Contents
- THE EUROPEAN COMMISSION, Having regard to the Treaty on th…
- 1 Subject matter
- 2 Definitions
- 3 Methods of sampling and preparation of samples for analysis for food
- 4 Methods of analysis, measurement uncertainty and interpretation of results for food and feed
- 5 Repeal
- 6 Entry into force and application
- PROCEDURE FOR SAMPLING AND ANALYSIS FOR FOOD AND FEED OF PLANT AND ANIMAL ORIGIN FOR THE DETERMINATION OF PESTICIDE RESIDUES FOR CHECKING COMPLIANCE WITH MRLs
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having 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 performed to ensure the application of food and feed law, rules on animal health and welfare, 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 (Official Controls Regulation)note, and in particular Article 34(6) thereof,Whereas:
(1)Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of Member States to check compliance with Union legislation, among others in the area of food and feed safety at all stages of production, processing and distribution. It provides for specific rules on official controls in relation to substances whose use may result in residues in food and feed and sets general requirements for the methods to be used for sampling, laboratory analyses and tests during official controls and other official activities.
(2)Articles 34, 35 and 36 of Regulation (EU) 2017/625 and Commission Delegated Regulation (EU) 2021/2244note provide for general rules with regard to sampling and analysis.
(3)Regulation (EC) No 396/2005 of the European Parliament and of the Councilnote establishes maximum residue levels (‘MRLs’) of pesticides in or on food and feed of plant and animal origin.
(4)Commission Directive 2002/63/ECnote provides for the methods of sampling for the official control of pesticide residues in and on products of plant and animal origin.
(5)However, Directive 2002/63/EC no longer reflects best practices in the field of pesticide residues in and on products of plant and animal origin.
(6)More clarity is necessary for the sampling rules of some product categories listed in Annex I to Regulation (EC) No 396/2005, in particular the categories ‘Honey and other apicultural products’, ‘Amphibians and Reptiles’, ‘Terrestrial invertebrate animals’, ‘Wild terrestrial vertebrate animals’ and ‘Fish, fish products and any other marine and freshwater food products’. In addition, the clarification of sampling requirements is necessary for products of high value, for products of very large size and for certain processed food as well as food supplements.
(7)The European Union Reference Laboratories in the field of pesticide residues have elaborated a ‘Guidance Document on Analytical Quality Control and Validation Procedures for pesticide residues analysis in food and feed’note. As that Guidance Document contains the best up to date technological knowledge, its principles on reporting and interpretation of results should become binding to ensure uniform enforcement action by Member States.
(8)Commission Regulation (EC) No 152/2009note establishes methods of sampling and analysis for the official control of feed. As regards the collection of samples and the preparation of samples for analysis for the purpose of control of pesticides residues in feed, the rules provided for in Annex I and Part A of Annex II to Regulation (EC) No 152/2009 are not affected by this Regulation and shall continue to apply. As regards the method for laboratory analyses, the measurement uncertainty and the interpretation of the analytical results for the purpose of control of pesticide residues in feed, specific rules are necessary and should therefore be established in this Regulation.
(9)It is therefore appropriate to update the specific provisions on sampling laid down in Directive 2002/63/EC, and to provide for rules on analysis for the control of pesticide residues in and on food and feed of plant and animal origin.
(10)For the purposes of clarity and legibility, Directive 2002/63/EC should be repealed and replaced by this Regulation.
(11)In view of the time and resources necessary for Member States to adapt to the new rules, it is appropriate that this Regulation applies from 1 January 2027.
(12)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Subject matter#
This Regulation lays down rules on:
—the methods for sampling and the preparation of samples for analysis for food,
—the methods for laboratory analyses, the measurement uncertainty and the interpretation of the analytical results for food and feed;
for the purpose of verifying compliance with maximum residue levels of pesticides in or on food and feed of plant and animal origin established in Regulation (EC) No 396/2005.
