2002L0026 — EN — 10.05.2004 — 001.001 — 1
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►B COMMISSIONDIRECTIVE2002/26/EC
of13March2002
layingdownthesamplingmethodsandthemethodsofanalysisfortheofficialcontrolofthelevels
ofochratoxinAinfoodstuffs
(TextwithEEArelevance)
(OJ L 75, 16.3.2002, p. 38)
Amended by:
Official Journal
No page date
►M1Commission Directive 2004/43/EC of 13 April 2004 L 113 14 20.4.2004
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COMMISSIONDIRECTIVE2002/26/EC
of13March2002
layingdownthesamplingmethodsandthemethodsofanalysisfor
theofficial controlofthelevels ofochratoxinAinfoodstuffs
(TextwithEEArelevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 315/93 of 8 February
1993 laying down Community procedures for contaminants in food (1),
and in particular Article 2 thereof,
Having regard to Council Directive 85/591/EEC of 20 December 1985
concerning the introduction of Community methods of sampling and
analysis for the monitoring of foodstuffs intended for human consump-tion (
2), and in particular Article 1 thereof,
Whereas:
(1)Commission Regulation (EC) No 466/2001 of 8 March 2001
setting maximum levels for certain contaminants in food-stuffs(
3), as last amended by Regulation (EC) No 472/2002 (4),
fixes maximum limits for ochratoxin A in certain foodstuffs.
(2)Council Directive 93/99/EEC of 29 October 1993 on the subjectof additional measures concerning the official control of food-stuffs(
5) introduces a system of quality standards for
laboratories entrusted by the Member States with the official
control of foodstuffs.
(3)Sampling plays a crucial part in the precision of the determina-
tion of the levels of ochratoxin A, which are very
heterogeneously distributed in a lot.
(4)It seems necessary to fix general criteria, which the method of
analysis has to comply with in order to ensure that laboratories,
in charge of the control, use methods of analysis with compar-able levels of performance.
(5)The provisions for the sampling and methods of analysis havebeen drawn upon the basis of p resent knowledge and they maybe adapted to take account of advances in scientific and techno-logical knowledge.
(6)The measures provided for in this Directive are in accordancewith the opinion of the Standing Committee on the Food Chainand Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The Member States shall take all measures necessary to ensure that the
sampling for the official control of the levels of ochratoxin A in food-stuffs is carried out in accordance with the methods described in AnnexI to this Directive.
Article 2
The Member States shall take all measures necessary to ensure that
sample preparation and methods of analyses used for the official2002L0026 — EN — 10.05.2004 — 001.001 — 2
(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 372, 31.12.1985, p. 50.
(3) OJ L 77, 16.3.2001, p. 1.
(4) See page 18 of this Official Journal.
(5) OJ L 290, 24.11.1993, p. 14.
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control of the levels of ochratoxin A in foodstuffs comply with the
criteria described in Annex II to this Directive.
Article 3
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive by 28
February 2003 at the latest. They shall forthwith inform the Commis-
sion thereof.
When Member States adopt those provisions, they shall contain a refer-
ence to this Directive or be accompanied by such a reference on theoccasion of their official publication. Member States shall determinehow such reference is to be made.
Article 4
This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
Article 5
This Directive is addressed to the Member States.2002L0026 — EN — 10.05.2004 — 001.001 — 3
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ANNEX I
METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE
LEVELSOFOCHRATOXINAINCERTAINFOODSTUFFS
1.Purposeandscope
Samples intended for official checking of the levels of ochratoxin A
content in foodstuffs shall be taken according to the methods described
below. Aggregate samples thus obtained shall be considered as representa-
tive of the lots. Compliance with maximum limits laid down in Regulation
(EC) No 466/2001 shall be established on the basis of the levels determined
in the laboratory samples.
2.Definitions
Lot: an identifiable quantity of a food commodity deliv-
ered 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 lot in order to apply the
sampling method on that designated part. Each sublot
must be physically separate and identifiable
Incremental sample: a quantity of material taken from a single place in
the lot or sublot
Aggregate sample: the combined total of all the incremental samples
taken from the lot or sublot.
3.General provisions
3.1.Personnel
Sampling shall be performed by an authorised person as specified by the
Member States.
3.2.Material to be sampled
Each lot which is to be examined must be sampled separately. In accor-
dance with the specific provisions of this Annex, large lots should be
subdivided into sublots to be sampled separately.
3.3.Precautions to be taken
In the course of sampling and preparation of the samples precautions must
be taken to avoid any changes which would affect the ochratoxin A
content, adversely affect the analytical determination or make the aggregate
samples unrepresentative.
3.4.Incremental samples
As far as possible incremental samples should be taken at various places
distributed throughout the lot or sublot. Departure from this procedure
must be recorded in the record.
