Decree No. 211 / 2004 Coll.
Order on methods of testing and method of sampling and preparation of reference samples
Valid
Order
Effective from 01.05.2004
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211
DECLARATION
of 15 April 2004
on methods of testing and method of sampling and preparation of control samples
According to Article 18 (n) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related laws, as amended by Act No. 119 / 2000 Coll., Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll. and Act No. 274 / 2003 Coll., (hereinafter "the Act '):
General provisions
(1) This Regulation (1) implements the relevant provisions of the European Community (1a) and establishes the methods of testing and the preparation of control samples (hereinafter referred to as "samples") for the purpose of determining the quality and health of foodstuffs and the quality of tobacco products, in the framework of national surveillance, with the exception of sampling for microbiological testing.
(2) Other scientifically proven methods (e.g. International Standardisation Organisation or Codex Alimentarius methods) may be used for the testing, sampling and preparation of samples of foodstuffs or tobacco products, provided that their use does not impede the free movement of goods. Where differences in test results occur, the test results obtained using the methods set out in this Decree shall be considered decisive.
(3) In the case of foodstuffs and tobacco products for which methods of testing are not laid down by this decree or the method of sampling and preparation of control samples cannot be applied by that decree, the procedure laid down in paragraph 2 of the first sentence shall be applied mutatis mutandis.
Basic concepts
For the purposes of this decree:
(a) part of the lot (2) - part of the lot defined for the purpose of applying a control sample method, each part being physically separated and separately identifiable, unless otherwise specified;
(b) the controlled dose - the defined quantity of food or tobacco product presented as a whole for inspection; it may be a lot or part of a lot,
(c) the sampled unit - one of the basic units of which the basic set or quantity of the food or tobacco product forming the generic unit is composed and taken at the same time from one place to form part of the incremental sample; a set of all sampled units considered shall be considered as a basic set;
(d) sample - one or more sampled units taken from the base set and intended to obtain information on the base set;
(e) by sub-sample - the quantity of material taken from one lot or sublot,
(f) aggregate sample - sample composed of all incremental samples,
(g) by a reduced sample - the aggregate sample or its representative part prepared from the aggregate sample by division; the reduced sample is prepared only if the aggregate sample is too large,
(h) laboratory sample - sample intended for laboratory testing,
(i) duplicate sample - one of two or more samples obtained at the same time using the same sampling or sample division procedure;
(j) by dividing the sample - the procedure for taking one or more subsamples from the sample of a non-piece food or tobacco product by means such as dividing by a lattice divider, mechanical division or separation;
(k) subsample - sample taken from the baseline; for the collection of a non-couture food or tobacco product, subsamples shall be prepared by dividing the samples;
(l) preparation of the sample - a summary of operations with food or tobacco products such as reduction of size, mixing, division, necessary to convert the aggregate sample into a laboratory sample;
(m) sampling (sampling) - sampling process,
(n) sampling range - number of sampled units taken,
(o) random sampling - sampling at the same level of probability that any sample of the batch checked will be selected,
(p) by targeted sampling - sampling with a particular intention with the same level of probability that any sample will be selected;
(q) by sampling from a non-piece food or tobacco product - sampling from a non-piece food or tobacco product presented at doses in which no direct distinction can be made between the sampled units;
(r) by multistage sampling - sampling at which the sample is formed in degrees such that the unit at each stage is taken from the larger unit selected in the previous step;
(s) layered sampling - sampling carried out on a basic sample which can be divided into mutually exclusive subsets and covering them in such a way that the specified part of the sample is taken from different layers and at least one unit taken from each layer;
(t) adoption plan - sampling scale plan,
(u) the test protocol - the document showing the results of the laboratory tests of the specified requirements,
(v) accuracy - tightness of conformity between the test result and the accepted reference value;
(w) accuracy - tightness of conformity between the average value obtained from a large series of test results and the accepted reference value;
x) Skills - tightness of conformity between independent test results obtained under pre-specified conditions,
(y) repeatability conditions - conditions where independent test results are obtained by the same test method, on the same test units, in the same laboratory, by the same worker, using the same equipment, within a short time span;
z) repeatability - conformity under repeatability conditions,
(aa) reproducibility - conformity under reproducibility conditions,
(bb) reproducibility conditions - conditions under which test results are obtained by the same test method, on the same test units, in different laboratories, by different personnel using different equipment,
(cc) test result - value of the character obtained by performing the test method,
(dd) by error of result - test result minus accepted character reference,
(ee) specificity - the characteristics of the test method specifying the characteristics for which the method is specific,
(ff) limit of detection - the lowest value that can be determined by the test method,
gg) fitness - characteristics of the test method defining the purpose for which the test method is defined,
(hh) usability - the characteristics of the test method determining for which purposes the test method is applicable,
(ii) precision experiment - inter-laboratory test for the suitability of the test method.
