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Category 4 Application

Registration of a new chemical product with an approved active constituent, for use on a major food crop.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 4 application as:

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

1. there is a registered chemical product containing the active constituent; and
2. the chemical product is to be used on a major food crop; and
3. there are no relevant maximum residue limits; and
4. poison schedule classification is required.

1.1.   Major food crop

The APVMA has defined those crops (including pasture) which are grown for the purpose of producing food for human or livestock consumption, and which are major food crops. The definition is on the APVMA website at Guidelines for determining minor uses. Table 1 lists the major food crops.

Table 1:  Major food crops

Crop group	Individual crops
Grasses	Barley, maize, oats, rice, sorghum, triticale, wheat, sugarcane
Citrus fruit	Oranges , mandarins
Pome fruit	Apples, pears
Stone fruit	Apricots, plums, peaches, nectarines, cherries
Berries and other small fruit	Grapes (wine and table), strawberries
Assorted tropical and sub-tropical fruit (inedible peel)	Avocados, bananas, mangoes, pineapples
Bulb vegetables	Onions
Brassica vegetables	Broccoli, cabbages, cauliflowers
Fruiting vegetables (cucurbits)	Melons (except watermelons), pumpkins
Fruiting vegetables (other than cucurbits)	Peppers (capsicums), mushrooms, tomatoes
Leafy vegetables	Lettuce
Legume vegetables and pulses	Beans (French and runner), chick-peas, field peas, green peas, lupins
Root and tuber vegetables	Carrots, potatoes
Stalk and stem vegetables	Asparagus
Tree nuts	Almonds, macadamias
Oilseeds	Cotton, canola, sunflowers
Pastures grown specifically for the purpose of being grazed by, or fed to, livestock	Lucerne , medics, clovers and grasses, whether for grazing or seed crops

2.   REQUIREMENTS

When making a Category 4 application for registration of a new product, applicants must provide:

• one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)
• one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
• the product label (refer to paragraph 2.3)
• the relevant fee (refer to paragraph 2.4)
• a data list (refer to paragraph 2.6).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25_F24). A single unbound copy of the combined document must be provided to the APVMA.

The Application Form is divided into separate sections for application for registration of the product and approval of the active constituent.

The Application Overview section of the combined document is in the form of a template. Applicants may use this template, or may submit their own Application Overview although this must conform to the instructions and format provided in Part 1 – Application overview in Volume 3.

Sub-parts 1.1–1.10 of the Application Overview must all be completed.

2.2.   Data

Data requirements for Category 4 applications are as follows:

Description	Data part	Equivalent module level
Application Overview	Part 1
Chemistry and Manufacture	Part 2	Module 2.3
Toxicology	Part 3	Module 3.3 or 3.2 & Module 4
Metabolism and Kinetics	Part 4	No equivalent module1
Residues and Trade	Part 5	Module 5.2 or 5.1
Occupational Health and Safety	Part 6	Module 6.2
Environment	Part 7	Module 7.2
Efficacy and Safety	Part 8	Module 8.1

Details of the module levels are in Module levels for modular categories in Volume 3.

Applicants may choose to submit scientific argument not to submit certain studies. If the APVMA accepts that the argument is valid, those studies need not be submitted. However the application will remain in Category 4 and the fee will remain the same.

Conversely, the APVMA may determine that the application requires a greater assessment level than described above. For example:

• a major environmental safety assessment (equivalent to Module 7.1) may be required due to the significantly different nature of the new use
• a toxicology assessment equivalent to Module 3.2 may be required if an acceptable daily intake (ADI) has not been established for the proposed product
• a residues assessment equivalent to Module 5.1 may be required if the active constituent has not previously been used in a food crop.

In these instances the APVMA may require additional relevant data. However, the application will remain in Category 4 and the fee will remain the same.

A single Category 4 application may include more than one crop use on the label if the assessments described above encompass the crops. However, if there are deficiencies or requirements relating to only one of these assessments, none of the crop uses contained in the application can be approved until all deficiencies or requirements for all crops have been addressed satisfactorily. An alternative is for the applicant to remove one of the crop uses from the application.

