Decree of the Ministry of Agriculture No. 220 / 1998 Coll.
Decree of the Ministry of Agriculture on the method and extent of assessment of food batches, the method of preparation and sampling of food and tobacco control samples by the manufacturer, the types of food for which a written declaration of conformity will be issued by the manufacturer or importer and the extent and content of that declaration (conformity assessment)
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220
DECLARATION
Ministry of Agriculture
of 15 September 1998
on the manner and extent of assessment of the conformity of foodstuffs, the preparation and collection by the manufacturer of control samples of foodstuffs and tobacco products, the types of foodstuffs for which a written declaration of conformity will be issued by the manufacturer or importer and the extent and content of such declaration (conformity assessment)
According to Article 18 (b) and (c) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related laws, hereinafter referred to as "the Act":
General provisions
The decree shall specify:
(a) the manner and scope of the conformity assessment of foodstuffs and tobacco products under Articles 3 (1) (f) and 12 (3) (a) of the Act;
(b) the extent and content of the written declaration of conformity by the manufacturer or importer pursuant to Article 3 (2) of the Act;
(c) foodstuffs covered by a written declaration of conformity by the manufacturer or importer;
(d) the method of sampling and preparation of food and tobacco control samples for conformity assessment by the manufacturer; The selection and number of samples for the assessment of microbiological requirements shall be laid down in a specific legislative act (1).
For the purposes of this decree:
(a) assessing the conformity of the comparison of the actual quality and health of the food or the actual quality of the tobacco product with the health and technical requirements for products (2) laid down by law and its implementing provisions, (3) with, where appropriate, other information declared on the packaging of the food or tobacco product intended for consumers;
(b) a declaration of conformity with a written document certifying the conformity of a foodstuff for all manufactured lots or imported consignments of that foodstuff by the manufacturer or importer in the manner and to the extent provided for in this Regulation;
(c) the supply of a quantity of food which is declared in accordance with the type, group or subgroup of foodstuffs, quality or quality class or variety, if any, if they are determined, in terms of labelling, of the imported food further in terms of the exporting country, the importer and the manufacturer, and of fresh vegetables, fruit and table potatoes imported also in terms of quantities in one means of transport transported in one day;
(d) an accompanying document which is issued for the supply of the food and which is accompanying it when it is put into circulation;
(e) by a test protocol, a document indicating the results of the laboratory tests of the quality and health requirements laid down.
Method and scope of conformity assessment of foodstuffs and tobacco products
(1) The manufacturer of foodstuffs and tobacco products shall ensure:
(a) regular testing and comparison of the actual quality and health of all foodstuffs or of the actual quality of tobacco products, with the health and technical requirements for products (2) laid down by law and its implementing provisions; (3) where appropriate, with the information declared on packaging;
(b) sensory, chemical, physical and microbiological testing in their laboratories and, where appropriate, other laboratories for testing the requirements laid down in implementing regulations, 3)
(c) the regularity of the tests referred to in points (a) and (b) by determining the frequency of sampling for control samples (hereinafter referred to as "samples") at intervals and the frequency of testing of individual quality and health requirements by type, group or subgroup of food or tobacco products, on the basis of their specific nature, frequency of occurrence of defects and following a check in critical view4) in the food production process; the frequency of testing must ensure that only quality and health products are put into circulation;
(d) for foodstuffs intended for infant formulae and infant formulae and uncooked meat products intended for consumption without heat treatment of the microbiological test for each production batch;
(e) testing and evaluation of radioactive contamination of foodstuffs for each production batch during a radiation accident, (5) whether the contamination of radionuclide does not exceed the levels laid down by specific legislation, (6)
(f) keeping records of the data recorded under points (b) to (e) in such a way that it is clear, legible, the data are authentic as soon as they are detected and marked with the lot to which they relate; the results of the examination of the relevant food sample must be documented from this register, the record being kept for 2 years.
(2) If the sampling and preparation of samples of cigarettes and tobacco products for conformity assessment is carried out in accordance with the standard ČSN ISO 8243, it shall be deemed to comply with the requirements of this Decree.
