Consideration of European Union-authorised health claims

Page last updated March 2023

When Standard 1.2.7 – Nutrition, health and related claims was gazetted in 2013, 183 food-health relationships from EU-authorised health claims were included in Schedule 4 of the Australia New Zealand Food Standards Code (the Code).

FSANZ looked at a further 32 EU-authorised health claims to establish whether food-health relationships from these could also be included in Standard 1.2.7. A summary of the outcomes of this work is in the table below. The full list of the 32 EU-authorised claims is in the Proposal P293 (Nutrition, Health and Related Claims) Review Report for Standard 1.2.7.

EU Health Claim		FSANZ Systematic review		Date and outcome of systematic review	Include in the Australia New Zealand Food Standards Code? (Yes/No)
Food, component, ingredient, constituent or other feature of food	Health effect	Food or property of food	Health effect	Date and outcome of systematic review
Potassium	Contributes to the maintenance of normal blood pressure	Potassium	Reduces blood pressure	Review completed: July 2014 Increased potassium intake reduces blood pressure in hypertensive adults ('High' degree of certainty) Increased potassium intake does not reduce blood pressure in normotensive adults ('Moderate' degree of certainty) Read the systematic review	No FSANZ considers a claim about the relationship would be therapeutic in nature. Claims that are therapeutic in nature are prohibited in Standard 1.2.7. Read about the decision
Meal replacement for weight control	Substituting one daily meal of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss	N/A	N/A	N/A	No Similar general level health claims about energy and weight loss or weight maintenance are already in Schedule 3 of Standard 1.2.7. Read about the decision
Meal replacement for weight control	Substituting two daily meals of an energy restricted diet with meal replacements contributes to weight loss	N/A	N/A	N/A
Walnuts	Contribute to the improvement of the elasticity of blood vessels	Walnuts	Contribute to the improvement of endothelium-dependent vasodilation (EDV)	Review completed: October 2014 Due to the small number, low quality and variable methods in the studies, the relationship cannot be reliably assessed. Read the systematic review	No Relationship cannot reliably be assessed.
Pectins	Contribute to the maintenance of normal blood cholesterol levels	Pectin	Reduces blood total cholesterol	Review completed: February 2015 In hypercholesterolaemic adults¹, increased pectin intake reduces blood total cholesterol ('Moderate' degree of certainty). In normocholesterolaemic adults², increased pectin intake has no effect on blood total cholesterol ('Low' degree of certainty). Note that the lowest daily additional intake of pectin tested in the studies included in the systematic review is 9g, which is above what could be obtained from a normal diet. Read the systematic review	No Based on the evidence obtained from high quality studies, it was not possible to establish the relationship to a high degree of certainty.
Docosahexanoic acid (DHA)	Contributes to the maintenance of normal brain function	Docosahexanoic acid (DHA)	Required to maintain normal brain function	Review completed October 2015 There were no studies examining the effects of dietary DHA deficiency, therefore the relationship cannot be assessed. Read the systematic review	No Relationship cannot be assessed
Docosahexanoic acid (DHA)	Contributes to the maintenance of normal vision	Docosahexanoic acid (DHA)	Required to maintain normal vision	Review completed October 2015 There were no studies examining the effects of dietary DHA deficiency, therefore the relationship cannot be assessed. Read the systematic review	No Relationship cannot be assessed
β-glucan from oats	Lowers/reduces blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Phytosterols/phytostanols and their esters	Lowers/reduces blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Plant sterols/plant stanol esters	Lowers/reduces blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Plant sterols: sterols extracted from plants, free or esterified with food grade fatty acids	Lowers/reduces blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Sugar-free chewing gum	Helps neutralise plaque acids. Plaque acids are a risk factor in the development of dental caries.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Sugar-free chewing gum	Helps reduce tooth demineralisation. Tooth demineralisation is a risk factor in the development of dental caries.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
Chewing gum sweetened with 100% xylitol	Reduces dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children.	N/A	N/A	N/A	No The construct of the claim does not fit explicitly within the current health claims framework. Read about the decision
α-linolenic acid (ALA) and linoleic acid (LA), essential fatty acids	Needed for normal growth and development of children	α-linolenic acid (ALA) and linoleic acid (LA) consumed together	Normal growth and development in children	Review completed: April 2016 There were no appropriate human studies that allowed the relationship to be assessed. Read the systematic review	No Relationship cannot be assessed.
Chromium	Contributes to the maintenance of normal blood glucose levels	Chromium	Reduces fasting blood glucose concentration in people with chromium deficiency	Review completed: March 2016 The relationship could not be assessed due to multiple uncontrolled confounders in the included studies. Read the systematic review	No Relationship cannot be assessed.
Chromium		Chromium	Reduces fasting blood glucose concentration in normoglycaemic people or people with impaired glucose tolerance consuming a wide range of foods	Review completed: March 2016 There was a 'moderate' degree of certainty for no relationship between chromium intake and blood glucose concentration in both normoglycaemic people and people with impaired glucose tolerance. Read the systematic review	No There was no effect of chromium on blood glucose concentration.
β-glucan from oats or barley as part of a meal	Contributes to the reduction of blood glucose rise after a meal	β-glucan from oats	Reduces peak postprandial blood glucose concentration	Review completed: April 2016 There is a ‘very low’ degree of certainty in the relationship between the intake of beta glucan from oats and the reduction in peak postprandial blood glucose concentration. Read the systematic review	No It was not possible to establish the relationship to a ‘high’ degree of certainty.
β-glucan from oats or barley as part of a meal		β-glucan from barley	Reduces peak postprandial blood glucose concentration	Review completed: April 2016 The relationship cannot be assessed due to the lack of studies enabling the health effect to be attributed to beta glucan. Read the systematic review	No Relationship cannot be assessed.
Pectins	Contribute to the reduction of blood glucose rise after a meal	Pectin	Reduces peak postprandial blood glucose concentration	Review completed: November 2016 At an intake of 1.4 – 5.2 g pectin in a meal there was no effect on peak postprandial blood glucose concentration. There was a 'very low' degree of certainty in this relationship. At an intake of 10 – 14.5 g pectin in a meal the degree of certainty in the relationship was 'very low'. Read the systematic review	No It was not possible to establish the relationship to a 'high' degree of certainty.
Arabinoxylan	Contributes to a reduction of blood glucose rise after a meal	Pure arabinoxylan	Reduces peak postprandial blood glucose concentration	Review completed: November 2016 The relationship cannot be assessed due to the lack of studies examining the effect of pure arabinoxylan. Read the systematic review	No Relationship cannot be assessed.
Arabinoxylan		Arabinoxylan-rich fibre	Reduces peak postprandial blood glucose concentration	Review completed: November 2016 There was a 'moderate' degree of certainty in the relationship. Read the systematic review	No It was not possible to establish the relationship to a 'high' degree of certainty.
Replacing saturated fats with unsaturated fats in the diet	Contributes to the maintenance of normal blood cholesterol levels [MUFA and PUFA are unsaturated fatty acids]	Replacement of saturated fatty acids with polyunsaturated and/or monounsaturated fatty acids	Decreases blood total cholesterol and LDL cholesterol concentrations	Review completed: July 2016 There was a 'high' degree of certainty in the relationship. Read the systematic review	No Read about the decision
α-linolenic acid	Contributes to the maintenance of normal blood cholesterol levels	Increased intake of alpha-linolenic acid	Decreases blood total cholesterol and LDL cholesterol concentrations	Review completed: July 2016 There was a ‘high’ degree of certainty in the relationship. Read the systematic review	No Read about the decision
Linoleic acid	Contributes to the maintenance of normal blood cholesterol levels	Increased intake of linoleic acid	Decreases blood total cholesterol and LDL cholesterol concentrations	Review completed: July 2016 There was a 'high' degree of certainty in the relationship. Read the systematic review	No Read about the decision
Replacing digestible starches with resistant starch in a meal	Contributes to a reduction in the blood glucose rise after that meal	Replacing digestible starch with resistant starch in a food	Reduces peak postprandial blood glucose concentration	Review completed: December 2017 There was a 'high' degree of certainty in the relationship. Read the systematic review	No Read about the decision
		Addition of resistant starch in a food	Reduces peak postprandial blood glucose concentration	Review completed: December 2017 There was a ‘moderate’ degree of certainty that a relationship does not exist. Read the systematic review	No It was not possible to establish the relationship to a 'high' degree of certainty. Read about the decision

