I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions

Applications to vary the shelf life details or storage conditions for registered products may be made via:

  • Item 12: No data of a technical nature is required. This type of application is used when risks are equivalent to a registered product not subject to data protection
  • Item 14: Technical modular application. All applications not meeting the requirements of Item 12.

Which application form do you need?

A number of active constituents are defined as “date-controlled”. When formulated into an agricultural product, the concentration of these active constituents may decline over time and any reaction taking place may also result in other toxic compounds. For this reason, products containing these active constituents have a defined shelf life and an expiry date must be included on the product label.

A date-controlled agricultural chemical product is a product containing any of the following active constituents:

  • organisms (including nematodes, bacteria, viruses, algae or protozoa)
  • Bacillus thuringiensis
  • mancozeb
  • zineb
  • diazinon
  • dimethoate.

Is a technical assessment required for my proposed variation?

Most variations of this type are likely to be made as Item 14 applications, as they will require a technical assessment.

For a variation to be processed without a technical assessment (Item 12), the application must only be supported by referencing another registered product (a reference product).

The suitability of a reference product includes the reference product as having:

  • the same active constituent/s at the same concentration/s
  • the other ingredients are the same or perform similar functions
  • the same formulation type
  • the label refers to the same crops, situations and pests
  • the same label claims
  • no limits on use of information apply (or consent has been provided).
Limits on use of information

When using a reference product, where there are limits on use of information on the product which is being referenced, written consent from the authorising party is required.

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.

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 to the applicant under section 159 of Agvet Code requesting additional information or clarification of submitted information. The extended assessment period for a non-technical variation (Item 12) is five months.

Examples

Scenario

Modules

Timeframe

Fee

Scenario 1

Variation to the shelf life (no label changes required)

N/A

3 months

5 months (extended assessment period)

$2 018

Scenario 2

Variation to the shelf life from a change in storage conditions (label required)

N/A

3 months

5 months (extended assessment period)

$2 018

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
  • supporting information to demonstrate the variation will not alter the safety, efficacy or trade risks related to the product
  • an information list
  • consent for use (if any of the information provided is subject to limits on use)
  • e-label (if required).

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).

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.

Consent for use from the relevant authorising party (if applicable)

When protected information is listed for a reference product, the applicant must obtain consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

You can check the APVMA PubCRIS database record to determine if protected data details exist for the 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.

Note: In many cases the change will only result in a change to the Conditions of Registration, not the label itself. An application must include an updated e-label for review if changes to shelf-life result in a change to the current relevant label particulars.

Examples

Scenario 1: Variation to the shelf life (no label changes required)

Objective

An application is made to extend the current shelf life for an agricultural chemical product containing mancozeb from 18 months to two years.

The applicant has nominated a closely similar registered reference product that has a shelf life of two years.

The reference product has the same active at the same concentration, the same other ingredients, is the same formation type and has the same label claims. There is no protected data.

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, and the proposed amendment does not require a technical assessment.

No label is required with this application as the change only applies to a condition of label approval.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there is no change to the product formulation. The change to shelf life has been assessed for the reference product.

3: Toxicology

The product is registered and there is no change to the risks previously assessed

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered and there is no change to the risks to residues and trade

6: Work health and safety

The product is currently registered and there is no change to the risks for work health and safety

7: Environment

The product is currently registered and there is no change to the risks to the environment

8: Efficacy and safety

The product is registered and there is no change to the risks previously assessed

9:  Non-food trade

The product is registered and there is no change to the risks previously assessed

10: Special data

The product is registered and there is no change to the risks previously assessed

Application type

Timeframe

Extended Timeframe

Fee

Item 12

3 months

5 months

$2 018

Scenario 2: Variation to the shelf life of a date-controlled agricultural product that does require a change to the label

Objective

An application is made to extend the current shelf life for an agricultural chemical product containing Bacillus thuringiensis from 12 months to two years. The current label includes the statement that the product 'not be exposed to extremes of temperature'.

The applicant has nominated a closely similar registered reference product that has a shelf life of two years if the product is stored at 20°C. The reference product has the same active at the same concentration, the same other ingredients, is the same formation type and has the same label claims. There is no protected data.

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, and the proposed amendment does not require a technical assessment.

An updated label reflecting the changed instructions is required.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there is no change to the product formulation. The change to shelf life has been assessed for the reference product.

3: Toxicology

 

The product is registered and there is no change to the risks previously assessed

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered and there is no change to the risks to residues and trade

6: Work health and safety

The product is currently registered and there is no change to the risks for work health and safety

7: Environment

The product is currently registered and there is no change to the risks to the environment

8: Efficacy and safety

The product is registered and there is no change to the risks previously assessed

9:  Non-food trade

The product is registered and there is no change to the risks previously assessed

10: Special data

The product is registered and there is no change to the risks previously assessed

Application type

Timeframe

Extended Timeframe

Fee

Item 12

3 months

5 months

$2 018

Start an application

If you want to vary your product to amend the shelf life, expiry date or storage conditions and a non-technical variation (Item 12) is required:

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