Agricultural Compounds and Veterinary Medicines Regulations 2001

　?。⊿R 2001/101）

　　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

　　approved operating plan means an operating plan approved under section 28（2） of the Act; and includes a code of practice deemed by section 21（2） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 to be an operating plan approved under section 28（2） of the Act

　　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—

　?。╝） 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—

　?。╝） means a substance or biological compound or mix of substances or biological compounds 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

　?。╥i） manganese, iron, zinc, copper, boron, cobalt, molybdenum, iodine, and selenium as minor nutrients; or

　　（iii） fertiliser additives; and

　?。╞） includes non-nutrient attributes of the materials used in fertiliser; but

　?。╟） does not include substances that are plant growth regulators that modify the physiological functions of plants fertiliser

         additive—

　?。╝） means a non-nutrient substance added to a fertiliser, or applied by itself to land or plants, that—

　?。╥） improves the supply and uptake of nutrients; or

　?。╥i） increases biological activity; or

　?。╥ii） modifies the physical characteristics of a fertiliser to make it more fit for its purpose; but

　?。╞） 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 practice that follows an approved operating plan

　　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 constituent substance of feed that is necessary for, or contributes to, the natural and normal physiological function and metabolic homeostasis of an animal; and

　?。╞） 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 gastrointestinal-acting microflora-enhancing compound means a substance ingested by an animal, or a preparation intended for oral administration to an animal, solely to modify the conditions of the animal's gastrointestinal tract to maintain or produce a normal or favourable microflora population

　　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

　?。╞） does not include a substance designed to prevent or treat subnormal levels of nutrients

　　topical, in relation to a substance or preparation, means the substance or preparation is applied only to the surface of the body,

which—

　?。╝） includes the skin, hoof, nail, or hair; but

　?。╞） does not include the eye or the ear canal.

　　Regulation 3 antisapstain: revoked, on 2 August 2007, by regulation 4（1） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Regulation 3 approved operating plan: inserted, on 18 October 2007, by section 57（1） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　Regulation 3 fertiliser paragraph （a）： amended, on 25 March 2004, by regulation 3（2） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2004 （SR 2004/17）。

　　Regulation 3 fertiliser additive paragraph （a）： amended, on 2 August 2007, by regulation 4（2）（a） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Regulation 3 fertiliser additive paragraph （a）（ii）： amended, on 2 August 2007, by regulation 4（2）（b） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Regulation 3 good manufacturing practice: substituted, on 18 October 2007, by section 57（2） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　Regulation 3 oral gastrointestinal-acting microflora-enhancing compound: inserted, on 2 August 2007, by regulation 4（3） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Regulation 3 topical: added, on 2 August 2007, by regulation 4（4） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　4 Agricultural compounds exempt from registration if applicable approved operating plans 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 approved operating plans are complied with.

　　Regulation 4 heading: amended, on 18 October 2007, by section 57（3）（a） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　Regulation 4: amended, on 18 October 2007, by section 57（3）（b） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　5 Agricultural compounds exempt from registration if conditions complied with

　　The compounds described in column 1 of Schedule 2 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:

　?。╝） regulation 6; and

　?。╞） any applicable conditions set out in column 2 of the schedule.

　　Regulation 5: amended, on 12 May 2005, by regulation 3（1） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　Regulation 5（b）： amended, on 12 May 2005, by regulation 3（2） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　5A Combined agricultural compounds exempt from registration

　　（1） An agricultural compound is exempt from registration under section 21 or section 27 of the Act if the agricultural compound is a combination of 2 or more agricultural compounds that are exempt from registration under these regulations.

　?。?） The combined agricultural compound is subject to any—

　?。╝） conditions set out in column 2 of Schedule 2; and

　　（b） other provision of these regulations that applies to each agricultural compound that comprises the combined agricultural compound.

　　Regulation 5A: inserted, on 12 May 2005, by regulation 4 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　6 Information requirements

　　The agricultural compounds described in column 1 of Schedule 2 must not be supplied to users unless they are supplied with a label containing the following information:

　　（a） trade name, if any; and

　?。╞） the name and address of the producer, if applicable; and

　　（c） the name and address of the manufacturer, if applicable; and

　?。╠） ingredients; and

　　（e） directions for use; and

　?。╢） any applicable information specified in Schedule 2; 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

　?。╤） batch number, if applicable; and

　　（i） date of manufacture, if applicable; and

　?。╦） use by date or expiry date, if applicable.

　　Regulation 6: amended, on 12 May 2005, by regulation 5（1） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　Regulation 6（f）： amended, on 12 May 2005, by regulation 5（2） of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　7 Reports on agricultural compounds[Revoked]

　　Regulation 7: revoked, on 12 May 2005, by regulation 6 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　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.

