Skip to main content
Food Standards Australia New Zealand Logo

Outcomes from consideration of European Union-authorised health claims

(July 2017)

In 2012, FSANZ considered 241 European Union (EU)-authorised health claims for inclusion as food-health relationships in Standard 1.2.7 – Nutrition, health and related claims.

In total, 183 food-health relationships from the EU were included in the Standard at gazettal. We committed to consider a further 32 health claims. The outcomes of our consideration are summarised in the table below. A full list of the 32 EU-authorised claims is in the Review Report for Standard 1.2.7.

EU Health Claim FSANZ Systematic review Date and outcome of systematic review

Include in the Australia New Zeala​nd Food Standards Code?

(Yes/No)

Food, component, ingredient, constituent or other feature of food Health effect Food or property of food Health effect
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 9 g, which is above which 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

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 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 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-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

It is anticipated that a proposal will be prepared to assess including this relationship in the Code.
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

FSANZ considers this claim is covered by the claim referring to the replacement of saturated fatty acids with polyunsaturated fatty acids.

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

FSANZ considers this claim is covered by the claim referring to the replacement of saturated fatty acids with polyunsaturated fatty acids.

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 are EU-authorised claims not being 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 such as in Europe. 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 as 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.

Two health claims about electrolyte drinks authorised in the EU are:

  • 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.

These two clams will be considered under a separate project given the connection of the claims to a current proposal on the FSANZ work plan (Proposal P1030 – Health Claims, Formulated Supplementary Sports Foods and Electrolyte Drinks​).​​​​

Print

Return to top