Australia New Zealand Food Standards Code – Standard 2.9.6 – Transitional standard for special purpose foods (including amino acid modified foods)

The standard defines two central concepts. “Special purpose food” means a food specially processed or formulated to satisfy particular dietary requirements that exist because of a particular physical or physiological condition, a specific disease or disorder, or both, and are presented as such. The key elements are that the food must be specially processed or formulated (not merely marketed as healthy), the dietary requirements must arise from a medical or physiological condition, and the food must be presented as meeting those requirements. This is a narrower definition than a general “health food” or “functional food” claim. “Amino acid modified food” is a subset of special purpose food where, in the preparation of the food, either there is a restriction in the use of ingredients containing one or more particular amino acids, or there is a reduction of the content of one or more particular amino acids in any of the ingredients. This definition captures products intended for individuals with inborn errors of amino acid metabolism, such as phenylketonuria (PKU), where dietary restriction of phenylalanine is required. The standard includes an important interpretative rule in section 2.9.6-2(2): other than in Division 2 of Standard 2.9.3 (Formulated meal replacements), a reference in the Code to a special purpose food is taken to be a reference to a formulated meal replacement. The explanatory note clarifies that this is an additive-permitting mechanism: additives permitted in formulated meal replacements are thereby permitted in special purpose foods. The subsection also exempts special purpose foods from the minimum protein and energy (kJ) requirements and the minimum and maximum vitamin and mineral levels that apply to formulated meal replacements. This interpretative rule is a regulatory shortcut to avoid expressly listing each permitted additive for special purpose foods, but it creates potential confusion: the definition of formulated meal replacement is not to be taken literally in relation to special purpose foods, because special purpose foods are not necessarily intended as a meal replacement. The standard also incorporates the concept of “very low energy food” via the application, saving and transitional provisions, but does not define that term itself - it relies on the VLED variation amendments to other parts of the Code.

The standard directly affects any person or business that produces, imports, labels, or sells special purpose foods or amino acid modified foods in New Zealand. This includes manufacturers of medical foods for metabolic disorders, manufacturers of low-protein foods for kidney disease, and importers of such products from overseas. Because the standard applies only in New Zealand (section 2.9.6-3(1) and (2)), Australian food businesses are not directly affected unless they export to New Zealand. However, Australian businesses that market the same product in both countries must comply with the different regulatory regimes in each, which increases compliance costs. The standard also affects consumers who rely on these products for medical or physiological needs - typically people with rare metabolic disorders, kidney disease, or other conditions requiring dietary manipulation. The labelling requirement to include “Take only on medical advice” signals that these products are not ordinary foods and should be used under supervision. Health professionals who prescribe or recommend these foods are indirectly affected because the accuracy of labelling (especially nutrition information panels and amino acid declarations) directly influences patient safety and treatment efficacy. The standard’s transitional nature means that businesses must monitor Code amendments to know when the standard ceases and what replaces it. Small manufacturers face disproportionate compliance burdens: they must keep up with changes to the Code, ensure labelling meets specific requirements (including 3 mm lettering for the medical advice warning), and potentially reformulate products if the compositional or labelling rules change when new standards commence. The VLED transitional arrangement (allowing compliance with either pre- or post-VLED Code during the transition period) reduces immediate pressure but adds complexity for inventory management and labelling for products that straddle the transition. Overall, the class of affected entities is small - the market for special purpose foods is narrow - but the compliance burden is high relative to product volumes.

