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Food Safety Act (Cap. 449) Contaminants In Food (Sampling And Analysis Methods) (Amendment) Regulations, 2005 (L.N. 91 Of 2005 )

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FOOD SAFETY ACT (CAP. 449)
Contaminants in Food (Sampling and Analysis Methods) (Amendment) Regulations, 2005

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>

1. The title of these regulations is the Contaminants in Food (Sampling and Analysis Methods) (Amendment) Regulations, 2005, and they shall be read and construed as one with the Contaminants in Food (Sampling and Analysis Methods) Regulations, 2004, hereinafter referred to as “the principal regulations”.

2. These regulations implement the provisions of Commission

Directive 2004#16#EC of the European Community.

3. The following shall be added as sub-paragraph (l) of subregulation 1.2 of the principal regulations>

“(l) Commission Directive 2004#16#EC of 12 February,

2004 laying down the sampling methods and the official methods of control for the levels of tin in canned foods.”.

4. Regulation 7.1 of the principal regulations shall be renumbered as regulation 8.1 thereof.

5. Immediately after regulation 6 of the principal regulations there shall be added the following new regulation>-

Citation.

L.N. 488 of 2004

.

Scope.

Amends regulation

1 of the principal regulations.

Renumbers regulation 7.1 of the principal

regulations.

Adds new regulation 7 to the principal regulations.

“Sampling

and analytical methods for

7.1 The sampling for the official control of the levels of tin in canned foods shall be carried out in accordance with

Tin in canned the methods described in the Eleventh Schedule to these

regulations.

7.2 The sample preparation and methods of analyses used for the official control of the levels of tin in canned foods shall comply with the criteria described in the Twelfth Schedule to these regulations.”.

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Adds Eleventh Schedule to the principal regulations.

Adds Twelfth Schedule to the principal regulations.

6. The First Schedule to these regulations is being added as the

Eleventh Schedule to the principal regulations.

7. The Second Schedule to these regulations is added as the

Twelfth Schedule to the principal regulations.

FIRST SCHEDULE “ELEVENTH SCHEDULE

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Methods Of Sampling For Official Control Of The Levels Of Tin In Canned
Foodstuffs
1. Purpose and scope
Samples intended for official checking of the levels of tin in canned 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 levels laid down in Commission Regulation (EC) No
466#2001 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 having been determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings.
Sublot> designated part of a 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.
3. General provisions
3.1. Personnel
Sampling shall be performed by an authorised person as specified by the Food Safety
Commission.
3.2. Material to be sampled
Each lot which is to be examined must be sampled separately.

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3.3. Precautions to be taken
In the course of sampling and preparation of the samples precautions must be taken to avoid any changes, which would affect the tin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.
3.4. Incremental samples
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.
3.5. Preparation of the aggregate sample
The aggregate sample is made up by uniting all incremental samples. This aggregate sample is homogenised in the laboratory.
3.6. Replicate laboratory samples
Replicate laboratory samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised aggregate sample unless this conflicts with other rules on sampling.
3.7. Packaging and transmission of samples
Each 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 sample, which might arise during transportation or storage.
3.8. Sealing and labelling of samples
Each sample taken for official use shall be sealed at the place of sampling and identified following procedures established by the Food Safety Commission. 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
The sampling method applied shall ensure that the aggregate sample is representative for the lot that is to be controlled.
4.1. Number of incremental samples

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The minimum number of incremental samples to be taken from cans within a lot shall be as given in Table 1. The incremental samples taken from each can shall be of similar weight, resulting in an aggregate sample (see point 3.5).

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Table 1

Number of cans (incremental samples) which shall be taken to form the aggregate sample
Number of cans in the lot or sublot Number of cans to be taken
1 to 25 at least 1 can
26 to100 at least 2 cans
> 100 5 cans
Note that the maximum levels apply to the contents of each can, but for feasibility of testing it is necessary to use an aggregate sampling approach. If the test result for the aggregate sample is less than but close to the maximum level and if it is suspected that individual cans might exceed the maximum level then it might be necessary to conduct further investigations.
4.2. 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.
5. Compliance of the lot or sublot with the specification
The control laboratory shall analyse the laboratory sample for enforcement in at least 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 measurement uncertainty and correction for recovery. The lot is non-compliant with the maximum level (as laid down in Regulation (EC) 466#2001) if the mean exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty and correction for recovery.”.
SECOND SCHEDULE “TWELFTH SCHEDULE

