{"id":"F2014L00850","name":"Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014","slug":"agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":91933,"registerId":"commonwealth-F2014L00850-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014","content":"![](image.001.png)\n\nAgricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014\n\nAgricultural and Veterinary Chemicals Code\n\nI, Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, make this Determination for subsection 5B(1) of the Agricultural and Veterinary Chemicals Code (the Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.\n\nKareena Arthy\n\nChief Executive Officer\n\nDated this 25th day of June 2014\n\nPlaceholder 1 of 11\n\nPlaceholder 2 of 11\n\nPlaceholder 3 of 11\n\nPlaceholder 4 of 11\n\nPlaceholder 5 of 11\n\nPlaceholder 6 of 11\n\nPlaceholder 7 of 11\n\nPlaceholder 8 of 11\n\nPlaceholder 9 of 11\n\nPlaceholder 10 of 11\n\nPlaceholder 11 of 11\n\nPart 1 Preliminary\n\nPlaceholder\n\nName of instrument\n\nThis instrument is the Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014.\n\nCommencement\n\nThis Determination commences on the commencement of the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013.\n\nPart 2 Agricultural chemical products\n\n3 Criteria based on type of product\n\n(1) The use of an agricultural chemical product, in accordance with instructions approved, or to be approved, by the APVMA for the product, is, or would be, effective if:\n\n(a) the use is as:\n\n    (i) a domestic or home garden product (see subsection (2)); or\n    (ii) an adjuvant, wetter or surfactant; or\n    (iii) a drift retardant; or\n    (iv) a plant growth regulator; or\n    (v) a semiochemical-based mating disruptor or semiochemical lure; or\n    (vi) a defoliant; or\n    (vii) a spray-marker dye; or\n    (viii) a mosquito coil or candle; and\n\n(b) each active constituent of the product is used in 1 or more other registered chemical products for an equivalent use (that is, for an equivalent pest or purpose at equivalent rates of active constituent application).\n\n(2) For subparagraph (1)(a)(i), a domestic or home garden product:\n\n(a) includes products developed only for use for domestic or home garden purposes and available to the general public via normal retail outlets, but only where those products are insecticides, herbicides, fungicides, miticides and nematicides, molluscicides, rodenticides or dog and cat repellents; and\n\n(b) does not include products used to sanitise swimming pools or spas.\n\n4 Criteria based on demonstrated effectiveness\n\nThe use of an agricultural chemical product, in accordance with instructions approved, or to be approved, by the APVMA for the product, is also taken to be effective if:\n\n(a) it would, to a reasonable degree, achieve one of the effects listed in paragraphs 4(2)(a) to (e) of the Agvet Code; and\n\n(b) this is evidenced or demonstrated by:\n\n    (i) results from efficacy trials or experiments; or\n    (ii) valid scientific argument; or\n    (iii) demonstrated history of sale and effective use in equivalent uses; or\n    (iv) full results from overseas efficacy trials or experiments and the associated assessment reports by an overseas regulator that are relevant to the proposed product and use; or\n    (v) a combination of 2 or more of the above.\n\nNote: The APVMA will consider, on a case by case basis, which of the above matters are necessary to demonstrate effectiveness in a particular case. The APVMA also takes into account other relevant matters: see subsection 5B(2) of the Code. The APVMA’s data guidelines and regulatory guidelines made under section 6A of the Code, published on the APVMA’s website, set out information about the kind of data considered sufficient to demonstrate effectiveness in particular cases.\n\nPart 3 Veterinary chemical products\n\n5 Criteria based on type of product\n\nThe use of a veterinary chemical product, in accordance with instructions approved, or to be approved, by the APVMA for the product, is, or would be, effective if:\n\n(a) the use is as:\n\n    (i) a counterirritant, rubifacient or poultice; or\n    (ii) an enzyme, direct‑fed microbial, or probiotic; or\n    (iii) a pet food containing enzymes or direct‑fed microbials; or\n    (iv) an autogenous vaccine which is the subject of an application for a permit, so long as the product and its use complies with, or would comply with, the guidelines issued by the APVMA in relation to autogenous vaccines under section 6A of the Agvet Code and as in force on the day this Determination commences; or\n    (v) a sheep branding substance; and\n\n(b) each active constituent of the product is used in 1 or more other registered veterinary chemical products that contain similar amounts of the active constituent and have similar claims and use patterns.\n\n6 Criteria based on demonstrated effectiveness\n\nThe use of a veterinary chemical product, in accordance with instructions approved, or to be approved, by the APVMA for the product, is also taken to be effective if:\n\n(a) it would, to a reasonable degree, achieve one of the effects listed in paragraphs 5(2)(a) to (d) of the Agvet Code; and\n\n(b) this is evidenced or demonstrated by:\n\n    (i) target animal efficacy studies, including dose determination studies, dose confirmation studies or confirmatory clinical or field studies; or\n    (ii) pharmacological studies, such as in vivo or in vitro bioequivalence studies in target animals, pharmacokinetic studies or pharmacodynamic studies; or\n    (iii) other relevant studies or data, such as clinical case studies, compatibility studies or palatability studies; or\n    (iv) full results from overseas efficacy trials or experiments and the associated assessment reports by an overseas regulator that are relevant to the proposed product and use; or\n    (v) valid scientific argument; or\n    (vi) a combination of 2 or more of the above.