Animal origin Regulations, 2004

L.N. 479 of 2004

PESTICIDES CONTROL ACT, 2001

(ACT NO.XI OF 2001)

European Community Methods of sampling for official

Control of pesticide residues in and on Products of Plant and

Animal origin Regulations, 2004

IN exercise of the powers conferred by article 5 of the Pesticides

Control Act 2001, the Minister for Rural Affairs and the Environment

has made the following regulations:-

(1) The title of these regulations is the European

Community Control of Pesticide Residues in and Products of Animal

and Plant Origin Regulations, 2004 and they shall come into force

on

(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 Pesticide

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, 2004, L.N 199 of 2004.

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

Community MRLs are based on good agricultural practice data and 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 to these

regulations.

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.

Notes

a) 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.

Lot

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.

Note: 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 .

Notes: a) 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.

Sample

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.

Notes: a) Specific sampling devices are described by ISO 1 2 3 and IDF 4 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

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.

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.

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 5

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 6 , pulses 7 and tea 8 are described in ISO recommendations and

those required for dairy products 9 are described by the IDF.

Table 1

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.

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

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

Minimum number of primary samples to be taken

from the lot

b) Other products

i) Products, packaged or in bulk, which can be

1 (A lot may be mixed by grading or manufacturing

assumed to be well mixed or homogenous

processes, for example)

ii) Products, packaged or in bulk, which may not be

For products comprised of large units, being

well mixed or homogeneous

primary food commodities of plant origin only, the

minimum 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 non-compliant residue

residues in the lot

with a probability of

%

90%

95%

99%

-

-

0,5

0,1

2 301

4 603

Notes: a) 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 = n u m b e r o f p r i m a r y s a m p l e s g i v e n i n T a b l e 2

N = n u m b e r o f u n i t s , c a p a b l e o f y i e l d i n g a p r i m a r y s a m p l e , i n t h e l o t .

c ) w h e r e a s i n g l e p r i m a r y s a m p l e i s t a k e n , t h e p r o b a b i l i t y o f d e t e c t i n g a n o n - c o m p l i a n c e a s i m i l a r t o t h e

i n c i d e n c e o f n o n - c o m p l i a n t r e s i d u e s .

d ) F o r e x a c t o r a l t e r n a t i v e p r o b a b i l i t i e s , o r f o r a d i f f e r e n t i n c i d e n c e o f n o n - c o m p l i a n c e , t h e n u m b e r o f

s a m p l e s t o b e t a k e n m a y b e c a l c u l a t e d f r o m

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.

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 4

Plant products: description of primary samples and minimum size of laboratory

samples

Commodity

Examples

Nature of primary

Minimum size of

classification

samples to be

each laboratory

taken

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 generally < 25g

olives

packages, or units

taken

with

a

sampling device

Medium sized fresh products, units

Apples, oranges

Whole units

1 kg

Generally 25 to 250 g

(at least 10 units)

Large sized fresh products, units

Cabbages,

Whole unit(s)

2 kg

generally > 250 kg

cucumbers, grapes

( at least 5 units)

(bunches)

Pulses

Beans, dried; peas,

1 kg

2. dried

Cereal grains

Rice, wheat

1 kg

Tree nuts

Except coconuts

1 kg

Coconuts

5 units

Oilseeds

Peanuts

0.5 kg

Seeds for beverages and sweets

Coffee beans

0.5 kg

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

0.1 kg

taken

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 value

Packages or units 0.1 kg

taken

with

a

sampling device

4.2

Solid products of low bulk

Hops, tea, herb tea

Packaged units or

0.2 kg

units taken with a

sampling device

4.3

Other solid products

Bread, flour, dried

Packages or units

0.5 kg

fruit

taken

with

a

sampling device

4.4

Liquid products

Vegetable

oils,

Packaged units or

0.5 l or 0.5 kg

juices

units taken with a

sampling device

Table 5

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

laboratory samples

Commodity

Examples

Nature of primary

Minimum size of each laboratory

classification

sample to be taken

sample

Primary food commodities of animal origin

1. Poultry eggs

Eggs, except quail

Whole eggs

12 whole chicken eggs, 6 whole goose

and similar

or duck eggs

Eggs,

quail

and

Whole eggs

24 whole eggs

similar

1.3 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

Packaged unit(s) or 0.5 l (liquid)

unit(s) taken with a

or

sampling device

0.5 kg (solid)

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.

