I want to vary my product to make a change to the product formulation

Changes to the formulation of an agricultural or veterinary chemical product may be required for a variety of reasons, including the availability of excipients or changes to the purity of the source of active used in the formulation.

All variations to approved product formulation details require an application to be made. The level of information supporting the variation and the assessment required will vary according to the proposed change and significance it may have with respect to ensuring the continued safety and efficacy of the product.

Depending on the change the following registration pathways may be utilised:

  • Item 12: No data of a technical nature is required—this application type is used when the change is minor and does not affect the physico-chemical properties of the product.
  • Item 13A: Prescribed variation—changes to non-active constituents (excipients) in certain limited circumstances.
  • Item 14: Technical modular application—all applications that are not Items 12 or 13A.

Most formulation variations are likely to be made as Item 14 applications. Applicants should familiarise themselves with the scope of each of these pathways and select the pathway which is most appropriate for the formulation change being sought.

This guidance does not cover changes to use patterns, or to the frequency or rate of application. This information is provided in other tailored guidance pathways.

Which application form do you need?

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.

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.

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.

Application guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the?timeframe and fees section on our website.

Legislation

Framework

The Agricultural and Veterinary Chemicals (Administration) Act 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 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act, 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.

Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:

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:

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, toxicology (including poison scheduling, residues, work health and safety, environment and target safety).

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.

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.

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.

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 (Section 29 of the Agvet Code).

Section 20(1)(c) of the Agvet Code 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
(b)? the constituents of the chemical product
(c)? the concentration of each constituent of the chemical product
(d)? if possible, the composition and purity of each active constituent of the chemical product
(da)? the formulation type for the chemical product
(db)? the net contents for the chemical product
(e)? identifying information for the holder of the registration of the chemical product
(g)? the name of each manufacturer of the chemical product
(h)? the address of each site at which the chemical product is manufactured by the manufacturer
(j)? the date of entry of these particulars in the Register of Chemical Products
(k)? identifying information for any nominated agent for the registration.

The Agvet Code defines particulars in relation to approval of a label as:

(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
(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 subregulation (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.

Application requirements

Section 8A of the Agvet Code provides the definition of 'meets the application requirements'.

Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument sets out the information that must be contained in, or accompany an, application under the Agvet Code.

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.

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines which fall under this, for example:

Applications may be withdrawn

Section 8D of the Agvet Code 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.

Timeframe and fees

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. Modules 1, 11 and 12 are mandatory modules for this application. Where an applicant considers that an assessment of any particular module is not necessary, justification must be provided.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to one month

$902

2: Chemistry

2.3

6 months

$1 954

3: Toxicology (if required)

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

No assessment is required if appropriate scheduling is already in place.

5: Residues and trade (if required)

May require assessment if the change to the formulation changes the spray drift characteristics of the product.

5.4

4 months

$7 465

6: Work health and safety (if required)

6.3

4 months

$3 913

7: Environment (if required)

7.3

4 months

$2 979

8: Efficacy and safety (if required)

8.3

3 months

$1 160

9: Non-food trade

No assessment required as minor formulation changes should not alter risks related to non-food trade.

10: Special data (if required)

10.3

7 months

$ nil

11: Finalisation

11.1 or

11.2

3 months

2 months

$8 110

$3 090

12: Limits on use (data protection)

12

N/A

$460

Examples

Scenario

Modules

Timeframe

Fee

Scenario 1:

Change in product formulation (no label change required)

1, 2.3, 8.3, 11.2 & 12

8 months

12 months (extended assessment period)

$7 566

Scenario 2:

Change in product formulation relying part on the Efficacy Instrument for a home garden product

1, 2.3, 8.3, 11.2 & 12

8 months

12 months (extended assessment period)

$7 566

Scenario 3:

Change in product formulation to substitute a solvent for one which is scheduled under the Poison Standard (label change required)

1, 2.3, 3.3, 6.3, 8.3, 11.1 & 12

9 months

13 months (extended assessment period)

$20 549

Scenario 4:

Change in product formulation involving a substitution of surfactant in an aquatic use product

1, 7.3, 11.2 & 12

6 months

9 months (extended assessment period)

$7 431

This application type is subject to an extended assessment period if a section 159 of Agvet Code 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.

Pre-application assistance

Pre-application assistance is?available to give applicants advice on the requirements of an application before submission.

Modules

The APVMA has developed a guideline for module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to it, but may depart from it, when determining which modules are necessary on a case by case basis. The guideline is not the law.

Module 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.

Module 2: 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.

c. A variation to:
(i) extension of shelf life;
(ii) extension of in use shelf life;?
(iii) changes to storage temperature or conditions; or
(iv) a formulation change.

Module level Module type Timeframe Fee
2.3 Chemistry—Limited assessment 6 months $1 954

Module 3: Toxicology

This module 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.

d. A variation which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements.
Module level Module type Timeframe Fee
3.3 Toxicology 5 months $4?050

Module 5: 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 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.

5.4: Residues—level 4

A limited residue assessment (Module 5.4) applies to variations of WHPs and, where necessary, the establishment of MRLs and the assessment of trade implications of an application to extend use to less than 6 food crops or crops producing feed for food-producing species (not including major export food commodity groups).

b. A variation where consideration of MRLs and WHPs and/or trade implications are required for:

  1. less than six food crops; and
  2. where trade consultations are not required.
Module level Module type Timeframe Fee
5.4 Residues and trade—limited residue assessment 4 months $7?465

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. These exposures include changes such as application rate, method, worker rates and practices including post application activities. The change in exposure may result in a change to the entry in the first aid instructions and safety directions (FAISD) handbook, including changes to personal protective equipment (PPE) and re-entry into treated areas following application.

