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

Version as at 18 July 2022

Coat of Arms of New Zealand

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

(SR 2011/327)

Jerry Mateparae, Governor-General

Order in Council

At Wellington this 19th day of September 2011

Present:
His Excellency the Governor-General in Council

Note

The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.

Note 4 at the end of this version provides a list of the amendments included in it.

These regulations are administered by the Ministry for Primary Industries.

Pursuant to section 75 of the Agricultural Compounds and Veterinary Medicines Act 1997, His Excellency the Governor-General, acting on the advice and with the consent of the Executive Council and on the recommendation of the Minister for Food Safety made in accordance with section 78 of that Act, makes the following regulations.

Regulations

1 Title

These regulations are the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011.

2 Commencement

These regulations come into force on 1 November 2011.

3 Interpretation

In these regulations, unless the context otherwise requires,—

active ingredient means a chemical or biological component in a formulated product that is principally responsible for the effect being claimed and is distinct from other components of the formulated product such as adjuvants or additives

agricultural chemical means an agricultural compound other than one used or intended to be used in the direct management of animals; and does not include a vertebrate toxic agent

animal material means a live or dead animal, or any tissue or other natural material taken from a live or dead animal

animal nutrient means a nourishing substance, 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

antibiotic means a naturally occurring, semi-synthetic, or synthetic antimicrobial substance that kills or inhibits the growth of bacteria to prevent or treat bacterial infections in or on an animal or a plant

approved operating plan means an operating plan approved under section 28(2) of the Act

compounded veterinary preparation means a preparation of 1 or more ingredients prepared by a veterinarian, or by a person who is not a veterinarian under contract to and under the instructions of the veterinarian, for use on animals as a veterinary medicine

compounding veterinarian means a veterinarian who prepares a compounded veterinary preparation or under whose instructions a compounded veterinary preparation is prepared

exempt compound product means a product that is an exempt agricultural compound specified in column 1 of Schedule 2 and that is intended for sale as a specific proprietary product

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 plant material, or a mix of substances or biological compounds or plant material, that is described as, or held out to be suitable for, sustaining or increasing the growth, productivity, or quality of plants through the delivery to plants or soil of plant nutrients; and

(b)

includes any—

(i)

non-nutrient attributes of the materials used in fertiliser; and

(ii)

animal nutrients used in fertiliser; but

(c)

does not include a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, that is intended for use as a plant growth regulator that modifies the physiological functions of plants

food crops means plants used as food or for food production for humans

inhibitor substance means a substance declared to be an agricultural compound by the Agricultural Compounds and Veterinary Medicines (Inhibitor Substances) Order 2022

intra-ruminal device means a device designed to be administered orally to a ruminant animal to provide prolonged and sustained release of animal nutrients or therapeutic or pharmacological substances or preparations

nutritional benefit means a contribution to the normal physiological function and metabolic homeostasis of an animal achieved by the oral provision of animal nutrients

nutritional preparation means a compounded mix of animal nutrients or animal 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

pharmacological substance means a substance that modifies a physiological function of an animal

plant biostimulant—

(a)

means a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, whose function when applied to plants, the rhizosphere, or soil is to stimulate natural processes to enhance or benefit plant nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality traits; but

(b)

does not include substances that are plant growth regulators that modify the physiological functions of plants

plant material means any live or dead plant, or any tissue or other natural material taken from a live or dead plant

plant nutrient means an essential element necessary for plant growth, including, but not limited to,—

(a)

a macronutrient (nitrogen, phosphorus, potassium, calcium, sulphur, or magnesium); and

(b)

a micronutrient (boron, chlorine, manganese, iron, zinc, copper, molybdenum, or nickel)

semiochemical preparation means a preparation containing a volatile substance that conveys a signal to an animal to modify the behaviour of the recipient animal

soil conditioner means a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, that is added to soil to improve its physical or chemical qualities including, but not limited to, structure, porosity, water retention, pH, and cation-exchange capacity

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 animal 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

unrefined extract means plant material that has not been subjected to purification processes that result in the isolation of, or alteration of the proportions of, specific chemical constituents of the plant.

Regulation 3 animal nutrient: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 antibiotic: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 fertiliser: replaced, on 23 July 2020, by regulation 4(4) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 fertiliser additive: revoked, on 23 July 2020, by regulation 4(1) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 inhibitor substance: inserted, on 18 July 2022, by regulation 4 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2022 (SL 2022/192).

