EUROPEAN COMMUNITY METHODS OF SAMPLING FOR OFFICIAL CONTROL OF PESTICIDE RESIDUES IN AND ON PRODUCTS OF

EU ROPEAN COM MUNITY METHO DS O F SAM PLING

FOR OFFICIAL C ONTROL OF PESTICID E RESIDUES IN

AND ON PROD UCTS OF PLANT AND ANIMA L O RIG IN

SUBSIDIARY LEGISLATION 430.04

EUROPEAN COMMUNITY METHODS OF

SAMPLING FOR OFFICIAL CONTROL OF

PESTICIDE RESIDUES IN AND ON PRODUCTS OF

PLANT AND ANIMAL ORIGIN REGULATIONS

19th November, 2004

LEGAL NOTICE 479 of 2004.

(1) The title of these regulations is the European

Community Methods of Sampling for Official Control of Pesticide

Residues in and on Products of Plant and Animal Origin

Regulations.

(2) The scope of these regulations is to implement the rules

found under European Union Council Directive 2002/63/EEC

establishing Community methods of sampling for the official

control of pesticide residues in and on products of plant and animal

origin and in accordance with the provisions of article 5 of the

Pesticides Control Act. The aforementioned Directive’s provisions

apply to the sampling of products of plant and animal origin in

order to determine the level of pesticide residues for the purposes

of European Union Directives 76/895/EEC, 86/362/EEC, 86/363/

EEC and 90/ 642/EEC and do not affect the sampling strategy,

sampling levels and frequency as specified in Annexes III and IV to

European Union Council Directive 96/23/EC on measures to

monitor certain substances and residues thereof in live animals and

animal products

Provided that European Union Council Directives 76/895/

EEC, 86/362/EEC and 90/642/EEC were transposed under the

Maximum Residue Level of Pesticides in Produce of Plant Origin

Regulations.

METHODS OF SAMPLING PRODUCTS OF PLANT AND ANIMAL ORIGIN

FOR THE DETERMINATION OF PESTICIDE RESIDUES FOR CHECKING

COMPLIANCE WITH MRLS

1. OBJECTIVE

Samples intended for the official control of the levels of pesticide residues in and

on fruit and vegetables and in products of animal origin shall be taken according to

the methods described below.

The objective of these sampling procedures is to enable a representative sample to

be obtained from a lot for analysis to determine compliance with maximum residue

levels (MRLs) for pesticides.

2. PRINCIPLES

Comm unity MRLs are b ased on go od agricultural practice data an d raw

commodities as well as foods derived from them that comply with the MRLs are

intended to be toxicologically acceptable.

A MRL for a plant, egg or dairy product takes into account the maximum level

expected to occur in a composite sample, which has been derived from multiple units

of the treated product and which is intended to represent the average residue level in

a lot. A MRL for meat and poultry takes into account the maximum level expected to

occur in the tissues of individual treated animals or birds.

In consequence, MRLs for meat and poultry apply to a bulk sample derived from a

single primary sample, whereas MRLs for plant products, eggs and dairy products

apply to a composite bulk sample derived from one to ten primary samples.

The territory of Malta shall require that sampling for the

checks provided for in Article 6 of Directive 76/895/EEC, in

Article 8 of Directive 86/362/EEC, in Article 8 of Directive 86/

363/EEC and in Article 6 of Directive 90/642/EEC, be carried out

in accordance with the methods described in the Schedule.

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

DEFINITION OF TERMS

Analytical portion

A representative quantity of material removed from the analytical sample, of

proper size for measurement of the residue concentration.

Note: A sampling device may be used to withdraw the analytical portion.

Analytical sample

The material prepared for analysis from the laboratory sample, by separation of

the portion of the product to be analysed and then by mixing, grinding, fine

chopping, etc., for the removal of analytical portions with minimal sampling error.

Note: Preparation of the analytical sample must 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.

Bulk sample/aggregate sample

For products other than meat and poultry, the combined and well-mixed aggregate

of the primary samples taken from a lot. For meat and poultry, the primary sample is

considered to be equivalent to the bulk sample.

Notes: (a)

The primary samples must contribute sufficient material to enable

all laboratory samples to be withdrawn from the bulk sample.

(b)

Where separate laboratory samples are prepared during collection of

the primary sample(s), the bulk sample is the conceptual sum of the

laboratory samples, at the time of taking the samples from the lot.

