts that are significant for the total exposure of the consumer.
3.3 Specific criteria
The following criteria should (not preventing the use of other relevant criteria)
be considered when developing MLs and/or other measures in connection with
the General Standard for Contaminants and Toxins in Food and Feed.
Toxicological information
• identification of the toxic substance(s);
• metabolism by humans and animals, as appropriate;
• toxicokinetics and toxicodynamics including information on possible carry-
over of the toxic substance from feed to edible animal tissue/products;
• information about acute and long term toxicity and other relevant toxicity
data; and
• integrated toxicological expert advice regarding the acceptability and safety
of intake levels of contaminants, including information on any population
groups which are especially vulnerable.
Analytical data
• validated qualitative and quantitative data on representative samples; and
• appropriate sampling procedures.
Intake data
• presence in food of dietary significance for the contaminant;
• presence in food that are widely consumed;
• presence in feed and feed components;
• food intake data for average and most exposed/high consumer groups;
• results from total diet studies;
• calculated contaminant intake data from food consumption models;
• data on intake by susceptible groups; and
• data on intake by food producing animals.
5
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

• 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.
6
AFLATOXINS, TOTAL
Reference to JECFA: 31 (1987), 46 (1996), 49 (1997), 68 (2007)
Carcinogenic potency estimates for aflatoxins B, G, M (1997, Intake
Toxicological guidance value:
should be reduced to levels as low as reasonably possible)
Contaminant definition: Aflatoxins total (B1 + B2 + G1 + G2)
Abbreviations, AFB, AFG, with numbers, to designate specific
Synonyms:
compounds
Code of Practice for the Prevention and Reduction of Aflatoxin
Contamination in Peanuts (CXC 55-2004)
Contamination in Tree Nuts (CXC 59-2005)
Related code of practice:
Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and
Supplemental Feedingstuffs for Milk Producing Animals (CXC 45-1997)
Contamination in Dried Figs (CXC 65-2008)
Maximum Portion of the
Commodity/Product
Level (ML) Commodity/Product
Notes/Remarks
Name to which the ML
μg/kg
applies
Almonds 10 Whole commodity after The ML applies to almonds “ready-to-
removal of shell. eat” (**)
For sampling plan, see Annex 2.
Almonds 15 Whole commodity after The ML applies to almonds intended
removal of shell. for further processing (*)
Brazil nuts 10 Whole commodity The ML applies to shelled Brazil nuts
ready-to-eat (**).
Brazil nuts 15 Whole commodity The ML applies to shelled Brazil nuts
intended for further processing (*)
Hazelnuts 10 Whole commodity after The ML applies to hazelnuts, also
removal of shell. known as filberts, “ready to eat” (**)
Hazelnuts 15 Whole commodity after The ML applies to hazelnuts, also
removal of shell. known as filberts, intended for further
processing (*)
Peanuts 15 Unless specified, seed The ML applies for peanuts, also
or kernels, after emoval known as groundnuts, intended for
of shell or husk. further processing (*).
Pistachios 10 Whole commodity after The ML applies to pistachios “ready to
removal of shell. eat” (**).
Pistachios 15 Whole commodity after The ML applies to pistachios intended
removal of shell. for further processing (*)
Dried figs 10 Whole commodity The ML applies to dried figs “ready-
to-eat” (**)
For sampling plan see Annex 3.
7
(*) “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.
With the exception of foodstuffs
Foods 20 Whole commodity
listed in table.
Dried fruit, other than dried figs, to
be subjected to sorting, or other
Dried fruit and dried
10 Whole commodity physical treatment, before human
fruit products
consumption or use as an
ingredient in foodstuffs
Dried fruit, other than dried figs,
and processed products thereof,
Dried fruit and dried
4 Whole commodity intended for direct human
fruit products
consumption or use as an
ingredient in foodstuffs
All cereals and all products
Cereals and all derived from cereals, including
products derived 4 Whole commodity processed cereal products, with
from cereals the exception of foodstuffs listed
in table.
Maize and rice to be subjected to
sorting or other physical treatment
Maize and rice 10 Whole commodity
before human consumption or use
as an ingredient in foodstuffs
Following species of spices:
Capsicum spp. (dried fruits
thereof, whole or ground,
including chillies, chilli powder,
Spices 10 Whole commodity
cayenne and paprika)
Piper spp. (fruits thereof, including
white and black pepper)
Myristica fragrans (nutmeg)
8
Zingiber officinale (ginger)

Curcuma longa (turmeric)
Mixtures of spices containing one
or more of the abovementioned
spices
Animal Feeds - Corn and peanut products
Corn and peanut 300 Whole commodity intended for finishing (i.e., feedlot)
products beef cattle
Cottonseed meal intended for
Animal Feeds - beef, cattle, swine, or poultry
300 Whole commodity
Cottonseed meal (regardless of age or breeding
status
Animal Feeds - Corn and peanut products
Corn and peanut 100 Whole commodity intended for breeding beef cattle,
products or mature poultry
Animal Feeds - Corn, peanut products, and other
Corn, peanut animal feeds and feed ingredients
20 Whole commodity
products, and other but excluding cottonseed meal,
animal feeds intended for immature animals
Corn, peanut products, cottonseed
Animal Feeds -
meal, and other animal feed
Corn, peanut
ingredients intended for dairy
products, cottonseed 20 Whole commodity
animals, for animal species or
meal, and other
uses not specified above, or when
animal feed
the intended use is not known
9
AFLATOXIN M1
Reference to JECFA: 56 (2001)
Cancer potency estimates at specified residue levels (2001, Using
worst-case assumptions, the additional risks for liver cancer predicted
with use of proposed maximum levels of aflatoxin M1 of 0.05 and 0.5
μg/kg are very small. The potency of aflatoxin M1 appears to be so low
in HBsAg- individuals that a carcinogenic effect of M1 intake in those
who consume large quantities of milk and milk products in comparison
with non-consumers of these products would be impossible to
demonstrate. Hepatitis B virus carriers might benefit from a reduction
in the aflatoxin concentration in their diet, and the reduction might also
offer some protection in hepatitis C virus carriers).
Contaminant definition: Aflatoxin M1
Synonyms: AFM1
Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and
Supplemental Feedingstuffs for Milk Producing Animals (CXC 45-1997)
Commodity/Product
Notes/Remarks
μg/kg
applies
Milk is the normal mammary
secretion of milking animals obtained
from one or more milkings without
0.5 either addition to it or extraction from
Milks Whole commodity.
it, intended for consumption as liquid
milk or for further processing.
A concentration factor applies to
partially or wholly dehydrated milks.
10
DEOXYNIVALENOL (DON)
Reference to JECFA: 56 (2001), 72 (2010)
Group PMTDI 0.001 mg/kg bw (2010, for DON and its acetylated
derivates)
Group ARfD 0.008 mg/kg bw (2010, for DON and its acetylated
derivates)
Contaminant definition: Deoxynivalenol
Synonyms: Vomitoxin; Abbreviation, DON
Code of Practice for the Prevention and Reduction of Mycotoxin
Contamination in Cereals (CXC 51-2003)
Commodity/Product
Notes/Remarks
μg/kg
applies
Cereal-based foods for 200 ML applies to the All cereal-based foods intended for
infants and young commodity on a dry infants (up to 12 months) and young
children matter basis. children (12 to 36 months)
Flour, meal, semolina 1000
and flakes derived from
wheat, maize or barley
“Destined for further processing”
means intended to undergo an
additional processing/treatment that
Cereal grains (wheat, has proven to reduce levels of DON
maize and barley) before being used as an ingredient in
2000
destined for further foodstuffs, otherwise processed or
processing offered for human consumption.
Codex members may define the
processes that have been shown to
reduce levels
Pasta (dry) 750
Bread, pastries, Bread (including small bakery wares),
biscuits, cereal snacks 500 pastries, biscuits, cereal snacks and
and breakfast cereals breakfast cereals
11
FUMONISINS (B1 + B2)

