Decree No. 238 / 2005 Coll.
Decree 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.
Valid
Effective from 01.09.2005
Text versions:
01.09.2005
17.06.2005
238
DECLARATION
of 3 June 2005
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.
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 by Act No. 316 / 2004 Coll.:
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., is amended as follows:
1. In the introductory sentence, the words "and in accordance with the law of the European Communities (1) ', including footnote 1, are deleted.
2. In Paragraph 1 (1), the words "This decree 'are replaced by the words" This decree'.
footnotes 1 and 1a read:
"(1) It shall be issued on the basis and within the limits of the law, the content of which allows the relevant provisions of the European Communities to be incorporated by decree.
(1a) First 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 establishing Community methods of analysis for the testing of certain sugars intended for human consumption. Commission Directive 80 / 891 / EEC of 25 July 1980 concerning the Community method of analysis for the determination of erucic acid content in oils and fats intended as such for human consumption and in foodstuffs containing added oils or fats. First Commission Directive 81 / 712 / EEC of 28 July 1981 laying down Community methods to verify compliance with purity criteria for certain additives used in foodstuffs. First Commission Directive 85 / 503 / EEC of 25 October 1985 on methods of analysis for food caseins and caseinates. 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. 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. Council Directive 93 / 99 / EEC of 29 October 1993 on additional measures concerning the official control of foodstuffs. Commission Directive 98 / 53 / EC of 16 July 1998 laying down methods of sampling and analysis for the official control of the levels of certain foreign substances in foodstuffs. Commission Directive 2001 / 22 / EC of 8 March 2001 laying down methods of sampling and analysis for the official control of compliance with maximum levels of lead, cadmium, mercury and 3-MCPD in foodstuffs. 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 / 26 / EC of 13 March 2002 laying down methods of sampling and analysis for the official control of the levels of ochratoxin A in foodstuffs. Commission Directive 2002 / 27 / EC of 13 March 2002 amending Directive 98 / 53 / EC laying down methods of sampling and analysis for the official control of the levels of certain contaminants in foodstuffs. 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. Commission Directive 2002 / 69 / EC of 26 July 2002 laying down methods of sampling and analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs. Commission Directive 2003 / 78 / EC of 11 August 2003 laying down methods of sampling and analysis for the official control of the levels of patulin in foodstuffs. Commission Directive 2003 / 121 / EC of 15 December 2003 amending Directive 98 / 53 / EC laying down methods of sampling and analysis for the official control of the levels of certain contaminants in foodstuffs. Directive 2003 / 114 / EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95 / 2 / EC on food additives other than colours and sweeteners. Commission Directive 2004 / 16 / EC of 12 February 2004 laying down methods of sampling and analysis for the official control of tin content of foodstuffs packed in cans. Commission Directive 2004 / 43 / EC of 13 April 2004 amending Directives 98 / 53 / EC and 2002 / 26 / EC as regards sampling methods and methods of analysis for the official control of levels of aflatoxin and ochratoxin A in foods for infants and young children. Commission Directive 2004 / 44 / EC of 13 April 2004 amending Directive 2002 / 69 / EC laying down methods of sampling and analytical methods for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs. Commission Directive 2005 / 4 / EC of 19 January 2005 amending Directive 2001 / 22 / EC laying down methods of sampling and analysis for the official control of compliance with maximum levels of lead, cadmium, mercury and 3-MCPD in foodstuffs. Commission Directive 2005 / 5 / EC of 26 January 2005 amending Directive 2002 / 26 / EC laying down methods of sampling and analysis for the official control of levels of ochratoxin A in foodstuffs. Commission Directive 2005 / 10 / EC of 4 February 2005 laying down methods of sampling and analysis for the official control of the levels of benzo [a] pyrene in foodstuffs. '
3. In Section 4, paragraphs 11 and 12 are added, including footnote 10a:
"(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.
10a) Commission Recommendation 2004 / 787 / EC of 4 October 2004 on technical guidelines for the sampling and detection of genetically modified organisms and material produced from or containing genetically modified organisms pursuant to Commission Regulation (EC) No 1830 / 2003. '
4. in Article 5 (2) (f) (1):
'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, '.
5. In Article 7, paragraphs 14 and 15 are added:
"(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) In preparing samples for the detection of genetically modified organisms and material produced from or containing genetically modified organisms, account shall be taken of the recommendation in the European Community Regulation (10a). ';
6. In Article 9 (3), the words "and for which its purpose and substance are not excluded 'shall be inserted after the word" control'.