Laboratory sample

The sample sent to, or received by, the laboratory. A representative quantity of

material removed from the bulk sample.

The laboratory sample may be the whole or a part of the bulk

sample.

(b)

Units should not be cut or broken to produce the laboratory

sample(s), except where subdivision of units is specified in Table 3.

(c)

Replicate laboratory samples may be prepared.

A quantity of a food material delivered at one time and known, or presumed, by

the sampling officer to have uniform characteristics such as origin, producer, variety,

packer, type of packing, markings, consignor, etc. A suspect lot is one which, for any

reason, is suspected to contain an excessive residue. A non-suspect lot is one for

which there is no reason to suspect that it may contain an excessive residue.

(a)

Where a consignment is comprised of lots which can be identified

as originating from different growers, etc, each lot should be

considered separately.

(b)

A consignment may consist of one or more lots.

(c)

Where the size or boundary of each lot in a large consignment is not

readily established, each one of a series of wagons, lorries, ships

bays, etc., may be considered to be a separate lot.

(d)

A lot may be mixed by grading or manufacturing processes, for

example.

Primary sample/incremental sample

One or more units taken from one position in a lot.

The position from which a primary sample is taken in the lot should

preferably be chosen randomly but, where this is physically

impractical, it should be from a random position in the accessible

parts of the lot.

(b)

The number of units required for a primary sample should be

determined by the minimum size and number of laboratory samples

required.

(c)

For plant, egg and dairy products, where more than one primary

sample is taken from a lot, each should contribute an approximately

similar proportion to the bulk sample.

(d)

Units may be allocated randomly to replicate laboratory samples at

the time of collecting the primary sample(s), in cases where the

units are of medium or large size and mixing the bulk sample would

not make the laboratory sample(s) more representative, or where the

units (e.g. eggs, soft fruit) could be damaged by mixing.

(e)

Where primary samples are taken at intervals during loading or

unloading of a lot, the sampling ‘position’ is a point in time.

(f)

Units should not be cut or broken to produce the primary sample(s),

except where subdivision of units is specified in Table 3.

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

One or more units selected from a population of units, or a portion of material

selected from a larger quantity of material. For the purposes of these

recommendations, a representative sample is intended to be representative of the lot,

the bulk sample, the animal, etc., in respect of its pesticide residue content and not

necessarily in respect of other attributes.

Sampling

The procedure used to draw and constitute a sample.

Sampling device

(i)

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 or poultry which are too large to be taken as

primary samples.

(ii) A tool such as a riffle box, used to prepare a laboratory sample from a

bulk sample, or to prepare an analytical portion from an analytical

sample.

Specific sampling devices are described by ISO *†‡ and IDF §

Notes: (a)

standards.

(b)

For materials such as loose leaves, the hand of the sampling officer

may be considered to be a sampling device.

Sampling officer

A person trained in sampling procedures and, where required, authorised by the

appropriate authorities to take samples.

Note: The sampling officer is responsible for all procedures leading to and

including preparation, packing and shipping of the laboratory sample(s). The officer

must understand that consistent adherence to the specified sampling procedures is

necessary, must provide complete documentation for samples, and should

collaborate closely with the laboratory.

Sample size

The number of units, or quantity of material, constituting the sample.

Unit

The smallest discrete portion in a lot, which should be withdrawn to form the

whole or part of a primary sample.

Notes: Units should be identified as follows.

(a) Fresh fruit and vegetables. Each whole fruit, vegetable or natural bunch

of them (e.g. grapes) should form a unit, except where these are small.

Units of packaged small products may be identified as in (d). Where a

sampling device may be used without damaging the material, units may

be created by this means. Individual eggs, fresh fruit or vegetables must

not be cut or broken to produce units.

*International Organisation for Standardisation, 1979. International standard ISO 950: Cereals - sampling

(as grain).

†International Organisation for Standardisation, 1979. International standard ISO 951: Pulses in bags -

sampling.

‡International Organisation for Standardisation, 1980. International standard ISO 1839: Sampling - tea.

§International Dairy Federation, 1995. International IDF standard 50C: Milk and milk products - methods of

sampling.

(b) Large animals or parts or organs of them. A portion, or the whole, of a

specified part or organ should form a unit. Parts or organs may be cut to

form units.

