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. Guidelines
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 that fall under this, for example:
1.6. 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.
2. Timeframe and fees
2.1. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
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 the Agvet Code. The extended assessment period for a non-technical variation (Item 12) is five months.
3. Modules
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.1 | Finalisation | 3 months | $8 110 |
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. 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.
4.4. 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.
4.5. 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.
4.6. 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.
4.7. 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
- supporting information to demonstrate that the proposed variation will be efficacious and will not cause unintended harm
- an information list
- consent for use (if any of the information provided is subject to limits on use)
- an e-label.
5. Examples
5.1. Scenario 1: Addition of a new pest within an existing crop based on a registered reference product
5.1.1. Objective
An application is made to extend the label of a 500 EC insecticide product currently registered to control redlegged earth mite in forage brassicas to include a claim for the control of blue oat mite in forage brassicas. The registrant is seeking to support the extension by citing a reference product registered for the control of both redlegged earth mite and blue oat mite in forage brassicas.
The reference product has the same active constituent at the same concentration, is of the same formulation type, and the registrant’s draft label has the same use instructions, withholding periods and precautions as the reference product for the control of blue oat mite in forage brassicas.
There are no limits on use of information on the reference product.
5.1.2. 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 as set out in the Agvet Code when used on forage brassicas for the control of blue oat mite.
In assessing the suitability of the reference product the APVMA will assess whether the proposed product, compared to the reference product, has the same or closely similar non-active constituents and if differences exist those perform similar functions to achieve equivalent efficacy and crop safety and whether extrapolation to the additional pest is acceptable.
An updated label reflecting the change in 'Directions for use' must be included.
|
Risk area by module type |
Reason technical assessment not required |
|---|---|
|
Chemistry |
The product is currently registered and there are no changes to the product formulation or packaging. |
|
Poison Scheduling |
The product is currently registered and relevant scheduling is established. |
|
Residues and trade |
Risks to residues and trade are equivalent to that previously assessed for the reference product. |
|
Health |
Risk to human health from handling the product are equivalent to that previously assessment, and risk through exposure is equivalent to that previously assessed for the reference product. |
|
Environment |
Risk to environment is equivalent to that previously assessed for the reference product. |
|
Efficacy and Safety |
Risk for the proposed extension is equivalent to that of the reference product. |
|
Non-food Trade |
Risk is equivalent to that of the reference product. |
|
Special Data |
Risk is equivalent to that of the reference product. |
Note: If during assessment, the APVMA determines that the reference product is not the same or closely similar to the product being varied, the APVMA may not be able to be satisfied that the product if varied would continue to meet the statutory criteria without a technical assessment. In this case, the APVMA would propose to refuse the application.
|
Application type |
Timeframe |
Extended timeframe |
Fee |
|---|---|---|---|
|
Item 12 |
3 months |
5 months |
$2 018 |
5.2. Scenario 2: Variation to increase the frequency of application for a product based on a registered reference product
5.2.1. Objective
An application is made to increase the frequency of application of a fungicide product used to control powdery mildew in cucurbits from every 14 days to every 10 days. The applicant has nominated a reference product, which has no relevant limits of use, in support of their application.
The reference product has the same active constituent at the same concentration, is of the same formulation type and the registrants draft label has the same use instructions, withholding periods and precautions as the reference product for the control of powdery mildew in cucurbits.
5.2.2. 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 as set out in the Agvet Code when used as proposed for the control of powdery mildew in cucurbits.
In assessing the suitability of the reference product the APVMA will assess whether the proposed product, compared to the reference product, has the same or similar non-active constituents and if differences exist those perform similar functions to achieve equivalent efficacy and crop safety and whether extrapolation is acceptable.
An updated label reflecting the change in 'Directions for use' must be included.
|
|
|
|---|---|
|
Chemistry |
The product is currently registered and there are no changes to the product formulation or packaging. |
|
Poison Scheduling |
The product is currently registered and relevant scheduling is established. |
|
Residues and trade |
Risks to residues and trade are equivalent to that assessed for the reference product. |
|
Health |
Risk to human health from handling the product are equivalent to that previously assessment, and risk through exposure is equivalent to that of the reference product. |
|
Environment |
Risk to environment is equivalent to that of the reference product. |
|
Efficacy and Safety |
Risk for the proposed extension is equivalent to that of the reference product. |
|
Non-food Trade |
Risk is equivalent to that of the reference product. |
|
Special Data |
Risk is equivalent to that of the reference product. |
|
Application type |
Timeframe |
Extended timeframe |
Fee |
|---|---|---|---|
|
Item 12 |
3 months |
5 months |
$2 018 |
5.3. Scenario 3: Variation of a directions for use statement on a registered agricultural product related to target crop safety, based on a registered reference product
5.3.1. Objective
An applicant wants to vary directions for use for an insecticide product to remove a critical comment that warns of the possibility of russeting following the application of the insecticide under certain conditions. The insecticide product was originally registered under Item 7 using a reference product held by a different company. The reference product was recently varied under an Item 14 application based on the results of a study demonstrating that the warning is only applicable to one particular species of apples. The applicant has consent to use this study to support this application.
|
Current approved label statement |
Reference product label statement and proposed new label statement |
|---|---|
|
This product may cause russeting of apples when applied in conditions of high humidity. |
This product may cause russeting of Golden Delicious apples when applied in conditions of high humidity. |
5.3.2. 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 as set out in the Agvet Code, and the proposed amendment does not require a change to the established maximum residue limits for the registered active constituent.