7. In Paragraph 10, paragraphs 21 and 22 are added:
"(21) The control of the levels of benzo (a) pyrene in foodstuffs shall be carried out in accordance with Annex 45.
(22) The detection of genetically modified organisms and material produced from or containing genetically modified organisms shall take account of the recommendation in the European Community Regulation (10a). ';
8. In Annex 1, point 4.3:
"4.3. Sampling procedure for cereals, dried grapes and roasted coffee
Table 1: Distribution of lots into parts depending on product and batch weight
| Komodita | Hmotnost šarže (t) | Hmotnost nebo počet částí šarže | Počet dílčích vzorků | Hmotnost souhrnného vzorku (kg) |
|---|---|---|---|---|
| Obiloviny a výrobky z obilovin | ≥ 1500 | 500 t | 100 | 10 |
| > 300 a < 1500 | 3 části šarže | 100 | 10 | |
| ≥ 50 a ≤ 300 | 100 t | 100 | 10 | |
| < 50 | – | 3 až 100 1) | 1 až 10 | |
| Sušené hrozny révy vinné (korintky, rozinky a sultánky) | ≥ 15 | 15 až 30 t | 100 | 10 |
| < 15 | – | 10 až 100 2) | 1 až 10 | |
| Pražená kávová zrna, mletá pražená káva a rozpustná káva | ≥ 15 | 15 až 30 t | 100 | 10 |
| < 15 | – | 10 až 100 2) | 1 až 10 | |
| 1) V závislosti na hmotnosti šarže – viz tabulka 2 této přílohy. 2) V závislosti na hmotnosti šarže – viz tabulka 3 této přílohy.“. | ||||
9. Point 4.4 of Annex 1 reads as follows:
"4.4. Sampling procedure for cereals and cereal products (lots ≥ 50 t) and for roasted coffee beans, minced roasted coffee, soluble coffee, dried grapes (lots ≥ 15 t)
Where parts of the lot can be physically separated, each batch shall be physically divided into parts as described in Table 1. Since the weight of the lot is not always an exact multiple of the weight of the parts of the lot, the weight of the part of the lot may exceed the said value by a maximum of 20%.
Each part of the lot must be sampled separately.
The number of incremental samples shall be 100.
The weight of the aggregate sample shall be 10 kg.
Where the above method of sampling cannot be used because of the economic consequences resulting from the damage to the lot (because of packaging, method of transport, etc.), an alternative method of sampling may be used provided that it is as representative as possible and is fully described and documented. '
10. Point 4.5 of Annex 1 reads as follows:
"4.5. Guidelines for the sampling of cereals and cereal products (lots < 50 t) and roasted coffee beans, minced roasted coffee, soluble coffee, dried grapes (lots < 15 t)
For lots of cereals up to 50 tonnes and lots of roasted coffee beans, minced roasted coffee, soluble coffee and dried grapes up to 15 tonnes, a sampling plan consisting of 10 to 100 incremental samples, resulting in an aggregate sample of 1 to 10 kg may be used depending on the weight of the lot. For very small batches (≤ 0,5 t) of cereals and cereal products, a lower number of samples may be taken, but the aggregate sample to be used shall be at least 1 kg.
The numbers shown in the table may be used to determine the number of incremental samples to be taken.
Table 2: Number of incremental samples to be taken depending on the weight of the lot of cereals and cereal products
| Hmotnost šarže (t) | Počet dílčích vzorků |
|---|---|
| ≤ 0,05 | 3 |
| > 0,05 až ≤ 0,5 | 5 |
| > 0,5 až ≤ 1 | 10 |
| > 1 až ≤ 3 | 20 |
| > 3 až ≤ 10 | 40 |
| > 10 až ≤ 20 | 60 |
| 20 až ≤ 50 | 100 |
Table 3: Number of incremental samples to be taken depending on the weight of the lot of roasted coffee beans, ground roasted coffee, soluble coffee and dried grapes
| Hmotnost šarže (t) | Počet dílčích vzorků |
|---|---|
| ≤ 0,1 | 10 |
| > 0,1 až ≤ 0,2 | 15 |
| > 0,2 až ≤ 0,5 | 20 |
| > 0,5 až ≤ 1,0 | 30 |
| > 1,0 až ≤ 2,0 | 40 |
| > 2,0 až ≤ 5,0 | 60 |
| > 5,0 až ≤ 10,0 | 80 |
| > 10,0 až ≤ 15,0 | 100“. |
11. In Annex 1, point 4.8 is inserted after point 4.7:
"4.8 Guidelines for wine and grape juice sampling
The aggregate sample shall be at least 1 kg, except where this is not possible, for example if the sample consists of one bottle.
