Decree No 231 / 2016 Coll.
Ordonnance on the collection, preparation and testing of food and tobacco control samples
Valid
Order
Effective from 01.08.2016
231
DECLARATION
of 14 July 2016
on the collection, preparation and testing methods of food and tobacco control samples
According to Article 18 (1) (m) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended:
General provisions
(1) This decree implements the relevant provisions of the European Union( 1), following the directly applicable provisions of the European Union on official controls2), (3) and (3)
(a) requirements for the collection, preparation and testing of a control sample (hereinafter referred to as "sample") in order to determine the conformity of foodstuffs and the conditions for their production or placing on the market under national supervision;
(b) requirements for the collection, preparation and testing of samples to determine the conformity of tobacco products and the conditions under which they are produced, distributed or marketed under national supervision;
(c) requirements for packaging, transport, storage and further treatment of samples, for marking of samples, for recording of sampling and for the details of the test report;
(d) how to assess the results of sample tests for the second expert opinion pursuant to Article 16 (7) (c) of the Act.
(2) The sampling, treatment, labelling, preparation and testing of the sample for the purpose of establishing compliance of foodstuffs and the conditions for their production or placing on the market shall be carried out in accordance with the rules laid down in Regulation (EU) 2017 / 6252 of the European Parliament and of the Council. In the area of the common organisation of the markets in agricultural products, the sampling, treatment, labelling, preparation and testing of the sample shall be carried out in accordance with the rules laid down in Regulation (EU) 2017 / 6252 of the European Parliament and of the Council, in order to determine the conformity of foodstuffs and the conditions for their production or placing on the market. If the provisions in question do not contain the rules laid down in Regulation (EU) 2017 / 6252 of the European Parliament and of the Council, the law, other legislation or this decree shall be followed.
(3) The sampling, treatment, labelling, preparation and testing of the sample for the purpose of establishing the conformity of tobacco products and the conditions for their production, distribution or marketing shall be carried out in accordance with the rules laid down in Regulation (EU) 2017 / 6252 of the European Parliament and of the Council. If the provisions in question do not contain the rules laid down in Regulation (EU) 2017 / 6252 of the European Parliament and of the Council, the law, other legislation or this decree shall be followed.
Basic concepts
For the purposes of this decree:
(a) part of a lot (4) the part of the lot defined for the purpose of applying a sampling method, each part being physically separated and separately identifiable, unless otherwise specified;
(b) a partial sample of the quantity of material taken from one lot or, where appropriate, the lot or consignment or part thereof; a sub-sample also means an initial sample within the meaning of European Union3),
(c) by a laboratory sample, a sample intended for laboratory testing;
(d) by preparing a laboratory sample, a summary of operations with a food or tobacco product required to convert the sample into a laboratory sample such as size reduction, mixing, homogenisation, division,
(e) by random sampling of incremental samples in such a way that any incremental sample from the controlled lot, batch or consignment is selected with the same level of probability;
(f) systematic sampling of incremental samples at which individual incremental samples are taken at pre-determined distances or time intervals from the random start;
(g) by local sampling of incremental samples carried out in such a way that the incremental samples are, as far as possible, taken from different layers or sites of the lot, lot or consignment or part thereof and at least one incremental sample is taken from each selected layer or site;
(h) by targeted sampling of incremental samples, where each incremental sample is taken from selected sites suspected of being of safety or quality breach; the sample obtained by the targeted sampling does not represent the whole lot, lot or consignment,
(i) by an inspection purchase of a sample provided by a controlled person to the supervisory authority without its prior identification by taking the sample by the supervisory authority;
(j) the result of the test is the value of the character obtained by performing the test method;
(k) swab sampling from sites or equipment used in the manufacture or marketing of foodstuffs.
Professional qualification requirements
(1) The sampling, preparation and testing of the sample shall be carried out by a person meeting the requirements laid down in Article 5 (4) of Regulation (EU) 2017 / 6252 of the European Parliament and of the Council.