Butter and butteroils

Butter, whey butter, low

Whole or parts of

0.2 kg

fat spreads containing

packaged unit(s) or

or

butter fat, anhydrous

unit (s) taken with a

0.5 l

butteroil,

anhydrous

sampling device

milkfat

Cheeses, including processed cheeses

Units 0.3 kg or greater

Whole unit(s) or

0.5 kg

unit(s) cut with a

Units < 0.3 kg

0.3 kg

sampling device

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 dried

Unit(s)

taken 0.5 kg

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 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 10 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 11 , the weights of the separated parts must be recorded.

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.

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.

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 non-

compliant 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.

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

Organizazzjoni Internazzjonali għall-Istandardazzjoni, 1979. Standard Internazzjonali ISO 951 : Ċereali

– teħid ta’ kampjuni (bhala qamħ)

Organizazzjoni Internazzjonali ghall-Istandardazzjoni ,1979. Standard Internazzjonali ISO 951; Legumi

f’ boroż - Teħid ta’ kampjuni.

Organizzazzjoni Internazzjonali għall-Istandardazzjoni, 1980. Standard Intenazzjonali ISO 1839: Tè –

teħid ta’ kampjuni.

Federazzjoni Internazzjonali tal- Ħalib, 1995. Standard Internazzjonali IDF standard 50C : Ħalib u

prodotti tal-ħalib- metodi ta’ teħid ta’ kampjuni.

TABELLA 1

Numru minimu ta’ kampjuni primarji li għandhom jittieħdu mill-lott

Numru minimu ta’ kampjuni primarji li għandhom

jittieħdu mill-lott

a) Laħam u tjur

Lott mhux suspettuż

Lott suspettuz

Determinat skond Tavola 2

Numru minimu ta’ kampjuni primarji li għandhom

jittieħdu mill-lott

b) Prodotti oħrajn

i) Prodotti, ipakkajati jew bl-ingrossa,, li jistgħu jiġu

1 (Lott jista’ jitħallat bil- gradi jew

assunti li huma mħallta sewwa jew omoġenej

manufatturazzjoni)

ii) Prodotti, ippakkjati jew bl-ingross, li jistgħu ma

Għal prodotti li jikkomprendu unitajiet kbar, li

jkunux mħallta sewwa jew omoġenej

huma prodotti ta’ ikel primarju li joriġina mill-

pjanti biss,, l-għadd minimu ta’ kampjuni primarji

għandu jikkonforma man-numru minimu

ta’

unitajiet meħtieġa għall- kampjun tal-laboratorju

(ara Tavola 4)

Jew

Piż tal- lott, kg

< 50

50-500

> 500

Inkella

Numru ta’ bottijiet, kartuni jew kontenituri oħra fil- lot

1-25

26-100

> 100

TABELLA 2

Numru ta’ kampjuni magħżulin forwitivament meħtieġa għal probabilita’ mogħtija

li jinstabu għallinqas kampjun wieħed non-konformi f’ lott ta’ laħama jew tjur, jew

inċidenza mogħtija ta’ residwi mhux konformi fill-lott

Inċidenza ta’ residwi mhux

Għadd minimu ta’ kampjun meħtieġa biex jinsab residwu mhux

konformi fill-lott

konformi b’probablità ta’

%

90%

95%

99%

-

-

0,5

0,1

2 301

/4 603

Noti: a) It-tabella tassumi teħid fortitiwit ta’ kampjuni .

b) Fejn in-numru ta’ kampjuni primarji indikati f’ Tavola 2 huwa ‘l fuq minn madwar 10% ta’

l- unitajiet fil-lot kollu, the numru ta’ kampjuni primarji meħuda jistgħu jkunu inqas u għandhom

jiġu kkalkulati kif ġej

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

fejn

n = għadd minimu ta’ kampjuni primarji

n o = n u m r u t a ’ k a m p j u n i p r i m a r j i f ’ T a v o l a 2

N = n u m r u t a ’ u n i t a j i e t , k a p a ċ i l i j i p p r o v d u k a m p j u n p r i m a r j u , f i l - l o t t a .

