Examples - Type 13 - Item 14 (Ag) - Scenario 1

Scenario 1: Variation to the shelf life

Objective

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 undertaken real-time stability studies demonstrating that the product continues to meet the product specifications after two years in storage.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the extended shelf life does not impact the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

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

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 this extension for Modules 2–10.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

 

A limited chemistry assessment is required to assess the data provided to demonstrate that the product continues to meet the product specifications after two years in storage.

2.3

6 months

$1 954

3: Toxicology

No assessment required as the product is currently registered and relevant health standards have previously been established.

4: Toxicology—Poison scheduling

No assessment required as appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes that would change residues.

6: Work health and safety

No assessment required as the product is currently registered and the rate and method of application is unchanged.

7: Environment

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

8: Efficacy and safety

No assessment required as the registered product formulation and use pattern are unchanged.

9: Non-food trade

No assessment required as there are no changes to product risks to non-food trade.

10: Special data

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

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

8 months

$6 406

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