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 A1151 which seeks to permit the use of β-galactosidase derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC) as a processing aid in the production of galacto-oligosaccharide (GOS) from lactose. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft Standard.
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 draft variation of a standard.
Section 94 of the FSANZ Act specifies that 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 purpose of the variation is to permit the use of the enzyme β-galactosidase, derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC), as a processing aid to produce GOS from lactose.
3. Documents incorporated by reference
The variation to food regulatory measures 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 A1151 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 1 March 2018 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Schedule 18 are 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 inserts a new entry into the table to subsection S18—9(3) in Schedule 18 of the Code.
The effect of the new entry is to permit the use of the enzyme β-galactosidase (EC number 3.2.1.23), derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE‑BLC), as a processing aid in food for the technological purpose of producing GOS from lactose, subject to the condition that the amount used must be consistent with good manufacturing practice (GMP).