c ) f e j n k a m p j u n p r i m a r j u w a ħ d a n i j i t t i e ħ e d , i l - p r o b a b i l i t a ′ l i t i n s t a b n o n - k o n f o r m i t a ′ s i m i l i g ħ a l l -

i n ċ i d e n z a t a ’ r e s i d w i m h u x k o n f o r m i

d ) G ħ a l p r o b a b i l t a j i e t j e w a l t e r n a t t i v i , j e w g ħ a l i n ċ i d e n z a t a ’ n o n - k o n f o r m i t a ′ , j i s t g ħ u j i ġ u k k a l k u l a t i

1 - p = ( 1 - i ) n

Fejn p hija l- probabilita′ u i hi l-inċidenza ta’ residwi non-konformi fil- lott ( it-tnejn espressi bħala

frazzjonjiet, mhux persentaġġi), u n huwa the n- numru ta’ kampjuni.

4.3.

Preparazzjoni tal-kampjun sħiħ

Il- proċeduri għal laħam u tjur huma deskritti f’ Tavola 3. Kull kampjun primarju għandu jitqies bħala

kampjun sħiħ separat.

Il-proċeduri għal prodotti ta’ pjanti, bajd jew prodotti tal-ħalib huma deskritti f’ Tabelli 4 u 5. Il-kampjuni

primarji għandhom ikunu kombinati u mħallta tajjeb, jekk pratikabbli, biex jiġi ffurmat il-kampjun sħiħ.

Fejn it-taħlit biex jiġi ffurmat il-kampjun sħiħ mhux f’waqtu jew impratikabbli, il- proċedura altenattiva

segwenti tista’ ssir.. Fejn unitajiet jistgħu jkunu ddaneġġati (u b’ hekk ir-residwi jistgħu jiġu affettwati)

bil- proċessi ta’ taħlit jew suddiviżjoni , jew fejn unitajiet kbar ma setgħux jiġu mħallta biex jipproduċu

distribuzzjoni aktar uniformi ta’ residwu, l-unitajiet għandhom jiġu allokati forwititvament biex jirreplikaw

kampjuni ta’ laboratorju fil-ħin tat-teħid tal-kampjuni primarji. F’dan il-każ, ir- riżultati li għandhom

jintużaw għandhom ikunu l-medja ta’ riżultati validi ottenunti mill-kampjuni tal-laboratorji analizzati..

TABELLA 3

Laħam u tiġieġ: deskrizzjoni ta’ kampjuni primarji u daqs minimu ta’ kampjuni

tal- laboratorji

Klassifikazzjoni

Eżempji

Ismijiet ta’

Daqs minimu ta’ kull kampjun

Tal- prodott

kampjuni

ta’ laboratorju

primarji li jridu

jittieħdu

Ikel ipproċessat li joriġina mill-annimali

Prodotti sekondarji li joriġina mill-animali, laħmijiet mnixxfin

Prodotti derivati li joriġinaw, xaħmijiet ipproċessati ta’ l-annimali, fosthom xaħmijiet reżi jew

estratti.

Ikel manifatturat (ingedjent singolu) li joriġina mill-annimali, bi jew mingħajr ippakkettjar ta’

ingredjenti medji jew minuri bħal aġenti tat-togħam, ħwawar u kondimenti, u li hu normalment

ipakkjat minn qable u lest għall- konsum, bi jew mingħajr tisjir.

