ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 1/13COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/2783 
of 14 December 2023
laying down the methods of sampling and analysis for the control of the levels of plant toxins in food 
and repealing Regulation (EU) 2015/705 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities perf ormed to ensure the application of food and feed law, rules on animal health and 
welf are, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) 
No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the 
European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council 
Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) 
No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Offici al 
Controls Regulation) (1), and in particular Article 34(6) thereof,
Whereas:
(1) Commission Regulation (EU) 2023/915 (2)sets maximum levels for certain plant toxins in food.
(2) Sampli ng plays a crucial part in the precision of the deter mination of the levels of plant toxins in a certain lot since 
plant toxins within a lot maybe be heterogeneously distr ibut ed. It is theref ore appropr iate to establish sampling 
methods for the official control of the levels of plant toxins in food.
(3) Commission Implementing Regulation (EU) No 2023/2782 (3)lays down the methods of sampli ng to be used for the 
official control of the levels of mycotoxins in food. Given that both plant toxins and mycotoxins are heterogeneously 
distr ibut ed within lots, it is appropr iate to apply those methods of sampling also as regards plant toxins.
(4) Offi cial controls can be performe d on foods for whic h no specifi c maximum level has been established for plant 
toxins and for which no specif ic samp ling procedure has been established. It is theref ore appropr iate to provide 
criteria to deter mine whic h sampli ng procedure should be applied in such cases.
(5) It is also necessar y to set out general perf ormance criteria which the method of analysis should comply with to 
ensure that control laborat ories use methods of analysis with comparable levels of performa nce. Since the European 
Union Reference Laboratory on mycotoxins and plant toxins have determined the analytical performa nce criteria for 
the analysis of plant toxins in food on the basis of the best available scientifi c information, it is appropr iate to lay 
down those criteria in this Regulation.
(1)OJ L 95, 7.4.2017, p. 1.
(2)Commission Regulation (EU) 2023/915 of 25 Apr il 2023 on maximum levels for certain contaminants in food and repealing 
Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103).
(3)Commission Implementing Regulation (EU) 2023/2782 of 14 December 2023 laying down the methods of samplin g and analysis for 
the control of the levels of mycoto xins in food and repealing Regulation (EC) No 401/2006 (OJ L, 2023/2782, 15.12.2023, ELI: 
http://data.europa.eu/eli/reg_impl /2023/2782/oj).
Offi cial Jour nal  
of the European Union EN 
L series    
2023/2783  15.12.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 2/13(6) Commission Regulation (EU) 2015/705 (4)lays down methods of samp ling and perf ormance criteria for the 
methods of analysis for the official control of the levels of erucic acid in foodstuffs. Since the methods of sampling 
and the analytical performa nce criteria laid down in this Regulation are also adequat e for the control of the plant 
toxin erucic acid in food, it is appropr iate, in the inter est of simplication to repeal Regulation (EU) 2015/705.
(7) It is necessar y to provi de the control laborat ories with a suffic ient time to meet the new requirements introduced by 
this Regulation. Theref ore, it is appropr iate to provi de for a reasonable time until this Regulation applies.
(8) In order to ensure continuity in the performa nce of official controls and other regulator y activities on maximum 
levels of plant toxins and in order to allow enough time for methods of analysis to be re-validate d, it is appropr iate 
to provide that methods of analysis which have been validate d before the date of application of this Regulation can 
remain in use for a defined period.
(9) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
For the purposes of this Regulation, the definitions set out in Article 1 of Commission Implementing Regulation 
(EU) 2023/2782 shall apply .
Article 2
(1) Sam pling for the control of the levels of plant toxins in food shall be carried out in accordance with the methods set 
out in Annex I.
(2) In case of a food that cannot be classified in a food cate gory for which a samp ling procedure has been established in 
Annex I, the sampli ng procedure shall be determined having regar d to the particle size of that food or the similar ity of that 
food with a product that can be classified in one of the food categor ies in Annex I.
(3) In case of a food that cannot be classif ied in any food catego ry listed in Annex I and provided that there is evidence 
that the plant toxin is homog eneously distr ibut ed in such a food, the food shall be sampled using the sam pling method 
laid down in Part B of the Annex to Commission Regulation (EC) No 333/2007 (5).
