Decree of the Ministry of Health No. 294 / 1997 Coll.
Decree of the Ministry of Health on microbiological requirements for food, their control and evaluation
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294
DECLARATION
Ministry of Health
of 28 November 1997
on microbiological requirements for food, their control and evaluation
According to § 19 (b) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws:
Preliminary provisions
(1) This decree sets out microbiological requirements for food intended for circulation, the way in which it is controlled and the way in which food is evaluated from a microbiological point of view.
(2) The microbiological requirements for bottled drinking water, bottled table water, bottled infant water and packaged natural mineral waters.1)
Microbiological requirements and microbiological investigation
(1) Foodstuffs put into circulation must comply with the microbiological requirements laid down in Parts 1 and 2 of the Annex to this Decree.
(2) The number of samples, groups and species of micro-organisms, their tolerated and limit values shall be determined in Parts 1 and 2 of the Annex for the control and evaluation of food compliance with microbiological requirements. A lower number of samples than those listed in Part 2 of the Annex may be taken only under the conditions laid down in Part 1 of the Annex.
(1) Samples shall be taken by random sampling which, for the purposes of this decree, means a selection in which any sample of the batch checked is equally likely to be selected. In epidemiological cases and in accidents, samples shall be taken by deliberate sampling which, for the purposes of this decree, means the selection into which samples are included with a particular purpose and the probability that any sample of the batch checked will be selected is not the same.
(2) Where methods other than those laid down in Czech technical standards are used for the sampling of foodstuffs for microbiological testing, the method of sampling, weight or volume, the method of transporting them to laboratories and the methods of microbiological testing shall be demonstrated, when used, that results are equivalent to those laid down in Czech technical standards. 2)
Evaluation of food from a microbiological point of view
(1) From a microbiological point of view, foods shall be considered as unfit for a given purpose, with a reduced use value or limited durability if the tolerated values laid down for each species, group or subgroup of foods in Part 2 of the Annex have been exceeded, but the maximum limits set out in Part 1, Parts A and B and Table 2 have not been exceeded.
(2) From a microbiological point of view, foodstuffs are considered to be medically harmful if:
(a) the maximum limit values for the number of micro-organisms set out in Part 1 of Table 1 of Part A. and Part B. of the Annex are exceeded;
(b) the maximum limits for bacterial toxins and mycotoxins set out in Part 1 of Table 2 of the Annex;
(c) micro-organisms and microbial metabolites causing the disease from foodstuffs other than those laid down in Part 1 of Tables 1 and 2 of the Annex are detected at levels which could endanger human health,
(d) the conditions of business sterility are not fulfilled; or
(e) undesirable changes caused by microbial activity and, where appropriate, undesirable growth of microorganisms have been identified.
(3) For the purposes of this decree, the commercial sterility referred to in paragraph 2 (d) shall mean the absence of viable micro-organisms which could multiply under the conditions of circulation (Annex, Part 1, point 8) and the absence of micro-organisms causing diseases from food.
Final provisions
The decree of the Ministry of Health and Social Affairs of the Czech Socialist Republic - the main hygienist of the Czech Republic, published under No. 75 / 1990 in the Collection of Hygiene Regulations, on microbiological requirements for food and packaging, and announced in the amount of 71 / 1991 Coll.
This decree shall take effect on the day of its publication.
Minister:
PhDr.
Annex to Decree No 294 / 1997 Coll.
GENERAL PRINCIPLES AND INJURY
1. Microbiological requirements for each species, group and subgroup of foodstuffs are specified in the form of sampling plans (Part 2).
2. The maximum limit values for the number of micro-organisms for the main food categories are set out in Table 1, Parts A and B.
3. The maximum limits for bacterial toxins and mycotoxins are set out in Table 2.
4. For the purposes of this decree, the following main food categories are generally distinguished:
(a) ready-to-eat foods: foods which are consumed in the unaltered state, cooked foods which are consumed in a warm, cold or microwave state, and dried foods which must be mixed with hot or cold liquid before consumption;
(b) food not intended for direct consumption: foodstuffs which are consumed after heat treatment, in particular baking, frying, cooking, microwave cooking or mixing with boiling liquid;
(c) foodstuffs intended for infant and infant nutrition;
(d) cooked, hermetically sealed and commercially sterile foodstuffs.
