Decree No. 544 / 2002 Coll.
Decree 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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544
DECLARATION
of 12 December 2002
amending Decree No. 451 / 2000 Coll., implementing Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll.
The Ministry of Agriculture provides pursuant to § 3 (13), § 4 (12) and § 8 (13) of Act No. 91 / 1996 Coll., on feedingstuffs, as amended by Act No. 244 / 2000 Coll., hereinafter referred to as "the Act ':
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., Decree No. 472 / 2001 Coll. and Decree No. 169 / 2002 Coll., is amended as follows:
1.
Prohibited substances and products, warehouse pests
(1) Prohibited substances and products listed in Annex 1 shall not be used in the manufacture of feed, additives and premixtures and for animal feed.
(2) Prohibited substances and products are to be classified as animal waste originating from animals not eligible for veterinary health assessment for human consumption as referred to in Annex 1, point 9.1.
(3) The list of warehouse pests is contained in Annex 2. ';
2. Paragraph 2, including the title and footnote 1, reads as follows:
Adverse Substance 1) and Products
(1) The undesirable substances, including their maximum permitted contents in products intended for animal feed, are listed in Annex 3. Products intended for animal feed (hereinafter referred to as "feed products') shall mean feed materials, premixtures, feed additives, feed and all other products intended for use in or used for animal feed, including wild farmed game.
(2) The content of undesirable substances is tolerated in feed products only if the limits and conditions laid down in Annex 3 are complied with.
(3) Products for feeding for which the undesirable substance or undesirable substance content exceeds the maximum content set out in column 3 of Annex 3 may not be mixed for dilution with the same or other feed products.
(4) In the absence of specific provisions in Annex 3 for the maximum content of an undesirable substance concerning feed additives or compound feed, the maximum content of the relevant undesirable substance, taking into account the prescribed proportion of the complementary feed or compound feed in the daily ration, shall not exceed the maximum content of that undesirable substance set out in Annex 3 for complete feed.
1) § 2 (i) of Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll. '.
3. In Article 4 (7), the first sentence is replaced by the following: "In manufacturing plants where feed is produced, including feed for domestic animals, intended for non-farm animals containing processed animal proteins as referred to in Article 15 (6), compound feed for farmed animals which are kept, reared or fattened for food production may not be produced. Where processed animal proteins other than fishmeal, dicalcium phosphate from defatted bones and hydrolysed proteins are not used in compound feed, those compound feedingstuffs may be produced in production plants where feed for farmed animals is produced, except ruminants, where the production operation is authorised for this purpose by the competent administrative authority. ';
4. Paragraph 8 (2), including footnote 2, reads:
"(2) Certain protein feed (2) must be of sound, unfalsified and marketable quality and must not pose a risk to human, animal and environmental health and may only be put into circulation under the names listed in Annex 12 in columns 2 and 7 and provided that they comply with the description in column 3 and the requirements in column 5 and, in the case in question, have been produced on the substrate referred to in column 4 of that Annex.
2) § 2 (p) of Act No. 91 / 1996 Coll., as amended by Act No. 244 / 2000 Coll. '.
5. In Paragraph 15, the following sentence is added at the end of paragraph 1: "Complete and complementary feedingstuffs must be of sound, genuine and marketable quality and must not pose a risk to human, animal and environmental health. '
6. Paragraph 15 (2) reads as follows:
"(2) For the manufacture of complete or complementary feed, milk compound feed and dietetic feed for farmed animals, feed materials referred to in Annex 11 (B) or (C) or mixtures thereof, certain protein feed referred to in Annex 12, feed additives referred to in Annex 14 (C), columns 2 and 3 and premixtures corresponding to the requirements laid down in Sections 12 and 14 and, for dietary feed, feed materials listed in Annex 15. ';
7. Paragraph 15 (4) reads as follows:
"(4) For the manufacture of complete or complementary feedingstuffs and dietetic feedingstuffs for domestic animals intended for putting into circulation, the feed additives referred to in Annex No 14, Part C, columns 2 and 3 and premixtures conforming to the requirements laid down in Sections 12 and 14 shall be used. Furthermore, feed materials as referred to in Annex 11 and certain protein feed as referred to in Annex 12 and, where appropriate, other feed products to be indicated in the labelling and, for dietary feed, feed materials as referred to in Annex 15 shall be used for production. '
8. Paragraph 15 (6) reads as follows:
"(6) Feed materials derived from mammalian tissues, dicalcium phosphate from defatted bones, poultry, fish and other marine organisms shall not be used in complete or complementary feedingstuffs for ruminants, or containing or containing, in accordance with Annex 1, point 9. These feed materials are meat-and-bone meal, meat meal, blood meal, dried plasma and other blood products, hydrolysed proteins, hoof meal, horn meal, poultry meal, feather meal, greaves, fishmeal, dicalcium phosphate from defatted bones, gelatin, animal fats from ruminants and all other similar products and mixtures thereof (" processed animal proteins') and feed, additives and premixtures containing these products. '
9. in Article 27 (2) (e) (5), after the words "in column 2," the words "for micro-organisms from the group of preservatives in column 3," shall be deleted;
10. in the first sentence of Paragraph 29 (1) (d), "B 1" is replaced by "C";
11. in Paragraph 29 (4) (d), the words "B 1" shall be deleted and the words "other feed products, where appropriate, shall be added at the end of the letter."
12. in Paragraph 29 (8):
"(8) In the case of pet feedingstuffs, the labelling may draw attention to an increased or reduced proportion of one or more feed materials or, where appropriate, of another feed product, provided that the list of feed materials shall indicate the percentage or weight of each raw material or product. ';
13. in Paragraph 29 (15):
"(15) For complete and complementary feed for farmed animals to which processed animal proteins listed in Section 15 (6) are used, or containing the use of ruminants which are prohibited under Annex 1, the appropriate warning shall be indicated on the labelling" Feed contains processed animal proteins derived from mammalian tissues and is prohibited from feeding ruminants', "Feed contains hydrolysed proteins and is prohibited from feeding ruminants'," Feed contains feed derived from fish or other marine animals and is prohibited from feeding to ruminants' or "Feed contains dicalciumphosphate from defatted bones'. For poultry waste meal and feather meal, the warning shall be provided mutatis mutandis. When using several types of processed animal proteins prohibited for ruminants, these may be identified in a single warning. Where the use of the above processed animal proteins is prohibited for animals other than ruminants, the warning shall be extended to include other species or categories of animals for which the prohibition of use is provided. ';
14. in Annex 1, point 9, including footnote 2, shall read:
'9. Prohibited substances and products following measures to prevent transmissive spongiform encephalopathies.
9.1. Feed materials containing the following animal waste:
(a) all animals from categories of bovine, porcine, caprine, ovine, solipeds, poultry, farmed fish and all other farmed animals which have died in breeding and have not been slaughtered for human consumption, including dead and unborn animals;
(b) dead animals comprising:
1. domestic animals,
2. zoo animals;
3. circus animals,
4. experimental animals; and
5. wild game;
(c) animals slaughtered in breeding as a result of health control measures and animals killed during transport.
9.2. Proteins derived from animals for feeding to ruminants. The prohibition shall not apply to the following feed materials obtained or produced from healthy animals in the following manner of use:
(a) milk and milk products and eggs and egg products,
(b) gelatine from non-ruminants as a feed additive,
(c) hydrolysed proteins from fish, feathers, leather and leather only for use in nutrition and feed for domestic and farmed animals other than ruminants which:
1. must be produced in undertakings intended only for the production of hydrolysed proteins approved by the competent authority; and
1.2. be sampled and verified after production that their molecular weight is less than 10,000 daltons.
