Contaminants in Food (Sampling and Analysis Methods)

L.N. 60 of 2006

FOOD SAFETY ACT

(CAP. 449)

Contaminants in Food (Sampling and Analysis Methods)

(Amendment) Regulations, 2006

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

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>-

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

(Sampling and Analysis Methods) (Amendment) Regulations, 2006,

and they shall be read and construed as one with the Contaminants in

Food (Sampling and Analysis Methods) Regulations, 2004, hereinafter L.N. 488 of 2004.

referred to as “the principal regulations”.

These regulations implement the provisions of Commission Scope.

Directive 2005#4#EC of 19 January, 2005 and Commission Directive

2005#5#EC of 26 January, 2005.

In the Third Schedule to the principal regulations, for point 5 Amends the Third

Schedule to the

there shall be substituted the following>-

principal

regulations.

“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 does not

exceed the respective maximum level as laid down in Regulation

(EC) No. 466#2001, taking into account the expanded measurement

uncertainty and correction for recovery (*). The lot is rejected if

the mean exceeds the respective maximum level beyond reasonable

doubt, taking into account the expanded measurement uncertainty

and correction for recovery.

The present interpretation rules are of application for the

analytical result obtained on the sample for official control. In case

of analysis for defence or referee purposes, the rules in the Maltese

legislation shall apply.”.

Amends the Fourth

In the Fourth Schedule to the principal regulations>-

Schedule to the

principal

regulations.

(a) in point 3, ‘Method of analysis to be used by the

laboratory and laboratory control requirements’, the following point

3.3.3. shall be inserted immediately after Table 4>-

“3.3.3. Performance Criteria — Uncertainty Function

Approach

However, an uncertainty approach may also be used to

assess the suitability of the method of analysis to be used by

the laboratory. The laboratory may use a method which will

produce results within a maximum standard uncertainty. The

maximum standard uncertainty can be calculated using the

following formula>

Uf = √ [ (LOD / 2) 2 + (aC) 2 ]

where>

Uf is the maximum standard uncertainty

LOD is the limit of detection of the method

C is the concentration of interest

α is a numeric factor to be used depending on the value

of C. The values to be used are given in the table

below>

C (µg/kg)

α

0,2

0,18

501-1000

0,15

1001-10 000

0,12

≥10 000

0,1

and U is the expanded uncertainty, using a coverage factor of

2 which gives a level of confidence of approximately 95 %.

If an analytical method provides results with uncertainty

measurements less than the maximum standard uncertainty

the method will be equally suitable to one which meets the

performance characteristics given above.”< and

(b) for point 3.4 there shall be substituted the following>-

“3.4. Estimation of the analytical trueness, recovery

calculations and reporting of results.

Wherever possible the trueness of analysis shall be

estimated by including suitable certified reference materials

in the analysis. The analytical result is to be reported, corrected

or uncorrected, for recovery. The manner of reporting and

the level of recovery must be reported. The analyst should

note the “European Commission Report on the relationship

between analytical results, the measurement of uncertainty,

recovery factors and the provisions in EU food legislation”

(*). The analytical result has to be reported as x +#– U whereby

x is the analytical result and U is the measurement uncertainty.

Amends the Fifth

In the Fifth Schedule to the principal regulations,

Schedule to the

principal

regulations.

(a) for points 4.3, 4.4 and 4.5 there shall be substituted the

following>-

“4.3. General survey of the sampling procedure for

cereals, dried vine fruit and roasted coffee

Table 1> Subdivision of lots into sublots depending on product and lot weight

Commodity

Lot weight (ton)

Weight or

No of

number of

incremental

sublots

samples

(kg)

Cereals and

≥ 1500

500 tonnes

cereal products

> 300 and < 1500 3 sublots

≥ 50 and ≤ 300

100 tonnes

3 – 100 ( 8 )

< 50

-

Dried vine fruit

≥ 15

15 – 30 tonnes

10 – 100 ( 9 )

