Examples – Type 14 – Item 14 (Ag): Scenario 2

Scenario 2: Application to vary a product formulation to for a home garden lawn product

Objective

A holder applies to vary the formulation of a registered home garden lawn product to add an alternate formulation that is similar to the existing formulation.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that if the formulation is changed, the product will continue to satisfy the safety, efficacy (including crop safety) and trade criteria.

The product is a home garden product so the efficacy of the new formulation is deemed under the Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014. However consideration still needs to be given to safety. The applicant has submitted bioequivalence data to demonstrate the crop safety of the new formulation compared to the existing formulation.

A chemistry package has been submitted to support the chemistry and manufacturing aspects of the new formulation.

No label update is required.

Note: if during assessment it is identified that there is a change that requires a WHS assessment (for example, an increase in a solvent that is an eye irritant), additional modules would be applied.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation.

2.3

6 months

$1 954

3: Toxicology

No assessment required if the formulation change does not alter the risk alter assessed for the product.

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is in place for the new solvent.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment is required as the product is registered and the formulation change does not affect the previously assessed risk to users.

7: Environment

No assessment required as there is no expected change to environmental risk.

8: Efficacy and safety

Assessment is required of the impact of changes to product formulation on the crop safety the product. Efficacy assessment is not required as the product is for home garden use only and is deemed to be effective according to the Efficacy Criteria Determination

8.3

3 months

$1 160

9: Non-food trade

No assessment required as the proposed formulation changes will not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the crop contain any GMOs.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12

N/A

$460

Total

 

8 months

$7 566

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Examples