(2) Sensory testing of the sample in the laboratory or on-site is carried out by persons properly trained for this activity in accordance with the requirements of selected Czech technical standards governing the procedure and training of assessors
a) ČSN ISO 5496 Sensory Analysis - Methodology - Instruction and training of assessors in the detection and recognition of odours,
b) ČSN EN ISO 8586 Sensory analysis - General Directive for the selection, training and monitoring of selected assessors and expert sensory assessors,
c) ČSN ISO 8587 Sensory analysis - Methodology - Serial test
d) ČSN ISO 11036 Sensory analysis - Methodology - Profile of texture,
e) ČSN ISO 3972 Sensory Analysis - Methodology - Method of examining taste sensitivity,
f) ČSN EN ISO 4120 Sensory analysis - Methodology - Triangle test,
g) ČSN EN ISO 5495 Sensory analysis - Methodology - Coupled comparison test; or
h) ČSN EN ISO 10399 Sensory analysis - Methodology - Duo-trio test.
Sampling
(1) Sampling is carried out
(a) by random sampling;
(b) systematic sampling;
(c) by local sampling;
(d) by targeted sampling;
(e) by inspection buying; or
(f) swab.
(2) Partial samples shall be taken from packaged food or from unpackaged food for immediate sale or from food packed at the point of sale at the consumer's request without breaching the packaging intended for consumers; In the case of non-packaged foodstuffs placed in outer packaging, partial samples shall be taken with a breach of the outer packaging if necessary for sampling.
(3) When sampling, precautions must be taken to avoid degradation and any changes affecting the methods of testing or affecting the results of the tests.
(4) Frozen foodstuffs must not be defrosted during sampling.
(5) Where the rules of European Union law, law, other legislation or this decree are not laid down for sampling, a method or part thereof suitable for the intended purpose may be used.
(1) The sampling to control the emissions of tar, nicotine and carbon monoxide from cigarettes shall be carried out in accordance with the procedures set out in Czech Technical Standard CSN ISO 8243 Cigarettes - Sampling.
(2) The sampling for the determination of pesticide content in and on foodstuffs and the sample for the control of the temperature of frozen foodstuffs shall be carried out in accordance with the procedures laid down in the Czech Technical Standards on the method of sampling
(a) ČSN 56 0253 Sampling for the determination of pesticides in and on foodstuffs and raw materials of plant and animal origin; or
(b) ČSN 56 0290-2 Methods of testing frozen products - Part 2: Sampling.
(3) The sampling of casein or caseinates shall be carried out in accordance with the procedures laid down in the Czech technical standards governing the methods of testing for dairy products, caseins and caseinates.
(a) ČSN 57 0111-1 Methods of testing casein and caseinates - Part 1: General provisions, or
(b) ČSN 57 0111-2 Methods of testing casein and caseinates - Part 2: Sampling for chemical analyses.
(4) The sampling of fruit and vegetables and processed fruit and vegetables at the point of retail sale to the final consumer (5) shall be carried out in accordance with the rules laid down in Annex V to the directly applicable European Union Regulation laying down detailed rules for the application of the fruit and vegetables sector (3).
Record of sampling
(1) A record of sampling must be drawn up for each sample taken.
(2) The sampling record shall contain at least:
(a) the number of the alert and the date of its copy;
(b) the identification of the person checked and the person from whom the sample was taken, if different from the person checked, if known;
(c) the name of the food under which it is placed on the market or the tobacco product under which it is distributed or placed on the market, unless it is indicated, other indication of the sample replacing the name which is provided for when it is taken;
(d) the name or business name and address of the food business operator or entrepreneur under whose name or business firm the food or tobacco product is marketed, if any,
(e) indication of the lot; If not stated, the indication of the lot or consignment shall be provided mutatis mutandis in accordance with this point.
1. the indication of the lot,
2. the size of the lot or part of the lot,
3. Date of manufacture, if indicated,
4. date of application or date of minimum durability, if stated;
(f) sampling data
1. reference to the rules under which sampling is carried out;
2. place of sampling, where appropriate, graphs, drawings or photographs;
3. Method of sampling,
4. the date and time of sampling;
5. the purpose of sampling;
6th quantity of sample taken,
7. name and signature of the person who carried out the sampling;
(g) the identification of the place or establishment from which the sample was taken when checking the conditions of manufacture or placing on the market of foodstuffs or the production, distribution or marketing of tobacco products; in such sampling, points (c), (d), (e) and (f) (6) shall not apply;
(h) information for the laboratory which may affect quality and safety, in particular the time of transport of the sample, the conditions under which sampling was carried out and any suspected breach of quality or safety;
(i) other data containing in particular the nature of the sample packaging, the method of ensuring the integrity of the sample and, where appropriate, other circumstances during sampling which could affect the assessment and the legal, scientific and technical validity of the sample taken pursuant to Article 34 (5) of Regulation (EU) 2017 / 625 of the European Parliament and of the Council;
(j) whether a sample has been taken for a second expert opinion for the purposes of the person checked.
