Decree No. 356 / 2008 Coll.
Decree implementing Act No. 91 / 1996 Coll., on Feed, as amended
Valid
Order
Effective from 16.10.2008
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356
DECLARATION
of 16 September 2008
implementing Act No. 91 / 1996 Coll., on feedingstuffs, as amended
The Ministry of Agriculture provides, pursuant to § 3 (9), § 4 (9), § 5 (9), § 6 (4), § 7 (6), § 13 and § 21a (9) of Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 214 / 2007 Coll., ("the Act '):
GENERAL PROVISIONS
(1) This decree implements the relevant provisions of the European Community1) and regulates the details and requirements for the production, import, use, labelling and putting into circulation of feed, additives and premixtures.
(2) This Decree was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and rules and of rules on information society services, as amended by Directive 98 / 48 / EC.
Contaminants
Adverse substances and products, warehouse pests
[K § 3 (7) (a) and (b) of the Act]
(1) The content of undesirable substances in products for feeding shall be considered satisfactory if the analytical result does not exceed the maximum levels of the content specified in the directly applicable European Union regulation governing the area of undesirable substances (17).
(2) The list of stock pests depicted is set out in Annex 3.
Radioactive contamination of feed
[K § 3 (7) (c) of the Act]
The maximum levels for radioactive contamination of feed intended for direct feeding to animals, expressed as the sum of the mass of the activities of caesium 134 and caesium 137, are:
(a) complete feedingstuffs for pigs 1 250 Bq.kg-1;
(b) complete feedingstuffs for poultry, lambs and calves 2 500 Bq.kg-1; and
(c) other complete feedingstuffs 5 000 Bq.kg-1
PRODUCTS FOR FEED
COMPLETE AND ADDITIONAL FEED
Special nutritional purposes
[K § 3 (7) (d) of the Act]
The specific nutritional purposes, their main nutritional characteristics, the designation, the recommended period of use and the mandatory indications on the labelling, including the declaration and use, are set out in Annex 10.
ADDITIONAL SUBSTANCES
Requirements for additives
[K § 3 (7) (e) of the Act]
The list and purpose of the use of the authorised additives are set out in the directly applicable provisions of the European Communities which regulate the field of additional matrices (5) and in Annex No 11, Part B, unless those additives are authorised by the directly applicable provisions of the European Communities which regulate the area of supplementary matrices (5).
MARKING OF FEED
(K § 13 of the Act)
Feed for non-food producing animals
The list of categories of feed materials which may be indicated instead of individual feed materials in the labelling of feed for non-food-producing animals, with the exception of fur animals, is set out in Annex No 4, Part E.
Labelling of feedingstuffs intended for particular nutritional purposes
The labelling requirements for feed intended for particular nutritional purposes are laid down directly by the European Union5b Regulation. Further mandatory indications on the labelling, including the declaration and use, are given in Annex 10 to this decree.
ANNEXES TO REQUESTS
Details of the contents of the annexes to applications for approval or registration of operations
(K § 4 and § 5 paragraph 9 of the Act)
(1) The application for approval of operations for the manufacture or putting into circulation of products for feeding shall be accompanied separately for each operation:
(a) the manufacturer of the Annex referred to in § 4 (4) (a) to (c), (e) to (g) and (j) to (l) of the Act;
(b) distributor of the annex referred to in § 4 (4) (a) and (j) to (m) of the Act;
(c) the supplier of the annexes referred to in § 4 (4) (a) and (j) to (l) of the Act, if he also carries out packaging in § 4 (4) (b) of the Act;
(d) the importer of the Annex referred to in § 4 (4) (h) to (m) of the Act, if he also carries out packaging in § 4 (4) (b) of the Act.
(2) The application for registration of operations for the production or putting into circulation of products for feeding shall be accompanied separately for each operation:
(a) the manufacturer, in addition to the primary producer and persons operating the mobile feed plant, the annexes referred to in § 5 (4) (a) to (c), (e) to (g) and (j) to (l) of the Act;
(b) the person operating the mobile feed production plant, other than the primary producer, of the Annex referred to in § 5 (4) (a) to (c) and (j) to (l) of the Act;
(c) distributor of the Annex referred to in § 5 (4) (a), (k) and (l) of the Act;
(d) supplier, outside carriers, of the annexes referred to in § 5 (4) (a) and (j) to (l) of the Act, where it also carries out packaging in § 5 (4) (b) of the Act,
(e) the carrier of the annexes referred to in § 5 (4) (j) and (l) of the Act,
(f) the importer of the Annex referred to in § 5 (4) (h) to (l) of the Act, if he also carries out packaging in § 5 (4) (b) of the Act,
(g) the primary producer producing compound feedingstuffs, an annex referred to in Section 5 (4) (a) of the Act.