Sampling
(1) Sampling shall be carried out by a person authorised and duly trained for this activity. (3)
(2) When sampling, first, it shall be established:
(a) the indication of the lot in accordance with the indications given on the packaging of the food intended for consumers or on the packaging and the documents relating to the food;
(b) the weight or volume of the lot or the number of units in the lot or controlled unit;
(c) the type and size of packages and their labelling;
(d) possible presence of sublots
1. corrupt, damaged or otherwise defective; those parts of the lot shall be separated and the sample for testing shall not be taken from them unless it is a suspected foodstuff followed in accordance with paragraph 12;
2. safe; samples shall be taken separately from each homogeneous part of the lot.
(3) No later than the beginning of the sampling period, provision should be made for:
(a) the sampling procedure or, if already established, the sampling procedure shall be specified;
(b) the types of tests required;
(c) the adoption plan;
(d) the sampling range for each test according to the sampling plan;
(e) the total weight or volume of the sample required to carry out all required checks and laboratory tests by combining the sampling range and the types of tests;
(f) the total number of packages or incremental samples required to be taken.
(4) The adoption plan shall be established in accordance with the procedures set out in the Czech technical standards governing the taking-over procedures, statistical surpluses and other details (4) or in accordance with the procedures developed by the supervisory authority and published on the website of the supervisory authority.
(5) The sample shall be taken separately from each lot checked to represent the whole lot, unless otherwise specified.
(6) The sample taken shall consist of one or more incremental samples. The incremental sample shall be taken from a randomly selected site in the lot; If this is not possible, it shall be taken from the randomly selected place in the accessible part of the lot. The size of the incremental sample shall be determined as the proportion between the required size of the aggregate or laboratory sample and the number of units collected.
(7) The partial sample should be taken
(a) random sampling at which all sampled units have the same probability of withdrawal;
(b) a targeted sampling at which individual sampled units are collected at a pre-determined distance or time intervals from the random start; or
(c) the way in which individual sampled units are collected from different locations.
(8) Partial samples shall be taken from packaged food without breaching the packaging intended for the consumer, the non-packaged food shall be taken from partial samples with a breach of the outer packaging.
(9) A partial sample shall be taken from the liquid or semi-liquid food in the storage containers after mixing the contents. If the contents cannot be mixed, a partial sample shall be taken from each layer by a layer sampling. Similarly, a bulk or unpackaged food shall be carried out where the incremental sample is taken from different strata or from different locations by an appropriate sampling device.
(10) Further partial sample may be taken
(a) unpackaged food by means of a sampling device or by desalination;
(b) unpackaged food consisting of solid and liquid substances separately from a solid and liquid component; or
(c) fresh fruit, fresh vegetables, table potatoes and fresh mushrooms.
(11) If the food is present in several packages at the same time, in particular in any outer packaging, a multi-stage sampling shall be used to select:
(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 consumers.
(12) For suspected food 2) targeted sampling shall be carried out for laboratory tests to detect defects in suspect food. A portion of the batch of the foodstuffs concerned must be specified before sampling. The sample thus obtained does not represent the whole lot and must be marked as such.
(13) When sampling, precautions must be taken to avoid degradation and any changes affecting the test methods.
(14) Frozen foods shall not be defrosted during sampling.
(15) The method of sampling referred to in paragraphs 1 to 13 shall also apply to on-the-spot evaluation of the sample.
(1) The sampling of tobacco products shall be carried out in accordance with the procedures set out in the Czech technical standards governing the sampling of tobacco products. 5)
(2) Paragraph 3 shall apply mutatis mutandis to the sampling of a tobacco product if it is not possible to follow paragraph 1.