(c) Small animals or parts or organs of them. Each whole animal or

complete animal part or organ present may form a unit. Where

packaged, units may be identified as in (d), below. Where a sampling

device may be used without affecting residues, units may be created by

this means.

(d) Packaged materials. The smallest discrete packages should be taken as

units. Where the smallest packages are very large, they should be

sampled as bulk, as in (e). Where the smallest packages are very small,

a pack of packages may form the unit.

(e) Bulk materials and large packages (such as drums, cheeses, etc) which

are individually too large to be taken as primary samples. The units are

created with a sampling device.

SAMPLING PROCEDURES *

4.1. Precautions to be taken

Contamination and deterioration of samples must be prevented at all stages,

because they may affect the analytical results. Each lot to be checked for compliance

must be sampled separately.

4.2. Collection of primary samples

The minimum number of primary samples to be taken from a lot is determined

from Table 1, or Table 2 in the case of a suspect lot of meat or poultry. Each primary

sample should be taken from a randomly chosen position in the lot, as far as

practicable. The primary samples must consist of sufficient material to provide the

laboratory sample(s) required from the lot.

Note: Sampling devices required for grain † , pulses ‡ and tea § are described in ISO

recommendations and those required for dairy products ** are described by the IDF.

Table 1

Minimum number of primary samples to be taken from a lot

Minimum number of primary samples

to be taken from the lot

a) Meat and poultry

A non-suspect lot

A suspect lot

Determined according to Table 2

*ISO recommendations for sampling of grain or other commodities shipped in bulk may be adopted, if

required.

†International Organisation for Standardisation, 1979. International standard ISO 951: Cereals - sampling

(as grain).

‡International Organisation for Standardisation, 1979. International standard ISO 951: Pulses in bags -

sampling.

§nternational Organisation for Standardisation, 1980. International standard ISO 1839: Sampling - tea.

**nternational Dairy Federation, 1995. International IDF standard 50C: Milk and milk products – methods

of sampling

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

Minimum number of primary samples

to be taken from the lot

b) Other products

i) Products, packaged or in bulk, which

1 (A lot may be mixed by grading or

can be assumed to be well mixed or

manufacturing processes, for

homogenous

example)

ii) Products, packaged or in bulk, which

For products comprised of large units,

may not be well mixed or homogeneous

being primary food commodities of

p l a n t o r i g i n o n l y, t h e m i n i m u m

number of primary samples should

comply with the minimum number of

units required for the laboratory

sample (see Table 4)

Either

Weight of lot, kg

< 50

50-500

> 500

Or

Number of cans, cartons or other containers in the lot

1-25

26-100

> 100

Table 2

Number of randomly selected primary samples required for a given probability of

finding at least one non-compliant sample in a lot of meat or poultry, for a given

incidence of non-compliant residues in the lot

Incidence of non-compliant

Minimum number of samples required to detect a

residues in the lot

non-compliant residue with a probability of

%

90%

95%

99%

-

-

0,5

0,1

2 301

4 603

The table assumes random sampling.

(b)

Where the number of primary samples indicated in Table 2 is more

than about 10% of the units in the total lot, the number of primary

samples taken may be fewer and should be calculated as follows

n = n o /((1+(n o -1))/N)

where n = minimum number of primary samples to be taken

n o = number of primary samples given in Table 2

N = number of units, capable of yielding a primary sample, in the

lot.

(c)

Where a single primary sample is taken, the probability of detecting

a non-compliance is similar to the incidence of non-compliant

residues.

(d)

For exact or alternative probabilities, or for a different incidence of

non-compliance, the number of samples to be taken may be

calculated from

1 - p = (1 - i) n

Where p is the probability and i is the incidence of non-compliant

residues in the lot (both expressed as fractions, not percentages),

and n is the number of samples.

4.3. Preparation of the bulk sample

The procedures for meat and poultry are described in Table 3. Each primary

sample is considered to be a separate bulk sample.

The procedures for plant products, eggs or dairy products are described in Tables 4

and 5. The primary samples should be combined and mixed well, if practicable, to

form the bulk sample.

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

Where mixing to form the bulk 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 bulk

sample, or where large units cannot be mixed to produce a more uniform residue

distribution, the units should be allocated randomly to replicate laboratory samples

at the time of taking the primary samples. In this case, the result to be used should be

the mean of valid results obtained from the laboratory samples analysed.

