Federal Register of Legislation - Australian Government

Primary content

Food Standards as made
The instrument varies standards in the Australia New Zealand Food Standards Code.
Administered by: Health
Exempt from sunsetting by the Food Standards Australia New Zealand Act 1991 s 94
Registered 31 May 2019
Tabling HistoryDate
Tabled HR02-Jul-2019
Tabled Senate02-Jul-2019
Date of repeal 07 Jun 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

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.

 

The Authority accepted application A1167 which seeks to permit the use of a β-galactosidase enzyme from Bacillus subtilis as a processing aid for use in dairy processing. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation to the Code.

 

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 approved a draft variation to permit the enzyme β-galactosidase sourced from Bacillus subtilis containing the gene for β-galactosidase from Bifidobacterium bifidum, to be used as a processing aid for use in the production of low lactose and lactose free dairy products and galacto-oligosaccharides at GMP. This permission requires an addition to the table to subsection S18—9(3) in Schedule 18.

 

3.       Documents incorporated by reference

 

The variations to food regulatory measures do not incorporate any documents by reference.

 

Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the processing aid to be permitted by the draft variation. Section 1.1.1—15 of the Code requires substances used as processing aids to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2016) and the United States Pharmacopeial Convention (2016) Food Chemicals Codex (10th edition). These include specifications for enzyme preparations used in food processing.

 

4.       Consultation

 

In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1167 included one round of public consultation following assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 22 November 2018 for an eight-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

 

The approved draft variation inserts a new entry into the table to subsection S18—9(3) in Schedule 18.

 

The new entry will permit the use of the enzyme, β-galactosidase (EC 3.2.1.23) sourced from Bacillus subtilis containing the gene for β-galactosidase from Bifidobacterium bifidum, as a processing aid in food for a specific technological purpose, with the condition that the maximum permitted level or amount that may be used must be consistent with good manufacturing practice. The technological purpose is for use in the production low lactose and lactose free dairy products and galacto-oligosaccharides.