The hydrolysed proteins from the skin and leather must be further
2. 1. obtained from leather and hides from animals slaughtered in slaughterhouses where official veterinary checks have been carried out before and after slaughter in accordance with the relevant legislation in which no defects have been detected; and
2. subjected to a production process which includes modifications suitable for the greatest possible prevention of skin and leather contamination by means of felling (in lacquer), lime lye leaching, followed by intensive piping followed by exposure of the raw material to pH greater than 11 for more than 3 hours at temperatures greater than 80 ° C, followed by heat treatment to more than 140 ° C for 30 minutes at pressures greater than 3,6 bar,
(d) dicalcium phosphate from defatted bones only for use in nutrition and feed for domestic and farm animals other than ruminants which have been
1. obtained from bones of animals suitable for human consumption after inspection carried out before and after slaughter;
2. produced by a process which ensures that all bone material is completely crushed and treated with hot water and dilute hydrochloric acid (minimum concentration of 4% and pH of less than 1,5) for at least two days, subsequently treated with a obtained phosphoric solution with lime for the formation of a precipitated dicalcium phosphate at pH 4 to 7 which is finally dried by air with an entry temperature of 65 to 325 ° C and a final temperature between 30 and 65 ° C, or by an equivalent procedure authorised in accordance with veterinary legislation,
(e) fishmeal and feed materials from other marine organisms only for use in nutrition and feed for domestic and farmed animals other than ruminants, which must come from establishments authorised by the competent authority, (1) which are intended exclusively for the manufacture of those products for which, on the basis of an official method check 2) microscopic identification of the constituents of animal origin has been verified that they do not contain mammalian tissues;
(f) dried plasma and other blood products for use in nutrition and feed for domestic and farm animals other than ruminants.
2) Decree No. 124 / 2001 Coll., laying down the requirements for sampling and the principles of methods of analysis of feedingstuffs, additives and premixtures and the method of storage of samples. '
15.
"Annex No. 3, Part I, to Decree No. 451 / 2000 Coll.
ADVERSE SUBSTANCES
| Nežádoucí látka | Produkty pro krmení | Maximálně přípustný obsah v mg/kg krmiva o sušině 88 % |
|---|---|---|
| 1 | 2 | 3 |
| 1. Arsen | Krmné suroviny s výjimkou: | 2 |
| travní moučky, jetelové moučky, vojtěškové moučky, sušené cukrovky a sušených cukrovarských řízků | 4 | |
| fosfátů a krmiv ze zpracování ryb nebo jiných mořských živočichů | 10 | |
| Kompletní krmiva1) s výjimkou: | 2 | |
| pro ryby | 4 | |
| Doplňková krmiva s výjimkou: | 4 | |
| minerálních krmiv | 12 | |
| 2. Olovo | Krmné suroviny s výjimkou: | 10 |
| zelené píce | 40 | |
| fosfátů | 30 | |
| kvasnic | 5 | |
| Kompletní krmiva1): | 5 | |
| Doplňková krmiva s výjimkou: | 10 | |
| minerálních krmiv | 30 | |
| 3. Fluor | Krmné suroviny s výjimkou: | 150 |
| krmiv živočišného původu | 500 | |
| fosfátů | 2 000 | |
| Kompletní krmiva1) s výjimkou: | 150 | |
| pro skot, ovce a kozy | ||
| - v mléce | 30 | |
| - ostatní | 50 | |
| pro prasata | 100 | |
| pro drůbež | 350 | |
| pro kuřata | 250 | |
| Minerální doplňková krmiva pro skot, ovce a kozy | 2 0002) | |
| Ostatní doplňková krmiva | 1252) | |
| 4. Rtuť | Krmné suroviny s výjimkou: | 0,1 |
| krmiv ze zpracování ryb nebo jiných mořských živočichů | 0,5 | |
| Kompletní krmiva1) s výjimkou: | 0,1 | |
| pro psy a kočky | 0,4 | |
| Doplňková krmiva s výjimkou: | 0,2 | |
| pro psy a kočky | ||
| 5. Dusitany | Rybí moučka | 60 (vyjádřeno jako NaNO2) |
| Kompletní krmiva1) s výjimkou: | 15 (vyjádřeno jako NaNO2) | |
| krmiv pro domácí zvířata mimo ptáky a akvarijní rybky | ||
| 6. Kadmium | Krmné suroviny rostlinného původu: | 1 |
| Krmné suroviny živočišného původu s výjimkou: | 2 | |
| krmiv pro domácí zvířata | ||
| Fosfáty | 10 | |
| Kompletní krmiva1) pro skot, ovce a kozy s výjimkou: | 1 | |
| kompletních krmiv1) pro telata, jehňata a kůzlata | ||
| Ostatní kompletní krmiva s výjimkou: | 0,5 | |
| krmiv pro domácí zvířata | ||
| Minerální krmiva | 5 | |
| Ostatní doplňková krmiva pro skot, ovce a kozy | 0,5 | |
| 7. Aflatoxin B1 | Krmné suroviny s výjimkou: | 0,05 |
| podzemnice olejné, kopry, palmojádra, bavlníkového semene, babassu, kukuřice a produktů jejích zpracování | 0,02 | |
| Kompletní krmiva1) pro skot, ovce a kozy s výjimkou: | 0,05 | |
| dojnic | 0,005 | |
| telat a jehňat | 0,01 | |
| Kompletní krmiva1) pro prasata a drůbež (s výjimkou mláďat) | 0,02 | |
| Ostatní kompletní krmiva1) | 0,01 | |
| Doplňková krmiva pro skot, ovce a kozy (s výjimkou doplňkových krmiv pro zvířata v laktaci, telata a jehňata) | 0,05 | |
| Doplňková krmiva pro prasata a drůbež (s výjimkou mladých zvířat) | 0,03 | |
| Ostatní doplňková krmiva | 0,005 | |
| 8. Kyselina kyanovodíková | Krmné suroviny s výjimkou: | 50 |
| lněného semene | 250 | |
| lněných pokrutin | 350 | |
| produktů manioku a mandlových pokrutin | 100 | |
| Kompletní krmiva1) s výjimkou: | 50 | |
| pro kuřata | 10 | |
| 9. Gossypol volný | Krmné suroviny s výjimkou: | 20 |
| bavlníkoých pokrutin | 1 200 | |
| Kompletní krmiva1) s výjimkou: | 20 | |
| kompletních krmiv pro skot, ovce a kozy | 500 | |
| kompletních krmiv pro telata a drůbež (s výjimkou nosnic) | 100 | |
| kompletních krmiv pro králíky a prasata (s výjimkou selat) | 60 | |
| 10. Theobromin | Kompletní krmiva1) s výjimkou: | 300 |
| kompletních krmiv pro dospělý skot | 700 | |
| 11. Hořčičný olej těkavý | Krmné suroviny s výjimkou: | 100 |
| řepkových pokrutin | 4 000 (vyjádřeno jako allylisothiokyanát) | |
| Kompletní krmiva1) s výjimkou: | 150 (vyjádřeno jako allylisothiokyanát) | |
| kompletních krmiv pro skot, ovce a kozy (s výjimkou mláďat) | 1 000 (vyjádřeno jako allylisothiokyanát) | |
| kompletních krmiv pro drůbež a prasata (s výjimkou selat) | 500 (vyjádřeno jako allylisothiokyanát) | |
| 12. Vinylthiooxa-zolidon | Kompletní krmiva1) pro drůbež s výjimkou: | 1 000 |
| kompletních krmiv pro nosnice | 500 | |
| 13. Námel (Claviceps purpurea) | Všechna krmiva obsahující nemleté obiloviny | 1 000 |
| 14. Semena plevelů a nemleté a nerozdrcené plody, obsahující alkaloidy, glykosidy nebo jiné jedovaté látky, samotné nebo v kombinaci, včetně: | Všechna krmiva | 3 000 |
| (a) Lolium temulentum (L.) | 1 000 | |
| (b) Lolium remotum Schrank, | 1 000 | |
| (c) Datura stramonium (L.) | 1 000 | |
| 15. Skočec obecný (Ricinus communis L.) | Všechna krmiva | 10 (vyjádřeno jako ricinové slupky) |
