The following sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together. Please review this information in consultation with the Module Descriptors.

Chemistry

Detailed data guidelines for chemistry and manufacture are available in Part 2.

Chemistry 1

For applications referred to at Chemistry 1 of the Module Descriptors, a chemistry data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

For approval of an active constituent

  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, spectral data, physicochemical properties)
  • stability data
  • manufacturer(s) name and physical address(es) of the site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures)
  • Declaration of Composition (DoC) and/or manufacturer’s specifications
  • batch analysis data (for batches analysed in the past five years)
  • analytical methods and validation data
  • analytical reference standards, including impurities where required
  • description of the primary packaging material for the technical active constituent

For registration of a product

  • active constituent approval number, site of manufacture and certificate of analysis product details
  • distinguishing name
  • formulation type
  • name(s) of formulator(s) and physical address(es) of site(s) of formulation
  • formulation composition
  • non-active constituent specifications
  • manufacturing process (including quality control)
  • physicochemical properties
  • product specifications
  • batch analysis data (analysed within the past five years)
  • stability data
  • analytical methods and validation data
  • description of the primary packaging material
  • draft label

Chemistry 2

For applications referred to at Chemistry 2 of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

For approval of an active constituent

  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, spectral data, physicochemical properties)
  • information on active constituent consisting of or derived from GMOs (where relevant)
  • stability data
  • manufacturer(s) name(s) and physical address(es) of site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures)
  • Declaration of composition (DoC) and/or manufacturer’s specifications
  • batch analysis data (analysed in the past five years)
  • analytical methods and validation data
  • if applicable, analytical reference standards, including impurities (where required)
  • description of the primary packaging material for the technical active constituent

For a product/permit

  • active constituent approval number, site of manufacture and certificate of analysis product details
  • distinguishing name
  • formulation type
  • name(s) of formulator(s) and physical address(es) of site(s) of formulation
  • formulation composition
  • non-active constituent specifications
  • manufacturing process (including quality control)
  • physicochemical properties
  • product specifications
  • batch analysis data (analysed within the past five years)
  • stability data
  • analytical methods and validation data
  • description of the primary packaging material
  • draft label

Chemistry 3

For applications referred to at Chemistry 3 of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

Registration of a new product/approval of a permit for an unregistered product containing an existing active [3(a) and (b)]

  • active constituent approval number, site of manufacture and certificate of analysis confirming compliance with the active constituent standard and composition and purity approved for the site of manufacture and generated within the last two years
  • product details
  • distinguishing name
  • formulation type
  • name(s) of formulator(s) and physical address(es) of site(s) of formulation
  • formulation composition
  • non-active constituent specifications
  • manufacturing process (including quality control)
  • product specifications
  • batch analysis data
  • stability data
  • analytical methods and validation data
  • description of the primary packaging material
  • draft label

Approval of a new source of existing active [3(c)]

  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, confirmation of identity through at least two spectral or chromatographic methods)
  • manufacturer(s) name and physical address(es) of the site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures))
  • Declaration of Composition (DoC) and/or manufacturer’s specifications
  • batch analysis data (for batches analysed in the past five years)
  • analytical methods and validation data

Variation of an active constituent (replacement or additional manufacturing site, change in active constituent specifications) [3(d)]

  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, confirmation of identity through at least two spectral or chromatographic methods)
  • manufacturer(s) name and physical address(es) of the site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures))
  • Declaration of Composition (DoC) and/or manufacturer’s specifications
  • batch analysis data (for batches analysed in the past five years)
  • analytical methods and validation data

Variation of a product (formulation change or additional formulation) [3(e)]

  • active constituent approval number, site of manufacture and certificate of analysis confirming compliance with the active constituent standard and composition and purity approved for the site of manufacture and generated within the last two years
  • product details
  • distinguishing name
  • formulation type
  • name(s) of formulator(s) and physical address(es) of site(s) of formulation
  • formulation composition
  • non-active constituent specifications
  • manufacturing process (including quality control)
  • product specifications
  • batch analysis data
  • stability data
  • analytical methods and validation data
  • description of the primary packaging material
  • draft label

