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

The fee for a non-technical variation (Item 12) is a fixed fee of $2018. The timeframe is three months. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

This application type is subject to an extended assessment period if a notice is sent requesting additional information or clarification of submitted information under section 159 of Agvet Code. The extended assessment period for a non-technical variation (Item 12) is five months.

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
  • an information list
  • consent for use (if any of the information provided 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 a summary as to why it does not require technical assessment to satisfy the statutory criteria. In particular, why it does not require technical assessment of risks to residues/trade, workplace health and safety, environment, target safety and efficacy. For example, this may include nomination of a single reference product.

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 Poisons 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:?Variation of a formulation to add a dye

Objective

A registrant is seeking to vary a herbicide formulation to add a dye.

The proposed formulation is similar to the current formulation but includes 0.5 g/L of a red dye. The other excipients in the formulation have been adjusted to account for the addition of a dye. The concentration of the active constituent is not changed.

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The addition of the dye is not expected to change the previous assessment of safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

Risk area

Reason technical assessment is not required

2: Chemistry

The formulation change is not expected to change the physico chemical properties of the formulation

3: Toxicology

Risks to human health is the same as that previously assessed

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues?and trade

Risks to residues and trade is equivalent to that previously assessed

6: Workplace health and safety

Risk to human health through exposure is equivalent to that previously assessed

7: Environment

Risk to environment is equivalent to that previously assessed

8: Efficacy?and safety

Efficacy and crop safety is equivalent to that previously assessed

9: Non-food trade

Risk is equivalent to that previously assessed

10: Special data

Risk is equivalent to that previously assessed

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Scenario 2: Variation of a formulation based on that of a registered reference product

Objective

A registrant is seeking to replace a current formulation with that of a reference product.

The reference product is registered and has the same active constituent at the same concentration, is of the same formulation type and the label of the reference product has the same use instructions, withholding periods and precautions as the current product. Both the current product and the reference product have the same packaging.

There is no protected data on the reference product.

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The registered reference product shows equivalent risk has already been assessed and the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria if the formulation of the reference product is used for the current product.

In assessing the suitability of the reference product the APVMA will assess whether the proposed new formulation is the same or closely similar to that of the reference product, and whether the reference product has the label instructions and packaging as the current product.

Risk area

Reason technical assessment is not required

2: Chemistry

The formulation of the reference product has been previously assessed as satisfying the relevant safety criteria and the product packaging is the same as that of the currently approved product.

3: Toxicology

Risks to human health are equivalent to that previously assessed for the reference product

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues?and trade

Risks to residues and trade are equivalent to that previously assessed for the reference product

6: Workplace health and safety

Risk to human health through exposure is equivalent to that previously assessed for the reference product

7: Environment

Risk to environment is equivalent to that previously assessed for the reference product

8: Efficacy?and safety

Efficacy and crop safety is equivalent to that previously assessed for the reference product

9: Non-food trade

Risk is equivalent to that previously assessed

10: Special data

Risk is equivalent to that previously assessed

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Scenario 3: Minor variation of a formulation based on the existing registered formulation

Objective

A registrant is seeking to add a second formulation which is closely similar to the current formulation.

The product is registered and the existing formulation is approved. The second formulation is the same formulation type, has the same active at the same concentration, and the other ingredients are the same or where they are not the same, perform the same function.

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The existing product formulation shows equivalent risk has already been assessed and the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria if the second formulation is used for the current product.

No label change is required.

Risk area

Reason technical assessment is not required

2: Chemistry

The formulation of the product has been previously assessed and the formulation change is not expected to change the physico chemical properties of the formulation

3: Toxicology

Risks to human health are equivalent to that previously assessed for the product

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues?and trade

Risks to residues and trade are equivalent to that previously assessed

6: Workplace health and safety

Risk to human health through exposure is equivalent to that previously assessed

7: Environment

Risk to environment is equivalent to that previously assessed

8: Efficacy?and safety

Efficacy and crop safety is equivalent to that previously assessed

9: Non-food trade

Risk is equivalent to that previously assessed

10: Special data

Risk is equivalent to that previously assessed

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Note: If during assessment of the variation, the APVMA determines that a technical assessment is required to ascertain if the product with the proposed new formulation continues to meet the statutory criteria, the application would be refused.

Start an application

If you want to vary the formulation of your product and a non-technical variation (Item 12) is required:

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