| 16. Rostliny r.Crotalaria | Všechna krmiva | 100 |
| 17. Aldrin | Všechna krmiva s výjimkou: | 0,01 |
| 18. Dieldrin (jednotlivě nebo dohromady, vyjádřeno jako dieldrin) | tuků | 0,2 |
| 19. Campechlor (toxaphen) | Všechna krmiva | 0,1 |
| 20. Chlordan | Všechna krmiva s výjimkou: | 0,02 |
| (suma z cis- a trans- izomerů a z oxychlordanu, vyjádřená jako chlordan) | tuků | 0,05 |
| 21. DDT (suma DDT-, TDE- a DDE-izomerů, vyjádřená jako DDT) | Všechna krmiva s výjimkou: | 0,05 |
| tuků | 0,5 | |
| 22. Endosulfan (suma alfa-a beta- izomerů a síranu endosulfanu, vyjádřená jako endosulfan) | Všechna krmiva s výjimkou: | 0,1 |
| kukuřice | 0,2 | |
| semen olejnin | 0,5 | |
| kompletních krmiv1) pro ryby | 0,005 | |
| 23. Endrin (suma endrinu a delta-ketoi-endrinu, vyjádřená jako endrin) | Všechna krmiva s výjimkou: | 0,01 |
| tuků | 0,05 | |
| 24. Heptachlor (suma heptachloru a heptachlor-epoxydu, vyjádřená jako heptachlor) | Všechna krmiva s výjimkou: | 0,01 |
| tuků | 0,2 | |
| 25. Hexachlor-benzen (HCB) | Všechna krmiva s výjimkou: | 0,01 |
| tuků | 0,2 | |
| 26. Hexachlor-cyklohexan (HCH) | ||
| 26.1 alfa-izomery | Všechna krmiva s výjimkou: | 0,02 |
| tuků | 0,2 | |
| 26.2 beta-izomery | Krmné směsi s výjimkou: | 0,01 |
| krmiv pro dojnice | 0,005 | |
| Krmné suroviny s výjimkou: | 0,01 | |
| tuků | 0,1 | |
| 26.3 gama-izomery | Všechna krmiva s výjimkou: | 0,2 |
| tuků | 2,0 | |
| 27. Dioxin (suma PCDD a PCDF), vyjádřený v mezinárodních toxických ekvivalentech) | Dužina citrusů | 500 pg I-TEQ/kg (horní hranice detekce3) |
| 28. Meruňka - Prunus armeniaca L. | Všechna krmiva | Semena a plody rostlinných druhů, uvedených ve sloupci 1 a produkty jejich zpracování nesmějí být v krmivu obsaženy v kvantitativně stanovitelném množství |
| 29.Mandloň - Prunus dulcis (Mill.) D. A. Webb var.amara (DC.) Focke (= Prunus amygdalus Batsch var.amara (DC.) Focke) | ||
| 30. Bukvice neloupané -Fagus silvatica L. | ||
| 31. Lnička setá -Camelina sativa (L.) Crantz | ||
| 32. Mowrah, Bassia, Madhuca -Madhuca longifolia (L.) Macbr. (= Bassia longifolia L. = Illiped malabrorum Engl.) Madhuca indica Gmelin (= Bassia latifolia Roxb.) = Illipe latifolia (Roscb.) F.Mueller) | Všechna krmiva | Semena a plody rostlinných druhů, uvedených ve sloupci 1 a produkty jejich zpracování nesmějí být v krmivu obsaženy v kvantitativně stanovitelném množství |
| 33. Keř - Jathropa curcas L. | ||
| 34. Kroton - Croton tiglium L. | ||
| 35. Indická hnědá hořčice -Brassica juncea (L.) Czern. And Coss. ssp. integrifolia (West.) Thell. | ||
| 36. Sareptská hořčice - Brassica juncea (L.) Czern. And Coss. ssp. juncea | ||
| 37. Čínská hořčice - Brassica juncea (L.) Czern. And Coss. ssp. juncea var. lutea Batalin | ||
| 38. Černá hořčice - Brassica nigra (L.) Koch | ||
| 39. Etiopská hořčice - Brassica carinata A.Braun | Všechna krmiva | Semena a plody rostlinných druhů, uvedených ve sloupci 1 a produkty jejich zpracování nesmějí být v krmivu obsaženy v kvantitativně stanovitelném množství |
1) Complete feedingstuffs are compound feedingstuffs which, according to their composition, are sufficient to cover the feed ration.
2) For each percentage of phosphorus.
3) Upper concentration limits are calculated provided that all values of different congeners lower than the limit of detection are placed at a level of detection.
"Annex No. 3, Part II, to Decree No. 451 / 2000 Coll.
| Nežádoucí látka | Produkty pro krmení | Maximálně přípustný obsah v krmivu o sušině 88 % |
|---|---|---|
| 1 | 2 | 3 |
| Dioxin (suma polychlorovaných dibenzoparadioxinů (PCDD) a polychlorovaných dibenzofuranů (PCDF), vyjádřená v jednotkách toxických ekvivalentů WHO, při použití WHO-TEFs (faktory toxické ekvivalence, 1997) PCDD/F | Všechny krmné suroviny rostlinného původu, včetně rostlinných olejů a vedlejších produktů | 0,75 ng WHO-PCDD/F-TEQ/kg(1,2) |
| Minerální látky | 1,0ngWHO-PCDD/F-TEQ/kg(1,2) | |
| Živočišný tuk, včetně mléčného tuku a vaječného tuku | 2,0 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| Ostatní produkty suchozemských zvířat, včetně mléka a mléčných produktů a vajec a výrobků z vajec | 0,75 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| Rybí tuk | 6,0 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| Ryby, ostatní vodní živočichové, jejich produkty a vedlejší výrobky s výjimkou rybího tuku3) | 1,25 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| Krmné směsi s výjimkou krmiv pro kožešinová zvířata, domácí zvířata a krmiv pro ryby | 0,75 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| Krmiva pro ryby, krmiva pro domácí zvířata | 2,25 ng WHO-PCDD/F-TEQ/kg(1,2) | |
| 1} Horní hranice koncentrací; horní hranice jsou vypočítány za předpokladu, že všechny hodnoty různých kongenerů, nižší než je mez stanovitelnosti, jsou rovny mezi stanovitelnosti. 2) Tyto maximální limity budou revidovány poprvé před 31.12.2004 podle nejnovějších údajů o přítomnosti dioxinů a PCB vyjádřených jako látky s dioxinovým účinkem, zejména s ohledem na zahrnutí PCB vyjádřených jako látky s dioxinovým účinkem ve stanovených úrovních, a dále budou revidovány před 31.12.2006 s cílem výrazného snížení maximálních hladin. 3) Čerstvé ryby přímo dodané a použité bez zprostředkované úpravy pro výrobu krmiv pro kožešinová zvířata jsou vyjmuty z maximálních limitů. Produkty, zpracované živočišné proteiny vyrobené z těchto kožešinových zvířat, se nesmějí dostat do potravinového řetězce a jejich krmení je zakázáno hospodářským zvířatům, která jsou držena, krmena nebo chována pro produkci potravin.“. | ||
16. In Annex No 14, Part C 2, to Group D. Anticoccidic and chemotherapeutic agents, the following section 9 is added:
| Poř.č. č.EU | Jméno a reg.č. osoby odpovědné za uvedení do oběhu | Doplňková látka (obchodní název) | Složení, chem.vzorec, popis | Druh nebo kategorie zvířat | Maxim. stáří | Min.obsah | Max.obsah | Jiná ustanoveni |
|---|---|---|---|---|---|---|---|---|
| mg účinné látky/kg kompletního krmiva | ||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
| poř.č. 9 č.EU 29 | Phibro Animal Health, sprl | SEMDURAMICINÁT SODNÝ (Aviax 5 %) | složení doplňkové látky: semduramicinát sodný: 51,3 g/kg uhličitan sodný: 40 g/kg minerální olej: 50 g/kg hlinitokřemičitan sodný: 20 g/kg sójový separát: 838,7 g/kg účinná látka: semduramicinát sodný C45H76O16Na číslo CAS: 113378-31-7 sodná sůl ionophorní polyetherické monokarboxylové kyseliny, produkované Actinomadura roseorufa (ATCC 53 664) přidružené cizí látky: dekarboxylsemduramicin ≤ 2% demetoxylsemduramicin ≤ 2% hydroxysemduramicin ≤ 2 % celkem ≤ 5 % | výkrm kuřat | - | 20 | 25 | povoleno do 1.6.2006 ochranná lhůta: nejméně 5 dní“. |
17. In Annex No 14, Part C, 3, Group I. Trace elements in heading No 7, Zinc in column 4, point 7.2 is as follows:
"Zinc chloride monohydrate, ZnCl2.H2O '.
