# Commission Regulation (EC) No 1916/98 of 9 September 1998 amending Annexes I and II 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) EU Regulation No 1916/1998 · adopted 9 September 1998 Commission Regulation (EC) No 1916/98 of 9 September 1998 amending Annexes I and II 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) ## Introductory text Commission Regulation (EC) No 1916/98 of 9 September 1998 amending Annexes I and II 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, as last amended by Commission Regulation (EC) No 1570/98, and in particular Articles 6 and 8 thereof, 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 food-producing animals; 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; Whereas, in establishing maximum residue limits for residues of 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); 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 carcases moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues; 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, Whereas toltrazuril and amitraz should be inserted into Annex I to Regulation (EEC) No 2377/90; Whereas clazuril, aluminium distearate, aluminium hydroxide acetate, aluminium phosphate, aluminium tristearate, ammonium chloride, cobalt carbonate, cobalt dichloride, cobalt gluconate, cobalt oxide, cobalt sulphate, cobalt trioxide, iron sulphate, terebinthinae laricina, coco alkyl dimethyl betaines, diprophylline, hexetidine, polyethylene glycol 15 hydroxystearate, polyethylene glycol 7 glyceryl cocoate, polyethylene glycol stearates with 8-40 oxyethylene units, prethcamide (crotethamide, cropropamide), terpin hydrate, balsamum peruvianum, oxidation products of terebinthinae oleum, ricini oleum and terebinthinae aetheroleum rectificatum and iron dichloride should be inserted into Annex II to Regulation (EEC) No 2377/90; 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, as last amended by Directive 93/40/EEC, to take account of the provisions of this Regulation; Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THIS REGULATION: ## 1 Annexes I and II to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. ## 2 This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities. ## Signature This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 9 September 1998. For the Commission Martin Bangemann Member of the Commission ## A.. Annex I to Regulation (EEC) No 2377/90 is amended as follows: 2.. Anti-parasitic agents 2.2. Agents acting against ectoparasites 2.2.2. Formamidines Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Amitraz Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz Bovine 200 μg/kg Fat 200 μg/kg Liver 200 μg/kg Kidney 10 μg/kg Milk Ovine 400 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney 10 μg/kg Milk’ 2.4. Agents acting against protozoa 2.4.1. Triazinetrione derivative Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Toltrazuril Toltrazuril sulfone Chicken 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption’ 200 μg/kg Skin + fat 600 μg/kg Liver 400 μg/kg Kidney Turkey 100 μg/kg Muscle 200 μg/kg Skin + fat 600 μ/kg Liver 400 μg/kg Kidney B.. Annex II to Regulation (EEC) No 2377/90 is amended as follows: 1.. Inorganic chemicals Pharmacologically active substance(s) Animal species Other provisions ‘Aluminium distearate All food producing species Aluminium hydroxide acetate All food producing species Aluminium phosphate All food producing species Aluminium tristearate All food producing species Aluminium chloride All food producing species Cobalt carbonate All food producing species Cobalt dichloride All food producing species Cobalt gluconate All food producing species Cobalt oxide All food producing species Cobalt sulphate All food producing species Cobalt trioxide All food producing species Iron dichloride AH food producing species Iron sulphate All food producing species’ 2.. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘Clazuril Pigeon Coco alkyl dimethyl betaines All food producing species For use as excipient Diprophylline All food producing species Hexetidine Equidae For topical use only Polyethylene glycol 15 hydroxystearate All food producing species For use as excipient Polyethylene glycol 7 glyceryl cocoate All food producing species For topical use only Polyethylene glycol stearates with 8-40 oxyethylene units All food producing species For use as excipient’ Prethcamide (crotethamide and cropropamide) All mammalian food producing species Terpin hydrate Bovine, porcine, ovine, caprine 6.. Substances of vegetable origin Pharmacologically active substance(s) Animal species Other provisions ‘Balsamum peruvianum All food producing species For topical use only Oxidation products of terebinthinae oleum Bovine, porcine, ovine, caprine Ricini oleum All food producing species For use as excipient Terebinthinae aetheroleum rectificatum All food producing species For topical use only Terebinthinae laricina All food producing species For topical use only’ --- Source: https://www.legislation.gov.uk/eur/1998/1916 (the official version) Page: https://openlegislation.uk/eu-regulation-1998-1916 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.