Article 2Definitions#
In addition to the definitions of Article 3 of Regulation (EC) No 396/2005, the following definitions apply for the purposes of this Regulation:
(1)‘lot’ means an identifiable quantity of food and feed delivered at one time and determined by the sampling officer to have common characteristics (such as origin, producer, variety, species, catch area, packer, type of packing, markings, hour of production or consignor);
(3)‘suspect lot’ means a lot which, for any reason, is suspected to contain pesticide residues exceeding the respective MRLs set out in Regulation (EC) No 396/2005;
(4)‘non-suspect lot’ means a lot for which there is no indication that it may contain pesticide residues exceeding MRLs set out in Regulation (EC) No 396/2005;
(6)‘sampling officer’ means a person designated by the competent authorities to take samples for purposes of control of pesticide residues of food and feed;
(7)‘sample’ means one or more units selected from a population of units, or a portion of material selected from a larger quantity of material;
(8)‘incremental (primary) sample’ means a quantity of material taken from a specific place in the lot or sublot;
(10)‘aggregate sample’ means the combined total of all the incremental samples taken from the lot or sublots;
(11)‘reduced sample’ is a part of the aggregate sample, obtained from the latter by a process of representative reduction;
(12)‘replicate sample’ means a sample taken from an aggregate sample for enforcement, defence and reference purposes in accordance with Article 35 of Regulation (EU) 2017/625;
(13)‘laboratory sample’ means a sample sent to, or received by, the laboratory that constitutes a representative quantity of material removed from the aggregate sample;
(14)‘analytical sample’ means material prepared for analysis from the laboratory sample;
(15)‘analytical portion’ means a representative quantity of material removed from the analytical sample, of proper size for measurement of the residue concentration;
(16)‘measurement uncertainty’ means a non-negative parameter associated with the result of measurement, which characterises the dispersion of values that could reasonably be attributed to the particular quantity subject to measurement;
(17)‘limit of quantification’ means the lowest concentration or mass of the analyte that has been validated with acceptable accuracy by applying the complete analytical method and identification criteria;
(18)‘expanded measurement uncertainty’ represents the uncertainty in a measurement by giving a confidence range, typically calculated by multiplying the range of values within which the true value of the measurement is expected to lie by a coverage factor;
(19)‘coverage factor (k)’ is a multiplier used in the calculation of expanded measurement uncertainty, which provides a range within which the true value of a measurement is expected to lie.
Article 3Methods of sampling and preparation of samples for analysis for food#
Samples of food shall be collected and prepared in accordance with Parts A and B of the Annex.
Article 4Methods of analysis, measurement uncertainty and interpretation of results for food and feed#
The analysis of the samples, the calculation of the measurement uncertainty and the interpretation of the results of such analysis, shall be carried out in accordance with Part C of the Annex to this Regulation for food and, by way of derogation from Articles 2 and 3 of Regulation (EC) No 152/2009, for feed.
Article 5Repeal#
Directive 2002/63/EC is repealed.References to the repealed Directive shall be construed as references to this Regulation.
Article 6Entry into force and application#
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 January 2027.
PROCEDURE FOR SAMPLING AND ANALYSIS FOR FOOD AND FEED OF PLANT AND ANIMAL ORIGIN FOR THE DETERMINATION OF PESTICIDE RESIDUES FOR CHECKING COMPLIANCE WITH MRLs
PART A — General provisions for food
(a)be responsible for procedures, including preparation, packing and shipping of the laboratory sample(s);
(b)ensure consistent adherence to the specified sampling procedures;
(c)complete documentation for samples and collaborate closely with the relevant laboratory;
Sampling shall be performed by a sampling officer.
The sampling officer shall:
Where the size or boundary of each lot in a large consignment is not readily established, the sampling officer may consider that other physical barriers, such as wagons, lorries or ships bays, form a separate lot or sublot.
Samples taken at growers shall be collected at farm-gate, from products ready to be placed on the market.
PART B — Sampling procedures for food
B.1 Division of lots into sublots
Where necessary and possible, the sampling officer shall divide larger lots into sublots to ensure all parts are represented, on condition that the sublot may be separated physically. The sampling officer shall ensure that each sublot is physically separated and identifiable.
For food traded in bulk consignments (e.g. cereals) Table 1 shall apply.
For food not traded in bulk Table 2 shall apply.
| Lot weight (ton) | Maximum weight or number of sublots |
|---|---|
| ≥ 1500 | 500 tonnes |
| > 300 and < 1500 | 3 sublots |
| ≥ 100 and ≤ 300 | 100 tonnes |
| < 100 | — |
| Lot weight (ton) | Weight of sublots |
|---|---|
| ≥ 15 | 7,5-30 tonnes |
| < 15 | — |
B.2 Collection of incremental samples
The sampling officer shall take incremental samples from various randomly chosen and evenly distributed positions throughout the whole sampled portion; the samples shall be of approximately equal size. In exceptional cases, where this is physically not practical, the sampling officer shall take incremental samples from random positions in the accessible part of the lot/sublot. In such case the sampling officer shall record the procedure followed in the sampling report.
The sampling officer shall identify unit(s) for incremental samples as follows:
(a) Fresh fruits and vegetables
Each whole fruit, vegetable or natural medium-sized bunch (e.g. grapes) shall form a unit, except where this fruit, vegetable or bunch is small. Units of packaged small products (e.g. currants) may be identified in accordance with point (e). If the material cannot be damaged a sampling device may be used and thus residues cannot be affected. In the case of bananas and similar fruits and vegetables made available in a bunch, individual items shall be considered as a unit.
(b) Eggs
Each egg shall form a unit.
(c) Large animals or parts or organs of them
A part or whole of a large animal or of a specified organ shall form a unit. Parts or organs may be cut to form units.