18. In Annex No 14, Part C 4, Group G. Conservatives:
| „Poř.č. č.EU | Jméno a reg.č. osoby odpovědné za uvedení do oběhu | Doplňková látka | Chem. vzorec, popis | Druh nebo kategorie zvířat | Maxim. stáří | Min. obsah | Max. obsah | Jiná ustanoveni |
|---|---|---|---|---|---|---|---|---|
| mg/kg kompletního krmiva | ||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
| G.Konzervanty | ||||||||
| poř.č. 1 č.EU 507 | KYSELINA CHLOROVODÍKOVÁ | HCl | jen pro siláže a pro krev ke krmným účelům, povoleno do 31.12.2003 | |||||
| poř.č. 2 č.EU 1 | BENZOÁT SODNÝ 140 g/kg KYSELINA PROPIONOVÁ 370 g/kg PROPIONÁT SODNÝ 110 g/kg | složení doplňkové látky: benzoát sodný 140 g/kg kyselina propionová 370 g/kg propionát sodný 110 g/kg voda 380 g/kg účinná látka: benzoát sodný C7H5O2Na kyselina propionová C3H6O2 propionát sodný C3H5O2Na | prasata | - | 3 000 | 22 000 | pro konzervaci obilovin s obsahem vlhkosti vyšším než 15% povoleno do 1.8.2006 | |
| dojnice | - | 3 000 | 22 000 | pro konzervaci obilovin s obsahem vlhkosti vyšším než 15% povoleno do 1.8.2006“. | ||||
19. In Annex No 14, Part C 4, group G / 1, micro-organisms and silage-only enzymes:
| „Poř.č. | Doplňková látka, složení přípravku | Chemický vzorec, popis, Obchodní označení | Druh nebo kategorie zvířat | Dávkování přípravku na 1 tunu původní hmoty | Jiná ustanovení | |
|---|---|---|---|---|---|---|
| min. | max. | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |
| G/1. Mikroorganismy a enzymy jen pro silážování | ||||||
| 1 | Lactobacillus plantarum (ATCC 4008) | 5,0.1010 CFU/g | skot | 2,5 g | 5g | vhodné zejména pro kukuřičné siláže |
| Pediococcus acidilactici (NCIB 30084) | 5,0.1010 CFU/g MAIZE-ALL | povoleno do 31.12.2003 | ||||
| 2 | Lactobacillus plantarum (ATCC 8014) | 4,5.1010 CFU/g | skot | 2,5 g | 10g | vhodné zejména pro bílkovinné a polobílkovinné siláže |
| Enterococcus faecium (ATCC 19434) | 1,0.1010 CFU/g | |||||
| Pediococcus acidilactici (ATCC 8042) | 4,5.1010 CFU/g SIL-ALL R | povoleno do 31.12.2003 | ||||
| 3 | Lactobacillus plantarum (ATCC 8014) | 5,0.1010 CFU/g | skot | 2,5 g | 5g | vhodné zejména pro kukuřičné siláže |
| Pediococcus acidilactici (ATCC 8042) | 5,0.1010 CFU/g MAIZE-ALL R | povoleno do 31.12.2003 | ||||
| 4 | Lactobacillus plantarum, Pedicococcus acidilactici (NCIB 30083) (NCIB 30084) (NCIB 30085) (NCIB 30086) celuláza | 1,0.106 CFU/g 43 000 HEC/g Feedtech | skot | 15 g | 21,4 g | povoleno do 31.12.2003 |
| 5 | Enterococcus faecium (DSM 4788) (DSM 4789) Lactobacillus plantarum (DSM 4784) (DSM 4785) (DSM 4786) (DSM 4787) | 1,35.1011 CFU/g nosič - maltodextrin thiosulfát sodný brilantní modř křemičitan sodno-hlinitý SILA-BAC vodorozpustný | skot | 8g (10 ml) | sušina hmoty 25-55% možno zkrmovat od 14. dne po naskladnění při dodržení podmínek silážování doba použití 3 roky naředěný 6 týdnů (zamražený) povoleno do 31.12.2003 | |
| 6 | Enterococcus faecium (DSM 4788) (DSM 4789) Lactobacillus plantarum (DSM 4784) (DSM 4785) (DSM 4786) (DSM 4787) | 2,0.108 CFU/g nosič - uhličitan vápenatý SILA-BAC granulovaný | skot | 500 g | všechny druhy pícnin sušina hmoty 25-45% možno zkrmovat od 14. dne po naskladnění při dodržení podmínek silážování doba použití 2 roky povoleno do 31.12.2003 | |
| 7 | Lactobacillus büchneri (ATCC 202118) | 1,0.1011 CFU/g nosič - maltodextrin thiosulfát sodný brilantní modř křemičitan sodno-hlinitý SILA-BAC stabilizer | skot | 1 g (10 ml) | zlepšení aerobní stability siláží povoleno do 21.12.2003 | |
| 8 | Enterococcus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pediococcus pentosaceus (CCM 3770) Endo-1,4-beta-glukanáza EC 3.2.1.4. Endo-1,4-beta-xylanáza EC 3.2.1.8. | 15.109 CFU/g 13 100 CU/ml 10 800 U/ml Cornsil | skot prasata | 10 g 100 ml | celkový počet jednotek tvořících kolonii 100 ml enzymatické složky se smíchá se 100 ml vody, ve které je rozpuštěno 10 g bakteriální složky určeno pro konzervaci dělené sklizně rostlin (silážování celých rostlin a drtí obilovin) povoleno do 31.12.2003 | |
| 9 | Enterecoccus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Lactobacillus büchneri (CCM 1819) Pediococcus pentosaceus (CCM 3770) | 15.109 CFU/g Microsil extra plus | skot prasata | 8g | 15 g | celkový počet jednotek tvořících kolonii dávkování podle silážovatelnosti a obsahu sušiny konzervované píce ve formě vodného roztoku určeno pro glycidová a obtížně silážovatelná objemná krmiva s rizikem sekundární fermentace povoleno do 31.12.2003 |
| 10 | Enterococcus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pediococcus pentosaceus (CCM 3770) Lactobacillus büchneri (CCM 1819) | 100.109 CFU/g Profisil | skot prasata | 5g | 10 g | celkový počet jednotek tvořících kolonii určeno pro konzervaci pícnin ohrožených nežádoucími typy fermentačních procesů povoleno do 31.12.2003 |
| 11 | Enterococcus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pediococcus pentosaceus (CCM 3770) Endo-1,4-beta-glukanáza EC 3.2.1.4. | 15.109 CFU/g 13 100 CU/ml Goldzym | skot | 10 g 100 ml | 100 ml enzymatické složky se smíchá se 100 ml vody, ve které je rozpuštěno 10 g bakteriální složky určeno pro konzervaci bílkovinných a polobílkovinných pícnin s vyšším obsahem sušiny povoleno do 31.12.2003 | |
