GTP addendum 1

GTP temporary monitoring for aflatoxin in 2012 and 2013 maize crops from
South and Eastern Europe and maize by-products derived thereof1
1. Introduction
Following the multiple RASFF alerts and information notifications reporting levels of aflatoxin B1
above the maximum limits in maize from South-Eastern Europe and maize by-products derived
thereof, decision was made to develop temporary monitoring requirements for aflatoxin B1 in maize
from South-Eastern Europe.
As a reminder, the applicable EU maximum limits for aflatoxin are:
For maize and processed maize products to be used as feed materials (as per amended version of
Directive 2002/32/EC)
 20 ppb for aflatoxin B1 (based on feed materials with a moisture content of 12 %).
For maize to be used as food (as per amended version of Regulation (EC) No 1881/2006)
 Code 2.1.11: all maize and all products derived from maize, including processed maize
products (with the exception of foodstuffs listed in Code 2.1.12); Maximum limits (μg/kg) of
2,0 ppb for aflatoxin B1 and 4,0 ppb for sum of aflatoxins B1+B2+G1+G2;
 Code 2.1.12: maize to be subjected to sorting or other physical treatment before human
consumption or use as an ingredient in foodstuffs. Maximum limits (μg/kg) of 5,0 ppb for
aflatoxin B1 and 10,0 ppb for sum of aflatoxins B1+B2+G1+G2.
2. Scope of application
2.1 Companies concerned
GTP certified companies carrying out the following activities must apply the provisions laid down in
this addendum to the currently applicable version of the GTP:
 Trading of maize originating from countries listed under 2.3 and maize by-products derived
thereof;
 Collection of maize originating from countries listed under 2.3 and maize by-products derived
thereof;
 Storage of maize originating from countries listed under 2.3 and maize by-products derived
thereof (e.g. warehouses and port terminals).
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The GTP temporary monitoring for aflatoxin in 2012 and 2013 maize crops from South and Eastern Europe
and maize by-products derived thereof remains in force until further notice. GTP is in the process of collecting
additional data in order to assess the situation for 2014 maize crops. Further information will follow in due
course.
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2.2 Products concerned
The protocol described further below is applicable to:
 Maize (grains of Zea mays L. ssp. mays.) destined to feed or to food directly or after
processing.
 Processed maize products derived from maize originating from countries listed under 2.3
The monitoring plan implemented by GTP certified companies must be adapted accordingly.
2.3 Origin
These high levels of aflatoxin in maize being caused by inclement weather conditions in SouthEastern Europe during cultivation and harvest 2012 and 2013, the determination of a precise
geographical area of application of this protocol is extremely difficult. The selection of countries
listed below was based on the origin of the maize supply as mentioned in the RASFF notifications
published since December 2012 until 15 October 2013:











Bulgaria
Czech Republic
Greece
Hungary
Italy
Poland
Romania
Serbia
Slovakia
Spain
Ukraine
In accordance with the precautionary principle, GTP certified companies must be vigilant and assess
the possible aflatoxin risk when purchasing/selling maize from South-Eastern European countries not
listed above which may have suffered similar climatic conditions. The need to add or remove a
certain country of origin will be assessed by the GTP on a regular basis and communicated to all GTP
certified companies for their convenience. It is however recommended to check on the GTP website
whether a new version of the document has been released.
2.4 Duration
This protocol is valid and applicable only for a limited period of time. Any change to the duration of
application of this protocol will be communicated in due time.
2.5 Boundaries
This protocol is applicable to intra-EU shipments of maize and processed maize products as well as
shipments of maize and processed maize products from third countries to the EU territory.
2.6 Derogation
This protocol does not apply when a company buying maize and/or processed products which has
already been sampled and analysed for aflatoxin B1 in compliance with the present GTP protocol. In
this case, the company must be informed about the analysis results of the delivered batch by means
of a certificate of analysis from a laboratory fulfilling the requirements foreseen in this protocol
under § 5. The following condition must however be fulfilled:
 The report analysis must explicitly indicate the same identification of the batch;
 The sampling method used as requirements referred to in the paragraph 3;
 The laboratory complies with requirements referred to in paragraph 5.
