Examples – Type 13 – Item 12 (Ag): Scenario 2

Scenario 2: Variation to the shelf life of a date-controlled agricultural product that does require a change to the label

Objective

An application is made to extend the current shelf life for an agricultural chemical product containing Bacillus thuringiensis from 12 months to two years. The current label includes the statement that the product 'not be exposed to extremes of temperature'.

The applicant has nominated a closely similar registered reference product that has a shelf life of two years if the product is stored at 20°C. The reference product has the same active at the same concentration, the same other ingredients, is the same formation type and has the same label claims. There is no protected data.

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, and the proposed amendment does not require a technical assessment.

An updated label reflecting the changed instructions is required.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there is no change to the product formulation. The change to shelf life has been assessed for the reference product.

3: Toxicology

 

The product is registered and there is no change to the risks previously assessed

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered and there is no change to the risks to residues and trade

6: Work health and safety

The product is currently registered and there is no change to the risks for work health and safety

7: Environment

The product is currently registered and there is no change to the risks to the environment

8: Efficacy and safety

The product is registered and there is no change to the risks previously assessed

9:  Non-food trade

The product is registered and there is no change to the risks previously assessed

10: Special data

The product is registered and there is no change to the risks previously assessed

Application type

Timeframe

Extended Timeframe

Fee

Item 12

3 months

5 months

$2 018

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Examples