Decree of the Ministry of Health No. 273 / 2000 Coll.

Decree of the Ministry of Health laying down the maximum permitted residues of veterinary medicinal products and bioactive substances used in animal production in food and food ingredients

Valid Order Effective from 01.09.2000
Contents
273
DECLARATION
Ministry of Health
of 28 July 2000
laying down maximum permitted residues of veterinary medicinal products and bioactive substances used in animal production in foodstuffs and food ingredients
According to Section 19 (a) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws:
§ 1
This decree sets maximum permitted residues ("maximum residue levels') for veterinary medicinal products and biologically active substances used in animal production in food and food raw materials.
§ 2
(1) For the purposes of this decree:
(a) veterinary medicinal products of all active substances and their mixtures or medicinal products under specific legislation, (1) except those administered to animals for the purpose of inducing active or passive immunity or diagnosis of immunity status;
(b) biologically active substances all additives which affect physiological functions and are administered to animals for purposes other than veterinary medicinal products,
(c) the maximum residue level for maximum residues of veterinary medicinal products and biologically active substances used in animal production which is permitted in or on the raw material of animal origin. The amount of residues is expressed in mg / kg of raw material. The conditions for the presence of residues in food and food ingredients, including the assessment method, shall be as set out in the Annex,
(d) the nature of the residues the presence of or on the food and food raw materials of the parent substance or their metabolism products;
(e) the parent substance of the parent active substance, unless otherwise specified in the Annex.
(2) When the maximum quantity of residues of veterinary medicinal products and bioactive substances used in animal production is exceeded, a food or food material shall not be considered to be inoperable.2)
(3) The purity and identity of veterinary medicinal products are laid down in specific legislation (3).
§ 4
(1) In view of the nature of the maximum residue limit established, veterinary medicinal products are to be classified in the following groups:
(a) Group I, where maximum residue limits are established,
(b) Group II, where maximum residue levels are not established for human health in view of the identified safety status,
(c) Group III, where MRLs in the European Union are only provisional.
(2) Group IV lists medicinal products dangerous to human health which must not be used for food-producing animals.
§ 5
This Decree shall take effect on 1 September 2000.
Minister:
Prof. MUDr. Fisher, CSc.