Regulation 3 intra-ruminal device: amended, on 23 July 2020, by regulation 4(3) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 non-medicated: revoked, on 23 July 2020, by regulation 4(1) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 nutrient: revoked, on 23 July 2020, by regulation 4(1) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 nutritional benefit: amended, on 23 July 2020, by regulation 4(3) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 nutritional preparation: amended, on 23 July 2020, by regulation 4(3) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 plant biostimulant: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 plant nutrient: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 semiochemical preparation: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 soil conditioner: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 therapeutic substance paragraph (b): amended, on 23 July 2020, by regulation 4(3) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 3 unrefined extract: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Prohibited agricultural compounds

4 Prohibition on use of certain agricultural compounds

(1)

The substances described in Schedule 1 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.

Exempt agricultural compounds

5 Agricultural compounds exempt from registration if conditions complied with

(1)

An agricultural compound described in column 1 of Schedule 2 may be imported, manufactured, sold, or used as an agricultural compound without registration under section 21 or 27 of the Act if the conditions described in subclause (2) are complied with.

(2)

The conditions are—

(a)

any conditions set out in relation to that agricultural compound in column 2 of Schedule 2; and

(b)

the applicable conditions in regulations 7 to 13, subject to any express provision in column 2 of Schedule 2 in relation to the particular agricultural compound that has the effect of excluding, modifying, or adding to the requirements in regulations 7 to 13.

(3)

Nothing in these regulations applies to any—

(a)

registered trade name product; or

(b)

substance generally recognised as safe under section 8B of the Act; or

(c)

agricultural compound exempt from registration under section 8C of the Act.

6 Combined agricultural compounds exempt from registration

An agricultural compound is exempt from registration under section 21 or 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, provided that—

(a)

the conditions applicable to each compound are complied with as described in regulation 5(2); and

(b)

the combined agricultural compound complies with the applicable conditions in regulations 7 to 15, subject to any express provision in column 2 of Schedule 2 in relation to a particular exempt compound in the combination that has the effect of excluding, modifying, or adding to the requirements in regulations 7 to 15.

Conditions of general application to exempt agricultural compounds

7 Fitness for purpose: importation, manufacture, or sale of exempt compound

An exempt agricultural compound that is imported, manufactured, or sold must be such that, when used as recommended, it will not—

(a)

spread organisms to a level or in a manner that could be harmful to humans; or

(b)

reduce the efficacy of medicines used on humans; or

(c)

result in residues in primary produce that exceed the limits prescribed in applicable food residue standards set in or under any enactment; or

(d)

be toxic to animals treated with or exposed to the compound to an extent that causes unnecessary or unreasonable pain or distress; or

(e)

fail to reduce or eliminate pain or distress to animals treated with the compound where the elimination of pain or distress is a stated purpose of the product; or

(f)

transmit disease, result in physical harm, or cause unnecessary pain and distress, to animals treated with or exposed to the compound; or

(g)

transmit pests or unwanted organisms as defined in the Biosecurity Act 1993 or specified in any national or regional pest management plan made under that Act; or

(h)

otherwise create or be likely to create any of the risks specified in section 4(a) of the Act.

Regulation 7(g): amended, on 18 September 2012, by section 93 of the Biosecurity Law Reform Act 2012 (2012 No 73).

8 Fitness for purpose: use of exempt agricultural compound

A person who uses an exempt agricultural compound must ensure that the use of the compound does not do anything described in regulation 7(a) to (h).

9 Manufacture of exempt compound product to be in accordance with documented system

(1)

An exempt compound product manufactured in New Zealand must be manufactured in accordance with a documented system for the manufacture of that product that contains the following:

(a)

the specifications for the product and specific processes to be followed, and requirements to be met, that are sufficient to ensure that the product, when used as recommended, complies with the conditions of exemption applicable to the product under these regulations; and

(b)

the formulation or recipe of the product; and

(c)

a description of the manufacturing process; and

(d)

the name or description under which the product will be sold in New Zealand; and

(e)

a description or illustration of any packaging and labelling requirements for the product; and

(f)

a nominated person or persons to monitor compliance with the requirements of the documented system; and

(g)

any other matter relevant to the manufacture of the product that is specified by the Director-General by notice.

(2)

If a product is imported into New Zealand that, when ready for sale, will be an exempt compound product and any process of manufacture of the product occurs in New Zealand, that manufacturing must be in accordance with a documented system that contains the matters described in subclause (1)(c) to (g).