Table 1
Maximum limit values for micro-organisms
| Mikroorganismus | Kategorie potravin | Nejvyšší mezní hodnota |
|---|---|---|
| Bacillus cereus | ||
| potraviny neurčené k přímé spotřebě | 105/g | |
| potraviny určené k přímé spotřebě | 104/g | |
| potraviny určené pro kojeneckou a dětskou výživu | 102/g | |
| Campylobacter jejuni/coli | ||
| potraviny určené k přímé spotřebě | negat/25 g | |
| Clostridium perfringens | ||
| potraviny neurčené k přímé spotřebě | 105/g | |
| potraviny určené k přímé spotřebě | 104/g | |
| potraviny určené pro kojeneckou a dětskou výživu | 102/g | |
| Escherichia coli 0157 | ||
| všechny druhy potravin | negat/25 | |
| Listeria monocytogenes | ||
| potraviny určené k přímé spotřebě | negat/25 g | |
| masné výrobky o aw nižší než 0,92 | <100/g | |
| Pseudomonas aeruginosa | ||
| potraviny určené k přímé spotřebě | 104/g | |
| potraviny určené pro kojeneckou a dětskou výživu | ||
| k přímé spotřebě | 10/g | |
| Salmonella spp. | ||
| potraviny určené pro kojeneckou a dětskou výživu | negat/50 g | |
| všechny ostatní potraviny*/ | negat/25 g | |
| Shigella spp. | ||
| všechny potraviny | negat/25 g | |
| Staphylococcus aureus | ||
| potraviny neurčené k přímé spotřebě | 105/g | |
| potraviny určené k přímé spotřebě | 104/g | |
| potraviny určené pro kojeneckou a dětskou výživu | ||
| k přímé spotřebě | 102/g | |
| nikoli k přímé spotřebě | 103/g | |
| Vibrio parahaemolyticus | ||
| ryby, měkkýši, korýši a hlavonozči z vod tropických | negat/25 | |
| a subtropických pásem určené k přímé spotřebě | ||
| Yersinia enterocolitica | ||
| (enteropatogenní sérotypy) všechny potraviny | negat/25 g |
negate: inconclusive in the mass of the test sample specified after the oblique line
aw: water activity is an internal food parameter (measurable by a special device); inlinearly related to the water content of the food, it takes values from zero to one.
* / In the case of a Salmonella test other than Salmonella typhi or Salmonella parathyphi or Salmonella choleraesuis, this maximum limit may be waived if it is a food which, due to its use and kitchen heat treatment (baking, cooking, etc.) and its packaging and separation from other foodstuffs, does not pose a health risk.
| Mikroorganismus | Kategorie potravin | Nejvyšší mezní hodnota |
|---|---|---|
| Aerobní mezofilní mikroorganismy (celkový počet mikroorganismů) | ||
| potraviny určené pro kojeneckou a dětskou výživu k přímé spotřebě nikoli k přímé spotřebě potraviny určené k přímé spotřebě s výjimkou potravin, kde jsou takové mikroorganismy součástí kulturní mikroflóry živočišného původu rostlinného původu | 105/g 106/g 107/g 108/g | |
| Koliformní bakterie | potraviny určené k přímé spotřebě potraviny určené pro kojeneckou a dětskou výživu k přímé spotřebě | 105/g 103/g |
| Escherichia coli | potraviny určené k přímé spotřebě potraviny určené pro kojeneckou a dětskou výživu k přímé spotřebě | 104/g 10/g |
| Mikroorganismy nenáležející ke kulturní mikroflóře ve fermentovaných potravinách nebo potravinách obsahujících fermentované složky | ||
| potraviny určené pro kojeneckou a dětskou výživu neurčené k přímé spotřebě určené k přímé spotřebě živočišného původu rostlinného původu a kombinované | 106/g 105/g 107/g 108/g | |
| Kvasinky | potraviny určené pro kojeneckou a dětskou výživu potraviny určené k přímé spotřebě s výjimkou potravin, kde jsou kvasinky součástí kulturní mikroflóry | 103/g 107/g |
| Plísně | potraviny určené pro kojeneckou a dětskou výživu ostatní potraviny s výjimkou potravin, kde jsou plísně součástí kulturní mikroflóry | 103/g růst plísní nesmí být viditelný prostým okem |