An updated label reflecting the change in 'Directions for use' must be included.
|
Risk Area |
Reason technical assessment is not required |
|---|---|
|
Chemistry |
The product is currently registered and there are no changes to the product formulation. |
|
Poison Scheduling |
The product is currently registered and relevant scheduling is established. |
|
Residues and Trade |
Risks to residues and trade are equivalent to that previously assessed for the reference product. |
|
Health |
No change to previous assessment. |
|
Environment |
No change to previous assessment. |
|
Efficacy and Safety |
Efficacy and target animal safety is equivalent to that previously assessed for the reference product. |
|
Non-food Trade |
No change to previous assessment. |
|
Special Data |
No change to previous assessment. |
|
Application type |
Timeframe |
Extended timeframe |
Fee |
|---|---|---|---|
|
Item 12 |
3 months |
5 months |
$2 018 |
5.4. Scenario 4: Application to add new equipment, based on a registered reference product
5.4.1. Objective
An application is made to vary the product registration for a fungicide used on stone fruit by air-blast spray to add use by handheld sprayer.
The fungicide product was originally registered under Item 7 using a reference product held by a different company. The reference product was varied under an Item 14 application to add use by handheld sprayer. The data protection period for the data submitted for the Item 14 variation application has ended and this reference product has no associated protected data.
|
|
Rate |
Critical comments |
|---|---|---|
|
Current label |
100–150 mL /100 L water (dilute spray)
|
Apply by air-blast sprayer or equivalent equipment.
Apply as a thorough foliar spray to the point of run off. |
|
Reference product and proposed label |
100–150 mL /100 L water (dilute spray)
OR
15–22.5 mL /15 L water |
Apply by air-blast sprayer or equivalent equipment.
Apply as a thorough foliar spray to the point of run off.
Spot spraying: Apply with low-pressure handheld sprayer. Thoroughly wet all foliage. |
5.4.2. 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 as set out in the Agvet Code.
An updated label reflecting the change in 'Directions for use' must be included.
|
Risk area |
Reason technical assessment not required |
|---|---|
|
Chemistry |
The product is currently registered and there are no changes to the product formulation or packaging. |
|
Poison Scheduling |
The product is currently registered and relevant scheduling is established. |
|
Residues and trade |
Risks to residues and trade are equivalent to that assessed for the reference product. |
|
Health |
Risk to human health from handling the product are equivalent to that previously assessment, and risk through exposure is equivalent to that of the reference product. |
|
Environment |
Risk to environment is equivalent to that of the reference product. |
|
Efficacy and Safety |
Risk for the proposed extension is equivalent to that of the reference product. |
|
Non-food Trade |
Risk is equivalent to that of the reference product. |
|
Special Data |
Risk is equivalent to that of the reference product. |
|
Application type |
Timeframe |
Extended timeframe |
Fee |
|---|---|---|---|
|
Item 12 |
3 months |
5 months |
$2 018 |
5.5. Scenario 5: Application to add a new use in an existing situation, based on the Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014
5.5.1. Objective
An application is made to vary the product registration for a home and garden product insecticide spray to add spiders to the list of target species. The product is currently registered for use on crawling and flying insects only.
The applicant has nominated a registered reference product with the same formulation type and active constituent used on spiders at the same rate proposed for the current product. The reference product has no protected data.
5.5.2. Application type
This application may be considered under a non-technical fixed fee variation (Item 12). The Efficacy Criteria Determination states that for domestic or home garden products, a product will be effective when there are one or more registered products approved for the proposed use with the same active constituent and equivalent rates.
An updated label reflecting the change must be included.
|
Risk area |
Reason technical assessment not required |
|---|---|
|
Chemistry |
The product is currently registered and there are no changes to the product formulation or packaging. |
|
Poison Scheduling |
The product is currently registered and relevant scheduling is established. |
|
Residues and trade |
Not required for a domestic insect spray. |
|
Health |
Risk to human health is equivalent to that already assessed to register the product. |
|
Environment |
Risk to environment is equivalent to that already assessed to register the product. |
|
Efficacy and Safety |
Based on the efficacy criteria the product is considered to be effective for use on spiders. |
|
Non-food Trade |
No change to previous assessment. |
|
Special Data |
No change to previous assessment. |
|
Application type |
Timeframe |
Extended timeframe |
Fee |
|---|---|---|---|
|
Item 12 |
3 months |
5 months |
$2018 |
6. Start an application
If you want to extend the use of your product and a non-technical variation (Item 12) is required:
You will be redirected to online services to log in.