(d) Small animals (except insects) or parts or organs of them
(e) Packaged materials
The smallest discrete packages shall be taken as units from the same lot/sublot. Where the smallest packages are very large, as much as practical, they shall be sampled as bulk, as specified in point (f). Where the smallest packages are very small, a pack of packages may form a unit and the packages shall be considered as part of the same lot.
(f) Bulk materials and large packages (e.g. drums, cheeses which are individually too large to be taken as incremental samples)
(a)a tool such as a scoop, dipper, borer, knife or spear, used to remove a unit from bulk material, from packages (such as drums, large cheeses) or from units of meat, poultry or fish which are too large to be taken as incremental samples;
(b)a tool such as a riffle box, used to prepare a laboratory sample from an aggregate sample, or to prepare an analytical portion from an analytical sample.
The units are created with a sampling device.
The minimum number/amount of incremental samples to be taken by the sampling officer from a lot/sublot to form the aggregate sample shall be determined as set out in Table 3.
The incremental samples shall ensure sufficient quantity to enable all laboratory samples, including replicate samples, drawn for analytical purposes, to be withdrawn from the aggregate sample.
For products where more than one incremental sample is taken from a lot/sublot, each shall contribute with a similar proportion to the aggregate sample.
The number of units required for incremental samples is specified in Table 3. The minimum sizes of laboratory samples are specified in Tables 4, 5 and 6. Units may be collected using sampling devices, for example:
For materials such as loose leaves, the sampling officer shall use gloves when sampling by hands to prevent cross-contamination.
The sampling devices shall be cleaned between uses as necessary, to prevent any cross-contamination.
Units may be allocated randomly to replicate laboratory samples at the time of collecting the incremental sample(s), in cases where the units are of medium or large size (as described in Table 5) and mixing the aggregate sample would not make the laboratory sample(s) more representative, or where the units (e.g. eggs, soft fruit) could be damaged by mixing.
Where the sampling is not carried out as set out in point B.2 due to unacceptable commercial consequences (e.g. because of packaging forms, damage to the lot), or the sampling officer applies an alternative method provided that it is sufficiently representative for the sampled lot or sublot and is fully documented, the sampling officer shall record the procedure followed in the sampling report referred to in point B.6.
Units shall not be cut or broken to produce incremental sample(s) except in accordance with the subdivision of units specified in Table 4.
| Minimum amount/number of incremental samples to be taken from the lot/sublot | |
|---|---|
| (a) Suspect lot | Two more samples shall be taken in addition to those determined in part (b) or part (c) of this table |
| (b) Products, packaged or in bulk, which can be assumed to be well mixed or homogeneous | 1 (A lot may be mixed, as an example, by grading or manufacturing processes)For large portions, see (i) and (ii) |
| (c) Products packaged or in bulk, which may not be well mixed or homogeneous | For primary food or commodities of plant origin, for products comprised of medium sized, large-sized or very large-sized units, the minimum number of incremental samples shall comply with the minimum number of units required for the laboratory sample (see Table 5) |
| Either: | |
| Weight or volume of lot/sublot(in kilogram or litre) | |
| < 50 | 3 |
| ≥ 50 and ≤ 500 | 5 |
| ≥ 500 and ≤ 30 tonnes | 10 |
| > 30 tonnes | √ (20 times the number of tonnes making up the sampled portion) (*), up to 40 incremental samples(*)Where the number obtained is a fraction, it shall be rounded up to the next whole numberFor large portions, see (i) and (ii) |
| In the case of large portions (sampled portions > 500 tonnes):(i) the number of incremental samples to be taken = 40 incremental samples + √ number of tonnes in relation to the control of substances or products uniformly distributed throughout the food (e.g. in the case of a lot of 529 tonnes, 40 + 23 = 63 incremental samples are to be taken);(ii) or 100 incremental samples + √ number of tonnes in relation to the control of constituents or substances likely to be distributed non-uniformly in food (e.g. in the case of a lot of 529 tonnes of wheat, 100 + 23 = 123 incremental samples are to be taken). | |
| Or: | |
| Number of packages, cans, cartons or other units in the lot/sublot | |
| ≤ 25 | 1 |
| 26-100 | 5 %, at least 2 units |
| > 100 | 5 %, at maximum 10 units |
| (d) Packaged food supplements | |
| Number of packages in the lot/sublot | |
| 1-50 | 1 |
| 51-250 | 2 |
| 251-1 000 | 4 |
| > 1000 | 4+1 package per 1000 retail packages with a maximum of 25 retail packages |
| (e) Miscellaneous products of unknown lot size (only applicable for e-commerce) | 1 |
| (f) Fishery and sea products including shellfish and crustaceansThe minimum sample quantities shall be defined in the national residue control programme. The minimum sample quantities shall be sufficient to enable the approved laboratories to carry out the analytical procedures necessary to complete the screening and the confirmatory analyses. Specifically, for fishery and sea products including shellfish and crustaceans, a sample consists out of one or more animals, depending on the requirements of the analytical methods. |
B.3 Preparation of the aggregate/reduced sample by the sampling officer
The aggregate sample shall be made up by combining the incremental samples.
