Regulation on maximum residue limits of veterinary medicinal products in foodstuffs of animal origin

THE MINISTRY OF AGRICULTURE, FISHERIES AND RURAL DEVELOPMENT Pursuant to Article 15, paragraph 1, subparagraph 2 of the Food Act (Official Gazette 46/07) and Article 87, paragraph 6 of the Veterinary Act (Official Gazette 41/07), the Minister of Agriculture, Fisheries and Rural Development hereby issues the ORDINANCE ON MAXIMUM RESIDUE LIMITS OF VETERINARY MEDICINAL PRODUCTS IN FOODSTUFFS OF ANIMAL ORIGIN 1 Article 1 1) This Ordinance lays down the maximum residue limits of veterinary medicinal products (hereinafter: VMP) in foodstuffs of animal origin. (2) This Ordinance shall not apply to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity used in immunological VMPs. (3) This Ordinance shall not prejudice the application of special regulations prohibiting the use in livestock farming of certain substances having a hormonal action nor shall it prejudice the measures taken to prevent the unauthorised use of VMPs. Definitions Article 2 1) For the purposes of this Ordinance, the following definitions shall apply: (a) ‘residues of veterinary medicinal products’ means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the VMP in question has been administered; b) ‘maximum residue limit’ (hereinafter: MRL) means the maximum concentration of residue resulting from the use of a VMP (expressed in mg/kg or µg/kg on a fresh weight basis) which may be legally permitted or recognised as acceptable in or on a food. MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the acceptable daily intake, or on the basis of a temporary acceptable daily intake that utilises an additional safety factor. It also takes into account other relevant public health risks as well as food technology (food production) aspects. When establishing a MRL, consideration is also given to residues that occur in food of plant origin and/or come from the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of VMPs and to the extent that practical analytical methods are available. Article 3 The list of pharmacologically active substances used in VMPs in respect of which MRLs have been established is contained in Annex I to this Ordinance. Article 4 The list of pharmacologically active substances used in VMP in respect of which it is considered that it is not necessary for the protection of public health to establish a MRL are contained in Annex II to this Ordinance. Article 5 The list of pharmacologically active substances used in VMPs in respect of which provisional MRLs have been established is contained in Annex III to this Ordinance. Article 6 (1) The list of pharmacologically active substances used in VMPs in respect of which MRLs cannot be established because residues of the substances concerned, at whatever limit, in foodstuffs of animal origin constitute a hazard to the health of the consumer is contained in Annex II to this Ordinance. (2) The administration of the substances referred to in paragraph 1 of this Article to food producing animals shall be prohibited. Article 7 (1) In order to obtain the inclusion in Annexes I, II or III to this Ordinance of a pharmacologically active substance which is intended for use in VMPs for administration to food-producing animals, an application to establish a MRL shall be submitted to the European Agency for the Evaluation of Medicinal Products. (2) The application referred to in paragraph 1 of this Article shall contain the information and particulars referred to in Annex V to this Ordinance. Article 8 The import of foodstuffs of animal origin shall be permitted if the level of residue does not exceed the MRL laid down in Annexes I or III to this Ordinance or if it contains the substance listed in Annex II to this Ordinance. Article 9 Where a competent authority, as a result of new information or a reassessment of existing information, considers that the urgent amendment of a provision contained in Annexes I to IV is necessary in order to protect human or animal health, that competent authority may temporarily suspend the application of the provision concerned in its own territory. In that case, it shall immediately notify the Member States of the European Union and the European Commission about the measures, attaching a statement of the reasons therefor. Article 10 1) The administration to food-producing animals of VMPs containing pharmacologically active substances which are not mentioned in Annexes I, II, III shall be prohibited. 2) The administration of VMPs referred to in paragraph 1 of this Article shall be permitted only in the case of clinical trials accepted by the competent authority in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health. Final provisions Article 11 Annexes I to V are printed along with this Ordinance and form an integral part thereof. Article 12 The regulation referred to in Annex II, Table 5. Substances used as food additives in foodstuffs for human consumption shall be adopted by 30 June 2008. Article 13 The regulation referred to in Annex V, item 1.6. of this Ordinance shall be adopted by 30 June 2009. Article 14 On the day of entry into force of this Ordinance, the Ordinance on maximum residue limits of veterinary medicines in foodstuffs (Official Gazette 29/05) shall cease to have effect. Article 15 1) This Ordinance shall enter into force on the eighth day after the day of its publication in the Official Gazette. 2) By way of derogation from paragraph 1 of this Article, Article 9 of this Ordinance shall enter into force on the day of the entry of the Republic of Croatia into the European Union. Class: 011-02/08-01/06 Reg. No.: 525-06-08-1 Zagreb, 24 June 2006 The Minister Božidar Pankretić, m.p. 1The Ordinance transposes the Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ANNEX I LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs FOR WHICH MRLs HAVE BEEN FIXED 1. Anti-infectious agents 1.1. Chemotheurapeutics 1.1.1. Sulfonamides Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Sulfonamidi (sve tvari iz skupine sulfonamida) All substances belonging to the sulfonamide group Parent drug All food producing species 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg Muscle Fat Liver Kidney The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg Bovine,ovine, caprine 100 µg/kg Milk 1.1.2. Diamino pyrimidine derivatives Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) English Marker residue Animal species MRLs Bakiloprim Baquiloprim Baquiloprim Bovine 10 µg/kg 300 µg/kg 150 µg/kg 30 µg/kg Porcine 40 µg/kg 50 µg/kg 50 µg/kg Trimetoprim Trimethoprim Trimethoprim All food producing species except equidae 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg Equidae 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg (1) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“ 2) = For fish this MRL relates to „muscle and skin in natural proportions“ 1.2. Antibiotics 1.2.1. Penicillins Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tar tiss Amoksicilin Amoxicyllin Amoxicyllin All food producing species 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 4 µg/kg Mu Fat Liv Kid Mil Ampicilin Ampicillin Ampicillin All food producing species 50 µg/kg 50 µg/kg 50 Mu Fat Liv Kid Mil Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tar tiss µg/kg 50 µg/kg 4 µg/kg Benzilpenicilin Benzylpenicillin Benzylpenicillin All food producing species 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 4 µg/kg Mu Fat Liv Kid Mil Kloksacilin Cloxacillin Cloxacillin All food producing species 300 µg/kg 300 µg/kg 300 µg/kg 300 µg/kg 30 µg/kg Mu Fat Liv Kid Mil Dikloksacilin Dicloxacillin Dicloxacillin All food producing species 300 µg/kg 300 µg/kg 300 µg/kg 300 µg/kg 30 µg/kg Mu Fat Liv Kid Mil Nafcilin Nafcillin Nafcillin All ruminants 300 µg/kg 300 µg/kg 300 µg/kg 300 µg/kg Mu Fat Liv Kid Mil Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tar tiss 30 µg/kg Oksacilin Oxacillin Oxacillin All food producing species 300 µg/kg 300 µg/kg 300 µg/kg 300 µg/kg 30 µg/kg Mu Fat Liv Kid Mil Penetamat Penethamate Benzylpenicillin Bovine 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 4 µg/kg Mu Fat Liv Kid Mil Porcine 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg Mu Fat Liv Kid All mammalian food producing species 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 4 µg/kg Mu Fat Liv Kid Mil Fenoksimetilpenicilin Phenoxymethylpenicillin Phenoxymethylpenicillin Porcine 25 µg/kg 25 Mu Liv Kid Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tar tiss µg/kg 25 µg/kg Poultry 25 µg/kg 25 µg/kg 25 µg/kg 25 µg/kg Mu Skin fat Liv Kid 1.2.2. Cephalosporins Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Oth provi Cefacetril Cefacetrile Cefacetrile Bovine 125 µg/kg Milk For intrama use only Cefaleksin Cefalexin Cefalexin Bovine 200 µg/kg 200 µg/kg 200 µg/kg 1 000 µg/kg 100 µg/kg Muscle Fat Liver Kidney Milk Cefalonij Cefalonium Cefalonium Bovine 20 µg/kg Milk Cefapirin Cephapirin Sum of cephapirin and desacetylcephapirin Bovine 50 µg/kg 50 µg/kg 100 µg/kg Muscle Fat Kidney Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Oth provi 60 µg/kg Cefazolin Cefazolin Cefazolin Bovine, ovine and caprine 50 µg/kg Milk Cefoperazon Cefoperazone Cefoperazon Bovine 50 µg/kg Milk Cefkinom Cefquinome Cefquinome Bovine 50 µg/kg 50 µg/kg 100 µg/kg 200 µg/kg 20 µg/kg Muscle Fat Liver Kidney Milk Porcine 50 µg/kg 50 µg/kg 100 µg/kg 200 µg/kg Muscle Skin and fat Liver Kidney Equidae 50 µg/kg 50 µg/kg 100 µg/kg 200 µg/kg Muscle Fat Liver Kidney Ceftiofur Ceftiofur Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur All mammalian food producing species 1 000 µg/kg 2 000 µg/kg 2 000 µg/kg 6 000 µg/kg 100 Muscle Fat (1) Liver Kidney Milk (1) = Fo porcine species MRL re to „skin fat in na proport Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Oth provi µg/kg 1.2.3. Quinolones Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi Danofloksacin Danofloxacin Danofloksacin All food producing species except bovine, ovine, caprine, porcine and poultry 100 µg/kg 50 µg/kg 200 µg/kg 200 µg/kg Muscle (2) Fat (1) Liver Kidney Bovine, ovine and caprine 200 µg/kg 100 µg/kg 400 µg/kg 400 µg/kg 30 µg/kg Muscle Fat Liver Kidney Milk Poultry 200 µg/kg 100 µg/kg 400 µg/kg 400 µg/kg Muscle Skin and fat Liver Kidney Not for u in anima from wh eggs are produce human consump Difloksacin Difloxacin Difloxacin All food producing species except bovine, ovine, 300 µg/kg 100 µg/kg 800 µg/kg Muscle (2) Fat Liver Kidney Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi caprine and poultry 600 µg/kg Bovine, ovine and caprine 400 µg/kg 100 µg/kg 1 400 µg/kg 800 µg/kg Muscle Fat Liver Kidney Not for u in anima from wh milk is produce human consump Porcine 400 µg/kg 100 µg/kg 800 µg/kg 800 µg/kg Muscle Skin and fat Liver