Neomycin
Neomycin is an aminoglycoside antibiotic used to treat bacterial infections in animals.
Neomycin review
Status: review in progress
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) considered neomycin on several occasions because of concerns that excessive residues of neomycin may remain in treated animals at injection sites and in the kidneys. Neomycin can cause nephrotoxicity (kidney damage) and ototoxicity (hearing loss and/or imbalance) in treated animals.
In March 2002 neomycin was nominated for review by the Victorian and New South Wales Departments of Primary Industry and the National Residue Survey (NRS) because of concerns that the use of oral, intramammary and injectable preparations of neomycin, in accordance with the registered use-pattern, could exceed the Australian Maximum Residue Limit (MRL). Neomycin residues exceeding the MRL posed a potential risk to human health through the consumption of meat and offal from treated animals, and a potential risk to Australian export trade with residues of treated animals being higher than the standards established for overseas markets.
In February 2007 the APVMA began a review of oral, intramammary and injectable products containing neomycin because of concerns about residues treated food-producing animals, possible effects to Australian trade, and the potential risks to animal safety. There were also concerns that the labels for registered products containing neomycin did not contain adequate instructions. However, no residue or animal safety concerns have been identified for topical formulations, neomycin used as an antibiotic preservation in small animal vaccines, or semen extender powder preparations.
The APVMA released the Neomycin Review Scope Document which outlined the information needed to conduct a comprehensive scientific assessment of neomycin and included a call for public submissions. The period for public comments and the submission of additional information closed on 11 May 2007.
Following the assessment the APVMA will release a Preliminary Review Findings (PRF) report outlining the proposed regulatory arrangements for the future use of neomycin. There will be a public consultation period providing all members of the community with an opportunity to comments on this report before it is finalised.
At the time this web summary was produced (August 2007) the review of neomycin was still in progress. The APVMA will issue a final report once the assessment of all available data is completed.
| Review Report | Date |
|---|---|
| No report available |
Contact
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Product Search
Search the PUBCRIS database for registered products that contain neomycin.
APVMA neomycin archive
| Title | Date |
|---|---|
| Neomycin Review – Scope Document (PDF, 227kb) | (RTF, 287kb) | Feb 2007 |
| Neomycin FAQ | Feb 2007 |
| Gazette Notice: Reconsideration of approvals and registrations related to neomycin | Feb 2007 |