0.1. Is a technical assessment required for my proposed variation?
Application for a formulation change as a prescribed variation (Item 13A) is only permitted in very limited circumstances. These circumstances are described below (select Item 13A Prescribed Variation).
Applications for formulation changes where the supporting information does not require a technical assessment to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). Formulation variations of an agricultural product that may be eligible for submission under Item 12 include formulation changes where:
- excipients in the formulation are the same and at similar concentrations to those in the approved formulation
- one or more excipients in the formulation have been substituted with similar chemicals that perform the same function and are not expected to impact on the physico chemical properties of the formulation or on efficacy or crop safety
- the variation is to add, remove or substitute dyes or fragrances
- the existing formulation is closely similar (see below) to the proposed new formulation
- the formulation has previously been assessed for a reference product which has the same label instructions as the current product.
0.1.1. Closely similar
For an agricultural product formulation to be considered closely similar to another formulation:
- its active constituent/s and concentration of active constituent/s must be the same as the reference formulation
- other ingredients in the formulation of the product may be different from those in the reference formulation, but must perform similar functions (eg emulsifier, surfactant, dye, solvent)
- its formulation type must be the same as that of the reference formulation.
Other formulation changes are likely to require technical assessment and should be made as Item 14 applications.
0.1.2. Limits on use (data protection)
Where there are limits on use of information on the reference product written consent from the authorising party is required when access to the information is necessary to determine the application.
Where the reference product does not fully support all risk areas or the product is subject to limits on use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.
Table of contents
1. Legislation
1.1. Framework
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.
The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.
The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.
The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.
1.2. Varying relevant particulars and conditions
The APVMA must vary the relevant particulars or conditions if it is satisfied application requirements and statutory criteria have been met (Agvet Code, s 29).
The Agvet Code, s 20(1)(c) defines relevant particulars in relation to the registration of a chemical product as:
- the distinguishing number
- any instructions for the use of the product
- any other particulars prescribed by the regulations.
Other particulars for chemical products prescribed by the regulations are:
(a) the distinguishing name of the chemical product
(i) the constituents of the chemical product
(ii) the concentration of each constituent of the chemical product
(iii) if possible, the composition and purity of each active constituent of the chemical product
(iv) the formulation type for the chemical product
(v) the net contents for the chemical product
(vi) identifying information for the holder of the registration of the chemical product
(vii) the name of each manufacturer of the chemical product
(viii) the address of each site at which the chemical product is manufactured by the manufacturer
(ix) the date of entry of these particulars in the Register of Chemical Products
(x) identifying information for any nominated agent for the registration.
The Agvet Code defines particulars in relation to approval of a label:
b)
(i) the name of the person who applied for the approval as the holder of the approval
(ii) the name of any nominated agent for the approval
(ii) the name of any nominated agent for the approval
(iii) the distinguishing number
(iv) the instructions and any particulars that are to be contained on the label
(iva) any other particulars prescribed by the regulations
(v) any conditions of the approval imposed by the APVMA.
Other particulars for labels prescribed by the regulations are:
Regulation 17(1)
a) the appropriate signal words required by the current Poisons Standard
b) the name of the chemical product that is to appear on a label for containers of the chemical product
c) the name of each active constituent of the product
d) the proportion of each active constituent of the product
e) the name of each constituent for the product that is
a. not an active constituent; and
b. classified as a poison in the current Poisons Standard
f) the proportion of each constituent referred to in paragraph (e)
g) the net contents of the product
h) particulars determined by the APVMA CEO under sub-regulation (2).
Regulation 17(2)
For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.
Regulation 17(3)
a) identifying information for the holder of the approval
b) identifying information for any nominated agent for the approval
c) the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register
d) the distinguishing number of the chemical product that is entered in the Register.
Conditions are:
a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.
1.3. Statutory criteria
In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:
- Safety (section 5A).
An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:
a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
To satisfy the s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.
- Efficacy (section 5B)
A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
- Trade (section 5C)
A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.
- Labelling (section 5D)
In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.
The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.
1.4. Application requirements
The Agvet Code, s 8A provides the definition of 'meets the application requirements'.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.
