Document ID: chunk:federal_register_of_legislation:F2015L00476:body:0:p2
Version: federal_register_of_legislation:F2015L00476
Segment Type: other
Provision Reference: 
Character Range: 2515–5051

non-response; and
 (v) the participant characteristics; and
 (vi) the method used to measure the food or property of food including amount consumed; and
 (vii) confounders measured; and
 (viii) the method used to measure the health effect; and
 (ix) the study results, including effect size and statistical significance; and
 (x) any adverse effects.
 (e) An assessment of the quality of each included study based on consideration of, as a minimum:
 (i) a clearly stated hypothesis; and
 (ii) minimisation of bias; and
 (iii) adequate control for confounding; and
 (iv) the study participants' background diets and other relevant lifestyle factors; and

 (v) study duration and follow-up adequate to demonstrate the health effect; and
 (vi) the statistical power to test the hypothesis.
 (f) An assessment of the results of the studies as a group by considering whether:
 (i) there is a consistent association between the food or property of food and the health effect across all high quality studies; and
 (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
 (iii) the proposed relationship between the food or property of food and the health effect is biologically plausible; and
 (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.
 (g) A conclusion based on the results of the studies that includes:
 (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
 (ii) where there is a causal relationship between the food or property of food and the health effect:
 (A) the amount of the food or property of food required to achieve the health effect; and
 (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.
 (h) An existing systematic review may be used if it is updated to include:
 (i) the required elements (a) to (f) above for any relevant scientific data not included in the existing systematic review; and
 (ii) the required element (g) above incorporating the new relevant scientific data with the conclusions of the existing systematic review.
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