Table 2
Maximum limits for bacterial toxins and mycotoxins
* * * / unproven RPLA test
5. Application of sampling plans
5.1. The sampled total is the production batch (dose), part or delivery.
5.2. Where a consignment consisting of several lots is examined, the examination shall be carried out separately for each lot.
5.3. The unit of the product is a single unit product or a specified quantity of unit or non-unit products.
5.4. The sample is a certain quantity of product taken from the sampled unit. For the purposes of this Decree, a unit of the product, part of the unit or several units (depending, inter alia, on their weight or volume) shall be taken as a sample.
6. The microbiological examination shall be carried out by means of a single selection check (hereinafter referred to as "the selection check '), where the assessment of the lot or parts thereof as satisfactory or non-compliant with the microbiological requirements set out in Part 1 and Part 2 of the Annex is decided on in accordance with the result of the examination of one selection in the range of N
6.1. During the sampling procedure, samples shall be taken from the lot in number n by random sampling (§ 3 (1)).
6.2. The summary of the requirements and rules applicable to sampling, testing and dose assessment shall be referred to as a sampling plan.
6.2.1. The microbiological requirements set out in Part 2 of the Annex include:
(a) the list of species or groups of micro-organisms prescribed for testing (list of characters);
(b) for each character, the data on the extent of selection n and the data on the relevant number c, i.e. sampling plan;
(c) for each characteristic of the tolerated amount of micro-organisms m, M, and M is allowed depending on c.
6.2.2. Definition of symbols:
| n | rozsah výběru, tj. počet vzorků určený k vyšetření, jehož účelem je rozhodnout, zda posuzovaná šarže výrobku (nebo její kontrolovaná část) bude posouzena jako vyhovující nebo nevyhovující stanoveným mikrobiologickým požadavkům; |
| m | množství mikroorganismů, které se připouští u všech vzorků výběru n; |
| M | množství mikroorganismů, které se ještě připouští u počtu vzorků, který je nižší nebo se rovná c; |
| c | rozhodné číslo, tj. počet vzorků z výběru n, u nichž se připouští hodnota M. |
If for all samples from sample n only the value m is accepted (M is not allowed), the value c is expressed by zero and the value M is crossed out.
The values m, M shall be determined taking into account the consistency of the test results. Configuration limits for conformity of test results are given in the relevant Czech technical standards .2)
6.2.3. Method of expression m, M:
(a) As quantity of micro-organisms
- in 1 g or 1 ml of the sample; it shall be examined by the colony counting technique using filler methods; as micro-organisms, the units forming colonies (cfu) are calculated, e.g. 105 indicates the tolerated amount of 1.105 microorganisms in 1 g or 1 ml of the sample, 5.103 indicates the tolerated amount of 5.103 microorganisms in 1 g or 1 ml of the sample;
- in the volume of the sample to be tested, as indicated behind the oblique line after the tolerated number of micro-organisms; is examined for filamentary fluids by membrane filtration techniques; e.g. 20 / 10 denotes a maximum of 20 microorganisms in 10 ml of the sample;
(b) As a requirement of absence of micro-organisms
- in 1 ml or 0,2 ml of liquid undiluted sample or in 1 ml or 0,2 ml dilution of 10-1 sample; The test shall be carried out using a plate method, the inoculum of 1 ml shall be watered with agar soil, the inoculum of 0,2 ml shall be spread to the surface, vaccinated and evaluated by two parallel plates.
