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Regulations, 2003

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Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

L.N. 240 of 2003

FOOD SAFETY ACT, 2002

(ACT No. XIV of 2002)

Contaminants in Food (Sampling and Analysis Methods)

Regulations, 2003

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health has made the following regulations

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

The title of these regulations is the Contaminants in Food Title.

(Sampling and Analysis Methods) Regulations, 2003.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

(Equivalent to Annex I of Commission Directive 98/53/EC)

Methods of sampling for official checking control of the levels of aflatoxins in

certain foodstuffs

1. Purpose and scope

Samples intended for official checking of the levels of aflatoxin content in

foodstuffs shall be taken according to the methods described below. Aggregate

samples thus obtained shall be considered as representative of the lots.

Compliance with maximum limits laid down in Commission Regulation (EC) No

1525/98 shall be established on the basis of the levels determined in the

laboratory samples.

2. Definitions

Lot: an identifiable quantity of a food commodity delivered at one time and

determined by the official to have common characteristics, such as origin, variety,

type of packing, packer, consignor or markings.

Sublot: designated part of a large lot in order to apply the sampling method on

that designated part. Each sublot must be physically separate and identifiable.

Incremental sample: a quantity of material taken from a single place in the lot or

sublot.

Aggregate sample: the combined total of all the incremental samples taken from

the lot or sublot.

Laboratory sample: sample intended for the laboratory (=subsample).

3. General provisions

Personnel

Sampling shall be performed by an official analyst as specified by the Act.

Material to be sampled

Each lot which is to be examined must be sampled separately. In accordance with

the specific provisions in point 5 of this Schedule, large lots should be subdivided

into sublots to be sampled separately.

Precautions to be taken

In the course of sampling and preparation of the laboratory samples precautions

must be taken to avoid any changes which would affect the aflatoxin content,

adversely affect the analytical determination or make the aggregate samples

unrepresentative.

Incremental samples

B

As far as possible incremental samples should be taken at various places

distributed throughout the lot or sublot. Departure from this procedure must be

recorded in the record provided for in 3.8.

Preparation of the aggregate sample and the laboratory samples (subsamples)

The aggregate sample is made up by uniting and sufficiently mixing the

incremental samples. After mixing, the aggregate sample must be divided into

equal subsamples in accordance with the specific provisions of point 5 of this

Schedule. The mixing is necessary to ensure that each subsample contains

portions of the whole lot or sublot.

Replicate samples

The replicate samples for enforcement, trade (defence) and referee purposes are to

be taken from the homogenised laboratory sample.

Packaging and transmission of laboratory samples

Each laboratory sample shall be placed in a clean, inert container offering

adequate protection from contamination and against damage in transit. All

necessary precautions shall be taken to avoid any change in composition of the

laboratory sample which might arise during transportation or storage.

Sealing and labelling of laboratory samples

Each sample taken for official use shall be sealed at the place of sampling and

identified. A record must be kept of each sampling, permitting each lot to be

identified unambiguously and giving the date and place of sampling together with

any additional information likely to be of assistance to the analyst.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

1 The sampling for the official control of the levels of aflatoxins Sampling Methods

for aflatoxins in

in foodstuffs shall be carried out in accordance with the methods foodstuffs.

described in the First Schedule to these regulations.

2.2 The sample preparation and methods of analyses used for

the official control of the levels of aflatoxins in foodstuffs shall comply

with the criteria described in the Second Schedule to these regulations.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

(Equivalent to Annex II of Commission Directive 98/53/EC)

Sample preparation and criteria for methods of analysis used in official checking of

the levels of aflatoxins in certain foodstuffs

1. Introduction

Precautions

Daylight should be excluded as much as possible during the procedure, since

aflatoxin gradually breaks down under the influence of ultra-violet light. As the

distribution of aflatoxin is extremely non-homogeneous, samples should be

prepared – and especially homogenised – with extreme care. All the material

received by the laboratory is to be used for the preparation of test material.

