Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review

The Schedule organises the concept of a systematic review into discrete, mandatory elements designed to make the evidentiary basis for nutrition and health claims transparent and reproducible. The principal concepts embedded in the Schedule are:

• Defined scope and causal hypothesis: The review must start with a clear description of the food or property of food, the health effect claimed, and the proposed relationship between them (S6,2(a)). This establishes the population, exposure and outcome that the review will address.

• Search strategy and study selection transparency: The Schedule requires an explicit description of the search strategy and the inclusion and exclusion criteria used to capture relevant scientific evidence (S6,2(b)), plus a final list of included studies (S6,2(c)). This mirrors standard systematic review methodology by documenting how studies were identified and filtered.

• Human evidence requirement: The Schedule states that studies in humans are essential and that a relationship cannot be established from animal and in vitro studies alone (S6,2(c)). This elevates human studies as necessary evidence for establishing the claimed relationship.

• Structured data extraction: A table capturing ten specified items for each included study is mandatory, including study design, objectives, sample sizes and loss to follow-up, participant characteristics, measurement methods for exposure and outcome, confounders measured, effect sizes and adverse effects (S6,2(d)(i)-(x)). This requires standardised reporting of both internal validity and context.

• Study quality appraisal: The Schedule sets minimum dimensions for assessing each study’s quality, including hypothesis clarity, bias minimisation, control for confounding, consideration of background diets and lifestyle, adequate duration and follow-up, and statistical power (S6,2(e)(i)-(vi)). These items focus the appraisal on design, conduct and relevance to diet.

• Synthesis criteria for causality and applicability: The review must assess the body of evidence for consistency across high-quality studies, causal independence from other factors with weight given to well-designed experimental human studies, biological plausibility, and whether the amount required for the effect is consumable as part of a normal diet in Australia and New Zealand (S6,2(f)(i)-(iv)). These criteria combine internal validity with external applicability.

• Conclusion and dose/consumption assessment: The systematic review must state whether a causal relationship is established on the weight of evidence and, where established, quantify the amount required to achieve the effect and judge the likelihood of that amount being consumed by relevant populations (S6,2(g)(i), (g)(ii)(A)-(B)).

• Reuse and updating of existing reviews: The Schedule permits reliance on an existing systematic review provided it is updated to include any relevant scientific data not already included and to incorporate the required conclusion addressing new data (S6,2(h)(i)-(ii)).

These concepts embed methodological standards (search transparency, study-level quality assessment), evidentiary thresholds (human studies required, experimental studies weighted), and population-level applicability (consumption feasibility in Australian and New Zealand diets). The Schedule therefore combines procedural detail with substantive gates for what counts as acceptable evidence for the specific Code provisions it supports.

The Schedule applies to any systematic review prepared for the purposes of sections 1.2.7,18, 1.2.7,19 and 1.2.7,20 of the Australia New Zealand Food Standards Code (S6,2). While the Schedule does not name actors such as applicants, manufacturers, regulators or third-party reviewers, the practical effect is that any person or entity producing a systematic review to satisfy those Code sections must comply with the Schedule’s required elements.

Two immediate groups are implicated by the text:

• Preparers of evidence used to support claims: Parties who compile systematic reviews to underpin nutrition, health or related claims under the specified Code provisions bear the obligation to include every element set out in S6,2(a)-(h). The Schedule prescribes what must be in the review when it is relied upon for these Code sections.

• Regulatory users and decision‑makers: Food Standards Australia New Zealand and any administrative or enforcement bodies that assess claims under Standard 1.2.7 will receive and evaluate systematic reviews against these specified elements. The Schedule supplies them with a checklist for the minimum content they should expect in such reviews (Note 1).

Geographical scope: The Schedule forms part of the Australia New Zealand Food Standards Code and thus applies in Australia and New Zealand as indicated. The document explicitly notes that the Code’s provisions that apply in New Zealand are incorporated in or adopted under the Food Act 2014 (NZ) (Note 2). The Schedule itself commenced on 1 March 2016 (S6,1, Commencement).