3. Protocol
3.1
When collecting maize in warehouses located in the countries “at risk”
If collection is done on the basis of receipt of truck or wagons, all incoming trucks or trains should be
sampled based on GAFTA 124 contract rules or in accordance with annex 1 point 5B to Commission
Regulation (EC) 152/2009. A laboratory sample of 0.5 kg shall be extracted from the aggregated
samples of each truck/train or a laboratory sample of 4,0 kg if extracted from the aggregated
samples taken from a group of trucks (up to a batch size of 1000 mt) or a group of wagons (up to a
max batch size of 1500 mt), after previous homogenisation and division. This sample will be well
grinded, and after correct mixing and homogenisation by the laboratory, a testing sample will be
extracted and tested for aflatoxin using a quick testing method (Elisa or lateral flow or other
equivalent quick testing method). If test results are above the EU maximum limits applicable for the
foreseen final use of the products, the cargo will be rejected and not stored into commercial cells.
3.2.
When purchasing maize and/or processed maize products on an in or ex-warehouse basis
When possible, each batch/cell of the cargo in the warehouse will be sampled, by an independent
superintendent organisation accredited according to ISO 17020 for sampling in this food or feed
domain or by an ISO 9001 certified + GAFTA approved body. The sampling should be done based on
GAFTA 124 contract rules or in accordance with annex 1 point 5B to Commission Regulation (EC)
152/2009 for maize and annex 1 point 5A to Commission Regulation (EC) 152/2009 for processed
maize products, so that final samples taken can be considered as representative of each batch (max
8000 mt per batch). The bulk final sample gathering all incremental samples (see table in point 4)
taken for each cells/batch/or warehouse shall be aggregated into a bulk sample which shall be
thoroughly homogenised and afterwards divided until reduced to the required quantity needed for
the contractual set(s) of aggregated samples (min 4 kg each). These samples shall be packed, sealed
without delay and kept as per GAFTA 124 contractual rules or in accordance with Commission
Regulation (EC) 152/2009.
The 4kg aggregated sample to be used to extract the final sample will be sent to the laboratory
where it will be fully grinded and homogenised. The final laboratory testing sample will be then
extracted for testing in a ISO 17025 accredited laboratory for the analysis of aflatoxin B1 (or for
aflatoxin B1 + Sum of aflatoxins B1+B2+G1+G2 if for food uses).
The batch tested should not be physically delivered to EU locations of customers as long as the
analysis results are unknown or if results are not compliant with EU maximum limits for aflatoxins in
food (if this is the final intended use) or in feed materials. The stored batches will remain in
quarantine pending the results.
 If the results are compliant with EU maximum limits, the tested batches can be loaded into
sea going vessels, inland waterway transports or trucks or railways without further testing, as
long as all measures are taken to preserve the identity of the concerned batches. These
analyses done before loading will be accepted as long as sampling/analyses have been done
no more than one month prior to the purchasing operations.
 If the results are above EU maximum limits for the intended use, the suppliers and the
authorities shall be duly and quickly informed as per applicable local regulations or rules.
Testing results are to be supplied to the concerned customers, on request.
The remainder of each aggregated samples should be also sealed, duly labelled and kept in adequate
storage conditions for a period agreed with the customer (minimum of three months).Finally, this
requirement is not applicable to samples taken during collection if made on a truck per truck or
wagon per wagon basis. Samples must be stored at a temperature that will not alter their
composition and in such conditions that the samples are not adversely affected by light.