The applicable requirements for meat and poultry are described in Table 4. Each incremental sample shall be considered to be a separate aggregate sample.
The applicable requirements for plant products, eggs or dairy products are described in Tables 5 and 6, respectively. The incremental samples shall be combined and mixed well, if practicable, to form the aggregate sample.
Where separate laboratory samples are prepared during collection of the incremental sample(s) from the lot/sublot, the aggregate sample shall be considered to be the combined sum of the laboratory samples.
If needed, the aggregate sample can be representatively reduced using a sample reduction method.
Where mixing to form the aggregate sample is inappropriate or impractical, the following alternative procedure may be followed. Where units may be damaged (and thus residues may be affected) by the processes of mixing or subdivision of the aggregate sample, or where large units cannot be mixed to produce a more uniform residue distribution, the units may be allocated randomly to replicate laboratory samples at the time of taking the incremental samples. In this case, the result to be used shall be the mathematical means of obtaining valid analytical results from the analytical portions analysed and formed from the replicate laboratory samples.
B.4 Preparation, packaging, sealing and transport of the laboratory sample by the sampling officer
The laboratory sample is formed from the aggregate sample and may be the whole or a part of the aggregate sample. The sampling officer shall then prepare the laboratory and replicate samples from the reduced sample of approximately the same amount and conforming to the quantitative requirements of Part B. The replicate sample may also be prepared in the laboratory by the laboratory staff. Units shall not be cut or broken to produce the laboratory sample(s), except where subdivision of units is specified in Tables 4 and 5.
Where the aggregate sample is larger than the required laboratory sample, it may be reduced to provide a representative portion. A sampling device, quartering, or other appropriate size reduction process may be used but units of fresh plant products or whole eggs shall not be cut or broken.
The minimum sizes required for laboratory samples are specified in Tables 4, 5 and 6.
A smaller sample size than those specified in Tables 4 and 5 may be taken from a product in duly justified cases (such as the high value of the product) and provided that the smaller sample does not result in insufficient sample material to perform appropriate analysis. The reason for doing so shall be noted in the sampling report.
The laboratory sample shall be placed in a clean, chemically inert container non-reactive with water, ensuring safe protection against environmental and atmospheric factors and preserving the homogeneity of the sample. The container shall be sealed at the place of sampling, securely and accurately labelled, and accompanied by the sampling report, if it is a paper report. In the case of paperless (digital) procedures, the sample shall be identifiably linked to the relevant digital record entry. Where a bar code is used, it is recommended that alphanumeric information is also provided.
The sampling officer shall deliver the laboratory sample to the laboratory as soon as practicable. Spoilage in transit shall be prevented, e.g. fresh samples shall be kept cool and frozen samples shall remain frozen. Samples of primary food commodities of animal origin shall be frozen prior to despatch, unless transported to the laboratory before spoilage can occur. In cases where samples of primary food commodities of animal origin are transported unfrozen decay or spoilage shall be avoided during transport.
Where a replicate sample is left with the food business operator, the food business operator shall be instructed (e.g. via a leaflet) on how to store and transfer the sample to the laboratory, to minimise degradation of residues. If the food business operator is not able to fulfil the storage requirements, the sample shall be delivered to the laboratory as soon as practicable for further processing (e.g. homogenisation) as required by Member State’s procedures and to store it at a low temperature until the decision for analysis is taken.