Table 3

Meat and poultry: description of primary samples and minimum size

of laboratory samples

Commodity classification

Examples

Nature of primary

Minimum size

samples to be taken

of each

laboratory

sample

Primary food commodities of animal origin

1. Mammalian meats

Note: for enforcement of MRLs for fat-soluble pesticides samples

must be taken according to part 2 below

1.1

Large mammals,

Cattle, sheep,

Whole or part of

0.5 kg

whole or half carcass,

pigs

diaphram,

usually 10 kg

supplemented by

c e r v i c a l mu sc l e , if

necessary

1.2

Small mammals,

Rabbits

Whole carcass or

0.5 kg after

whole carcass

hind quarters

removal of skin

and bone

1.3

Mammal meat parts,

Quarters,

Whole unit(s) or a

0.5 kg after

loose fresh/chilled/

chops, steaks,

portion of a large unit

removal of bone

frozen packaged or

shoulders

otherwise

1.4

Mammal meat parts,

Quarters,

Either a frozen cross-

0.5 kg after

bulk frozen

chops

section

of

a

removal of bone

containers or the

whole (or portions)

of individual meta

parts

2. Mammalian fats, including carcass fat

Note: samples of fat taken as described in parts 2.1, 2.2 and 2.3 may be used to

determine compliance of the fat, or the whole product, with the corresponding MRLs

2.1

L a rg e m a m m a l s , a t

Cattle, sheep,

Kidney, abdominal or

0.5 kg

sl a u g h t e r, w h o l e o r

pigs

subcutaneous fat cut

half carcass, usually >

from one animal

10 kg

2.2

Small mammals, at

Abdominal

or

0.5 kg

sl a u g h t e r, w h o l e o r

subcutaneous fat cut

half carcass, usually <

from one animal

10 kg

Legs, chops,

Either visible fat,

0.5 kg

steaks

trimmed from unit(s)

Or whole unit(s)

Or portions of whole

2 kg

unit(s) where fat is

not trimmable

Mammal bulk fat

Units taken with a

0.5 kg

tissue

sampling device from

at

least

three

positions

3. Mammalian offal

Ma m m a l l i v e r f r s h ,

Whole liver(s), or

0.4 kg

chilled, frozen

part of liver

Mammal

kidney

One or both kidneys,

0.2 kg

fresh, chilled, frozen

from one or two

animals

Mammal heart fresh,

Whole heart(s), or

0.4 kg

chilled, frozen

ventricle portion

only, if large

Other mammal offal

Part or whole unit

0.5 kg

fresh, chilled, frozen

from one or more

animals, or a cross-

section taken from

bulk frozen product

4. Poultry meats

Note: for enforcement of MRLs for fat-soluble pesticides, samples must be taken

according to Part 5 below.

Bird, large-sized

Turkey, goose,

Thighs, legs and

0.5 kg after

carcase > 2 kg

cocks, capons

other dark meat

removal of skin

and ducks

and bone

Bird, medium-sized

Hens, guinea

Thighs, legs or other

0.5 kg after

carcase 500 g - 2 kg

fowl,

dark meat from at

removal of skin

Young chicken

least three birds

and bone

Bird, small-sized

Quail, pigeon

Carcasses from at

0.2 kg of

carcase < 500 g

least six birds

muscle tissue

Bird parts fresh,

Legs, quarters

Packaged units or

0.5 kg after

chilled frozen retail or

breasts and

individual units

removal of skin

wholesale packaged

wings

and bone

Poultry fats, including carcase fat

Note: samples of fat taken as described in parts 5.1 and 5.2 may be used to determine

compliance of the fat, or the whole product, with the corresponding MRLs.

