This content is current only at the time of printing. This document was printed on 7 April 2020. A current copy is located at https://apvma.gov.au/taxonomy/term/18201
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I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
Applications to vary the shelf life details or storage conditions for registered products may be made via:
- Item 12: No data of a technical nature is required. This type of application is used when risks are equivalent to a registered product not subject to data protection
- Item 14: Technical modular application. All applications not meeting the requirements of Item 12.
Which application form do you need?
A number of active constituents are defined as “date-controlled”. When formulated into an agricultural product, the concentration of these active constituents may decline over time and any reaction taking place may also result in other toxic compounds. For this reason, products containing these active constituents have a defined shelf life and an expiry date must be included on the product label.
A date-controlled agricultural chemical product is a product containing any of the following active constituents:
- organisms (including nematodes, bacteria, viruses, algae or protozoa)
- Bacillus thuringiensis
Is a technical assessment required for my proposed variation?
Most variations of this type are likely to be made as Item 14 applications, as they will require a technical assessment.
For a variation to be processed without a technical assessment (Item 12), the application must only be supported by referencing another registered product (a reference product).
The suitability of a reference product includes the reference product as having:
- the same active constituent/s at the same concentration/s
- the other ingredients are the same or perform similar functions
- the same formulation type
- the label refers to the same crops, situations and pests
- the same label claims
- no limits on use of information apply (or consent has been provided).
Limits on use of information
When using a reference product, where there are limits on use of information on the product which is being referenced, written consent from the authorising party is required.