It is expressed as zero with indices and up to d, where:
0a indicates that micro-organisms must not be demonstrable by watering 1 ml of liquid undiluted sample (0a indicates less than 1 / ml of sample)
0b indicates that micro-organisms must not be demonstrable by watering 1 ml of dilution 10-1 sample (0b indicates less than 10 / ml sample or < 10 / g sample)
0c indicates that micro-organisms must not be demonstrable by spreading 0,2 ml of liquid undiluted sample (0c indicates less than 5 / ml of sample)
0d indicates that micro-organisms must not be demonstrable by spreading 0,2 ml dilution of 10-1 sample. (0d stands for less than 50 / ml of sample or < 50 / g of sample)
- in the volume of the sample to be tested, as indicated behind the oblique line after zero; is tested for filtration fluids by the membrane filtration method;
e.g. 0 / 10 indicates the requirement of absence of micro-organisms in 10 ml of the sample;
- in the weight or volume of the sample to be tested, as indicated behind the oblique line after zero; is examined by inoculating the whole of the tuber or the whole volume of the sample into the relevant liquid soil followed by propagation, vaccination on the fence soil and confirmation of suspicious colonies;
e.g. 0 / 25 indicates a requirement of absence of micro-organisms in 25 g or 25 ml of the sample;
0 / 1 indicates the requirement of absence of micro-organisms in 1 g or 1 ml of the sample.
6.2.4. Interpretation of test results in application of sampling plans:
The dose or part thereof shall be assessed and the test result interpreted as not complying with the specified microbiological requirements if:
6.2.4.1. for one or more samples of sample n, a value greater than M for one or more of the prescribed characters has been found (see example 1);
6.2.4.2. for more than a number of samples than the value c, values above m and below or equal to M have been found for one or more of the prescribed characters (see example 2);
6.2.4.3. in cases where the absence of micro-organisms is required for all samples from selection n, i.e. when c = 0, m is expressed / according to 6.2.3 (b) / as zero with the relevant index and up to d or as 0 / 10 or 0 / 25 or 0 / 1 and M is crossed out, one or more samples of the micro-organisms monitored have been demonstrated (see example 3).
Example 1:
Sampling plan (for one character)
| n | c | m | M |
| 5 | 1 | 102 | 103 |
| zjištěno: u jednoho vzorku ve sledovaném znaku 5.103/g | |||
| interpretace: překročení hodnoty M | |||
Example 2:
Sampling plan (for one character)
| n | c | m | M |
| 5 | 2 | 103 | 104 |
| zjištěno: hodnoty maximálně m pouze u dvou vzorků, | |||
| u tří vzorků hodnoty 5.103/ml, 7.103/ml, 1.104/ml | |||
| interpretace: překročení hodnoty c | |||
Example 3:
Sampling plan (for one character)
| n | c | m | M |
| 5 | 0 | 0/25 | - |
| zjištěno: u jednoho vzorku prokázána přítomnost sledovaných mikroorganismů z navážky 25 g. | |||
| interpretace: průkaz určitých mikroorganismů v navážce (objemu) vzorku určené k vyšetření při požadavku nepřítomnosti těchto mikroorganismů | |||
6.2.5. However, where a lot or part of it has been assessed as non-compliant for exceeding the tolerated values up to the maximum limit, the competent authority of the State shall decide on the continued management of the food, taking into account in particular the type of food, the degree of excess of the tolerated values, the type of micro-organisms and other relevant circumstances (e.g. the accelerated sale of goods, the implementation of sanitary measures in the manufacture or circulation of foodstuffs, the prohibition on the use of the food for the originally identified range of consumers).
The manufacturer (importer) shall take measures to detect the causes of the exceedance (for example, using a system of critical control points) and to avoid recurrence of exceedance when finding such a defined excess of tolerated values.
When the maximum levels are exceeded, the competent authority of the State shall decide to suspend and withdraw the food. In the event that the overrun concerns the maximum limits laid down for micro-organisms causing a disease from foodstuffs, the competent authority of the State surveillance authority shall issue an order to dispose of the non-compliant batch or part thereof.
6.2.6. Efficiency of sampling plan:
(a) the sampling plan shall be defined by an indication of the extent of selection n and by an indication of the relevant number c and its effectiveness expressed by operational characteristics. Each sampling plan shall be subject to a single operational characteristic expressing the probability with which the checked batch or part of it is considered to satisfy the microbiological requirements,
(b) the operational characteristics of the sampling plans used and the statistically calculated probabilities are given in Tables 3 to 6.
