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SR 2001/101 农业化合物及兽药条例2001(Agricultural Compounds and Veterinary Medicines Regulations 2001)

时间:2011-08-31

  Agricultural Compounds and Veterinary Medicines Regulations 2001

  (SR 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—

  (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 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

  (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 by itself to land or plants, that—

  (i) improves the supply and uptake of nutrients; or

  (ii) increases biological activity; 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 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) 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 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

  (b) 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—

  (a) includes the skin, hoof, nail, or hair; but

  (b) 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:

  (a) regulation 6; and

  (b) 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.

  (2) The combined agricultural compound is subject to any—

  (a) 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

  (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; 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.

  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

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

  (2) 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):

  (b) antibiotic active ingredients:

  (c) hormones:

  (d) substances that are prohibited by countries importing New Zealand primary produce:

  (e) 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:

  (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) 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 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—

  (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 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:

  (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 for which use is intended:

  (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 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:

  (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) 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—

  (a) 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:

  (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 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.

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