Calculation of proportion of shell/kernel of whole nuts

The limits fixed for aflatoxins in the Contaminants in Food Regulations apply to

the edible part. The level of aflatoxins in the edible part can be determined by

shelling samples of nuts `in shell' and the level of aflatoxins is directly

determined in the edible part,

homogenise the nuts `in shell' by taking them through the sample

preparation procedure. The sampling and analytical procedure must

estimate the weight of nut kernel in the aggregate sample. The weight of

nut kernel in the aggregate sample is estimated after establishing a suitable

factor for the proportion of nut shell to nut kernel in whole nuts. This

proportion is used to ascertain the amount of kernel in the bulk sample

taken through the sample preparation and analysis procedure.

Approximately 100 whole nuts are taken at random separately from the lot

or are to be put aside from each aggregate sample. The ratio may, for each

laboratory sample, be obtained by weighing the whole nuts, shelling and

re-weighing the shell and kernel portions. However, the proportion of shell

to kernel may be established by the laboratory from a number of samples

and so can be assumed for future analytical work. But if a particular

laboratory sample is found to be in contravention of any limit, the

proportion should be determined for that sample using the approximately

100 nuts that have been set aside.

2. Treatment of the sample as received in the laboratory

Finely grind and mix thoroughly each laboratory sample using a process that has

been demonstrated to achieve complete homogenisation.

3. Subdivision of samples for enforcement and defence purposes

The replicate samples for enforcement, trade (defence) and referee purposes shall

be taken from the homogenized material.

4. Method of analysis to be used by the laboratory and laboratory control

requirements

Definitions

A number of the most commonly used definitions that the laboratory will be

required to use are given below

The most commonly quoted precision parameters are repeatability and

reproducibility.

r = repeatability, the value below which the absolute difference between two

single test results obtained under repeatability conditions (i. e. same sample, same

operator, same apparatus, same laboratory, and short interval of time) may be

expected to lie within a specific probability (typically 95 %) and hence r = 2.8 . s r

s r = Standard deviation, calculated from results generated under repeatability

conditions

RSD r = relative standard deviation, calculated from results generated under

repeatability conditions [(S r /x) . 100], where x is the average of results over all

laboratories and samples

R = reproducibility, the value below which the absolute difference between single

test results obtained under reproducibility conditions (i.e. on identical material

obtained by operators in different laboratories, using the standardised test method)

may be expected to lie within a certain probability (typically 95 %); R = 2.8 s R

s R = standard deviation, calculated from results under reproducibility conditions

RSD R = relative standard deviation calculated from results generated under

reproducibility conditions [(S R /x).100]

General requirements

Methods of analysis used for food control purposes must comply whenever

possible with the provisions of points 1 and 2 of the Annex to Council Directive

85/591/EEC.

Specific requirements

B

Where no specific methods for the determination of aflatoxin levels in foodstuffs

are prescribed at Community level, laboratories may select any method provided

the selected method meets the following criteria

Criterion

Concentration range

Recommended value

Maximum permitted

value

All

Negligible

0.01 – 0.05 µg/kg

Recovery – Aflatoxin

60 to120 %

70 to 110 %

> 0.05 µg/kg

< 1.0 µg/kg

Recovery – Aflatoxins

50 to 120 %

70 to110 %

1-10 µg/kg

80 to 110 %

> 10 µg/kg

Precision RSD R

All

As derived from

2 x value derived from

Horwitz equation

Horwitz equation

Precision RSD R may be calculated as 0.66 times precision RSD R at the

concentration of interest.

Notes

Values to apply to both B 1 and sum of B 1 +B 2 +G 1 +G 2 ,

if sum of individual aflatoxins B 1 +B 2 +G 1 +G 2 are to be reported, then response of

each to the analytical system must be either known or equivalent,

the detection limits of the methods used are not stated as the precision values are

given at the concentrations of interest,

the precision values are calculated from the Horwitz equation, i. e.

RSD R = 2 (1-0,5 logC)

where

–

RSD R is the relative standard deviation calculated from results generated

under reproducibility conditions [(S R /x) .100]

–

C is the concentration ratio (i. e. 1 = 100 g/100 g, 0,001 = 1 000 mg/kg).

This is a generalised precision equation which has been found to be independent

of analyte and matrix but solely dependent on concentration for most routine

methods of analysis.

Recovery calculation

The analytical result is to be reported corrected or uncorrected for recovery. The

manner of reporting and the level of recovery must be reported.