The minimum number of incremental samples to be taken from the lot is given in Table 4. The number of subsamples determined depends on the form in which the products in question are normally marketed. In the case of bulk liquid products, the batch shall be mixed manually or mechanically prior to sampling, without affecting the quality of the product. At least three incremental samples shall be taken from the lot to form the aggregate sample.
The incremental samples, which are most often in the form of bottles or packages, shall be of the same mass. The weight of the incremental sample shall be at least 100 g and shall be such that a aggregate sample of at least 1 kg is obtained by the association of incremental samples.
Table 4: Minimum number of incremental samples to be taken from the lot
| Forma uvádění na trh | Hmotnost šarže vyjádřená v objemových jednotkách (l) | Minimální počet dílčích vzorků, které mají být odebrány |
|---|---|---|
| Volně ložené výrobky (hroznová šťáva, víno) | - | 3 |
| Láhve / balení hroznové šťávy | ≤ 50 | 3 |
| Láhve / balení hroznové šťávy | >50 až 500 | 5 |
| Láhve / balení hroznové šťávy | > 500 | 10 |
| Láhve / balení vína | ≤ 50 | 1 |
| Láhve / balení vína | >50 až 500 | 2 |
| Láhve / balení vína | > 500 | 3“. |
12. In Annex 3, point 5 reads:
"5. Compliance with the specified maximum content in the lot or sublot
For control purposes, the control laboratory shall carry out at least two independent tests and calculate the average of the results.
The lot shall be accepted unless the average of the relevant maximum content laid down in Commission Regulation (EC) No 466 / 2001 exceeds, taking into account the increased uncertainty of measurement and correction for recovery following the European Commission's report on the relationship between analytical results, measurement of uncertainty, recovery factors and EC food legislation.
The lot shall be rejected if the average exceeds the relevant maximum content, taking into account the expanded measurement uncertainty and recovery correction. ';
13. In Annex 6, the following point 3.3.3 is inserted after point 3.3.2:
"3.3.3. Working characteristics - the concept of uncertainty
The suitability of the test method to be used in the laboratory may also be assessed using the uncertainty concept. The laboratory may use a method to provide results with maximum standard uncertainty. The maximum standard uncertainty shall be calculated using the equation:
Uf = LOD / 22 + αC2
where:
Uf is the maximum standard uncertainty,
LOD is the limit of detection of the method,
C is the appropriate concentration,
α is the numerical factor used depending on the value C. The values to be used are given in Table 5:
Table 5: Values of a numerical factor α depending on C
| C(μg/kg) | α |
|---|---|
| ≤ 50 | 0,2 |
| 51-500 | 0,18 |
| 501-1000 | 0,15 |
| 1 001-10 000 | 0,12 |
| ≥ 10 000 | 1 |
Uf is the expanded measurement uncertainty using a coverage factor 2 that provides a level of confidence of approximately 95%.
If the test method provides results with uncertainty of measurement less than the maximum standard uncertainty, the method shall be as appropriate as the method which meets the working characteristics set out in Tables 3 and 4. ';
14. Point 3.4 of Annex 6 reads as follows:
"3.4. Estimation of the accuracy of the test, calculation of recovery and presentation of results
The accuracy of the test shall be estimated whenever possible by carrying out a control test of the appropriate certified reference material.
Test results shall be reported as corrected or not corrected for recovery. This information shall be provided in the test report as well as recovery.
A report by the European Commission on the relationship between analytical results, measurement of uncertainty, recovery factors and EC food legislation will be taken into account.
The test result shall be given in the form x ± U where x is the test result and U is the measurement uncertainty. ';
15. the following Annexes 44 and 45 are inserted after Annex 43:
"Annex No 44 to Decree No 211 / 2004 Coll.
Methods of sampling for official control of levels of benzo [a] pyrene in foodstuffs
1. Purpose and scope
Samples for official control of the levels of benzo [a] pyrene in foodstuffs shall be taken using the following methods. The aggregate samples thus obtained shall be considered representative of the lots. Compliance with the maximum levels laid down in Commission Regulation (EC) No 466 / 2001 shall be assessed on the basis of the quantities found in the laboratory samples.
