Commission Implementing Regulation (EU) 2023/2782 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of mycotoxins in food and repealing Regulation (EC) No 401/2006

Article 1

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘lot’ means an identifiable quantity of a food commodity delivered at one time and determined by the competent authority to have common characteristics, such as origin, variety, type of package, packer, consignor or markings;

(2) ‘sublot’ means a physically separate and identifiable part of a large lot designated to apply the sampling method;

(3) ‘incremental sample’ means a quantity of material taken from a single place in the lot or sublot;

(4) ‘aggregate sample’ means the combined total of all the incremental samples taken from the lot or sublot;

(5) ‘subsample’ means a quantity of material taken from the aggregate sample for control of ergot sclerotia by visual examination;

(6) ‘laboratory sample’ means a representative part or quantity of the aggregate sample intended for the laboratory;

(7) ‘recovery (Rec, %)’ means the percentage obtained by applying the following formula x/xref × 100 % where: x = measured concentration (for spiked samples corrected for background concentration if not blank), and xref = reference concentration (concentration of a Certified Reference Material (CRM), Proficiency Test material, or spiked sample);

(8) ‘bias’ means the difference between the measured value and the reference concentration;

(9) ‘repeatability relative standard deviation (RSDr)’ means the relative standard deviation (%) calculated from results generated under repeatability conditions (repeatability precision): using the same method on the same sample material in one laboratory by the same operator, with the same instrument, within a short interval of time (1 day or 1 sequence);

(10) ‘within-laboratory reproducibility relative standard deviation (RSDwR)’ means the relative standard deviation (%) calculated from results generated under within-laboratory reproducibility conditions (intermediate precision): using the same method on the same sample material in one laboratory but different days (preferably a longer time interval), and may include other conditions, such as involving different operators and/or different (equivalent) instruments;

(11) ‘reproducibility relative standard deviation (RSDR)’ means the relative standard deviation (%) calculated from results generated under reproducibility conditions (interlaboratory precision), meaning the same material is analysed by different laboratories. The RSDR may be derived from, in particular, collaborative studies and proficiency tests;

(12) ‘limit of Quantification (LOQ)’ means the lowest content of the analyte which can be measured with reasonable statistical certainty. In the context of this regulation this means the lowest successfully validated level: the lowest tested concentration of analyte in a sample material, for which it has been demonstrated that the criteria for recovery, precision, and identification are met (¹);

(13) ‘screening target concentration (STC)’ means the concentration of interest for detection of the mycotoxin in a sample. When the aim is to test compliance with regulatory limits, the STC is equal to the applicable maximum level. For other purposes or in case no maximum level has been established, the STC is predefined by the laboratory;

(14) ‘screening method’ means the method used for selection of those samples with levels of mycotoxins that exceed the screening target concentration (STC), with a given certainty. For the purpose of mycotoxin screening, a certainty of 95 % is considered fit-for-purpose. The result of the screening analysis is either ‘negative’ or ‘suspect’. Screening methods shall allow a cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks to consumers. These methods shall be based on bio-analytical, LC-MS or HPLC methods. Results from samples exceeding the cut-off value shall be verified by a full re-analysis from the original sample by a confirmatory method;

(15) ‘negative sample’ means the mycotoxin content in the sample is < STC with a certainty of 95 % (i.e. there is a 5 % chance that samples will be incorrectly reported as negative);

(16) ‘false negative sample’ means the mycotoxin content in the sample is >STC but it has been identified as negative;

(17) ‘suspect sample’ (screen positive) means the sample exceeds the cut-off value and may contain the mycotoxin at a level higher than the STC;

(18) ‘false suspect sample’ means a negative sample that has been identified as suspect;

(19) ‘confirmatory methods’ means methods that provide full or complementary information enabling the mycotoxin to be identified and quantified unequivocally at the level of interest;

(20) ‘cut-off value’ means the response, signal, or concentration, obtained with the screening method, above which the sample is classified as ‘suspect’. The cut-off value is determined during the validation and takes the variability of the measurement into account;

(21) ‘negative control (blank matrix) sample’ means a sample known to be free of the mycotoxin to be screened for, by previous determination using a confirmatory method of sufficient sensitivity or by other method or, where such sample cannot be obtained, material with the lowest obtainable level as long as the level allows the conclusion that the screening method is fit for that purpose;

(22) ‘sample known to be free’ means a sample where the amount present of the analyte does not exceed 1/5 of the STC. If the level can be quantified with a confirmatory method, the level shall be taken into consideration for the validation assessment;

(23) ‘positive control sample’ means a sample containing the mycotoxin at the screening target concentration, such as a certified reference material, a material of known content (e.g. test material of proficiency tests) or otherwise sufficiently characterised by a confirmatory method. In the absence of any of the above, a blend of samples with different levels of contamination or a spiked sample prepared within laboratory and sufficiently characterised can be used, provided it can be proven that the contamination level has been verified.