Table 3
The probability of assessing the controlled dose as satisfactory * depending on the actual representation of non-compliant units in this dose for sampling plans
c = 0; n = 5
c = 0; n = 10
| skutečné % nevyhovujících jednotek v dávce (p) | počet vyšetřených jednotek, tj. počet vzorků výběr v rozsahu n | |
|---|---|---|
| 5 | 10 | |
| 1,0 | 0,95 | 0,90 |
| 2,0 | 0,90 | 0,82 |
| 3,0 | 0,86 | 0,74 |
| 4,0 | 0,82 | 0,67 |
| 5,0 | 0,77 | 0,60 |
| 10,0 | 0,59 | 0,35 |
| 20,0 | 0,33 | 0,11 |
| 30,0 | 0,17 | 0,03 |
| 40,0 | 0,08 | 0,01 |
| 50,0 | 0,03 | < |
| 60,0 | 0,01 | < |
| 70,0 | < | < |
* for the probability of assessing the controlled dose as satisfactory use of the symbol Pa
Pa 0,95 (first row of Table 3): in 95 cases out of 100, the batch containing in fact 1% of non-compliant units (equivalent to the sample taken) shall be considered satisfactory if the selection range n is equal to 5; with the rising n value Pa decreases
<: Pa less than 0,005
Table 4
The probability of assessing the controlled dose as satisfactory * depending on the actual representation of non-compliant and still compliant units in this dose for the sampling plan: c = 1; n = 5
| pd | pm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90 | |
| 0 | 1,00 | 0,92 | 0,74 | 0,53 | 0,34 | 0,19 | 0,09 | 0,03 | 0,01 | < |
| 1 | 0,95 | 0,87 | 0,70 | 0,50 | 0,31 | 0,17 | 0,08 | 0,03 | 0,01 | |
| 2 | 0,90 | 0,83 | 0,66 | 0,47 | 0,29 | 0,16 | 0,07 | 0,02 | < | |
| 3 | 0,86 | 0,79 | 0,62 | 0,44 | 0,27 | 0,15 | 0,06 | 0,02 | ||
| 4 | 0,82 | 0,74 | 0,59 | 0,41 | 0,25 | 0,13 | 0,06 | 0,02 | ||
| 5 | 0,77 | 0,70 | 0,55 | 0,38 | 0,23 | 0,12 | 0,05 | 0,01 | ||
| 10 | 0,59 | 0,53 | 0,41 | 0,27 | 0,16 | 0,07 | 0,03 | 0,01 | ||
| 20 | 0,33 | 0,29 | 0,21 | 0,13 | 0,06 | 0,02 | 0,01 | < | ||
| 30 | 0,17 | 0,14 | 0,09 | 0,05 | 0,02 | < | < | |||
| 40 | 0,08 | 0,06 | 0,04 | 0,01 | < | |||||
| 50 | 0,03 | 0,02 | 0,01 | < | ||||||
| 60 | 0,01 | 0,01 | < | |||||||
| 70 | < | < | ||||||||
* for the probability of assessing the controlled dose as satisfactory use of the symbol Pa
Pd: representation of non-compliant units in%
pm: representation of still compliant units in%
<: Pa less than 0,005
Table 5
The probability of assessing the controlled dose as satisfactory * depending on the actual representation of non-compliant and still compliant units in this dose for the sampling plan: c = 2; n = 5
| pd | pm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90 | |
| 0 | 1,00 | 0,99 | 0,94 | 0,84 | 0,68 | 0,50 | 0,32 | 0,16 | 0,06 | 0,01 |
| 1 | 0,95 | 0,94 | 0,89 | 0,79 | 0,64 | 0,47 | 0,29 | 0,15 | 0,05 | 0,01 |
| 2 | 0,90 | 0,90 | 0,85 | 0,75 | 0,60 | 0,43 | 0,27 | 0,13 | 0,04 | < |
| 3 | 0,86 | 0,85 | 0,81 | 0,71 | 0,57 | 0,40 | 0,24 | 0,12 | 0,04 | |
| 4 | 0,82 | 0,81 | 0,76 | 0,67 | 0,53 | 0,38 | 0,22 | 0,10 | 0,03 | |
| 5 | 0,77 | 0,70 | 0,72 | 0,63 | 0,50 | 0,35 | 0,20 | 0,09 | 0,02 | |