Indirectly affected parties include researchers, test laboratories and contract research organisations that will be engaged to produce human studies or to extract and appraise data. The Schedule’s emphasis on human studies and well‑designed experimental work (S6,2(c), S6,2(f)(ii)) creates demand-side effects on the types of studies that claim-supporting bodies commission.

The Schedule does not set fees, penalties within its own text, nor does it name who must submit the review or the timing of submissions. Those procedural aspects are handled elsewhere in the Code and the FSANZ Act; this Schedule defines the required content of the systematic review only (Note 1).

The Schedule imposes a set of mandatory duties that attach to any systematic review used for the specified sections of the Code. It does not, within its text, create enforcement mechanisms, appeal rights or administrative processes; it prescribes evidentiary duties. The duties are granular and cumulative:

• Duty to define scope and hypothesis: The review must include a clear description of the food or property of food, the health effect and the proposed relationship (S6,2(a)). This imposes a duty to articulate exposure, outcome and causal claim in the submission.

• Duty to document search methods: The review must describe the search strategy and the inclusion and exclusion criteria used to capture relevant evidence (S6,2(b)). The duty requires methodological transparency so that study identification can be audited.

• Duty to include human studies: The Schedule mandates that studies in humans are essential and disallows establishing the claimed relationship on animal or in vitro studies alone (S6,2(c)). The duty requires the inclusion of human data.

• Duty to present a final list of studies: A final list of included studies based on the stated criteria must be provided (S6,2(c)). This creates a traceable record of which studies were considered.

• Duty to tabulate key study information: For each included study, a table must contain ten enumerated pieces of information, covering reference, design, objectives, sample size and attrition, participant characteristics, exposure measurement, confounders measured, outcome measurement, results (including effect size and statistical significance), and any adverse effects (S6,2(d)(i)-(x)).

• Duty to assess study quality: Each included study must be assessed against a set of minimum quality considerations: clear hypothesis, minimisation of bias, adequate control for confounding, background diets and lifestyle, duration and follow-up, and statistical power (S6,2(e)(i)-(vi)).

• Duty to assess the evidence as a whole: The review must address consistency across high-quality studies, whether associations are causal and independent of other factors (with most weight to well-designed human experimental studies), biological plausibility, and whether the effective amount is achievable in normal diets in Australia and New Zealand (S6,2(f)(i)-(iv)).

• Duty to reach and state a conclusion: The review must conclude whether a causal relationship has been established on the totality and weight of the evidence and, if so, quantify the amount required and judge whether that amount is likely to be consumed by the relevant populations (S6,2(g)(i), (g)(ii)(A)-(B)).

• Duty when relying on an existing review: If an existing systematic review is used, it must be updated to incorporate any missing required elements and any new relevant scientific data and to update the conclusion accordingly (S6,2(h)(i)-(ii)).

Rights implicit in the text are limited to procedural clarity: a party preparing a review has the right to rely on an existing systematic review only if it performs the required updates (S6,2(h)). The Schedule does not confer explicit legal entitlements such as review rights or timelines, nor does it specify who may demand additional information, leaving those operational aspects to the broader Code and the FSANZ Act (Note 1).

In practice, these duties allocate the evidentiary burden to the entity submitting the systematic review. The Schedule’s items create a checklist against which reviewers, regulators and other decision‑makers can assess whether the review meets the minimum content standards required for the relevant sections of the Code.

The Schedule itself does not contain penalty provisions or an enforcement regime. It is a standard under the Food Standards Australia New Zealand Act 1991 (see Note 1), and it sets content requirements for systematic reviews used for specified sections of the Code (S6,2). The text of this Schedule prescribes minimum evidentiary elements rather than sanctions.

Because the instrument is part of the Australia New Zealand Food Standards Code, compliance and any enforcement measures are governed by the Code and the FSANZ Act, as referenced in Note 1. The Schedule does not specify which enforcement bodies, administrative sanctions, civil liabilities or criminal penalties attach to non-compliance. It likewise does not set procedural mechanisms such as submission timelines, opportunities to cure deficiencies, or administrative review routes; those matters are managed elsewhere in the Code and under the FSANZ Act.