| 12 | Enterecoccus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pedioucoccus pentosaceus (CCM 3770) | 600.106 CFU/g Microsil granulát | skot prasata | 250 g | 350 g | celkový počet jednotek tvořících kolonii určeno pro konzervaci glycidových typů pícnin, výhradně pro suchou aplikaci povoleno do 31.12.2003 |
| 13 | Enterococcus faecium (CCM 6226) Laktobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pediococcus pentosaceus (CCM 3770) Endo-1,4-beta-glukanáza EC 3.2.1.4. Glukozo-oxidáza EC 1.1.3.4. | 15.109 CFU/g 16875 CU/ml 288 IU/ml Bactozym | skot | 10 g 100 ml | celkový počet jednotek tvořících kolonii 100 ml enzymatické složky se smíchá se 100 ml vody, ve které je rozpuštěno 10 g bakteriální složky určeno ke konzervaci obtížně silážovatelných pícnin povoleno do 31.12.2003 | |
| 14 | Enterococcus faecium (CCM 6226) Lactobacillus casei (CCM 3775) Lactobacillus plantarum (CCM 3769) Pediococcus pentosaceus (CCM 3770) | 10,0.109 CFU/g Microsil | skot prasata | 8g | 15 g | určeno pro konzervaci glycidových a obtížně silážovatelných objemných krmiv povoleno do 31.12.2003 |
| 15 | Lactobacillus plantarum (INTL 30) | 2,34.1011 CFU/g nosič - glukóza monohydrát AGROS CLAMP (LIQUID) | skot | 6g | 6g | určeno pro polobílkovinné a bílkovinné siláže, senáže, povoleno do 31.12.2003 |
| 16 | Lactobacillus plantarum (INTL 30) Lactobacillus brevis (DSM 12835) | 2,5.1010 CFU/g 6,25.109 CFU/g nosič - sušený česnekový extrakt AGROS MAIZE | skot | 8g | 16g | určeno pro kukuřici na siláž a LKS povoleno do 31.12.2003 |
| 17 | Lactobacillus plantarum (DSM 13366) Lactobacillus plantarum (DSM 13367) | 1,0.105 CFU/g Biomax 5 | skot | 1 g | určeno pro kukuřičná siláž povoleno do 31.12.2003 | |
| 18 | Lactobacillus plantarum (DSM 12771) | 1,0.105 CFU/g Biomax Si | skot | 2g | určeno pro všechny druhy objemných a koncentrovaných krmiv povoleno do 31.12.2003 | |
| 19 | Lactobacillus plantarum (DSM 4744) Pediococcus pentosaceus (DSM 4745) | 1,0.105 CFU/g Biomax MP | skot | 2g | určeno pro všechny druhy objemných a koncentrovaných krmiv povoleno do 31.12.2003 | |
| 20 | Lactobasillus casei ssp. rhamnosus (DSM 7061) Propionibacterium freundenreichii ssp. Shermanii (DSM 6067) | 1,0.106 CFU/g Bioprofit | skot | 1 g | 2g | určeno pro všechny druhy objemných a koncentrovaných krmiv povoleno do 31.12.2003 |
| 21 | Lactobacillus plantarum (NCIMB 30146) (NCIMB 30147) (NCIMB 30148) | 1,0.106 CFU/g LIVESYSTEM | skot | 1 g | vhodné pro silážování kukuřice povoleno do 31.12.2003 | |
| 22 | Lactobacillus plantarum (NCIMB 30148) (NCIMB 41028) Lactobacillus lactis (NCIMB 30149) | 1,0.106 CFU/g POWERSTART | skot | 1 g | vhodné pro silážování trav jetelotravních a vojtěškotravních směsí povoleno do 31.12.2003 | |
| 23 | Lactobacillus rhamnosus (NCIMB 30121) Enterococcus faecium (NCIMB 30122) | 2,0.108 CFU/g nosič - uhličitan vápenatý BONSILAGE granulát | skot | 500 g | 500 g | určeno pro travní siláže, jetelotravní, vojtěškové siláže (22-45% sušiny), kukuřičné siláže. zkrmování povoleno od 3. týdne od ukončení naskladnění. povoleno do 31.12.2003 |
| 24 | Lactobacillus rhamnosus (NCIMB 30121) Enterococcus faecium (NCIMB 30122) | 1,0.1011 CFU/g nosič - sušená syrovátka BONSDLAGE vodorozpustná | skot | 1 g | 1 g | určeno pro travní siláže, jetelotravní, vojtěškové siláže (22-45 % sušiny), kukuřičné siláže zkrmování povoleno od 3.týdne od ukončení naskladnění povoleno do 31.12.2003 |
| 25 | Lactobacillus rhamnosus (NCIMB 30121) Lactobacillus plantarum (DSM 12836) Lactobacillus brevis (DSM 12835) Lactobacillus büchneri (DSM 12856) Pediococcus acidilactici (DSM 12834) | 2,0.108 CFU/g nosič - uhličitan vápenatý BONSILAGE PLUS granulát | skot | 50 g | 50 g | určeno pro kukuřičnou, travní, jetelotravní, vojtěškovou siláž a GPS (>30% sušiny), kvašení podporující fázi sekundární stability je ukončeno po 8 týdnech po naskladnění povoleno do 31.12.2003 |
| 26 | Lactobacillus rhamnosus (NCIMB 30121) Lactobacillus plantarum (DSM 12836) Lactobacillus brevis (DSM 12835) Lactobacillus büchneri (DSM 12856) Pediococcus acidilactici (DSM 12834) | 1,0.1011 CFU/g nosič - sušená syrovátka BONSILAGE PLUS vodorozpustná | skot | 1 g | 1 g | určeno pro kukuřičnou, travní, jetelotravní, vojtěškovou siláž a GPS (>30% sušiny) kvašení podporující fázi sekundární stability je ukončeno po 8 týdnech po naskladnění povoleno do 31.12.2003 |
| 27 | Lactobacillus büchneri (DSM 12856) Lactobacillus plantarum (DSM 12837) Pediococcus acidilactici (DSM 12834) | 4,0.108 CFU/g nosič - uhličitan vápenatý BONSILAGE MAIS granulát | skot | 250 g | 250 g | určeno pro kukuřičnou siláž (28-35% sušiny), GPS (30-40% sušiny) minimální doba fermentace pro dosažení dobré sekundární stability je 8 týdnů povoleno do 31.12.2003 |
| 28 | Lactobacillus büchneri (DSM 12856) Lactobacillus plantarum (DSM 12837) Pediococcus acidilactici (DSM 12834) | 1,0.1011 CFU/g nosič - laktóza BONSILAGE MAIS vodorozpustná | skot | 1 g | 1 g | určeno pro kukuřičnou siláž (28-35% sušiny), GPS (30-40% sušiny) minimální doba fermentace pro dosažení dobré sekundární stability je 8 týdnů povoleno do 31.12.2003 |