| 10 | 0,59 | 0,58 | 0,55 | 0,47 | 0,36 | 0,23 | 0,12 | 0,05 | 0,01 | |
| 20 | 0,33 | 0,32 | 0,29 | 0,24 | 0,16 | 0,09 | 0,03 | 0,01 | < | |
| 30 | 0,17 | 0,16 | 0,14 | 0,11 | 0,06 | 0,02 | < | < | ||
| 40 | 0,08 | 0,08 | 0,06 | 0,04 | 0,02 | < | ||||
| 50 | 0,03 | 0,03 | 0,02 | 0,01 | < | |||||
| 60 | 0,01 | 0,01 | 0,01 | < | ||||||
| 70 | < | < | < | |||||||
* for the probability of assessing the controlled dose as satisfactory use of the symbol Pa
Pd: representation of non-compliant units in%
pm: representation of still compliant units in%
<: Pa less than 0,005
Table 6
The probability of assessing the controlled dose as satisfactory depending on the actual representation of non-compliant and still compliant units in this dose for the sampling plan: c = 3; n = 5
| pd | pm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90 | |
| 0 | 1,00 | 1,00 | 0,99 | 0,97 | 0,91 | 0,81 | 0,66 | 0,47 | 0,26 | 0,08 |
| 1 | 0,95 | 0,95 | 0,94 | 0,92 | 0,86 | 0,77 | 0,62 | 0,44 | 0,23 | 0,07 |
| 2 | 0,90 | 0,90 | 0,90 | 0,87 | 0,81 | 0,72 | 0,58 | 0,40 | 0,21 | 0,05 |
| 3 | 0,86 | 0,86 | 0,85 | 0,83 | 0,78 | 0,68 | 0,54 | 0,37 | 0,18 | 0,04 |
| 4 | 0,82 | 0,82 | 0,81 | 0,79 | 0,73 | 0,64 | 0,50 | 0,34 | 0,16 | 0,03 |
| 5 | 0,77 | 0,77 | 0,77 | 0,75 | 0,69 | 0,60 | 0,47 | 0,31 | 0,14 | 0,02 |
| 10 | 0,59 | 0,59 | 0,58 | 0,56 | 0,52 | 0,43 | 0,32 | 0,18 | 0,06 | < |
| 20 | 0,33 | 0,33 | 0,32 | 0,30 | 0,27 | 0,20 | 0,12 | 0,04 | < | |
| 30 | 0,17 | 0,17 | 0,16 | 0,15 | 0,12 | 0,07 | 0,03 | < | ||
| 40 | 0,08 | 0,08 | 0,07 | 0,06 | 0,04 | 0,02 | < | |||
| 50 | 0,03 | 0,03 | 0,03 | 0,02 | 0,01 | < | ||||
| 60 | 0,01 | 0,01 | 0,01 | < | < | |||||
| 70 | < | < | < | |||||||
* for the probability of assessing the controlled dose as satisfactory use of the symbol Pa
Pd: representation of non-compliant units in%
pm: representation of still compliant units in%
<: Pa less than 0,005
7. Testing of lower number of samples
7.1. The number of samples lower than n may be taken for testing not intended to assess the lot.
In this case, the test samples shall be considered satisfactory if the amount of micro-organisms found does not exceed 3 m.
For cases where m is expressed as zero with indices and up to d, the values shall be 3 m:
| m | 3m | |
| 0a | 3/ml | |
| 0b | 30/g nebo < 30/ml | |
| 0c | < 15/ml | |
| 0d | < 150/g nebo /ml. | |
For cases where m is expressed as a requirement for the absence of micro-organisms in the volume or weight of the sample to be tested as indicated behind the oblique line after zero, e.g. 0 / 10, the value shall be 3m 0 / 3,3. The requirement is therefore mitigated to the absence of micro-organisms in a threefold reduced volume or weight of the sample to be tested. This provision does not apply to bacterial agents of food diseases listed in Table 1 of Part A, as in these cases neither the volume nor the weight of the sample to be tested is reduced.