Kidney Poultry 300 µg/kg 400 µg/kg 1 900 µg/kg 600 µg/kg Muscle Skin and fat Liver Kidney Not for u in anima from wh eggs are produce human consump Enrofloksacin Enrofloxacin Sum of enrofloxacin and ciprofloxacin All food producing species except bovine, ovine, caprine, porcine, rabbits and poultry 100 µg/kg 100 µg/kg 200 µg/kg 200 µg/kg Muscle (2) Fat Liver Kidney Bovine, ovine and caprine 100 µg/kg 100 µg/kg 300 µg/kg Muscle Fat Liver Kidney Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi 200 µg/kg 100 µg/kg Porcine and rabbits 100 µg/kg 100 µg/kg 200 µg/kg 300 µg/kg Muscle Fat (1) Liver Kidney Poultry 100 µg/kg 100 µg/kg 200 µg/kg 300 µg/kg Muscle Skin and fat Liver Kidney Not for u in anima from wh eggs are produce human consump Flumekin Flumequine Flumequine All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish 200 µg/kg 250 µg/kg 500 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney Bovine, ovine, caprine and porcine 200 µg/kg 300 µg/kg 500 µg/kg 1 500 µg/kg 50 µg/kg Muscle Fat (1) Liver Kidney Milk Poultry 400 µg/kg Muscle Skin and Not for u in anima Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi 250 µg/kg 800 µg/kg 1 000 µg/kg fat Liver Kidney from wh eggs are produce human consump Fin fish 600 µg/kg Muscle and skin in natural proportions Marbofloksacin Marbofloxacin Marbofloxacin Bovine 150 µg/kg 50 µg/kg 150 µg/kg 150 µg/kg 75 µg/kg Muscle Fat Liver Kidney Milk Porcine 150 µg/kg 50 µg/kg 150 µg/kg 150 µg/kg Muscle Skin and fat Liver Kidney Oksolinska kiselina Oxolinic acid Oxolinic acid Porcine 100 µg/kg 50 µg/kg 150 µg/kg 150 µg/kg Muscle Skin and fat Liver Kidney Chicken 100 µg/kg 50 µg/kg 150 µg/kg Muscle Skin and fat Liver Kidney Not for u in anima from wh eggs are produce human Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi 150 µg/kg consump Fin fish 100 µg/kg Muscle i koža in natural proportions All food producing species (3) 100 µg/kg 50 µg/kg 150 µg/kg 150 µg/kg Muscle (1) Fat (4) Liver Kidney Sarafloksacin Sarafloxacin Sarafloxacin Chicken 10 µg/kg 100 µg/kg Skin and fat Liver Salmonidae 30 µg/kg Muscle and skin in natural proportions (1) = For fin fish this MRL relates to „muscle and skin in natural proportions“. (2) = For porcine species this MRL relates to „skin and fat in natural proportions“. (3) = Not for use in animals from which milk or eggs are produced for human consumption; MRLs for fat, liver and kidney do not apply to fin fish. (4) = For porcine species and poultry thisMRL relates to „skin and fat in natural proportions“. 1.2.4. Macrolides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tilvalozin Tylvalosin Sum of tylvalosin and 3-O-acetyltylosin Porcine 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg Poultry 50 µg/kg 50 µg/kg Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Eritromicin Erythromycin Erythromycin A All food producing species 200 µg/kg 200 µg/kg 200 µg/kg 200 µg/kg 40 µg/kg 150 µg/kg Spiramicin Spiramycin Sum of spiramycin and neospiramycin Bovine 200 µg/kg 300 µg/kg 300 µg/kg 300 µg/kg 200 µg/kg Chicken 200 µg/kg 300 µg/kg 400 µg/kg Spiramycin 1 Porcine 250 µg/kg 2 000 µg/kg 1 000 µg/kg Tilmikozin Tilmicosin Tilmicosin All food producing species except poultry 50 µg/kg 50 µg/kg 1 000 µg/kg 1 000 µg/kg 50 µg/kg Poultry 75 µg/kg 75 µg/kg 1 000 µg/kg 250 µg/kg Tulatromicin Tulathromycin (2R, 3S,4R,5R, 8R,10R,11R,12S,13S, 14R)-2-ethyl 3,4,10,13 tetrahydrosy 3,5,8,10,12,14 hexamethyl-11 [[(3,4,6,-tri-deoxy-3 (di-methylamino)-β D-xylo-hexo Bovine 100 µg/kg 3 000 µg/kg 3 000 µg/kg Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs pyranoxyl]ox]-1-oxa 6- aza cyclopentadecan-15 one expressed as tulathromycin equivalents Porcine 100 µg/kg 3 000 µg/kg 3 000 µg/kg Tilozin Tylosin Tylosin A All food producing species 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg 50 µg/kg 200 µg/kg (1) = For porcine species this MRL relates to „skin and fat in natural proportions“. (2) = For poultry this MRL relates to „skin and fat in natural proportions“. (3) = For fin fish this MRL relates to „muscle and skin in natural proportions“. (4) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“. 1.2.5. Fluorfenicol and related compounds Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Tiamfenikol Thiamphenicol Thiamphenicol All food producing species 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg (1) = For fin fish „Muscle“ relates to „muscle and skin in natural proportions“ (2) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“ 1.2.6.Tetracyclines Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Klortetraciklin Chlortetracycline Sum of parent drug and its 4 epimer All food producing species 100 µg/kg 300 µg/kg 600 µg/kg 100 µg/kg 200 µg/kg Doksiciklin Doxycycline Doxycycline Bovine 100 µg/kg 300 µg/kg 600 µg/kg Porcine 100 µg/kg 300 µg/kg 300 µg/kg 600 µg/kg Poultry 100 µg/kg 300 µg/kg 300 µg/kg 600 µg/kg Oksitetraciklin Oxytetracycline Sum of parent drug and its 4 epimer All food producing species 100 µg/kg 300 µg/kg 600 µg/kg 100 µg/kg 200 µg/kg Tetraciklin Tetracycline Sum of parent drug and its 4 epimer All food producing species 100 µg/kg 300 µg/kg 600 µg/kg 100 µg/kg 200 µg/kg 1.2.7. Naphtalene-ringed ansamycin Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Rifaksimin Rifaximin Rifaximin Bovine 60 µg/kg Milk 1.2.8. Pleuromutilines Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Tiamulin Tiamulin Sum of metabolites that may be hydrolysed to 8-a hydroxymutilin Porcine 100 µg/kg 500 µg/kg Muscle Liver Chicken 100 µg/kg 100 µg/kg 1 000 µg/kg Muscle Skin and fat Liver Rabbits 100 µg/kg 500 µg/kg Muscle Liver Turkey 100 µg/kg 100 µg/kg 300 µg/kg Muscle Skin and fat Liver Tiamulin 1 000 µg/kg Eggs Valnemulin Valnemulin Valnemulin Porcine 50 µg/kg 500 µg/kg 100 µg/kg Muscle Liver Kidney 1.2.9. Linkozamidi Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Linkomicin Lincomycin Lincomycin All food producing species 50 µg/kg 100 µg/kg Fat (1) Muscle (2) Liver Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions 500 µg/kg 1 500 µg/kg 150 µg/kg 50 µg/kg Kidney Milk Eggs Pirlimicin Pirlimycin Pirlimycin Bovine 100 µg/kg 100 µg/kg 1 000 µg/kg 400 µg/kg 100 µg/kg Muscle Fat Liver Kidney Milk Porcine 100 µg/kg 50 µg/kg 500 µg/kg 1 500 µg/kg Muscle Skin and fat Liver Kidney Chicken 100 µg/kg 50 µg/kg 500 µg/kg 1 500 µg/kg 50 µg/kg Muscle Skin and fat Liver Kidney Eggs (1) = For oorcineand poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „muscle and skin in natural proportions“. 1.2.10. Aminoglycosides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Ot prov Apramicin Apramycin Apramycin Bovine 1 000 µg/kg 1 000 µg/kg 10 000 µg/kg 20 000 µg/kg Muscle Fat Liver Kidney Not fo in ani from milk i produ huma consu Dihidrostreptomicin Dihydrostreptomycin Dihydrostreptomycin All ruminants 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg 200 µg/kg Muscle Fat Liver Kidney Milk Porcine 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Koža i masno Liver Kidney Rabbits 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney Streptomicin Streptomycin Streptomycin All ruminants 500 µg/kg 500 Muscle Fat Liver Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Ot prov µg/kg 500 µg/kg 1 000 µg/kg 200 µg/kg Kidney Milk Porcine 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Koža i masno Liver Kidney Rabbits 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Masno tk Liver Kidney Gentamicin Gentamicin Sum of gentamicin C1, gentamicin C1a, gentamicin C2 and gentamicin C2a Bovine 50 µg/kg 50 µg/kg 200 µg/kg 750 µg/kg 100 µg/kg Muscle Fat Liver Kidney Milk Porcine 50 µg/kg 50 µg/kg 200 µg/kg 750 µg/kg Muscle Koža i masno Liver Kidney Kanamicin Kanamycin Kanamycin A All food producing 100 µg/kg Muscle Fat (1) Not fo in ani Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Ot prov species except fin fish 100 µg/kg 600 µg/kg 2 500 µg/kg 150 µg/kg Liver Kidney Milk from eggs a produ huma consu Neomicin (uključujući i framicetin) Neomycin (including framycetin) Neomycin B All food producing species 500 µg/kg 500 µg/kg 500 µg/kg 5 000 µg/kg 1 500 µg/kg 500 µg/kg Fat (1) Muscle (2) Liver Kidney Milk Eggs Paromomicin Paromomycin Paromomycin All food producing species 500 µg/kg 1 500 µg/kg 1 500 µg/kg Muscle (2) Liver Kidney Not fo in ani from milk o are produ huma consu Spektinomicin Spectinomycin Spectinomycin All food producing species except sheep 500 µg/kg 300 µg/kg 1 000 µg/kg 5 000 µg/kg 200 µg/kg Fat (1) Muscle (2) Liver Kidney Milk Not fo in ani from eggs a produ huma consu Ovine 300 µg/kg 500 µg/kg 2 000 Muscle Fat Liver Kidney Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Ot prov µg/kg 5 000 µg/kg 200 µg/kg Streptomicin Streptomycin Streptomycin All ruminants 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg 200 µg/kg Muscle Fat Liver Kidney Milk Porcine 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Skin and fat Liver Kidney Rabbits 500 µg/kg 500 µg/kg 500 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney (1) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „Muscle and skin in natural proportions“. 1.2.11. Other antibiotics Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Novobiocin Novobiocin Novobiocin Bovine 50 Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions µg/kg 1.2.12. Polypeptides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Bacitracin Bacitracin Sum of bacitracin A, bacitracin B, and bacitracin C Bovine 100 µg/kg Rabbits 150 µg/kg 150 µg/kg 150 µg/kg 150 µg/kg 1.2.13. Beta-lactamase inhibitors Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Klavulanska kiselina Clavulanic acid Clavulanic acid Bovine 100 µg/kg 100 µg/kg 200 µg/kg 400 µg/kg 200 µg/kg Muscle Fat Liver Kidney Milk Porcine 100 µg/kg 100 µg/kg 200 µg/kg 400 µg/kg Muscle Skin and fat Liver Kidney 1.2.14. Polymyxins Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Kolistin Colistin Colistin All food producing species 150 µg/kg 150 µg/kg 150 µg/kg 200 µg/kg 50 µg/kg 300 µg/kg Fat (1) Muscle (2) Liver Kidney Milk Eggs (1) = For porcine apecies and poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „muscle and skin in natural proportions“. 