Ikel manifatturat (multi-ingredjent) li joriġina mill-annimali, u ikel li fih ingredjenti li joriġina

kemm mill-pjanti kif ukoll mill-pjanti jiġi inkluż hawnhekk jekk l-ingredjent(i) li joriġina mill-

annimali hu(ma) predominant(i)

Mammal

jew

għasfur,

Perżut, zalzett,

Unitajiet

0.5 kg je 2 kg jekk

imfarrak biċċiet żgħar, inixxef,

kapuljat, pejst tat-

ippakkjati,

jew

il-kontentu

tax-

imbiddel,

jew

prodotti

tiġieġ

kampjun

xaħam < 5%

pproċessati

mod

ieħor,

rappreżentattiv

fosthom prodotti b’multi-

minn

kontenitur

ingredjenti

jew

unitajiet

(inkluż

il-meraq

jekk ikun hemm)

meħud b’ tagħmir

għat-teħid

tal-

kampjuni

Tabella 4

Prodotti tal- pjanti: deskrizzjoni ta’ kampjuni primarji u daqs minimu ta’

kampjuni tal-laboratorju

Klassifikazzjoni tal-prodott

Eżempji

Natura tal-

Daqs minimu ta’

kampjuni primarji

kull kampjun tal-

li għandhom

laboratorju

jittieħdu

Prodotti ta’ ikel primarju li joriġina mill-pjanti

1. Frott frisk kollu

Ħaxix frisk kollu inklużi patata u pitravi u esklużi ħxejjex aromatiċi

Prodotti friski ta’ daqs żgħir

Frott żgħir mgerred

Unitajiet sħaħ, jew

1 kg

unitajiet ġeneralment < 25g

bla għadma, piżelli,

pakketti

,

jew

żebbuġ

unitajiet meħudin

b’ tagħmit għat-

teħid tal-kampjuni

Prodotti friski ta’ daqs medju ,

Tuffieħ, larinġ

Unitajiet sħaħ

1 kg

unitajiet ġeneralment 25 sa 250 g

(għallinqas

unitajiet)

Prodotti kbar friski,

unitajiet

Kaboċċi,

ħjar,

Unitajiet sħaħ

2 kg

ġeneralment > 250 kg

għeneb

( għallinqas 5

(għenqiened)

unitajiet)

Legumi

Ful,

imnixxef;

1 kg

2. piżelli, innixxfin

Żrieragħ taċ-ċereali

Ross, qamħ

1 kg

Tas-siġar

Ħlief coconuts

1 kg

Coconuts

5 unitajiet

Żrieragħ taż-żjut

Karawett

0.5 kg

Żrieragħ għax-xorb u ħelu

Tal-kafe’

0.5 kg

3. Ħxejjex aromatiċi

Tursin frisk

Unitajiet sħaħ

0.5 kg

Oħrajn, friski

0.2 kg

(għal ħxejjex aromatiċi ara parti 4 ta’ din it-tavola)

Ħwawar

Innixxfa

Unitajiet sħaħ jew

0.1 kg

meħuda b’tagħmir

tat-teħid

ta’

kampjuni

Ikel ipproċessat li joriġina mill-pjanti

4. Prodotti ta’ ikel sekondarju li joriġina mill-pjanti, frott imnixxef, ħaxix, ħxejjex aromatiċi, hops,

prodotti mitħuna taċ-ċereali

Prodotti derivati li joriġinaw mill-pjanti, tejiet, tejiet , żjut veġetali , meraq u prodotti mixellanji e.g.

żebbuġ ipproċessat u ġulepp taċ-ċitru

Ikel manufatturat (ingredjent singolu) li joriġina mill-pjanti, bi jew mingħajr ingredjenti minuri

jew medji, bħal aġenti tat-togħma, ħwawar u kondimenti u li huwa diġà ppakkjat u lest għall –

konsum bi mingħajr tisjir

Ikel manifatturat (multi-ingredjent) li joriġina mill-pjanti, fosthom prodotti b’ ingredjenti li

joriġina mill- annimali fejn l- ingredjent(i) li jorinġinaw mill-pjanti jippredomina(w), ħobż u

prodotti oħra taċ-ċereali

Prodotti ta’ unita’ ta’ valur għoli

Pakketti

jew 0.1 kg

unitajiet meħudin

b’tagħmir li jieħu

l-kampjuni

Prodotti solidi ta’ massa baxxa

Hops, te’, te’