(3) The inspection authority shall correct the irregularities in the sampling record in the form of an addendum to the sampling record. A supplement to the sampling record may also alter the purpose of the sampling referred to in the record if this is necessary for the protection of the consumer and if the change does not result in the object of the check being exceeded.
Packaging, labelling, transport and storage 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.
(2) Packs complying with the requirements of the European Union Regulation on materials and articles intended to come into contact with food (6), which do not affect the results of laboratory tests, shall be used to package the sample of unpackaged foodstuffs.
(3) The sample shall be marked, sealed and sealed in such a way that the sample cannot be confused and the package opened without breaching the package or seal.
(4) The sample shall be marked with the number of the sampling record and any other data necessary to identify it.
(5) The sample must be delivered to the laboratory without undue delay.
(6) Samples or samples of chilled food, frozen food or quick-frozen food shall be delivered to the laboratory at specified temperatures. However, short-term derogations are permitted outside the specified temperature environment if it is necessary to adapt to the practical handling conditions during the collection, transport, storage or transfer of the sample to the laboratory.
(7) The provisions of paragraphs 1 to 6 shall not apply in the case of a sample for on-the-spot evaluation if its evaluation takes place immediately after collection.
Preparation of the laboratory sample
(1) If a laboratory sample is to be prepared, the nature of the food or tobacco product taken shall be:
(a) homogenisation of the sample, such as mixing, mixing, crushing, grinding,
(b) dividing the sample, such as reducing the sample into dividers, cutting, separation, 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 of the sample.
(2) Where a sample is provided for a second expert opinion at the request of the checked person and the inhomogeneity of the character evaluated within the lot, part of the lot, lot or consignment may be assumed, a laboratory sample shall be prepared in the laboratory in accordance with the procedure referred to in paragraph 1 (a), which shall be divided into a laboratory sample or samples for official control and a laboratory sample for a second expert opinion.
(3) The laboratory sample shall be marked with the number of the sampling record and, where appropriate, by other means enabling it to be clearly identified.
(4) Laboratory samples may be prepared directly at the sampling point in accordance with the procedure laid down in paragraphs 1 to 3 only if the composition of the sample is not affected and it is not degraded.
Test methods
The sensory evaluation of the sample in the laboratory shall be carried out by an evaluation committee composed of the persons referred to in Section 3 (2) in accordance with the methods suitable for the intended purpose under the conditions set out in the Czech technical standard governing sensory analyses of the CSN ISO EN 8589 Sensory Analysis - General guidelines for the organisation of the sensory workstation.
(1) The control of the emissions of tar, nicotine and carbon monoxide from cigarettes shall be carried out in accordance with the procedures laid down in Czech technical standards.
(a) CSN ISO 4387 Cigarettes - Determination of raw and nicotine-free smoke condensate using a routine analytical smoking apparatus, in the case of tar,
(b) CSN ISO 10315 Cigarettes - Determination of nicotine content in smoke condensates - Gas chromatography method, in the case of nicotine, or
(c) CSN ISO 8454 Cigarettes - Determination of carbon monoxide in smoke condensates - NDIR method, for carbon monoxide.
Accuracy of measurement of tar, nicotine and carbon monoxide is determined according to Czech technical standard ČSN ISO 8243 Cigarettes - Sampling.
(2) The physical and chemical properties of casein and caseinates shall be checked in accordance with the procedures laid down in Czech technical standards governing the methods of testing casein and caseinates.
(a) ČSN 57 0111-1 Methods of testing caseins and caseinates - Part 1: General provisions,
b) ČSN 57 0111-3 Methods of testing casein and caseinates - Part 3: Determination of moisture,
c) ČSN 57 0111-5 Methods of testing casein and caseinates - Part 5: Determination of protein content,
d) ČSN 57 0111-7 Methods of testing casein and caseinates - Part 7: Determination of ash content,
(e) ČSN 57 0111-8 Methods of testing casein and caseinates - Part 8: Determination of titration acidity, or
(f) ČSN 57 0111-12 Methods of testing casein and caseinates - Part 12: Determination of pH.