Chemistry 4

For applications referred to at Chemistry 4 of the Module Descriptors, a chemistry data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Variation of a product or approval of a permit for extension of shelf life or change in storage conditions for a date-controlled product, change in net contents (pack size) [4(a)]

  • product specifications
  • stability data
  • analytical methods
  • validation data
  • packaging details
  • draft oversticker/label

Additional manufacturing site for a non-pharmacopoeia active constituent [4(b)]

  • batch analysis data (generated within the last five years)
  • analytical methods
  • validation data

Chemistry 5

For applications referred to at Chemistry 5 of the Module Descriptors, a chemistry data package for limited assessment may include submission of the following data or submission of valid scientific argument:

New source or variation to an existing approval for an existing active constituent complying with a recognised pharmacopoeia

  • 3 certificates of analysis confirming compliance with the British, European or United States Pharmacopoeia, as well as other relevant guidelines such as VICH GL18 or ICH Q3D

Health

Detailed data guidelines for toxicology are available in Part 3.

Health 1

For applications referred to at Health 1 of the Module Descriptors, a toxicology and an OH&S data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (data Part 4)
  • acute toxicity studies
    • studies on the active constituent
    • studies on the product
  • short-term toxicity studies (repeat-dose)
  • sub-chronic toxicity studies (repeat dose)
  • long-term (chronic) toxicity studies (repeat dose)
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies (including developmental neurotoxicity)
  • genotoxicity studies
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • no-observed-adverse-effect level (NOAEL)
  • acceptable daily intake (ADI)
  • acute reference dose (ARfD)
  • first aid instructions and safety directions
  • toxicological database/bibliography

Hazard characterisation:

  • physical and chemical properties:
    • toxicity;
    • active constituent;
    • product;
    • individual constituents

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE)
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information:

  • measures to control user exposure:
    • before and during end-use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  •  other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • occupational exposure monitoring
  • exposure standard
  • ambient air monitoring
  • health surveillance
  • tank mixing
  • contraindications

Health 2

For applications referred to at Health 2 of the Module Descriptors, a toxicology data package may include submission of the following data or submission of valid scientific argument:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (data Part 4)
  • acute toxicity studies:
    • studies on the active constituent
    • studies on the product
  • short-term toxicity studies (repeat-dose)
  • sub-chronic toxicity studies (repeat dose)
  • long-term (chronic) toxicity studies (repeat dose):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies (including developmental neurotoxicity)
  • genotoxicity studies
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • no-observed-adverse-effect level (NOAEL)
  • acceptable daily intake (ADI)
  • acute reference dose (ARfD)
  • first aid instructions and safety directions
  • toxicological database/bibliography

Health 3

Health 3(a)

For applications referred to at Health 3(a) of the Module Descriptors, a toxicology and OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (data Part 4);
  • acute toxicity studies:
    • studies on the active constituent;
    • studies on the product;
  • short-term toxicity studies (repeat-dose studies of less than 90 days duration);
  • sub-chronic toxicity studies (90 days to less than 12 months);
  • developmental studies (including developmental neurotoxicity)
  • reproductive studies
  • genotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data;
  • first aid instructions and safety directions;
  • toxicological database/bibliography

Hazard characterisation:

  • physical and chemical properties:
  • toxicity;
    • active constituent;
    • product;
    • individual constituents

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL);
  • margin of exposure (MOE);
  • further requirements where the MOE is inadequate;
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading;
  • product application;
  • re-entry or re-handling;
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information:

  • measures to control user exposure:
    • before and during end-use;
    • re-entry or re-handling;
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  •  other restrains and restrictions of use
  • product label;
  • Material Safety Data Sheet (MSDS);
  • training requirements;
  • occupational exposure monitoring:
  • exposure standard
  • ambient air monitoring;
  • health surveillance;
  • tank mixing
  • contraindications

Health (b)

For applications referred to at Health (b) of the Module Descriptors, a toxicology data package may include submission of the following data or submission of valid scientific argument:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (data Part 4);
  • acute toxicity studies:
    • studies on the active constituent;
    • studies on the product;
  • short-term toxicity studies (repeat-dose studies of less than 90 days duration);
  • sub-chronic toxicity studies (90 days to less than 12 months);
  • developmental studies (including developmental neurotoxicity)
  • reproductive studies
  • genotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data;
  • first aid instructions and safety directions;
  • toxicological database/bibliography