Pakketti

jew 0.2 kg

unitajiet meħudin

b’tagħmir li jieħu

l-kampjuni

Prodotti oħra solidi

Ħobż, , dqiq, frott Pakketti

jew 0.5 kg

niexef

unitajiet meħudin

b’tagħmir li jieħu

l-kampjuni

Prodotti likwidi

Żjut

veġetali, Pakketti

jew 0.5 l jew 0.5 kg

meraq

unitajiet meħudin

b’tagħmir li jieħu

l-kampjuni

Tabella 5

Prodotti tal-bajd jew halib: deskrizzjoni ta’ kampjuni primarji u daqs minimu ta’

kampjuni tal-laboratorju

Klasifikazzjoni tal-

Eżempji

Ismijiet ta’

Daqs minimu ta’ kull kampjun tal-

prodott

kampjuni primarji

laboratorju

li jridu

jittieħdu

Prodotti ta’ ikel primarju li joriġina mill-annimali

1. Bajd tat-tjur

Bajd,

ħlief

tas-

Bajd sħiħ

12 bajd sħih tat-tiġieġ, 6 bajdiet sħaħ tal

summien

u

tjur

wiżż jew papri

simili,

Bajd, summien u tjur

Bajd sħiħ

24 bajd sħiħ

simili

Ħalib

Unitajiet sħah jew

0.5 l

unitajiet

li

jittieħdu

b’

tagħmir għat-teħid

ta’ kampjuni

Ikel ipproċessat li joriġinaw mill-annimali

3. Prodotti li joriġinaw mill-annimali,prodotti sekondarji tal-ħalib bħal ħalib xkumat, ħalib tal-bott u

trab tal-ħasil

Prodtti derivati li jistgħu jittieklu li joriġinaw mill-annimali, prodotti derivati xaħmijiet tal-ħalib u

ħalib bħal butir, żjut tal- butir, kremi, trabijiet tal- kremi, kaseini eċċetera

Ikel manifatturat ( ingredjent singolu) li joriċina mill-annimali, prodotti manifatturati tal- ħalib bħal

jogurt, ġobnijiet

Ikel manifatturat (multi-ingredjent) ġej mill-annimali, prodotti manifatturati tal-ħalib (inklużi

prodotti b’ingredjenti li joriġinaw mill-pjanti fejn l-ingredjent(i) li joriġinaw mill-annimali

jipredomina(w) bħal prodotti u preprazzjonijetta’ ġobon, jogurt bit-togħma, ħalib tal- bott ħelu

Ħalib likwidu, trab

Unitajiet ippakkjati 0.5 l (likwidi)

tal-ħalib, ħalib u

jew unitajiet

li

jew

krema evaporata,

jittieħdu b’ tagħmir 0.5 kg (solidi)

ġelati,

kremi,

għat-teħid

ta’

jogurts.

kampjuni

Ħalib u krema evaporata fil-massa għandom jitħalltu sewwa qabel it-teħid ta’ kampjuni , tibrix ta’

materjal aderenti min-naħat u l-qiegħ tal -kontenituri u jitħawwad sewwa. Minn 2 sa 3 1 għandu

jitneħħa u mħallat sewwa qabel ma jitneħħa l-kampjun tal-laboratorju.

ii) Trab tal- ħalib fil- massa għandu jittieħed għall-kmapjuni axxetikament, u jitghadda minn tubu taqqab

ġot-trab b’rata uniformi.

iii) Kremi fil-massa għandhom jitħalltu sewwa bi plunger qabel it-teħid ta’ kampjuni imma l-iffurmar ta’

ragħwa, tħabbit tal- krema u taħwid biex isir butir għandu jiġi evitat.

3.2

Butir u żjut tal- butir

Butir, butir tax-xorrox

0.2 kg

spreads b’ livell baxx ta’

Unitajiet

jew

jew

xaħam li jkun fih xaħam

partijiet minnhom

0.5 l

tal- butir, żejt tal- butir

li

jittieħdu

b’

anidru , xaħam tal-ħalib

tagħmir għat-teħid

anidru

ta’ kampjuni

3.3

Ġobnijiet, nklużi ġobnjiet ipproċessati

Unitajiet 0.3 kg jew ikbar

Unitajiet

jew

0.5 kg

partijiet minnhom

Unitajiet < 0.3 kg

0.3 kg

ippakkajti

li

jittieħdu b’ tagħmir

għat-teħid

ta’

kampjuni

Nota:Ġobnijet b’bażi ċirkolari għandu jittehdilhom kampjuni billi jsiru żewġ qatgħat miċ-ċentru.