(3) The control of dried milk products and concentrated milk products shall be carried out in accordance with the procedures laid down in the Czech technical standards governing the methods of testing milk products.
(a) ČSN 57 0105-3 Methods of testing milk products dried and concentrated - Part 3: Determination of dry matter content in concentrated sweetened and unsweetened milk,
(b) ČSN 57 0105-11 Methods of testing milk products dried and concentrated - Part 11: Determination of phosphatase activity in dried milk, or
(c) ČSN 57 0105-13 Methods of testing milk products dried and concentrated - Part 13: Determination of the water content of dried milk.
(4) The temperature control of frozen foodstuffs shall be carried out in accordance with the procedures set out in the Czech technical standards governing the testing methods for frozen products: ČSN 56 0290-7 Methods for testing frozen products - Part 7: Temperature measurement.
(5) The physical and chemical characteristics of certain sugars shall be checked in accordance with the procedures laid down in Czech technical standards.
(a) ČSN 56 0160 Methods of testing sugar products,
(b) ČSN 56 0160-3 Methods of testing sugar products - Determination of loss by drying and dry matter,
(c) ČSN 56 0160-5 Methods of testing sugar products - Determination of sucrose by polarisation,
(d) ČSN 56 0160-6 Methods of testing sugar products - Part 6: Determination of ash,
(e) ČSN 56 0160-7 Methods of testing sugar products - Determination of reducing levels,
(f) ČSN 56 0160-17 Methods of testing sugar products - Part 17: Determination of dry matter content (A. Refractometry method); or
(g) ČSN 56 0160-18 Methods of testing sugar products - Part 18: Determination of glucose equivalent (Method according to Lane and Eynon constant titre).
Test report
(1) The result of the laboratory test shall be given in the test report.
(2) The test report shall contain the data required by the Czech technical standard adjusting the requirements for test laboratories ČSN EN ISO / IEC 17 025 General requirements for the competence of test and calibration laboratories.
Where, at the request of the person checked, a sample is provided for a second expert opinion, the inspected person shall ensure compliance with the requirements laid down in this order for the maintenance of the sample, the methods of testing, the formalities for the test report and the laboratory to analyse the sample,
(a) upon receipt, have obtained a detailed photo-documenting of the sealed sample, including all the safety features used in its sealing and the photo-documenting, where requested by the competent supervisory authority; and
(b) in the test report referred to in Article 11,
1. the number of the sampling record that it was a sample for the second expert opinion and whether its packaging and safety features were intact, including the indication of the safety packaging or seal number, if indicated on the packaging or seal; and
2. Extended measurement uncertainty for individual test results, if these are determined, including an indication of whether the uncertainty is relative or absolute, where this is not obvious.
Method of assessing the result of the sample test for the second expert opinion pursuant to § 16 (7) (c) of the Act
(1) The control authority will assess the result and the method of evaluation of the sample test for the second expert opinion as non-compliant if it finds that the result of the sample test for the second expert opinion does not comply with the requirements for the character to be observed or that the test result has been misevaluated.
(2) If a test of the laboratory sample for official control reveals a result not complying with the requirements for the character to be followed, the expanded measurement uncertainty is not established for that result, and the checked person submits the result of the sample test for the second expert opinion declaring compliance with the requirements for the character to be followed, the control authority shall assess the result of the sample test for the second expert opinion as complying with Article 16 (7) (c) of the Law.
(3) If a test of the laboratory sample for official control reveals a result not complying with the requirements of the character to be followed, the expanded measurement uncertainty being established for that result, and the checked person submits the result of the sample test for the second expert opinion declaring compliance with the requirements of the mark to be followed, the control authority shall assess the result of the sample test for the second expert opinion in accordance with the procedure set out in the Annex to this Regulation.
(4) If the result of the assessment referred to in paragraph 3 and the Annex thereto is such that the difference in R results is less than the critical difference of Delta, the result of the sample test for the second expert opinion shall be considered as non-compliant.
(5) If, when checking the requirements of Commission Regulation (EC) No 1881 / 20067), the result of the assessment referred to in paragraph 3 and the Annex thereto is such that the difference in R results is equal to or greater than the critical difference of Delta, the supervisory authority shall ensure that the arbitration sample is tested. The final assessment of the sample shall be based on the result of the arbitration test. The result of the examination of the sample for official control and of the sample for the second expert opinion shall not be taken into account when the result of the test of the arbitration sample is assessed as non-compliant.