3.5.Preparation of the aggregate sample
The aggregate sample is made up by uniting the incremental samples.
3.6.Replicate samples
The replicate samples for enforcement, trade (defence) and referee purposes
are to be taken from the homogenised sample, unless this conflicts with
Member States' rules on sampling.
3.7.Packaging and transmission of samples
Each 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
sample, which might arise during transportation or storage.2002L0026 — EN — 10.05.2004 — 001.001 — 4
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3.8.Sealing and labelling of samples
Each sample taken for official use shall be sealed at the place of sampling
and identified following the Member State's regulations.
A record must be kept of each sampling, permitting each lot to be identi-
fied unambiguously and giving the date and place of sampling together
with any additional information likely to be of assistance to the analyst.
4.Specific provisions
4.1.Different types of lots
Food commodities may be traded in bulk, containers, or individual pack-
ings (sacks, bags, retail packings, etc.). The sampling procedure can be
applied to all the different forms in which the commodities are put on the
market.
Without prejudice to the specific provisions as laid down in points 4.3, 4.4
and 4.5 of this Annex, the following formula can be used as a guide for the
sampling of lots traded in individual packings (sacks, bags, retail packings,
etc.):
— Weight: in kg
— Sampling Frequency (SF): every nth sack or bag from which an incre-
mental sample must be taken (decimal figures should be rounded to the
nearest whole number).
4.2.Weight of the aggregate sample
The weight of the incremental sample should be about 100 grams, unless
otherwise defined in this Annex. In the case of lots in retail packings, the
weight of the incremental sample depends on the weight of the retail
packing.
4.3.General survey of the sampling procedure for cereals and dried vine fruit
Table 1: Subdivision of lots into sublots depending on product and lot weight
CommodityLot weight
(tonnes)Weight or number
of sublotsNumber of incre-
mental samplesAggregate sample
Weight
(kg)
Cereals and cereal
products≥1 500 500 tonnes 100 10
> 300 and
< 15003 sublots 100 10
≥50 and
≤300100 tonnes 100 10
< 50 — 10-100 (1) 1-10
Dried vine fruit (currants,
raisins and sultanas)≥15 15-30 tonnes 100 10
< 15 — 10-100 (2) 1-10
(1) Depending on the lot weight — see Table 2 of this Annex.
(2) Depending on the lot weight — see Table 3 of this Annex.
4.4.Sampling procedure for cereals and cereal products (lots ≥50 tonnes) and
dried vine fruit (lots ≥15 tonnes)
— On condition that the sublot can be separated physically, each lot must
be subdivided into sublots following Table 1. 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 %.
— Each sublot must be sampled separately.— Number of incremental samples: 100. In the case of lots of cereals
under 50 tonnes and lots of dried vine fruit under 15 tonnes, see point
4.5. Weight of the aggregate sample = 10 kg.2002L0026 — EN — 10.05.2004 — 001.001 — 5
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— If it is not possible to carry out the method of sampling described above
because of the commercial consequences resulting from damage to the
lot (because of packaging forms, means of transport, etc.) an alternative
method of sampling may be applied provided that it is as representative
as possible and is fully described and documented.
4.5.Sampling provisions for cereals and cereal products (lots < 50 tonnes) and
for dried vine fruit (lots < 15 tonnes)
For cereal lots under 50 tonnes and for dried vine fruit lots under 15
tonnes, the sampling plan has to be used with 10 to 100 incremental
samples, depending on the lot weight, resulting in an aggregate sample of
1 to 10 kg.
The figures in the following table can 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 cereals
Lot weight
(tonnes)Number of incremental samples
≤11 0
>1-≤32 0
>3-≤10 40
>1 0-≤20 60
>2 0-≤50 100
Table 3: Number of incremental samples to be taken depending on the
weight of the lot of dried vine fruit
Lot weight
(tonnes)Number of incremental samples
≤0,1 10
> 0,1 -≤0,2 15
> 0,2 -≤0,5 20
> 0,5 -≤1,0 30
> 1,0 -≤2,0 40
> 2,0 -≤5,0 60
> 5,0 -≤10,0 80
> 10,0 -≤15,0 100
4.6.Sampling procedure for foods intended for infants and young children
The sampling procedure as mentioned for cereals and cereal products in
point 4.5 of this Annex applies. This means that the number of incrementalsamples to be taken depends on the weight of the lot, with a minimum of
10 and a maximum of 100, in accordance with Table 2 at point 4.5.
— The weight of the incremental sample should be about 100 grams. In
case of lots in retail packing, the weight of the incremental sample
depends on the weight of the retail packing.
— Weight of aggregate sampling = 1 to 10 kg sufficiently mixed.