(3) Sampling for the determination of aflatoxins in foodstuffs, for the determination of the pesticide content of foodstuffs and on their surface, for tea, for cereal, for pulses and for milling products, for animal and vegetable fat and oil samples and for the control of the temperature of frozen foodstuffs shall be carried out as specified in Czech technical standards on the method of sampling and testing of certain foodstuffs. 6)
(4) The sampling of milk products dried, milk products concentrated, casein or caseinates shall be carried out in the manner specified in the Czech technical standards governing the methods of testing milk products, caseins and caseinates. 7)
(5) When sampling ochratoxin A food, dioxin control samples and determination of dioxin-like polychlorinated biphenyls in certain foods and samples for compliance with the levels of lead, cadmium, mercury and 3-chloropropanediol shall be carried out in accordance with Annexes 1 to 3.
(6) Sampling of raw and heat-treated milk shall be carried out in accordance with the procedures laid down in the Regulation of the European Communities. 8)
(7) Sampling of fresh fruit and fresh vegetables shall be carried out in accordance with the procedures laid down in the Regulation of the European Communities. 9)
(8) Sampling for the control of olive oil shall be carried out in accordance with the procedures laid down in the Regulation of the European Communities. 10)
(9) Sampling for the control of tin content of food packed in cans shall be carried out in accordance with Annex 40.
(10) Sampling to check the levels of patulin in foodstuffs shall be carried out in accordance with Annex 41.
(11) Sampling for the control of the levels of benzo (a) pyrene in foodstuffs shall be carried out in accordance with Annex 44.
(12) When sampling for the detection of genetically modified organisms and material produced from or containing genetically modified organisms, the recommendation in the European Community Regulation 10a shall be taken into account.
(13) Sampling to check the content of Fusarium toxins in foodstuffs shall be carried out in accordance with Annex 46.
Sampling protocol
(1) A sampling report shall be drawn up for each sample which allows the food or tobacco product, batch or sublot to be clearly identified.
(2) The sampling protocol shall contain:
(a) the number of the Protocol;
(b) the particulars referred to in Article 6 (1) (a) of the Act or the identification of the food business operator;
(c) the name of the food or tobacco product under which it is put into circulation;
(d) an indication of the quantity of food or tobacco product in the package (volume, weight or number of pieces),
(e) indication of the lot:
1. the lot designation referred to in § 3 (2) (a),
2. the extent or size of the sampled lot; in the case of unpackaged food, the number of units of packaging or their weight, in the case of non-bite food, the total weight or volume;
3. Date of manufacture, if indicated,
4. the date of application or the date of minimum durability;
(f) sampling data:
1. a reference to the Czech technical standard or, where applicable, a derogation from the Czech technical standard used, or a reference to this decree;
2. details of all environmental conditions during sampling which may affect the test results;
3. place of sampling, where appropriate, graphs, drawings or photographs;
4. the date and time of sampling;
5. the purpose of sampling;
6. the quantity of sample for laboratory testing; the number of pieces and quantities in the package for unpackaged food, weight or volume for non-concentrated food,
7. the name and signature of the person taking the sample and the signature of the person checked;
(g) information for a laboratory which may affect quality and health, in particular the time of transport of the sample, the conditions under which sampling was carried out and any suspected breach of quality or health,
(h) other data containing in particular the nature of the sample packaging, the method of ensuring the integrity of the sample, the sampling equipment used and, where appropriate, other circumstances in the sampling which could affect the assessment of the sample taken, the condition of the food or tobacco product checked, the possible presence of rotten, contaminated or otherwise defective parts of the lot and the sampling of those parts of the lot;
(i) whether a duplicate sample has been taken.
Packaging, labelling and transport of the sample
(1) Each sample shall be stored in a clean and inert package which protects the sample from contamination and damage during transport. At the same time, the necessary measures shall be taken to eliminate any changes in the composition of the sample that could occur during transport.
(2) Packaging complying with the requirements of a specific legislation shall be used to package the sample, 11) which do not affect the results of the laboratory tests.