The standard imposes two main categories of duties: compositional duties and labelling duties. For composition, a special purpose food may contain any of the vitamins and minerals specified in the table to section S29-12 or S29-13 of the Code. This is a permissive provision - it permits, not requires, the inclusion of those vitamins and minerals. There is no duty to include them, but there is a duty not to include other vitamins or minerals unless separately permitted by another part of the Code. The labelling duties are more prescriptive. For all special purpose foods, the required information is a statement of the special purpose of the food. This is a broad requirement: the manufacturer must decide what wording adequately describes the special purpose. For amino acid modified foods additional duties apply. The label must include one or more of: the words “amino acid modified food”; the name of the restricted amino acid(s); the name of the disease or a name describing the condition of the target group; or the words “low protein”, where applicable. The nutrition information panel must state amounts of carbohydrate, protein, fat (in grams), energy (in kJ), sodium and potassium (in mg), and the amount of the particular amino acid or protein present, or both, as appropriate for the intended use. Additionally, the principal display panel must bear, in 3 mm lettering, the words “Take only on medical advice”. These are mandatory duties; non-compliance means the food cannot lawfully be sold. The standard also confers certain rights. By virtue of section 2.9.6-2(2), manufacturers of special purpose foods are entitled to use additives that are permitted in formulated meal replacements under Standard 2.9.3, without needing to seek separate approval. The transitional provisions give a right to elect compliance: during the VLED transition period (1 June 2022 to 1 June 2025), a food product may be sold if it complies with either the pre-VLED Code or the post-VLED Code. This right to choose which version to follow reduces disruption but requires the manufacturer to track both sets of rules. The standard also creates a right of reliance on the standard itself - so long as it remains in force, manufacturers and importers can rely on its provisions as the applicable regulatory framework. However, that right is inherently temporary given the sunset clause.

The standard itself does not specify penalties. Enforcement occurs under the Food Standards Australia New Zealand Act 1991 (Cth) in Australia and the Food Act 2014 (NZ) in New Zealand. Because the standard applies only in New Zealand, the primary enforcement regime is the New Zealand Food Act 2014, which incorporates the Australia New Zealand Food Standards Code as part of New Zealand law. Under that Act, selling food that does not comply with the Code is an offence. Penalties for non-compliance can include fines, seizure of non-compliant products, and in serious cases, imprisonment for individuals. The standard’s labelling requirements are strict liability provisions - a product sold without the required “Take only on medical advice” warning or with an incomplete nutrition information panel would be non-compliant regardless of the seller’s intent. Businesses that deliberately misrepresent the special purpose of a food, or fail to declare restricted amino acids accurately, face higher penalties for misleading conduct. The transitional provisions (e.g., the option to comply with pre- or post-VLED Code) may create a defence if the manufacturer can prove compliance with one of the two permitted versions. However, the burden of proof would fall on the enforcement authority. There is also a risk of enforcement action under Australian law if a product sold in Australia is labelled as a special purpose food but does not meet the relevant Australian standard - though Standard 2.9.6 does not apply in Australia, so Australian businesses must look to the other applicable Code standards (e.g., Standard 2.9.3 for formulated meal replacements or any future specific standard). The standard’s sunset clauses mean that reliance on it as a defence becomes impossible after the relevant cessation date. Businesses should be aware that enforcement authorities may take action against products that continue to rely on Standard 2.9.6 after alternative provisions have commenced and the two-year transition period has expired.

Standard 2.9.6 is part of the Australia New Zealand Food Standards Code, which is established under the Food Standards Australia New Zealand Act 1991 (Cth). It interacts with several other parts of the Code. Most directly, it cross-references Standard 1.2.1 for labelling provisions and Standard 2.9.3 for formulated meal replacements (Division 2). The interpretive rule in section 2.9.6-2(2) imports the additive permissions from formulated meal replacements into special purpose foods, while exempting special purpose foods from the minimum protein and energy requirements and the vitamin and mineral ranges that apply to formulated meal replacements. This creates a hierarchy: if a food qualifies as a formulated meal replacement under Standard 2.9.3, it must meet those standards; if it qualifies as a special purpose food, it may use the formulated meal replacement additive list but is not bound by the other compositional requirements. The standard also interacts with any future Code standard that provides “alternative applicable provisions”. Section 2.9.6-3(3) provides that the standard ceases two years after commencement of such alternative provisions. This means that when FSANZ develops a permanent standard for special purpose foods (or for amino acid modified foods specifically), this transitional standard will automatically sunset after two years. The VLED variation (Application A1230) directly affects section 2.9.6-3(4), which triggers a three-year cessation period for VLED-related provisions. The application, saving and transitional provisions table in the standard notes that section 1.1.1-9 (which deals with transitional provisions generally) does not apply to the VLED variation - meaning the VLED transition is governed solely by the specific clause in the variation. In New Zealand, the standard is incorporated into domestic law under the Food Act 2014 (NZ). That Act provides the enforcement mechanisms and penalties. The standard also recalls that under the Australia New Zealand Food Standards Code, the provisions that apply in New Zealand are incorporated in or adopted under the Food Act 2014. Practitioners should note that the standard does not deal with food produced in or imported into Australia; Australian businesses must look to other Code standards for special purpose foods or formulated meal replacements. The standard’s narrow New Zealand-only scope means it has no interaction with Australian state food legislation.