3.3
Loading (or unloading) of a seagoing vessel or of an Inland waterway transport
Each batch /hold of the seagoing cargo or each full tonnage of an inland waterway vessel (barge or
vessel) or each full train (batch of max 1500 mt) will be sampled (at loading or at unloading), by an
independent superintendent organisation accredited according to ISO 17020 for sampling in this food
or feed domain or by an ISO 9001 certified + GAFTA approved bodies. The sampling should be done
GTP addendum 1 – V 3.0 bis (17.11.2014)
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based on GAFTA 124 contract rules or in accordance with annex 1 point 5B to Commission Regulation
(EC) 152/2009 for maize and annex 1 point 5A to Commission Regulation (EC) 152/2009 for
processed maize products, as amended, so that final samples taken can be considered as
representative of each batch (max 8000 mt per batch for a sea-vessel hold). The bulk final sample
gathering all incremented samples (see table in point 4) taken for each hold/batch/train/barge shall
be aggregated into a bulk sample which shall be thoroughly homogenised and afterwards divided
until reduced to the required quantity needed for the contractual set(s) of aggregated samples (min
4 kg each), and these samples shall be packed, sealed without delay and kept as per GAFTA 124
contractual rules or in accordance with Commission Regulation (EC) 152/2009.
The 4kg aggregated sample to be used to extract the final sample (one final sample for each
batch/hold or barge or train) will be sent to the laboratory where it will be fully grinded and
homogenised. The final laboratory testing sample will be extracted for testing in a ISO 17025
accredited laboratory for the analysis of aflatoxin B1 (or for aflatoxin B1 + sum of aflatoxins
B1+B2+G1+G2 if for food uses).Where possible, the results of the laboratory testing should be
available before arrival of the transport mean at destination.
The batches tested should not be physically delivered to EU locations of customers as long as the
analysis results are unknown or if results are not compliant with EU maximum limits for aflatoxins in
food (if this is the final intended use) or in feed materials. In case test results are not available,
unloading or transshipment into barges or warehouses, for temporary quarantine, are allowed as
long as products are not delivered to customers.
 If the results are compliant with EU maximum limits, the tested batches can be shipped/
unloaded/released/marketed/used. Additional local testing requirements must be taken into
account, where appropriate.
 If the results are above EU maximum limits for the intended use, and if the results of the
testing at loading are available prior to the arrival of the transport at destination, then a full
re-testing of the cargo should be done, using the same methodology /procedure previously
described, in order to ascertain newly the exact safety status of the cargo. If the testing at
loading took place in an EU member state, the local authorities and/customers should be
immediately advised as per applicable legislation.
Testing results are to be supplied to the concerned customers, on request.
The remainder of each aggregated samples should be also sealed and kept for a period agreed with
the customer (minimum of three months). Samples must be stored at a temperature that will not
alter their composition and in such conditions that the samples are not adversely affected by light.
4. Table overview of sampling requirements
4.1 As per GAFTA 124 contractual rules
Sampling point
Parcel max size
Minimum number of
incremental samples
Weight of each
incremental sample
Minimum bulk
aggregate sample per
lot
Final sample to be
analysed
Analyses
Sampling
Trucks
Trains
Barges/coasters
Vessels
Representative sample should be taken at loading or unloading of the
transport means2
1 final sample
per hold (max
1 final sample
8000 mt per
1000 mt
1500 mt
per barge
hold)
Minimum 5
incremental samples
per truck when
weight of truck <15
mt.
Minimum
8 incremental
Minimum 20 incremental samples every 500 metric
samples per truck
tons sub lot, ensuring a minimum of 40 incremental
when truck weight
samples in case the parcel is below 1000 mt
>15 mt.
A minimum of 40
incremental samples
should be taken per
parcel of various
trucks.
