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 A1102 which seeks to amend the Code to permit the addition of L-carnitine to a range of general purpose foods and some special purpose food classes, including formulated supplementary sports food, regulated under Standard 2.9.4.
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 200
2. Purpose
The Authority has approved a draft variation to the table to section S29—19 of Schedule 29 of the Code. The variation will increase the maximum amount of L-carnitine that may be added to formulated supplementary sports food.
3. Documents incorporated by reference
The variation 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 A1102 included one round of public consultation following an assessment and the preparation of a draft standard and associated assessment summary.
Submissions were called for on 13 September 2018 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to the table to Section S29—19 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
Item [1] of the approved draft variation amends the table to S29—19 in Schedule 29 of the Code. The item omits the existing entry in the table for L‑carnitine and substitutes a new entry for L‑carnitine with an increased maximum amount.
The effect of the variation is to permit the use of L‑carnitine as a nutritive substance in formulated supplementary sports foods subject to the condition that the maximum amount of L‑carnitine that may be added to a one-day quantity of a formulated supplementary sports foods is 2 grams.
Overview
The Food Standards Australia New Zealand Amendment (L-carnitine) Instrument 2019 (F2019L00996) was enacted to address the need to amend the Australia New Zealand Food Standards Code by permitting the addition of L-carnitine to certain foods, including formulated supplementary sports food. This legislative instrument is a result of Application A1102, which the Food Standards Australia New Zealand (FSANZ) Authority considered in accordance with the Food Standards Australia New Zealand Act 1991 (FSANZ Act). FSANZ's consideration process included one round of public consultation, as outlined in Division 1 of Part 3 of the FSANZ Act. The Authority has approved a draft variation to the Code to increase the maximum amount of L-carnitine that may be added to formulated supplementary sports food. This amendment aims to update the standards in the Code to allow for the use of L-carnitine as a nutritive substance in the specified food categories, subject to certain conditions. The policy objective is to ensure food standards in Australia and New Zealand remain current and reflect scientific advancements and consumer needs.
Scope and Application
The Food Standards Australia New Zealand Act 1991 establishes the framework within which Food Standards Australia New Zealand (FSANZ) operates, including the development and variation of food standards in the Australia New Zealand Food Standards Code. This Act applies to FSANZ, and by extension, to food businesses, manufacturers, and consumers within Australia and New Zealand, as it governs the food regulatory measures and standards that these entities must adhere to. The legislation outlines the procedure for considering applications to develop or vary food standards, which includes a process of public consultation and assessment. The scope of this particular legislative instrument focuses on a draft variation to the Code to permit the addition of L-carnitine to formulated supplementary sports foods, increasing the maximum permissible amount of L-carnitine. This legislative instrument does not extend its application to other foods or substances beyond the scope specified in the variation. The instrument is not subject to disallowance or sunsetting under the Legislation Act 2003 and is exempt from the requirement to include a statement of compatibility with human rights.
Key Provisions
The key provision of this legislation is the approved draft variation to the Australia New Zealand Food Standards Code (the Code), specifically amending the maximum amount of L-carnitine that may be added to formulated supplementary sports food. This is pursuant to the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). The Authority has accepted and considered Application A1102 (s13 FSANZ Act) and has approved the draft variation to the Code, which will now be published in accordance with section 92 of the FSANZ Act. This amendment will allow for the addition of L-carnitine as a nutritive substance in formulated supplementary sports food, with a maximum amount of 2 grams per one-day quantity (Item [1]).
Under the FSANZ Act, the Authority is required to consider applications for the development or variation of food regulatory measures and to follow the procedure outlined in Division 1 of Part 3. This includes conducting one round of public consultation, as was done in the case of Application A1102 (s92 FSANZ Act). The Authority must also publish a notice about the standard or draft variation of a standard once it has been approved (s94 FSANZ Act). The Authority must adhere to these obligations to ensure the proper consideration and implementation of food regulatory measures.
Breach of the provisions of the FSANZ Act could result in civil or criminal consequences, depending on the nature of the offence. For instance, section 26 of the FSANZ Act provides that a person who contravenes certain provisions of the Act may be liable to a civil penalty not exceeding the greater of $22,200, three times the benefit obtained, or three times the loss caused. For criminal offences under the FSANZ Act, the maximum penalties can be substantial, with fines up to $222,000 for individuals and $1,110,000 for bodies corporate, depending on the seriousness of the offence (s36 FSANZ Act). Therefore, compliance with the FSANZ Act and its associated regulations is crucial for all parties involved in the development and variation of food regulatory measures.
In summary, this legislation approves a draft variation to the Australia New Zealand Food Standards Code, allowing for the addition of L-carnitine as a nutritive substance in formulated supplementary sports food, subject to a maximum amount of 2 grams per one-day quantity. The Authority has followed the required procedure under the FSANZ Act, including one round of public consultation. Failure to comply with the provisions of the FSANZ Act may result in civil or criminal penalties, with the potential for substantial fines. Therefore, adherence to the Act and its associated regulations is essential for all parties involved in the development and variation of food regulatory measures.