Laboratory quality standards

Laboratories must comply with Council Directive 93/99/EEC.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

1 The sampling for the official control of the levels of lead, Sampling Methods

for lead, cadmium,

cadmium, mercury and 3-MCPD in foodstuffs shall be carried out in mercury and 3-

accordance with the methods described in the Third Schedule to these MPCD

foodstuffs.

regulations.

3.2 The sample preparation and methods of analyses used for

the official control of the levels of lead, cadmium, mercury and 3-MCPD

in foodstuffs shall comply with the criteria described in the Fourth

Schedule to these regulations.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

(Equivalent to Annex I of Commission Directive 2001/22/EC)

Methods Of Sampling For Offical Control Of The Levels Of Lead, Cadmium,

Mercury And 3-MPCD In Certain Foodstuffs

1. PURPOSE AND SCOPE

Samples intended for the official control of the levels of lead, cadmium, mercury

and 3-MCPD contents in foodstuffs shall be taken according to the methods

described below. Aggregate samples thus obtained shall be considered as

representative of the lots or sublots from which they are taken. Compliance with

maximum levels laid down in the Contaminants in Food Regulations shall be

established on the basis of the levels determined in the laboratory samples.

2. DEFINITIONS

Lot: an identifiable quantity of food delivered at one time and determined by the

official to have common characteristics, such as origin, variety, type of packing,

packer, consignor or markings. In the case of fish, also the size of fish shall be

comparable.

Sublot: designated part of a large lot in order to apply the sampling method on

that designated part. Each sublot must be physically separated and identifiable.

Incremental sample: a quantity of material taken from a single place in the lot or

sublot.

Aggregate sample: the combined total of all the incremental samples taken from

the lot or sublot.

Laboratory sample: sample intended for the laboratory

3. GENERAL PROVISIONS

Personnel

Sampling shall be performed by an authorised analyst as specified by the Act.

Material to be sampled

Each lot which is to be examined must be sampled separately.

Precautions to be taken

In the course of sampling and preparation of laboratory samples precautions must

be taken to avoid any changes which would affect the lead, cadmium, mercury

and 3-MCPD contents, adversely affect the analytical determination or make the

aggregate samples unrepresentative.

B

Incremental samples

As far as possible incremental samples shall be taken at various places distributed

throughout the lot or sublot. Departure from this procedure must be recorded in

the record provided for under 3.8.

Preparation of the aggregate sample

The aggregate sample is made up by uniting all incremental samples. It shall be at

least 1 kg unless not practical, e.g. when a single package has been sampled.

Subdivision of aggregate sample in laboratory samples for enforcement,

defence and referee purposes

The laboratory samples for enforcement, trade (defence) and referee purposes

shall be taken from the homogenised aggregate sample. The size of the laboratory

samples for enforcement shall be sufficient to allow at least for duplicate

analyses.

Packaging and transmission of aggregate and laboratory samples

Each aggregate and laboratory sample shall be placed in a clean, inert container

offering adequate protection from contamination, from loss of analytes by

adsorption to the internal wall of the container and against damage in transit. All

necessary precautions shall be taken to avoid change of composition of the

aggregate and laboratory samples which might arise during transportation or

storage.

Sealing and labelling of aggregate and laboratory samples

Each sample taken for official use shall be sealed at the place of sampling and

identified. A record must be kept of each sampling, permitting each lot to be

identified unambiguously and giving the date and place of sampling together with

any additional information likely to be of assistance to the analyst.

4. SAMPLING PLANS

Sampling should ideally take place at the point where the commodity enters the

food chain and a discrete lot becomes identifiable. The sampling method applied

shall ensure that the aggregate sample is representative for the lot that is to be

controlled.

Number of incremental samples

In the case of liquid products for which a homogeneous distribution of the

contaminant in question can be assumed within a given lot, it is sufficient to take

one incremental sample per lot which forms the aggregate sample. Reference to

the lot number shall be given. Liquid products containing hydrolysed vegetable

protein (HVP) or liquid soya sauce shall be shaken well, or homogenised by other

suitable means, before the incremental sample is taken. For other products, the

minimum number of incremental samples to be taken from the lot shall be as

given in Table 1. The incremental samples shall be of similar weight. Departure

from this procedure must be recorded in the record provided for under 3.8.

