Decree of the Ministry of Agriculture No. 339 / 2001 Coll.

Decree of the Ministry of Agriculture on methods of testing and the preparation of control samples for the purpose of determining the quality and health of foodstuffs or raw materials intended for their manufacture and the quality of tobacco products

Valid Order Effective from 01.01.2002
339
DECLARATION
Ministry of Agriculture
of 11 September 2001
on the methods of testing and the method of sampling and preparation of control samples to determine the quality and health of foodstuffs or raw materials intended for their manufacture and the quality of tobacco products
The Ministry of Agriculture provides, pursuant to § 3 (1) (f), § 16 (2) and § 18 (o) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll., hereinafter referred to as "the Act":

Oddíl 1

General provisions
§ 1
(1) This Decree provides for the procedure for the collection and preparation of control samples of foodstuffs or raw materials intended for their production (hereinafter referred to as "food and raw materials') and tobacco products carried out in the framework of national surveillance, with the exception of the sampling for microbiological testing, and specifies the manner and extent of the quality and health check carried out by the manufacturer.
(2) Where samples of tobacco products are taken and prepared in accordance with the relevant technical standard, (1) they shall be considered to comply with the requirements of this Decree.
§ 2
Basic concepts
For the purposes of this decree:
(a) a part of the lot of the part of the lot defined for the purpose of applying a method of control sampling ("sample"); each part of the lot must be physically separated and separately identifiable;
(b) a partial sample of the quantity of food taken from one lot or sublot, which may be described and defined separately,
(c) a aggregate sample composed of all incremental samples taken from the lot or sublot,
(d) a reduced sample aggregate sample or a representative part prepared from the aggregate sample by division; the reduced sample is prepared only if the aggregate sample is too large;
(e) by a laboratory sample, a sample intended for a laboratory prepared as a representative part of the aggregate or reduced sample;
(f) a duplicate sample resulting from the division of the laboratory sample to carry out any repeated or additional analyses and tests;
(g) by a test protocol, a document indicating the results of the laboratory tests laid down in the quality and health requirements.