　　8A Oral gastrointestinal-acting microflora-enhancing compounds conditions

　　Compounds may be imported, manufactured, sold, or used as oral gastrointestinal-acting microflora-enhancing compounds without registration under section 21 or 27 of the Act if the conditions in Schedule 4A are complied with.

　　Regulation 8A: inserted, on 2 August 2007, by regulation 5 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　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.

　　10 Prohibition on use of certain agricultural compounds

　?。?） The substances described in Schedule 8 are prohibited from use as agricultural compounds or as ingredients in agricultural compounds.

　?。?） This regulation overrides anything to the contrary in any other regulation.

　　Regulation 10: added, on 23 September 2004, by regulation 3 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations （No 2） 2004 （SR 2004/248）。

　　    Schedule 1

　　Agricultural compounds exempt from registration under sections 21 and 27 of Act if applicable approved operating plans complied with

　　Schedule 1: substituted, on 2 August 2007, by regulation 6 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Schedule 1 heading: amended, on 18 October 2007, by section 57（4）（a） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　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.

　　The following compounds are excluded unless there is an applicable approved operating plan:

　　（a） active ingredients that are prescription medicines or restricted medicines （as those terms are defined in the Medicines Act 1981）：

　?。╞） antibiotic active ingredients:

　?。╟） hormones:

　?。╠） substances that are prohibited by countries importing New Zealand primary produce:

　?。╡） vertebrate toxic agents.

　　2 Homeopathic plant compounds used commercially.

　　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-absorbable masking agents used to disguise odours.

　　6 Topical non-absorbable 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 Compounds used in the production of plant tissue cultures.

　　9 Compounds （not containing biologically active ingredients） used to protect plant grafts or plant wounds.

　　10 Vertebrate and invertebrate attractants and repellants that are not applied directly to animals or plants.

　　11 Invertebrate mating disrupters that are not applied directly to animals or plants.

　　12 Compounds used in the post-harvest treatment of wood-producing crops.

　　13 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 1 item 1: amended, on 18 October 2007, by section 57（4）（b） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　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 rr 5, 5A, 6

　　Schedule 2: substituted, on 2 August 2007, by regulation 6 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations
2007 （SR 2007/181）。

