Official Journal of the European Communities

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1 EN Official Journal of the European Communities L 328/23 COMMISSION REGULATION (EC) No 2728/1999 of 20 December 1999 amending Annexes I, II and III to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to 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 ( 1 ), as last amended by Commission Regulation (EC) No 2593/1999 ( 2 ), and in particular Articles 6 and 8 thereof; (1) Whereas, in accordance with Regulation (EEC) No 2377/ 90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to foodproducing animals; (2) Whereas maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs; (3) Whereas, in establishing maximum residue limits for veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue); (4) Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney; whereas, however, the liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues; (5) Whereas, in the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey; (6) Whereas flunixin, cefalexin, flumequine, meloxicam and tiamulin should be inserted into Annex Ito Regulation (EEC) No 2377/90; (7) Whereas butafosfan, eucalyptus globulus, furosemide, echinacea, cupressi aetheroleum, crataegus, cefalonium, carlinae radix, cardiospermum halicacabum, turnera diffusa, calendula officinalis, euphrasia officinalis, boldo folium, bellis perennis, artemisia abrotanum, arnicae radix, arnica montana (arnicae flos, arnicae planta tota), aloes, Barbados, Capae, their standardised dry extract, preparations thereof, allium cepa, ailanthus altissima, agnus Castus, aesculus hippocastanum, camphora, lobaria pulmonaria, syzygium cumini, solidago virgaurea, silybum marianum, serenoa repens, prunus laucerasus, okoubaka aubrevillei, viscum album, symphyti radix, lidocaine, hamamelis virginiana, lachnanthes tinctoria, hypericum perforatum and ginkgo biloba and harpagophytum procumbens and lavandulæ ætheroleum and ginseng should be inserted into Annex II to Regulation (EEC) No 2377/90; (8) Whereas, in order to allow for the completion of scientific studies, tiamulin, spectinomycin, doramectin, mebendazole, propetamphos, metamizole, abamectin, cefalonium and rafoxanide should be inserted into Annex III to Regulation (EEC) No 2377/90; (9) Whereas a period of 60 days should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/ 851/EEC ( 3 ), as last amended by Directive 93/40/EEC ( 4 ), to take account of the provisions of this Regulation; (10) Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, ( 1 ) OJ L 224, , p. 1. ( 3 ) OJ L 317, , p. 1. ( 2 ) OJ L 315, , p. 26. ( 4 ) OJ L 214, , p. 31.

2 L 328/24 EN Official Journal of the European Communities HAS ADOPTED THE FOLLOWING REGULATION: Article 1 Annexes I, II and III to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. Article 2 This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities. It shall apply from the 60th day following its publication. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 December For the Commission Erkki LIIKANEN Member of the Commission

3 EN Official Journal of the European Communities L 328/25 ANNEX A. Annex Ito Regulation (EEC) No 2377/90 is amended as follows: 1. Anti-infectious agents 1.2. Antibiotics Quinolones Cefalexin Cefalexin Bovine 200 µg/kg Muscle 200 µg/kg Fat 200 µg/kg Liver µg/kg Kidney 100 µg/kg Milk Quinolones Flumequine Flumequine Bovine, ovine 200 µg/kg Muscle Not for use in animals from 300 µg/kg Fat which milk is produced for 500 µg/kg Liver µg/kg Kidney Porcine 200 µg/kg Muscle 300 µg/kg Skin and fat 500 µg/kg Liver µg/kg Kidney Chicken 400 µg/kg Muscle Not for use in animals from 250 µg/kg Skin and fat which eggs are produced for 800 µg/kg Liver µg/kg Kidney Salmonidae 600 µg/kg Muscle and skin in natural proportions

4 L 328/26 EN Official Journal of the European Communities Pleuromutilines Tiamulin Sum of metabolites that may be Porcine 100 µg/kg Muscle hydrolysed to 8-a-hydroxymu- 500 µg/kg Liver tilin Chicken 100 µg/kg Muscle 100 µg/kg Skin and fat µg/kg Liver Tiamulin µg/kg Eggs 4. Anti-inflammatory agents 4.1. Nonsteroidal anti-inflammatory agents Fenamate group derivates Flunixin Flunixin Bovine 20 µg/kg Muscle 30 µg/kg Fat 300 µg/kg Liver 100 µg/kg Kidney 5-Hydroxyflunixin 40 µg/kg Milk Flunixin Porcine 50 µg/kg Muscle 10 µg/kg Skin and fat 200 µg/kg Liver 30 µg/kg Kidney Oxicam derivatives Meloxicam Meloxicam Bovine 20 µg/kg Muscle 65 µg/kg Liver 65 µg/kg Kidney 15 µg/kg Milk

5 EN Official Journal of the European Communities L 328/27 B. Annex II to Regulation (EEC) No 2377/90 is amended as follows: 2. Organic compounds Animal species Other provisions Butafosfan Bovine For intravenous use only and not for use in animals from which milk is produced for Cefalonium Bovine For intramammary use and eye treatment only, and for all tissues except milk Furosemide Bovine, equidae For intravenous administration only Lidocaine Equidae For local-regional anaesthesia only 4. Substances used in homeopathic veterinary medicinal products Animal species Other provisions Aesculus hippocastanum All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per ten only Agnus castus All-food producing species For use in homeopathic veterinary medicinal products prepared Ailanthus altissima All-food producing species For use in homeopathic veterinary medicinal products prepared Allium cepa All-food producing species For use in homeopathic veterinary medicinal products prepared Arnicae radix All-food producing species For use in homeopathic veterinary medicinal products prepared corresponding in the products not exceeding one part per ten only