Oddíl 2

Method of sampling and preparation
(Paragraph 16 (2) of the Law)
§ 3
(1) Pre-sampling surveillance authorities ascertain2)
(a) for foodstuffs intended for consumers, the indication of the lot according to the labelling of the food intended for consumers and the accompanying documents;
(b) for raw materials, the indication of the lot by external packaging and by accompanying documents;
(c) the weight or volume of the lot or the number of units in the lot;
(d) the type and size of the packaging, its numbering or other marking;
(e) the apparent presence of different parts of the lot, if any, and if they are detected, the sample must be taken separately from each such part of the lot; each part of the lot so removed shall be considered as a separate lot.
(2) Before sampling shall be determined:
(a) the purpose of the collection;
(b) the sampling procedure;
(c) the types of tests required;
(d) the definition of the unit at collection; for a food unit or raw material, the number of pieces, volume or weight, for a sub-sample the volume or weight,
(e) the extent of selection (symbol n), which means the number of sampling units from which each sampling unit is tested separately;
(f) the total weight or volume of the sample needed to carry out the checks and laboratory tests, a combination of the sampling range and the types of tests;
(g) the necessary number of packages or incremental samples taken with regard to the types of tests.
(3) Where a food or raw material is present in several packages at the same time, in particular in transport or in group packages, a multi-stage sampling shall be applied by selecting:
(a) at first instance, the primary sample, which is the transport packaging;
(b) at the second stage, a secondary sample, which is a group pack taken from the packaging;
(c) a sample at further stages, mutatis mutandis referred to in (b), so that at the last stage a partial sample is taken from the packaging intended for the consumer and, where appropriate, from the outer packaging.
(4) The sample shall be taken and prepared in such a way as to avoid deterioration or change affecting the test result. During the collection and preparation of the laboratory sample, precautions shall be taken to avoid any changes affecting the result of the tests.
§ 4
Sampling
(1) The sample shall be taken separately from each lot checked and shall be representative of the whole lot, unless otherwise indicated in paragraph 3.
(2) The sample taken shall consist of one or more incremental samples. The workshop sample may be
(a) a predefined separate unit of unit food or raw material as a single package intended for consumers or, where appropriate, one group pack or transport pack;
(b) a predetermined quantity of a non-coupled food or raw material taken from one place at a time, provided that this definition applies to a particular species, group or subgroup of food or raw material and may vary according to the type of test required.
(3) For suspected foods or raw materials, targeted sampling shall be carried out for laboratory tests to detect defects in suspect foods or raw materials. The sample thus obtained does not represent the lot and must be marked as such.
(4) The use of the sample for laboratory analyses shall cease with an expired expiry date or minimum shelf life of a food that would have occurred at the time of collection until the start of the laboratory test.
(5) Frozen food or raw materials shall not be defrosted when sampling.
§ 5
(1) The partial sample shall be taken
(a) by random sampling in which all units of the lot have the same likelihood of withdrawal; If separate units of lots are to be numbered or otherwise assigned serial numbers, samples shall be taken from them according to the evenly distributed random numbers listed in Annex 1,
(b) a systematic sampling at which the individual units of the lot are collected at a predetermined distance or time intervals from the random start;
(c) the way in which the individual units of the lot are collected from different locations.
(2) The required number of incremental samples shall be taken from packaged foodstuffs to carry out analyses without breaching the packaging. A partial sample is taken from large packs with a breakdown of the packaging.
(3) A partial sample shall be taken from liquid or semi-liquid food or raw material in storage containers, in particular in barrels or tanks, after mixing the contents. If the contents cannot be mixed, a partial sample shall be taken from each layer by stratified sampling. Similarly, a bulk food or raw material shall be carried out in free bags or other packaging where the incremental sample is taken from different layers or from different locations with an appropriate sampling device.
(4) Furthermore, a partial sample may be taken
(a) from unpackaged food or raw material in bulk with a sampling or desalination device;
(b) unpackaged food or raw material composed of solid and liquid substances separately from solid and liquid constituents;
(c) fresh fruit, fresh vegetables, table potatoes and fresh mushrooms.
(5) The method of sampling provided for in Sections 3 and 4 also applies to laboratory tests and on-the-spot evaluation of the sample.
§ 6
Preparation of the sample
(1) In the preparation of the sample, the following shall be used:
(a) homogenisation, such as blending, mixing, shrinking, grazing, crushing, grinding, or
(b) division, such as, in particular, reduction of the sample into dividers, cutting, cutting or quartering; the quarting is the elimination of two diagonally opposite quarters, mixing and re-quarters of the balance until the required size is reached; or
(c) a combination of homogenisation and division.
(2) By combining and mixing all incremental samples of non-lump material, a aggregate sample is produced. the aggregate sample is produced by combining and homogenising the composite sample of the packaged food. If the whole package of food is taken, the packaging and the integrity of the sample must not be infringed when preparing the sample.
(3) Where necessary, the aggregate sample may be adjusted as specified in paragraph 1 or a reduced sample prepared.
(4) The size of the laboratory sample depends on the extent of the number of analyses needed.
(5) Multiple laboratory samples shall be prepared from the entire quantity obtained prepared in accordance with paragraph 3 by dividing the necessary number of duplicate samples into two or more samples.
(6) The duplicate sample shall be kept for further tests, if any, after packaging, labelling and closure.
(7) Where a laboratory sample is composed of several packages intended for consumers, each unit of packaging shall be marked as a sub-sample when taken.
(8) Where a laboratory sample is taken to carry out tests in several laboratories, a laboratory sample of the minimum mass determined by the national surveillance authorities shall be taken for each laboratory.
§ 7
Sample packaging
(1) Each sample shall be placed in a clean and inert package which will adequately protect the sample from contamination and damage during transport. At the same time, the necessary measures shall be taken to exclude any changes to the composition of the laboratory sample that could occur during transport and storage,
(a) in the case of an unpacked sample, always:
(b) for a packaged sample consisting of a food or raw material unit only if its packaging is not sufficient for that purpose.
(2) Packaging corresponding to health requirements and not affecting the results of laboratory tests are used to package the sample; the sample must remain permanently frozen in the case of a frozen food or raw material and permanently chilled or frozen in the case of a food or a perishable raw material.
(3) For a sample of a food or perishable raw material or a frozen sample of a food or raw material, the sample shall be submitted to the laboratory immediately after its collection.
§ 8
Sample labelling
(1) Each sample shall be marked with a label affixed to the packaging in such a way as to prevent its substitution, to close and seal or seal it in such a way that it cannot be opened or the label removed without breaking the seal or seal.
(2) If the label cannot be placed on the packaging or affixed to the packaging, the packaging shall be marked with a abbreviated reference to the accompanying sampling document.
(3) The label must contain particulars of:
(a) the product and its identity;
(b) the lot designation referred to in Article 3 (1) (a);
(c) the designation of the sampling protocol;
(d) other necessary data on the sampling method.
§ 9
Sampling protocol
(1) A "sampling report 'shall be drawn up for each sample taken, which shall include the particulars referred to in paragraph 2, enabling the sampled food or raw material, their batch or sublot to be clearly identified.
(2) The sampling protocol contains:
(a) an indication of the trading firm or name of the manufacturer or importer or, where appropriate, the seller and his registered office, if any, if it is a legal person, and the permanent residence or place of business, if it is a natural person;
(b) the name of the food or raw material under which it is put into circulation;
(c) indication of the quantity of food or raw material in the package (volume, weight or number of packages),
(d) indication of the lot:
1. the lot designation referred to in Article 3 (1) (a);
2. the extent or size of the sampled lot; for unit food or raw material, the number of units of packaging or their weight, for non-unit food or raw material, the total weight or volume;
3. date of manufacture, if known,
4. date of using3) or date of minimum durability, 4)
(e) the sampling data:
1. reference to the sampling procedure; details and method of sampling, if any, for deviation from the prescribed or agreed procedures; the actual sampling procedure, unless reference is made to the prescribed or agreed procedure in the sampling report;
2. the place of sampling and, where appropriate, the name and address of the establishment;
3. the date and time of sampling;
4. the quantity of sample for laboratory testing; the number of pieces and quantities put up for packaging for a unit food or raw material, weight or volume for a non-unit food or raw material,
5. name and signature of the person responsible for carrying out the sampling;
(f) information for the laboratory, in particular the time of transport of the sample, the conditions of sampling which may affect quality and health, and the suspected breach of quality or health,
(g) other information, in particular the nature of the sample packaging, the method of ensuring the integrity of the sample, the purpose of the sampling, the reference to a specific entry, if any, of the sampling equipment used and other circumstances in the sampling, the condition of the food or raw material checked, the presence of rotten, contaminated or otherwise defective parts and the sampling of those parts of the lot, the time of transport.