Standard 2.9.6 was originally published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (registered as F2015L00473 on 1 April 2015). The standard commenced on 1 March 2016. Since then, it has been amended twice. Amendment 161 (F2016L00120, registered 8 February 2016, Gazette FSC103, 22 February 2016) corrected a formatting error in the Note to section 2.9.6-3. This was a minor technical correction. The more significant amendment was Amendment 208 (F2022L00733, registered 1 June 2022, Gazette FSC 148, 1 June 2022), which repealed and substituted section 2.9.6-3 (the application provision). The substituted section added the VLED-related cessation provision (section 2.9.6-3(4)) and the sunset provision tying cessation to the commencement of alternative applicable provisions (section 2.9.6-3(3)). Amendment 208 also introduced the application, saving and transitional provisions table that sets out the VLED transition period. The compilation before us is Compilation 2, prepared by Food Standards Australia New Zealand on 1 June 2022, incorporating amendments up to No. 208. The amendment history table uses abbreviations: ad (added or inserted), am (amended), exp (expired or ceased to have effect), rep (repealed), rs (repealed and substituted). The standard is itself a transitional instrument, and its life is limited. Future amendments are anticipated - likely a repeal or further substitution when a permanent standard for special purpose foods is enacted. The uncommenced amendments section notes that shaded boxed text may indicate provisions that will cease or commence at a future date. As of the date of this compilation, the VLED transition period runs from 1 June 2022 to 1 June 2025. After that date, section 2.9.6-3(4) will have had effect, and the relevant provisions will cease. The entire standard may cease before then if alternative applicable provisions commence elsewhere in the Code.

The source material does not record any litigation history involving Standard 2.9.6. This is consistent with its nature as a narrow transitional standard applicable only in New Zealand and covering a small product category. No court or tribunal decisions are cited in the standard’s notes or amendment history. The absence of recorded litigation does not necessarily mean no disputes have arisen; it may be that enforcement actions are resolved through regulatory compliance mechanisms rather than formal litigation. The standard’s requirements are relatively prescriptive (specific wording, letter sizes, nutrient declarations), which limits the scope for interpretive disputes. However, potential legal questions could arise. For example, what constitutes “presented as such” for a special purpose food - aggressive marketing implying medical benefits without explicit statements? Whether a product that is a formulated meal replacement under Standard 2.9.3 can also be sold as a special purpose food? The interaction between the additive-permission rule and the exemptions from other compositional requirements could be contested in a prosecution. Because the standard applies only in New Zealand, any litigation would occur in New Zealand courts under the Food Act 2014. Australian courts would not have jurisdiction over compliance with this specific standard. For Australian practitioners, the relevance is limited to advice on whether a product exported to New Zealand meets the standard. The standard’s sunset clauses might also generate disputes about the precise date on which “alternative applicable provisions” commence, and whether a two-year grace period has begun. Given the small market and the technical nature of the field, litigation is likely to be rare. Businesses should focus on regulatory compliance and maintain records demonstrating compliance with the chosen version of the Code (pre- or post-VLED, where applicable) to avoid enforcement action.