Written declaration of conformity of foodstuffs
(1) The written declaration of conformity of foodstuffs is issued by the manufacturer or importer in accordance with Article 3 (2) of the Act and subject to the following conditions:
(a) for the foodstuffs listed in Annex No 1, the manufacturer shall issue a written declaration of conformity on the basis of the results of the conformity assessment provided for in Article 3 (1) (a) and (b), or on the basis of an importer's own assessment of the conformity of the imported food or the supporting documents of the foreign producer from which the food is imported;
(b) in the case of foodstuffs listed in Annex 2, the manufacturer or importer shall issue a written declaration of conformity on the basis of a test report from an accredited 7) or an authorized 8) person, provided that no other defects have been identified in the assessment of conformity pursuant to Article 3 for the food under assessment;
(c) for food intended for particular nutritional uses listed in Annex 3, the placing into circulation of which is subject to the consent of the Ministry of Health under the special legislation, 10) a written declaration of conformity shall be issued by the manufacturer or importer on the basis of the valid consent. No later than the expiry of the consent issued by the Ministry of Health, but not more than 1 year after the issuance of the declaration of conformity, the manufacturer or importer shall issue a new written declaration of conformity on the basis of a certificate from an authorised person with a validity of no more than 1 year for such foodstuffs,
(d) where the conditions under which a written declaration of conformity has been issued or which have affected the characteristics of the product are changed, the manufacturer or importer shall issue a new certificate of conformity.
(2) A declaration of conformity shall not be issued where a novel food has been produced or imported for one-off purposes, in particular to verify consumers' interest in purchasing it (market research), presentation at exhibitions.
(3) Where the food manufacturer has obtained a certificate (certificate) 10a) on the critical point system 10b) in production, issued by a person accredited under a specific legislation, 10c) does not need to issue a declaration of conformity.
(4) The minimum range of laboratory tests with specific quality and health requirements for the purposes of the written declaration of conformity is set out in Annexes 2 and 3 for each foodstuff.
(5) During the period of the radiation accident, the manufacturer shall issue a written declaration of conformity for each production batch of all the foodstuffs he produces or the importer for each imported consignment. 10d)
(6) The period of validity of the written declaration of conformity issued pursuant to paragraph 1 (a) shall be not more than 1 year.
(7) The period of validity of the test report and the certificate on the basis of which the written declaration of conformity for foodstuffs referred to in paragraph 1 (b), (c) and (d) is issued shall be no more than 1 year after their issue. For the same period, a written declaration of conformity issued on their basis shall be valid; for food from imports, the importer shall issue a written declaration of conformity for each consignment.
(8) Foodstuffs put into circulation by the manufacturer or importer on any day of validity of the written declaration of conformity shall be put into circulation in accordance with Sections 10 (1) (c) and 10 (2) of the Act.
(9) In order to assess the conformity of foodstuffs referred to in paragraph 1 (b), the manufacturer shall agree with the person accredited to test the relevant requirements; for the foodstuffs referred to in paragraph 1 (c), the assessment and issue of the certificate shall be carried out by the relevant person authorised for the required certificate. The authorised person may recognise as a basis for issuing the certificate the results of the tests carried out by the person accredited for those tests.
(10) The written declaration of conformity for imported foodstuffs referred to in paragraph 1 (b) and (c) may be issued by the importer on the basis of a certificate or test report issued by the competent authority or the competent laboratory in the exporting country in accordance with international obligations on the mutual recognition of such documents.
(11) Protocols of trials, certificates and written declarations of conformity of foodstuffs issued in accordance with paragraph 1 shall be kept by the manufacturer or importer for a period of 2 years from the expiry of the tests, except for fresh fruit, fresh vegetables and table potatoes from imports.
(1) The manufacturer, importer or supplier, (11) who supplies the food to the seller, (12) confirms on each accompanying document that a written declaration of conformity has been issued. At the request of the seller, the manufacturer, importer or supplier shall simultaneously submit a declaration of conformity.
(2) Where the manufacturer, importer or supplier who puts food into circulation, with the exception of offering it for sale to another supplier who does not offer it for sale or sell it to the consumer, 13) he shall always provide a written declaration of conformity with the first supply of the food. Each accompanying document shall certify that a written declaration of conformity has been issued.
