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 A1143 which seeks permission for the sale and use of food derived from a genetically modified canola line, NS-B50027-4, which produces long-chain omega-3 fatty acids, particularly docosahexaenoic acid (DHA) in the seed. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved 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 purpose of this instrument is to vary Schedule 26 of the Code to permit the sale, or use in food, of food derived from DHA canola line NS-B50027-4 and to ensure that labelling requirements set out in section 1.5.2–4, in relation to such food, are met.
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 A1143 included one round of public consultation following an assessment and the preparation of a draft variation. Submissions were called for on 14 September 2017 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR), in a letter to FSANZ dated 24 November 2010, granted a standing exemption from the need for the OBPR to assess if a Regulatory Impact Statement is required for the approval of genetically modified foods (ref 12065). Therefore, a Regulation Impact Statement was not required in this case because the proposed variation to Schedule 26 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
Subitem [1.1] inserts into subsection S26—3(2) of Schedule 26 of the Code a reference to item 1(g) of the table to subsection S26—3(4). The effect of this change will be to require a food for sale that consists of DHA canola line NS-B50027-4 or that has the latter as an ingredient to comply with the labelling requirement imposed by section 1.5.2—4 of the Code.
Subitem [1.2] inserts paragraph (g) into item 1 of the table to subsection S26—3(4) in Schedule 26. The new paragraph refers to DHA canola line NS-B50027-4. It also states that oil derived from DHA canola line NS-B50027-4 must not be used as an ingredient in infant formula products. The effect of the change is to permit the sale and use of food derived from that canola line in accordance with Standard 1.5.2, subject to the limitation that oil derived from DHA canola line NS-B50027-4 not be used as an ingredient in infant formula products.