| 29 | Lactobacillus plantarum (MA 541/2 E) Lactobacillus casei (MA 67/4 U ) Lactobacillus bulgaricus (MA 547 3 M) Alfa-amyláza (EC. 3.2.1.1.) Endo-1,4-beta-glukanáza (Celuláza) Endo-1,3 (4)-beta-glukanáza (EC 3.2.1.6.) | 9,8.108 CFU/g 2,0.107 CFU/g 5,0.105 CFU/g nosič - laktóza (92,40) MIN. 100μ/g MIN. 100μ/g MIN. 100μ/g KEM LAC DRY | skot | 10 g | 15 g | určeno pro konzervaci vojtěškových, jetelových a travních senáží GPS leguminóz kukuřičného zrna kukuřičné siláže povoleno do 31.12.2003 |
| 30 | Lactobacillus plantarum (MA 18/5 U) Pediococcus acidilactici (MA 18/5 M) | 1,0.1010 CFU/g 3,0.109 CFU/g nosič - laktóza KEM SIL LAC ULTRA DRY | skot | 15g | 25 g | určeno pro konzervaci vojtěškových, jetelových a travních senáží GPS leguminóz kukuřičného zrna kukuřičné siláže povoleno do 31.12.2003 |
| 31 | Lactobacillus plantarum (DSM 8862) (DSM 8866) | 3,0.105 CFU/g nosič - laktóza -ad 200g AG-BAG BIO-SIL | skot výkrm prasat | 1 g | 2g | určeno pro polobílkovinné siláže sušina - min 35% max 45% kukuřičné siláže - vhodné i pro vlhké zrno a kukuřičné (CCM) zkrmování siláže povoleno od 6 týdne od ukončení uskladnění skladovat v chladu a suchu chránit před slunečními paprsky neředit chlorovanou vodou povoleno do 31.12.2003 |
| 32 | Celuláza (EC3.2. 1.4.) (endo-1,4 - beta-glukanáza) Manan Endo - 1,4,-beta-manosidáza (EC3.2. 1.78) (hemiceluláza) | nosič - glukóza monohydrát AGROS CLAMP (LIQUID) plus | skot | 6g | 6g | V označení se uvede název podle sloupce 2 povoleno do 31.12.2003 |
| 33 | Alfa-amyláza (EC 3.2.1.1) Hemiceluláza (EC 3.2.1.78 Lipáza (EC 3.1.1.3) Pektináza (polygalakturonáza) (EC 3.2.1.15) Proteáza (EC 3.4.24.4) | minimum aktivity 20 000 RAU/ml pro kapalnou formu 1,4-beta-D-mannan-mannanohydroláza triacylglycerol-acelhydroláza poly (1,4-alfa-D-galaktouronido)-glykanhydróza mikrobiální metaloproteinázy nosič - - kukuřičné otruby - 1.36 - kukuřičný škrob - 1.41 - uhličitan vápenatý (krmný vápenec) -11.01 - křemičitan sodnohlinitý, syntetický CEU 554 AG-BAG PLUS | skot výkrm prasat | 1 800 RAU | - | určeno pro těžce senážovatelné plodiny -vojtěška, jetel, trávy obsah sušiny (28-45%) zkrmování siláže povoleno od 6 týdne od naskladnění skladovat v chladu (pod 18°C) a suchu, chránit před slunečními paprsky, neředit chlorovanou vodou V označení se uvede název podle sloupce 2 povoleno do 31.12.2003 |
| 34 | Pediococcus acidilactici CNCMMA 18/5 M | 1,75.1010 CFU/g | skot | 10 g | v návodu pro užití uvedena teplota při skladování, doba trvanlivosti a stabilita při granulování zlepšení mléčné fermentace u siláží s nízkým obsahem cukru | |
| Lactobacillus plantarum CNCMMA 18/5 U | 7,5.1010 CFU/g | |||||
| Endo-1,4-beta-glukanáza (celuláza, EC 3.2.1.4) | nosič - laktóza (mléčné výrobky, 8.07) | |||||
| LALSIL */ PS | povoleno do 31.12.2003 | |||||
| 35 | Probionibacterium acidipropionici CNCM MA 26/4 U | 3,0.1010 CFU/g nosič - laktóza (mléčné výrobky, 8.07) | skot prasata výkrm | 5g | v návodu pro užití uvedena teplota při skladování, doba trvanlivosti a stabilita při granulování zlepšení mléčné fermentace u siláží s vysokým obsahem cukru | |
| Lactobacillus plantarum CNCMMA 18/5 U | 3,0.1010 CFU/g | |||||
| LALSIL* MS01 | povoleno do 31.12.2003 | |||||
| 36 | Pediococcus acidilactici CNCMMA 18/5 U Lactobacillus plantarum CNCMMA 18/5 U | 1,0.1010 CFU/g nosič - laktóza (mléčné výrobky, 8.07) 3,0.109 CFU/g | skot | 10 g | v návodu pro užití uvedena teplota při skladování, doba trvanlivosti a stabilita při granulování zlepšení mléčné fermentace u siláží s vysokým obsahem cukru | |
| LALSIL* CL | povoleno do 31.12.2003 | |||||
| 37 | Lactobacillus plantarum (ATCC 4008) | 4,5.1010 CFU/g | skot | 2,5 g | 10g | vhodné zejména pro bílkovinné a polobílkovinné siláže |
| Enterococcus faecium (ATCC 19434) | 1,0.1010 CFU/g | |||||
| Pediococcus acidilactici (NCIB 30084) | 4,5.1010 CFU/g SIL-ALL | povoleno do 31.12.2003 | ||||
20. In Annex No 14, Part C 4, Group I. Trace elements are:
| „Poř.č. č.EU | Jméno a reg.č. osoby odpovědné za uvedení do oběhu | Prvek | Doplňková látka | Maximální obsah prvku v mg/kg kompletního krmiva | Jiná ustanovení |
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 |
| I. Stopové prvky | |||||
| poř.č. 1 č.EU 4 | MĚĎ | Síran lyzino-měďnatý, Cu(C6H13N2O2)2SO4 | výkrm prasat: - při počtu 175 prasat/100 ha využívané zemědělské půdy nebo vyšším - do 16 týdnů: celkem 175 - při počtu nižším než 175 prasat/100 ha využívané zemědělské půdy: - do 16 týdnů: celkem 175 | 1. max.50 mg Cu ze síranu lyzino-měďnatého v 1 kg kompletního krmiva 2. povoleno do 30.9.2004 | |
| výkrm prasat: - při počtu 175 prasat/100 ha využívané zemědělské půdy nebo vyšším - od 17 týdnů do dospělosti: celkem 35 - při počtu nižším než 175 prasat/100 ha využívané zemědělské půdy: - od 17 týdnů do 6 měsíců: celkem 100 - od 6 měsíců do porážky: celkem 35 chovná prasata: celkem 35 ostatní druhy nebo kategorie zvířat kromě telat do počátku přežvykování a ovcí: celkem 35 | 1. max.25 mg Cu ze síranu lyzino-měďnatého v 1 kg kompletního krmiva 2. povoleno do 30.9.2004 | ||||
| poř.č. 2 | CHROM | Mléčnan chromitý, trihydrát Cr(C3H5O3)3.3 H2O | 0,3 pro výkrm prasat | výrobce Agrobac CZ povoleno do 31.12.2003 | |
| poř.č. 3 | KOBALT | Mléčnan kobaltnatý trihydrát, Co(C3H5O3)2.3H2O | 0,072 pro výkrm prasat a kuřat | výrobce Agrobac CZ povoleno do 31.12.2003 | |
| poř.č. 4 | MANGAN | Mléčnan manganatý trihydrát Mn(C3H5O3)2.3H2O | 35 pro výkrm prasat a kuřat | výrobce Agrobac CZ povoleno do 31.12.2003“. | |
