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 A1111 which seeks approval for a preparation of two bacteriophages (S16 and FO1a) (tradename Salmonelex™) as a processing aid to reduce Salmonella contamination in specific foods. The Authority considered the Application in accordance with Division 1 of Part 3 and has proposed 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 proposed that Salmonella phage preparation (S16 and FO1a) be added to the list of approved processing aids with miscellaneous technological functions for use in specific foods. The table to section S18―9 in Schedule 18 lists permissions for these processing aids, as well as the foods and levels which are allowed. An entry for Salmonella phage preparation (S16 and FO1a) will be included for use on the surface of raw meat and raw poultry meat during processing at levels up to Good Manufacturing Practice (GMP). A specification stating what the preparation is composed of will also be included into Schedule 3.
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 A1111 included one round of public consultation following an assessment and the preparation of a draft variation and associated report.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 and Schedule 3 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] varies Schedule 3.
Item [1.1] amends the table to subsection S3—2(2) by inserting a reference to Salmonella phage preparation (S16 and FO1a) and to new subsection S3—33. This in effect provides that the specification listed in new subsection S3—33 is the specification for Salmonella phage preparation (S16 and FO1a).
Item [1.2] new subsection S3—33 into Schedule 3. The new subsection provides a compositional specification for Salmonella phage preparation (S16 and FO1a) (S3—33) by reference to the biological classification of its component phages.
Item [2] varies Schedule 18 by amending the table to section S18―9 to include an entry for Salmonella phage preparation (S16 and FO1a) in the list of approved processing aids with miscellaneous technological functions. The new entry states that the phage preparation can be used for the technological purpose of reducing Salmonella species on the surface of raw meat and raw poultry meat during processing. The entry also states that the maximum permitted level is that which is consistent with GMP.