Toxicological guidance value: PMTDI 0.002 mg/kg bw (2001, 2011)
Contaminant definition: Fumonisins (B1+ B2)
Several related compounds have been described, notably fumonisin B1,
Synonyms:
B2 and B3 (abbreviation: FB1 etc.)
Commodity/Product
Notes/Remarks
μg/kg
applies
Raw maize grain 4000 Whole commodity
Maize flour and maize 2000 Whole commodity
meal
Processed maize- 200
based foods and baby
foods for infants and
young children
12
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
(The term “ochratoxins” includes a number of related mycotoxins (A, B,
Synonyms: C and their esters and metabolites), the most important one being
ochratoxin A)
Code of Practice for the Prevention and Reduction of Ochratoxin A
Contamination in Wine (CXC 63-2007)
Contamination in Coffee (CXC 69-2009)
contamination in Cocoa (CXC 72-2013)
Commodity/Product
Notes/Remarks
μg/kg
applies
Wheat 5 Whole commodity The ML applies to raw common
wheat, raw durum wheat, raw spelt
and raw emmer.
Barley 5 Whole commodity The ML applies to raw barley.
Rye 5 Whole commodity The ML applies to raw rye.
Unprocessed cereals 5 Unprocessed cereals
Products derived from 3 All products derived from
unprocessed cereals, unprocessed cereals, including
including processed processed cereal products and
cereal products and cereals intended for direct human
cereals consumption with the exception of
foodstuffs listed in table.
Dried vine fruit 10 Dried vine fruit (currants, raisins and
sultanas)
Roasted coffee beans 5 excluding soluble coffee
and ground roasted
coffee
Soluble coffee 10
Grape juice and 2 Grape juice, concentrated grape juice
concentrated grape as reconstituted, grape nectar, grape
juice must and concentrated grape must as
reconstituted, intended for direct
human consumption
Processed cereal- 0.5
young children
Dietary foods for 0.5
special medical
purposes intended
specifically for infants
Spices, including dried 15 Piper spp (fruits thereof, including
spices white and black pepper)
13
Myristica fragrans (nutmeg)

Zingiber officinale (ginger)
Curcuma longa (turmeric)
Pepper 15 Capsicum spp. (dried fruits thereof,
whole or ground, including chillies,
chilli powder, cayenne and paprika)
Mixtures of spices 15 Mixtures of spices containing one of
the abovementioned spices
Liquorice root 20 Liquorice root, ingredient for herbal
infusion
Liquorice extract 80 For use in food in particular
beverages and confectionary
Wheat gluten 8 not sold directly to the consumer
14
PATULIN
Toxicological guidance value: PMTDI 0.0004 mg/kg bw (1995)
Contaminant definition: Patulin
Code of Practice for the Prevention and Reduction of Patulin
Related code of practice: Contamination in Apple Juice and Apple Juice Ingredients in Other
Beverages (CXC 50-2003)
Commodity/Product
Notes/Remarks
μg/kg
applies
Apple juice 50 Whole commodity (not Relevant Codex commodity standard
concentrated) or include CXS 247-2005 (apple
commodity products only).
reconstituted to the The ML applies also to apple juice
original juice used as an ingredient in other
concentration. beverages.
Solid apple products 25 Solid apple products, including apple
and apple puree compote, apple puree intended for
direct consumption with exception
mentioned
Apple juice and solid 10 Apple juice and solid apple products,
apple products including apple compote and apple
puree, for infants and young children
and labelled and sold as such
Baby foods other than 10
processed cereal-
based foods for infants
and young children
15
ARSENIC
Reference to JECFA: 5 (1960), 10 (1967), 27 (1983), 33 (1988), 72 (2010)
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.
Arsenic: total (As-tot) when not otherwise mentioned; inorganic
Contaminant definition:
arsenic (As-in); or other specification
Synonyms: As
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
Notes/Remarks
mg/kg
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
applying the ML for As-in in fish oils
Edible fats and oils 0.1 Whole commodity 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 Relevant Codex commodity standard
0.1
blended spreads is CXS 256-2007.
Relevant Codex commodity standard
Natural mineral waters 0.01 is CXS 108-1981.
Calculated as total As in mg/l.
Rice, husked 0.25 Whole commodity Determined as inorganic Arsenic
Rice, polished 0.2 Whole commodity Determined as inorganic Arsenic
Salt, food grade 0.5
is CXS 150-1985.
0.3 Determined as inorganic Arsenic
Rice Products
Rice pies, rice flakes and rice cakes
16
Rice for baby and 0.1 Determined as inorganic Arsenic

infant food Rice for baby and infant food
17
CADMIUM
16 (1972), 33 (1988), 41 (1993), 55 (2000), 61 (2003), 64 (2005), 73
Reference to JECFA:
(2010)
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
Commodity/Product
Notes/Remarks
mg/kg
applies
Head cabbages and
kohlrabi: whole
commodity as
marketed, after
removal of obviously
decomposed or
The ML does not apply to Brassica
Brassica vegetables 0.05 withered leaves.
leafy vegetables.
Cauliflower and
broccoli: flower heads
(immature
inflorescence only).
Brussels sprouts:
“buttons” only.
Bulb/dry onions and
garlic: whole
commodity after
Bulb vegetables 0.05 removal of roots and
adhering soil and
whatever parchment
skin is easily detached.
Whole commodity after The ML does not apply to tomatoes
removal of stems. and edible fungi.
Fruiting vegetables 0.05 Sweet corn and fresh
corn: kernels plus cob
without husk.
Whole commodity as The ML also applies to Brassica leafy
usually marketed, after vegetables.
Leafy vegetables 0.2 removal of obviously
decomposed or
withered leaves.
Whole commodity as
consumed. The
Legume vegetables 0.1
succulent forms may
be consumed as whole
18
pods or as the shelled

product.
Whole commodity The ML does not apply to soya bean
Pulses 0.1
(dry).
Whole commodity after The ML does not apply to celeriac.
removing tops.
Remove adhering soil
Root and tuber (e.g. by rinsing in
0.1
vegetables running water or by
gentle brushing of the
dry commodity).
Potato: peeled potato.
Whole commodity as
marketed after removal
of obviously
decomposed or
withered leaves.
Stalk and stem
0.1 Rhubarb: leaf stems
vegetables
only.
Globe artichoke: flower
head only.
Celery and asparagus:
remove adhering soil.
Whole commodity The ML does not apply to buckwheat,
Cereal grains 0.1
cañihua, quinoa, wheat and rice.
Rice, polished 0.4 Whole commodity
Whole commodity The ML applies to common wheat,
Wheat 0.2
durum wheat, spelt and emmer.
Whole commodity after The ML applies to clams, cockles and
Marine bivalve
2 removal of shell. mussels but not to oysters and
molluscs
scallops.
Whole commodity after The ML applies to cuttlefishes,
Cephalopods 2
removal of shell. octopuses and squids without viscera
The ML is expressed in mg/l.
Salt, food grade 0.5
is CXS 150-1985.
Whole commodity as Including sweet chocolate, Gianduja
Chocolate containing
prepared for wholesale chocolate, semi – bitter table
or declaring ≥ 50% to <
0.8 or retail distribution chocolate, Vermicelli chocolate /
70% total cocoa solids
chocolate flakes, and bitter table
on a dry matter basis
chocolate.
Whole commodity as Including sweet chocolate, Gianduja
Chocolate containing
prepared for wholesale chocolate, semi – bitter table
or declaring ≥ 70%
0.9 or retail distribution chocolate, Vermicelli chocolate /
total cocoa solids on a
chocolate flakes, and bitter table
dry matter basis
chocolate.
Vegetables and fruit, with exception mentioned
with exception 0.05
mentioned
Mushroom 0.2
Fungi with exception with exception mentioned
1
mentioned
Soy beans 0.2
Cocoa powder Cocoa powder sold to the final
0.6
(drinking chocolate) consumer or as an ingredient in
19
sweetened cocoa powder sold to the

final consumer (drinking chocolate)
Milk chocolate with <
30 % total dry cocoa 0.1
solids
Chocolate with < 50 %
total dry cocoa solids;
milk chocolate with ≥ 0.3
30 % total dry cocoa
solids
Meat of bovine excluding offal
animals, sheep and 0.05
poultry
Horsemeat 0.2 excluding offal
Liver of bovine
animals, sheep, poultry 0.5
and horse
Kidney of bovine
animals, sheep, poultry 1
and horse
Muscle meat of fish: Muscle meat
Mackerel, tuna and 0.1
bichique
0.15
bullet tuna
Anchovy, swordfish 0.25
and sardine
Muscle meat of Fish Muscle meat
with exception 0.05
mentioned
Crustaceans 0.5 Muscle meat Excluding brown meat (offal)
Powdered formulae
manufactured from
0.01
cows' milk proteins or
protein hydrolysates
Liquid formulae
manufactured from
0.005
cows' milk proteins or
protein hydrolysates
Powdered formulae
manufac-tured from
soya protein isolates, 0.02
alone or in a mixture
with cows' milk proteins
Liquid formulae
manufactured from
soya protein isolates, 0.01
alone or in a mixture
with cows' milk proteins
Processed cereal-
0.04
young children
Food supplements
consisting exclusively
3
or mainly of dried
seaweed, products
20
derived from seaweed,

or of dried bivalve
molluscs
Food supplements with
1
exception mentioned
21
LEAD
10 (1966), 16 (1972), 22 (1978), 30 (1986), 41 (1993), 53 (1999), 73
Reference to JECFA:
(2010)
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
Toxicological guidance value: 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
Code of Practice for the Prevention and Reduction of Lead
Contamination in Foods (CXC 56-2004)
Commodity/Product
Level (ML) Commodity/Product to
Notes/Remarks
Name which the ML applies
mg/kg
Whole commodity after
Berries and other small The ML does not apply to cranberry,
0.1 removal of caps and
fruits currant and elderberry.
stems.
Cranberry 0.2 removal of caps and
stems.
Currants 0.2 Fruit with stem.
Elderberry 0.2 removal of 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
The ML does not apply to cranberry,
Fruits 0.1 olives: whole
currant and elderberry.
commodity after
removal of stems and
stones, but the level
calculated and
expressed on the
whole commodity
without stem.
Pineapple: whole
commodity after
removal of crown.
22