21. In Annex No 14, Part C, 4, to Group P. Enzymes, point 5 shall be deleted for headings 62 and 64 in column 7.
22. Annex No 14, Part C 4, to Group P. Enzymes, Nos 23 and 63, read:
| „Poř.č. č.EU1) | Doplňková látka | Chem. vzorec, popis | Druh nebo kategorie zvířat | Maxim. stáří | Min. obsah | Max. obsah | Jiná ustanovení |
|---|---|---|---|---|---|---|---|
| jednotek aktivity v 1 kg kompletního krmiva | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | |
| poř.č. 23 č.EU 24 | Endo-1,3(4)-beta- glukanáza (EC 3.2.1.6.) Endo-1,4-beta-xylanáza (EC 3.2.1.8.) | Přípravek endo-1,4-beta-xylanázy a endo-1,3(4)-beta-glukanázy z Aspergillus niger (CNCM 1-1517) s minimem aktivity 28 000 QXU31)/g a 140 000 QGU32)/g | výkrm kuřat | - | 420 QXU 2 100 QGU | 1 120 QXU 5 600 QGU | 1. jako u poř. č. 1 2. doporučená dávka 560 QXU a 2 800 QGU na 1 kg komplet, krmiva 3. pro krmné směsi bohaté neškrobovými polysacharidy (hlavně arabinoxylany a beta - glukany), např. obsahující více než 30% pšenice a 30% ječmene (platí pro výkrm kuřat) nebo více než 20% pšenice a/nebo ječmene (platí pro nosnice) 4. povoleno do 30.6 2004 (platí pro výkrm kuřat a do 1.10.2006 (platí pro nosnice) |
| nosnice | - | 560 QXU 2 800 QGU | - - | ||||
| poř.č. 63 | Endo-1,3 (4)-beta- glukanáza (EC 3.2.1.6.) Endo-1,4-beta-xylanáza (EC 3.2.1.8.) | přípravek endo-1,3 (4)-beta-glukanázy a endo-1,4-beta-xylanázy z Trichoderrna longibrachiatum (CBS 357.94) s minimem aktivity 8 000 BGU19)/g a 11 000 EXU20)/g pro práškovou, 6 000 BGU/g a 8250 EXU/g pro granulovanou a 2 000 BGU/ml a 2 750 EXU/ml pro kapalnou formu | selata | 4 měsíce | 600 BGU 800EXU | - | 1. jakou poř.č. 1 2. doporučená dávka 600 BGU a 800 EXU na 1 kg kompletního krmiva 3. pro krmné směsi bohaté neškrobovými polysacharidy (hlavně arabinoxylany a (β-glukany), např.obsahující více než 35 % pšenice, 20 % triticale, 5 % žita a 15 % ječmene 4. povoleno do 31.12.2003“. |
| výkrm prasat | - | 600 BGU 800EXU | - | ||||
23. Annex No 23 Part I read:
"Annex No 23, Part I, to Decree No 451 / 2000 Coll.
BIOLOGICAL TESTING OF ADDITIONAL SUBSTANCES
BIOLOGICAL TESTING OF ADDITIVES OTHER THAN MICROORGANISMS AND ENZYMES
The biological testing of feed additives other than micro-organisms and enzymes shall follow the procedures set out in Part I.A. All tests and tests listed below may be required and further information may be required.
The tests carried out are a basis for the processing of dossier (dossier) on substances and preparations for which authorisation should be sought as feed additives or for the new use of an authorised additive. In this Part of the Annex, the term "additive 'refers to active chemically defined substances or preparations containing active substances in the state in which they are incorporated into premixtures and feedingstuffs. The dossier shall allow the evaluation of additives on the basis of the current state of knowledge which is a prerequisite for their authorisation to comply with the established principles.
Where the dossier concerns a feed additive originating in or containing genetically modified organisms within the meaning of Article 2 (1) and (2) of Council Directive 2001 / 18 / EC, the information listed in the first subparagraph of Article 7a of Council Directive 70 / 524 / EEC shall be included in the dossier in addition to the information required in this Annex.
The document shall contain detailed reports of all tests carried out, presented in the order and numbering set out in this Annex. It shall contain references and copies of all published scientific data concerning the evaluation of the additive. An electronic version of the documentation shall be supplied. The conclusion of the tests is to clarify whether the use of the additive is safe:
(a) in view of the target species at concentrations proposed in feedingstuffs;
(b) against persons who may be exposed to the additive by inhalation, other contact of mucous membranes, eyes or skin during handling of the additive as such or incorporated into premixtures or feedingstuffs;
(c) consumers who eat food derived from animals to which the additive has been submitted and which may contain residues of the additive or its metabolites; the safety of use will generally be ensured by setting maximum residue levels (MRLs) and withdrawal periods;
(d) animals and humans, due to the selection and distribution of antimicrobial-resistant genes;
(e) to the environment, taking into account the risks arising from the additive itself or its products directly or eliminated by animals.
In principle tests shall be carried out to determine the identity, conditions of use, physico-chemical properties, methods of determination and efficacy of the additive, its metabolism and residues, physiological and toxicological effects on the target species. If the additive is intended for an animal category belonging to a particular species, the efficacy and residues tests shall be carried out on that target category. The tests necessary for the assessment of the risk to human health and the environment will in principle depend on the nature of the additive and the circumstances of its use. There is no strict rule in this respect.
Additional information may be required if necessary. If no information specified in the instructions is supplied in the documentation, this shall be justified. In particular, tests on mutagenicity, carcinogenicity and reproductive toxicity may be omitted only if the chemical composition, practical results or other evidence reasonably eliminates these effects.
Expert opinions on the quality, efficacy and safety of the additive shall be drawn up. The authors of these opinions must have competence based on higher education obtained by study in an accredited study programme in the relevant field of study, be recognised experts in the field concerned and must not be personally involved in conducting experiments included in the documentation. The assessments shall contain a critical assessment of the documentation supplied by the applicant; just a summary is not enough.
The determination of physicochemical, toxicological and ecotoxicological properties shall be carried out using official methods or updated methods recognised by international scientific institutions. The use of other methods shall be justified.
Each dossier shall contain an appropriate summary of the tests and the design of the Annex and may contain a monograph. Documentation concerning antibiotics, coccidiostats and therapeutic substances and growth promoters shall be accompanied by a monograph in accordance with Annex 25 to this Regulation and shall allow the additive concerned to be identified and characterised. An identification record shall be provided for all additives.
For feed additives intended exclusively for domestic animals, it is not always necessary to submit these additives to an exhaustive number of attempts at chronic toxicity, mutagenicity, reproductive toxicity and carcinogenicity as required for feed additives for farmed animals whose products are intended for human consumption. Tests on residues in domestic animals are not required.
The test for the metabolism of feed additives in target food-producing animals and in laboratory species used for toxicity testing shall be carried out in accordance with specific legislation1) and is necessary to:
(a) there are adequate data on the toxicity of the parent additive and any metabolite produced in the target species to which the consumer might be exposed. To this end, it is important to compare the metabolism of the additive in the target species and in laboratory animal species used for toxicity testing;
(b) identify and quantify the appropriate residue marker applicable for the determination of residue labelling MRLs and the duration of the withdrawal period for the final product.
1. Summary of data
The summary shall be arranged in the order set out in the Annex and shall contain all the ingredients in the same order as the Annex with a reference to the relevant pages in the dossier.
2. Identity, properties and conditions of use of the additive; control methods
2.1. Identity
2.1.1. Proposed protected name
2.1.2. Type according to its main effect. Information on the mode of action should be provided as far as possible. Any other active substances must be specified.
2.1.3. Qualitative and quantitative composition (active substance, other ingredients, impurities, variability of individual batches). If the active substance is a mixture of active ingredients, each of which is clearly definable, the main components must be described separately, indicating their ratio in the mixture.
2.1.4. Physical condition, particle size distribution, particle form, density, volume density; for liquids: viscosity, surface tension.
2.1.5. Method of production, including any special treatment.
2.2. Properties of active substance (s)
2.2.1. Generic name, chemical name according to IUPAC nomenclature, other generic international names and abbreviations. CAS number (Chemical abstract service number).
2.2.2. Structural formula, molecular formula and molecular weight
For active substances from fermentation production: microbial origin (name and place of culture collection, recognised as an international depository preferably in the European Union where the strain is stored, the storage number and all morphological, physiological, genetic and molecular properties relevant for its identification). For genetically modified strains, information on genetic modification shall be provided.
2.2.3. Purity
Identification and qualification of any chemical and microbial impurities and toxic substances, confirmation of absence of production of organisms.
2.2.4. Important properties
Physical properties of chemically defined substances: degradation constant, pKa, electrostatic properties, melting point, boiling point, density, steam pressure, solubility in water and organic solvents, Kow and Koc, mass and absorption spectrum, NMR data, possible isomers and any other important properties
2.2.5. Method of production, cleaning processes, used media and for fermentation products variability of individual batches.
2.3. Characteristics of the additive: physico-chemical and technological properties
2.3.1. Stability of each form of additive when exposed to external conditions such as light, temperature, pH, moisture, oxygen and packaging materials. Expected storage life of the additive in marketable form.
