A460-MRLs(Antibiotics)IDAR ExecSum

INITIAL/DRAFTASSESSMENT

(Preliminary/FULL ASSESSMENT - ss.13/15 - s.36)

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EXECUTIVE SUMMARY

• This Application (A460) seeks to amend Maximum Residue Limits (MRLs) for the antibiotic cephapirin in cattle meat, milk and offal and semduramicin in chicken fat/skin, kidney, liver and meat in the Food Standards Code. It is a routine application from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), to update the Food Standards Code in order to reflect current registration status of cephapirin and semduramicin in use in Australia.
• On 24 November 2000, the Australia New Zealand Food Standards Council (ANZFSC) adopted the Australia New Zealand Food Standards Code (published as Volume 2 of the Food Standards Code ). Subsequently, all applications to amend MRLs will now also be incorporated into Volumes 1 and 2 of the Food Standards Code (Standard A14 and Standard 1.4.2 respectively). Consequently, all references throughout this document to the Food Standards Code are references to both Volumes 1 and 2 of the Food Standards Code.

• The Agreement between the Commonwealth of Australia and the Government of New Zealand to establish a system for the development of joint food standards (the Treaty), excluded MRLs for agricultural and veterinary chemicals in food from the joint Australia New Zealand food standards setting system. Australia and New Zealand separately and independently develop MRLs for agricultural and veterinary chemicals in food.

• The Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Aged Care has undertaken a toxicological assessment of the antibiotics cephapirin and semduramicin and has established acceptable daily intakes(ADI).

• The Expert Advisory Group on Antimicrobial Resistance (EAGAR) has considered the issue of the potential for antimicrobial resistance developing as a result of dietary exposure to cephapirin and semduramicin residues in food. EAGAR did not raise any objections in terms of either the use or the residues associated with the use of these antibiotics.

• The dietary exposure assessments indicate that the residues associated with the proposed MRLs for cephapirin and semduramicin do not represent an unacceptable risk to public health and safety.

• None of the Australia New Zealand Food Authority' s (ANZFA' s) section 10 objectives of food regulatory measures are compromised by the proposed change.

• ANZFA will make a Sanitary and Phytosanitary notification to the World Trade Organization at the Initial / Draft Assessment (Preliminary Assessment - s.13 / Full Assessment - s.15).

Full Report [ pdf 193kb ]