Annex to Decree No 273 / 2000 Coll.
Maximum residue levels
GROUP I
1. ANTI-INFECTION SUBSTANCES
Chemotherapies
1.1.1 Sulphonamides *:
All substances belonging to the sulfonamide group
Nature of residues: parent substance
Druh živočichůMLR1)
(mg/kg)
Surovina
všechny druhy živočichů0,100maso, játra, ledviny, tuk
skot, ovce, koza0,100mléko
* The final residue combination of all substances belonging to the sulfonamide group must not exceed 0,100 mg / kg.
1.1.2. Diamino pyrimidine derivatives:
Bakviloprim
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,300játra
0,150ledviny
0,010tuk
0,030mléko
prasata0,050játra, ledviny
0,040kůže a tuk
Trimethoprim
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů* s výjimkou lichokopytníků0,050maso, játra, ledviny, tuk, mléko
lichokopytníci0,100maso, játra, ledviny, tuk
* Trimethoprim must not be used in animals whose eggs are produced for human consumption. Fat in pigs and poultry means fat including skin in natural form. Meat in fish means meat, including skin in natural form.
1.2 Antibiotics
1.2.1 Penicillins:
Amoxicillin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů0,050maso, játra, ledviny, tuk
0,004mléko
Ampicillin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů0,050maso, játra, ledviny, tuk
0,004mléko
Benzylpenicillin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů0,050maso, játra, ledviny, tuk
0,004mléko
Dicloxacillin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů0,300maso, játra, ledviny, tuk
0,030mléko
Phenoxymethylpenicillin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
prasata0,025maso, játra, ledviny
Cloxacillin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů0,300maso, játra, ledviny, tuk
0,030mléko
Nafcillin *
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
skot0,300maso, játra, ledviny, tuk
0,030mléko
* Nafcillin is used only for intramammary application.
Oxacillin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů0,300maso, játra, ledviny, tuk
0,030mléko
Penethamate
Nature of residues: benzylpenicillin
Druh živočichůMLRSurovina
(mg/kg)
skot0,050maso, játra, ledviny, tuk
0,004mléko
prasata0,050maso, játra, ledviny, kůže a tuk
1.2.2 Cephalosporins:
Cefacetril *
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,125mléko
* Cefacetril is used only for intramammary application.
Cefalexine
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
skot0,200maso, játra, tuk
1,000ledviny
0,100mléko
Cephalonium
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
skot0,020mléko
Cefapirine
Nature of residues: sum of cefapirin and desacetyl cefapirine
Druh živočichůMLRSurovina
(mg/kg)
skot0,050maso, tuk
0,100ledviny
0,060mléko
Cefazoline
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot, ovce, koza0,050mléko
Cefchinome
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,050maso, tuk
0,100játra
0,200ledviny
0,020mléko
prasata0,050maso, kůže a tuk
0,100játra
0,200ledviny
Cefoperazone
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,050mléko
Ceftiofur
Nature of residues: sum of all residues containing the beta-lactam structure and determined as desfuroylceftiofur
Druh živočichůMLR
(mg/kg)
Surovina
skot1,000maso
2,000játra, tuk
6,000ledviny
0,100mléko *
prasata1,000maso
2,000játra, kůže a tuk
6,000ledviny
* It must not be used for intramammary application.
1.2.3 Quinolones:
Danofloxacin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot, ovce, kozy0,200maso
0,400játra, ledviny
0,100tuk
0,030mléko
všechny druhy živočichů* s výjimkou skotu ovcí, koz a drůbeže0,100maso
0,200játra, ledviny
0,050tuk
drůbež **0,200maso
0,400játra, ledviny
0,100kůže a tuk
* Meat in fish means meat including skin in natural form.
* * Danofloxacin must not be used in laying hens, their eggs are intended for human consumption.
Difloxacin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů* s výjimkou skotu, ovcí, koz a drůbeže0,300maso
0,100tuk
0,800játra
0,600ledviny
skot**, ovce**, kozy**0,400maso
1,400játra
0,800ledviny
0,100tuk
drůbež ***0,300maso
1,900játra
0,600ledviny
0,400kůže a tuk
prasata0,800játra a ledviny
0,400maso
0,100kůže a tuk
* Meat in fish means meat including skin in natural form.
* * Difloxacin must not be used in animals whose milk is used for human consumption.
* * * Difloxacin must not be used in animals whose eggs are used for human consumption.
Enrofloxacin
Nature of residues: sum of enrofloxacin and ciprofloxacin
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů* s výjimkou skotu, ovcí, koz, prasat, králíků a drůbeže0,100maso, tuk
0,200játra, ledviny
skot, ovce, kozy0,100maso, tuk, mléko
0,300játra
0,200ledviny
králík0,100maso, tuk
0,200játra
0,300ledviny
prasata0,100maso, kůže a tuk
0,200játra
0,300ledviny
drůbež **0,100maso, kůže a tuk
0,200játra
0,300ledviny
* Meat in fish means meat including skin in natural form.
* * Enrofloxacin must not be used in laying hens whose eggs are produced for human consumption.
Flumequine
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů, s výjimkou skotu, ovcí, koz, prasat, drůbeže a ryb0,200maso
0,250tuk
0,500játra
1,000ledviny
skot, ovce, kozy0,200maso
0,500játra
1,500ledviny
0,300tuk
0,050mléko
prasata0,200maso
0,500játra
1,500ledviny
0,300kůže a tuk