(3)

A notice made under subclause (1)(g) is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

Legislation Act 2019 requirements for secondary legislation made under this regulation
PublicationIt is not required to be publishedLA19 s 73(2)
PresentationIt is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 of the Legislation Act 2019LA19 s 114, Sch 1 cl 32(1)(a)
DisallowanceIt may be disallowed by the House of Representatives LA19 ss 115, 116
This note is not part of the secondary legislation.

Regulation 9(1)(g): amended, on 28 October 2021, by regulation 8(1) of the Legislation Act (Sub-delegated Secondary Legislation) Regulations 2021 (LI 2021/248).

Regulation 9(3): inserted, on 28 October 2021, by regulation 8(2) of the Legislation Act (Sub-delegated Secondary Legislation) Regulations 2021 (LI 2021/248).

10 Compounded veterinary preparation to be prepared in accordance with documented system

(1)

A compounded veterinary preparation must be prepared in accordance with a documented system for that preparation that contains the following:

(aaa)

a statement of the purpose of the preparation; and

(a)

the description of the preparation that is supplied to users; and

(b)

the formulation or recipe of the preparation; and

(c)

a description of the compounding process that is sufficient to ensure that the preparation, when used as recommended, complies with the conditions of exemption applicable to the preparation under these regulations; and

(d)

a description or illustration of packaging and labelling requirements (if any) for the preparation; and

(e)

a nominated person or persons to monitor compliance with the requirements of the documented system (which must be, or include, the compounding veterinarian); and

(f)

any other matter relevant to the preparation that is specified by the Director-General by notice.

(2)

The compounding veterinarian must ensure that the documented system—

(a)

complies with the conditions of exemption applicable to a compounded veterinary preparation under these regulations; and

(b)

is sufficient to provide a compounded veterinary preparation that is fit for its intended purpose.

(3)

A notice made under subclause (1)(f) is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

Legislation Act 2019 requirements for secondary legislation made under this regulation
PublicationIt is not required to be publishedLA19 s 73(2)
PresentationIt is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 of the Legislation Act 2019LA19 s 114, Sch 1 cl 32(1)(a)
DisallowanceIt may be disallowed by the House of Representatives LA19 ss 115, 116
This note is not part of the secondary legislation.

Regulation 10(1)(aaa): inserted, on 23 July 2020, by regulation 5(1) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 10(1)(f): amended, on 28 October 2021, by regulation 9(1) of the Legislation Act (Sub-delegated Secondary Legislation) Regulations 2021 (LI 2021/248).

Regulation 10(2): inserted, on 23 July 2020, by regulation 5(2) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Regulation 10(3): inserted, on 28 October 2021, by regulation 9(2) of the Legislation Act (Sub-delegated Secondary Legislation) Regulations 2021 (LI 2021/248).

11 Regulations 9 and 10 not to apply if operating plan required

Nothing in regulation 9 or 10 applies in respect of an agricultural compound that is exempt from registration under section 21 or 27 of the Act on the condition (specified in these regulations) that an applicable operating plan is approved and complied with.

12 Information requirements

(1)

This regulation applies to—

(a)

an exempt compound product, when supplied to a user; and

(b)

a compounded veterinary preparation, when supplied with a label to a user.

(1A)

This regulation does not apply to a veterinarian who prepares a compounded veterinary preparation and administers the preparation to an animal.

(2)

The product or preparation must be supplied with the following information:

(a)

the name (if any) under which it is sold or supplied; and

(b)

a description of the product or preparation sufficient to enable the user to determine the nature and purpose of it; and

(c)

the name and contact details of the manufacturer or importer or, in the case of a compounded veterinary preparation, the compounding veterinarian; and

(d)

the active ingredients; and

(e)

directions for use; and

(f)

use-by date or expiry date, if applicable; and

(g)

details of precautions (if any) to be taken to prevent or manage the risks described in section 19 of the Act when using the product or preparation; and

(h)

in the case of an exempt compound product only, the batch number or other information sufficient to allow the date and place of manufacture or preparation to be ascertained; and

(i)

any other information specified in Schedule 2 in relation to the exempt compound, or exempt compounds, concerned.

Regulation 12(1A): inserted, on 23 July 2020, by regulation 6 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

13 Misleading statements about exempt compound product or compounded veterinary preparation

(1)

This regulation applies to any advertisement or label in relation to an exempt compound product or compounded veterinary preparation.

(2)

No advertisement or label referred to in subclause (1) may include any comment, reference, or explanation in relation to the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, proportion, ingredients, or components of the product or preparation, or its effectiveness for any particular purpose, that is inconsistent with the conditions to which that product or preparation is subject under these regulations.