1.2.15. Orthosomycins Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision Avilamicin Avilamycin Dichloroisoeverninic acid Porcine 50 µg/kg 100 µg/kg 300 µg/kg 200 µg/kg Muscle Fat (1) Liver Kidney Kunić 50 µg/kg 100 µg/kg 300 µg/kg 200 µg/kg Muscle Fat Liver Kidney Poultry 50 Muscle Not for us Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision µg/kg 100 µg/kg 300 µg/kg 200 µg/kg Fat (1) Liver Kidney in animals from whic eggs are produced human consumpti (1) = For porcine apecies and poultry this MRLs relates to „skin and fat in natural proportions“ 1.2.16. Ionophores Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Monenzin Monensin Monensin A Bovine 2 µg/kg 10 µg/kg 30 µg/kg 2 µg/kg 2 µg/kg Muscle Fat Liver Kidney Milk Lasalocid Lasalocid Lasalocid A Poultry 20 µg/kg 100 µg/kg 100 µg/kg 50 µg/kg 150 µg/kg Muscle Fat Liver Kidney Eggs For fat MRL relates to „skin and fat in natural proportions“ 2. Antiparasitic agents 2.1. Agents acting against endoparasites 2.1.1. Salicylanilides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Klozantel Closantel Closantel Bovine 1 000 µg/kg 3 000 µg/kg 1 000 µg/kg 3 000 µg/kg Muscle Fat Liver Kidney Ovine 1 500 µg/kg 2 000 µg/kg 1 500 µg/kg 5 000 µg/kg Muscle Fat Liver Kidney Rafoksanid Rafoxanide Rafoxanide Bovine 30 µg/kg 30 µg/kg 10 µg/kg 40 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption Ovine 100 µg/kg 250 µg/kg 150 µg/kg 150 µg/kg Muscle Fat Liver Kidney 2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles) Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Levamizol Levamisole Levamisole Bovine, ovine, porcine 10 µg/kg 10 Muscle Fat Liver Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions and poultry µg/kg 100 µg/kg 10 µg/kg Kidney 2.1.3. Benzimidazoles and pro-benzimidazoles Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Albendazol Albendazole Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2 amino sulphone, expressed as albendazole All ruminants 100 µg/kg 100 µg/kg 1 000 µg/kg 500 µg/kg 100 µg/kg Albendazol oksid Albendazole oxide Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2 amino sulphone, expressed as albendazole Bovine and ovine 100 µg/kg 100 µg/kg 1 000 µg/kg 500 µg/kg 100 µg/kg Febantel Febantel Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 µg/kg 50 µg/kg 500 µg/kg 50 µg/kg 10 µg/kg Fenbendazol Fenbendazole Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 µg/kg 50 µg/kg 500 µg/kg 50 µg/kg 10 µg/kg Flubendazol Flubendazole Sum of flubendazole and (2-amino1H benzimidazol-5-yl) (4fluorophenyl) Poultry and porcine 50 µg/kg 50 µg/kg 400 µg/kg 300 µg/kg Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs methanone Flubendazol Flubendazole Flubendazol Poultry 400 µg/kg Mebendazol Mebendazole Sum of mebendazolemethyl (5 (1-hydroxy,1-phenyl) methyl-1H benzimidazol-2-yl) carbamateand (2 amino-1H benzimidazol-5-yl) phenyl methanone, expressed as mebendazole equivalents Ovine, caprine and equidae 60 µg/kg 60 µg/kg 400 µg/kg 60 µg/kg Netobimin Netobimin Sum of albendazole oxide, albendazole sulphone and albendazole 2-amino sulphone, expressed as albendazole Bovine i ovine 100 µg/kg 100 µg/kg 1 000 µg/kg 500 µg/kg 100 µg/kg Oksfendazol Oxfendazole Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 µg/kg 50 µg/kg 500 µg/kg 50 µg/kg 10 µg/kg Oksibendazol Oxibendazole Oxibendazole Porcine 100 µg/kg 500 µg/kg 200 µg/kg 100 µg/kg Tiabendazol Thiabendazole Sum of thiabendazole and 5 hydroxythiabendazole Caprine 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg Triklabendazol Triclabendazole Sum of extractable residues that may be oxidised to ketotriclabendazole All ruminants 225 µg/kg 100 µg/kg 250 µg/kg 150 µg/kg 2.1.4. Phenol derivatives including salicylanides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Nitroksinil Nitroxinil Nitroxinil Bovine and ovine 400 µg/kg 200 µg/kg 20 µg/kg 400 µg/kg Muscle Fat Liver Kidney Oksiklozanid Oxyclozanide Oxyclozanide All ruminants 20 µg/kg 20 µg/kg 500 µg/kg 100 µg/kg 10 µg/kg Muscle Fat Liver Kidney Milk 2.1.5. Benzenesulphonamides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Klorsulon Clorsulon Clorsulon Bovine 35 µg/kg 100 µg/kg 200 µg/kg Muscle Liver Kidney 2.1.6. Piperazine derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Piperazin Piperazine Piperazine Porcine 400 µg/kg 800 µg/kg 2 000 µg/kg 1 000 µg/kg Muscle Skin and fat Liver Kidney Chicken 2 000 µg/kg Eggs 2.1.7. Tetrahydropyrimides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Morantel Morantel Sum of residues which may be hydrolysed toN methyl 1,3 propane diamine and expressed as morantel equivalents Bovine and ovine 100 µg/kg 100 µg/kg 800 µg/kg 200 µg/kg 50 µg/kg Muscle Fat Liver Kidney Milk All ruminants 100 µg/kg 100 µg/kg 800 µg/kg 200 µg/kg 50 µg/kg Muscle Fat Liver Kidney Milk 2.2. Agents acting against ectoparasites 2.2.1. Organophosphates Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Kumafos Coumafos Coumafos Bees 100 µg/kg Med Diazinon Diazinon Diazinon Bovine, ovine and caprine 20 µg/kg Milk Bovine, porcine, ovine and caprine 20 µg/kg 700 µg/kg 20 µg/kg 20 µg/kg Muscle Fat Liver Kidney Foksim Phoxim Phoxim Ovine 50 µg/kg 400 µg/kg 50 µg/kg Muscle Fat Kidney Not for use in animals from which milk is produced for human consumption Porcine 20 µg/kg 700 µg/kg 20 µg/kg 20 µg/kg Muscle Skin and fat Liver Kidney Chicken 25 µg/kg 550 Muscle Skin and fat Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions µg/kg 50 µg/kg 30 µg/kg 60 µg/kg Liver Kidney Eggs 2.2.2. Formamidines Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Amitraz Amitraz Sum of amitraz and all metabolites containing the 2,4 DMA moiety, expressed as amitraz Bovine 200 µg/kg 200 µg/kg 200 µg/kg 10 µg/kg Fat Liver Kidney Milk Ovine 400 µg/kg 100 µg/kg 200 µg/kg 10 µg/kg Fat Liver Kidney Milk Porcine 400 µg/kg 200 µg/kg Skin and fat Liver Kidney Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions 200 µg/kg Bees (honey) 200 µg/kg Honey Caprine 200 µg/kg 100 µg/kg 200 µg/kg 10 µg/kg Fat Liver Kidney Milk 2.2.3. Pyrethroids Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision Cihalotrin Cyhalothrin Cyhalothrin (sum of isomers) Bovine 500 µg/kg 50 µg/kg 50 µg/kg Fat Kidney Milk Further provisions of Ordinance on maximum residue levels of pesticides i food and feed (Official Gazette 119/07) to Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision be observe 1 Ciflutrin Cyfluthrin Cyfluthrin (sum of isomers) Bovine 10 µg/kg 50 µg/kg 10 µg/kg 10 µg/kg 20 µg/kg Muscle Fat Liver Kidney Milk Deltametrin Deltamethrin Deltamethrin All ruminants 10 µg/kg 50 µg/kg 10 µg/kg 10 µg/kg 20 µg/kg Muscle Fat Liver Kidney Milk Fin fish 10 µg/kg Muscle and skin in natural proportions Fenvalerat Fenvalerate Fenvalerate (sum RR, SS, RS and isomers) Bovine 25 µg/kg 250 µg/kg Muscle Fat Liver Kidney 1 Propis će se uskladiti s odredbama Uredbe Europskog Parlamenta i Vijeća (EC) 396/2005 od 23. veljače 2005. godine o maksimalnim razinama ostataka pesticida u i na hrani i hrani za životinje biljnog i životinjskog podrijetla koja nadopunjuje Direktivu Vijeća 91/414/EEC; Uredbe Komisije (EC) 178/2006 od 1. veljače 2006. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa I. popisa hrane i hrane za životinje na koju se maksimalne razine ostataka pesticida odnose, Uredbe Komisije (EC) 149/2008 od 29. siječnja 2008. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa II., III. i IV. koji određuju maksimalne razine ostataka pesticida za proizvode navedene u Aneksu I., Uredbe Komisije (EC) 260/2008 od 18. ožujka 2008. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa VII. popisom aktivnih tvari/kombinacija proizvoda navedenim u odredbama o iznimkama u vezi s tretiranjem fumigantima poslije žetve i Uredbe Europskog Parlamenta i Vijeća (EC) 299/2008 od 11. ožujka 2008. godine kojom se dopunjuje Uredba (EC) 396/2005 o maksimalnim razinama ostataka pesticida u i na hrani i hrani za životinje biljnog i životinjskog podrijetla u pogledu provedbe vlasti povjerene Komisiji. Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision 25 µg/kg 25 µg/kg 40 µg/kg Milk Flumetrin Flumethrin Flumethrin (sum trans-Z isomers) Bovine 10 µg/kg 150 µg/kg 20 µg/kg 10 µg/kg 30 µg/kg Muscle Fat Liver Kidney Milk Ovine 10 µg/kg 150 µg/kg 20 µg/kg 10 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced f human consumptio Permetrin Permethrin Permethrin (sum of isomers) Bovine 50 µg/kg 500 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg Muscle Fat Liver Kidney Milk* Cipermetrin Cypermethrin Cypermethrin (sum of isomers) Pastrvske vrste riba 50 µg/kg Muscleand skin in natural proportions All ruminants 20 µg/kg 200 µg/kg Muscle Fat Liver Kidney * Further provisions of Ordinance Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision 20 µg/kg 20 µg/kg 20 µg/kg Milk* on maximum residue levels of pesticides i food and feed (Official Gazette 119/07) to be observe Alfacipermetrin Alphacypermethrin Cipermetrin (sum of isomers) Bovine and ovine 20 µg/kg 200 µg/kg 20 µg/kg 20 µg/kg 20 µg/kg Muscle Fat Liver Kidney Milk* * Further provisions of Ordinance on maximum residue levels of pesticides i food and feed (Official Gazette 119/07) to be observe * The regulation will be aligned with the provisions of the Regulation (EC) 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; Commission Regulation (EC) 178/2006 of 1 February 2006 amending Regulation (EC) 396/2005 of the European Parliament and of the Council to establish Annex I listing the food and feed products to which maximum levels for pesticide residues apply, Commission Regulation (EC) 149/2008 of 29 January 2008 amending Regulation (EC) No. 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex 1 thereto, Commission Regulation (EC) 260/2008 of 18 March 2008 amending Regulation (EC) 396/2005 of the European Parliament and of the Council by establishing Annex VII listing active substances/product combinations covered by a derogation as regards post harvest treatments with a fumigant and Regulation (EC) 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) 396/2005 on maximum resiude levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission. 