1.5. Applications may be withdrawn
The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.
For variations to formulations, the Applications Requirements Instrument requires the submission of formulation information:
(1) The following information is the formulation information in relation to a chemical product:
(a) for each active or other constituent in relation to the chemical product:
(i) the name of the constituent; and
(ii) the CAS number of the constituent; and
(iii) the applicable constituent standard (if any); and
(iv) the concentration of the constituent; and
(v) the purpose of the constituent in the formulation of the product;
(b) the total weight or volume of the product (as applicable);
(c) if the product is a liquid –the specific gravity of the product;
(d) the formulation type of the product;
(e) whether the product contains any ingredients that have a risk of transmitting agents of animal spongiform encephalopathies;
(f) whether the product contains any genetically modified organism or any product derived from a genetically modified organism;
(g) whether the product contains any ingredients intentionally engineered to be less than 100 nanometres in one or more dimensions and, if so, those ingredients.
(2) Where this Instrument requires an application to contain, or be accompanied by, formulation information:
(a) the information need not be provided by the applicant (for example, it may be provided by a manufacturer of the product); and
(b) the person providing the information must state the persons, if any, to whom the information may be disclosed; and
(c) the information must be accompanied by a declaration, signed by the person providing the information, that the information is complete and correct.
2. Timeframe and fees
This application type is subject to an extended assessment period if an Agvet Code s 159 notice is sent requesting additional information or clarification of submitted information. The extended assessment period will vary, depending on the nature of the application and the modules specified for that particular application.
2.1. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
A technical variation is a modular application type, therefore the fees and timeframe are variable according to the assessments necessary. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.
Applications for a change in formulation must satisfy the statutory criteria of safety, efficacy and trade. The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframes and associated fees are likely to apply to this application type. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application. Where an applicant considers that an assessment of any particular module is not necessary, justification must be provided.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Preliminary assessment |
Up to one month |
$902 |
|
Chemistry 3 |
6 months |
$1 954 |
|
Health (if required) – health 4 or 5 |
5 months or 4 months |
7 963 |
|
Poison Scheduling |
No assessment is required if appropriate scheduling is already in place. |
|
|
Residues 5 |
May require assessment if the change to the formulation changes the spray drift characteristics of the product. |
|
|
3 months |
$7 465 |
|
|
|
|
|
|
Environment 3 (if required) |
4 months |
$2 979 |
|
Efficacy and Safety 3 (if required) |
3 months |
$1 160 |
|
Non-food Trade |
No assessment required as minor formulation changes should not alter risks related to non-food trade. |
|
|
Special Data 3 (if required) |
7 months |
$ nil |
|
Finalisation 1 or 2 |
3 months 2 months |
$8 110 $3 090 |
|
Limits on use (data protection) |
N/A |
$460 |
2.1.1. Examples
|
Scenario |
Modules |
Timeframe |
Fee |
|---|---|---|---|
|
Change in product formulation (no label change required) |
Preliminary assessment, Chemistry 3, Efficacy and Safety 3, Finalisation 2 & Limits on use |
8 months 12 months (extended assessment period) |
$7 566 |
|
Change in product formulation relying part on the Efficacy Instrument for a home garden product |
Preliminary assessment, Chemistry 3, Efficacy and Safety 3, Finalisation 2 & Limits on use |
8 months 12 months (extended assessment period) |
$7 566 |
|
Change in product formulation to substitute a solvent for one which is scheduled under the Poison Standard (label change required) |
Preliminary assessment, Chemistry 3, Health 5, Environment 3, Efficacy and Safety 3, Finalisation 1 & Limits on use |
9 months 13 months (extended assessment period) |
$19 565 |
|
Change in product formulation involving a substitution of surfactant in an aquatic use product |
Preliminary assessment, Environment 3, Finalisation 2 & Limits on use |
6 months 9 months (extended assessment period) |
$7 431 |
3. Modules
The APVMA has developed the module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to this document, but may depart from it, when determining which modules are necessary on a case-by-case basis.
3.1. Preliminary assessment
Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.
Applies to all modular application items.