Article 3
Sample preparation and methods of analysis used for the control of the levels of plant toxins in foodstuffs shall comply 
with the criteria set out in Annex II.
Article 4
Regulation (EU) 2015/705 is hereby repealed. References to the repealed Regulation shall be constr ued as referen ces to this 
Implementing Regulation.
(4)Commission Regulation (EU) 2015/705 of 30 Apr il 2015 laying down methods of sampling and performance criteria for the methods 
of analysis for the official control of the levels of erucic acid in foodstuffs and repealing Commission Directive 80/891/EEC (OJ L 113, 
1.5.2015, p. 29).
(5)Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of 
the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29).OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 3/13Article 5
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
It shall apply from 1 Apr il 2024 . However , methods of analysis which have been validated before the entr y into application 
of this Regulation may remain in use until 1 July 2028 , even if they do not comply with all specific requirements provided 
for in point 4.2 in Annex II to this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 December 2023 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 4/13ANNEX I 
Methods of sampling for the control of the levels of plant toxins in food
PART I
GENERAL PROVISIONS
A.1. General provisions
A.1.1. Personnel
Sam pling shall be performe d by a person as designate d by the compet ent author ity of the Member State.
A.1.2. Mater ial to be sampled
Each lot which is to be examined shall be sampled separate ly. In accordance with the specific sam pling provisions 
for the differ ent plant toxins, large lots shall be subdivided into sublots to be sample d separate ly.
A.1.3. Precau tions to be taken
In the course of sampli ng and preparation of the sam ples, precautions shall be taken to avoid any changes, whic h 
would:
— affect the plant toxin content, adversely affect the analytical determination or make the aggrega te samples 
unrepresentative;
— affect the food safety of the lots to be sampled.
Also, all measures necessar y to ensure the safety of the persons taking the samples shall be take n.
A.1.4. Increm ental samples
As far as possible incremental samples shall be taken at various places distr ibuted throughout the lot or sublot. 
Depar ture from such procedure shall be recorded in the record provid ed for under part A.1.8. of this Annex.
A.1.5. Prep aration of the aggregate sample
The aggregat e sample shall be made up by combining the incremental sam ples.
A.1.6. Replicate samples
The replicate sam ples for enforcement, defe nce and referen ce purposes shall be take n from the homogenised 
aggrega te sample, unless such procedure conf licts with Member State s’ rules as regar ds the rights of the food 
business operator .
A.1.7. Packaging and transmission of samples
Each sample shall be placed in a clean, iner t container offering adequate prote ction from contamination and against 
damage in transit. All necessar y precautions shall be take n to avoid any chang e in compo sition of the sample, whic h 
might arise during transpor tation or storag e.
A.1.8. Sealing and labelling of samples
Each sam ple taken for official use shall be sealed at the place of sampling and identified followi ng the rules of the 
Member State .
A record of each sam pling shall be kept, permitting each lot to be identified unambiguously and giving the date and 
place of sampli ng together with any additional information likely to be of assistance to the analyst.OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 5/13A.2. Different types of lots
Food commodities may be traded in bulk , containers, or individual packag es, such as sacks, bags, retail/individual 
packag es. The method of sam pling may be applied to commodities put on the mark et in bulk , containers, or 
individual packag es, such as sacks, bags, retail/individual packag es or any other diffe rent form.
Without prejudice to the specifi c sampli ng provisions set out in other parts of this Annex, the following formula 
shall be used as a guide for calculating the sampling frequency of lots put on the mark et in individual packag es, 
such as sacks, bags, retail/individual packag es.
Sampli ng frequency (SF) n =Weight of the lot x Weight of the incremental sample
Weight of the aggregat e sample x Weight of individual packag e
— weight: in kg
— sam pling frequency (SF): ever y nth individual packag e from whic h an incremental sam ple shall be take n (decimal 
figures should be rounded to the nearest whole number).
