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 A1214 which seeks to permit the use of nicotinamide riboside chloride as a form of niacin in food for special medical purposes (FSMPs). The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Food Ministers’ Meeting[1], 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 amending the table to section S29—20 of the Code to include ‘nicotinamide riboside chloride’ in the list of permitted forms of niacin that may be added to FSMPs. The draft variation also amends Schedule 3 to include a specification for nicotinamide riboside chloride in that Schedule.
The amendments in the draft variation permit the use of nicotinamide riboside chloride as a form of niacin in FSMPs in accordance with the Code.
3. Documents incorporated by reference
The variation in this instrument does not incorporate any documents by reference.
However, the instrument will vary Schedule 3 of the Code which does incorporate documents
by reference. Section 1.1.1—15 of the Code requires certain substances (such as nutritive substances) to comply with any relevant identity and purity specifications listed in Schedule 3. Schedule 3 incorporates documents by reference to set specifications for various substances in the circumstances specified in that Schedule. The documents incorporated include: the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2017); the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition); and the Commission Regulation (EU) No 231/2012.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1214 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 22 April 2021 for a four week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement for the voluntary addition of a nutritive substance to food (OBPR correspondence dated 16 April 2013, reference 14943). This standing exemption was provided as permitting an additional nutritive substance to food is deregulatory as their use will be voluntary if the application is approved. This standing exemption relates to the introduction of a food to the food supply that has been determined to be safe.
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] amends Schedule 3.
Sub item [1.1] inserts a reference to ‘nicotinamide riboside chloride’ and its relevant provision into the table to S3—2(2), in alphabetical order. The table to S3—2(2) lists certain substances and their ‘relevant provisions’ i.e. provisions indicating where specifications for the listed substances are located in Schedule 3.
Sub item [1.2] inserts new section S3—44 into Schedule 3, which contains the new specification for ‘nicotinamide riboside chloride’.
Item [2] amends Schedule 29 by omitting the existing entry of ‘Niacin’ in the table to section S29—20 and substituting it with a new entry. The new entry for Niacin lists ‘nicotinamide riboside chloride’ as one of two permitted forms of Niacin that may be added to FSMPs. The effect of this amendment is that nicotinamide riboside chloride will be a permitted form of niacin that may be added to FSMPs in accordance with the Code.
[1] Formerly the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum). The Forum name change took effect on 21 February 2021 following a decision by Ministers.
Overview
The Food Standards Australia New Zealand Amendment (2021 Measure) Instrument 2021 was enacted to amend the Australia New Zealand Food Standards Code by permitting the use of nicotinamide riboside chloride as a form of niacin in food for special medical purposes. This legislative instrument responds to an application made to Food Standards Australia New Zealand (FSANZ) under the Food Standards Australia New Zealand Act 1991. FSANZ has accepted the application and approved a draft variation to the Code to allow for the use of this substance. The purpose of this instrument is to formally amend the Code to include nicotinamide riboside chloride as a permitted form of niacin in food for special medical purposes, thereby providing an additional option for the fortification of such foods. Enacted by the Commonwealth of Australia, the policy objective is to facilitate safe and voluntary additions of nutritive substances to food, ensuring that any new substances introduced are assessed for safety and comply with relevant standards and specifications.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) governs the development and variation of food regulatory measures, including standards, by Food Standards Australia New Zealand (the Authority). This legislation applies to the Authority, the food industry, and all entities involved in the manufacture, import, and distribution of food products within Australia and New Zealand. The Act extends its jurisdiction nationally, with its provisions applicable across the Commonwealth, including the states, territories, and national borders of both countries. The legislation does not specify any exclusions or thresholds but allows for variations to be made through subordinate instruments, which are subject to the approval process outlined in Division 1 of Part 3 of the FSANZ Act. This process includes mandatory public consultation and assessment of any proposed variations. Notably, the Act exempts certain non-disallowable instruments from requiring a statement of compatibility with human rights, reflecting the non-legislative nature of these instruments. The Authority's acceptance of Application A1214, which seeks to permit the use of nicotinamide riboside chloride as a form of niacin in food for special medical purposes, exemplifies this process and underscores the Authority's role in ensuring food safety and regulatory compliance across the region.
Key Provisions
The main operative sections of the legislation pertain to the variation of the Australia New Zealand Food Standards Code (the Code) to include nicotinamide riboside chloride as a permitted form of niacin in food for special medical purposes (FSMPs). Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) outlines the Authority's functions, including the development and variation of food regulatory measures. The Authority has accepted and approved a draft variation following the procedure specified in Division 1 of Part 3 of the FSANZ Act, and in consultation with the Food Ministers’ Meeting. The Authority must publish a notice about the standard or draft variation of a standard as per section 92 of the FSANZ Act, and the variation is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 as per section 94 of the FSANZ Act.
The obligations and requirements imposed by the Act on the parties or entities it governs include the development and variation of food regulatory measures, such as standards, in accordance with the procedures outlined in the FSANZ Act. The Authority must consider applications for the development or variation of food regulatory measures and conduct public consultation as necessary. The Authority must also publish a notice about the standard or draft variation of a standard as per section 92 of the FSANZ Act, and the variation is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 as per section 94 of the FSANZ Act. The Authority must also consider any relevant identity and purity specifications listed in Schedule 3 of the Code, which incorporates documents by reference to set specifications for various substances.
There are no specific offences, penalties, or civil/criminal consequences for breach mentioned in the legislation. However, the variation in this instrument does not incorporate any documents by reference, but the instrument will vary Schedule 3 of the Code which does incorporate documents by reference. The Office of Best Practice Regulation granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement for the voluntary addition of a nutritive substance to food, as permitting an additional nutritive substance to food is deregulatory as their use will be voluntary if the application is approved. This standing exemption relates to the introduction of a food to the food supply that has been determined to be safe. The 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.