(3) The model of the written "Declaration of Conformity" is set out in Annex 4.
Fresh fruit, fresh vegetables and table potatoes of import
(1) The condition that fresh fruit, fresh vegetables and table potatoes intended for direct consumption in the original raw state or for further processing comply with the requirements laid down in specific legislation14) and may be put into circulation is demonstrated by the importer by a certificate issued by the competent inspection authority of the exporting country or by a certificate issued locally by the competent State surveillance authority, 15) issued for each consignment.
(2) The issuing of the certificate referred to in paragraph 1 on fresh fruit and vegetables intended for direct consumption and table potatoes shall be deemed to have been issued a certificate of conformity. It shall be forwarded to the customers or certified accompanying documents of its issue in accordance with the procedure set out in Section 5. The certificate shall not release the importer from liability for compliance with all requirements laid down for these foodstuffs by specific legislation.
(3) Importers of fresh fruit, fresh vegetables and table potatoes intended for further processing after delivery or part thereof to the manufacturer for processing shall ensure that the certificate is certified by the manufacturer and shall immediately deliver a copy of this certified certificate to the competent authority of the State of surveillance at the place. 15) The sorting of the supply shall not be regarded as processing.
(4) Certificates shall be kept by the importer for a period of 1 year from the end of their period of validity.
(5) The model forms for certificates for fresh fruit, fresh vegetables and table potatoes intended for direct consumption or processing are set out in Annexes 5 and 6.
Method of sampling and preparation of food by the manufacturer for conformity assessment, excluding sampling for checking the assessment of microbiological requirements
For sampling, the manufacturer shall ensure:
(a) taking samples from the lot to the extent and quantities necessary to carry out all the checks and tests required, including the necessary repetition;
(b) taking samples by persons with the necessary knowledge and practical experience;
(c) a sampling protocol in accordance with Section 14 if the sample is sent for testing outside its laboratory.
Sampling
(1) Prior to sampling, it is found that:
(a) the batch identification mark according to the particulars on the packaging of the food intended for the consumer or on the packaging or on the documents relating to the product;
(b) the weight or volume of the lot or the number of units in the lot;
(c) the type and size of the packages, their numbering or other marking.
(2) Before sampling, it is to be determined:
(a) the sampling procedure and whether samples are taken for on-the-spot or laboratory testing or both;
(b) the types of tests required;
(c) the definition of the unit at collection; for unit of product the number of pieces, volume or weight, for incremental sample volume or weight,
(d) the adoption plan or plans taking into account the specific characteristics of the food or by mutual agreement with the operator putting the food into circulation;
(e) whether the sample is taken
1. for all tests universally; or
2. for certain additional tests by a derogation procedure,
(f) the selection range (symbol n), which means the number of sampling units, each sampling unit being tested separately;
(g) the total weight or volume of the sample needed to carry out the checks and laboratory tests, a combination of the sampling range and the types of tests;
(h) the total number of packages or incremental samples taken on the basis of knowledge of the quantity of foodstuffs in a single package or subsample, taking into account the types of tests.
(3) If the adoption plan referred to in paragraph 2 (d) is not already established, the following shall apply:
(a) acceptance plans for checking by comparison according to the standard CSN ISO 2859-1 marked "AQL" (Acceptable Quality Level) and intended for individual batches or, where applicable, CSN ISO 2859-2 or the acceptance plans for checking by measurements contained in the standard CSN ISO 3951 and deemed to be carried out in accordance with the requirements of this decree; individual adoption plans shall be indicated with operational characteristics or graphs of operational characteristics;
(b) the take-over plan by type of sign checked; the types of adoption plans corresponding to the types of characteristics checked are listed in Annex 8.
(4) In the case where the food is present simultaneously in several packages, in transport or in groups, multi-stage sampling shall be carried out by:
(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) further steps shall be carried out in a similar manner to that of the second stage, so that final samples are taken at the last stage of sampling in a package intended for consumers.
(5) Samples shall be taken and prepared to avoid contamination or changes affecting the test result.
(1) Samples shall be taken separately from each controlled lot.