Column 1		Column 2
Agricultural compound		Conditions
Oral and topical preparations— (a) prepared by a process of solution, extraction, or titration of an active ingredient followed by strictly regimented serial dilution; and (b) that do not claim to prevent, control, or cure a specific disease characterised by pain or distress in animals		If used as a veterinary medicine, the label information must— (a) identify the compound as a homeopathic preparation; and (b) include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
Oral and topical preparations— (a) prepared from either any part of a plant or an unrefined extract from a plant, except a plant listed in Schedule 6; and (b) that do not claim to prevent, control, or cure a specific disease characterised by pain or distress in animals; and (c) that do not claim to have pharmacological or anabolic effects, or to modify the physiological function of an animal		If used as a veterinary medicine, the label information must— (a) identify the compound as a herbal preparation; and (b) include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption
Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily
Over-the-counter first aid preparations, including general disinfectants, antiseptics, and sanitisers		Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption
Preparations scheduled as pharmacy-only, prescription, or restricted medicines under the Medicines Act 1981, and used as veterinary medicines		Preparations must not be used on animals except under the direct care, authority, or prescription of a veterinarian
		The veterinarian must act in accordance with any applicable approved operating plan
Preparations compounded and used by veterinarians		Preparations must not be used on animals except under the direct care, anthority, or prescription of a veterinarian
		The veterinarian must act in accordance with any applicable approved operating plan
A substance or biological compound or a mix of substances or biological compounds (to which this schedule does not otherwise apply) to be used as a veterinary medicine		May be imported only if the Director-General is satisfied that— (a) there is no equivalent veterinary medicine registered under the Act; and (b) it is required to ensure the immediate welfare of animals
		Must not contain any substance or biological compound that is prohibited from use as an agricultural compound
		Must not be used on animals except under the direct care, authority, or prescription of a veterinarian
		The veterinarian must act in accordance with any applicable approved operating plan
Topical preparations— (a) containing ingredients not able to be absorbed through the skin; and (b) used solely to treat minor injuries or to prevent dermatological abnormalities; and (c) that do not include any of the following ingredients: (i) active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981: (ii) antibiotic active ingredients: (iii) hormones: (iv) substances that are prohibited by countries importing New Zealand primary produce		Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption Must be manufactured in accordance with good manufacturing practice
Topical hoof preparations— (a) containing ingredients that act only on the surface to which they are applied; and (b) used solely to treat or prevent minor injuries or abnormalities of the surface of the hoof; and (c) that do not include any of the following ingredients: (i) active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981): (ii) antibiotic active ingredients: (iii) substances that are prohibited by countries importing New Zealand primary produce		Must be manufactured in accordance with good manufacturing practice
Non-medicated antidiarrhoeal preparations that— (a) are used solely as gastrointestinal adsorbent or protectant agents; and (b) do not make claims in relation to binding any specific micro-organism or toxin		Must be manufactured in accordance with good manufacturing practice The label information must include statements that— (a) the preparation is suitable for use without veterinary advice only in the treatment of minor cases of diarrhoea; and (b) the preparation will not treat dehydration; and (c) if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
Non-medicated orally and rectally administered laxatives and lubricants		Must be manufactured in accordance 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 moist or dry poultice preparations that— (a) are used to treat or prevent inflammation, swelling, or pain solely by heating or cooling, or drawing fluid from, the affected area; and (b) are intended for use on intact skin or minor wounds		Must be manufactured in accordance 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 used or applied superficially		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 and alkalisers) that are oral preparations used solely for modification of urinary pH		Must not be used on animals from which animal material is intended to be used for the production of human 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 (expectorants and cough suppressants) that— (a) have only a locally acting, superficial effect on the respiratory tract; and (b) are given orally, applied topically to the nose, or inhaled; and (c) are used solely in companion animals to promote mucolysis, for cough suppression (by alleviating only irritation), and to relieve compromised airways and upper respiratory tract congestion		Must not be used on animals from which animal material is intended to be used for the production of human 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
Compounds used to extend animal semen or to be used as media for animal ova		An applicable operating plan must have been approved and must be complied with
Spray markers that are coloured indicators to show where liquid agri-chemicals have been applied to help prevent overlaps		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Plant compound adjuvants, including wetting and sticking agents, pH buffers, drift retardants, and water conditioners		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Repellants applied directly to plants and used solely to repel vertebrates or invertebrates		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Attractants applied directly to plants and used solely to attract vertebrates or invertebrates		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Mating disrupters applied directly to plants and used solely to interfere with the reproduction of invertebrates		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Anti-transpirants used solely to prevent drying of plants		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Frost protectants of a chemical nature used solely to prevent frost damage		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Sunblocks used solely to prevent or reduce sunburn in plants		Must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment
Plant compounds used solely— (a) in home gardens or amenity horticulture; and (b) on plants that are not intended to be used as food for humans or animals		The label must clearly state that the product must not be used on crops intended for consumption by humans or animals

　　　  Schedule 2: amended, on 18 October 2007, by section 57（5）（a） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　Schedule 2: amended, on 18 October 2007, by section 57（5）（b） of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 （2007 No 93）。

　　Schedule 3

　　Ingredients excluded from topical preparations containing ingredients not able to be absorbed through skin and used solely to treat

minor injuries or to prevent dermatological abnormalities Schedule 2

　　[Revoked]

　　Schedule 3: revoked, on 2 August 2007, by regulation 7 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations

2007 （SR 2007/181）。

　　Schedule 4

　　Oral nutritional compounds exempt from registration under sections 21 and 27 of Act if following conditions complied with r 8

　　Schedule 4: substituted, on 12 May 2005, by regulation 7 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005 （SR 2005/90）。

　　1 They must be supplied with a label containing the following information:

　?。╝） trade name:

　?。╞） the name and address of the producer, if applicable:

　?。╟） the name and address of the manufacturer, if applicable:

　　（d） ingredients:

　?。╡） directions for use, including the species, type, and class of animal intended to be used for:

　?。╢） 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:

　?。╤） manufacturing date, if applicable:

　?。╥） 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:

　?。╝） 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:

　?。╟） result in malnutrition causing pain or distress in the animal:

　　（d） result in physical harm causing pain or distress in the animal:

　?。╡） contain pathogenic micro-organisms at levels that could cause disease resulting in pain and distress in the animal.

　　4 Agricultural compounds that are therapeutic or pharmacological substances or preparations may be incorporated into oral nutritional compounds only if—

　?。╝） the agricultural compounds are registered under the Act; and

　?。╞） 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 Schedule 7 and used in accordance with any relevant limitations specified in that schedule.

　　6 Oral nutritional compounds that are feed commodities are subject only to clauses 2 and 3.

　　For the purposes of this clause, feed commodities means plants （or any part or parts of those plants） that are raised in an agricultural context and used as feed or for feed production for animals.