3.2. Health
A Health assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. This includes changes such as application rate, method, worker rates and practices including post-application activities. The change may result in a change to the entry in the first aid instructions and safety directions (FAISD) Handbook, including changes to first aid statements, personal protective equipment (PPE) and re-entry into treated areas following application.
3.3. Efficacy and Safety
Efficacy assessment ensures that the product works as described on the label, when used according to label directions.
Safety assessment ensures that the product is safe to use on or in the target crop or animal, when used according to label directions.
An efficacy and safety assessment may include assessing the effect of the product on crops, non-target crops and germination, effects of residues, organoleptic tests or pharmacologic studies.
3.4. Chemistry
There are general guidelines for chemistry and manufacture of agricultural and veterinary products available and you should consider any of the specific guidelines which relate to your product type.
3.5. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
3.6. Residues and trade
Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).
There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.
Formulation changes that are likely to require a residues assessment are those for products where a formulation change may increase the potential for residues or is intended to alter the spray drift characteristics of a product and the applicant is requesting changed spray drift instructions on the product label. In situations where the proposed formulation change does not change the risk to residues and trade, and this can be determined without further assessment, no residues assessment is required.
For a major variation to a formulation, a residues assessment will be required if there is a potential change to the residues risk and trade risk. The module may be a Residues 2, Residues 3, Residues 4 or Residues 5, depending on the number of crops affected and the inclusion of major export commodities. Many formulation changes will not affect the residues or trade risks, and a scientific argument (with no residues module) will be acceptable.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Residues 2 |
8 months |
$11 149 |
|
Residues 3 |
6 months |
$9 000 |
|
Residues 4 |
4 months |
$7 465 |
|
Residues 5 |
3 months |
$2 000 |
3.7. Environment
Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.
Formulation changes that are likely to require an environmental assessment are those for products registered with aquatic uses, where the formulation change involves the addition of excipients that may pose a risk to the environment. In situations where the proposed formulation change does not change the risk to the environment, and this can be determined without further assessment, no environmental assessment is required.
3.7.1. Efficacy and Safety 3
An Efficacy and Safety 3 module may be required for formulation changes to assess equivalence of the proposed new formulation to the current formulation or equivalent product, particularly in relation to crop safety and efficacy.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Efficacy 3 |
3 months |
$1 160 |
3.8. Special Data assessment
This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) and require a Special Data assessment.
Specifically, you should consider the following guidelines:
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Special Data 3 |
7 months |
$Nil |
3.9. Module Finalisation
This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.
Finalisation 2 is included when fewer than 3 technical modules (modules other than Preliminary Assessment, Finalisation or Limits on Use), apply and Finalisation 1 is included when 3 or more technical modules apply.
3.9.1. Finalisation 1
A variation where 3 or more modules other than Preliminary Assessment, Finalisation or Limits on Use apply.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Finalisation 1 |
3 months |
$8 110 |
3.9.2. Finalisation 2
A variation where fewer than 3 modules other than Preliminary Assessment, Finalisation or Limits on Use apply.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Finalisation 2 |
2 months |
$3 090 |
3.10. Limits on use of information
Limites on use relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Limits on use |
N/A |
$460 |
A variation to:
(i) extension of shelf life;
(ii) extension of in use shelf life; or
(iii) changes to storage temperature or conditions;
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Chemistry 4 |
3 months |
$970 |
- A Health module also assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product. this may result in changes to the Poisons Standard.
3.10.1. Health 4 or 5
Health 4 is required where the application involves a change or reassessment of both the hazard of the formulation and user safety directions and/or re-entry or re-handling statements.
A Health 5 is required when either a hazard assessment or an exposure assessment is required (but not both). It may include a major change in formulation, which is not anticipated to change the systemic exposure, or may include use of a previously assessed formulation on new crops or situations.
A change to the toxicity profile of formulation due to a change in excipients may lead to new safety directions and re-entry statements on the product label.
A variation that is not described in Health 3, that requires a Health assessment due to a varied exposure scenario (for example, to consider re-entry/re-handling statements and/or safety directions).
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Health 4 |
5 months |
$7 963 |
|
Health 5 |
4 months |
$4 000 |
3.10.2. Environment 3
An Environment 3 module applies for formulation changes that may change the risk to the environment.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Environment 3 |
4 months |
$2 979 |
4. What you need to provide
4.1. Completed online application form
First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.