2.2.4. Acyl urea derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Othe provisi Diflubenzuron Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg Muscle and skin in natural proportions Fluazuron Fluazuron Fluazuron Bovine 200 µg/kg 7 000 µg/kg 500 µg/kg 500 µg/kg Muscle Fat Liver Kidney Not for u in anima from wh milk is produced human consump Teflubenzuron Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg Muscle and skin in natural proportions 2.2.5. Pyrimidines derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Diciklanil Dicyclanil Sum of dicyclanil and 2, 4, 6 triamino pyrimidine 5 carbonitrile Ovine 200 µg/kg 150 µg/kg 400 µg/kg 400 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption 2.2.6. Triazine derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Ciromazin Cyromazine Cyromazine Ovine 300 µg/kg Muscle Fat Not for use in animals Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions 300 µg/kg 300 µg/kg 300 µg/kg Liver Kidney from which milk is produced for human consumption 2.3. Agents acting against endo- and ectoparasites 2.3.1. Avermectins Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisio Abamektin Abamectin Avermektin B1a Bovine 10 µg/kg 20 µg/kg Fat Liver Ovine 20 µg/kg 50 µg/kg 25 µg/kg 20 µg/kg Muscle Fat Liver Kidney Not for us in animal from whi milk is produced human consumpt Doramektin Doramectin Doramectin All mammalian food producing species 40 µg/kg 150 µg/kg 100 µg/kg 60 µg/kg Muscle Fat Liver Kidney Not for us in animal from whi milk is produced human consumpt Emamektin Emamectin Emamectin B1a Fin fish 100 µg/kg Muscle and skin in natural proportions Eprinomektin Eprinomectin Eprinomectin B1a Bovine 50 µg/kg 250 Muscle Fat Liver Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisio µg/kg 1 500 µg/kg 300 µg/kg 20 µg/kg Kidney Milk Ivermektin Ivermectin 22, 23 Dihydro avermectin B1a Bovine 40 µg/kg 100 µg/kg Fat Liver Porcine, ovine, equidae 20 µg/kg 15 µg/kg Fat Liver Deer, including reindeer 20 µg/kg 100 µg/kg 50 µg/kg 20 µg/kg Muscle Fat Liver Kidney All mammalian food producing species 100 µg/kg 100 µg/kg 30 µg/kg Muscle Liver Kidney Not for us in animal from whi milk is produced human consumpt Moksidektin Moxidectin Moxidectin Bovine and ovine 50 µg/kg 500 µg/kg 100 µg/kg 50 µg/kg Muscle Fat Liver Kidney Bovine 40 µg/kg Milk Equidae 50 µg/kg Muscle Fat Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisio 500 µg/kg 100 µg/kg 50 µg/kg Liver Kidney Ovine 40 µg/kg Milk 2.4. Agents acting against protozoa 2.4.1. Triazinetrione derivative Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Toltrazuril Toltrazuril Toltrazuril sulfon Chicken 100 µg/kg 200 µg/kg 600 µg/kg 400 µg/kg Muscle Skin and fat Liver Kidney Not for use in animals from which eggs are produced for human consumption Purani 100 µg/kg 200 µg/kg 600 µg/kg 400 µg/kg Muscle Skin and fat Liver Kidney Porcine 100 µg/kg 150 µg/kg 500 µg/kg 250 µg/kg Muscle Skin and fat Liver Kidney All mammalian food 100 µg/kg 150 Muscle Fat(1) Liver Not for use in animals from which Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions producing species µg/kg 500 µg/kg 250 µg/kg Kidney milk is produced for human consumption Poultry 100 µg/kg 200 µg/kg 600 µg/kg 400 µg/kg Muscle Skin and fat Liver Kidney Not for use in animals from which eggs are produced for human consumption (1) = For porcine species this MRL relates to „skin and fat in natural proportions“ 2.4.2. Quinazolone derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Halofuginon Halofuginone Halofuginone Bovine 10 µg/kg 25 µg/kg 30 µg/kg 30 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption 2.4.3. Carbanilides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Imidokarb Imidocarb Imidocarb Bovine 300 µg/kg 50 µg/kg 2 000 µg/kg 1 500 Muscle Fat Liver Kidney Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions µg/kg 50 µg/kg Ovine 300 µg/kg 50 µg/kg 2 000 µg/kg 1 500 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption 3. Agents acting on the nervous system 3.1. Agents acting on the central nervous system 3.1.1. Butyrophenone tranquillisers Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Azaperon Azaperone Sum of azaperone and azaperol Porcine 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg Muscle Skin and fat Liver Kidney 3.2. Agents acting on the autonomic nervous system 3.2.1. Anti-adrenergics Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Karazolol Carazolol Carazolol Porcine 5 µg/kg 5 µg/kg 25 µg/kg 25 Muscle Koža i masno tki. Liver Kidney Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions µg/kg Bovine 5 µg/kg 5 µg/kg 15 µg/kg 15 µg/kg 1 µg/kg Muscle Fat Liver Kidney Milk 3.2.2. ß2- sympathomimetic agents Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Klenbuterolklorid Clenbuterol hydrochloride Clenbuterol Bovine 0,1 µg/kg 0,5 µg/kg 0,5 µg/kg 0,05 µg/kg Muscle Liver Kidney Milk Equidae 0,1 µg/kg 0,5 µg/kg 0,5 µg/kg Muscle Liver Kidney 4. Anti-inflammatory agents 4.1. Nonsteroidal anti-inflammatory agents 4.1.1. Arylpropionic acid derivative Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Karprofen Carprofen Carprofen Bovine 500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption Equidae 500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney Vedaprofen Vedaprofen Vedaprofen Equidae 50 µg/kg 20 µg/kg 100 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney Karprofen Carprofen Sum of carprofen and carprofen glucuronide conjugate Bovine i Equidae 500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg Muscle Fat Liver Kidney 4.1.2. Fenamate group derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Fluniksin Flunixin Flunixin Bovine 20 µg/kg Muscle Fat Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions 30 µg/kg 300 µg/kg 100 µg/kg Liver Kidney 5 Hydroxyflunixin Bovine 40 µg/kg Milk Flunixin Porcine 50 µg/kg 10 µg/kg 200 µg/kg 30 µg/kg Muscle Skin and fat Liver Kidney Equidae 10 µg/kg 20 µg/kg 100 µg/kg 200 µg/kg Muscle Fat Liver Kidney Tolfenamatna kiselina Tolfenamic acid Tolfenamic acid Bovine 50 µg/kg 400 µg/kg 100 µg/kg 50 µg/kg Muscle Liver Kidney Milk Porcine 50 µg/kg 400 µg/kg 100 µg/kg Muscle Liver Kidney 4.1.3. Enolic acid derivates Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions 4.1.4. Oxican derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Meloksikam Meloxicam Meloxicam Porcine, equidae and rabbits 20 µg/kg 65 µg/kg 65 µg/kg Muscle Liver Kidney Bovine and caprine 20 µg/kg 65 µg/kg 65 µg/kg 15 µg/kg Muscle Liver Kidney Milk 4.1.5. Pyrazolone derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisio Metamizol Metamizole 4 Methylaminoantipyrin Bovine 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg 50 µg/kg Muscle Fat Liver Kidney Milk Porcine 100 µg/kg 100 Muscle Skin and fat Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisio µg/kg 100 µg/kg 100 µg/kg Liver Kidney Equidae 100 µg/kg 100 µg/kg 100 µg/kg 100 µg/kg Muscle Fat Liver Kidney 4.1.6. Phenyl acetic acid derivatives Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Diklofenak Diclofenac Diclofenak Bovine 5 µg/kg 1 µg/kg 5 µg/kg 10 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced for human consumption Porcine 5 µg/kg 1 µg/kg 5 µg/kg 10 µg/kg Muscle Skin and fat Liver Kidney 4.1.7. Sulphonated fenyl lactones Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Firokoksib Firocoxib Firocoxib Equidae 10 µg/kg 15 µg/kg 60 µg/kg 10 µg/kg Muscle Fat Liver Kidney 5. Corticoides 5.1. Glucocorticoides Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision Betametazon Betamethasone Betamethasone Bovine 0,75 µg/kg 2 µg/kg 0,75 µg/kg 0,3 µg/kg Muscle Liver Kidney Milk Porcine 0,75 µg/kg 2 µg/kg 0,75 µg/kg Muscle Liver Kidney Deksametazon Dexamethasone Dexamethasone Bovine 0,3 µg/kg Milk Bovine, porcine and equidae 0,75 µg/kg 2 µg/kg 0,75 µg/kg Muscle Liver Kidney Caprine 0,75 µg/kg 2 µg/kg 0,75 Muscle Liver Kidney Milk Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provision µg/kg 0,3 µg/kg Metilprednizolon Methylprednisolone Methylprednisolone Bovine 10 µg/kg 10 µg/kg 10 µg/kg 10 µg/kg Muscle Fat Liver Kidney Not for use in animals from which milk is produced f human consumptio Prednizolon Prednisolone Prednisolone Bovine 4 µg/kg 4 µg/kg 10 µg/kg 10 µg/kg 6 µg/kg Muscle Fat Liver Kidney Milk 6. Agents acting on the reproductive system 6.1. Progestogens Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions Klormadinon Chlormadinone Chlormadinone Bovine 4 µg/kg 2 µg/kg 2,5 µg/kg Fat Liver Milk For zootechnical use only Flugeston acetat Flugestone acetate Flugestone acetate Ovine 1 µg/kg Milk For intravaginal use for zootechnical purposes only Caprine 1 Milk For Pharmacologically active substance(s) Pharmacologically active substance(s) English Marker residue Animal species MRLs Target tissues Other provisions µg/kg intravaginal use for zootechnical purposes only Ovine i caprine 0,5 µg/kg 0,5 µg/kg 0,5 µg/kg 0,5 µg/kg Muscle Fat Liver Kidney For therapeutic and zootechnical purposes only Altrenogest Altrenogest (1) Altrenogest Porcine 1 µg/kg 0,4 µg/kg Skin and fat Liver Equidae 1 µg/kg 0,9 µg/kg Fat Liver Norgestomet Norgestomet Norgestomet Bovine 0,2 µg/kg 0,2 µg/kg 0,2 µg/kg 0,2 µg/kg 0,12 µg/kg Muscle Fat Liver Kidney Milk For therapeutic and zootechnical purposes only (1) = For zootechnical purposes only in accordance with Order prohibiting the use in stockfarming of certain beta-agonists and substances having a hormonal or thyrostatic action (Official Gazette21/03) transposing the provisions of Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists. ANNEX II LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs NOT SUBJECT TO MAXIMUM RESIDUE LIMITS 1. Inorganic chemicals Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) English Animal species Other provisions 1. Aluminijev distearat Aluminium distearate All food-producing species 2. Aluminijev hydroksid acetatat Aluminium hydroxide acetate All food-producing species 3. Aluminijev fosfat Aluminium phosphate All food-producing species 4. Aluminijev salicilat, bazični Aluminium salicylate, basic Bovine For oral use only. Not for use in animals from which milk is produced for human consumption 5. Aluminijev tristearat Aluminium tristearate All food-producing species 6. Aluminijev klorid Aluminium chloride All food-producing species 7. Barijev selenat Barium selenate Bovine, ovine 8. Bizmutov subkarbonat Bismuth subcarbonate All food-producing species For oral use only 9. Bizmutov subgalat Bismuth subgallate All food-producing species For oral use only 10. Bizmutov subnitrat Bismuth subnitrate All food-producing species For oral use only 11. Bizmutov subsalicilat Bismuth subsalicylate All food-producing species For oral use only 12. Borna kiselina i borati Boric acid and borates All food-producing species 13. Bromid, kalijeva sol Bromide, potassium salt All food-producing species For topical use only 14. Bromid, natrijeva sol Bromide, sodium salt All mammalian food producing species 15. Kalcijev Calcium acetate All food-producing species 16. Kalcijev benzoat Calcium benzoate All food-producing species 17. Kalcijev karbonat Calcium carbonate All food-producing species 18. Kalcijev klorid Calcium chloride All food-producing species 19. Kalcijev glukonat Calcium gluconate All food-producing species 20. Kalcijev hidroksid Calcium hydroxide All food-producing species 21. Kalcijev hipofosfit Calcium hypophosphite All food-producing species 22. Kalcijev malat Calcium malate All food-producing species 23. Kalcijev oksid Calcium oxide All food-producing species 24. Kalcijev fosfat Calcium phosphate All food-producing species 25. Kalcijev polifosfat Calcium polyphosphates All food-producing species 26. Kalcijev propionat Calcium propionate All food-producing species 27. Kalcijev silikat Calcium silicate All food-producing species 28. Kalcijev stearat Calcium stearate All food-producing species 29. Kalcijev sulfat Calcium sulphate All food-producing species 30. Kalcijev glukoheptonat Calcium glucoheptonate All food-producing species 31. Kalcijev glukonoglukoheptonat Calcium glucono glucoheptonate All food-producing species 32. Kalcijev glukonolaktat Calcium All