　　Schedule 4A

　　Oral gastrointestinal-acting microflora-enhancing compounds exempt from registration under sections 21 and 27 of Act if following conditions complied with r 8A

　　Schedule 4A: inserted, on 2 August 2007, by regulation 8 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　1 The compounds must be supplied with a label containing the following information:

　?。╝） trade name:

　　（b） the name and address of the producer, if applicable:

　?。╟） the name and address of the manufacturer, if applicable:

　?。╠） ingredients:

　?。╡） directions for use, including the species, type, and class of animal for which use is intended:

　?。╢） 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:

　?。╤） manufacturing date, if applicable:

　?。╥） use-by date or expiry date, if applicable.

　　2 The compounds must be fit for the purpose of feeding or administering to the species, type, and class of animal specified under clause 1（e）。

　　3 The compounds are fit for their purpose only if they are used as recommended and do not do any of the following:

　?。╝） 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:

　?。╟） result in malnutrition causing pain or distress in the animal:

　?。╠） result in physical harm causing pain or distress in the animal:

　　（e） contain pathogenic micro-organisms at levels that could cause disease resulting in pain or distress in the animal.

　　4 The compounds must not make therapeutic or pharmacological claims to prevent, treat, or cure any disease characterised by pain or distress in animals.

　　5 The compounds must contain only ingredients that—

　?。╝） are described in Schedule 7; and

　　（b） comply with any relevant limitations specified in that schedule.

　　Schedule 5

　　Fertiliser and fertiliser additives exempt from registration under sections 21 and 27 of Act if following conditions complied with r 9

　　1 They must be supplied with a label containing the following information:

　?。╝） trade name:

　?。╞） the name and address of the producer, if applicable:

　?。╟） the name and address of the manufacturer, if applicable:

　　（d） batch number, if applicable:

　?。╡） the order number, if applicable:

　?。╢） the date of delivery, if applicable:

　?。╣） nutrient content and modifying pH value, if applicable:

　?。╤） 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:

　?。╥） 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:

　?。╞） cause pain and distress in animals due to toxic reactions or physical damage:

　?。╟） contain micro-organisms at pathogenic levels or any other plant or animal pest that is likely to promote disease or pest transmission:

　?。╠） have a selenium content that would result in the application of selenium as sodium selenate at a rate exceeding 10 grams per hectare.

　　Schedule 6

　　Plants not to be included in oral and topical preparations Schedule 2

　　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

　　Substances generally recognised as safe feed additives in oral nutritional compounds or safe ingredients in oral gastrointestinal-acting microflora-enhancing compounds Schedules 4, 4A

　　Schedule 7: substituted, on 2 August 2007, by regulation 9 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2007 （SR 2007/181）。

　　Interpretation

　　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.

　　General limitations

　　Each substance in this schedule is subject to the following limitations:

　　that it is included in a trade name product formulated in accordance with good manufacturing practice; and

　　that it is of an appropriate grade, and the amount added to the product must not exceed the amount reasonably required to accomplish the intended technical effect.