| # | Commodity classificationnote | Examples | Part of incremental sample to be taken | Minimum size of each laboratory sample |
|---|---|---|---|---|
| Primary food commodities of animal origin | ||||
| 1 | Mammalian muscle –Categories: 1011010, 1012010, 1013010, 1014010, 1015010, 1017010 | |||
| 1.1 | Large mammals, whole or half carcass, usually ≤10 kg | Cattle, sheep, pigs | Whole or part of diaphragm, supplemented by cervical muscle, if necessary | 0,5 kg |
| 1.2 | Small mammals, whole carcass | Rabbits | Whole carcass or hindquarters | 0,5 kgafter removal of skin and bone |
| 1.3 | Mammal parts, loose fresh/frozen, packaged or otherwise | Quarters, chops, steaks, shoulders | Whole unit(s), or a portion of a large unit | 0,5 kgafter removal of bone |
| 1.4 | Mammal parts, bulk frozen | Quarters, chops | Either a frozen cross-section of a container or the whole (or portions) of individual muscle parts | 0,5 kgafter removal of bone |
| 2 | Mammalian fats, including carcass fat –Categories: 1011020, 1012020, 1013020, 1014020, 1015020, 1017020 | |||
| 2.1 | Large mammals, at slaughter, whole or half carcass, usually ≥ 10 kg | Cattle, sheep, pigs | Kidney, abdominal or subcutaneous fat cut from one animal | 0,5 kg |
| 2.2 | Small mammals, at slaughter, whole or half carcass < 10 kg | Abdominal or subcutaneous fat from one or more animals | 0,5 kg | |
| 2.3 | Mammal parts | Legs, chops, steaks | Either visible fat, trimmed from unit(s) orWhole unit (s) or portions of whole unit(s), where fat is not trimmable | 0,5 kg2 kg |
| 2.4 | Mammal bulk fat tissue | Units taken with a sampling device from at least three positions, where feasible in practice | 0,5 kg | |
| 3 | Mammalian offal –Categories: 1011030, 1012030, 1013030, 1014030, 1015030, 10170301011040, 1012040, 1013040, 1014040, 1015040, 10170401011050, 1012050, 1013050, 1014050, 1015050, 1017050 | |||
| 3.1 | Mammal liver fresh, chilled, frozen | Whole liver(s), or part of liver | 0,4 kg | |
| 3.2 | Mammal kidney fresh, chilled, frozen | One or both kidneys, from one or two animals | 0,2 kg | |
| 3.3 | Mammal heart fresh, chilled, frozen | Whole heart(s), or ventricle portion only, if large | 0,4 kg | |
| 3.4 | Other mammal offal fresh, chilled, frozen | Part or whole unit from one or more animals, or a cross-section taken from bulk frozen product | 0,5 kg | |
| 4 | Poultry muscle – Category: 1016010 | |||
| 4.1 | Bird, large-sized carcass > 2kg | Turkey, goose, cocks, capons and ducks | Thighs, legs and other dark muscle | 0,5 kgafter removal of skin and bone |
| 4.2 | Bird, medium-sized carcass 500 g-2 kg | Hens, guinea fowl, young chicken | Thigh, legs or other dark muscle from at least three birds | 0,5 kgafter removal of skin and bone |
| 4.3 | Bird, small-sized carcass < 500g carcass | Quail, pigeon | Carcasses from at least six birds | 0,2 kgof muscle tissue |
| 4.4 | Bird parts fresh, chilled, frozen retail or wholesale packaged | Legs, quarters, breasts and wings | Packaged units, or individual units | 0,5 kgafter removal of skin and bone |
| 5 | Poultry fats, including carcass fat – Category: 1016020 | |||
| 5.1 | Birds at slaughter, whole or part carcass | Chickens, turkeys | Units of abdominal fat from at least 3 birds, where feasible in practice | 0,5 kg |
| 5.2 | Bird parts | Legs, breast, muscle | Either visible fat, trimmed from unit(s) orWhole unit(s) or portions of whole unit(s), where fat is not trimmable | 0,5 kg0,5 kgor2 kg if fat content < 5 % |
| 5.3 | Bird fat tissue in bulk | Units taken with a sampling device from at least three positions | 0,5 kg | |
| 6 | Poultry Offal – Categories: 1016030, 1016040, 1016050 | |||
| 6.1 | Edible bird offal, except goose and duck fat liver and similar high-value products | Units from at least six birds, or a cross-section from a container, where feasible in practice | 0,2 kg | |
| 6.2 | Goose and duck fat liver and similar high-value products | Unit from one bird or container | 0,1 kg | |
| 7 | Honey – Category: 1040000 | |||
| 7.1 | Honey | Packaged units | 0,5 kg | |
| 8 | Amphibians and Reptiles – Category: 1050000note | |||
| 8.1 | Muscle | Crocodile, lizard | Units from tail, body, legs | 0,5 kg |
| 8.2 | Frogs | Legs | 0,5 kg | |
| 8.2 | Snake | Units from body | 0,5 kg | |
| 9 | Terrestrial invertebrate animals – Category: 1060000 | |||
| 9.1 | Snails | Roman snail | Whole snails | 12 snails |
| 9.2 | Insects | Crickets | Whole insects | 10 whole insectsor0,2 kg |
| Larvae of locusts, mealworms | Larvae | 0,5 kg | ||
| 10 | Wild Terrestrial vertebrate animals – Category: 1070000 | |||
| 10.1 | The rules set for domesticated animals under categories 1-3 of this table shall apply for the corresponding tissue. | |||
| Processed foods of animal origin | ||||
| 11 | Secondary food commodities of animal origin, dried meats.Derived edible products of animal origin, processed animal fats, including rendered or extracted fats, food supplements.Manufactured food (single ingredient) of animal origin, with or without packing medium or minor ingredients such as flavouring agents, colorants (e.g. carmine), spices and condiments, insect powder and which is normally pre-packed and ready for consumption, with or without cooking.Manufactured food (multi-ingredient) of animal origin, a multi-ingredient food consisting of ingredients of both animal and plant origin will be included here if the ingredient(s) of animal origin is (are) predominant, including baby food. | |||