Article 2

Article 3

Sample preparation and methods of analysis used for the control of the levels of mycotoxins in foodstuffs shall comply with the criteria set out in Annex II.

Article 4

Regulation (EC) No 401/2006 is hereby repealed. References to the repealed Regulation shall be construed as references to this Implementing Regulation.

However, until 1 January 2029, the specific requirements provided for in point 4.3 in Annex II to Regulation (EC) No 401/2006 shall continue to apply to methods which have been validated before the entry into application of this Regulation.

Article 5

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 April 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

PART I

GENERAL PROVISIONS

A.1.   General provisions

Sampling shall be performed by a person as designated by the competent authority of the Member State.

Each lot which is to be examined shall be sampled separately. In accordance with the specific sampling provisions for the different mycotoxins, large lots shall be subdivided into sublots to be sampled separately.

In the course of sampling and preparation of the samples, precautions shall be taken to avoid any changes, which would:

— affect the mycotoxin content, adversely affect the analytical determination or make the aggregate samples unrepresentative;

— affect the food safety of the lots to be sampled.

Also, all measures necessary to ensure the safety of the persons taking the samples shall be taken.

As far as possible incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from such procedure shall be recorded in the record provided for under part I. point A.1.8. of this Annex.

The aggregate sample shall be made up by combining the incremental samples.

The replicate samples for enforcement, defence and reference purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with Member States’ rules as regards the rights of the food business operator.

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.

Each sample taken for official use shall be sealed at the place of sampling and identified following the rules of the Member State.

A record of each sampling shall be kept, 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.

A.2.   Different types of lots

Food commodities may be traded in bulk, containers, or individual packages, such as sacks, bags, retail/individual packages. The method of sampling may be applied to commodities put on the market in bulk, containers, or individual packages, such as sacks, bags, retail/individual packages or any other different form.

Without prejudice to the specific sampling 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 market in individual packages, such as sacks, bags, retail/individual packages.

Sampling frequency (SF) n =	Weight of the lot x Weight of the incremental sample
Weight of the aggregate sample x Weight of individual package

— weight: in kg

— sampling frequency (SF): every n^th individual package from which an incremental sample shall be taken (decimal figures shall be rounded to the nearest whole number).

A.3.   Sampling of commodities with a high volume/weight ratio

With the exception of the food commodities falling under parts L and M of part II of this Annex, in the case of sampling 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

This part lays down the methods of sampling for the following categories of food:

A. Cereals, oilseeds other than groundnuts, cereal and oilseed products other than groundnut products

B. Dried fruit and derived/processed products with the exception of dried figs

C. Dried figs and derived/processed products

D. Groundnuts (peanuts), apricot kernels, tree nuts and dried spices with large particle size and derived/processed products

E. Dried spices except dried spices with large particle size and powdered spices

F. Milk and milk products, infant formula, follow-on formula, foods for special medical purposes intended for infants and young children and young child formula

G. Coffee, coffee products, cocoa, cocoa products, liquorice root and liquorice products

H. Beverages

I. Solid processed fruit and vegetable products

J. Baby foods and processed cereal-based food for infants and young children

K. Vegetable oils

L. Food supplements, pollen and pollen products

M. Dried herbs, herbal infusions (dried product), teas (dried product) and powdered spices

N. Very large lots or lots stored or transported in a way whereby sampling throughout the lot is not feasible

A. METHOD OF SAMPLING FOR CEREALS, OILSEEDS OTHER THAN GROUNDNUTS, CEREAL AND OILSEED PRODUCTS OTHER THAN GROUNDNUT PRODUCTS

The weight of the incremental sample shall be about 100 g, unless otherwise defined in this part and except for oilseeds or cereal grains for which 1 000 seeds/grains weigh less than 10 g (‘small particle oilseeds or cereal grains’)

For these small particle oilseeds or cereal grains the incremental sample shall be about 25 g.