food-producing species Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) English Animal species Other provisions gluconolactate 33. Kalcijev glutamate Calcium glutamate All food-producing species 34. Kalcijev glicerofosfat Calcium glycerophosphate All food-producing species 35. Kobaltov karbonat Cobalt carbonate All food-producing species 36. Kobaltov diklorid Cobalt dichloride All food-producing species 37. Kobaltov glukonat Cobalt gluconate All food-producing species 38. Kobaltov oksid Cobalt oxide All food-producing species 39. Kobaltov sulfat Cobalt sulphate All food-producing species 40. Kobaltov trioksid Cobalt trioxide All food-producing species 41. Bakrov klorid Copper chloride All food-producing species 42. Bakrov gluconat Copper gluconate All food-producing species 43. Bakrov heptanoat Copper heptanoate All food-producing species 44. Bakrov metionat Copper methionate All food-producing species 45. Bakrov oksid Copper oxide All food-producing species 46. Bakrov sulfat Copper sulphate All food-producing species 47. Dicopper oxide All food-producing species 48. Kloridna kiselina Hydrochloric acid All food-producing species For use as excipient 49. Vodikov peroksid Hydrogen peroxide All food-producing species 50. Jod i anorganski spojevi joda uključujući: Natrije i kalijev jodid Natrijev i kalijev jodat Jodofori uključujući polivinlpirolidone Iodine and iodine inorganic compounds including: Sodium and potassium-iodide Sodium and potassium-iodate Iodophors including polyvinylpyrrolidone iodine All food-producing species 51. Željezov diklorid Iron dichloride All food-producing species 52. Željezov sulfat Iron sulphate All food-producing species 53. Magnezij Magnezijev sulfat Magnezijev hidroksid Magnezijev stearat Magnezijev glutamat Magnezijev orotat Magnezijev aluminij silikat Magnezijev oksid Magnezijev karbonat Magnezijev fosfat Magnezijev glicerofosfat Magnesium Magnesium sulphate Magnesium hydroxide Magnesium stearate Magnesium glutamate Magnesium orotate Magnesium aluminium silicate Magnesium oxide Magnesium carbonate Magnesium phosphate Magnesium All food-producing species Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) English Animal species Other provisions Magnezijev aspartat Magnezijev citrat Magnezijev acetat Magnezijev trisilikat glycerophosphate Magnesium aspartate Magnesium citrate Magnesium acetate Magnesium trisilicate 54. Niklov glukonat Nickel gluconate All food-producing species 55. Niklov sulfat Nickel sulphate All food-producing species 56. Kalijev DL aspartat Potassium DL aspartate All food-producing species 57. Kalijev glukuronat Potassium glucuronate All food-producing species 58. Kalijev glicerofosfat Potassium glycerophosphate All food-producing species 59. Kalijev nitrat Potassium nitrate All food-producing species 60. Kalijev selenat Potassium selenate All food-producing species 61. Natrijev klorit Sodium chlorite Bovine For topical use only 62. Natrijev dikloroizocianurat Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only 63. Natrijev glicerofosfat Sodium glycerophosphate All food-producing species 64. Natrijev hipofosfit Sodium hypophosphite All food-producing species 65. Natrijev nitrit Sodium nitrite Bovine For topical use only 66. Natrijev propionat Sodium propionate All food-producing species 67. Natrijev selenat Sodium selenate All food-producing species 68. Natrijev selenit Sodium selenite All food-producing species 69. Sumpor Sulphur All food-producing species 70. Cinkov acetat Zinc acetate All food-producing species 71. Cinkov klorid Zinc chloride All food-producing species 72. Cinkov glukonat Zinc gluconate All food-producing species 73. Cinkov oleat Zinc oleate All food-producing species 74. Cinkov stearat Zinc stearate All food-producing species 2. Organic compounds cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions radiol 17β-Oestradiol All food-producing species For therapeutic and zootechnical uses only oetanol 2-Aminoethanol All food-producing species oetil enfosfat 2-Aminoethyl dihydrogenphosphate All food-producing species don 2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw ksikinolin 8-Hydroxyquinoline All mammalian food producing species For topical use in newborn animals only cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions stein Acetyl cysteine All food-producing species idol Alfacalcidol Bovine For parturient cows only stol Alfaprostol Rabbits, bovine, porcine, equidae in Bacitracin Bovine For intramammary use in lactating cows and for a except milk onijev klorid Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0.0 ain Benzocaine All food-producing species For use as local anaesthetic only alkohol Benzylalcohol All food-producing species For use as excipient Betaine All food-producing species ol Bronopol Salmonidae For use only on farmed fertilised eggs am Brotizolam Bovine For therapeutic uses only n Buserelin All food-producing species nolov tartarat Butorphanol tartrate Equidae For intravenous administration only hidroksibenzoat Butyl 4 hydroxybenzoate All food-producing species polaminiumov Butylscopolaminium bromide All food-producing species Caffeine All food-producing species cin Carbetocin All mammalian food producing species n Cefazolin Bovine, ovine, caprine For intramammary use, except if the udder may b food for human consumption stearilni alkohol Cetostearyl alcohol All food-producing species d Cetrimide All food-producing species sidin Chlorhexidine All food-producing species For topical use only ezol Chlorocresol All food-producing species Clazuril Golubovi tenol Cloprostenol Bovine, porcine i equidae v alkih dimetil Coco alkyl dimethyl betaines All food-producing species For use as excipient ropin Corticotropin All food-producing species Luteinizrajući oslobađanja D-Phe 6 -luteinising hormone releasing hormone All food-producing species ksin Dembrexine Equidae in hidroklorid Denaverine hydrochloride Bovine din Detomidine Bovine, equidae For therapeutic uses only ril Diclazuril All ruminants, porcine For oral use only lat Diethyl phtalate All food-producing species cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions lni eter glikola Diethylene glycol monoethyl ether Bovine, porcine anov trioksid Dimanganese trioxide All food-producing species For oral use only ftalat Dimethyl phtalate All food-producing species st Dinoprost All mammalian food producing species sttrometamin Dinoprost tromethamine All mammalian food producing species in Diprophylline All food-producing species ilin Etamiphylline camsylate All food-producing species Ethanol All food-producing species For use as excipient at Ethyl lactate All food-producing species ton Etiproston tromethamine Bovine, porcine acetat Fertirelin acetate Bovine n Flumethrin Bees (honey) kiselina Folic acid All food-producing species l formal Glycerol formal All food-producing species ropni hormon anja Gonadotrophin releasing hormone All food-producing species nol Heptaminol All food-producing species din Hesperidin Equidae din metil Hesperidin methyl chalcone Equidae din Hexetidine Equidae For topical use only korionski ropin Human chorion gonadotrophin All food-producing species menopauzalni gonadotropin Human menopausal urinary gonadotrophin Bovine rtizon Hydrocortisone All food-producing species For topical use only i jod spojevi m Iodine organic compounds — Iodoform All food-producing species n Isobutane All food-producing species n Isoflurane Equidae For use as anaesthetic only rin Isoxsuprine Bovine, equidae For therapeutic use only in accordance with the O prohibiting the use in stockfarming of certain beta cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions and substances having a hormonal or thyrostatic a 21/03)2 Ketamine All food-producing species rin tartrat Ketanserin tartrate equidae fen Ketoprofen Bovine, porcine, equidae na kiselina I mono i di bazične ija, kalija i kalcija L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium All food-producing species For use as excipient a kiselina Lactic acid All food-producing species n Lecirelin Bovine, equidae, rabbits Lobeline All food-producing species ol Luprostiol All mammalian species a kiselina Malic acid All food-producing species For use as excipient ov karbonat Manganese carbonate All food-producing species For oral use only ov klorid Manganese chloride All food-producing species For oral use only ov glukonat Manganese gluconate All food-producing species For oral use only ov glicerofosfat Manganese glycerophosphate All food-producing species For oral use only ov oksid Manganese oxide All food-producing species For oral use only ov pidolat Manganese pidolate All food-producing species For oral use only ov ribonukleat Manganese ribonucleate All food-producing species For oral use only ov sulfat Manganese sulphate All food-producing species For oral use only am Mecillinam Bovine For use as excipient siprogesteronacetat Medroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes on in Melatonin Ovine, caprine on Menadione All food-producing species on Menbutone Bovine, ovine, caprine, porcine, equidae Menthol All food-producing species kotinat Methyl nicotinate Bovine, equidae For topical use only ni ugljikovodici, visoko viskozni ući mikrokristalini približno C10 fatski, podjela na i Mineral hydrocarbons, low to high viscosity including microcris talline waxes, approximately C10 C60; aliphatic, All food-producing species Excludes aromatic and unsaturated compounds 2The Order transposes the provisions of Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions ne spojevi branched aliphatic and alicyclic compounds N-butane All food-producing species ol N-butanol All food-producing species For use as excipient in Natamycin Bovine, equidae For topical use only min Neostigmine All food-producing species ksil Nicoboxil Equidae For topical use only mid Nonivamide Equidae For topical use only leat Oleyloleate All food-producing species For topical use only n Oxytocin All mammalian food producing species tin Pancreatin All mammalian food producing species For topical use only Papain All food-producing species in Papaverine Bovine Newborn calves only tna kiselina Peracetic acid All food-producing species Phenol All food-producing species ciol Phloroglucinol All food-producing species adion Phytomenadione All food-producing species ulen Policresulen All food-producing species For topical use only n glikol 15 stearat Polyethylene glycol 15 hydroxystearate All food-producing species For use as excipient n glikol 7 gliceril Polyethylene glycol 7 glyceryl cocoate All food-producing species For topical use only n glikol stearat sa ietilenskih Polyethylene glycol stearates with 8-40 oxyethylene units All food-producing species For use as excipient at minglikan Polysulphated glycosaminoglycan Equidae antel Praziquantel