Substance		Identification (CAS number)		Limitations
Acacia (gum arabic)		9000-01-5
Acetaldehyde		75-07-0
Acetic acid		64-19-7
Acetoin		513-86-0
Acetophenone		98-86-2
Adipic acid		124-04-9
Aldehyde C-18		104-61-0
Allura red		25956-17-6
Almond shell meal
Aloe vera		8001-97-6
alpha-galactosidase		9025-35-8		From the following sources: Aspergillus niger var, Morteirella vinaceae var raffinoutiliser, Saccharomyces spp
alpha-pinene		7785-70-8		No more than 2% of a pesticide formulation
Aluminium hydroxide		21645-51-2
Amaranth		915-67-3
Ammonium chloride		12125-02-9
Ammonium formate		540-69-2
Ammonium hydroxide		1336-21-6
Ammonium phosphate (dibasic)		7783-28-0
Ammonium phosphate (monobasic)		7722-76-1
Ammonium propionate		17496-08-1
Ammonium sulphate		7783-20-2
Amyl butyrate		540-18-1
Amylase		9000-92-4		From the following sources: animal pancreatic tissue, Aspergillus oryzae var, A. niger var, Bacillus amyloliquefaciens, B. lentus, B. licheniformis, B. licheniformis containing a B. stearothermophilus gene for alpha-amylase, B. stearothermophilus
Anethole		4180-23-8
p-Anisaldehyde		123-11-5
Aniseed oil		8007-70-3
Anisole		100-66-3
Ascorbic acid		50-81-7
Ascorbyl palmitate		137-66-6
Aspartame		22839-47-0
Aspergillus niger		68038-55-1
Aspergillus oryzae		68038-56-2
Astaxanthin		472-61-7
Bacillus licheniformis		68038-66-4
Bacillus subtilis		68038-70-0		Non-pathogenic strains
Baliospermum montanum
Beeswax		8012-89-3
Beetroot
Bentonite		1302-78-9
Benzaldehyde		100-52-7
Benzoic acid		65-85-0		No more than 0.1% of final feed
Benzyl acetate		140-11-4
Benzyl alcohol		100-51-6
Benzyl benzoate		120-51-4
Benzyl paraben		94-18-8
beta-apo-8-carotenoic acid, ethyl ester		1109-11-1
beta-carotene
beta-glucanase		9074-98-0		From the following sources: Aspergillus niger var, Bacillus lentius, B. subtilis, B. amyloliquefaciens var, Humicola insolens, Trichoderma longibrachiatum, Penicillium funiculosum
Betaine hydrochloride		590-46-5
Bifidobacterium spp
Birch oil		8001-88-5
Boerhavia diffusa
Brilliant black BN		2519-30-4
Brilliant blue FCF		3844-45-9
Bromolain		9001-00-7
Bronopol		52-51-7
Brown HT		4556-89-3
Butyl paraben		94-26-8
Butylated hydroxy-anisole		25013-16-5		Total content of antioxidants to be no more than 0.02% fat content of final feed
Butylated hydroxy-toluene		128-37-0		Total content of antioxidants to be no more than 0.02% fat content of final feed
Butylidenephthalide		551-08-6
Butyric acid		107-92-6
Calcium carbonate		471-34-1
Calcium caseinate		9005-43-0
Calcium chloride		10035-04-8
Calcium disodium EDTA		62-33-9
Calcium formate		544-17-2
Calcium hydroxide		1305-62-0
Calcium lactate		814-80-2
Calcium lignosulfonate		8061-52-7
Calcium methyl paraben		40167-95-1
Calcium oxide		1305-78-8
Calcium propionate		4057-81-4
Calcium propyl paraben		83542-69-2
Calcium silicate		1344-95-2
Calcium sulphate		7778-18-9
Camphor		76-22-2		No more than 5% of any premix used in production of animal feeds
Candida pintolepesii
Canthaxanthin		514-78-3
Capric (decanoic) acid		334-48-5
Caproic acid		142-62-1
Caprylic acid		124-07-2
Capsanthin		465-42-9
Capsicum oleoresin		8023-77-6
Caramel
Caraway
Carbon black		1333-86-4
Carminic acid (cochineal)		1260-17-9
Carmosine		3567-69-9
Carnauba wax		8015-86-9
Carophyll pink		514-78-3
Carrageenan		9000-07-1
Cassia gum		5373-11-5 or 8013-11-4
Cayenne pepper
Cedrus deodara
Cellulase		9012-54-8		From the following sources: Aspergillus niger var, Bacillus lentus, Humicola insolens, Trichoderma longibrachiatum, T. reesei
Cellulose		9004-34-6
Charcoal, activated		16291-96-6
CharSol C 10		87139-45-5
Chitosan		9012-76-4
Chlorophyll		1406-65-1
Choline chloride		67-48-1
Chromium proprionates
Chymotrypsin		9004-07-3
Cinnamic aldehyde		104-55-2
Cinnamon
Citranaxanthin
Citric acid		77-92-9
Clove oil		8000-34-8
Cobalt carbonate		513-79-1
Copper carbonate		1184-64-1
Cryptoxanthin		465-42-9
Curcuma domestica
Curcuma longa
Cyperus scarriosus				Specify source
