New Zealand Gazette – 2013 – No. 3

Page 138

✨ Food Health Claims Regulations



NEW ZEALAND GAZETTE, No. 3

18 JANUARY 2013

SCHEDULE 6

Required elements of a systematic review

A systematic review must include the following elements -

  1. 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.

  2. 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.

  3. 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.

  4. A table with key information from each included study. This must include information on:

    • (a) the study reference
    • (b) the study design
    • (c) the objectives
    • (d) the sample size in the study groups and loss to follow-up or non-response
    • (e) the participant characteristics
    • (f) the method used to measure the food or property of food including amount consumed
    • (g) confounders measured
    • (h) the method used to measure the health effect
    • (i) the study results, including effect size and statistical significance
    • (j) any adverse effects.

  5. An assessment of the quality of each included study based on consideration of, as a minimum:

    • (a) a clearly stated hypothesis
    • (b) minimisation of bias
    • (c) adequate control for confounding
    • (d) the study participants’ background diets and other relevant lifestyle factors
    • (e) study duration and follow-up adequate to demonstrate the health effect
    • (f) the statistical power to test the hypothesis.

  6. An assessment of the results of the studies as a group by considering whether:

    • (a) there is a consistent association between the food or property of food and the health effect across all high quality studies
    • (b) 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)
    • (c) the proposed relationship between the food or property of food and the health effect is biologically plausible
    • (d) 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.

  7. A conclusion based on the results of the studies that includes:

    • (a) 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
    • (b) where there is a causal relationship between the food or property of food and the health effect:


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Online Sources for this page:

Gazette.govt.nz — PDF NZ Gazette 2013, No 3




✨ LLM interpretation of page content

🏥 Conditions for permitted general level health claims (continued from previous page)

🏥 Health & Social Welfare
Food Standards, Nutrition Claims, Health Claims, Regulations, Systematic Review, Scientific Evidence, Study Design, Human Studies, Bias Minimization, Confounding Control, Statistical Power, Causal Relationship, Biological Plausibility, Dietary Consumption