Oddíl 3

Test methods
[K § 18 (n) of the Act]
§ 10
(1) The quality and health check of foodstuffs and raw materials shall be carried out on samples taken by appropriate test methods. The test methods referred to in the technical standards, 5) and methods that are applicable in the same way to different commodity groups shall be used in preference to those that are only applicable to a commodity.
(2) The results of the laboratory tests for the quality and health of the sample checked shall be given in the test report to be issued in accordance with the requirements of EN ISO / IEC 17025.
(3) If alternative methods of testing are indicated, the sample may be analysed by any of these procedures.
(4) The accuracy, repeatability and reproducibility values are based on the results of one laboratory and on an interlaboratory comparison. The method of determination is set out in CSN ISO 5725 or Annex No 2.

Oddíl 4

Method and extent of the quality and health check carried out by the manufacturer
[K § 3 (1) (f) of the Act]
§ 11
(1) The manufacturer shall ensure, including the keeping of a demonstrable record of the food produced,
(a) regular testing and comparison of actual quality and health with the quality and health requirements laid down by law and implementing legislation; (6) where appropriate, the particulars declared on packaging;
(b) the regularity of the testing referred to in (a) by determining the frequency of control samples at time intervals and the frequency of testing of individual quality and health requirements by type, group or subgroup of food, on the basis of their specific nature, frequency of occurrence of defects and following a check in critical measures7) in the food production process; the frequency of testing must ensure that only quality and health foodstuffs are put into circulation;
(c) for each production batch of foodstuffs intended for infant and infant formulae and uncooked meat products intended for consumption without heat treatment, health inspection in accordance with specific legislation. 8)
(2) When taking and preparing samples for quality and health control, the manufacturer shall take appropriate steps in accordance with paragraphs 4 to 7.
§ 12
Repeal
They shall be deleted:
1. Decree No. 220 / 1998 Coll., on the method and extent of assessment of the conformity of foodstuffs, the method of preparation and sampling of food and tobacco control samples by the manufacturer, the types of food for which a written declaration of conformity will be issued by the manufacturer or importer and the extent and content of that declaration (conformity assessment).
2. Decree No. 43 / 2000 Coll., amending Decree No. 220 / 1998 Coll., on the manner and extent of assessment of the conformity of foodstuffs, the method of preparation and collection of the manufacturer's control samples of foodstuffs and tobacco products, the types of foodstuffs for which a written declaration of conformity will be issued by the manufacturer or importer and the extent and content of that declaration (conformity assessment).
§ 13
Efficacy
This Decree shall take effect on 1 January 2002.
Minister:
Ing. Fencl v. r.

