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

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 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. Contents Page 1 Title 3 2 Commencement 3 3 Interpretation 3 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. Version as at 14 March 2025 1 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415171 https://www.legislation.govt.nz/pdflink.aspx?id=DLM414576 https://www.legislation.govt.nz/pdflink.aspx?id=DLM414576 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415174 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298371 Prohibited agricultural compounds 4 Prohibition on use of certain agricultural compounds 7 Exempt agricultural compounds 5 Agricultural compounds exempt from registration if conditions complied with 7 6 Combined agricultural compounds exempt from registration 7 Conditions of general application to exempt agricultural compounds 7 Fitness for purpose: importation, manufacture, or sale of exempt compound 8 8 Fitness for purpose: use of exempt agricultural compound 8 9 Manufacture of exempt compound product to be in accordance with documented system 8 10 Compounded veterinary preparation to be prepared in accordance with documented system 9 11 Regulations 9 and 10 not to apply if operating plan required 10 12 Information requirements 10 13 Misleading statements about exempt compound product or compounded veterinary preparation 11 Record-keeping requirements in relation to exempt agricultural compounds 14 Recording of documented system and of actions taken in accordance with documented system 11 15 Records to be kept by importer in relation to exempt compound product 12 Revocation 16 Revocation 12 Schedule 1 Substances prohibited from use as agricultural compounds or as ingredients in agricultural compounds 13 Schedule 2 Agricultural compounds exempt from registration under sections 21 and 27 of Act 14 Schedule 3 Plants not to be included in oral and topical preparations [Revoked] 22 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 2 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,— Act means the Agricultural Compounds and Veterinary Medicines Act 1997 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 antimicro‐ bial 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 ingre‐ dients 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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 r 3 3 https://www.legislation.govt.nz/pdflink.aspx?id=DLM414576 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415097 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415097 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 homeo‐ stasis 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 physio‐ logical 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 com‐ pound 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 sub‐ stance 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 r 3 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 4 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701264 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701264 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, includ‐ ing, but not limited to,— (a) a macronutrient (nitrogen, phosphorus, potassium, calcium, sulphur, or magnesium); and (b) a micronutrient (boron, chlorine, manganese, iron, zinc, copper, molyb‐ denum, or nickel) semiochemical preparation means a preparation containing a volatile sub‐ stance 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 abnor‐ mal 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 purifica‐ tion processes that result in the isolation of, or alteration of the proportions of, specific chemical constituents of the plant. Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 r 3 5 Regulation 3 animal nutrient: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Com‐ pounds 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 Regula‐ tions 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 Regula‐ tions 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 Regula‐ tions 2020 (LI 2020/130). Regulation 3 non-medicated: revoked, on 23 July 2020, by regulation 4(1) of the Agricultural Com‐ pounds 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 Regula‐ tions 2020 (LI 2020/130). Regulation 3 nutritional preparation: amended, on 23 July 2020, by regulation 4(3) of the Agricul‐ tural 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 Regula‐ tions 2020 (LI 2020/130). Regulation 3 plant nutrient: inserted, on 23 July 2020, by regulation 4(2) of the Agricultural Com‐ pounds 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 Agri‐ cultural 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 Com‐ pounds 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 Regula‐ tions 2020 (LI 2020/130). r 3 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 6 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701214 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355888 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 col‐ umn 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 agricul‐ tural 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 agricul‐ tural 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 condi‐ tions 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. Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 r 6 7 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415087 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415094 https://www.legislation.govt.nz/pdflink.aspx?id=DLM1100247 https://www.legislation.govt.nz/pdflink.aspx?id=DLM1100249 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415087 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415094 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 manu‐ factured 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 r 7 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 8 https://www.legislation.govt.nz/pdflink.aspx?id=DLM314622 https://www.legislation.govt.nz/pdflink.aspx?id=DLM314622 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415060 https://www.legislation.govt.nz/pdflink.aspx?id=DLM3388552 (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 require‐ ments 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 Publication It is not required to be published LA19 s 73(2) Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 of the Legislation Act 2019 LA19 s 114, Sch 1 cl 32(1)(a) Disallowance It 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-dele‐ gated 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 condi‐ tions 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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 r 10 9 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298343 https://www.legislation.govt.nz/pdflink.aspx?id=LMS260120 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298525 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298429 https://www.legislation.govt.nz/pdflink.aspx?id=LMS7911 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298431 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298432 https://www.legislation.govt.nz/pdflink.aspx?id=LMS509144 