Agricultural Compounds and Veterinary Medicines Regulations 2001

Agricultural Compounds and Veterinary Medicines Regulations 2001 Silvia Cartwright, Governor-General Order in Council At Wellington this 28th day of May 2001 Present: Her Excellency the Governor-General in Council Pursuant to section 75 of the Agricultural Compounds and Veterinary Medicines Act 1997, Her Excellency the Governor-General, acting on the recommendation of the Minister of Agriculture and on the advice and with the consent of the Executive Council, makes the following regulations. Contents 1 Title 2 Commencement 3 Interpretation 4 Agricultural compounds exempt from registration if applicable codes of practice complied with 5 Agricultural compounds exempt from registration if conditions complied with 6 Information requirements 7 Reports on agricultural compounds 8 Oral nutritional compounds conditions 9 Fertiliser and fertiliser additive conditions Schedule 1 Agricultural compounds exempt from registration under sections 21 and 27 of Act if applicable codes of practice complied with Schedule 2 Agricultural compounds exempt from registration under sections 21 and 27 of Act if conditions in column 2 and requirements in regulation 6 complied with Schedule 3 Agricultural compounds exempt from registration under sections 21 and 27 of Act if conditions in column 2 and regulations 6 and 7 complied with Schedule 4 Oral nutritional compounds exempt from registration under sections 21 and 27 of Act if following conditions complied with Schedule 5 Fertiliser and fertiliser additives exempt from registration under sections 21 and 27 of Act if following conditions complied with Schedule 6 Plants not to be included in oral and topical preparations Schedule 7 Substances generally recognised as safe if used in accordance with any applicable conditions in Schedules 3 and 4 Regulations 1 Title These regulations are the Agricultural Compounds and Veterinary Medicines Regulations 2001. 2 Commencement These regulations come into force on 2 July 2001. 3 Interpretation In these regulations, unless the context otherwise requires, Act means the Agricultural Compounds and Veterinary Medicines Act 1997 animal material means a live or dead animal, or any tissue or other natural material taken from a live or dead animal compound feed means a preparation of 2 or more feeds, or 1 or more feeds together with feed additives, intended for consumption by animals as a source of feed or nutrients to achieve a nutritional benefit feed means edible material that (a) provides nourishment in the form of energy and for building tissues; and (b) contributes to the normal physiological function and metabolic homeostasis of an animal feed additive means a non-nutrient substance added to the feed of animals to improve the preservation, digestion, colour, palatability, texture, or nutritive value of the feed fertiliser (a) means a substance or mix of substances that is described as, or held out to be for, or suitable for, sustaining or increasing the growth, productivity, or quality of plants or, indirectly, animals through the application to plants or soil of (i) nitrogen, phosphorus, potassium, sulphur, magnesium, calcium, chlorine, and sodium as major nutrients; or (ii) manganese, iron, zinc, copper, boron, cobalt, molybdenum, iodine, and selenium as minor nutrients; or (iii) fertiliser additives; and (b) includes non-nutrient attributes of the materials used in fertiliser; but (c) does not include substances that are plant growth regulators that modify the physiological functions of plants fertiliser additive (a) means a non-nutrient substance added to a fertiliser, or applied to land by itself, that (i) improves the supply and uptake of nutrients; or (ii) increases the biological activity of soil; or (iii) modifies the physical characteristics of a fertiliser to make it more fit for its purpose; but (b) does not include substances that are plant growth regulators that modify the physiological functions of plants food crops means plants raised in an agricultural context (or parts of those plants) and used as food or for food production for humans good manufacturing practice means a code of good manufacturing practice in force under section 28 of the Act intra-ruminal device means a device designed to be administered orally to a ruminant animal to provide prolonged and sustained release of nutrients or therapeutic or pharmacological substances or preparations label, in relation to any agricultural