This content is current only at the time of printing. This document was printed on 21 January 2021. A current copy is located at https://apvma.gov.au/node/43066
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Scheduled excipients in agricultural chemical formulations
Agricultural chemicals can contain other ingredients in addition to the active constituents. These non-active constituents or excipients generally are not required to be included on the product label, unless they are scheduled poisons according to the current Poisons Standard.
The Agvet Code, Agvet Regulations and Agricultural Labelling Code require that the label of an agricultural chemical product must include the name and proportion of any constituent contained in the formulation that is a scheduled poison. The appropriate signal heading (for example, CAUTION or POISON) must also be displayed on the label.
Common excipients in agricultural chemical products that are scheduled poisons and required to be on the label (at various concentrations) include:
- ethylene glycol
- diethylene glycol
- diethylene glycol monobutyl ether
- polyethanoxy (15) tallow amine (also called tallow amine ethoxylate)
Please check the Poisons Standard for all scheduled chemicals. Some of these common scheduled excipients will also require additional first aid and safety directions as required by the First Aid and Safety Directions (FAISD) handbook.
It is a holder’s responsibility to ensure their product labels comply with the relevant legislation including the Agvet Code, Agricultural Labelling Code, the Poisons Standard and the FAISD Handbook. When submitting an application to register an agricultural chemical product, please ensure that any scheduled excipients in the formulation are included on the proposed label. If you are the holder of a product that contains a scheduled excipient that is not on the approved product label, you are required to submit a variation application to the APVMA to update your label.
Please send any questions on this to firstname.lastname@example.org.