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SR 2001/101 雷竞技ap官网入口 化合物及兽药条例2001(Agricultural Compounds and Veterinary Medicines Regulations 2001)

2011-08-31 中国食品网 中食网 777 0

  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 de scriptive 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 pre scription 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 inSchedule 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.

更多国外法规翻译,请联系食品翻译中心
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