compound or any container used to contain an agricultural compound, means any written, pictorial, or other descriptive matter under which the compound is sold or to be sold and which purports to give some information about the compound non-medicated, in relation to a product, means a product that does not contain any pharmacological or therapeutic substances nutrient means a nourishing substance given orally, including, but not limited to, (a) a constituent substance of feed that is necessary for, or contributes to, the natural and normal physiological function and metabolic homeostasis of an animal; and (b) proteins, carbohydrates, fats, oils, minerals, vitamins, water, and their naturally occurring components nutritional benefit means a contribution to the normal physiological function and metabolic homeostasis of an animal achieved by the oral provision of nutrients nutritional preparation means a compounded mix of nutrients or nutrients and feed additives oral nutritional compound means a substance ingested by an animal as feed, or a nutritional preparation intended for oral administration to an animal to achieve a nutritional benefit pharmacological substance means a substance that modifies a physiological function of an animal plant compound means any substance, mixture of substances, or biological compound used, or intended for use, in the direct management of a plant plant material means any live or dead plant, or any tissue or other natural material taken from a live or dead plant therapeutic substance (a) means a substance designed to prevent, treat, or cure a disease or abnormal physiological condition; but (b) does not include a substance designed to prevent or treat subnormal levels of nutrients. 4 Agricultural compounds exempt from registration if applicable codes of practice complied with The compounds described in Schedule 1 may be imported, manufactured, sold, or used as agricultural compounds without registration under section 21 or section 27 of the Act if applicable codes of practice are complied with. 5 Agricultural compounds exempt from registration if conditions complied with The compounds described in column 1 of Schedules 2 and 3 may be imported, manufactured, sold, or used as agricultural compounds without registration under section 21 or section 27 of the Act if the following are complied with: (a) regulation 6; and (b) any applicable conditions set out in column 2 of the schedules. 6 Information requirements The agricultural compounds described in column 1 of Schedules 2 and 3 must not be supplied to users unless they are supplied with a label containing the following information: (a) trade name, if any; and (b) the name and address of the producer, if applicable; and (c) the name and address of the manufacturer, if applicable; and (d) ingredients; and (e) directions for use; and (f) any applicable information specified in Schedule 2 or Schedule 3; and (g) details of any precautions to be taken to prevent or manage the risks described in section 19 of the Act when using it, particularly potential hazards to animals treated with or exposed to it; and (h) batch number, if applicable; and (i) date of manufacture, if applicable; and (j) use by date or expiry date, if applicable. 7 Reports on agricultural compounds (1) A person who imports into New Zealand for sale, or manufactures for sale in New Zealand, an agricultural compound described in Schedule 3 must supply the following reports to the Director-General: (a) a report when the agricultural compound is first imported into New Zealand or manufactured in New Zealand; and (b) an annual report for every subsequent year on 1 July in that year. (2) The report must contain the following information: (a) if the agricultural compound is a trade name product, its trade name; and (b) the name and address of the producer, if applicable; and (c) the name and address of the manufacturer, if applicable; and (d) if the agricultural compound is not manufactured in New Zealand, the name and address of the person who imported it into New Zealand. 