7.2 The number of samples lower than n may also be taken for testing to assess the lot, provided that the results obtained from previous examinations have been satisfactory and demonstrate the correct functioning of the critical control points system.
In this case, the test samples shall also be considered satisfactory if the amount of micro-organisms found does not exceed 3m.
7.3 When the values of 3m are exceeded, further testing shall be carried out according to the appropriate sampling plan set out in Part 2 of the Annex.
8. Testing of heat-treated hermetically sealed food
Sampling plans for such products are not specified, as the risk of such products with regard to the possible presence of Clostridium botulinum and / or botulinum toxins cannot be affected by any realistic sampling plan; their safety must be ensured in particular by compliance with the established technological procedures and the application of a system of critical control points.
The sampling plan is replaced by a requirement of commercial sterility for these products (Section 4 (3)). The absence of viable micro-organisms that could multiply under circulation conditions means that, in the case of a thermostat test in closed packages, there will be no greater increase in the number of micro-organisms than 102 after 7 to 10 days incubation at 35 ° C to 37 ° C. Business sterility testing shall be carried out before the products are put into circulation or, where appropriate, in the cases indicated.
SOLERATED VALUES FOR SINGLE SPECIES, FOODSTUFFS OR FOODSTUFFS
1. MEAT AND MEAT PRODUCTS, POINTS AND ARTICLES OF MEAT, ROLLING MEAT, VERIFICATION AND OTHER MEAT SPECIES
1.1. Meat, cut, cut, packed, including offal - fresh and frozen
| n | c | m | M | |
|---|---|---|---|---|
| Koliformní bakterie | 5 | 2 | 5.102 | 5.103 |
| Staphylococcus auerus | 5 | 2 | 102 | 5.103 |
| Salmonella | 5 | 0 | 0/25 | - |
1.2. Smoked meat raw, minced or cut meat for heat treatment or processing - fresh and frozen
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismůa) | 5 | 2 | 106 | 5.106 |
| Koliformní bakterie | 5 | 2 | 5.102 | 5.103 |
| Staphylococcus aureus | 5 | 1 | 5.102 | 5.103 |
| Salmonella | 5 | 0 | 0/25 | - |
(a) is determined only for minced masses
1.3. Meat products not heat-treated for direct consumption (e.g. tea salami, salmon ham)
| n | c | m | M | |
|---|---|---|---|---|
| Koliformní bakterie | 5 | 2 | 2.103 | 104 |
| Sulfitredukující klostridia | 5 | 2 | 102 | 103 |
| Staphylococcus aureus | 5 | 2 | 5.102 | 5.103 |
| Salmonella | 5 | 0 | 0/25 | - |
1.4. Permanent meat products
| n | c | m | M | |
|---|---|---|---|---|
| Koliformní bakterie | 5 | 1 | 102 | 2.103 |
| Sulfitredukující klostridia | 5 | 1 | 102 | 103 |
| Staphylococcus aureus | 5 | 0 | 0d | - |
| Salmonella | 5 | 0 | 0/25 | - |
1.5. Heat-treated meat products
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 104 | 105 |
| Koliformní bakterie | 5 | 1 | 0b | 5.102 |
| Sulfitredukující klostridia | 5 | 1 | 102 | 103 |
| Staphylococcus aureus | 5 | 1 | 0d | 102 |
| Salmonella | 5 | 0 | 0/25 | - |
1.5.1. Coated and cut packaged heat-treated meat products
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 5.104 | 5.105 |
| Bakterie mléčného kvašení | 5 | 2 | 5.104 | 106 |
| Koliformní bakterie | 5 | 2 | 102 | 103 |
| Sulfitredukující klostridia | 5 | 2 | 0b | 102 |
| Staphylococcus aureus | 5 | 2 | 102 | 103 |
| Salmonella | 5 | 0 | 0/25 | - |