A.3. Sampling of commodities with a high volume/w eight ratio
With the excep tion of the food commodities falling under part L and M of part II of Annex I to Implementing 
Regulation (EU) 2023/2782, in the case of sampli ng food commodities which have a high volume in comparison 
to their weight (i.e. volume (dm3)/weight (kg) > 5) the weight requirements can be replaced by equivalent volume 
requirement (i.e. 1 kg replaced by 1 dm3).
PART II
METHODS OF SAMPLING
The methods of sampling established in part II of Annex I to Commission Implementing Regulation (EU) 
No 2023/2782 shall apply .
Howe ver, for the sampli ng of potatoes and potato products (glycoalkaloids) and honey (pyrrolizidine alkaloids), 
part B of the Annex to Regulation (EC) No 333/2007 shall apply .OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 6/13ANNEX II 
Criter ia for sample preparation and for methods of analysis used for the control of the levels of plant 
toxins in food
1. INTR ODUCTION Precautions
As the distr ibution of plant toxins is generally non-homog eneous, sam ples shall be prepared, and especially 
homog enised, with extreme care.
The complet e samp le as received by the laborat ory shall be homogenised, in case the homog enisation is 
perf ormed by the laborat ory.
2. TREA TMENT OF THE SAMPLE AS RECEIVED IN THE LABORA TOR Y
Each laboratory sample shall be mixed thoroughly using a process, including fine grinding if needed, that has 
been demonstrated to achi eve compl ete homogenisation
In case the maximum level applies to the dry matt er, the dry matte r content of the product shall be determined 
on a part of the homogenised sam ple, using a method that has been demonstrated to determi ne accurately the 
dry matter conte nt.
3. REPLICA TE SAMPLES
The replicate sam ples for enforcement, defe nce and referen ce purposes shall be taken from the homogenised 
mat erial unless such procedure conf licts with Member State s’ rules as regards the rights of the food business 
operat or.
4. METHOD OF ANAL YSIS TO BE USED BY THE LABORA TOR Y AND LABORA TOR Y CONTR OL REQUIREMENTS
4.1. General requirements
Confir matory methods of analysis used for food control purposes shall compl y with the provisions of points 1 
and 2 of Annex III to Regulation (EU) 2017/625.
Wherever possible, the trueness of the method should be verified by analysis of a certified reference 
mat erial and/or successful participation in proficiency tests on a regular basis.
4.2. Specif ic requirements
4.2.1. Specific requir ements for confir mator y methods
4.2.1.1. Performance criteria
For conf irmatory methods the following performa nce criteria apply:
Recov ery: the average recovery should be between 70 and 120 %.
The average recovery is the average value from replicates obtained during validation when determining the 
precision parameters RSDr and RSDw R. The criterion applies to all concentrations and all individual toxins.
In excep tional cases, average recoveri es outside the above rang e can be acceptable but shall lie within 50-130 %, 
and only when the precision criteria for RSDr and RSDw R are met.
Precision
RSDr shall be ≤ 20 %.
RSDwR shall be ≤ 20 %.
RSDR should be ≤ 25 %.
These criteria apply to all concentrations.
In case a laborat ory provides the evidence that the RSDwR criterion is complied with, there is no need to 
provi de that evidence for the RSDr criterion as compl iance with the RSDwR guarantees compliance with the 
RSDr criterion.
In case the maximum level applies to a sum of toxins, then the criteria for precision apply to both the sum and 
the individual toxins.OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 7/13Limit of quantification
When a specifi c requirement for the LOQ of a plant toxin has been set in the table 1 below , the method shall 
have an LOQ at or below this value.
Table 1
LOQ requirements for certain plant toxins 
Plant toxin Comments FoodLOQ requirement (μg/kg) 
or (μg/l)
Pyrrolizidine 
alkaloidsLOQ requirement for 
individual pyrrolizidine 
alkaloidsDried product
Liquid product≤ 10
≤ 0,15
Tropane alkaloids LOQ requirement for 
atropine and scopolamine 
separatelyProcessed cereal based foods for 
infant and young children
Cereals and cereal products
Herbal infusions (dried pro­
duct)
Herbal infusions (liquid)≤ 1
≤ 2
≤ 5
≤ 0,05
Opium alkaloids LOQ requirement for 
mor phine and codeine 
separatelyBakery products ≤ 500
In all other cases, the followi ng applies:
LOQ: shall be ≤ 0,5*ML and should preferably be lower (≤ 0,2*ML).