8 Oral nutritional compounds conditions Compounds (other than compounds used in intra-ruminal devices) may be imported, manufactured, sold, or used as oral nutritional compounds without registration under section 21 or section 27 of the Act if the conditions in Schedule 4 are complied with. 9 Fertiliser and fertiliser additive conditions Compounds may be imported, manufactured, sold, or used as fertiliser or fertiliser additives without registration under section 21 or section 27 of the Act if the conditions in Schedule 5 are complied with. Schedule 1 r 4 Agricultural compounds exempt from registration under sections 21 and 27 of Act if applicable codes of practice complied with 1 Compounds (including homeopathic, herbal, chemical, and oral nutritional compounds) prepared by a person for use by the person as an agricultural compound on animals or plants owned by the person, or in any land, place, or water owned or occupied by the person. 2 Commercial compressed gases, including medical-grade gases used for surgery. 3 Non-medicated topical hoof preparations used solely to maintain or improve hoof condition. 4 Non-medicated topical skin preparations used solely to maintain or improve skin condition. 5 Non-absorbent masking agents used to disguise odours. 6 Topical non-absorbent and non-solvent cleaning products, including non-medicated shampoos, soaps, tear-stain removers, and toothpaste. 7 In vitro diagnostics used to confirm the presence or absence of disease or as an aid in the diagnosis of disease or abnormal conditions. 8 Plant material. 9 Fertiliser or fertiliser additives that are raw or composted biological wastes. 10 A preparation of 2 or more ingredients if each ingredient is an agricultural compound described in this schedule and the combination of ingredients does not increase or change any of the risks described in section 19 of the Act. Schedule 2 rr 5, 6 Agricultural compounds exempt from registration under sections 21 and 27 of Act if conditions in column 2 and requirements in regulation 6 complied with Column 1 Column 2 Agricultural compound Conditions Oral and topical preparations--- If used as a veterinary medicine, the label information must (a) prepared by a process of solution, extraction, or titration of an (a) identify the compound as a active ingredient followed by homeopathic preparation; and strictly regimented serial dilution; and (b) include a statement that, if the preparation fails to (b) that do not claim to prevent, alleviate the condition being control, or cure a specific treated, the user should seek disease characterised by pain or veterinary advice distress in animals Oral and topical preparations--- If used as a veterinary medicine, the label information must (a) prepared from either any part of a plant or an unrefined extract (a) identify the compound as a from a plant, except a plant herbal preparation; and listed in Schedule 6; and (b) that do not claim to prevent, (b) include a statement that, if control, or cure a specific the preparation fails to disease characterised by pain or alleviate the condition being distress in animals treated, the user should seek veterinary advice Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily Over the counter first aid Must not be used on the teats of preparations, including general lactating animals if the milk of disinfectants, antiseptics, and the animals is intended for sanitisers human consumption Preparations scheduled as pharmacy Preparations must not be used only, prescription, or restricted on animals except under the direct medicines under the Medicines Act care, authority, or prescription 1981, used as veterinary medicines of a veterinarian The veterinarian must act in accordance with any applicable code of practice in force under section 28 of the Act Preparations must not be used on animals except under the direct care, authority, or prescription of a veterinarian Preparations compounded and used by The veterinarian must act in veterinarians accordance with any applicable code of practice in force under section 28 of the Act Preparations must not be used on animals except under the direct care, authority, or prescription of a veterinarian Schedule 3 rr 5, 6, 7 Agricultural compounds exempt from registration under sections 21 and 27 of Act if conditions in column 2 and regulations 6 and 7 complied with Column 1 Column 2 Agricultural compound Conditions Topical preparations--- Must not be used on the teats of lactating animals if the milk of (a) containing ingredients not able the animals is intended for human to be absorbed through the skin; consumption and (b) used solely to prevent Must be manufactured in accordance dermatological abnormalities with good manufacturing practice Non-medicated anti-diarrhoea Must be manufactured in accordance preparations with good manufacturing practice The label information must include a statement that if the preparation fails to