Table 1: Minimum number of incremental samples to be taken from the lot

Weight of lot

Minimum number of incremental samples to be

(kg)

taken

< 50

50 to 500

> 500

If the lot consists of individual packages, then the number of packages which shall

be taken to form the aggregate sample is given in Table 2.

Table 2: Number of packages (incremental samples) which shall be taken to form the

aggregate sample if the lot consists of individual packages

Number of packages or units in the lot

Number of packages or units to be taken

1 to 25

1 package or unit

26 to 100

About 5 %, at least 2 packages or units

> 100

About 5 % at maximum 10 packages or units

5. COMPLIANCE OF THE LOT OR SUBLOT WITH THE SPECIFICATION

The control laboratory shall analyse the laboratory sample for enforcement at

least in two independent analyses, and calculate the mean of the results. The lot is

accepted if the mean conforms to the respective maximum level as laid down in

the Contaminants in Food Regulations. It is rejected if the mean exceeds the

respective maximum level.

B

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

Explanatory provisions

Different types of lots

Food commodities may be traded in bulk, containers, or individual packings

(sacks, bags, retail packings, etc.). The sampling procedure can be applied to all

the different forms in which the commodities are put on the market. Without

prejudice to the specific provisions as laid down in point 5 of this Schedule, the

following formula can be used as a guide for the sampling of lots traded in

individual packings (sacks, bags, retail packings, etc.)

Sampling frequency (SF) = {Weight of the lot} x {Weight of the incremental sample}/{Weight of

the aggregate sample} x {Weight of individual packing}

–

Weight: in kg

–

Sampling frequency (SF): every nth sack or bag from which an

incremental sample must be taken (decimal figures should be rounded to

the nearest whole number).

Weight of the incremental sample

The weight of the incremental sample should be about 300 grams unless

otherwise defined in point 5 of this Schedule and with the exception of spices in

which case the weight of the incremental sample is about 100 grams. In the case

of retail packings, the weight of the incremental sample depends on the weight of

the retail packing.

Number of incremental samples for lots of less than 15 tonnes

The number of incremental samples to be taken depends on the weight of the lot,

with a minimum of 10 and a maximum of 100, unless otherwise defined in point 5

of this Schedule. The figures in the following table may be used to determine the

number of incremental samples to be taken.

Table 1: Number of incremental samples to be taken depending on the weight of

the lot

Lot weight

No of incremental samples

(tonnes)

≤ 0.1

> 0.1 - ≤ 0.2

> 0.2 - ≤ 0.5

> 0.5 - ≤ 1.0

> 1.0 - ≤ 2.0

> 2.0 - ≤ 5.0

> 5.0 - ≤ 10.0

> 10.0 - ≤ 15.0

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

(Equivalent to Annex II of Commission Directive 2001/22/EC)

Sample Preparation And Criteria For Methods Of Analysis Used In Offical Control

Of The Levels Of Lead, Cadmium, Mercury And 3-MCPD In Certain Foodstuffs

1. INTRODUCTION

The basic requirement is to obtain a representative and homogeneous laboratory

sample without introducing secondary contamination.

2. SPECIFIC SAMPLE PREPARATION PROCEDURES FOR LEAD, CADMIUM

AND MERCURY

There are many satisfactory specific sample preparation procedures which may be

used for the products under consideration. Those described in the draft CEN

Standard ‘Foodstuffs — Determination of trace elements — Performance criteria

and general consideration’ have been found to be satisfactory ( 3 ) but others may

be equally valid.

The following points must be noted for any procedure used

—

bivalve molluscs, crustaceans and small fish: where these are normally

eaten whole, the viscera are to be included in the material to be analysed,

—

vegetables: only the edible portion of is to be tested, with note to be taken

of the requirements of the Contaminants in Food Regulations.