Příloha č. 1

Annex No 1 to Decree No 339 / 2001 Coll.
Table of evenly distributed random numbers
sloupec
řádek
12345678910
11564804863598802286035463117735799455739
26022967657683888991888971119944189348555
38418990600190550422355864842878608555650
45948165225453981210235237419235903818457
56945362973513502176005508874459978099474
60370116580354415981243123524138247322303
76702645722708611847914190835186613074211
83740472230028020018244519389173033947094
93833335690255749478060423829845813396948
108683794747199403786307019245596092572588
116794173248099473589311540067089911848630
125054153294987702054400879602625938077276
131733656097688586326325326668288814043887
146609626391600600430427841089732156186172
153970771688076123374810360516060727103700
169504276905340758982495367825298538243449
170668963660019372874615796102799045263429
184364060643552395207089158461982068115873
198875304171832261721060727128082582816815
204521339166955986241679798106775963792101
215066145496428675876705820410551526971575
229138500386332670757540210391011894932291
230975183676295136782439160542261465673015
241049992534083029724417661013022184923801
250682134374548600859899535773848244396708
260263490998320627115540070446698846991740
272733339876303824073477368465084904598733
281441268411160758541133654489624164133615
295014561617218772460503881399599374594445
303745595655128577417800313090229601245896
318384872755675881372118963758723668601740
329944836170508783381597683247170693553510
333045246666406804170486652539232098319442
345939574172100872327931776021204501633706
354294177753867182723884087674171990689921
363787251626616711924059943068552409325520
374764233945415415631479793634532054006714
380292957402854230228352328830566264042514
397876166226270940783637413217882473937306
403490307129674922365843336452914944206091
413670896064773671931813176355498268150814
423665236781449663099061554520029475040223
433792055784898446808211221181814271193200
442618220494332527574493300721886636951081
458972882909625597883458579800737592090630
467305885216883571339329909488888324769136
471794455112624845403977601565474511788370
483179130477674769737351955013689457345852
492930382871723188748721911225777039990006
508418962779486243117693932252037797988648
1. Procedure for using a table of random numbers, selecting random numbers and assigning serial numbers to units in a batch:
(a) the number of units in the lot (batch range) and the number of units to be withdrawn (selection range) shall be determined;
(b) the units in the lot are numbered or otherwise assigned serial numbers;
(c) in the table of random numbers, the number at the intersection of the line and column shall be selected as the beginning. This starting point is selected on repeated use of the table at different locations, preferably randomly, e.g. by drawing tickets with numbers 1 to 10 (the column number in the table is drawn gradually, the field number in column 10 and the line number in the box; The box is always five rows in the column). There are four-digit numbers in the intersecting lines and columns,
(d) depending on the extent of the lot, only those random numbers which do not have more than the range of the lot shall be used: the first two digits of the four-digit number with a lot range of 10 to 99, the first three-digit number of the four-digit number with a lot range of 100 to 999 or a whole four-digit number with a lot range of 1000 to 9999, without taking into account random numbers greater than that of the lot,
(e) the direction of selecting additional random numbers (in the column downwards or in the line to the right) shall be chosen, and after exhaustion in the selected column the numbers shall be selected from the next column to the right, after exhaustion in the selected row mutatis mutandis from the next row;
(f) in the selected direction, the number of random numbers meeting the above conditions shall be selected as many as the range of sampling;
(g) each of the numbers thus selected and arranged shall indicate the serial number of the unit to be removed from the lot
2. Example of procedure:
(a) the number of units in the lot (batch range) N = 75, the number of units taken or the packaging (selection range) n = 5,
(b) the units in the lot shall be assigned serial numbers from 1 to 75 (without their physical numbering);
(c) selected beginning: the intersection of the fifth column and the seventh row (quadruples 8479), determined by drawing the fifth column in the table, the second field in the column and the second row in the field,
(d) only two-digit random numbers less than or equal to 75 are selected;
(e) selected direction: from the specified beginning down in the column,
(f) in the selected direction, select the following five two-digit numbers: 01, 47, 58, 05, 32,
(g) units with assigned serial numbers shall be collected: 1, 5, 32, 47, 58.