(2) The sample taken, representing a controlled lot, consists of one or more units. The unit means the part of the lot which can be described separately, defined and may be
(a) a predefined separate unit of a piece product as a single package intended for consumers or, where appropriate, one group pack or transport pack (the product unit);
(b) a pre-defined quantity of non-pieces of material taken at the same time from one place ("sub-sample");
This definition applies to a particular species, group or subgroup of food and may vary according to the type of test required.
(3) Sampling is carried out
(a) by random sampling in which all units of the lot have the same likelihood of withdrawal; If separate units of lots are to be numbered or otherwise assigned serial numbers, these units shall be taken from them according to the table of evenly distributed random numbers set out in Annex 7,
(b) a systematic sampling at which the individual units of the lot are collected at predetermined distances or time intervals from the random start;
(c) the way in which the individual units of the lot are collected from different locations (stratified sampling); the lot units are:
1. incremental samples taken from different layers of non-bite material of the lot; or
2. units of the product taken by random sampling from each site and subsequently connected; the size of the samples taken from the samples (hereinafter referred to as "sub-samples') obtained from each part of the lot is directly proportional to the size of those parts.
(4) By deliberate sampling, a sample not representative of the lot obtained and marked as such is intended for:
(a) the detection of defects by laboratory tests of suspected products; or
(b) searching for defective units of the product in the lot in the acceptance plan for inspection by comparison with the acceptance number (symbol Ac) equal to zero; when a single defective unit of the product is detected, the whole batch is rejected.
(5) The validity of the sample expires with the expired date of application or minimum shelf life of the food.
Methods of sampling
(1) Individual units of the product are taken from packaged food in the necessary number to carry out analyses without breaching the packaging. partial samples or units of the product with broken packaging shall be taken from large packages.
(2) Partial samples shall be taken from liquid or semi-liquid foodstuffs in storage containers, in particular in barrels or tanks, after mixing the contents. If the contents cannot be mixed, partial samples shall be taken from each layer by stratified sampling. Similarly, bulk foodstuffs stored freely, in sacks or in other packages shall be treated; sub-samples shall be taken from different layers or from different locations by appropriate sampling agents.
(3) Furthermore, they are to be collected:
(a) from unpackaged foodstuffs in large pieces by means of a sampling or desalination device;
(b) non-packaged foodstuffs consisting of solids and liquids, samples separately from solids and liquid constituents;
(c) fresh fruit, fresh vegetables and table potatoes samples for on-the-spot inspection or laboratory testing.
(4) Frozen foodstuffs must not be defrosted during sampling.
(5) Samples taken for on-the-spot checks shall be used for non-destructive tests, visual inspection of colour, opacity, weight measurement and search for suspected or manifestly corrupt products.
Preparation of samples
(1) For the preparation of samples, use
(a) homogenisation, such as mixing, mixing, reducing, crushing or grinding;
(b) division, such as, in particular, reduction of the sample by dividing or quartering, cutting or cutting;
(c) a combination of homogenisation and division.
(2) By combining and mixing all incremental samples of non-lump material, a aggregate sample is produced. when the units of the product are collected, a gross sample shall be formed by means of a combination.
(3) The aggregate sample shall be adjusted in accordance with the procedures referred to in paragraph 1. The gross sample shall be taken and prepared from the product units, as appropriate, as for the aggregate sample.
(4) The laboratory sample (hereinafter referred to as the laboratory sample) is prepared from the aggregate sample or from the gross sample; the laboratory sample represents the aggregate or gross sample.
(5) Multiple laboratory samples shall be prepared from the entire quantity obtained prepared in accordance with paragraph 3 by dividing the necessary number of duplicate samples into two or more samples.
(6) The duplicate samples shall be sent as laboratory samples to laboratories competent to carry out the required tests or shall be kept for any further tests after packaging, labelling and sealing.
(7) When a laboratory sample consists of several packages intended for consumers, each unit of packaging shall be marked as a sub-sample when taken.
Packaging of samples
(1) Samples are protected against external influences and damage or deterioration by transport by suitable packaging and ensure against unauthorised opening
(a) in unpacked always,
(b) for packaged consisting of a unit of product only if their packaging is not sufficient for that purpose.