https://www.legislation.govt.nz/pdflink.aspx?id=LMS509144 (e) a nominated person or persons to monitor compliance with the require‐ ments of the documented system (which must be, or include, the com‐ pounding 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 Publication It is not required to be published LA19 s 73(2) Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 of the Legislation Act 2019 LA19 s 114, Sch 1 cl 32(1)(a) Disallowance It 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-dele‐ gated 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. r 11 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 10 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298343 https://www.legislation.govt.nz/pdflink.aspx?id=LMS260120 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298525 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298429 https://www.legislation.govt.nz/pdflink.aspx?id=LMS7911 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298431 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298432 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355889 https://www.legislation.govt.nz/pdflink.aspx?id=LMS473401 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355889 https://www.legislation.govt.nz/pdflink.aspx?id=LMS473401 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415087 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415094 (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 veterin‐ arian; 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 com‐ ment, 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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 r 14 11 https://www.legislation.govt.nz/pdflink.aspx?id=DLM415085 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355890 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. r 15 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 12 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355891 https://www.legislation.govt.nz/pdflink.aspx?id=DLM27749 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 ingre‐ dients HCH (also known as hexachlorocyclohexane or benzenehexachloride) Heptachlor Lindane Methoxychlor, including any isomer of dimethoxydiphenyltrichloroethane or combin‐ ation of isomers Mirex Pentachlorobenzene Pentachlorophenol and its salts and esters Toxaphene Schedule 1: amended, on 14 March 2025, by regulation 4 of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2025 (SL 2025/46). 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). Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Schedule 1 13 https://www.legislation.govt.nz/pdflink.aspx?id=LMS1028385 https://www.legislation.govt.nz/pdflink.aspx?id=LMS426341 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7048614 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 1 Column 2 Agricultural compound Conditions 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 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 Schedule 2 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 14 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355892 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions 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 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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Schedule 2 15 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions 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 If used as a veterinary medicine, the label information must,— (a) if applicable, identify the compound as a herbal preparation; and Schedule 2 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 16 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions (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 (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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Schedule 2 17 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions 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 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 Schedule 2 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 18 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions (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 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 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Schedule 2 19 Column 1 Column 2 Agricultural compound Conditions 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 Schedule 2 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 20 https://www.legislation.govt.nz/pdflink.aspx?id=DLM53789 Column 1 Column 2 Agricultural compound Conditions 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). Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Schedule 2 21 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701217 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. Schedule 3 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Version as at 14 March 2025 22 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355893 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298104 Notes 1 General This is a consolidation of the Agricultural Compounds and Veterinary Medi‐ cines (Exemptions and Prohibited Substances) Regulations 2011 that incorpor‐ ates 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 presump‐ tion applies unless the contrary is shown. Section 78 of the Legislation Act 2019 provides that this consolidation, pub‐ lished 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 con‐ solidations 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) Amend‐ ment Regulations 2025 (SL 2025/46) Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amend‐ ment 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) Amend‐ ment Regulations (No 2) 2020 (LI 2020/290) Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amend‐ ment Regulations 2020 (LI 2020/130) Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amend‐ ment Regulations 2016 (LI 2016/301) Biosecurity Law Reform Act 2012 (2012 No 73): section 93 Wellington, New Zealand: Published under the authority of the New Zealand Government—2025 Version as at 14 March 2025 Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 Notes 23 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298365 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7298371 http://www.pco.govt.nz/editorial-conventions/ https://www.legislation.govt.nz/pdflink.aspx?id=LMS1028379 https://www.legislation.govt.nz/pdflink.aspx?id=LMS1028379 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701206 https://www.legislation.govt.nz/pdflink.aspx?id=LMS701206 https://www.legislation.govt.nz/pdflink.aspx?id=LMS509144 https://www.legislation.govt.nz/pdflink.aspx?id=LMS509144 https://www.legislation.govt.nz/pdflink.aspx?id=LMS473401 https://www.legislation.govt.nz/pdflink.aspx?id=LMS426334 https://www.legislation.govt.nz/pdflink.aspx?id=LMS426334 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355857 https://www.legislation.govt.nz/pdflink.aspx?id=LMS355857 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7048606 https://www.legislation.govt.nz/pdflink.aspx?id=DLM7048606 https://www.legislation.govt.nz/pdflink.aspx?id=DLM3388552