The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published its final regulatory decisions for the reconsideration of neomycin, an antibiotic contained in certain veterinary products for use in both companion and food-producing animals.
The final decisions varied and then affirmed all 7 chemical product registrations and associated label approvals within scope of the reconsideration.
The APVMA varied the conditions of registration to require that holders of neomycin products undertake additional trials within 2 years of the decision, to fully determine the level of residues remaining after treatment with neomycin.
This will allow calculation of permanent Maximum Residue Limits (MRLs), and withholding periods (the minimum time that must elapse between administration of neomycin to an animal and their processing for food)
The current temporary MRLs will remain in place until this additional data has been evaluated.
There is no concern related to food safety in taking this approach.
Minor changes have also been made to the instructions for use to improve worker health and safety and that of treated animals.
Neomycin was nominated for reconsideration due to concerns that its use in various forms could exceed the Australian MRLs and considered the risks posed by residues in food, risk to trade and animal safety.
The reconsideration related to the use of oral, intramammary (to treat conditions such as mastitis in dairy cows) and injectable preparations of neomycin, in accordance with the registered use pattern.
A summary of the underlying risk assessments and the product-specific assessment outcomes, including consideration of the submissions received during the 3-month public consultation period that ended on 26 May 2024, has been published in the Neomycin Final Review Technical Report.
The APVMA Gazette No 19, Tuesday 16 September 2025 includes more information about the decision.
Enquiries about the decision can be directed to enquiries@apvma.gov.au.
Media enquiries must be directed to media@apvma.gov.au.