alleviate the condition being treated the user should seek veterinary advice Non-medicated oral laxatives and Must be manufactured in accordance lubricants with good manufacturing practice The label information must include a statement that if the preparation fails to alleviate the condition being treated the user should seek veterinary advice Cauterising preparations Must be manufactured in accordance with good manufacturing practice The label must include a statement that if the preparation fails to stop bleeding the user should seek veterinary advice Urinary tract modifiers (acidifiers Must not be used on animals from and alkalisers) that are oral which animal material is intended to preparations used solely for be used for the production of human modification of urinary pH food or human pharmaceutical products Must be manufactured in accordance with good manufacturing practice Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended Respiratory tract modifiers Must not be used on animals from (expectorants and cough which animal material is intended to suppressants) that--- be used for the production of human food or human pharmaceutical products (a) have only a locally acting, superficial effect on the respiratory tract; and Must be manufactured in accordance with good manufacturing practise (b) are given orally, applied topically to the nose, or inhaled; and Must be packaged for sale in dosage-size packages (not in bulk or (c) are used solely in companion concentrated form) appropriate for animals to promote mucolysis, the animals for which the cough suppression (by alleviating agricultural compound is recommended only irritation) and relieve compromised airways and upper respiratory tract congestion Spray markers that are coloured Must not be used on food crops indicators to show where liquid unless they contain only a agri-chemicals have been applied to substance or substances described help prevent overlaps in Part B of Schedule 7 Plant compound adjuvants, including Must not be used on food crops wetting and sticking agents, pH unless they contain only a buffers, drift retardants, and water substance or substances described conditioners in Part B of Schedule 7 Repellants applied directly to Must not be used on food crops plants and used solely for control unless they contain only a by repelling invertebrates, birds, substance or substances described and other vertebrates in Part B of Schedule 7 Anti-transpirants used solely to Must not be used on food crops prevent drying of plants unless they contain only a substance or substances described in Part B of Schedule 7 Frost protectants of a chemical Must not be used on food crops nature used solely to prevent unless they contain only a frost damage substance or substances described in Part B of Schedule 7 Sunblocks used solely to prevent or Must not be used on food crops reduce sunburn in plants unless they contain only a substance or substances described in Part B of Schedule 7 Schedule 4 r 8 Oral nutritional compounds exempt from registration under sections 21 and 27 of Act if following conditions complied with 1 They must be supplied with a label containing the following information: (a) trade name: (b) the name and address of the producer, if applicable: (c) the name and address of the manufacturer, if applicable: (d) ingredients: (e) directions for use, including the species, type, and class of animal intended to be used for: (f) details of any precautions to be taken to prevent or manage risks described in section 19 of the Act when being used, particularly potential hazards to animals fed with or exposed to them: (g) batch number, if applicable: (h) manufacturing date, if applicable: (i) use by date or expiry date, if applicable. 2 They must be fit for the purpose of feeding to the species, type, and class of animal specified under clause 1(e). 3 They are fit for their purpose only if they are used as recommended and do not do any of the following: (a) produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment: (b) result in toxic reactions causing pain or distress in the animal: (c) result in malnutrition causing pain or distress in the animal: (d) contain pathogenic micro-organisms at levels that could cause disease resulting in pain and distress. 4 Agricultural compounds that are therapeutic or pharmacological substances or preparations may be incorporated into oral nutritional compounds only if (a) the agricultural compounds are registered under the Act; and (b) the incorporation of the agricultural compounds is consistent with any conditions of their registration. 