Bi r d s , a t s l a u gh t e r,

Chickens,

Units of abdominal

0.5 kg

whole or part carcase

turkeys

fat from at least 3

birds

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

Bird meat parts

Legs, breast

Either visible fat,

muscle

trimmed from unit(s)

0.5 kg

Or whole unit(s) or

2 kg

portions of whole

unit(s) where fat is

not trimmable

Bird fat tissue in bulk

Units taken with a

0.5 kg

sampling device from

at

least

three

positions

Poultry offal

Edible bird offal,

Units fr om at least

0.2 kg

except goose and dark

six birds, or a cross-

fat liver and similar

section from a

high value products

container

Go o s e a n d d u c k f a t

Unit from one bird or

0.05 kg

liver and similar high-

container

value products

Processed foods of animal origin

Secondary food commodities of animal origin, dried meats

Derived edible products of animal origin, processed animal fats, including rendered

or extracted fats

Manufactured food (single ingredient) of animal origin, with or without packing

medium or minor ingredients such as flavouring agents, spices and condiments, 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

Mammal or bird,

Ham, sausage,

Packaged units, or a

0.5 kg or 2 kg

comminuted, cooked,

minced beef,

representative cross-

if fat content

canned,

dried

chicken paste

section from a

< 5%

rendered, or otherwise

container or units

processed products,

(including juices, if

including multi-

any) taken with a

ingredient products

sampling device

Table 4

Plant products: description of primary samples and minimum size

of laboratory samples

Commodity classification

Examples

Nature of primary

Minimum size

samples to be taken

of each

laboratory

sample

Primary food commodities of plant origin

1. All fresh fruits

All fresh vegetables including potatoes and sugar beets and excluding herbs

Small sized fresh

Berries, peas,

Whole units, or

1 kg

Products

units

olives

packages, or units

generally < 25g

taken

with

a

sampling device

Medium sized fresh

Apples,

Whole units

1 kg

products, units

oranges

(at least 10

Generally 25 to 250 g

units)

Large sized fresh

Cabbages,

Whole unit(s)

2 kg

products,

units

cucumbers,

(at least 5 units)

generally > 250 kg

grapes

(bunches)

2. Pulses

Beans, dried;

1 kg

peas, dried

Cereal grains

Rice, wheat

1 kg

Tree nuts

Except

1 kg

coconuts

Coconuts

5 units

Oilseeds

Peanuts

0.5 kg

Seeds for beverages

Coffee beans

0.5 kg

and sweets

3. Herbs

Fresh parsley

Whole units

0.5 kg

Others, fresh

0.2 kg

(for dried herbs see part 4 of this table)

Spices

Dried

Whole units or taken

0.1 kg

with a sampling

device

Processed foods of plant origin

4. Secondary food commodities of plant origin, dried fruits, vegetables, herbs, hops,

milled cereal products

Derived products of plant origin, teas, herb teas, vegetable oils, juices 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, 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),

breeds and other cooked cereal products

Products of high-unit

Packages or units

0.1 kg

value

taken

with

a

sampling device

Solid products of

Hops,

tea,

Packaged units or

0.2 kg

low bulk

herb tea

un its taken with a

sampling device

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

Other solid products

Br e a d , f l o u r,

Packages or units

0.5 kg

dried fruit

taken

with

a

sampling device

Liquid products

Vegetable oils,

Packaged units or

0.5 l or 0.5 kg

juices

un its taken with a

sampling device

Table 5

Egg and dairy products: description of primary samples and minimum size

of laboratory samples

Commodity classification

Examples

Nature of primary

Minimum size

samples to be taken

of each

laboratory

sample

Primary food commodities of animal origin

Poultry eggs

Eggs, except quail

Whole eggs

whole

and similar

chicken eggs,

whole

goose

or

duck eggs

Eggs,

quail

and

Whole eggs

whole

similar

eggs

Milks

Whole units, or

0.5 l

units taken with a

sampling device

Processed foods of animal origin

3. Secondary food commodities of animal origin, secondary milk products such as

skimmed milks, evaporated milks and milk powders

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 yogurt, 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 predominate (s) such as processed cheese products, cheese preparations,

flavoured yogurt, sweetened condensed milk

Liquid

milk,

Packaged unit(s) or

0.5 l (liquid)

powdered milk,

unit(s) taken with a

or

evaporated milk and

sampling device

0.5 kg (solid)

cream, ice-creams,

creams, yoghurts

i) Evaporated milks and evaporated creams in bulk must be mixed thoroughly before

sampling, scraping adhering material from the sides and bottom of containers and stirring

well. About 2 to 3 1 should be removed and again stirred well before removing the

laboratory sample.

ii) Milk powders in bulk should be sampled aseptically, passing a dry borer tube through

the powder at an even rate.

iii) Creams in bulk should be mixed thoroughly with a plunger before sampling but

foaming, whipping and churning must be avoided.