For New Zealand, the Schedule notes that the Code provisions that apply there are incorporated in or adopted under the Food Act 2014 (NZ) (Note 2). The Schedule itself does not set out New Zealand enforcement mechanisms or penalties. Any enforcement or sanctioning in New Zealand would therefore follow the domestic legal framework for the Food Act and the incorporation/adoption process, not this Schedule.

Because the Schedule is prescriptive about the content of systematic reviews, non-compliance would manifest as a failure to satisfy the evidentiary requirements for the related Code sections. The Schedule does not, however, define the consequences of such failure within its text. Assessors or decision-makers operating under the Code would apply their statutory enforcement and compliance tools consistent with the FSANZ Act and the relevant domestic implementation arrangements.

Users and readers of this Schedule should therefore treat it as a content standard. The presence or absence of penalties, and the mechanisms for enforcement, will depend on the wider Code and on the statutory frameworks (FSANZ Act 1991 and, in New Zealand, the Food Act 2014) that manage compliance and enforcement.

The Schedule expressly situates itself within the legal architecture of the Australia New Zealand Food Standards Code and the enabling statutes. The Schedule is a standard under the Food Standards Australia New Zealand Act 1991 (Note 1) and was made under section 92 of that Act, with commencement notice and publication in the Commonwealth and New Zealand Gazettes (S6,1 and accompanying notes). Section 93 of the FSANZ Act is also referenced in the context of commencement (S6,1, Note).

Operationally, the Schedule is linked to specific provisions of the Code , sections 1.2.7,18, 1.2.7,19 and 1.2.7,20 , and is intended to be used together with Schedule 4, Schedule 5 and Standard 1.2.7 (Note 1). Therefore, the Schedule modifies or supplements the evidentiary requirements for the nutrition, health and related claims regime contained in that part of the Code. It functions as a procedural annex that determines what a systematic review must contain when used to support claims governed by those Code provisions.

For New Zealand, the Schedule notes that the provisions of the Code that apply there are incorporated in, or adopted under, the Food Act 2014 (NZ) (Note 2). This indicates that adherence to the Schedule’s requirements will feed into the domestic regulatory regime in New Zealand via the Food Act’s incorporation or adoption mechanism. The Schedule itself does not restate or amend the Food Act; it operates within the Code which is, in turn, given effect in New Zealand through the Food Act.

The Schedule does not reference other Acts, regulations or administrative instruments beyond the FSANZ Act and the Food Act 2014 (NZ). It does not override other statutory obligations, nor does it expressly displace competing evidentiary rules outside the Code’s scope. The Schedule is therefore a component of the Code’s internal architecture, establishing specific methodological requirements for evidence used within the Code regime, while leaving other legal domains and enforcement routes to their governing statutes.

Practitioners should read the Schedule in conjunction with Standard 1.2.7 and the related Schedules (4 and 5) to understand the full regulatory requirements for nutrition, health and related claims. The Schedule’s requirements will inform the evidentiary assessment that regulators apply under the FSANZ Act in Australia and the Food Act mechanisms in New Zealand.

The Schedule records its making and procedural history within the Code in the instrument text. Key dates and administrative facts in the instrument are:

• Decision and delegate: The Board of Food Standards Australia New Zealand gives notice of making this standard under section 92 of the Food Standards Australia New Zealand Act 1991. The instrument is signed off by the Standards Management Officer as a delegate of the Board (front matter).

• Date of instrument: The instrument is dated 25 March 2015 (front matter).

• Gazette notification: The instrument notes that it will be published in the Commonwealth of Australia Gazette No. FSC 96 on 10 April 2015 (front matter note).

• Commencement: The Standard commences on 1 March 2016, being the date specified as the commencement date in notices in the Gazette and the New Zealand Gazette under section 92 of the FSANZ Act 1991; a cross-reference to section 93 of that Act is included (S6,1, Commencement and Note).