Record-keeping requirements in relation to exempt agricultural compounds

14 Recording of documented system and of actions taken in accordance with documented system

(1)

A documented system must be recorded or otherwise maintained in a manner that enables evidence of the content of it at any given time to be readily accessible and retrievable.

(2)

A person who manufactures an exempt compound product must, in relation to that product, keep records of the application of the specific processes, and taking of required steps, identified in the documented system in accordance with regulation 9(1)(a).

(3)

Where a compounded veterinary preparation is prepared, the compounding veterinarian must, in relation to that preparation, keep records of—

(a)

the matters specified in regulation 10(1)(aaa) to (d) and (f); and

(b)

the date on which, and place at which, the preparation was prepared.

Regulation 14(3)(a): amended, on 23 July 2020, by regulation 7 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

15 Records to be kept by importer in relation to exempt compound product

A person who imports an exempt compound product into New Zealand must keep the following records in relation to that product:

(a)

the name and contact details of the overseas manufacturer of the product; and

(b)

the batch numbers for the imported consignment; and

(c)

the name or description under which the product will be sold in New Zealand.

Revocation

16 Revocation

The Agricultural Compounds and Veterinary Medicines Regulations 2001 (SR 2001/101) are revoked.

Schedule 1 Substances prohibited from use as agricultural compounds or as ingredients in agricultural compounds

r 4

Aldrin

Chlordane

Chlordecone

DDT including DDD (also known as TDE) and DDE

Dicofol

Dieldrin

Technical endosulfan and its related isomers

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

Pentachlorophenol and its salts and esters

Toxaphene

Schedule 1: amended, on 3 December 2020, by regulation 4 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations (No 2) 2020 (LI 2020/290).

Schedule 1: amended, on 15 December 2016, by regulation 4 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2016 (LI 2016/301).

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

r 5

Schedule 2: replaced, on 23 July 2020, by regulation 8 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

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—

(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 active ingredient 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 its use

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 substances:

(c)

animal 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 active ingredients 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 an active ingredient 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 active ingredient to be used is within the scope of agricultural compounds approved for use under that operating plan

4

Vertebrate and invertebrate attractants and repellents 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 in places where animals and plants are housed or cultivated

Animals and plants must not be exposed to the substance or compound
8

Agricultural compounds with a solely mechanical mode of action applied to the environment in which animals or plants are kept, to control invertebrate pests of animals or plants

Must not contain any biologically active ingredients
8A

Inhibitor substances

The exemption applies to an inhibitor substance for sale in New Zealand on 18 July 2022, unless the inhibitor substance is registered as a trade name product under the Act

Part B. Exemptions relating to agricultural compounds that could be used in relation to animals
9

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

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

10

Compounded veterinary preparations

Must not be used on animals except under the direct care 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

Must not be advertised for sale for use 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

11

Homeopathic 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 to the point that the active ingredient is no longer practically detectable; and

(b)

that are not claimed 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

12

Topical veterinary preparations (non-absorbable) for—

(a)

treatment or prevention of minor wounds or dermatological abnormalities; and

(b)

cleaning teeth, skin, hair, fur, or hooves; and

(c)

maintaining skin, hair, fur, or hoof health/condition; and

(d)

disguising odours

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

(f)

substances that are prohibited by countries importing New Zealand primary produce

The compound must not be used on the udders and teats of animals whose milk is being collected for human consumption

For the preparation described in paragraph 12(a), the label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

13

Oral and topical preparations for animals—

(a)

prepared from either any part of a plant or an unrefined extract from a plant; and

(b)

that are not claimed to prevent, control, or cure a specific disease characterised by pain or distress in animals; and

(c)

that are not claimed 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)

if applicable, 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 udders and teats of animals whose milk is being collected for human consumption

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

(f)

substances that are prohibited by countries importing New Zealand primary produce

14

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

15

Antidiarrhoeal preparations that—

(a)

are used solely as gastrointestinal adsorbent or protectant agents; and

(b)

are not claimed to bind any specific micro-organism or toxin; and

(c)

have only a local, surface-acting effect on the gastrointestinal tract

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

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

(f)

substances that are prohibited by countries importing New Zealand primary produce

16

Laxatives and lubricants used on animals that have only a local, surface-acting effect on the gastrointestinal tract, vulva, and vagina

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

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

(f)

substances that are prohibited by countries importing New Zealand primary produce

17

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

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

(f)

substances that are prohibited by countries importing New Zealand primary produce

18

Cauterising preparations used or applied superficially

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

19

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

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

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

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

21

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

22

Any agricultural compound (excluding agricultural compounds administered in 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 (an 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 only be incorporated into oral nutritional compounds if the agricultural compound is registered as a veterinary medicine under the Act and—