2. Definitions
For the purposes of this Annex, a lot shall mean the identifiable quantity of food delivered at the same time, which, according to the person referred to in Article 3 (1), has common characteristics such as origin, type, type of packaging, packer, consignor or mark.
3. General provisions
3.1. Material to be collected
Each batch to be tested must be sampled separately.
3.2. Preliminary measures
When samples are taken and prepared, precautions must be taken to prevent any changes likely to affect the level of benzo [a] pyrene, adversely affect the analytical determination or impair the representativeness of the aggregate samples.
3.3. Partial samples
Where possible, incremental samples shall be taken from different locations throughout the lot or sublot.
Any deviation from the procedure shall be recorded in the report.
3.4 Preparation of the aggregate sample
The aggregate sample shall be prepared by association of incremental samples. This sample shall be homogenised in the laboratory.
3.5 Duplicated laboratory samples
Duplicated samples shall be taken from a homogenised aggregate sample for testing to confirm the result, defence in a trade dispute or for arbitration.
3.6 Packaging and transport of samples
Each sample shall be stored in a clean container of inert material which provides adequate protection against contamination and damage during transport. All necessary measures must be taken to prevent a change in the composition of the sample which may occur during transport or storage.
3.7 Closure and marking of samples
Each sample taken for official purposes shall be sealed at the place of collection and marked in accordance with Section 6.
Each sampling shall be subject to a sampling report in accordance with Section 5.
4. Sampling plans
The method of sampling used ensures that the aggregate sample is representative of the lot checked.
4.1 Number of incremental samples
In the case of oils for which a homogeneous distribution of benzo (a) pyrene in a given batch can be expected, it shall be sufficient to take three incremental samples per batch for the examination of the aggregate sample. Reference must be made to the batch number. In the case of olive oil and olive-residue oil, further information on sampling is provided in the European Community Regulation (30).
For other products, the minimum number of incremental samples to be taken from the lot is given in Table 1. The incremental samples shall have a similar mass not less than 100 g per incremental sample and shall form together a aggregate sample with a total mass of at least 300 g. The aggregate sample shall be prepared according to paragraph 3.4.
Table 1:
Minimum number of incremental samples to be taken from the lot
| Hmotnost šarže (kg) | Minimální počet dílčích vzorků, které mají být odebrány |
|---|---|
| < 50 | 3 |
| 50 až 500 | 5 |
| > 500 | 10 |
Sestává-li šarže z jednotlivých balení, je počet balení odebíraných za účelem vytvoření souhrnného vzorku uveden v tabulce 2.
Table 2:
Number of packages (incremental samples) taken to form the aggregate sample if the lot consists of individual packages
| Počet balení nebo jednotek v šarži | Počet balení nebo jednotek, které mají být odebrány |
|---|---|
| 1 až 25 | 1 balení nebo jednotka |
| 26 až 100 | asi 5 %, nejméně 2 balení nebo jednotky |
| > 100 | asi 5 %, maximálně 10 balení nebo jednotek |
4.2 Sampling at retail sale
Sampling of foodstuffs at retail stage shall be carried out mutatis mutandis in accordance with the provisions of this Annex concerning sampling. Where this is not possible, effective retail sampling procedures may be applied provided that they are sufficiently representative of the sampled lot.
5. Compliance with specifications in the lot or sublot
The control laboratory shall perform a repeat test of the laboratory sample for the purpose of confirming the result if the result obtained in the first test is 20% lower than or above the maximum level and in these cases calculate the average of the two results.
The lot shall be accepted if the result of the first test is satisfactory or if a repeated test is necessary, if the average of the relevant maximum limit laid down in the European Community Regulation (30), taking into account measurement uncertainty and correction for recovery.
The lot shall be rejected if the result of the first test or the average, when a repeated test is necessary, exceeds the maximum limit laid down in Commission Regulation (EC) No 466 / 2001, taking into account the measurement uncertainty and correction for recovery.
Příloha č. 45
Annex No 45 to Decree No 211 / 2004 Coll.
Preparation of samples and test methods for official control of the levels of benzo [a] pyrene in foodstuffs
1. Precautions and general principles for the official control of the levels of benzo (a) pyrene in foodstuffs
The basic requirement is to obtain a representative and homogeneous laboratory sample without secondary contamination.
The analyst must ensure that the samples are not contaminated when they are prepared. The containers shall be rinsed with high purity acetone or hexane (p.a., HPLC class or equivalent) before use to minimise the risk of contamination. Instruments and equipment in contact with the sample should be made of inert materials such as aluminium, glass or polished stainless steel. Plastics such as polypropylene, polytetrafluoroethylene, etc., are not used as they may absorb the analytical sample.