Dandelion
Diacetyl		431-03-8
Diatomaceous earth		7631-86-9
Dicalcium phosphate		7757-93-9
2,4-Dichlorobenzyl alcohol		1777-82-8		To be used as a preservative only
Didecyl dimethyl ammonium bromide		2390-68-3
Dimethyl polysiloxane		9016-00-6
Disodium EDTA		139-33-3		No more than 240 mg/kg in final feed
Disodium guanylate		5550-12-9
Disodium inosinate		4691-65-0
Disodium succinate		150-90-3
Dolomite		16389-88-1
Echinacea
Elephantopus scaber
Embelia ribes				No more than 5% of any premix used in production of animal feeds
Enterococcus faecium
Erythorbic acid		89-65-6
Erythrosine		16423-68-0
Ethoxyquin		91-53-2		No more than 0.015% of final feed
Ethyl acetate		141-78-6
Ethyl alcohol		64-17-5		No more than 10% of the formulation
Ethyl butyrate		105-54-4
Ethyl cellulose		9004-57-3
Ethyl formate		109-94-4
Ethyl heptanoate		106-30-9
Ethyl lactate		97-64-3
Ethyl paraben		120-47-8
Ethyl phenylacetate		101-97-3
Ethyl propionate		105-37-3
Ethyl sorbate		2396-84-1
Ethyl vanillin		121-32-4
Ethylene diamine tetra-acetic acid (EDTA)		60-00-4
Ethyl-o-aminobenzoate		87-25-2
Eugenol		97-53-0
Fennel		8006-84-6
Fenugreek
Ferric chloride		7705-08-0
Ferrous oxide		1345-25-1
Ferrous sulphate		7720-78-7
Food starch and modified food starch		9005-25-8		Use at a level not in excess of the amount reasonably required to accomplish the intended effect
Formaldehyde		50-00-0		No more than 0.25% of final feed
Formic acid		64-18-6
Fumaric acid		110-17-8
Furaneol		3658-77-3
gamma nonalactone		104-61-0
gamma undecalactone		104-67-6
Garlic		8000-78-0
Ginger		8007-08-7
Glucose		50-99-7		Includes dextrose and its hydrated and anhydrous forms
Glutamic acid		56-86-0
Glycerides (mono and di)
Glycerine		56-81-5
Glycerol		56-81-5
Glycerol monooleate		25496-72-4
Glycerol monostearate		31566-31-1
Glycerol poly-ethyleneglycolricinoleate
Glycerol triacetate		102-76-1
Green S		3087-16-9
Guar gum		9000-30-0
Gypsum		10101-41-4
Haematococcus algae
Hemicellulase		9025-56-3		From the following sources: Aspergillus niger var, A. aculeatus, Bacillus lentus, B. subtilis var, Humicola insolens, Trichoderma longibrachiatum
2-Hexenal		505-57-7
Holarrhena antidysenterica		90045-74-2
Hydrogenated palm stearine		11099-07-3
Hydroxypropyl cellulose		9004-64-2
i-carrageenan		9062-07-1
Indigo carmine (indigotine)		860-22-0
Inulin		9005-80-5
Iron oxides (black)		1317-61-9
Iron oxides (red)		1309-37-1
Iron oxides (yellow)		51274-00-1
Isoamyl acetate		123-92-2
Isoamyl isovalerate		659-70-1		No more than 1 ppm in final feed
Iso-eugenol		97-54-1
Isopropyl alcohol		67-63-0
Kaolin		1332-58-7
k-carrageenan		11114-20-8
Kombu seaweed
Konjac gum		9000-36-6
Lactic acid		50-21-5
Lactobacillus acidophilus		68333-16-4
Lactobacillus bifidus
Lactobacillus bulgaricus		68333-15-3
Lactobacillus casei		68333-14-2
Lactobacillus delbrueckii subsp lactis		68919-91-5
Lactobacillus fermentum
Lactobacillus plantarum
Lactobacillus rhannosus
Lactose		63-42-3
Lauric acid		143-07-7
Lecithin		8002-43-5
Lemon grass
Lemon oil		8008-56-8
Licorice (Glycyrrhiza)				Includes all licorice derivatives. No more than 0.1% of final feed
Lignosulphonate		8062-15-5
Lime oil		8008-26-2
Limonene		138-86-3
Linalool		78-70-6
Lipase		9001-62-1		From the following sources: animal pancreatic tissue, Aspergillus niger var, A. oryzae var, Candida rugosa, Rhizopus spp, edible forestomach of calves, kids, and lambs
Locust bean gum		9000-40-2
Lutein		57-83-0
Lycopene		502-65-8
Macrogol esters (polyethylene esters)		9000-99-3
Magnesium acetate		142-72-3		Includes hydrated forms. Only added to the levels needed
Magnesium aluminium silicate		1327-43-1		Includes hydrated forms. Only added to the levels needed
Magnesium aspartate		18962-61-3		Includes hydrated forms. Only added to the levels needed
Magnesium carbonate		546-93-0		Includes hydrated forms. Only added to the levels needed
Magnesium chloride		7791-18-6		Includes hydrated forms. Only added to the levels needed