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 < 5.5 mmol/l

Why were some EU-authorised claims not included in the Code?

Our work has highlighted differences between the health claims frameworks applying in Australia/New Zealand and those used by overseas agencies. For example, a key difference between the processes used by FSANZ and the European Food Safety Authority (EFSA) is that FSANZ requires a systematic review of the available evidence, whereas EFSA makes an assessment based on an evidence dossier submitted by the petitioner.

Other differences between EFSA and FSANZ are:

the definition of food in the EU includes substances which are not considered to be food in Australia and New Zealand and so are not captured under Standard 1.2.7.
EFSA considers claims under the classification type under which they are submitted (e.g. general function claims, disease risk reduction claims), even if a different classification might be possible.
EFSA does not permit disease risk reduction claims to directly refer to the risk of disease, whereas Standard 1.2.7 does permit the direct link between a food or property of food and risk of disease, provided the food-health relationship is substantiated and meets other requirements in the Standard.
the Australia/New Zealand policy framework differs from that in Europe and FSANZ must have regard to the Australia and New Zealand Ministerial Forum on Food Regulation Policy Guideline on Nutrition, Health and Related Claims when it considers claims.

These differences can result in different outcomes.

Based on the knowledge and experience gained from our work on the claims in the table above and other specific issues (e.g. similar claims or concepts covered by existing permitted claims, definitional issues or potential for consumer confusion), FSANZ has decided not to include the following EU-authorised health claims in Standard 1.2.7:

Replacing saturated fats in the diet with unsaturated fats contributes to the maintenance of normal blood cholesterol levels. Oleic acid is an unsaturated fat.
Olive oil polyphenols contribute to the protection of blood lipids from oxidative stress.
Consumption of foods/drinks containing <name of sugar replacer> instead of sugar induces a lower blood glucose rise after their consumption compared to sugar-containing foods/drinks.
Consumption of foods/drinks containing <name of sugar replacer> instead of sugar contributes to the maintenance of tooth mineralization.
Water contributes to the maintenance of normal physical and cognitive functions.
Water contributes to the maintenance of normal regulation of the body's temperature.
Meat or fish contributes to the improvement of iron absorption when eaten with other foods containing iron.

The following two EU-authorised health claims about electrolyte drinks were considered under Proposal P1030 – Composition and Labelling of Electrolyte Drinks:

Carbohydrate electrolyte solutions contribute to the maintenance of endurance performance during prolonged endurance exercise
Carbohydrate electrolyte solutions enhance the absorption of water during physical exercise.

As a result, three health claims for electrolyte drinks have been included in Standard 2.6.2 (gazetted 12 August 2022).

Keeping up with international developments

At the time Standard 1.2.7 was gazetted, our plan was to continue monitoring the approval of new health claims in the EU, as well as in the USA and Canada, and consider adopting any that were relevant into the Standard. FSANZ continues to monitor developments through regular contact and meetings with regulatory counterparts overseas.

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