B.

Annexe II to Regulation (EEC) No 2377/90 is amended as follows: 1. Inorganic chemicals Pharmacologically active substance(s) Animal species Other provisions ‘Bismuth subcarbonate All food producing species For oral use only Bismuth subgallate All food producing species For oral use only Bismuth subnitrate All food producing species For oral use only Bismuth subsalicylate All food producing species For oral use only Boric acid and borates All food producing species Bromide, Sodium salt All mammalian food producing species For topical use only Calcium acetate All food producing species Calcium benzoate Calcium carbonate Calcium chloride Calcium gluconate Calcium hydroxide Calcium hypophosphite Calcium malate Calcium oxide Calcium phosphate Calcium polyphosphates Calcium propionate Calcium silicate Calcium stearate Calcium sulphate Hydrochloric acid All food producing species For use as excipient Hydrogen peroxide All food producing species Iodine and iodine inorganic compounds including: — All food producing species — Sodium and potassium-iodide — Sodium and potassium-iodide Iodophors including polyvinylpyrrolidone-iodine Magnesium All food producing species Magnesium sulphate Magnesium hydroxide Magnesium stearate Magnesium glutamate Magnesium orotate Magnesium aluminium silicate Magnesium oxide Magnesium carbonate Magnesium phosphate Magnesium glycerophosphate Magnesium asparate Magnesium citrate Magnesium acetate Magnesium trisilicate Potassium DL-aspartate All food producing species Potassium glucuronate All food producing species Potassium glycerophosphate All food producing species Potassium nitrate All food producing species Potassium selenate All food producing species Sodium chlorite Bovine For topical use only Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only’ Sodium selenate All food producing species Sodium selenite All food producing species Sulphur Bovine, porcine, ovine, caprine, equidae Zinc acetate All food producing species Zinc chloride Zinc gluconate Zinc oleate Zinc stearate 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘17B-Oestradiol All mammalian food producing species For therapeutic and zootechnical uses only Acetyl cysteine All food producing species Alfaprostol Bovine, porcine, equidae Benzylalcohol All food producing species For use as excipient Betaine All food producing species Brotizolam Bovine For therapeutic uses only Buserelin All food producing species Butyl 4-hydroxybenzoate All food producing species Caffeine All food producing species Carbetocin All mammalian food producing species Cefazolin Bovine Ovine, caprine For intramammary use (except if the udder may be used as food for human consumption) Cetrimide All food producing species Chlorhexidine All food producing species For topical use only Chlorocresol All food producing species Cloprostenol Bovine, porcine, equidae D-phe 6-luteinizing-hormone-releasing-hormone All food producing species Dembrexine Equidae Detomidine Bovine, equidae For therapeutic uses only Diclazuril Ovine For oral use in lambs only Dicloxacillin All food producing species Diethyl phtalate All food producing species Dimethyl phtalate All food producing species Dinoprost tromethamine All mammalian food producing species Etamiphylline camsylate All food producing species Ethanol All food producing species For use as excipient Ethyl lactate All food producing species Etiproston tromethamine Bovine, porcine Fertirelin acetate Bovine Folic acid All food producing species Glycerol formal All food producing species Gonadotrophin releasing hormone All food producing species Heptaminol All food producing species Hesperidin Equidae Hesperidin methyl chalcone Equidae Human chorion gonadotrophin (HCG) All food producing species Human menopausal urinary gonadotrophin Bovine Iodine organic compounds: — Iodoform All food producing species Isobutane All food producing species Isoflurane Equidae For use as anaesthetic only Isoxsuprine Bovine, equidae For therapeutic use only in accordance with Council Directive 96/22/EEC (OJ L 125, 23.5.1996, p. 3) Ketanserin tartrate Equidae Ketoprofen Bovine, equidae Porcine L-tartaric acid and its mono- and di- basic salt of sodium, potassium and calcium All food producing species For use as excipient Lactic acid All food producing species Lecirelin Lini oleum All food producing species Lobeline All food producing species Luprostiol All mammalian species Malic acid All food producing species For use as excipient Medroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes only Melatonin Ovine, caprine Menbutone Bovine, ovine, caprine, porcine, equidae Menthol All food producing species Mineral hydrocarbons, low to high viscosity including micro-cristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds All food producing species Excludes aromatic and unsaturated compounds N-butane All food producing species N-butanol All food producing species For use as excipient