Health 3(c)

For applications referred to at Health 3(c) of the Module Descriptors, in addition to submission of the OH&S data package listed above (Health 3(a)), or submission of valid scientific argument, the following data may be included:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (data Part 4)
  • acute toxicity studies
    • studies on the active constituent
    • studies on the product
  • short-term toxicity studies (repeat-dose)
  • sub-chronic toxicity studies (repeat dose)
  • long-term (chronic) toxicity studies (repeat dose);
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies (including developmental neurotoxicity)
  • genotoxicity studies
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • no-observed-adverse-effect level (NOAEL)
  • acceptable daily intake (ADI)
  • acute reference dose (ARfD)
  • first aid instructions and safety directions
  • toxicological database/bibliography

Health 3(d) and (e)

For applications referred to at Health 3(d) and (e) of the Module Descriptors, in addition to submission of the OH&S data package listed above (Health 3(a)), or submission of valid scientific argument, the following data may be included:

Toxicity:

  • long-term (chronic) toxicity studies (12 months or longer):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • acceptable daily intake (ADI);
  • acute reference dose (ARfD)
  •  first aid instructions and safety directions
  •  toxicological database/bibliography

Health 4

Health 4(a)

For applications referred to at Health 4(a) of the Module Descriptors, a toxicology and an OH&S data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Toxicity:

  • chemistry and manufacture (data Part 2)
  • acute toxicity studies on a product or data on individual constituents in the formulation

Hazard characterisation:

  • physical and chemical properties:
  • toxicity;
    • active constituent;
    • product;

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE);
  • further requirements where the MOE is inadequate;
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading;
  • product application;
  • re-handling or re-entry;
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information:

  • measures to control user exposure:
    • before and during end-use;
    • re-entry or re-handling;
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  •  other restrains and restrictions of use
  • product label;
  • Material Safety Data Sheet (MSDS);
  • training requirements;
  • occupational exposure monitoring:
  • exposure standard
  • ambient air monitoring;
  • health surveillance;
  • tank mixing
  • contraindications

Health 4(a)1

For applications referred to at Health 4(a)1 of the Module Descriptors, in addition to the submission of the toxicity and OH&S data above for Health 4(a), a toxicology data on the active constituent for limited assessment may include submission of the following data or submission of valid scientific argument:

Toxicity:

  • long-term (chronic) toxicity studies (12 months or longer):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
      • toxicity of metabolites and impurities
  • acceptable daily intake (ADI);
  • acute reference dose (ARfD)
  • justification for rescheduling
  • first aid instructions and safety directions
  • toxicological database/bibliography

Health 4(b) – approval of a new biological active constituent

For applications referred to at Health 4(b) of the Module Descriptors, a toxicology data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Toxicology:

  • chemistry and manufacture (data Part 2)
  • metabolism/kinetic studies
  • active constituent:
    • acute oral toxicity
    • acute dermal toxicity
    • acute inhalation toxicity
    • genotoxicity
    • short-term studies (route depending on likely source/s of human exposure)
  • sub-chronic toxicity studies by an appropriate route
  • chronic toxicity/oncogenicity studies
  • reproduction studies
  • developmental studies (may include developmental neurotoxicity)
  • human exposure data
  • other studies to determine special forms of toxicity

Health 4(c) – registration of a product containing a new biological active constituent

For applications referred to at Health 4(c) of the Module Descriptors, in addition to the submission of the toxicity data listed in Health 4(b), toxicity studies and OH&S data package for assessment may include submission of the following data or submission of valid scientific argument:

Toxicity:

  • acute toxicity studies on a product or data on individual constituents in the formulation
  • and if applicable, for ADI/ARfD:
  • neurotoxicity studies
  • long-term (chronic) toxicity studies (12 months or longer):
    • chronic toxicity studies
    • carcinogenicity studies
  • combined chronic toxicity and carcinogenicity studies
  • toxicity of metabolites and impurities

Hazard characterisation:

  • physical and chemical properties:
  • toxicity;
    • active constituent;
    • product;

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE)
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information: 