Ovine, equidae For use in non-lactating sheep only drebnih kobila Pregnant mare serum gonadotrophin All food-producing species id (krotetamid i amid) Prethcamide (crotethamide and cropropamide) All mammalian food producing species Procaine All food-producing species Propane All food-producing species glikol Propylene glycol All food-producing species n Quatresin All food-producing species For use as preservative only at concentrations of u ostenol R-Cloprostenol Bovine, porcine, equidae min Rifaximin All mammalian food producing species, bovine For topical use only For intramammary use, except if the udder may b cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions food for human consumption in Romifidine Equidae For therapeutic uses only 2-metil 2 fenoksi at Sodium 2-methyl-2 phenoxy-propanoate Bovine, porcine, caprine, equidae benzil 4 benzoat Sodium benzyl 4 hydroxybenzoate All food-producing species butil 4 benzoat Sodium butyl 4 hydroxybenzoate All food-producing species cetostearilsulfat Sodium cetostearyl sulphate All food-producing species alm Somatosalm Salmon m Tanninum All food-producing species alinat Tau fluvalinate idrat Terpin hydrate Bovine, porcine, ovine, caprine n Tetracaine All food-producing species For use as anaesthetic only min Theobromine All food-producing species Theophylline All food-producing species al Thiomersal All food-producing species For use only as preservatives in multidose vaccine concentration not exceeding 0.02 % Thymol All food-producing species nat Timerfonate All food-producing species For use only as preservatives in multidose vaccine concentration not exceeding 0.02 % idroglucinol Trimethylphloroglucinol All food-producing species D Vitamin D All food-producing species ski alkoholi Wool alcohols All food-producing species For topical use only 2-pirolidon 1 -Methyl-2-pyrrolidone Equidae il Cefacetrile Bovine For intramammary use only and for all tissues exc azol Enilconazole Bovine, equidae For topical use only at Etamsylate All food-producing species n Strychnine bovine For oral use only, at dose to 0.1 mg/kg bw zol Parconazole Guinea fowl Biotin All food-producing species ksin Bromhexine Bovine Not for use in animals from which milk is produced for human consumption Porcine Poultry Not for use in animals from which eggs are produced for human consumption cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions aminhidroklorid Mercaptamine hydrochloride All mammalian food producing species antel Praziquantel Ovine embonat Pyrantel embonate Equidae B1 Vitamin B1 All food-producing species B12 Vitamin B12 All food-producing species B2 Vitamin B2 All food-producing species B3 Vitamin B3 All food-producing species B5 Vitamin B5 All food-producing species B6 Vitamin B6 All food-producing species E Vitamin E All food-producing species Tiaprost Bovine, ovine, porcine, equidae cin Apramycin Porcine, rabbits Ovine Not for use in animals from which milk is produced for human consumption Chicken Not for use in animals from which eggs are produced for human consumption For oral use only hifos Azamethiphos Salmonidae am Doxapram All mammalian food producing species l butoksid Piperonyl butoxide Bovine, ovine, caprine, equidae For topical use only akol Sulfogaiacol All food-producing species tin hidroklorid Vetrabutine hydrochloride Porcine amid hidroklorid Fenpipramide hydrochloride Equidae For intravenous use only ortiazid Hydrochlorothiazide Bovine tadon Levomethadone Equidae For intravenous use only mesilat Tricaine mesilate Fin fish For water borne use only metiazid Trichlormethiazide All mammalian food producing species Not for use in animals from which milk is produc human consumption in Vincamine Bovine For use in newborn animals only Atropine All food-producing species azon Cefoperazone Bovine For intramammary use in lactating cows only and cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions tissues except milk etanol glukuronat 2-aminoethanol glucuronate All food-producing species lukuronat Betaine glucuronate osulfonati, ve i natrijeve soli Bituminosulfonates, ammonium and sodium salts All mammalian food producing species For topical use only amin Chlorphenamine All mammalian food producing species For oral use only ka kiseline i natrijeve soli Humic acids and their sodium salts All food-producing species mol Paracetamol Porcine For oral use only ramid natrij Tosylchloramide sodium – m88, 125 Fin fish, Bovine Equidae For water-borne use only For topical use only For topical use only 2-pirolidon 1 -methyl-2-pyrrolidone All food-producing species rin maleat Ergometrine maleate All mammalian food producing species For use in parturient animals only je Jecoris oleum All food-producing species For topical use only kain Mepivacaine Equidae For intra-articular and epidural use as local anaest ocin Novobiocin Bovine For intrammary use only and for all tissues excep n dihidroklorid Piperazine dihydrochloride Chicken For all tissues except eggs l ricinus ulje sa ksietilenskih Polyoxyl castor oil with 30 to 40 oxyethylene units All food-producing species For use as excipient l hidrogenizirano vo ulje sa 40-60 nskih jedinica Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units All food-producing species For use as excipient hidroklorid Xylazine hydrochloride Bovine, equidae Not for use in animals from which milk is produc human consumption fan Butafosfan Bovine For intravenous use only j Cefalonium Bovine For intramammary use and eye treatment only, an tissues except milk mid Furosemide Bovine, equidae For intravenous administration only n Lidocaine Equidae For local-regional anaesthesia only dov L-tirozin 3,5-Diiodo-L-thyrosine All mammalian food producing species ksin Levothyroxine All mammalian food producing species aluminijev Aluminium salicylate, All food producing species For topical use only cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions basic except fish v subnitrat Bismuth subnitrate Bovine For intramammary use only aspartat Calcium aspartate All food-producing species licilat Methyl salicylate All food-producing species, except fish For topical use only na kiselina Salicylic acid All food-producing species, except fish For topical use only salicilat Sodium salicylate Bovine, porcine For oral use. Not for use in animals from which m produced for human consumption aspartat Zinc aspartate All food-producing species os Toldimfos All food-producing species nat Decoquinate Bovine, ovine For oral use. Not for use in animals from which m produced for human consumption boroformijat Sodium boroformiate All food-producing species Thiamylal All mammalian food producing species For intravenous administration only al natrij Thiopental sodium All food-producing species For intravenous administration only licilna kiselina Acetylsalicylic acid All food-producing species, except fish Not for use in animals from which milk or eggs ar for human consumption licilna kiselina DL Acetylsalicylic acid DL lysine All food-producing species, except fish Not for use in animals from which milk or eggs ar for human consumption at kalcij Carbasalate calcium All food-producing species, except fish Not for use in animals from which milk or eggs ar for human consumption acetilsalicilat Sodium acetylsalicylate All food-producing species, except fish Not for use in animals from which milk or eggs ar for human consumption a alkil benzen a kiselina s lancem dužine od 13 koja sadrži d 2,5% lanca dužih Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13 Bovine, ovine For topical use only soli Amprolium Poultry For oral use only nska kiselina, ve Tiludronic acid, disodium salt Equidae For intravenous use only trioleat Sorbitan trioleate All food-producing species A Vitamin A All food-producing species ev laurilsulfat Ammonium lauryl sulphate All food-producing species ol Bronopol Fin fish pantotenat Calcium pantothenate All food-producing species n Allantoin All food-producing species For topical use only cologically active ce(s) - Croatian Pharmacologically active substance(s) English Animal species Other provisions ain Benzocaine Salmonidae ntenol Dexpanthenol All food-producing species nafarelin Azagly-nafarelin Salmonidae Not for use in fish from which eggs are produced consumption in acetat Deslorelin acetate Equidae ietilsalicilat Hydroxyethylsalicylate All food-producing species, except fish For topical use only hidroklorid Xylazine hydrochloride Bovine, equidae zol Omeprazole Equidae For oral use only metiazid Trichlormethiazide All mammalian food producing species ron Progesterone (*) Bovine, ovine, caprine, Equidae (female) Only for intravaginal therapeutic or zootechnical accordance with the Order prohibiting the use in stockfarming of certain beta-agonists and substan a hormonal or thyrostatic action (OG 21/03)3 etazondipropionat Beclomethasone dipropionate Equidae For inhalation only tenol Cloprostenol Caprine ostenol R-cloprostenol Caprine seskvioleat Sorbitan sesquioleate All food-producing species glikol monoetil Diethylene glycol monoethyl ether All ruminants and porcine n Peforelin Porcine 3. Substances generally recognised as safe Pharmacologically active ubstance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions Ekstrakt pelina Absinthium extract All food-producing species Acetilmetionin Acetylmethionine All food-producing species Aluminijev hidroksid Aluminium hydroxide All food-producing species Aluminijev monostearat Aluminium monostearate All food-producing species Amonijev sulfat Ammonium sulfate All food-producing species Benzoil benzoat Benzoyl benzoate All food-producing species Benzil p-hidroksibenzoat Benzyl p-hydroxybenzoate All food-producing species Kalcijev boroglukonat Calcium borogluconate All food-producing species Kalcijev citrat Calcium citrate All food-producing species 3 The Order transposes the provisions of Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Pharmacologically active ubstance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions Kamfor Camphor All food-producing species For topical use only Ekstrakt kardamona Cardamon extract All food-producing species Dietil sebakat Diethyl sebacate All food-producing species Dimetikon Dimethicone All food-producing species Dimetil acetamid Dimethyl acetamide All food-producing species Dimetil sulfoksid Dimethyl sulphoxide All food-producing species Epinefrin Epinephrine All food-producing species Etiloleat Ethyl oleate All food-producing species Etilendiamintetraacetatna iselina i njezine soli Ethylenediaminetetraacetic acid and salts All food-producing species Eukaliptol Eucalyptol All food-producing species olikulostimulirajući ormon (prirodni FSH od vih vrsta i njihovih intetskih analoga) Follicle stimulating hormone (natural FSH from all species and their synthetic analogues) All food-producing species