Neostigmine All food producing species Oxytocin All mammalian food producing species Pancreatin All mammalian food producing species For topical use only Papain All food producing species Papaverine Bovine New-born calves only Peracetic acid All food producing species Phenol All food producing species Phloroglucinol All food producing species Policresulene All food producing species For topical use only Polysulphated glycosaminoglycan Equidae Praziquantel Ovine For non-lactating sheep only Pregnant mare serum gonadotrophin All food producing species Propane All food producing species Propylene glycol All food producing species Quatresin All food producing species For use as preservative only at concentrations of up to 0,5 % Quillaia saponins All food producing species R-clopostenol Bovine, porcine, equidae Rifaximin Bovine For intramammary use - except if the udder may be used as food for human consumption - and intra-uterine use only Romifidine Equidae For therapeutic uses only Sodium benzyl 4-hydroxybenzoate All food producing species Sodium butyl 4-hydroxybenzoate All food producing species Somatosalm Salmon Tau fluvalinate Honey bees Theobromine All food producing species Theophylline All food producing species Thiomersal All food producing species For use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 % Thymol All food producing species Timerfonate All food producing species For use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 %’ Trimethylphloroglucinol All food producing species 3. Substances generally recognised as safe Pharmacologically active substance(s) Animal species Other provisions ‘Absinthium extract All food producing species Acetylmethionine All food producing species Aluminium hydroxide All food producing species Aluminium monostearate All food producing species Ammonium sulfate All food producing species Benzoyl benzoate All food producing species Benzyl p-hydroxybenzoate All food producing species Calcium borogluconate All food producing species Calcium citrate All food producing species Camphor All food producing species External use only’ Cardamon extract All food producing species Diethyl sebacate All food producing species Dimethicone All food producing species Dimethyl acetamide All food producing species Dimethyl sulphoxide All food producing species Epinephrine All food producing species Ethyl oleate All food producing species Ethylenediaminetetraacetic acid and salts All food producing species Eucalyptol All food producing species Follicle stimulating hormone (natural FSH from all species and their synthetic analogues) All food producing species Formaldehyde All food producing species Formic acid All food producing species Glutaraldehyde All food producing species Guaiacol All food producing species Heparin and its salts All food producing species Human chorionic gonadotropin (natural HCG and its synthetic analogues) All food producing species Iron ammonium citrate All food producing species Iron dextran All food producing species Iron glucoheptonate All food producing species Isopropanol All food producing species Luteinising hormone (natural LH from all species and their synthetic analogues) All food producing species Lanolin All food producing species Magnesium chloride All food producing species Magnesium gluconate All food producing species Magnesium hypophosphite All food producing species Mannitol All food producing species Methylbenzoate All food producing species Monothioglycerol All food producing species Montanide All food producing species Myglyol All food producing species Orgotein All food producing species Poloxalene All food producing species Poloxamer All food producing species Polyethylene glycols (molecular weight ranging from 200 to 10 000) All food producing species Polysorbate 80 All food producing species Serotonin All food producing species Sodium chloride All food producing species Sodium cromoglycate All food producing species Sodium dioctylsulphosuccinate All food producing species Sodium formaldehydesulphoxylate All food producing species Sodium lauryl sulphate All food producing species Sodium pyrosulphite All food producing species Sodium stearate All food producing species Sodium thiosulphate All food producing species Tragacanth All food producing species Urea All food producing species Zinc oxide All food producing species Zinc sulphate All food producing species 4. Substances used in homeopathic veterinary medicinal products Pharmacologically active substance(s) Animal species Other provisions ‘All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per 10 000 All food producing species’ 5. Substances used as food additives in foodstuffs for human consumption Pharmacologically active substance(s) Animal species Other provisions ‘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 Part C of Annex III to European Parliament and Council Directive 95/2/EC (OJ L 61, 18. 3. 1995, p. 1.)’