| 11.1 | Mammal or bird, comminuted, cooked, canned, dried, rendered, or otherwise processed products, including multi-ingredient products | Ham, sausage, minced beef, chicken paste | Packaged units, or a representative cross-section from a container or units (including juices, if any) taken with a sampling device | 0,5 kg |
| 11.2 | Food Supplements | Collagen | Packaged units | 0,1 l or 0,1 kg |
| Commodity classificationnote | Examplesnote | Part of incremental sample to be taken | Minimum size of each laboratory sample | |
|---|---|---|---|---|
| Primary food commodities of plant origin | ||||
| 1 | Fruits, fresh or frozen – Category: 0100000Vegetables, fresh or frozen – Category: 0200000, including mushrooms (0280000) | |||
| 1.1 | Small-sized product units< 25 g | Berries, peas, olives | Whole units, or packages, or units taken with a sampling device | 1 kg |
| 1.2 | Medium-sized products, units25-250 g | Apples, oranges | Whole units | 1 kg butat least 10 units |
| 1.3 | Large-sized fresh products, units250-1000 g | Cucumbers, grapes (bundles, bunches) | Whole unit(s) | 2 kgbutat least 5 units |
| 1.4 | Very large-sized fresh products, units > 1000 g | Pumpkins, melons | Whole unit(s) | 2 kgbutat least 3 units |
| 1.5 | Tree nuts(0120000) | Except coconuts | Packages, or units taken with a sampling device | 1 kg |
| Coconuts | Whole units | 5 units | ||
| 1.6 | Herbs(0256000) | Parsley, sage | Whole units | 0,2 kg |
| 2 | Pulses(0300000) | Beans, Peas | Packages, or units taken with a sampling device | 1 kg |
| 3 | Oilseeds(0401000) | Linseeds | Packages, or units taken with a sampling device | 0,5 kg |
| 4 | Cereal grains(0500000) | Rice, wheat | Packages, or units taken with a sampling device | 1 kg |
| 5 | Seeds for beverages and sweets | (Green) coffee beans | Packages, or units taken with a sampling device | 0,5 kg |
| 6 | Sugar Plants (0900000) | Sugar beets | Whole units | 2 kgat least 2 units |
| Processed foods of plant origin | ||||
| 7 | Secondary food commodities of plant origin, dried fruits, dried vegetables, dried herbs, herbal infusions (0630000), hops (0700000), spices (0800000), milled cereal products, extracts.Derived products of plant origin, teas, herb teas, vegetable oils and drinks, juices, food supplements and miscellaneous products e.g. processed olives and citrus molasses.Manufactured foods (single ingredient) of plant origin, with or without packing medium or minor ingredients, such as flavouring agents, colorants, spices and condiments, and which is normally pre-packed and ready for consumption with or without cooking.Manufactured foods (multi-ingredient) of plant origin, including products with ingredients of animal origin where the ingredient(s) of plant origin predominate(s), breads and other cooked cereal products, including cereal-based baby food. | |||
| 7.1 | Spices(0800000) | Nutmeg | Packages of units taken with a sampling device | 0,1 kg |
| 7.2 | Products of high unit value | Rose petals, saffron | Packages of units taken with a sampling device | 0,1 kgnote |
| 7.3 | Solid products of low bulk | Hops, tea, herb tea | Packaged units or units taken with a sampling device | 0,1kgnote |
| 7.4 | Other solid products | Bread, flour, dried fruit | Packages or other whole units, or units taken with a sampling device | 0,5 kg |
| 7.5 | Liquid products | Vegetable oils, juices | Packaged units or units taken with a sampling device | 0,5 l or 0,5 kg |
| 7.6 | Food Supplements | Ashwagandha, acai, spirulina | Packaged units | 0,1 l or 0,1 kgnote |
| 7.7 | Baby food | Ready to eat, fruit-/vegetable-based | Packaged units or units taken with a sampling device | 0,5 l or 0,5 kg |
| Commodity classificationnote | Examples | Part of incremental sample to be taken | Minimum size of each laboratory sample | |
|---|---|---|---|---|
| Primary food commodities of animal origin | ||||
| 1 | Poultry eggs – Category: 1030000 | |||
| 1.1 | Eggs, large | Goose, duck or similar | Whole eggs | 6 whole eggs |
| 1.2 | Eggs, medium | Chicken and similar | Whole eggs | 10 whole eggs |
| 1.3 | Eggs, small | Quail and similar | Whole eggs | 24 whole eggs |
| 2 | Milks – Category: 1020000 | |||
| 2.1 | Milks | Whole units, or units taken with a sampling device | 0,5 l | |
| Processed foods of animal origin | ||||
| 3 | Secondary food commodities of animal origin, secondary milk products such as skimmed milks, evaporated milks, milk powders, including infant formulae, and egg powder.Derived edible products of animal origin, milkfats, derived milk products such as butters, butteroils, creams, cream powders, caseins, etc.Manufactured food (single ingredient) of animal origin, manufactured milk products such as yoghurt, cheeses.Manufactured food (multi-ingredient) of animal origin, manufactured milk products (including products with ingredients of plant origin where the ingredient(s) of animal origin predominates(s)) such as processed cheese products, cheese preparations, flavoured yoghurt, sweetened condensed milk. | |||
