This checklist is to assist food businesses when making general level health claims based on self-substantiated food-health relationships and is useful for documenting due diligence. It should be read in conjunction with ‘Getting Your Claims Right: A Guide to Complying with the Nutrition, Health and Related Claims Standard of the Australia New Zealand Food Standards Code’.
Claims not permitted or foods not permitted to carry claims by Standard 1.2.7.
The claim is not about kava or about an infant formula product.
The claim does not compare a food with a good that is represented in any way to be for therapeutic use; or likely to be taken for therapeutic use, whether because of the way in which the food or substance is presented or for any other reason.
The claim does not compare the vitamin or mineral content of a food with another food, unless specifically permitted by another Standard in the Code.
Standard 1.2.7 applies
The claim does not concern risks or dangers of alcohol consumption, or concern moderating alcohol intake.
The claim is not a mandatory declaration required by the Act (as defined in the Food Standards Code).
Conditions for making general level health claims
The words in the claim do not refer to a serious disease or a biomarker of a serious disease.
The correct Nutrient Profiling Scoring Criterion (NPSC) category is identified for the food (Schedule 4), except for food standardised in part 2.9 of the Food Standards Code.
The health claim is based on the details of a relationship between a food or property of food and a health effect that has been established by a process of systematic review described in Schedule 6 of Standard 1.2.7.
The person responsible for making the claim has notified the CEO of FSANZ of the details of the relationship between a food or property of food and a health effect that has been established by a process of systematic review described in Schedule 6 of Standard 1.2.7.
The person giving notice to the CEO of the Authority has provided:
- the name of the person giving the notice and the address in Australia or New Zealand of that person;
- consent to the publication by the Authority of information concerning the relationship that is the subject of the notice plus information in (i) above; and
- certification that the relationship that is the subject of the notice provided in question 3 above has been established by a process of systematic review that is described in Schedule 6.
The responsible person has records to demonstrate, if requested by a relevant authority,
- the systematic review was conducted in accordance with the process of systematic review described in Schedule 6; and
- the notified relationship is a reasonable conclusion of the systematic review.
A dietary context statement2 is included with the health claim which:
- states that the stated health effect must be considered in the context of a healthy diet involving the consumption of a variety of food;
- is appropriate to the type of food or the property of food that is the subject of the claim and the health effect claimed; and
- is a reasonable conclusion of the systematic review.
A statement concerning the form of the food to which the claim relates is included with the health claim (unless the claim relates to the form of the food as sold).
The nutrient or biologically active substance that is the subject of the claim has been included in the nutrition information panel (NIP) of the package containing the food.
None of the words used in the health claim alter or contradict the effect of a statement or information required by Standard 1.2.7.
Schedule 6 components
A search strategy has been provided that describes how scientific evidence has been captured relevant to the proposed relationship, between the food or property of food and the health effect, including inclusion and exclusion criteria.
Studies in humans have been reviewed and are included as part of the evidence provided in support of the claimed food-health relationship.
A table with key information from each included study has been provided as part of demonstrating compliance with Schedule 6. This table 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) 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; and
(j) any adverse effects.
An assessment of the quality of each included study has been undertaken that includes, 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; and
(f) the statistical power to test the hypothesis.
An assessment of the results of the included studies as a group has been provided, that considers 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; and
(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.
A conclusion has been provided 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.
(b) where there is a causal relationship between the food or property of food and the health effect:
(i) the amount of the food or property of food required to achieve the health effect; and
(ii) 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.