  • measures to control user exposure:
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • contraindications

Health 4(d) – permit for new active constituent with non-food uses

For applications referred to at Health 4(d) of the Module Descriptors, toxicity studies and on OH&S data package for limited assessment may include submission of the following data, or submission of valid scientific argument, the following data may be included:

Toxicity:

  • metabolism/kinetic studies
  • acute toxicity studies
    • active constituent
    • product
  • short-term toxicity studies (repeat-dose)
  • subchronic toxicity studies by an appropriate route
  • chronic toxicity/oncogenicity studies
  • developmental studies
  • reproduction studies
  • human exposure data
  • additional genotoxicity studies
  • other studies to determine special forms of toxicity (ie mode of action)

Hazard characterisation:

  • physical and chemical properties:
    • toxicity
    • active constituent
    • product

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE)
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information: 

  • measures to control user exposure:
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • contraindications

Health 4(e) – permit for unregistered product containing an approved active constituent in a new formulation

For applications referred to at Health 4(e) of the Module Descriptors, toxicity studies and on OH&S data package may include submission of the following data, or submission of valid scientific argument, the following data may be included:

Toxicity:

  • acute toxicity studies on a product or data on individual constituents in the formulation.

Hazard characterisation:

  • physical and chemical properties (data Part 2)
  • toxicity
  • active constituent
  • product

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE);
  • further requirements where the MOE is inadequate;
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information: 

  • measures to control user exposure
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • contraindications

More information for Health 4 level applications can be obtained from the Guideline for the Regulation of Biological Agricultural Products on the APVMA website.

Health 5

Health 5(a)

For applications referred to at Health 5(a) of the Module Descriptors, toxicity studies and an OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicity:

  • acute toxicity studies on a product or data on individual constituents in the formulation.

Hazard characterisation:

  • physical and chemical properties
  • toxicity
  • active constituent
  • product

Risk characterisation:

  • risk assessment proposed by the applicant (acute and repeat dose)

Risk management and workplace information: 

  • measures to control user exposure
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • contraindications

Health 5(b)

For applications referred to at Health 5(b) of the Module Descriptors, an OH&S data package may include submission of the following data or submission of valid scientific argument:

Hazard characterisation:

  • physical and chemical properties
  • toxicity
  • active constituent
  • product

Risk characterisation:

  • no-observed-adverse-effect level (NOAEL)
  • margin of exposure (MOE)
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose)

Exposure assessment:

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information: 

  • measures to control user exposure
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • contraindications

Health 6

For applications referred to at Health 6 of the Module Descriptors, a toxicity data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Toxicity:

  • in silico (computational) analysis on genotoxicity, including a rules based method and a statistically based method
  • in vivo genotoxicity
  • in vitro genotoxicity

More information for Health 6 level applications can be obtained from the APVMA websites:

Poisons Scheduling

This is an additional module that applies to any application for either an agricultural or veterinary chemical, where the application must be referred to Therapeutic Goods Administration (TGA) for poisons scheduling. Data relevant to scheduling is covered by modules Health 1, Health 2 or Health 3.

Residues and Trade

Detailed data guidelines for residues are available in Part 5A.

Detailed data guidelines for trade are available Part 5B.

Residues 1

For applications referred to at Residues 1 of the Module Descriptors, a residues data package for comprehensive assessment may include submission of the following data and/or submission of valid scientific argument:

  • metabolism data for target animals and plants;
  • residues trial data;
  • processing studies;
  • analytical methodology;
  • residue storage stability data;
  • animal transfer data;
  • rotational crop data
  • residues-in-trade information for major export commodities

Residues 2

For applications referred to at Residues 2 of the Module Descriptors, a residues data package for assessment may include submission of the following data and/or submission of valid scientific argument:

  • residues trial data;
  • processing studies;
  • analytical methodology;
  • animal transfer data;
  • rotational crop data;
  • residues-in-trade information for major export commodities

Residues 3

For applications referred to at Residues 3 of the Module Descriptors, a residues data package for assessment may include submission of the following data and/or submission of valid scientific argument:

  • residues trial data;
  • processing studies;
  • analytical methodology;
  • animal transfer data;
  • rotational crop data;
  • residues-in-trade information for major export commodities

