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
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
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
(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
8A Oral gastrointestinal-acting microflora-enhancing compounds conditions
Compounds may be
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
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
(b) antibiotic active ingredients:
(c) hormones:
(d) substances that are prohibited by countries
(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— | If used as a veterinary medicine, the label information must— | |
Oral and topical preparations— (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)(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.