5 Feed additives may be used in oral nutritional compounds only if the feed additives are described in Part A of Schedule 7. Schedule 5 r 9 Fertiliser and fertiliser additives exempt from registration under sections 21 and 27 of Act if following conditions complied with 1 They must be supplied with a label containing the following information: (a) trade name: (b) the name and address of the producer, if applicable: (c) the name and address of the manufacturer, if applicable: (d) batch number, if applicable: (e) the order number, if applicable: (f) the date of delivery, if applicable: (g) nutrient content and modifying pH value, if applicable: (h) details of any precautions to be taken to prevent or manage risks described in section 19 of the Act when being used, particularly potential hazards to animals exposed to them: (i) directions for use. 2 They must be fit for the purpose specified in the directions for use. 3 They are fit for their purpose only if they are used as recommended and do not do any of the following: (a) produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment: (b) cause pain and distress in animals due to toxic reactions or physical damage: (c) contain micro-organisms at pathogenic levels or any other plant or animal pest that is likely to promote disease or pest transmission: (d) have a selenium content that would result in the application of selenium as sodium selenate at a rate exceeding 10 grams per hectare. Schedule 2 Schedule 6 Plants not to be included in oral and topical preparations Abrus precatorius seed and root Acorus calamus Amanita (all species) Anadenanthera peregrina Argyreia nervosa Aristolochia (all species) Banisteriopsis caapi Cannabis Catha edulis Conocybe (all species) Crotalaria (all species) Cynoglossum officinale Erythroxylum coca Haemadictyon (all species) Heliotropium (all species) Ipomoea burmanni (Rivea corymbosa) Ipomoea hederacea Ipomoea violacea (Ipomoea tricolor) Lophophora (all species) Opuntia cylindrica Papaver bracteatum Papaver somniferum Peganum harmala Petasites (all species) Piptadenia macrocarpa Piptadenia peregrina Psylocybe (all species) Pteridium aquilinum Sophora secundiflora Stropharia cubensis Strychnos gaulthieriana Strychnos ignatti (Ignatia amara) Virola sebifera (for external use) Schedule 7 Schedules 3 and 4 Substances generally recognised as safe if used in accordance with any applicable conditions in Schedules 3 and 4 Part (A) Substances generally regarded as safe feed additives in oral nutritional compounds A reference to a substance is to all forms of the substance unless a chemical abstract (CAS) number is specified or otherwise stated. Where the first column refers to an organism (including plants), the reference means the whole or any part or any extract of the organism. Substance Identification Limitations CAS number (if appropriate) unless otherwise stated Acetic acid 64-19-7 Adipic acid 124-04-9 Allium sativum Aloe vera Amyl butyrate 540-18-1 Aluminium hydroxide 20768-67-6 Ammonium hydroxide 1336-21-6 Ammonium propionate Anethole 104-46-1 Aniseed oil 8007-70-3 Anisole 100-66-3 Apple Ascorbic acid 50-81-7 Ascorbyl palmitate 137-66-6 Aspartame 22839-47-0 Aspergillus niger Aspergillus oryzae Astaxanthin Azorubine 3567-69-9 apo carotenoic acid ethyl ester Beetroot Bentonite 1302-78-9 Benzaldehyde 100-52-7 Benzoic acid 65-85-0 <0.1% of final feed Benzyl acetate 140-11-4 Benzyl alcohol 100-51-6 Bifidobacterium spp. Birch oil Brilliant Black BN 2519-30-4 Brilliant Blue FCF 3844-45-9 Butylated hydroxy-toluene 64742-46-7 Total content of antioxidants must be <0.02% fat content of feed Butylated hydroxy-anisole 25013-16-5 Total content of antioxidants must be <0.02% fat content of feed Butyric acid 107-92-6 Calcium formate 544-17-2 Calcium lignosulfonate 8061-52-7 Calcium propionate 4057-81-4 Calcium silicate 1344-95-2 Canthaxanthin 514-78-3 Capric canoic acid 334-48-5 Caproic acid 142-62-1 Caramel Caraway Carbon black 1333-86-4 Carminic acid 1260-17-9 Carob 9000-40-2 Cayenne pepper Cedrus deodura Cellulose 9004-34-6 Chlorophyll 1406-65-1 Cinnamic aldehyde 104-55-2 Cinnamon Citric acid 77-92-9 Citranaxanthin Clove oil 8000-34-8 Curcuma longa Cyperus scarriosus Dandelion Didecyl dimethyl ammonium 2390-68-3 bromide Dimethyl polysiloxane 8050-81-5 Disodium guanylate 5550-12-9 Disodium inosinate 4691-65-0 Echinacea Elephantopous scaber Ethoxyquin 91-153-2 