(6) If, in a case other than that referred to in paragraph 5, the result of the assessment referred to in paragraph 3 and the Annex thereto is such that the difference in the results of the R results is equal to or greater than the critical difference of Delta, the result of the sample test for the second expert opinion shall be considered satisfactory under Paragraph 16 (7) (c) of the Law.
The Ministry of Agriculture will allow everyone in the official hours free of charge to consult the text of the Czech technical standards mentioned in this decree.
Final provisions
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Repeal
The following shall be deleted:
1. Decree No. 211 / 2004 Coll., on methods of testing and method of sampling and preparation of reference samples.
2. Decree No. 611 / 2004 Coll., amending Decree No. 211 / 2004 Coll., on methods of testing and method of sampling and preparation of reference samples.
3. Decree No. 238 / 2005 Coll., amending Decree No. 211 / 2004 Coll., on methods of testing and method of sampling and preparation of reference samples, as amended by Decree No. 611 / 2004 Coll.
4. Decree No. 459 / 2005 Coll., amending Decree No. 211 / 2004 Coll., on methods of testing and method of sampling and preparation of reference samples, as amended.
Efficacy
This Decision shall enter into force on 1 August 2016.
Minister:
Ing. Jurečka v. r.
Annex to Decree No 231 / 2016 Coll.
Procedure for assessing the result of the sample test for the second expert opinion
Sample for official control:
XK numerical value of sample test result for official control
UK numerical value of absolute expanded uncertainty of measurement of sample test result for official control
Sample for second expert opinion:
XD numerical value of sample test result for second expert opinion
UD numerical value of absolute expanded uncertainty of measurement of sample test result for second expert opinion
Difference of R results:
R = str 124; XK - XD 124;
Critical difference Delta:
Delta = UK2 + UD2
1) Commission Directive 79 / 1067 / EEC of 13 November 1979 laying down Community methods of analysis for the testing of certain types of concentrated and dried milk intended for human consumption. First Commission Directive 79 / 796 / EEC of 26 July 1979 laying down Community methods of analysis for the testing of certain sugars intended for human consumption. First Commission Directive 85 / 503 / EEC of 25 October 1985 on methods for analysing food caseins and caseinates. First Commission Directive 86 / 424 / EEC of 15 July 1986 laying down methods of sampling for the chemical analysis of food caseins and caseinates. First Commission Directive 87 / 524 / EEC of 6 October 1987 laying down Community methods of sampling for the chemical analysis of the milk products monitored. Commission Directive 92 / 2 / EEC of 13 January 1992 laying down the sampling procedure and methods of Community analysis for the official control of temperatures of frozen foodstuffs intended for human consumption. Directive 2001 / 37 / EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the manufacture, presentation and sale of tobacco products. Commission Directive 2002 / 63 / EC of 11 July 2002 laying down Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79 / 700 / EEC. Directive 2014 / 40 / EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001 / 37 / EC.
(2) Regulation (EU) 2017 / 625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities carried out to ensure the application of food and feed rights and rules relating to animal health and animal welfare, plant health and plant protection products, amending Regulations (EC) No 999 / 2001, (EC) No 396 / 2005, (EC) No 1069 / 2009, (EC) No 1107 / 2009, (EU) No 1151 / 2012, (EU) No 652 / 2014, (EU) No 652 / 43 / EC, (EU) 2008 / 119 / EC and (EU) 2016 / 120 / EC, Council Regulation (EC) No 1099 / 2009 and Council Directives 98 / 58 / EC, 1999 / 74 / EC, 2007 / 43 / EC, 2008 / 119 / EC and 2008 / 120 / EC and repealing Regulation (EC.
3) Commission Implementing Regulation (EU) No 543 / 2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors.
4) Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended.
5) The second subparagraph of Article 17 (1) of Commission Implementing Regulation (EU) No 543 / 2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors.
6) Regulation (EC) No 1935 / 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food.
7) Commission Regulation (EC) No 1881 / 2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, as amended.
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Regulation Information
| Citation | Decree No 231 / 2016 Coll., on the collection, preparation and testing methods of food and tobacco control samples |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.07.2016 |
|---|---|
| Effective from | 01.08.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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