In case the maximum level applies to a sum of toxins, then the LOQ of the individual toxins shall be ≤ 0,5*ML/n, 
with n being the number of toxins included in the ML definition.
Identification
For identification the criteria as laid down in the Guidance document on identif ication of mycoto xins and plant 
toxins in food and feed(1)shall be applied.
4.2.1.2. Exten sion of the scope of the method
4.2.1.2.1. Exten sion of scope to other plant toxins:
When additional analyte s are added to the scope of an existing confir matory method, a full validation is required 
to demonstrate the suitability of the method.
4.2.1.2.2. Exten sion to other commodities:
If the conf irmatory method is known or expected to be applicable to other commodities, the validity to these 
other commodities shall be verified. As long as the new commodity belongs to a commodity group (see Table 2 
in this Annex) for which an initial validation has already been performed, a limited additional validation is 
sufficient.
4.2.2. Specific requir ements for semi-quantitative scree ning methods
4.2.2.1. Scope
This section applies to bioanalytical methods based on immuno-recognition or recep tor binding (suc h as ELISA, 
dipstic ks, latera l flow devices, immuno-sensors) and physicoch emical methods based on chromat ography or 
direct detection by mass spectrometr y (e.g. ambient MS). Other methods (e.g. thin layer chromatograph y) are 
not excl uded provid ed the signals generated relat e directly to the plant toxins of interest and allow that the 
principle descr ibed hereunder is applicable.
(1)Available at: https://f ood.ec.europa.eu/system/files/2023-10/cs_contaminants_sampling_guid-doc-ident-m ycoto xins.pdfOJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 8/13The specific requirements apply to methods of which the result of the measurement is a numer ical value, for 
exam ple a (relative) response from a dip-stick reader , a signal from LC-MS, etc., and that normal statistics apply .
The requirements do not apply to methods that do not give numer ical values (e.g. only a line that is present or 
absent), whic h require diffe rent validation approaches. Specific requirements for these methods are provided in 
point 4.2.3.
This document descr ibes procedures for the validation of screening methods by means of an inter -laboratory 
validation, the verification of the performa nce of a method validat ed by means of an inter-laboratory exercise 
and the sing le-laboratory validation of a screening method.
4.2.2.2. Validation procedure
The aim of the validation is to demonstrate the fitness of purpose of the screening method. This is done by 
determination of the cut-off value and determi nation of the false negative and false suspect rate. In these two 
paramete rs performance character istics such as detection capability , selectivity , and precision are embedded.
Screening methods may be validat ed by inter -laboratory or by sing le laboratory validation. If inter -laboratory 
validation data is already available for a certain plant toxin/matr ix/STC combination, a verification of method 
perf ormance is suffi cient in a laboratory implementing the method.
4.2.2.2.1. Initial validation by sing le laboratory validation
Plant toxins
The validation shall be performed for ever y individual plant toxin in the scope. In case of bio-analytical methods 
that give a combined response for a certain plant toxin group (e.g. pyrrolizidine alkaloids), applicability shall be 
demonstrate d and limitations of the test mentioned in the scope of the method. Undesired cross-reactivity is not 
considered to increase the false negative rate of the target plant toxins, but may increase the false suspect rate. 
This unwant ed increasing shall be diminished by conf irmatory analysis for unambiguous identif ication and 
quantification of the plant toxins.
Matr ices
An initial validation shall be performe d for each commodity , or, when the method is known to be applicable to 
multiple commodities, for each commodity group. In the latter case, one representative and relevant commodity 
shall be selected from that group (see table 2).
Sample set
The minimum number of different samp les required for validation is 20 homog eneous negative control sam ples 
and 20 homogeneous positive control sample s that contain the plant toxin at the STC, analysed under within- 
laborat ory reproducibility (RSDw R) conditions spread over 5 different days. Additional sets of 20 samples 
containing the plant toxin at other levels may be added to the validation set to gain insight to what extent the 
method can distinguish between differ ent plant toxin concentrations.