If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.
4.2. The application fee
You may choose to:
- pay the total fee on submission or
- pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.
You can choose to pay by credit card, electronic funds transfer or BPAY.
Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).
4.3. Information list
It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in or accompanying the application – an information list.
Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.
The online application form contains fields to assist applicants in entering the information required to generate the information list.
Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.
4.4. Supporting information
The application must contain, or be accompanied by, information relevant to the whether the chemical product meets the safety and efficacy criteria, but only to the extent that the variation proposed affects whether the product meets the safety, efficacy and trade criteria. Applicants should include an explanation of why they believe supporting information is not required if they choose not to provide it with the application.
Relevant data for module levels—agricultural chemical products 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.
- Chemistry
Detailed data guidelines for chemistry and manufacture are available in Part 2 - Health
Detailed data guidelines for toxicology are available in Part 3 - Residues and Trade
Detailed data guidelines for residues are in Part 5A
Detailed data guidelines for trade are in Part 5B - Health
Detailed data guidelines for occupational health and safety are in Part 6 - Environment
Detailed data guidelines for environment are in Part 7 - Efficacy and Safety
Detailed data guidelines for efficacy and safety are in Part 8 - Trade
Detailed data guidelines for trade are in Part 5B - Non-food Trade
For applications referred to under Non-food trade in the module descriptors, data specifically relevant to the trade risk may be submitted - Special Data Assessment
Published data and results of Australian field trials, relevant to the criteria for approval of an active constituent or registration of a product described in s 14 of the Agvet Code, may be submitted
4.5. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
To meet the application requirements you will need to provide:
- a completed online application form
- the application fee plus any amount that is due to the APVMA
- formulation information
- supporting information to demonstrate the impact the variation to the product formulation is expected to have on the safety, efficacy and trade risks related to the product, and appropriate mitigation measures
- an information list
- consent for use (if any of the information is subject to limits on use)
- an e-label (only required if label changes are necessary).
4.6. Formulation information
The application must contain (or be accompanied by) the proposed new formulation including:
(a) for each active or other constituent in relation to the chemical product:
(i) the name of the constituent; and
(ii) the CAS number of the constituent; and
(iii) the applicable constituent standard (if any); and
(iv) the concentration of the constituent; and
(v) the purpose of the constituent in the formulation of the product;
(b) the total weight or volume of the product (as applicable);
(c) if the product is a liquid –the specific gravity of the product;
(d) the formulation type of the product;
(e) whether the product contains any ingredients that have a risk of transmitting agents of animal spongiform encephalopathies;
(f) whether the product contains any genetically modified organism or any product derived from a genetically modified organism;
(g) whether the product contains any ingredients intentionally engineered to be less than 100 nanometres in one or more dimensions and, if so, those ingredients.
The information can be provided by the applicant, or by a third party. The person providing the information must state to whom the information may be disclosed, and the information must be accompanied by a declaration, signed by the person providing the information, that the information is complete and correct.
Only one new formulation should be submitted per variation application.
4.7. Electronic label (e-label)
The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (Agvet Code, ss 5D and 14). Applicants must use the e-label template to submit the label details that the APVMA must take into account.
Introduction to preparing a label and the label approval process provides more detailed information.
An example of when a proposed formulation change would require an updated label is when an excipient that is listed in the Poisons Standard is added or removed and this changes the scheduling of the product. The name and concentration of any excipients in Schedule 5 or Schedule 6 of the Poison Standard also need to be included in the constituent panel on the product label.
5. Examples
5.1. Scenario 1: Application to vary the excipients in the product formulation
5.1.1. Objective
A holder applies to vary the formulation of a registered fungicide to replace the approved formulation with a similar formulation. The proposed new formulation has the same active constituent, however the source of active is a greater purity (98 per cent compared to the previous 90 per cent), so less volume of the active constituent is required in the formulation to provide the label amount for the product. A number of excipients are also being changed.
5.1.2. Application type
This application is considered under a technical variation (Item 14) as assessment is required to demonstrate that the change in formulation will continue to satisfy the safety, efficacy and target crop safety criteria.
