Ministry of Primary Industries -Rules and Regulations

Petfood sold in NZ must comply with the requirements for oral nutritional compounds (ONCs) set out in the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 under the ACVM Act.

New Zealand Legislation: ACVM (Exemptions and Prohibited Substances) Regulations 2011 (External website)

You must:

• Ensure that your petfood is fit for use (Regulation 7)
• Ensure that the specified information is on the label (Regulation 12)
• Meet the specific requirements for oral nutritional compounds in entry 25 of Schedule 2 of the Regulations
• Ensure that you do not make misleading statements about your petfood (Regulation 13), particularly in regard to making therapeutic claims.

If you are selling a product manufactured by another party, if you alter the product or its labelling, or you will be classed as a manufacturer under the law and subject to the minimum manufacturing requirements.



NB: Some of the rules in the above ACVM Act that I thought were interesting and pretty important to look at.

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).

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

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

  • (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.

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

Aldrin

Chlordane

Chlordecone

DDT including DDD (also known as TDE) and DDE

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

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

r 5

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 (not being an agricultural compound described elsewhere in this schedule)— (a) prepared by a person (person A) for use on animals or plants owned by person A, or in any land, place, or water owned or occupied by person A (and not for sale); or (b) used by person A, or a person employed or engaged by person A, or another person expressly authorised by person A, as described in paragraph (a)		If the substance or compound is used by a person employed or engaged by person A or another person expressly authorised by person A, the use must be in accordance with written instructions from person A about— (a) how the substance or compound is to be stored, prepared for use, administered, applied, and (if applicable) disposed of; and (b) how the safety and welfare of any person or animal who may come into contact with the substance or compound is to be protected and how any pain or distress of an animal is to be mitigated; and (c) how third parties are to be contacted or advised of the use of the substance or compound and warned of any hazards relating to the use of the compound The following substances or compounds may be prepared or used as described in column 1 only in compliance with an approved operating plan: (a) active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981): (b) antibiotic active ingredients: (c) hormones: (d) substances that are prohibited by countries importing New Zealand primary produce: (e) vertebrate toxic agents
3 Agricultural compounds used for— (a) any investigative, analytical, experimental, or diagnostic work or toxicity or potency testing work that involves any agricultural compounds; or (b) any work that is carried out for the purpose of testing the safety or efficacy of any agricultural compound; or (c) any training or teaching of persons, of a kind specified in the approved operating plan, involving agricultural compounds, within the scope of the substances or compounds specified in the plan		An operating plan covering the type or class of agricultural compounds the person or organisation wishes to use for research, testing, or training, and the nature of the activities contemplated must have been approved and must be complied with The person or organisation subject to the operating plan must, on an ongoing basis, notify the Director-General if a substance or compound is to be used that was not notified to the Director-General as being used or contemplated for use at the time the operating plan was approved, even where the substance or compound to be used is within the scope of agricultural compounds approved for use under that operating plan
4 Vertebrate and invertebrate attractants and repellants that are not applied directly to animals or plants
5 Invertebrate mating disrupters that are not applied directly to animals or plants
6 Agricultural compounds used to control the characteristics of water where— (a) the water is used on or in relation to animals or plants; and (b) the characteristic must be controlled to maintain the animals or plants in a healthy state or to facilitate the management of the animals or plants
7 Sterilisers, sanitisers, and disinfectants (excluding fumigants) used to maintain hygienic conditions for the purposes of hygiene and pest management in places where animals and plants are housed or cultivated		Animals and plants must not be exposed to the substance or compound
Part B. Exemptions relating to agricultural compounds that could be used in relation to animals
8 Preparations scheduled as medicines under the Medicines Act 1981, and used as veterinary medicines		Must not be used on animals except under the direct care, or with the authorisation, of a veterinarian The conditions in regulations 9 to 13 do not apply Must not be advertised for sale for use on animals
9 Compounded veterinary preparations used by veterinarians		Must not be used on animals except under the direct care, or with the authorisation, of the compounding veterinarian Preparations may be used only on animals specified by the compounding veterinarian or animals of a type specified by the compounding veterinarian
10 Oral and topical preparations for use on animals— (a) prepared by a process of solution, extraction, or titration of an active ingredient followed by strictly regimented serial dilution; and (b) that do not claim to prevent, control, or cure a specific disease characterised by pain or distress in animals		If used as a veterinary medicine, the label information must— (a) identify the compound as a homeopathic preparation; and (b) include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
11 Oral and topical preparations for animals— (a) prepared from either any part of a plant or an unrefined extract from a plant, except a plant listed in Schedule 3; and (b) that do not claim to prevent, control, or cure a specific disease characterised by pain or distress in animals; and (c) that do not claim to have pharmacological or anabolic effects, or to modify the physiological function of an animal		If used as a veterinary medicine, the label information must— (a) identify the compound as a herbal preparation; and (b) include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption
12 Non-absorbable masking agents used to disguise odours
13 Topical non-absorbable and non-solvent cleaning products, including non-medicated shampoos, soaps, tear-stain removers, and toothpaste
14 Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily
15 Over-the-counter first aid preparations, including general disinfectants, antiseptics, and sanitisers		Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption
16 Topical preparations for animals— (a) containing ingredients not able to be absorbed through the skin; and (b) used solely to treat minor injuries or to prevent minor dermatological abnormalities; and (c) that do not include any of the following ingredients: (i) active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981): (ii) antibiotic active ingredients: (iii) hormones: (iv) substances that are prohibited by countries importing New Zealand primary produce		Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption
17 Topical hoof preparations— (a) containing ingredients that act only on the surface to which they are applied; and (b) used solely to treat or prevent minor injuries or abnormalities of the surface of the hoof; and (c) that do not include any of the following ingredients: (i) active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981): (ii) antibiotic active ingredients: (iii) substances that are prohibited by countries importing New Zealand primary produce
18 Non-medicated antidiarrhoeal preparations that— (a) are used solely as gastrointestinal adsorbent or protectant agents; and (b) do not make claims in relation to binding any specific micro-organism or toxin		The label information must include statements that— (a) the preparation is suitable for use without veterinary advice only in the treatment of minor cases of diarrhoea; and (b) the preparation will not treat dehydration; and (c) if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
19 Non-medicated orally and rectally administered laxatives and lubricants used on animals		The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
20 Non-medicated moist or dry poultice preparations used on animals that— (a) are used to treat or prevent inflammation, swelling, or pain solely by heating or cooling, or drawing fluid from, the affected area; and (b) are intended for use on intact skin or minor wounds		The label must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice
21 Cauterising preparations used or applied superficially		The label must include a statement that, if the preparation fails to stop bleeding, the user should seek veterinary advice
22 Oral urinary tract modifiers (acidifiers and alkalisers) that are used solely for modification of urinary pH
23 Respiratory tract modifiers (expectorants and cough suppressants) for use on animals that— (a) have only a locally acting, superficial effect on the respiratory tract; and (b) are given orally, applied topically to the nose, or inhaled; and (c) are used solely in animals to promote mucolysis, for cough suppression (by alleviating only irritation), and to relieve compromised airways and upper respiratory tract congestion		Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended
24 Agricultural compounds used to extend animal semen or to be used as media for animal sperm, cells, ova, and embryos
25 Any agricultural compound (not being an intra-ruminal device) ingested by an animal as feed, or a nutritional preparation intended for oral administration to an animal to achieve a nutritional benefit (oral nutritional compound)		The directions for use on the label must specify the species, type, and class of animal for which use is intended An agricultural compound that is a therapeutic or pharmacological substance or preparation may be incorporated into oral nutritional compounds only if— (a) the agricultural compounds are registered under the Act; and (b) the incorporation of the agricultural compounds is consistent with any conditions of their registration Feed additives may be used in oral nutritional compounds only if the feed additives are— (a) substances generally recognised as safe in accordance with section 8B of the Act; and (b) used in accordance with any relevant conditions imposed by the Director-General under section 8B of the Act Oral nutritional compounds that are feed commodities are not subject to the conditions in regulations 9 and 12 For the purpose of this special condition, feed commodities means plants (or any part or parts of those plants) that are raised and used as feed or for feed production for animals
26 Oral gastrointestinal-acting microflora-enhancing compounds		The directions for use on the label must specify the species, type, and class of animal for which use is intended The compounds must not make therapeutic or pharmacological claims to prevent, treat, or cure any disease characterised by pain or distress in animals The compounds must contain only ingredients that are— (a) substances generally recognised as safe in accordance with section 8B of the Act; and (b) used in accordance with any relevant conditions imposed by the Director-General under section 8B of the Act
Part C. Exemptions for agricultural compounds used to manage plants or plant production
27 Spray markers that are coloured indicators to show where liquid agricultural chemicals have been applied to help prevent overlaps
28 Agricultural chemical synergists and other adjuvants, including wetting and sticking agents, pH buffers, drift retardants, and water conditioners
29 Repellants applied directly to plants and used solely to repel vertebrates or invertebrates
30 Attractants applied directly to plants and used solely to attract vertebrates or invertebrates
31 Mating disrupters applied directly to plants and used solely to interfere with the reproduction of invertebrates
32 Anti-transpirants used solely to prevent drying of plants
33 Frost protectants of a chemical nature used solely to prevent frost damage
34 Sunblocks used solely to prevent or reduce sunburn in plants
35 Agricultural chemicals used solely— (a) in home gardens or amenity horticulture on plants that are not intended to be used as food for humans or animals; or (b) in commercial plant production on plants that are not intended to be used as food for humans or animals; or (c) for the post-harvest treatment of cut flowers and bulbs		The label must clearly state that the product must not be used on crops intended for consumption by humans or animals
36 Homeopathic agricultural chemicals used commercially
37 Agricultural compounds used in the production of plant tissue cultures
38 Agricultural compounds (not containing biologically active ingredients) used to protect plant grafts or plant wounds
39 Agricultural compounds (not containing biologically active ingredients) used to provide a physical barrier to infestation or infection of plants
40 Agricultural compounds used in the post-harvest treatment of wood-producing crops
41 Fertiliser and fertiliser additives The label must specify nutrient content and modifying pH value, if applicable Schedule 3 Plants not to be included in oral and topical preparations Abrus precatorius seed and root Acorus calamus Amanita (all species) Anadenanthera peregrina Argyreia nervosa Aristolochia (all species) Banisteriopsis caapi Cannabis (all species) Catha edulis Conocybe (all species) Crotalaria (all species) Cynoglossum officinale Erythroxylum coca Haemadictyon (all species) Heliotropium (all species) Ipomoea burmannii (Rivea corymbosa) Ipomoea hederacea Ipomoea violacea (Ipomoea tricolor) Lophophora (all species) Opuntia cylindrica Papaver bracteatum Papaver somniferum Peganum harmala Petasites (all species) Piptadenia macrocarpa Piptadenia peregrina Psilocybe (all species) Pteridium aquilinum Sophora secundiflora Strychnos gaulthieriana Strychnos ignatii (Ignatia amara) Virola sebifera (for external use)