Concentr ation
For each STC to be used in routine application, a validation has to be performe d.
4.2.2.2.2. Initial validation through collaborative trials
Validation through collaborative trials shall be done in accordance with ISO 5725:1994 or the IUPAC 
International Harmonised Protocol or other intern ationally recognised prot ocol on collaborative trials which 
requires inclusion of valid data from at least eight different laborat ories. The only other differ ence compare d to 
sing le laboratory validations shall be that the ≥ 20 samples per commodity/level may be evenly divided over the 
participating laboratori es, with a minimum of two sam ples per laborat ory.OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 9/134.2.2.3. Determination of cut-off value and rate of false suspected results of blank samples
The (relative) responses for the negative control and positive control samples shall be taken as basis for the 
calculation of the required parameter s.
Screening met hods with a response propor tional with the plant toxin concentr ation
For screening methods with a response propor tional with the plant toxin concentration the followi ng applies:
Cut-of f value = RSTC – t-value 0,05 *SD STC
RSTC= mean response of the positive control samples (at STC)
t-value: one tailed t-value for a rate of false negat ive results of 5 % (see table 3)
SD STC= standard deviation
Screening met hods with a response inversely propor tional with the plant toxin concentr ation
Similarly , for screening methods with a response inversely propor tional with the plant toxin concentration, the 
cut-off value is determi ned as:
Cut-off value = RSTC + t-value 0,05 *SD STC
By using this specific t-value for determining the cut-off value, the rate of false negativ e results is by default set at 
5 %.
Fitness for purpose assessment
Results from the negat ive control samples are used to estimate the corresponding rate of false suspect results. 
The t-value is calculat ed corresponding to the event that a result of a negative control sample is above the cut- 
off value, thus erroneously classifie d as suspect.
t-value = (cut-off value- mean blank)/SD blank
for screening methods with a response propor tional with the plant toxin concentration
or
t-value = (mean blank – cut-off value)/SD blank
for screening methods with a response inversely propor tional with the plant toxin concentration
From the obtained t-value, based on the degrees of freedom calculated from the number of exper iments, the 
probability of false suspect samples for a one tailed distr ibution can either be calculated (e.g. spread sheet 
function "TDIST") or taken from a table for t-distr ibution (see table 3).
The corresponding value of the one tailed t-distr ibution specifi es the rate of false suspect results.
This concep t is descr ibed in detail with an example in Analytical and Bioanalytical Chemistr y DOI 10.1007/ 
s00216 -013-6922-1.
4.2.2.4. Exten sion of the scope of the method
4.2.2.4.1. Exten sion of scope to other plant toxins:
When new plant toxins are added to the scope of an existing screening method, a full validation shall be required 
to demonstrate the suitability of the method.OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 10/134.2.2.4.2. Exten sion to other commodities:
If the screening method is kno wn or expect ed to be applicable to other commodities, the validity to these other 
commodities shall be verified. As long as the new commodity belongs to a commodity group (see Table 2 in this 
Annex) for which an initial validation has already been perf ormed, a limited additional validation is suffi cient. 
For this, a minimum of 10 homogene ous negative control and 10 homog eneous positive control (at STC) 
sam ples shall be analysed under within-laborat ory reproducibility conditions. The positive control samples 
shall all be above the cut-off value. In case this criterion is not met, a full validation is required.
4.2.2.5. Verification of methods already validat ed through collaborative trials
For screening methods that have already been successfully validat ed through a collaborative laboratory trial, the 
method perf ormance shall be verified. For this a minimum of 6 negative control and 6 positive control (at STC) 
sam ples shall be analysed. The positive control samples shall all be abov e the cut-off value. In case this criterion 
is not met, the laboratory has to perform a root-cause analysis to identify why it cannot meet the specifi cation as 
obtained in the collaborative trial. Only after taking corrective action, it shall re-ver ify the method performa nce 
in its laboratory . In case the laborat ory is not capable to verify the results from the collaborative trial, it will need 
to deter mine its own cut-off value in a complet e sing le laboratory validation.
