Getting Your Claims Right

Compliance template – general level health claims (systematic review)

Page last updated: 21 October 2014

This template may help food businesses build a general level health claim based on a food-health relationship established by systematic review; and demonstrate due diligence in attempting to comply with the Food Standards Code.

See sections 2, 4 and 5 of this document for conditions on making general level health claims.

General information

1. What is the wording of the proposed general level health claim?

2. What food will the general level health claim be applied to?

3. Has the form of the food to which the claim relates been determined in accordance with the Table to clause 6 of Standard 1.2.7?

Yes No

If NO, the claim is NOT permitted.

4. Does the general level health claim state the form of the food to which the claim applies together with the claim as required by subclause 19(3)(b) of Standard 1.2.7, unless the form of the food is as sold?

Yes No

If NO, the claim is NOT permitted in its current form.

5. Do the words in the general level health claim refer to the prevention, diagnosis, cure, or alleviation of a disease, disorder or condition or compare a food with a good that is represented in any way to be for therapeutic use or likely to be taken to be for therapeutic use, whether because of the way in which the good is presented or for any other reason?

Yes No

If YES, the claim is NOT permitted.

6. Do words used in the general level health claim alter or contradict the effect of a statement or information required by Standard 1.2.7?

Yes No

If YES, the claim is NOT permitted.

7. Does the claim refer to a serious disease or a biomarker of a serious disease?

Yes No

If YES, the claim is NOT permitted as a general level health claim.

8. What category does the food belong to in the Nutrient Profiling Scoring Criterion (NPSC) as listed in the ‘Category’ column of Schedule 4 of Standard 1.2.7?

Category 1 Category 2 Category 3

9. What is the final nutrient profiling score of the food in its specific category, as listed in the ‘NPSC category’ column of Schedule 4 of Standard 1.2.7?

For information on calculating the nutrient profiling score refer to the FSANZ website.

If food is Category 1, nutrient profiling score must be less than 1 to qualify for health claim.

If food is Category 2, nutrient profiling score must be less than 4 to qualify for health claim.

If food is Category 3, nutrient profiling score must be less than 28 to qualify for health claim.

Foods defined in Part 2.9 of the Food Standards Code do not need to comply with the NPSC.

If the food DOES NOT meet the NPSC the health claim is NOT permitted.

10. Does the general level health claim advise consumers that the claimed health effect must be considered in the context of a healthy diet involving the consumption of a variety of foods and include words to the effect of a relevant dietary context statement that is a reasonable conclusion of the systematic review and is the dietary context statement appropriate for the claim being made, as required by paragraph 19(3) (a) of Standard 1.2.7?

Yes No

If NO, the claim is NOT permitted in its current form (unless the food is contained in a small package).

Health claims about phytosterols, phytostanols and their esters do not require a statement that the health effect must be considered in the context of a healthy diet involving the consumption of a variety of foods as part of a dietary context statement to be made in conjunction with the health claim if the claim is presented together with the advisory statement required by Clause 2 of Standard 1.2.3.

11. Is the general level health claim being made as a split claim? If so, is a statement available with the stated food or property of food and the health effect on the label of the food or advertisement indicating where all required elements of the general level health claim may be found on the label or advertisement, as required by clause 20 of Standard 1.2.7?

Yes No

If NO, the claim is NOT permitted in its current form.

12. Do the details of the nutrients or biologically active substances used to make the general level health claim appear in the nutrition information panel (NIP) on the label of the package of the food as required by clause 5 of Standard 1.2.8?

Yes No

If NO, the particulars of the nutrient or biologically active substance MUST BE declared in the NIP, or if no label is required under subclause 2(1) of Standard 1.2.1, the NIP (with the particulars of the claimed nutrient or biologically active substance) should be displayed on or in connection with the display of the food or provided to the purchaser upon request. This requirement does not apply to food in small packages however certain information must be included on the label of the small package (clauses 8 and 8A of Standard 1.2.8).

13. If the general level health claim is based on 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, has the person responsible for making the claim notified the CEO of FSANZ of the details of that relationship?

Yes No

If NO, the claim does NOT comply with Standard 1.2.7.

14. Has a person giving notice in question 13 above to the CEO of FSANZ provided:

  • The name of the person giving the notice and the address in Australia or New Zealand of that person, and

Yes No

  • 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;

Yes No

  • Certification that the relationship that is the subject of the notice provided in question 13 above has been established by a process of systematic review that is described in Schedule 6.

Yes No

If NO to any of the above, the claim DOES NOT COMPLY with Standard 1.2.7.

15. Would the person giving notice in question 13 above to the CEO of the Authority, if requested by a relevant authority, be able to provide records to the relevant authority that demonstrate that:

  • The systematic review was conducted in accordance with the process of systematic review described in Schedule 6; and

Yes No

  • The notified relationship is a reasonable conclusion of the systematic review.

Yes No

Required elements of a systematic review

16. Do you intend to undertake a systematic review by reviewing the original (primary) literature or starting with an existing systematic review and updating it?

If undertaking a systematic review by reviewing the original (primary) literature, answer questions 17–24.

If starting with an existing systematic review and updating it answer questions 17–24 for the updated systematic review including any relevant scientific data not included in the existing systematic review.

17. Has a statement been made that describes the food or property of food, the health effect and the proposed relationship between the food or property of food and the health effect?

Yes No

If NO, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

18. Has a search strategy 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 the inclusion and exclusion criteria?

Yes No

If NO, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

19. Has a final list of studies, based on the inclusion and exclusion criteria, been provided to support the proposed relationship?

Yes No

If NO, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

20. If yes to question 19, are there studies among this list that involve studies in humans?

Yes No

If NO, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6. Studies in humans are essential.

21. Has a table with key information from each included study been provided? This table must include information on:

  • the study reference

Yes No

  • the study design

Yes No

  • the objectives

Yes No

  • the sample size in the study groups and loss to follow-up or non-response

Yes No

  • the participant characteristics

Yes No

  • method used to measure the food or property of food including amount consumed

Yes No

  • confounders measured

Yes No

  • the method used to measure the health effect

Yes No

  • the study results, including effect size and statistical significance

Yes No

  • any adverse effects.

Yes No

If NO to any of the above, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

22. Has an assessment of the quality of each included study been undertaken, based on consideration of, as a minimum:

  • a clearly stated hypothesis

Yes No

  • minimisation of bias

Yes No

  • adequate control for confounding

Yes No

  • the study participants’ background diets and other relevant lifestyle factors

Yes No

  • study duration and follow-up adequate to demonstrate the health effect

Yes No

  • the statistical power to test the hypothesis.

Yes No

If NO to any of the above, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

23. Has an assessment of the results of the included studies as a group been provided, that considers whether:

  • is a consistent association between the food or property of food and the health effect across all high quality studies.

Yes No

  • 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).

Yes No

  • the proposed relationship between the food or property of food and the health effect is biologically plausible.

Yes No

  • 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.

Yes No

If NO to any of the above, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.

24. Has a conclusion been provided based on the results of the studies that includes:

  1. 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.

Yes No

  1. 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

Yes No

(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.

Yes No

If NO to any of the above, the systematic review HAS NOT BEEN CONDUCTED in accordance with the process described in Schedule 6.