Commodity/Product
Notes/Remarks
mg/kg
Avocado, mangos and
similar fruit with hard
seeds: whole
commodity after
removal of stone but
calculated on whole
fruit.
Bulb/dry onions and
garlic: whole
commodity after
The ML does not apply to kale and
Brassica vegetables 0.1 removal of roots and
leafy Brassica vegetables.
adhering soil and
whatever parchment
Bulb/dry onions and
garlic: whole
commodity after
Bulb vegetables 0.1 removal of roots and
adhering soil and
whatever parchment
removal of stems
The ML does not apply to fungi and
Fruiting vegetables 0.05 Sweet corn and fresh
mushrooms.
corn: kernels plus cob
without husk.
Whole commodity as
usually marketed, after The ML applies to leafy Brassica
Leafy vegetables 0.3 removal of obviously vegetables but does not apply to
decomposed or spinach.
withered leaves.
Whole commodity as
consumed. The
succulent forms may
Legume vegetables 0.1
be consumed as whole
pods or as the shelled
product.
Fresh farmed
mushrooms (common
mushrooms (Agaricus
bisporous), shiitake Relevant Codex commodity standard
0.3 Whole commodity
mushrooms (Lentinula is CXS 38-1981
edodes), and oyster
mushrooms (Pleurotus
ostreatus))
Pulses 0.1 Whole commodity
removing tops.
Remove adhering soil
Root and tuber (e.g. by rinsing in
0.1
vegetables running water or by
gentle brushing of the
dry commodity).
Potato: peeled potato.
23

Commodity/Product
Notes/Remarks
mg/kg
Relevant Codex commodity standards
are CXS 242-2003, CXS 254-2007,
The ML applies to the
Canned fruits 0.1 CXS 78-1981, CXS 159-1987, CXS
product as consumed.
42-1981, CXS 99-1981, CXS 60-
1981, CXS 62-1981
Jams, jellies and
0.4 is CXS 296-2009 (for jams and jellies
marmalades
only).
Mango chutney 0.4
is CXS 160-1987.
The ML applies to the Relevant Codex commodity standard
Canned vegetables 0.1
product as consumed. is CXS 297-2009.
is CXS 13-1981.
In order to consider the concentration
of the product, the determination of
Preserved tomatoes 0.05
the maximum levels for contaminants
shall take into account the natural
total soluble solids, the reference
value being 4.5 for fresh fruit.
Table olives 0.4
is CXS 66-1981.
Pickled cucumbers Relevant Codex commodity standard
0.1
(cucumber pickles) is CXS 115-1981.
Canned chestnuts and
canned chestnuts 0.05
is CXS 145-1985.
puree
Whole commodity (not
concentrated) or
commodity The ML does not apply to juices
reconstituted to the exclusively from berries and other
Fruit juices 0.03 original juice small fruit.
concentration, ready to Relevant Codex commodity standard
drink. is CXS 247-2005.
The ML applies also to
nectars, ready to drink.
concentrated) or
commodity
Fruit juices obtained
reconstituted to the The ML does not apply to grape juice.
exclusively from
0.05 original juice Relevant Codex commodity standard
berries and other small
concentration, ready to is CXS 247-2005.
fruits
drink. The ML applies
also to nectars, ready
to drink.
concentrated) or
commodity
reconstituted to the
Grape juice 0.04 original juice
is CXS 247-2005.
concentration, ready to
drink. The ML applies
also to nectars, ready
to drink.
24

Commodity/Product
Notes/Remarks
mg/kg
The ML does not apply to buckwheat
Cereal grains 0.2 Whole commodity
cañihua and quinoa.
Infant formula, formula
for special medical
are CXS 72-1981 and CXS 156-1987.
purposes intended for 0.01 Whole commodity
The ML applies to formula as
infants and follow-up
consumed.
formula
Whole commodity (in
Fish 0.3 general after removing
the digestive tract)
Meat of cattle and Whole commodity The ML also applies to fat from the
0.1
sheep (without bones) meat.
Whole commodity
Meat and fat of poultry 0.1
(without bones)
Cattle, edible offal of 0.5 Whole commodity
Poultry, edible offal of 0.5 Whole commodity
Whole commodity as
are CXS 19-1981, CXS 33-1981, CXS
Edible fats and oils 0.08 prepared for wholesale
210-1999, CXS 211-1999 and CXS
or retail distribution.
329-2017
Whole commodity as
Fat spreads and Relevant Codex commodity standard
0.04 prepared for wholesale
blended spreads is CXS 256-2007.
or retail distribution.
Milk is the normal mammary secretion
of milking animals obtained from one
or more milkings without either
addition to it or extraction from it,
Milk 0.02 Whole commodity
intended for consumption as liquid
milk or for further processing.
A concentration factor applies to
partially or wholly dehydrated milks
Secondary milk The ML applies to the food as
0.02 Whole commodity
products consumed.
Whole commodity as Relevant Codex commodity standard
Salt, food grade 1 prepared for wholesale is CXS 150-1985.
or retail distribution Excluding salt from marshes
Concentrated fruit
0.05
juices and fruit nectars
Infant formulae and 0.02
follow-on formulae
Crustaceans 0.5 Muscle meat
Bivalve molluscs 1.5
Cephalopods 1 Without viscera
Food supplements 3
25
MERCURY
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
Toxicological guidance value: 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
Commodity/Product
Notes/Remarks
mg/kg
Salt food grade 0.1
is CXS 150-1985.
Tuna 1.2 removing the digestive
tract
Alfonsino 1.5 removing the digestive
tract
Marlin 1.7 removing the digestive
tract
Shark 1.6 removing the digestive
tract
Fishery products and 1
muscle meat of fish
with exception
mentioned,
Crustaceans and crabs
Food supplements 0.1
Wheat pink kernels 1 Pink kernels only
26
METHYLMERCURY IN CERTAIN FISH SPECIES AND CRUSTACEANS

Toxicological guidance value: PTWI 0.0016 mg/kg bw (2003, confirmed in 2006)
Contaminant definition: Methylmercury
Commodity/Product
Notes/Remarks
mg/kg
Tuna 1.2
Whole commodity
Alfonsino 1.5 fresh or frozen (in The ML also applies to fresh or frozen
Marlin 1.7 general after removing fish intended for further processing.
the digestive tract)
Shark 1.6
Crustaceans and crabs 1
27
TIN
10 (1966), 14 (1970), 15 (1971), 19 (1975), 22 (1978), 26 (1982), 33
Reference to JECFA:
(1988), 55 (2000), 64 (2005)
PTWI 14 mg/kg bw (1988, expressed as Sn; includes tin from food
additive uses; maintained in 2000)
Tin, total (Sn-tot) when not otherwise mentioned; inorganic tin (Sn-in);
Contaminant definition:
or other specification
Synonyms: Sn
Code of Practice for the Prevention and Reduction of Inorganic Tin
Contamination in Canned Foods (CXC 60-2005)
Commodity/Product
Notes/Remarks
mg/kg
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.
standards include CXS 62-1981, CXS
Canned foods (other 254-2007, CXS 296-2009, CXS 242-
250
than beverages) 2003, CXS 297-2009, CXS 78-1981,
CXS 159-1987, CXS 42-1981, CXS
60-1981, CXS 99-1981, CXS 160-
1987, CXS 66-1981, CXS 13-1981,
CXS 115-1981, CXS 57-1981, CXS
145-1981, CXS 98-1981, CXS 96-
1981, CXS 97-1981, CXS 88-
1981,CXS 89-1981.
Canned beverages 150
standards include CXS 247-2005.
The ML applies to products in
containers other than tinplate
Cooked cured chopped
50 containers.
meat
is CXS 98-1981.
The ML applies to products in
Corned beef 50 containers.
is CXS 88-1981.
50 The ML applies to products in
Luncheon meat containers.
is CXS 89-1981.
Canned baby foods 50
and processed cereal-
based foods for infants
and young children,
28
excluding dried and