Any quantity of food received by the laboratory shall be used to prepare the test sample. Only thoroughly homogenised samples provide reproducible results.
Other methods for the preparation of samples referred to in Section 1 may also be used.
2. Processing of the sample received by the laboratory
The whole aggregate sample shall be finely ground and thoroughly mixed by a process to achieve complete homogenisation.
3. Distribution of samples for testing for confirmation and defence
Duplicated samples shall be taken from a homogenised sample for testing for confirmation, defence in a trade dispute and for arbitration.
4. Methods of testing and requirements for laboratory control
4.1 Definitions
The most common definitions to be used by the laboratory are:
r = repeatability: the value below which the absolute value of the difference between the results of 2 separate determinations under repeatability conditions (i.e. the same sample, same worker, same apparatus, same laboratory, is expected to lie with a given probability (usually 95%); r = 2,8 × sr.
sr = standard deviation calculated from results obtained under repeatability conditions.
RSDr = Relative standard deviation, calculated from results obtained under repeatability conditions sr / x cd x 100, where x cd is the mean of results from all laboratories and samples.
R = Reproducibility: the value below which the absolute value of the difference between the results of the two separate determinations under reproducibility conditions (i.e. for the same material obtained by the workers of different laboratories, using the standardised test method, is expected to lie with a given probability (usually 95%); R = 2,8 × sR.
sR = standard deviation calculated from results obtained under reproducibility conditions.
RSDR = relative standard deviation calculated from results obtained under reproducibility conditions sR / x ^ × 100, where x ^ is the mean of results from all laboratories and samples.
HORRATr = determined RSDr value divided by RSDr value calculated from Horwitz equation, assuming r = 0,66 R.
HORRATR = determined RSDR value divided by RSDR value calculated from the Horwitz equation.
U = Extended measurement uncertainty using a coverage factor of 2 corresponding to a confidence level of approximately 95%.
4.2 General requirements
The methods of testing used for food control purposes shall comply with Section 9.
4.3. Specific requirements
Where specific methods for the determination of benzo (a) pyrene in foodstuffs are not laid down directly by the European Communities regulation applicable, laboratories shall choose a validated method provided that the method chosen meets the criteria set out in the table. The validated reference material shall be used.
Table: Performance characteristics of analytical methods for benzo [a] pyrene
| Parametr | Hodnota/komentář |
|---|---|
| Použitelnost | Potraviny specifikované v nařízení (ES) č. 208/2005 |
| Mez detekovatelnosti | Nižší nebo roven 0,3 μg/kg |
| Mez stanovitelnosti | Nižší nebo roven 0,9 μg/kg |
| Přesnost | Hodnoty HORRATr nebo HORRATR dosažené ve validační kolaborativní studii musí být menší než 1,5 |
| Výtěžnost | 50 % až 120 % |
| Specifičnost | Stanovení nesmí být rušeno matricovými a spektrálními jevy, ověření detekce |
4.3.1 Working characteristics
The suitability of the test method to be used in the laboratory shall also be assessed using the uncertainty concept. The laboratory shall use a method that provides results with maximum standard uncertainty. The maximum standard uncertainty shall be calculated using the following equation:
Uf = LOD / 22 + 0,22
where:
Uf is the maximum standard uncertainty,
LOD is the limit of detection of the method,
C is the appropriate concentration.
If the test method provides results with uncertainty of measurement less than the maximum standard uncertainty, the method shall be appropriate to the same extent as the method that meets the performance characteristics specified in the table.
4.4 Calculation of recovery and presentation of results
The results of the analysis shall be reported with or without correction for recovery. The method of indicating recovery and its value shall be indicated. The result of the recovery correction test shall be used to check compliance with the limit.
A report by the European Commission on the relationship between analytical results, measurement of uncertainty, recovery factors and EC food legislation will be taken into account.
The analytical result shall be given in the form (x ± U) where x is the analytical result and U is the measurement uncertainty. ';
Efficacy
This Decree shall take effect on 1 September 2005.
Minister:
Ing. Zgarba v. r.
30) Commission Regulation (EC) No 1989 / 2003 of 6 November 2003 amending Regulation (EEC) No 2568 / 91 on the characteristics of olive oil and olive-residue oil and on the relevant methods of analysis.
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Regulation Information
| Citation | 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. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.06.2005 |
|---|---|
| Effective from | 01.09.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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