• Relation to a proposal: The instrument is presented as "Food Standards (Proposal P1025 - Code Revision) Variation" indicating it forms part of that proposal and its code revision process (title line).

Beyond these items, the Schedule does not document prior versions, repeals or subsequent amendments within its text. The instrument as supplied is a single variation to the Code (Schedule 6) and does not present a history of iterative amendments or prior schedules. The Schedule’s procedural origin is bound to the FSANZ Act processes (s 92 notices and Gazette publication) as recorded.

Any further changes to this Schedule subsequent to the dates shown would be recorded in later legislative instruments or variations to the Code. The text provided does not include such subsequent amendment language, so the amendment history contained in this document is limited to its date of making, publication notice and commencement schedule as set out above.

The Schedule contains no references to judicial decisions, administrative determinations or litigation. It cites no cases and records no disputes. The instrument is a standard made under the Food Standards Australia New Zealand Act 1991; however, it does not include any mention of litigation, challenges to its validity, or decisions interpreting its provisions.

Because the document itself is a legislative instrument setting out procedural requirements for systematic reviews, it is silent on any litigation that may have arisen in relation to its content, application or interpretation. The Schedule does not provide examples of contested administrative decisions or judicial review outcomes, and it does not identify precedent on how its requirements should be applied in practice.

Users requiring information about litigation or legal interpretation arising from this Schedule will need to consult case law databases, administrative tribunal records or recorded decisions under the FSANZ Act and the Code. That material falls outside the text of the Schedule and is not provided here. The Schedule itself remains a prescriptive list of evidentiary elements without embedded litigation history.

The Schedule contains precise requirements and some traps for those preparing or relying on systematic reviews for nutrition, health and related claims under sections 1.2.7,18, 1.2.7,19 and 1.2.7,20. Key pitfalls to note, all taken directly from the text, include:

• Human evidence is mandatory: The Schedule states unequivocally that studies in humans are essential and that a relationship cannot be established from animal and in vitro studies alone (S6,2(c)). A review that relies only on non-human data fails the Schedule’s threshold.

• Comprehensive tabulation required: For each included study the review must include a table with ten specified items (S6,2(d)(i)-(x)). Omitting any of these items, such as confounders measured or adverse effects, would leave the review non-compliant with the Schedule’s content requirements.

• Quality assessment is multi-dimensional: The Schedule sets six minimum study-quality considerations, including hypothesis clarity, bias minimisation, confounding control, background diets and lifestyle, duration and follow-up, and statistical power (S6,2(e)(i)-(vi)). A superficial or incomplete appraisal that does not address these six points would not meet the Schedule’s standard.

• Causality and experimental weight: The Schedule requires consideration of whether the association is causal and independent of other factors, "with most weight given to well-designed experimental studies in humans" (S6,2(f)(ii)). Reviews that give equal or greater weight to observational studies without rationalising departures risk falling short of the Schedule’s expectations.

• Real-world consumption test: The review must assess whether the amount of the food or property required to achieve the effect can be consumed as part of a "normal diet of the Australian and New Zealand populations" (S6,2(f)(iv)). Claims based on dosages impracticable in normal dietary patterns must be explicitly addressed in the review’s conclusion (S6,2(g)(ii)(A)-(B)).

• Updating existing reviews is not optional: Use of an existing systematic review is permitted only if it is updated to include any missing required elements and to incorporate new relevant data with an updated conclusion (S6,2(h)(i)-(ii)). Copying an existing review without these updates will not satisfy the Schedule.

• Adverse effects are required reporting: The table of key information must include any adverse effects (S6,2(d)(x)). Failure to report harms or safety data is a specific omission under the Schedule.

• Statistical power and loss to follow-up must be documented: The Schedule expressly asks for sample size and loss to follow-up or non-response (S6,2(d)(iv)) and assessment of statistical power (S6,2(e)(vi)). Reviews that omit these data or fail to comment on power considerations run counter to the Schedule’s requirements.