Residues 4

For applications referred to at Residues 4 of the Module Descriptors, a residues data package for assessment may include submission of the following data and/or submission of valid scientific argument:

  • residues trial data;
  • processing studies;
  • analytical methodology

Residues 5(a) and (b)

For applications referred to at Residues 5(a) and (b) of the Module Descriptors, a residues data package for assessment may include submission of the following data and/or submission of valid scientific argument:

  • residues trial data;
  • analytical methodology

Residues 5(c)

For applications referred to at Residues 5 (c) of the Module Descriptors, a residues data package for assessment may include reference to previously submitted residues trial data, published residues information and/or valid scientific argument as well as residues-in-trade information and risk mitigation strategies.

Environment

Detailed data guidelines for environment are in Part 7.

Environment

Module 7.1(a), 7.2(a),(b),(c) and (d), and 7.3(a) and (c)

For applications referred to at 7.1(a), 7.2(a),(b),(c) and (d), and 7.3(a) and (c) of the Module Descriptors, an environment data package may include submission of the following studies or submission of valid scientific argument and/or reference to previous assessments:

Environmental chemistry and fate

  • physical and chemical properties of the active constituent (solubility in water, vapour pressure, low Kow, dissociation constant, UV-visible absorption)
  • rate and route of degradation
  • abiotic degradation (hydrolysis, soil photolysis, aqueous photolysis)
  • biodegradation under aerobic and anaerobic conditions in soil and water/sediment systems
  • mobility (volatility, adsorption/desorption, leaching potential)
  • field accumulation/ dissipation (terrestrial, aquatic)

Environmental toxicology

  • terrestrial vertebrates
  • aquatic species
  • bees and other non-target arthropods
  • soil organisms
  • non-target terrestrial plants
Definition of a major formulation change

For the purposes of module 7.2 a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to the environment and/or target species may need separate assessment. Some examples include:

  • where there has been a significant increase in the concentration of active constituent which could affect the hazard potential;
  • where a major change in non-active constituent significantly affects the environmental fate, ecotoxicity or other attributes of the product; or
  • where the formulation has been changed significantly to accommodate a new application method/use pattern (eg changing from a seed treatment to an emulsifiable concentrate).

Efficacy and Safety

Detailed data guidelines for efficacy and safety are in Part 8.

Efficacy and Safety 1 Module 8.1(a), (b) and (c)

For applications referred to at 8.1(a), (b) and (c) of the Module Descriptors, an efficacy and crop safety data package for comprehensive assessment should include submission of the following Australian and/or international data or submission of valid scientific argument:

Efficacy studies

  • efficacy studies for every host and pest combination claimed on the label;
  • studies to demonstrate the optimum application rate for each host/pest combination

Host crop safety studies

  • safety to host crops including yield data;
  • safety to following crops;
  • safety to non-target or adjacent crops;
  • effects on taste of produce (organoleptic effects)

Other related studies (where relevant)

  • compatibility/tank mix tests;
  • effects of residues on subsequent processing (such as wine or malting barley);
  • implications for resistance management;
  • effects on other industries;
  • compatibility with integrated pest management strategies

Efficacy and Safety 2

For applications referred to at Efficacy and Safety 2 of the Module Descriptors, an efficacy and host safety data package for reduced assessment should include submission of the following Australian and/or international data or submission of valid scientific argument:

Efficacy studies

  • efficacy studies for any new host or pest claimed on the label
  • studies to demonstrate the optimum application rate for the new host/pest combination

Host safety studies (if a new host or higher application rate is proposed)

  • safety to host crop including yield data
  • safety to following crops
  • safety to non-target crops
  • effects on taste of produce (organoleptic effects)
  • effects of residues on subsequent processing (such as wine and malting barley)
  • compatibility with integrated pest management strategies
  • effects on other industries

Efficacy and Safety 3

For applications referred to at Efficacy and Safety 3 of the Module Descriptors, an efficacy and host crop safety data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Efficacy studies

  • target efficacy studies to demonstrate comparable efficacy with the registered reference product.

Host safety studies

  • host crop safety studies to demonstrate that any phytotoxicity and yield effects are comparable to the registered reference product.
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