In the case of lots in retail/individual packages, the weight of the incremental sample shall depend on the weight of the retail/individual package.

In the case of retail/individual packages of more than 100 g (or 25 g in the case of small particle oilseeds or cereal grains), this will result in aggregate samples weighing more than the required weight indicated in tables 1 and 2 of point A.2. If the weight of a single retail/individual package is much more (i.e. more than double) than 100 g (or 25 g in the case of small particle oilseeds or cereal grains), 100 g (or 25 g in the case of small particle oilseeds or cereal grains) shall be taken from each retail/individual package as an incremental sample. This may be done either when the sample is taken or in the laboratory.

However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, or other reasons), an alternative method of sampling may be applied. In particular, in case where a valuable product is marketed in retail/individual packages of 500 g or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in tables 1 and 2, on the condition that the weight of the aggregate sample is equal to the required weight of the aggregate sample mentioned in those tables.

Where the retail/individual packages are less than 100 g (or 25 g in the case of small particle oilseeds or cereal grains) and if the difference is not very large (i.e. not less than half of 100 g or 25 g) one retail/individual package is to be considered as one incremental sample, resulting in an aggregate sample of less than the required weight indicated in tables 1 and 2. If the weight of the retail/individual packages are much less than 100 g (or 25 g in the case of small particle oilseeds or cereal grains), one incremental sample consists of two or more retail/individual packages, whereby the 100 g (or 25 g in the case of small particle oilseeds or cereal grains) are approximated as closely as possible.

Commodity	Lot weight (tonne)	Weight or number of sublots	No incremental samples	Aggregate sample weight (kg)
Cereals, oilseeds other than groundnuts, cereal products and oilseed products, other than groundnut products	> 300 and < 1 500	3 sublots	100	10 2,5 for small particle oilseeds or cereal grains
≥ 100 and ≤ 300	100 tonnes	100	10 2,5 for small particle oilseeds or cereal grains
< 100	—	3 -100  (*1)	1 -10 0,25 – 2,5 for small particle oilseeds or cereal grains
(*1) Depending on the lot weight – see Table 2 of Point A.4.

— On condition that the sublot can be separated physically, each lot shall be subdivided into sublots according to 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 %. In case the lot is not or cannot be physically separated into sublots, a minimum of 100 incremental samples is taken from the lot. For lots > 500 tonnes, the number of incremental samples is provided for in point N.2.

— Each sublot shall be sampled separately.

— Number of incremental samples: 100. Weight of the aggregate sample = 10 kg (or 2,5 kg in the case of small particle cereals and oilseeds).

— If it is not possible to carry out the method of sampling set out in this point because of the unacceptable 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. An alternative method of sampling may also be applied in cases where it is practically impossible to apply the abovementioned method of sampling. This is the case where large lots of cereals are stored in warehouses or where cereals are stored in silos (⁴). The sampling of such lots shall be performed in accordance with the rules set out in part N.

For lots of cereals, oilseeds other than groundnuts, cereal products and oilseed products, other than groundnut products less than 50 tonnes, the sampling plan shall be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg (or 0,25 – 2,5 kg in the case of small particle oilseeds or cereal grains). For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample combining all incremental samples shall also be in that case at least 1 kg (or 0,25 kg in the case of small particle cereals and oilseeds) and for the determination of ergot sclerotia, at least 1 kg.

The figures in Table 2 shall be used to determine the number of incremental samples to be taken.

Lot weight (tonnes)	Number of incremental samples	Aggregate sample weight(kg) (*1)	Aggregate sample weight(kg) (*1) for small particle oilseeds or cereal grains
≤ 0,05	3	1	0,25
> 0,05 -≤ 0,5	5	1	0,25
> 0,5 -≤ 1	10	1	0,25
> 1 -≤ 3	20	2	0,5
> 3 -≤ 10	40	4	1,0
> 10 -≤ 20	60	6	1,5
> 20 -≤ 100	100	10	2,5
(*1) In case of control for the presence of ergot sclerotia, the aggregate sample weight is at least 1 kg.

Sampling of foodstuffs at the retail stage shall be done where possible in accordance with the sampling provisions set out in this part A.

Where that is not possible, an alternative method of sampling at retail stage may be applied provided that it ensures that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented. In any case, the aggregate sample shall be at least 1 kg (⁵).