<15

-

raisins and

Roasted coffee

≥ 15

15 – 30 tonnes

10 – 100 ( 9 )

beans, ground

<15

-

roasted coffee

and soluble

Depending on the lot weight – see Table 2 of this Schedule

Depending on the lot weight – see Table 3 of this Schedule

4.4. Sampling procedure for cereals and cereal

products (lots ≥ 50 tonnes) and for roasted coffee beans,

ground roasted coffee, soluble coffee and dried vine fruit (lots

≥ 15 tonnes)

• On condition that the sublot can be separated

physically, each lot must be subdivided into sublots following

table 1. Taking into account that the weight of the lot is not

always an exact multiple of the weight of the sublots, the

weight of the sublot may vary from the mentioned weight by

a maximum of 20 %.

•

Each sublot must to be sampled separately.

•

Number of incremental samples> 100.

•

Weight of the aggregate sample = 10 kg.

• 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.

4.5. Sampling provisions for cereals and cereal

products (lots < 50 tonnes) and for roasted coffee beans,

ground roasted coffee, soluble coffee, dried vine fruit (lots <

15 tonnes)

For cereal lots under 50 tonnes and for roasted coffee

beans, ground roasted coffee, soluble coffee and dried vine

fruit lots under 15 tonnes the sampling plan has to be used

with 10 to 100 incremental samples, depending on the lot

weight, resulting in an aggregate sample of 1 to 10 kg. For

very small lots (≤ 0,5 tonnes) of cereals and cereal products a

lower number of incremental samples can be taken, but the

aggregate sample uniting all incremental samples shall be also

in that case at least 1 kg.

The figures in the following table can be used to

determine the number of incremental samples to be taken.

Table 2> Number of incremental samples to be taken depending on the weight

of the lot of cereals and cereal products

Lot weight (tones)

No of incremental samples

≤ 0,05

> 0,05 - ≤ 0,5

> 0,5 - ≤ 1

> 3 - ≤ 10

> 10 - ≤ 20

> 20 - ≤ 50

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

lot of roasted coffee beans, ground roasted coffee, soluble coffee and dried vine fruit

Lot weight (tonnes)

No of incremental samples

≤ 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

100”; and

(b) the following point 4.6A shall be inserted immediately

after point 4.6> -

“4.6A Sampling provisions for wine and grape juice

The aggregate sample shall be at least 1 kg except where

it is not possible e.g. when the sample consists of 1 bottle.

The minimum number of incremental samples to be taken

from the lot shall be as given in table 4. The number of

incremental samples determined is function of the usual form

in which the products concerned are commercialised. In the

case of bulk liquid products, the lot shall be thoroughly mixed

insofar as possible and insofar as it does not affect the quality

of the product, by either manual or mechanical means

immediately prior to sampling. In this case, a homogeneous

distribution of ochratoxin A can be assumed within a given

lot. It is therefore sufficient to take three incremental samples

from a lot to form the aggregate sample.

The incremental samples, which might frequently be a

bottle or a package, shall be of similar weight. The weight of

an incremental sample should be at least 100 grams, resulting

in an aggregate sample of at least about 1 kg. Departure from

this procedure must be recorded in the record provided for in

point 3.8.

Table 4> Minimum number of incremental samples to be taken from the lot

Form of commercialisation

Weight of lot (in litres)

Minimum number of

incremental samples to be

taken

Bulk (grape juice, wine)

…

Bottles/packages grape juice

≤ 50

Bottles/packages grape juice

50 to 500

Bottles/packages grape juice

> 500

Bottles/packages wine

≤ 50

Bottles/packages wine

50 to 500

Bottles/packages wine

> 500

3”.

References

(*) European Commission Report on the relationship between

analytical results, the measurement of uncertainty, recovery factors and

the provisions in EU food legislation, 2004

(http>##europa.eu.int#comm#food#food#chemicalsafety#contaminants#sampling_en.htm).

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