drůbež *0,400maso
0,800játra
1,000ledviny
0,250kůže a tuk
lososovité ryby0,600maso a kůže v přirozené podobě
* Flumequine must not be used in animals whose eggs are produced for human consumption.
Oxolinic acid
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
prasata0,100maso
0,050kůže a tuk
0,150játra, ledviny
kur domácí *0,100maso
0,050kůže a tuk
0,150játra, ledviny
ryby0,100maso a kůže v přirozené podobě
* Oxolinic acid must not be used in animals whose eggs are produced for human consumption.
Marbofloxacin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,150maso, játra, ledviny
0,050tuk
0,075mléko
prasata0,150maso, játra, ledviny
0,050kůže a tuk
Sarafycin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
kur domácí0,100játra
0,010kůže a tuk
lososovití0,030maso a kůže v přirozené podobě
1.2.4. Macrolides:
Erythromycin
Nature of residues: erythromycin A
Druh živočichůMLRSurovina
(mg/kg)
všechny druhy živočichů*0,200maso, tuk, játra, ledviny
0,040mléko
0,150vejce
* Meat in fish means meat including skin in natural form. Fat in pigs means fat including skin in natural form.
Spiramycin
Nature of residues (pigs): spiramycin 1
Nature of residues (other animals): sum of spiramycin and neospiramycin
Druh živočichůMLR
(mg/kg)
Surovina
skot0,200maso, mléko
0,300játra, ledviny, tuk
prasata0,250maso
2,000játra
1,000ledviny
kur domácí0,200maso
0,400játra
0,300kůže a tuk
Tilmicosin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů* s výjimkou drůbeže0,050maso, tuk, mléko
1,000játra, ledviny
drůbež**0,075maso, kůže a tuk
1,000játra
0,250ledviny
* Meat in fish means meat including skin in natural form. Fat in pigs means fat including skin in natural form.
* * Tilmicosin must not be used in animals whose eggs are used for human consumption.
Tylosin
Nature of residues: tylosin A
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů*0,100maso, tuk, játra, ledviny
0,050mléko
0,200vejce
* Fat in pigs and poultry means fat including skin in natural form. Meat in fish means meat, including skin in natural form.
Acetyl isovaleryltylosin
Nature of residues: sum of acetylisovaleryltylosin and 3-O-acetyltylosin
Druh živočichůMLR
(mg/kg)
Surovina
prasata0,050maso, kůže a tuk, játra, ledviny
1.2.5. Florfenicol and similar compounds:
Florfenicol
Nature of residues: sum of florfenicol and its metabolites measured as florfenicol-amine
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů s výjimkou skotu, ovcí, koz, prasat, drůbeže a ryb0,100maso
0,200tuk
2,000játra
0,300ledviny
skot*, ovce*, kozy*0,200maso
3,000játra
0,300ledviny
prasata0,300maso
2,000játra
0,500ledviny, kůže a tuk
drůbež **0,100maso
0,200kůže a tuk
2,500játra
0,750ledviny
ryby1,000maso a kůže v přirozené podobě
* Florfenicol must not be used in animals producing milk for human consumption.
* * Florfenicol must not be used in laying hens whose eggs are produced for human consumption.
Thiamphenicol
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,050maso, játra, ledviny, tuk, mléko
kur domácí *0,050maso, játra, ledviny, kůže a tuk
* Thiamphenicol must not be used in laying hens whose eggs are produced for human consumption.
1.2.6 Tetracyclines:
Doxycycline
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
prasata, drůbež *0,100maso
0,300játra, kůže a tuk
0,600ledviny
skot **0,100maso
0,300játra
0,600ledviny
* Doxycycline must not be used in laying hens whose eggs are produced for human consumption.
Doxycycline must not be used in dairy cows producing milk for human consumption.
Chlorotetracycline
Nature of residues: parent substance including 4 - epimer
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů0,100maso, mléko
0,300játra
0,600ledviny
0,200vejce
Oxytetracycline
Nature of residues: parent substance including 4 - epimer
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů0,100maso, mléko
0,300játra
0,600ledviny
0,200vejce
Tetracycline
Nature of residues: parent substance including 4 - epimer
Druh živočichůMLR
(mg/kg)
Surovina
všechny druhy živočichů0,100maso, mléko
0,300játra
0,600ledviny
0,200vejce
Ansamycin with naphthalene ring:
Rifaximin
Nature of residues: parent substance
Druh živočichůMLR
(mg/kg)
Surovina
skot0,060mléko
1.2.8. Pleuromutilines:
Tiamulin
Nature of residues (chicken eggs): parent substance
Nature of residues (other raw materials): sum of metabolites that may be hydrolysed to 8-alpha-hydroxymutiline
Druh živočichůMLR
(mg/kg)
Surovina
prasata, králík0,100maso
0,500játra
kur domácí0,100maso, kůže a tuk
1,000játra
1,000vejce
krůta0,100maso, kůže a tuk
0,300játra
Valnemulin
Nature of residues: parent substance
Druh živočichůMLRSurovina
(mg/kg)
prasata0,050maso
0,500játra
0,100ledviny
1.2.9 Lincosamides:

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Regulation Information

CitationDecree of the Ministry of Health No. 273 / 2000 Coll., laying down the maximum permitted residues of veterinary medicinal products and bioactive substances used in animal production in food and food raw materials
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation18.08.2000
Effective from01.09.2000
Effective until-
Status Valid
The regulation text is for informational purposes only.
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