Category 3 application
Registration of a new chemical product with an approved active constituent where no registered chemical product contains the active constituent

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 3 application as:

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

1. there is no registered chemical product containing the active constituent; and
2. a full assessment of the chemical product is required.

Category 3 applications may be made for registration of a new product, where one or more of the approved active constituents has not previously been included in a registered product.

A full¹ assessment for Category 3 is where a comprehensive assessment of data for the product is required for the following data Parts:

and a limited assessment of data for the product is required for the following data Parts:

Where applicable, the following data may also be required:

Note: The Parts relate to Volume 3: Data requirements and guidelines.

The list of data studies for a full (comprehensive) assessment may be determined by reference to Module levels for modular categories in Volume 3. The studies required for Category 3 applications are described in Level 1 of the relevant modules.

Further information on data requirements and guidelines may be found in Parts 1–10 of Volume 3.

1.1.   Agricultural products which do not require a Category 3 application

Some products will not require a full (comprehensive) assessment of residues and trade, or occupational health and safety, or environment, or efficacy and safety, or poisons scheduling. These product applications will be eligible for evaluation under Category 10. Examples are:

• products which are not proposed for use on crops for human food or animal feed (residues assessment not required)
• products to be used by the householder in the home and home garden (OHS assessment not usually required)
• products to be used as a treatment for stored produce or goods (limited environmental assessment required).

Category 10 is a modular category which allows reduced levels of assessment (as appropriate) for the data Parts listed above. See the Category 10 chapter in this volume for more information.

2.   REQUIREMENTS

When making a Category 3 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 (KP25F04) which is available on the APVMA website. 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.

When the product is only for use in a non-food situation, sub-part 1.5 need only state this fact and a separate Part 5 (Residues and Trade) need not be submitted.

2.2.   Data

Data requirements for Category 3 applications are as follows:

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

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 3 application is $31,750.

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 3 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 at http://www.apvma.gov.au/registration/data_protection.shtml . This requirement applies irrespective of whether an application is eligible for data protection.

Applicants under Category 3 may need to refer to data relied on by the APVMA to approve the active constituents. Where the Category 3 applicant is not the authorising party for the data used to approve an active constituent, 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 that is being used for the first time, for use as an insecticide on pulse cereal crops.

This application requires a full data package and would be assessed under Category 3.

Example 2: Application is made for registration of a new product containing an approved chemically-synthesised active constituent that is being used for the first time, for use as a broadleaf selective herbicide in pasture.

This application requires a full data package and would be assessed under Category 3.

Example 3: Application is made for a new product containing an approved biologically-derived active constituent that is being used for the first time, for use as a fungicide in vegetables. The active constituent is derived from the spores of another fungus.

If toxicological data demonstrate negligible mammalian toxicity, a full residues assessment would not be required and this application could be assessed under the modular Category 10.

Example 4: Application is made for registration of a new product containing an approved biologically derived active constituent that is being used for the first time, for use as an insecticide in vegetables. The active constituent is the extract of a native plant.

If the plant extract is not highly purified and is of low toxicological significance, a full residues assessment would not be required. This application could be assessed under the modular Category 10.

Example 5: Application is made for registration of a new product containing an approved chemically-synthesised active constituent that is being used for the first time, for use as a personal insect repellent.

This application would be assessed under Category 10 because full (comprehensive) assessment would not be required for residues, OHS or environment.

Footnotes

1. A full assessment for Category 3 is equivalent to the following modules in Schedule 7 of the Agvet Code Regulations: Modules 1, 2.3, 3.3, 4, 5.1, 6.1, 7.1, 8.1, 11.1 and 12.

Revision history