| 3.1 | Liquid milks, milk powders, evaporated milks and creams, dairy ice creams, creams, yoghurts | Packaged unit(s) or unit(s) taken with a sampling device | 0,5 l (liquid)or0,5 kg (solid) | |
| (i) Evaporated milks and evaporated creams in bulk shall be mixed thoroughly before sampling, scraping adhering material from the sides and bottom of containers and stirring well. About 2 to 3 l shall be removed and again stirred well before removing the laboratory sample(ii) Milk powders in bulk shall be sampled aseptically, passing a dry borer tube through the powder at an even rate.(iii) Creams in bulk shall be mixed thoroughly with a plunger before sampling but foaming, whipping and churning shall be avoided. | ||||
| 3.2 | Butter and butteroils | Butter, whey butter, low fat spreads containing butter fat, anhydrous butteroil, anhydrous fat | Whole or parts of packaged unit(s) or unit(s) taken with a sampling device | 0,2 kgor0,2 l |
| 3.3 | Cheeses, including processed cheeses | |||
| Units 0,3 kg or greater | Whole unit(s) or unit(s) cut with a sampling device | 0,5 kg | ||
| Units < 0,3 kg | 0,3 kg | |||
| Note:Cheeses with a circular base shall be sampled by making two cuts radiating from the centre. Cheeses with a rectangular base shall be sampled by making two cuts parallel to the sides. | ||||
| 3.4 | Liquid, frozen or dried egg products | Unit(s) taken aseptically with a sampling device | 0,5 kg |
B.5 Replicate sample
The replicate sample shall be taken from the well-mixed aggregate sample or from the laboratory or analytical sample by the laboratory staff or by the sampling officer. Replicate samples are prepared in the same way as laboratory samples.
B.6 Sampling report
(1)Declaration that sampling was performed in accordance with the rules laid down in Implementing Regulation (EU) 2026/765;
(2)Address of the competent authorities;
(3)Name of the sampling officer or identification code;
(4)(Official) identification number of the sample;
(5)Sampling date;
(6)Name and address of the food business operator;
(7)Name and address of the farm of origin (when sampling on farm);
(8)Registration number of the establishment or slaughterhouse number, where relevant;
(9)Animal, plant or product description or name of the food;
(10)Lot size;
(11)Lot identification;
(13)Sampling programme, where relevant;
(14)Particular remarks, where relevant.
(a)sign or authenticate a paper or electronic copy of the sampling report;
(b)provide a copy of the sampling report to the food business operator of the lot/sublot, or his, her or its representative, regardless of whether that business operator is to be provided with a replicate sample.
A report shall be produced after each sampling procedure and include, at least, the following data:
The sampling officer shall:
Where sampling records are in paper form, the competent authority shall keep the original of the sampling report or the sampling officer shall send the original sampling report to the laboratory.
Confidentiality shall be ensured in accordance with Article 8 of Regulation (EU) 2017/625.
Where sampling records are in paper form, a signed copy of the record shall accompany each replicate laboratory sample. Where sampling records are produced in a paperless (digital) form, arrangements shall be made ensuring a similar verifiable audit trail.
B.7 Preparation of the analytical sample by the laboratory
Laboratory samples which are not analysed immediately shall be stored in the laboratory under conditions that minimise decay. Fresh products, drinks, oils shall be stored in the refrigerator, but typically no longer than five days. Dried, preserved and canned products may be stored at room temperature, but if storage time is expected to exceed four weeks, they shall be sub-sampled and stored in the freezer.
The laboratory shall prepare the analytical sample from the laboratory sample by separating the portion of the product to be analysed, i.e. the part of the product to which the MRL appliesnote, and then by mixing, grinding, fine chopping, comminuting, etc., for the removal of analytical portions with minimal subsampling bias. The preparation of the analytical sample shall reflect the procedure used in setting MRLs and thus the portion of the product to be analysed may include parts that are not normally consumed.
If needed, the laboratory sample can be representatively reduced using a sample reduction method.
The part of the product to be analysed, i.e. the analytical sample, shall be separated as soon as practicable. Where the residue level is required to be calculated to include parts which are not analysednote, the weights of the separated parts shall be recorded.
B.8 Preparation and storage of the analytical portion by the laboratory
The analytical sample shall be comminuted, if appropriate, and mixed well, to enable representative analytical portions to be withdrawn by the laboratory. A device may be used to withdraw the analytical portion. The size of the analytical portion shall be determined by the analytical method and the efficiency of mixing. The methods for comminution and mixing shall be recorded and shall not affect the residues present in the analytical sample. Where appropriate, the analytical sample shall be processed under special conditions, e.g. frozen, to minimise adverse effects.