3. METHOD OF ANALYSIS TO BE USED BY THE LABORATORY AND

LABORATORY CONTROL REQUIREMENTS

Definitions

A number of the most commonly used definitions that the laboratory will be

required to use are given below

r = repeatability, the value below which the absolute difference between two

single test results obtained under repeatability conditions (i.e., same sample, same

operator, same apparatus, same laboratory, and short interval of time) may be

expected to lie within a specific probability (typically 95 %) and hence r = 2.8 . s r .

s r = standard deviation, calculated from results generated under repeatability

conditions.

RSD r = relative standard deviation, calculated from results generated under

repeatability conditions [( s r / x ) × 100 ] , where x is the average of results over all

laboratories and samples.

Draft Standard prEN 13804, ‘Foodstuffs — Determination of Trace Elements — Performance Criteria

and General Considerations’, CEN, Rue de Stassart 36, B-1050 Brussels.

R = reproducibility, the value below which the absolute difference between single

test results obtained under reproducibility conditions (i.e., on identical material

obtained by operators in different laboratories, using the standardised test

method), may be expected to lie within a certain probability (typically 95 %); R =

2.8 . s R .

s R = standard deviation, calculated from results under reproducibility conditions.

RSD R = relative standard deviation calculated from results generated under

reproducibility conditions [( s R / x ) × 100 ]

HORRAT r = the observed RSD r divided by the RSD r value estimated from the

Horwitz equation using the assumption r = 0,66R

HORRAT R = the observed RSD R value divided by the RSD R value calculated

from the Horwitz equation ( 4 ).

General requirements

Methods of analysis used for food control purposes must comply whenever

possible with the provisions of paragraphs 1 and 2 of the Annex to Directive

85/591/EEC of the European Community. For the analysis of lead in wine,

Commission Regulation (EEC) No 2676/90( 5 ) determining Community methods

for the analysis of wines lays down the method to be used in Chapter 35 of its

Annex.

Specific requirements

3.3.1. Lead, cadmium and mercury analyses

Specific methods for the determination of lead, cadmium and mercury contents

are not prescribed. Laboratories shall use a validated method that fulfils the

performance criteria indicated in Table 3. Where possible, the validation shall

include a certified reference material in the collaborative trial test materials.

Table 3: Performance criteria of methods for lead, cadmium and mercury analyses

Parameter

Value/comment

Applicability

Foods specified in the Contaminants in Food

Regulations

Detection limit

No more than one tenth of the value of the

specification in the Contaminants in Food

Regulations, except if the value of the specification

W Horwitz, ‘Evaluation of Analytical Methods for Regulation of Foods and Drugs’, Anal. Chem., 1982,

No 54, 67A-76A

OJ L 272, 3.10.1990, p. 1.

B

Parameter

Value/comment

for lead is less than 0.1 mg/kg. For the latter, no

more than one fifth of the value of the specification

Limit of quantification

No more than one fifth of the value of the

specification in the Contaminants in Food

Regulations, except if the value of the specification

for lead is less than 0.1 mg/kg. For the latter, no

more than two fifths of the value of the specification

Precision

HORRAT r or HORRAT R values of less than 1.5 in

the validation collaborative trial

Recovery

80-120 % (as indicated in the collaborative trial)

Specificity

Free from matrix or spectral interferences

3.3.2. 3-MCPD analysis

Specific methods for the determination of 3-MCPD contents are not prescribed.

Laboratories shall use a validated method that fulfils the performance criteria

indicated in Table 4. Where possible, the validation shall include a certified

reference material in the collaborative trial test materials. A specific method has

been validated by collaborative trial and has been shown to meet the requirements

of Table 4 ( 6 ).

Table 4: Performance criteria of methods for 3-MCPD analysis

Criterion

Recommended value

Concentration

Field blanks

Less than the detection limit

-

Recovery

75 – 110 %

All

10 (or less) µg on a dry matter

Limit of quantification

-

basis

Less than 4 µg/kg

Standard deviation of the field

-

blank signal

< 4 µg/kg

20 µg/kg

In-house precision estimates –

standard deviation of replicate

< 6 µg/kg

30 µg/kg

measurements at different

< 7 µg/kg

40 µg/kg

concentrations

< 8 µg/kg

50 µg/kg

< 15 µg/kg

100 µg/kg

Estimation of the analytical trueness and recovery calculations

Wherever possible the trueness of the analysis shall be estimated by including

suitable certified reference materials in the analytical run. The ‘Harmonised

Guidelines for the Use of Recovery Information in Analytical Measurement’ ( 7 )

Method of Analysis to determine 3-Monochloropropane-1,2-Diol in Food and Food Ingredients using

Mass Spectrometric Detection, submitted to CEN TC 275 and AOAC International (also available as

‘Report of the Scientific Cooperation task 3.2.6: Provision of validated methods to support the Scientific

Committee on Food’s recommendations regarding 3-MCPD in hydrolysed protein and other foods’).

