{"id":"F2015L00476","name":"Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review","slug":"australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":93117,"registerId":"commonwealth-F2015L00476-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review","content":"![Description: FS_Logo_K](image.001.png)\n\nFood Standards (Proposal P1025 – Code Revision) Variation\n\nThe Board of Food Standards Australia New Zealand gives notice of the making of this standard under section 92 of the Food Standards Australia New Zealand Act 1991. The Standard commences on 1 March 2016.\n\nDated 25 March 2015\n\n![](image.002.png)\n\nStandards Management Officer\n\nDelegate of the Board of Food Standards Australia New Zealand\n\n> Note:\n\n> Note: This Standard will be published in the Commonwealth of Australia Gazette No. FSC 96 on 10 April 2015.\n\nSchedule 6 Required elements of a systematic review\n\nNote 1 This instrument is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). The standards together make up the Australia New Zealand Food Standards Code. See also section 1.1.1—3.\n\nThis Standard, together with Schedule 4 and Schedule 5, relates to Standard 1.2.7 (nutrition, health and related claims), and sets out information for the purpose of that Standard.\n\nNote 2 The provisions of the Code that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ). See also section 1.1.1—3.\n\nS6—1 Name\n\nThis Standard is Australia New Zealand Food Standards Code – Schedule 6 – Required elements of a systematic review.\n\nNote Commencement:  \nThis 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 Food Standards Australia New Zealand Act 1991 (Cth). See also section 93 of that Act.\n\nS6—2 Required elements of a systematic review\n\nFor sections 1.2.7—18, 1.2.7—19 and 1.2.7—20, a systematic review must include the following elements:\n\n(a) A description of the food or property of food, the \\*health effect and the proposed relationship between the food or \\*property of food and the health effect.\n\n(b) A description of the search strategy used to capture the scientific evidence relevant to the proposed relationship between the food or property of food and the health effect, including the inclusion and exclusion criteria.\n\n(c) A final list of studies based on the inclusion and exclusion criteria. Studies in humans are essential. A relationship between a food or property of food and the health effect cannot be established from animal and in vitro studies alone.\n\n(d) A table with key information from each included study. This must include information on:\n\n    (i) the study reference; and\n    (ii) the study design; and\n    (iii) the objectives; and\n    (iv) the sample size in the study groups and loss to follow-up or non-response; and\n    (v) the participant characteristics; and\n    (vi) the method used to measure the food or property of food including amount consumed; and\n    (vii) confounders measured; and\n    (viii) the method used to measure the health effect; and\n    (ix) the study results, including effect size and statistical significance; and\n    (x) any adverse effects.\n\n(e) An assessment of the quality of each included study based on consideration of, as a minimum:\n\n    (i) a clearly stated hypothesis; and\n    (ii) minimisation of bias; and\n    (iii) adequate control for confounding; and\n    (iv) the study participants’ background diets and other relevant lifestyle factors; and\n    (v) study duration and follow-up adequate to demonstrate the health effect; and\n    (vi) the statistical power to test the hypothesis.\n\n(f) An assessment of the results of the studies as a group by considering whether:\n\n    (i) there is a consistent association between the food or property of food and the health effect across all high quality studies; and\n    (ii) there is a causal association between the consumption of the food or property of food and the health effect that is independent of other factors (with most weight given to well-designed experimental studies in humans); and\n    (iii) the proposed relationship between the food or property of food and the health effect is biologically plausible; and\n    (iv) the amount of the food or property of food to achieve the health effect can be consumed as part of a normal diet of the Australian and New Zealand populations.\n\n(g) A conclusion based on the results of the studies that includes:\n\n    (i) whether a causal relationship has been established between the food or property of food and the health effect based on the totality and weight of evidence; and\n    (ii) where there is a causal relationship between the food or property of food and the health effect:\n\n(A) the amount of the food or property of food required to achieve the health effect; and\n\n(B) whether the amount of the food or property of food to achieve the health effect is likely to be consumed in the diet of the Australian and New Zealand populations or by the target population group, where relevant.\n\n(h) An existing systematic review may be used if it is updated to include:\n\n    (i) the required elements (a) to (f) above for any relevant scientific data not included in the existing systematic review; and\n    (ii) the required element (g) above incorporating the new relevant scientific data with the conclusions of the existing systematic review.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This Schedule performs exactly the function its title suggests—specifying required elements for systematic reviews to support nutrition and health claims. It has not expanded beyond this original purpose; it remains tightly focused on evidentiary standards for food labelling claims without encroaching into unrelated regulatory areas."},"complexity_factors":["Single purpose instrument with clear, enumerated requirements (8 distinct elements labelled a-h)","Minimal cross-referencing—only refers to three specific sections of Standard 1.2.7 and one defined term ('property of food' marked with asterisk)","Straightforward structure with no nested exceptions or conditional logic beyond the single condition in element (h) about updating existing reviews","Uses plain language scientific concepts (bias, confounding, statistical power) rather than dense legal terminology","Short length—approximately 500 words of substantive content"],"plain_english_summary":"This law requires food companies to back any health claim on packaging with a proper scientific review showing the food actually causes the claimed benefit. Reviews must clearly state the claimed effect, rely on human studies (animal evidence alone is insufficient), search and summarise relevant research, assess study quality and bias, conclude on causation, and confirm the effective intake is realistically achievable in a normal diet. Existing reviews may be reused only if updated to meet these requirements."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The text itself sets out mandatory elements for systematic reviews supporting specific nutrition and health claim provisions; it does not state or indicate any expansion or narrowing of scope relative to an earlier instrument in the supplied material. Therefore no scope change can be identified from the provided document."},"complexity_factors":["Checklist-style structure: a fixed list of required elements (description, search strategy, final study list, study table, quality assessment, group assessment, conclusion) reduces interpretive complexity but requires thorough documentation (S6—2(a)–(g)).","Evidence standard: human studies are mandatory; animal or in vitro evidence alone is insufficient, increasing the burden on applicants to source clinical data (S6—2(c)).","Detailed study reporting: each included study must be summarised with specific data fields (design, sample size, measurement methods, confounders, effect sizes, adverse effects), increasing preparation work (S6—2(d)(i)–(x)).","Quality appraisal requirements: applicants must assess bias, confounding, power and follow-up adequacy, requiring methodological expertise (S6—2(e)(i)–(vi)).","Causality and plausibility tests: reviewers must evaluate consistency, causality (with weight to human experimental studies), biological plausibility and dietary feasibility, which entail judgement calls and supporting analyses (S6—2(f)(i)–(iv)).","Burden of demonstrating real-world relevance: conclusions must state amounts needed for effect and whether those amounts are likely to be consumed by target populations, adding nutritional-exposure assessment tasks (S6—2(g)(ii)(A)–(B)).","Use of prior reviews: existing systematic reviews may be reused only if updated to include all required elements and new data, creating potential work to retrofit older reviews (S6—2(h))."],"plain_english_summary":"This Standard prescribes the mandatory elements that must be included in any systematic review used to support nutrition and health claims under specified provisions of the Australia New Zealand Food Standards Code. It affects businesses, consultants and researchers who prepare evidence for such claims because it fixes what types of studies and quality checks are required (including human studies, measures of effect, causality assessment and whether required consumption amounts are realistic)."}},"importantCases":[],"_links":{"self":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review","history":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review/history","analysis":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review/analysis","conflicts":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review/conflicts","importantCases":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review/important-cases","documents":"/api/acts/australia-new-zealand-food-standards-code-schedule-6-required-elements-of-a-systematic-review/documents"}}