(3) The sample must be delivered to the laboratory as soon as possible. The sample shall not be degraded during transport. The sample of frozen food shall remain permanently frozen and the sample of perishable food shall be permanently chilled or frozen.
(4) The sample shall be marked, sealed and sealed in such a way that the sample cannot be confused and the packaging opened without breaching the package or seal.
(5) The sample shall be marked with data on:
(a) the name of the product;
(b) the lot referred to in Article 3 (2) (a),
(c) the sampling protocol;
(d) other information on the sampling method if they could affect the results of the tests.
(6) If the sample cannot be marked in accordance with paragraph 5, the sample may only be marked in accordance with paragraph 5 (c).
(7) The sample shall be delivered and transmitted to the laboratory immediately after collection. If the sample is not under official control during transport, the person who carried out the sampling shall ensure that the sample is not damaged during transport.
(8) In the event that the sample cannot be sent to the laboratory immediately after it has been taken, the person who carried out the sample shall take measures to preserve the sample until the time of dispatch under conditions where it is not degraded and the sample confused. This does not apply to quick-kill or frozen-food samples.
Preparation of the sample
(1) Při přípravě vzorku se použije
(a) homogenisation, such as mixing, mixing, and reducing grains, crushing, grinding,
(b) dividing, for example, by reducing the sample into dividers, cutting, cutting or quartering; Quartation means the elimination of two opposite quarters, mixing and reassembly of the balance until the required size is reached; or
(c) a combination of homogenisation and division.
(2) In the preparation of a laboratory sample, precautions shall be taken to avoid any change affecting the result of the test.
(3) The aggregate sample shall be prepared by combining and mixing all incremental samples unless otherwise specified. Where necessary, the aggregate sample may be adjusted in the manner referred to in paragraph 1 or the reduced sample prepared.
(4) A laboratory sample and a duplicate sample shall be prepared from the aggregate sample. The laboratory sample shall be marked in such a way that it is clearly identified. If the quantities of the substance analysed are to be calculated by including parts that are not analysed, the mass of the separate parts shall be recorded.
(5) The laboratory sample is diluted and well mixed as necessary in order to remove representative test proportions. The size of the test pieces is determined by the method of testing and the efficiency of mixing. The dilution and mixing methods shall not affect the composition of the test portion. The test portion shall be processed under specific conditions, as appropriate, to minimise adverse effects.
(6) The duplicate sample shall be marked in a manner which allows its unambiguous identification and shall be retained for repeated testing or further testing. The method and duration of storage of the duplicate sample shall not affect its composition.
(7) The use of the sample for laboratory analyses shall cease to be the date of application or the date of minimum durability which would have occurred when it was taken until the start of the laboratory test.
(8) The preparation of samples for testing animal and vegetable fats and oils shall be carried out according to the Czech technical standard governing the procedure for preparing the samples for certain fats and oils. 12)
(9) In the preparation of samples for the determination of the levels of ochratoxin A, for the determination of lead, cadmium, mercury and 3-chloropropane-1,2-diol in certain foods and for the determination of dioxins and dioxin-like PCBs in certain foods, the procedure shall be followed in accordance with Annexes 5 to 7.
(10) The preparation of samples for the control of olive oil shall be carried out in accordance with Regulation of the European Communities. 10)
(11) Laboratory samples may be prepared directly at the sampling point only if the composition of the sample is not affected and is not degraded. The preparation of the sample shall be carried out in accordance with paragraphs 1 to 10.
(12) The preparation of samples for the control of tin content of food packed in cans shall be carried out in accordance with Annex 42.
(13) The preparation of samples to check compliance with the maximum levels for patulin in foodstuffs shall be as set out in Annex 43.
(14) The preparation of samples for the control of the levels of benzo (a) pyrene in foodstuffs shall be as set out in Annex 45.
(15) When preparing samples for the detection of genetically modified organisms and material produced from or containing genetically modified organisms, the recommendation in the European Community Regulation (10a) shall be taken into account.
(16) The preparation of samples to check the content of Fusarium toxins in foodstuffs shall be carried out in accordance with Annex 47.