powdered products
Canned infant formulae 50
and follow-on formulae,
excluding dried and
powdered products
Canned dietary foods 50
for special medical
purposes intended
specifically for infants,
excluding dried and
powdered products
29
RADIONUCLIDES
Guideline Representative Portion of the
Commodity/Product
Level (GL) radionuclides Commodity/Product
Notes/Remarks
Name to which the GL
(Bq/kg)
applies
Pu-238, Pu-239, The GL applies to foods
Infant foods 1 Pu-240, Am-241 intended for consumption
by infants.
Infant foods Sr-90, Ru-106, I- The GL applies to foods
100 129, I-131, U-235 intended for consumption
by infants.
Infant foods S-35 (*), Co-60, Sr- The GL applies to foods
89, Ru-103, Cs- intended for consumption
1000
134, Cs-137, Ce- by infants.
144, Ir-192
Infant foods H-3(**), C-14, Tc- The GL applies to foods
1000 99 intended for consumption
by infants.
Foods other than Pu-238, Pu-239,
10
infant foods Pu-240, Am-241
Foods other than Sr-90, Ru-106, I-
100
infant foods 129, I-131, U-235
Foods other than 1000 S-35 (*), Co-60, Sr-
infant foods 89, Ru-103, Cs-
134, Cs-137, Ce-
144, Ir-192
Foods other than 10000 H-3(**), C-14, Tc-
infant foods 99
)*(This represents the value for organically bound sulphur
)**(This represents the value for organically bound tritium
Scope: The Guideline Levels apply to radionuclides contained in foods destined for human
consumption and traded internationally, which have been contaminated
following a nuclear or radiological 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 corresponding Guideline Levels,
the food should be considered as safe for human consumption. in the case of
wide-spread radioactive contamination. For foods that are consumed in small
quantities, such as spices, that represent a small percentage of total diet and
hence a small addition to the total dose, the Guideline Levels may be increased
by a factor of 10.
Radionuclides: The Guideline Levels do not include all radionuclides. Radionuclides
included are those important for uptake into the food chain; are usually contained
in nuclear installations or used as a radiation source in large enough quantities
to be significant potential contributors to levels in foods, and; could be
accidentally released into the environment from typical installations or might be
1
For the purposes of this document, the term “emergency” includes both accidents and malevolent actions.
30
employed in malevolent actions. Radionuclides of natural origin are generally

excluded from consideration in this document.
In the Table, the radionuclides are grouped according to the guideline levels
rounded logarithmically by orders of magnitude. Guideline levels are defined for
two separate categories “infant foods” and “other foods”. This is because, for a
number of radionuclides, the sensitivity of infants could pose a problem. The
guideline levels have been checked against age-dependent ingestion dose
coefficients defined as committed effective doses per unit intake for each
radionuclide, which are taken from the “International Basic Safety Standards”
(IAEA, 1996)1.
Multiple radionuclides in foods: The guideline levels have been developed with the
understanding that there is no need to add contributions from radionuclides in
different groups. Each group should be treated independently. However, the
activity concentrations of each radionuclide within the same group should be
added together2.
1
Food and Agriculture Organization of the United Nations, International Atomic Energy Agency,
International Labour Office, OECD Nuclear Energy Agency, Pan American Health Organization, World
Health Organization (1996) International Basic Safety Standards for Protection against Ionizing Radiation
and for the Safety of Radiation Sources, IAEA, Vienna.
2
For example, if 134Cs and 137Cs are contaminants in food, the guideline level of 1 000 Bq/kg refers to the
summed activity of both these radionuclides.
31
Annex A
SCIENTIFIC JUSTIFICATION FOR THE GUIDELINE LEVELS FOR
RADIONUCLIDES IN FOODS CONTAMINATED FOLLOWING A
NUCLEAR OR RADIOLOGICAL EMERGENCY
Infants and adults: The levels of human exposure resulting from consumption of foods
containing radionuclides listed in Table 1 at the suggested guideline levels have been
assessed both for infants and adults and checked for compliance with the appropriate dose
criterion.
In order to assess public exposure and the associated health risks from intake of radionuclides
in food, estimates of food consumption rates and ingestion dose coefficients are needed. It
is assumed that 550 kg of food is consumed by an adult in a year. The value of infant food
and milk consumption during first year of life used for infant dose calculation equal to 200
kg is based on contemporary human habit assessments. The most conservative values of the
radionuclide-specific and age-specific ingestion dose coefficients, i.e. relevant to the
chemical forms of radionuclides which are most absorbed from the gastro-intestinal tract and
retained in body tissues, are taken from the IAEA.
Radiological criterion: The appropriate radiological criterion, which has been used for
comparison with the dose assessment data below, is a generic intervention exemption level
of around 1 mSv for individual annual dose from radionuclides in major commodities, e.g.
food, recommended by the International Commission on Radiological Protection as safe for
members of the public.
Naturally occurring radionuclides: Radionuclides of natural origin are ubiquitous and as
a consequence are present in all foodstuffs to varying degrees. Radiation doses from the
consumption of foodstuffs typically range from a few tens to a few hundreds of microsieverts
in a year. In essence, the doses from these radionuclides when naturally present in the diet
are unamenable to control; the resources that would be required to affect exposures would
be out of proportion to the benefits achieved for health. These radionuclides are excluded
from consideration in this document as they are not associated with emergencies.
One-year exposure assessment: It is conservatively assumed that during the first year after
major environmental radioactive contamination caused by a nuclear or radiological
emergency it might be difficult to 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 B). 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
32
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.
33
Annex B
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:
E = GL(A) M(A) eing(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 factor1 (dimensionless)
Assessment results presented in Table 2 both for infants and adults demonstrate that for all
the twenty radionuclides doses from consumption of imported foods during the 1st year after
major radioactive contamination do not exceed 1 mSv. It should be noted that the doses were
calculated on the 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
estimate is conservative. This is because elevated gastro-intestinal tract absorption factors
and associated ingestion dose coefficients are applied for the whole first year of life whereas
this is valid mainly during suckling period recently estimated by ICRP to be as average first
six months of life. For the subsequent six months of the first year of life the gut absorption
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 = 1 000 Bq/kg 550 kg 1.3 10-5 mSv/Bq 0.1 = 0.7 mSv;
For infants: E = 1 000 Bq/kg 200 kg 2.1 10-5 mSv/Bq 0.1 = 0.4 mSv
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.
34
TABLE 2
ASSESSMENT OF EFFECTIVE DOSE FOR INFANTS AND ADULTS FROM
INGESTION OF IMPORTED FOODS IN A YEAR
Guideline Level (Bq/kg) Effective dose (mSv)
1st year after major
Radionuclide
Infant foods Other foods contamination
Infants Adults
238Pu 0.08 0.1
239Pu 0.08 0.1
1 10
240Pu 0.08 0.1
241Am 0.07 0.1
90Sr 0.5 0.2
106Ru 0.2 0.04
129I 100 100 0.4 0.6
131I 0.4 0.1
235U 0.7 0.3
35S* 0.2 0.04
60Co 1 0.2
89Sr 0.7 0.1
103Ru 0.1 0.04
1000 1000
134Cs 0.5 1
137Cs 0.4 0.7
144Ce 1 0.3
192Ir 0.3 0.08
3H** 0.002 0.02
14C 1000 10000 0.03 0.3
99Tc 0.2 0.4
* This represents the value for organically bound sulphur

** This represents the value for organically bound tritium
35
ACRYLONITRILE
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)
2-Propenenitrile; vinyl cyanide (VCN); cyanoethylene; abbreviations,
Synonyms:
AN, CAN.
Commodity/Product
Notes/Remarks
mg/kg
Food 0.02
36
CHLOROPROPANOLS
Reference to JECFA: 41 (1993; for 1,3-dichloro-2-propanol only), 57 (2001), 67 (2006)
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
Toxicological guidance value: 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
Two substances are the most important members of this group: 3-
Synonyms: monochloropropane-1,2-diol (3-MCPD, also referred to as 3-
monochloro-1,2-propanediol) and 1,3-dichloro-2-propanol (1,3-DCP).
Code of Practice for the Reduction of 3-Monochloropropane-1,2-diol
(3-MCPD) during the production of Acid-Hydrolyzed Vegetable
Related code of practice: Proteins (Acid-HVPs) and Products that Contain Acid-HVPs (CXC 64–
2008).
Technical Regulations SFDA.FD 26:2018 “Soy sauce”
Commodity/Product
Notes/Remarks
mg/kg
applies
Liquid condiments
containing acid The ML does not apply to naturally
0.4
hydrolyzed vegetable fermented soy sauce.
proteins
Soy sauce 0.02
37
HYDROCYANIC ACID
ARfD 0.09 mg/kg bw as cyanide (2011, this cyanide-equivalent ARfD
applies only to foods containing cyanogenic glycosides as the main
Toxicological guidance value: source of cyanide)
PMTDI 0.02 mg/kg bw as cyanide (2011)
Contaminant definition: See explanatory notes in the column “Notes/Remarks”
Synonyms: HCN
Code of Practice for the Reduction of Hydrocyanic Acid (HCN) in
Cassava and Cassava products (CXC 73-2013)
Commodity/Product
Notes/Remarks
mg/kg
The ML is expressed as free
hydrocyanic acid.
Gari 2 Whole commodity
include CXS 151-1989.
The ML is expressed as total
hydrocyanic acid
Cassava flour 10
include CXS 176-1989.
38
MELAMINE
Reference to JECFA: FAO/WHO Expert Meeting (2008)
Toxicological guidance value: TDI 0.2 mg/kg bw (2008)
Contaminant definition: Melamine
Commodity/Product
Notes/Remarks
mg/kg
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:
• Authorised use of cyromazine as
Food (other than infant
2.5 insecticide. The melamine level shall
formulae) and feed
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
The ML applies to liquid infant
Liquid infant formula 0.15
formula as consumed.
Powdered infant
formulae and follow-on 1
formulae
39
VINYL CHLORIDE MONOMER