3.2

Butter and butteroils

Butter, whey butter,

Whole or parts of

0.2 kg

low fat spreads

packaged unit(s) or

or

containing butter

unit(s) taken with a

0.5 l

fat, anhydrous

sampling device

butteroil, anhydrous

milkfat

3.3

Cheeses, including processed cheeses

Units 0.3 kg or

Whole unit(s) or

0.5 kg

greater

unit (s) cut wit h a

sampling device

Units < 0.3 kg

0.3 kg

Note: Cheeses with a circular base should be sampled by making two cuts radiating

from the centre. Cheeses with a rectangular base should be sampled by making two

cuts parallel to the sides

3.4

Liquid, frozen or

Unit(s)

taken

0.5 kg

dried egg products

aseptically with a

sampling device

4.4. Preparation of the laboratory sample

Where the bulk sample is larger than is required for a laboratory sample, it should

be divided 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 should not be cut or broken. Where required, replicate

laboratory samples should be withdrawn at this stage or they may be prepared using

the alternative procedure described above. The minimum sizes required for

laboratory samples are given in Tables 3, 4 and 5.

4.5. Sampling record

The sampling officer must record the nature and origin of the lot; the owner,

supplier or carrier of it; the date and place of sampling; and any other relevant

information. Any departure from the recommended method of sampling must be

recorded. A signed copy of the record must accompany each replicate laboratory

sample and a copy should be retained by the sampling officer. A copy of the

sampling record should be given to the owner of the lot, or a representative of the

owner, whether or not they are to be provided with a laboratory sample. If sampling

records are produced in computerised form, these should be distributed to the same

recipients and a similar verifiable audit trail maintained.

4.6. Packaging and transmission of the laboratory sample

The laboratory sample must be placed in a clean, inert container which provides

secure protection from contamination, damage and leakage. The container should be

sealed, securely labelled and the sampling record must be attached. Where a bar code

is utilised, it is recommended that alphanumeric information is also provided. The

sample must be delivered to the laboratory as soon as practicable. Spoilage in transit

AND ON PRO DUCTS OF PLANT AND AN IM AL O RIG IN

must be avoided, e.g. fresh samples should be kept cool and frozen samples must

remain frozen. Samples of meat and poultry should be frozen prior to despatch,

unless transported to the laboratory before spoilage can occur.

4.7. Preparation of the analytical sample

The laboratory sample should be given a unique identifier which, together with the

date of receipt and the sample size, should be added to the sample record. The part of

the commodity to be analysed * i.e. the analytical sample, should be separated as

soon as practicable. Where the residue level must be calculated to include parts

which are not analysed † , the weights of the separated parts must be recorded.

4.8. Preparation and storage of the analytical portion

The analytical sample should be comminuted, if appropriate, and mixed well, to

enable representative analytical portions to be withdrawn. The size of the analytical

portion should be determined by the analytical method and the efficiency of mixing.

The methods for comminution and mixing should be recorded and should not affect

the residues present in the analytical sample. Where appropriate, the analytical

sample should be processed under special conditions, e.g. at sub-zero temperature, to

minimise adverse effects. Where processing could affect residues 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 must be analysed, to indicate the uncertainty of the

mean value. If analytical portions are to be stored before analysis, the method and

length of time of storage should be such that they do not affect the level of residues

present. Additional portions must be withdrawn for replicate and confirmatory

analyses, as required.

5. CRITERIA FOR DETERMINING COMPLIANCE

Analytical results must be derived from one or more laboratory samples taken

from the lot and received in a fit state for analysis. The results must be supported by

acceptable quality control data. Where a residue is found to exceed a MRL, its

identity should be confirmed and its concentration must be verified by analysis of

one or more additional analytical portions derived from the original laboratory

sample(s). The MRL applies to the bulk sample. The lot complies with a MRL where

the MRL is not exceeded by the analytical result(s). Where results for the bulk

sample exceed the MRL, a decision that the lot is noncompliant must take into

account

(i)

the results obtained from one or more laboratory samples, as applicable,

and

(ii) the accuracy and precision of analysis, as indicated by the supporting

quality control data.

*Part of products to which maximum limits apply

†For example, the stones of stone fruit are not analysed but the residue level is calculated assuming that they

are included but contain no residue.