Explanatory Statement
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
FSANZ accepted Application A1061 which seeks to approve the use of a new enzyme processing aid, amylomaltase sourced from Bacillus amyloliquefaciens containing the gene for amylomaltase derived from Thermus thermophilus (for use to produce modified potato starch as an ingredient in food). The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation of a standard.
Following consideration by the COAG Legislative and Governance Forum on Food Regulation[1] (the Forum), section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the standard or draft variation of a standard.
Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003.
2. Purpose and operation
Currently there is no permission in the Code for the use of amylomaltase sourced from genetically modified B. amyloliquefaciens as a processing aid.
The Authority has approved the draft variation to the Table to clause 17 of Standard 1.3.3 – Processing Aids, to permit the use of amylomaltase EC 2.4.1.25 sourced from B. amyloliquefaciens containing the T. thermophilus gene for amylomaltase.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1061 has included one round of public consultation following an assessment and the preparation of a draft Standard. An Assessment Report (which included the draft Standard) was released for consultation on 31 October 2011 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Standard 1.3.3 is likely to have a minor impact on business and individuals.
5. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act.
6. Variation
Item [1] inserts an entry into the Table to clause 17 of Standard 1.3.3 to permit the use of amylomaltase from genetically modified B. amyloliquefaciens in the course of manufacture of any food sold in Australia and New Zealand provided the amylomaltase gene is derived from T. thermophilus.
[1] Previously known as the Australia and New Zealand Food Regulation Ministerial Council