Nutrition, Health and Related Claims

In December 2003, the Australia New Zealand Food Regulation Ministerial Council agreed to a new Policy Guideline for the regulation of Nutrition, Health and Related Claims. This policy is guiding Food Standards Australia New Zealand (FSANZ) during the development of the standard that will become part of the Food Standards Code(the Code) . The Code covers all foods produced and imported into Australia and New Zealand.

Currently, nutrient content claims are allowed (e.g.‘This food is high in fibre’) and some function maintenance claims (e.g. ‘Calcium is good for healthy bones and teeth’). However, there is a prohibition on all health claims, other than the claim regarding the benefit of mothers consuming folate and reducing the risk of neural tube defects in unborn babies.

The new policy recommends an important change to the regulation of nutrition, health and related claims that will mean a wider range of claims will be allowed.

What is a claim?

As a consequence of the work being undertaken in the draft Standard 1.2.7 – Nutrition, Health and Related Claims, a revised definition of the term ‘claim’ has been proposed in Standard 1.1.1 – Preliminary Provisions – Application, Interpretation and General Prohibitions.  

If adopted, ‘Claim’ would mean any statement, representation, design or information in relation to a food or property of the food which is not mandatory in the Food Standards Code, and includes an implied claim’. 

Types of Claims

The Claims Classification Framework identifies the categories of nutrition, health and related claims. A nutrition content claim is a statement regarding the amount of a nutrient, energy or a biologically active substance in the food.   Health claims are claims that describe a relationship between the consumption of a food or constituent of a food and particular benefits of the food in relation to health.  Health claims are furthermore divided into high level health claims and general level health claims.  The categorisation of the claim is based on the extent to which the claim identifies particular benefit(s) for consumers in consuming that food.

Nutrition Content Claims

Nutrition content claims are those which:

•  describe or indicate the presence or absence of a component in food.   
   For example ‘This food is high in calcium’.

General level health claims

General level health claims are those which:

• describe a component and its function in the body.
  For example‘Calcium is good for strong bones and teeth, when consumed as part of a healthy diet containing a variety of foods’.
• refer to specific benefits for performance and well-being in relation to foods.  
  For example ‘gives you energy, when consumed as part of a healthy diet with a variety of foods’.
• describes how a diet, food or component can modify a function beyond its role in normal growth and development.
  For example ‘exercise and a diet high in calcium helps build stronger bones, when combined with a healthy diet containing a variety of foods.’
• refers to the potential for a food or component to assist in reducing the risk of or helping to control a non-serious disease or condition.  
  For example ‘Yoghurt high in X and Y may reduce your risk of stomach upset, when consumed as part of a healthy diet with a variety of foods’.

High level health claims

High level health claims reference a serious disease or condition, or a biomarker of a serious disease or condition. They include:

• claims that refer to the potential for a food or component to assist in controlling a serious disease or condition by either reducing risk factors or improving health.
  For example‘This food is high in calcium. Healthy diets high in calcium may increase bone mineral density, which has particular importance for women’.
• claims that refer to the potential for a food or component to assist in reducing the risk of a serious disease or condition.
  For example ‘This food is low in sodium. A healthy, varied diet including foods low in sodium may assist in reducing blood pressure.’

Regulation of claims

The level of a claim determines how the claim is regulated, including the evidence required for substantiation.  

 

Substantiation

All nutrition, health and related claims on food labels or in associated advertising supplied in New Zealand and Australia will be required to be substantiated by scientific evidence, to ensure claims are soundly based and do not mislead consumers. Verification of the health benefit is required for all nutrition and health related claims except nutrition content claims, as the latter are simply a statement about content.  A substantiation framework has been developed that outlines the set of principles that will apply to the substantiation of claims.   This framework has drawn on similar approaches developed in Canada and the United States. It has been reviewed and refined based on advice from the FSANZ Scientific Advisory Group established for this purpose.

Key aspects of the requirements for substantiation of high level health claims are:

• Human studies are required to substantiate claims and acceptable study types include well-designed experimental and observational studies. Caution needs to be exercised when the available evidence is drawn solely from observational studies, even those with established biological plausibility, in the absence of experimental human data.
• Evaluation of claims will be based on an assessment of the totality of the available evidence with consistent and convincing findings likely to be required across study types.
• Approval of a claim will also take into account the relevance and applicability of the evidence to Australians and New Zealanders.

Nutrition content claims qualifying criteria and Nutrient Profiling scoring criteria will be established in relation to the use of the claim to which all foods bearing that claim must comply.   Seven diet – disease relationships have undergone a review by external experts.   Of these, five have been substantiated and claims about these will be allowed on food products, subject to certain conditions.

The five diet-disease relationships that have been substantiated as reaching levels of evidence commensurate with requirements for a high level health claim are:

• Sodium (with or without potassium) AND hypertension
• Fruit and vegetables AND coronary heart disease
• Saturated fat and/or trans fat AND elevated serum cholesterol or heart disease
• Calcium (with or without Vitamin D) AND osteoporosis
• Folate AND neural tube defects

Two further diet-disease relationships were assessed but did not reach a sufficient level of evidence for high level health claims:

• Wholegrains AND coronary heart disease
• Omega-3 fatty acids AND cardiovascular disease

Key aspects of the requirements for the substantiation of general level health claims are that:

• They will need to be substantiated, and the evidence held, by the manufacturers or suppliers.
• There must be evidence to demonstrate that the food contains the ingredient, nutrient or other component that is the subject of the claim, in the quantities required to achieve the outcome indicated by the claim.

Manufacturers or suppliers can either:

• make use of the pre-approved authoritative statements in the FSANZ Model List;
• provide authoritative scientific texts, National dietary guidelines to substantiate a claim; or
• provide their own structured review of the totality of evidence as for high level health claims, where a ‘probable’ level of evidence must be demonstrated.

Progress on Health Claims

The first round of public consultation for the Initial Assessment Report for P293 - Nutrition, Health and Related Claims was held in 2004, and in 2005 the Draft Assessment Report was made available for public consultation. Submissions to the Draft Assessment Report highlighted a number of critical issues that required further consideration.  

In response, FSANZ prepared a third public consultation document, the Preliminary Final Assessment Report.   The consultation period for this Assessment Report closed on 16 May 2007.   FSANZ is reviewing stakeholder comments that were received and intends to conduct further targeted consultation on the few specific issues that remain.   It is anticipated the final recommendations on health claims will be ready for consideration by the Ministerial Council in May 2008.

For More information

Further information on the development of the standard for nutrition, health and related claims, Proposal P293 - Nutrition, Health & Related Claims visit our website www.foodstandards.gov.au or contact the Information Officer on 02 6271 2241 or email info@foodstandards.gov.au

Updated August 2007