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Sample Preparation And Criteria For Methods Of Analysis Used In Official
Checking Of The Levels Of Tin In Canned Foodstuffs
1. Precautions and general considerations for tin
The basic requirement is to obtain a representative and homogeneous laboratory sample without introducing secondary contamination. The analyst should ensure that samples do not become contaminated during sample preparation. Wherever possible, apparatus coming into contact with the sample should be made of inert materials e.g. plastics such as polypropylene, PTFE etc., and these should be acid cleaned to minimise the risk of contamination. High quality stainless steel can be used for cutting edges. All of the sample material received by the laboratory is to be used for the preparation of test material. Only very finely homogenised samples give reproducible results. There are many satisfactory specific sample preparation procedures which may be used. Those described in the CEN Standard on the ‘Determination of trace elements — Performance criteria and general consideration’ have been found to be satisfactory (1) but others may be equally valid.
2. Treatment of the sample as received in the laboratory
Finely grind (where relevant) and mix thoroughly the complete aggregate 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 homogenised material unless this conflicts with other rules on sampling.
4. Method of analysis to be used by the laboratory and laboratory control requirements
4.1. 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 2 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 x s .

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s = Standard deviation, calculated from results generated under repeatability conditions.
RSD = Relative standard deviation, calculated from results generated under repeatability conditions [(sr# ) x 100], where 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 x s .
= Standard deviation, calculated from results under reproducibility conditions.
RSD
= Relative standard deviation calculated from results generated under
reproducibility conditions [(sR# ) x 100].
HORRAT = the observed RSD divided by the RSD value estimated from the Horwitz

r r r

equation using the assumption r = 0,66R.
HORRAT
= the observed RSD
value divided by the RSD
value calculated from the
Horwitz equation (2).
U = the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.
4.2. General requirements
Methods of analysis used for food control purposes must comply with the provisions of items 1 and 2 of the Annex to Council Directive 85#591#EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption.
4.3. Specific requirements
Where no specific methods for the determination of tin in canned foodstuffs are prescribed at Community level, laboratories may select any validated method provided the selected method meets the performance criteria indicated in Table 2. The validation should ideally include a certified reference material.

Table 2

Performance criteria for methods of analysis for tin

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4.3.1. 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>

U¦ = Ö (LOD/2)2 + (0,1C)2

where>

Ufis the maximum standard uncertainty LOD is the limit of detection of the method C is the concentration of interest

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 in Table 2.
4.4. Recovery calculation and reporting of results
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 analytical result corrected for recovery is used for checking compliance (see Annex I, point 5). The analyst should note the ‘Harmonised Guidelines for the Use of Recovery Information in Analytical Measurement’ (3) developed under IUPAC#ISO#AOAC. These Guidelines assist when

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determining recovery factors. The analytical result has to be reported as x ± U whereby

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

4.5. Laboratory quality standards
Laboratories must comply with Council Directive 93#99#EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs.
4.6. Other considerations for the analysis
Proficiency testing
Participation in appropriate proficiency testing schemes which comply with the
‘International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories’ (4) developed under the auspices of IUPAC#ISO#AOAC. Some of these schemes specifically include the determination of tin in foods, and participation in such a scheme is recommended rather than a general scheme for the determination of metals in foods.
Internal quality control
Laboratories should be able to demonstrate that they have internal quality control procedures in place. Examples of these are the ‘ISO#AOAC#IUPAC Guidelines on Internal Quality Control in Analytical Chemistry Laboratories’ (5).
Sample preparation
Care must be taken to ensure that all the tin in the sample is taken into solution for analysis. In particular it is recognised that the sample dissolution procedure must be such that no hydrolysed Sn(IV) species is precipitated (i.e. species such as stannic oxide SnO , Sn(OH) , SnO .H O). Keep prepared samples in 5 mol#l HCl. However,

2 4 2 2

SnCl
is easily volatilised and so solutions should not be boiled.
REFERENCES
1. MSA EN 13804>2002> Foodstuffs — Determination of trace elements — Performance criteria, general considerations and sample preparation, CEN, Rue de Stassart 36, B-1050 Brussels.
2. W Horwitz, ‘Evaluation of Analytical Methods for Regulation of Foods and
Drugs’, Anal. Chem., 1982, 54, 67A — 76A.
3. ISO#AOAC#IUPAC Harmonised Guidelines for the Use of Recovery
Information in Analytical Measurement. Edited Michael Thompson, Steven L

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R Ellison, Ales Fajgelj, Paul Willetts and Roger Wood, Pure Appl. Chem.,
1999, 71, 337 — 348.
4. ISO#AOAC#IUPAC International Harmonised Protocol for Proficiency Testing of (Chemical) Analytical Laboratories, Edited by M Thompson and R Wood, Pure Appl. Chem., 1993, 65, 2123 — 2144 (Also published in J. AOAC International, 1993, 76, 926).
5. ISO#AOAC#IUPAC International Harmonised Guidelines for Internal Quality Control in Analytical Chemistry Laboratories, Edited by M Thompson and R Wood, Pure Appl. Chem., 1995, 67, 649 — 666.”.

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