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 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
The Authority prepared Proposal P1031 to allow for specific exemptions from mandatory allergen declarations. The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved a draft Standard.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[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 the variation to Standard 1.2.3 to exempt certain foods and ingredients derived from allergenic foods from mandatory declaration of allergens where available evidence indicates the production methods used remove or reduce allergenic proteins to levels that are of negligible risk to allergic consumers. These foods and ingredients are glucose syrups from wheat starch, fully refined soy oil, soy derivatives (tocopherols and phytosterols), and distilled alcohol from wheat or whey.
The Authority has also approved the variation to Schedule 10 to remove the requirement to declare in the statement of ingredients the specific source name for soybean oil that has been appropriately refined.
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 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1031 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 12 August 2015 for a six-week consultation period.
Further targeted consultation was undertaken with key stakeholders including industry and consumer representatives. Advice on the risk assessment was sought from the Food Allergy and Intolerance Scientific Advisory Group.
A Regulation Impact Statement was not required because the proposed variations to Standard 1.2.3 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] of Schedule 1 of the variation amends Standard 1.2.3
Item [1.1] inserts sub‑subparagraphs (A), (B) and (C) into subparagraph 1.2.3—(4)(1)(b)(i). Each sub-paragraph provides an exemption from the mandatory allergen declaration for cereals containing gluten. Sub-subparagraph (A) maintains the subparagraph’s existing exemption for substances present in beer and spirits. Sub‑subparagraph (B) provides a new exemption for glucose syrups derived from wheat that contain the lowest levels of gluten protein reasonably achievable and contain no more than 20 mg gluten/kg glucose syrup. Sub-subparagraph (C) provides a new exemption for alcohol distillates derived from wheat.
Item [1.2] amends subparagraph 1.2.3—(4)(1)(b)(v) by inserting the words ‘other than alcohol distilled from whey’. The effect of this amendment is to exempt alcohol distillates derived from whey from the mandatory allergen declaration requirements for milk or products of milk.
Item [1.3] inserts sub-subparagraphs (A) and (B) into subparagraph 1.2.3—(4)(1)(b)(vii). Each sub-subparagraph provides an exemption from the mandatory allergen declaration requirements for soybeans. Sub-subparagraph (A) provides an exemption for oils derived from soybeans provided that the oils have been degummed, neutralised, bleached and deodorised. Sub-subparagraph (B) provides an exemption for tocopherols and phytosterols derived from soybeans.
Item [1.4] inserts new subsection 1.2.3—(4)(3) into the Standard. The new subsection makes clear that subsection 1.2.3—(4)(1) does not require the declaration of the presence of a food or substance derived from a food or product exempted from declaration under paragraph 1.2.3—(4)(1)(b). For example, the declaration of the presence of a product of vinegar derived from alcohol distilled from whey is not required as subsection 1.2.3—(4)(2) exempts alcohol distilled from wheat or from whey from declaration.
Item [2] of Schedule 2 of the variation amends the entry for ‘fats or oils’ in the Table to section S10—2 in Schedule 10. The effect of this amendment is to remove the requirement to declare in the statement of ingredients the specific source name for soybean oil that has been degummed, neutralised, bleached and deodorised.
[1] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Amendment Regulation 2016 (F2016L00783) was enacted to address the need for specific exemptions from mandatory allergen declarations in food products. This regulation was introduced to align with the provisions of the Food Standards Australia New Zealand Act 1991, which empowers Food Standards Australia New Zealand (FSANZ) to develop and vary food standards. The objective of this regulation is to exempt certain foods and ingredients derived from allergenic sources from mandatory allergen declarations when evidence shows that the production methods effectively reduce allergenic proteins to levels posing negligible risk to allergic consumers. The regulation was developed following a public consultation and expert advice, ensuring that the changes are informed by scientific evidence and stakeholder input. It was enacted by the Commonwealth of Australia under the authority granted by the FSANZ Act, aiming to refine food regulatory measures in a manner that balances safety with practical considerations for industry and consumers.
The enactment of this regulation by the Parliament of Australia through FSANZ is intended to provide clarity and flexibility in food labelling practices, particularly regarding allergenic substances. By allowing specific exemptions under certain conditions, the regulation seeks to enhance food safety while also accommodating technological advancements in food production that reduce allergenic risks. This legislative instrument is designed to be compatible with existing human rights frameworks, as it does not require a statement of compatibility due to its nature as a non-disallowable instrument under section 94 of the FSANZ Act.
Scope and Application
The proposed variation to food regulatory measures under F2016L00783 applies to food manufacturers, processors, and retailers who are subject to the requirements of the Australia New Zealand Food Standards Code. This legislative instrument pertains to the specific exemption of certain allergenic foods and ingredients from mandatory allergen declarations, provided that the production methods employed effectively remove or reduce allergenic proteins to levels considered to pose negligible risk to allergic consumers. This applies to glucose syrups from wheat starch, fully refined soy oil, soy derivatives such as tocopherols and phytosterols, and distilled alcohol from wheat or whey. The geographic reach of this legislation is dual, applying to both Australia and New Zealand, as it pertains to the Australia New Zealand Food Standards Code. The exemption from mandatory allergen declarations does not extend to all allergenic foods, but rather to specific instances where scientific evidence supports the safety of certain production methods. The Authority has determined that these variations are non-disallowable instruments under section 94 of the FSANZ Act and therefore exempt from the requirements for a statement of compatibility with human rights.
Key Provisions
The primary sections of this legislative instrument, as stated in the explanatory statement, focus on the variations to food regulatory measures under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 92 of the FSANZ Act requires Food Standards Australia New Zealand (the Authority) to publish a notice about the standard or draft variation of a standard, which is the case with the variations to Standard 1.2.3 and Schedule 10 (Item [1] and [2] of Schedule 1 and Schedule 2 respectively). Additionally, 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. These sections ensure transparency and adherence to legislative procedures.
The obligations imposed by the Act on the parties or entities it governs include the requirement for Food Standards Australia New Zealand to develop standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code. This is pursuant to section 13 of the FSANZ Act. The Authority must also prepare a proposal for the development or variation of food regulatory measures, following the procedure specified in Division 2 of Part 3 of the FSANZ Act. Furthermore, the Authority is required to consider public submissions and seek advice from relevant scientific advisory groups, as seen in the process for Proposal P1031. Additionally, entities must comply with the variations to Standard 1.2.3 and Schedule 10, which exempt certain foods and ingredients from mandatory allergen declarations where evidence indicates the production methods used reduce allergenic proteins to negligible risk levels.
Offences, penalties, or consequences for breach of these provisions are not explicitly stated in the explanatory statement. However, the FSANZ Act generally provides for enforcement actions and penalties for non-compliance with food standards, which may include fines and other civil or criminal consequences. The maximum penalties for such offences can vary depending on the specific breach and jurisdiction but are typically detailed in the relevant legislation or regulatory guidelines. The lack of specific penalties in the explanatory statement suggests that compliance with the new variations is expected to be managed through existing regulatory frameworks and enforcement mechanisms.
In summary, the key provisions of this legislation focus on variations to food regulatory measures under the FSANZ Act, including the exemption of certain foods and ingredients from mandatory allergen declarations. The obligations on the Authority and relevant entities involve developing, considering, and complying with the approved variations. While specific penalties for breach are not detailed, compliance is expected to be enforced through existing regulatory frameworks.