(2) Packaging corresponding to health requirements and not affecting the results of laboratory tests are used for the packaging of samples; samples of frozen foodstuffs shall remain permanently frozen and samples of perishable foodstuffs shall remain permanently chilled or frozen.
(3) For samples of perishable foodstuffs, the sample should be sent to the laboratory as soon as it has been taken.
Sample labelling
(1) The sample shall be provided with a label attached to the packaging in such a way as to avoid confusion, seal and seal or seal against unauthorised opening.
(2) The label contains information on:
(a) the product and its identity;
(b) the indication of the lot,
(c) sampling.
(3) If the label cannot be placed on the packaging or affixed to the packaging, the packaging should be marked with a abbreviated reference to the accompanying document of sampling.
(4) The accompanying proof of sampling is:
(a) the sampling protocol; or
(b) a specific entry containing:
1. the data referred to in paragraph 2 and other necessary data;
2. information for the laboratory, in particular on the time of transport, the conditions of sampling and the suspected quality breach.
Sampling protocol
The sampling protocol shall contain:
(a) details of the manufacturer, in particular the trade name and registered office of the legal person or the name and permanent residence of the natural person;
(b) the name of the product under which it is put into circulation;
(c) particulars of the quantity of food packed as volume, weight or number of packages;
(d) details of the lot, namely:
1. the indication of the lot,
2. the extent or size of the sampled lot; for unit products, the number of units of packaging or their weight, for non-unit materials, the total weight or volume,
3. the date of manufacture of the imported foodstuffs, if indicated,
(e) sampling data
1. reference to the sampling procedure; details and method of sampling, if any, for deviation from the prescribed or agreed procedures; the actual sampling procedure if there is no reference to the prescribed or agreed procedure in the protocol,
2. the place of sampling and, where appropriate, the name and address of the establishment;
3. the date and time of sampling;
4. the quantity of sample to be tested in the laboratory; the number of pieces and the quantity of food packed for unit products, weight or volume for non-unit products,
5. name and signature of the person responsible for carrying out the sampling;
(f) other information, such as, in particular, the type of sample packaging, the method of ensuring the integrity of the sample, the purpose of sampling, the validity of the sample, the reference to the specific record, if any, of the sampling equipment used and other circumstances in the sampling, the state of the product checked, the presence of rotten, contaminated or otherwise defective parts and the removal of the sample from part of the lot, the time of transport and any suspected quality breach.
Sampling records
The sampling records shall contain:
(a) data on samples taken and the name of the product;
(b) the package size of the packaged products,
(c) details of the lot, the date and time of sampling and its size;
(d) where appropriate, any other necessary information, in particular for which purpose the sample was taken and tested.
Transitional provisions
(1) The conditions for issuing the written declaration of conformity referred to in paragraphs 4 and 6 shall be ensured by the manufacturer or importer no later than 31 December 1998.
(2) For the foodstuffs listed in Annexes No 2 and No 3, except those subject to the consent of the Ministry of Health under a special regulation, 10) the manufacturer or importer may issue a written declaration of conformity on the basis of a valid product approval decision (16) no later than 31 December 1999.
Efficacy
This Decree shall take effect on 1 October 1998.
Minister:
Ing. Fencl v. r.
Příloha č. 1
Annex No 1 to Decree No. 220 / 1998 Coll.
Foodstuffs to be put into circulation by the manufacturer or importer shall issue a written declaration of conformity of the foodstuffs on the basis of the findings or supporting documents of the foreign producer.
Food names:
Preserved meat product
Swine (in flesh or leather)
Fresh fish
Protein milk products
Dairy products heat treated after the fermentation process
Liquid milk, concentrated, dried
Cream
Processed cheese
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Regulation Information
| Citation | Decree of the Ministry of Agriculture No. 220 / 1998 Coll., on the manner and extent of assessment of food batches, the method of preparation and collection of food control samples and tobacco products by the manufacturer, the types of food for which a written declaration of conformity will be issued by the manufacturer or importer and the extent and content of that declaration (conformity assessment) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.09.1998 |
|---|---|
| Effective from | 01.10.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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