Magnesium citrate		3344-18-1		Includes hydrated forms. Only added to the levels needed
Magnesium gluconate		3632-91-5		Includes hydrated forms. Only added to the levels needed
Magnesium glutamate		64407-99-4		Includes hydrated forms. Only added to the levels needed
Magnesium glycerophosphate		927-20-8		Includes hydrated forms. Only added to the levels needed
Magnesium hydroxide		1309-42-8		Includes hydrated forms. Only added to the levels needed
Magnesium hypophosphite		13446-24-7		Includes hydrated forms. Only added to the levels needed
Magnesium orotate		34717-03-8		Includes hydrated forms. Only added to the levels needed
Magnesium oxide		1309-48-4		Includes hydrated forms. Only added to the levels needed
Magnesium phosphate		10043-83-1		Includes hydrated forms. Only added to the levels needed
Magnesium silicate		1343-88-0		Includes hydrated forms. Only added to the levels needed
Magnesium stearate		557-04-0		Includes hydrated forms. Only added to the levels needed
Magnesium sulphate		7487-88-9		Includes hydrated forms. Only added to the levels needed
Magnesium trisilicate		14987-04-3		Includes hydrated forms. Only added to the levels needed
Malic acid		6915-15-7
Maltodextrin		9050-36-6
Maltol		118-71-8		Use at a level not in excess of the amount reasonably required to accomplish the intended effect
Mannan endo-1,4-beta-mannosidase		37288-54-3		From the following sources: Aspergillus niger var, Bacillus lentus, Trichoderma longibrachiatum. For use in poultry feed only
Mannitol		87-78-5
Marigold (Aztec)
Menthol		89-78-1		Not for use in cats
Metalloproteinase				From Bacillus subtilis var
Methyl alcohol		67-56-1
6-Methyl-5-hepten-2-one		110-93-0
Methyl paraben		99-76-3
3-Methyl-3-phenyl glycidic acid, ethyl ester		77-83-8
Methyl salicylate		119-36-8
Mineral oil (high viscosity)
Mineral oil (medium and low viscosity)		8012-95-1		No more than 0.06% of final feed
Monoisopropyl citrate		1321-57-9
Monopotassium phosphate		7778-77-0
Monosodium glutamate		142-47-2
Myrica nagi (bayberry)		8006-78-8
Neohesperidine dihydrochalcone		20702-77-6		No more than 30 ppm in final feed
Neotame		165450-17-9
Nonyl phenol ethoxylate		9016-45-9 or 26027-38-3
Octyl gallate		1034-01-1
Onion oil		8002-72-0
Operculina turpethum
Orange oil		8008-57-9
Oregano
Pancreatin		8049-47-6
Papain		9001-73-4
Paprika
Para-formaldehyde		30525-89-4		See formaldehyde
Patent blue V		129-17-9 or 3536-49-0
Pectinase		9032-75-1
Pediococcus acidilactici
Pediococcus pentosaceus
Peppermint oil		8006-90-4		Not for use in cats
Pericol black		2519-30-4
Phenylacetic acid		103-82-2
Phosphoric acid		7664-38-2
Phyllanthus emblica
Phytase		9001-89-2		From the following sources: Aspergillus niger var, A. oryzae var, Schizosaccharomyces pombe
Picrorhiza kurroa
Piper longum
Piper nigrum
Piper officinarum
Pistacia integerrima
Plumbago zeylanica
Polyethylene oxide, polypropylene glycol block copolymer		9003-11-6
Polyoxethylene nonyl phenyl ester		9016-45-9		Only to be used as a wetting agent. No more than 0.5% of formulated product
Polyoxyethylene (20) sorbitan monolaurate		9005-64-5
Polyoxyethylene (20) sorbitan monooleate		9005-65-6
Polyoxyethylene (35) castor oil		61791-12-6
Polyoxyethylene sorbitan monopalmitate		9005-66-7
Polyoxyethylene sorbitan monostearate		9005-67-8
Polyvinylpyrrolidone		9003-39-8
Ponceau 4R		2611-82-7		No more than 50 mg/kg in final feed
Potassium carbonate		584-08-7
Potassium chloride		7447-40-7
Potassium hydroxide		1310-58-3
Potassium lactate		996-31-6
Potassium lactate/sodium lactate mixture		996-31-6 and 72-17-3
Potassium sorbate		590-00-1
Propionic acid		79-09-4
Propyl acetate		109-60-4
Propyl alcohol		71-23-8		No more than 55 g/head/day
Propyl benzoate		2315-68-6
Propyl gallate		121-79-9		Total content of antioxidants to be no more than 0.02% fat content of final feed
Propyl paraben		94-13-3
Propylene glycol		57-55-6
