Explanatory Statement
Food Standards (Application A1057 – Endo-protease (EC 3.4.21.26) as a Processing Aid (Enzyme)) Variation
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 A1057 which sought approval of a new enzyme processing aid, an endo-protease (EC 3.4.21.26) sourced from a genetically modified Aspergillus niger microorganism, to be used as a processing aid. The Authority considered the Application in accordance with Division 1 of Part 3 and approved a variation to Standard 1.3.3. FSANZ notified the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) of the approval.
Following consideration by Ministerial Council, section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the draft 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 for using this endo-protease sourced from a genetically modified Aspergillus niger microorganism, to process food. The variation is proposed to address this.
3. Documents incorporated by reference
The variation does 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 A1057 has included one round of public consultation following an assessment and the preparation of the draft variation. An Assessment Report (which included the draft Standard) was released for consultation on 18 July 2011 for a six-week consultation period.
A Regulation Impact Statement (RIS) was not required because the 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 97 of the FSANZ Act.
6. Variations
Item [1] inserts a permission in the Table to clause 17 of Standard 1.3.3 to permit the use of endo-protease (EC 3.4.21.26) sourced from Aspergillus niger as an enzyme processing aid from microbial sources able to be used in the manufacture of any food.