Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011

Schedule 2 Agricultural compounds exempt from registration under sections 21 and 27 of Act

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Column 1Column 2
Agricultural compoundConditions
Part A. Exemptions relating to agricultural compounds that could be used in relation to either animals or plants
1

In vitro diagnostics used to confirm the presence or absence of disease or as an aid in the diagnosis of disease or abnormal conditions

2

Substance or compound (not being an agricultural compound described elsewhere in this schedule)—

(a)

prepared by a person (person A) for use on animals or plants owned by person A, or in any land, place, or water owned or occupied by person A (and not for sale); or

(b)

used by person A, or a person employed or engaged by person A, or another person expressly authorised by person A, as described in paragraph (a)

If the substance or compound is used by a person employed or engaged by person A or another person expressly authorised by person A, the use must be in accordance with written instructions from person A about—

(a)

how the substance or compound is to be stored, prepared for use, administered, applied, and (if applicable) disposed of; and

(b)

how the safety and welfare of any person or animal who may come into contact with the substance or compound is to be protected and how any pain or distress of an animal is to be mitigated; and

(c)

how third parties are to be contacted or advised of the use of the substance or compound and warned of any hazards relating to the use of the compound

The following substances or compounds may be prepared or used as described in column 1 only in compliance with an approved operating plan:

(a)

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

(b)

antibiotic active ingredients:

(c)

hormones:

(d)

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

(e)

vertebrate toxic agents

3

Agricultural compounds used for—

(a)

any investigative, analytical, experimental, or diagnostic work or toxicity or potency testing work that involves any agricultural compounds; or

(b)

any work that is carried out for the purpose of testing the safety or efficacy of any agricultural compound; or

(c)

any training or teaching of persons, of a kind specified in the approved operating plan, involving agricultural compounds, within the scope of the substances or compounds specified in the plan

An operating plan covering the type or class of agricultural compounds the person or organisation wishes to use for research, testing, or training, and the nature of the activities contemplated must have been approved and must be complied with

The person or organisation subject to the operating plan must, on an ongoing basis, notify the Director-General if a substance or compound is to be used that was not notified to the Director-General as being used or contemplated for use at the time the operating plan was approved, even where the substance or compound to be used is within the scope of agricultural compounds approved for use under that operating plan

4

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

5

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

6

Agricultural compounds used to control the characteristics of water where—

(a)

the water is used on or in relation to animals or plants; and

(b)

the characteristic must be controlled to maintain the animals or plants in a healthy state or to facilitate the management of the animals or plants

7

Sterilisers, sanitisers, and disinfectants (excluding fumigants) used to maintain hygienic conditions for the purposes of hygiene and pest management in places where animals and plants are housed or cultivated

Animals and plants must not be exposed to the substance or compound
Part B. Exemptions relating to agricultural compounds that could be used in relation to animals
8

Preparations scheduled as medicines under the Medicines Act 1981, and used as veterinary medicines

Must not be used on animals except under the direct care, or with the authorisation, of a veterinarian

The conditions in regulations 9 to 13 do not apply

Must not be advertised for sale for use on animals

9

Compounded veterinary preparations used by veterinarians

Must not be used on animals except under the direct care, or with the authorisation, of the compounding veterinarian

Preparations may be used only on animals specified by the compounding veterinarian or animals of a type specified by the compounding veterinarian

10

Oral and topical preparations for use on animals—

(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

11

Oral and topical preparations for animals—

(a)

prepared from either any part of a plant or an unrefined extract from a plant, except a plant listed in Schedule 3; 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

12

Non-absorbable masking agents used to disguise odours

13

Topical non-absorbable and non-solvent cleaning products, including non-medicated shampoos, soaps, tear-stain removers, and toothpaste

14

Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily

15

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

16

Topical preparations for animals—

(a)

containing ingredients not able to be absorbed through the skin; and

(b)

used solely to treat minor injuries or to prevent minor 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

17

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

18

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

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

19

Non-medicated orally and rectally administered laxatives and lubricants used on animals

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

20

Non-medicated moist or dry poultice preparations used on animals 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

The label must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

21

Cauterising preparations used or applied superficially

The label must include a statement that, if the preparation fails to stop bleeding, the user should seek veterinary advice

22

Oral urinary tract modifiers (acidifiers and alkalisers) that are used solely for modification of urinary pH

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

23

Respiratory tract modifiers (expectorants and cough suppressants) for use on animals 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 animals to promote mucolysis, for cough suppression (by alleviating only irritation), and to relieve compromised airways and upper respiratory tract congestion

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

24

Agricultural compounds used to extend animal semen or to be used as media for animal sperm, cells, ova, and embryos

25

Any agricultural compound (not being an intra-ruminal device) ingested by an animal as feed, or a nutritional preparation intended for oral administration to an animal to achieve a nutritional benefit (oral nutritional compound)

The directions for use on the label must specify the species, type, and class of animal for which use is intended

An agricultural compound that is a therapeutic or pharmacological substance or preparation 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

Feed additives may be used in oral nutritional compounds only if the feed additives are—

(a)

substances generally recognised as safe in accordance with section 8B of the Act; and

(b)

used in accordance with any relevant conditions imposed by the Director-General under section 8B of the Act

Oral nutritional compounds that are feed commodities are not subject to the conditions in regulations 9 and 12

For the purpose of this special condition, feed commodities means plants (or any part or parts of those plants) that are raised and used as feed or for feed production for animals

26

Oral gastrointestinal-acting microflora-enhancing compounds

The directions for use on the label must specify the species, type, and class of animal for which use is intended

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

The compounds must contain only ingredients that are—

(a)

substances generally recognised as safe in accordance with section 8B of the Act; and

(b)

used in accordance with any relevant conditions imposed by the Director-General under section 8B of the Act

Part C. Exemptions for agricultural compounds used to manage plants or plant production
27

Spray markers that are coloured indicators to show where liquid agricultural chemicals have been applied to help prevent overlaps

28

Agricultural chemical synergists and other adjuvants, including wetting and sticking agents, pH buffers, drift retardants, and water conditioners

29

Repellants applied directly to plants and used solely to repel vertebrates or invertebrates

30

Attractants applied directly to plants and used solely to attract vertebrates or invertebrates

31

Mating disrupters applied directly to plants and used solely to interfere with the reproduction of invertebrates

32

Anti-transpirants used solely to prevent drying of plants

33

Frost protectants of a chemical nature used solely to prevent frost damage

34

Sunblocks used solely to prevent or reduce sunburn in plants

35

Agricultural chemicals used solely—

(a)

in home gardens or amenity horticulture on plants that are not intended to be used as food for humans or animals; or

(b)

in commercial plant production on plants that are not intended to be used as food for humans or animals; or

(c)

for the post-harvest treatment of cut flowers and bulbs

The label must clearly state that the product must not be used on crops intended for consumption by humans or animals

36

Homeopathic agricultural chemicals used commercially

37

Agricultural compounds used in the production of plant tissue cultures

38

Agricultural compounds (not containing biologically active ingredients) used to protect plant grafts or plant wounds

39

Agricultural compounds (not containing biologically active ingredients) used to provide a physical barrier to infestation or infection of plants

40

Agricultural compounds used in the post-harvest treatment of wood-producing crops

41

Fertiliser and fertiliser additives

The label must specify nutrient content and modifying pH value, if applicable