As the amount of active constituent in the formula is not changing, an updated label is not required to accompany the submission. There are no changes to scheduled solvents or surfactants so the first aid instruction and safety directions do not need to be changed.
Note: if during assessment it is identified that there is a change that requires a Health assessment (for example, an increase in a solvent that is an eye irritant), additional modules would be applied.
The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Preliminary Assessment, Finalisation and Limits on Use are mandatory modules for this application. Considerations are necessary for all modules other than Preliminary Assessment, Finalisation, or Limits on Use, for this variation.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Preliminary assessment |
Up to 1 month |
$902 |
|
Chemistry 3 |
An assessment is required of the chemistry and manufacturing aspects of the new formulation to ensure the change in formulation does not change the physico-chemical properties of the product. |
|
|
6 months |
$1 954 |
|
|
Poison Scheduling |
No assessment required if appropriate scheduling is already in place. |
|
|
Residues and trade |
No assessment required as there are no changes to residue risks associated with use of the product. |
|
|
Work health and safety |
No assessment would be required if there is no change to risks associated with product handling, and the proposed changes do not affect the toxicology profile of the product. |
|
|
Environment |
No assessment required as there is no change to environmental risk associated with the use of the product. |
|
|
Efficacy and Safety 3 |
An assessment is required in this situation as the changes to excipients may impact on efficacy or target crop safety. |
|
|
3 months |
$1 160 |
|
|
Non-food Trade |
No assessment required as minor formulation changes should not alter risks related to non-food trade. |
|
|
Special Data |
No assessment required as neither the product nor the target crop contain any GMOs. |
|
|
Finalisation 2 |
2 months |
$3 090 |
|
Limits on use (data protection) |
N/A |
$460 |
|
Total |
8 months |
$7 566 |
5.2. Scenario 2: Application to vary a product formulation for a home garden lawn product
5.2.1. Objective
A holder applies to vary the formulation of a registered home garden lawn product to add an alternate formulation that is similar to the existing formulation.
5.2.2. Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that if the formulation is changed, the product will continue to satisfy the safety, efficacy (including crop safety) and trade criteria.
The product is a home garden product so the efficacy of the new formulation is deemed under the Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014. However consideration still needs to be given to safety. The applicant has submitted bioequivalence data to demonstrate the crop safety of the new formulation compared to the existing formulation.
A chemistry package has been submitted to support the chemistry and manufacturing aspects of the new formulation.
No label update is required.
Note: if during assessment it is identified that there is a change that requires a Health assessment (for example, an increase in a solvent that is an eye irritant), additional modules would be applied.
The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Preliminary Assessment, Finalisation and Limits on Use are mandatory modules for this application. Considerations are necessary for all modules other than Preliminary Assessment, Finalisation, or Limits on Use for this variation.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Preliminary assessment |
Up to 1 month |
$902 |
|
Chemistry 3 |
Assessment is required of the chemistry and manufacturing aspects of the new formulation. |
|
|
6 months |
$1 954 |
|
|
|
|
|
|
Poison Scheduling |
No assessment required if appropriate scheduling is in place for the new solvent. |
|
|
Residues and trade |
No assessment required as there are no changes to product residue risks. |
|
|
Health |
No assessment is required as the product is registered and the formulation change does not affect the previously assessed risk to users, and the formulation change does not alter the risk alter assessed for the product. |
|
|
Environment |
No assessment required as there is no expected change to environmental risk. |
|
|
Efficacy and Safety 3 |
Assessment is required of the impact of changes to product formulation on the crop safety the product. Efficacy assessment is not required as the product is for home garden use only and is deemed to be effective according to the Efficacy Criteria Determination. |
|
|
3 months |
$1 160 |
|
|
Non-food Trade |
No assessment required as the proposed formulation changes will not alter risks related to non-food trade. |
|
|
Special Data |
No assessment required as neither the product nor the crop contain any GMOs. |
|
|
Finalisation 2 |
2 months |
$3 090 |
|
Limits on use (data protection) |
N/A |
$460 |
|
Total |
8 months |
$7 566 |
5.3. Scenario 3: Application to vary a product formulation to substitute a solvent for a solvent in a schedule of the Poisons Standard
5.3.1. Objective
An applicant applies to vary the formulation of a registered insecticide to substitute one excipient solvent for another. The new solvent is a scheduled poison (schedule 6 of the Poison Standard) and is known to have health risks to humans that must be considered. A new constituent statement, safety directions, first aid instructions and re-entry periods may be required. The product does not have any registered aquatic uses, so an environmental assessment is not required.
