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.
Overview
The legislative instrument F2018L00132, published under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), was introduced to address the need for updating food standards to include a new genetically modified canola line, specifically NS-B50027-4, which produces long-chain omega-3 fatty acids, particularly docosahexaenoic acid (DHA) in the seed. Enacted by the Parliament of Australia, this legislative instrument aims to facilitate the sale and use of food products derived from this genetically modified canola while ensuring compliance with existing labelling requirements. The instrument responds to an application by the Authority to vary food regulatory measures, following a public consultation and assessment. It allows for the inclusion of this genetically modified canola in the Australia New Zealand Food Standards Code, subject to specific labelling conditions and a restriction on using the derived oil in infant formula products.
Scope and Application
The F2018L00132 instrument pertains to the Food Standards Australia New Zealand Act 1991 (FSANZ Act), which outlines the functions of Food Standards Australia New Zealand (FSANZ) including the development and variation of standards for the Australia New Zealand Food Standards Code. This particular instrument focuses on Application A1143, which seeks approval for the sale and use of food derived from a genetically modified canola line, NS-B50027-4, producing long-chain omega-3 fatty acids, specifically docosahexaenoic acid (DHA) in the seed. The instrument aims to vary Schedule 26 of the Code to allow the sale and use of food derived from this specific canola line, while ensuring compliance with labelling requirements. The Authority’s consideration of the application included a round of public consultation, and the instrument is exempt from requiring a Regulatory Impact Statement due to its minor impact on business and individuals. The variations introduced by this instrument include specific labelling requirements for food containing DHA canola line NS-B50027-4, and a prohibition on using oil derived from this canola line in infant formula products.
Key Provisions
The primary sections of this legislation are concerned with the variation of the Australia New Zealand Food Standards Code (the Code) to allow 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. This variation follows the consideration of Application A1143 by Food Standards Australia New Zealand (the Authority), as provided for in section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). After the Authority’s approval, the Australia and New Zealand Ministerial Forum on Food Regulation must consider the draft variation, and section 92 of the FSANZ Act requires that a notice be published regarding the standard or draft variation of a standard. The variation becomes a legislative instrument, as specified in section 94 of the FSANZ Act, which is not subject to parliamentary disallowance or sunsetting.
The obligations imposed by this legislation are primarily on the Authority and entities wishing to sell or use the genetically modified canola line. The Authority must follow the procedures outlined in Division 1 of Part 3 of the FSANZ Act, which includes accepting applications and considering them in accordance with specified processes. Additionally, the Authority must publish a notice about the variation as per section 92 of the FSANZ Act. For entities selling or using food derived from the genetically modified canola line, compliance with labelling requirements set out in section 1.5.2–4 of the Code is mandatory. Specifically, section 1.1 of the variation mandates that any food consisting of or containing DHA canola line NS-B50027-4 must adhere to these labelling requirements. Furthermore, section 1.2 of the variation explicitly prohibits the use of oil derived from this canola line as an ingredient in infant formula products.
The FSANZ Act does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of the new standards set by this legislation. However, non-compliance with food standards in general could lead to enforcement actions under the FSANZ Act, which may include fines, legal action, and other regulatory measures. The specific penalties for non-compliance with food standards would be determined by the relevant authorities, including the courts, based on the nature and severity of the breach. Additionally, failure to meet labelling requirements may result in actions by consumer protection agencies, which could include fines and other corrective measures.