Provisional Acceptance (1984, the use of food-contact materials from
which vinyl chloride may migrate is provisionally accepted, on
condition that the amount of the substance migrating into food is
reduced to the lowest level technologically achievable.
Contaminant definition: Vinylchloride monomer
Synonyms: Monochloroethene, chloroethylene; abbreviation VC or VCM
Commodity/Product
Notes/Remarks
mg/kg
applies
The GL in food packaging material is
Food 0.01
1.0 mg/kg.
40
TUTIN
Reference to JECFA:
Contaminant definition: Tutin
Synonyms: Tutin
Food Standards Australia New Zealand (Food Standard: Tutin in
Honey 2016)
Commodity/Product
Notes/Remarks
mg/kg
applies
Honey comb 0.7 Honey bees in honeycomb cell
Honey 0.7
41
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
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 large lot in order to apply the sampling method on
that designated part. Each sublot must be physically separate and
identifiable.
Sampling plan It is defined by an aflatoxin test procedure and an accept/reject limit. An
aflatoxin test procedure consists of three steps: sample selection, sample
preparation and aflatoxin quantification.
Incremental A quantity of material taken from a single random place in the lot or
sample 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 large as the 20 kg
laboratory sample.
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 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.
Test portion A portion of the comminuted laboratory sample. The entire 20 kg
laboratory sample should be comminuted in a mill. A portion of the
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. Large lots should be
subdivided into sublots to be sampled separately. The subdivision can be done following
provisions laid down in Table 1 below.
42
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

Weight or Number of Laboratory
Lot weight –
Commodity number of incremental sample
tonne (T)
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
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
43
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.
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)
44
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.
D. ANALYTICAL METHODS
45
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 1 – 15 μg/kg 70 to 110%
Total
> 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.:
RSDR = 2(1-0.5logC)
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.
46
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
An identifiable quantity of a food commodity delivered at one time and
Lot determined by the official to have common characteristics, such as origin,
variety, type of packing, packer, consignor, or markings.
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.
It is defined by an aflatoxin test procedure and an accept/reject limit. An
aflatoxin test procedure consists of three steps: sample selection, sample
Sampling plan
preparation and aflatoxin quantification. The accept/reject limit is a tolerance
usually equal to the Codex maximum level.
Incremental The quantity of material taken from a single random place in the lot or sublot.
sample
The combined total of all the incremental samples that is taken from the lot
Aggregate sample or sublot. The aggregate sample has to be at least as large as the laboratory
sample or samples combined.
The smallest quantity of tree nuts comminuted in a mill. The laboratory
Laboratory sample may be a portion of or the entire aggregate sample. If the aggregate
sample sample is larger than the laboratory sample(s), the laboratory sample(s)
should be removed in a random manner from the aggregate sample.
A portion of the comminuted laboratory sample. The entire laboratory
sample should be comminuted in a mill. A portion of the comminuted
Test portion
laboratory sample is randomly removed for the extraction of the aflatoxin for
chemical analysis.
Nuts, which are not intended to undergo an additional processing/treatment
Ready-to-eat that has proven to reduce levels of aflatoxins before being used as an
treenuts ingredient in foodstuffs, otherwise processed or offered for human
consumption.
Nuts, which are intended to undergo an additional processing/treatment that
has proven to reduce levels of aflatoxins before being used as an ingredient
Treenuts destined in foodstuffs, otherwise processed or offered for human consumption.
for further Processes that have proven to reduce levels of aflatoxins are shelling,
processing 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.
A plot of the probability of a accepting a lot versus lot concentration when
Operating
using a specific sampling plan design. The OC curve 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.
SAMPLING PLAN DESIGN CONSIDERATIONS
47
1. Importers may commercially classify treenuts 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, pistachios are
predominately marketed as in-shell nuts while almonds are predominately marketed as
shelled nuts.
3. Sampling statistics, shown in Annex, are based upon the uncertainty and aflatoxin
distribution among laboratory samples of shelled nuts. Because the shelled nut count per
kg is different for each of the treenuts, the laboratory sample size is expressed in number
of nuts for statistical purposes. However, the shelled nut count per kg for each treenut,
shown in Annex, can be used to convert laboratory sample size from number of nuts to
mass and vice versa.
4. Uncertainty estimates associated with sampling, sample preparation, and analysis, shown
in Annex, and the negative binomial distribution are used to calculate operating
characteristic (OC) curves that describe the performance of the proposed aflatoxin-
sampling plans.
5. In Annex, the analytical variance reflects a reproducibility relative standard deviation of
22%, which is based upon Food Analysis Performance Assessment Scheme (FAPAS)
data. 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 four treenuts.
6. The issue of correcting the analytical test result for recovery is not addressed in this
document. However, Table 2 specifies several performance criteria for analytical methods
including suggestions for the range of acceptable recovery rates.
AFLATOXIN TEST PROCEDURE AND MAXIMUM LEVELS
7. An aflatoxin-sampling plan is defined by an aflatoxin test procedure and a maximum level.
A value for the maximum level and the aflatoxin test procedure are given below in this
section.
8. The maximum levels for total aflatoxins in treenuts (almonds, hazelnuts, pistachios and
shelled Brazil nuts) “ready-to-eat” and “destined for further processing” are 10 and 15
μg/kg, 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
restricting trade. For simplicity, it is recommended that the proposed aflatoxin sampling
plans use a 20 kg aggregate sample for all four treenuts.
10. The two sampling plans (RTE and DFP) have been designed for enforcement and
controls concerning total aflatoxins in bulk consignments (lots) of treenuts traded in the
export market.
Treenuts destined for further processing
Maximum level – 15 μg/kg total aflatoxins
Number of laboratory samples – 1
48
Laboratory sample size – 20 kg

Almonds – shelled nuts
Hazelnuts – shelled nuts
Pistachios – in-shell nuts (equivalent to about 10 kg shelled nuts that is calculated
on the basis of the actual edible portion in the sample)
Brazil nuts – shelled nuts
Sample preparation - sample shall be finely ground and mixed thoroughly
using a process, e.g., dry grind with a vertical cutter
mixer type mill, that has been demonstrated to
provide the lowest sample preparation variance.
Preferably, Brazil nuts should be ground as slurry.
Analytical method – performance based (see Table 2)
Decision rule If the aflatoxin test result is less than or equal to 15
μg/kg total aflatoxins, then accept the lot. Otherwise,
reject the lot.
Ready-to-eat treenuts
Number of laboratory samples – 2
Almonds– shelled nuts
Hazelnuts – shelled nuts
Pistachios – in-shell 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)
Brazil nuts – shelled nuts
Sample preparation sample shall be finely ground and mixed thoroughly
using a process, e.g., dry grind with a vertical cutter
mixer type mill, that has been demonstrated to
provide the lowest sample preparation variance.
Preferably, Brazil nuts should be ground as slurry.
Decision rule if the aflatoxin test result is less than or equal to 10
μg/kg total aflatoxin in both test samples, then accept
the lot. Otherwise, reject the lot.
11. To assist member countries implement these two 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.
49
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 unloaded to allow representative
sampling to be carried out.
INCREMENTAL SAMPLE SELECTION
16. Procedures used to take incremental samples from a treenut 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 select
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
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
NUMBER OF INCREMENTAL SAMPLES FOR LOTS OF VARYING
WEIGHT
18. The number and size of the laboratory sample(s) will not vary 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.
Table 1. Number and size of incremental samples composited for an aggregate sample
of 20 kga as a function of lot (orsublot) weight
Minimum number Minimum
Lot or sublot weight b Minimum aggregate
of incremental incremental sample
(T in tonnes) sample size (Kg)
samples size c (g)
50
T<1 10 2 000 20
1≤T<5 25 800 20
5 ≤ T < 10 50 400 20
10 ≤ T < 15 75 267 20
15 ≤T 100 200 20
a / Minimum aggregate sample size = laboratory sample size of 20 kg
b / 1 Tonne = 1 000 kg
c / Minimum incremental sample size = laboratory sample size (20 kg) / minimum number
of incremental samples, i.e. for 0.5 < T < 1 tonne,
2 000 g = 20 000/10
WEIGHT OF THE INCREMENTAL SAMPLE
20. The suggested minimum weight of the incremental sample should be approximately 200
g for lots of 25 metric tonnes (25000 kg). The number and/or size of incremental samples
will have to be larger than that suggested in Table 1 for lots sizes below 25000 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 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.
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 produced when selecting
incremental 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 sample is larger
51
than the required laboratory sample(s), then blend and subdivide the aggregate sample
to obtain the desired size laboratory sample(s).
26. Automatic sampling equipment such as a cross-cut sampler is commercially available
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.
opening of the diverter cup should be perpendicular to the direction of the flow; (2) the
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.
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).
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.
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 20000 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 (2 400 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
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.
SEALING AND LABELLING OF SAMPLES
52
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,
environmental temperature and relative humidity should be controlled and not favour
mould growth and aflatoxin formation.
HOMOGENISATION - 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
laboratory. 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) approaches zero. After grinding, the grinder should be cleaned to
prevent aflatoxin cross-contamination.
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 reduction. A better homogenization (finer grind), such as a liquid slurry,
can be obtained by more sophisticated equipment and should provide the lowest sample
preparation variance.
TEST PORTION
38. The suggested weight of the test portion taken from the comminuted laboratory sample
should be approximately 50 g. 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
comminuted 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, appeal, and confirmation
if needed.
ANALYTICAL METHODS
BACKGROUND
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
53
detection limit, repeatability coefficient of variation (within lab), reproducibility

