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08/03
19 March 2003
FINAL ASSESSMENT REPORT
Executive Summary
This Application (A478) seeks to amend the Maximum Residue Limits (MRLs) for the insecticide endosulfan in brassica and leafy vegetables in the Australia New Zealand Food Standards Code. It is an application from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), to update the Code in order to reflect the current registration status of endosulfan use in Australia and to remove the MRLs that are no longer necessary.
The NRA has amended the registration of endosulfan products to prohibit their use on Brussels sprouts and leafy vegetables. As a result the NRA has proposed the deletion of endosulfan MRLs for these foods.
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 independently and separately develop MRLs for agricultural and veterinary chemicals in food.
The dietary exposure assessments indicate that the residues associated with the revised proposed MRLs for endosulfan do not represent an unacceptable risk to public health and safety.
Statement of Reasons
FSANZ recommends progressing the Application for the following reasons:
- New residue trials data assessed by the NRA as part of its Existing Chemicals Review Program has shown that the current use of endosulfan on some vegetables may result in residues that represent an unacceptable risk to public health and safety. Specifically, estimates of the acute dietary exposure indicate that the acute reference dose may be exceeded from the current use on Brussels sprouts and the leafy vegetables, silver beet, Chinese cabbage, choi sum, all lettuce varieties, cress, Japanese greens (mizuna and Indian mustard), spinach, pak choi and bok choi.
- This Application proposes that the existing MRLs of 2 mg/kg for the commodity groups Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas and Leafy vegetables (including brassica leafy vegetables) be amended to specifically remove MRLs for all those commodities for which there may be an unacceptable risk to public health and safety. The MRLs for the specific commodities of broccoli, cabbage head and cauliflower need to be retained as the current use of endosulfan on these vegetables would result in residues that do not present an unacceptable risk to public health and safety.
- The dietary exposure assessments indicate that the residues associated with the proposed MRLs for endosulfan do not represent an unacceptable risk to public health and safety. The NRA has already amended the registration status of endosulfan and the rejection of the proposed MRLs would leave MRLs in the Code that do not reflect this amended registration status.
- The NRA has assessed appropriate toxicology, residue, animal transfer, processing and metabolism studies, in accordance with theGuidelines for Registering Agricultural and Veterinary Chemicals, the Ag and Vet Requirements Series, 1997, to support the deletion of the use of this chemical on the commodities as outlined in this Application.
- The Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Ageing has undertaken an appropriate toxicological assessment of endosulfan and has established an ADI and the ARfD.
- None of FSANZ's section 10 objectives of food regulatory measures are compromised by the proposed changes.
FSANZ has undertaken a preliminary regulation impact assessment process. That process has concluded that the amendment to the Food Standards Code is necessary, cost-effective and of benefit to both producers and consumers.
Full Report [ pdf 259 kb | Word Document 334 kb ]