\n\nNote: The APVMA will consider, on a case by case basis, which of the above matters are necessary to demonstrate effectiveness in a particular case. The APVMA also takes into account other relevant matters: see subsection 5B(2) of the Code. The APVMA’s data guidelines and regulatory guidelines made under section 6A of the Code, published on the APVMA’s website, set out information about the kind of data considered sufficient to demonstrate effectiveness in particular cases.","sortOrder":0}],"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"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation appears consistent with its original intent. It implements subsection 5B(1) of the Agvet Code by specifying efficacy criteria, which is precisely the purpose stated in the enabling provision. The scope remains tightly focused on defining when chemical products are considered effective for registration purposes."},"complexity_factors":["Moderate cross-referencing to the Agricultural and Veterinary Chemicals Code (Agvet Code) for definitions of effects and general criteria","Two distinct regulatory pathways (type-based exemption vs. demonstrated effectiveness) with slightly different evidentiary requirements for agricultural vs. veterinary products","Specific technical terminology requiring domain knowledge (e.g., 'semiochemical-based mating disruptor', 'autogenous vaccine', 'rubifacient', 'pharmacokinetic studies')","Conditional logic with nested subparagraphs (e.g., domestic product definition excludes pool sanitisers in subsection 3(2)(b))","Reference to external guidelines (APVMA data guidelines and regulatory guidelines under section 6A) that are not reproduced in the instrument itself","Relatively short length (11 placeholders suggest full instrument is brief, though only Parts 1-3 shown)","Limited defined terms within the instrument itself — relies heavily on Agvet Code definitions"],"plain_english_summary":"This Determination tells when the APVMA can be satisfied a pesticide or veterinary medicine \"works\" — establishing two proof pathways: a simplified route for low‑risk products that rely on existing uses, and a full evidence route requiring trials, scientific justification, or reliable overseas data.  \n\nIt affects chemical manufacturers, farmers and pet owners, and the APVMA by keeping ineffective products out of the market while cutting needless retesting for proven, low‑risk products."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"This Determination operationalises subsection 5B(1) by specifying which product types and what kinds of evidence the APVMA will accept as showing a use is 'effective'. Its text sets criteria and evidentiary pathways and cross‑refers to the Agvet Code and APVMA guidelines, but does not itself state any expansion or contraction of the statutory scope beyond providing those criteria."},"complexity_factors":["Separate but overlapping criteria for agricultural (Part 2, s3–4) and veterinary products (Part 3, s5–6), requiring applicants to identify applicable pathway.","Multiple product-category lists with specific inclusions/exclusions (e.g. domestic/home garden exceptions in s3(2)), increasing categorical compliance checks.","Several alternative evidentiary pathways accepted (s4(b)(i)–(v); s6(b)(i)–(vi)), allowing combinations which complicate dossier assembly and assessment.","Key ambiguous thresholds and terms—'equivalent use' (s3(1)(b)), 'reasonable degree' (s4(a), s6(a))—rely on APVMA interpretation rather than fixed metrics.","APVMA discretion flagged: 'will consider, on a case by case basis' and cross-reference to s5B(2) of the Agvet Code and APVMA guidelines (notes to s4 and s6), increasing uncertainty for applicants.","Dependence on external materials and cross‑jurisdictional evidence (overseas trial results and regulator assessment reports in s4(b)(iv) and s6(b)(iv)), creating variable evidentiary weight.","References to APVMA data and regulatory guidelines under section 6A of the Code (notes), which can change evidentiary expectations without amending this Determination.","Commencement tied to another instrument (Commencement), requiring coordination with separate regulatory changes."],"plain_english_summary":"This Determination tells the APVMA what product types and kinds of evidence count as demonstrating a chemical product is “effective” under subsection 5B(1) of the Agvet Code. It lists specific agricultural and veterinary product categories that may be treated as effective and sets accepted evidence routes (trials, valid scientific argument, overseas reports, history of sale).\n\nIt affects manufacturers, registrants and applicants by clarifying the data or precedents they must supply or rely on, which shapes compliance costs, approval timing and regulator discretion."}},"importantCases":[],"_links":{"self":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014","history":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014/history","analysis":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014/analysis","conflicts":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014/conflicts","importantCases":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014/important-cases","documents":"/api/acts/agricultural-and-veterinary-chemicals-code-efficacy-criteria-determination-2014/documents"}}