5.3.2. Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that if the formulation is changed, the product will continue to satisfy the safety, efficacy (including crop safety) and trade criteria.
As the formulation change will result in changes to the relevant label particulars, an updated label must be included in the application.
The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Preliminary Assessment, Finalisation and Limits on Use are mandatory modules for this application. Considerations are necessary for other than Preliminary Assessment, Finalisation and Limits on Use for this variation.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Preliminary assessment |
Up to 1 month |
$902 |
|
Chemistry 3 |
Assessment is required of the chemistry and manufacturing aspects of the new formulation. |
|
|
6 months |
$1 954 |
|
|
Poison scheduling |
No assessment required if appropriate scheduling is in place for the new solvent. |
|
|
Residues and trade |
No assessment required as there are no changes to product residue risks. |
|
|
Health 4 |
Assessment is required to assess changes to health and safety risks related to product handling and usage, set new safety directions and re-entry periods, and to assess changes in toxicity related to the formulation change. |
|
|
5 months |
$7 963 |
|
|
Environment |
No assessment required as there is no expected change to environmental risk. |
|
|
Efficacy and Safety 3 |
Assessment is required of the impact of changes to product formulation on the crop safety and efficacy of the product. |
|
|
3 months |
$1 160 |
|
|
Non-food Trade |
No assessment required as the proposed formulation changes will not alter risks related to non-food trade. |
|
|
Special Data |
No assessment required as neither the product nor the crop contain any GMOs. |
|
|
Finalisation 1 |
3 months |
$8 110 |
|
Limits on use (data protection) |
N/A |
$460 |
|
Total |
9 months |
$20 549 |
5.4. Scenario 4: Application to vary a product formulation to substitute a surfactant in an aquatic use product
5.4.1. Objective
An applicant applies to vary the formulation of a registered glyphosate product to substitute the current surfactant for a similar surfactant. The proposed new formulation is closely similar to the existing formulation, however the product is registered for use in aquatic situations and the proposed new surfactant has not been assessed for aquatic species.
5.4.2. Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the change in formulation will not affect the product’s capacity to meet safety, efficacy and trade criteria. As surfactants may pose a risk to aquatic environments, an assessment of the environmental impact the product on aquatic species is also required.
No label change is required.
The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Preliminary Assessment, Finalisation and Limits on Use are mandatory modules for this application. Considerations are necessary for all modules other than Preliminary Assessment, Finalisation and Limits on Use for this variation.
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Preliminary assessment |
Up to 1 month |
$902 |
|
Chemistry |
Assessment is not required if the change in surfactants does not alter the physico-chemical properties of the product. |
|
|
Poison Scheduling |
No assessment required as appropriate scheduling is already in place. |
|
|
Residues and trade |
No assessment required as there are no changes to product residue risks. |
|
|
Health |
No assessment as the change in formulation does not alter the risk to users of the product and the proposed changes do not affect the toxicology profile of the product. |
|
|
Environment 3 |
An assessment is required to consider if changes to the formulation of the product alter risks relating to aquatic species. |
|
|
4 months |
$2 979 |
|
|
Efficacy and Safety |
An assessment is not required as there is no change to the efficacy or safety to target crop. |
|
|
Non-food Trade |
No assessment required as minor formulation changes should not alter risks related to non-food trade. |
|
|
Special Data |
No assessment required as neither the product nor the crop contain any GMOs. |
|
|
Finalisation 2 |
2 months |
$3 090 |
|
Limits on use (data protection) |
N/A |
$460 |
|
Total |
6 months |
$7 431 |
6. Start an application
If you want to make a change to the formulation of your product and a technical variation (Item 14) is required:
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