ormaldehid Formaldehyde All food-producing species Mravlja kiselina Formic acid All food-producing species Glutaldehid Glutaraldehyde All food-producing species Gvajakol Guaiacol All food-producing species Heparin i njegove soli Heparin and its salts All food-producing species Ljudski korionski onadotropin (prirodni HCG i njegovi sintetski nalozi) Human chorionic gonadotropin (natural HCG and its synthetic analogues) All food-producing species Željezov amonij citrat Iron ammonium citrate All food-producing species Željezov dekstran Iron dextran All food-producing species Željezov glukoheptonat Iron glucoheptonate All food-producing species zopropanol Isopropanol All food-producing species Lanolin Lanolin All food-producing species Luteinizirajući hormon prirodni LH od svih vrsta njihovi sintetski analozi Luteinising hormone (natural LH from all species and their synthetic analogues) All food-producing species Magnezijev klorid Magnesium chloride All food-producing species Magnezijev glukonat Magnesium gluconate All food-producing species Magnezijev hipofosfit Magnesium hypophosphite All food-producing species Manitol Mannitol All food-producing species Metilbenzoat Methylbenzoate All food-producing species Monotioglicerol Monothioglycerol All food-producing species Montanid Montanide All food-producing species Migliol Myglyol All food-producing species Orgotein Orgotein All food-producing species oloksalen Poloxalene All food-producing species Pharmacologically active ubstance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions oloksamer Poloxamer All food-producing species olietilenski glikoli molekularne težine od 00-10000) Polyethylene glycols (molecular weight ranging from 200 to 10 000) All food-producing species olisorbat 80 Polysorbate 80 All food-producing species erotonin Serotonin All food-producing species Natrijev klorid Sodium chloride All food-producing species Natrijev kromoglikat Sodium cromoglycate All food-producing species Natrijev ioktilsulfosukcinat Sodium dioctylsulphosuccinate All food-producing species Natrijev ormaldehidsulfoksilat Sodium formaldehydesulphoxylate All food-producing species Natrijev lauril sulfat Sodium lauryl sulphate All food-producing species Natrijev pirosulfit Sodium pyrosulphite All food-producing species Natrijev stearat Sodium stearate All food-producing species Natrijev tiosulfat Sodium thiosulphate All food-producing species Tragant Tragacanth All food-producing species Urea Urea All food-producing species Cinkov oksid Zinc oxide All food-producing species Cinkov sulfat Zinc sulphate All food-producing species Adenozin i njegovi 5 mono, 5-di i 5-trifosfati Adenosine and its 5′ mono-, 5′-di- and 5′ triphosphates All food-producing species Alanin Alanine All food-producing species Arginin Arginine All food-producing species Asparagin Asparagine All food-producing species Aspartatna kiselina Aspartic acid All food-producing species Karnitin Carnitine All food-producing species Kolin Choline All food-producing species Kimotripsin Chymotrypsin All food-producing species Citrulin Citrulline All food-producing species Cistein Cysteine All food-producing species Citidin i njegovi 5-mono, di i 5-trifosfati Cytidine and its 5′-mono-, 5′-di- and 5′-triphosphates All food-producing species Glutamatna kiselina Glutamic acid All food-producing species Glutamin Glutamine All food-producing species Glicin Glycine All food-producing species Gvanozin i njegovi 5 mono, 5-di i 5-trifosfati Guanosine and its 5′ mono-, 5′-di- and 5′ triphosphates All food-producing species Histidin Histidine All food-producing species Hijaluronska kiselina Hyaluronic acid All food-producing species Pharmacologically active ubstance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions nozin i njegovi 5′-mono, ′- di i 5′-trifosfati Inosine and its 5′-mono-, 5′-di- and 5′-triphosphates All food-producing species nozitol Inositol zoleucin Isoleucine Leucin Leucine Lizin Lysine All food-producing species Metionin Methionine All food-producing species Ornitin Ornithine All food-producing species Orotna kiselina Orotic acid All food-producing species epsin Pepsin All food-producing species enilalanin Phenylalanine All food-producing species rolin Proline All food-producing species erine Serine All food-producing species Tioktna kiselina Thioctic acid All food-producing species Treonin Threonine All food-producing species Timidine Thymidine All food-producing species Tripsin Trypsin All food-producing species Triptofan Tryptophan All food-producing species Tirozin Tyrosine All food-producing species Uridine i njegovi 5′-mono, ′-di- i 5′-trifosfati Uridine and its 5′-mono-, 5′-di- and 5′-triphosphates All food-producing species Valin Valine All food-producing species olioksietilen sorbitan monooleat Polyoxyethylene sorbitan monooleate All food-producing species olioksietilen sorbitan monooleat i trioleat Polyoxyethylene sorbitan monooleate and trioleate All food-producing species 4. Substances used in homeopathic veterinary medicinal products (VMP) rmacologically e substance(s) oatian Pharmacologically active substance(s) Latin Animal species Other provisions ubstances used meopathic inary medicinal ucts provided heir entration in the uct does not ed one part per housand All food-producing species etni gorocvijet Adonis vernalis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only Acqua levici All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias only bilje Atropa belladonna All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only ica Convallaria majalis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per thousand only ska konoplja Apocynum cannabinum All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only use only Harunga madagascariensis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only ica noći Selenicereus grandiflorus All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only njačka tuja Thuja occidentalis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only Virola sebifera All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per thousand only Ruta graveolens All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per thousand only use in animals from which milk is produced for huma consumption i kesten Aesculus hippocastanum130 All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per ten only oplja Agnus castus All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the en Ailanthus altissima All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the ni luk (crveni) Allium cepa All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the nkin korjen, ka Arnicae radix All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding in the products not exceeding one part only Artemisia abrotanum All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the nčica Bellis perennis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the n Calendula officinalis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding in the products not exceeding one part only for Camphora All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per hundred only Cardiospermum halicacabum All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the ovi Crataegus All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the bekija, acea Echinacea All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the For topical use only. For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per hundred only liptus Eucalyptus globulus All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the azija/Vidac Euphrasia officinalis All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the o Ginkgo biloba All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per thousand only eng Ginseng All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the amelis Hamamelis virginiana All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per ten only ja kanđa Harpagophytum procumbens All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the časta Hypericum All food-producing species For use in homeopathic veterinary medicinal product kavica perforatum according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the Lachnanthes tinctoria All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per thousand only Lobaria pulmonaria All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the Okoubaka aubrevillei All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the r-višnja Prunus laurocerasus All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent the products not exceeding one part per thousand only l palma Serenoa repens All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the vica i stričak bad Silybum marianum All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the n europske ice Solidago virgaurea All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the ul Syzygium cumini All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the iana Turnera diffusa All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the a imela Viscum album All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias at concent corresponding to the mother tincture and dilutions the rički kermes ili bojka Phytolacca americana All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per thousand only ki luk Urginea maritima All food-producing species For use in homeopathic veterinary medicinal product according to homeopathic pharmacopoeias, at concen the products not exceeding one part per hundred only use only 1 5. Substances used as food additives in foodstuffs for human consumption Pharmacologically active substance(s) - English Animal species Other provisions 1. Substances with an E number All food-producing species Only substances approved as additives in foodstuffs for human consumption, with the exception of preservatives listed in the Ordinance on additives4 6. Substances of vegetable origin Pharmacologically active substance(s) Croatian Pharmacologically active substance(s) Latin Animal species Other provisions Aloj gel i ekstrakt cijelog lista aloje Aloe vera gel and whole leaf extract of Aloe vera All food-producing species For topical use only Aloji, barbadoški i kapski, njihovi standardizirani ekstrakti i njihovi pripravci Aloes, Barbados and Capae, their standardised dry extract and preparations thereof All food-producing species Eterično ulje anđelikina korjena Angelicae radix aetheroleum All food-producing species Aniševo eterično ulje Anisi aetheroleum All food-producing species Plod zvjezdastog anisa, standardizirani ekstrakti i njihovi pripravci Anisi stellati fructus, standardised extracts and preparations thereof All food-producing species Brđanka (cvijet i cijela biljka) Arnica montana (arnicae flos and arnicae planta tota) All food-producing species For topical use only Peruanski balzam Balsamum peruvianum All