Ġobnijet b’bażi rettangolari għandhom jitteħdilhom il- kampjuni billi jsiru żewġ qatgħat paralleli

għan-naħat.

3.4

Prodotti tal- bajd, likwidi,

Unitajiet

li 0.5 kg

frozen jew imnixxfin

jittieħdu

axxettikament b’

tagħmir tat-teħid

tal- kampjuni

4.4.

Preparazzjoni tal-kampjun tal- laboratorju

Fejn il-kampjun tal- massa huwa ikbar minn dak li hu meħtieġ għal kampjun ta’ laboratorju, dan

għandu jkun maqsum sabiex jipprovdi porzjoni rappreżentativa. Tagħmir tat-teħid, qsim fi kwarti,, jew

kwalunkwe proċess ta’ tnaqqis ieħor propizju jista’ jseħħ, iżda unitajiet prodotti friski tal-pjanti jew bajd

sħiħ m’għandux ikun maqtugħ jew imkisser. Fejn meħtieġ, kampjuni repliki tal-laboraotrju għanadhom

jitneħħew f’ dan l-istadju, jew jistgħu jiġu ppreparati bl-użu tal –proċedura alternattiva deskritta hawn fuq.

Id- daqsijiet minimi rikjesti għall-kampjuni tal- laboratorji qed jingħataw f’ Tabelli 3, 4 u 5.

4.5.

Rekord ta’ teħid ta’ kampjuni

The uffiċjal li jieħu l-kampjuni għandu jżomm rekord tan-natura u l-oriġini tal- lott; tas-sid, ta’

min qed jissupplixxih jew iġorru; id- data u l-post tat-teħid tal- kampjuni u kull tagħrif ieħor relevanti . Kull

żvijar mill-metodu rakkomandat ta’ teħid ta’ kampjuni għandu jiġi rrekordjat. Kopja ffirmata tar-rekord

għandu jakkumpanja kull kampjun replikat u kopja għandha tinżamm mill-uffiċjal tat-teħid tal- kampjuni.

Kopja ta’ dan ir-rekord għandha tingħata lis-sid tal-lott, jew rappreżentant tas-sid, sew jekk se jiġu

pprovduti b’ kampjun ta’ laboraotrju jew le. Jekk rekords ta’ kampjuni huma prodotti f’għamla

kompjuterizzata, dawn għandhom jiġu distribwiti lill-istess riċevituri u tinżamm verifika.

4.6.

Ippakkettjar u trasmissjoni ta’ kampjun tal- laboratorju

Il-kampjun tal- laboratorju għandu jitqiegħed f’ kontenitur nadif u inattiv li jipprovdi protezzjoni

sikura minn kontainazzjoni, ħsara u ħruġ ta’ likwidi. Il-kontenitur għandu jkun isiġillat, ittikkettjat b’ mod

sekur u r-rekord ta’ teħid tal- kampjun għandu jkun mehmuż. Fejn tintuża kodiċi ta’ barra, huwa

rrakomandat illi, informazzjoni alfanumerika tiġi pprovduta wkoll . Il-kampjun għandu jiġi konsenjat lill-

laboratorju malajr sa fejn hu pratikabbli.Ħsara li tista’ ssir waqt il-vjaġġ in għandu jiġi evitat, e.g. kampjuni

friski għandhom jibqgħu friski u kampjuni ffriżati għandhom jibqgħu ffriżati. Kampjuni ta’ laħam jew tjur

għandhom jiġu ffriżati qabel jintbagħatu, sakemm ma jiġux trasportati lejn il-laboratorju qabel ma’ jista’

jiġrilhom xi ħsara.

4.7.