Max 1 kg
Min 20 kg sample per sub-lot of 500 mt (batch size 0 to 5000 mt) or min 30
kg per sub-lot of 1000 mt (batch size 5001 to 10 000 mt)
Min 1 sample of min 4 kg to be fully grinded by the laboratory and well
homogenised before extraction of the test aliquot sample
To be done by laboratory accredited according ISO 17025
To be done by an inspection company accredited according to ISO 17020 or
according an ISO 9001 certified + GAFTA approved body
2
Analyses done before loading will be accepted as long as sampling/analyses has been done no more than two
months prior to the loading operation
GTP addendum 1 – V 3.0 bis (17.11.2014)
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4.2 As per Commission Regulation (EC) 152/2009
Sampling point
Parcel max size
Minimum number of
incremental samples
Weight of each
incremental sample
Minimum bulk
aggregate sample per
lot
Final sample to be
analysed
Analyses
Sampling
Trucks
Trains
Barges/coasters
Vessels
Representative sample should be taken at loading or unloading of the
transport means3
4 final samples
4 final samples
per hold (max
1000 mt
1500 mt
per barge
8000 mt per
hold)
Minimum 5
incremental samples
per truck when
weight of truck <15
mt.
Minimum
8 incremental
√20 times the tonnage making up the sampled
samples per truck
portion, up to a max of 40 incremental samples
when truck weight
>15 mt.
A minimum of 40
incremental samples
should be taken per
parcel of various
trucks.
Max 1 kg
Min 4 kg
(which means 4*4kg=16kg for a sampled portion >40mt)
4 samples of min 0.5 kg to be fully grinded by the laboratory and well
homogenised before extraction of the test aliquot sample
To be done by laboratory accredited according ISO 17025
To be done by an inspection company accredited according to ISO 17020 or
according an ISO 9001 certified + GAFTA approved body
5. Analysis requirements
Samples must be analysed on aflatoxin B1 level (if final use is feed material) and also for aflatoxin B1
and sum of aflatoxins B1, B2, G1 and G2 (if final use for food). This analysis must be carried out by a
laboratory which is accredited according to ISO 17025 for the aflatoxin analysis in products covered
by this protocol.
6. Reporting analysis results
GTP certified companies must report every two months to the GTP ([email protected]) the analysis
results. Collected data will be handled with confidentiality and only used for the agreed scope. They
will be compiled into an internal monitoring database for the products covered by this protocol as
per rules stated in paragraph 2 of this addendum. Collected data will be only transferred to defined
3
Analyses done before loading will be accepted as long as sampling/analyses has been done no more than two
months prior to the loading operation
and agreed third parties on an anonymous and sanitised way. If the results show level of aflatoxin
above the EU maximum limits, requirements laid down in paragraph 3.1.7 of the currently applicable
GTP Code must be complied with.
7. Definitions
Lot (or batch): an identified quantity of a product delivered within a defined period of time and
having common characteristics, such as origin, variety, type of packing, packer, consignor or labelling,
and in case of a production process, a unit of production from a single plant using uniform
production parameters or a number of such units, when produced in continuous order and stored
together
Sampled portion: a lot or an identified part of the lot and/or of the sub-lot.
Sealed sample: a sample sealed in such a manner as to prevent any access to the sample without
breaking or removing the seal. The seal's mark should be clearly identifiable and clearly visible.
Alternatively, the sample can be put in a recipient which can be closed in such a manner that it
cannot be opened without irreversibly damaging the recipient, avoiding the re-use of the recipient.
Identification of the sample: the sample has to be indelibly marked and must be identified in such a
way that there is an unambiguous link to the sampling report.
Incremental sample: a quantity taken from one point in the sampled portion.
Aggregate sample: an aggregate of incremental samples taken from the same sampled portion. From
each aggregate sample at least two (or three) final samples are taken: 1 for control (enforcement),
one for trade (defence) and eventually one for reference
Reduced sample: a part of the aggregate sample, obtained from the latter by a process of
representative reduction.
Final sample: a part of the reduced sample or of the homogenised aggregate sample.
Laboratory sample: a sample intended for the laboratory (as received by the laboratory) and can be
the final, reduced or aggregate sample.
Test aliquot: a measured portion of the final sample taken for analysis.
GTP addendum 1 – V 3.0 bis (17.11.2014)
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