If data deficiencies can only be satisfied by the generation of new data (eg by conducting new trials), applicants must make a separate new modular application (which will include screening, finalisation and relevant data modules and fees), in order to seek approval for the use that is subject to deficiencies or requirements. Argument and clarification using existing data are acceptable under the original application.

2.3.   Label

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

• two copies of the text label (TXL) printed on paper; or
• an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

• Labelling Code; and
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and
• Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

2.4.   Fee and timeframe

The fee for a Category 4 application is $23,330.

The timeframe is 15 months.

2.5.   Public consultation

Prior to approval of the active constituent and registration of the product, the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice called a Public Release Summary (PRS) which invites comment on the APVMA’s intention to approve the active constituent and register the product.

If the product is intended for use in crops that will result in residues in food or animal commodities, the APVMA will normally also publish a Trade Advice Notice (TAN), inviting comment.

2.6.   Data protection

Data protection applies for all applications which are assessed under Category 4 where the applicant is providing data to the APVMA that are eligible for protection. Publicly available data are ineligible for protection.

Applicants must provide a data list, including an entry for all information that meets the definition given on the APVMA website data protection page. This requirement applies irrespective of whether an application is eligible for data protection.

Applicants under Category 4 may need to refer to data relied on by the APVMA to approve the active constituent/s or register the first or following products containing the active constituents. Where the Category 4 applicant is not the authorising party for the data used to approve the active constituents or register the products, the applicant must obtain consent for use from the relevant authorising parties. Applicants can determine the presence of protected data by checking the product details on the product search facility on the APVMA website.

3.   EXAMPLES

Example 1: Application is made for registration of a new product containing an approved chemically-synthesised active constituent, for use as a fungicide in pome and stone fruit. This is a new formulation requiring scheduling by the National Drugs and Poisons Schedule Committee (NDPSC).

This application would be assessed under Category 4 because all data Parts and assessments listed in paragraph 2.2 would be required.

Chemistry data and toxicity data on the product formulation (or as a minimum on the individual ingredients) are required for all new formulations.

Residues data are required to demonstrate likely residues present (when used according to the maximum label rate), in order to determine a maximum residue limit (MRL) for the active constituent in the new food commodity.

Efficacy data are required to demonstrate the product will be effective for the new use in Australia when used in accordance with label directions.

New data may not be required for OHS or environment evaluation, because data already held by the APVMA from previous applications involving the active constituent may be sufficient to allow the OHS or environment assessments to be undertaken. However, the applicant should provide suitable argument in the Application Overview, using the current information, as to why the new use pattern will not pose unacceptable risks to workers or the environment.

Example 2: Application is made for registration of a new product containing an approved chemically-synthesised active constituent, for use as an insecticide in banana plantations. This is a new formulation requiring scheduling by the NDPSC.

This application would be assessed under Category 4 because all data Parts and assessments listed in paragraph 2.2 would be required.

The minimum data expected to be provided for this application are the same as discussed in Example 1. However, due to the possibly different levels of exposure coming from applying insecticide to banana bunches, worker exposure data and/or argument may be required.

Again, where a separate data volume is not provided, the applicant should provide suitable argument, in the Application Overview, using the current information as to why the new use pattern will not pose unacceptable risks to workers or the environment.

Example 3: Application is made for registration of a new product containing an approved chemically synthesised active constituent, for use as a post-emergent herbicide in cotton. The formulation is identical to another registered product with a different use pattern.

This application would not be assessed under Category 4 because there is no need for a chemistry assessment. Category 10 should be used and the appropriate modules chosen depending on the assessments required.

Example 4: Application is made for registration of a new product containing an approved chemically synthesised active constituent, for use as an insecticide in cereals. The active constituent has never before been used in crops.

This application would not be assessed under Category 4. A full residues assessment equivalent to Module 5.1 would be required rather than a reduced assessment equivalent to Module 5.2.

If the original registration did not need a full environmental data assessment due to the limited use or a full toxicological package due to the non-food use, then for this application the APVMA would require additional data and hence assessments as well.

For these reasons, the application would be assessed under Category 10 with the appropriate modules to cover the different assessments required.

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