{"id":"F2019L00360","name":"Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019","slug":"agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98956,"registerId":"commonwealth-F2019L00360-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n This instrument commences on the day after the day it is registered.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 26B(6) of the Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n(1) Unless the contrary intention appears:\n\n(a) words and expressions that are used in the Code have the same meaning in this Instrument; and\n\n(b) words and expressions that are used in the Regulations have the same meaning in this Instrument.\n\n(2) In this Instrument:\n\nCode means the Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.\n\nPrimary steps of manufacture means all steps in the manufacturing process that result in direct contact with the veterinary chemical product.\n\nRegulations means the Agricultural and Veterinary Chemicals Code Regulations 1995 and a reference to subregulations has a corresponding meaning.\n\nSecondary steps of manufacture means labelling or relabelling or secondary/supplementary labelling; secondary packaging; storage; release for supply; analysis and testing; or manufacturing steps that do not result in direct contact with the veterinary chemical product released to market.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Prescribed variations","content":"#### 5 Prescribed variations\n\nThe following table prescribes, for the purposes of paragraph 26B(4)(a) of the Code, prescribed variations of the relevant particulars that are listed in an item in the table, for the registrations listed in the table for that item.\n\n```html\n

Prescribed variations

Item

Prescribed variation of relevant particular

Registration

1

A variation of either or both of the following particulars:

(a) the name of a manufacturer of a chemical product in Australia;

(b) the address of each site in Australia at which the chemical product is manufactured by a manufacturer;

but only if, under the varied particulars:

(c) the manufacturer and the address of each manufacturing site are in Australia; and either:

  1. the manufacturer is the holder of a valid licence under Part 8 of the Code that authorises carrying out a step in the manufacture of the chemical product at premises at the site; or
  2. the manufacturer is an exempt person as mentioned in paragraph 121(4)(a) of the Code in relation to the manufacture of the chemical product

any registration of a chemical product other than a chemical product that is prescribed under subregulation 59(1)

2

A variation of either or both of the following particulars:

(a) the name of a manufacturer of a chemical product outside Australia;

(b) the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts secondary steps of manufacture (excluding the step of a biological assay for an immunobiological product) in relation to the chemical product, but only if, under the varied particulars:

(i) the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

a registration of a chemical product, other than a chemical product that is prescribed under subregulation 59(1)

3

A variation of either or both of the following particulars:

(a) the name of a manufacturer of a chemical product outside Australia;

(b) the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts primary steps of manufacture in relation to the chemical product, but only if, under the varied particulars:

(i) at the time of the holder’s application, the site of manufacture is entered in the Register as a site for another chemical product of the holder, and the manufacturer conducts the same steps of manufacture in relation to the other chemical product; and

(ii) the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

a registration of a chemical product, other than

(a) a chemical product that is prescribed under subregulation 59(1); or

(b) an immunobiological product

4

A variation of one or more constituents of a chemical product if:

(a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and

(b) the original constituent is not an active constituent of the product; and

(c) the replacement constituent will not be an active constituent of the product; and

(d) the original and replacement constituents have the same purpose in the product; and

(e) the original and replacement constituents differ only in solvates or hydrates; and

(f) the original and replacement constituents have the same:

(i) pH; and

(ii) dissolution profile; and

(iii) hydrophilic or hydrophobic behaviour; and

(iv) hygroscopic behaviour; and

(g) neither the original nor replacement constituent are a nanomaterial; and

(h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33% of the length of the original constituent’s hydrocarbon chain; and

(i) the replacement constituent does not introduce material of human or animal origin into the product; and

(j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and

(k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and

(l) the variation does not require the formulation type entered in the Register for the product to be varied; and

(m) in the case of a product that has 9 or more constituents entered in the Register for the product—the variation is to no more than 25% of the number of constituents entered in the Register for the product; and

(n) in the case of a product that has less than 9 constituents entered in the Register for the product—the variation is to one or 2 of the constituents entered in the Register for the product

a registration of a chemical product, other than a chemical product that is:

(a) an antibiotic product; or

(b) an immunobiological product; or

(c) a product that is administered through direct injection into an animal

\n```\n\n> Note: Endnotes\n\n> Note: Endnote 1—About the endnotes\n\nThe endnotes provide information about this compilation and the compiled law.\n\nThe following endnotes are included in every compilation:\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\nAbbreviation key—Endnote 2\n\nThe abbreviation key sets out abbreviations that may be used in the endnotes.\n\nLegislation history and amendment history—Endnotes 3 and 4\n\nAmending laws are annotated in the legislation history and amendment history.\n\nThe legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.\n\nThe amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.\n\nMisdescribed amendments\n\nA misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.\n\nIf a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.\n\n> Note: Endnote 2—Abbreviation key\n\n| ad = added or inserted | o = order(s) |\n| ---------------------------------------------- | ----------------------------------- |\n| am = amended | Ord = Ordinance |\n| amdt = amendment | orig = original |\n| c = clause(s) | par = paragraph(s)/subparagraph(s) |\n| C[x] = Compilation No. x | /sub‑subparagraph(s) |\n| Ch = Chapter(s) | pres = present |\n| def = definition(s) | prev = previous |\n| Dict = Dictionary | (prev…) = previously |\n| disallowed = disallowed by Parliament | Pt = Part(s) |\n| Div = Division(s) | r = regulation(s)/rule(s) |\n| exp = expires/expired or ceases/ceased to have | reloc = relocated |\n| effect | renum = renumbered |\n| F = Federal Register of Legislation | rep = repealed |\n| gaz = gazette | rs = repealed and substituted |\n| LA = Legislation Act 2003 | s = section(s)/subsection(s) |\n| LIA = Legislative Instruments Act 2003 | Sch = Schedule(s) |\n| (md) = misdescribed amendment can be given | Sdiv = Subdivision(s) |\n| effect | SLI = Select Legislative Instrument |\n| (md not incorp) = misdescribed amendment | SR = Statutory Rules |\n| cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |\n| mod = modified/modification | SubPt = Subpart(s) |\n| No. = Number(s) | underlining = whole or part not |\n| | commenced or to be commenced |\n\n> Note: Endnote 3—Legislation history\n\n| Name | Registration | Commencement | Application, saving and transitional provisions |\n| ----------- | -------------- | -------------- | ----------------------------------------------- |\n| F2020L01027 | 18 August 2020 | 19 August 2020 | - |\n\n> Note: Endnote 4—Amendment history\n\n| Provision affected | How affected |\n| ------------------------------ | ---------------------- |\n| Section 4…………….Section 5……………. | F2020L01027F2020L01027 |\n| | |","sortOrder":4}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"The instrument does not expand or remove classes of chemical products regulated by the Code. Under the authority in section 3 it prescribes which particular registration changes qualify as 'prescribed variations' under paragraph 26B(4)(a). Mechanically, it narrows and clarifies the administrative pathway for certain manufacturer detail updates and limited constituent substitutions while listing explicit exclusions and conditions (see section 5)."},"complexity_factors":["Multiple categories of permitted variations with distinct conditions (manufacturer details for Australian sites; manufacturer details for overseas sites doing secondary steps; overseas sites doing primary steps; and constituent substitutions) (Item 1–4 of section 5).","Detailed technical tests for allowable constituent substitutions, including non‑active status, identical functional purpose, matching pH, dissolution profile, hydrophilic/hydrophobic and hygroscopic behaviour, limits on hydrocarbon chain change, no nanomaterials, exclusions for human/animal origin, and limits on proportion/number of constituents changed (Item 4(a)–(n)).","Different evidentiary requirements depending on location and step of manufacture: Australian manufacturers must hold a Part 8 licence or be an exempt person; overseas manufacturers must supply evidence APVMA has determined comparable standards (Definitions; Item 1(c); Item 2(i); Item 3(ii)).","Interplay with other regulatory instruments and registers: exclusions for products prescribed under subregulation 59(1), immunobiologicals, antibiotics and injectable products; and requirement that a site already be entered in the Register for certain primary‑step overseas sites (Items 1–4 and Registration columns).","Operational complexity from distinguishing primary versus secondary manufacturing steps (Definitions) and specific carve‑outs (e.g. biological assays are excluded from secondary steps in Item 2).","Administrative timing and commencement mechanics (commences day after registration) and reliance on delegated determinations by the APVMA (Commencement; Authority; multiple references in Item conditions).","Compliance burden on registrants to hold, produce and maintain documentary evidence of conformity with APVMA‑determined comparable standards and to monitor limits on constituent changes (Items 2(i), 3(ii), 4(m)–(n))."],"plain_english_summary":"This instrument lists specific, pre‑approved changes to registered agricultural and veterinary chemical products that can be accepted without a full re‑assessment. It affects product registrants and manufacturers by permitting updates to manufacturer names/addresses and limited substitutions of non‑active constituents, subject to conditions (Australian licensing or APVMA‑comparable overseas standards, limits on constituent changes). It matters because it changes the compliance and evidentiary steps required of registrants and gives the APVMA a role in judging acceptable manufacturing standards."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument appears tightly scoped to its original purpose of prescribing specific variations eligible for streamlined processing. The four items cover distinct but related administrative scenarios (manufacturer changes and ingredient swaps) without apparent scope creep beyond the enabling provision in section 26B(6) of the Code."},"complexity_factors":["Multiple nested conditions in Item 4 (14 separate criteria for ingredient swaps)","Cross-references to external documents: the Code, Regulations, Australian GMP Code, Poisons Standard, and Register","Technical scientific terminology requiring specialist knowledge (solvates, hydrates, dissolution profile, hygroscopic behaviour, nanomaterials)","Distinction between 'primary' and 'secondary' steps of manufacture with specific exclusions (e.g., biological assays for immunobiologicals)","Percentage-based thresholds (33% hydrocarbon chain length, 25% of constituents) that require calculation","Multiple product exclusions that vary by item (immunobiologicals, antibiotics, injectables, subregulation 59(1) products)"],"plain_english_summary":"This instrument creates a faster pathway for certain administrative changes to registered agricultural and veterinary chemical products, letting registrants update manufacturer details (Australian or overseas, with conditions) and substitute some non‑active ingredients without a full APVMA variation. It affects chemical companies, manufacturers and the APVMA, and excludes higher‑risk items like antibiotics, vaccines and injectables. The aim is to reduce red tape for low‑risk changes while preserving safety and overseas‑manufacturing standards."}},"importantCases":[],"_links":{"self":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019","history":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019/history","analysis":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019/analysis","conflicts":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019/conflicts","importantCases":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019/important-cases","documents":"/api/acts/agricultural-and-veterinary-chemicals-code-prescribed-variations-instrument-2019/documents"}}