(a)

incorporation of the registered veterinary medicine is consistent with the indications, use patterns, and target species approved for the registered product; and

(b)

the registered veterinary medicine remains adequately distributed throughout the oral nutritional compound for the entirety of the claimed shelf life of the feed; and

(c)

the efficacy of the registered veterinary medicine is maintained for the entirety of the claimed shelf life of the feed

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

If an oral nutritional compound is incorporated with an agricultural compound the label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

23

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

No therapeutic or pharmacological claims that the compound prevents, treats, or cures any disease characterised by pain or distress in animals may be made

24

Semiochemical preparations that modify an animal’s behaviour by sending communication signals through chemicals and are not claimed to prevent, control, or cure a particular disease characterised by pain or distress in animals

Must not contain the following ingredients—

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

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

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

25

Biologically active agricultural compounds applied to the contained environment in which non-food producing animals are kept to control invertebrate pests of animals

Must not be used when any animal is present

The label information must state the safe re-entry period for non-food-producing animals and that food-producing animals must not be exposed to the product

26

Topically absorbable animal nutrients

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

27

Products with a solely mechanical mode of action applied topically, that are not claimed to prevent, control, or cure a particular disease characterised by pain or distress in animals

Must not contain any biologically active ingredients

Must not be absorbable

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

Must not be an irritant

Part C. Exemptions relating to agricultural compounds that could be used to manage plants or plant production
28

Products applied to, or within, empty structures to remove pests before—

(a)

introducing produce; or

(b)

growing plants

Must not be used when plants or produce are present

The label information must state the re-entry period before plants or produce are re-introduced (to avoid non-compliant residues)

29

Products with a solely mechanical mode of action to control invertebrate pests on plants or plant produce

Must not contain any biologically active ingredients

30

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

31

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

32

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

33

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

34

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

35

Agricultural chemical compounds used to protect plants from climatological conditions

Must not contain any biologically active ingredients

36

Agricultural chemicals used solely—

(a)

in home gardens or amenity horticulture on plants that are not intended to produce food for consumption by humans or animals; or

(b)

in commercial plant production on plants that are not intended to produce food for consumption by humans or animals; or

(c)

for the post-harvest treatment of cut flowers and bulbs

The label information must clearly state that the product must not be—

(a)

used on plants that are intended to produce food for consumption by humans or animals; and

(b)

applied to areas that may be grazed by food-producing animals

37

Homeopathic agricultural chemicals used commercially

38

Agricultural compounds used in the production of plant tissue cultures

39

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

40

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

41

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

42

Fertilisers

The label information must specify nutrient content value, as applicable

The product must comply with any applicable notice issued under the Act

43

Plant biostimulants

The label information must specify mode of action, as applicable

The product must comply with any applicable notice issued under the Act

44

Soil conditioners

The label information must specify mode of action, as applicable

The product must comply with any applicable notice issued under the Act

Schedule 2 item 8A: inserted, on 18 July 2022, by regulation 6(1) of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2022 (SL 2022/192).

Schedule 3 Plants not to be included in oral and topical preparations

[Revoked]

Sch 2

Schedule 3: revoked, on 23 July 2020, by regulation 9 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130).

Rebecca Kitteridge,
Clerk of the Executive Council.

Issued under the authority of the Legislation Act 2019.

Date of notification in Gazette: 22 September 2011.

Notes
1 General

This is a consolidation of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 that incorporates the amendments made to the legislation so that it shows the law as at its stated date.

2 Legal status

A consolidation is taken to correctly state, as at its stated date, the law enacted or made by the legislation consolidated and by the amendments. This presumption applies unless the contrary is shown.

Section 78 of the Legislation Act 2019 provides that this consolidation, published as an electronic version, is an official version. A printed version of legislation that is produced directly from this official electronic version is also an official version.

3 Editorial and format changes

The Parliamentary Counsel Office makes editorial and format changes to consolidations using the powers under subpart 2 of Part 3 of the Legislation Act 2019. See also PCO editorial conventions for consolidations.

4 Amendments incorporated in this consolidation

Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2022 (SL 2022/192)

Legislation Act (Sub-delegated Secondary Legislation) Regulations 2021 (LI 2021/248): regulations 8, 9

Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations (No 2) 2020 (LI 2020/290)

Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020 (LI 2020/130)

Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2016 (LI 2016/301)

Biosecurity Law Reform Act 2012 (2012 No 73): section 93