Several features of Standard 2.9.6 can trap the unwary. First, the standard applies solely to New Zealand (section 2.9.6-3(1) and (2)). Australian food businesses that assume the standard covers them, or that their products are automatically compliant in New Zealand because they comply with Australian standards, may mislabel products. Conversely, New Zealand businesses that rely on Standard 2.9.6 must be alert to its transitional nature - it will cease, possibly without much warning, when alternative provisions commence elsewhere in the Code. The two-year sunset in section 2.9.6-3(3) creates a hard deadline; if a new standard commences on an unpredictable date, affected businesses have only two years to transition. Second, the definition of “special purpose food” requires that the food be “presented as such”. This means that labelling, advertising, and other representations matter. A food that meets the technical formulation criteria but is not marketed as satisfying particular dietary requirements due to a condition or disorder will not qualify, and therefore cannot rely on the permissive additive rule. Manufacturers might inadvertently fall outside the definition if they do not make the required claims. Third, the interpretive rule in section 2.9.6-2(2) is confusing. It states that elsewhere in the Code, a reference to “special purpose food” is taken to be a reference to “formulated meal replacement,” except in Division 2 of Standard 2.9.3. The note clarifies that this is an additive-permitting mechanism and that the definition of formulated meal replacement is not to be taken literally for special purpose foods. This means that when checking additive permissions, the tables for formulated meal replacements are used, but other requirements of Standard 2.9.3 (energy, protein, vitamin and mineral levels) do not apply. Misreading this rule could lead a manufacturer to believe they must meet all formulated meal replacement compositional requirements, or conversely, that no limits apply. Fourth, the labelling for amino acid modified foods includes a specific list of declarations: carbohydrate, protein, fat in grams; energy in kJ; sodium and potassium in mg; and the amount of the particular amino acid or protein. This is more detailed than the standard nutrition information panel requirements. Failing to include any of these specific items, or expressing them in wrong units, breaches the standard. The “Take only on medical advice” warning must be in 3 mm lettering on the principal display panel - a small but mandatory detail. Fifth, the VLED transition period (1 June 2022 to 1 June 2025) allows compliance with either the pre-VLED Code or the post-VLED Code. Businesses must choose which version to follow and cannot mix requirements from both. The transition applies only to variations made by the VLED instrument, not to other changes. Sixth, the standard does not define “very low energy food” - it relies on the definition elsewhere in the Code as amended by the VLED variation. Businesses producing VLED products must consult the broader Code to understand the compositional and labelling rules that apply after the transition ends.

For a business producing or importing special purpose foods or amino acid modified foods into New Zealand, the first step is to confirm that the product falls within the definitions. Ask: is the food specially processed or formulated to satisfy dietary requirements arising from a physical or physiological condition, a disease, or a disorder? Is it presented as such? If yes, it is a special purpose food. Then ask: does the preparation involve restriction or reduction of one or more particular amino acids? If yes, it is an amino acid modified food and must meet the additional labelling requirements. Next, check composition. The food may contain any vitamin or mineral from tables S29-12 or S29-13. It must not contain other vitamins or minerals unless separately permitted. Additives are permitted if they are allowed in formulated meal replacements (Standard 2.9.3, Division 2) - rely on the crossing reference but do not apply the other formulated meal replacement rules. For labelling of special purpose foods, include a statement of the special purpose. For amino acid modified foods, include on the label one or more of: “amino acid modified food”, the name of the restricted amino acid(s), the name of the disease or condition group, or “low protein” where applicable. On the nutrition information panel, include: carbohydrate (g), protein (g), fat (g), energy (kJ), sodium (mg), potassium (mg), and the amount of the particular amino acid or protein (or both) as appropriate. On the principal display panel, include “Take only on medical advice” in 3 mm lettering. Ensure compliance with Standard 1.2.1 for general labelling provisions (e.g., legibility, placement). For products affected by the VLED variation, consider whether to comply with the Code as it stood before 1 June 2022 or as amended by the VLED variation. During the transition period (until 1 June 2025), you may sell product labelled under either regime, but you cannot mix. After 1 June 2025, only post-VLED Code compliance is possible. Monitor the Federal Register of Legislation and FSANZ announcements for commencement of alternative applicable provisions that will trigger the two-year sunset for the whole standard. When that happens, plan to transition to the new standard within two years. Keep records demonstrating which compliance route was elected and how each product meets the applicable requirements. Given the complexity, engage a food regulatory consultant or lawyer with experience in the Australia New Zealand Food Standards Code. Do not assume that compliance with Australian standards suffices for New Zealand; the reverse is also true. For small volume products, the cost of compliance (labelling changes, reformulation, legal review) may be disproportionate, so consider whether the market justifies the investment.