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Nutrition and Health Related Claims

September 2005

In December 2003, the Australia New Zealand Food Regulation Ministerial Council (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 covers all foods produced and imported into Australia and New Zealand.

Currently, nutrient content claims are allowed (eg.‘this food is high in fibre’) and some function maintenance claims (eg,calcium is good for healthy bones and teeth). However, there is a ban 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?

A claim means any statement, representation, information, design words or reference in relation to a food that is not mandatory in theFood Standards Code(Standard 1.1.1).

Types of Claims

The Claims Classification Framework identifies the categories of nutrition, health and related claims. A 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 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.

General level claims

General level claims are those which:

describe or indicate the presence or absence of a component in food
(Nutrient Content Claim).
For example
‘This food is high in calcium’.
refer to the maintenance of good health.
For example
‘helps keep you regular as part of a high fibre diet’.
describe a component and its function in the body.
For example
‘Calcium is good for strong bones and teeth’.
refer to specific benefits for performance and well-being in relation to foods.
For example
‘gives you energy’.
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.’
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 as part of a healthy diet may reduce your risk of stomach upsets’.

High level 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. Diets high in calcium may increase bone mineral density’.
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. Diets low in sodium may reduce risk of elevated blood pressure.’

Regulation of claims

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

Health_Claims_Regualtion_table

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 content claims, as the latter are simply a statement about content. A substantiation framework has been developed, outlining the set of principles that will apply to the substantiation of claims. Seven high level claims are undergoing review by external experts. If substantiated, claims about these will be allowed on food products, subject to certain conditions.

Key aspects of the requirements for substantiation of high level 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.
Qualifying criteria may be established in relation to the use of the claim to which all foods bearing that claim must comply.

General level claims will need to be substantiated, and the evidence held, by the manufacturers or suppliers. FSANZ will develop material to assist in determining whether their evidence is sufficient to substantiate a general level claim. Key aspects of the requirements for the substantiation of general level claims are:

Substantiation must be based on authoritative, current and generally accepted information, or on a structured review of the totality of evidence as for high level claims.
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.

The substantiation framework has been developed drawing on similar frameworks 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.

Progress on Health Claims

The first round of public consultation was conducted after the publication of the initial assessment report in September 2004. The second round of consultation will occur after the publication of the draft assessment report, expected to be in late 2005.

To inform those people who are interested in a briefing on the recommendations outlined in the draft Assessment Report on Proposal P293, a series of one-day briefing workshops are provisionally planned for late 2005. Stakeholders, including consumers, are welcome to register their interest in attending. The workshops will take place in several major cities in Australia and New Zealand.

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

For More information

Food Standards Australia New Zealand

Australia New Zealand

PO Box 7186 PO Box 10559

Canberra Business Centre The Terrace

ACT 2610 Australia Wellington 6036 New Zealand

Ph: +61 2 6271 2222 Ph: +64 4 978 5630

Fax: +61 2 6271 2278 Fax: +64 4 473 9855

Email: info@foodstandards.gov.au Email: info@foodstandards.govt.nz