1.6. Heat-treated products hermetically packaged
1.6.1. Sterile containers must meet the conditions of commercial sterility
1.6.2. Semi-preserved
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 5.103 | 5.104 |
| Sulfitredukující klostridia | 5 | 2 | 0 b | 102 |
| Staphylococcus auerus | 5 | 1 | 0d | 2.102 |
| Salmonella | 5 | 0 | 0/25 | - |
1.7. Animal fat (excluding butter)
| n | c | m | M | |
|---|---|---|---|---|
| Salmonella | 5 | 0 | 0/25 | - |
2. FISH, OTHER AQUATIC ANIMALS AND ARTICLES THEREOF
2.1. Fresh, frozen and salted fish and parts thereof, intended for heat treatment
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 105 | 106 |
| Escherichia coli | 5 | 2 | 102 | 5.102 |
| Sulfitredukující klostridia | 5 | 2 | 0b | 102 |
| Salmonella | 5 | 0 | 0/25 | - |
2.2. Smoked, fried and dried fish
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismůb) | 5 | 2 | 5.103 | 2.104 |
| Koliformní bakterie | 5 | 2 | 0b | 102 |
| Sulfitredukující klostridia | 5 | 2 | 0b | 102 |
| Staphylococcus auerus | 5 | 2 | 102 | 5.102 |
| Salmonella | 5 | 0 | 0/25 | - |
(b) For products with an ingredient of spices and / or smoked with cold smoke, values higher than those of Staphylococcus aureus and Salmonella shall be tolerated.
2.3. Crustines, molluscs and cephalopods
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů+) | 5 | 2 | 104 | 105 |
| Koliformní bakterie | 5 | 2 | 102 | 5.102 |
| Staphylococcus auerus | 5 | 2 | 0 d | 102 |
| Salmonella | 5 | 0 | 0/25 | - |
+) In the case of crab meat, values higher are tolerated.
2.4. Fish products not hermetically sealed
NOTE: For products of shallow fish intended for heat treatment see 20.2.
2.4.1. Products marinated uncooked without preservatives (for example, jelly, oil, brine, remoulade)
| n | c | m | M | |
|---|---|---|---|---|
| Koliformní bakterie | 5 | 2 | 103 | 104 |
| Sulfitredukující klostridia | 5 | 2 | 0b | 5.102 |
| Staphylococcus aureus | 5 | 2 | 0d | 5.102 |
| Bacillus cereus | 5 | 2 | 103 | 5.103 |
| Salmonella | 5 | 0 | 0/25 | - |
| Kvasinky | 5 | 2 | 104 | 106 |
2.4.2. Products marinated with heat treated or with preservatives (for example, jelly, oil, brine, remoulade)
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 105 | 106 |
| Koliformní bakterie | 5 | 2 | 102 | 5.102 |
| Sulfitredukující klostridia | 5 | 2 | 0b | 102 |
| Staphylococcus aureus | 5 | 2 | 0d | 5.102 |
| Bacillus cereus | 5 | 1 | 102 | 5.102 |
| Salmonella | 5 | 0 | 0/25 | - |
| Kvasinky | 5 | 2 | 103 | 5.104 |
2.5. Hermetically packaged fish "semi-preserved"
2.5.1. Hermetically packaged fish semi-preserved, unpasteurised, without preservatives (caviar, eyes, anchovy paste, oil salmon, crab sticks, etc.)
| n | c | m | M | |
|---|---|---|---|---|
| Celkový počet mikroorganismů | 5 | 2 | 5.103 | 5.104 |
| Koliformní bakterie | 5 | 1 | 102 | 5.103 |
| Sulfitredukující klostridia | 5 | 2 | 102 | 103 |
| Staphylococcus auerus | 5 | 2 | 0d | 5.102 |
| Salmonella | 5 | 0 | 0/25 | - |
2.5.2. Hermetically packaged fish semi-preserved pasteurised or with preservative
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Regulation Information
| Citation | Decree of the Ministry of Health No. 294 / 1997 Coll., on microbiological requirements for foodstuffs, their control and evaluation |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.12.1997 |
|---|---|
| Effective from | 12.12.1997 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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