Protease		9001-92-7		From the following sources: Aspergillus niger var, A. oryzae var, Bacillus amyloliquefaciens, B. licheniformis, B. subtilis var, B. subtilis containing a B. amyloliquefaciens gene for protease, Rhizopus spp
Pumice		1332-09-8
Raffinase
Rapeseed oil		8002-13-9		Includes hydrated forms
Rennet		9042-08-4
Rosemary		8000-25-7
Rosemary oleoresin
Rum ether		8030-89-5
Rutin		153-18-4
Saccharin sodium		128-44-9
Saccharomyces cerevisiae		68876-77-7
Sage oil		8022-56-8
Saponified marigold extract
Saponified paprika extract
Silica (silicon dioxide)		7631-86-9
Silicone antifoam		63148-62-9
Skatole		83-34-1
Sodium acid pyrophosphate		7758-16-9
Sodium alginate		9005-38-3
Sodium alkyl benzene sulphonate		25155-30-0		No more than 0.2% in solution
Sodium aluminosilicate		1344-00-9		No more than 2% of final feed
Sodium ascorbate		134-03-2
Sodium benzoate		532-32-1		No more than 0.1% of final feed
Sodium bicarbonate		144-55-8
Sodium butyl paraben		36457-20-2
Sodium carbonate		497-19-8
Sodium carboxy methylcellulose		9004-32-4
Sodium chloride		7647-14-5
Sodium citrate		68-04-2
Sodium cyclamate		139-05-9
Sodium erythorbate		6381-77-7
Sodium formate		141-53-7
Sodium fumarate		7704-73-6
Sodium hexametaphosphate		10124-56-8
Sodium hydroxide		1310-73-2		No more than 0.5% of final feed
Sodium lignosulphonate		8061-51-6
Sodium metabisulphite		7681-57-4
Sodium methyl paraben		5026-62-0
Sodium nitrite		7632-00-0		No more than 1% of final feed
Sodium propionate		137-40-6
Sodium propyl paraben		35285-69-9
Sodium thiosulfate		7772-98-7
Sodium tri-polyphosphate		7758-29-4
Sorbic acid		110-44-1
Sorbitan fatty acid esters (fatty acids limited to C12, C14, C16, and C18 containing minor amounts of associated fatty acids) and poly(oxyethylene) derivatives of sorbitan fatty acid esters
Sorbitan monooleate		1338-43-8
Sorbitan monostearate		1338-41-6
Sorbitol		50-70-4
Streptococcus (Enterococcus) salivarius subsp thermophilus
Sulphamic acid		5329-14-6
Sulphuric acid		7664-93-9
Sunflower oil		8001-21-6
Sunset yellow		2783-94-0
Tagetes oil		8016-84-0
Tangerine oil		8008-31-9
Tartaric acid		87-69-4
Tartrazine		1934-21-0
Terminalia belerica
Terminalia chebula
Tertiary butylhydroquinone (TBHQ)		1984-33-0
Tetra potassium pyrophosphate		7320-34-5
Tetra sodium pyrophosphate		7722-88-5
Thaumatin		53850-34-3
Thyme oil		8007-46-3
Thymol		89-83-8		When added at levels consistent with good feeding practice
Titanium dioxide		13463-67-7
Tocopherols (extracts of natural origin)		1406-66-2
Tricalcium phosphate		7758-87-4
Trimethylamine		75-50-3
Trisodium phosphate		7601-54-9
Trypsin		9002-07-7
Turmeric		8024-37-1
Undecylenic alcohol		112-43-6
Urea		57-13-6
Valerian
Valeric acid		109-52-4
Vanillin		121-33-5
Vermiculite		1318-00-9
Vitamin B1		59-43-8
Vitamin B12		68-19-9
Xanthan gum		11138-66-2
Xanthophyll		127-40-2
Xylanase		9025-57-4		From the following sources: Aspergillus oryzae containing a Thermomyces lanuginosus gene for xylanase, Penicillium funiculosum, Trichoderma longibrachiatum, T. viride
Yucca schidigera
Zeaxanthin
Zinc oxide		1314-13-2
Zinc proprionate		557-28-8
Zingiber officinale

　　Schedule 8

　　Substances prohibited from use as agricultural compounds or as ingredients in agricultural compounds

　　   Schedule 8: added, on 23 September 2004, by regulation 4 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations （No 2） 2004 （SR 2004/248）.

　　Aldrin

　　Chlordane

　　Chlordecone

　　DDT including DDD （also known as TDE） and DDE

　　Dieldrin

　　Endrin

　　HCB （also known as hexachlorobenzene） except as an impurity in other active ingredients

　　HCH （also known as hexachlorocyclohexane or benzenehexachloride）

　　Heptachlor

　　Lindane

　　Mirex

　　Pentachlorobenzene

　　Strychnine

　　Technical endosulfan and its related isomers

　　Schedule 8: amended, on 18 August 2011, by regulation 4 of the Agricultural Compounds and Veterinary Medicines Amendment Regulations 2011 （SR 2011/256）.

　　Martin Bell,

　　Acting for Clerk of the Executive Council.