Examples – Type 14 – Item 14 (Ag): Scenario 4

Scenario 4: Application to vary a product formulation to substitute a surfactant in an aquatic use product

Objective

An applicant applies to vary the formulation of a registered glyphosate product to substitute the current surfactant for a similar surfactant. The proposed new formulation is closely similar to the existing formulation, however the product is registered for use in aquatic situations and the proposed new surfactant has not been assessed for aquatic species.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the change in formulation will not affect the product’s capacity to meet safety, efficacy and trade criteria. As surfactants may pose a risk to aquatic environments, an assessment of the environmental impact the product on aquatic species is also required.

No label change is required.

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 not required if the change in surfactants does not alter the physico-chemical properties of the product.

3: Toxicology

No assessment required. The product is registered and the proposed changes do not affect the toxicology profile of the product.

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 to product residue risks.

6: Work health and safety

No assessment as the change in formulation does not alter the risk to users of the product.

7: Environment

An assessment is required to consider if changes to the formulation of the product alter risks relating to aquatic species.

7.3

4 months

$2 979

8: Efficacy and safety

An assessment is not required as there is no change to the efficacy or safety to target crop.

9: Non-food trade

No assessment required as minor formulation changes should 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

 

6 months

$7 431

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Examples