Schematic of the assignment of serial numbers to discrete units (by packing) in the batch according to the location of storage, which is spacely defined by each layer:
- number of horizontal layers: 5,
- number of "layers" from left to right: 5,
- number of "layers" front to right: 3.
Batch range N = 5 x 5 x 3 = 75
The four units on the diagram are marked with a dot (i.e. • 1, • 5, • 32 and • 47).

Příloha č. 2

Annex No 2 to Decree No 339 / 2001 Coll.
Method of determining the accuracy values
1. r = repeatability limit; a value which can be assumed to be 95% below or equal to the absolute value of the difference between the two test results obtained under repeatability conditions (i.e. the same sample, the same operator, the same equipment, the same laboratory and the short time span);
r = 2,8 x sr,
2. sr = repeatability standard deviation; is calculated from results obtained under repeatability conditions,
3. RSDr = relative standard deviation of repeatability; calculate the results obtained under repeatability conditions as [(sr / x) x 100], where x is the average of the results of the participating laboratories for a particular sample;
4.R = Reproducibility limit; a value that can be assumed to be 95% below or equal to the absolute value of the difference between the two test results obtained under reproducibility conditions (i.e. the same material from the participating laboratories, using the same test method); R = 2,8 sR,
5. SR = Reproducibility standard deviation; shall be calculated from results obtained under reproducibility conditions,
6. RSDR = Reproducibility relative standard deviation; is calculated from results obtained under reproducibility conditions; RSDR = [(SR / X) x 100],
7. in some special cases, accuracy values (e.g. mycotoxin determination) can be calculated according to the Horwitz equation:
RSDR = 2 (1-0,5 log C)
where:
RSDR is the relative standard deviation calculated from results obtained under reproducibility conditions; RSDR = [(sR / x) x 100]
C is the mass fraction (i.e. 1 = 100 g / 100g, 0,001 = 1000 mg / kg),
The results of the analyses shall be reported with or without correction for recovery. If recovery correction is indicated, the recovery value shall be indicated in the test report. The recovery value is the ratio of the quantity of substance found in the sample to the actual (known or added) quantity of substance in the sample and expressed as a percentage.
The accuracy parameters adopted pursuant to this Annex shall be arranged in an appropriate form recommended for testing methods by the International Organisation for Standardisation (ISO).
1) ČSN ISO 8243.
2) Article 16 of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll.
3) § 2 (p) of Act No. 110 / 1997 Coll.
4) § 2 (q) of Act No. 110 / 1997 Coll.
5) Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll. and Act No. 102 / 2001 Coll.
6) For example, Decree No. 326 / 1997 Coll., implementing § 18 (a), (d), (h), (i), (j) and (k) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the modification and addition of certain related laws for frozen foods, as amended by Decree No. 44 / 2000 Coll., Decree No. 328 / 1997 Coll., which implements § 18 (a), (d), (h), (i) and (k) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws, for milk and milk products, ice cream and edible fats and oils, as amended by Decree No. 347 / 1999 Coll.
7) Decree No. 147 / 1998 Coll., on the method of determining critical points in production technology.

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Regulation Information

CitationDecree of the Ministry of Agriculture No. 339 / 2001 Coll., on methods of testing and method of sampling and preparation of control samples to determine the quality and health of foodstuffs or raw materials intended for their manufacture and the quality of tobacco products
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation27.09.2001
Effective from01.01.2002
Effective until-
Status Valid
The regulation text is for informational purposes only.
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