• Narrow scope requirement: The Schedule begins with a duty to describe the proposed relationship (S6,2(a)). Vague or shifting outcome or exposure definitions undermine compliance.

These "gotchas" are not discretionary; they are explicit elements of the Schedule. Practitioners preparing systematic reviews under the relevant Code sections should use the Schedule as a checklist to avoid technical non-compliance that could lead to regulatory rejection or queries. The Schedule’s combination of internal validity, applicability and consumption‑feasibility criteria makes it necessary to document both scientific robustness and practical dietary relevance.

The Schedule provides a clear, itemised framework for what a compliant systematic review must contain for use with sections 1.2.7,18, 1.2.7,19 and 1.2.7,20. Compliance consists of preparing a review that addresses each element in S6,2(a)-(h). Practical steps derived directly from the Schedule are:

1. Define scope and hypothesis (S6,2(a))

   • Draft a concise description of the food or property of food, the specific health effect claimed, and the proposed causal relationship. Ensure exposure and outcome definitions are explicit and match the claim language used in the Code.

2. Document search strategy and selection criteria (S6,2(b))

   • Record databases searched, date ranges, search terms, language limits and any other search filters used.
   • State clear inclusion and exclusion criteria for study eligibility (population, exposure, comparator, outcomes, study designs).
   • Keep an audit trail of search outputs and screening decisions.

3. Produce a final list of included studies (S6,2(c))

   • After screening, provide a final list of studies that meet the inclusion criteria.
   • Ensure human studies are included; do not rely solely on animal or in vitro studies.

4. Create the required study table (S6,2(d)(i)-(x))

   • For each included study, provide the ten specified data points: full reference; study design; objectives; sample sizes and attrition; participant characteristics; how the food/property was measured (including amount consumed); confounders measured; method of measuring the health effect; results including effect size and statistical significance; and any adverse effects.

5. Undertake study-level quality assessments (S6,2(e)(i)-(vi))

   • For each study, explicitly address whether the hypothesis was stated; how bias was minimised; adequacy of confounding control; consideration of participants’ background diets and lifestyle; whether duration and follow-up were adequate; and whether the study had sufficient statistical power.
   • Use these points to justify any downgrading or exclusion of studies from the weight-of-evidence assessment.

6. Synthesize evidence across studies (S6,2(f)(i)-(iv))

   • Assess consistency of associations across high-quality studies.
   • Consider causality and independence from other factors, explicitly explaining why experimental human studies are weighted most heavily where available.
   • Discuss biological plausibility with reference to mechanisms or human biology.
   • Evaluate whether the effective amount can be consumed as part of normal Australian and New Zealand diets.

7. Reach and state a conclusion (S6,2(g)(i), (g)(ii)(A)-(B))

   • State whether, on the totality and weight of evidence, a causal relationship is established.
   • If causal, quantify the amount of food/property required to achieve the effect and assess whether that amount is likely to be consumed by the Australian and New Zealand populations or the target group.

8. Update existing reviews properly (S6,2(h)(i)-(ii))

   • If relying on an existing systematic review, explicitly update it to include any required elements not present and any new relevant scientific data.
   • Revise the conclusion to incorporate the new data and state how the updated evidence affects causality and dose/consumption assessments.

9. Prepare documentation for auditability

   • Keep search logs, screening decisions, data extraction sheets and quality assessment records so the review can be audited against the Schedule’s items.

10. Check alignment with related Code provisions

• Although the Schedule defines content requirements, ensure the review’s scope and conclusions align with the relevant Code provisions (sections 1.2.7,18, ,19, ,20) and any procedural submission requirements in the Code or under the FSANZ Act, as those are the contexts in which the review will be assessed (Note 1).

These steps are a direct operationalisation of the Schedule’s mandatory elements. They do not address submission timing, interaction with administrative procedures or enforcement outcomes, which are governed by the broader Code and the FSANZ Act. Following the Schedule as a checklist will ensure that the systematic review contains the minimum content the Schedule requires for consideration under the specified Code sections.