Where processing could affect residues and where practical alternative procedures are not available, the analytical portion may consist of whole units, or segments removed from whole units. If the analytical portion thus consists of few units or segments, it is unlikely to be representative of the analytical sample and sufficient replicate portions shall be analysed, to indicate the uncertainty of the mean value.
Depending on available storage stability data, it might be possible to store analytical portions before analysis. In this case, the method, the duration of storage time and the temperature during storage shall be such that they do not affect the level of residues present.
B.9 Schematic presentations
Schematic presentations of the sampling procedures described in points B.2, B.3 and B.4:
B.9.1. Sampling products of meat and poultry
| Incremental samples from suspect lot/sublot(see Tables 3 and 4) | Incremental samples from non-suspect lot/sublot(see Tables 3 and 4) |
B.9.2. Sampling products other than meat and poultry
| Incremental samples from suspect lot/sublot(see Tables 3, 5 and 6) | Incremental samples from non-suspect lot/sublot(see Tables 3, 5 and 6) |
B.9.3. Typical sampling and analytical process
PART C — Methods of analysis, measurement uncertainty and interpretation of results
C.1 Methods of analysis and deriving the analytical results
C.1.1Methods of analysis shall be supported by quality control data and shall be validated for the specific substance/commodity group combination. As a minimum, one representative commodity from each commodity group must be validated, depending on the intended scope of the method. When the method is applied to a wider variety of matrices, complementary validation data should be acquired.Analytical results for food shall be derived from one or more laboratory samples and for feed from at least one final sample taken from the lot/sublot and provided that the analytical sample contains the correct part(s) of the product as laid down in Annex I to Regulation (EC) No 396/2005. Where a residue is found to exceed an MRL, its identity shall be confirmed and its concentration shall be verified by a duplicate analysis (independent second determinations).
C.1.2.The analytical result shall be reported as x +/– U whereby ‘x’ is the analytical result and ‘U’ is the expanded measurement uncertainty and shall be reported in the same units and with the same number of decimal figures as the result.
C.2 Measurement uncertainty and interpretation of results
C.2.1.The MRL shall apply to the analytical sample derived from the aggregate sample through the laboratory or replicate sample. The result of the laboratory sample for food and final sample for feed shall be considered representative for the lot/sublot and it applies to the entire lot/sublot.
C.2.2.When checking exceedances of the MRL, official laboratories and enforcement authorities shall apply a default expanded measurement uncertaintynote that was calculated from long-term data of EU inter-laboratory comparative tests applying a coverage factor of 2 (confidence level of 95 %). The expanded measurement uncertainty is 50 % with the exception of copper, where a value of 20 % applies, to enforce MRLs. The analytical laboratory shall demonstrate that its own expanded measurement uncertainty for the specific analytical method / substance / commodity group combination is equal to or lower than the above stated default values. In the case of MRL-exceedances, the harmonised default expanded measurement uncertainty shall be reported by the laboratory.Where the level found in a food sample leads to an International Estimate of Short-term Intake (IESTI) that exceeds the Acute Reference Dose (ARfD), as a precautionary measure, the competent authority may apply a lower expanded measurement uncertainty, based on the laboratory’s own estimated measurement uncertainty (if supported by sufficient intra- and inter-laboratory evidence) and/or a lower confidence level (lower coverage factor, k).
C.2.3.Interpretation of the analytical result taking into account the expanded measurement uncertainty
(a)compliant with the MRL if the result of the analytical sample complies with the MRL, taking into account the expanded measurement uncertainty and if necessary, the correction for recovery. This means the sample is compliant if the measured value is below or equal to the MRL when subtracting the expanded uncertainty (x – U ≤ MRL);
(b)non-compliant with the MRL if the result of the analytical sample exceeds the MRL beyond reasonable doubt taking into account the expanded measurement uncertainty and if necessary, the correction for method bias where indicated. This means the sample is not compliant if the measured value exceeds the MRL when subtracting the expanded uncertainty (x – U > MRL)note.
C.2.5.Acceptance and rejection of consignment consisting of more than one lotAny lot sampled in accordance with this Regulation and where the analytical result shows exceedance of the MRL shall be regarded as non-compliant as specified in point C.2.4.b. in its entirety and shall be rejected.The sampling officer shall determine the sampled lot of a consignment, that can be different from the lot of the food business operator. The sampled lot can be one lot, or a group of lots sharing the same properties (date of production, origin, description, etc.).If one lot, part of a group of lots sharing the same properties, has been found to be non-compliant and there is a reasonable doubt that the other similar lots are in MRL exceedance, these other similar lots shall be regarded as suspect lots.
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