coefficient of variation (among lab), and the percent recovery necessary for various
statutory limits. Analytical methods that are accepted by chemists internationally (such
as AOAC, ISO) 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 methods of analysis should comply with
Criterion Concentration Recommended value Maximum permitted
range (ng/g) value
Blanks All Negligible n/a
1 to 15 70 to 100% n/a
Recovery
> 15 80 to 110% n/a
Precision or relative 2 x value derived from
1 to 120 Equation 4
standard deviation Equation 4
RSDR 2 x value derived from
(Reproducibility) > 120 Equation 5
Equation 5
Calculated as 0.66
Precision or relative 1 to 120 n/a
times Precision RSDR
standard deviation
RSDr (Repeatability) Calculated as 0.66
> 120 n/a
times Precision RSDr
n/a = not applicable
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.
Equation 4: RSDR = 22.0 (for C ≤ 120 μg/kg or c ≤ 120 x 10-9)
Equation 5: RSDR = 2 (1-0.5logc) (for C > 120 μg/kg or c > 120 x 10-9)
where:
• RSDR = the relative standard deviation calculated from results generated under
reproducibility conditions
• RSDr = the relative standard deviation calculated from results generated under
repeatability conditions = 0.66 RSDR
•c = the aflatoxin concentration ratio (i.e. 1 = 100 g/100 g, 0.001 = 1 000
mg/kg)
•C = aflatoxin concentration or mass of aflatoxin to mass of treenuts (i.e.
μg/kg)
54
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.
55
Uncertainty, as measured by the variance, associated with sampling, sample

preparation, and analytical steps of the aflatoxin test procedure used to estimate
aflatoxin in almonds, hazelnuts, pistachios and shelled Brazil nuts.
Sampling data for almonds, hazelnuts, pistachios and shelled Brazil nuts were supplied by
the United States, Turkey, Iran and Brazil, respectively.
Sampling, sample preparation, and analytical variances associated with testing almonds,
hazelnuts, pistachios and shelled Brazil nuts are shown in Table 1 below.
Table 1. Variancesa associated with the aflatoxin test procedure for each treenut
Shelled Brazil
Test procedure Almonds Hazelnuts Pistachios
nuts
Samplingb,c S2s = (7 730/ns) S2s = (10000/ns) S2s = 8000/ns) ss2 = (1 850/ns)
5.759C1.561 4.291C1.609 7.913C1.475 4.8616C1.889
Sample Prepd S2sp = (100/nss) S2sp = (50/nss) S2sp = (25/nss) sss2 = (50/nss)
0.170C1.646 0.021C1.545 2.334C1.522 0.0306C0.632
Analyticale S2a = (1/na) S2a = (1/na) S2a = (1/na) experimental sa2 =
2.0 2.0 2.0
0.0484C 0.0484C 0.0484C (1/n) 0.0164C1.117
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.
56
Annex 3
SAMPLING PLAN FOR AFLATOXIN CONTAMINATION IN DRIED FIGS
DEFINITIONS
An identifiable quantity of a food commodity delivered at one time
Lot and determined by the official to have common characteristics, such
as origin, variety, type of packing, packer, consignor, or markings.
Designated part of a larger lot in order to apply the sampling method
Sublot on that designated part. Each sublot must be physically separate and
identifiable.
It is defined by an aflatoxin test procedure and an accept/reject level.
An aflatoxin test procedure consists of three steps: sample selection
Sampling plan of sample(s) of a given size, sample preparation and aflatoxin
quantification. The accept/reject level is a tolerance usually equal to
the Codex maximum level.
The quantity of material taken from a single random place in the lot
Incremental sample
or sublot.
The combined total of all the incremental samples that is taken from
Aggregate sample the lot or sublot. The aggregate sample has to be at least as large as
the laboratory sample or samples combined.
The smallest quantity of dried figs comminuted in a mill. The
laboratory sample may be a portion of or the entire aggregate
Laboratory sample 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.
A portion of the comminuted laboratory sample. The entire
laboratory sample should be comminuted in a mill. A portion of the
Test portion
comminuted laboratory sample is randomly removed for the
extraction of the aflatoxin for chemical analysis.
Dried figs, which are not intended to undergo an additional
Ready-to-eat dried processing/treatment that have proven to reduce levels of aflatoxin
figs before being used as an ingredient in foodstuffs, otherwise
processed or offered for human consumption.
A plot of the probability of accepting a lot versus lot concentration
Operating when using a specific sampling plan design. The OC curve also
characteristic (OC) provides an estimate of good lots rejected (exporter’s risk) and bad
curve lots accepted (importer’s risk) by a specific aflatoxin sampling plan
design.

1. Importers commercially classify dried figs mostly as “ready-to-eat” (RTE). As a result,
maximum levels and sampling plans are established only for ready-to-eat dried figs.
57
2. The performance of the sampling plan was computed using the variability and aflatoxin
distribution among laboratory samples of dried figs taken from contaminated lots.
Because the dried fig count per kg is different for different varieties of dried figs, the
laboratory sample size is expressed in number of dried figs for statistical purposes.
However, the dried fig count per kg for each variety of dried figs can be used to convert
laboratory sample size from number of dried figs to mass and vice versa.
3. Uncertainty estimates (variances) associated with sampling, sample preparation, and
analysis and the negative binomial distribution are used to calculate operating
characteristic (OC) curves that describe the performance of the aflatoxin-sampling plans
for dried figs.
4. The analytical variance measured in the sampling study reflects within laboratory variance
and was replaced with an estimate of analytical variance reflects a reproducibility relative
standard deviation of 22%, which is based upon Food Analysis Performance Assessment
Scheme (FAPAS) data. 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 dried figs.
5. The issue of correcting the analytical test result for recovery is not addressed in this
document. However, Table 2 specifies several performance criteria for analytical methods
including suggestions for the range of acceptable recovery rates.
AFLATOXIN TEST PROCEDURE AND MAXIMUM LEVELS
6. An aflatoxin sampling plan is defined by an aflatoxin test procedure and a maximum level.
A value for the maximum level and the aflatoxin test procedure are given below in this
section.
7. The maximum level for “ready-to-eat” dried figs is 10 ng/g total aflatoxins.
8. 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
restricting trade. For simplicity, it is recommended that the aflatoxin sampling plan uses
three 10 kg aggregate samples of dried figs.
9. The RTE sampling plan has been designed for enforcement and controls concerning total
aflatoxins in bulk consignments (lots) of dried figs traded in the export market.
Number of laboratory samples –3
Sample preparation – water-slurry grind and a test portion that represents
55 g mass of dried figs
Decision rule – If the aflatoxin test result is less than or equal to 10
μg/kg total aflatoxins for all three 10 kg laboratory
samples, then accept the lot. Otherwise, reject the lot.
10. To assist member countries implement the above sampling plan, sample selection
methods, sample preparation methods, and analytical methods required to quantify
58
aflatoxin in laboratory samples taken from bulk dried fig lots are described in the
following sections.
SAMPLE SELECTION
11. Each lot, which is to be examined for aflatoxin, must be sampled separately. Lots larger
than 15 tonnes should be subdivided into sublots to be sampled separately. If a lot is
greater than 15 tonnes, the number of sublots is equal to the lot weight in tonnes divided
by 15 tonnes. It is recommended that a lot or a sublot should not exceed 15 tonnes.
12. Taking into account that the weight of the lot is not always an exact multiple of 15 tonnes,
the weight of the sublot may exceed the mentioned weight by a maximum of 25%.
13. 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.
14. In most cases any truck or container will have to be unloaded to allow representative
sampling to be carried out.
INCREMENTAL SAMPLE SELECTION
15. Procedures used to take incremental samples from a dried fig lot are extremely important.
Every individual fig 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 select
the incremental samples prohibit or reduce the chances of any item in the lot from being
chosen.
16. Since there is no way to know if the contaminated figs are uniformly dispersed
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
17. For lots less than 10 tonnes, the size of the aggregate sample is reduced so that the
aggregate sample size doesn’t exceed a significant portion of the lot or sublot size.
NUMBER AND SIZE OF INCREMENTAL SAMPLES FOR LOTS OF VARYING
WEIGHT
18. 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. The number of incremental samples varies
from 10 to 100 for lots or sublots of various sizes.
Table 1. Number and size of incremental samples composited for an aggregate sample
of 30 kga as a function of lot (or sublot) weight
59
Lot or sublot Minimum Minimum Minimum Laboratory Number of

