10/03
16 July 2003
INITIAL/DRAFT ASSESSMENT REPORT (Section 36)
Executive Summary
Food Standards Australia New Zealand (FSANZ) received an Application (A463) from Swift and Company Ltd seeking approval of copper citrate (2% on a calcium bentonite base [1] ) as a processing aid in the production of wine. This application was received on the 7 February 2002 and commenced on 31 March 2003 under Workplan Group 2. The product containing copper citrate is commercially known as Kupzit R.
The Applicant is specifically applying for permission for use of copper citrate as a processing aid in Standard 1.3.3-Processing Aids and Standard 4.1.1-Wine Production Requirements (Australia only). Processing aids are required to undergo a pre-market safety assessment through an application to FSANZ before being offered for sale in Australia and New Zealand. The Application is considered to raise issues of minor significance or complexity only and will be progressed under section 36 of theFood Standards Australia New Zealand Act 1991(FSANZ Act).
Copper citrate is to be used to remove hydrogen sulphide from wine and is then filtered out of the wine. Therefore, there would be low levels of residual copper in the wine and copper citrate would not fulfil a technological function in the final product. The Applicant has requested no specific maximum permissions for use of copper citrate; rather, Good Manufacturing Practice (GMP) will ensure appropriate use of the processing aid.
The Initial/Draft Assessment Report concludes that copper citrate fulfils a specific technological purpose consistent with that of a processing aid and that it is safe by virtue of the previous extensive toxicological evaluation undertaken on copper under the review of the Australia New Zealand Food Standards Code. The use of copper citrate raises no additional safety concerns and is comparable in safety with already permitted forms of copper used as processing aids (eg copper sulphate).
No ingredient labelling of processing aids is required in the Australia New Zealand Food Standards Code and the regulatory impact analysis has concluded that the option to approve copper citrate has advantages for consumers and for industry. There are no identified disadvantages to the approval of copper citrate.
[1] Any reference to copper citrate in this Report refers to 2% copper citrate on a bentonite (clay) base