6 L 328/28 EN Official Journal of the European Communities Animal species Other provisions Artemisia abrotanum All-food producing species For use in homeopathic veterinary medicinal products prepared Bellis perennis All-food producing species For use in homeopathic veterinary medicinal products prepared Calendula officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared corresponding in the products not exceeding one part per ten only Camphora All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per hundred only. Cardiospermum halicacabum All-food producing species For use in homeopathic veterinary medicinal products prepared Crataegus All-food producing species For use in homeopathic veterinary medicinal products prepared Echinacea All-food producing species For use in homeopathic veterinary medicinal products prepared For topical use only. For use in homeopathic veterinary medicinal products prepared corresponding in the products not exceeding one part per ten only Eucalyptus globulus All-food producing species For use in homeopathic veterinary medicinal products prepared

7 EN Official Journal of the European Communities L 328/29 Animal species Other provisions Euphrasia officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared Ginkgo biloba All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per thousand only. Ginseng All-food producing species For use in homeopathic veterinary medicinal products prepared Hamamelis virginiana All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per ten only Harpagophytum procumbens All-food producing species For use in homeopathic veterinary medicinal products prepared Hypericum perforatum All-food producing species For use in homeopathic veterinary medicinal products prepared Lachnanthes tinctoria All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per thousand only. Lobaria pulmonaria All-food producing species For use in homeopathic veterinary medicinal products prepared Okoubaka aubrevillei All-food producing species For use in homeopathic veterinary medicinal products prepared

8 L 328/30 EN Official Journal of the European Communities Animal species Other provisions Prunus laurocerasus All-food producing species For use in homeopathic veterinary medicinal products prepared in the products not exceeding one part per thousand only. Serenoa repens All-food producing species For use in homeopathic veterinary medicinal products prepared Silybum marianum All-food producing species For use in homeopathic veterinary medicinal products prepared Solidago virgaurea All-food producing species For use in homeopathic veterinary medicinal products prepared Syzygium cumini All-food producing species For use in homeopathic veterinary medicinal products prepared Turnera diffusa All-food producing species For use in homeopathic veterinary medicinal products prepared Viscum album All-food producing species For use in homeopathic veterinary medicinal products prepared

9 EN Official Journal of the European Communities L 328/31 6. Substances of vegetable origin Animal species Other provisions Aloes, Barbados and Capae, their standardised dry extract and preparations thereof All food-producing species Arnica montana (arnicae flos and arnicae planta tota) All food-producing species For topical use only Boldo folium All food-producing species Carlinae radix All food-producing species For topical use only Cupressi aetheroleum All food-producing species For topical use only Lavandulae aetheroleum All food-producing species For topical use only Symphyti radix All food-producing species For topical use on intact skin only C. Annex III to Regulation (EEC) No 2377/90 is amended as follows: 1. Anti-infectious agents 1.2. Antibiotics Cephalosporins Cefalonium Cefalonium Bovine 10 µg/kg Milk Provisional MRLs expire on Aminoglycosides Spectinomycin Spectinomycin Ovine 300 µg/kg Muscle Provisional MRLs expire on Not for use in animals from 500 µg/kg Fat which milk is produced for µg/kg Liver µg/kg Kidney Chicken 200 µg/kg Eggs

10 L 328/32 EN Official Journal of the European Communities Pleuromutilines Tiamulin Sum of metabolites that may be Turkey 100 µg/kg Muscle Provisional MRLs expire on hydrolysed to 8-a-hydroxymu- 100 µg/kg Skin and fat tilin 300 µg/kg Liver 2. Antiparasitic agents 2.1. Agents acting against endoparasites Benzimidazoles and pro-benzimidazoles Mebendazole Sum of mebendazole methyl (5- Ovine, caprine, equidae 60 µg/kg Muscle Provisional MRLs expire on (1-hidroxy, 1-phenyl) methyl-1h- Not for use in animals from 60 µg/kg Fat benzimidazol-2-yl) carbamate and which milk is produced (2-amino-1H-benzimidazol-5-yl) for 400 µg/kg Liver phenylmethanone, expressed as mebendazole equivalents 60 µg/kg Kidney

11 EN Official Journal of the European Communities L 328/ Salicylanilides Rafoxanide Rafoxanide Bovine 30 µg/kg Muscle Provisional MRLs expire on Not for use in animals from 30 µg/kg Fat which milk is produced for 10 µg/kg Liver 40 µg/kg Kidney Ovine 100 µg/kg Muscle Not for use in animals from 250 µg/kg Fat which milk is produced for 150 µg/kg Liver 150 µg/kg Kidney 2.2. Agents acting against ectoparasites Organophosphates Propetamphos Sum of residues of propetam- Ovine 90 µg/kg Fat Provisional MRLs expire on µg/kg Kidney phos and desisopropyl-propetamphos Not for use in animals from which milk is produced for 2.3. Agents acting against endo- and ectoparasites Avermectins Abamectin Avermectin B1a Ovine 20 µg/kg Muscle Provisional MRLs expire on µg/kg Fat 25 µg/kg Liver 20 µg/kg Kidney Doramectin Doramectin Deer, inclusing reindeer 20 µg/kg Muscle Provisional MRLs expire on µg/kg Fat 50 µg/kg Liver 30 µg/kg Kidney

12 L 328/34 EN Official Journal of the European Communities Anti-inflammatory agents 5.1. Nonsteroidal anti-infammatory agents Pyrazolone derivatives Metamizole 4-Methylaminoantipyrin Bovine, porcine, equidae 200 µg/kg Muscle Provisional MRLs expire on Not for use in animals from 200 µg/kg Fat which milk is produced for 200 µg/kg Liver 200 µg/kg Kidney