weightb (T in number of incremental aggregate sample size laboratory
tonnes) incremental sample sizec sample size (Kg) samples
samples (g) (Kg)
15.0 ≥T > 10.0 100 300 30 10 3
10.0 ≥T > 5.0 80 300 24 8 3
5.0 ≥T > 2.0 60 300 18 9 2
2.0 ≥T > 1.0 40 300 12 6 2
1.0 ≥T > 0.5 30 300 9 9 1
0.5 ≥T > 0.2 20 300 6 6 1
0.2 ≥T > 0.1 15 300 4.5 4.5 1
0.1 ≥T 10 300 3 3 1
a/ Minimum aggregate sample size = laboratory sample size of 30 kg for lots above 10 tonnes
b/ 1 Tonne = 1 000 kg
c/ Minimum incremental sample size = laboratory sample size (30 kg)/minimum number of
incremental samples,
i.e. for 10 < T ≤ 15 tonnes, 300 g = 30 000/100
19. The suggested minimum weight of the incremental sample is 300 g for lots and sublots
of various sizes.
STATIC LOTS
20. A static lot can be defined as a large mass of dried figs 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 dried figs 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.
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.
60
DYNAMIC LOTS
incremental samples from a moving stream of dried figs as the lot is transferred from
one location to another. When sampling from a moving stream, take small incremental
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).
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 figs flow past the sampling point.
velocity (cm/sec).
from Equation 3 as a function of S, V, D, and MR.
29. 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 30 kg aggregate sample from a 20000 kg lot where the diverter cup width is 5.0
cm and the cup velocity through the stream 20 cm/sec. Solving for T in Equation 2.
T = (5.0 cm x 20 000 kg) / (30 kg x 20 cm/sec) = 167 sec.
30. 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 14.4 cuts (14 incremental samples) will be made by the
cup through the lot (Equation 3). This may be considered too infrequent, in that too
much product (1388.9 kg) passes through the sampler between the time the cup cuts
through the stream.
61
dark place.
SEALING AND LABELLING OF SAMPLES
SAMPLE PREPARATION
PRECAUTIONS
aflatoxin gradually breaks down under the influence of ultra-violet light. Also,
environmental temperature and relative humidity should be controlled and not favour
mould growth and aflatoxin formation.
HOMOGENISATION - GRINDING
34. As the distribution of aflatoxin is extremely non-homogeneous, the laboratory samples
should be homogenized by grinding the entire laboratory sample received by the
laboratory. Homogenization is a procedure that reduces particle size and disperses the
that approaches as complete homogenization as possible. Complete homogenization
preparation approaches zero. After grinding, the grinder should be cleaned to prevent
aflatoxin cross-contamination.
36. 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 reduction. A better homogenization (finer grind), such as a liquid slurry,
can be obtained by more sophisticated equipment and should provide the lowest sample
preparation variance.
TEST PORTION
should be approximately 50 g. If the laboratory sample is prepared using a liquid slurry,
the slurry should contain 50 g of fig mass.
38. 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
comminuted laboratory sample. Otherwise, the 50 g test portion should be the
accumulation of several small portions selected throughout the laboratory sample.
if needed.
62
ANALYTICAL METHODS
BACKGROUND
modify the specific analytical method. The performance criteria established for
analytical methods should include all the parameters that need to be addressed by each
laboratory such as the detection limit, repeatability coefficient of variation (within lab),
reproducibility coefficient of variation (among lab), and the percent recovery necessary
for various statutory limits. 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
41. 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 with
Criterion Concentration Recommended value Maximum permitted
range (ng/g) value
Blanks All Negligible n/a
1 to 15 70 to 100% n/a
Recovery
> 15 80 to 110% n/a
Precision or relative 2 x value derived from
1 to 120 Equation 4
standard deviation Equation 4
RSDR 2 x value derived from
(Reproducibility) > 120 Equation 5
Equation 5
Calculated as 0.66
Precision or relative 1 to 120 n/a
times Precision RSDR
standard deviation
RSDr (Repeatability) Calculated as 0.66
> 120 n/a
times Precision RSDr
n/a = not applicable
42. The detection limits of the methods used are not stated. Only the precision values are
given at the concentrations of interest. The precision values (expressed as a%) are
calculated from equations 4 and 5.
Equation 4: RSDR = 22.0
Equation 5: RSDR = 45.25C-0.15
where:
• RSDR = the relative standard deviation calculated from results generated under
reproducibility conditions
63
• RSDr = the relative standard deviation calculated from results generated under
repeatability conditions = 0.66RSDR
• C = aflatoxin concentration or mass of aflatoxin to mass of dried figs (i.e. ng/g)
43. 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.
44. Results should be reported on the sample.
UNCERTAINTY, AS MEASURED BY THE VARIANCE, ASSOCIATED WITH
THE SAMPLING, SAMPLE PREPARATION, AND ANALYTICAL STEPS OF
THE AFLATOXIN TEST PROCEDURE USED TO DETECT AFLATOXIN IN
DRIED FIGS
45. The sampling, sample preparation, and analytical variances associated with the aflatoxin
test procedure for dried figs are shown in Table 3.
Table 3. Variancesa associated with the aflatoxin test procedure for dried figs
------------------------------------------------------------
Test Procedure Variances for Dried Figs
------------------------------------------------------------
Samplingb,c S2s = (590/ns) 2.219C1.433
Sample Prepd S2sp = (55/nss) 0.01170C1.465
Analyticale S2a = (1/na) 0.0484C2.0
Total S2t = S2s + S2sp + S2a
-------------------------------------------------------------
a / Variance = S2 (t, s, sp, and a denote total, sampling, sample preparation, and analytical
steps, respectively, of aflatoxin test procedure)
b / ns = laboratory sample size in number of dried figs, nss =test portion size in grams of fig
mass, na = number of aliquots quantified by HPLC, and C = aflatoxin concentration in
ng/g total aflatoxins
c / Count/kg for dried figs averaged 59/kg
d / Sample preparation variance reflects a water-slurry method and a test portion that reflects
55 g fig mass
e / Analytical variances reflect FAPAS recommendation for upper limit of analytical
reproducibility uncertainty. A relative standard deviation of 22% is based upon FAPAS
data and 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 three dried figs.
64
Annex 4
SAMPLING PLANS AND PERFORMANCE CRITERIA FOR
DEOXYNIVALENOL (DON) IN CEREAL-BASED FOODS FOR INFANTS
AND YOUNG CHILDREN; IN FLOUR, MEAL, SEMOLINA AND FLAKES
DERIVED FROM WHEAT, MAIZE OR BARLEY; AND IN CEREAL GRAINS
(WHEAT, MAIZE AND BARLEY) DESTINED FOR FURTHER PROCESSING
Cereal grains (wheat, maize and barley) destined for further processing
Maximum level 2000 μg/kg DON
Increments increments of 100 g, depending on the lot weight (≥ 0.5 tonnes)
Sample preparation dry grind with a suitable mill (particles smaller than 0.85 mm -
20 mesh)
Laboratory sample weight ≥ 1 kg
Number of laboratory 1
samples
Test portion 25 g test portion
Method HPLC
Decision rule If the DON-sample test result for the laboratory samples is equal
or less than 2000 μg/kg, accept the lot. Otherwise, reject the lot.
Cereal-based foods for infants and young children
Increments 10 x 100 g
Sample preparation None
Laboratory sample weight 1 kg
Number of laboratory samples 1
Method HPLC
Decision rule If the DON sample test result is equal or less than
200 μg/kg, accept the lot. Otherwise, reject the lot.
Flour, semolina, meal and flakes derived from wheat, maize or barley
Laboratory sample weight 1 kg
Method HPLC
65
Decision rule If the DON sample test result is equal or less than
1000 μg/kg, accept the lot. Otherwise, reject the lot.
DEFINITIONS
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 It is defined by a DON test procedure and an accept/reject level. A DON
test procedure consists of three steps: sample selection, sample preparation
and analysis or DON quantification. The accept/reject level is a tolerance
usually equal to the Codex maximum level (ML).
Incremental The quantity of material taken from a single random place in the lot or
sample 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 The smallest quantity of shelled cereal comminuted in a mill. The
sample 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
laboratory sample is randomly removed for the extraction of the DON for
chemical analysis.