4.2.2.6. Continuous method verification/on-going method validation
After initial validation, additional validation data are acquired by including at least two positive control sam ples 
in each batch of samples screened. One positive control sample shall be a kno wn sample (e.g., one used during 
initial validation), the other shall be a different commodity from the same commodity group (in case only one 
commodity is analysed, a differ ent sample of that commodity is used instead). Inclusion of a negative control 
sam ple is optional. The results obtained for the two positive control samples are added to the existing 
validation set.
At least once a year the cut-off value is re-determ ined, and the validity of the method is re-assessed (re-evaluation 
of the available QA/QC data obtained in the last year). The continuous method verification serves several 
purposes, including:
— quality control for the batch of sam ples screened;
— provi ding information on robustness of the method at conditions in the laborat ory that applies the method
— justification of applicability of the method to differ ent commodities
— allowing to adjust cut-off values in case of gradual drifts over time.
4.2.2.7. Validation repor t
The validation repor t shall contain:
— a statement on the STC
— a statement on the deter mined cut-off value.
Note: The cut-off value shall have the same number of signif icant figures as the STC. Numer ical values used 
to calculate the cut-off value need at least one more significant figure than the STC.
— a statement on calculated false suspect ed rate
— a statement on how the false suspect ed rate was generated.
Note: The statement on the calculated false suspect ed rate indicates if the method is fit-for-pur pose as it 
indicates the number of blank (or low-level contamination) samples that will be subject to 
verification.OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 11/13Table 2
Commodity groups for the validation of conf irmatory and screening methods 
Commodity groups Commodity categor iesTypical representative commodities included in 
the categor y
High water cont ent Beverages
Fruits and vegetables
Cereal or fruit based purees
Fresh culinar y herbsHerbal infusions (liquid), borage leaves, 
potatoes, purees intended for infants and 
small children
High oil conte nt Tree nuts
Oil seeds and products thereof
Oily fruits and products thereofAlmonds, apricot kern els, rapeseed, cot­
tonseed, linseed, lupin seeds, popp y seeds, 
hem p seeds etc.
Oils and pastes
High starc h and/or 
protein content and low 
wate r and fat contentCereal grain and products thereof
Dietar y productsMaize, buckwheat, millet, sorghum, cassava 
flour , potato products,
Bread, baker y products, crack ers, breakf ast 
cereals, pasta
Dried powders for the preparation of food 
for infants and small children
High acid content and 
high water conte nt(*)Citrus products
‘Diff icult or unique 
commodities ’(**)Pollen and pollen products, food supple ­
ments, herbal infusions (dried product),
tea (dried product)
Spices, liquor ice
High sugar low water 
contentDried fruits Figs, raisins, currants, sultanas, honey
Milk and milk
productsMilk
Cheese
Dair y products (e.g. milk powder)Cow , goat and buffalo milk
Cow , goat cheese
Yogur t, cream
(*) If a buffer is used to stabilise the pH chang es in the extraction step, then this commodity group can be merged into one 
commodity group ‘High water content’.
(**) ‘Difficult or unique commodities’ needs only to be fully validated if they are frequently analysed. If they are only analysed 
occasionally , validation may be reduced to just chec king the repor ting levels using spiked blank extracts.
Table 3
One tailed t-value for a false negativ e rate of 5 % 
Degrees of Freedom Number of replicates t-value (5 %)
10 11 1,812
11 12 1,796
12 13 1,782OJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 12/1313 14 1,771
14 15 1,761
15 16 1,753
16 17 1,746
17 18 1,74
18 19 1,734
19 20 1,729
20 21 1,725
21 22 1,721
22 23 1,717
23 24 1,714
24 25 1,711
25 26 1,708
26 27 1,706
27 28 1,703
28 29 1,701
29 30 1,699
30 31 1,697
40 41 1,684
60 61 1,671
120 121 1,658
∞ ∞ 1,645
4.2.3. Requirements for qualitativ e scree ning methods (methods that do not give numer ical values)
The development of validation guidelines for binar y test methods is currently carried out by various 
standardisation bodies (e.g., AOAC, ISO). AOAC has draf ted a guideline on the validation of binar y test 
methods. This document can be regarded as the current state of the art in the field of validation of binar y test 
methods. Theref ore, methods that give binar y results (e.g., visual inspection of dip-stick tests) should be 
validat ed according to AOAC Internatio nal Guidelines for Validation of Qualitative Binar y Chemistr y 
Methods (2)
Howe ver, other recognised validation guidelines can be used such as the approac h provided for 
in ISO/TS 23758:2021 | IDF/RM 251 Guidelines for the validation of qualitative screening methods for the 
detection of residues of veteri nary drugs in milk and milk products.