(3) Where an applicant for approval of operations also carries out activities subject to registration, it shall also attach the annexes referred to in paragraph 2.
Feed data
(K § 4 and § 5 paragraph 9 of the Act)
(1) The applicant for approval or registration of operations for production in the Annex concerning feed data shall indicate:
(a) in the case of feed materials, additives of the group and species and, where appropriate, their trade names;
(b) in the case of compound feedingstuffs, the animal species for which they are intended; are
1. livestock,
2. farmed animals other than ruminants;
3. ruminants,
4. domestic animals,
5. carnivorous fur animals,
6. fish,
(c) particulars of the use of feed materials of animal origin,
(d) a method of testing new feed materials, unless specified in a separate legislation10).
(2) The applicant for approval or registration of operations for the placing into circulation of feed products in the Annex concerning feed data shall indicate:
(a) groups of feed materials,
(b) for additives of category and functional group,
(c) in the case of compound feedingstuffs, the species for which they are intended; the animals are the animals referred to in paragraph 1 (b);
(d) the types of feed materials of animal origin and, where appropriate, the particulars of their use in complete and complementary feedingstuffs;
(e) a method of testing new feed materials, unless specified in another legislation10).
(3) The importer in the Annex concerning feed data, in addition to those referred to in paragraph 2, shall indicate the types of products imported for feeding, their composition and use and, where appropriate, the trade name for premixtures and compound feedingstuffs.
(4) The operator at the level of the primary production producing compound feedingstuffs using additional feed in the Annex concerning feed data shall indicate:
(a) the species for which they are intended,
(b) particulars of the use of feed materials of animal origin.
Verification of homogeneity of feed additives or premixtures
(K § 4 and § 5 paragraph 9 of the Act)
(1) Homogeneity is a property that expresses the uniform dispersion of individual components in the premixture or feed in general. The operator of the institute shall demonstrate the effectiveness of the agitator in terms of homogeneity by means of a document containing:
(a) the name and address of the operation;
(b) the type of mixing device, the serial number and the year of manufacture;
(c) the name of the manufacturer of the mixing device;
(d) the mixing time and the number of revolutions of the stirring element;
(e) evidence of homogeneity accompanying the manufacturer of the mixing device as part of the technical documentation or the operator's declaration that he has demonstrated the effectiveness of the mixing device as regards homogene13).
(2) The method of verification of homogeneity will be published by the Institute in a way that allows remote access.
Certificate of competence
(K § 6 (4) of the Act)
The certificate of competence shall be issued by the Institute for:
(a) the production and putting into circulation of additives to applicants with completed higher education in biological biology (chemistry, biology, biotechnology, pharmacy, medicine, veterinary medicine, food or agriculture), with the exception of Bachelor's study programmes and professional practice in the manufacture or use of additives of a minimum duration of two years;
(b) the manufacture of premixtures, complete and complementary feedingstuffs using additives or premixtures
1. applicants with completed university studies of agriculture or veterinary medicine, with the exception of bachelor programmes; or
2. applicants with completed higher education studies of biological focus and with professional experience in the manufacture or putting into circulation of premixtures or complete and complementary feedingstuffs using additives or using premixtures of a minimum duration of two years;
(c) the production of feed using additives or premixtures to an applicant with a graduate examination at a secondary vocational school in the agricultural or veterinary or food direction and professional practice in the manufacture of feed using additives or premixtures of a minimum duration of two years;
(d) the putting into circulation of premixtures to the applicant with a secondary education with a graduate examination.
REQUIREMENTS FOR OPERATIONS
(Paragraph 7 (6) of the Law)
Mobile feed plant
The timetable for the production of feed shall include the expected period of operation, the date, hour and place of production, the types of feed produced and the registration mark of the vehicle of the mobile feed factory.
Risk control in primary producers
(1) In operations at the level of primary production, the operator focuses mainly on the control of:
(a) physical hazards, in particular foreign bodies in products such as plant-origin pollution products, wood, metals;
(b) the biological hazard which is:
1. pathogenic micro-flora (for example, soil, water, salmonella),
2. mycotoxins produced by fungi (aflatoxins, fumonisins),
3. Animal pests (e.g. risk of introduction of insect disease and wild birds and rodents),
(c) chemical hazards which are:
1. heavy metals (e.g. arsenic, cadmium, lead, mercury),
2. prohibited substances and products listed in Annex 1 and undesirable substances and products listed in Annex 2,
3. incorrect use of additives in feedingstuffs.
(2) Paragraph 1 is without prejudice to the requirements arising from other legislation14) and directly applicable European Communities rules on the safety of the food chain 15).