ISO/AOAC/IUPAC Harmonised Guidelines for the Use of Recovery Information in Analytical

Measurement. Edited Michael Thompson, Steven L R Ellison, Ales Fajgelj, Paul Willetts and Roger Wood,

Pure Appl. Chem., 1999, No 71, 337-348

developed under the auspices of IUPAC/ISO/AOAC shall be taken into account.

The analytical result shall be reported corrected or uncorrected. The manner of

reporting and the level of recovery must be reported.

Laboratory quality standards

Laboratories must comply with Directive 93/99/EEC.

Expression of results

The results shall be expressed in the same units as the maximum levels laid down

in the Contaminants in Foods Regulations.

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

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

Specific provisions

General survey of the sampling procedure for groundnuts, nuts, dried fruit, spices

and cereals

Table 2: Subdivision of lots into sublots depending on product and lot weight

Commodity

Lot weight

Weight or

Number of

Aggregate

(tonnes)

number of

incremental

sample weight

sublots

samples

(kg)

≥ 15

Dried figs and other dried fruit

15-30 tonnes

10-100 ( * )

≤ 30

-

< 15

≥ 500

Groundnuts, pistachios, Brazil

100 tonnes

nuts and other nuts

5 sublots

> 125 & < 500

25 tonnes

≥ 15 & ≤ 125

10-100 ( * )

≤ 30

-

< 15

≥ 1500

Cereals

500 tonnes

3 sublots

> 300 & < 1500

100 tonnes

≥ 50 & ≤ 300

10-100 ( * )

-

1-10

< 50

Depending on the lot weight – see point 4.3 or 5.3 of this Schedule

B

Commodity

Lot weight

Weight or

Number of

Aggregate

(tonnes)

number of

incremental

sample weight

sublots

samples

(kg)

≥ 15

25 tonnes

-

10-100 (*)

1-10

< 15

Groundnuts, pistachios and Brazil nuts

Dried figs

Cereals (lots ≥ 50 tonnes)

Spices

5.2.1. Sampling procedure

On condition that the sublot can be separated physically, each lot must be

subdivided into sublots following Table 2 at point 5.1. Taking into account

that the weight of the lot is not always an exact multiple of the weight of

the sublots, the weight of the sublot may exceed the mentioned weight by

a maximum of 20 %,

each sublot must be sampled separately,

number of incremental samples: 100. In the case of lots under 15 tonnes,

the number of incremental samples to be taken depends on the weight of

the lot, with a minimum of 10 and a maximum of 100 (see point 4.3),

weight of the aggregate sample = 30 kg which has to be mixed and to be

divided into three equal subsamples of 10 kg before grinding (this division

into three subsamples is not necessary in the case of groundnuts, nuts and

dried fruit intended for further sorting or other physical treatment,

however, this will depend upon the availability of equipment which is able

to homogenise a 30 kg sample). In cases where the aggregate sample

weights are under 10 kg, the aggregate sample must not be divided into

three subsamples. In the case of spices the aggregate sample weighs not

more than 10 kg and therefore no division in subsamples is necessary.

laboratory sample: a subsample of 10 kg (each subsample must be

separately ground finely and mixed thoroughly to achieve complete

homogenisation, in accordance with the provisions laid down in the

Second Schedule),

if it is not possible to carry out the method of sampling described above

because of the commercial consequences resulting from damage to the lot

(because of packaging forms, means of transport, etc.) an alternative

method of sampling may be applied provided that it is as representative as

possible and is fully described and documented.