Maximum quantity used and to remain in feed must be <0.015% Ethyl butyrate 105-54-4 Ethyl formate 109-94-4 Ethyl propionate 105-37-3 Ethyl sorbate 2396-84-1 Ethyl vanillin 121-32-4 Ethylene diamine tetra- 60-00-4 acetic acid Erythorbic acid 7378-23-6 Fennel 8006-84-6 Fenugreek Ferrous oxide 1345-25-1 Formaldehyde 50-00-0 <0.25% of final feed Formic acid 64-18-6 Fumaric acid 110-17-8 Garlic 8000-78-0 Ginger 8007-08-7 Glycerine 56-81-5 Haematococcus algae Isopropyl alcohol 67-63-0 Lactic acid 50-21-5 Lactobacillus acidophilus Lactobacillus bulgaricus Lactobacillus plantarum Lecithin 8002-43-5 Lemon oil 8008-56-8 Lemon grass Lime oil 8008-26-2 Linalool 78-70-6 Lycopene 502-65-8 Maltol 118-71-8 Methyl alcohol 67-56-1 Methyl paraben 99-76-3 <0.1% of final feed 3-Methyl-3-phenyl glycidic 77-83-8 acid, ethyl ester Methyl salicylate 119-36-8 Monosodium glutamate 32221-81-1 Myrica nagi [bayberry] Onion oil 2179-59-1 Operculina turpethum Orange oil 8008-57-9 Oregano Paprika Para-formaldehyde 30525-89-4 See formaldehyde Pediococcus acidilactici Pediococcus pentosaceus Phosphoric acid 7664-38-2 Phyllanthus emblica Picorhiza kurroua Piper longum Piper nigrum Piper officinarum Pistacia integerima Plumbago zeylanica Polyethylene oxide, 9003-11-6 polyproylene glycol block Copolymer Potassium hydroxide 1310-58-3 Propionic acid 79-09-4 Propyl gallate 121-79-9 Total content of antioxidants must be <0.02% fat content of feed Propyl paraben 94-13-3 <0.1% of final feed Raspberry flavour Rennet Rosemary 8000-25-7 Rum ether 8030-89-5 Saccharin sodium 128-44-9 Saccharomyces cerevisiae Sage oil Silica 7631-86-9 Silicone antifoam 63148-62-9 Silicon dioxide 7631-86-9 Skatole 83-34-1 Sodium alkyl benzene 25155-30-0 Sulphonate Sodium ascorbate 134-03-2 Sodium benzoate 532-32-1 <0.1% of final feed Sodium carboxy 9004-32-4 methylcellulose Sodium citrate 68-04-2 Sodium formate 141-53-7 Sodium hydroxide 1310-73-2 Sodium lignosulphonate 8061-51-6 Sodium metabisulphite 7681-57-4 Sodium propionate 137-40-6 Sodium silico aluminate 1344-00-9 <2% of final feed Sorbic acid 110-44-1 Sorbitan monostearate 1338-41-6 Sorbitol 50-70-4 Strawberry Sulphamic acid 5329-14-6 Sulphuric acid 7664-93-9 Tagetes oil 8016-84-0 Tangerine oil 8008-31-9 Tartaric acid 87-69-4 Tartrazine 1934-21-0 Terminalia chebula Terminalia balerica Thyme oil 8007-46-3 Titanium dioxide 13463-67-7 Trimethylamine 75-50-3 Turmeric 8024-37-1 Valerian Valeric acid 109-52-4 Vanillin 121-33-5 Vermiculite 1318-00-9 Xanthan gum 11138-66-2 Xanthophyll 127-40-2 Xylanase From Aspergillus oryzae carrying a gene from Thermomyces lanuginosus coding for xylanase Yucca schidigera Zeaxanthin Zingiber officinale Part (B) Substances generally recognised as safe in plant compounds A reference to a substance is to all forms of the substance unless a chemical abstract (CAS) number is specified or otherwise stated. Where the first column refers to an organism (including plants), the reference means the whole or any part or any extract of the organism. Substance Identification Limitations CAS number (if appropriate) unless otherwise stated Garlic powder Martin Bell, for Clerk of the Executive Council. Explanatory Note This note is not part of the regulations, but is intended to indicate their general effect. These regulations, which come into force on 2 July 2001, exempt certain agricultural compounds from the registration requirements of sections 21 and 27 of the Agricultural Compounds and Veterinary Medicines Act 1997. Schedule 1 lists agricultural compounds that are exempt from registration if applicable codes of practice are complied with. Schedule 2 lists agricultural compounds that are exempt from registration if certain conditions are complied with. Schedule 3 lists agricultural compounds that are exempt from registration if notification and information requirements are complied with. Schedule 4 lists conditions that apply to oral nutritional compounds exempt from registration. Schedule 5 lists conditions that apply to fertiliser and fertiliser additives exempt from registration. Schedule 6 lists plants that are not to be included in oral and topical preparations. Schedule 7 lists substances that are generally recognised as safe feed additives in oral nutritional compounds and generally recognised as safe in plant compounds. Issued under the authority of the Acts and Regulations Publication Act 1989. Date of notification in Gazette: 31 May 2001. These regulations are administered in the Ministry of Agriculture and Forestry.