BIOLOGICAL TEST
(K § 21a (9) of the Act)
(1) Biological testing of feed materials or products which have been obtained or modified by new technological processes or which do not yet have the character of feed shall be carried out in simultaneous comparative trials and shall be carried out in accordance with Annexes 12 to 18.
(2) The testing of additives is carried out in accordance with Commission Regulation (EC) No 429 / 200816). Where Article 4 of Commission Regulation (EC) No 429 / 200816 applies, the procedure laid down in Articles 29 (2), 30 (2), 12 (3), 14, 16 (I) and 18 shall apply.
(3) Data on biological test results should be reported separately for each repeated experiment.
(4) The biological testing shall include analytical verification of the composition of the additives used, premixtures, feed materials or products which have been obtained or modified by means of new technological processes or which do not yet have the character of feed. The results of the analytical verification shall adequately express the nutrient content, the additive content and the health.
(1) In the case of basic biological testing,
(a) the name and registered office of the legal person who carried out the examinations and the name and, where applicable, the name of the person responsible for carrying out the tests;
(b) the type of feed tested, the additive or premixture contained, their composition and quality characteristics established by analysis, the reference number of the lot used, the qualitative and quantitative composition of the daily ration;
(c) the species, breed, age and sex of the animals and their marking;
(d) the number of animal test and control groups, the number of animals per group and the number of simultaneous comparative trials;
(e) animal health, feeding and rearing conditions, including any changes;
(f) the date of commencement and completion of the test;
(g) place of test;
(h) the results and, in the case in question, the statistical evaluation of the evidence of the results, the adverse effects and other changes arising during the test.
(2) For the testing of preservative efficacy, evidence of
(a) the name and registered office of the legal person who carried out the examinations and the name and, where applicable, the name of the person responsible for carrying out the tests;
(b) the type of preservative tested, its composition and concentration;
(c) the route of dosing of the preservative,
(d) the type of feed used for the preservation, the manner in which it is prepared, the composition and the quality of the feed determined at the beginning of the test by physical, chemical and other testing;
(e) venue, date of commencement and completion of the test;
(f) in particular the indicators observed during the test as temperature, weight loss during preservation;
(g) the composition and quality of the feed determined after completion of the test by physical, chemical and other testing;
(h) any adverse effects and other changes occurring during the test;
(i) the results of further testing, if any.
(3) For testing the quality of animal products, the following shall be recorded:
(a) the name and address of the legal person who carried out the examinations, the name and, where appropriate, the name and surname of the person responsible for the execution and the place of execution;
(b) the species of samples taken of animal products;
(c) the number of animals sampled, the category and age of animals, the method of feeding, the quality of the feed tested, the additive or the premixture;
(d) the date of sampling and the method of keeping the samples until the start of the test;
(e) test results.
(4) For safety testing,
(a) the name and address of the legal person who carried out the examinations, the name and, where appropriate, the name and surname of the person responsible for the execution and the place of execution;
(b) the type of test and the method for carrying out the test;
(c) the species and number of animals on which the test has been carried out, the number of repetitions;
(d) the date of commencement and completion of the test;
(e) test results and statistical evidence of results;
(f) results of animal health monitoring and animal health monitoring.
(5) All tests carried out shall be individually documented.
(1) The summary dossier for biological testing, feed materials or products which have been obtained or modified by new technological processes or which do not yet have the character of feed shall be processed as set out in Annex 17.
(2) The summary dossier for the testing of additives is supplemented by the monograph set out in Annex 18.
TRANSITIONAL PROVISIONS
(1) Feed, additives and premixtures labelled in accordance with existing legislation may be put into circulation until 31 December 2009 at the latest.
(2) Paragraph 28 (2), second sentence, Paragraph 29 (2), Paragraph 30 (2), Annex 12 (3), Annex 14 and Annex 18 shall expire on 31 May 2009.
REPEAL PROVISIONS
The following shall be deleted:
1. Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
2. Decree No. 343 / 2001 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
3. Decree No. 472 / 2001 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll., as amended by Decree No. 343 / 2001 Coll.
4. Decree No. 169 / 2002 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll., as amended.
5. Decree No. 544 / 2002 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
6. Decree No. 284 / 2003 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
7. Decree No. 434 / 2003 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
8. Decree No. 184 / 2004 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended.
9. Decree No. 77 / 2005 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended.
10. Decree No. 84 / 2006 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended.
11. Decree No. 278 / 2007 Coll., amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
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Regulation Information
| Citation | Decree No. 356 / 2008 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.10.2008 |
|---|---|
| Effective from | 16.10.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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