Test methods
(1) Sensorial evaluation is carried out by a person authorised and properly trained for this activity (3) in accordance with the requirements of Czech technical standards governing the procedure and training of assessors. 13)
(2) In sensory evaluation, the person referred to in paragraph 1 shall follow the Czech technical standards governing sensory analysis. 14)
(3) The monitoring of the sensory characteristics of olive oil is carried out in accordance with the procedure laid down in the Regulation of the European Communities. 10)
(1) The quality and health check of foodstuffs and the quality of tobacco products shall be carried out on samples taken in accordance with Sections 3 and 4 by appropriate test methods.
(2) Test methods that are applicable in the same way to different groups of foodstuffs or tobacco products shall preferably be used before test methods that are applicable only to a food or tobacco product.
(3) For each test method to be used for official control and for which its purpose and substance do not preclude it, at least the following characteristics shall be laid down:
(a) specificity;
(b) accuracy;
(c) conformity, repeatability and reproducibility;
(d) limit of detection;
(e) fitness and applicability.
(4) The testing methods must be arranged in the form recommended for the testing methods by the International Organisation for Standardisation. 15)
(5) The exact values of conformity shall be obtained by evaluating the accuracy experiments carried out in accordance with the procedures set out in the Czech technical standards governing the accuracy of the measurement methods and results. 16)
(6) Repeatability and reproducibility values must be expressed in the form specified in the technical standards, 16) with a normal probability value of 95%.
(7) The results of the accuracy experiments will be published by the supervisory authority on its website.
(8) The methods of testing are carried out by the laboratories of the supervisory authorities (3) To carry out the methods of testing for official control, other laboratories which comply with the requirements of the specific legislation17) and the Czech technical standards governing the requirements for laboratories may also be entrusted. 17)
(1) In the case of cigarettes, the monitoring of the content of tar, nicotine and carbon monoxide and the evaluation of the accuracy of the data on tar and nicotine on packaging intended for consumers is carried out according to the Czech technical standards governing cigarettes. 18)
(2) The physical and chemical characteristics of olive oils and their composition are checked by the methods laid down in the Regulation of the European Communities. 10)
(3) The physical and chemical properties of casein and caseinates are checked according to Czech technical standards governing the methods of testing casein and caseinates. 19)
(4) The control of dried milk products and concentrated milk products is carried out according to Czech technical standards governing the methods of testing milk products. 20)
(5) The temperature control of frozen foodstuffs shall be carried out according to the Czech technical standard governing the testing methods for frozen products. 21)
(6) The physical and chemical characteristics of spirit drinks are checked by the methods laid down in the Regulation of the European Communities. 22)
(7) The determination of the value of refractometry shall be carried out in accordance with the procedure laid down in the Regulation of the European Communities. 23)
(8) When determining the starch content and its fissile products, including glucose, the starch content or dextrins or other modified starches shall be determined in accordance with the methods laid down in the Regulation of the European Communities. 24)
(9) When checking the ochratoxin content A shall be followed in accordance with Annex 5.
(10) The control of the levels of lead, cadmium, mercury and 3-chloropropane-1,2-diol in certain foodstuffs shall be carried out in accordance with Annex 6.
(11) The level of dioxins and the determination of dioxin-like PCBs in certain foodstuffs shall be as set out in Annex 7.
(12) The control of the erucic acid content in fats, oils and foodstuffs derived therefrom shall be carried out in accordance with Annex 11.
(13) The physical and chemical characteristics of certain sugars shall be checked in accordance with Annexes 12 to 22 and Annex 39.
(14) The control of the freezing, phosphatase and peroxidase activity of raw and heat-treated milk shall be carried out in accordance with the test methods laid down in the Regulation of the European Communities. 8)
(15) The purity of additives in foodstuffs shall be checked in accordance with Annexes 23 to 38.
(16) The control of the water content, non-fat dry matter and butter fat shall be carried out in accordance with the test methods laid down in the Regulation of the European Communities. 25)
(17) The quality control of fresh fruit and fresh vegetables shall be carried out in accordance with the test methods laid down in the Regulation of the European Communities. 8)
(18) The examination of the physical, chemical and sensory characteristics of the wine shall be carried out in accordance with specific legislation. 26)
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Regulation Information
| Citation | Decree No. 211 / 2004 Coll., on methods of testing and method of sampling and preparation of reference samples |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 28.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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