food-producing species For topical use only Boldov list Boldo folium All food-producing species Nevenov cvijet Calendulae flos All food-producing species For topical use only Paprikin plod Capsici fructus acer All food-producing species Korijen kravljaka Carlinae radix All food-producing species For topical use only Kimovo eterično ulje Carvi aetheroleum All food-producing species Klinčićevo eterično ulje Caryophylli aetheroleum All food-producing species Ekstrakt centelina, zeleni Centellae asiaticaer extractum All food-producing species For topical use only 4 Article 7 of the special ordinance will transpose the provisions of European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. Krizantema-cvijet Chrysanthemi cinerariifolii flos All food-producing species For topical use only Podanak cimicifuge Cimicifugae racemosae rhizoma All food-producing species Not for use in animals from whic milk is produced for human consumption Kininovčeva kora, standardizirani ekstrakti i njihovi pripravci Cinchonae cortex, standardised extracts and preparations thereof All food-producing species eterično ulje kineskog cimetovca Cinnamomi cassiae aetheroleum All food-producing species Kora kineskog cimetovca, standardizirani ekstrakti i njihovi pripravci Cinnamomi cassiae cortex, standardised extracts and preparations thereof All food-producing species eterično ulje cejlonskog cimetovca Cinnamomi ceylanici aetheroleum All food-producing species Kora cejlonskog cimetovca, standardizirani ekstrakti i njihovi pripravci Cinnamomi ceylanici cortex, standardised extracts and preparations thereof All food-producing species Eterično ulje limuna Citri aetheroleum All food-producing species Eterično ulje oštre vlaske Citronellae aetheroleum All food-producing species Kora kondurago kondorvine Condurango cortex, standardised extracts and preparations thereof All food-producing species Korijanderovo eterično ulje Coriandri aetheroleum All food-producing species Eterično ulje čempresa Cupressi aetheroleum All food-producing species For topical use only Purpurna rudbekija Echinacea purpurea All food-producing species For topical use only Eukaliptusovo eterično ulje Eucalypti aetheroleum All food-producing species Komoračevo eterično ulje Foeniculi aetheroleum All food-producing species Krkavinina kora, standardizirani ekstrakti i njihovi pripravci Frangulae cortex, standardised extracts and preparations thereof All food-producing species Sirištavin korjen, standardizirani ekstrakti i njihovi Gentianae radix, standardised extracts and preparations thereof All food-producing species pripravci Ginseng, standardizirani ekstrakti i njihovi pripravci Ginseng, standardised extracts and preparations thereof All food-producing species Hamamelis Hamamelis virginiana All food-producing species For topical use only Sjeme divljeg kestena Hippocastani semen All food-producing species For topical use only Ulje gospine trave Hyperici oleum All food-producing species For topical use only Plod borovice Juniperi fructus All food-producing species Eterično ulje lovorova lista Lauri folii aetheroleum All food-producing species Lovorov plod Lauri fructus All food-producing species Lavandino eterično ulje Lavandulae aetheroleum All food-producing species For topical use only Glavica lesperdeza Lespedeza capitata All food-producing species Laneno ulje Lini oleum All food-producing species Mažuran-zelen Majoranae herba All food-producing species Kamilica i njezini pripravci Matricaria recutita and preparations thereof All food-producing species Kamiličin cvijet Matricariae flos All food-producing species Ekstrakt vije lucerne Medicago sativa extractum All food-producing species For topical use only Matičnjakovo eterično ulje Melissae aetheroleum All food-producing species Matičnjakov list Melissae folium All food-producing species eterično ulje poljske metvice Menthae arvensis aetheroleum All food-producing species eterično ulje paprene metvice Menthae piperitae aetheroleum All food-producing species Stolisnikova zelen Millefolii herba All food-producing species eterično ulje muškatnog oraščića Myristicae aetheroleum All food-producing species For use in newborn animals only Ekstrakt turiona („mladice“ smreke) Piceae turiones recentes extractum All food-producing species For oral use only Oksidacijski produkti terpentinskog ulja Oxidation products of Terebinthinae oleum All food-producing species Ekstrakt buhača Pyrethrum extract All food-producing species For topical use only Hrastova kora Quercus cortex All food-producing species Quillaja ekstrakt Quillaia saponins All food-producing species Rabarbarin korjen, standardizirani Rhei radix, standardised extracts and preparations All food-producing species ekstrakti i njihovi pripravci thereof Ricinusovo ulje Ricini oleum All food-producing species For use as excipient Ružmarinovo eterično ulje Rosmarini aetheroleum All food-producing species Ružmarinov list Rosmarini folium All food-producing species Veprina Ruscus aculeatus All food-producing species For topical use only Kaduljin list Salviae folium All food-producing species Bazgov cvijet Sambuci flos All food-producing species Sjeme crne gorušice Sinapis nigrae semen All food-producing species Sjemenka strihinovca Strychni semen All food-producing species For oral use only at doses up to th equivalent of 0.1 mg strychnine/k Korijen gaveza Symphyti radix All food-producing species For topical use on intact skin only Terpetinsko eterično ulje Terebinthinae aetheroleum rectificatum All food-producing species For topical use only Balzam od ariša Terebinthinae laricina All food-producing species For topical use only Timijanovo eterično ulje Thymi aetheroleum All food-producing species Lipin cvijet Tiliae flos All food-producing species Kopriva Urticae herba All food-producing species 7. Anti-infectious agents Pharmacologically active substance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions Oksalna kiselina Oxalic acid Honey bees 8. Anti-inflammatory agents Pharmacologically active substance(s) - Croatian Pharmacologically active substance(s) - English Animal species Other provisions Karprofen Carprofen bovine For bovine milk only ANNEX III LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs FOR WHICH PROVISIONAL MRLs HAVE BEEN ESTABLISHED 1. ANTIMICROBIAL AGENTS 1.2. ANTIBIOTICS 1.2.2. Macrolides Pharmacologically active substance English name of the pharmacologically active substance Marker residue Animal species MRLs μg/kg or μg/kg Target tissues Other provisions Gamitromicin Gamithromycin Gamithromycin Bovines 20 200 100 Fat Liver Kidney Provisional MRLs expire on 1 July 2009; not for use in animals from which milk is produced for human consumption ANNEX IV LIST OF PROHIBITED PHARMACOLOGICALLY ACTIVE SUBSTANCES Pharmalogically active substance English name of the pharmacologically active substance 1. Vučja stopa (Aristolochia spp.) i njezini pripravci Aristolochia spp. and preparations thereof 2. Kloramfenikol Cholramphenicol 3. Kloroform Chloroform 4. Klorpromazin Chlorpromazine 5. Kolhicin Colchicine 6. Dapson Dapsone 7. Dimetridazol Dimetridazole 8. Metronidazol Metronidazole 9. Nitrofurani Nitrofurans (including furazolidone) 10. Ronidazol Ronidazole ANNEX V INFORMATION AND PARTICULARS TO BE INCLUDED IN AN APPLICATION FOR THE ESTABLISHMENT OF A MRL FOR A PHARMACOLOGICALLY ACTIVE SUBSTANCE USED IN VMPs Administrative particulars 1. Name or corporate name and permanent address of the person submitting the application for placing the VMP on the market. 2. Name of the VMP 3. Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name (INN) recommended by the World Health Organisation, where such name exists 4. Manufacturing authorisation, if any. 5. VMP marketing authorisation, if any. 6. Summary of the characteristics of the VMP(s) prepared in accordance with Article 5a of a special regulation on veterinary medicinal products1 A. Safety documentation A.0. Expert report A.1. Precise identification of the substance concerned by the application for the establishment of a MRL 1.1. International non-proprietary name (INN) 1.2. International Union of Pure and Applied Chemistry Name (IUPAC) 1.3. Chemical Abstract Service (CAS) name 1.4. Classification therapeutic pharmcological 1.5. Synonyms and abbreviations 1.6. Structural formula 1.7. Molecular formula 1.8. Molecular weight 1.9. Degree of purity 1.10. Qualitative and quantitative composition of impurities 1.11. Description of physical properties: fusion point boiling point vapour pressure solubility in water and organic solvents expressed in g/l, with indication of temperature density spectra of refraction, rotation, etc. A.2. Relevant pharmacological studies 2.1. Pharmacodynamic studies 2.2. Pharmacokinetic studies A.3. Toxicological studies 3.1. Single dose toxicity (acute toxicity) 3.2. Repeated dose toxicity (chronic toxicity) 3.3. Tolerance in the target species of animal(s) 3.4. Reproductive toxicity, including teratogenicity 3.4.1. Study of the effects on reproduction 3.4.2. Embryotoxicity/fetotoxicity, including teratogenicity 3.5. Mutagenicity 3.6. Caricinogenicity A.4. Studies of other effects 4.1. Immunotoxicity 4.2. Microbiological properties of residues 4.2.1. Effects on the human gut flora 4.2.2. Effects on the micro-organisms used for industrial food processing 4.3. Observations in humans B. VMP residue documentation B.0. Expert report B.1. Precise identification of the substance concerned by the application for the establishment of a MRL The substance concerned should be identified in accordance with item A.1. However, where the application relates to one or more veterinary medicinal products, the product itself should be identified in detail, including: qualitative and quantitative composition; purity; identification of the manufacturer’s batch used in the studies; comparison with the final product; specific activity and purity of radioactive isotopes; position of labelled atoms on the molecule. B.2. Residue studies 2.1. Pharmacokinetics (resorption, distribution, biotransformation, excretion) 2.2. Depletion of residues 2.3. Elaboration of MRLs B.3. Routine analytical methods for the detection of residues 3.1. Description of the method 3.2. Validation of the method 3.2.1. Specificity 3.2.2. Accuracy, including sensitivity 3.2.3. Precision 3.2.4. Limit of detection (LOD) 3.2.5. Limit of quantitation (LOQ) 3.2.6. Practicability and applicability under normal laboratory conditions 3.2.7. Susceptibility to interference 1A special regulation on veterinary medicinal products will transpose the provisions of Directive (EC) No 2001/82, on its entry into force Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products ceased to have effect. The regulation referred to in Annex V, item 1.6. shall be adopted by 30 June 2009.