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
66
Lot weight (t) Maximum Weight Number of Minimum

or minimum incremental sample laboratory Sample
number of sub lots Weight (kg)
≥ 1500 500 tonnes 100 1
> 300 and < 1500 3 sublots 100 1
≥ 100 and ≤ 300 100 tonnes 100 1
≥ 50 and < 100 2 sublots 100 1
< 50 - 3-100* 1
* see table 2
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
Lot weight (t) Number of incremental Minimum Laboratory
sample 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
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.
67
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.
incremental sample weight (IS), aggregate sample weight (AS) and the individual packing
weight (IP), as follows:
SF = (LT x IS)/(AS x IP).
DYNAMIC LOTS
incremental samples from a moving stream of shelled cereal as the lot is transferred from
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).
intervals throughout the entire time the cereal flow past the sampling point.
S=(D x LT) / (T x V),
velocity (cm/sec).
as a function of S, V, D, and MR.
SF = (S x V) / (D x MR).
68

dark place.
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.
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.
that approaches as complete homogenisation as possible. Complete homogenisation
DON cross-contamination.
TEST PORTION
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.
if needed.
ANALYTICAL METHODS
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.
69
Table 3. Proposed method criteria for DON in cereals.

Commodity ML (mg/kg) LOD LOQ Precision Minimum Recovery
(mg/kg) (mg/kg) on HorRat applicable
range
(mg/kg)
Cereal grains 2.0 ≤ 0.2 ≤ 0.4 ≤2 1-3 80 - 110%
(wheat, maize
and barley)
destined for
further
processing
Cereal-based 0.2 ≤ 0.02 ≤ 0.04 ≤2 0.1 – 0.3 80 – 110%
foods for infants
and young
children
Flour, semolina, 1.0 ≤ 0.1 ≤ 0.2 ≤2 0.5 – 1.5 80 – 110%
meal and flakes
derived from
wheat, maize or
barley
70
Annex 5
SAMPLING PLANS AND PERFORMANCE CRITERIA FOR FUMONISINS (FB1 +
FB2) IN MAIZE GRAIN AND MAIZE FLOUR AND MAIZE MEAL
Maize grain, unprocessed
Maximum level 4 000 μg/kg FB1 + FB2
Increments increments of 100 g, depending on the lot weight (≥ 0.5
tonnes)
Sample preparation dry grind with a suitable mill (particles smaller than 0.85 mm
- 20 mesh)
Method HPLC
Decision rule If the fumonisin-sample test result for the laboratory samples
is equal or less than 4 000 μg/kg, accept the lot. Otherwise,
reject the lot.
Maize flour and maize meal
Maximum level 2 000 μg/kg FB1 + FB2
Method HPLC
Decision rule If the fumonisin-sample test result is equal or less than 2000
μg/kg, accept the lot. Otherwise, reject the lot.
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 The 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 It is defined by a fumonisin test procedure and an accept/reject level.
A fumonisin test procedure consists of three steps: sample selection,
sample preparation and analysis or fumonisin quantification. The
accept/reject level is a tolerance usually equal to the Codex maximum
level (ML).
71
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 maize 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
laboratory sample is randomly removed for the extraction of the
fumonisin for chemical analysis.

1. Each lot of maize, which is to be examined for fumonisin, 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 maize sublots according to lot weight
Lot weight (t) Maximum weight Number of Minimum
or minimum incremental sample laboratory sample
number of sub lots weight (kg)
≥ 1500 500 tonnes 100 1
> 300 and < 1500 3 sublots 100 1
≥ 100 and ≤ 300 100 tonnes 100 1
≥ 50 and < 100 2 sublots 100 1
< 50 - 3-100* 1
* see table 2
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
72
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
Lot weight (t) Number of Minimum
incremental laboratory sample
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
STATIC LOTS
5. A static lot can be defined as a large mass of shelled maize 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 maize 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.
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.
incremental sample weight (IS), aggregate sample weight (AS) and the individual packing
weight (IP), as follows:
SF = (LT x IS)/(AS x IP).
DYNAMIC LOTS
incremental samples from a moving stream of shelled maize as the lot is transferred from
incremental samples to obtain an aggregate sample; if the aggregate sample is larger than
73
the required laboratory sample(s), then blend and subdivide the aggregate sample to
obtain the desired size laboratory sample(s).
intervals throughout the entire time the maize flow past the sampling point.
S=(D x LT) / (T x V),
velocity (cm/sec).
as a function of S, V, D, and MR.
SF = (S x V) / (D x MR).
dark place.
SAMPLE PREPARATION
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
74
that approaches as complete homogenisation as possible. Complete homogenisation
fumonisin cross-contamination.
TEST PORTION
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.
if needed.
ANALYTICAL METHODS
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
Analyte ML (mg/Kg) LOD (mg/Kg) LOQ (mg/Kg) RSDR Recovery (%)
FB1 + FB2 4.0 - - - -
FB1 ≤ 0.3* ≤ 0.6* HorRat ≤ 2 80 - 110
(< 27%)
FB2 ≤ 0.15* ≤ 0.3* HorRat ≤ 2 80 - 110
(< 32%)
* - The LOD and LOQ were derived based upon typical B1:B2 ratio of 5:2 in naturally-
contaminated samples
Maize Flour/Meal
Analyte ML (mg/Kg) LOD (mg/Kg) LOQ (mg/Kg) RSDR Recovery (%)
FB1 + FB2 2.0 - - - -
FB1 ≤ 0.15* ≤ 0.3* HorRat ≤ 2 80 – 110
(< 30%)
75
FB2 ≤ 0.06* ≤ 0.15* HorRat ≤ 2 80 – 110

(< 34%)
* - The LOD and LOQ were derived based upon typical B1:B2 ratio of 5:2 in naturally-
contaminated samples
76
Reference:
- General Standard For Contaminants And Toxins In Food And Feed Codex Stan 193-
1995
- Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting
maximum levels for certain contaminants in foodstuffs
77

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‫هيئة التقييس لدول مجلس التعاون لدول الخليج العربية‬

GCC STANDARDIZATION ORGANIZATION (GSO)

‫مشروع مواصفة أولي‬

TC05 ‫اعداد اللجنة الخليجية رقم‬

Prepared by GSO Technical Committee No. TC05

‫الملوثات والسموم في األغذية واألعالف‬

GCC Standardization Organization (GSO) is a regional Organization which consists of the

- GSO 1807:2007 “Maximum level for cadmium in food”.

Contaminants and toxins in food and feed

3. Principles Regarding Contaminants in Food and Feed

Good Manufacturing Practice as well as Good Agricultural Practice in relation

Risk assessment and risk management considerations

Zingiber officinale (ginger)

FUMONISINS (B1 + B2)

Myristica fragrans (nutmeg)

Rice for baby and 0.1 Determined as inorganic Arsenic

pods or as the shelled

sweetened cocoa powder sold to the

derived from seaweed,

Maximum Portion of the

Maximum Portion of the

Maximum Portion of the

METHYLMERCURY IN CERTAIN FISH SPECIES AND CRUSTACEANS

excluding dried and

employed in malevolent actions. Radionuclides of natural origin are generally

* This represents the value for organically bound sulphur

The ML does not apply to melamine

VINYL CHLORIDE MONOMER

Table 1. Subdivision of large lots into sublots for sampling

Number of incremental samples for lots of less than 15 tonnes

Table 2. Number of incremental samples to be taken depending on the weight

Incremental sample selection

1. Importers may commercially classify treenuts as either “ready-to-eat” (RTE) or “destined

Laboratory sample size – 20 kg

detection limit, repeatability coefficient of variation (within lab), reproducibility

Uncertainty, as measured by the variance, associated with sampling, sample

SAMPLING PLAN DESIGN CONSIDERATIONS

Lot or sublot Minimum Minimum Minimum Laboratory Number of

SAMPLING PLAN DESIGN CONSIDERATIONS

Table 1. Subdivision of cereal sublots according to lot weight

Lot weight (t) Maximum Weight Number of Minimum

PACKAGING AND TRANSPORTATION OF SAMPLES

Table 3. Proposed method criteria for DON in cereals.

SAMPLING PLAN DESIGN CONSIDERATIONS

FB2 ≤ 0.06* ≤ 0.15* HorRat ≤ 2 80 – 110

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