Preparazzjoni tal-kampjun analitiku

Il-kampjun tal-laboratorju għandu jingħata identifikur uniku li, flimkien mad-data ta’ rċevuta u d-

daqs tal-kampjun, għandu jiżdied fir-rekord tat-teħid ta’ kampjuni. Il- parti tal-prodott li ser jiġi analizzata 1

i.e. il-kampjun analittiku, għandu jiġi separat maljar sa fejn hu pratikabbli . Meta l-livell ta’ residwu għadu

jkun ikkalkulat li jinkludi partijiet li mhumiex analizzati 2 , il-piżijiet tal-partijet separati għandom jiġu

rrekordjati.

4.8.

Preparazjoni u ħażna tal-porzjoni analittika

Il-kampjun analittiku għandu jitfarrak f’ biċċiet żgħar, jekk ikun xieraq, u mħallat tajjeb, sabiex

porzjonijet analittiċi repreżentattivi jistgħu jittieħdu. Id-daqs tal-porzjoni analittika għandha tiġi

ddeterminata bil-metodu analittiku u l-effiċjenza tat-taħlit. Il- metodi ta’ tifrik f’ biċċiet żgħar u taħlit

għandhom jiġu rrekordjati u m’ għandhomx jaffettwaw ir-residwi preżenti fil- kampjun analitiku .. Fejn

xieraqa, il-kampjun analitiku għandu jkun ipproċessat taħt kundizzjonijiet speċjali,, e.g. temperatura taħt

iż-żero, biex jiġu minimizzati effetti negattivi. Fejn l-ipproċessar jista’ jaffetwa residwi , fejn proċeduri

alternattivi prattiċi m’humiex disponibbli , il-porzjoni analitika tista’ tikkonsisti f’ unitajiet sħaħ, jew

segmenti mneħħija minn unitajiet sħaħ. Jekk il-porzjoni analitika tikkonsisti fi ftit unitajiat jew segmenti ,

aktarx li ma ma jkunx rappreżentattiv tal-kampjun analitiku u jridu jiġu analizzati porzjoniet replikati, biex

jindikaw l-inċertezza tal- valur medju . Jekk porzjonijet analittiċi għandhom jinħażnu qabel l-analiżi il-

metodu u tul ta’ żmien ta’ ħażna għandhom ikunu tali illi ma jaffettwawx il- livell ta’ residwi preżenti.

Porzjonijet addizjonali għandhom jitneħħew għal analiżi replikata u konfirmatorja, jekk ikun meħtieġ.

5. KRITERJI BIEX TIĠI DDETERMINATA L-KONFORMITA′

Riżultati analittiċi għandhom jiġu dderivati minn kampjun wieħed jew iktar tal-laboratorju

meħudin mil-lott u rċevut fi stat tajjeb għall-analiżi. Ir-riżultati għandhom jiġu ssostanzjati b’ data

aċċettabbli ta’ kontroll ta’ kwalita′. Fejn residwu jinstab li jeċċedi LMR, l- identita′ tiegħu ghandu jiġi

kkonfermat u l-konċentrazzjoni tiegħu għandha tiġi vverifikata b’ analiżi ta’ porzjoni jew porzjonijiet

analittiċi derivati mill-kampjun(i) oriġinali tal -laboratorji). Il-LMR japplika għall-kampjun tal-massa . Il-

lott jikkonforma ma’ LMR meta l-LMR ma jiġix eċċedut mir-riżultati analittiċi . Fejn ir-riżultati għall-

kampjun tal-massa jeċċedu l-LMR , daċiżjoni li l-lott huwa non-konformi għandu jieħu in konsiderazzjoni

(i) ir- riżultati ottenuti minn kampjun jew aktar tal- laboratorji, u

(ii) l-akkuratezza u l- preċizjoni ta’analiżi, kif indikat mid-data tal- kwalita′ ta’ kontroll.

Parti mill-prodotti li lilhom japplika il-livell massimu ta’ residwu

Per eżempju, l-għadmiet ta’ frott bl-għadma imma l-livell ta’ residwu jiġi kkalkulat bl-assunzjoni li

huma nklużi imma li ma fihomx residwu .