4.3. Estimation of measurement uncer tainty , reco very calculation and repor ting of results (3)
4.3.1. Confir mator y methods
(2)Available at: https://academic.oup.com/jaoac/ar ticle-pdf/97/5/1492/32425003/jaoac1492.pdf
(3)More details on procedures for the estimation of measurement uncer tainty and on procedures for assessing recover y can be found in 
the repor t ‘Repor t on the relationship between analytical results, measurement uncer tainty , recovery factors and the provisions of EU 
food and feed legislation’ 
https://f ood.ec.europa.eu/system/files/2016-10/cs_contaminants_sampling_analysis-repor t_2004_en.pdfOJ L, 15.12.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj 13/13The analytical result shall be repor ted as follows:
(a) Corrected for recovery , where appropr iate and relevant, and when corrected it shall be stated. The reco very 
rate is to be quoted unless intrinsic correction for bias is part of the procedure. The correction for reco very 
is not necessar y in case the recovery rate is between 90-110 %.
(b) As x +/– U whereby x is the analytical result and U is the expanded analytical measurement uncer tainty , 
using a coverag e factor of 2 which gives a level of conf idence of appro ximat ely 95 %.
As a possibility a default expanded measurement uncer tainty of 50 % may be repor ted, provided that the 
laborat ory meets all precision requirements specifi ed in point 4.2. An individual laboratory can demonstrate 
that by achi eving the criteria for the repeatability (RSD r) and the within-laboratory reproducibility (RSD wR), 
supplement ed by successful participation in prof iciency testing programs (unless no suitable proficiency testing 
program is available), as a mean z-score |z| ≤ 2 demonstrates that the required reproducibility (RSD R) is met 
(based on a target standard deviation of 25 %).
In case the maximum level has been set for the sum of toxins, the analytical results of all individual toxins shall 
be repor ted.
Recov ery correction, if applicable, shall be done for each of the individual toxins before summation of the 
concentrations.
For compliance verification with the sum-ML, a lowe r-bound approac h shall be applied which means that results 
for individual toxins that are <LOQ shall be replaced by zero for the calculation of the sum.
The present interpr etation rules of the analytical result in view of acceptance or rejection of the lot apply to the 
analytical result obtained on the sample for offici al control. In case of analysis for defe nse or referee purposes, 
the national rules apply . In particular , if:
the analytical result of the official control sample indicates a non-compliance beyond reasonable doubt, taking 
into account the expanded measurement uncer tainty and
the analytical result of the defense samp le indicates a non-com pliance but not beyond reasonable doubt with a 
larger expanded measurement uncer tainty than the one of the official control,
then the analytical result of the defense sam ple cannot supersede the non-com pliance established for the official 
control sam ple.
4.3.2. Screening methods
The result of the screening shall be expressed as compl iant or suspecte d to be non-com pliant.
‘Suspecte d to be non-com pliant’ means the sam ple exceed s the cut-off value and may contain the plant toxin at a 
level higher than the STC. Any suspect result trigge rs a conf irmatory analysis for unambiguous identification 
and quantifi cation of the plant toxin.
‘Compli ant’ means that the plant toxin content in the sam ple is < STC with a level of confidence of 95 % (i.e. 
there is a 5 % chance that samples will be incor rectly repor ted as negative). The analytical result is repor ted as ‘< 
level of STC’ with the level of STC specifi ed.
4.4. Laborato ry quality standards
A laborat ory shall compl y with the provis ions of Article 37(4) and (5) of Regulation (EU) 2017/625.OJ L, 15.12.2023 EN