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Reviews of food-health relationships for high level health claims

Standard 1.2.7 - Nutrition, health and related claims includes requirements for making high level health claims. High level health claims must be based on a food-health relationship pre-approved by FSANZ. These relationships are listed in Schedule 4 of the Australia New Zealand Food Standards Code (the Code).

New food-health relationships for high level health claims can only be included in Schedule 4 following assessment of an application or proposal to change the Code. This assessment includes a systematic review of the evidence supporting the food-health relationship, in accordance with the high level health claims variation procedure in the FSANZ Act 1991.

Reviews of existing high level health claims in Schedule 4

FSANZ has updated reviews for five existing high level health claims. Details are given in the table below

The Health Claims Scientific Advisory Group provided scientific and technical advice about the reviews to FSANZ.

Health Claim - Food, component, ingredient, constituent or other feature of food Health Claim - Health effect Date and outcome of systematic review FSANZ decision on maintaining the claim
Sodium or salt Reduces blood pressure

Review completed: August 2014

Reduced sodium or salt intake reduces blood pressure in normotensive and hypertensive adults ('High' degree of certainty for each group).

Read the systematic review

Food-health relationship is current. Refer to section S4 - 4 of the Code for conditions.
Phytosterols, phytostanols and their esters Reduces blood cholesterol

Review completed: September 2014

Intake of phytosterols, phytostanols and their esters reduces blood total cholesterol and LDL cholesterol in normocholesterolaemic adults1 and hypercholesterolaemic adults2

Read the systematic review

Food-health relationship is current. Refer to section S4 - 4 of the Code for conditions.
Saturated fatty acids Reduces total blood cholesterol or blood LDL cholesterol

Review completed: July 2016

There was a 'high' degree of certainty in the relationship.

Read the systematic review

Food-health relationship is current. Refer to section  S4 - 4 of the Code for conditions.
Saturated and trans fatty acids Reduces total blood cholesterol or blood LDL cholesterol

Saturated fatty acid component:  

Review completed: July 2016

There was a 'high' degree of certainty in the relationship.

Read the systematic review

Trans fatty acid component:

Review completed: July 2014

Additional commentary completed: August 2015

There was a 'high' degree of certainty in the relationship.

Read the systematic review and the additional commentary

Food-health relationship is current. Refer to section  S4 - 4 of the Code for conditions.
Beta-glucan Reduces blood cholesterol

Review completed: August 2015

Dietary intake of beta-glucan from oats or barley reduces blood cholesterol concentration (not assessable).

Dietary intake of wholegrain oats or oat bran reduces blood total and LDL cholesterol concentrations ('High' degree of certainty).

Dietary intake of wholegrain barley reduces blood total and LDL cholesterol concentrations ('moderate' degree of certainty).

Read the systematic review

Read an update

 

1 'hypercholesterolaemic adults' refers to adults with blood total cholesterol levels ≥ 5.5 mmol/L 
2 'normocholesterolaemic adults' refers to adults with blood total cholesterol levels

FSANZ is not currently reviewing the scientific currency of the existing pre-approved high level health claims, but remains up to date on the latest developments through regular contact and meetings with regulatory counterparts overseas. 

Earlier reviews of food-health relationships for high level health claims

There are currently 13 pre-approved food-health relationships for high level health claims listed in Schedule 4.  

These were based on a series of commissioned reviews carried out in 2004-05 and considered by the former Scientific Advisory Group, or on subsequent scientific evaluations. Copies of the reviews considered by the former Scientific Advisory Group are available below, including two (#6 and #7 below) that were assessed as not being established. 

Food-health relationship Review report
1. Sodium (with or without potassium) AND hypertension The relationship between dietary sodium intake, alone or in combination with potassium intake, and risk of hypertension in adults
Download as a PDF (181kb)

2. Fruit & vegetables AND coronary heart disease

Dietary fruit and vegetable intake and risk of coronary heart disease
Download as a PDF (689kb)
3. Saturated fat and/or trans fat AND elevated serum cholesterol or heart disease The relationship between saturated and trans unsaturated fatty acids and LDL-cholesterol and coronary heart disease.
Download as a PDF (912kb)
4. Calcium (with or without Vitamin D) AND osteoporosis The relationship between dietary calcium intake, alone or in association with Vitamin D status, and risk of developing osteoporosis
Download as a PDF (318kb)
5. Folic acid AND neural tube defects The relationship between dietary folate intake of women of childbearing age and risk of neural tube defects
Download as a PDF (287kb)
6. Wholegrains AND coronary heart disease Relationship between wholegrain intake and risk of coronary heart disease
Download as a PDF (383kb)
Download the FSANZ consideration of review PDF (114kb)
7. Omega-3 fatty acids AND cardiovascular disease The relationship between omega -3 fatty acid intake and risk of cardiovascular disease
Download as a PDF (563kb)
Download the FSANZ consideration of review PDF (79kb)

More information 

Page last updated 11 April 2024