6.3: Work health and safety—level 3

Work health and safety—level 3 (Module 6.3) is required where the application involves a change or reassessment of user safety directions and/or re-entry or re-handling statements.

A change to toxicity profile of formulation due to a change in excipients may lead to new safety directions and re-entry statements on the product label.

b.?A variation that is not referred to in Module 6.2 above, that requires a WH&S assessment due to a varied exposure scenario (for example, to consider re-entry/re-handling statements and/or safety directions).

Module level Module type Timeframe Fee
6.3 Workplace health and safety 4 months $3 913

Module 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.

7.3: Environment—level 3

An environment assessment level 3 (Module 7.3) applies for formulation changes which may change the risk to the environment.

b. A variation which involves:

  1. a new crop in an existing crop group;
  2. domestically in the home, home garden or a swimming pool or spa;
  3. in buildings not used in animal production (for example, warehouses, offices, or glasshouses);
  4. a spray drift assessment that does not involve an increase in rate or new exposure scenarios for non-target species; or
  5. a formulation change which could change the risk to the environment.
Module level Module type Timeframe Fee
7.3 Environment 4 months $2 979

Module 8: 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.

8.3: Efficacy and safety—level 3

An efficacy and safety assessment level 3 (Module 8.3) 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.

b. A variation which involves:

  1. a formulation change; or
  2. where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety to a currently registered product.
Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $1 160

Module 10: 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) require a Module 10 assessment.

Specifically, you should consider the following guidelines:

b.?A product including an assessment of products containing GMOs, requiring a Module 10 assessment.

Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

Module 11: 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.

11.1 Finalisation—type 1

b.?A variation where three or more modules between 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.1 Finalisation 3 months $8 110

11.1 Finalisation—type 2

b. A variation where fewer than three modules between 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.2 Finalisation 2 months $3 090

Module 12: Limits on use of information

Module 12 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 level Module type Timeframe Fee
12 Data protection N/A $460

Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.?

What you need to provide

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).

Completed online application form

First time applicants will need to complete an online services new user access form to access APVMA online services.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

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).

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.

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.

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.

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 (sections 5D and 14 of the Agvet Code). 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.

Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

Examples

Scenario 1:?Application to vary the excipients in the product formulation

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.

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 WHS 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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

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.

2.3

6 months

$1 954

3: Toxicology

No assessment required. The product is registered and the proposed changes do not affect the toxicology profile of the product.

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes to residue risks associated with use of the product.

6: Work health and safety

No assessment would be required if there is no change to risks associated with product handling.

7: Environment

No assessment required as there is no change to environmental risk associated with the use of the product.

8: Efficacy and safety

An assessment is required in this situation as the changes to excipients may impact on efficacy or target crop safety.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as minor formulation changes should not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the target crop contain any GMOs.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

?

8 months

$7 566

Scenario 2:?Application to vary a product formulation to for a home garden lawn product

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.

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 WHS 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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation.

2.3

6 months

$1 954

3: Toxicology

No assessment required if the formulation change does not alter the risk alter assessed for the product.

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is in place for the new solvent.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment is required as the product is registered and the formulation change does not affect the previously assessed risk to users.

7: Environment

No assessment required as there is no expected change to environmental risk.

8: Efficacy and safety

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

8.3

3 months

$1 160

9: Non-food trade

No assessment required as the proposed formulation changes will not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the crop contain any GMOs.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12

N/A

$460

Total

?

8 months

$7 566

Scenario 3:?Application to vary a product formulation to substitute a solvent for a solvent in a schedule of the Poisons Standard

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.

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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation.

2.3

6 months

$1 954

3: Toxicology

An assessment may be required to assess changes in toxicity related to the formulation change.

3.3

5 months

$4 050

4: Toxicology – Poison scheduling

No assessment required if appropriate scheduling is in place for the new solvent.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

Assessment is required to assess changes to health and safety risks related to product handling and usage and set new safety directions and re-entry periods.

6.3

4 months

$3 913

7: Environment

No assessment required as there is no expected change to environmental risk.

8: Efficacy and safety

Assessment is required of the impact of changes to product formulation on the crop safety and efficacy of the product.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as the proposed formulation changes will not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the crop contain any GMOs.

11: Finalisation

11.1

3 months

$8 110

12: Limits on use (data protection)

12

N/A

$460

Total

?

9 months

$20 549

Scenario 4:?Application to vary a product formulation to substitute a surfactant in an aquatic use product

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.

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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

Assessment is not required if the change in surfactants does not alter the physico-chemical properties of the product.

3: Toxicology

No assessment required. The product is registered and the proposed changes do not affect the toxicology profile of the product.

4: Toxicology—Poison scheduling

No assessment required as appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment as the change in formulation does not alter the risk to users of the product.

7: Environment

An assessment is required to consider if changes to the formulation of the product alter risks relating to aquatic species.

7.3

4 months

$2 979

8: Efficacy and safety

An assessment is not required as there is no change to the efficacy or safety to target crop.

9: Non-food trade

No assessment required as minor formulation changes should not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the crop contain any GMOs.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12

N/A

$460

Total

?

6 months

$7 431

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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