4.7.Sampling at retail stage
Sampling of foodstuffs at the retail stage should be done where possible in
accordance with the above sampling provisions. Where this is not possible,
other effective sampling procedures at retail stage can be used, provided
that they ensure sufficient representativeness for the sampled lot.
5.Acceptanceofalotorsublot
— Acceptance if the aggregate sample conforms to the maximum limit,
taking into account the measurement uncertainty and correction for
recovery,2002L0026 — EN — 10.05.2004 — 001.001 — 6
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— Rejection if the aggregate sample exceeds the maximum limit beyond
reasonable doubt, taking into account the measurement uncertainty and
correction for recovery.2002L0026 — EN — 10.05.2004 — 001.001 — 7
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ANNEX II
SAMPLE PREPARATION ANDCRITERIA FOR METHOD S OF
ANALYSIS USEDIN OFFICIAL CHECKING OF THE LEVELS OF
OCHRATOXINAINCERTAINFOODSTUFFS
1.Precautions
As the distribution of ochratoxin A is non-homogeneous, samples should be
prepared — and especially homogenised — with extreme care.
All the material received by the laboratory is to be used for the preparation
of test material.
2.Treatmentofthesampleasreceived inthelaboratory
Finely grind and thoroughly mix each laboratory sample using a process
that has been demonstrated to achieve complete homogenisation.
In case the maximum level applies to the dry matter, the dry matter content
shall be determined on a part of the homogenised sample, using a proce-
dure that has been demonstrated to determine accurately the dry matter
content.
3.Subdivisionofsamplesforenforcementanddefencepurposes
The replicate samples for enforcement, trade (defence) and referee purposes
shall be taken from the homogenised material unless this conflicts with
Member States' rules on sampling.
4.Methodofanalysistobeusedbythelaboratoryandlaboratorycontrol
requirements
4.1.Definitions
A number of the most commonly used definitions that the laboratory will
be required to use are given below:
The most commonly quoted precision parameters are repeatability and
reproducibility.
r= Repeatability, the value below which the absolute difference
between two single test results obtained under repeatability
conditions (i.e. same sample, same operator, same apparatus,
same laboratory, and short interval of time) may be expected to
lie within a specific probability (typically 95 %) and hence
r = 2,8 × sr
sr= 1 Standard deviation, calculated from results generated under
repeatability conditions
RSDr= Relative standard deviation, calculated from results generated
under repeatability conditions s r=x/C0ðÞ /C2 100 ½/C138 where x/C0is the
average of results over all laboratories and samples
R = Reproducibility, the value below which the absolute difference
between single test results obtained under reproducibility condi-
tions (i.e. on identical material obtained by operators in different
laboratories, using the standardised test method) may be
expected to lie within a certain probability (typically 95 %);
R = 2,8 × sR
sR= Standard deviation, calculated from results under reproducibility
conditions
RSDR= Relative standard deviation calculated from results generated
under reproducibility conditions s R=x/C0ðÞ /C2 100 ½/C138 :
4.2.General requirements
Methods of analysis used for food control purposes must comply with the
provisions of items 1 and 2 of the Annex to Directive 85/591/EEC
concerning the introduction of Community methods of sampling and
analysis for the monitoring of foodstuffs intended for human consumption.2002L0026 — EN — 10.05.2004 — 001.001 — 8
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4.3.Specific requirements
Where no specific methods for the determination of ochratoxin A levels in
foodstuffs are prescribed at Community level, laboratories may select any
method provided the selected method meets the following criteria:
Performance characteristics for ochratoxin A
Level
µg/kgOchratoxin A
RSDr(%)RSDR(%)Recovery
(%)
<1 ≤40 ≤60 50 to 120
1-10 ≤20 ≤30 70 to 110
— 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:
RSDR=2 (1-0,5logC)
where:
— RSDRis the relative standard deviation calculated from results
generated under reproducibility conditions s R=x/C0ðÞ /C2 100 ½/C138 ;
— C is the concentration ratio (i.e. 1 = 100 g/100 g, 0,001 = 1,000 mg/
kg).
This is a generalised precision equation, which has been found to be
independent of analyte and matrix but solely dependent on concentra-
tion for most routine methods of analysis.
4.4.Recovery calculation and reporting of results
The analytical result is to be reported corrected or uncorrected for recovery.
The manner of reporting and the level of recovery must be reported. The
analytical result corrected for recovery shall be used for checking compli-
ance (see Annex I, point 5)
The analytical result has to be reported as x +/- U, whereby x is the analy-
tical result and U is the expanded measurement uncertainty.
U is the expanded uncertainty, using a coverage factor of 2 which gives a
level of confidence of approximately 95 %.
4.5.Laboratory quality standards
Laboratories must comply with Directive 93/99/EEC on the subject of addi-
tional measures concerning the official control of foodstuffs.2002L0026 — EN — 10.05.2004 — 001.001 — 9
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