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 A1135 which seeks to permit the use of a genetically modified strain of Bacillus licheniformis as a new source for the enzyme β-galactosidase (lactase) as a processing aid. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, 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 Legislation Act 2003.
2. Purpose
The Authority has prepared an amendment to the Code to permit a new microbial source for the enzyme ‘β-Galactosidase (EC number 3.2.1.23)’, namely Bacillus licheniformis containing the gene for β-Galactosidase isolated from Bifidobacterium bifidum.
The effect of the proposed variation is to permit the use of the enzyme β-Galactosidase (EC number 3.2.1.23) derived from this new source as a processing aid in food in accordance with Standard 1.3.3– Processing aids.
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 A1135 included one round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. Submissions were called for on 2nd February 2017 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 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 of the variation amends Schedule 18 of the Code by omitting the entry for the enzyme ‘β-Galactosidase (EC 3.2.1.23)’ in the table to subsection S18––4(5) and substituting it with a new entry for that enzyme.
The new entry includes an additional microbial source for the enzyme β-Galactosidase (EC 3.2.1.23), Bacillus licheniformis, containing the gene for β-Galactosidase isolated from Bifidobacterium bifidum.