5.2.2. Acceptance of a lot or sublot

For groundnuts, nuts and dried fruit subjected to a sorting or other

physical treatment and spices

–

acceptance if the aggregate sample or the average of the

subsamples conforms to the maximum limit,

–

rejection if the aggregate sample or the average of the subsamples

exceeds the maximum limit,

–

for groundnuts, nuts, dried fruit and cereals intended for direct human

consumption

–

acceptance if none of the subsamples exceeds the maximum limit,

–

rejection if one or more of the subsamples exceeds the maximum

limit,

–

where the aggregate sample is under 10 kg

–

acceptance if the aggregate sample conforms to the maximum

limit,

–

rejection if the aggregate sample exceeds the maximum limit.

Nuts other than groundnuts, pistachios and Brazil nuts

Dried fruit other than figs

Cereals (lots under 50 tonnes)

5.3.1. Sampling procedure

For these products, the sampling procedure laid down in point 5.2.1 may be

applied. However, taking into account the low incidence of contamination for

these products and/or the newer forms of packaging in which products can be

traded, simpler sampling methods may be applied. For cereal lots under 50

tonnes, a sampling plan consisting of, depending on the lot weight, 10 to 100

incremental samples each of 100 grams, resulting in an aggregate sample of 1 to

10 kg may be used. The figures in the following table can be used to determine

the number of incremental samples to be taken.

Table 3: Number of incremental samples to be taken depending on the weight of the lot of

cereals

Lot weight

Number of incremental samples

(tonnes)

≤ 1

> 3 - ≤ 10

> 10 - ≤ 20

> 20 - ≤ 50

5.3.2. Acceptance of a lot or sublot

See point 5.2.2.

Milk

5.4.1. Sampling procedure

B

Sampling in accordance with Commission Decision 91/180/EEC of 14 February

1991 laying down certain methods of analysis and testing of raw milk and heat-

treated milk 1

number of incremental samples: minimum 5,

weight of aggregate sample: minimum 0,5 kg or litres.

5.4.2. Acceptance of a lot or sublot

Acceptance if the aggregate sample conforms to the maximum limit,

rejection if the aggregate sample exceeds the maximum limit.

Derived products and compound foods

5.5.1. Milk products

5.5.1.1. Sampling procedure

Sampling in accordance with Commission Directive 87/524/EEC of 6 October

1987 laying down Community methods of sampling for chemical analysis for the

monitoring of preserved milk products 2 .

Number of incremental samples: minimum 5.

For the other milk products an equivalent method of sampling is used.

5.5.1.2. Acceptance of a lot or sublot

Acceptance if the aggregate sample conforms to the maximum limit,

rejection if the aggregate sample exceeds the maximum limit.

5.5.2. Other derived products with very small particle weight, i.e. flour, fig paste, peanut

butter (homogeneous distribution of aflatoxin contamination)

5.5.2.1. Sampling procedure

Number of incremental samples: 100. For lots of under 50 tonnes the

number of incremental samples should be 10 to 100, depending on the lot

weight (see Table 3 at point 5.3.1 of this Schedule),

the weight of the incremental sample should be about 100 grams. In the

case of lots in retail packing, the weight of the incremental sample

depends on the weight of the retail packing,

weight of aggregate sample = 1-10 kg sufficiently mixed.

5.5.2.2. Number of samples to be taken

The number of aggregate samples to be taken depends on the lot weight.

The division of large lots into sublots must be done as defined for cereals

in Table 2 under point 5.1,

each sublot must be sampled separately.

OJ L 93, 13. 4. 1991, p. 1.

OJ L 306, 28. 10. 1987, p. 24.

5.5.2.3 Acceptance of a lot or sublot

–

Acceptance if the aggregate sample conforms to the maximum limit,

–

rejection if the aggregate sample exceeds the maximum limit.

Other derived products with a relatively large particle size (heterogeneous

distribution of aflatoxin contamination)

Sampling procedure and acceptance as defined at points 5.2 and 5.3 of this

Schedule for the raw agricultural product.

Malta Government Gazette — Legal Notice 2003 240 — Regulations, 2003

Sampling at retail stage

Sampling of foodstuffs at the retail stage should be done where possible in

accordance with the above sampling provisions. Where this is not possible, other

effective sampling procedures at retail stage can be used provided that they ensure

sufficient representativeness for the sampled lot.

B

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