2.3.2. The stability of each form of additive in the preparation and storage of premixtures and feedingstuffs in particular stability under the assumed conditions of production or storage (moisture, temperature, pressure, cut, time and packaging material). Possible deterioration of quality or degradation of products. Expected durability of the additive.
2.3.3. Other appropriate physicochemical or technological properties for producing and maintaining homogeneous mixtures in premixtures and feedingstuffs, dust and electrostatic properties, solubility in liquids.
2.3.4. Incompatibility or interactions that could occur in contact with feed, media, other authorised additives or therapeutic substances.
2.4. Conditions of use of the additive.
2.4.1. If the additive has technological and zootechnical significant effects, it shall meet the requirements for both the technological and zootechnical aspects. The requirements concerning each additive shall be marked and justified.
2.4.2. Proposed technological use in the production of feed or, where appropriate, feed materials.
2.4.3. The proposed method of use in animal nutrition (e.g.: species or categories of animals, age groups, animal production stage, feed type and contraindications).
2.4.4. The proposed method and the level of incorporation in premixtures and feedingstuffs or, where appropriate, feed materials and quantities, expressed as a proportion of the additive and chemically defined substances for feed premixtures, or, where appropriate, feed materials with the proposed dosage in final feed and the proposed period of administration and, if necessary, the duration of the withdrawal period.
2.4.5. Data concerning other known uses of the active substance, such as food, human or veterinary medicine, agriculture and industry, should be provided.
2.4.6. List of data on material safety and, where appropriate, measures proposed to prevent professional risks and protective equipment in the manufacture, handling, use and disposal of material.
2.5. Control methods
2.5.1 Description of the methods used to determine the criteria listed in points 2.1.3, 2.1.4, 2.2.3, 2.3.1, 2.3.2 and 2.3.3.
2.5.2. Description of qualitative and quantitative analytical methods for routine control of the active substance in premixtures and feedingstuffs. These methods shall be validated by a ring test involving at least four laboratories or be validated on the spot according to international harmonised guidelines for the internal validation of methods of analysis according to the following parameters: usability, selectivity, calibration, accuracy, accuracy, extent, limits of detection, measurable sensitivity limit, materiality and feasibility. Evidence must be provided that these characteristics were actually assessed (2.5.4.).
2.5.3. Description of qualitative and quantitative analytical methods for the determination of labelled residues of active substance in tissues of target animals and animal products.
2.5.4. The methods referred to in points 2.5.2 and 2.5.3 shall be supplemented by information concerning the sampling method used, the percentage results, the specificity, accuracy, the limit of detection, the limit of quantification and the validation procedure used. The active substance or labelled residue reference standards shall be available as well as information on the optimal storage conditions of those reference standards. When designing methods, account must be taken of the fact that their levels must be lower than the MRLs. Furthermore, it must be assumed that this method is suitable for routine analysis.
3. Tests concerning the efficacy of the additive
3.1. These studies concern technological additives such as antioxidants, preservatives, binders, stabilisers, emulsifiers, gelling agents, pH control substances, etc., which are intended to improve or stabilise the properties of premixtures and feedingstuffs but do not have direct biological effects on animal production. All required effects shall be supported by scientific data.
The efficacy of the additive shall be demonstrated using the appropriate criteria specified in the methods recognised as acceptable under the intended conditions of use as compared to appropriate control feed. Such research shall be designed and carried out in such a way that it can be statistically evaluated.
Complete information on active substances, preparations, premixtures and tested feedingstuffs, batch reference number, detailed processing and test conditions shall be provided. For each test, both technological and biological effects shall be described.
3.2. Tests on animal effects
Tests on zootechnical additives shall be carried out on target species / categories of animals to which the additive is intended compared to negative control groups (i.e. groups that do not receive antibiotics or growth promoters or any other medicinal substances) and, where appropriate, groups of animals that receive feed containing feed authorised, the efficacy of which is known and used at recommended doses (positive control).
The animals must be healthy and preferably come from a homogeneous group.
Tests shall allow the assessment of the efficacy of the additive in accordance with agricultural practice. Where possible, similar protocols for all experiments should be used, so that data can be verified in a consistent and aggregated manner (if tests so require) for statistical assessment.
No single model is recommended, while some flexibility is left for scientific opinion on the model and conduct of studies. The experimental protocol used shall be justified in view of the intended use of the additive and shall include consideration of appropriate statistical evidence.
3.2.1. For coccidiostats and other medicinal substances
In particular, attention must be drawn to the existence of specific effects (e.g. controlled species, stage or stage of the developmental life cycle concerned) and, in particular, to prophylactic properties such as pathological phenomena, mortality, oocysts, lesions.
Information relating to the effect on production efficiency and the increase in live weight shall be provided.
The required efficacy data relate to three stages in target animals:
(a) controlled cage experiments (single and mixed infections);
(b) controlled free-housing experiments (simulated conditions of use);
(c) field trials controlled (actual conditions of use)
At the same time and if necessary, additional data shall be recorded in production efficiency experiments in order to assess the interaction between growth and feed conversion or effects on fertilisation and hatching of eggs (breeding poultry).
3.2.2. For other zootechnical additives
Information on the effects on feed intake, body weight, production efficiency (preferably dry matter), product quality and yield and any other parameter having a positive effect on the animal, the environment, the producer or the consumer shall be provided. Alternatively, studies should include dose relationship and response data.
3.2.3. Experimental Conditions
Attempts must be carried out at least two different locations. Two separate reports shall be drawn up specifying the results of the checks and each experiment. The test report shall be carefully prepared and shall contain the basic information described below:
3.2.3.1. herd or flock: place and number, conditions of feeding and rearing, method of feeding; for aquatic species: size and number of tanks or cages on farms and water quality.
3.2.3.2. Animals: species (for aquatic species intended for human consumption, the name of the species shall be given and the Latin name or name according to Linné- (a), breed, age, sex, labelling method, physiological stage and general health status shall be indicated.
3.2.3.3. Number of test and control groups, number of animals per group. The number of animals used for experiments shall allow statistical analysis. The statistical evaluation methods used shall be indicated. At least three independent comparative experiments shall be carried out on a probability level of p < 0,05 in each animal category to show the expected effect. In the case of ruminants, a lower level of probability p < 0,10 may be accepted. All animals or experimental units with which experiments have been carried out shall be included in the report. Cases which cannot be classified due to deficiencies or loss of data shall be reported and their presence in animal groups evaluated.
3.2.3.4. Diets: description of production and quantitative composition of diet (diets), indicating the ingredients used, the relevant nutrients (analysed values) and energy values. Feed intake data.
3.2.3.5. The concentration of the active substance (and in the case of substances) used for comparative purposes in feedingstuffs shall be determined by a control analysis according to the appropriate recognised method. Batch reference numbers.
3.2.3.6. Data and exact duration of experiments. Data and nature of tests carried out.
3.2.3.7. A dose determination study: the purpose of these studies is to explain the reasons for the selection of the dose or dosage scale that shows the optimal effect. The determination of the dose is based on control (without antibiotics, growth promoters or other medicinal substances) and at least three non-zero levels in target animals.
3.2.3.8. The moment and occurrence of any undesirable effect of experiments in individuals or groups shall be recorded including any details of the observation programme used in the test.
3.2.3.9. All additives tested under field conditions shall have good scientific records of safety for users, consumers, animals and the environment. If the additive does not satisfy the consumer safety requirements, any study carried out shall be designed to prevent the introduction of animal products derived from experimental animals into the human food chain.
3.3. Study on the quality of products of animal origin
Products of animal origin shall be tested for their organoleptic, nutritional, hygienic and technological properties.
3.4. Study on the effects on the properties of animal waste
If the additive is intended to alter certain properties of animal waste (such as nitrogen, phosphorus, odour, volume) studies demonstrating these properties are required.
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Regulation Information
| Citation | 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. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.2002 |
|---|---|
| Effective from | 01.01.2003 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Agriculture
The regulation text is for informational purposes only.
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